Susan London

DENVER – The majority of patients with chronic obstructive pulmonary disease who acquire a rhinovirus infection develop a secondary bacterial infection shortly thereafter, suggesting that early antiviral therapy might do double duty.

In a study reported at the International Conference of the American Thoracic Society, 60% of patients with COPD who were experimentally infected with rhinovirus and who gave serial sputum samples developed a bacterial infection as well, approximately a week later. This rate was six times higher than the rates seen among smokers with normal lung function and among nonsmokers.

Temporal patterns of pathogen loads and molecular markers suggested that the virus may incite inflammation that, in turn, results in degradation of key defense peptides in the airways, leaving patients vulnerable to bacteria.

The findings raise the possibility that "dual infection is a lot more common than has been reported in [previous] studies," said lead investigator Dr. Patrick Mallia, a U.K. National Institute for Health Research clinical lecturer at the Imperial College London.

"In terms of therapeutics, this may suggest that antiviral drugs may not only be effective against virus-induced exacerbations, but also potentially could prevent or reduce secondary bacterial infection," he commented.

At his institution, COPD patients with an exacerbation are not routinely tested for viruses. But that may change, given the advent of rapid PCR (polymerase chain reaction) assays for detecting viruses and, possibly, expansion of the indications for antiviral agents.

"So although at the moment [testing for viruses] is very much a research exercise, I think the possibility of using antiviral treatment in the future is not that far away," he said.

Interest in the role of viruses and of dual viral-bacterial infection in COPD exacerbations has intensified recently, according to Dr. Mallia. As both types of infections are common in this population, one might expect that dual infection is common as well; yet, on average, studies have found dual infection in only 13% of exacerbations.

"This tends to suggest that actually it’s not so common, but I think there are a number of reasons why these studies may have underestimated the rate of dual infection," he said, such as their cross-sectional or retrospective nature, and one-time testing for pathogens.

"Studies using a single sampling time point during exacerbation will probably underestimate the true prevalence of coinfection, and also can’t tell us what the sequence of infection is," he explained.

To get around these issues, the investigators used their newly developed model of experimental rhinovirus-induced COPD exacerbation. "These patients catch a cold, get lower respiratory symptoms, and get an exacerbation with increased airflow obstruction and airway inflammation," he said.

The study included 30 patients with GOLD (Global Initiative for Chronic Obstructive Lung Disease) stage II COPD who were using only short-acting bronchodilators, 28 smokers with normal lung function, and 18 nonsmokers.

They were experimentally inoculated with rhinovirus, the virus most commonly detected in COPD exacerbations. Induced sputum was collected before inoculation and at 5, 9, 12, 15, 21, and 42 days afterward.

None of the participants received treatment for infections because their symptoms did not become severe enough to meet preestablished study criteria for treatment initiation, according to Dr. Mallia.

The load of rhinovirus in sputum was assessed with PCR. The load of bacteria that were classified as potentially pathogenic microorganisms (PPMs) was assessed with semiquantitative bacterial culture.

Study results showed that 20 of the COPD patients, 21 of the smokers, and 11 of the nonsmokers developed rhinovirus infection after inoculation.

Fully 60% of the rhinovirus-infected COPD patients developed secondary bacterial infections (mainly with Haemophilus influenzae and Streptococcus pneumoniae), compared with just 9.5% of the smokers and 10% of the nonsmokers (P less than .001).

Within the COPD group, bacterial infections were significantly more common among the patients who acquired rhinovirus infection than among those who did not. "This suggests that the bacterial infections we were detecting were a consequence of the rhinovirus infections," Dr. Mallia commented.

Both viral and bacterial loads rose and fell over time, but the former infection preceded the latter: The viral load peaked on day 9, whereas the bacterial load peaked almost a week later, on day 15. These are "really the first data that [show] a temporal sequence, that first you get the rhinovirus infection, and then you get the bacterial infection following this," he noted.

Moreover, "you can see immediately that if you take a single sample and you sample early, you may pick up a virus and call it a viral exacerbation, but not pick up the subsequent bacterial infection," he added. "Whereas if the patient happens to present later, you might detect the bacterial infection but not detect ... the virus infection that actually initiated it."

To assess potential mechanisms whereby rhinovirus might induce bacterial infections, the investigators measured sputum levels of two antimicrobial peptides found in the airways that are part of the lung’s innate defenses against infection: secretory leukocyte protease inhibitor (SLPI) and elafin.

Levels of both peptides fell in rhinovirus-infected COPD patients who developed bacterial infection before or at the time when bacterial load peaked. In contrast, levels remained the same or rose slightly in those who did not develop bacterial infection. Furthermore, lower levels of the peptides were correlated with higher bacterial loads.

"This would suggest that bacterial infection is a consequence of low SLPI and elafin levels in the airways," Dr. Mallia commented.

Finally, sputum levels of neutrophil elastase (an enzyme that could degrade the protective peptides) rose in rhinovirus-infected COPD patients who developed bacterial infection but remained essentially at baseline levels in their counterparts who did not.

"We hypothesize that possibly you have a sequence of events – viral infection, high neutrophil elastase levels, and degradation of SLPI and elafin – and that may progress to secondary bacterial infection," he said.

The study gives rise to several potential, related avenues of research, according to Dr. Mallia.

"Certainly, one of the things we are interested in is, Are there markers that can identify those people who are going to go on to develop bacterial infections?" he said. And some evidence suggests that in addition to having antibacterial activity, macrolide antibiotics also have antirhinovirus activity, which the investigators plan to test using their model.

Dr. Mallia reported previously having received research grants from Pfizer and GlaxoSmithKline, and currently receiving a travel grant from Boehringer Ingelheim. The study was funded in part by Pfizer and GlaxoSmithKline.

DENVER – The majority of patients with chronic obstructive pulmonary disease who acquire a rhinovirus infection develop a secondary bacterial infection shortly thereafter, suggesting that early antiviral therapy might do double duty.

In a study reported at the International Conference of the American Thoracic Society, 60% of patients with COPD who were experimentally infected with rhinovirus and who gave serial sputum samples developed a bacterial infection as well, approximately a week later. This rate was six times higher than the rates seen among smokers with normal lung function and among nonsmokers.

Temporal patterns of pathogen loads and molecular markers suggested that the virus may incite inflammation that, in turn, results in degradation of key defense peptides in the airways, leaving patients vulnerable to bacteria.

The findings raise the possibility that "dual infection is a lot more common than has been reported in [previous] studies," said lead investigator Dr. Patrick Mallia, a U.K. National Institute for Health Research clinical lecturer at the Imperial College London.

"In terms of therapeutics, this may suggest that antiviral drugs may not only be effective against virus-induced exacerbations, but also potentially could prevent or reduce secondary bacterial infection," he commented.

At his institution, COPD patients with an exacerbation are not routinely tested for viruses. But that may change, given the advent of rapid PCR (polymerase chain reaction) assays for detecting viruses and, possibly, expansion of the indications for antiviral agents.

"So although at the moment [testing for viruses] is very much a research exercise, I think the possibility of using antiviral treatment in the future is not that far away," he said.

Interest in the role of viruses and of dual viral-bacterial infection in COPD exacerbations has intensified recently, according to Dr. Mallia. As both types of infections are common in this population, one might expect that dual infection is common as well; yet, on average, studies have found dual infection in only 13% of exacerbations.

"This tends to suggest that actually it’s not so common, but I think there are a number of reasons why these studies may have underestimated the rate of dual infection," he said, such as their cross-sectional or retrospective nature, and one-time testing for pathogens.

"Studies using a single sampling time point during exacerbation will probably underestimate the true prevalence of coinfection, and also can’t tell us what the sequence of infection is," he explained.

To get around these issues, the investigators used their newly developed model of experimental rhinovirus-induced COPD exacerbation. "These patients catch a cold, get lower respiratory symptoms, and get an exacerbation with increased airflow obstruction and airway inflammation," he said.

The study included 30 patients with GOLD (Global Initiative for Chronic Obstructive Lung Disease) stage II COPD who were using only short-acting bronchodilators, 28 smokers with normal lung function, and 18 nonsmokers.

They were experimentally inoculated with rhinovirus, the virus most commonly detected in COPD exacerbations. Induced sputum was collected before inoculation and at 5, 9, 12, 15, 21, and 42 days afterward.

None of the participants received treatment for infections because their symptoms did not become severe enough to meet preestablished study criteria for treatment initiation, according to Dr. Mallia.

The load of rhinovirus in sputum was assessed with PCR. The load of bacteria that were classified as potentially pathogenic microorganisms (PPMs) was assessed with semiquantitative bacterial culture.

Study results showed that 20 of the COPD patients, 21 of the smokers, and 11 of the nonsmokers developed rhinovirus infection after inoculation.

Fully 60% of the rhinovirus-infected COPD patients developed secondary bacterial infections (mainly with Haemophilus influenzae and Streptococcus pneumoniae), compared with just 9.5% of the smokers and 10% of the nonsmokers (P less than .001).

Within the COPD group, bacterial infections were significantly more common among the patients who acquired rhinovirus infection than among those who did not. "This suggests that the bacterial infections we were detecting were a consequence of the rhinovirus infections," Dr. Mallia commented.

Both viral and bacterial loads rose and fell over time, but the former infection preceded the latter: The viral load peaked on day 9, whereas the bacterial load peaked almost a week later, on day 15. These are "really the first data that [show] a temporal sequence, that first you get the rhinovirus infection, and then you get the bacterial infection following this," he noted.

Moreover, "you can see immediately that if you take a single sample and you sample early, you may pick up a virus and call it a viral exacerbation, but not pick up the subsequent bacterial infection," he added. "Whereas if the patient happens to present later, you might detect the bacterial infection but not detect ... the virus infection that actually initiated it."

To assess potential mechanisms whereby rhinovirus might induce bacterial infections, the investigators measured sputum levels of two antimicrobial peptides found in the airways that are part of the lung’s innate defenses against infection: secretory leukocyte protease inhibitor (SLPI) and elafin.

Levels of both peptides fell in rhinovirus-infected COPD patients who developed bacterial infection before or at the time when bacterial load peaked. In contrast, levels remained the same or rose slightly in those who did not develop bacterial infection. Furthermore, lower levels of the peptides were correlated with higher bacterial loads.

"This would suggest that bacterial infection is a consequence of low SLPI and elafin levels in the airways," Dr. Mallia commented.

Finally, sputum levels of neutrophil elastase (an enzyme that could degrade the protective peptides) rose in rhinovirus-infected COPD patients who developed bacterial infection but remained essentially at baseline levels in their counterparts who did not.

"We hypothesize that possibly you have a sequence of events – viral infection, high neutrophil elastase levels, and degradation of SLPI and elafin – and that may progress to secondary bacterial infection," he said.

The study gives rise to several potential, related avenues of research, according to Dr. Mallia.

"Certainly, one of the things we are interested in is, Are there markers that can identify those people who are going to go on to develop bacterial infections?" he said. And some evidence suggests that in addition to having antibacterial activity, macrolide antibiotics also have antirhinovirus activity, which the investigators plan to test using their model.

Dr. Mallia reported previously having received research grants from Pfizer and GlaxoSmithKline, and currently receiving a travel grant from Boehringer Ingelheim. The study was funded in part by Pfizer and GlaxoSmithKline.

DENVER – The majority of patients with chronic obstructive pulmonary disease who acquire a rhinovirus infection develop a secondary bacterial infection shortly thereafter, suggesting that early antiviral therapy might do double duty.

In a study reported at the International Conference of the American Thoracic Society, 60% of patients with COPD who were experimentally infected with rhinovirus and who gave serial sputum samples developed a bacterial infection as well, approximately a week later. This rate was six times higher than the rates seen among smokers with normal lung function and among nonsmokers.

Temporal patterns of pathogen loads and molecular markers suggested that the virus may incite inflammation that, in turn, results in degradation of key defense peptides in the airways, leaving patients vulnerable to bacteria.

The findings raise the possibility that "dual infection is a lot more common than has been reported in [previous] studies," said lead investigator Dr. Patrick Mallia, a U.K. National Institute for Health Research clinical lecturer at the Imperial College London.

"In terms of therapeutics, this may suggest that antiviral drugs may not only be effective against virus-induced exacerbations, but also potentially could prevent or reduce secondary bacterial infection," he commented.

At his institution, COPD patients with an exacerbation are not routinely tested for viruses. But that may change, given the advent of rapid PCR (polymerase chain reaction) assays for detecting viruses and, possibly, expansion of the indications for antiviral agents.

"So although at the moment [testing for viruses] is very much a research exercise, I think the possibility of using antiviral treatment in the future is not that far away," he said.

Interest in the role of viruses and of dual viral-bacterial infection in COPD exacerbations has intensified recently, according to Dr. Mallia. As both types of infections are common in this population, one might expect that dual infection is common as well; yet, on average, studies have found dual infection in only 13% of exacerbations.

"This tends to suggest that actually it’s not so common, but I think there are a number of reasons why these studies may have underestimated the rate of dual infection," he said, such as their cross-sectional or retrospective nature, and one-time testing for pathogens.

"Studies using a single sampling time point during exacerbation will probably underestimate the true prevalence of coinfection, and also can’t tell us what the sequence of infection is," he explained.

To get around these issues, the investigators used their newly developed model of experimental rhinovirus-induced COPD exacerbation. "These patients catch a cold, get lower respiratory symptoms, and get an exacerbation with increased airflow obstruction and airway inflammation," he said.

The study included 30 patients with GOLD (Global Initiative for Chronic Obstructive Lung Disease) stage II COPD who were using only short-acting bronchodilators, 28 smokers with normal lung function, and 18 nonsmokers.

They were experimentally inoculated with rhinovirus, the virus most commonly detected in COPD exacerbations. Induced sputum was collected before inoculation and at 5, 9, 12, 15, 21, and 42 days afterward.

None of the participants received treatment for infections because their symptoms did not become severe enough to meet preestablished study criteria for treatment initiation, according to Dr. Mallia.

The load of rhinovirus in sputum was assessed with PCR. The load of bacteria that were classified as potentially pathogenic microorganisms (PPMs) was assessed with semiquantitative bacterial culture.

Study results showed that 20 of the COPD patients, 21 of the smokers, and 11 of the nonsmokers developed rhinovirus infection after inoculation.

Fully 60% of the rhinovirus-infected COPD patients developed secondary bacterial infections (mainly with Haemophilus influenzae and Streptococcus pneumoniae), compared with just 9.5% of the smokers and 10% of the nonsmokers (P less than .001).

Within the COPD group, bacterial infections were significantly more common among the patients who acquired rhinovirus infection than among those who did not. "This suggests that the bacterial infections we were detecting were a consequence of the rhinovirus infections," Dr. Mallia commented.

Both viral and bacterial loads rose and fell over time, but the former infection preceded the latter: The viral load peaked on day 9, whereas the bacterial load peaked almost a week later, on day 15. These are "really the first data that [show] a temporal sequence, that first you get the rhinovirus infection, and then you get the bacterial infection following this," he noted.

Moreover, "you can see immediately that if you take a single sample and you sample early, you may pick up a virus and call it a viral exacerbation, but not pick up the subsequent bacterial infection," he added. "Whereas if the patient happens to present later, you might detect the bacterial infection but not detect ... the virus infection that actually initiated it."

To assess potential mechanisms whereby rhinovirus might induce bacterial infections, the investigators measured sputum levels of two antimicrobial peptides found in the airways that are part of the lung’s innate defenses against infection: secretory leukocyte protease inhibitor (SLPI) and elafin.

Levels of both peptides fell in rhinovirus-infected COPD patients who developed bacterial infection before or at the time when bacterial load peaked. In contrast, levels remained the same or rose slightly in those who did not develop bacterial infection. Furthermore, lower levels of the peptides were correlated with higher bacterial loads.

"This would suggest that bacterial infection is a consequence of low SLPI and elafin levels in the airways," Dr. Mallia commented.

Finally, sputum levels of neutrophil elastase (an enzyme that could degrade the protective peptides) rose in rhinovirus-infected COPD patients who developed bacterial infection but remained essentially at baseline levels in their counterparts who did not.

"We hypothesize that possibly you have a sequence of events – viral infection, high neutrophil elastase levels, and degradation of SLPI and elafin – and that may progress to secondary bacterial infection," he said.

The study gives rise to several potential, related avenues of research, according to Dr. Mallia.

"Certainly, one of the things we are interested in is, Are there markers that can identify those people who are going to go on to develop bacterial infections?" he said. And some evidence suggests that in addition to having antibacterial activity, macrolide antibiotics also have antirhinovirus activity, which the investigators plan to test using their model.

Dr. Mallia reported previously having received research grants from Pfizer and GlaxoSmithKline, and currently receiving a travel grant from Boehringer Ingelheim. The study was funded in part by Pfizer and GlaxoSmithKline.

DENVER – The majority of patients with chronic obstructive pulmonary disease who acquire a rhinovirus infection develop a secondary bacterial infection shortly thereafter, suggesting that early antiviral therapy might do double duty.

In a study reported at the International Conference of the American Thoracic Society, 60% of patients with COPD who were experimentally infected with rhinovirus and who gave serial sputum samples developed a bacterial infection as well, approximately a week later. This rate was six times higher than the rates seen among smokers with normal lung function and among nonsmokers.

Temporal patterns of pathogen loads and molecular markers suggested that the virus may incite inflammation that, in turn, results in degradation of key defense peptides in the airways, leaving patients vulnerable to bacteria.

The findings raise the possibility that "dual infection is a lot more common than has been reported in [previous] studies," said lead investigator Dr. Patrick Mallia, a U.K. National Institute for Health Research clinical lecturer at the Imperial College London.

"In terms of therapeutics, this may suggest that antiviral drugs may not only be effective against virus-induced exacerbations, but also potentially could prevent or reduce secondary bacterial infection," he commented.

At his institution, COPD patients with an exacerbation are not routinely tested for viruses. But that may change, given the advent of rapid PCR (polymerase chain reaction) assays for detecting viruses and, possibly, expansion of the indications for antiviral agents.

"So although at the moment [testing for viruses] is very much a research exercise, I think the possibility of using antiviral treatment in the future is not that far away," he said.

Interest in the role of viruses and of dual viral-bacterial infection in COPD exacerbations has intensified recently, according to Dr. Mallia. As both types of infections are common in this population, one might expect that dual infection is common as well; yet, on average, studies have found dual infection in only 13% of exacerbations.

"This tends to suggest that actually it’s not so common, but I think there are a number of reasons why these studies may have underestimated the rate of dual infection," he said, such as their cross-sectional or retrospective nature, and one-time testing for pathogens.

"Studies using a single sampling time point during exacerbation will probably underestimate the true prevalence of coinfection, and also can’t tell us what the sequence of infection is," he explained.

To get around these issues, the investigators used their newly developed model of experimental rhinovirus-induced COPD exacerbation. "These patients catch a cold, get lower respiratory symptoms, and get an exacerbation with increased airflow obstruction and airway inflammation," he said.

The study included 30 patients with GOLD (Global Initiative for Chronic Obstructive Lung Disease) stage II COPD who were using only short-acting bronchodilators, 28 smokers with normal lung function, and 18 nonsmokers.

They were experimentally inoculated with rhinovirus, the virus most commonly detected in COPD exacerbations. Induced sputum was collected before inoculation and at 5, 9, 12, 15, 21, and 42 days afterward.

None of the participants received treatment for infections because their symptoms did not become severe enough to meet preestablished study criteria for treatment initiation, according to Dr. Mallia.

The load of rhinovirus in sputum was assessed with PCR. The load of bacteria that were classified as potentially pathogenic microorganisms (PPMs) was assessed with semiquantitative bacterial culture.

Study results showed that 20 of the COPD patients, 21 of the smokers, and 11 of the nonsmokers developed rhinovirus infection after inoculation.

Fully 60% of the rhinovirus-infected COPD patients developed secondary bacterial infections (mainly with Haemophilus influenzae and Streptococcus pneumoniae), compared with just 9.5% of the smokers and 10% of the nonsmokers (P less than .001).

Within the COPD group, bacterial infections were significantly more common among the patients who acquired rhinovirus infection than among those who did not. "This suggests that the bacterial infections we were detecting were a consequence of the rhinovirus infections," Dr. Mallia commented.

Both viral and bacterial loads rose and fell over time, but the former infection preceded the latter: The viral load peaked on day 9, whereas the bacterial load peaked almost a week later, on day 15. These are "really the first data that [show] a temporal sequence, that first you get the rhinovirus infection, and then you get the bacterial infection following this," he noted.

Moreover, "you can see immediately that if you take a single sample and you sample early, you may pick up a virus and call it a viral exacerbation, but not pick up the subsequent bacterial infection," he added. "Whereas if the patient happens to present later, you might detect the bacterial infection but not detect ... the virus infection that actually initiated it."

To assess potential mechanisms whereby rhinovirus might induce bacterial infections, the investigators measured sputum levels of two antimicrobial peptides found in the airways that are part of the lung’s innate defenses against infection: secretory leukocyte protease inhibitor (SLPI) and elafin.

Levels of both peptides fell in rhinovirus-infected COPD patients who developed bacterial infection before or at the time when bacterial load peaked. In contrast, levels remained the same or rose slightly in those who did not develop bacterial infection. Furthermore, lower levels of the peptides were correlated with higher bacterial loads.

"This would suggest that bacterial infection is a consequence of low SLPI and elafin levels in the airways," Dr. Mallia commented.

Finally, sputum levels of neutrophil elastase (an enzyme that could degrade the protective peptides) rose in rhinovirus-infected COPD patients who developed bacterial infection but remained essentially at baseline levels in their counterparts who did not.

"We hypothesize that possibly you have a sequence of events – viral infection, high neutrophil elastase levels, and degradation of SLPI and elafin – and that may progress to secondary bacterial infection," he said.

The study gives rise to several potential, related avenues of research, according to Dr. Mallia.

"Certainly, one of the things we are interested in is, Are there markers that can identify those people who are going to go on to develop bacterial infections?" he said. And some evidence suggests that in addition to having antibacterial activity, macrolide antibiotics also have antirhinovirus activity, which the investigators plan to test using their model.

Dr. Mallia reported previously having received research grants from Pfizer and GlaxoSmithKline, and currently receiving a travel grant from Boehringer Ingelheim. The study was funded in part by Pfizer and GlaxoSmithKline.

DENVER – The majority of patients with chronic obstructive pulmonary disease who acquire a rhinovirus infection develop a secondary bacterial infection shortly thereafter, suggesting that early antiviral therapy might do double duty.

In a study reported at the International Conference of the American Thoracic Society, 60% of patients with COPD who were experimentally infected with rhinovirus and who gave serial sputum samples developed a bacterial infection as well, approximately a week later. This rate was six times higher than the rates seen among smokers with normal lung function and among nonsmokers.

Temporal patterns of pathogen loads and molecular markers suggested that the virus may incite inflammation that, in turn, results in degradation of key defense peptides in the airways, leaving patients vulnerable to bacteria.

The findings raise the possibility that "dual infection is a lot more common than has been reported in [previous] studies," said lead investigator Dr. Patrick Mallia, a U.K. National Institute for Health Research clinical lecturer at the Imperial College London.

"In terms of therapeutics, this may suggest that antiviral drugs may not only be effective against virus-induced exacerbations, but also potentially could prevent or reduce secondary bacterial infection," he commented.

At his institution, COPD patients with an exacerbation are not routinely tested for viruses. But that may change, given the advent of rapid PCR (polymerase chain reaction) assays for detecting viruses and, possibly, expansion of the indications for antiviral agents.

"So although at the moment [testing for viruses] is very much a research exercise, I think the possibility of using antiviral treatment in the future is not that far away," he said.

Interest in the role of viruses and of dual viral-bacterial infection in COPD exacerbations has intensified recently, according to Dr. Mallia. As both types of infections are common in this population, one might expect that dual infection is common as well; yet, on average, studies have found dual infection in only 13% of exacerbations.

"This tends to suggest that actually it’s not so common, but I think there are a number of reasons why these studies may have underestimated the rate of dual infection," he said, such as their cross-sectional or retrospective nature, and one-time testing for pathogens.

"Studies using a single sampling time point during exacerbation will probably underestimate the true prevalence of coinfection, and also can’t tell us what the sequence of infection is," he explained.

To get around these issues, the investigators used their newly developed model of experimental rhinovirus-induced COPD exacerbation. "These patients catch a cold, get lower respiratory symptoms, and get an exacerbation with increased airflow obstruction and airway inflammation," he said.

The study included 30 patients with GOLD (Global Initiative for Chronic Obstructive Lung Disease) stage II COPD who were using only short-acting bronchodilators, 28 smokers with normal lung function, and 18 nonsmokers.

They were experimentally inoculated with rhinovirus, the virus most commonly detected in COPD exacerbations. Induced sputum was collected before inoculation and at 5, 9, 12, 15, 21, and 42 days afterward.

None of the participants received treatment for infections because their symptoms did not become severe enough to meet preestablished study criteria for treatment initiation, according to Dr. Mallia.

The load of rhinovirus in sputum was assessed with PCR. The load of bacteria that were classified as potentially pathogenic microorganisms (PPMs) was assessed with semiquantitative bacterial culture.

Study results showed that 20 of the COPD patients, 21 of the smokers, and 11 of the nonsmokers developed rhinovirus infection after inoculation.

Fully 60% of the rhinovirus-infected COPD patients developed secondary bacterial infections (mainly with Haemophilus influenzae and Streptococcus pneumoniae), compared with just 9.5% of the smokers and 10% of the nonsmokers (P less than .001).

Within the COPD group, bacterial infections were significantly more common among the patients who acquired rhinovirus infection than among those who did not. "This suggests that the bacterial infections we were detecting were a consequence of the rhinovirus infections," Dr. Mallia commented.

Both viral and bacterial loads rose and fell over time, but the former infection preceded the latter: The viral load peaked on day 9, whereas the bacterial load peaked almost a week later, on day 15. These are "really the first data that [show] a temporal sequence, that first you get the rhinovirus infection, and then you get the bacterial infection following this," he noted.

Moreover, "you can see immediately that if you take a single sample and you sample early, you may pick up a virus and call it a viral exacerbation, but not pick up the subsequent bacterial infection," he added. "Whereas if the patient happens to present later, you might detect the bacterial infection but not detect ... the virus infection that actually initiated it."

To assess potential mechanisms whereby rhinovirus might induce bacterial infections, the investigators measured sputum levels of two antimicrobial peptides found in the airways that are part of the lung’s innate defenses against infection: secretory leukocyte protease inhibitor (SLPI) and elafin.

Levels of both peptides fell in rhinovirus-infected COPD patients who developed bacterial infection before or at the time when bacterial load peaked. In contrast, levels remained the same or rose slightly in those who did not develop bacterial infection. Furthermore, lower levels of the peptides were correlated with higher bacterial loads.

"This would suggest that bacterial infection is a consequence of low SLPI and elafin levels in the airways," Dr. Mallia commented.

Finally, sputum levels of neutrophil elastase (an enzyme that could degrade the protective peptides) rose in rhinovirus-infected COPD patients who developed bacterial infection but remained essentially at baseline levels in their counterparts who did not.

"We hypothesize that possibly you have a sequence of events – viral infection, high neutrophil elastase levels, and degradation of SLPI and elafin – and that may progress to secondary bacterial infection," he said.

The study gives rise to several potential, related avenues of research, according to Dr. Mallia.

"Certainly, one of the things we are interested in is, Are there markers that can identify those people who are going to go on to develop bacterial infections?" he said. And some evidence suggests that in addition to having antibacterial activity, macrolide antibiotics also have antirhinovirus activity, which the investigators plan to test using their model.

Dr. Mallia reported previously having received research grants from Pfizer and GlaxoSmithKline, and currently receiving a travel grant from Boehringer Ingelheim. The study was funded in part by Pfizer and GlaxoSmithKline.

DENVER – The majority of patients with chronic obstructive pulmonary disease who acquire a rhinovirus infection develop a secondary bacterial infection shortly thereafter, suggesting that early antiviral therapy might do double duty.

In a study reported at the International Conference of the American Thoracic Society, 60% of patients with COPD who were experimentally infected with rhinovirus and who gave serial sputum samples developed a bacterial infection as well, approximately a week later. This rate was six times higher than the rates seen among smokers with normal lung function and among nonsmokers.

Temporal patterns of pathogen loads and molecular markers suggested that the virus may incite inflammation that, in turn, results in degradation of key defense peptides in the airways, leaving patients vulnerable to bacteria.

The findings raise the possibility that "dual infection is a lot more common than has been reported in [previous] studies," said lead investigator Dr. Patrick Mallia, a U.K. National Institute for Health Research clinical lecturer at the Imperial College London.

"In terms of therapeutics, this may suggest that antiviral drugs may not only be effective against virus-induced exacerbations, but also potentially could prevent or reduce secondary bacterial infection," he commented.

At his institution, COPD patients with an exacerbation are not routinely tested for viruses. But that may change, given the advent of rapid PCR (polymerase chain reaction) assays for detecting viruses and, possibly, expansion of the indications for antiviral agents.

"So although at the moment [testing for viruses] is very much a research exercise, I think the possibility of using antiviral treatment in the future is not that far away," he said.

Interest in the role of viruses and of dual viral-bacterial infection in COPD exacerbations has intensified recently, according to Dr. Mallia. As both types of infections are common in this population, one might expect that dual infection is common as well; yet, on average, studies have found dual infection in only 13% of exacerbations.

"This tends to suggest that actually it’s not so common, but I think there are a number of reasons why these studies may have underestimated the rate of dual infection," he said, such as their cross-sectional or retrospective nature, and one-time testing for pathogens.

"Studies using a single sampling time point during exacerbation will probably underestimate the true prevalence of coinfection, and also can’t tell us what the sequence of infection is," he explained.

To get around these issues, the investigators used their newly developed model of experimental rhinovirus-induced COPD exacerbation. "These patients catch a cold, get lower respiratory symptoms, and get an exacerbation with increased airflow obstruction and airway inflammation," he said.

The study included 30 patients with GOLD (Global Initiative for Chronic Obstructive Lung Disease) stage II COPD who were using only short-acting bronchodilators, 28 smokers with normal lung function, and 18 nonsmokers.

They were experimentally inoculated with rhinovirus, the virus most commonly detected in COPD exacerbations. Induced sputum was collected before inoculation and at 5, 9, 12, 15, 21, and 42 days afterward.

None of the participants received treatment for infections because their symptoms did not become severe enough to meet preestablished study criteria for treatment initiation, according to Dr. Mallia.

The load of rhinovirus in sputum was assessed with PCR. The load of bacteria that were classified as potentially pathogenic microorganisms (PPMs) was assessed with semiquantitative bacterial culture.

Study results showed that 20 of the COPD patients, 21 of the smokers, and 11 of the nonsmokers developed rhinovirus infection after inoculation.

Fully 60% of the rhinovirus-infected COPD patients developed secondary bacterial infections (mainly with Haemophilus influenzae and Streptococcus pneumoniae), compared with just 9.5% of the smokers and 10% of the nonsmokers (P less than .001).

Within the COPD group, bacterial infections were significantly more common among the patients who acquired rhinovirus infection than among those who did not. "This suggests that the bacterial infections we were detecting were a consequence of the rhinovirus infections," Dr. Mallia commented.

Both viral and bacterial loads rose and fell over time, but the former infection preceded the latter: The viral load peaked on day 9, whereas the bacterial load peaked almost a week later, on day 15. These are "really the first data that [show] a temporal sequence, that first you get the rhinovirus infection, and then you get the bacterial infection following this," he noted.

Moreover, "you can see immediately that if you take a single sample and you sample early, you may pick up a virus and call it a viral exacerbation, but not pick up the subsequent bacterial infection," he added. "Whereas if the patient happens to present later, you might detect the bacterial infection but not detect ... the virus infection that actually initiated it."

To assess potential mechanisms whereby rhinovirus might induce bacterial infections, the investigators measured sputum levels of two antimicrobial peptides found in the airways that are part of the lung’s innate defenses against infection: secretory leukocyte protease inhibitor (SLPI) and elafin.

Levels of both peptides fell in rhinovirus-infected COPD patients who developed bacterial infection before or at the time when bacterial load peaked. In contrast, levels remained the same or rose slightly in those who did not develop bacterial infection. Furthermore, lower levels of the peptides were correlated with higher bacterial loads.

"This would suggest that bacterial infection is a consequence of low SLPI and elafin levels in the airways," Dr. Mallia commented.

Finally, sputum levels of neutrophil elastase (an enzyme that could degrade the protective peptides) rose in rhinovirus-infected COPD patients who developed bacterial infection but remained essentially at baseline levels in their counterparts who did not.

"We hypothesize that possibly you have a sequence of events – viral infection, high neutrophil elastase levels, and degradation of SLPI and elafin – and that may progress to secondary bacterial infection," he said.

The study gives rise to several potential, related avenues of research, according to Dr. Mallia.

"Certainly, one of the things we are interested in is, Are there markers that can identify those people who are going to go on to develop bacterial infections?" he said. And some evidence suggests that in addition to having antibacterial activity, macrolide antibiotics also have antirhinovirus activity, which the investigators plan to test using their model.

Dr. Mallia reported previously having received research grants from Pfizer and GlaxoSmithKline, and currently receiving a travel grant from Boehringer Ingelheim. The study was funded in part by Pfizer and GlaxoSmithKline.

Major Finding: The combined rate of cesarean and vaginal instrumental deliveries specifically for fetal distress was significantly lower in the 411 women in the Foley catheter group, compared with the 408 women who received vaginal prostaglandin gel (12% vs. 18%), while the former group had less maternal and neonatal morbidity. In the other trial, the rate of delivery within 24 hours was highest in the Foley plus oxytocin group of 92 women, at 94%. It was statistically similar at 87% in the Foley plus misoprostol group of 85 women, but significantly lower at 74% in the misoprostol-only group of 88 women.

Data Source: Two randomized controlled trials involving 819 pregnant women and 265 pregnant women, respectively. The women in both groups were at term with an indication for labor induction and an unfavorable cervix.

Disclosures: Dr. JóŸwiak and Dr. Dionne did not report any relevant financial disclosures.

SAN FRANCISCO – In women with term pregnancies and an unfavorable cervix, different methods of labor induction have their pros and cons, according to the results of a pair of randomized trials reported at the meeting.

A trial conducted in the Netherlands found that roughly one-fifth of women eventually had a cesarean section whether labor was induced with a Foley catheter or with vaginal prostaglandin gel. But there was less maternal and neonatal morbidity with the former.

And a trial conducted in Canada found that a Foley catheter plus oxytocin or misoprostol was associated with a higher rate of delivery within 24 hours than misoprostol alone. However, the misoprostol methods were associated with a lower cesarean rate.

Dutch Trial

U.S. and Dutch guidelines indicate that both prostaglandin E analogues and Foley catheters are options for inducing labor, said Dr. Marta JóŸwiak, an obstetrician at the Groene Hart Hospital in Gouda, the Netherlands.

As a result, clinical practice varies. Although these methods have been compared, questions remain about their relative benefits and drawbacks, including complications and their costs.

Dr. JóŸwiak and her coinvestigators conducted a trial called PROBAAT (Prostaglandins or Balloon for Induction of Labor at Term) in 819 women with a term pregnancy who had a vital singleton fetus in cephalic presentation, intact membranes, and an unfavorable cervix, defined as a Bishop score of less than 6.

The women were 31 years old, on average, and 81% were white. The median gestational age was 40 weeks. Two-thirds were nulliparous, and most (83%) had a Bishop score of 3 or less. The leading indications for labor induction were postterm pregnancy (36%) and hypertensive disorders (34%). Patients were excluded from the study if they had had a cesarean delivery, or had placenta previa, a fetus with congenital anomalies, or hypersensitivity to either of the products used for labor induction.

The investigators randomized the women in equal numbers to nonblinded treatment with a transcervical Foley catheter or vaginal prostaglandin E2 gel. Analyses were based on 411 women in the former group and 408 in the latter group.

Trial results showed that the rate of cesarean section, the primary outcome, was 23% in the Foley catheter group and 20% in the prostaglandin gel group, a difference that was not significant, Dr. JóŸwiak reported.

The rate of vaginal instrumental delivery did not differ, but the combined rate of cesarean and vaginal instrumental deliveries specifically for fetal distress was significantly lower in the Foley group (12% vs. 18%). The rate of maternal infection during labor also was lower in that group (2% vs. 4%).

The groups were similar with respect to rates of other maternal outcomes (hyperstimulation, postpartum hemorrhage, and blood transfusion). There were two cases of uterine rupture, both in the prostaglandin group.

In terms of neonatal outcomes, neonates in the Foley group were significantly less likely than their counterparts in the prostaglandin group to be admitted to the ward (12% vs. 19%), while rates of intensive care unit admission were identical.

The groups were similar with respect to rates of other neonatal outcomes, such as Apgar scores, umbilical cord blood pH, reasons for admission, and length of admission.

Subgroup analyses are still ongoing, according to Dr. JóŸwiak, but preliminary results suggest that the Foley catheter was the more successful of the two methods in nulliparous women, who are more likely to have trouble with labor induction.

“Induction with a Foley catheter is, in terms of cesarean section, as effective as induction with prostaglandin E2 gel, with less neonatal and maternal morbidity,” she concluded.

“We recommend considering the Foley catheter as a first choice for induction of labor at term in women with an unfavorable cervix,” Dr. JóŸwiak said.

Canadian Trial

Elective induction of labor now occurs in 21%–30% of all births, noted Dr. Marie-Danielle Dionne, a fetal-maternal medicine specialist at the University of Montreal. “An improved Bishop score before induction increases the rate of vaginal birth.”

She and her coinvestigators enrolled women with a normal singleton pregnancy at term who had intact membranes and an unfavorable cervix, with a Bishop score of 5 or less. Women were ineligible if they had prostaglandin hypersensitivity, previous uterine surgery, a noncephalic fetal presentation, or nonreassuring fetal cardiac monitoring.

The women were randomized in equal numbers to nonblinded treatment with a Foley catheter plus intravenous oxytocin infusion, a Foley catheter plus intravaginal misoprostol, or intravaginal misoprostol alone.

The trial was stopped early because of an elevated rate of cesarean deliveries in the first group, according to Dr. Dionne.

Intention-to-treat analyses were based on 92 women in the Foley plus oxytocin group, 85 women in the Foley plus misoprostol group, and 88 women in the misoprostol-only group.

On average, the women were 30 years old, and the median gestational age was 40.5 weeks. About three-fourths of the women were nulliparous. The mean Bishop score was 3. The leading indications for induction were a postdate pregnancy (54%) and diabetes (27%).

Trial results showed that the rate of delivery within 24 hours, the primary outcome, was highest in the Foley plus oxytocin group at 94%, Dr. Dionne reported. It was statistically similar in the Foley plus misoprostol group at 87%, but significantly lower in the misoprostol-only group at 74%.

However, the rate of cesarean delivery was 44% in the Foley plus oxytocin group. It was significantly lower in both the Foley plus misoprostol group at 24%, and in the misoprostol-only group at 28%.

The three groups did not differ with respect to rates of maternal complications (postpartum hemorrhage, hyperstimulation, receipt of antibiotics, and placental retention) and fetal and neonatal outcomes (Apgar scores, cord blood arterial pH, admission to the neonatal intensive care unit, meconium in amniotic fluid, receipt of antibiotics, and nonreassuring fetal monitoring).

“We can say that in our institutions, the use of a Foley catheter is associated with more deliveries within 24 hours,” said Dr. Dionne.

“This is mostly due to a smaller delay from induction to labor,” she said.

“Misoprostol use significantly reduced the rate of c-section, with or without a Foley catheter,” she further noted.

Dr. Dionne speculated that the higher rate of cesareans with the Foley catheter plus oxytocin, despite the more rapid delivery, was due to inadequate cervical ripening in the face of contractions. “There is a small change in the cervix and there are regular contractions, but it is probably not as physiological as with the misoprostol,” she said.

“So we have to decide which is best: more deliveries within 24 hours or more vaginal births,” Dr. Dionne concluded. “The answer is easy for me: We think more vaginal births is better.”

Major Finding: The combined rate of cesarean and vaginal instrumental deliveries specifically for fetal distress was significantly lower in the 411 women in the Foley catheter group, compared with the 408 women who received vaginal prostaglandin gel (12% vs. 18%), while the former group had less maternal and neonatal morbidity. In the other trial, the rate of delivery within 24 hours was highest in the Foley plus oxytocin group of 92 women, at 94%. It was statistically similar at 87% in the Foley plus misoprostol group of 85 women, but significantly lower at 74% in the misoprostol-only group of 88 women.

Data Source: Two randomized controlled trials involving 819 pregnant women and 265 pregnant women, respectively. The women in both groups were at term with an indication for labor induction and an unfavorable cervix.

Disclosures: Dr. JóŸwiak and Dr. Dionne did not report any relevant financial disclosures.

SAN FRANCISCO – In women with term pregnancies and an unfavorable cervix, different methods of labor induction have their pros and cons, according to the results of a pair of randomized trials reported at the meeting.

A trial conducted in the Netherlands found that roughly one-fifth of women eventually had a cesarean section whether labor was induced with a Foley catheter or with vaginal prostaglandin gel. But there was less maternal and neonatal morbidity with the former.

And a trial conducted in Canada found that a Foley catheter plus oxytocin or misoprostol was associated with a higher rate of delivery within 24 hours than misoprostol alone. However, the misoprostol methods were associated with a lower cesarean rate.

Dutch Trial

U.S. and Dutch guidelines indicate that both prostaglandin E analogues and Foley catheters are options for inducing labor, said Dr. Marta JóŸwiak, an obstetrician at the Groene Hart Hospital in Gouda, the Netherlands.

As a result, clinical practice varies. Although these methods have been compared, questions remain about their relative benefits and drawbacks, including complications and their costs.

Dr. JóŸwiak and her coinvestigators conducted a trial called PROBAAT (Prostaglandins or Balloon for Induction of Labor at Term) in 819 women with a term pregnancy who had a vital singleton fetus in cephalic presentation, intact membranes, and an unfavorable cervix, defined as a Bishop score of less than 6.

The women were 31 years old, on average, and 81% were white. The median gestational age was 40 weeks. Two-thirds were nulliparous, and most (83%) had a Bishop score of 3 or less. The leading indications for labor induction were postterm pregnancy (36%) and hypertensive disorders (34%). Patients were excluded from the study if they had had a cesarean delivery, or had placenta previa, a fetus with congenital anomalies, or hypersensitivity to either of the products used for labor induction.

The investigators randomized the women in equal numbers to nonblinded treatment with a transcervical Foley catheter or vaginal prostaglandin E2 gel. Analyses were based on 411 women in the former group and 408 in the latter group.

Trial results showed that the rate of cesarean section, the primary outcome, was 23% in the Foley catheter group and 20% in the prostaglandin gel group, a difference that was not significant, Dr. JóŸwiak reported.

The rate of vaginal instrumental delivery did not differ, but the combined rate of cesarean and vaginal instrumental deliveries specifically for fetal distress was significantly lower in the Foley group (12% vs. 18%). The rate of maternal infection during labor also was lower in that group (2% vs. 4%).

The groups were similar with respect to rates of other maternal outcomes (hyperstimulation, postpartum hemorrhage, and blood transfusion). There were two cases of uterine rupture, both in the prostaglandin group.

In terms of neonatal outcomes, neonates in the Foley group were significantly less likely than their counterparts in the prostaglandin group to be admitted to the ward (12% vs. 19%), while rates of intensive care unit admission were identical.

The groups were similar with respect to rates of other neonatal outcomes, such as Apgar scores, umbilical cord blood pH, reasons for admission, and length of admission.

Subgroup analyses are still ongoing, according to Dr. JóŸwiak, but preliminary results suggest that the Foley catheter was the more successful of the two methods in nulliparous women, who are more likely to have trouble with labor induction.

“Induction with a Foley catheter is, in terms of cesarean section, as effective as induction with prostaglandin E2 gel, with less neonatal and maternal morbidity,” she concluded.

“We recommend considering the Foley catheter as a first choice for induction of labor at term in women with an unfavorable cervix,” Dr. JóŸwiak said.

Canadian Trial

Elective induction of labor now occurs in 21%–30% of all births, noted Dr. Marie-Danielle Dionne, a fetal-maternal medicine specialist at the University of Montreal. “An improved Bishop score before induction increases the rate of vaginal birth.”

She and her coinvestigators enrolled women with a normal singleton pregnancy at term who had intact membranes and an unfavorable cervix, with a Bishop score of 5 or less. Women were ineligible if they had prostaglandin hypersensitivity, previous uterine surgery, a noncephalic fetal presentation, or nonreassuring fetal cardiac monitoring.

The women were randomized in equal numbers to nonblinded treatment with a Foley catheter plus intravenous oxytocin infusion, a Foley catheter plus intravaginal misoprostol, or intravaginal misoprostol alone.

The trial was stopped early because of an elevated rate of cesarean deliveries in the first group, according to Dr. Dionne.

Intention-to-treat analyses were based on 92 women in the Foley plus oxytocin group, 85 women in the Foley plus misoprostol group, and 88 women in the misoprostol-only group.

On average, the women were 30 years old, and the median gestational age was 40.5 weeks. About three-fourths of the women were nulliparous. The mean Bishop score was 3. The leading indications for induction were a postdate pregnancy (54%) and diabetes (27%).

Trial results showed that the rate of delivery within 24 hours, the primary outcome, was highest in the Foley plus oxytocin group at 94%, Dr. Dionne reported. It was statistically similar in the Foley plus misoprostol group at 87%, but significantly lower in the misoprostol-only group at 74%.

However, the rate of cesarean delivery was 44% in the Foley plus oxytocin group. It was significantly lower in both the Foley plus misoprostol group at 24%, and in the misoprostol-only group at 28%.

The three groups did not differ with respect to rates of maternal complications (postpartum hemorrhage, hyperstimulation, receipt of antibiotics, and placental retention) and fetal and neonatal outcomes (Apgar scores, cord blood arterial pH, admission to the neonatal intensive care unit, meconium in amniotic fluid, receipt of antibiotics, and nonreassuring fetal monitoring).

“We can say that in our institutions, the use of a Foley catheter is associated with more deliveries within 24 hours,” said Dr. Dionne.

“This is mostly due to a smaller delay from induction to labor,” she said.

“Misoprostol use significantly reduced the rate of c-section, with or without a Foley catheter,” she further noted.

Dr. Dionne speculated that the higher rate of cesareans with the Foley catheter plus oxytocin, despite the more rapid delivery, was due to inadequate cervical ripening in the face of contractions. “There is a small change in the cervix and there are regular contractions, but it is probably not as physiological as with the misoprostol,” she said.

“So we have to decide which is best: more deliveries within 24 hours or more vaginal births,” Dr. Dionne concluded. “The answer is easy for me: We think more vaginal births is better.”

Major Finding: The combined rate of cesarean and vaginal instrumental deliveries specifically for fetal distress was significantly lower in the 411 women in the Foley catheter group, compared with the 408 women who received vaginal prostaglandin gel (12% vs. 18%), while the former group had less maternal and neonatal morbidity. In the other trial, the rate of delivery within 24 hours was highest in the Foley plus oxytocin group of 92 women, at 94%. It was statistically similar at 87% in the Foley plus misoprostol group of 85 women, but significantly lower at 74% in the misoprostol-only group of 88 women.

Data Source: Two randomized controlled trials involving 819 pregnant women and 265 pregnant women, respectively. The women in both groups were at term with an indication for labor induction and an unfavorable cervix.

Disclosures: Dr. JóŸwiak and Dr. Dionne did not report any relevant financial disclosures.

SAN FRANCISCO – In women with term pregnancies and an unfavorable cervix, different methods of labor induction have their pros and cons, according to the results of a pair of randomized trials reported at the meeting.

A trial conducted in the Netherlands found that roughly one-fifth of women eventually had a cesarean section whether labor was induced with a Foley catheter or with vaginal prostaglandin gel. But there was less maternal and neonatal morbidity with the former.

And a trial conducted in Canada found that a Foley catheter plus oxytocin or misoprostol was associated with a higher rate of delivery within 24 hours than misoprostol alone. However, the misoprostol methods were associated with a lower cesarean rate.

Dutch Trial

U.S. and Dutch guidelines indicate that both prostaglandin E analogues and Foley catheters are options for inducing labor, said Dr. Marta JóŸwiak, an obstetrician at the Groene Hart Hospital in Gouda, the Netherlands.

As a result, clinical practice varies. Although these methods have been compared, questions remain about their relative benefits and drawbacks, including complications and their costs.

Dr. JóŸwiak and her coinvestigators conducted a trial called PROBAAT (Prostaglandins or Balloon for Induction of Labor at Term) in 819 women with a term pregnancy who had a vital singleton fetus in cephalic presentation, intact membranes, and an unfavorable cervix, defined as a Bishop score of less than 6.

The women were 31 years old, on average, and 81% were white. The median gestational age was 40 weeks. Two-thirds were nulliparous, and most (83%) had a Bishop score of 3 or less. The leading indications for labor induction were postterm pregnancy (36%) and hypertensive disorders (34%). Patients were excluded from the study if they had had a cesarean delivery, or had placenta previa, a fetus with congenital anomalies, or hypersensitivity to either of the products used for labor induction.

The investigators randomized the women in equal numbers to nonblinded treatment with a transcervical Foley catheter or vaginal prostaglandin E2 gel. Analyses were based on 411 women in the former group and 408 in the latter group.

Trial results showed that the rate of cesarean section, the primary outcome, was 23% in the Foley catheter group and 20% in the prostaglandin gel group, a difference that was not significant, Dr. JóŸwiak reported.

The rate of vaginal instrumental delivery did not differ, but the combined rate of cesarean and vaginal instrumental deliveries specifically for fetal distress was significantly lower in the Foley group (12% vs. 18%). The rate of maternal infection during labor also was lower in that group (2% vs. 4%).

The groups were similar with respect to rates of other maternal outcomes (hyperstimulation, postpartum hemorrhage, and blood transfusion). There were two cases of uterine rupture, both in the prostaglandin group.

In terms of neonatal outcomes, neonates in the Foley group were significantly less likely than their counterparts in the prostaglandin group to be admitted to the ward (12% vs. 19%), while rates of intensive care unit admission were identical.

The groups were similar with respect to rates of other neonatal outcomes, such as Apgar scores, umbilical cord blood pH, reasons for admission, and length of admission.

Subgroup analyses are still ongoing, according to Dr. JóŸwiak, but preliminary results suggest that the Foley catheter was the more successful of the two methods in nulliparous women, who are more likely to have trouble with labor induction.

“Induction with a Foley catheter is, in terms of cesarean section, as effective as induction with prostaglandin E2 gel, with less neonatal and maternal morbidity,” she concluded.

“We recommend considering the Foley catheter as a first choice for induction of labor at term in women with an unfavorable cervix,” Dr. JóŸwiak said.

Canadian Trial

Elective induction of labor now occurs in 21%–30% of all births, noted Dr. Marie-Danielle Dionne, a fetal-maternal medicine specialist at the University of Montreal. “An improved Bishop score before induction increases the rate of vaginal birth.”

She and her coinvestigators enrolled women with a normal singleton pregnancy at term who had intact membranes and an unfavorable cervix, with a Bishop score of 5 or less. Women were ineligible if they had prostaglandin hypersensitivity, previous uterine surgery, a noncephalic fetal presentation, or nonreassuring fetal cardiac monitoring.

The women were randomized in equal numbers to nonblinded treatment with a Foley catheter plus intravenous oxytocin infusion, a Foley catheter plus intravaginal misoprostol, or intravaginal misoprostol alone.

The trial was stopped early because of an elevated rate of cesarean deliveries in the first group, according to Dr. Dionne.

Intention-to-treat analyses were based on 92 women in the Foley plus oxytocin group, 85 women in the Foley plus misoprostol group, and 88 women in the misoprostol-only group.

On average, the women were 30 years old, and the median gestational age was 40.5 weeks. About three-fourths of the women were nulliparous. The mean Bishop score was 3. The leading indications for induction were a postdate pregnancy (54%) and diabetes (27%).

Trial results showed that the rate of delivery within 24 hours, the primary outcome, was highest in the Foley plus oxytocin group at 94%, Dr. Dionne reported. It was statistically similar in the Foley plus misoprostol group at 87%, but significantly lower in the misoprostol-only group at 74%.

However, the rate of cesarean delivery was 44% in the Foley plus oxytocin group. It was significantly lower in both the Foley plus misoprostol group at 24%, and in the misoprostol-only group at 28%.

The three groups did not differ with respect to rates of maternal complications (postpartum hemorrhage, hyperstimulation, receipt of antibiotics, and placental retention) and fetal and neonatal outcomes (Apgar scores, cord blood arterial pH, admission to the neonatal intensive care unit, meconium in amniotic fluid, receipt of antibiotics, and nonreassuring fetal monitoring).

“We can say that in our institutions, the use of a Foley catheter is associated with more deliveries within 24 hours,” said Dr. Dionne.

“This is mostly due to a smaller delay from induction to labor,” she said.

“Misoprostol use significantly reduced the rate of c-section, with or without a Foley catheter,” she further noted.

Dr. Dionne speculated that the higher rate of cesareans with the Foley catheter plus oxytocin, despite the more rapid delivery, was due to inadequate cervical ripening in the face of contractions. “There is a small change in the cervix and there are regular contractions, but it is probably not as physiological as with the misoprostol,” she said.

“So we have to decide which is best: more deliveries within 24 hours or more vaginal births,” Dr. Dionne concluded. “The answer is easy for me: We think more vaginal births is better.”

SAN DIEGO – For men undergoing heart transplantation, the sex of their donor may mean the difference between life and death, according to a pair of large retrospective cohort studies

The studies, which were reported at the meeting each analyzed data from more than 60,000 recipients over periods spanning several decades.

Their conclusion: Men were more likely to die if they received a heart from a female donor vs. a male donor, with the elevation in risk largely resulting from excess deaths in the first year. Overall mortality was 13% higher for these men after potential confounders were taken into account.

In contrast, women undergoing heart transplantation had a similar risk of death regardless of whether their donor was male or female.

A possible explanation for this finding, according to Dr. Ingo Kaczmarek, a cardiac surgeon at the Transplantation Center Munich of Ludwig-Maximilians University of Munich and the lead investigator of one of the studies, is that women's hearts are smaller than men's, even given the same body height and weight (J. Am. Coll. Cardiol. 2002;39:1055-60).

Additionally, medication nonadherence may play a part. “In our population … I can tell you that females take their medication and males don't,” he said. “And that might be a big confounder that you can't measure.”

Although her study took donor characteristics into account, it is still possible that the smaller size of female hearts played a role, agreed Dr. Kiran K. Khush, lead investigator of the other study. “But I think there are probably also some immunological processes involved and sex differences that we don't completely understand,” she added.

This new information helps explain why some patients fare better than others after heart transplantation, but it would not necessarily alter her practice, said Dr. Khush, a cardiologist and instructor in cardiovascular medicine at Stanford (Calif.) University.

“I would worry about it clinically, but I'm not sure that would preclude me from accepting a female graft for a male recipient, because – as we all know – when you have a very sick recipient who is in imminent danger of dying, you just want to have a heart for that patient,” she commented. However, she added, perhaps given a situation wherein several highest-priority patients on the waiting list were otherwise similar, sex matching might be something to consider.

Dr. Khush and her colleagues analyzed data from the International Society of Heart and Lung Transplantation (ISHLT) database for the years 1990-2008, restricting analyses to 60,584 adult recipients having at least 2 years of follow-up post transplantation.

Fully 79% of the heart transplant recipients were men. On average, the men were 52 years old and the women were 49 years old at the time of transplantation.

Men's odds of acute rejection within 2 years of transplantation were higher if their donor was female vs. male before adjustment for more than a dozen potential confounders (odds ratio, 1.22), although not afterward. Women's odds of this outcome did not differ by the sex of their donor.

The donor's sex did not affect the likelihood of cardiac allograft vasculopathy for either group before adjustment. But afterward, men actually had a lower risk of this outcome if their donor was female (OR, 0.77).

In terms of the hard end point of death, results showed that men were more likely to die after transplantation if their donor was female vs. male, both before statistical adjustment (hazard ratio, 1.18) and afterward (HR, 1.13). The donor's sex had no influence on this outcome in women.

Dr. Kaczmarek and his coinvestigators similarly analyzed data from the ISHLT database, but for a wider range of years (1980-2009). Their analyses were based on 67,833 heart transplant recipients.

Overall, 80% were men. On average, the men were 53 years old and the women were 51 years old. One-quarter of men received a female donor heart, and slightly fewer than one-half of women received a male donor heart.

The 15-year survival rate was best for women who were given a female heart and worst for men who were given a female heart. “The curves divide in the first year,” Dr. Kaczmarek pointed out. “In the long run, they seem to be parallel, but women with female hearts do a bit better.”

The 1-year rate of survival ranged from a low of 78% among men who were given a female heart to a high of 84% among men who were given a male heart. “This [latter] effect lasts for a few years, and then the better combination is female donor, female recipient,” he said.

Dr. Khush had no relevant conflicts of interest. Dr. Kaczmarek reported receiving travel or research grants from Novartis, Astellas, Roche, Orion Pharma, and Berlin Heart.

The fact that women's hearts are smaller than men's even given the same body height and weight, may be a factor.

Source DR. KACZMAREK

SAN DIEGO – For men undergoing heart transplantation, the sex of their donor may mean the difference between life and death, according to a pair of large retrospective cohort studies

The studies, which were reported at the meeting each analyzed data from more than 60,000 recipients over periods spanning several decades.

Their conclusion: Men were more likely to die if they received a heart from a female donor vs. a male donor, with the elevation in risk largely resulting from excess deaths in the first year. Overall mortality was 13% higher for these men after potential confounders were taken into account.

In contrast, women undergoing heart transplantation had a similar risk of death regardless of whether their donor was male or female.

A possible explanation for this finding, according to Dr. Ingo Kaczmarek, a cardiac surgeon at the Transplantation Center Munich of Ludwig-Maximilians University of Munich and the lead investigator of one of the studies, is that women's hearts are smaller than men's, even given the same body height and weight (J. Am. Coll. Cardiol. 2002;39:1055-60).

Additionally, medication nonadherence may play a part. “In our population … I can tell you that females take their medication and males don't,” he said. “And that might be a big confounder that you can't measure.”

Although her study took donor characteristics into account, it is still possible that the smaller size of female hearts played a role, agreed Dr. Kiran K. Khush, lead investigator of the other study. “But I think there are probably also some immunological processes involved and sex differences that we don't completely understand,” she added.

This new information helps explain why some patients fare better than others after heart transplantation, but it would not necessarily alter her practice, said Dr. Khush, a cardiologist and instructor in cardiovascular medicine at Stanford (Calif.) University.

“I would worry about it clinically, but I'm not sure that would preclude me from accepting a female graft for a male recipient, because – as we all know – when you have a very sick recipient who is in imminent danger of dying, you just want to have a heart for that patient,” she commented. However, she added, perhaps given a situation wherein several highest-priority patients on the waiting list were otherwise similar, sex matching might be something to consider.

Dr. Khush and her colleagues analyzed data from the International Society of Heart and Lung Transplantation (ISHLT) database for the years 1990-2008, restricting analyses to 60,584 adult recipients having at least 2 years of follow-up post transplantation.

Fully 79% of the heart transplant recipients were men. On average, the men were 52 years old and the women were 49 years old at the time of transplantation.

Men's odds of acute rejection within 2 years of transplantation were higher if their donor was female vs. male before adjustment for more than a dozen potential confounders (odds ratio, 1.22), although not afterward. Women's odds of this outcome did not differ by the sex of their donor.

The donor's sex did not affect the likelihood of cardiac allograft vasculopathy for either group before adjustment. But afterward, men actually had a lower risk of this outcome if their donor was female (OR, 0.77).

In terms of the hard end point of death, results showed that men were more likely to die after transplantation if their donor was female vs. male, both before statistical adjustment (hazard ratio, 1.18) and afterward (HR, 1.13). The donor's sex had no influence on this outcome in women.

Dr. Kaczmarek and his coinvestigators similarly analyzed data from the ISHLT database, but for a wider range of years (1980-2009). Their analyses were based on 67,833 heart transplant recipients.

Overall, 80% were men. On average, the men were 53 years old and the women were 51 years old. One-quarter of men received a female donor heart, and slightly fewer than one-half of women received a male donor heart.

The 15-year survival rate was best for women who were given a female heart and worst for men who were given a female heart. “The curves divide in the first year,” Dr. Kaczmarek pointed out. “In the long run, they seem to be parallel, but women with female hearts do a bit better.”

The 1-year rate of survival ranged from a low of 78% among men who were given a female heart to a high of 84% among men who were given a male heart. “This [latter] effect lasts for a few years, and then the better combination is female donor, female recipient,” he said.

Dr. Khush had no relevant conflicts of interest. Dr. Kaczmarek reported receiving travel or research grants from Novartis, Astellas, Roche, Orion Pharma, and Berlin Heart.

The fact that women's hearts are smaller than men's even given the same body height and weight, may be a factor.

Source DR. KACZMAREK

SAN DIEGO – For men undergoing heart transplantation, the sex of their donor may mean the difference between life and death, according to a pair of large retrospective cohort studies

The studies, which were reported at the meeting each analyzed data from more than 60,000 recipients over periods spanning several decades.

Their conclusion: Men were more likely to die if they received a heart from a female donor vs. a male donor, with the elevation in risk largely resulting from excess deaths in the first year. Overall mortality was 13% higher for these men after potential confounders were taken into account.

In contrast, women undergoing heart transplantation had a similar risk of death regardless of whether their donor was male or female.

A possible explanation for this finding, according to Dr. Ingo Kaczmarek, a cardiac surgeon at the Transplantation Center Munich of Ludwig-Maximilians University of Munich and the lead investigator of one of the studies, is that women's hearts are smaller than men's, even given the same body height and weight (J. Am. Coll. Cardiol. 2002;39:1055-60).

Additionally, medication nonadherence may play a part. “In our population … I can tell you that females take their medication and males don't,” he said. “And that might be a big confounder that you can't measure.”

Although her study took donor characteristics into account, it is still possible that the smaller size of female hearts played a role, agreed Dr. Kiran K. Khush, lead investigator of the other study. “But I think there are probably also some immunological processes involved and sex differences that we don't completely understand,” she added.

This new information helps explain why some patients fare better than others after heart transplantation, but it would not necessarily alter her practice, said Dr. Khush, a cardiologist and instructor in cardiovascular medicine at Stanford (Calif.) University.

“I would worry about it clinically, but I'm not sure that would preclude me from accepting a female graft for a male recipient, because – as we all know – when you have a very sick recipient who is in imminent danger of dying, you just want to have a heart for that patient,” she commented. However, she added, perhaps given a situation wherein several highest-priority patients on the waiting list were otherwise similar, sex matching might be something to consider.

Dr. Khush and her colleagues analyzed data from the International Society of Heart and Lung Transplantation (ISHLT) database for the years 1990-2008, restricting analyses to 60,584 adult recipients having at least 2 years of follow-up post transplantation.

Fully 79% of the heart transplant recipients were men. On average, the men were 52 years old and the women were 49 years old at the time of transplantation.

Men's odds of acute rejection within 2 years of transplantation were higher if their donor was female vs. male before adjustment for more than a dozen potential confounders (odds ratio, 1.22), although not afterward. Women's odds of this outcome did not differ by the sex of their donor.

The donor's sex did not affect the likelihood of cardiac allograft vasculopathy for either group before adjustment. But afterward, men actually had a lower risk of this outcome if their donor was female (OR, 0.77).

In terms of the hard end point of death, results showed that men were more likely to die after transplantation if their donor was female vs. male, both before statistical adjustment (hazard ratio, 1.18) and afterward (HR, 1.13). The donor's sex had no influence on this outcome in women.

Dr. Kaczmarek and his coinvestigators similarly analyzed data from the ISHLT database, but for a wider range of years (1980-2009). Their analyses were based on 67,833 heart transplant recipients.

Overall, 80% were men. On average, the men were 53 years old and the women were 51 years old. One-quarter of men received a female donor heart, and slightly fewer than one-half of women received a male donor heart.

The 15-year survival rate was best for women who were given a female heart and worst for men who were given a female heart. “The curves divide in the first year,” Dr. Kaczmarek pointed out. “In the long run, they seem to be parallel, but women with female hearts do a bit better.”

The 1-year rate of survival ranged from a low of 78% among men who were given a female heart to a high of 84% among men who were given a male heart. “This [latter] effect lasts for a few years, and then the better combination is female donor, female recipient,” he said.

Dr. Khush had no relevant conflicts of interest. Dr. Kaczmarek reported receiving travel or research grants from Novartis, Astellas, Roche, Orion Pharma, and Berlin Heart.

The fact that women's hearts are smaller than men's even given the same body height and weight, may be a factor.

Source DR. KACZMAREK

Major Finding: Donor-heart left ventricular hypertrophy did not increase recipients' risk of death overall. However, LVH did increase mortality risk when combined with either of two other high-risk characteristics: older donor age and longer graft ischemic time.

Data Source: A retrospective study of 2,626 adult patients who underwent heart transplantation between 2006 and 2010.

Disclosures: Dr. Pinzon reported that he had no relevant conflicts of interest.

SAN DIEGO – Cardiac transplant recipients who are given hearts from donors with left ventricular hypertrophy are not at increased risk of death, Dr. Omar Wever Pinzon reported at the meeting.

In a retrospective, nationwide study of more than 2,500 adults who underwent cardiac transplantation during 2006-2010, nearly half of the donor hearts had LVH.

Recipients who had been given hearts with LVH did not have poorer survival overall than did their counterparts who had been given hearts without this high-risk characteristic. But getting a heart with LVH did reduce survival if, in addition, the donor was older than 55 years or the graft had a longer ischemic time.

“Overall survival of recipients of donor hearts with LVH is similar to those without LVH, which indicates that the current donor selection and allocation algorithms successfully mitigate the risk that donor LVH could pose to recipient survival,” Dr. Pinzon said. However, “the combination of donor LVH with certain other high-risk characteristics can result in excess mortality.”

Because few donor hearts had moderate or severe LVH, “I think we have to be very cautious” when using those hearts, he added. But hearts having an interventricular septum and posterior wall thickness up to 1.3 cm “may be safe in the absence of other high-risk characteristics.”

The scarcity of donor hearts – coupled with growing knowledge about the impact of various donor characteristics on recipient outcomes – has led to strategies to make more hearts available for transplantation, according to Dr. Pinzon.

“Thanks to these strategies, patients with left ventricular hypertrophy, considered a high-risk characteristic, are more likely now to become donors,” he commented. However, some studies have raised concerns that such hearts are more susceptible to ischemic graft injury, which could translate into poorer outcomes for the recipients.

Using data from the United Network for Organ Sharing and the Organ Procurement and Transplantation Network, the investigators studied 2,626 adult patients who underwent a first, single-organ heart transplantation in 2006-2010.

On the basis of the thickness of the interventricular septum and posterior wall, donor hearts were classified as having no LVH (less than 1.1 cm) or LVH that was mild (1.1-1.3 cm), moderate (1.4-1.6 cm), or severe (1.7 cm or greater).

The transplant recipients were 52 years old on average, and 78% were men. The donors were 33 years old on average, and 72% were men.

Fully 44% of the donor hearts had some degree of LVH, reported Dr. Pinzon of the UTAH (Utah Transplantation Affiliated Hospitals) Cardiac Transplant Program in Salt Lake City. The LVH was mild in most cases (38%) but occasionally moderate (5%) or severe (1%).

Relative to their peers who had been given donor hearts without LVH, recipients who had been given donor hearts with LVH had a higher body mass index and a higher ratio of donor-to-recipient BMI, had been on the waiting list for a shorter time, and were more likely to have a graft ischemic time exceeding 4 hours.

During a follow-up period of 3.3 years post transplantation, 13% of the recipients died or underwent retransplantation.

In univariate and multivariate analyses, neither recipients of donor hearts with mild LVH nor recipients of donor hearts with moderate or severe LVH were more likely to die than their counterparts whose donor hearts did not have any LVH, Dr. Pinzon reported.

However, recipients' risk of death increased with the age of their donor (hazard ratio, 1.01) and with their own serum creatinine level (HR, 1.31) and mean pulmonary artery pressure (HR, 1.01).

Also, they were more likely to die if their donor had used tobacco (HR, 1.32), or if they themselves were older than 55 years of age (HR, 1.30) or had been on extracorporeal membrane oxygenation support (HR, 6.0).

Further analyses revealed an interaction between donor heart LVH and donor age. Of recipients whose donor was older than 55 years, those getting a heart with any LVH had roughly six times the risk of death. But there was no such association in recipients from younger donors.

There was also an interaction between donor heart LVH and graft ischemic time. Of recipients whose graft had an ischemic time of 4 hours or longer, those receiving a heart with moderate or severe LVH had twice the risk of death.

Major Finding: Donor-heart left ventricular hypertrophy did not increase recipients' risk of death overall. However, LVH did increase mortality risk when combined with either of two other high-risk characteristics: older donor age and longer graft ischemic time.

Data Source: A retrospective study of 2,626 adult patients who underwent heart transplantation between 2006 and 2010.

Disclosures: Dr. Pinzon reported that he had no relevant conflicts of interest.

SAN DIEGO – Cardiac transplant recipients who are given hearts from donors with left ventricular hypertrophy are not at increased risk of death, Dr. Omar Wever Pinzon reported at the meeting.

In a retrospective, nationwide study of more than 2,500 adults who underwent cardiac transplantation during 2006-2010, nearly half of the donor hearts had LVH.

Recipients who had been given hearts with LVH did not have poorer survival overall than did their counterparts who had been given hearts without this high-risk characteristic. But getting a heart with LVH did reduce survival if, in addition, the donor was older than 55 years or the graft had a longer ischemic time.

“Overall survival of recipients of donor hearts with LVH is similar to those without LVH, which indicates that the current donor selection and allocation algorithms successfully mitigate the risk that donor LVH could pose to recipient survival,” Dr. Pinzon said. However, “the combination of donor LVH with certain other high-risk characteristics can result in excess mortality.”

Because few donor hearts had moderate or severe LVH, “I think we have to be very cautious” when using those hearts, he added. But hearts having an interventricular septum and posterior wall thickness up to 1.3 cm “may be safe in the absence of other high-risk characteristics.”

The scarcity of donor hearts – coupled with growing knowledge about the impact of various donor characteristics on recipient outcomes – has led to strategies to make more hearts available for transplantation, according to Dr. Pinzon.

“Thanks to these strategies, patients with left ventricular hypertrophy, considered a high-risk characteristic, are more likely now to become donors,” he commented. However, some studies have raised concerns that such hearts are more susceptible to ischemic graft injury, which could translate into poorer outcomes for the recipients.

Using data from the United Network for Organ Sharing and the Organ Procurement and Transplantation Network, the investigators studied 2,626 adult patients who underwent a first, single-organ heart transplantation in 2006-2010.

On the basis of the thickness of the interventricular septum and posterior wall, donor hearts were classified as having no LVH (less than 1.1 cm) or LVH that was mild (1.1-1.3 cm), moderate (1.4-1.6 cm), or severe (1.7 cm or greater).

The transplant recipients were 52 years old on average, and 78% were men. The donors were 33 years old on average, and 72% were men.

Fully 44% of the donor hearts had some degree of LVH, reported Dr. Pinzon of the UTAH (Utah Transplantation Affiliated Hospitals) Cardiac Transplant Program in Salt Lake City. The LVH was mild in most cases (38%) but occasionally moderate (5%) or severe (1%).

Relative to their peers who had been given donor hearts without LVH, recipients who had been given donor hearts with LVH had a higher body mass index and a higher ratio of donor-to-recipient BMI, had been on the waiting list for a shorter time, and were more likely to have a graft ischemic time exceeding 4 hours.

During a follow-up period of 3.3 years post transplantation, 13% of the recipients died or underwent retransplantation.

In univariate and multivariate analyses, neither recipients of donor hearts with mild LVH nor recipients of donor hearts with moderate or severe LVH were more likely to die than their counterparts whose donor hearts did not have any LVH, Dr. Pinzon reported.

However, recipients' risk of death increased with the age of their donor (hazard ratio, 1.01) and with their own serum creatinine level (HR, 1.31) and mean pulmonary artery pressure (HR, 1.01).

Also, they were more likely to die if their donor had used tobacco (HR, 1.32), or if they themselves were older than 55 years of age (HR, 1.30) or had been on extracorporeal membrane oxygenation support (HR, 6.0).

Further analyses revealed an interaction between donor heart LVH and donor age. Of recipients whose donor was older than 55 years, those getting a heart with any LVH had roughly six times the risk of death. But there was no such association in recipients from younger donors.

There was also an interaction between donor heart LVH and graft ischemic time. Of recipients whose graft had an ischemic time of 4 hours or longer, those receiving a heart with moderate or severe LVH had twice the risk of death.

Major Finding: Donor-heart left ventricular hypertrophy did not increase recipients' risk of death overall. However, LVH did increase mortality risk when combined with either of two other high-risk characteristics: older donor age and longer graft ischemic time.

Data Source: A retrospective study of 2,626 adult patients who underwent heart transplantation between 2006 and 2010.

Disclosures: Dr. Pinzon reported that he had no relevant conflicts of interest.

SAN DIEGO – Cardiac transplant recipients who are given hearts from donors with left ventricular hypertrophy are not at increased risk of death, Dr. Omar Wever Pinzon reported at the meeting.

In a retrospective, nationwide study of more than 2,500 adults who underwent cardiac transplantation during 2006-2010, nearly half of the donor hearts had LVH.

Recipients who had been given hearts with LVH did not have poorer survival overall than did their counterparts who had been given hearts without this high-risk characteristic. But getting a heart with LVH did reduce survival if, in addition, the donor was older than 55 years or the graft had a longer ischemic time.

“Overall survival of recipients of donor hearts with LVH is similar to those without LVH, which indicates that the current donor selection and allocation algorithms successfully mitigate the risk that donor LVH could pose to recipient survival,” Dr. Pinzon said. However, “the combination of donor LVH with certain other high-risk characteristics can result in excess mortality.”

Because few donor hearts had moderate or severe LVH, “I think we have to be very cautious” when using those hearts, he added. But hearts having an interventricular septum and posterior wall thickness up to 1.3 cm “may be safe in the absence of other high-risk characteristics.”

The scarcity of donor hearts – coupled with growing knowledge about the impact of various donor characteristics on recipient outcomes – has led to strategies to make more hearts available for transplantation, according to Dr. Pinzon.

“Thanks to these strategies, patients with left ventricular hypertrophy, considered a high-risk characteristic, are more likely now to become donors,” he commented. However, some studies have raised concerns that such hearts are more susceptible to ischemic graft injury, which could translate into poorer outcomes for the recipients.

Using data from the United Network for Organ Sharing and the Organ Procurement and Transplantation Network, the investigators studied 2,626 adult patients who underwent a first, single-organ heart transplantation in 2006-2010.

On the basis of the thickness of the interventricular septum and posterior wall, donor hearts were classified as having no LVH (less than 1.1 cm) or LVH that was mild (1.1-1.3 cm), moderate (1.4-1.6 cm), or severe (1.7 cm or greater).

The transplant recipients were 52 years old on average, and 78% were men. The donors were 33 years old on average, and 72% were men.

Fully 44% of the donor hearts had some degree of LVH, reported Dr. Pinzon of the UTAH (Utah Transplantation Affiliated Hospitals) Cardiac Transplant Program in Salt Lake City. The LVH was mild in most cases (38%) but occasionally moderate (5%) or severe (1%).

Relative to their peers who had been given donor hearts without LVH, recipients who had been given donor hearts with LVH had a higher body mass index and a higher ratio of donor-to-recipient BMI, had been on the waiting list for a shorter time, and were more likely to have a graft ischemic time exceeding 4 hours.

During a follow-up period of 3.3 years post transplantation, 13% of the recipients died or underwent retransplantation.

In univariate and multivariate analyses, neither recipients of donor hearts with mild LVH nor recipients of donor hearts with moderate or severe LVH were more likely to die than their counterparts whose donor hearts did not have any LVH, Dr. Pinzon reported.

However, recipients' risk of death increased with the age of their donor (hazard ratio, 1.01) and with their own serum creatinine level (HR, 1.31) and mean pulmonary artery pressure (HR, 1.01).

Also, they were more likely to die if their donor had used tobacco (HR, 1.32), or if they themselves were older than 55 years of age (HR, 1.30) or had been on extracorporeal membrane oxygenation support (HR, 6.0).

Further analyses revealed an interaction between donor heart LVH and donor age. Of recipients whose donor was older than 55 years, those getting a heart with any LVH had roughly six times the risk of death. But there was no such association in recipients from younger donors.

There was also an interaction between donor heart LVH and graft ischemic time. Of recipients whose graft had an ischemic time of 4 hours or longer, those receiving a heart with moderate or severe LVH had twice the risk of death.

Major Finding: Relative to sexagenarians, septuagenarians had both shorter unadjusted median survival (8.5 vs. 9.8 years) and predicted median adjusted survival (8.15 vs. 9.83 years), although most of the difference between groups appeared to result from a difference in the first year.

Data Source: A retrospective cohort study of 18,534 patients aged 60 years or older who were on the waiting list for heart transplantation.

Disclosures: Dr. Goldstein reported that he had no relevant financial disclosures.

SAN DIEGO – Heart transplant recipients in their 70s have outcomes that are generally similar to those of their counterparts in their 60s, new data show.

In a retrospective study of 18,534 wait-listed older adults, the rates of posttransplantation complications in septuagenarians were much the same as those in sexagenarians, except that the former were in fact less likely to experience rejection. And on average, the septuagenarians lived roughly 8 years after getting their new heart, which is not much shorter than the 9.8 years seen in sexagenarians, according to results reported at the meeting.

“Selected septuagenarians – and I underscore the word selected – with advanced heart failure derive great benefit from heart transplantation,” said lead investigator Dr. Daniel Goldstein. “This is not every 70-year-old [who is] going to walk into your office.”

The findings raise the thorny ethical issue of expanding age limits on eligibility for heart transplantation, as organs are scarce and every heart given to an older adult is one that is not given to a young person, he noted.

One approach would be to limit transplantation to those septuagenarians who have the best risk profile. Another would be to use an alternative list, as first tested by the University of California, Los Angeles, whereby older recipients are given hearts that are typically rejected by transplant centers.

“I don't see being able to do this without having an alternative list situation. UCLA is the perfect model,” asserted Dr. Goldstein, a cardiothoracic surgeon at the Montefiore Einstein Center for Heart and Vascular Care at Montefiore Medical Center in the Bronx, N.Y. “It would be hard to get an 18-year-old donor and give the heart to a 70-year-old, but if you take in a heart that nobody else wants, I think it's a little more palatable.”

With the aging of the population and the epidemic of heart failure among older adults, this dilemma is likely to intensify, he noted.

Centers generally use an age cutoff of 65 years for cardiac transplantation eligibility. But an informal survey of centers in the New York City and New Jersey areas suggests that “there is great variability in who we think is too old for transplantation,” he said. “It's clear that more centers are doing away with chronological age criteria.”

In the study, the investigators analyzed data from the UNOS (United Network for Organ Sharing) database for 1987-2010, first looking at trends among 18,534 adults aged 60 years or older put on the waiting list for a primary, single-organ heart transplantation. Results showed that “in the current era, septuagenarians are being transplanted more frequently, without a doubt,” Dr. Goldstein said. The number undergoing transplantation increased almost every year, and their median age was 71 years.

For age-group comparisons, the investigators restricted analyses to the years 1998-2010, a period when the data became robust and contemporary medical and surgical practices were in use, he explained.

Relative to the 5,807 sexagenarians who underwent transplantation during this period, the 332 septuagenarians who did were generally similar in terms of a wide range of comorbidities and risk factors, with a few exceptions.

Patients in the older group were more likely to be male and nondiabetic and, in terms of acuity, were less likely to be on a ventricular assist device and more likely to have the lower status 2 priority at transplantation.

With respect to recipient-donor matching, the septuagenarians were more likely to have a donor who was not an identical ABO match and who died from intracranial hemorrhage. Also, their donors were older.

In findings that Dr. Goldstein called “quite eye opening,” there were no differences between septuagenarians and sexagenarians in most posttransplantation complications (rejection during hospitalization, stroke, length of hospital stay, and receipt of a pacemaker) or in cause of death. The former were less likely to be treated for graft rejection in the first year (19% vs. 32%).

In a multivariate analysis, an age of 70 years or older was a significant risk factor for death (hazard ratio, 1.29).

Relative to sexagenarians, septuagenarians had both shorter unadjusted median survival (8.5 vs. 9.8 years) and predicted median adjusted survival (8.15 vs. 9.83 years), although most of the difference between groups appeared to result from a difference in the first year.

“I was rather surprised” by the 8-year value for the septuagenarians. “That's a very important number,” commented Dr. Goldstein.

“While survival is comparatively reduced, it still exceeds by a lot what we currently see with mechanical support therapy,” he said.

In a final analysis that was restricted to patients who survived the first year post transplantation, patients aged 70 years or older no longer had an increased risk of death, compared with their counterparts aged 60-69 years.

View on the News

Consider Ethics, Consequences

The boundaries of reasonable medical care are being pushed daily, and it now appears that heart transplantation can be done safely with acceptable survival in septuagenerians. Do these recipients receive the same posttransplant survival benefit as sexagenerians? Not quite, but it's pretty close. The small survival differences between the septuagenarians and sexagenerians suggest that age (and perhaps selection bias) should allow for older patients to be considered, in certain circumstances, as candidates. What sets organ transplantation apart from other heroic interventions (e.g., experimental chemotherapy for patients with metastatic cancer) is that donor organs are an exquisitely limited commodity. The ethics of increasing the recipient pool by including older patients must be considered, and this change may have significant consequences for younger patients on the wait list.

DR. SUDISH MURTHY is an ACS fellow and surgical director of the Center for Major Airway Disease at the Cleveland Clinic.

Vitals

Major Finding: Relative to sexagenarians, septuagenarians had both shorter unadjusted median survival (8.5 vs. 9.8 years) and predicted median adjusted survival (8.15 vs. 9.83 years), although most of the difference between groups appeared to result from a difference in the first year.

Data Source: A retrospective cohort study of 18,534 patients aged 60 years or older who were on the waiting list for heart transplantation.

Disclosures: Dr. Goldstein reported that he had no relevant financial disclosures.

SAN DIEGO – Heart transplant recipients in their 70s have outcomes that are generally similar to those of their counterparts in their 60s, new data show.

In a retrospective study of 18,534 wait-listed older adults, the rates of posttransplantation complications in septuagenarians were much the same as those in sexagenarians, except that the former were in fact less likely to experience rejection. And on average, the septuagenarians lived roughly 8 years after getting their new heart, which is not much shorter than the 9.8 years seen in sexagenarians, according to results reported at the meeting.

“Selected septuagenarians – and I underscore the word selected – with advanced heart failure derive great benefit from heart transplantation,” said lead investigator Dr. Daniel Goldstein. “This is not every 70-year-old [who is] going to walk into your office.”

The findings raise the thorny ethical issue of expanding age limits on eligibility for heart transplantation, as organs are scarce and every heart given to an older adult is one that is not given to a young person, he noted.

One approach would be to limit transplantation to those septuagenarians who have the best risk profile. Another would be to use an alternative list, as first tested by the University of California, Los Angeles, whereby older recipients are given hearts that are typically rejected by transplant centers.

“I don't see being able to do this without having an alternative list situation. UCLA is the perfect model,” asserted Dr. Goldstein, a cardiothoracic surgeon at the Montefiore Einstein Center for Heart and Vascular Care at Montefiore Medical Center in the Bronx, N.Y. “It would be hard to get an 18-year-old donor and give the heart to a 70-year-old, but if you take in a heart that nobody else wants, I think it's a little more palatable.”

With the aging of the population and the epidemic of heart failure among older adults, this dilemma is likely to intensify, he noted.

Centers generally use an age cutoff of 65 years for cardiac transplantation eligibility. But an informal survey of centers in the New York City and New Jersey areas suggests that “there is great variability in who we think is too old for transplantation,” he said. “It's clear that more centers are doing away with chronological age criteria.”

In the study, the investigators analyzed data from the UNOS (United Network for Organ Sharing) database for 1987-2010, first looking at trends among 18,534 adults aged 60 years or older put on the waiting list for a primary, single-organ heart transplantation. Results showed that “in the current era, septuagenarians are being transplanted more frequently, without a doubt,” Dr. Goldstein said. The number undergoing transplantation increased almost every year, and their median age was 71 years.

For age-group comparisons, the investigators restricted analyses to the years 1998-2010, a period when the data became robust and contemporary medical and surgical practices were in use, he explained.

Relative to the 5,807 sexagenarians who underwent transplantation during this period, the 332 septuagenarians who did were generally similar in terms of a wide range of comorbidities and risk factors, with a few exceptions.

Patients in the older group were more likely to be male and nondiabetic and, in terms of acuity, were less likely to be on a ventricular assist device and more likely to have the lower status 2 priority at transplantation.

With respect to recipient-donor matching, the septuagenarians were more likely to have a donor who was not an identical ABO match and who died from intracranial hemorrhage. Also, their donors were older.

In findings that Dr. Goldstein called “quite eye opening,” there were no differences between septuagenarians and sexagenarians in most posttransplantation complications (rejection during hospitalization, stroke, length of hospital stay, and receipt of a pacemaker) or in cause of death. The former were less likely to be treated for graft rejection in the first year (19% vs. 32%).

In a multivariate analysis, an age of 70 years or older was a significant risk factor for death (hazard ratio, 1.29).

Relative to sexagenarians, septuagenarians had both shorter unadjusted median survival (8.5 vs. 9.8 years) and predicted median adjusted survival (8.15 vs. 9.83 years), although most of the difference between groups appeared to result from a difference in the first year.

“I was rather surprised” by the 8-year value for the septuagenarians. “That's a very important number,” commented Dr. Goldstein.

“While survival is comparatively reduced, it still exceeds by a lot what we currently see with mechanical support therapy,” he said.

In a final analysis that was restricted to patients who survived the first year post transplantation, patients aged 70 years or older no longer had an increased risk of death, compared with their counterparts aged 60-69 years.

View on the News

Consider Ethics, Consequences

The boundaries of reasonable medical care are being pushed daily, and it now appears that heart transplantation can be done safely with acceptable survival in septuagenerians. Do these recipients receive the same posttransplant survival benefit as sexagenerians? Not quite, but it's pretty close. The small survival differences between the septuagenarians and sexagenerians suggest that age (and perhaps selection bias) should allow for older patients to be considered, in certain circumstances, as candidates. What sets organ transplantation apart from other heroic interventions (e.g., experimental chemotherapy for patients with metastatic cancer) is that donor organs are an exquisitely limited commodity. The ethics of increasing the recipient pool by including older patients must be considered, and this change may have significant consequences for younger patients on the wait list.

DR. SUDISH MURTHY is an ACS fellow and surgical director of the Center for Major Airway Disease at the Cleveland Clinic.

Vitals

Major Finding: Relative to sexagenarians, septuagenarians had both shorter unadjusted median survival (8.5 vs. 9.8 years) and predicted median adjusted survival (8.15 vs. 9.83 years), although most of the difference between groups appeared to result from a difference in the first year.

Data Source: A retrospective cohort study of 18,534 patients aged 60 years or older who were on the waiting list for heart transplantation.

Disclosures: Dr. Goldstein reported that he had no relevant financial disclosures.

SAN DIEGO – Heart transplant recipients in their 70s have outcomes that are generally similar to those of their counterparts in their 60s, new data show.

In a retrospective study of 18,534 wait-listed older adults, the rates of posttransplantation complications in septuagenarians were much the same as those in sexagenarians, except that the former were in fact less likely to experience rejection. And on average, the septuagenarians lived roughly 8 years after getting their new heart, which is not much shorter than the 9.8 years seen in sexagenarians, according to results reported at the meeting.

“Selected septuagenarians – and I underscore the word selected – with advanced heart failure derive great benefit from heart transplantation,” said lead investigator Dr. Daniel Goldstein. “This is not every 70-year-old [who is] going to walk into your office.”

The findings raise the thorny ethical issue of expanding age limits on eligibility for heart transplantation, as organs are scarce and every heart given to an older adult is one that is not given to a young person, he noted.

One approach would be to limit transplantation to those septuagenarians who have the best risk profile. Another would be to use an alternative list, as first tested by the University of California, Los Angeles, whereby older recipients are given hearts that are typically rejected by transplant centers.

“I don't see being able to do this without having an alternative list situation. UCLA is the perfect model,” asserted Dr. Goldstein, a cardiothoracic surgeon at the Montefiore Einstein Center for Heart and Vascular Care at Montefiore Medical Center in the Bronx, N.Y. “It would be hard to get an 18-year-old donor and give the heart to a 70-year-old, but if you take in a heart that nobody else wants, I think it's a little more palatable.”

With the aging of the population and the epidemic of heart failure among older adults, this dilemma is likely to intensify, he noted.

Centers generally use an age cutoff of 65 years for cardiac transplantation eligibility. But an informal survey of centers in the New York City and New Jersey areas suggests that “there is great variability in who we think is too old for transplantation,” he said. “It's clear that more centers are doing away with chronological age criteria.”

In the study, the investigators analyzed data from the UNOS (United Network for Organ Sharing) database for 1987-2010, first looking at trends among 18,534 adults aged 60 years or older put on the waiting list for a primary, single-organ heart transplantation. Results showed that “in the current era, septuagenarians are being transplanted more frequently, without a doubt,” Dr. Goldstein said. The number undergoing transplantation increased almost every year, and their median age was 71 years.

For age-group comparisons, the investigators restricted analyses to the years 1998-2010, a period when the data became robust and contemporary medical and surgical practices were in use, he explained.

Relative to the 5,807 sexagenarians who underwent transplantation during this period, the 332 septuagenarians who did were generally similar in terms of a wide range of comorbidities and risk factors, with a few exceptions.

Patients in the older group were more likely to be male and nondiabetic and, in terms of acuity, were less likely to be on a ventricular assist device and more likely to have the lower status 2 priority at transplantation.

With respect to recipient-donor matching, the septuagenarians were more likely to have a donor who was not an identical ABO match and who died from intracranial hemorrhage. Also, their donors were older.

In findings that Dr. Goldstein called “quite eye opening,” there were no differences between septuagenarians and sexagenarians in most posttransplantation complications (rejection during hospitalization, stroke, length of hospital stay, and receipt of a pacemaker) or in cause of death. The former were less likely to be treated for graft rejection in the first year (19% vs. 32%).

In a multivariate analysis, an age of 70 years or older was a significant risk factor for death (hazard ratio, 1.29).

Relative to sexagenarians, septuagenarians had both shorter unadjusted median survival (8.5 vs. 9.8 years) and predicted median adjusted survival (8.15 vs. 9.83 years), although most of the difference between groups appeared to result from a difference in the first year.

“I was rather surprised” by the 8-year value for the septuagenarians. “That's a very important number,” commented Dr. Goldstein.

“While survival is comparatively reduced, it still exceeds by a lot what we currently see with mechanical support therapy,” he said.

In a final analysis that was restricted to patients who survived the first year post transplantation, patients aged 70 years or older no longer had an increased risk of death, compared with their counterparts aged 60-69 years.

View on the News

Consider Ethics, Consequences

The boundaries of reasonable medical care are being pushed daily, and it now appears that heart transplantation can be done safely with acceptable survival in septuagenerians. Do these recipients receive the same posttransplant survival benefit as sexagenerians? Not quite, but it's pretty close. The small survival differences between the septuagenarians and sexagenerians suggest that age (and perhaps selection bias) should allow for older patients to be considered, in certain circumstances, as candidates. What sets organ transplantation apart from other heroic interventions (e.g., experimental chemotherapy for patients with metastatic cancer) is that donor organs are an exquisitely limited commodity. The ethics of increasing the recipient pool by including older patients must be considered, and this change may have significant consequences for younger patients on the wait list.

DR. SUDISH MURTHY is an ACS fellow and surgical director of the Center for Major Airway Disease at the Cleveland Clinic.

Vitals

SAN DIEGO – Transplantation physicians may be increasingly avoiding the use of hearts from donors who have high-risk characteristics, even as demand for transplantable hearts continues to outstrip supply, suggests a retrospective study of more than 42,000 heart transplant recipients.

The percentages of transplanted hearts from donors who have characteristics that are associated with an elevated risk of poor outcomes for the recipient (such as older age or hypertension) initially increased during the recent 2-decade study period. But thereafter, they plateaued or fell – in some cases to levels seen at the start of the period.

There are two possible explanations for the declining use of hearts from high-risk donors, lead investigator Dr. Jose N. Nativi told attendees of the meeting.

“One hypothesis is that there is a concern about adverse outcomes” for recipients who would be given these hearts, in the wake of publications describing actual experience with their use, he explained.

“The second hypothesis is that, probably, we have another option to offer these patients, that is, the increasing utilization of left ventricular assist devices,” Dr. Nativi said.

“So for a patient who is critically ill, instead of offering them a high-risk donor, now we have the luxury in some centers to offer them an alternative, that is, mechanical support,” he added.

There have been several key milestones in efforts to make more organs available for transplantation in the United States, according to Dr. Nativi, a fellow in cardiology with the University of Utah and the UTAH (Utah Transplantation Affiliated Hospitals) Cardiac Transplant Program in Salt Lake City.

The Crystal City Conference in 2001 resulted in a formal recommendation to expand the use of hearts from high-risk donors (Circulation 2002;106:836-41). In addition, the Organ Donation Breakthrough Collaborative in 2003 encouraged increased consent and donation by individuals with high-risk features (Crit. Care Nurs. Q. 2008;31:190-210).

“These efforts are resulting in the expansion of acceptable donor criteria toward high-risk donors,” he said. “But the high-risk donor still remains a matter of controversy.”

In the year after the collaborative, there was an increase in the number of all types of organs donated – with the sole exception of hearts. “So we are still struggling to find donors for heart recipients,” Dr. Nativi commented.

To assess temporal patterns in the use of hearts from high-risk donors, the investigators analyzed data from the U.S. Scientific Registry of Transplant Recipients, identifying adult patients who underwent single-organ heart transplantation in 1987-2009.

They were divided into three eras by transplantation date: era 1 (1987-1996), when standard donor criteria were used; era 2 (1997-2003), when there was increasing acceptance of the high-risk donor, and reports about the use of organs from such donors increased; and era 3 (2004-2009), after the collaborative was established.

Results were based on 42,023 patients who underwent transplantation during the study period (42% in era 1, 32% in era 2, and 26% in era 3), Dr. Nativi reported.

In multivariate analyses that included more than 40 donor characteristics as well as a transplant center's patient volume, recipients were more likely to die in the first year post transplantation if their donor was older than 40 years of age (hazard ratio, 1.2), was female (HR, 1.2), had a cerebrovascular cause of death (HR, 1.6), or had a history of hypertension (HR, 1.3).

Temporal trends showed a biphasic pattern for three of these high-risk characteristics, with the percentage of hearts having the characteristic increasing significantly between era 1 and era 2, but then decreasing significantly between era 2 and era 3.

For example, the percentage of hearts from donors older than 40 years averaged 21%, 30%, and 28% in eras 1, 2, and 3, respectively. The pattern was similar for hearts from donors who were female (29%, 31%, and 27%) and those having a cerebrovascular cause of death (26%, 29%, and 23%).

The percentage of hearts from donors having hypertension increased from 4% to 11% between eras 1 and 2, and again from 11% to 13% between eras 2 and 3. But in clinical terms, the latter change was really more of a plateau, according to Dr. Nativi.

We can now offer a critically ill patient a left ventricular assist device rather than a high-risk donor heart.

Source DR. NATIVI

SAN DIEGO – Transplantation physicians may be increasingly avoiding the use of hearts from donors who have high-risk characteristics, even as demand for transplantable hearts continues to outstrip supply, suggests a retrospective study of more than 42,000 heart transplant recipients.

The percentages of transplanted hearts from donors who have characteristics that are associated with an elevated risk of poor outcomes for the recipient (such as older age or hypertension) initially increased during the recent 2-decade study period. But thereafter, they plateaued or fell – in some cases to levels seen at the start of the period.

There are two possible explanations for the declining use of hearts from high-risk donors, lead investigator Dr. Jose N. Nativi told attendees of the meeting.

“One hypothesis is that there is a concern about adverse outcomes” for recipients who would be given these hearts, in the wake of publications describing actual experience with their use, he explained.

“The second hypothesis is that, probably, we have another option to offer these patients, that is, the increasing utilization of left ventricular assist devices,” Dr. Nativi said.

“So for a patient who is critically ill, instead of offering them a high-risk donor, now we have the luxury in some centers to offer them an alternative, that is, mechanical support,” he added.

There have been several key milestones in efforts to make more organs available for transplantation in the United States, according to Dr. Nativi, a fellow in cardiology with the University of Utah and the UTAH (Utah Transplantation Affiliated Hospitals) Cardiac Transplant Program in Salt Lake City.

The Crystal City Conference in 2001 resulted in a formal recommendation to expand the use of hearts from high-risk donors (Circulation 2002;106:836-41). In addition, the Organ Donation Breakthrough Collaborative in 2003 encouraged increased consent and donation by individuals with high-risk features (Crit. Care Nurs. Q. 2008;31:190-210).

“These efforts are resulting in the expansion of acceptable donor criteria toward high-risk donors,” he said. “But the high-risk donor still remains a matter of controversy.”

In the year after the collaborative, there was an increase in the number of all types of organs donated – with the sole exception of hearts. “So we are still struggling to find donors for heart recipients,” Dr. Nativi commented.

To assess temporal patterns in the use of hearts from high-risk donors, the investigators analyzed data from the U.S. Scientific Registry of Transplant Recipients, identifying adult patients who underwent single-organ heart transplantation in 1987-2009.

They were divided into three eras by transplantation date: era 1 (1987-1996), when standard donor criteria were used; era 2 (1997-2003), when there was increasing acceptance of the high-risk donor, and reports about the use of organs from such donors increased; and era 3 (2004-2009), after the collaborative was established.

Results were based on 42,023 patients who underwent transplantation during the study period (42% in era 1, 32% in era 2, and 26% in era 3), Dr. Nativi reported.

In multivariate analyses that included more than 40 donor characteristics as well as a transplant center's patient volume, recipients were more likely to die in the first year post transplantation if their donor was older than 40 years of age (hazard ratio, 1.2), was female (HR, 1.2), had a cerebrovascular cause of death (HR, 1.6), or had a history of hypertension (HR, 1.3).

Temporal trends showed a biphasic pattern for three of these high-risk characteristics, with the percentage of hearts having the characteristic increasing significantly between era 1 and era 2, but then decreasing significantly between era 2 and era 3.

For example, the percentage of hearts from donors older than 40 years averaged 21%, 30%, and 28% in eras 1, 2, and 3, respectively. The pattern was similar for hearts from donors who were female (29%, 31%, and 27%) and those having a cerebrovascular cause of death (26%, 29%, and 23%).

The percentage of hearts from donors having hypertension increased from 4% to 11% between eras 1 and 2, and again from 11% to 13% between eras 2 and 3. But in clinical terms, the latter change was really more of a plateau, according to Dr. Nativi.

We can now offer a critically ill patient a left ventricular assist device rather than a high-risk donor heart.

Source DR. NATIVI

SAN DIEGO – Transplantation physicians may be increasingly avoiding the use of hearts from donors who have high-risk characteristics, even as demand for transplantable hearts continues to outstrip supply, suggests a retrospective study of more than 42,000 heart transplant recipients.

The percentages of transplanted hearts from donors who have characteristics that are associated with an elevated risk of poor outcomes for the recipient (such as older age or hypertension) initially increased during the recent 2-decade study period. But thereafter, they plateaued or fell – in some cases to levels seen at the start of the period.

There are two possible explanations for the declining use of hearts from high-risk donors, lead investigator Dr. Jose N. Nativi told attendees of the meeting.

“One hypothesis is that there is a concern about adverse outcomes” for recipients who would be given these hearts, in the wake of publications describing actual experience with their use, he explained.

“The second hypothesis is that, probably, we have another option to offer these patients, that is, the increasing utilization of left ventricular assist devices,” Dr. Nativi said.

“So for a patient who is critically ill, instead of offering them a high-risk donor, now we have the luxury in some centers to offer them an alternative, that is, mechanical support,” he added.

There have been several key milestones in efforts to make more organs available for transplantation in the United States, according to Dr. Nativi, a fellow in cardiology with the University of Utah and the UTAH (Utah Transplantation Affiliated Hospitals) Cardiac Transplant Program in Salt Lake City.

The Crystal City Conference in 2001 resulted in a formal recommendation to expand the use of hearts from high-risk donors (Circulation 2002;106:836-41). In addition, the Organ Donation Breakthrough Collaborative in 2003 encouraged increased consent and donation by individuals with high-risk features (Crit. Care Nurs. Q. 2008;31:190-210).

“These efforts are resulting in the expansion of acceptable donor criteria toward high-risk donors,” he said. “But the high-risk donor still remains a matter of controversy.”

In the year after the collaborative, there was an increase in the number of all types of organs donated – with the sole exception of hearts. “So we are still struggling to find donors for heart recipients,” Dr. Nativi commented.

To assess temporal patterns in the use of hearts from high-risk donors, the investigators analyzed data from the U.S. Scientific Registry of Transplant Recipients, identifying adult patients who underwent single-organ heart transplantation in 1987-2009.

They were divided into three eras by transplantation date: era 1 (1987-1996), when standard donor criteria were used; era 2 (1997-2003), when there was increasing acceptance of the high-risk donor, and reports about the use of organs from such donors increased; and era 3 (2004-2009), after the collaborative was established.

Results were based on 42,023 patients who underwent transplantation during the study period (42% in era 1, 32% in era 2, and 26% in era 3), Dr. Nativi reported.

In multivariate analyses that included more than 40 donor characteristics as well as a transplant center's patient volume, recipients were more likely to die in the first year post transplantation if their donor was older than 40 years of age (hazard ratio, 1.2), was female (HR, 1.2), had a cerebrovascular cause of death (HR, 1.6), or had a history of hypertension (HR, 1.3).

Temporal trends showed a biphasic pattern for three of these high-risk characteristics, with the percentage of hearts having the characteristic increasing significantly between era 1 and era 2, but then decreasing significantly between era 2 and era 3.

For example, the percentage of hearts from donors older than 40 years averaged 21%, 30%, and 28% in eras 1, 2, and 3, respectively. The pattern was similar for hearts from donors who were female (29%, 31%, and 27%) and those having a cerebrovascular cause of death (26%, 29%, and 23%).

The percentage of hearts from donors having hypertension increased from 4% to 11% between eras 1 and 2, and again from 11% to 13% between eras 2 and 3. But in clinical terms, the latter change was really more of a plateau, according to Dr. Nativi.

We can now offer a critically ill patient a left ventricular assist device rather than a high-risk donor heart.

Source DR. NATIVI

SEATTLE – Text message reminders improve timely receipt of the human papillomavirus vaccine, according to results of a study of more than 1,500 girls who had started the three-dose series.

About a third of parents offered the reminders signed up for them, and girls whose parents signed up were twice as likely to receive their next dose of vaccine within a month of when it was due, compared with their counterparts whose parents did not sign up.

“We found that text messaging can increase on-time vaccination,” commented first author Dr. Elyse O. Kharbanda, a pediatrician who was with Columbia University Medical Center, New York, at the time of the study and is now with the Health Partners Research Foundation in Minneapolis. “We recommend these findings should be replicated in a larger and more diverse sample,” she added. “And future studies should really explore what our main issue was: How to get more parents to sign up for this type of service.”

Although the Food and Drug Administration approved the quadrivalent human papillomavirus (HPV) vaccine (Gardasil, Merck) in 2006, the rate of receipt of all three doses among girls remains low, and receipt of doses on time is also problematic, according to Dr. Kharbanda. Several factors may explain this poor adherence.

“Unlike routine vaccines that we give to infants, this three-dose vaccine series is not aligned with routine adolescent health care visits,” she said. Financial barriers and provider factors also may explain some of the adherence problem.

“But what actually I think is the most important barrier is the parents and teens themselves,” Dr. Kharbanda commented. “It's not that [the parents] explicitly oppose the vaccine, it's just that they are busy – they have busy lives with competing priorities, and getting their child or their teen in for three visits to get a shot over a 6-month period is just not high on their To-Do list.”

There is good reason to believe that use of text messaging to send reminders could help solve this problem. “We thought cellular technology may provide an advantage because of its penetrance: Over 96% of U.S. adults now own a cell phone,” she explained. “And especially in low-income populations, cell phone numbers may be even more stable than land-line numbers.”

The study, part of the Text4Health study exploring use of this technology among underserved, low-income populations, was conducted in nine clinical sites in New York. It was open to English- or Spanish-speaking parents with a cell phone who brought daughters aged 10–18 years in for the first or second dose of the quadrivalent HPV vaccine between January and June 2009. The parents were given a recruitment card with instructions in English and Spanish on how to sign up for text message reminders for the next dose of vaccine. Parents who signed up received up to three automated text messages reminding them that their daughter had an upcoming due date for her next HPV vaccine dose. In all, recruitment cards were given to the parents of 434 girls, 29% of whom signed up. The 124 who entered a valid personal identification number were sent text message reminders. The comparison groups consisted of 308 girls whose parents did not sign up for the reminders and 1,080 girls who had received a first or second dose of HPV vaccine in the same clinics in the 6 months before the intervention and served as historic controls. The girls were 14 years old on average, and nearly three-quarters had Medicaid or state Children's Health Insurance Program (SCHIP). Most (84%) received their care in an academic clinic.

Study results showed that the percentage of girls who received their next HPV vaccine dose within 1 month of the due date, the primary end point, was 52% among those whose parents signed up for reminders, 35% among those whose parents did not sign up, and 38% among those who served as historic controls.

Dr. Kharbanda reported that Vaughn I. Rickert, Psy.D., one of the study co-investigators, is a consultant to Sanofi Pasteur and receives research funding from and sits on the advisory board of Merck.

SEATTLE – Text message reminders improve timely receipt of the human papillomavirus vaccine, according to results of a study of more than 1,500 girls who had started the three-dose series.

About a third of parents offered the reminders signed up for them, and girls whose parents signed up were twice as likely to receive their next dose of vaccine within a month of when it was due, compared with their counterparts whose parents did not sign up.

“We found that text messaging can increase on-time vaccination,” commented first author Dr. Elyse O. Kharbanda, a pediatrician who was with Columbia University Medical Center, New York, at the time of the study and is now with the Health Partners Research Foundation in Minneapolis. “We recommend these findings should be replicated in a larger and more diverse sample,” she added. “And future studies should really explore what our main issue was: How to get more parents to sign up for this type of service.”

Although the Food and Drug Administration approved the quadrivalent human papillomavirus (HPV) vaccine (Gardasil, Merck) in 2006, the rate of receipt of all three doses among girls remains low, and receipt of doses on time is also problematic, according to Dr. Kharbanda. Several factors may explain this poor adherence.

“Unlike routine vaccines that we give to infants, this three-dose vaccine series is not aligned with routine adolescent health care visits,” she said. Financial barriers and provider factors also may explain some of the adherence problem.

“But what actually I think is the most important barrier is the parents and teens themselves,” Dr. Kharbanda commented. “It's not that [the parents] explicitly oppose the vaccine, it's just that they are busy – they have busy lives with competing priorities, and getting their child or their teen in for three visits to get a shot over a 6-month period is just not high on their To-Do list.”

There is good reason to believe that use of text messaging to send reminders could help solve this problem. “We thought cellular technology may provide an advantage because of its penetrance: Over 96% of U.S. adults now own a cell phone,” she explained. “And especially in low-income populations, cell phone numbers may be even more stable than land-line numbers.”

The study, part of the Text4Health study exploring use of this technology among underserved, low-income populations, was conducted in nine clinical sites in New York. It was open to English- or Spanish-speaking parents with a cell phone who brought daughters aged 10–18 years in for the first or second dose of the quadrivalent HPV vaccine between January and June 2009. The parents were given a recruitment card with instructions in English and Spanish on how to sign up for text message reminders for the next dose of vaccine. Parents who signed up received up to three automated text messages reminding them that their daughter had an upcoming due date for her next HPV vaccine dose. In all, recruitment cards were given to the parents of 434 girls, 29% of whom signed up. The 124 who entered a valid personal identification number were sent text message reminders. The comparison groups consisted of 308 girls whose parents did not sign up for the reminders and 1,080 girls who had received a first or second dose of HPV vaccine in the same clinics in the 6 months before the intervention and served as historic controls. The girls were 14 years old on average, and nearly three-quarters had Medicaid or state Children's Health Insurance Program (SCHIP). Most (84%) received their care in an academic clinic.

Study results showed that the percentage of girls who received their next HPV vaccine dose within 1 month of the due date, the primary end point, was 52% among those whose parents signed up for reminders, 35% among those whose parents did not sign up, and 38% among those who served as historic controls.

Dr. Kharbanda reported that Vaughn I. Rickert, Psy.D., one of the study co-investigators, is a consultant to Sanofi Pasteur and receives research funding from and sits on the advisory board of Merck.

SEATTLE – Text message reminders improve timely receipt of the human papillomavirus vaccine, according to results of a study of more than 1,500 girls who had started the three-dose series.

About a third of parents offered the reminders signed up for them, and girls whose parents signed up were twice as likely to receive their next dose of vaccine within a month of when it was due, compared with their counterparts whose parents did not sign up.

“We found that text messaging can increase on-time vaccination,” commented first author Dr. Elyse O. Kharbanda, a pediatrician who was with Columbia University Medical Center, New York, at the time of the study and is now with the Health Partners Research Foundation in Minneapolis. “We recommend these findings should be replicated in a larger and more diverse sample,” she added. “And future studies should really explore what our main issue was: How to get more parents to sign up for this type of service.”

Although the Food and Drug Administration approved the quadrivalent human papillomavirus (HPV) vaccine (Gardasil, Merck) in 2006, the rate of receipt of all three doses among girls remains low, and receipt of doses on time is also problematic, according to Dr. Kharbanda. Several factors may explain this poor adherence.

“Unlike routine vaccines that we give to infants, this three-dose vaccine series is not aligned with routine adolescent health care visits,” she said. Financial barriers and provider factors also may explain some of the adherence problem.

“But what actually I think is the most important barrier is the parents and teens themselves,” Dr. Kharbanda commented. “It's not that [the parents] explicitly oppose the vaccine, it's just that they are busy – they have busy lives with competing priorities, and getting their child or their teen in for three visits to get a shot over a 6-month period is just not high on their To-Do list.”

There is good reason to believe that use of text messaging to send reminders could help solve this problem. “We thought cellular technology may provide an advantage because of its penetrance: Over 96% of U.S. adults now own a cell phone,” she explained. “And especially in low-income populations, cell phone numbers may be even more stable than land-line numbers.”

The study, part of the Text4Health study exploring use of this technology among underserved, low-income populations, was conducted in nine clinical sites in New York. It was open to English- or Spanish-speaking parents with a cell phone who brought daughters aged 10–18 years in for the first or second dose of the quadrivalent HPV vaccine between January and June 2009. The parents were given a recruitment card with instructions in English and Spanish on how to sign up for text message reminders for the next dose of vaccine. Parents who signed up received up to three automated text messages reminding them that their daughter had an upcoming due date for her next HPV vaccine dose. In all, recruitment cards were given to the parents of 434 girls, 29% of whom signed up. The 124 who entered a valid personal identification number were sent text message reminders. The comparison groups consisted of 308 girls whose parents did not sign up for the reminders and 1,080 girls who had received a first or second dose of HPV vaccine in the same clinics in the 6 months before the intervention and served as historic controls. The girls were 14 years old on average, and nearly three-quarters had Medicaid or state Children's Health Insurance Program (SCHIP). Most (84%) received their care in an academic clinic.

Study results showed that the percentage of girls who received their next HPV vaccine dose within 1 month of the due date, the primary end point, was 52% among those whose parents signed up for reminders, 35% among those whose parents did not sign up, and 38% among those who served as historic controls.

Dr. Kharbanda reported that Vaughn I. Rickert, Psy.D., one of the study co-investigators, is a consultant to Sanofi Pasteur and receives research funding from and sits on the advisory board of Merck.

Major Finding: Only 44% of parents who were aware of the meningococcal vaccine had had their child vaccinated. The leading reason cited for nonvaccination was that a health care provider did not mention or recommend the vaccine.

Data Source: A telephone survey of 1,281 parents of adolescents aged 11–17 years in North Carolina

Disclosures: Dr. Coyne-Beasley reported that she did not have any relevant financial disclosures.

SEATTLE – Awareness is not enough when it comes to promoting uptake of the meningococcal vaccine among adolescents, suggest results of a recent North Carolina survey.

Two-thirds of the more than 1,000 parents of adolescents polled had heard of the vaccine, which the Advisory Committee on Immunization Practices (ACIP) recommends be given at the age of 11–12 years and, because of waning immunity, again as a booster at the age of 16 years.

But just 44% of these parents had had their adolescent vaccinated, lead investigator Dr. Tamera Coyne-Beasley reported at the meeting. In addition, 39% of the parents of unvaccinated adolescents indicated that they probably or definitely would not vaccinate them in the next year.

The leading reason parents cited for nonvaccination was that their health care provider had not mentioned or recommended the vaccine.

Some also gave as a reason not having seen their doctor recently.

“Interventions are urgently needed to increase the uptake of meningococcal conjugate vaccine, particularly in light of the new recommendation for a booster dose, and the substantial proportion of parents … who reported that they still definitely or probably will not get the vaccine,” Dr. Coyne-Beasley said.

“Strategies such as increasing provider recommendations and increasing regular preventive visits may be important,” she noted.

“One of the things I would like to explore is what are those issues [behind nonvaccination] and how can we overcome them,” she commented.

Some people “may have just an inherent philosophy that we may not understand about why they don't want to get vaccines. But I do think that there are things we can work with, with families,” Dr. Coyne-Beasley said.

The investigators analyzed data from the 2008 Child Health Assessment and Monitoring Program (CHAMP) telephone survey conducted in North Carolina, a state that does not mandate receipt of the meningococcal vaccine for school entry. The survey involved households from a larger, random, population-based survey that had at least one child under age 18.

The individual in the household most knowledgeable about the child's health was read a list of possible names of the meningococcal vaccine (meningitis shot, meningococcal shot, Menactra) and asked whether they had heard of it, and if they had, whether the child had received it.

Data from parents of adolescents aged 11–17 years were weighted to provide population-based estimates, according to Dr. Coyne-Beasley, who is an associate professor of pediatrics and internal medicine at the University of North Carolina, Chapel Hill.

In all, 1,281 parents completed the survey. Some 48% were 40–49 years old, and two-thirds were female. Some 74% were married or cohabiting with a partner, and 71% were employed.

On average, the adolescents were 14.1 years old. They were equally split by sex. Some 63% were white, 23% were black, 9% were Hispanic, and 5% were of other races/ethnicities.

The majority of the adolescents attended public school (88%), had health insurance (93%), had a regular health care provider (83%), and had had a preventive checkup in the past 12 months (78%).

Fully 65% of the surveyed parents were aware of the meningococcal vaccine, according to Dr. Coyne-Beasley.

She noted that the state did not have any meningitis outbreaks during the survey year, which usually increase awareness.

In multivariate analyses, parents were significantly more likely to be aware of the vaccine if their child was aged 16–17 years compared with 11–12 years (odds ratio 1.82), attended private school compared with public school (OR 1.95), and had health insurance (OR 1.90).

On the other hand, parents were significantly less likely to be aware of the vaccine if their child was Hispanic compared with white (OR 0.50).

Just 44% of the parents who were aware of the meningococcal vaccine had had their adolescent vaccinated.

In multivariate analyses, adolescents were significantly more likely to have been vaccinated if they were black versus white (OR 2.17), had had a preventive health checkup in the past 12 months (OR 3.03), and lived in a household having two or more children under age 18 (OR 1.83).

Among the parents who had not had their adolescent vaccinated, the single most common reason, cited by 25%, was that their health care provider did not mention or recommend the vaccine, Dr. Coyne-Beasley reported.

Other reasons cited included believing that their adolescent did not need the vaccine (14%), wanting to wait until he or she was older (10%), concerns about vaccine safety (9%), and not having been to a doctor recently (8%).

More than half of these parents of unvaccinated children said that in the next year, they definitely would (21%) or probably would (33%) have them vaccinated, and a small minority (8%) were unsure.

However, sizable proportions said they probably would not (29%) or definitely would not (10%) have their child vaccinated in the next year.

“Awareness of a vaccine doesn't necessarily mean that one will get it,” Dr. Coyne-Beasley concluded, and it will be important to ascertain the reasons for the observed disconnect between awareness and uptake of the meningococcal vaccine among adolescents.

The study had its limitations, she acknowledged. They included the self-reported nature of the data, potential limited generalizability, inclusion of only households having a landline telephone, and availability of just a single meningococcal conjugate vaccine at the time of the survey.

The leading reason for nonvaccination was that a health care provider did not mention or recommend the vaccine.

Source DR. COYNE-BEASLEY

Major Finding: Only 44% of parents who were aware of the meningococcal vaccine had had their child vaccinated. The leading reason cited for nonvaccination was that a health care provider did not mention or recommend the vaccine.

Data Source: A telephone survey of 1,281 parents of adolescents aged 11–17 years in North Carolina

Disclosures: Dr. Coyne-Beasley reported that she did not have any relevant financial disclosures.

SEATTLE – Awareness is not enough when it comes to promoting uptake of the meningococcal vaccine among adolescents, suggest results of a recent North Carolina survey.

Two-thirds of the more than 1,000 parents of adolescents polled had heard of the vaccine, which the Advisory Committee on Immunization Practices (ACIP) recommends be given at the age of 11–12 years and, because of waning immunity, again as a booster at the age of 16 years.

But just 44% of these parents had had their adolescent vaccinated, lead investigator Dr. Tamera Coyne-Beasley reported at the meeting. In addition, 39% of the parents of unvaccinated adolescents indicated that they probably or definitely would not vaccinate them in the next year.

The leading reason parents cited for nonvaccination was that their health care provider had not mentioned or recommended the vaccine.

Some also gave as a reason not having seen their doctor recently.

“Interventions are urgently needed to increase the uptake of meningococcal conjugate vaccine, particularly in light of the new recommendation for a booster dose, and the substantial proportion of parents … who reported that they still definitely or probably will not get the vaccine,” Dr. Coyne-Beasley said.

“Strategies such as increasing provider recommendations and increasing regular preventive visits may be important,” she noted.

“One of the things I would like to explore is what are those issues [behind nonvaccination] and how can we overcome them,” she commented.

Some people “may have just an inherent philosophy that we may not understand about why they don't want to get vaccines. But I do think that there are things we can work with, with families,” Dr. Coyne-Beasley said.

The investigators analyzed data from the 2008 Child Health Assessment and Monitoring Program (CHAMP) telephone survey conducted in North Carolina, a state that does not mandate receipt of the meningococcal vaccine for school entry. The survey involved households from a larger, random, population-based survey that had at least one child under age 18.

The individual in the household most knowledgeable about the child's health was read a list of possible names of the meningococcal vaccine (meningitis shot, meningococcal shot, Menactra) and asked whether they had heard of it, and if they had, whether the child had received it.

Data from parents of adolescents aged 11–17 years were weighted to provide population-based estimates, according to Dr. Coyne-Beasley, who is an associate professor of pediatrics and internal medicine at the University of North Carolina, Chapel Hill.

In all, 1,281 parents completed the survey. Some 48% were 40–49 years old, and two-thirds were female. Some 74% were married or cohabiting with a partner, and 71% were employed.

On average, the adolescents were 14.1 years old. They were equally split by sex. Some 63% were white, 23% were black, 9% were Hispanic, and 5% were of other races/ethnicities.

The majority of the adolescents attended public school (88%), had health insurance (93%), had a regular health care provider (83%), and had had a preventive checkup in the past 12 months (78%).

Fully 65% of the surveyed parents were aware of the meningococcal vaccine, according to Dr. Coyne-Beasley.

She noted that the state did not have any meningitis outbreaks during the survey year, which usually increase awareness.

In multivariate analyses, parents were significantly more likely to be aware of the vaccine if their child was aged 16–17 years compared with 11–12 years (odds ratio 1.82), attended private school compared with public school (OR 1.95), and had health insurance (OR 1.90).

On the other hand, parents were significantly less likely to be aware of the vaccine if their child was Hispanic compared with white (OR 0.50).

Just 44% of the parents who were aware of the meningococcal vaccine had had their adolescent vaccinated.

In multivariate analyses, adolescents were significantly more likely to have been vaccinated if they were black versus white (OR 2.17), had had a preventive health checkup in the past 12 months (OR 3.03), and lived in a household having two or more children under age 18 (OR 1.83).

Among the parents who had not had their adolescent vaccinated, the single most common reason, cited by 25%, was that their health care provider did not mention or recommend the vaccine, Dr. Coyne-Beasley reported.

Other reasons cited included believing that their adolescent did not need the vaccine (14%), wanting to wait until he or she was older (10%), concerns about vaccine safety (9%), and not having been to a doctor recently (8%).

More than half of these parents of unvaccinated children said that in the next year, they definitely would (21%) or probably would (33%) have them vaccinated, and a small minority (8%) were unsure.

However, sizable proportions said they probably would not (29%) or definitely would not (10%) have their child vaccinated in the next year.

“Awareness of a vaccine doesn't necessarily mean that one will get it,” Dr. Coyne-Beasley concluded, and it will be important to ascertain the reasons for the observed disconnect between awareness and uptake of the meningococcal vaccine among adolescents.

The study had its limitations, she acknowledged. They included the self-reported nature of the data, potential limited generalizability, inclusion of only households having a landline telephone, and availability of just a single meningococcal conjugate vaccine at the time of the survey.

The leading reason for nonvaccination was that a health care provider did not mention or recommend the vaccine.

Source DR. COYNE-BEASLEY

Major Finding: Only 44% of parents who were aware of the meningococcal vaccine had had their child vaccinated. The leading reason cited for nonvaccination was that a health care provider did not mention or recommend the vaccine.

Data Source: A telephone survey of 1,281 parents of adolescents aged 11–17 years in North Carolina

Disclosures: Dr. Coyne-Beasley reported that she did not have any relevant financial disclosures.

SEATTLE – Awareness is not enough when it comes to promoting uptake of the meningococcal vaccine among adolescents, suggest results of a recent North Carolina survey.

Two-thirds of the more than 1,000 parents of adolescents polled had heard of the vaccine, which the Advisory Committee on Immunization Practices (ACIP) recommends be given at the age of 11–12 years and, because of waning immunity, again as a booster at the age of 16 years.

But just 44% of these parents had had their adolescent vaccinated, lead investigator Dr. Tamera Coyne-Beasley reported at the meeting. In addition, 39% of the parents of unvaccinated adolescents indicated that they probably or definitely would not vaccinate them in the next year.

The leading reason parents cited for nonvaccination was that their health care provider had not mentioned or recommended the vaccine.

Some also gave as a reason not having seen their doctor recently.

“Interventions are urgently needed to increase the uptake of meningococcal conjugate vaccine, particularly in light of the new recommendation for a booster dose, and the substantial proportion of parents … who reported that they still definitely or probably will not get the vaccine,” Dr. Coyne-Beasley said.

“Strategies such as increasing provider recommendations and increasing regular preventive visits may be important,” she noted.

“One of the things I would like to explore is what are those issues [behind nonvaccination] and how can we overcome them,” she commented.

Some people “may have just an inherent philosophy that we may not understand about why they don't want to get vaccines. But I do think that there are things we can work with, with families,” Dr. Coyne-Beasley said.

The investigators analyzed data from the 2008 Child Health Assessment and Monitoring Program (CHAMP) telephone survey conducted in North Carolina, a state that does not mandate receipt of the meningococcal vaccine for school entry. The survey involved households from a larger, random, population-based survey that had at least one child under age 18.

The individual in the household most knowledgeable about the child's health was read a list of possible names of the meningococcal vaccine (meningitis shot, meningococcal shot, Menactra) and asked whether they had heard of it, and if they had, whether the child had received it.

Data from parents of adolescents aged 11–17 years were weighted to provide population-based estimates, according to Dr. Coyne-Beasley, who is an associate professor of pediatrics and internal medicine at the University of North Carolina, Chapel Hill.

In all, 1,281 parents completed the survey. Some 48% were 40–49 years old, and two-thirds were female. Some 74% were married or cohabiting with a partner, and 71% were employed.

On average, the adolescents were 14.1 years old. They were equally split by sex. Some 63% were white, 23% were black, 9% were Hispanic, and 5% were of other races/ethnicities.

The majority of the adolescents attended public school (88%), had health insurance (93%), had a regular health care provider (83%), and had had a preventive checkup in the past 12 months (78%).

Fully 65% of the surveyed parents were aware of the meningococcal vaccine, according to Dr. Coyne-Beasley.

She noted that the state did not have any meningitis outbreaks during the survey year, which usually increase awareness.

In multivariate analyses, parents were significantly more likely to be aware of the vaccine if their child was aged 16–17 years compared with 11–12 years (odds ratio 1.82), attended private school compared with public school (OR 1.95), and had health insurance (OR 1.90).

On the other hand, parents were significantly less likely to be aware of the vaccine if their child was Hispanic compared with white (OR 0.50).

Just 44% of the parents who were aware of the meningococcal vaccine had had their adolescent vaccinated.

In multivariate analyses, adolescents were significantly more likely to have been vaccinated if they were black versus white (OR 2.17), had had a preventive health checkup in the past 12 months (OR 3.03), and lived in a household having two or more children under age 18 (OR 1.83).

Among the parents who had not had their adolescent vaccinated, the single most common reason, cited by 25%, was that their health care provider did not mention or recommend the vaccine, Dr. Coyne-Beasley reported.

Other reasons cited included believing that their adolescent did not need the vaccine (14%), wanting to wait until he or she was older (10%), concerns about vaccine safety (9%), and not having been to a doctor recently (8%).

More than half of these parents of unvaccinated children said that in the next year, they definitely would (21%) or probably would (33%) have them vaccinated, and a small minority (8%) were unsure.

However, sizable proportions said they probably would not (29%) or definitely would not (10%) have their child vaccinated in the next year.

“Awareness of a vaccine doesn't necessarily mean that one will get it,” Dr. Coyne-Beasley concluded, and it will be important to ascertain the reasons for the observed disconnect between awareness and uptake of the meningococcal vaccine among adolescents.

The study had its limitations, she acknowledged. They included the self-reported nature of the data, potential limited generalizability, inclusion of only households having a landline telephone, and availability of just a single meningococcal conjugate vaccine at the time of the survey.

The leading reason for nonvaccination was that a health care provider did not mention or recommend the vaccine.

Source DR. COYNE-BEASLEY

SEATTLE – Both a high rate of trichomoniasis among sexually active teenage and adult women who seek self-testing and the elevated rate of adverse reproductive health outcomes in infected women raise the question of whether trichomoniasis should be a reportable infection in the United States, Charlotte A. Gaydos said.

Some 10% of the more than 1,500 women who were recruited through the Internet and offered free self-testing, and who then submitted vaginal samples, were positive for this sexually transmitted infection (STI) in an observational study reported at the annual meeting of the Society for Adolescent Health and Medicine. Rates were highest among those aged 25-29 years and among blacks.

These findings, coupled with the adverse health effects of trichomoniasis, may have implications for tracking the infection in the population, according to lead investigator Charlotte A. Gaydos, Dr.P.H., a professor in the division of infectious diseases at Johns Hopkins University in Baltimore.

Trichomoniasis is currently not reportable to the Centers for Disease Control and Prevention, she noted. But study estimates from the CDC suggest that there are 7-8 million new cases every year in the United States.

Infected men and – in particular – women have elevated rates of adverse reproductive health outcomes, including pelvic inflammatory disease, low infant birth weight, and premature delivery. Furthermore, this STI has been increasingly implicated as a risk factor for HIV transmission, she said.

"My question to the proponents of adolescent health and health for women in general is, should we start to do surveillance for Trichomonas [vaginalis] in the United States, so that we can have good data?" Dr. Gaydos asked. "I think more studies are needed."

Additionally, "should we make this a reportable infection in the future?" she inquired, given the many negative outcomes associated with trichomoniasis and the fact that it can be asymptomatic.

The investigators studied women who were recruited through IWantTheKit.org, an educational Internet program on STIs that offers free self-testing to sexually active individuals aged 14 years or older in Denver, Philadelphia, Alaska, Maryland, West Virginia, selected counties in Illinois, and Washington, D.C.

"We know that submission of self-collected samples at home can remove some barriers for adolescents and other women in testing for sexually transmitted diseases," Dr. Gaydos commented. "We have shown in the past that an Internet-recruited population can do this for Chlamydia and gonorrhea."

Starting in mid-2006, the program added testing for trichomoniasis to its existing testing for Chlamydia and gonorrhea. Women ordered the kit online and sent self-collected vaginal samples by U.S. mail to the testing lab. They also completed questionnaires on demographics and risk factors.

The lab tested for trichomoniasis using a nucleic acid amplification test, which has a sensitivity of about 90%, compared with roughly 50% for wet prep and 70% for culture, according to Dr. Gaydos.

The women were instructed to call for their test results in 1-2 weeks, and – should they forget to call – to indicate their preferred method of notification (e-mail, cell phone, letter, or text message).

A total of 1,525 women requested and returned self-collected vaginal swab kits in 2006-2010.

Overall, 10% of women tested positive for trichomoniasis, Dr. Gaydos reported. In addition, 10% tested positive for Chlamydia, 1% tested positive for gonorrhea, and 18% tested positive for at least one of the three infections studied.

By age, the rate of trichomoniasis ranged from 8.3% among those aged 20-24 years to 11.5% among 25- to 29-year-olds. And by race, it ranged from 0% among Asian women to 13.2% among black women.

In a multivariate analysis, women were more likely to have trichomoniasis if they were black compared with white, Asian, or other race/ethnicity (odds ratio, 2.69); did not have health insurance (OR, 1.57); did not have a bachelor’s degree (OR, 5.53); had 2-15, or 16 or more partners in the past year vs. none or a single partner (OR, 1.60 and 3.51); were bisexual (OR, 2.00); did not always use a condom (3.04); or had a partner who had an STI (OR, 1.71).

Age, having had trichomoniasis previously, and having had any STI in the past were not independent risk factors for trichomoniasis, according to Dr. Gaydos.

Participants reported hearing about the program in a variety of ways. "About 30% say that they found it surfing the Internet, and about 28% say they heard about it on the radio, which is how we advertise the presence of the kit in our local areas most of the time," Dr. Gaydos said. Additionally, small proportions reported learning about the program from friends, fliers, and partners.

"Interestingly enough, when we queried the men, a much higher percentage answer on their questionnaire that they were told by their partner," she commented. "So the men are not telling their female partners to get tested, but the females are telling their male partners to get tested."

The study had its limitations, Dr. Gaydos acknowledged. "Obviously, it is biased because it’s selecting people who are empowered to think about their own sexual health. They are interested in finding out if they are infected, and they do report high [levels of] risk factors, which are similar to those that we see in STD clinics," she said.

Dr. Gaydos reported that she has received free diagnostic kits from Gen-Probe Inc.

SEATTLE – Both a high rate of trichomoniasis among sexually active teenage and adult women who seek self-testing and the elevated rate of adverse reproductive health outcomes in infected women raise the question of whether trichomoniasis should be a reportable infection in the United States, Charlotte A. Gaydos said.

Some 10% of the more than 1,500 women who were recruited through the Internet and offered free self-testing, and who then submitted vaginal samples, were positive for this sexually transmitted infection (STI) in an observational study reported at the annual meeting of the Society for Adolescent Health and Medicine. Rates were highest among those aged 25-29 years and among blacks.

These findings, coupled with the adverse health effects of trichomoniasis, may have implications for tracking the infection in the population, according to lead investigator Charlotte A. Gaydos, Dr.P.H., a professor in the division of infectious diseases at Johns Hopkins University in Baltimore.

Trichomoniasis is currently not reportable to the Centers for Disease Control and Prevention, she noted. But study estimates from the CDC suggest that there are 7-8 million new cases every year in the United States.

Infected men and – in particular – women have elevated rates of adverse reproductive health outcomes, including pelvic inflammatory disease, low infant birth weight, and premature delivery. Furthermore, this STI has been increasingly implicated as a risk factor for HIV transmission, she said.

"My question to the proponents of adolescent health and health for women in general is, should we start to do surveillance for Trichomonas [vaginalis] in the United States, so that we can have good data?" Dr. Gaydos asked. "I think more studies are needed."

Additionally, "should we make this a reportable infection in the future?" she inquired, given the many negative outcomes associated with trichomoniasis and the fact that it can be asymptomatic.

The investigators studied women who were recruited through IWantTheKit.org, an educational Internet program on STIs that offers free self-testing to sexually active individuals aged 14 years or older in Denver, Philadelphia, Alaska, Maryland, West Virginia, selected counties in Illinois, and Washington, D.C.

"We know that submission of self-collected samples at home can remove some barriers for adolescents and other women in testing for sexually transmitted diseases," Dr. Gaydos commented. "We have shown in the past that an Internet-recruited population can do this for Chlamydia and gonorrhea."

Starting in mid-2006, the program added testing for trichomoniasis to its existing testing for Chlamydia and gonorrhea. Women ordered the kit online and sent self-collected vaginal samples by U.S. mail to the testing lab. They also completed questionnaires on demographics and risk factors.

The lab tested for trichomoniasis using a nucleic acid amplification test, which has a sensitivity of about 90%, compared with roughly 50% for wet prep and 70% for culture, according to Dr. Gaydos.

The women were instructed to call for their test results in 1-2 weeks, and – should they forget to call – to indicate their preferred method of notification (e-mail, cell phone, letter, or text message).

A total of 1,525 women requested and returned self-collected vaginal swab kits in 2006-2010.

Overall, 10% of women tested positive for trichomoniasis, Dr. Gaydos reported. In addition, 10% tested positive for Chlamydia, 1% tested positive for gonorrhea, and 18% tested positive for at least one of the three infections studied.

By age, the rate of trichomoniasis ranged from 8.3% among those aged 20-24 years to 11.5% among 25- to 29-year-olds. And by race, it ranged from 0% among Asian women to 13.2% among black women.

In a multivariate analysis, women were more likely to have trichomoniasis if they were black compared with white, Asian, or other race/ethnicity (odds ratio, 2.69); did not have health insurance (OR, 1.57); did not have a bachelor’s degree (OR, 5.53); had 2-15, or 16 or more partners in the past year vs. none or a single partner (OR, 1.60 and 3.51); were bisexual (OR, 2.00); did not always use a condom (3.04); or had a partner who had an STI (OR, 1.71).

Age, having had trichomoniasis previously, and having had any STI in the past were not independent risk factors for trichomoniasis, according to Dr. Gaydos.

Participants reported hearing about the program in a variety of ways. "About 30% say that they found it surfing the Internet, and about 28% say they heard about it on the radio, which is how we advertise the presence of the kit in our local areas most of the time," Dr. Gaydos said. Additionally, small proportions reported learning about the program from friends, fliers, and partners.

"Interestingly enough, when we queried the men, a much higher percentage answer on their questionnaire that they were told by their partner," she commented. "So the men are not telling their female partners to get tested, but the females are telling their male partners to get tested."

The study had its limitations, Dr. Gaydos acknowledged. "Obviously, it is biased because it’s selecting people who are empowered to think about their own sexual health. They are interested in finding out if they are infected, and they do report high [levels of] risk factors, which are similar to those that we see in STD clinics," she said.

Dr. Gaydos reported that she has received free diagnostic kits from Gen-Probe Inc.

SEATTLE – Both a high rate of trichomoniasis among sexually active teenage and adult women who seek self-testing and the elevated rate of adverse reproductive health outcomes in infected women raise the question of whether trichomoniasis should be a reportable infection in the United States, Charlotte A. Gaydos said.

Some 10% of the more than 1,500 women who were recruited through the Internet and offered free self-testing, and who then submitted vaginal samples, were positive for this sexually transmitted infection (STI) in an observational study reported at the annual meeting of the Society for Adolescent Health and Medicine. Rates were highest among those aged 25-29 years and among blacks.

These findings, coupled with the adverse health effects of trichomoniasis, may have implications for tracking the infection in the population, according to lead investigator Charlotte A. Gaydos, Dr.P.H., a professor in the division of infectious diseases at Johns Hopkins University in Baltimore.

Trichomoniasis is currently not reportable to the Centers for Disease Control and Prevention, she noted. But study estimates from the CDC suggest that there are 7-8 million new cases every year in the United States.

Infected men and – in particular – women have elevated rates of adverse reproductive health outcomes, including pelvic inflammatory disease, low infant birth weight, and premature delivery. Furthermore, this STI has been increasingly implicated as a risk factor for HIV transmission, she said.

"My question to the proponents of adolescent health and health for women in general is, should we start to do surveillance for Trichomonas [vaginalis] in the United States, so that we can have good data?" Dr. Gaydos asked. "I think more studies are needed."

Additionally, "should we make this a reportable infection in the future?" she inquired, given the many negative outcomes associated with trichomoniasis and the fact that it can be asymptomatic.

The investigators studied women who were recruited through IWantTheKit.org, an educational Internet program on STIs that offers free self-testing to sexually active individuals aged 14 years or older in Denver, Philadelphia, Alaska, Maryland, West Virginia, selected counties in Illinois, and Washington, D.C.

"We know that submission of self-collected samples at home can remove some barriers for adolescents and other women in testing for sexually transmitted diseases," Dr. Gaydos commented. "We have shown in the past that an Internet-recruited population can do this for Chlamydia and gonorrhea."

Starting in mid-2006, the program added testing for trichomoniasis to its existing testing for Chlamydia and gonorrhea. Women ordered the kit online and sent self-collected vaginal samples by U.S. mail to the testing lab. They also completed questionnaires on demographics and risk factors.

The lab tested for trichomoniasis using a nucleic acid amplification test, which has a sensitivity of about 90%, compared with roughly 50% for wet prep and 70% for culture, according to Dr. Gaydos.

The women were instructed to call for their test results in 1-2 weeks, and – should they forget to call – to indicate their preferred method of notification (e-mail, cell phone, letter, or text message).

A total of 1,525 women requested and returned self-collected vaginal swab kits in 2006-2010.

Overall, 10% of women tested positive for trichomoniasis, Dr. Gaydos reported. In addition, 10% tested positive for Chlamydia, 1% tested positive for gonorrhea, and 18% tested positive for at least one of the three infections studied.

By age, the rate of trichomoniasis ranged from 8.3% among those aged 20-24 years to 11.5% among 25- to 29-year-olds. And by race, it ranged from 0% among Asian women to 13.2% among black women.

In a multivariate analysis, women were more likely to have trichomoniasis if they were black compared with white, Asian, or other race/ethnicity (odds ratio, 2.69); did not have health insurance (OR, 1.57); did not have a bachelor’s degree (OR, 5.53); had 2-15, or 16 or more partners in the past year vs. none or a single partner (OR, 1.60 and 3.51); were bisexual (OR, 2.00); did not always use a condom (3.04); or had a partner who had an STI (OR, 1.71).

Age, having had trichomoniasis previously, and having had any STI in the past were not independent risk factors for trichomoniasis, according to Dr. Gaydos.

Participants reported hearing about the program in a variety of ways. "About 30% say that they found it surfing the Internet, and about 28% say they heard about it on the radio, which is how we advertise the presence of the kit in our local areas most of the time," Dr. Gaydos said. Additionally, small proportions reported learning about the program from friends, fliers, and partners.

"Interestingly enough, when we queried the men, a much higher percentage answer on their questionnaire that they were told by their partner," she commented. "So the men are not telling their female partners to get tested, but the females are telling their male partners to get tested."

The study had its limitations, Dr. Gaydos acknowledged. "Obviously, it is biased because it’s selecting people who are empowered to think about their own sexual health. They are interested in finding out if they are infected, and they do report high [levels of] risk factors, which are similar to those that we see in STD clinics," she said.

Dr. Gaydos reported that she has received free diagnostic kits from Gen-Probe Inc.