David Douglas

NEW YORK (Reuters Health) - Higher-volume hospitals do better in treatment of obstructive hypertrophic cardiomyopathy (HCM), but more efforts are needed to direct patients to these centers, according to New York-based researchers.

In an April 27 online paper in JAMA Cardiology, they note that recommendations are that the treatments, septal myectomy (SM) and alcohol septal ablation (ASA), be performed only by experienced operators with dedicated HCM clinical programs.

"Our study demonstrates that a significant number of cases of septal myectomy and alcohol septal ablation are not being performed at centers of excellence despite the guideline," Dr. Luke K. Kim, of Weill Cornell Medical College, told Reuters Health by email.

Dr. Kim and colleagues investigated compliance and its influence on outcome by examining nationwide data from 2003 to 2009 on 6,386 patients who underwent SM and 4,862 who had ASA. During this period almost 60% of institutions performed 10 or fewer SM procedures. The corresponding proportion for ASAs was 67%.

The incidence of in-hospital death after SM was significantly lower in hospitals in the highest volume tertile (3.8%) than those in the middle (9.6%) and lowest tertiles (15.6%). Corresponding proportions for ASA were 0.6%, 0.8% and 2.3%. There was a similar pattern for acute renal failure after ASA (2.4%, 7.6% and 6.2%).

After adjustment, being in the lowest tertile of SM volume was an independent predictor of in-hospital all-cause mortality (odds ratio, 3.11) and bleeding (OR, 3.77). However, being in the lowest volume for ASA was not independently associated with an increased risk of adverse post-procedural events.

In addition, hospitalization at a high-volume center was associated with a shorter stay and lower costs for both procedures.

However, over the study period, wrote the investigators, "Most centers that provide septal reduction therapy performed few SM and ASA procedures" and were "below the threshold recommended."

In particular, they concluded "Low SM volume was associated with worse outcomes, including higher mortality, longer length of stay, and higher costs. More efforts are needed to encourage referral of patients to centers of excellence for septal reduction therapy."

Commenting on the findings by email, Dr. Steve R. Ommen, coauthor of an accompanying invited opinion, told Reuters Health that "patients deserve to be offered the best care and outcomes possible and that appears to be possible only at centers with focused expertise in the management of HCM. Simply being a high-volume facility does not translate into achieving the safety nor the success observed at expert centers."

Dr. Ommen of the Mayo Clinic, Rochester, Minnesota, added that "Success takes a comprehensive understanding of the underlying HCM disease process. That is really the main take-home message from my point of view."

The other really astonishing finding," he concluded, "was that the median number of procedures performed was only one per year per hospital in the study."

The Michael Wolk Heart Foundation and the New York Cardiac Center supported this research. Two coauthors reported disclosures.

NEW YORK (Reuters Health) - Higher-volume hospitals do better in treatment of obstructive hypertrophic cardiomyopathy (HCM), but more efforts are needed to direct patients to these centers, according to New York-based researchers.

In an April 27 online paper in JAMA Cardiology, they note that recommendations are that the treatments, septal myectomy (SM) and alcohol septal ablation (ASA), be performed only by experienced operators with dedicated HCM clinical programs.

"Our study demonstrates that a significant number of cases of septal myectomy and alcohol septal ablation are not being performed at centers of excellence despite the guideline," Dr. Luke K. Kim, of Weill Cornell Medical College, told Reuters Health by email.

Dr. Kim and colleagues investigated compliance and its influence on outcome by examining nationwide data from 2003 to 2009 on 6,386 patients who underwent SM and 4,862 who had ASA. During this period almost 60% of institutions performed 10 or fewer SM procedures. The corresponding proportion for ASAs was 67%.

The incidence of in-hospital death after SM was significantly lower in hospitals in the highest volume tertile (3.8%) than those in the middle (9.6%) and lowest tertiles (15.6%). Corresponding proportions for ASA were 0.6%, 0.8% and 2.3%. There was a similar pattern for acute renal failure after ASA (2.4%, 7.6% and 6.2%).

After adjustment, being in the lowest tertile of SM volume was an independent predictor of in-hospital all-cause mortality (odds ratio, 3.11) and bleeding (OR, 3.77). However, being in the lowest volume for ASA was not independently associated with an increased risk of adverse post-procedural events.

In addition, hospitalization at a high-volume center was associated with a shorter stay and lower costs for both procedures.

However, over the study period, wrote the investigators, "Most centers that provide septal reduction therapy performed few SM and ASA procedures" and were "below the threshold recommended."

In particular, they concluded "Low SM volume was associated with worse outcomes, including higher mortality, longer length of stay, and higher costs. More efforts are needed to encourage referral of patients to centers of excellence for septal reduction therapy."

Commenting on the findings by email, Dr. Steve R. Ommen, coauthor of an accompanying invited opinion, told Reuters Health that "patients deserve to be offered the best care and outcomes possible and that appears to be possible only at centers with focused expertise in the management of HCM. Simply being a high-volume facility does not translate into achieving the safety nor the success observed at expert centers."

Dr. Ommen of the Mayo Clinic, Rochester, Minnesota, added that "Success takes a comprehensive understanding of the underlying HCM disease process. That is really the main take-home message from my point of view."

The other really astonishing finding," he concluded, "was that the median number of procedures performed was only one per year per hospital in the study."

The Michael Wolk Heart Foundation and the New York Cardiac Center supported this research. Two coauthors reported disclosures.

NEW YORK (Reuters Health) - Higher-volume hospitals do better in treatment of obstructive hypertrophic cardiomyopathy (HCM), but more efforts are needed to direct patients to these centers, according to New York-based researchers.

In an April 27 online paper in JAMA Cardiology, they note that recommendations are that the treatments, septal myectomy (SM) and alcohol septal ablation (ASA), be performed only by experienced operators with dedicated HCM clinical programs.

"Our study demonstrates that a significant number of cases of septal myectomy and alcohol septal ablation are not being performed at centers of excellence despite the guideline," Dr. Luke K. Kim, of Weill Cornell Medical College, told Reuters Health by email.

Dr. Kim and colleagues investigated compliance and its influence on outcome by examining nationwide data from 2003 to 2009 on 6,386 patients who underwent SM and 4,862 who had ASA. During this period almost 60% of institutions performed 10 or fewer SM procedures. The corresponding proportion for ASAs was 67%.

The incidence of in-hospital death after SM was significantly lower in hospitals in the highest volume tertile (3.8%) than those in the middle (9.6%) and lowest tertiles (15.6%). Corresponding proportions for ASA were 0.6%, 0.8% and 2.3%. There was a similar pattern for acute renal failure after ASA (2.4%, 7.6% and 6.2%).

After adjustment, being in the lowest tertile of SM volume was an independent predictor of in-hospital all-cause mortality (odds ratio, 3.11) and bleeding (OR, 3.77). However, being in the lowest volume for ASA was not independently associated with an increased risk of adverse post-procedural events.

In addition, hospitalization at a high-volume center was associated with a shorter stay and lower costs for both procedures.

However, over the study period, wrote the investigators, "Most centers that provide septal reduction therapy performed few SM and ASA procedures" and were "below the threshold recommended."

In particular, they concluded "Low SM volume was associated with worse outcomes, including higher mortality, longer length of stay, and higher costs. More efforts are needed to encourage referral of patients to centers of excellence for septal reduction therapy."

Commenting on the findings by email, Dr. Steve R. Ommen, coauthor of an accompanying invited opinion, told Reuters Health that "patients deserve to be offered the best care and outcomes possible and that appears to be possible only at centers with focused expertise in the management of HCM. Simply being a high-volume facility does not translate into achieving the safety nor the success observed at expert centers."

Dr. Ommen of the Mayo Clinic, Rochester, Minnesota, added that "Success takes a comprehensive understanding of the underlying HCM disease process. That is really the main take-home message from my point of view."

The other really astonishing finding," he concluded, "was that the median number of procedures performed was only one per year per hospital in the study."

The Michael Wolk Heart Foundation and the New York Cardiac Center supported this research. Two coauthors reported disclosures.

NEW YORK (Reuters Health) - Among medically treated patients with acute coronary syndrome (ACS), prior clopidogrel therapy appears to be associated with more cardiovascular events, researchers have found.

As Dr. Chee Tang Chin told Reuters Health by email, "We found that among patients who were admitted for an acute coronary syndrome and did not undergo coronary revascularization, those patients who were already taking clopidogrel were at a higher risk for a subsequent

cardiovascular event, as compared to patients not taking clopidogrel on admission."

The study, a prespecified subanalysis of the TRILOGY ACS trial, was published online March 30 in Heart.

Of almost 9,000 patients, 73% first received clopidogrel in-hospital within 72 hours of presentation and daily until randomization to clopidogrel versus prasugrel (plus aspirin). The remaining 27% were taking clopidogrel prior to admission and continued daily clopidogrel therapy until the date of randomization.

Over 30 months, those with prior clopidogrel use had a significantly higher frequency of cardiovascular death, MI and stroke (20.8% vs. 18.3%, p=0.002). There was no significant  difference in the frequency of bleeding events.

Dr. Chin pointed out that in the prior users, "This excess risk was largely accounted for by the higher burden of high-risk co-morbidities among this group, such as diabetes and prior

cardiovascular disease. However, consistent with the overall TRILOGY-ACS results, the use of a more potent antiplatelet agent such as prasugrel did not modify this risk."

"These results," Dr. Chin concluded, "are important as they imply that among ACS patients treated only medically, strategies beyond platelet inhibition need to be considered for further optimizing outcomes."

NEW YORK (Reuters Health) - Among medically treated patients with acute coronary syndrome (ACS), prior clopidogrel therapy appears to be associated with more cardiovascular events, researchers have found.

As Dr. Chee Tang Chin told Reuters Health by email, "We found that among patients who were admitted for an acute coronary syndrome and did not undergo coronary revascularization, those patients who were already taking clopidogrel were at a higher risk for a subsequent

cardiovascular event, as compared to patients not taking clopidogrel on admission."

The study, a prespecified subanalysis of the TRILOGY ACS trial, was published online March 30 in Heart.

Of almost 9,000 patients, 73% first received clopidogrel in-hospital within 72 hours of presentation and daily until randomization to clopidogrel versus prasugrel (plus aspirin). The remaining 27% were taking clopidogrel prior to admission and continued daily clopidogrel therapy until the date of randomization.

Over 30 months, those with prior clopidogrel use had a significantly higher frequency of cardiovascular death, MI and stroke (20.8% vs. 18.3%, p=0.002). There was no significant  difference in the frequency of bleeding events.

Dr. Chin pointed out that in the prior users, "This excess risk was largely accounted for by the higher burden of high-risk co-morbidities among this group, such as diabetes and prior

cardiovascular disease. However, consistent with the overall TRILOGY-ACS results, the use of a more potent antiplatelet agent such as prasugrel did not modify this risk."

"These results," Dr. Chin concluded, "are important as they imply that among ACS patients treated only medically, strategies beyond platelet inhibition need to be considered for further optimizing outcomes."

NEW YORK (Reuters Health) - Among medically treated patients with acute coronary syndrome (ACS), prior clopidogrel therapy appears to be associated with more cardiovascular events, researchers have found.

As Dr. Chee Tang Chin told Reuters Health by email, "We found that among patients who were admitted for an acute coronary syndrome and did not undergo coronary revascularization, those patients who were already taking clopidogrel were at a higher risk for a subsequent

cardiovascular event, as compared to patients not taking clopidogrel on admission."

The study, a prespecified subanalysis of the TRILOGY ACS trial, was published online March 30 in Heart.

Of almost 9,000 patients, 73% first received clopidogrel in-hospital within 72 hours of presentation and daily until randomization to clopidogrel versus prasugrel (plus aspirin). The remaining 27% were taking clopidogrel prior to admission and continued daily clopidogrel therapy until the date of randomization.

Over 30 months, those with prior clopidogrel use had a significantly higher frequency of cardiovascular death, MI and stroke (20.8% vs. 18.3%, p=0.002). There was no significant  difference in the frequency of bleeding events.

Dr. Chin pointed out that in the prior users, "This excess risk was largely accounted for by the higher burden of high-risk co-morbidities among this group, such as diabetes and prior

cardiovascular disease. However, consistent with the overall TRILOGY-ACS results, the use of a more potent antiplatelet agent such as prasugrel did not modify this risk."

"These results," Dr. Chin concluded, "are important as they imply that among ACS patients treated only medically, strategies beyond platelet inhibition need to be considered for further optimizing outcomes."

NEW YORK (Reuters Health) - Edoxaban (Savaysa, Daiichi-Sankyo) shows advantages over warfarin in long-term treatment of patients with venous thromboembolism (VTE), according to a post-hoc analysis of multinational trial data.

As Dr. Gary Raskob told Reuters Health by email, "Our results indicate that once-daily edoxaban provides an effective

and more convenient alternative to warfarin, with lower major bleeding risk, for patients who require extended treatment

beyond three months to prevent recurrent venous thromboembolism."

In a March 22 online paper in the Lancet Haematology, Dr.Raskob, of the University of Oklahoma, Oklahoma City, and colleagues note that guidelines recommend anticoagulant treatment for at least three months. However, "The risk of recurrence is substantial for patients with unprovoked venous thromboembolism or continuing risk factors and many of these

patients need extended anticoagulation therapy beyond three months."

To shed more light on longer term effects, the team examined outcome after three to 12 months in 3,633 patients treated with heparin and edoxaban and 3,594 treated with heparin and warfarin who took part in a randomized, double-blind trial. Median treatment duration was close to 9 months.

At three months, recurrent VTE was seen in 1.1% of the edoxaban group and 1.2% of the warfarin patients. At three to six months, the corresponding proportions were 0.7% and 0.5%. At more than six but less than 12 months, they were 0.2% and 0.8%.

Among other findings was that the cumulative incidence of major bleeding was 0.3% in the edoxaban-treated group and 0.7%

in the warfarin-treated patients. Intention-to-treat analysis gave similar results to these per-protocol findings.

Use of edoxaban, Dr. Raskob concluded, "may enable more patients to stay on extended anticoagulant treatment and help reduce the burden from recurrent venous thromboembolism."

Commenting on the findings by email, Dr. Jerrold H. Levy, coauthor of an accompanying editorial, told Reuters Health, "This post-hoc analysis reports that edoxaban is an alternative to warfarin for extended use in the secondary prevention of venous thromboembolism."

Dr. Levy, of Duke University Hospital, Durham, North Carolina, concluded, "The only other study where a direct oral anticoagulant was compared with warfarin for extended use in this setting was the RE-MEDY trial that compared dabigatran with warfarin in patients for six to 36 months and found dabigatran was similar to warfarin for efficacy with a lower incidence of clinically relevant major bleeding."

This study was funded by Daiichi-Sankyo.  Dr. Raskob received fees from the company during the study. Other coauthors

also have ties to the company and a number are employees of Daiichi-Sankyo.

NEW YORK (Reuters Health) - Edoxaban (Savaysa, Daiichi-Sankyo) shows advantages over warfarin in long-term treatment of patients with venous thromboembolism (VTE), according to a post-hoc analysis of multinational trial data.

As Dr. Gary Raskob told Reuters Health by email, "Our results indicate that once-daily edoxaban provides an effective

and more convenient alternative to warfarin, with lower major bleeding risk, for patients who require extended treatment

beyond three months to prevent recurrent venous thromboembolism."

In a March 22 online paper in the Lancet Haematology, Dr.Raskob, of the University of Oklahoma, Oklahoma City, and colleagues note that guidelines recommend anticoagulant treatment for at least three months. However, "The risk of recurrence is substantial for patients with unprovoked venous thromboembolism or continuing risk factors and many of these

patients need extended anticoagulation therapy beyond three months."

To shed more light on longer term effects, the team examined outcome after three to 12 months in 3,633 patients treated with heparin and edoxaban and 3,594 treated with heparin and warfarin who took part in a randomized, double-blind trial. Median treatment duration was close to 9 months.

At three months, recurrent VTE was seen in 1.1% of the edoxaban group and 1.2% of the warfarin patients. At three to six months, the corresponding proportions were 0.7% and 0.5%. At more than six but less than 12 months, they were 0.2% and 0.8%.

Among other findings was that the cumulative incidence of major bleeding was 0.3% in the edoxaban-treated group and 0.7%

in the warfarin-treated patients. Intention-to-treat analysis gave similar results to these per-protocol findings.

Use of edoxaban, Dr. Raskob concluded, "may enable more patients to stay on extended anticoagulant treatment and help reduce the burden from recurrent venous thromboembolism."

Commenting on the findings by email, Dr. Jerrold H. Levy, coauthor of an accompanying editorial, told Reuters Health, "This post-hoc analysis reports that edoxaban is an alternative to warfarin for extended use in the secondary prevention of venous thromboembolism."

Dr. Levy, of Duke University Hospital, Durham, North Carolina, concluded, "The only other study where a direct oral anticoagulant was compared with warfarin for extended use in this setting was the RE-MEDY trial that compared dabigatran with warfarin in patients for six to 36 months and found dabigatran was similar to warfarin for efficacy with a lower incidence of clinically relevant major bleeding."

This study was funded by Daiichi-Sankyo.  Dr. Raskob received fees from the company during the study. Other coauthors

also have ties to the company and a number are employees of Daiichi-Sankyo.

NEW YORK (Reuters Health) - Edoxaban (Savaysa, Daiichi-Sankyo) shows advantages over warfarin in long-term treatment of patients with venous thromboembolism (VTE), according to a post-hoc analysis of multinational trial data.

As Dr. Gary Raskob told Reuters Health by email, "Our results indicate that once-daily edoxaban provides an effective

and more convenient alternative to warfarin, with lower major bleeding risk, for patients who require extended treatment

beyond three months to prevent recurrent venous thromboembolism."

In a March 22 online paper in the Lancet Haematology, Dr.Raskob, of the University of Oklahoma, Oklahoma City, and colleagues note that guidelines recommend anticoagulant treatment for at least three months. However, "The risk of recurrence is substantial for patients with unprovoked venous thromboembolism or continuing risk factors and many of these

patients need extended anticoagulation therapy beyond three months."

To shed more light on longer term effects, the team examined outcome after three to 12 months in 3,633 patients treated with heparin and edoxaban and 3,594 treated with heparin and warfarin who took part in a randomized, double-blind trial. Median treatment duration was close to 9 months.

At three months, recurrent VTE was seen in 1.1% of the edoxaban group and 1.2% of the warfarin patients. At three to six months, the corresponding proportions were 0.7% and 0.5%. At more than six but less than 12 months, they were 0.2% and 0.8%.

Among other findings was that the cumulative incidence of major bleeding was 0.3% in the edoxaban-treated group and 0.7%

in the warfarin-treated patients. Intention-to-treat analysis gave similar results to these per-protocol findings.

Use of edoxaban, Dr. Raskob concluded, "may enable more patients to stay on extended anticoagulant treatment and help reduce the burden from recurrent venous thromboembolism."

Commenting on the findings by email, Dr. Jerrold H. Levy, coauthor of an accompanying editorial, told Reuters Health, "This post-hoc analysis reports that edoxaban is an alternative to warfarin for extended use in the secondary prevention of venous thromboembolism."

Dr. Levy, of Duke University Hospital, Durham, North Carolina, concluded, "The only other study where a direct oral anticoagulant was compared with warfarin for extended use in this setting was the RE-MEDY trial that compared dabigatran with warfarin in patients for six to 36 months and found dabigatran was similar to warfarin for efficacy with a lower incidence of clinically relevant major bleeding."

This study was funded by Daiichi-Sankyo.  Dr. Raskob received fees from the company during the study. Other coauthors

also have ties to the company and a number are employees of Daiichi-Sankyo.

NEW YORK (Reuters Health) - Use of the marker procalcitonin to guide antibacterial therapy in the critically ill is associated with shorter treatment and reduced mortality, according to Dutch researchers.

As Dr. Evelien de Jong told Reuters Health by email, "Antibiotic overconsumption is one of the largest threats to medicine in the near future. Our study is the largest randomized controlled trial of antibiotic reduction in intensive care units (ICUs) and will, hopefully, contribute to a more individualized antibiotic duration per patient and an overall reduction of antibiotic use."

In a February 29 online paper in the Lancet Infectious Diseases, Dr. de Jong, of VU University Medical Center, Amsterdam, and colleagues noted that a "drop in procalcitonin concentration might help (clinicians) to discontinue antibiotic use in a more timely fashion" than reliance on biomarkers such as C-reactive protein.

To investigate, the researchers studied 1,575 ICU patients who received antibiotics and were randomized to procalcitonin-guided antibiotic discontinuation or standard of care. Fifteen were excluded from the procalcitonin group and 14 were excluded from the standard care group.

"In the procalcitonin-guided group, a non-binding advice to discontinue antibiotics was provided if procalcitonin concentration had decreased by 80% or more of its peak value or to 0.5 ug/L or lower," the authors reported.

In all, 538 (71%) of 761 patients in the procalcitonin-guided group and 457 (58%) of 785 patients in the standard-of-care group completed their antibiotic treatment in the ICU.

Median consumption of antibiotics was 7.5 daily defined doses in the procalcitonin group, significantly less than the 9.3 daily defined doses in the standard-of-care group, for a mean group absolute difference of 2.69 (p<0.0001).

Median duration of treatment was also significantly shorter in the procalcitonin-guided group (five versus seven days), for a mean group absolute difference of 1.22 (p<0.0001).

Mortality at 28 days was also significantly less than in the standard-of-care group. This was 20% versus 27% in intention-to-treat analysis. At one year, corresponding per protocol proportions were 36% and 43%.

Overall, the researchers concluded, "Procalcitonin concentrations might help physicians in deciding whether or not the presumed infection is truly bacterial, leading to more adequate diagnosis and treatment, the cornerstones of antibiotic stewardship."

Commenting by email, Dr. Philipp Schuetz, coauthor of an accompanying editorial, told Reuters Health, "This well-done and large landmark trial proves that procalcitonin-guided care reduces unnecessary antibiotic courses in critical care patients with assumed or proven infection and thereby improves patient outcomes, namely overall survival."

Dr. Schuetz, of the University of Basel, Switzerland, concluded, "We should now adapt our guidelines and start to (adopt) more widespread use of procalcitonin protocols in clinical practice to slow emergence of bacterial resistance and improve sepsis care."

NEW YORK (Reuters Health) - Use of the marker procalcitonin to guide antibacterial therapy in the critically ill is associated with shorter treatment and reduced mortality, according to Dutch researchers.

As Dr. Evelien de Jong told Reuters Health by email, "Antibiotic overconsumption is one of the largest threats to medicine in the near future. Our study is the largest randomized controlled trial of antibiotic reduction in intensive care units (ICUs) and will, hopefully, contribute to a more individualized antibiotic duration per patient and an overall reduction of antibiotic use."

In a February 29 online paper in the Lancet Infectious Diseases, Dr. de Jong, of VU University Medical Center, Amsterdam, and colleagues noted that a "drop in procalcitonin concentration might help (clinicians) to discontinue antibiotic use in a more timely fashion" than reliance on biomarkers such as C-reactive protein.

To investigate, the researchers studied 1,575 ICU patients who received antibiotics and were randomized to procalcitonin-guided antibiotic discontinuation or standard of care. Fifteen were excluded from the procalcitonin group and 14 were excluded from the standard care group.

"In the procalcitonin-guided group, a non-binding advice to discontinue antibiotics was provided if procalcitonin concentration had decreased by 80% or more of its peak value or to 0.5 ug/L or lower," the authors reported.

In all, 538 (71%) of 761 patients in the procalcitonin-guided group and 457 (58%) of 785 patients in the standard-of-care group completed their antibiotic treatment in the ICU.

Median consumption of antibiotics was 7.5 daily defined doses in the procalcitonin group, significantly less than the 9.3 daily defined doses in the standard-of-care group, for a mean group absolute difference of 2.69 (p<0.0001).

Median duration of treatment was also significantly shorter in the procalcitonin-guided group (five versus seven days), for a mean group absolute difference of 1.22 (p<0.0001).

Mortality at 28 days was also significantly less than in the standard-of-care group. This was 20% versus 27% in intention-to-treat analysis. At one year, corresponding per protocol proportions were 36% and 43%.

Overall, the researchers concluded, "Procalcitonin concentrations might help physicians in deciding whether or not the presumed infection is truly bacterial, leading to more adequate diagnosis and treatment, the cornerstones of antibiotic stewardship."

Commenting by email, Dr. Philipp Schuetz, coauthor of an accompanying editorial, told Reuters Health, "This well-done and large landmark trial proves that procalcitonin-guided care reduces unnecessary antibiotic courses in critical care patients with assumed or proven infection and thereby improves patient outcomes, namely overall survival."

Dr. Schuetz, of the University of Basel, Switzerland, concluded, "We should now adapt our guidelines and start to (adopt) more widespread use of procalcitonin protocols in clinical practice to slow emergence of bacterial resistance and improve sepsis care."

NEW YORK (Reuters Health) - Use of the marker procalcitonin to guide antibacterial therapy in the critically ill is associated with shorter treatment and reduced mortality, according to Dutch researchers.

As Dr. Evelien de Jong told Reuters Health by email, "Antibiotic overconsumption is one of the largest threats to medicine in the near future. Our study is the largest randomized controlled trial of antibiotic reduction in intensive care units (ICUs) and will, hopefully, contribute to a more individualized antibiotic duration per patient and an overall reduction of antibiotic use."

In a February 29 online paper in the Lancet Infectious Diseases, Dr. de Jong, of VU University Medical Center, Amsterdam, and colleagues noted that a "drop in procalcitonin concentration might help (clinicians) to discontinue antibiotic use in a more timely fashion" than reliance on biomarkers such as C-reactive protein.

To investigate, the researchers studied 1,575 ICU patients who received antibiotics and were randomized to procalcitonin-guided antibiotic discontinuation or standard of care. Fifteen were excluded from the procalcitonin group and 14 were excluded from the standard care group.

"In the procalcitonin-guided group, a non-binding advice to discontinue antibiotics was provided if procalcitonin concentration had decreased by 80% or more of its peak value or to 0.5 ug/L or lower," the authors reported.

In all, 538 (71%) of 761 patients in the procalcitonin-guided group and 457 (58%) of 785 patients in the standard-of-care group completed their antibiotic treatment in the ICU.

Median consumption of antibiotics was 7.5 daily defined doses in the procalcitonin group, significantly less than the 9.3 daily defined doses in the standard-of-care group, for a mean group absolute difference of 2.69 (p<0.0001).

Median duration of treatment was also significantly shorter in the procalcitonin-guided group (five versus seven days), for a mean group absolute difference of 1.22 (p<0.0001).

Mortality at 28 days was also significantly less than in the standard-of-care group. This was 20% versus 27% in intention-to-treat analysis. At one year, corresponding per protocol proportions were 36% and 43%.

Overall, the researchers concluded, "Procalcitonin concentrations might help physicians in deciding whether or not the presumed infection is truly bacterial, leading to more adequate diagnosis and treatment, the cornerstones of antibiotic stewardship."

Commenting by email, Dr. Philipp Schuetz, coauthor of an accompanying editorial, told Reuters Health, "This well-done and large landmark trial proves that procalcitonin-guided care reduces unnecessary antibiotic courses in critical care patients with assumed or proven infection and thereby improves patient outcomes, namely overall survival."

Dr. Schuetz, of the University of Basel, Switzerland, concluded, "We should now adapt our guidelines and start to (adopt) more widespread use of procalcitonin protocols in clinical practice to slow emergence of bacterial resistance and improve sepsis care."

NEW YORK (Reuters Health) - Cardiac resynchronization therapy (CRT) in patients with heart failure (HF) without left bundle branch block (LBBB) may not help and might even harm, according to an international group of investigators.

As Dr. Yitschak Biton told Reuters Health by email, "Our findings suggest that patients without LBBB electrocardiogram (ECG) morphology are not likely to benefit from CRT implantation and a subgroup of patients with short QRS duration might even be at higher risk for mortality."

In a January 28 online paper in Circulation: Heart Failure, Dr. Biton, of the University of Rochester Medical Center, New York, and colleagues note that the efficacy of CRT is well established in patients with both mild and moderate to severe HF symptoms. However, data on non-LBBB patients "are more limited and conflicting."

To investigate, the team examined data on 537 such patients with mild HF taking part in a larger study. At seven years, the cumulative probability of HF hospitalization or death was 45% in those randomized to an implantable cardioverter-defibrillator (ICD) and 56% in those given CRT with a defibrillator (CRT-D).

Multivariable-adjusted subgroup analysis by QRS duration showed that patients from the lower quartile (134 ms or less) had a 2.4-fold greater risk of HF hospitalization or death with CRT-D versus those with ICD-only therapy.

However, the effect of CRT-D in patients from the upper quartiles group (QRS greater than 134 ms) was neutral (hazard ratio 0.97).

In a further analysis based on PR interval, patients with prolonged QRS (more than 134 ms) and prolonged PR (at least 230 ms) were protected with CRT-D (HR 0.31). The association was neutral with prolonged QRS and shorter PR.

"Overall," the researchers conclude, "patients with mild HF but without left bundle branch block morphology did not derive clinical benefit with CRT-D during long-term follow-up. Relatively shorter QRS was associated with a significantly increased risk with CRT-D relative to implantable cardioverter-defibrillator only."

"This information should be taken into account when CRT therapy is considered in this subgroup of patients," Dr. Biton told Reuters Health.

Boston Scientific Corporation funded the clinical trial this research is based on. Five coauthors reported disclosures.

NEW YORK (Reuters Health) - Cardiac resynchronization therapy (CRT) in patients with heart failure (HF) without left bundle branch block (LBBB) may not help and might even harm, according to an international group of investigators.

As Dr. Yitschak Biton told Reuters Health by email, "Our findings suggest that patients without LBBB electrocardiogram (ECG) morphology are not likely to benefit from CRT implantation and a subgroup of patients with short QRS duration might even be at higher risk for mortality."

In a January 28 online paper in Circulation: Heart Failure, Dr. Biton, of the University of Rochester Medical Center, New York, and colleagues note that the efficacy of CRT is well established in patients with both mild and moderate to severe HF symptoms. However, data on non-LBBB patients "are more limited and conflicting."

To investigate, the team examined data on 537 such patients with mild HF taking part in a larger study. At seven years, the cumulative probability of HF hospitalization or death was 45% in those randomized to an implantable cardioverter-defibrillator (ICD) and 56% in those given CRT with a defibrillator (CRT-D).

Multivariable-adjusted subgroup analysis by QRS duration showed that patients from the lower quartile (134 ms or less) had a 2.4-fold greater risk of HF hospitalization or death with CRT-D versus those with ICD-only therapy.

However, the effect of CRT-D in patients from the upper quartiles group (QRS greater than 134 ms) was neutral (hazard ratio 0.97).

In a further analysis based on PR interval, patients with prolonged QRS (more than 134 ms) and prolonged PR (at least 230 ms) were protected with CRT-D (HR 0.31). The association was neutral with prolonged QRS and shorter PR.

"Overall," the researchers conclude, "patients with mild HF but without left bundle branch block morphology did not derive clinical benefit with CRT-D during long-term follow-up. Relatively shorter QRS was associated with a significantly increased risk with CRT-D relative to implantable cardioverter-defibrillator only."

"This information should be taken into account when CRT therapy is considered in this subgroup of patients," Dr. Biton told Reuters Health.

Boston Scientific Corporation funded the clinical trial this research is based on. Five coauthors reported disclosures.

NEW YORK (Reuters Health) - Cardiac resynchronization therapy (CRT) in patients with heart failure (HF) without left bundle branch block (LBBB) may not help and might even harm, according to an international group of investigators.

As Dr. Yitschak Biton told Reuters Health by email, "Our findings suggest that patients without LBBB electrocardiogram (ECG) morphology are not likely to benefit from CRT implantation and a subgroup of patients with short QRS duration might even be at higher risk for mortality."

In a January 28 online paper in Circulation: Heart Failure, Dr. Biton, of the University of Rochester Medical Center, New York, and colleagues note that the efficacy of CRT is well established in patients with both mild and moderate to severe HF symptoms. However, data on non-LBBB patients "are more limited and conflicting."

To investigate, the team examined data on 537 such patients with mild HF taking part in a larger study. At seven years, the cumulative probability of HF hospitalization or death was 45% in those randomized to an implantable cardioverter-defibrillator (ICD) and 56% in those given CRT with a defibrillator (CRT-D).

Multivariable-adjusted subgroup analysis by QRS duration showed that patients from the lower quartile (134 ms or less) had a 2.4-fold greater risk of HF hospitalization or death with CRT-D versus those with ICD-only therapy.

However, the effect of CRT-D in patients from the upper quartiles group (QRS greater than 134 ms) was neutral (hazard ratio 0.97).

In a further analysis based on PR interval, patients with prolonged QRS (more than 134 ms) and prolonged PR (at least 230 ms) were protected with CRT-D (HR 0.31). The association was neutral with prolonged QRS and shorter PR.

"Overall," the researchers conclude, "patients with mild HF but without left bundle branch block morphology did not derive clinical benefit with CRT-D during long-term follow-up. Relatively shorter QRS was associated with a significantly increased risk with CRT-D relative to implantable cardioverter-defibrillator only."

"This information should be taken into account when CRT therapy is considered in this subgroup of patients," Dr. Biton told Reuters Health.

Boston Scientific Corporation funded the clinical trial this research is based on. Five coauthors reported disclosures.

NEW YORK (Reuters Health) - Bisphosphonate use is associated with better survival in patients admitted to the intensive care unit (ICU), according to Australian researchers.

As Dr. Paul Lee told Reuters Health by email, "Bone loss in critical illness may have wider effects on the body beyond bone itself, and bisphosphonates, by reducing bone loss, may attenuate these potentially adverse effects on the body."

Increased bone resorption is known to predict mortality in the community setting, Dr. Lee of the Gavan Institute of Medical Research in Sydney and colleagues note in the Journal of Clinical Endocrinology and Metabolism, online January 18. The team theorized that mortality would be lower among patients treated with bisphosphonates prior to their acute illness.

To investigate, they examined data on more than 7,800 patients admitted to the ICU between 2003 and 2014; 245 had received bisphosphonates before admission.

The bisphosphonate users were older and had more co-morbidities, yet their in-hospital mortality rate was significantly lower than that of non-users(mortality rate ratio, 0.41; p<0.01). The difference remained significant after adjusting for factors including age, sex, and principal diagnosis.

Bisphosphonate-associated survival benefit was independent of vitamin D use, but bisphosphonate and vitamin D co-use was associated with a further reduction in mortality (MRR, 0.38).

A substudy involving CT scans of 37 patients with preadmission bisphosphonate use and 74 matched patients without such use found that baseline bone density was significantly lower among bisphosphonate users. However, all users survived admission whereas six of the non-users died.

The researchers speculate that the apparent benefits of bisphosphonate "may be partly related to modulation of systemic inflammation through antibone resorption."

However, Dr. Lee made it clear that "causality is not proven in the study, and prospective intervention trials are required to evaluate effects of bisphosphonates in critical illness."

NEW YORK (Reuters Health) - Bisphosphonate use is associated with better survival in patients admitted to the intensive care unit (ICU), according to Australian researchers.

As Dr. Paul Lee told Reuters Health by email, "Bone loss in critical illness may have wider effects on the body beyond bone itself, and bisphosphonates, by reducing bone loss, may attenuate these potentially adverse effects on the body."

Increased bone resorption is known to predict mortality in the community setting, Dr. Lee of the Gavan Institute of Medical Research in Sydney and colleagues note in the Journal of Clinical Endocrinology and Metabolism, online January 18. The team theorized that mortality would be lower among patients treated with bisphosphonates prior to their acute illness.

To investigate, they examined data on more than 7,800 patients admitted to the ICU between 2003 and 2014; 245 had received bisphosphonates before admission.

The bisphosphonate users were older and had more co-morbidities, yet their in-hospital mortality rate was significantly lower than that of non-users(mortality rate ratio, 0.41; p<0.01). The difference remained significant after adjusting for factors including age, sex, and principal diagnosis.

Bisphosphonate-associated survival benefit was independent of vitamin D use, but bisphosphonate and vitamin D co-use was associated with a further reduction in mortality (MRR, 0.38).

A substudy involving CT scans of 37 patients with preadmission bisphosphonate use and 74 matched patients without such use found that baseline bone density was significantly lower among bisphosphonate users. However, all users survived admission whereas six of the non-users died.

The researchers speculate that the apparent benefits of bisphosphonate "may be partly related to modulation of systemic inflammation through antibone resorption."

However, Dr. Lee made it clear that "causality is not proven in the study, and prospective intervention trials are required to evaluate effects of bisphosphonates in critical illness."

NEW YORK (Reuters Health) - Bisphosphonate use is associated with better survival in patients admitted to the intensive care unit (ICU), according to Australian researchers.

As Dr. Paul Lee told Reuters Health by email, "Bone loss in critical illness may have wider effects on the body beyond bone itself, and bisphosphonates, by reducing bone loss, may attenuate these potentially adverse effects on the body."

Increased bone resorption is known to predict mortality in the community setting, Dr. Lee of the Gavan Institute of Medical Research in Sydney and colleagues note in the Journal of Clinical Endocrinology and Metabolism, online January 18. The team theorized that mortality would be lower among patients treated with bisphosphonates prior to their acute illness.

To investigate, they examined data on more than 7,800 patients admitted to the ICU between 2003 and 2014; 245 had received bisphosphonates before admission.

The bisphosphonate users were older and had more co-morbidities, yet their in-hospital mortality rate was significantly lower than that of non-users(mortality rate ratio, 0.41; p<0.01). The difference remained significant after adjusting for factors including age, sex, and principal diagnosis.

Bisphosphonate-associated survival benefit was independent of vitamin D use, but bisphosphonate and vitamin D co-use was associated with a further reduction in mortality (MRR, 0.38).

A substudy involving CT scans of 37 patients with preadmission bisphosphonate use and 74 matched patients without such use found that baseline bone density was significantly lower among bisphosphonate users. However, all users survived admission whereas six of the non-users died.

The researchers speculate that the apparent benefits of bisphosphonate "may be partly related to modulation of systemic inflammation through antibone resorption."

However, Dr. Lee made it clear that "causality is not proven in the study, and prospective intervention trials are required to evaluate effects of bisphosphonates in critical illness."

NEW YORK - Endovascular repair (EVAR) of abdominal aortic aneurysms (AAAs) is associated with an initial survival advantage over open repair, according to a study of "real-world" data from California.

However, the difference disappears in the long term, researchers report in JAMA Surgery, online September 2.

Dr. David C. Chang of Harvard Medical School in Boston said by email that the study "highlights the importance of looking at real-world data in evaluating surgical options. Clinically, our study found that the survival advantage for EVAR repairs is maintained until 3 years, after which mortality was higher for patients who had EVAR repairs."

The team studied more than 23,000 patients who underwent AAA repair between 2001 and 2009. Just over half had EVAR while the remaining patients underwent open repair. Median follow-up was for three years.

EVAR was associated with improved 30-day all-cause mortality (1.54% vs. 4.74%) and significantly improved survival until three years postoperatively. After that mortality rose, and the researchers found no difference in long-term mortality for the entire cohort after adjusting for confounders (hazard ratio, 0.99; p=0.64).

EVAR was linked with a significantly higher rate of reinterventions and AAA late ruptures. At five years, for instance, the reintervention rate was 6.59% in the EVAR group vs. 1.48% in the open group.

"This is different from data from clinical trials," Dr. Chang pointed out. "The short-term survival advantage of EVAR from clinical trials data likely eroded as patient risk factors exact their toll over time. These are real-world issues and concerns that are often not captured in idealized clinical trials."

Senior author Dr. Samuel E. Wilson, of the University of California-Irvine Medical Center, added by email that EVAR is safer than the open procedure, which it has replaced. The mortality advantage last for three years, "then other morbidity, especially effects of smoking, even out survival."

Dr. Chang went on to note that "our use of data from the State of California also has an important policy implication: That many states actually have better and more complete population data than the federal government when it comes to healthcare quality. While research and policies related to healthcare quality are driven mostly by the federal government

currently (through Medicare), the federal government has limited data on patient care outside of Medicare."

"Therefore," Dr. Chang concluded, "an argument can be made that the federal government should delegate healthcare research and quality improvement responsibilities to individual states, and support state-level efforts to examine and improve healthcare quality. Healthcare, like politics, is all local."

In an accompanying editorial, Drs. Jamie E. Anderson and James W. Holcroft, of the University of California Davis Medical Center, Sacramento, observe that the study "offers a glimpse into the future of population-based health services research methods."

In a joint email, they said, "Harnessing information already captured for patient care or billing purposes to advance medical research makes sense."

NEW YORK - Endovascular repair (EVAR) of abdominal aortic aneurysms (AAAs) is associated with an initial survival advantage over open repair, according to a study of "real-world" data from California.

However, the difference disappears in the long term, researchers report in JAMA Surgery, online September 2.

Dr. David C. Chang of Harvard Medical School in Boston said by email that the study "highlights the importance of looking at real-world data in evaluating surgical options. Clinically, our study found that the survival advantage for EVAR repairs is maintained until 3 years, after which mortality was higher for patients who had EVAR repairs."

The team studied more than 23,000 patients who underwent AAA repair between 2001 and 2009. Just over half had EVAR while the remaining patients underwent open repair. Median follow-up was for three years.

EVAR was associated with improved 30-day all-cause mortality (1.54% vs. 4.74%) and significantly improved survival until three years postoperatively. After that mortality rose, and the researchers found no difference in long-term mortality for the entire cohort after adjusting for confounders (hazard ratio, 0.99; p=0.64).

EVAR was linked with a significantly higher rate of reinterventions and AAA late ruptures. At five years, for instance, the reintervention rate was 6.59% in the EVAR group vs. 1.48% in the open group.

"This is different from data from clinical trials," Dr. Chang pointed out. "The short-term survival advantage of EVAR from clinical trials data likely eroded as patient risk factors exact their toll over time. These are real-world issues and concerns that are often not captured in idealized clinical trials."

Senior author Dr. Samuel E. Wilson, of the University of California-Irvine Medical Center, added by email that EVAR is safer than the open procedure, which it has replaced. The mortality advantage last for three years, "then other morbidity, especially effects of smoking, even out survival."

Dr. Chang went on to note that "our use of data from the State of California also has an important policy implication: That many states actually have better and more complete population data than the federal government when it comes to healthcare quality. While research and policies related to healthcare quality are driven mostly by the federal government

currently (through Medicare), the federal government has limited data on patient care outside of Medicare."

"Therefore," Dr. Chang concluded, "an argument can be made that the federal government should delegate healthcare research and quality improvement responsibilities to individual states, and support state-level efforts to examine and improve healthcare quality. Healthcare, like politics, is all local."

In an accompanying editorial, Drs. Jamie E. Anderson and James W. Holcroft, of the University of California Davis Medical Center, Sacramento, observe that the study "offers a glimpse into the future of population-based health services research methods."

In a joint email, they said, "Harnessing information already captured for patient care or billing purposes to advance medical research makes sense."

NEW YORK - Endovascular repair (EVAR) of abdominal aortic aneurysms (AAAs) is associated with an initial survival advantage over open repair, according to a study of "real-world" data from California.

However, the difference disappears in the long term, researchers report in JAMA Surgery, online September 2.

Dr. David C. Chang of Harvard Medical School in Boston said by email that the study "highlights the importance of looking at real-world data in evaluating surgical options. Clinically, our study found that the survival advantage for EVAR repairs is maintained until 3 years, after which mortality was higher for patients who had EVAR repairs."

The team studied more than 23,000 patients who underwent AAA repair between 2001 and 2009. Just over half had EVAR while the remaining patients underwent open repair. Median follow-up was for three years.

EVAR was associated with improved 30-day all-cause mortality (1.54% vs. 4.74%) and significantly improved survival until three years postoperatively. After that mortality rose, and the researchers found no difference in long-term mortality for the entire cohort after adjusting for confounders (hazard ratio, 0.99; p=0.64).

EVAR was linked with a significantly higher rate of reinterventions and AAA late ruptures. At five years, for instance, the reintervention rate was 6.59% in the EVAR group vs. 1.48% in the open group.

"This is different from data from clinical trials," Dr. Chang pointed out. "The short-term survival advantage of EVAR from clinical trials data likely eroded as patient risk factors exact their toll over time. These are real-world issues and concerns that are often not captured in idealized clinical trials."

Senior author Dr. Samuel E. Wilson, of the University of California-Irvine Medical Center, added by email that EVAR is safer than the open procedure, which it has replaced. The mortality advantage last for three years, "then other morbidity, especially effects of smoking, even out survival."

Dr. Chang went on to note that "our use of data from the State of California also has an important policy implication: That many states actually have better and more complete population data than the federal government when it comes to healthcare quality. While research and policies related to healthcare quality are driven mostly by the federal government

currently (through Medicare), the federal government has limited data on patient care outside of Medicare."

"Therefore," Dr. Chang concluded, "an argument can be made that the federal government should delegate healthcare research and quality improvement responsibilities to individual states, and support state-level efforts to examine and improve healthcare quality. Healthcare, like politics, is all local."

In an accompanying editorial, Drs. Jamie E. Anderson and James W. Holcroft, of the University of California Davis Medical Center, Sacramento, observe that the study "offers a glimpse into the future of population-based health services research methods."

In a joint email, they said, "Harnessing information already captured for patient care or billing purposes to advance medical research makes sense."

NEW YORK—Although venous thromboembolism (VTE) rates are low in hospitalized patients following colorectal surgery, the increasing use of prophylaxis seems to have little impact, according to Washington state-based researchers.

Dr. Scott R. Steele, of Madigan Army Medical Center, Tacoma, and colleagues in JAMA Surgery note that although VTE is an important complication of such surgery its incidence in the current era of prophylaxis is unclear. To investigate further, the team examined Washington state data on more than 16,000 patients who underwent colorectal surgery between 2006 and 2011. Over the study period, the use of perioperative VTE chemoprophylaxis increased significantly from 31.6% to 86.4%. In-hospital VTE chemoprophylaxis rose from 59.6% to 91.4%. A total of 10.6% were discharged on VTE prophylaxis.

VTE within 90 days was seen in 360 patients (2.2%) overall. Patients undergoing abdominal operations had higher rates than those having pelvic operations (2.5% versus 1.8%, p=0.001). Rates were similar, but nonsignificant, in patients having an operation for cancer or for nonmalignant processes (2.1% versus 2.3%).

On adjusted analysis, being older, non-elective surgery, a history of VTE, and operations for inflammatory disease were associated with increased risk of 90-day VTE. However, despite the steady increase in chemoprophylaxis use in the perioperative and in-hospital settings, the annual VTE incidence remained low and largely unchanged, the researchers say. For example, the rate was 2.6% in 2007 and 3.0% in 2011.

In fact, the investigators say, "If nonselective perioperative and in-hospital prophylaxis is not successful in reducing rates of in-hospital VTE over time, are we placing patients at undue risk without significant benefit? With almost 40% of VTE events occurring after discharge, this may represent an area for quality improvement implementation."

As Dr. Steele told Reuters Health by email, "Despite our best practices, a small percentage of patients may still develop a VTE."

Prophylaxis efforts have improved greatly in the preoperative and perioperative in-hospital settings, but "in the post-discharge setting, we likely need a much larger randomized prospective study involving patients with similar risk profiles evaluating extended prophylaxis versus none to demonstrate whether or not this is a benefit." TH

—Reuters Health

NEW YORK—Although venous thromboembolism (VTE) rates are low in hospitalized patients following colorectal surgery, the increasing use of prophylaxis seems to have little impact, according to Washington state-based researchers.

Dr. Scott R. Steele, of Madigan Army Medical Center, Tacoma, and colleagues in JAMA Surgery note that although VTE is an important complication of such surgery its incidence in the current era of prophylaxis is unclear. To investigate further, the team examined Washington state data on more than 16,000 patients who underwent colorectal surgery between 2006 and 2011. Over the study period, the use of perioperative VTE chemoprophylaxis increased significantly from 31.6% to 86.4%. In-hospital VTE chemoprophylaxis rose from 59.6% to 91.4%. A total of 10.6% were discharged on VTE prophylaxis.

VTE within 90 days was seen in 360 patients (2.2%) overall. Patients undergoing abdominal operations had higher rates than those having pelvic operations (2.5% versus 1.8%, p=0.001). Rates were similar, but nonsignificant, in patients having an operation for cancer or for nonmalignant processes (2.1% versus 2.3%).

On adjusted analysis, being older, non-elective surgery, a history of VTE, and operations for inflammatory disease were associated with increased risk of 90-day VTE. However, despite the steady increase in chemoprophylaxis use in the perioperative and in-hospital settings, the annual VTE incidence remained low and largely unchanged, the researchers say. For example, the rate was 2.6% in 2007 and 3.0% in 2011.

In fact, the investigators say, "If nonselective perioperative and in-hospital prophylaxis is not successful in reducing rates of in-hospital VTE over time, are we placing patients at undue risk without significant benefit? With almost 40% of VTE events occurring after discharge, this may represent an area for quality improvement implementation."

As Dr. Steele told Reuters Health by email, "Despite our best practices, a small percentage of patients may still develop a VTE."

Prophylaxis efforts have improved greatly in the preoperative and perioperative in-hospital settings, but "in the post-discharge setting, we likely need a much larger randomized prospective study involving patients with similar risk profiles evaluating extended prophylaxis versus none to demonstrate whether or not this is a benefit." TH

—Reuters Health

NEW YORK—Although venous thromboembolism (VTE) rates are low in hospitalized patients following colorectal surgery, the increasing use of prophylaxis seems to have little impact, according to Washington state-based researchers.

Dr. Scott R. Steele, of Madigan Army Medical Center, Tacoma, and colleagues in JAMA Surgery note that although VTE is an important complication of such surgery its incidence in the current era of prophylaxis is unclear. To investigate further, the team examined Washington state data on more than 16,000 patients who underwent colorectal surgery between 2006 and 2011. Over the study period, the use of perioperative VTE chemoprophylaxis increased significantly from 31.6% to 86.4%. In-hospital VTE chemoprophylaxis rose from 59.6% to 91.4%. A total of 10.6% were discharged on VTE prophylaxis.

VTE within 90 days was seen in 360 patients (2.2%) overall. Patients undergoing abdominal operations had higher rates than those having pelvic operations (2.5% versus 1.8%, p=0.001). Rates were similar, but nonsignificant, in patients having an operation for cancer or for nonmalignant processes (2.1% versus 2.3%).

On adjusted analysis, being older, non-elective surgery, a history of VTE, and operations for inflammatory disease were associated with increased risk of 90-day VTE. However, despite the steady increase in chemoprophylaxis use in the perioperative and in-hospital settings, the annual VTE incidence remained low and largely unchanged, the researchers say. For example, the rate was 2.6% in 2007 and 3.0% in 2011.

In fact, the investigators say, "If nonselective perioperative and in-hospital prophylaxis is not successful in reducing rates of in-hospital VTE over time, are we placing patients at undue risk without significant benefit? With almost 40% of VTE events occurring after discharge, this may represent an area for quality improvement implementation."

As Dr. Steele told Reuters Health by email, "Despite our best practices, a small percentage of patients may still develop a VTE."

Prophylaxis efforts have improved greatly in the preoperative and perioperative in-hospital settings, but "in the post-discharge setting, we likely need a much larger randomized prospective study involving patients with similar risk profiles evaluating extended prophylaxis versus none to demonstrate whether or not this is a benefit." TH

—Reuters Health