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Neoadjuvant chemotherapy improves survival for some with pancreatic cancer
MONTREAL – For individuals with stage III pancreatic cancer, neoadjuvant therapy may improve survival, compared with surgery-first treatment. “This study supports, however does not prove, the hypothesis that early and continued control of occult metastatic disease prolongs survival in surgical patients,” said Dr. Christopher Shubert.
Dr. Shubert and his colleagues used an intention-to-treat (ITT) analysis to compare overall survival (OS) for 377 patients who were to receive neoadjuvant chemotherapy with 216 patients who received surgery first. Median OS for the neoadjuvant group was 20.7 months, compared with 13.7 months for the surgery-first group (log-rank P less than .0001).
This study was the first to utilize national data to look at how patients who received neoadjuvant chemotherapy for stage III pancreatic cancer fared, when compared with those treated with a surgery-first approach, Dr. Shubert, a general surgery resident at the Mayo Clinic in Rochester, Minn., said at the annual meeting of the Central Surgical Association.
Stage III pancreatic cancer (T4, any N, M0) means that the cancer has invaded the celiac trunk, or there is superior mesenteric artery involvement, he noted.
Using data from the National Cancer Database from 2002 to 2011, the investigators identified patients with clinical stage III pancreatic adenocarcinoma of the head or body of the pancreas. The ITT neoadjuvant therapy cohort included all patients whose treatment recommendations included curative-intent surgery and neoadjuvant chemotherapy, regardless of what therapies the patients received. The surgery-first cohort included those who were recommended to receive adjuvant therapy.
A total of 593 patients were identified, of whom 377 (63.5%) were in the neoadjuvant group. Of these, 104 (27.6%) were lost to presurgical attrition. The surgery-first group included 216 patients (36.3%), 30 (13.9%) of whom did not receive the intended adjuvant chemotherapy. Comparing the two ITT groups yielded an adjusted hazard ratio of 0.68 (P = .001).
A secondary aim of the study was to see which aspects of therapy, and which pathologic features, were associated with longer OS. The addition of postsurgical therapy was associated with additional survival benefit (31.6 vs. 22.6 months for no postsurgical therapy; HR, 0.60; P = .002). Node-negative and R0 status were both also significantly increased among those receiving neoadjuvant chemotherapy, and both disease characteristics were associated with increased OS, he reported.
Dr. Shubert said that study limitations included its review of a prospective database. Also, investigators could not determine the type or duration of chemotherapy; they also were unable to tell when systemic chemotherapy plus chemoradiation or just chemoradiation alone had been used. No recurrence data were available, and all cases were grouped under one procedure code, limiting information about vascular resections.
“Neoadjuvant therapy may offer survival advantages compared to a surgery-first approach,” said Dr. Shubert, and control of small occult metastases may be the mechanism behind this advantage. Still to be determined, however, are the optimal type, duration, and sequencing of neoadjuvant chemotherapy and chemoradiation, he said.
Dr. Shubert reported no relevant disclosures.
On Twitter @karioakes
MONTREAL – For individuals with stage III pancreatic cancer, neoadjuvant therapy may improve survival, compared with surgery-first treatment. “This study supports, however does not prove, the hypothesis that early and continued control of occult metastatic disease prolongs survival in surgical patients,” said Dr. Christopher Shubert.
Dr. Shubert and his colleagues used an intention-to-treat (ITT) analysis to compare overall survival (OS) for 377 patients who were to receive neoadjuvant chemotherapy with 216 patients who received surgery first. Median OS for the neoadjuvant group was 20.7 months, compared with 13.7 months for the surgery-first group (log-rank P less than .0001).
This study was the first to utilize national data to look at how patients who received neoadjuvant chemotherapy for stage III pancreatic cancer fared, when compared with those treated with a surgery-first approach, Dr. Shubert, a general surgery resident at the Mayo Clinic in Rochester, Minn., said at the annual meeting of the Central Surgical Association.
Stage III pancreatic cancer (T4, any N, M0) means that the cancer has invaded the celiac trunk, or there is superior mesenteric artery involvement, he noted.
Using data from the National Cancer Database from 2002 to 2011, the investigators identified patients with clinical stage III pancreatic adenocarcinoma of the head or body of the pancreas. The ITT neoadjuvant therapy cohort included all patients whose treatment recommendations included curative-intent surgery and neoadjuvant chemotherapy, regardless of what therapies the patients received. The surgery-first cohort included those who were recommended to receive adjuvant therapy.
A total of 593 patients were identified, of whom 377 (63.5%) were in the neoadjuvant group. Of these, 104 (27.6%) were lost to presurgical attrition. The surgery-first group included 216 patients (36.3%), 30 (13.9%) of whom did not receive the intended adjuvant chemotherapy. Comparing the two ITT groups yielded an adjusted hazard ratio of 0.68 (P = .001).
A secondary aim of the study was to see which aspects of therapy, and which pathologic features, were associated with longer OS. The addition of postsurgical therapy was associated with additional survival benefit (31.6 vs. 22.6 months for no postsurgical therapy; HR, 0.60; P = .002). Node-negative and R0 status were both also significantly increased among those receiving neoadjuvant chemotherapy, and both disease characteristics were associated with increased OS, he reported.
Dr. Shubert said that study limitations included its review of a prospective database. Also, investigators could not determine the type or duration of chemotherapy; they also were unable to tell when systemic chemotherapy plus chemoradiation or just chemoradiation alone had been used. No recurrence data were available, and all cases were grouped under one procedure code, limiting information about vascular resections.
“Neoadjuvant therapy may offer survival advantages compared to a surgery-first approach,” said Dr. Shubert, and control of small occult metastases may be the mechanism behind this advantage. Still to be determined, however, are the optimal type, duration, and sequencing of neoadjuvant chemotherapy and chemoradiation, he said.
Dr. Shubert reported no relevant disclosures.
On Twitter @karioakes
MONTREAL – For individuals with stage III pancreatic cancer, neoadjuvant therapy may improve survival, compared with surgery-first treatment. “This study supports, however does not prove, the hypothesis that early and continued control of occult metastatic disease prolongs survival in surgical patients,” said Dr. Christopher Shubert.
Dr. Shubert and his colleagues used an intention-to-treat (ITT) analysis to compare overall survival (OS) for 377 patients who were to receive neoadjuvant chemotherapy with 216 patients who received surgery first. Median OS for the neoadjuvant group was 20.7 months, compared with 13.7 months for the surgery-first group (log-rank P less than .0001).
This study was the first to utilize national data to look at how patients who received neoadjuvant chemotherapy for stage III pancreatic cancer fared, when compared with those treated with a surgery-first approach, Dr. Shubert, a general surgery resident at the Mayo Clinic in Rochester, Minn., said at the annual meeting of the Central Surgical Association.
Stage III pancreatic cancer (T4, any N, M0) means that the cancer has invaded the celiac trunk, or there is superior mesenteric artery involvement, he noted.
Using data from the National Cancer Database from 2002 to 2011, the investigators identified patients with clinical stage III pancreatic adenocarcinoma of the head or body of the pancreas. The ITT neoadjuvant therapy cohort included all patients whose treatment recommendations included curative-intent surgery and neoadjuvant chemotherapy, regardless of what therapies the patients received. The surgery-first cohort included those who were recommended to receive adjuvant therapy.
A total of 593 patients were identified, of whom 377 (63.5%) were in the neoadjuvant group. Of these, 104 (27.6%) were lost to presurgical attrition. The surgery-first group included 216 patients (36.3%), 30 (13.9%) of whom did not receive the intended adjuvant chemotherapy. Comparing the two ITT groups yielded an adjusted hazard ratio of 0.68 (P = .001).
A secondary aim of the study was to see which aspects of therapy, and which pathologic features, were associated with longer OS. The addition of postsurgical therapy was associated with additional survival benefit (31.6 vs. 22.6 months for no postsurgical therapy; HR, 0.60; P = .002). Node-negative and R0 status were both also significantly increased among those receiving neoadjuvant chemotherapy, and both disease characteristics were associated with increased OS, he reported.
Dr. Shubert said that study limitations included its review of a prospective database. Also, investigators could not determine the type or duration of chemotherapy; they also were unable to tell when systemic chemotherapy plus chemoradiation or just chemoradiation alone had been used. No recurrence data were available, and all cases were grouped under one procedure code, limiting information about vascular resections.
“Neoadjuvant therapy may offer survival advantages compared to a surgery-first approach,” said Dr. Shubert, and control of small occult metastases may be the mechanism behind this advantage. Still to be determined, however, are the optimal type, duration, and sequencing of neoadjuvant chemotherapy and chemoradiation, he said.
Dr. Shubert reported no relevant disclosures.
On Twitter @karioakes
AT THE ANNUAL MEETING OF THE CENTRAL SURGICAL ASSOCIATION
Key clinical point: Overall survival in stage III pancreatic cancer was better with neoadjuvant chemotherapy.
Major finding: Median survival with neoadjuvant chemotherapy was 20.7 months, compared with 13.7 months for surgery-first patients.
Data source: Review of stage III pancreatic cancer patients in the prospective National Cancer Database, comparing 377 patients recommended to receive neoadjuvant chemotherapy with 216 patients who were to receive surgery first.
Disclosures: Dr. Shubert reported no relevant disclosures.
Surgeons commonly off the mark in estimating blood loss
MONTREAL – Surgeons, nurses, and anesthesia providers were all pretty bad at estimating surgical blood loss in a small study. And more experience doesn’t improve accuracy, though experienced providers were more confident in their estimates.
These were the findings from a study that simulated operating room scenarios and asked providers to estimate blood loss. “Estimation of blood loss is inaccurate and unreliable,” Dr. Luke Rothermel said at the Central Surgical Association’s annual meeting.
Dr. Rothermel, a resident at Case Western Reserve University, Cleveland, noted that although the Joint Commission requires operative notes to contain estimated blood loss, “no study in the United States has compared the characteristics of operating room personnel or conditions associated with improved accuracy or reliability of blood loss estimation.”
Beyond the required reporting, estimating blood loss (EBL) also provides important guidance in perioperative care. Still, said Dr. Rothermel, previous studies have shown that EBL is typically inaccurate.
To assess providers’ ability to be accurate and reliable in estimating blood loss, Dr. Rothermel and his collaborator, Dr. Jeremy Lipman, assistant residency director at MetroHealth, Cleveland, designed a study to simulate three different operating room scenarios, involving high, medium, and low blood loss volumes. The materials used, such as blood-soaked sponges and suction canisters, were identical to what’s actually used in the operating room (porcine blood was used in the simulations).
Before the study, Dr. Rothermel said that he and Dr. Lipman hypothesized that those providers who had more experience and those who were working at the operating field would be more accurate in estimating blood loss. They also hypothesized that estimations in procedures with lower volumes of blood loss would be more accurate.
The study recruited providers from the surgery, anesthesia, and nursing services at an urban level 1 trauma center. Each scenario included a written description of the procedure performed and the course of surgery, and participants could handle study materials for each scenario under the supervision of study staff.
A total of 60 participants (22 from surgery, 17 from anesthesia, and 21 from nursing) participated; they had an average of 12.8 years of experience. The surgical participants included surgical scrub techs, trainees, and attending physicians. Anesthesia participants included anesthesia assistants, CRNAs, trainees, and attending physicians. Nursing participants were all RNs.
The findings? All over the board: “There was no association between specialty, years of experience, or confidence in ability with the consistency or accuracy of estimated blood loss,” said Dr. Rothermel.
Most participants were far shy of the mark, with just 5% of study participants overall able to come within 25% accuracy in judging EBL in all scenarios. Just over a quarter were consistent in over- or underestimating blood loss.
These findings held true across scenarios, across disciplines, and regardless of the number of years of experience. “Increased years of experience trended toward increased error,” said Dr. Rothermel, though the difference was not statistically significant. However, those with more years of experience tended to be more confident of their judgments.
Dr. Rothermel noted the small study size and single institution studied as limitations. Also, “this model was not a high fidelity representation of the OR experience, “ he said, explaining that during surgery, caregivers continually assess intraoperative blood loss and may form an estimate in a different – and potentially more accurate – manner than occurs when presented with the contrived presentation of a scenario.
The study calls into question the validity of using EBL as a quality indicator in assessing physician performance and patient outcomes, said Dr. Rothermel, who had no financial disclosures.
On Twitter @karioakes
MONTREAL – Surgeons, nurses, and anesthesia providers were all pretty bad at estimating surgical blood loss in a small study. And more experience doesn’t improve accuracy, though experienced providers were more confident in their estimates.
These were the findings from a study that simulated operating room scenarios and asked providers to estimate blood loss. “Estimation of blood loss is inaccurate and unreliable,” Dr. Luke Rothermel said at the Central Surgical Association’s annual meeting.
Dr. Rothermel, a resident at Case Western Reserve University, Cleveland, noted that although the Joint Commission requires operative notes to contain estimated blood loss, “no study in the United States has compared the characteristics of operating room personnel or conditions associated with improved accuracy or reliability of blood loss estimation.”
Beyond the required reporting, estimating blood loss (EBL) also provides important guidance in perioperative care. Still, said Dr. Rothermel, previous studies have shown that EBL is typically inaccurate.
To assess providers’ ability to be accurate and reliable in estimating blood loss, Dr. Rothermel and his collaborator, Dr. Jeremy Lipman, assistant residency director at MetroHealth, Cleveland, designed a study to simulate three different operating room scenarios, involving high, medium, and low blood loss volumes. The materials used, such as blood-soaked sponges and suction canisters, were identical to what’s actually used in the operating room (porcine blood was used in the simulations).
Before the study, Dr. Rothermel said that he and Dr. Lipman hypothesized that those providers who had more experience and those who were working at the operating field would be more accurate in estimating blood loss. They also hypothesized that estimations in procedures with lower volumes of blood loss would be more accurate.
The study recruited providers from the surgery, anesthesia, and nursing services at an urban level 1 trauma center. Each scenario included a written description of the procedure performed and the course of surgery, and participants could handle study materials for each scenario under the supervision of study staff.
A total of 60 participants (22 from surgery, 17 from anesthesia, and 21 from nursing) participated; they had an average of 12.8 years of experience. The surgical participants included surgical scrub techs, trainees, and attending physicians. Anesthesia participants included anesthesia assistants, CRNAs, trainees, and attending physicians. Nursing participants were all RNs.
The findings? All over the board: “There was no association between specialty, years of experience, or confidence in ability with the consistency or accuracy of estimated blood loss,” said Dr. Rothermel.
Most participants were far shy of the mark, with just 5% of study participants overall able to come within 25% accuracy in judging EBL in all scenarios. Just over a quarter were consistent in over- or underestimating blood loss.
These findings held true across scenarios, across disciplines, and regardless of the number of years of experience. “Increased years of experience trended toward increased error,” said Dr. Rothermel, though the difference was not statistically significant. However, those with more years of experience tended to be more confident of their judgments.
Dr. Rothermel noted the small study size and single institution studied as limitations. Also, “this model was not a high fidelity representation of the OR experience, “ he said, explaining that during surgery, caregivers continually assess intraoperative blood loss and may form an estimate in a different – and potentially more accurate – manner than occurs when presented with the contrived presentation of a scenario.
The study calls into question the validity of using EBL as a quality indicator in assessing physician performance and patient outcomes, said Dr. Rothermel, who had no financial disclosures.
On Twitter @karioakes
MONTREAL – Surgeons, nurses, and anesthesia providers were all pretty bad at estimating surgical blood loss in a small study. And more experience doesn’t improve accuracy, though experienced providers were more confident in their estimates.
These were the findings from a study that simulated operating room scenarios and asked providers to estimate blood loss. “Estimation of blood loss is inaccurate and unreliable,” Dr. Luke Rothermel said at the Central Surgical Association’s annual meeting.
Dr. Rothermel, a resident at Case Western Reserve University, Cleveland, noted that although the Joint Commission requires operative notes to contain estimated blood loss, “no study in the United States has compared the characteristics of operating room personnel or conditions associated with improved accuracy or reliability of blood loss estimation.”
Beyond the required reporting, estimating blood loss (EBL) also provides important guidance in perioperative care. Still, said Dr. Rothermel, previous studies have shown that EBL is typically inaccurate.
To assess providers’ ability to be accurate and reliable in estimating blood loss, Dr. Rothermel and his collaborator, Dr. Jeremy Lipman, assistant residency director at MetroHealth, Cleveland, designed a study to simulate three different operating room scenarios, involving high, medium, and low blood loss volumes. The materials used, such as blood-soaked sponges and suction canisters, were identical to what’s actually used in the operating room (porcine blood was used in the simulations).
Before the study, Dr. Rothermel said that he and Dr. Lipman hypothesized that those providers who had more experience and those who were working at the operating field would be more accurate in estimating blood loss. They also hypothesized that estimations in procedures with lower volumes of blood loss would be more accurate.
The study recruited providers from the surgery, anesthesia, and nursing services at an urban level 1 trauma center. Each scenario included a written description of the procedure performed and the course of surgery, and participants could handle study materials for each scenario under the supervision of study staff.
A total of 60 participants (22 from surgery, 17 from anesthesia, and 21 from nursing) participated; they had an average of 12.8 years of experience. The surgical participants included surgical scrub techs, trainees, and attending physicians. Anesthesia participants included anesthesia assistants, CRNAs, trainees, and attending physicians. Nursing participants were all RNs.
The findings? All over the board: “There was no association between specialty, years of experience, or confidence in ability with the consistency or accuracy of estimated blood loss,” said Dr. Rothermel.
Most participants were far shy of the mark, with just 5% of study participants overall able to come within 25% accuracy in judging EBL in all scenarios. Just over a quarter were consistent in over- or underestimating blood loss.
These findings held true across scenarios, across disciplines, and regardless of the number of years of experience. “Increased years of experience trended toward increased error,” said Dr. Rothermel, though the difference was not statistically significant. However, those with more years of experience tended to be more confident of their judgments.
Dr. Rothermel noted the small study size and single institution studied as limitations. Also, “this model was not a high fidelity representation of the OR experience, “ he said, explaining that during surgery, caregivers continually assess intraoperative blood loss and may form an estimate in a different – and potentially more accurate – manner than occurs when presented with the contrived presentation of a scenario.
The study calls into question the validity of using EBL as a quality indicator in assessing physician performance and patient outcomes, said Dr. Rothermel, who had no financial disclosures.
On Twitter @karioakes
AT THE ANNUAL MEETING OF THE CENTRAL SURGICAL ASSOCIATION
Key clinical point: Surgery, anesthesia, and nursing providers were inaccurate and unreliable in estimating surgical blood loss.
Major finding: Only 5% of providers could come within 25% accuracy of simulated surgical blood loss.
Data source: Simulations of surgical scenarios depicting varying amounts of blood loss using porcine blood, presented to 60 providers.
Disclosures: The study authors reported no relevant disclosures.
Hospital scoring model predicts high-quality surgical outcomes in low-volume centers
MONTREAL – A “hospital ecosystem score” derived from examining high-volume, high-quality hospitals has good specificity in predicting which hospitals will have high-quality outcomes, though these hospitals have low surgical volume for a given procedure.
“What we’re talking about is a care delivery macro-environment,” said Dr. Anai Kothari, presenting results of a retrospective study of surgical outcomes at the Central Surgical Association’s annual meeting.
The study built on previous work that had identified “hospital system factors that actually equipped hospitals to provide high quality care,” said Dr. Kothari, a surgical research resident at Loyola University Medical Center in Maywood, Ill. “These high-volume ecosystems do exist at low-volume hospitals,” he said.
The study was designed as a retrospective review of 24,784 patient encounters over a 5-year period from 302 hospitals; data were taken from the Hospital Consumer Assessment of Healthcare Providers and Services (HCAHPS) databases in California and Florida, with hospital resources data taken from the American Hospital Association (AHA) Annual Survey Database.
Adult patients were included if they had a malignancy of the esophagus, pancreas, or rectum, and had a surgical resection of the malignancy.
Dr. Kothari and his coinvestigators used patient mortality as a marker of quality, and analyzed the relationship between quality and case volume for each of the three procedures. “We used very strict definitions for high and low-volume” of surgical procedures, based on criteria set by the “Take the Volume Pledge” campaign that discourages surgeons from performing certain complex procedures unless they do them frequently, he said.
When procedural volume was mapped against risk-adjusted patient mortality in the data, the results could be divided into quadrants: high-volume/high-quality, high-volume/low-quality, low-volume/high-quality, and low-volume/low-quality.
Dr. Kothari said that an interesting pattern emerged, where a significant number of hospitals had low case volume but high quality outcomes. “In some cases … there are actually more low-volume/high-quality centers than high-volume/high-quality centers,” he said.
The researchers then looked at centers that performed at least two of the three surgical procedures at a high volume, to tease out some of the hospital system factors at play. They settled on examining 13 hospitals of over 300 initially studied, looking at more than 30 hospital characteristics that fell into five broad categories. These included infrastructure, size, staffing, perioperative services, and support intensity.
Within these categories, infrastructure characteristics associated with better outcomes included the facility’s being a level 1 trauma center and having transplant services. Size characteristics associated with better outcomes included total number of hospital admissions and total inpatient surgical volume. In terms of staffing, higher resident-to-bed and nurse-to-bed ratio (but not a higher physician-to-bed ratio) were both linked to better outcomes.
The perioperative services that mattered for outcomes were patient rehabilitation, geriatric services, speech and language pathology, and inpatient palliative care. Patients in facilities with a high level of oncology support also fared better.
Using different analytic models, Dr. Kothari and his colleagues attempted to determine whether these factors were predictive of a high-volume ecosystem that would result in better outcomes, even if volume for a particular procedure was low.
They found that their model, which assigned one point for each hospital ecosystem characteristic present at a given hospital, was very specific for identifying low-volume, high-quality care centers. “So a score of 7 and above has a specificity for low volume/high quality of care of over 70%” in esophageal resection, said Dr. Kothari.
Dr. Kothari noted how few high-volume centers were identified for this study, a finding that points to the practical importance for hospital administrators of knowing what factors may contribute to better surgical outcomes in smaller facilities.
Dr. Luke Funk, director of minimally invasive surgery research at the University of Wisconsin-Madison and a sometime collaborator of Dr. Kothari’s, had some suggestions for next steps. “Perhaps you could drill down qualitatively, going into some of these centers and talking to folks. Then you could take aspects from these programs and apply them to lower volume centers.” Dr. Kothari agreed, saying this would be a “very natural next step.”
Dr. Kothari reported no relevant disclosures; he is supported by an NIH training grant.
On Twitter @karioakes
MONTREAL – A “hospital ecosystem score” derived from examining high-volume, high-quality hospitals has good specificity in predicting which hospitals will have high-quality outcomes, though these hospitals have low surgical volume for a given procedure.
“What we’re talking about is a care delivery macro-environment,” said Dr. Anai Kothari, presenting results of a retrospective study of surgical outcomes at the Central Surgical Association’s annual meeting.
The study built on previous work that had identified “hospital system factors that actually equipped hospitals to provide high quality care,” said Dr. Kothari, a surgical research resident at Loyola University Medical Center in Maywood, Ill. “These high-volume ecosystems do exist at low-volume hospitals,” he said.
The study was designed as a retrospective review of 24,784 patient encounters over a 5-year period from 302 hospitals; data were taken from the Hospital Consumer Assessment of Healthcare Providers and Services (HCAHPS) databases in California and Florida, with hospital resources data taken from the American Hospital Association (AHA) Annual Survey Database.
Adult patients were included if they had a malignancy of the esophagus, pancreas, or rectum, and had a surgical resection of the malignancy.
Dr. Kothari and his coinvestigators used patient mortality as a marker of quality, and analyzed the relationship between quality and case volume for each of the three procedures. “We used very strict definitions for high and low-volume” of surgical procedures, based on criteria set by the “Take the Volume Pledge” campaign that discourages surgeons from performing certain complex procedures unless they do them frequently, he said.
When procedural volume was mapped against risk-adjusted patient mortality in the data, the results could be divided into quadrants: high-volume/high-quality, high-volume/low-quality, low-volume/high-quality, and low-volume/low-quality.
Dr. Kothari said that an interesting pattern emerged, where a significant number of hospitals had low case volume but high quality outcomes. “In some cases … there are actually more low-volume/high-quality centers than high-volume/high-quality centers,” he said.
The researchers then looked at centers that performed at least two of the three surgical procedures at a high volume, to tease out some of the hospital system factors at play. They settled on examining 13 hospitals of over 300 initially studied, looking at more than 30 hospital characteristics that fell into five broad categories. These included infrastructure, size, staffing, perioperative services, and support intensity.
Within these categories, infrastructure characteristics associated with better outcomes included the facility’s being a level 1 trauma center and having transplant services. Size characteristics associated with better outcomes included total number of hospital admissions and total inpatient surgical volume. In terms of staffing, higher resident-to-bed and nurse-to-bed ratio (but not a higher physician-to-bed ratio) were both linked to better outcomes.
The perioperative services that mattered for outcomes were patient rehabilitation, geriatric services, speech and language pathology, and inpatient palliative care. Patients in facilities with a high level of oncology support also fared better.
Using different analytic models, Dr. Kothari and his colleagues attempted to determine whether these factors were predictive of a high-volume ecosystem that would result in better outcomes, even if volume for a particular procedure was low.
They found that their model, which assigned one point for each hospital ecosystem characteristic present at a given hospital, was very specific for identifying low-volume, high-quality care centers. “So a score of 7 and above has a specificity for low volume/high quality of care of over 70%” in esophageal resection, said Dr. Kothari.
Dr. Kothari noted how few high-volume centers were identified for this study, a finding that points to the practical importance for hospital administrators of knowing what factors may contribute to better surgical outcomes in smaller facilities.
Dr. Luke Funk, director of minimally invasive surgery research at the University of Wisconsin-Madison and a sometime collaborator of Dr. Kothari’s, had some suggestions for next steps. “Perhaps you could drill down qualitatively, going into some of these centers and talking to folks. Then you could take aspects from these programs and apply them to lower volume centers.” Dr. Kothari agreed, saying this would be a “very natural next step.”
Dr. Kothari reported no relevant disclosures; he is supported by an NIH training grant.
On Twitter @karioakes
MONTREAL – A “hospital ecosystem score” derived from examining high-volume, high-quality hospitals has good specificity in predicting which hospitals will have high-quality outcomes, though these hospitals have low surgical volume for a given procedure.
“What we’re talking about is a care delivery macro-environment,” said Dr. Anai Kothari, presenting results of a retrospective study of surgical outcomes at the Central Surgical Association’s annual meeting.
The study built on previous work that had identified “hospital system factors that actually equipped hospitals to provide high quality care,” said Dr. Kothari, a surgical research resident at Loyola University Medical Center in Maywood, Ill. “These high-volume ecosystems do exist at low-volume hospitals,” he said.
The study was designed as a retrospective review of 24,784 patient encounters over a 5-year period from 302 hospitals; data were taken from the Hospital Consumer Assessment of Healthcare Providers and Services (HCAHPS) databases in California and Florida, with hospital resources data taken from the American Hospital Association (AHA) Annual Survey Database.
Adult patients were included if they had a malignancy of the esophagus, pancreas, or rectum, and had a surgical resection of the malignancy.
Dr. Kothari and his coinvestigators used patient mortality as a marker of quality, and analyzed the relationship between quality and case volume for each of the three procedures. “We used very strict definitions for high and low-volume” of surgical procedures, based on criteria set by the “Take the Volume Pledge” campaign that discourages surgeons from performing certain complex procedures unless they do them frequently, he said.
When procedural volume was mapped against risk-adjusted patient mortality in the data, the results could be divided into quadrants: high-volume/high-quality, high-volume/low-quality, low-volume/high-quality, and low-volume/low-quality.
Dr. Kothari said that an interesting pattern emerged, where a significant number of hospitals had low case volume but high quality outcomes. “In some cases … there are actually more low-volume/high-quality centers than high-volume/high-quality centers,” he said.
The researchers then looked at centers that performed at least two of the three surgical procedures at a high volume, to tease out some of the hospital system factors at play. They settled on examining 13 hospitals of over 300 initially studied, looking at more than 30 hospital characteristics that fell into five broad categories. These included infrastructure, size, staffing, perioperative services, and support intensity.
Within these categories, infrastructure characteristics associated with better outcomes included the facility’s being a level 1 trauma center and having transplant services. Size characteristics associated with better outcomes included total number of hospital admissions and total inpatient surgical volume. In terms of staffing, higher resident-to-bed and nurse-to-bed ratio (but not a higher physician-to-bed ratio) were both linked to better outcomes.
The perioperative services that mattered for outcomes were patient rehabilitation, geriatric services, speech and language pathology, and inpatient palliative care. Patients in facilities with a high level of oncology support also fared better.
Using different analytic models, Dr. Kothari and his colleagues attempted to determine whether these factors were predictive of a high-volume ecosystem that would result in better outcomes, even if volume for a particular procedure was low.
They found that their model, which assigned one point for each hospital ecosystem characteristic present at a given hospital, was very specific for identifying low-volume, high-quality care centers. “So a score of 7 and above has a specificity for low volume/high quality of care of over 70%” in esophageal resection, said Dr. Kothari.
Dr. Kothari noted how few high-volume centers were identified for this study, a finding that points to the practical importance for hospital administrators of knowing what factors may contribute to better surgical outcomes in smaller facilities.
Dr. Luke Funk, director of minimally invasive surgery research at the University of Wisconsin-Madison and a sometime collaborator of Dr. Kothari’s, had some suggestions for next steps. “Perhaps you could drill down qualitatively, going into some of these centers and talking to folks. Then you could take aspects from these programs and apply them to lower volume centers.” Dr. Kothari agreed, saying this would be a “very natural next step.”
Dr. Kothari reported no relevant disclosures; he is supported by an NIH training grant.
On Twitter @karioakes
AT THE ANNUAL MEETING OF THE CENTRAL SURGICAL ASSOCIATION
Key clinical point: Hospital macro-environment factors can predict good outcomes even with low procedural volume.
Major finding: A “hospital ecosystem score” can predict which low-volume centers will have high-quality outcomes for some surgeries.
Data source: Retrospective review of 5 years of patient-level data, yielding 24,784 encounters from 302 hospitals from the Hospital Consumer Assessment of Healthcare Providers and Services (HCAHPS) database; hospital resource data taken from the American Hospital Association (AHA) Annual Survey Database.
Disclosures: The study authors reported no relevant disclosures.
Trauma checklist in ED can increase discharge rates
MONTREAL – A trauma checklist may help increase the proportion of trauma patients who are discharged home from an emergency department, according to a single-center study that tracked trauma admissions before and after institution of a trauma checklist.
Dr. Amani Jambhekar, a surgery resident at New York Methodist Hospital, Brooklyn, presented the study findings at the Central Surgical Association’s annual meeting. Discharges in July and August of 2015, after the checklist had been implemented, increased significantly, from a 6.5% rate in the first study month, before the checklist was implemented, to a 23.4% and 16.7% rate for the last two study months (P = .004).
However, the injury severity score decreased over the period of the study, from a mean of 7.27 in the first month of the study to 4.60 in the last month of the study (P = .019), and the injury severity level was generally low.
When a trauma patient is admitted who might fare well at home, not only does the admission represent a potentially avoidable cost, it also exposes patients, particularly elderly patients, to infection risk, increased immobility, and other negative effects of hospitalization.
“Why don’t we discharge patients from the emergency department more? Well, there’s a significant fear of ‘bounce-backs,’ ” Dr. Jambhekar said. The bounce-back phenomenon, where patients who are discharged and then present again and are admitted, had not been well studied among trauma patients discharged from the emergency department, he added.
Risk factors for readmission after a hospital discharge had been studied, and may include low socioeconomic status, no insurance or publicly provided insurance, long initial inpatient stay, and higher Injury Severity Score (ISS). “But none of this had been evaluated in patients who were initially discharged from the emergency department,” said Dr. Jambhekar.
New York Methodist, the study site, is a 651-bed urban community hospital. It sees approximately 100,000 emergency department (ED) visits per year, with 8,000 trauma patients coming through the door of the ED in the first 11 months of the hospital’s designation as a level II trauma center.
Dr. Jambhekar and her colleagues evaluated 376 trauma patients, divided into two groups. The first group of 198 patients was seen in the 3 months before the checklist was put in place. The second group of 178 patients was seen in the 60 days after the trauma checklist was mandated. Patients were included in the study if they had been evaluated by the trauma surgery service.
The trauma checklist contained basic demographic and history information, as well as information about the patients’ ED course – for example, what imaging studied were obtained, lab values, what consults they received. The ISS was calculated prior to patient disposition.
“We wanted to present a template to all of our providers to use, in order to correctly document patients’ injuries. If they knew the extent of every patient’s injuries, they could correctly identify patients who were safe to discharge from the emergency department.” One limitation of the study, said Dr. Jambhekar, is overtriage of patients to the trauma center. This is evidenced by the relatively low ISS scores. “As our trauma center became more popular in Brooklyn and in New York City, more patients were brought to our trauma center, even when they could have adequately been treated elsewhere.”
The study didn’t have long-term follow-up of patients to see if they were satisfied with their care, and if they had recovered from their injuries. The exact cost of outpatient follow-up is also uncertain, said Dr. Jambhekar.
Dr. Jambhekar and her colleagues plan to investigate safety and cost outcomes for discharge of trauma patients from the ED; they also will look at the bounce-back phenomenon, and long-term outcomes for outpatient care of trauma patients.
They reported no relevant financial disclosures.
On Twitter @karioakes
MONTREAL – A trauma checklist may help increase the proportion of trauma patients who are discharged home from an emergency department, according to a single-center study that tracked trauma admissions before and after institution of a trauma checklist.
Dr. Amani Jambhekar, a surgery resident at New York Methodist Hospital, Brooklyn, presented the study findings at the Central Surgical Association’s annual meeting. Discharges in July and August of 2015, after the checklist had been implemented, increased significantly, from a 6.5% rate in the first study month, before the checklist was implemented, to a 23.4% and 16.7% rate for the last two study months (P = .004).
However, the injury severity score decreased over the period of the study, from a mean of 7.27 in the first month of the study to 4.60 in the last month of the study (P = .019), and the injury severity level was generally low.
When a trauma patient is admitted who might fare well at home, not only does the admission represent a potentially avoidable cost, it also exposes patients, particularly elderly patients, to infection risk, increased immobility, and other negative effects of hospitalization.
“Why don’t we discharge patients from the emergency department more? Well, there’s a significant fear of ‘bounce-backs,’ ” Dr. Jambhekar said. The bounce-back phenomenon, where patients who are discharged and then present again and are admitted, had not been well studied among trauma patients discharged from the emergency department, he added.
Risk factors for readmission after a hospital discharge had been studied, and may include low socioeconomic status, no insurance or publicly provided insurance, long initial inpatient stay, and higher Injury Severity Score (ISS). “But none of this had been evaluated in patients who were initially discharged from the emergency department,” said Dr. Jambhekar.
New York Methodist, the study site, is a 651-bed urban community hospital. It sees approximately 100,000 emergency department (ED) visits per year, with 8,000 trauma patients coming through the door of the ED in the first 11 months of the hospital’s designation as a level II trauma center.
Dr. Jambhekar and her colleagues evaluated 376 trauma patients, divided into two groups. The first group of 198 patients was seen in the 3 months before the checklist was put in place. The second group of 178 patients was seen in the 60 days after the trauma checklist was mandated. Patients were included in the study if they had been evaluated by the trauma surgery service.
The trauma checklist contained basic demographic and history information, as well as information about the patients’ ED course – for example, what imaging studied were obtained, lab values, what consults they received. The ISS was calculated prior to patient disposition.
“We wanted to present a template to all of our providers to use, in order to correctly document patients’ injuries. If they knew the extent of every patient’s injuries, they could correctly identify patients who were safe to discharge from the emergency department.” One limitation of the study, said Dr. Jambhekar, is overtriage of patients to the trauma center. This is evidenced by the relatively low ISS scores. “As our trauma center became more popular in Brooklyn and in New York City, more patients were brought to our trauma center, even when they could have adequately been treated elsewhere.”
The study didn’t have long-term follow-up of patients to see if they were satisfied with their care, and if they had recovered from their injuries. The exact cost of outpatient follow-up is also uncertain, said Dr. Jambhekar.
Dr. Jambhekar and her colleagues plan to investigate safety and cost outcomes for discharge of trauma patients from the ED; they also will look at the bounce-back phenomenon, and long-term outcomes for outpatient care of trauma patients.
They reported no relevant financial disclosures.
On Twitter @karioakes
MONTREAL – A trauma checklist may help increase the proportion of trauma patients who are discharged home from an emergency department, according to a single-center study that tracked trauma admissions before and after institution of a trauma checklist.
Dr. Amani Jambhekar, a surgery resident at New York Methodist Hospital, Brooklyn, presented the study findings at the Central Surgical Association’s annual meeting. Discharges in July and August of 2015, after the checklist had been implemented, increased significantly, from a 6.5% rate in the first study month, before the checklist was implemented, to a 23.4% and 16.7% rate for the last two study months (P = .004).
However, the injury severity score decreased over the period of the study, from a mean of 7.27 in the first month of the study to 4.60 in the last month of the study (P = .019), and the injury severity level was generally low.
When a trauma patient is admitted who might fare well at home, not only does the admission represent a potentially avoidable cost, it also exposes patients, particularly elderly patients, to infection risk, increased immobility, and other negative effects of hospitalization.
“Why don’t we discharge patients from the emergency department more? Well, there’s a significant fear of ‘bounce-backs,’ ” Dr. Jambhekar said. The bounce-back phenomenon, where patients who are discharged and then present again and are admitted, had not been well studied among trauma patients discharged from the emergency department, he added.
Risk factors for readmission after a hospital discharge had been studied, and may include low socioeconomic status, no insurance or publicly provided insurance, long initial inpatient stay, and higher Injury Severity Score (ISS). “But none of this had been evaluated in patients who were initially discharged from the emergency department,” said Dr. Jambhekar.
New York Methodist, the study site, is a 651-bed urban community hospital. It sees approximately 100,000 emergency department (ED) visits per year, with 8,000 trauma patients coming through the door of the ED in the first 11 months of the hospital’s designation as a level II trauma center.
Dr. Jambhekar and her colleagues evaluated 376 trauma patients, divided into two groups. The first group of 198 patients was seen in the 3 months before the checklist was put in place. The second group of 178 patients was seen in the 60 days after the trauma checklist was mandated. Patients were included in the study if they had been evaluated by the trauma surgery service.
The trauma checklist contained basic demographic and history information, as well as information about the patients’ ED course – for example, what imaging studied were obtained, lab values, what consults they received. The ISS was calculated prior to patient disposition.
“We wanted to present a template to all of our providers to use, in order to correctly document patients’ injuries. If they knew the extent of every patient’s injuries, they could correctly identify patients who were safe to discharge from the emergency department.” One limitation of the study, said Dr. Jambhekar, is overtriage of patients to the trauma center. This is evidenced by the relatively low ISS scores. “As our trauma center became more popular in Brooklyn and in New York City, more patients were brought to our trauma center, even when they could have adequately been treated elsewhere.”
The study didn’t have long-term follow-up of patients to see if they were satisfied with their care, and if they had recovered from their injuries. The exact cost of outpatient follow-up is also uncertain, said Dr. Jambhekar.
Dr. Jambhekar and her colleagues plan to investigate safety and cost outcomes for discharge of trauma patients from the ED; they also will look at the bounce-back phenomenon, and long-term outcomes for outpatient care of trauma patients.
They reported no relevant financial disclosures.
On Twitter @karioakes
AT THE ANNUAL MEETING OF THE CENTRAL SURGICAL ASSOCIATION
Key clinical point: Use of a standardized trauma checklist in the emergency department (ED) may increase discharge rates.
Major finding: Discharge rates increased significantly after implementation of a trauma checklist.
Data source: Single-center study comparing discharge rates before and after implementation of a trauma checklist.
Disclosures: Dr. Ambhekar and her colleagues reported no disclosures.
Pump-delivered anesthetic reduces pain post-hernia repair
MONTREAL – An elastomeric pump delivering local anesthetic to the site of a ventral hernia repair can significantly reduce postoperative pain, according to a small, single-center study.
The prospective, randomized, double-blind placebo-controlled trial of the use of an elastomeric bupivacaine-containing pump for pain management after laparoscopic ventral hernia repair (LVHR) found that patients receiving bupivacaine reported significantly less postoperative pain than did those receiving saline through the pump.
“The idea is that the use of this technology, in combination with standard postoperative pain medication, would do two things: It would maintain the same level of postoperative pain control, as well as reducing the amount of narcotic and non-narcotic pain medication used,” said Francis DeAsis, a medical student at Midwestern University, Chicago.
“For our project, we focused on the specific anatomic location of the catheter,” Mr. DeAsis said in a presentation at the annual meeting of the Central Surgical Association. A previous study, he said, had shown no efficacy for pump-delivered bupivacaine when it was delivered directly into the hernia sac.
In the present study, the cannula for the pump was placed inferior to the costochondral margin, with catheters tunnelled bilaterally between the transversalis fascia and the parietal peritoneum. “The idea behind this was to knock out as many pain receptors as possible,” said Mr. DeAsis.
Primary outcome measures were the self-reported level of postoperative pain and the amount of postoperative medication use. Adult patients at a single site who were undergoing nonemergent ventral hernia repair and who had no history of opioid abuse or adverse reactions to opioids or local anesthetics were enrolled.
Patients were then prospectively randomized to the placebo arm, where they received 400 mL of saline via pump, or to the intervention arm, where they received 400 mL of 0.5% bupivacaine following LVHR. The pump delivered the study drug for a period of 4 days after placement in both groups.
Patients completed a pain diary and medication log for the 7 days after discharge. They rated their current pain level, reported how frequently they had pain, and reported satisfaction with pain control.
In-hospital use of opioid pain medication did not differ significantly between groups, but patients receiving bupivacaine through their pumps used significantly less ketorolac as inpatients (mean 30 mg, compared with 53 mg in the saline group, P = .01).
“Ketorolac is our first-line; we try to avoid narcotics for many different reasons ... Ketorolac PRN was ordered for everybody,” said Dr. Michael Ujiki, a general surgeon at NorthShore University HealthSystem, Evanston, Ill., and senior investigator for the study.
The median pain score on a 1-10 Likert scale at discharge was 2.0 (interquartile range, 0.0-3.0) for the bupivacaine group and 4.0 (interquartile range, 2.0-5.0) for the saline group (P = .06).
Once patients were discharged from the hospital, patients receiving bupivacaine had significantly less postoperative pain through postoperative day 4 and significantly less frequent pain through postoperative day 4. Finally, they reported being significantly more satisfied with their pain management scores on postoperative days 1-3.
The study was limited by the small cohort size. “The primary reason behind this was that during recruitment, we had a lot of patients voice concern about potentially receiving placebo,” thereby forgoing the chance for additional pain relief, said Mr. DeAsis. “A well-powered study should be conducted in the future.”
The investigators reported no relevant financial disclosures, but all study pumps were provided by the manufacturer, On-Q.
On Twitter @karioakes
MONTREAL – An elastomeric pump delivering local anesthetic to the site of a ventral hernia repair can significantly reduce postoperative pain, according to a small, single-center study.
The prospective, randomized, double-blind placebo-controlled trial of the use of an elastomeric bupivacaine-containing pump for pain management after laparoscopic ventral hernia repair (LVHR) found that patients receiving bupivacaine reported significantly less postoperative pain than did those receiving saline through the pump.
“The idea is that the use of this technology, in combination with standard postoperative pain medication, would do two things: It would maintain the same level of postoperative pain control, as well as reducing the amount of narcotic and non-narcotic pain medication used,” said Francis DeAsis, a medical student at Midwestern University, Chicago.
“For our project, we focused on the specific anatomic location of the catheter,” Mr. DeAsis said in a presentation at the annual meeting of the Central Surgical Association. A previous study, he said, had shown no efficacy for pump-delivered bupivacaine when it was delivered directly into the hernia sac.
In the present study, the cannula for the pump was placed inferior to the costochondral margin, with catheters tunnelled bilaterally between the transversalis fascia and the parietal peritoneum. “The idea behind this was to knock out as many pain receptors as possible,” said Mr. DeAsis.
Primary outcome measures were the self-reported level of postoperative pain and the amount of postoperative medication use. Adult patients at a single site who were undergoing nonemergent ventral hernia repair and who had no history of opioid abuse or adverse reactions to opioids or local anesthetics were enrolled.
Patients were then prospectively randomized to the placebo arm, where they received 400 mL of saline via pump, or to the intervention arm, where they received 400 mL of 0.5% bupivacaine following LVHR. The pump delivered the study drug for a period of 4 days after placement in both groups.
Patients completed a pain diary and medication log for the 7 days after discharge. They rated their current pain level, reported how frequently they had pain, and reported satisfaction with pain control.
In-hospital use of opioid pain medication did not differ significantly between groups, but patients receiving bupivacaine through their pumps used significantly less ketorolac as inpatients (mean 30 mg, compared with 53 mg in the saline group, P = .01).
“Ketorolac is our first-line; we try to avoid narcotics for many different reasons ... Ketorolac PRN was ordered for everybody,” said Dr. Michael Ujiki, a general surgeon at NorthShore University HealthSystem, Evanston, Ill., and senior investigator for the study.
The median pain score on a 1-10 Likert scale at discharge was 2.0 (interquartile range, 0.0-3.0) for the bupivacaine group and 4.0 (interquartile range, 2.0-5.0) for the saline group (P = .06).
Once patients were discharged from the hospital, patients receiving bupivacaine had significantly less postoperative pain through postoperative day 4 and significantly less frequent pain through postoperative day 4. Finally, they reported being significantly more satisfied with their pain management scores on postoperative days 1-3.
The study was limited by the small cohort size. “The primary reason behind this was that during recruitment, we had a lot of patients voice concern about potentially receiving placebo,” thereby forgoing the chance for additional pain relief, said Mr. DeAsis. “A well-powered study should be conducted in the future.”
The investigators reported no relevant financial disclosures, but all study pumps were provided by the manufacturer, On-Q.
On Twitter @karioakes
MONTREAL – An elastomeric pump delivering local anesthetic to the site of a ventral hernia repair can significantly reduce postoperative pain, according to a small, single-center study.
The prospective, randomized, double-blind placebo-controlled trial of the use of an elastomeric bupivacaine-containing pump for pain management after laparoscopic ventral hernia repair (LVHR) found that patients receiving bupivacaine reported significantly less postoperative pain than did those receiving saline through the pump.
“The idea is that the use of this technology, in combination with standard postoperative pain medication, would do two things: It would maintain the same level of postoperative pain control, as well as reducing the amount of narcotic and non-narcotic pain medication used,” said Francis DeAsis, a medical student at Midwestern University, Chicago.
“For our project, we focused on the specific anatomic location of the catheter,” Mr. DeAsis said in a presentation at the annual meeting of the Central Surgical Association. A previous study, he said, had shown no efficacy for pump-delivered bupivacaine when it was delivered directly into the hernia sac.
In the present study, the cannula for the pump was placed inferior to the costochondral margin, with catheters tunnelled bilaterally between the transversalis fascia and the parietal peritoneum. “The idea behind this was to knock out as many pain receptors as possible,” said Mr. DeAsis.
Primary outcome measures were the self-reported level of postoperative pain and the amount of postoperative medication use. Adult patients at a single site who were undergoing nonemergent ventral hernia repair and who had no history of opioid abuse or adverse reactions to opioids or local anesthetics were enrolled.
Patients were then prospectively randomized to the placebo arm, where they received 400 mL of saline via pump, or to the intervention arm, where they received 400 mL of 0.5% bupivacaine following LVHR. The pump delivered the study drug for a period of 4 days after placement in both groups.
Patients completed a pain diary and medication log for the 7 days after discharge. They rated their current pain level, reported how frequently they had pain, and reported satisfaction with pain control.
In-hospital use of opioid pain medication did not differ significantly between groups, but patients receiving bupivacaine through their pumps used significantly less ketorolac as inpatients (mean 30 mg, compared with 53 mg in the saline group, P = .01).
“Ketorolac is our first-line; we try to avoid narcotics for many different reasons ... Ketorolac PRN was ordered for everybody,” said Dr. Michael Ujiki, a general surgeon at NorthShore University HealthSystem, Evanston, Ill., and senior investigator for the study.
The median pain score on a 1-10 Likert scale at discharge was 2.0 (interquartile range, 0.0-3.0) for the bupivacaine group and 4.0 (interquartile range, 2.0-5.0) for the saline group (P = .06).
Once patients were discharged from the hospital, patients receiving bupivacaine had significantly less postoperative pain through postoperative day 4 and significantly less frequent pain through postoperative day 4. Finally, they reported being significantly more satisfied with their pain management scores on postoperative days 1-3.
The study was limited by the small cohort size. “The primary reason behind this was that during recruitment, we had a lot of patients voice concern about potentially receiving placebo,” thereby forgoing the chance for additional pain relief, said Mr. DeAsis. “A well-powered study should be conducted in the future.”
The investigators reported no relevant financial disclosures, but all study pumps were provided by the manufacturer, On-Q.
On Twitter @karioakes
AT THE ANNUAL MEETING OF THE CENTRAL SURGICAL ASSOCIATION
Key clinical point: Pain scores were reduced when patients had pump-delivered local anesthetic after hernia repair.
Major finding: Pain level and frequency of pain were reduced, and satisfaction with pain control was increased, when patients received local anesthetic via pump after laparoscopic ventral hernia repair.
Data source: Single-center double-blind, placebo-controlled study of elastomeric pump-delivered bupivacaine vs. placebo in 29 patients undergoing laparoscopic ventral hernia repair.
Disclosures: The pump was supplied by the manufacturer (On-Q); the investigators reported no other relevant disclosures.
Pump-delivered anesthetic reduces pain post-hernia repair
MONTREAL – An elastomeric pump delivering local anesthetic to the site of a ventral hernia repair can significantly reduce postoperative pain, according to a small, single-center study.
The prospective, randomized, double-blind placebo-controlled trial of the use of an elastomeric bupivacaine-containing pump for pain management after laparoscopic ventral hernia repair (LVHR) found that patients receiving bupivacaine reported significantly less postoperative pain than did those receiving saline through the pump.
“The idea is that the use of this technology, in combination with standard postoperative pain medication, would do two things: It would maintain the same level of postoperative pain control, as well as reducing the amount of narcotic and non-narcotic pain medication used,” said Francis DeAsis, a medical student at Midwestern University, Chicago.
“For our project, we focused on the specific anatomic location of the catheter,” Mr. DeAsis said in a presentation at the annual meeting of the Central Surgical Association. A previous study, he said, had shown no efficacy for pump-delivered bupivacaine when it was delivered directly into the hernia sac.
In the present study, the cannula for the pump was placed inferior to the costochondral margin, with catheters tunnelled bilaterally between the transversalis fascia and the parietal peritoneum. “The idea behind this was to knock out as many pain receptors as possible,” said Mr. DeAsis.
Primary outcome measures were the self-reported level of postoperative pain and the amount of postoperative medication use. Adult patients at a single site who were undergoing nonemergent ventral hernia repair and who had no history of opioid abuse or adverse reactions to opioids or local anesthetics were enrolled.
Patients were then prospectively randomized to the placebo arm, where they received 400 mL of saline via pump, or to the intervention arm, where they received 400 mL of 0.5% bupivacaine following LVHR. The pump delivered the study drug for a period of 4 days after placement in both groups.
Patients completed a pain diary and medication log for the 7 days after discharge. They rated their current pain level, reported how frequently they had pain, and reported satisfaction with pain control.
In-hospital use of opioid pain medication did not differ significantly between groups, but patients receiving bupivacaine through their pumps used significantly less ketorolac as inpatients (mean 30 mg, compared with 53 mg in the saline group, P = .01).
“Ketorolac is our first-line; we try to avoid narcotics for many different reasons ... Ketorolac PRN was ordered for everybody,” said Dr. Michael Ujiki, a general surgeon at NorthShore University HealthSystem, Evanston, Ill., and senior investigator for the study.
The median pain score on a 1-10 Likert scale at discharge was 2.0 (interquartile range, 0.0-3.0) for the bupivacaine group and 4.0 (interquartile range, 2.0-5.0) for the saline group (P = .06).
Once patients were discharged from the hospital, patients receiving bupivacaine had significantly less postoperative pain through postoperative day 4 and significantly less frequent pain through postoperative day 4. Finally, they reported being significantly more satisfied with their pain management scores on postoperative days 1-3.
The study was limited by the small cohort size. “The primary reason behind this was that during recruitment, we had a lot of patients voice concern about potentially receiving placebo,” thereby forgoing the chance for additional pain relief, said Mr. DeAsis. “A well-powered study should be conducted in the future.”
The investigators reported no relevant financial disclosures, but all study pumps were provided by the manufacturer, On-Q.
On Twitter @karioakes
MONTREAL – An elastomeric pump delivering local anesthetic to the site of a ventral hernia repair can significantly reduce postoperative pain, according to a small, single-center study.
The prospective, randomized, double-blind placebo-controlled trial of the use of an elastomeric bupivacaine-containing pump for pain management after laparoscopic ventral hernia repair (LVHR) found that patients receiving bupivacaine reported significantly less postoperative pain than did those receiving saline through the pump.
“The idea is that the use of this technology, in combination with standard postoperative pain medication, would do two things: It would maintain the same level of postoperative pain control, as well as reducing the amount of narcotic and non-narcotic pain medication used,” said Francis DeAsis, a medical student at Midwestern University, Chicago.
“For our project, we focused on the specific anatomic location of the catheter,” Mr. DeAsis said in a presentation at the annual meeting of the Central Surgical Association. A previous study, he said, had shown no efficacy for pump-delivered bupivacaine when it was delivered directly into the hernia sac.
In the present study, the cannula for the pump was placed inferior to the costochondral margin, with catheters tunnelled bilaterally between the transversalis fascia and the parietal peritoneum. “The idea behind this was to knock out as many pain receptors as possible,” said Mr. DeAsis.
Primary outcome measures were the self-reported level of postoperative pain and the amount of postoperative medication use. Adult patients at a single site who were undergoing nonemergent ventral hernia repair and who had no history of opioid abuse or adverse reactions to opioids or local anesthetics were enrolled.
Patients were then prospectively randomized to the placebo arm, where they received 400 mL of saline via pump, or to the intervention arm, where they received 400 mL of 0.5% bupivacaine following LVHR. The pump delivered the study drug for a period of 4 days after placement in both groups.
Patients completed a pain diary and medication log for the 7 days after discharge. They rated their current pain level, reported how frequently they had pain, and reported satisfaction with pain control.
In-hospital use of opioid pain medication did not differ significantly between groups, but patients receiving bupivacaine through their pumps used significantly less ketorolac as inpatients (mean 30 mg, compared with 53 mg in the saline group, P = .01).
“Ketorolac is our first-line; we try to avoid narcotics for many different reasons ... Ketorolac PRN was ordered for everybody,” said Dr. Michael Ujiki, a general surgeon at NorthShore University HealthSystem, Evanston, Ill., and senior investigator for the study.
The median pain score on a 1-10 Likert scale at discharge was 2.0 (interquartile range, 0.0-3.0) for the bupivacaine group and 4.0 (interquartile range, 2.0-5.0) for the saline group (P = .06).
Once patients were discharged from the hospital, patients receiving bupivacaine had significantly less postoperative pain through postoperative day 4 and significantly less frequent pain through postoperative day 4. Finally, they reported being significantly more satisfied with their pain management scores on postoperative days 1-3.
The study was limited by the small cohort size. “The primary reason behind this was that during recruitment, we had a lot of patients voice concern about potentially receiving placebo,” thereby forgoing the chance for additional pain relief, said Mr. DeAsis. “A well-powered study should be conducted in the future.”
The investigators reported no relevant financial disclosures, but all study pumps were provided by the manufacturer, On-Q.
On Twitter @karioakes
MONTREAL – An elastomeric pump delivering local anesthetic to the site of a ventral hernia repair can significantly reduce postoperative pain, according to a small, single-center study.
The prospective, randomized, double-blind placebo-controlled trial of the use of an elastomeric bupivacaine-containing pump for pain management after laparoscopic ventral hernia repair (LVHR) found that patients receiving bupivacaine reported significantly less postoperative pain than did those receiving saline through the pump.
“The idea is that the use of this technology, in combination with standard postoperative pain medication, would do two things: It would maintain the same level of postoperative pain control, as well as reducing the amount of narcotic and non-narcotic pain medication used,” said Francis DeAsis, a medical student at Midwestern University, Chicago.
“For our project, we focused on the specific anatomic location of the catheter,” Mr. DeAsis said in a presentation at the annual meeting of the Central Surgical Association. A previous study, he said, had shown no efficacy for pump-delivered bupivacaine when it was delivered directly into the hernia sac.
In the present study, the cannula for the pump was placed inferior to the costochondral margin, with catheters tunnelled bilaterally between the transversalis fascia and the parietal peritoneum. “The idea behind this was to knock out as many pain receptors as possible,” said Mr. DeAsis.
Primary outcome measures were the self-reported level of postoperative pain and the amount of postoperative medication use. Adult patients at a single site who were undergoing nonemergent ventral hernia repair and who had no history of opioid abuse or adverse reactions to opioids or local anesthetics were enrolled.
Patients were then prospectively randomized to the placebo arm, where they received 400 mL of saline via pump, or to the intervention arm, where they received 400 mL of 0.5% bupivacaine following LVHR. The pump delivered the study drug for a period of 4 days after placement in both groups.
Patients completed a pain diary and medication log for the 7 days after discharge. They rated their current pain level, reported how frequently they had pain, and reported satisfaction with pain control.
In-hospital use of opioid pain medication did not differ significantly between groups, but patients receiving bupivacaine through their pumps used significantly less ketorolac as inpatients (mean 30 mg, compared with 53 mg in the saline group, P = .01).
“Ketorolac is our first-line; we try to avoid narcotics for many different reasons ... Ketorolac PRN was ordered for everybody,” said Dr. Michael Ujiki, a general surgeon at NorthShore University HealthSystem, Evanston, Ill., and senior investigator for the study.
The median pain score on a 1-10 Likert scale at discharge was 2.0 (interquartile range, 0.0-3.0) for the bupivacaine group and 4.0 (interquartile range, 2.0-5.0) for the saline group (P = .06).
Once patients were discharged from the hospital, patients receiving bupivacaine had significantly less postoperative pain through postoperative day 4 and significantly less frequent pain through postoperative day 4. Finally, they reported being significantly more satisfied with their pain management scores on postoperative days 1-3.
The study was limited by the small cohort size. “The primary reason behind this was that during recruitment, we had a lot of patients voice concern about potentially receiving placebo,” thereby forgoing the chance for additional pain relief, said Mr. DeAsis. “A well-powered study should be conducted in the future.”
The investigators reported no relevant financial disclosures, but all study pumps were provided by the manufacturer, On-Q.
On Twitter @karioakes
AT THE ANNUAL MEETING OF THE CENTRAL SURGICAL ASSOCIATION
Key clinical point: Pain scores were reduced when patients had pump-delivered local anesthetic after hernia repair.
Major finding: Pain level and frequency of pain were reduced, and satisfaction with pain control was increased, when patients received local anesthetic via pump after laparoscopic ventral hernia repair.
Data source: Single-center double-blind, placebo-controlled study of elastomeric pump-delivered bupivacaine vs. placebo in 29 patients undergoing laparoscopic ventral hernia repair.
Disclosures: The pump was supplied by the manufacturer (On-Q); the investigators reported no other relevant disclosures.
Malpractice claims for small bowel obstruction costly, frequent for general surgeons
MONTREAL – When surgeons are sued and lose or settle in cases relating to management of small bowel obstruction, the payout is often costly, according a study involving a close examination of 158 such cases.
The odds of a positive outcome aren’t great. “When looking at award payouts, close to half of cases resulted in a verdict with monetary compensation for the patient,” said Dr. Asad Choudhry, a postdoctoral fellow in the department of trauma, critical care, and surgery at the Mayo Clinic, Rochester, Minn.
Dr. Choudhry, presenting his findings at the annual meeting of the Central Surgical Association, said that general surgeons are the third most likely specialty to be sued, coming only after neurosurgeons and cardiothoracic surgeons. In a given year, about 15% of all general surgeons will be sued, with almost a third of those suits resulting in a payment to the plaintiff. By age 65 years, said Dr. Choudhry, 99% of physicians in higher-risk specialties will face a malpractice claim, compared with 75% of those in lower-risk specialties.
Overall, one-third of malpractice payments come from suits that allege diagnostic error; 24% of suits allege malpractice in surgery. “Small bowel obstruction accounts for 12% to 16% of surgical admissions, with 300,000 operations performed each year,” he said.
Dr. Choudhry and his colleagues searched the Westlaw database using key search terms to identify U.S. malpractice cases that involved small bowel obstruction (SBO), focusing only on cases in which management of SBO was the primary reason for the suit. Cases from 1982 to 2015 were included.
Looking more closely at the 158 cases that resulted from the search, Dr. Choudhry examined variables that included patient demographics, the alleged reason for the malpractice, the settlement or verdict, and the amount paid out, adjusted to 2015 dollars.
In this sample of SBO cases, 139 patients were adults and 19 were children. The median age was 45 years. Over half of the patients in the group died (94/158, 60%), although neither age nor patient death were factors significantly associated with verdict outcome or award amount, he said.
The decade-over-decade growth in the number of suits was striking, increasing 188% during the 1994-2004 period from the previous decade and another 87% from 2005 to 2015.
In a lawsuit involving a SBO, the defendant is more likely to be a general surgeon than to belong to any other specialty. General surgeons were the defendant in 37% of cases, followed by internists in 24% and emergency physicians in 11%.
Dr. Choudhry and his associates conceptually grouped the reasons for the suits into preoperative, intraoperative, and postoperative care. Among the reasons for litigation, by far the most common was untimely intervention in managing of the SBO, a preoperative care component. This was the primary allegation in over 100 of the 158 cases; the next most common reason for bringing suit was incomplete or incorrect surgical procedure, deemed an intraoperative problem and seen in fewer than 20 of the suits.
Almost half of the cases resulted either in a verdict in favor of the plaintiff (n = 37, 23%) or a settlement (n = 36, 23%). When verdicts were returned against the defendant physician, payout amounts varied widely. The smallest amount paid was $29,575 and the largest was over $12 million. Payment amounts were larger with a verdict in favor of the plaintiff, at a median $1,438,800, compared with the median of $1,043,100 received by the plaintiff in a settlement.
Dr. Choudhry noted that early intervention may improve mortality from SBO in some patient groups. “Small bowel obstruction protocols which identify patients at high risk for adverse outcomes and ensure timely management may lessen the chance of litigation,” he said.
Dr. Choudhry acknowledged that the Westlaw database included just a limited amount of medical information. Various tort reform initiatives may have had a confounding effect on award size. It’s possible that using malpractice insurance data could provide more detailed medical information, he said.
Dr. Choudhry reported no relevant disclosures.
On Twitter @karioakes
MONTREAL – When surgeons are sued and lose or settle in cases relating to management of small bowel obstruction, the payout is often costly, according a study involving a close examination of 158 such cases.
The odds of a positive outcome aren’t great. “When looking at award payouts, close to half of cases resulted in a verdict with monetary compensation for the patient,” said Dr. Asad Choudhry, a postdoctoral fellow in the department of trauma, critical care, and surgery at the Mayo Clinic, Rochester, Minn.
Dr. Choudhry, presenting his findings at the annual meeting of the Central Surgical Association, said that general surgeons are the third most likely specialty to be sued, coming only after neurosurgeons and cardiothoracic surgeons. In a given year, about 15% of all general surgeons will be sued, with almost a third of those suits resulting in a payment to the plaintiff. By age 65 years, said Dr. Choudhry, 99% of physicians in higher-risk specialties will face a malpractice claim, compared with 75% of those in lower-risk specialties.
Overall, one-third of malpractice payments come from suits that allege diagnostic error; 24% of suits allege malpractice in surgery. “Small bowel obstruction accounts for 12% to 16% of surgical admissions, with 300,000 operations performed each year,” he said.
Dr. Choudhry and his colleagues searched the Westlaw database using key search terms to identify U.S. malpractice cases that involved small bowel obstruction (SBO), focusing only on cases in which management of SBO was the primary reason for the suit. Cases from 1982 to 2015 were included.
Looking more closely at the 158 cases that resulted from the search, Dr. Choudhry examined variables that included patient demographics, the alleged reason for the malpractice, the settlement or verdict, and the amount paid out, adjusted to 2015 dollars.
In this sample of SBO cases, 139 patients were adults and 19 were children. The median age was 45 years. Over half of the patients in the group died (94/158, 60%), although neither age nor patient death were factors significantly associated with verdict outcome or award amount, he said.
The decade-over-decade growth in the number of suits was striking, increasing 188% during the 1994-2004 period from the previous decade and another 87% from 2005 to 2015.
In a lawsuit involving a SBO, the defendant is more likely to be a general surgeon than to belong to any other specialty. General surgeons were the defendant in 37% of cases, followed by internists in 24% and emergency physicians in 11%.
Dr. Choudhry and his associates conceptually grouped the reasons for the suits into preoperative, intraoperative, and postoperative care. Among the reasons for litigation, by far the most common was untimely intervention in managing of the SBO, a preoperative care component. This was the primary allegation in over 100 of the 158 cases; the next most common reason for bringing suit was incomplete or incorrect surgical procedure, deemed an intraoperative problem and seen in fewer than 20 of the suits.
Almost half of the cases resulted either in a verdict in favor of the plaintiff (n = 37, 23%) or a settlement (n = 36, 23%). When verdicts were returned against the defendant physician, payout amounts varied widely. The smallest amount paid was $29,575 and the largest was over $12 million. Payment amounts were larger with a verdict in favor of the plaintiff, at a median $1,438,800, compared with the median of $1,043,100 received by the plaintiff in a settlement.
Dr. Choudhry noted that early intervention may improve mortality from SBO in some patient groups. “Small bowel obstruction protocols which identify patients at high risk for adverse outcomes and ensure timely management may lessen the chance of litigation,” he said.
Dr. Choudhry acknowledged that the Westlaw database included just a limited amount of medical information. Various tort reform initiatives may have had a confounding effect on award size. It’s possible that using malpractice insurance data could provide more detailed medical information, he said.
Dr. Choudhry reported no relevant disclosures.
On Twitter @karioakes
MONTREAL – When surgeons are sued and lose or settle in cases relating to management of small bowel obstruction, the payout is often costly, according a study involving a close examination of 158 such cases.
The odds of a positive outcome aren’t great. “When looking at award payouts, close to half of cases resulted in a verdict with monetary compensation for the patient,” said Dr. Asad Choudhry, a postdoctoral fellow in the department of trauma, critical care, and surgery at the Mayo Clinic, Rochester, Minn.
Dr. Choudhry, presenting his findings at the annual meeting of the Central Surgical Association, said that general surgeons are the third most likely specialty to be sued, coming only after neurosurgeons and cardiothoracic surgeons. In a given year, about 15% of all general surgeons will be sued, with almost a third of those suits resulting in a payment to the plaintiff. By age 65 years, said Dr. Choudhry, 99% of physicians in higher-risk specialties will face a malpractice claim, compared with 75% of those in lower-risk specialties.
Overall, one-third of malpractice payments come from suits that allege diagnostic error; 24% of suits allege malpractice in surgery. “Small bowel obstruction accounts for 12% to 16% of surgical admissions, with 300,000 operations performed each year,” he said.
Dr. Choudhry and his colleagues searched the Westlaw database using key search terms to identify U.S. malpractice cases that involved small bowel obstruction (SBO), focusing only on cases in which management of SBO was the primary reason for the suit. Cases from 1982 to 2015 were included.
Looking more closely at the 158 cases that resulted from the search, Dr. Choudhry examined variables that included patient demographics, the alleged reason for the malpractice, the settlement or verdict, and the amount paid out, adjusted to 2015 dollars.
In this sample of SBO cases, 139 patients were adults and 19 were children. The median age was 45 years. Over half of the patients in the group died (94/158, 60%), although neither age nor patient death were factors significantly associated with verdict outcome or award amount, he said.
The decade-over-decade growth in the number of suits was striking, increasing 188% during the 1994-2004 period from the previous decade and another 87% from 2005 to 2015.
In a lawsuit involving a SBO, the defendant is more likely to be a general surgeon than to belong to any other specialty. General surgeons were the defendant in 37% of cases, followed by internists in 24% and emergency physicians in 11%.
Dr. Choudhry and his associates conceptually grouped the reasons for the suits into preoperative, intraoperative, and postoperative care. Among the reasons for litigation, by far the most common was untimely intervention in managing of the SBO, a preoperative care component. This was the primary allegation in over 100 of the 158 cases; the next most common reason for bringing suit was incomplete or incorrect surgical procedure, deemed an intraoperative problem and seen in fewer than 20 of the suits.
Almost half of the cases resulted either in a verdict in favor of the plaintiff (n = 37, 23%) or a settlement (n = 36, 23%). When verdicts were returned against the defendant physician, payout amounts varied widely. The smallest amount paid was $29,575 and the largest was over $12 million. Payment amounts were larger with a verdict in favor of the plaintiff, at a median $1,438,800, compared with the median of $1,043,100 received by the plaintiff in a settlement.
Dr. Choudhry noted that early intervention may improve mortality from SBO in some patient groups. “Small bowel obstruction protocols which identify patients at high risk for adverse outcomes and ensure timely management may lessen the chance of litigation,” he said.
Dr. Choudhry acknowledged that the Westlaw database included just a limited amount of medical information. Various tort reform initiatives may have had a confounding effect on award size. It’s possible that using malpractice insurance data could provide more detailed medical information, he said.
Dr. Choudhry reported no relevant disclosures.
On Twitter @karioakes
AT THE ANNUAL MEETING OF THE CENTRAL SURGICAL ASSOCIATION
Key clinical point: Almost half of surgical small bowel obstruction lawsuits involved a payout of a median $1.1 million.
Major finding: About 15% of general surgeons are sued annually, and SBO is a common diagnosis in these suits.
Data source: Review of the Westlaw database that identified 158 lawsuits involving general surgeons and small bowel obstruction from 1982 to 2015.
Disclosures: The study authors reported no relevant disclosures.
Outcomes in major surgery unchanged by continuing clopidogrel
MONTREAL – Patients who stayed on antiplatelet therapy close to – or even up until – major surgery fared just as well as those who stopped their medication earlier in a retrospective, single-center study.
The study found no difference in blood product administration, adverse perioperative events, or all-cause 30-day mortality regardless of whether patients stopped clopidogrel (Plavix) the recommended 5 days before surgery.
“We believe that continuing clopidogrel in elective and emergent surgical situations appears to be safe, and may challenge the current recommendations,” said presenter Dr. David Strosberg.
The study addressed a thorny question for surgeons, Dr. Strosberg said. “As surgeons, we face a dilemma: Do we take the risk of thrombotic complications in stopping the antiplatelet drugs, or do we take the risk of increased surgical bleeding with continuing therapy?”
The package insert for clopidogrel advises discontinuation 5 days prior to surgery. However, manufacturer labeling also states that discontinuation of clopidogrel can lead to adverse cardiac events, said Dr. Strosberg, a general surgery resident at Ohio State University in Columbus.
The aim of the study, presented at the annual meeting of the Central Surgical Association, was to ascertain whether continuing antiplatelet therapy increased the rate of adverse surgical outcomes in those undergoing major emergent or elective surgery.
Dr. Strosberg and his colleagues retrospectively reviewed the record of patients over a 4-year period at a single institution and included those undergoing major general, thoracic, or vascular surgery who were taking clopidogrel at the time of presentation.
Data collected included patient characteristics, including demographic data and comorbidities, as well as transfusion requirements and perioperative events.
A total of 200 patients who had 205 qualifying procedures and were taking clopidogrel were included in the study. Of these, 116 patients (Group A) had their clopidogrel held for at least 5 days preoperatively. The remaining 89 patients (Group B) had their clopidogrel held for less than 5 days, or not at all.
Patient demographics were similar between the two groups. Patients in Group A were more likely to have emergency surgery, to have peripheral stents placed, to have COPD or peripheral vascular disease, to have a malignancy, and to have received aspirin within five days of surgery (P less than .01 for all).
Blood product administration rates and volumes did not differ significantly between the two groups, and there was no difference between the groups in the incidence of myocardial infarctions, cerebrovascular events, or acute visceral or lower extremity ischemia.
Three patients in each group died within 30 days of the procedure, a nonsignificant difference. However, in the group that had clopidogrel held, three patients had perioperative myocardial infarctions, and two of these patients died. In discussing the study, Dr. Michael Dalsing said, “I think a lot of us would accept bleeding more over myocardial infarction.”
A subgroup analysis of the group who had clopidogrel held for fewer than 5 days compared outcomes for emergent vs. non-emergent surgery. The emergent surgery subgroup had a significantly higher rate of preoperative platelet transfusions, although numbers overall were small (2/17, 11.8%, vs. 0/72; P = .03).
Dr. Strosberg noted study limitations that included the retrospective, single-center nature of the study, and the fact that one variable, estimated blood loss, is notoriously subjective and inaccurate.
Dr. Dalsing, chief of vascular surgery at Indiana University, Indianapolis, said that he “was surprised that not even one patient went back for postoperative bleeding in this high-risk group of patients,” and raised the question of potential selection bias. Dr. Strosberg replied that comorbidities were ascertained by the physician at the time of surgery planning; since no differences were seen between study groups, investigators didn’t go back and parse out details about comorbid conditions.
In discussion following the presentation, surgeons spoke to the real-world challenges of performing surgery on a patient with antiplatelet therapy on board.
“Overall, I think your data support kind of a bias I have. Since I’m a vascular surgeon, we almost always operate on clopidogrel, and I don’t know if our bleeding risk is worse or better. But it’s something we almost have to do to keep our grafts going,” Dr. Dalsing said.
Dr. Peter Henke, professor of vascular surgery at the University of Michigan, Ann Arbor, said, “I’d be a little bit cautious with this. If you’ve ever done a big aortic procedure on someone on Plavix, I’ve seen them lose up to a couple of liters of blood just with oozing.”
“Those of us who do open aortic surgery know that very few things bleed like the back wall of an aortic anastomosis of a patient on Plavix,” echoed Dr. Peter Rossi, associate professor of vascular surgery at the Medical College of Wisconsin, Milwaukee.
The study authors reported no relevant disclosures.
On Twitter @karioakes
MONTREAL – Patients who stayed on antiplatelet therapy close to – or even up until – major surgery fared just as well as those who stopped their medication earlier in a retrospective, single-center study.
The study found no difference in blood product administration, adverse perioperative events, or all-cause 30-day mortality regardless of whether patients stopped clopidogrel (Plavix) the recommended 5 days before surgery.
“We believe that continuing clopidogrel in elective and emergent surgical situations appears to be safe, and may challenge the current recommendations,” said presenter Dr. David Strosberg.
The study addressed a thorny question for surgeons, Dr. Strosberg said. “As surgeons, we face a dilemma: Do we take the risk of thrombotic complications in stopping the antiplatelet drugs, or do we take the risk of increased surgical bleeding with continuing therapy?”
The package insert for clopidogrel advises discontinuation 5 days prior to surgery. However, manufacturer labeling also states that discontinuation of clopidogrel can lead to adverse cardiac events, said Dr. Strosberg, a general surgery resident at Ohio State University in Columbus.
The aim of the study, presented at the annual meeting of the Central Surgical Association, was to ascertain whether continuing antiplatelet therapy increased the rate of adverse surgical outcomes in those undergoing major emergent or elective surgery.
Dr. Strosberg and his colleagues retrospectively reviewed the record of patients over a 4-year period at a single institution and included those undergoing major general, thoracic, or vascular surgery who were taking clopidogrel at the time of presentation.
Data collected included patient characteristics, including demographic data and comorbidities, as well as transfusion requirements and perioperative events.
A total of 200 patients who had 205 qualifying procedures and were taking clopidogrel were included in the study. Of these, 116 patients (Group A) had their clopidogrel held for at least 5 days preoperatively. The remaining 89 patients (Group B) had their clopidogrel held for less than 5 days, or not at all.
Patient demographics were similar between the two groups. Patients in Group A were more likely to have emergency surgery, to have peripheral stents placed, to have COPD or peripheral vascular disease, to have a malignancy, and to have received aspirin within five days of surgery (P less than .01 for all).
Blood product administration rates and volumes did not differ significantly between the two groups, and there was no difference between the groups in the incidence of myocardial infarctions, cerebrovascular events, or acute visceral or lower extremity ischemia.
Three patients in each group died within 30 days of the procedure, a nonsignificant difference. However, in the group that had clopidogrel held, three patients had perioperative myocardial infarctions, and two of these patients died. In discussing the study, Dr. Michael Dalsing said, “I think a lot of us would accept bleeding more over myocardial infarction.”
A subgroup analysis of the group who had clopidogrel held for fewer than 5 days compared outcomes for emergent vs. non-emergent surgery. The emergent surgery subgroup had a significantly higher rate of preoperative platelet transfusions, although numbers overall were small (2/17, 11.8%, vs. 0/72; P = .03).
Dr. Strosberg noted study limitations that included the retrospective, single-center nature of the study, and the fact that one variable, estimated blood loss, is notoriously subjective and inaccurate.
Dr. Dalsing, chief of vascular surgery at Indiana University, Indianapolis, said that he “was surprised that not even one patient went back for postoperative bleeding in this high-risk group of patients,” and raised the question of potential selection bias. Dr. Strosberg replied that comorbidities were ascertained by the physician at the time of surgery planning; since no differences were seen between study groups, investigators didn’t go back and parse out details about comorbid conditions.
In discussion following the presentation, surgeons spoke to the real-world challenges of performing surgery on a patient with antiplatelet therapy on board.
“Overall, I think your data support kind of a bias I have. Since I’m a vascular surgeon, we almost always operate on clopidogrel, and I don’t know if our bleeding risk is worse or better. But it’s something we almost have to do to keep our grafts going,” Dr. Dalsing said.
Dr. Peter Henke, professor of vascular surgery at the University of Michigan, Ann Arbor, said, “I’d be a little bit cautious with this. If you’ve ever done a big aortic procedure on someone on Plavix, I’ve seen them lose up to a couple of liters of blood just with oozing.”
“Those of us who do open aortic surgery know that very few things bleed like the back wall of an aortic anastomosis of a patient on Plavix,” echoed Dr. Peter Rossi, associate professor of vascular surgery at the Medical College of Wisconsin, Milwaukee.
The study authors reported no relevant disclosures.
On Twitter @karioakes
MONTREAL – Patients who stayed on antiplatelet therapy close to – or even up until – major surgery fared just as well as those who stopped their medication earlier in a retrospective, single-center study.
The study found no difference in blood product administration, adverse perioperative events, or all-cause 30-day mortality regardless of whether patients stopped clopidogrel (Plavix) the recommended 5 days before surgery.
“We believe that continuing clopidogrel in elective and emergent surgical situations appears to be safe, and may challenge the current recommendations,” said presenter Dr. David Strosberg.
The study addressed a thorny question for surgeons, Dr. Strosberg said. “As surgeons, we face a dilemma: Do we take the risk of thrombotic complications in stopping the antiplatelet drugs, or do we take the risk of increased surgical bleeding with continuing therapy?”
The package insert for clopidogrel advises discontinuation 5 days prior to surgery. However, manufacturer labeling also states that discontinuation of clopidogrel can lead to adverse cardiac events, said Dr. Strosberg, a general surgery resident at Ohio State University in Columbus.
The aim of the study, presented at the annual meeting of the Central Surgical Association, was to ascertain whether continuing antiplatelet therapy increased the rate of adverse surgical outcomes in those undergoing major emergent or elective surgery.
Dr. Strosberg and his colleagues retrospectively reviewed the record of patients over a 4-year period at a single institution and included those undergoing major general, thoracic, or vascular surgery who were taking clopidogrel at the time of presentation.
Data collected included patient characteristics, including demographic data and comorbidities, as well as transfusion requirements and perioperative events.
A total of 200 patients who had 205 qualifying procedures and were taking clopidogrel were included in the study. Of these, 116 patients (Group A) had their clopidogrel held for at least 5 days preoperatively. The remaining 89 patients (Group B) had their clopidogrel held for less than 5 days, or not at all.
Patient demographics were similar between the two groups. Patients in Group A were more likely to have emergency surgery, to have peripheral stents placed, to have COPD or peripheral vascular disease, to have a malignancy, and to have received aspirin within five days of surgery (P less than .01 for all).
Blood product administration rates and volumes did not differ significantly between the two groups, and there was no difference between the groups in the incidence of myocardial infarctions, cerebrovascular events, or acute visceral or lower extremity ischemia.
Three patients in each group died within 30 days of the procedure, a nonsignificant difference. However, in the group that had clopidogrel held, three patients had perioperative myocardial infarctions, and two of these patients died. In discussing the study, Dr. Michael Dalsing said, “I think a lot of us would accept bleeding more over myocardial infarction.”
A subgroup analysis of the group who had clopidogrel held for fewer than 5 days compared outcomes for emergent vs. non-emergent surgery. The emergent surgery subgroup had a significantly higher rate of preoperative platelet transfusions, although numbers overall were small (2/17, 11.8%, vs. 0/72; P = .03).
Dr. Strosberg noted study limitations that included the retrospective, single-center nature of the study, and the fact that one variable, estimated blood loss, is notoriously subjective and inaccurate.
Dr. Dalsing, chief of vascular surgery at Indiana University, Indianapolis, said that he “was surprised that not even one patient went back for postoperative bleeding in this high-risk group of patients,” and raised the question of potential selection bias. Dr. Strosberg replied that comorbidities were ascertained by the physician at the time of surgery planning; since no differences were seen between study groups, investigators didn’t go back and parse out details about comorbid conditions.
In discussion following the presentation, surgeons spoke to the real-world challenges of performing surgery on a patient with antiplatelet therapy on board.
“Overall, I think your data support kind of a bias I have. Since I’m a vascular surgeon, we almost always operate on clopidogrel, and I don’t know if our bleeding risk is worse or better. But it’s something we almost have to do to keep our grafts going,” Dr. Dalsing said.
Dr. Peter Henke, professor of vascular surgery at the University of Michigan, Ann Arbor, said, “I’d be a little bit cautious with this. If you’ve ever done a big aortic procedure on someone on Plavix, I’ve seen them lose up to a couple of liters of blood just with oozing.”
“Those of us who do open aortic surgery know that very few things bleed like the back wall of an aortic anastomosis of a patient on Plavix,” echoed Dr. Peter Rossi, associate professor of vascular surgery at the Medical College of Wisconsin, Milwaukee.
The study authors reported no relevant disclosures.
On Twitter @karioakes
AT THE ANNUAL MEETING OF THE CENTRAL SURGICAL ASSOCIATION
Key clinical point: Outcomes were similar whether patients did or didn’t stop clopidogrel before major surgery.
Major finding: No significant differences in blood product use, adverse events, or death were seen with continuing clopidogrel.
Data source: Retrospective, single-center review of 200 patients undergoing major elective or emergent surgery and taking clopidogrel.
Disclosures: The study authors reported no relevant disclosures.
