User login
TCT: Bivalirudin no better than heparin for preventing post-TAVR bleeding
SAN FRANCISCO – The reversible direct thrombin inhibitor bivalirudin, compared with unfractionated heparin, did not reduce the rate of major bleeding at 48 hours after transcatheter aortic valve replacement, in the randomized, open label, phase IIIb BRAVO 3 trial.
Bivalirudin, which has a half-life of 25 minutes, has been shown to reduce major bleeding in the setting of percutaneous coronary intervention when compared with other regimens, but its safety and efficacy as compared with that of unfractionated heparin was unknown. In BRAVO 3 (The effect of BivaliRudin on Aortic Valve Intervention Outcomes trial), the rate of major bleeding at 48 hours, defined as Bleeding Academic Research Consortium (BARC) 3b or greater, was 6.9% in 404 patients treated with bivalirudin vs. 9.0% in 398 patients treated with heparin (relative risk, 0.77), Dr. Thierry Lefevre reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
Further, the rate of net adverse clinical outcomes (NACE), including all-cause mortality, myocardial infarction, stroke, and major bleeding at up to 30 days was 14.4% in the bivalirudin group vs. 16.1% in the heparin group (relative risk, 0.89), Dr. Lefevre of Institut Hospitalier Jacques Cartier, Massy, France, said at the meeting, which was sponsored by the Cardiovascular Research Foundation.
The differences on both measures failed to meet statistical significance. With respect to bleeding at 48 hours, bivalirudin did not meet superiority, and with respect to cardiovascular events at 30 days, the prespecified noninferiority hypothesis was met.
No difference was seen between the groups for secondary endpoints, including bleeding defined according to various other bleeding scales and other BARC types.
The findings were published simultaneously in the Journal of the American College of Cardiology (J Am Coll Cardiol. 2015;Oct 15. doi: 10.1016/j.jacc.2015.10.003).
Heparin should remain the standard of care, especially given its lower cost compared to the cost of bivalirudin, Dr. Lefevre said.
However, Dr. Lefevre noted, major bleeding remains an important concern in transcatheter aortic valve replacement (TAVR), and “bivalirudin may be used as an alternative to heparin during TAVR in patients who cannot be treated with UFH.”
BRAVO III participants were adults with aortic stenosis who were at high surgical risk and who were scheduled for TAVR via transfemoral access. They were enrolled at 31 centers in seven countries throughout Europe and North America.
Those randomized to the bivalirudin group received an initial bolus of 0.75 mg/kg followed by a continuous infusion at a rate of 1.75 mg/kg per hour in those with an estimated glomerular filtration rate (eGFR) of 60 mL/min or greater, 1.4 mg/kg per hour in those with eGFR of 30-59 mL/min, and 1.0 mg/kg per hour in those with eGFR lower than 30 mL/min.
Heparin dosing and administration included a recommended target activated clotting time of greater than 25 seconds. Protamine was used for reversal at the end of the procedure based on standard local institution practice.
Session moderator Dr. Ajay J. Kirtane said that “one of the reasons this trial is exciting is that there has been a hypothesis that bivalirudin could reduce bleeding compared to heparin alone in PCI patients. While this is a much bigger access site, you don’t necessarily see these trends. On the other hand, when you have a bigger access site there is potential for increased signal, but this study is still somewhat underpowered.”
The Medicines Company provided funding for the BRAVO 3 trial to the Icahn School of Medicine at Mount Sinai, New York. Dr. Lefevre disclosed ties with Boston Scientific, Directflow, Edwards, Symetis and Medtronic.
SAN FRANCISCO – The reversible direct thrombin inhibitor bivalirudin, compared with unfractionated heparin, did not reduce the rate of major bleeding at 48 hours after transcatheter aortic valve replacement, in the randomized, open label, phase IIIb BRAVO 3 trial.
Bivalirudin, which has a half-life of 25 minutes, has been shown to reduce major bleeding in the setting of percutaneous coronary intervention when compared with other regimens, but its safety and efficacy as compared with that of unfractionated heparin was unknown. In BRAVO 3 (The effect of BivaliRudin on Aortic Valve Intervention Outcomes trial), the rate of major bleeding at 48 hours, defined as Bleeding Academic Research Consortium (BARC) 3b or greater, was 6.9% in 404 patients treated with bivalirudin vs. 9.0% in 398 patients treated with heparin (relative risk, 0.77), Dr. Thierry Lefevre reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
Further, the rate of net adverse clinical outcomes (NACE), including all-cause mortality, myocardial infarction, stroke, and major bleeding at up to 30 days was 14.4% in the bivalirudin group vs. 16.1% in the heparin group (relative risk, 0.89), Dr. Lefevre of Institut Hospitalier Jacques Cartier, Massy, France, said at the meeting, which was sponsored by the Cardiovascular Research Foundation.
The differences on both measures failed to meet statistical significance. With respect to bleeding at 48 hours, bivalirudin did not meet superiority, and with respect to cardiovascular events at 30 days, the prespecified noninferiority hypothesis was met.
No difference was seen between the groups for secondary endpoints, including bleeding defined according to various other bleeding scales and other BARC types.
The findings were published simultaneously in the Journal of the American College of Cardiology (J Am Coll Cardiol. 2015;Oct 15. doi: 10.1016/j.jacc.2015.10.003).
Heparin should remain the standard of care, especially given its lower cost compared to the cost of bivalirudin, Dr. Lefevre said.
However, Dr. Lefevre noted, major bleeding remains an important concern in transcatheter aortic valve replacement (TAVR), and “bivalirudin may be used as an alternative to heparin during TAVR in patients who cannot be treated with UFH.”
BRAVO III participants were adults with aortic stenosis who were at high surgical risk and who were scheduled for TAVR via transfemoral access. They were enrolled at 31 centers in seven countries throughout Europe and North America.
Those randomized to the bivalirudin group received an initial bolus of 0.75 mg/kg followed by a continuous infusion at a rate of 1.75 mg/kg per hour in those with an estimated glomerular filtration rate (eGFR) of 60 mL/min or greater, 1.4 mg/kg per hour in those with eGFR of 30-59 mL/min, and 1.0 mg/kg per hour in those with eGFR lower than 30 mL/min.
Heparin dosing and administration included a recommended target activated clotting time of greater than 25 seconds. Protamine was used for reversal at the end of the procedure based on standard local institution practice.
Session moderator Dr. Ajay J. Kirtane said that “one of the reasons this trial is exciting is that there has been a hypothesis that bivalirudin could reduce bleeding compared to heparin alone in PCI patients. While this is a much bigger access site, you don’t necessarily see these trends. On the other hand, when you have a bigger access site there is potential for increased signal, but this study is still somewhat underpowered.”
The Medicines Company provided funding for the BRAVO 3 trial to the Icahn School of Medicine at Mount Sinai, New York. Dr. Lefevre disclosed ties with Boston Scientific, Directflow, Edwards, Symetis and Medtronic.
SAN FRANCISCO – The reversible direct thrombin inhibitor bivalirudin, compared with unfractionated heparin, did not reduce the rate of major bleeding at 48 hours after transcatheter aortic valve replacement, in the randomized, open label, phase IIIb BRAVO 3 trial.
Bivalirudin, which has a half-life of 25 minutes, has been shown to reduce major bleeding in the setting of percutaneous coronary intervention when compared with other regimens, but its safety and efficacy as compared with that of unfractionated heparin was unknown. In BRAVO 3 (The effect of BivaliRudin on Aortic Valve Intervention Outcomes trial), the rate of major bleeding at 48 hours, defined as Bleeding Academic Research Consortium (BARC) 3b or greater, was 6.9% in 404 patients treated with bivalirudin vs. 9.0% in 398 patients treated with heparin (relative risk, 0.77), Dr. Thierry Lefevre reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
Further, the rate of net adverse clinical outcomes (NACE), including all-cause mortality, myocardial infarction, stroke, and major bleeding at up to 30 days was 14.4% in the bivalirudin group vs. 16.1% in the heparin group (relative risk, 0.89), Dr. Lefevre of Institut Hospitalier Jacques Cartier, Massy, France, said at the meeting, which was sponsored by the Cardiovascular Research Foundation.
The differences on both measures failed to meet statistical significance. With respect to bleeding at 48 hours, bivalirudin did not meet superiority, and with respect to cardiovascular events at 30 days, the prespecified noninferiority hypothesis was met.
No difference was seen between the groups for secondary endpoints, including bleeding defined according to various other bleeding scales and other BARC types.
The findings were published simultaneously in the Journal of the American College of Cardiology (J Am Coll Cardiol. 2015;Oct 15. doi: 10.1016/j.jacc.2015.10.003).
Heparin should remain the standard of care, especially given its lower cost compared to the cost of bivalirudin, Dr. Lefevre said.
However, Dr. Lefevre noted, major bleeding remains an important concern in transcatheter aortic valve replacement (TAVR), and “bivalirudin may be used as an alternative to heparin during TAVR in patients who cannot be treated with UFH.”
BRAVO III participants were adults with aortic stenosis who were at high surgical risk and who were scheduled for TAVR via transfemoral access. They were enrolled at 31 centers in seven countries throughout Europe and North America.
Those randomized to the bivalirudin group received an initial bolus of 0.75 mg/kg followed by a continuous infusion at a rate of 1.75 mg/kg per hour in those with an estimated glomerular filtration rate (eGFR) of 60 mL/min or greater, 1.4 mg/kg per hour in those with eGFR of 30-59 mL/min, and 1.0 mg/kg per hour in those with eGFR lower than 30 mL/min.
Heparin dosing and administration included a recommended target activated clotting time of greater than 25 seconds. Protamine was used for reversal at the end of the procedure based on standard local institution practice.
Session moderator Dr. Ajay J. Kirtane said that “one of the reasons this trial is exciting is that there has been a hypothesis that bivalirudin could reduce bleeding compared to heparin alone in PCI patients. While this is a much bigger access site, you don’t necessarily see these trends. On the other hand, when you have a bigger access site there is potential for increased signal, but this study is still somewhat underpowered.”
The Medicines Company provided funding for the BRAVO 3 trial to the Icahn School of Medicine at Mount Sinai, New York. Dr. Lefevre disclosed ties with Boston Scientific, Directflow, Edwards, Symetis and Medtronic.
AT TCT 2015
Key clinical point: The reversible direct thrombin inhibitor bivalirudin did not reduce the rate of major bleeding at 48 hours after transcatheter aortic valve replacement, compared with unfractionated heparin, in the BRAVO 3 trial.
Major finding: The rate of major bleeding at 48 hours was 6.9% vs. 9.0% in patients treated with bivalirudin vs. heparin (relative risk, 0.77).
Data source: A randomized, open-label, phase IIIb study of 802 patients.
Disclosures: The Medicines Company provided funding for the BRAVO 3 trial to the Icahn School of Medicine at Mount Sinai, New York. Dr. Lefevre disclosed ties with Boston Scientific, Directflow, Edwards, Symetis and Medtronic.
Early TIPS tied to mortality reduction in esophageal bleeds
HONOLULU – Early use of a transjugular intrahepatic portosystemic shunt (TIPS) is associated with substantial reductions in mortality, according to an analysis of a national inpatient database.
Based on this study, “early use of TIPS, together with patient and physician education on current guidelines and protocols, should continue to be a priority to improve patient outcomes” in patients with hepatic cirrhosis and risk of recurrent esophageal variceal bleeds, reported Dr. Basile Njei, a gastroenterology fellow at Yale University, New Haven, Conn.
In this study, the Nationwide Inpatient Sample database was queried by ICD-9 codes to identify patients with esophageal variceal bleeding treated between the years 2000 and 2010. The goal was to compare early use of TIPS, defined as TIPS administered within 72 hours of the bleeding, relative to rescue TIPS, defined as TIPS after two or more episodes of bleeding or one bleeding episode followed by another endoscopic intervention, such as balloon tamponade or surgery.
Over the period of study, a Poisson regression analysis used to control for multiple variables associated any TIPS utilization with an inverse association with overall mortality, producing a relative risk of 0.88 (95% confidence interval, 0.83-0.92). In the context of timing of TIPS, in-hospital mortality fell from 5.6% for those who received rescue TIPS to 1.5% in those who underwent early TIPS.
On multivariate analysis, an advantage was observed for early TIPS relative to rescue TIPS for in-hospital mortality (RR, 0.85; P less than .01), in-hospital rebleeding (RR, 0.57; P less than .01), and length of hospital stay (RR, 0.87; P less than .01). Rates of sepsis (RR, 0.83; P = .32) and hepatic encephalopathy (RR, 0.87; P = .22) were not significantly lower in the early TIPS group, but they were also not increased. For early TIPS versus no TIPS, the advantages on multivariate analysis were similar for both in-hospital deaths (RR, 0.87; P less than .01) and in-hospital rebleeding (RR, 0.57; P less than .01), but no advantage was seen for length of stay for TIPS versus no TIPS (RR, 0.99; P = .18).
Overall, there was a steady decline in mortality associated with esophageal variceal bleeding over the period of evaluation, falling incrementally over time from 656 deaths per 100,000 hospitalizations in 2000 to 412 deaths per 100,000 in 2010. This 37.2% reduction was statistically significant (P less than .01). The reduction in mortality was inversely associated with an increasing use of TIPS over the study period.
The data from this analysis are consistent with a multicenter randomized trial conducted several years ago in Europe (N Engl J Med. 2010;362:2370-9). In that study 63 patients with hepatic cirrhosis and acute variceal bleeding who had been treated with vasoactive drugs plus endoscopic therapy were randomized to early TIPS or rescue TIPS. At 1 year, 86% of those in the early TIPS group were alive versus 61% (P = .01) of those randomized to receive TIPS as a rescue strategy.
Relative to the previous study, the key finding of this study is that early TIPS “is associated with significant short-term reductions in rebleeding and mortality without a significant increase in encephalopathy in real world U.S. clinical practice,” according to Dr. Njei. It substantiates the European study and encourages a protocol that emphasizes early TIPS, particularly in those with a high risk of repeat esophageal variceal bleeding.
In the discussion that followed the presentation of these results at the annual meeting of the American College of Gastroenterology, the moderator, Dr. Paul Y. Kwo, medical director of liver transplantation, Indiana University, Indianapolis, pointed out, that some of those in the rescue TIPS group might simply have been poor candidates for this intervention. Although he praised the methodology of this study, which won the 2015 ACG Fellows-In-Training Award, he questioned whether rescue TIPS was a last resort salvage therapy in those initially considered poor risks for TIPS. Dr. Njei responded that the multivariate analysis was specifically designed to control for variables such as risk status to diminish this potential bias. Indeed, he said he believes TIPS is underemployed.
“The relatively small percentage of eligible cases receiving early TIPS suggests that there is room for further improvement in the treatment of patients with decompensated cirrhosis and esophageal variceal bleeding,” Dr. Njei concluded.
Dr. Njei reported that he had no relevant financial relationships to disclose.
HONOLULU – Early use of a transjugular intrahepatic portosystemic shunt (TIPS) is associated with substantial reductions in mortality, according to an analysis of a national inpatient database.
Based on this study, “early use of TIPS, together with patient and physician education on current guidelines and protocols, should continue to be a priority to improve patient outcomes” in patients with hepatic cirrhosis and risk of recurrent esophageal variceal bleeds, reported Dr. Basile Njei, a gastroenterology fellow at Yale University, New Haven, Conn.
In this study, the Nationwide Inpatient Sample database was queried by ICD-9 codes to identify patients with esophageal variceal bleeding treated between the years 2000 and 2010. The goal was to compare early use of TIPS, defined as TIPS administered within 72 hours of the bleeding, relative to rescue TIPS, defined as TIPS after two or more episodes of bleeding or one bleeding episode followed by another endoscopic intervention, such as balloon tamponade or surgery.
Over the period of study, a Poisson regression analysis used to control for multiple variables associated any TIPS utilization with an inverse association with overall mortality, producing a relative risk of 0.88 (95% confidence interval, 0.83-0.92). In the context of timing of TIPS, in-hospital mortality fell from 5.6% for those who received rescue TIPS to 1.5% in those who underwent early TIPS.
On multivariate analysis, an advantage was observed for early TIPS relative to rescue TIPS for in-hospital mortality (RR, 0.85; P less than .01), in-hospital rebleeding (RR, 0.57; P less than .01), and length of hospital stay (RR, 0.87; P less than .01). Rates of sepsis (RR, 0.83; P = .32) and hepatic encephalopathy (RR, 0.87; P = .22) were not significantly lower in the early TIPS group, but they were also not increased. For early TIPS versus no TIPS, the advantages on multivariate analysis were similar for both in-hospital deaths (RR, 0.87; P less than .01) and in-hospital rebleeding (RR, 0.57; P less than .01), but no advantage was seen for length of stay for TIPS versus no TIPS (RR, 0.99; P = .18).
Overall, there was a steady decline in mortality associated with esophageal variceal bleeding over the period of evaluation, falling incrementally over time from 656 deaths per 100,000 hospitalizations in 2000 to 412 deaths per 100,000 in 2010. This 37.2% reduction was statistically significant (P less than .01). The reduction in mortality was inversely associated with an increasing use of TIPS over the study period.
The data from this analysis are consistent with a multicenter randomized trial conducted several years ago in Europe (N Engl J Med. 2010;362:2370-9). In that study 63 patients with hepatic cirrhosis and acute variceal bleeding who had been treated with vasoactive drugs plus endoscopic therapy were randomized to early TIPS or rescue TIPS. At 1 year, 86% of those in the early TIPS group were alive versus 61% (P = .01) of those randomized to receive TIPS as a rescue strategy.
Relative to the previous study, the key finding of this study is that early TIPS “is associated with significant short-term reductions in rebleeding and mortality without a significant increase in encephalopathy in real world U.S. clinical practice,” according to Dr. Njei. It substantiates the European study and encourages a protocol that emphasizes early TIPS, particularly in those with a high risk of repeat esophageal variceal bleeding.
In the discussion that followed the presentation of these results at the annual meeting of the American College of Gastroenterology, the moderator, Dr. Paul Y. Kwo, medical director of liver transplantation, Indiana University, Indianapolis, pointed out, that some of those in the rescue TIPS group might simply have been poor candidates for this intervention. Although he praised the methodology of this study, which won the 2015 ACG Fellows-In-Training Award, he questioned whether rescue TIPS was a last resort salvage therapy in those initially considered poor risks for TIPS. Dr. Njei responded that the multivariate analysis was specifically designed to control for variables such as risk status to diminish this potential bias. Indeed, he said he believes TIPS is underemployed.
“The relatively small percentage of eligible cases receiving early TIPS suggests that there is room for further improvement in the treatment of patients with decompensated cirrhosis and esophageal variceal bleeding,” Dr. Njei concluded.
Dr. Njei reported that he had no relevant financial relationships to disclose.
HONOLULU – Early use of a transjugular intrahepatic portosystemic shunt (TIPS) is associated with substantial reductions in mortality, according to an analysis of a national inpatient database.
Based on this study, “early use of TIPS, together with patient and physician education on current guidelines and protocols, should continue to be a priority to improve patient outcomes” in patients with hepatic cirrhosis and risk of recurrent esophageal variceal bleeds, reported Dr. Basile Njei, a gastroenterology fellow at Yale University, New Haven, Conn.
In this study, the Nationwide Inpatient Sample database was queried by ICD-9 codes to identify patients with esophageal variceal bleeding treated between the years 2000 and 2010. The goal was to compare early use of TIPS, defined as TIPS administered within 72 hours of the bleeding, relative to rescue TIPS, defined as TIPS after two or more episodes of bleeding or one bleeding episode followed by another endoscopic intervention, such as balloon tamponade or surgery.
Over the period of study, a Poisson regression analysis used to control for multiple variables associated any TIPS utilization with an inverse association with overall mortality, producing a relative risk of 0.88 (95% confidence interval, 0.83-0.92). In the context of timing of TIPS, in-hospital mortality fell from 5.6% for those who received rescue TIPS to 1.5% in those who underwent early TIPS.
On multivariate analysis, an advantage was observed for early TIPS relative to rescue TIPS for in-hospital mortality (RR, 0.85; P less than .01), in-hospital rebleeding (RR, 0.57; P less than .01), and length of hospital stay (RR, 0.87; P less than .01). Rates of sepsis (RR, 0.83; P = .32) and hepatic encephalopathy (RR, 0.87; P = .22) were not significantly lower in the early TIPS group, but they were also not increased. For early TIPS versus no TIPS, the advantages on multivariate analysis were similar for both in-hospital deaths (RR, 0.87; P less than .01) and in-hospital rebleeding (RR, 0.57; P less than .01), but no advantage was seen for length of stay for TIPS versus no TIPS (RR, 0.99; P = .18).
Overall, there was a steady decline in mortality associated with esophageal variceal bleeding over the period of evaluation, falling incrementally over time from 656 deaths per 100,000 hospitalizations in 2000 to 412 deaths per 100,000 in 2010. This 37.2% reduction was statistically significant (P less than .01). The reduction in mortality was inversely associated with an increasing use of TIPS over the study period.
The data from this analysis are consistent with a multicenter randomized trial conducted several years ago in Europe (N Engl J Med. 2010;362:2370-9). In that study 63 patients with hepatic cirrhosis and acute variceal bleeding who had been treated with vasoactive drugs plus endoscopic therapy were randomized to early TIPS or rescue TIPS. At 1 year, 86% of those in the early TIPS group were alive versus 61% (P = .01) of those randomized to receive TIPS as a rescue strategy.
Relative to the previous study, the key finding of this study is that early TIPS “is associated with significant short-term reductions in rebleeding and mortality without a significant increase in encephalopathy in real world U.S. clinical practice,” according to Dr. Njei. It substantiates the European study and encourages a protocol that emphasizes early TIPS, particularly in those with a high risk of repeat esophageal variceal bleeding.
In the discussion that followed the presentation of these results at the annual meeting of the American College of Gastroenterology, the moderator, Dr. Paul Y. Kwo, medical director of liver transplantation, Indiana University, Indianapolis, pointed out, that some of those in the rescue TIPS group might simply have been poor candidates for this intervention. Although he praised the methodology of this study, which won the 2015 ACG Fellows-In-Training Award, he questioned whether rescue TIPS was a last resort salvage therapy in those initially considered poor risks for TIPS. Dr. Njei responded that the multivariate analysis was specifically designed to control for variables such as risk status to diminish this potential bias. Indeed, he said he believes TIPS is underemployed.
“The relatively small percentage of eligible cases receiving early TIPS suggests that there is room for further improvement in the treatment of patients with decompensated cirrhosis and esophageal variceal bleeding,” Dr. Njei concluded.
Dr. Njei reported that he had no relevant financial relationships to disclose.
AT ACG 2015
Key clinical point:Early use of a transjugular intrahepatic portosystemic shunt to reduce the risk of esophageal variceal rebleeding is associated with reduced mortality.
Major finding: In those receiving early TIPS (TIPS administered within 72 hours of the bleeding) mortality was 1.5% vs. 5.6% for those receiving TIPS as rescue therapy.
Data source: A retrospective evaluation of a national inpatient database.
Disclosures: Dr. Njei reported that he had no relevant financial relationships to disclose.
Frail elders at high mortality risk in the year following surgery
SAN DIEGO – Frail elderly patients face a significantly increased risk of mortality in the year after undergoing major elective noncardiac surgery, a large study from Canada showed.
“The current literature on perioperative frailty clearly shows that being frail before surgery substantially increases your risk of adverse postoperative outcomes,” Dr. Daniel I. McIsaac said in an interview prior to the annual meeting of the American Society of Anesthesiologists, where the study was presented. “In fact, frailty may underlie a lot of the associations between advanced age and adverse postoperative outcomes. Frailty increases in prevalence with increasing age, and as we all know, the population is aging. Therefore, we expect to see an increasing number of frail patients coming for surgery.”
In an effort to determine the risk of 1-year mortality in frail elderly patients having major elective surgery, the researchers used population-based health administrative data in Ontario, to identify 202,811 patients over the age of 65 who had intermediate- to high-risk elective noncardiac surgery between 2002 and 2012. They used the Johns Hopkins Adjusted Clinical Groups (ACG) frailty indicator and captured all deaths that occurred within 1 year of surgery. Proportional hazards regression models adjusted for age, gender, and socioeconomic status were used to evaluate the impact of frailty on 1-year postoperative mortality.
Of the 202,811 patients, 6,289 (3.1%) were frail, reported Dr. McIsaac of the department of anesthesiology at the University of Ottawa. The 1-year postoperative mortality was 13.6% among frail patients, compared with 4.8% of nonfrail patients, for an adjusted hazard ratio of 2.23. Mortality was higher among frail patients for all types of surgery, compared with their nonfrail counterparts, with the exception of pancreaticoduodenectomy. Frailty had the strongest impact on the risk of mortality after total joint arthroplasty (adjusted hazard ratio of 3.79 for hip replacement and adjusted HR of 2.68 for knee replacement).
The risk of postoperative mortality for frail patients was much higher than for nonfrail patients in the early time period after surgery, especially during the first postoperative week. “Depending on how you control for other variables, a frail patient was 13-35 times more likely to die in the week after surgery than a nonfrail patient of the same age having the same surgery,” said Dr. McIsaac, who is also a staff anesthesiologist at the Ottawa Hospital. “This makes a lot of sense; frail patients are vulnerable to stressors, and surgery puts an enormous physiological stress on even healthy patients. Future work clearly needs to focus [on] addressing this high-risk time in the immediate postoperative period.”
He acknowledged certain limitations of the study, including its reliance on health administrative data and the fact that frailty “is a challenging exposure to study because there are a plethora of instruments that can be used to call someone frail. We used a validated set of frailty-defining diagnoses that have been shown to identify people with multidimensional frailty. That said, you can’t necessarily generalize our findings to patients identified as frail using other instruments.”
The findings, Dr. McIsaac concluded, suggest that clinicians should focus on identifying frail patients prior to surgery, “support them to ensure that they are more likely to derive benefit from surgery than harm, and focus on optimizing their care after surgery to address this early mortality risk.”
The study was funded by departments of anesthesiology at the University of Ottawa and at the Ottawa Hospital. Dr. McIsaac reported having no financial disclosures.
SAN DIEGO – Frail elderly patients face a significantly increased risk of mortality in the year after undergoing major elective noncardiac surgery, a large study from Canada showed.
“The current literature on perioperative frailty clearly shows that being frail before surgery substantially increases your risk of adverse postoperative outcomes,” Dr. Daniel I. McIsaac said in an interview prior to the annual meeting of the American Society of Anesthesiologists, where the study was presented. “In fact, frailty may underlie a lot of the associations between advanced age and adverse postoperative outcomes. Frailty increases in prevalence with increasing age, and as we all know, the population is aging. Therefore, we expect to see an increasing number of frail patients coming for surgery.”
In an effort to determine the risk of 1-year mortality in frail elderly patients having major elective surgery, the researchers used population-based health administrative data in Ontario, to identify 202,811 patients over the age of 65 who had intermediate- to high-risk elective noncardiac surgery between 2002 and 2012. They used the Johns Hopkins Adjusted Clinical Groups (ACG) frailty indicator and captured all deaths that occurred within 1 year of surgery. Proportional hazards regression models adjusted for age, gender, and socioeconomic status were used to evaluate the impact of frailty on 1-year postoperative mortality.
Of the 202,811 patients, 6,289 (3.1%) were frail, reported Dr. McIsaac of the department of anesthesiology at the University of Ottawa. The 1-year postoperative mortality was 13.6% among frail patients, compared with 4.8% of nonfrail patients, for an adjusted hazard ratio of 2.23. Mortality was higher among frail patients for all types of surgery, compared with their nonfrail counterparts, with the exception of pancreaticoduodenectomy. Frailty had the strongest impact on the risk of mortality after total joint arthroplasty (adjusted hazard ratio of 3.79 for hip replacement and adjusted HR of 2.68 for knee replacement).
The risk of postoperative mortality for frail patients was much higher than for nonfrail patients in the early time period after surgery, especially during the first postoperative week. “Depending on how you control for other variables, a frail patient was 13-35 times more likely to die in the week after surgery than a nonfrail patient of the same age having the same surgery,” said Dr. McIsaac, who is also a staff anesthesiologist at the Ottawa Hospital. “This makes a lot of sense; frail patients are vulnerable to stressors, and surgery puts an enormous physiological stress on even healthy patients. Future work clearly needs to focus [on] addressing this high-risk time in the immediate postoperative period.”
He acknowledged certain limitations of the study, including its reliance on health administrative data and the fact that frailty “is a challenging exposure to study because there are a plethora of instruments that can be used to call someone frail. We used a validated set of frailty-defining diagnoses that have been shown to identify people with multidimensional frailty. That said, you can’t necessarily generalize our findings to patients identified as frail using other instruments.”
The findings, Dr. McIsaac concluded, suggest that clinicians should focus on identifying frail patients prior to surgery, “support them to ensure that they are more likely to derive benefit from surgery than harm, and focus on optimizing their care after surgery to address this early mortality risk.”
The study was funded by departments of anesthesiology at the University of Ottawa and at the Ottawa Hospital. Dr. McIsaac reported having no financial disclosures.
SAN DIEGO – Frail elderly patients face a significantly increased risk of mortality in the year after undergoing major elective noncardiac surgery, a large study from Canada showed.
“The current literature on perioperative frailty clearly shows that being frail before surgery substantially increases your risk of adverse postoperative outcomes,” Dr. Daniel I. McIsaac said in an interview prior to the annual meeting of the American Society of Anesthesiologists, where the study was presented. “In fact, frailty may underlie a lot of the associations between advanced age and adverse postoperative outcomes. Frailty increases in prevalence with increasing age, and as we all know, the population is aging. Therefore, we expect to see an increasing number of frail patients coming for surgery.”
In an effort to determine the risk of 1-year mortality in frail elderly patients having major elective surgery, the researchers used population-based health administrative data in Ontario, to identify 202,811 patients over the age of 65 who had intermediate- to high-risk elective noncardiac surgery between 2002 and 2012. They used the Johns Hopkins Adjusted Clinical Groups (ACG) frailty indicator and captured all deaths that occurred within 1 year of surgery. Proportional hazards regression models adjusted for age, gender, and socioeconomic status were used to evaluate the impact of frailty on 1-year postoperative mortality.
Of the 202,811 patients, 6,289 (3.1%) were frail, reported Dr. McIsaac of the department of anesthesiology at the University of Ottawa. The 1-year postoperative mortality was 13.6% among frail patients, compared with 4.8% of nonfrail patients, for an adjusted hazard ratio of 2.23. Mortality was higher among frail patients for all types of surgery, compared with their nonfrail counterparts, with the exception of pancreaticoduodenectomy. Frailty had the strongest impact on the risk of mortality after total joint arthroplasty (adjusted hazard ratio of 3.79 for hip replacement and adjusted HR of 2.68 for knee replacement).
The risk of postoperative mortality for frail patients was much higher than for nonfrail patients in the early time period after surgery, especially during the first postoperative week. “Depending on how you control for other variables, a frail patient was 13-35 times more likely to die in the week after surgery than a nonfrail patient of the same age having the same surgery,” said Dr. McIsaac, who is also a staff anesthesiologist at the Ottawa Hospital. “This makes a lot of sense; frail patients are vulnerable to stressors, and surgery puts an enormous physiological stress on even healthy patients. Future work clearly needs to focus [on] addressing this high-risk time in the immediate postoperative period.”
He acknowledged certain limitations of the study, including its reliance on health administrative data and the fact that frailty “is a challenging exposure to study because there are a plethora of instruments that can be used to call someone frail. We used a validated set of frailty-defining diagnoses that have been shown to identify people with multidimensional frailty. That said, you can’t necessarily generalize our findings to patients identified as frail using other instruments.”
The findings, Dr. McIsaac concluded, suggest that clinicians should focus on identifying frail patients prior to surgery, “support them to ensure that they are more likely to derive benefit from surgery than harm, and focus on optimizing their care after surgery to address this early mortality risk.”
The study was funded by departments of anesthesiology at the University of Ottawa and at the Ottawa Hospital. Dr. McIsaac reported having no financial disclosures.
AT THE ASA ANNUAL MEETING
Key clinical point: Frail elderly patients face an increased risk of mortality within 1 year of undergoing noncardiac surgery.
Major finding: The 1-year postoperative mortality was 13.6% among frail patients, compared with 4.8% of nonfrail patients, for an adjusted hazard ratio of 2.23.
Data source: A study of 202,811 patients over the age of 65 years who underwent noncardiac surgery between 2002 and 2012.
Disclosures: The study was funded by departments of anesthesiology at the University of Ottawa and at The Ottawa Hospital. Dr. McIsaac reported having no financial disclosures.
ACS: Hopkins risk score predicts need for early nutrition after cardiac surgery
CHICAGO – A few simple baseline variables predict if heart surgery patients will need early nutritional support after their operations, based on a review of more than 1,000 cardiac surgery patients from Johns Hopkins Hospital in Baltimore.
Nonelective surgery and a cardiopulmonary bypass time of 100 minutes or more, plus five preop variables – previous cardiac interventions; total albumin below 4 g/dL; total bilirubin at or above 1.2 mg/dL; white blood cell counts at or above 11,000/mcL; and hematocrit below 27% – predict the need for nutrition in the first few days after cardiac surgery, they found (J Am Coll Surg. 2015 Oct: 221[4];e70).
The Hopkins team has combined those factors into a risk score, with 4 points assigned for low albumin, 6 points for nonelective surgery, 6 points for low hematocrit, and 5 points for the other four variables, yielding a maximum score of 36 points.
The researchers developed the system after discovering that it sometimes took more than a week for cardiac patients who needed postop nutrition to get it. About 40% of patients with scores of 20 or higher will need early nutritional support, and those heart patients are now the ones at Hopkins who get a nutrition consult as soon as they return from the operating room, said Dr. Rika Ohkuma, a general surgery research fellow at Johns Hopkins. “The score can be used for risk stratification and has potential quality improvement implications related to early initiation of nutritional support in high-risk patients.”
Just 2% of patients who score 10 points or below need early nutrition, so consults are less pressing. About 9% of patients who score from 10-20 points will require nutrition, so consults are at the discretion of the physician, the investigators concluded.
Those insights came from a review of 1,056 adult heart cases in 2012. Just 87 patients (8%) had a postop consult for nutritional support. Most wound up with enteral feedings, but they started an average of 5 days after surgery. The handful that needed both parenteral and enteric feedings started them an average of 7 days after surgery.
Meanwhile, those 87 patients had significantly higher hospital mortality (29% vs. 3%), ventilator time (278 vs. 20 hours), and gastrointestinal complications (32% vs. 5%), and fewer discharges to home (49% vs. 84%) than did other patients.
The team thought that the delay in feeding might have had something to do with the poor outcomes, so “we tried to improve our behavior. We know that nutrition is beneficial for critically ill patients and that we need to start early, but there was no gold standard for when to start,” Dr. Ohkuma said.
The investigators came up with the risk score after figuring out how patients who needed nutrition differed from those who did not. They found, for example, that patients who have emergent surgery were more than three times as likely to have a nutrition consult than were those who had elective procedures.
Now when patients are admitted to the ICU after cardiac surgery, “we all know their [nutrition] score; if they are likely to need support, we immediately call the nutritional support service for a consult.” Patients no longer have to wait, Dr. Ohkuma said.
The researchers launched a prospective study in January 2015. Nutritional needs were addressed sooner, at about postop day 4, for the 70 patients who have needed, and mortality seems to be dropping.
The investigators have no relevant disclosures.
CHICAGO – A few simple baseline variables predict if heart surgery patients will need early nutritional support after their operations, based on a review of more than 1,000 cardiac surgery patients from Johns Hopkins Hospital in Baltimore.
Nonelective surgery and a cardiopulmonary bypass time of 100 minutes or more, plus five preop variables – previous cardiac interventions; total albumin below 4 g/dL; total bilirubin at or above 1.2 mg/dL; white blood cell counts at or above 11,000/mcL; and hematocrit below 27% – predict the need for nutrition in the first few days after cardiac surgery, they found (J Am Coll Surg. 2015 Oct: 221[4];e70).
The Hopkins team has combined those factors into a risk score, with 4 points assigned for low albumin, 6 points for nonelective surgery, 6 points for low hematocrit, and 5 points for the other four variables, yielding a maximum score of 36 points.
The researchers developed the system after discovering that it sometimes took more than a week for cardiac patients who needed postop nutrition to get it. About 40% of patients with scores of 20 or higher will need early nutritional support, and those heart patients are now the ones at Hopkins who get a nutrition consult as soon as they return from the operating room, said Dr. Rika Ohkuma, a general surgery research fellow at Johns Hopkins. “The score can be used for risk stratification and has potential quality improvement implications related to early initiation of nutritional support in high-risk patients.”
Just 2% of patients who score 10 points or below need early nutrition, so consults are less pressing. About 9% of patients who score from 10-20 points will require nutrition, so consults are at the discretion of the physician, the investigators concluded.
Those insights came from a review of 1,056 adult heart cases in 2012. Just 87 patients (8%) had a postop consult for nutritional support. Most wound up with enteral feedings, but they started an average of 5 days after surgery. The handful that needed both parenteral and enteric feedings started them an average of 7 days after surgery.
Meanwhile, those 87 patients had significantly higher hospital mortality (29% vs. 3%), ventilator time (278 vs. 20 hours), and gastrointestinal complications (32% vs. 5%), and fewer discharges to home (49% vs. 84%) than did other patients.
The team thought that the delay in feeding might have had something to do with the poor outcomes, so “we tried to improve our behavior. We know that nutrition is beneficial for critically ill patients and that we need to start early, but there was no gold standard for when to start,” Dr. Ohkuma said.
The investigators came up with the risk score after figuring out how patients who needed nutrition differed from those who did not. They found, for example, that patients who have emergent surgery were more than three times as likely to have a nutrition consult than were those who had elective procedures.
Now when patients are admitted to the ICU after cardiac surgery, “we all know their [nutrition] score; if they are likely to need support, we immediately call the nutritional support service for a consult.” Patients no longer have to wait, Dr. Ohkuma said.
The researchers launched a prospective study in January 2015. Nutritional needs were addressed sooner, at about postop day 4, for the 70 patients who have needed, and mortality seems to be dropping.
The investigators have no relevant disclosures.
CHICAGO – A few simple baseline variables predict if heart surgery patients will need early nutritional support after their operations, based on a review of more than 1,000 cardiac surgery patients from Johns Hopkins Hospital in Baltimore.
Nonelective surgery and a cardiopulmonary bypass time of 100 minutes or more, plus five preop variables – previous cardiac interventions; total albumin below 4 g/dL; total bilirubin at or above 1.2 mg/dL; white blood cell counts at or above 11,000/mcL; and hematocrit below 27% – predict the need for nutrition in the first few days after cardiac surgery, they found (J Am Coll Surg. 2015 Oct: 221[4];e70).
The Hopkins team has combined those factors into a risk score, with 4 points assigned for low albumin, 6 points for nonelective surgery, 6 points for low hematocrit, and 5 points for the other four variables, yielding a maximum score of 36 points.
The researchers developed the system after discovering that it sometimes took more than a week for cardiac patients who needed postop nutrition to get it. About 40% of patients with scores of 20 or higher will need early nutritional support, and those heart patients are now the ones at Hopkins who get a nutrition consult as soon as they return from the operating room, said Dr. Rika Ohkuma, a general surgery research fellow at Johns Hopkins. “The score can be used for risk stratification and has potential quality improvement implications related to early initiation of nutritional support in high-risk patients.”
Just 2% of patients who score 10 points or below need early nutrition, so consults are less pressing. About 9% of patients who score from 10-20 points will require nutrition, so consults are at the discretion of the physician, the investigators concluded.
Those insights came from a review of 1,056 adult heart cases in 2012. Just 87 patients (8%) had a postop consult for nutritional support. Most wound up with enteral feedings, but they started an average of 5 days after surgery. The handful that needed both parenteral and enteric feedings started them an average of 7 days after surgery.
Meanwhile, those 87 patients had significantly higher hospital mortality (29% vs. 3%), ventilator time (278 vs. 20 hours), and gastrointestinal complications (32% vs. 5%), and fewer discharges to home (49% vs. 84%) than did other patients.
The team thought that the delay in feeding might have had something to do with the poor outcomes, so “we tried to improve our behavior. We know that nutrition is beneficial for critically ill patients and that we need to start early, but there was no gold standard for when to start,” Dr. Ohkuma said.
The investigators came up with the risk score after figuring out how patients who needed nutrition differed from those who did not. They found, for example, that patients who have emergent surgery were more than three times as likely to have a nutrition consult than were those who had elective procedures.
Now when patients are admitted to the ICU after cardiac surgery, “we all know their [nutrition] score; if they are likely to need support, we immediately call the nutritional support service for a consult.” Patients no longer have to wait, Dr. Ohkuma said.
The researchers launched a prospective study in January 2015. Nutritional needs were addressed sooner, at about postop day 4, for the 70 patients who have needed, and mortality seems to be dropping.
The investigators have no relevant disclosures.
AT THE AMERICAN COLLEGE OF SURGEONS CLINICAL CONGRESS
Key clinical point: Early evaluation for nutritional needs following heart surgery might prove to reduce morbidity and mortality.
Major finding: In a retrospective study, the 87 patients who received nutritional support an average of 5 or more days after surgery had significantly higher hospital mortality (29% vs. 3%), ventilator time (278 vs. 20 hours), and gastrointestinal complications (32% vs. 5%) than did other post-op patients.
Data source: Review of 1,056 heart surgery patients
Disclosures: The investigators have no relevant disclosures.
Blacks receive inferior care for localized prostate cancer
Black patients with localized prostate cancer who underwent radical prostatectomy received inferior surgical care, compared with whites, as evidenced by fewer lymph node dissections and longer delays from diagnosis to treatment, among other indicators, researchers reported.
The time from diagnosis to treatment was longer in blacks than whites (79 vs. 71 days, P = .001). Overall, 57.7% of blacks had surgery without adjuvant therapy, compared with 61.3% of whites (P = .001). Blacks were less likely to undergo lymph node dissection (52.8% vs. 61.5%, P less than .001). The difference persisted but was not significant when the lymph node dissection analysis was restricted to patients with intermediate- and high-risk disease. Blacks were more likely to visit the emergency department within 30 days (P = .04) and beyond 30 days (P = .006) (JAMA Oncol. 2015 Oct 22. doi: 10.1001/jamaoncol/2015.3384).
When the lymph node dissection analysis was adjusted for geographic location (health service area), there were no differences between groups, which suggests that geographic variation in quality of care is tightly linked to racial disparities and may account for a large proportion of the differences.
The retrospective analysis of Medicare billing records evaluated 26,482 patients (2,020 blacks [7.6%] and 24,462 non-Hispanic whites [92.4%]) who underwent radical prostatectomy from 1992 through 2009.
Prostate cancer–specific mortality was not significantly different between blacks and whites. Unadjusted overall mortality was increased in blacks, but after adjustment for geographic location, overall mortality was similar between groups.
“Despite important constellations of poor quality of care for blacks undergoing [radical prostatectomy], we did not detect significant differences in overall and cancer-specific survival,” wrote Dr. Marianne Schmid of Brigham and Women’s Hospital, Harvard Medical School, Boston, and her colleagues. Furthermore, the research revealed no regional variation in cancer-specific mortality among patients who underwent surgery.
“A possible interpretation of our findings is that the biological differences in tumor aggressiveness among blacks may have been exaggerated, and that the perceived gap in survival is a result of lack of access or cultural perceptions with regard to surgical care for [prostate cancer] or other factors that differentiate who makes it to the operating table,” the researchers noted.
Median total calculated costs were lower for blacks ($13,015 vs. $15,758), but surgical treatment was associated with higher incremental annual costs, with the top 50% spending $1,185 more. Increased costs are likely due to the higher prevalence of radiotherapy and androgen deprivation therapy, and increased rates of emergency department visits, rather than the use of newer, more expensive technologies.
The research indicates that unfavorable quality of care for black patients did not translate to worse overall survival and cancer-specific survival. Rather, lower survival among black patients with prostate cancer may result from barriers to definitive treatment, according to the investigators.
Dr. Schmid reported having no relevant financial disclosures. Several of her coauthors reported financial ties to several industry sources.
The findings of the study by Dr. Schmid and her colleagues point to racial health inequalities in the United States and are applicable to medical care of the American population in general, not just to men with prostate cancer.
 |
Dr. Otis Brawley |
Despite the fact that black patients in this study had insurance and access to care and were considered healthy enough for surgery, there was still a disparity in quality of care. Interestingly, there were no differences between the groups in all-cause or cancer-specific mortality. This is hard evidence that the biology of prostate cancer is similar for black and white men with localized disease.
Is the disparity in quality of care due to racism on the part of physicians? Probably not. More likely, a higher proportion of black men have physicians who do not routinely perform radical prostatectomies, and a higher proportion of blacks are treated at hospitals that have a low volume of prostate surgery.
Even though a significant proportion of blacks received inferior treatment, similar outcomes for the two groups suggests that some patients with localized prostate cancer are overtreated, and the medical community should be more discerning in who receives treatment.
Dr. Otis Brawley is the chief medical officer for the American Cancer Society and professor of hematology, oncology, medicine, and epidemiology at Emory University, Atlanta. These remarks were part of an editorial accompanying the report (JAMA Oncol. 2015 Oct 22. doi: 10.1001/jamaoncol/2015.3384). Dr. Brawley reported having no relevant financial disclosures.
The findings of the study by Dr. Schmid and her colleagues point to racial health inequalities in the United States and are applicable to medical care of the American population in general, not just to men with prostate cancer.
|
Dr. Otis Brawley |
Despite the fact that black patients in this study had insurance and access to care and were considered healthy enough for surgery, there was still a disparity in quality of care. Interestingly, there were no differences between the groups in all-cause or cancer-specific mortality. This is hard evidence that the biology of prostate cancer is similar for black and white men with localized disease.
Is the disparity in quality of care due to racism on the part of physicians? Probably not. More likely, a higher proportion of black men have physicians who do not routinely perform radical prostatectomies, and a higher proportion of blacks are treated at hospitals that have a low volume of prostate surgery.
Even though a significant proportion of blacks received inferior treatment, similar outcomes for the two groups suggests that some patients with localized prostate cancer are overtreated, and the medical community should be more discerning in who receives treatment.
Dr. Otis Brawley is the chief medical officer for the American Cancer Society and professor of hematology, oncology, medicine, and epidemiology at Emory University, Atlanta. These remarks were part of an editorial accompanying the report (JAMA Oncol. 2015 Oct 22. doi: 10.1001/jamaoncol/2015.3384). Dr. Brawley reported having no relevant financial disclosures.
The findings of the study by Dr. Schmid and her colleagues point to racial health inequalities in the United States and are applicable to medical care of the American population in general, not just to men with prostate cancer.
|
Dr. Otis Brawley |
Despite the fact that black patients in this study had insurance and access to care and were considered healthy enough for surgery, there was still a disparity in quality of care. Interestingly, there were no differences between the groups in all-cause or cancer-specific mortality. This is hard evidence that the biology of prostate cancer is similar for black and white men with localized disease.
Is the disparity in quality of care due to racism on the part of physicians? Probably not. More likely, a higher proportion of black men have physicians who do not routinely perform radical prostatectomies, and a higher proportion of blacks are treated at hospitals that have a low volume of prostate surgery.
Even though a significant proportion of blacks received inferior treatment, similar outcomes for the two groups suggests that some patients with localized prostate cancer are overtreated, and the medical community should be more discerning in who receives treatment.
Dr. Otis Brawley is the chief medical officer for the American Cancer Society and professor of hematology, oncology, medicine, and epidemiology at Emory University, Atlanta. These remarks were part of an editorial accompanying the report (JAMA Oncol. 2015 Oct 22. doi: 10.1001/jamaoncol/2015.3384). Dr. Brawley reported having no relevant financial disclosures.
Black patients with localized prostate cancer who underwent radical prostatectomy received inferior surgical care, compared with whites, as evidenced by fewer lymph node dissections and longer delays from diagnosis to treatment, among other indicators, researchers reported.
The time from diagnosis to treatment was longer in blacks than whites (79 vs. 71 days, P = .001). Overall, 57.7% of blacks had surgery without adjuvant therapy, compared with 61.3% of whites (P = .001). Blacks were less likely to undergo lymph node dissection (52.8% vs. 61.5%, P less than .001). The difference persisted but was not significant when the lymph node dissection analysis was restricted to patients with intermediate- and high-risk disease. Blacks were more likely to visit the emergency department within 30 days (P = .04) and beyond 30 days (P = .006) (JAMA Oncol. 2015 Oct 22. doi: 10.1001/jamaoncol/2015.3384).
When the lymph node dissection analysis was adjusted for geographic location (health service area), there were no differences between groups, which suggests that geographic variation in quality of care is tightly linked to racial disparities and may account for a large proportion of the differences.
The retrospective analysis of Medicare billing records evaluated 26,482 patients (2,020 blacks [7.6%] and 24,462 non-Hispanic whites [92.4%]) who underwent radical prostatectomy from 1992 through 2009.
Prostate cancer–specific mortality was not significantly different between blacks and whites. Unadjusted overall mortality was increased in blacks, but after adjustment for geographic location, overall mortality was similar between groups.
“Despite important constellations of poor quality of care for blacks undergoing [radical prostatectomy], we did not detect significant differences in overall and cancer-specific survival,” wrote Dr. Marianne Schmid of Brigham and Women’s Hospital, Harvard Medical School, Boston, and her colleagues. Furthermore, the research revealed no regional variation in cancer-specific mortality among patients who underwent surgery.
“A possible interpretation of our findings is that the biological differences in tumor aggressiveness among blacks may have been exaggerated, and that the perceived gap in survival is a result of lack of access or cultural perceptions with regard to surgical care for [prostate cancer] or other factors that differentiate who makes it to the operating table,” the researchers noted.
Median total calculated costs were lower for blacks ($13,015 vs. $15,758), but surgical treatment was associated with higher incremental annual costs, with the top 50% spending $1,185 more. Increased costs are likely due to the higher prevalence of radiotherapy and androgen deprivation therapy, and increased rates of emergency department visits, rather than the use of newer, more expensive technologies.
The research indicates that unfavorable quality of care for black patients did not translate to worse overall survival and cancer-specific survival. Rather, lower survival among black patients with prostate cancer may result from barriers to definitive treatment, according to the investigators.
Dr. Schmid reported having no relevant financial disclosures. Several of her coauthors reported financial ties to several industry sources.
Black patients with localized prostate cancer who underwent radical prostatectomy received inferior surgical care, compared with whites, as evidenced by fewer lymph node dissections and longer delays from diagnosis to treatment, among other indicators, researchers reported.
The time from diagnosis to treatment was longer in blacks than whites (79 vs. 71 days, P = .001). Overall, 57.7% of blacks had surgery without adjuvant therapy, compared with 61.3% of whites (P = .001). Blacks were less likely to undergo lymph node dissection (52.8% vs. 61.5%, P less than .001). The difference persisted but was not significant when the lymph node dissection analysis was restricted to patients with intermediate- and high-risk disease. Blacks were more likely to visit the emergency department within 30 days (P = .04) and beyond 30 days (P = .006) (JAMA Oncol. 2015 Oct 22. doi: 10.1001/jamaoncol/2015.3384).
When the lymph node dissection analysis was adjusted for geographic location (health service area), there were no differences between groups, which suggests that geographic variation in quality of care is tightly linked to racial disparities and may account for a large proportion of the differences.
The retrospective analysis of Medicare billing records evaluated 26,482 patients (2,020 blacks [7.6%] and 24,462 non-Hispanic whites [92.4%]) who underwent radical prostatectomy from 1992 through 2009.
Prostate cancer–specific mortality was not significantly different between blacks and whites. Unadjusted overall mortality was increased in blacks, but after adjustment for geographic location, overall mortality was similar between groups.
“Despite important constellations of poor quality of care for blacks undergoing [radical prostatectomy], we did not detect significant differences in overall and cancer-specific survival,” wrote Dr. Marianne Schmid of Brigham and Women’s Hospital, Harvard Medical School, Boston, and her colleagues. Furthermore, the research revealed no regional variation in cancer-specific mortality among patients who underwent surgery.
“A possible interpretation of our findings is that the biological differences in tumor aggressiveness among blacks may have been exaggerated, and that the perceived gap in survival is a result of lack of access or cultural perceptions with regard to surgical care for [prostate cancer] or other factors that differentiate who makes it to the operating table,” the researchers noted.
Median total calculated costs were lower for blacks ($13,015 vs. $15,758), but surgical treatment was associated with higher incremental annual costs, with the top 50% spending $1,185 more. Increased costs are likely due to the higher prevalence of radiotherapy and androgen deprivation therapy, and increased rates of emergency department visits, rather than the use of newer, more expensive technologies.
The research indicates that unfavorable quality of care for black patients did not translate to worse overall survival and cancer-specific survival. Rather, lower survival among black patients with prostate cancer may result from barriers to definitive treatment, according to the investigators.
Dr. Schmid reported having no relevant financial disclosures. Several of her coauthors reported financial ties to several industry sources.
FROM JAMA ONCOLOGY
Key clinical point: Compared with whites, black patients with localized prostate cancer received lower quality of care.
Major finding: Blacks were less likely to undergo lymph node dissection than whites (52.8% vs. 61.5%; OR, 0.76; P less than .001), and had more postoperative complications, emergency department visits, and readmissions (P less than .05 for all comparisons).
Data source: A retrospective analysis of Medicare billing records of 26,482 patients (7.6% blacks and 92.4% non-Hispanic whites) who underwent radical prostatectomy from 1992 through 2009.
Disclosures: Dr. Schmid reported having no relevant financial disclosures. Several of her coauthors reported financial ties to several industry sources.
Decline in antibiotic effectiveness could harm surgical, chemotherapy patients
An increase of surgical site infections (SSIs) stemming from pathogens resistant to antibiotic prophylaxis could result in thousands of infection-related deaths in surgical and chemotherapy patients, according to a new study published in the Lancet Infectious Diseases.
A total of 31 published meta-analyses of randomized or quasi–randomized controlled trials were included in the study by Dr. Ramanan Laxminarayan of the Center for Disease Dynamics, Economics & Policy in Washington, and his associates. The researchers surveyed the 10 most common surgeries in which antibiotic prophylaxis provides the greatest benefit. The infection rate in surgical patients receiving prophylaxis was 4.2%, and was 11.1% in patients who did not receive prophylaxis. Relative risk reduction for infection was least in cancer chemotherapy at 35% and greatest in pacemaker implantation at 86%.
Between 38.7% and 50.9% of SSIs and 26.8% of infections after chemotherapy are caused by antibiotic-resistant pathogens. A decrease in prophylaxis effectiveness of 10% would cause 40,000 additional infections and 2,100 additional deaths, while a decrease in effectiveness of 70% would cause 280,000 additional infections and 15,000 additional deaths.
The authors say more data are needed to establish how antibiotic prophylaxis recommendations should be modified in the context of increasing rates of resistance.
In a related comment, Dr. Joshua Wolf from St. Jude Children’s Research Hospital, Memphis, said, “To improve stewardship outcomes, we need more research that focuses on understanding impediments to appropriate antibiotic prescribing, strategies that target these impediments, resources to implement the strategies, and leadership that understands the urgency and complexity of the task. In view of the lack of progress so far, mandatory implementation of these steps could be necessary to achieve notable change.”
Find the full study in the Lancet Infectious Diseases (doi: 10.1016/S1473-3099[15]00270-4).
An increase of surgical site infections (SSIs) stemming from pathogens resistant to antibiotic prophylaxis could result in thousands of infection-related deaths in surgical and chemotherapy patients, according to a new study published in the Lancet Infectious Diseases.
A total of 31 published meta-analyses of randomized or quasi–randomized controlled trials were included in the study by Dr. Ramanan Laxminarayan of the Center for Disease Dynamics, Economics & Policy in Washington, and his associates. The researchers surveyed the 10 most common surgeries in which antibiotic prophylaxis provides the greatest benefit. The infection rate in surgical patients receiving prophylaxis was 4.2%, and was 11.1% in patients who did not receive prophylaxis. Relative risk reduction for infection was least in cancer chemotherapy at 35% and greatest in pacemaker implantation at 86%.
Between 38.7% and 50.9% of SSIs and 26.8% of infections after chemotherapy are caused by antibiotic-resistant pathogens. A decrease in prophylaxis effectiveness of 10% would cause 40,000 additional infections and 2,100 additional deaths, while a decrease in effectiveness of 70% would cause 280,000 additional infections and 15,000 additional deaths.
The authors say more data are needed to establish how antibiotic prophylaxis recommendations should be modified in the context of increasing rates of resistance.
In a related comment, Dr. Joshua Wolf from St. Jude Children’s Research Hospital, Memphis, said, “To improve stewardship outcomes, we need more research that focuses on understanding impediments to appropriate antibiotic prescribing, strategies that target these impediments, resources to implement the strategies, and leadership that understands the urgency and complexity of the task. In view of the lack of progress so far, mandatory implementation of these steps could be necessary to achieve notable change.”
Find the full study in the Lancet Infectious Diseases (doi: 10.1016/S1473-3099[15]00270-4).
An increase of surgical site infections (SSIs) stemming from pathogens resistant to antibiotic prophylaxis could result in thousands of infection-related deaths in surgical and chemotherapy patients, according to a new study published in the Lancet Infectious Diseases.
A total of 31 published meta-analyses of randomized or quasi–randomized controlled trials were included in the study by Dr. Ramanan Laxminarayan of the Center for Disease Dynamics, Economics & Policy in Washington, and his associates. The researchers surveyed the 10 most common surgeries in which antibiotic prophylaxis provides the greatest benefit. The infection rate in surgical patients receiving prophylaxis was 4.2%, and was 11.1% in patients who did not receive prophylaxis. Relative risk reduction for infection was least in cancer chemotherapy at 35% and greatest in pacemaker implantation at 86%.
Between 38.7% and 50.9% of SSIs and 26.8% of infections after chemotherapy are caused by antibiotic-resistant pathogens. A decrease in prophylaxis effectiveness of 10% would cause 40,000 additional infections and 2,100 additional deaths, while a decrease in effectiveness of 70% would cause 280,000 additional infections and 15,000 additional deaths.
The authors say more data are needed to establish how antibiotic prophylaxis recommendations should be modified in the context of increasing rates of resistance.
In a related comment, Dr. Joshua Wolf from St. Jude Children’s Research Hospital, Memphis, said, “To improve stewardship outcomes, we need more research that focuses on understanding impediments to appropriate antibiotic prescribing, strategies that target these impediments, resources to implement the strategies, and leadership that understands the urgency and complexity of the task. In view of the lack of progress so far, mandatory implementation of these steps could be necessary to achieve notable change.”
Find the full study in the Lancet Infectious Diseases (doi: 10.1016/S1473-3099[15]00270-4).
VIDEO: Tranexamic acid didn’t increase postop infections
CHICAGO – Tranexamic acid was not independently associated with any infection within 30 days of injury in U.S. soldiers undergoing trauma surgery, a case-control study showed.
The antifibrinolytic has been used for years to reduce morbidity and the risk of death associated with hemorrhage in the military setting. Tranexamic acid (TXA) made its way into the civilian setting after the 2010 provocative CRASH-2 trial in adult trauma patients.
Because TXA (Cyklokapron, Lysteda) also has anti-inflammatory properties, Dr. Clayton Lewis of Brooke Army Medical Center in San Antonio and his colleagues decided to evaluate the effect of TXA on the development of posttraumatic infections, including time to first infection, in combat casualties.
The findings were presented at the annual clinical congress of the American College of Surgeons, where we caught up with Dr. Lewis for an interview.
Dr. Lewis reported having no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
CHICAGO – Tranexamic acid was not independently associated with any infection within 30 days of injury in U.S. soldiers undergoing trauma surgery, a case-control study showed.
The antifibrinolytic has been used for years to reduce morbidity and the risk of death associated with hemorrhage in the military setting. Tranexamic acid (TXA) made its way into the civilian setting after the 2010 provocative CRASH-2 trial in adult trauma patients.
Because TXA (Cyklokapron, Lysteda) also has anti-inflammatory properties, Dr. Clayton Lewis of Brooke Army Medical Center in San Antonio and his colleagues decided to evaluate the effect of TXA on the development of posttraumatic infections, including time to first infection, in combat casualties.
The findings were presented at the annual clinical congress of the American College of Surgeons, where we caught up with Dr. Lewis for an interview.
Dr. Lewis reported having no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
CHICAGO – Tranexamic acid was not independently associated with any infection within 30 days of injury in U.S. soldiers undergoing trauma surgery, a case-control study showed.
The antifibrinolytic has been used for years to reduce morbidity and the risk of death associated with hemorrhage in the military setting. Tranexamic acid (TXA) made its way into the civilian setting after the 2010 provocative CRASH-2 trial in adult trauma patients.
Because TXA (Cyklokapron, Lysteda) also has anti-inflammatory properties, Dr. Clayton Lewis of Brooke Army Medical Center in San Antonio and his colleagues decided to evaluate the effect of TXA on the development of posttraumatic infections, including time to first infection, in combat casualties.
The findings were presented at the annual clinical congress of the American College of Surgeons, where we caught up with Dr. Lewis for an interview.
Dr. Lewis reported having no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE ACS CLINICAL CONGRESS
SSI risk after cesarean is nearly double for Medicaid patients
SAN DIEGO – Medicaid patients were nearly twice as likely to develop surgical site infections after cesarean delivery than privately insured women, according to investigators from the Centers for Disease Control and Prevention.
The association remained even after researchers accounted for several demographic and clinical variables, Dr. Sarah Yi said in an interview at an annual scientific meeting on infectious diseases.
“If we can identify a population that is at higher risk for health care–associated infections, then maybe we can intervene at some level,” said Dr. Yi of the division of healthcare quality promotion at the CDC. “If we can elucidate the mechanism better, it will give us other clues about where we can prevent infections.”
More than 1.2 million cesareans were performed in the United States in 2012, and low transverse C-sections ranked fifth among all procedures performed during hospital stays, Dr. Yi noted. Post-cesarean surgical site infections (SSIs) remain a major cause of expense and morbidity, but not many studies have evaluated the relationship between insurance type and the risk of SSIs or other health care–associated infections, she added.
To explore the issue, Dr. Yi and her associates analyzed national health care safety data for 2,769 women who had a cesarean delivery in New York in 2010 or 2011 and had either Medicaid or private insurance at the time of their delivery. The Medicaid group included 1,763 women, while the privately insured group included 1,006 women. Medicaid patients were younger, more likely to be Hispanic, black, or homeless, and were more often treated at government and teaching facilities than privately insured patients were.
After researchers accounted for age, race, ethnicity, body mass index, facility type, American Society of Anesthesiologists score, emergency and labor status, use of anesthesia, duration of surgery, and wound classification, Medicaid patients still had nearly double the risk of an SSI after cesarean as did their counterparts with private insurance (risk ratio, 1.8; 95% confidence interval, 1.2-2.8; P = .02).
While homelessness could potentially increase the risk of SSI by limiting opportunities for self-care, social support, and clinical follow-up, Medicaid remained a significant predictor of SSI even after excluding homeless women from the analysis, Dr. Yi said.
But Medicaid might represent one, or several, factors that the model did not account for, such as socioeconomic status or prenatal care, said Dr. Yi.
Prenatal care, in particular, might have been lower among Medicaid patients for women who did not obtain coverage until after arriving at the hospital for delivery, she said. Inadequate prenatal care has been linked to complications after delivery, and the proportion of eligible women who are enrolled in Medicaid has been found to vary at different times during pregnancy, she added (MMWR Surveill Summ. 2015 Jun 19;64[4]:1-19).
The CDC investigators plan to continue the research by trying to validate the association in other populations, in other years, and in other states, Dr. Yi said.
IDWeek marks the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
The researchers reported having no financial disclosures.
SAN DIEGO – Medicaid patients were nearly twice as likely to develop surgical site infections after cesarean delivery than privately insured women, according to investigators from the Centers for Disease Control and Prevention.
The association remained even after researchers accounted for several demographic and clinical variables, Dr. Sarah Yi said in an interview at an annual scientific meeting on infectious diseases.
“If we can identify a population that is at higher risk for health care–associated infections, then maybe we can intervene at some level,” said Dr. Yi of the division of healthcare quality promotion at the CDC. “If we can elucidate the mechanism better, it will give us other clues about where we can prevent infections.”
More than 1.2 million cesareans were performed in the United States in 2012, and low transverse C-sections ranked fifth among all procedures performed during hospital stays, Dr. Yi noted. Post-cesarean surgical site infections (SSIs) remain a major cause of expense and morbidity, but not many studies have evaluated the relationship between insurance type and the risk of SSIs or other health care–associated infections, she added.
To explore the issue, Dr. Yi and her associates analyzed national health care safety data for 2,769 women who had a cesarean delivery in New York in 2010 or 2011 and had either Medicaid or private insurance at the time of their delivery. The Medicaid group included 1,763 women, while the privately insured group included 1,006 women. Medicaid patients were younger, more likely to be Hispanic, black, or homeless, and were more often treated at government and teaching facilities than privately insured patients were.
After researchers accounted for age, race, ethnicity, body mass index, facility type, American Society of Anesthesiologists score, emergency and labor status, use of anesthesia, duration of surgery, and wound classification, Medicaid patients still had nearly double the risk of an SSI after cesarean as did their counterparts with private insurance (risk ratio, 1.8; 95% confidence interval, 1.2-2.8; P = .02).
While homelessness could potentially increase the risk of SSI by limiting opportunities for self-care, social support, and clinical follow-up, Medicaid remained a significant predictor of SSI even after excluding homeless women from the analysis, Dr. Yi said.
But Medicaid might represent one, or several, factors that the model did not account for, such as socioeconomic status or prenatal care, said Dr. Yi.
Prenatal care, in particular, might have been lower among Medicaid patients for women who did not obtain coverage until after arriving at the hospital for delivery, she said. Inadequate prenatal care has been linked to complications after delivery, and the proportion of eligible women who are enrolled in Medicaid has been found to vary at different times during pregnancy, she added (MMWR Surveill Summ. 2015 Jun 19;64[4]:1-19).
The CDC investigators plan to continue the research by trying to validate the association in other populations, in other years, and in other states, Dr. Yi said.
IDWeek marks the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
The researchers reported having no financial disclosures.
SAN DIEGO – Medicaid patients were nearly twice as likely to develop surgical site infections after cesarean delivery than privately insured women, according to investigators from the Centers for Disease Control and Prevention.
The association remained even after researchers accounted for several demographic and clinical variables, Dr. Sarah Yi said in an interview at an annual scientific meeting on infectious diseases.
“If we can identify a population that is at higher risk for health care–associated infections, then maybe we can intervene at some level,” said Dr. Yi of the division of healthcare quality promotion at the CDC. “If we can elucidate the mechanism better, it will give us other clues about where we can prevent infections.”
More than 1.2 million cesareans were performed in the United States in 2012, and low transverse C-sections ranked fifth among all procedures performed during hospital stays, Dr. Yi noted. Post-cesarean surgical site infections (SSIs) remain a major cause of expense and morbidity, but not many studies have evaluated the relationship between insurance type and the risk of SSIs or other health care–associated infections, she added.
To explore the issue, Dr. Yi and her associates analyzed national health care safety data for 2,769 women who had a cesarean delivery in New York in 2010 or 2011 and had either Medicaid or private insurance at the time of their delivery. The Medicaid group included 1,763 women, while the privately insured group included 1,006 women. Medicaid patients were younger, more likely to be Hispanic, black, or homeless, and were more often treated at government and teaching facilities than privately insured patients were.
After researchers accounted for age, race, ethnicity, body mass index, facility type, American Society of Anesthesiologists score, emergency and labor status, use of anesthesia, duration of surgery, and wound classification, Medicaid patients still had nearly double the risk of an SSI after cesarean as did their counterparts with private insurance (risk ratio, 1.8; 95% confidence interval, 1.2-2.8; P = .02).
While homelessness could potentially increase the risk of SSI by limiting opportunities for self-care, social support, and clinical follow-up, Medicaid remained a significant predictor of SSI even after excluding homeless women from the analysis, Dr. Yi said.
But Medicaid might represent one, or several, factors that the model did not account for, such as socioeconomic status or prenatal care, said Dr. Yi.
Prenatal care, in particular, might have been lower among Medicaid patients for women who did not obtain coverage until after arriving at the hospital for delivery, she said. Inadequate prenatal care has been linked to complications after delivery, and the proportion of eligible women who are enrolled in Medicaid has been found to vary at different times during pregnancy, she added (MMWR Surveill Summ. 2015 Jun 19;64[4]:1-19).
The CDC investigators plan to continue the research by trying to validate the association in other populations, in other years, and in other states, Dr. Yi said.
IDWeek marks the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
The researchers reported having no financial disclosures.
AT IDWEEK 2015
Key clinical point: Medicaid patients had about a twofold higher risk of surgical site infections after cesarean delivery than did privately insured women.
Major finding: The association between Medicaid coverage and surgical site infections after cesarean delivery remained significant after researchers controlled for several potential confounders (risk ratio, 1.8; P = .02).
Data source: Analysis of national health care safety data for 2,769 women who had a cesarean in New York in 2010 or 2011.
Disclosures: The investigators reported having no financial disclosures.
VIDEO: Dialysis-dependent patients face rocky road after colorectal surgery
CHICAGO – The odds of emergency surgery were sevenfold higher in dialysis-dependent patients undergoing colorectal surgery than patients with renal insufficiency not on dialysis or those with normal renal function.
Dialysis patients were also far less likely to undergo laparoscopic surgery and to be rescued from death if they experienced a complication.
These are just some of the results of a retrospective study involving 156,645 elective colorectal surgery cases selected as a poster of exceptional merit here at the annual clinical congress of the American College of Surgeons.
Dialysis patients are known to be at high risk for postoperative complications, but few studies have evaluated outcomes after colorectal surgery in these patients or distinguished them from patients with non–dialysis dependent renal insufficiency (NDDRI) or normal renal function (NRF), observed study author Dr. Isibor Arhuidese of Johns Hopkins University in Baltimore.
Indeed, when the researchers compared these three groups, perioperative mortality and morbidity after elective colorectal surgery was the worst in dialysis patients.
Absolute perioperative mortality was highest for dialysis patients vs. NDDRI and NRF patients after open (13.4% vs. 4.8% vs. 2%; P less than .001) and laparoscopic (8% vs. 2% vs. 0.6%; P less than .001) surgery.
Three complications were significantly associated with death in dialysis patients: myocardial infarction (adjusted odds ratio, 48.6; P = .027), bleeding (aOR, 14.5; P = .025), and sepsis or septic shock (aOR, 8.7; P = .001).
It is not enough to simply identify dialysis dependence as a predictor of poor outcomes, but one must identify targets for improvement in surgical care, Dr. Arhuidese stressed.
Dr. Arhuidese reported having no relevant conflicts of interest.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @pwendl
CHICAGO – The odds of emergency surgery were sevenfold higher in dialysis-dependent patients undergoing colorectal surgery than patients with renal insufficiency not on dialysis or those with normal renal function.
Dialysis patients were also far less likely to undergo laparoscopic surgery and to be rescued from death if they experienced a complication.
These are just some of the results of a retrospective study involving 156,645 elective colorectal surgery cases selected as a poster of exceptional merit here at the annual clinical congress of the American College of Surgeons.
Dialysis patients are known to be at high risk for postoperative complications, but few studies have evaluated outcomes after colorectal surgery in these patients or distinguished them from patients with non–dialysis dependent renal insufficiency (NDDRI) or normal renal function (NRF), observed study author Dr. Isibor Arhuidese of Johns Hopkins University in Baltimore.
Indeed, when the researchers compared these three groups, perioperative mortality and morbidity after elective colorectal surgery was the worst in dialysis patients.
Absolute perioperative mortality was highest for dialysis patients vs. NDDRI and NRF patients after open (13.4% vs. 4.8% vs. 2%; P less than .001) and laparoscopic (8% vs. 2% vs. 0.6%; P less than .001) surgery.
Three complications were significantly associated with death in dialysis patients: myocardial infarction (adjusted odds ratio, 48.6; P = .027), bleeding (aOR, 14.5; P = .025), and sepsis or septic shock (aOR, 8.7; P = .001).
It is not enough to simply identify dialysis dependence as a predictor of poor outcomes, but one must identify targets for improvement in surgical care, Dr. Arhuidese stressed.
Dr. Arhuidese reported having no relevant conflicts of interest.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @pwendl
CHICAGO – The odds of emergency surgery were sevenfold higher in dialysis-dependent patients undergoing colorectal surgery than patients with renal insufficiency not on dialysis or those with normal renal function.
Dialysis patients were also far less likely to undergo laparoscopic surgery and to be rescued from death if they experienced a complication.
These are just some of the results of a retrospective study involving 156,645 elective colorectal surgery cases selected as a poster of exceptional merit here at the annual clinical congress of the American College of Surgeons.
Dialysis patients are known to be at high risk for postoperative complications, but few studies have evaluated outcomes after colorectal surgery in these patients or distinguished them from patients with non–dialysis dependent renal insufficiency (NDDRI) or normal renal function (NRF), observed study author Dr. Isibor Arhuidese of Johns Hopkins University in Baltimore.
Indeed, when the researchers compared these three groups, perioperative mortality and morbidity after elective colorectal surgery was the worst in dialysis patients.
Absolute perioperative mortality was highest for dialysis patients vs. NDDRI and NRF patients after open (13.4% vs. 4.8% vs. 2%; P less than .001) and laparoscopic (8% vs. 2% vs. 0.6%; P less than .001) surgery.
Three complications were significantly associated with death in dialysis patients: myocardial infarction (adjusted odds ratio, 48.6; P = .027), bleeding (aOR, 14.5; P = .025), and sepsis or septic shock (aOR, 8.7; P = .001).
It is not enough to simply identify dialysis dependence as a predictor of poor outcomes, but one must identify targets for improvement in surgical care, Dr. Arhuidese stressed.
Dr. Arhuidese reported having no relevant conflicts of interest.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @pwendl
AT THE ACS CLINICAL CONGRESS
Lavage does not reduce severe complications in perforated diverticulitis
Patients needing emergency surgery for perforated diverticulitis saw no decrease in serious complications when treated with laparoscopic lavage, a minimally invasive procedure, than with primary resection of the colon, according to results from a randomized multicenter trial in Scandinavia.
Likelihood of reoperation also was significantly higher among patients undergoing laparoscopic lavage, and more sigmoid carcinomas were missed.
For their research, published Oct. 6 in JAMA (2015;314:1364-75), a group led by Dr. Johannes Kurt Schultz of the Akershus University Hospital in Lørenskog, Norway, and the University of Oslo sought to eliminate the selection bias that may have contributed to more favorable outcomes associated with laparoscopic lavage in observational studies.
Dr. Schultz and colleagues randomized patients with suspected perforated diverticulitis from 21 centers in Sweden and Norway to laparoscopic peritoneal lavage (n = 101) or colon resection (n = 98), with the choice of open or laparoscopic approach used for resection, as well as the option of colorectal anastomosis, left to the surgeon.
The study did not use laparoscopic Hinchey staging to classify the severity of the perforation prior to treatment assignment as a way of reducing the selection bias that may have occurred in observational studies.
The preoperative randomization resulted in both groups having similar rates of feculent peritonitis and incorrect preoperative diagnoses. Patients assigned to laparoscopic lavage were treated instead with resection if they were found to have fecal peritonitis. Also, patients in both groups whose pathology required additional treatment were treated at surgeon discretion. This left 74 patients randomized to lavage who received it as assigned and 70 patients undergoing resection per assigned protocol. In the intention-to-treat analysis, 31% of patients in the lavage group and 26% of patients in the resection group saw severe postoperative complications within 90 days, a difference of 4.7% that did not reach statistical significance (95% confidence interval, −7.9% to 17%; P = .53). Severe postoperative complications were defined as any complications resulting in a reintervention requiring general anesthesia, a life-threatening organ dysfunction, or death.
Of the patients treated as assigned with lavage, about 20% (n = 15) required reoperation, compared with 6% (n = 4) in the resection arm, a difference of about 14.6% (95% CI, 3.5% to 25.6%; P =.01).
The main reasons for reoperation were secondary peritonitis in the lavage group and wound rupture in the resection group. Intra-abdominal infections were more frequent in the laparoscopic lavage group, Dr. Schultz and colleagues found.
Also in the lavage group, four carcinomas were missed, compared with two in the resection group. “Because of the relatively high rate of missed colon carcinomas in the lavage group, it was essential to perform a colonoscopy after a patient recovered from the perforation,” the researchers wrote in their analysis.
Although patients in the laparoscopic lavage group had significantly shorter operating times, less blood loss, and lower incidence of stoma at 3 months, the researchers concluded that, based on these results, laparoscopic lavage could not be supported in perforated diverticulitis.
Dr. Schultz and colleagues had planned to enroll about half of eligible patients at the study sites. They noted as a limitation of their study that those not enrolled had more severe disease and worse postoperative outcomes, raising the possibility that the results “may not pertain to patients with perforated diverticulitis who are very ill.”
The study was funded by the South-Eastern Norway Regional Health Authority and Akershus University Hospital. None of its authors reported conflicts of interest.
Dr. Schultz and associates detail findings from a randomized, multicenter clinical trial conducted in Scandinavia designed to assess the superiority of laparoscopic lavage plus drainage, compared with laparoscopic or open resection with or without anastomosis for diverticulitis (Hinchey grades I-III) requiring urgent surgery.
The primary outcome was the incidence of severe complications (Clavien-Dindo classification IIIb-V). Of 144 patients, 74 were randomized to receive laparoscopic lavage and 70 to resection. The two groups were similar in characteristics, although significantly fewer of the lavage procedures were performed by a specialty-trained surgeon. Severe complications occurred in 25.7% of patients in the lavage group and 14.3% in the resection group (difference, 11.4%; 95% CI, −1.8 to 24.1), and significantly more patients in the lavage group developed secondary peritonitis (12% vs. 0%) or returned to the operating room (20% vs. 6%). The hospital mortality rates and follow-up quality-of-life scores were comparable between the groups (3% vs. 4% and 0.75 vs. 0.73, respectively). Somewhat worrisome is that four colon cancers were initially missed in patients treated by laparoscopic lavage alone.
Performing laparoscopic lavage is more difficult than merely irrigating the abdomen and placing drains within the pelvis. Surgeons vary in their attitudes related to concomitant adhesiolysis or debridement, and consensus about these procedures is lacking. Furthermore, subjective signs and objective criteria that identify patients at risk for secondary peritonitis or reoperation must be studied, and risk models should be validated to determine which patients are best suited for this less invasive approach. The utility of less intrusive strategies and minimally invasive approaches will undoubtedly expand as technologies evolve, but they must be responsibly incorporated into surgical practice based on evidence rather than subjective reasons.
Dr. Scott A. Strong and Dr. Nathaniel J. Soper are with Northwestern University, Chicago. These comments were taken from an accompanying editorial (JAMA 2015;314[13]:1343-5). They declared no conflicts of interest.
Dr. Schultz and associates detail findings from a randomized, multicenter clinical trial conducted in Scandinavia designed to assess the superiority of laparoscopic lavage plus drainage, compared with laparoscopic or open resection with or without anastomosis for diverticulitis (Hinchey grades I-III) requiring urgent surgery.
The primary outcome was the incidence of severe complications (Clavien-Dindo classification IIIb-V). Of 144 patients, 74 were randomized to receive laparoscopic lavage and 70 to resection. The two groups were similar in characteristics, although significantly fewer of the lavage procedures were performed by a specialty-trained surgeon. Severe complications occurred in 25.7% of patients in the lavage group and 14.3% in the resection group (difference, 11.4%; 95% CI, −1.8 to 24.1), and significantly more patients in the lavage group developed secondary peritonitis (12% vs. 0%) or returned to the operating room (20% vs. 6%). The hospital mortality rates and follow-up quality-of-life scores were comparable between the groups (3% vs. 4% and 0.75 vs. 0.73, respectively). Somewhat worrisome is that four colon cancers were initially missed in patients treated by laparoscopic lavage alone.
Performing laparoscopic lavage is more difficult than merely irrigating the abdomen and placing drains within the pelvis. Surgeons vary in their attitudes related to concomitant adhesiolysis or debridement, and consensus about these procedures is lacking. Furthermore, subjective signs and objective criteria that identify patients at risk for secondary peritonitis or reoperation must be studied, and risk models should be validated to determine which patients are best suited for this less invasive approach. The utility of less intrusive strategies and minimally invasive approaches will undoubtedly expand as technologies evolve, but they must be responsibly incorporated into surgical practice based on evidence rather than subjective reasons.
Dr. Scott A. Strong and Dr. Nathaniel J. Soper are with Northwestern University, Chicago. These comments were taken from an accompanying editorial (JAMA 2015;314[13]:1343-5). They declared no conflicts of interest.
Dr. Schultz and associates detail findings from a randomized, multicenter clinical trial conducted in Scandinavia designed to assess the superiority of laparoscopic lavage plus drainage, compared with laparoscopic or open resection with or without anastomosis for diverticulitis (Hinchey grades I-III) requiring urgent surgery.
The primary outcome was the incidence of severe complications (Clavien-Dindo classification IIIb-V). Of 144 patients, 74 were randomized to receive laparoscopic lavage and 70 to resection. The two groups were similar in characteristics, although significantly fewer of the lavage procedures were performed by a specialty-trained surgeon. Severe complications occurred in 25.7% of patients in the lavage group and 14.3% in the resection group (difference, 11.4%; 95% CI, −1.8 to 24.1), and significantly more patients in the lavage group developed secondary peritonitis (12% vs. 0%) or returned to the operating room (20% vs. 6%). The hospital mortality rates and follow-up quality-of-life scores were comparable between the groups (3% vs. 4% and 0.75 vs. 0.73, respectively). Somewhat worrisome is that four colon cancers were initially missed in patients treated by laparoscopic lavage alone.
Performing laparoscopic lavage is more difficult than merely irrigating the abdomen and placing drains within the pelvis. Surgeons vary in their attitudes related to concomitant adhesiolysis or debridement, and consensus about these procedures is lacking. Furthermore, subjective signs and objective criteria that identify patients at risk for secondary peritonitis or reoperation must be studied, and risk models should be validated to determine which patients are best suited for this less invasive approach. The utility of less intrusive strategies and minimally invasive approaches will undoubtedly expand as technologies evolve, but they must be responsibly incorporated into surgical practice based on evidence rather than subjective reasons.
Dr. Scott A. Strong and Dr. Nathaniel J. Soper are with Northwestern University, Chicago. These comments were taken from an accompanying editorial (JAMA 2015;314[13]:1343-5). They declared no conflicts of interest.
Patients needing emergency surgery for perforated diverticulitis saw no decrease in serious complications when treated with laparoscopic lavage, a minimally invasive procedure, than with primary resection of the colon, according to results from a randomized multicenter trial in Scandinavia.
Likelihood of reoperation also was significantly higher among patients undergoing laparoscopic lavage, and more sigmoid carcinomas were missed.
For their research, published Oct. 6 in JAMA (2015;314:1364-75), a group led by Dr. Johannes Kurt Schultz of the Akershus University Hospital in Lørenskog, Norway, and the University of Oslo sought to eliminate the selection bias that may have contributed to more favorable outcomes associated with laparoscopic lavage in observational studies.
Dr. Schultz and colleagues randomized patients with suspected perforated diverticulitis from 21 centers in Sweden and Norway to laparoscopic peritoneal lavage (n = 101) or colon resection (n = 98), with the choice of open or laparoscopic approach used for resection, as well as the option of colorectal anastomosis, left to the surgeon.
The study did not use laparoscopic Hinchey staging to classify the severity of the perforation prior to treatment assignment as a way of reducing the selection bias that may have occurred in observational studies.
The preoperative randomization resulted in both groups having similar rates of feculent peritonitis and incorrect preoperative diagnoses. Patients assigned to laparoscopic lavage were treated instead with resection if they were found to have fecal peritonitis. Also, patients in both groups whose pathology required additional treatment were treated at surgeon discretion. This left 74 patients randomized to lavage who received it as assigned and 70 patients undergoing resection per assigned protocol. In the intention-to-treat analysis, 31% of patients in the lavage group and 26% of patients in the resection group saw severe postoperative complications within 90 days, a difference of 4.7% that did not reach statistical significance (95% confidence interval, −7.9% to 17%; P = .53). Severe postoperative complications were defined as any complications resulting in a reintervention requiring general anesthesia, a life-threatening organ dysfunction, or death.
Of the patients treated as assigned with lavage, about 20% (n = 15) required reoperation, compared with 6% (n = 4) in the resection arm, a difference of about 14.6% (95% CI, 3.5% to 25.6%; P =.01).
The main reasons for reoperation were secondary peritonitis in the lavage group and wound rupture in the resection group. Intra-abdominal infections were more frequent in the laparoscopic lavage group, Dr. Schultz and colleagues found.
Also in the lavage group, four carcinomas were missed, compared with two in the resection group. “Because of the relatively high rate of missed colon carcinomas in the lavage group, it was essential to perform a colonoscopy after a patient recovered from the perforation,” the researchers wrote in their analysis.
Although patients in the laparoscopic lavage group had significantly shorter operating times, less blood loss, and lower incidence of stoma at 3 months, the researchers concluded that, based on these results, laparoscopic lavage could not be supported in perforated diverticulitis.
Dr. Schultz and colleagues had planned to enroll about half of eligible patients at the study sites. They noted as a limitation of their study that those not enrolled had more severe disease and worse postoperative outcomes, raising the possibility that the results “may not pertain to patients with perforated diverticulitis who are very ill.”
The study was funded by the South-Eastern Norway Regional Health Authority and Akershus University Hospital. None of its authors reported conflicts of interest.
Patients needing emergency surgery for perforated diverticulitis saw no decrease in serious complications when treated with laparoscopic lavage, a minimally invasive procedure, than with primary resection of the colon, according to results from a randomized multicenter trial in Scandinavia.
Likelihood of reoperation also was significantly higher among patients undergoing laparoscopic lavage, and more sigmoid carcinomas were missed.
For their research, published Oct. 6 in JAMA (2015;314:1364-75), a group led by Dr. Johannes Kurt Schultz of the Akershus University Hospital in Lørenskog, Norway, and the University of Oslo sought to eliminate the selection bias that may have contributed to more favorable outcomes associated with laparoscopic lavage in observational studies.
Dr. Schultz and colleagues randomized patients with suspected perforated diverticulitis from 21 centers in Sweden and Norway to laparoscopic peritoneal lavage (n = 101) or colon resection (n = 98), with the choice of open or laparoscopic approach used for resection, as well as the option of colorectal anastomosis, left to the surgeon.
The study did not use laparoscopic Hinchey staging to classify the severity of the perforation prior to treatment assignment as a way of reducing the selection bias that may have occurred in observational studies.
The preoperative randomization resulted in both groups having similar rates of feculent peritonitis and incorrect preoperative diagnoses. Patients assigned to laparoscopic lavage were treated instead with resection if they were found to have fecal peritonitis. Also, patients in both groups whose pathology required additional treatment were treated at surgeon discretion. This left 74 patients randomized to lavage who received it as assigned and 70 patients undergoing resection per assigned protocol. In the intention-to-treat analysis, 31% of patients in the lavage group and 26% of patients in the resection group saw severe postoperative complications within 90 days, a difference of 4.7% that did not reach statistical significance (95% confidence interval, −7.9% to 17%; P = .53). Severe postoperative complications were defined as any complications resulting in a reintervention requiring general anesthesia, a life-threatening organ dysfunction, or death.
Of the patients treated as assigned with lavage, about 20% (n = 15) required reoperation, compared with 6% (n = 4) in the resection arm, a difference of about 14.6% (95% CI, 3.5% to 25.6%; P =.01).
The main reasons for reoperation were secondary peritonitis in the lavage group and wound rupture in the resection group. Intra-abdominal infections were more frequent in the laparoscopic lavage group, Dr. Schultz and colleagues found.
Also in the lavage group, four carcinomas were missed, compared with two in the resection group. “Because of the relatively high rate of missed colon carcinomas in the lavage group, it was essential to perform a colonoscopy after a patient recovered from the perforation,” the researchers wrote in their analysis.
Although patients in the laparoscopic lavage group had significantly shorter operating times, less blood loss, and lower incidence of stoma at 3 months, the researchers concluded that, based on these results, laparoscopic lavage could not be supported in perforated diverticulitis.
Dr. Schultz and colleagues had planned to enroll about half of eligible patients at the study sites. They noted as a limitation of their study that those not enrolled had more severe disease and worse postoperative outcomes, raising the possibility that the results “may not pertain to patients with perforated diverticulitis who are very ill.”
The study was funded by the South-Eastern Norway Regional Health Authority and Akershus University Hospital. None of its authors reported conflicts of interest.
FROM JAMA
Key clinical point: Laparoscopic lavage carries risks of severe postoperative complications similar to colon resection in people presenting with suspected perforated diverticulitis requiring emergency surgery.
Major finding: Mortality and severe complications did not differ significantly at 90 days postoperation between intention-to-treat groups, while reoperation was significantly higher among patients treated with lavage (5.7% for resection vs. 20.3% for lavage, P < .01).
Data source: A multicenter, open-label randomized trial in which patients presenting with likely perforated diverticulitis were randomized to lavage (n = 74) or resection (n = 70).
Disclosures: The study was sponsored by investigator institutions and Norwegian regional government grants. No conflicts of interest were reported.
