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Bundled preventive care reduced surgical site infections
Implementing a systematic bundle of prevention strategies reduced the absolute rate of superficial surgical site infections after colorectal surgery by 14% at one institution.
The findings came from a retrospective study of data from 2008 through 2012 on 559 patients who underwent major elective colorectal surgery at Duke University, Durham, N.C., either before the implementation of the preventive bundle on July 1, 2011 (62% of patients) or afterward (38%). Among all patients, the rate of superficial surgical site infection was 25% before the bundled care and 6% afterward, Dr. Jeffrey E. Keenan and his associates reported.
To eliminate any significant differences in patient demographics, baseline characteristics, or procedure-specific factors that might affect the surgical site infection rate, they conducted a propensity-matched comparison of 212 patients from each of the pre- and postbundling groups. The surgical site infection rate was 19.3% before implementation of bundled preventive services and 5.7% with bundled care, a significant difference of 13.6%, reported Dr. Keenan of the university.
The results were published online in JAMA Surgery (2014 Aug. 27 [doi:10.1001/jamasurg.2014.346]).
Among secondary outcomes, sepsis rates were significantly higher in the pre–bundled-care period, compared with the bundled-care period, both in the unadjusted cohort (10% vs. 2%, respectively) and in the comparison of matched patients (8% vs. 2%, respectively).
The bundle of care was a multidisciplinary effort involving surgeons, anesthesiologists, clinic nurses, operating room staff, unit nurses, house staff, and hospital midlevel providers led by a colorectal surgeon who met monthly with the various groups to review infection rates and address issues with delivering the bundled strategies.
Designed by colorectal surgeons at the university, the bundle included giving patients educational materials before surgery on preventing surgical site infection. The patients received instructions and materials for a full-body chlorhexidine gluconate shower the night before surgery. The bundled-care team adopted a standardized polyethylene glycol 33350 bowel preparation with oral antibiotics (neomycin sulfate and erythromycin). All patients without allergy received a single 1-g dose of ertapenem sodium for preoperative antibiotic prophylaxis within 1 hour of incision. Patients with an allergy received ciprofloxacin HCl and metronidazole phosphate as an alternative.
Standardized preparation of the surgical field involved use of a 2% chlorhexidine gluconate–70% isopropyl alcohol solution. A wound protector was used during surgery for open incision. Only essential personnel were allowed in and out of the operating room. Anesthesiologists paid close attention to maintaining normothermia and euglycemia. Surgeons and scrub staff changed gowns and gloves at the time of wound closure. A dedicated wound closure tray was used to close the fascia and skin, and a sterile occlusive dressing was placed over the incision following closure. The dressing was removed within 48 hours of surgery, and the wound was washed daily with chlorhexidine. Patients being discharged were given materials and instructions to continue the chlorhexidine washes for 1 week after surgery.
A subgroup analysis of patients who underwent surgery after implementation of the bundled care showed that variable direct costs were 36% higher (after multivariable adjustment) in patients who developed surgical site infection, and patients with infection stayed 72% longer in the hospital, Dr. Keenan reported. Average variable direct costs were $13,253 in patients with superficial surgical site infection and $9,779 in those who did not develop infection. Lengths of stay during the index admission averaged 8 days with infection and 5 days without infection.
It is unlikely that any one part of the preventive bundle was responsible for the reduced infection rate and costs, though it’s impossible to tell, the investigators said. More likely, the framework of bundling preventive strategies supported reliable delivery of multiple preventive measures with high fidelity, they suggested.
Dr. Keenan reported having no relevant financial disclosures.
On Twitter @sherryboschert
The study by Dr. Keenan and several separate recent studies support the idea that surgical site infections after colorectal surgery can be prevented by management based on published evidence, best practice guidelines, and culture change, according to Dr. Ira L. Leeds and Dr. Elizabeth C. Wick.
This involves implementing "processes that span the continuum of care from before surgery through postoperative recovery, and these interventions are far more complex than the Surgical Care Improvement Program measures now held as the gold standard for surgical quality reporting," they wrote (JAMA Surgery 2014 Aug. 27 [doi:10.1001/jamasurg.2014.389]).
The studies also suggest that the subspecialty of colorectal surgery is well situated for developing models of care starting from the patient care level rather than from a typical top-down approach, they added. "The tribelike culture of medicine means that many of the fixes to the health care system will need to come at the unit level rather than [through] institutional, systemic solutions," Dr. Leeds and Dr. Wick wrote.
Their remarks were published in a commentary simultaneously with the publication of Dr. Keenan’s study. Dr. Leeds and Dr. Wick are at the Johns Hopkins University, Baltimore. They reported having no financial disclosures.
The study by Dr. Keenan and several separate recent studies support the idea that surgical site infections after colorectal surgery can be prevented by management based on published evidence, best practice guidelines, and culture change, according to Dr. Ira L. Leeds and Dr. Elizabeth C. Wick.
This involves implementing "processes that span the continuum of care from before surgery through postoperative recovery, and these interventions are far more complex than the Surgical Care Improvement Program measures now held as the gold standard for surgical quality reporting," they wrote (JAMA Surgery 2014 Aug. 27 [doi:10.1001/jamasurg.2014.389]).
The studies also suggest that the subspecialty of colorectal surgery is well situated for developing models of care starting from the patient care level rather than from a typical top-down approach, they added. "The tribelike culture of medicine means that many of the fixes to the health care system will need to come at the unit level rather than [through] institutional, systemic solutions," Dr. Leeds and Dr. Wick wrote.
Their remarks were published in a commentary simultaneously with the publication of Dr. Keenan’s study. Dr. Leeds and Dr. Wick are at the Johns Hopkins University, Baltimore. They reported having no financial disclosures.
The study by Dr. Keenan and several separate recent studies support the idea that surgical site infections after colorectal surgery can be prevented by management based on published evidence, best practice guidelines, and culture change, according to Dr. Ira L. Leeds and Dr. Elizabeth C. Wick.
This involves implementing "processes that span the continuum of care from before surgery through postoperative recovery, and these interventions are far more complex than the Surgical Care Improvement Program measures now held as the gold standard for surgical quality reporting," they wrote (JAMA Surgery 2014 Aug. 27 [doi:10.1001/jamasurg.2014.389]).
The studies also suggest that the subspecialty of colorectal surgery is well situated for developing models of care starting from the patient care level rather than from a typical top-down approach, they added. "The tribelike culture of medicine means that many of the fixes to the health care system will need to come at the unit level rather than [through] institutional, systemic solutions," Dr. Leeds and Dr. Wick wrote.
Their remarks were published in a commentary simultaneously with the publication of Dr. Keenan’s study. Dr. Leeds and Dr. Wick are at the Johns Hopkins University, Baltimore. They reported having no financial disclosures.
Implementing a systematic bundle of prevention strategies reduced the absolute rate of superficial surgical site infections after colorectal surgery by 14% at one institution.
The findings came from a retrospective study of data from 2008 through 2012 on 559 patients who underwent major elective colorectal surgery at Duke University, Durham, N.C., either before the implementation of the preventive bundle on July 1, 2011 (62% of patients) or afterward (38%). Among all patients, the rate of superficial surgical site infection was 25% before the bundled care and 6% afterward, Dr. Jeffrey E. Keenan and his associates reported.
To eliminate any significant differences in patient demographics, baseline characteristics, or procedure-specific factors that might affect the surgical site infection rate, they conducted a propensity-matched comparison of 212 patients from each of the pre- and postbundling groups. The surgical site infection rate was 19.3% before implementation of bundled preventive services and 5.7% with bundled care, a significant difference of 13.6%, reported Dr. Keenan of the university.
The results were published online in JAMA Surgery (2014 Aug. 27 [doi:10.1001/jamasurg.2014.346]).
Among secondary outcomes, sepsis rates were significantly higher in the pre–bundled-care period, compared with the bundled-care period, both in the unadjusted cohort (10% vs. 2%, respectively) and in the comparison of matched patients (8% vs. 2%, respectively).
The bundle of care was a multidisciplinary effort involving surgeons, anesthesiologists, clinic nurses, operating room staff, unit nurses, house staff, and hospital midlevel providers led by a colorectal surgeon who met monthly with the various groups to review infection rates and address issues with delivering the bundled strategies.
Designed by colorectal surgeons at the university, the bundle included giving patients educational materials before surgery on preventing surgical site infection. The patients received instructions and materials for a full-body chlorhexidine gluconate shower the night before surgery. The bundled-care team adopted a standardized polyethylene glycol 33350 bowel preparation with oral antibiotics (neomycin sulfate and erythromycin). All patients without allergy received a single 1-g dose of ertapenem sodium for preoperative antibiotic prophylaxis within 1 hour of incision. Patients with an allergy received ciprofloxacin HCl and metronidazole phosphate as an alternative.
Standardized preparation of the surgical field involved use of a 2% chlorhexidine gluconate–70% isopropyl alcohol solution. A wound protector was used during surgery for open incision. Only essential personnel were allowed in and out of the operating room. Anesthesiologists paid close attention to maintaining normothermia and euglycemia. Surgeons and scrub staff changed gowns and gloves at the time of wound closure. A dedicated wound closure tray was used to close the fascia and skin, and a sterile occlusive dressing was placed over the incision following closure. The dressing was removed within 48 hours of surgery, and the wound was washed daily with chlorhexidine. Patients being discharged were given materials and instructions to continue the chlorhexidine washes for 1 week after surgery.
A subgroup analysis of patients who underwent surgery after implementation of the bundled care showed that variable direct costs were 36% higher (after multivariable adjustment) in patients who developed surgical site infection, and patients with infection stayed 72% longer in the hospital, Dr. Keenan reported. Average variable direct costs were $13,253 in patients with superficial surgical site infection and $9,779 in those who did not develop infection. Lengths of stay during the index admission averaged 8 days with infection and 5 days without infection.
It is unlikely that any one part of the preventive bundle was responsible for the reduced infection rate and costs, though it’s impossible to tell, the investigators said. More likely, the framework of bundling preventive strategies supported reliable delivery of multiple preventive measures with high fidelity, they suggested.
Dr. Keenan reported having no relevant financial disclosures.
On Twitter @sherryboschert
Implementing a systematic bundle of prevention strategies reduced the absolute rate of superficial surgical site infections after colorectal surgery by 14% at one institution.
The findings came from a retrospective study of data from 2008 through 2012 on 559 patients who underwent major elective colorectal surgery at Duke University, Durham, N.C., either before the implementation of the preventive bundle on July 1, 2011 (62% of patients) or afterward (38%). Among all patients, the rate of superficial surgical site infection was 25% before the bundled care and 6% afterward, Dr. Jeffrey E. Keenan and his associates reported.
To eliminate any significant differences in patient demographics, baseline characteristics, or procedure-specific factors that might affect the surgical site infection rate, they conducted a propensity-matched comparison of 212 patients from each of the pre- and postbundling groups. The surgical site infection rate was 19.3% before implementation of bundled preventive services and 5.7% with bundled care, a significant difference of 13.6%, reported Dr. Keenan of the university.
The results were published online in JAMA Surgery (2014 Aug. 27 [doi:10.1001/jamasurg.2014.346]).
Among secondary outcomes, sepsis rates were significantly higher in the pre–bundled-care period, compared with the bundled-care period, both in the unadjusted cohort (10% vs. 2%, respectively) and in the comparison of matched patients (8% vs. 2%, respectively).
The bundle of care was a multidisciplinary effort involving surgeons, anesthesiologists, clinic nurses, operating room staff, unit nurses, house staff, and hospital midlevel providers led by a colorectal surgeon who met monthly with the various groups to review infection rates and address issues with delivering the bundled strategies.
Designed by colorectal surgeons at the university, the bundle included giving patients educational materials before surgery on preventing surgical site infection. The patients received instructions and materials for a full-body chlorhexidine gluconate shower the night before surgery. The bundled-care team adopted a standardized polyethylene glycol 33350 bowel preparation with oral antibiotics (neomycin sulfate and erythromycin). All patients without allergy received a single 1-g dose of ertapenem sodium for preoperative antibiotic prophylaxis within 1 hour of incision. Patients with an allergy received ciprofloxacin HCl and metronidazole phosphate as an alternative.
Standardized preparation of the surgical field involved use of a 2% chlorhexidine gluconate–70% isopropyl alcohol solution. A wound protector was used during surgery for open incision. Only essential personnel were allowed in and out of the operating room. Anesthesiologists paid close attention to maintaining normothermia and euglycemia. Surgeons and scrub staff changed gowns and gloves at the time of wound closure. A dedicated wound closure tray was used to close the fascia and skin, and a sterile occlusive dressing was placed over the incision following closure. The dressing was removed within 48 hours of surgery, and the wound was washed daily with chlorhexidine. Patients being discharged were given materials and instructions to continue the chlorhexidine washes for 1 week after surgery.
A subgroup analysis of patients who underwent surgery after implementation of the bundled care showed that variable direct costs were 36% higher (after multivariable adjustment) in patients who developed surgical site infection, and patients with infection stayed 72% longer in the hospital, Dr. Keenan reported. Average variable direct costs were $13,253 in patients with superficial surgical site infection and $9,779 in those who did not develop infection. Lengths of stay during the index admission averaged 8 days with infection and 5 days without infection.
It is unlikely that any one part of the preventive bundle was responsible for the reduced infection rate and costs, though it’s impossible to tell, the investigators said. More likely, the framework of bundling preventive strategies supported reliable delivery of multiple preventive measures with high fidelity, they suggested.
Dr. Keenan reported having no relevant financial disclosures.
On Twitter @sherryboschert
FROM JAMA SURGERY
Key clinical point: Bundled preventive care significantly reduced surgical site infection after colorectal surgery.
Major finding: Superficial surgical site infection occurred in about 19% before and about 6% after implementing bundled care.
Data source: A retrospective study of 559 patients undergoing colorectal surgery, 62% before bundled-care implementation.
Disclosures: Dr. Keenan reported having no relevant financial disclosures.
Evidence questioned in debate over monitoring dabigatran levels to avert bleeds
The manufacturer of the oral anticoagulant dabigatran "withheld analyses that calculate how many major bleeds dose adjustment could prevent," the BMJ charges in an article based on internal documents released during litigation in the United States and freedom of information act requests obtained by the journal.
Boehringer Ingelheim "found that if the plasma levels of the drug were measured and the dose was adjusted accordingly major bleeds could be reduced by 30%-40%, compared with well-controlled warfarin," according to the article (BMJ 2014;349:g4670), which was published along with an editorial and an analysis. The article further stated that the manufacturer "has failed to share with regulators information about the potential benefits of monitoring anticoagulant activity and adjusting the dose to make sure the drug is working as safely and effectively as possible."
In the analysis, Thomas Moore, senior scientist at the Institute for Safe Medication Practices, Horsham, Pa., and his coauthors said that "the bleeding risk of dabigatran can be reduced and efficacy improved by individualizing the dose in patients based on plasma level, age, and kidney function" (BMJ 2014;349:g4517[doi:10.1136/bmj.g4517]).
Dr. Rita Redberg and Dr. Blake Charlton of the University of California, San Francisco, wrote in an accompanying editorial that the analysis "illuminates a lack of transparency about the safety of unmonitored dabigatran, compounded by the drug’s fickle pharmacokinetics, which can cause a fivefold variation of plasma concentration." (BMJ 2014;349:g4681 [doi:10.1136/bmj.g4681]).
The BMJ article, written by Deborah Cohen, includes responses from the manufacturer of dabigatran (Pradaxa).
Boehringer Ingelheim officials have asserted that no data were withheld. Additionally, the company has released a statement calling the BMJ article "biased" and "misleading."
Dabigatran is a direct thrombin inhibitor that was approved in the United States in October 2010 for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation at a fixed dose of 150 mg or 75 mg twice a day, with the lower dose recommended for those with renal impairment. Since its initial approval, dabigatran has gained indications for treating and reducing the risk of recurrence of deep venous thrombosis and pulmonary embolism.
The drug’s approval was based on the results of the Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) trial, which compared the drug to warfarin in 18,113 patients with nonvalvular atrial fibrillation and at least one other risk factor for stroke. The annual rate of stroke and systemic embolism in RE-LY was 1.5% in the patients on the 110-mg twice daily dose, 1.1% in those on the 150-mg twice daily dose, and 1.7% among those on warfarin. The risk reductions with dabigatran were 10% and 35% for the 110-mg and 150-mg doses, respectively, compared with warfarin.
"Our company has provided regulators with the complete data set and analyses of clinical evidence demonstrating Pradaxa’s benefits and safety," Boehringer Ingelheim said in its statement. "Contrary to the BMJ’s accusation that BI withheld analyses, here are the facts: In 2012, our scientists performed preliminary, exploratory simulations with mathematical models to understand whether dose adjustments based on plasma concentrations might further improve Pradaxa’s benefits and safety. Because the simulations did not offer reliable predictions of actual patient outcomes, they were not provided to regulators. However, all of the data that was used for the simulations had already been provided."
Dr. Sanjay Kaul, who was on the Food and Drug Administration’s advisory panel that recommended approval of dabigatran, said in an interview that the FDA reviewers raised questions at that meeting about the utility of using plasma concentrations to monitor individual subjects and adjust dose based on dabigatran concentrations. "But they also acknowledged an exposure-response relationship existed that demonstrated that going from the 10th to 90th percentile of dabigatran concentration (23 to 283 ng/mL) reduced the probability of having a stroke by 50% (from 1% to 0.5%) while increasing sixfold (from 0.3% to 1.8%) the probability of having major bleeding within 1 year."
It is well known that plasma concentration is one of the factors – among others, such as age, renal function, or history of stroke – that affect the benefit-risk balance, said Dr. Kaul, a cardiologist at Cedars-Sinai Medical Center, Los Angeles. Even in patients with moderate to severe renal dysfunction (up to creatinine clearance of 15-30 mL/min) and elevated plasma concentrations, benefit still exceeds risk.
"To what degree monitoring drug levels could potentially optimize benefit-risk balance remains an open question. For example, benefit-risk balance for dabigatran 150 mg vs 110 mg was not predicted by pharmacokinetic/pharmacodynamic modeling. Based on the PK/PD modeling, one stroke would be prevented at the cost of three extra major bleeds using 150 mg , compared with 110 mg. The RE-LY data indicate four strokes prevented and three major bleeding events incurred with the 150-mg dose as compared with the 110-mg dose," he said. "There is quite a discordance in predicted vs. observed benefit-risk balance."
Therefore, "while monitoring drug levels to optimize benefit-risk balance has intuitive appeal, given the complex exposure-response relationship and confounding effects of demographic variables, this should remain an area of active investigation. It is not ready for prime time to inform or guide clinical practice," Dr. Kaul said.
Dr. Kaul disclosed that he is a consultant for Boehringer Ingelheim and has equity interest in Johnson and Johnson.
At press time, the FDA had not responded to a request for a comment on the BMJ investigation.
The manufacturer of the oral anticoagulant dabigatran "withheld analyses that calculate how many major bleeds dose adjustment could prevent," the BMJ charges in an article based on internal documents released during litigation in the United States and freedom of information act requests obtained by the journal.
Boehringer Ingelheim "found that if the plasma levels of the drug were measured and the dose was adjusted accordingly major bleeds could be reduced by 30%-40%, compared with well-controlled warfarin," according to the article (BMJ 2014;349:g4670), which was published along with an editorial and an analysis. The article further stated that the manufacturer "has failed to share with regulators information about the potential benefits of monitoring anticoagulant activity and adjusting the dose to make sure the drug is working as safely and effectively as possible."
In the analysis, Thomas Moore, senior scientist at the Institute for Safe Medication Practices, Horsham, Pa., and his coauthors said that "the bleeding risk of dabigatran can be reduced and efficacy improved by individualizing the dose in patients based on plasma level, age, and kidney function" (BMJ 2014;349:g4517[doi:10.1136/bmj.g4517]).
Dr. Rita Redberg and Dr. Blake Charlton of the University of California, San Francisco, wrote in an accompanying editorial that the analysis "illuminates a lack of transparency about the safety of unmonitored dabigatran, compounded by the drug’s fickle pharmacokinetics, which can cause a fivefold variation of plasma concentration." (BMJ 2014;349:g4681 [doi:10.1136/bmj.g4681]).
The BMJ article, written by Deborah Cohen, includes responses from the manufacturer of dabigatran (Pradaxa).
Boehringer Ingelheim officials have asserted that no data were withheld. Additionally, the company has released a statement calling the BMJ article "biased" and "misleading."
Dabigatran is a direct thrombin inhibitor that was approved in the United States in October 2010 for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation at a fixed dose of 150 mg or 75 mg twice a day, with the lower dose recommended for those with renal impairment. Since its initial approval, dabigatran has gained indications for treating and reducing the risk of recurrence of deep venous thrombosis and pulmonary embolism.
The drug’s approval was based on the results of the Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) trial, which compared the drug to warfarin in 18,113 patients with nonvalvular atrial fibrillation and at least one other risk factor for stroke. The annual rate of stroke and systemic embolism in RE-LY was 1.5% in the patients on the 110-mg twice daily dose, 1.1% in those on the 150-mg twice daily dose, and 1.7% among those on warfarin. The risk reductions with dabigatran were 10% and 35% for the 110-mg and 150-mg doses, respectively, compared with warfarin.
"Our company has provided regulators with the complete data set and analyses of clinical evidence demonstrating Pradaxa’s benefits and safety," Boehringer Ingelheim said in its statement. "Contrary to the BMJ’s accusation that BI withheld analyses, here are the facts: In 2012, our scientists performed preliminary, exploratory simulations with mathematical models to understand whether dose adjustments based on plasma concentrations might further improve Pradaxa’s benefits and safety. Because the simulations did not offer reliable predictions of actual patient outcomes, they were not provided to regulators. However, all of the data that was used for the simulations had already been provided."
Dr. Sanjay Kaul, who was on the Food and Drug Administration’s advisory panel that recommended approval of dabigatran, said in an interview that the FDA reviewers raised questions at that meeting about the utility of using plasma concentrations to monitor individual subjects and adjust dose based on dabigatran concentrations. "But they also acknowledged an exposure-response relationship existed that demonstrated that going from the 10th to 90th percentile of dabigatran concentration (23 to 283 ng/mL) reduced the probability of having a stroke by 50% (from 1% to 0.5%) while increasing sixfold (from 0.3% to 1.8%) the probability of having major bleeding within 1 year."
It is well known that plasma concentration is one of the factors – among others, such as age, renal function, or history of stroke – that affect the benefit-risk balance, said Dr. Kaul, a cardiologist at Cedars-Sinai Medical Center, Los Angeles. Even in patients with moderate to severe renal dysfunction (up to creatinine clearance of 15-30 mL/min) and elevated plasma concentrations, benefit still exceeds risk.
"To what degree monitoring drug levels could potentially optimize benefit-risk balance remains an open question. For example, benefit-risk balance for dabigatran 150 mg vs 110 mg was not predicted by pharmacokinetic/pharmacodynamic modeling. Based on the PK/PD modeling, one stroke would be prevented at the cost of three extra major bleeds using 150 mg , compared with 110 mg. The RE-LY data indicate four strokes prevented and three major bleeding events incurred with the 150-mg dose as compared with the 110-mg dose," he said. "There is quite a discordance in predicted vs. observed benefit-risk balance."
Therefore, "while monitoring drug levels to optimize benefit-risk balance has intuitive appeal, given the complex exposure-response relationship and confounding effects of demographic variables, this should remain an area of active investigation. It is not ready for prime time to inform or guide clinical practice," Dr. Kaul said.
Dr. Kaul disclosed that he is a consultant for Boehringer Ingelheim and has equity interest in Johnson and Johnson.
At press time, the FDA had not responded to a request for a comment on the BMJ investigation.
The manufacturer of the oral anticoagulant dabigatran "withheld analyses that calculate how many major bleeds dose adjustment could prevent," the BMJ charges in an article based on internal documents released during litigation in the United States and freedom of information act requests obtained by the journal.
Boehringer Ingelheim "found that if the plasma levels of the drug were measured and the dose was adjusted accordingly major bleeds could be reduced by 30%-40%, compared with well-controlled warfarin," according to the article (BMJ 2014;349:g4670), which was published along with an editorial and an analysis. The article further stated that the manufacturer "has failed to share with regulators information about the potential benefits of monitoring anticoagulant activity and adjusting the dose to make sure the drug is working as safely and effectively as possible."
In the analysis, Thomas Moore, senior scientist at the Institute for Safe Medication Practices, Horsham, Pa., and his coauthors said that "the bleeding risk of dabigatran can be reduced and efficacy improved by individualizing the dose in patients based on plasma level, age, and kidney function" (BMJ 2014;349:g4517[doi:10.1136/bmj.g4517]).
Dr. Rita Redberg and Dr. Blake Charlton of the University of California, San Francisco, wrote in an accompanying editorial that the analysis "illuminates a lack of transparency about the safety of unmonitored dabigatran, compounded by the drug’s fickle pharmacokinetics, which can cause a fivefold variation of plasma concentration." (BMJ 2014;349:g4681 [doi:10.1136/bmj.g4681]).
The BMJ article, written by Deborah Cohen, includes responses from the manufacturer of dabigatran (Pradaxa).
Boehringer Ingelheim officials have asserted that no data were withheld. Additionally, the company has released a statement calling the BMJ article "biased" and "misleading."
Dabigatran is a direct thrombin inhibitor that was approved in the United States in October 2010 for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation at a fixed dose of 150 mg or 75 mg twice a day, with the lower dose recommended for those with renal impairment. Since its initial approval, dabigatran has gained indications for treating and reducing the risk of recurrence of deep venous thrombosis and pulmonary embolism.
The drug’s approval was based on the results of the Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) trial, which compared the drug to warfarin in 18,113 patients with nonvalvular atrial fibrillation and at least one other risk factor for stroke. The annual rate of stroke and systemic embolism in RE-LY was 1.5% in the patients on the 110-mg twice daily dose, 1.1% in those on the 150-mg twice daily dose, and 1.7% among those on warfarin. The risk reductions with dabigatran were 10% and 35% for the 110-mg and 150-mg doses, respectively, compared with warfarin.
"Our company has provided regulators with the complete data set and analyses of clinical evidence demonstrating Pradaxa’s benefits and safety," Boehringer Ingelheim said in its statement. "Contrary to the BMJ’s accusation that BI withheld analyses, here are the facts: In 2012, our scientists performed preliminary, exploratory simulations with mathematical models to understand whether dose adjustments based on plasma concentrations might further improve Pradaxa’s benefits and safety. Because the simulations did not offer reliable predictions of actual patient outcomes, they were not provided to regulators. However, all of the data that was used for the simulations had already been provided."
Dr. Sanjay Kaul, who was on the Food and Drug Administration’s advisory panel that recommended approval of dabigatran, said in an interview that the FDA reviewers raised questions at that meeting about the utility of using plasma concentrations to monitor individual subjects and adjust dose based on dabigatran concentrations. "But they also acknowledged an exposure-response relationship existed that demonstrated that going from the 10th to 90th percentile of dabigatran concentration (23 to 283 ng/mL) reduced the probability of having a stroke by 50% (from 1% to 0.5%) while increasing sixfold (from 0.3% to 1.8%) the probability of having major bleeding within 1 year."
It is well known that plasma concentration is one of the factors – among others, such as age, renal function, or history of stroke – that affect the benefit-risk balance, said Dr. Kaul, a cardiologist at Cedars-Sinai Medical Center, Los Angeles. Even in patients with moderate to severe renal dysfunction (up to creatinine clearance of 15-30 mL/min) and elevated plasma concentrations, benefit still exceeds risk.
"To what degree monitoring drug levels could potentially optimize benefit-risk balance remains an open question. For example, benefit-risk balance for dabigatran 150 mg vs 110 mg was not predicted by pharmacokinetic/pharmacodynamic modeling. Based on the PK/PD modeling, one stroke would be prevented at the cost of three extra major bleeds using 150 mg , compared with 110 mg. The RE-LY data indicate four strokes prevented and three major bleeding events incurred with the 150-mg dose as compared with the 110-mg dose," he said. "There is quite a discordance in predicted vs. observed benefit-risk balance."
Therefore, "while monitoring drug levels to optimize benefit-risk balance has intuitive appeal, given the complex exposure-response relationship and confounding effects of demographic variables, this should remain an area of active investigation. It is not ready for prime time to inform or guide clinical practice," Dr. Kaul said.
Dr. Kaul disclosed that he is a consultant for Boehringer Ingelheim and has equity interest in Johnson and Johnson.
At press time, the FDA had not responded to a request for a comment on the BMJ investigation.
VEGF-A value may stratify risk in pediatric heart transplant recipients
SAN FRANCISCO – Monitoring plasma vascular endothelial growth factor A (VEGF-A) may help identify pediatric heart transplant patients who are at increased risk for poor outcomes, according to a study reported at the 2014 World Transplant Congress.
"Cardiac allograft vasculopathy [CAV] remains the leading cause of chronic allograft failure after heart transplantation. ... Therefore, it’s important for us to be able to anticipate the development of CAV and open up a therapeutic window," said Dr. Kevin P. Daly of Harvard Medical School and Boston Children’s Hospital.
"Our pilot data suggest that plasma VEGF-A levels below 90 pg/mL identify a low-risk patient population in whom a decreased frequency of coronary angiography can be considered. Future studies are needed to determine if using plasma VEGF-A levels to modify CAV screening frequency results in equivalent patient outcomes, with decreased resource utilization and improved quality of life," Dr. Daly commented at the congress, which was sponsored by the American Society of Transplant Surgeons.
As the vascular endothelium is the primary target of the immune response in CAV, the researchers hypothesized that VEGF-A likely contributes to an inflammatory cycle that leads to vascular damage and occlusion in the graft.
Participants in the single-center prospective cohort study were 44 consecutive children aged 2 years or older who were at least 18 months (median, 6 years) out from heart transplantation. They were scheduled for routine annual screening coronary angiography during 2009, and had no or mild CAV.
Moderate or severe CAV developed in 32% of patients who had VEGF-A values above the median value at baseline (90 pg/mL), compared with 5% of patients who had VEGF-A values below the median level (P = .02). Patients who developed this vasculopathy were more likely to die (38% vs. 0%), undergo retransplantation (38% vs. 0%), experience a myocardial infarction (12% vs. 0%), and be listed for retransplantation (12% vs. 0%).
"While this is a biomarker and we have shown it is associated with CAV, we have not shown that it is causal," Dr. Daly cautioned. Any treatment directed against VEGF would have to be conducted in the context of a clinical trial to assess its impact.
A subset of patients becomes nonadherent to therapy; a subset that is highly sensitized before transplant may have donor-specific antibody, Dr. Daly said. So "we don’t think we fully understand the inciting event, ... [but] VEGF-A has been shown before to be elevated in antibody-mediated rejection, so it’s not surprising to see this association."
"We didn’t have these data available clinically because it was all a research study, so we didn’t intervene on any of the patients in this cohort. But we have started to think about whether or not we could use VEGF-A levels at least in our ... patients who might not have arterial access, and it might be difficult to survey them for CAV. I think in order to really understand the appropriate way to use it, we would need a larger study," he remarked.
Dr. Daly disclosed that he had no conflicts of interest relevant to the study.
This was a very nice preliminary study but extremely limited in scope, as it has few patients and limited mechanistic studies. Most importantly, there was no validation cohort as is required to have confidence that a biomarker is predictive. A lot more work will be necessary before significance can be assigned to the use of VEGF-A as a potential biomarker.
Dr. Daniel R. Salomon is a professor and program medical director at the Scripps Center for Organ Transplantation, Scripps Research Institute, La Jolla, Calif. He was the cochair at the session where the research was presented, and made his remarks in an interview. He had no relevant conflicts of interest.
This was a very nice preliminary study but extremely limited in scope, as it has few patients and limited mechanistic studies. Most importantly, there was no validation cohort as is required to have confidence that a biomarker is predictive. A lot more work will be necessary before significance can be assigned to the use of VEGF-A as a potential biomarker.
Dr. Daniel R. Salomon is a professor and program medical director at the Scripps Center for Organ Transplantation, Scripps Research Institute, La Jolla, Calif. He was the cochair at the session where the research was presented, and made his remarks in an interview. He had no relevant conflicts of interest.
This was a very nice preliminary study but extremely limited in scope, as it has few patients and limited mechanistic studies. Most importantly, there was no validation cohort as is required to have confidence that a biomarker is predictive. A lot more work will be necessary before significance can be assigned to the use of VEGF-A as a potential biomarker.
Dr. Daniel R. Salomon is a professor and program medical director at the Scripps Center for Organ Transplantation, Scripps Research Institute, La Jolla, Calif. He was the cochair at the session where the research was presented, and made his remarks in an interview. He had no relevant conflicts of interest.
SAN FRANCISCO – Monitoring plasma vascular endothelial growth factor A (VEGF-A) may help identify pediatric heart transplant patients who are at increased risk for poor outcomes, according to a study reported at the 2014 World Transplant Congress.
"Cardiac allograft vasculopathy [CAV] remains the leading cause of chronic allograft failure after heart transplantation. ... Therefore, it’s important for us to be able to anticipate the development of CAV and open up a therapeutic window," said Dr. Kevin P. Daly of Harvard Medical School and Boston Children’s Hospital.
"Our pilot data suggest that plasma VEGF-A levels below 90 pg/mL identify a low-risk patient population in whom a decreased frequency of coronary angiography can be considered. Future studies are needed to determine if using plasma VEGF-A levels to modify CAV screening frequency results in equivalent patient outcomes, with decreased resource utilization and improved quality of life," Dr. Daly commented at the congress, which was sponsored by the American Society of Transplant Surgeons.
As the vascular endothelium is the primary target of the immune response in CAV, the researchers hypothesized that VEGF-A likely contributes to an inflammatory cycle that leads to vascular damage and occlusion in the graft.
Participants in the single-center prospective cohort study were 44 consecutive children aged 2 years or older who were at least 18 months (median, 6 years) out from heart transplantation. They were scheduled for routine annual screening coronary angiography during 2009, and had no or mild CAV.
Moderate or severe CAV developed in 32% of patients who had VEGF-A values above the median value at baseline (90 pg/mL), compared with 5% of patients who had VEGF-A values below the median level (P = .02). Patients who developed this vasculopathy were more likely to die (38% vs. 0%), undergo retransplantation (38% vs. 0%), experience a myocardial infarction (12% vs. 0%), and be listed for retransplantation (12% vs. 0%).
"While this is a biomarker and we have shown it is associated with CAV, we have not shown that it is causal," Dr. Daly cautioned. Any treatment directed against VEGF would have to be conducted in the context of a clinical trial to assess its impact.
A subset of patients becomes nonadherent to therapy; a subset that is highly sensitized before transplant may have donor-specific antibody, Dr. Daly said. So "we don’t think we fully understand the inciting event, ... [but] VEGF-A has been shown before to be elevated in antibody-mediated rejection, so it’s not surprising to see this association."
"We didn’t have these data available clinically because it was all a research study, so we didn’t intervene on any of the patients in this cohort. But we have started to think about whether or not we could use VEGF-A levels at least in our ... patients who might not have arterial access, and it might be difficult to survey them for CAV. I think in order to really understand the appropriate way to use it, we would need a larger study," he remarked.
Dr. Daly disclosed that he had no conflicts of interest relevant to the study.
SAN FRANCISCO – Monitoring plasma vascular endothelial growth factor A (VEGF-A) may help identify pediatric heart transplant patients who are at increased risk for poor outcomes, according to a study reported at the 2014 World Transplant Congress.
"Cardiac allograft vasculopathy [CAV] remains the leading cause of chronic allograft failure after heart transplantation. ... Therefore, it’s important for us to be able to anticipate the development of CAV and open up a therapeutic window," said Dr. Kevin P. Daly of Harvard Medical School and Boston Children’s Hospital.
"Our pilot data suggest that plasma VEGF-A levels below 90 pg/mL identify a low-risk patient population in whom a decreased frequency of coronary angiography can be considered. Future studies are needed to determine if using plasma VEGF-A levels to modify CAV screening frequency results in equivalent patient outcomes, with decreased resource utilization and improved quality of life," Dr. Daly commented at the congress, which was sponsored by the American Society of Transplant Surgeons.
As the vascular endothelium is the primary target of the immune response in CAV, the researchers hypothesized that VEGF-A likely contributes to an inflammatory cycle that leads to vascular damage and occlusion in the graft.
Participants in the single-center prospective cohort study were 44 consecutive children aged 2 years or older who were at least 18 months (median, 6 years) out from heart transplantation. They were scheduled for routine annual screening coronary angiography during 2009, and had no or mild CAV.
Moderate or severe CAV developed in 32% of patients who had VEGF-A values above the median value at baseline (90 pg/mL), compared with 5% of patients who had VEGF-A values below the median level (P = .02). Patients who developed this vasculopathy were more likely to die (38% vs. 0%), undergo retransplantation (38% vs. 0%), experience a myocardial infarction (12% vs. 0%), and be listed for retransplantation (12% vs. 0%).
"While this is a biomarker and we have shown it is associated with CAV, we have not shown that it is causal," Dr. Daly cautioned. Any treatment directed against VEGF would have to be conducted in the context of a clinical trial to assess its impact.
A subset of patients becomes nonadherent to therapy; a subset that is highly sensitized before transplant may have donor-specific antibody, Dr. Daly said. So "we don’t think we fully understand the inciting event, ... [but] VEGF-A has been shown before to be elevated in antibody-mediated rejection, so it’s not surprising to see this association."
"We didn’t have these data available clinically because it was all a research study, so we didn’t intervene on any of the patients in this cohort. But we have started to think about whether or not we could use VEGF-A levels at least in our ... patients who might not have arterial access, and it might be difficult to survey them for CAV. I think in order to really understand the appropriate way to use it, we would need a larger study," he remarked.
Dr. Daly disclosed that he had no conflicts of interest relevant to the study.
AT THE 2014 WORLD TRANSPLANT CONGRESS
Key clinical point: Plasma VEGF-A levels may be a biomarker of risk for pediatric heart transplant patients.
Major finding: Patients with plasma VEGF-A levels above the median value of 90 pg/mL had a 32% rate of moderate or severe cardiac allograft vasculopathy within 5 years.
Data source: A prospective cohort study of 44 consecutive children who had undergone heart transplantation.
Disclosures: Dr. Daly disclosed no relevant conflicts of interest.
Open surgery for 34% of inpatient breast biopsies
Open breast biopsy accounted for 34% of breast biopsies in 25,965 U.S. inpatients between 2008 and 2010, a retrospective study found.
The finding suggests that minimally invasive breast biopsy techniques are underutilized, with a national rate that’s far off the widely acknowledge goal of having at least 90% of biopsies for suspicious breast lesions be minimally invasive, Dr. Linda Adepoju reported.
Most breast biopsies are performed in outpatient settings. Although the study analyzed a national data sample for hospitalized patients, the rate of open breast biopsy is consistent with previous studies of outpatient databases for individual institutions or states that have reported rates of open breast biopsy from 24% to 36%, noted Dr. Adepoju of the University of Toledo (Ohio).
She and her associates analyzed data from 46 states in the Healthcare Cost and Utilization Project National Inpatient Sample for 2008-2010, excluding 222 cases in which an open breast biopsy and minimally invasive breast biopsy were performed during the same hospital stay.
Open breast biopsy rates were significantly higher in women aged 49 years or younger (47%), compared with older women (29%), and in Asian women (40%) or Hispanic women (41%), compared with white women (34%) or black women (31%). Open breast biopsy also was significantly more likely in women who had private insurance than in women covered by Medicaid or Medicare – 41% vs. 31% (Am. J. Surg. 2014;208:382-90).
The type and location of hospital also was associated with open biopsy rates, with higher rates in small, private, rural, and/or nonteaching hospitals.
"Interventions targeting small, rural, and nonteaching hospitals could significantly decrease hospital costs and improve the overall quality of breast care," Dr. Adepoju and her associates commented, but "we must be sensitive" to the needs and limitations of various health care delivery settings, they added.
"A critical access hospital in rural Ohio may not be able to afford a mammographer and stereotactic equipment" for minimally invasive breast biopsy. Previous data "are clear that patients preferably seek their care in and near their community. Given workforce shortages and the current economic climate, this may mean accepting higher open breast biopsy rates in rural America," the investigators concluded.
Patients who had open breast biopsies in the current study were more likely to need more than one biopsy for diagnosis (1.2%), compared with women who had minimally invasive breast biopsies (0.5%). Hematoma drainage was needed in 1.4% of patients after open breast biopsy and 0.6% after minimally invasive biopsy. Open breast biopsy also was more expensive, based on analysis of data from the University of Toledo, averaging $1,700 in Medicare reimbursement, compared with $300-$1,100 for minimally invasive breast biopsy, depending on the specific procedure, Dr. Adepoju reported.
Previous data have shown that minimally invasive breast biopsies are less expensive, less scarring, require less recovery time, cause fewer complications, reduce the time between diagnosis and definitive treatment, produce fewer positive margins, and facilitate preoperative multidisciplinary treatment planning, compared with open breast biopsies.
The report from the third international consensus conference on image-detected breast cancer in 2009 called minimally invasive breast biopsy a best practice that should be the gold standard for initial diagnosis and proposed a goal of limiting open breast biopsy to 5%-10% of cases (J. Am. Coll. Surg. 2009;209:504-20).
Dr. Adepoju reported having no financial disclosures.
On Twitter @sherryboschert
The methodology of the study makes it impossible to know the overall national rates of breast biopsy techniques because the National Inpatient Sample data that the investigators analyzed capture only inpatient procedures, while most breast biopsies are done in outpatient settings, Dr. Taylor S. Riall said in an interview.
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The study may underestimate the national rate of minimally invasive breast biopsy because of that. Regardless, the true rate is likely below national goals of 90% of breast biopsies being done using minimally invasive methods, she said.
Because the National Inpatient Sample data represent single hospital stays that cannot be linked to show multiple admissions for individuals, it’s possible that some of the 34% of patients who had open breast biopsies previously underwent failed minimally invasive breast biopsies. "If minimally invasive breast biopsy was done first, then open biopsy, this is appropriate" in cases with failed (nondiagnostic) minimally invasive biopsies, she said.
The study looked at patient and hospital factors associated with biopsy rates but not at physician factors. "While there is geographic variation in the use of minimally invasive breast biopsy, there also is significant variation across physicians and facilities. Based on data we recently reviewed, I feel that physician practice and referral patterns are a major contributor to underuse of minimally invasive breast biopsy," Dr. Riall said.
"These practice patterns may be tied to reimbursement, lack of knowledge of the guidelines, access to minimally invasive breast biopsy facilities, or referral networks. Many surgeons may work in settings where mammography and biopsy are done before they even see a patient, whereas other surgeons may see patients before diagnosis and be responsible for this decision. Targeting interventions at the hospital and physician factors that are associated with low rates of minimally invasive breast biopsy can definitely improve outcomes," she added.
Organizational networks that are associated with low rates of minimally invasive breast biopsy should be assessed to find ways to increase those rates, Dr. Riall suggested. "Who do these patients see first? Do groups of physicians who refer to each other have practice patterns that violate the current recommendations?"
More in-depth analysis of racial disparities also is in order, she said. "Are these patients choosing open biopsy? If so, why? Or, alternatively, are they seeing physicians that exclusively or mostly do open biopsy? The answers to these questions will guide interventions to improve minimally invasive breast biopsy rates."
Dr. Taylor S. Riall is a professor of surgery and the John Sealy Distinguished Chair in Clinical Research at the University of Texas, Galveston. She reported having no financial disclosures.
The methodology of the study makes it impossible to know the overall national rates of breast biopsy techniques because the National Inpatient Sample data that the investigators analyzed capture only inpatient procedures, while most breast biopsies are done in outpatient settings, Dr. Taylor S. Riall said in an interview.
|
|
The study may underestimate the national rate of minimally invasive breast biopsy because of that. Regardless, the true rate is likely below national goals of 90% of breast biopsies being done using minimally invasive methods, she said.
Because the National Inpatient Sample data represent single hospital stays that cannot be linked to show multiple admissions for individuals, it’s possible that some of the 34% of patients who had open breast biopsies previously underwent failed minimally invasive breast biopsies. "If minimally invasive breast biopsy was done first, then open biopsy, this is appropriate" in cases with failed (nondiagnostic) minimally invasive biopsies, she said.
The study looked at patient and hospital factors associated with biopsy rates but not at physician factors. "While there is geographic variation in the use of minimally invasive breast biopsy, there also is significant variation across physicians and facilities. Based on data we recently reviewed, I feel that physician practice and referral patterns are a major contributor to underuse of minimally invasive breast biopsy," Dr. Riall said.
"These practice patterns may be tied to reimbursement, lack of knowledge of the guidelines, access to minimally invasive breast biopsy facilities, or referral networks. Many surgeons may work in settings where mammography and biopsy are done before they even see a patient, whereas other surgeons may see patients before diagnosis and be responsible for this decision. Targeting interventions at the hospital and physician factors that are associated with low rates of minimally invasive breast biopsy can definitely improve outcomes," she added.
Organizational networks that are associated with low rates of minimally invasive breast biopsy should be assessed to find ways to increase those rates, Dr. Riall suggested. "Who do these patients see first? Do groups of physicians who refer to each other have practice patterns that violate the current recommendations?"
More in-depth analysis of racial disparities also is in order, she said. "Are these patients choosing open biopsy? If so, why? Or, alternatively, are they seeing physicians that exclusively or mostly do open biopsy? The answers to these questions will guide interventions to improve minimally invasive breast biopsy rates."
Dr. Taylor S. Riall is a professor of surgery and the John Sealy Distinguished Chair in Clinical Research at the University of Texas, Galveston. She reported having no financial disclosures.
The methodology of the study makes it impossible to know the overall national rates of breast biopsy techniques because the National Inpatient Sample data that the investigators analyzed capture only inpatient procedures, while most breast biopsies are done in outpatient settings, Dr. Taylor S. Riall said in an interview.
|
|
The study may underestimate the national rate of minimally invasive breast biopsy because of that. Regardless, the true rate is likely below national goals of 90% of breast biopsies being done using minimally invasive methods, she said.
Because the National Inpatient Sample data represent single hospital stays that cannot be linked to show multiple admissions for individuals, it’s possible that some of the 34% of patients who had open breast biopsies previously underwent failed minimally invasive breast biopsies. "If minimally invasive breast biopsy was done first, then open biopsy, this is appropriate" in cases with failed (nondiagnostic) minimally invasive biopsies, she said.
The study looked at patient and hospital factors associated with biopsy rates but not at physician factors. "While there is geographic variation in the use of minimally invasive breast biopsy, there also is significant variation across physicians and facilities. Based on data we recently reviewed, I feel that physician practice and referral patterns are a major contributor to underuse of minimally invasive breast biopsy," Dr. Riall said.
"These practice patterns may be tied to reimbursement, lack of knowledge of the guidelines, access to minimally invasive breast biopsy facilities, or referral networks. Many surgeons may work in settings where mammography and biopsy are done before they even see a patient, whereas other surgeons may see patients before diagnosis and be responsible for this decision. Targeting interventions at the hospital and physician factors that are associated with low rates of minimally invasive breast biopsy can definitely improve outcomes," she added.
Organizational networks that are associated with low rates of minimally invasive breast biopsy should be assessed to find ways to increase those rates, Dr. Riall suggested. "Who do these patients see first? Do groups of physicians who refer to each other have practice patterns that violate the current recommendations?"
More in-depth analysis of racial disparities also is in order, she said. "Are these patients choosing open biopsy? If so, why? Or, alternatively, are they seeing physicians that exclusively or mostly do open biopsy? The answers to these questions will guide interventions to improve minimally invasive breast biopsy rates."
Dr. Taylor S. Riall is a professor of surgery and the John Sealy Distinguished Chair in Clinical Research at the University of Texas, Galveston. She reported having no financial disclosures.
Open breast biopsy accounted for 34% of breast biopsies in 25,965 U.S. inpatients between 2008 and 2010, a retrospective study found.
The finding suggests that minimally invasive breast biopsy techniques are underutilized, with a national rate that’s far off the widely acknowledge goal of having at least 90% of biopsies for suspicious breast lesions be minimally invasive, Dr. Linda Adepoju reported.
Most breast biopsies are performed in outpatient settings. Although the study analyzed a national data sample for hospitalized patients, the rate of open breast biopsy is consistent with previous studies of outpatient databases for individual institutions or states that have reported rates of open breast biopsy from 24% to 36%, noted Dr. Adepoju of the University of Toledo (Ohio).
She and her associates analyzed data from 46 states in the Healthcare Cost and Utilization Project National Inpatient Sample for 2008-2010, excluding 222 cases in which an open breast biopsy and minimally invasive breast biopsy were performed during the same hospital stay.
Open breast biopsy rates were significantly higher in women aged 49 years or younger (47%), compared with older women (29%), and in Asian women (40%) or Hispanic women (41%), compared with white women (34%) or black women (31%). Open breast biopsy also was significantly more likely in women who had private insurance than in women covered by Medicaid or Medicare – 41% vs. 31% (Am. J. Surg. 2014;208:382-90).
The type and location of hospital also was associated with open biopsy rates, with higher rates in small, private, rural, and/or nonteaching hospitals.
"Interventions targeting small, rural, and nonteaching hospitals could significantly decrease hospital costs and improve the overall quality of breast care," Dr. Adepoju and her associates commented, but "we must be sensitive" to the needs and limitations of various health care delivery settings, they added.
"A critical access hospital in rural Ohio may not be able to afford a mammographer and stereotactic equipment" for minimally invasive breast biopsy. Previous data "are clear that patients preferably seek their care in and near their community. Given workforce shortages and the current economic climate, this may mean accepting higher open breast biopsy rates in rural America," the investigators concluded.
Patients who had open breast biopsies in the current study were more likely to need more than one biopsy for diagnosis (1.2%), compared with women who had minimally invasive breast biopsies (0.5%). Hematoma drainage was needed in 1.4% of patients after open breast biopsy and 0.6% after minimally invasive biopsy. Open breast biopsy also was more expensive, based on analysis of data from the University of Toledo, averaging $1,700 in Medicare reimbursement, compared with $300-$1,100 for minimally invasive breast biopsy, depending on the specific procedure, Dr. Adepoju reported.
Previous data have shown that minimally invasive breast biopsies are less expensive, less scarring, require less recovery time, cause fewer complications, reduce the time between diagnosis and definitive treatment, produce fewer positive margins, and facilitate preoperative multidisciplinary treatment planning, compared with open breast biopsies.
The report from the third international consensus conference on image-detected breast cancer in 2009 called minimally invasive breast biopsy a best practice that should be the gold standard for initial diagnosis and proposed a goal of limiting open breast biopsy to 5%-10% of cases (J. Am. Coll. Surg. 2009;209:504-20).
Dr. Adepoju reported having no financial disclosures.
On Twitter @sherryboschert
Open breast biopsy accounted for 34% of breast biopsies in 25,965 U.S. inpatients between 2008 and 2010, a retrospective study found.
The finding suggests that minimally invasive breast biopsy techniques are underutilized, with a national rate that’s far off the widely acknowledge goal of having at least 90% of biopsies for suspicious breast lesions be minimally invasive, Dr. Linda Adepoju reported.
Most breast biopsies are performed in outpatient settings. Although the study analyzed a national data sample for hospitalized patients, the rate of open breast biopsy is consistent with previous studies of outpatient databases for individual institutions or states that have reported rates of open breast biopsy from 24% to 36%, noted Dr. Adepoju of the University of Toledo (Ohio).
She and her associates analyzed data from 46 states in the Healthcare Cost and Utilization Project National Inpatient Sample for 2008-2010, excluding 222 cases in which an open breast biopsy and minimally invasive breast biopsy were performed during the same hospital stay.
Open breast biopsy rates were significantly higher in women aged 49 years or younger (47%), compared with older women (29%), and in Asian women (40%) or Hispanic women (41%), compared with white women (34%) or black women (31%). Open breast biopsy also was significantly more likely in women who had private insurance than in women covered by Medicaid or Medicare – 41% vs. 31% (Am. J. Surg. 2014;208:382-90).
The type and location of hospital also was associated with open biopsy rates, with higher rates in small, private, rural, and/or nonteaching hospitals.
"Interventions targeting small, rural, and nonteaching hospitals could significantly decrease hospital costs and improve the overall quality of breast care," Dr. Adepoju and her associates commented, but "we must be sensitive" to the needs and limitations of various health care delivery settings, they added.
"A critical access hospital in rural Ohio may not be able to afford a mammographer and stereotactic equipment" for minimally invasive breast biopsy. Previous data "are clear that patients preferably seek their care in and near their community. Given workforce shortages and the current economic climate, this may mean accepting higher open breast biopsy rates in rural America," the investigators concluded.
Patients who had open breast biopsies in the current study were more likely to need more than one biopsy for diagnosis (1.2%), compared with women who had minimally invasive breast biopsies (0.5%). Hematoma drainage was needed in 1.4% of patients after open breast biopsy and 0.6% after minimally invasive biopsy. Open breast biopsy also was more expensive, based on analysis of data from the University of Toledo, averaging $1,700 in Medicare reimbursement, compared with $300-$1,100 for minimally invasive breast biopsy, depending on the specific procedure, Dr. Adepoju reported.
Previous data have shown that minimally invasive breast biopsies are less expensive, less scarring, require less recovery time, cause fewer complications, reduce the time between diagnosis and definitive treatment, produce fewer positive margins, and facilitate preoperative multidisciplinary treatment planning, compared with open breast biopsies.
The report from the third international consensus conference on image-detected breast cancer in 2009 called minimally invasive breast biopsy a best practice that should be the gold standard for initial diagnosis and proposed a goal of limiting open breast biopsy to 5%-10% of cases (J. Am. Coll. Surg. 2009;209:504-20).
Dr. Adepoju reported having no financial disclosures.
On Twitter @sherryboschert
FROM THE AMERICAN JOURNAL OF SURGERY
Key clinical point: Inpatient breast biopsies may underemploy minimally invasive techniques.
Major finding: Open breast biopsies comprised 34% of breast biopsies.
Data source: Retrospective analysis of National Inpatient Sample data on 25,965 women who underwent breast biopsy in 2008-2010.
Disclosures: Dr. Adepoju reported having no financial disclosures.
Health care faces a long, bumpy ride
CHICAGO – Health care is going to change more in this decade than in the past 45 years, according to health futurist and medical economist Jeffrey Bauer, Ph.D.
"We’re going to go through an incredible period of disequilibrium and readjustment," he said in a plenary session at the American Academy of Dermatology summer meeting. "It’s going to be several years of real ups and downs."
Dr. Bauer’s forecast for 2015 through 2019 is far less bullish than most, giving just a 20% chance that national health spending will increase as a percentage of gross domestic product. The potential for stagnation is 35% and for decline is 45%.
Over the same time period, 35% of health care providers will cease to exist as currently organized, 40% will continue as organized, although precariously, and 25% will thrive by reinventing the way health care is delivered, said the nationally recognized author and management consultant.
Dr. Bauer made the following recommendations for improving the odds of success in the changing health care system:
• Manage the transition in core function from acute care to disease management.
The one-size-fits-all clinical paradigm is fast disappearing as a result of the ongoing revolution in medical science that is making medicine more precise. Cost-effective care will be achieved through personalized, preventive medicine that matches therapies to each patient’s specific disease characteristics.
• Those who build care teams will do better.
The site of care will continue to shift from hospital to clinic, pharmacy, worksite, and home, and care teams that extend physicians’ reach with nonphysician practitioners will become the best-practices delivery model. "The real key, if you want to be the 40% that survives or the 25% that thrives, is to recognize the value of care teams," Dr. Bauer said.
• Physicians need to position themselves to transition from fee-for-service reimbursement to bundled and value-based payment.
Patients simply don’t have the disposable income to pay more for care, forcing providers to rationalize pricing. Embrace the concept that future successes will be based on multi-stakeholder partnerships comprised of purchasers, payers, practitioners, and providers.
• Work to reform how health care is delivered.
"It’s important that we reform health care delivery so that people can get to you when they need to, but I am just as fervently of the belief that the Affordable Care Act doesn’t do that," he said. "We’ve got to find another way there."
Many of the tools needed to fix the way health care is delivered are already in physicians’ hands. They include advocacy through professional societies, utilization of advanced data analytics to demonstrate value and eliminate unexplained variation from objective performance standards, and adoption of performance improvement tools such as Six Sigma or Lean to ensure that care is delivered correctly all the time and as inexpensively as possible.
Dr. Bauer disclosed no conflicts of interest. He is the author of the just-released book: "Paradox and Imperatives in Health Care: Redirecting Reform for Efficiency and Effectiveness" (CRC Press, 2014).
CHICAGO – Health care is going to change more in this decade than in the past 45 years, according to health futurist and medical economist Jeffrey Bauer, Ph.D.
"We’re going to go through an incredible period of disequilibrium and readjustment," he said in a plenary session at the American Academy of Dermatology summer meeting. "It’s going to be several years of real ups and downs."
Dr. Bauer’s forecast for 2015 through 2019 is far less bullish than most, giving just a 20% chance that national health spending will increase as a percentage of gross domestic product. The potential for stagnation is 35% and for decline is 45%.
Over the same time period, 35% of health care providers will cease to exist as currently organized, 40% will continue as organized, although precariously, and 25% will thrive by reinventing the way health care is delivered, said the nationally recognized author and management consultant.
Dr. Bauer made the following recommendations for improving the odds of success in the changing health care system:
• Manage the transition in core function from acute care to disease management.
The one-size-fits-all clinical paradigm is fast disappearing as a result of the ongoing revolution in medical science that is making medicine more precise. Cost-effective care will be achieved through personalized, preventive medicine that matches therapies to each patient’s specific disease characteristics.
• Those who build care teams will do better.
The site of care will continue to shift from hospital to clinic, pharmacy, worksite, and home, and care teams that extend physicians’ reach with nonphysician practitioners will become the best-practices delivery model. "The real key, if you want to be the 40% that survives or the 25% that thrives, is to recognize the value of care teams," Dr. Bauer said.
• Physicians need to position themselves to transition from fee-for-service reimbursement to bundled and value-based payment.
Patients simply don’t have the disposable income to pay more for care, forcing providers to rationalize pricing. Embrace the concept that future successes will be based on multi-stakeholder partnerships comprised of purchasers, payers, practitioners, and providers.
• Work to reform how health care is delivered.
"It’s important that we reform health care delivery so that people can get to you when they need to, but I am just as fervently of the belief that the Affordable Care Act doesn’t do that," he said. "We’ve got to find another way there."
Many of the tools needed to fix the way health care is delivered are already in physicians’ hands. They include advocacy through professional societies, utilization of advanced data analytics to demonstrate value and eliminate unexplained variation from objective performance standards, and adoption of performance improvement tools such as Six Sigma or Lean to ensure that care is delivered correctly all the time and as inexpensively as possible.
Dr. Bauer disclosed no conflicts of interest. He is the author of the just-released book: "Paradox and Imperatives in Health Care: Redirecting Reform for Efficiency and Effectiveness" (CRC Press, 2014).
CHICAGO – Health care is going to change more in this decade than in the past 45 years, according to health futurist and medical economist Jeffrey Bauer, Ph.D.
"We’re going to go through an incredible period of disequilibrium and readjustment," he said in a plenary session at the American Academy of Dermatology summer meeting. "It’s going to be several years of real ups and downs."
Dr. Bauer’s forecast for 2015 through 2019 is far less bullish than most, giving just a 20% chance that national health spending will increase as a percentage of gross domestic product. The potential for stagnation is 35% and for decline is 45%.
Over the same time period, 35% of health care providers will cease to exist as currently organized, 40% will continue as organized, although precariously, and 25% will thrive by reinventing the way health care is delivered, said the nationally recognized author and management consultant.
Dr. Bauer made the following recommendations for improving the odds of success in the changing health care system:
• Manage the transition in core function from acute care to disease management.
The one-size-fits-all clinical paradigm is fast disappearing as a result of the ongoing revolution in medical science that is making medicine more precise. Cost-effective care will be achieved through personalized, preventive medicine that matches therapies to each patient’s specific disease characteristics.
• Those who build care teams will do better.
The site of care will continue to shift from hospital to clinic, pharmacy, worksite, and home, and care teams that extend physicians’ reach with nonphysician practitioners will become the best-practices delivery model. "The real key, if you want to be the 40% that survives or the 25% that thrives, is to recognize the value of care teams," Dr. Bauer said.
• Physicians need to position themselves to transition from fee-for-service reimbursement to bundled and value-based payment.
Patients simply don’t have the disposable income to pay more for care, forcing providers to rationalize pricing. Embrace the concept that future successes will be based on multi-stakeholder partnerships comprised of purchasers, payers, practitioners, and providers.
• Work to reform how health care is delivered.
"It’s important that we reform health care delivery so that people can get to you when they need to, but I am just as fervently of the belief that the Affordable Care Act doesn’t do that," he said. "We’ve got to find another way there."
Many of the tools needed to fix the way health care is delivered are already in physicians’ hands. They include advocacy through professional societies, utilization of advanced data analytics to demonstrate value and eliminate unexplained variation from objective performance standards, and adoption of performance improvement tools such as Six Sigma or Lean to ensure that care is delivered correctly all the time and as inexpensively as possible.
Dr. Bauer disclosed no conflicts of interest. He is the author of the just-released book: "Paradox and Imperatives in Health Care: Redirecting Reform for Efficiency and Effectiveness" (CRC Press, 2014).
EXPERT OPINION FROM THE AAD SUMMER ACADEMY 2014
Successful bariatric surgery also may improve urinary incontinence
WASHINGTON – The majority of obese women who had urinary incontinence before bariatric surgery had complete or near-complete resolution of symptoms for up to 3 years after surgery in a study of more than 1,500 women, Dr. Leslee Subak reported at the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association.
These results indicate that "improvement in incontinence may be another long-term benefit of weight loss, in this case surgical weight loss," said Dr. Subak, professor of obstetrics and gynecology and reproductive sciences, epidemiology and biostatistics, and urology at the University of California, San Francisco.
The study evaluated the effect of surgery on urinary incontinence in 1,565 severely obese women who were part of the multicenter Longitudinal Cohort Study of Bariatric Surgery-2 and had completed self-administered questionnaires about urinary incontinence episodes before surgery and at one or more annual follow-up assessments within 3 years of surgery.
The results were based on outcomes of the 772 women who reported experiencing episodes of incontinence at least weekly, with an average of about 11 incontinence episodes per week. Their median age was 46 years and most were white; about 7% had undergone previous incontinence surgery and about 8% had received or were receiving behavioral treatment or medication for incontinence.
Most of the patients underwent a Roux-en-Y gastric bypass (71%) or laparoscopic adjustable gastric banding (25%). After the first year, they had lost a median of about 30% of their baseline weight, which was maintained through the third year.
At all follow-up times after surgery, there were significantly fewer incontinence episodes, compared with baseline, with a remission rate of 60%-65%, Dr. Subak said.
Urinary incontinence episodes dropped from an average of about 11 episodes per week before surgery to an average of almost 3 episodes per week at 1 year and 4 episodes per week at 2 and 3 years, she noted. Episodes of stress incontinence also decreased from an average of about 5 episodes per week at baseline to about 1 episode per week at 1 year and almost 2 episodes per week at 2 and 3 years.
The remission rate – defined as less than 1 weekly urinary incontinence episode over the past 3 months – was 70% at 1 year, dropping to and stabilizing at about 61%-62% at 2 and 3 years. Moreover, 25% of the women had a complete remission (no episodes of incontinence during the past 3 months) at 3 years, a slight increase from almost 27% at 1 year, Dr. Subak said.
"The magnitude of weight loss was the strongest predictor of improvement in incontinence over time," she noted. "Incontinence and BMI [body mass index] seemed to track together, as [whenever] there’s a reduction in BMI ... there’s a reduction in urinary incontinence episode frequency."
A younger age also was significantly associated with a reduction in the frequency or a remission of urinary incontinence, while being pregnant in the previous year and having had a hysterectomy were associated with a lower likelihood of having a remission.
Dr. Subak noted that limitations of the study included the observational design and the lack of a control group, as well as the fact that data were based on self-reports.
She referred to urinary incontinence and obesity as "twin epidemics," with about a fourfold increased risk of urinary incontinence associated with obesity. About one-third of women in the United States are obese and about 70% of women with incontinence are obese, she pointed out.
The Longitudinal Cohort Study of Bariatric Surgery-2 is funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Subak received additional funding from the NIDDK; she had no other disclosures.
WASHINGTON – The majority of obese women who had urinary incontinence before bariatric surgery had complete or near-complete resolution of symptoms for up to 3 years after surgery in a study of more than 1,500 women, Dr. Leslee Subak reported at the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association.
These results indicate that "improvement in incontinence may be another long-term benefit of weight loss, in this case surgical weight loss," said Dr. Subak, professor of obstetrics and gynecology and reproductive sciences, epidemiology and biostatistics, and urology at the University of California, San Francisco.
The study evaluated the effect of surgery on urinary incontinence in 1,565 severely obese women who were part of the multicenter Longitudinal Cohort Study of Bariatric Surgery-2 and had completed self-administered questionnaires about urinary incontinence episodes before surgery and at one or more annual follow-up assessments within 3 years of surgery.
The results were based on outcomes of the 772 women who reported experiencing episodes of incontinence at least weekly, with an average of about 11 incontinence episodes per week. Their median age was 46 years and most were white; about 7% had undergone previous incontinence surgery and about 8% had received or were receiving behavioral treatment or medication for incontinence.
Most of the patients underwent a Roux-en-Y gastric bypass (71%) or laparoscopic adjustable gastric banding (25%). After the first year, they had lost a median of about 30% of their baseline weight, which was maintained through the third year.
At all follow-up times after surgery, there were significantly fewer incontinence episodes, compared with baseline, with a remission rate of 60%-65%, Dr. Subak said.
Urinary incontinence episodes dropped from an average of about 11 episodes per week before surgery to an average of almost 3 episodes per week at 1 year and 4 episodes per week at 2 and 3 years, she noted. Episodes of stress incontinence also decreased from an average of about 5 episodes per week at baseline to about 1 episode per week at 1 year and almost 2 episodes per week at 2 and 3 years.
The remission rate – defined as less than 1 weekly urinary incontinence episode over the past 3 months – was 70% at 1 year, dropping to and stabilizing at about 61%-62% at 2 and 3 years. Moreover, 25% of the women had a complete remission (no episodes of incontinence during the past 3 months) at 3 years, a slight increase from almost 27% at 1 year, Dr. Subak said.
"The magnitude of weight loss was the strongest predictor of improvement in incontinence over time," she noted. "Incontinence and BMI [body mass index] seemed to track together, as [whenever] there’s a reduction in BMI ... there’s a reduction in urinary incontinence episode frequency."
A younger age also was significantly associated with a reduction in the frequency or a remission of urinary incontinence, while being pregnant in the previous year and having had a hysterectomy were associated with a lower likelihood of having a remission.
Dr. Subak noted that limitations of the study included the observational design and the lack of a control group, as well as the fact that data were based on self-reports.
She referred to urinary incontinence and obesity as "twin epidemics," with about a fourfold increased risk of urinary incontinence associated with obesity. About one-third of women in the United States are obese and about 70% of women with incontinence are obese, she pointed out.
The Longitudinal Cohort Study of Bariatric Surgery-2 is funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Subak received additional funding from the NIDDK; she had no other disclosures.
WASHINGTON – The majority of obese women who had urinary incontinence before bariatric surgery had complete or near-complete resolution of symptoms for up to 3 years after surgery in a study of more than 1,500 women, Dr. Leslee Subak reported at the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association.
These results indicate that "improvement in incontinence may be another long-term benefit of weight loss, in this case surgical weight loss," said Dr. Subak, professor of obstetrics and gynecology and reproductive sciences, epidemiology and biostatistics, and urology at the University of California, San Francisco.
The study evaluated the effect of surgery on urinary incontinence in 1,565 severely obese women who were part of the multicenter Longitudinal Cohort Study of Bariatric Surgery-2 and had completed self-administered questionnaires about urinary incontinence episodes before surgery and at one or more annual follow-up assessments within 3 years of surgery.
The results were based on outcomes of the 772 women who reported experiencing episodes of incontinence at least weekly, with an average of about 11 incontinence episodes per week. Their median age was 46 years and most were white; about 7% had undergone previous incontinence surgery and about 8% had received or were receiving behavioral treatment or medication for incontinence.
Most of the patients underwent a Roux-en-Y gastric bypass (71%) or laparoscopic adjustable gastric banding (25%). After the first year, they had lost a median of about 30% of their baseline weight, which was maintained through the third year.
At all follow-up times after surgery, there were significantly fewer incontinence episodes, compared with baseline, with a remission rate of 60%-65%, Dr. Subak said.
Urinary incontinence episodes dropped from an average of about 11 episodes per week before surgery to an average of almost 3 episodes per week at 1 year and 4 episodes per week at 2 and 3 years, she noted. Episodes of stress incontinence also decreased from an average of about 5 episodes per week at baseline to about 1 episode per week at 1 year and almost 2 episodes per week at 2 and 3 years.
The remission rate – defined as less than 1 weekly urinary incontinence episode over the past 3 months – was 70% at 1 year, dropping to and stabilizing at about 61%-62% at 2 and 3 years. Moreover, 25% of the women had a complete remission (no episodes of incontinence during the past 3 months) at 3 years, a slight increase from almost 27% at 1 year, Dr. Subak said.
"The magnitude of weight loss was the strongest predictor of improvement in incontinence over time," she noted. "Incontinence and BMI [body mass index] seemed to track together, as [whenever] there’s a reduction in BMI ... there’s a reduction in urinary incontinence episode frequency."
A younger age also was significantly associated with a reduction in the frequency or a remission of urinary incontinence, while being pregnant in the previous year and having had a hysterectomy were associated with a lower likelihood of having a remission.
Dr. Subak noted that limitations of the study included the observational design and the lack of a control group, as well as the fact that data were based on self-reports.
She referred to urinary incontinence and obesity as "twin epidemics," with about a fourfold increased risk of urinary incontinence associated with obesity. About one-third of women in the United States are obese and about 70% of women with incontinence are obese, she pointed out.
The Longitudinal Cohort Study of Bariatric Surgery-2 is funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Subak received additional funding from the NIDDK; she had no other disclosures.
AT AUGS/IUGA 2014
Key clinical point: Obese women who report urinary incontinence may experience improvement or even resolution of symptoms after bariatric surgery.
Major finding: About one-quarter of the 772 severely obese women who reported having urinary incontinence before undergoing bariatric surgery had complete remission of urinary incontinence 3 years after surgery.
Data source: The frequency of urinary incontinence symptoms at baseline and for up to 3 years after bariatric surgery was evaluated in a substudy of 1,565 severely obese women who were enrolled in a multicenter, longitudinal cohort study based on self-administered questionnaires.
Disclosures: The Longitudinal Cohort Study of Bariatric Surgery-2 is funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Subak received additional funding from the NIDDK; she had no other disclosures.
HHS appoints chief executive to run healthcare.gov
The U.S. Department of Health & Human Services has named a new chief executive officer to run the federal marketplace, which includes the healthcare.gov website.
Kevin Counihan, currently the CEO for Connecticut’s marketplace, has been named to run the federal marketplace. He also will be in charge of the Center for Consumer Information and Insurance Oversight (CCIIO), which regulates health insurance. HHS Secretary Sylvia Mathews Burwell announced in June that the department would be looking for a new CEO.
Mr. Counihan has served as CEO for Health Access CT since June 2012, after having served as chief marketing officer from 2006 to 2011 for the Commonwealth of Massachusetts Health Insurance Connector Authority, which administered that state’s health insurance exchange. Before that, he was a sales and marketing executive for Tufts Health Plan of Massachusetts and regional vice president for CIGNA.
"We are committed to instilling ongoing accountability for reaching milestones, measuring results, and ensuring a successful open enrollment period," Ms. Burwell said in a statement. Mr. Counihan "brings additional operational and technological expertise to the position and will be a clear, single point of contact for streamlined decision making."
Mr. Counihan will report to Centers for Medicare & Medicaid Services Administrator Marilyn Tavenner.
On Twitter @aliciaault
The U.S. Department of Health & Human Services has named a new chief executive officer to run the federal marketplace, which includes the healthcare.gov website.
Kevin Counihan, currently the CEO for Connecticut’s marketplace, has been named to run the federal marketplace. He also will be in charge of the Center for Consumer Information and Insurance Oversight (CCIIO), which regulates health insurance. HHS Secretary Sylvia Mathews Burwell announced in June that the department would be looking for a new CEO.
Mr. Counihan has served as CEO for Health Access CT since June 2012, after having served as chief marketing officer from 2006 to 2011 for the Commonwealth of Massachusetts Health Insurance Connector Authority, which administered that state’s health insurance exchange. Before that, he was a sales and marketing executive for Tufts Health Plan of Massachusetts and regional vice president for CIGNA.
"We are committed to instilling ongoing accountability for reaching milestones, measuring results, and ensuring a successful open enrollment period," Ms. Burwell said in a statement. Mr. Counihan "brings additional operational and technological expertise to the position and will be a clear, single point of contact for streamlined decision making."
Mr. Counihan will report to Centers for Medicare & Medicaid Services Administrator Marilyn Tavenner.
On Twitter @aliciaault
The U.S. Department of Health & Human Services has named a new chief executive officer to run the federal marketplace, which includes the healthcare.gov website.
Kevin Counihan, currently the CEO for Connecticut’s marketplace, has been named to run the federal marketplace. He also will be in charge of the Center for Consumer Information and Insurance Oversight (CCIIO), which regulates health insurance. HHS Secretary Sylvia Mathews Burwell announced in June that the department would be looking for a new CEO.
Mr. Counihan has served as CEO for Health Access CT since June 2012, after having served as chief marketing officer from 2006 to 2011 for the Commonwealth of Massachusetts Health Insurance Connector Authority, which administered that state’s health insurance exchange. Before that, he was a sales and marketing executive for Tufts Health Plan of Massachusetts and regional vice president for CIGNA.
"We are committed to instilling ongoing accountability for reaching milestones, measuring results, and ensuring a successful open enrollment period," Ms. Burwell said in a statement. Mr. Counihan "brings additional operational and technological expertise to the position and will be a clear, single point of contact for streamlined decision making."
Mr. Counihan will report to Centers for Medicare & Medicaid Services Administrator Marilyn Tavenner.
On Twitter @aliciaault
Study outlines risk factors for solid organ cancers after liver transplantation
SAN FRANCISCO – The indication for liver transplant, the selection of immunosuppression therapy, and smoking status influence the long-term risk of new solid organ malignancies after liver transplantation, Dr. Sebastian Rademacher reported at the 2014 World Transplant Congress.
Multivariate analysis showed that recipients’ risk of a new solid organ cancer was elevated for those who had a history of smoking (1.89). Risk was reduced for recipients who received tacrolimus, compared with cyclosporine A (0.56), and for patients who had primary biliary cirrhosis/primary sclerosing cholangitis (0.47) or hepatitis C infection (0.21) as the indication for transplantation.
"I think we have to reoptimize and reevaluate the currently used immunosuppressive regimens," Dr. Rademacher said. "We have to adapt cancer surveillance programs for high-risk patients. Further studies into surveillance protocols and surrogate markers and long-term outcomes are recommended."
Researchers led by Dr. Rademacher, a surgeon at the Campus Virchow Clinic, Charité, Berlin, retrospectively studied 1,179 consecutive adults who underwent liver transplantation between 1988 and 2002 and had follow-up evaluations until 2013. Patients were 47 years old, on average, at the time of transplantation, and the median follow-up was 13.3 years.
Their 20-year cumulative incidence of solid organ cancers was 14%, he reported at the congress, which was sponsored by the American Society of Transplant Surgeons. The mean age at cancer diagnosis was 56 years.
The researchers used age- and sex-matched individuals from the German general population for comparison. The standardized incidence ratio in transplant recipients was 1.2 for breast cancer, 9.4 for cancer of the oropharynx and larynx, 1.7 for cancers of the colon and rectum, 3.0 for lung cancer, 3.9 for esophageal and stomach cancers, 4.5 for kidney and bladder cancers, and 4.6 for cancers of the female genitourinary system.
"We tried to evaluate the different immunosuppressive regimens and, over time, we had, I think, 27 different primary regimens," Dr. Rademacher said. Steroid-free regimens and low-dose steroid were part of that consideration, "but we segregated them out. For the five most frequent regimens, there was no significance. We assessed immunosuppressive regimens given over at least 2 years, but there was no difference between the regimens. Also, the trough levels of tacrolimus did not have any significant influence," he said.
The investigators did not have data on cumulative immunosuppression or mTOR [mammalian target of rapamycin] inhibitors, which were introduced late in the study period, according to Dr. Rademacher, who disclosed no relevant conflicts of interest. A surrogate marker of immunosuppression, rejection frequency, did not significantly predict the development of solid organ malignancies.
The devil is in the details of this study. The incidence of solid organ tumors being high in the immunosuppressed population is well known, well documented. The difficulty is getting at what is driving that risk.
Lots of things have changed in immunosuppressive therapy over the last 20-25-years. The authors give us a snapshot, but they weren’t able to tell us whether the changes in immunosuppression had any impact on cancer risk, especially in regard to specific types of cancers.
Dr. Darius Mirza of the University of Birmingham, England, was the session cochair at the meeting. He made his remarks in an interview after the session and declared having no relevant conflicts of interest.
The devil is in the details of this study. The incidence of solid organ tumors being high in the immunosuppressed population is well known, well documented. The difficulty is getting at what is driving that risk.
Lots of things have changed in immunosuppressive therapy over the last 20-25-years. The authors give us a snapshot, but they weren’t able to tell us whether the changes in immunosuppression had any impact on cancer risk, especially in regard to specific types of cancers.
Dr. Darius Mirza of the University of Birmingham, England, was the session cochair at the meeting. He made his remarks in an interview after the session and declared having no relevant conflicts of interest.
The devil is in the details of this study. The incidence of solid organ tumors being high in the immunosuppressed population is well known, well documented. The difficulty is getting at what is driving that risk.
Lots of things have changed in immunosuppressive therapy over the last 20-25-years. The authors give us a snapshot, but they weren’t able to tell us whether the changes in immunosuppression had any impact on cancer risk, especially in regard to specific types of cancers.
Dr. Darius Mirza of the University of Birmingham, England, was the session cochair at the meeting. He made his remarks in an interview after the session and declared having no relevant conflicts of interest.
SAN FRANCISCO – The indication for liver transplant, the selection of immunosuppression therapy, and smoking status influence the long-term risk of new solid organ malignancies after liver transplantation, Dr. Sebastian Rademacher reported at the 2014 World Transplant Congress.
Multivariate analysis showed that recipients’ risk of a new solid organ cancer was elevated for those who had a history of smoking (1.89). Risk was reduced for recipients who received tacrolimus, compared with cyclosporine A (0.56), and for patients who had primary biliary cirrhosis/primary sclerosing cholangitis (0.47) or hepatitis C infection (0.21) as the indication for transplantation.
"I think we have to reoptimize and reevaluate the currently used immunosuppressive regimens," Dr. Rademacher said. "We have to adapt cancer surveillance programs for high-risk patients. Further studies into surveillance protocols and surrogate markers and long-term outcomes are recommended."
Researchers led by Dr. Rademacher, a surgeon at the Campus Virchow Clinic, Charité, Berlin, retrospectively studied 1,179 consecutive adults who underwent liver transplantation between 1988 and 2002 and had follow-up evaluations until 2013. Patients were 47 years old, on average, at the time of transplantation, and the median follow-up was 13.3 years.
Their 20-year cumulative incidence of solid organ cancers was 14%, he reported at the congress, which was sponsored by the American Society of Transplant Surgeons. The mean age at cancer diagnosis was 56 years.
The researchers used age- and sex-matched individuals from the German general population for comparison. The standardized incidence ratio in transplant recipients was 1.2 for breast cancer, 9.4 for cancer of the oropharynx and larynx, 1.7 for cancers of the colon and rectum, 3.0 for lung cancer, 3.9 for esophageal and stomach cancers, 4.5 for kidney and bladder cancers, and 4.6 for cancers of the female genitourinary system.
"We tried to evaluate the different immunosuppressive regimens and, over time, we had, I think, 27 different primary regimens," Dr. Rademacher said. Steroid-free regimens and low-dose steroid were part of that consideration, "but we segregated them out. For the five most frequent regimens, there was no significance. We assessed immunosuppressive regimens given over at least 2 years, but there was no difference between the regimens. Also, the trough levels of tacrolimus did not have any significant influence," he said.
The investigators did not have data on cumulative immunosuppression or mTOR [mammalian target of rapamycin] inhibitors, which were introduced late in the study period, according to Dr. Rademacher, who disclosed no relevant conflicts of interest. A surrogate marker of immunosuppression, rejection frequency, did not significantly predict the development of solid organ malignancies.
SAN FRANCISCO – The indication for liver transplant, the selection of immunosuppression therapy, and smoking status influence the long-term risk of new solid organ malignancies after liver transplantation, Dr. Sebastian Rademacher reported at the 2014 World Transplant Congress.
Multivariate analysis showed that recipients’ risk of a new solid organ cancer was elevated for those who had a history of smoking (1.89). Risk was reduced for recipients who received tacrolimus, compared with cyclosporine A (0.56), and for patients who had primary biliary cirrhosis/primary sclerosing cholangitis (0.47) or hepatitis C infection (0.21) as the indication for transplantation.
"I think we have to reoptimize and reevaluate the currently used immunosuppressive regimens," Dr. Rademacher said. "We have to adapt cancer surveillance programs for high-risk patients. Further studies into surveillance protocols and surrogate markers and long-term outcomes are recommended."
Researchers led by Dr. Rademacher, a surgeon at the Campus Virchow Clinic, Charité, Berlin, retrospectively studied 1,179 consecutive adults who underwent liver transplantation between 1988 and 2002 and had follow-up evaluations until 2013. Patients were 47 years old, on average, at the time of transplantation, and the median follow-up was 13.3 years.
Their 20-year cumulative incidence of solid organ cancers was 14%, he reported at the congress, which was sponsored by the American Society of Transplant Surgeons. The mean age at cancer diagnosis was 56 years.
The researchers used age- and sex-matched individuals from the German general population for comparison. The standardized incidence ratio in transplant recipients was 1.2 for breast cancer, 9.4 for cancer of the oropharynx and larynx, 1.7 for cancers of the colon and rectum, 3.0 for lung cancer, 3.9 for esophageal and stomach cancers, 4.5 for kidney and bladder cancers, and 4.6 for cancers of the female genitourinary system.
"We tried to evaluate the different immunosuppressive regimens and, over time, we had, I think, 27 different primary regimens," Dr. Rademacher said. Steroid-free regimens and low-dose steroid were part of that consideration, "but we segregated them out. For the five most frequent regimens, there was no significance. We assessed immunosuppressive regimens given over at least 2 years, but there was no difference between the regimens. Also, the trough levels of tacrolimus did not have any significant influence," he said.
The investigators did not have data on cumulative immunosuppression or mTOR [mammalian target of rapamycin] inhibitors, which were introduced late in the study period, according to Dr. Rademacher, who disclosed no relevant conflicts of interest. A surrogate marker of immunosuppression, rejection frequency, did not significantly predict the development of solid organ malignancies.
AT THE 2014 WORLD TRANSPLANT CONGRESS
Key clinical point: Immunosuppression regimen selection influences risk for solid cancers after liver transplantation.
Major Finding: Risk of a new solid organ cancer was reduced for liver transplant recipients who got tacrolimus, compared with cyclosporine A (0.56), for their immunosuppression regimen.
Data Source: A retrospective cohort study of 1,179 adults who underwent liver transplantation between 1988 and 2002
Disclosures: Dr. Rademacher disclosed no relevant conflicts of interest.
Early elimination of cyclosporine after heart transplant has renal benefit
SAN FRANCISCO – Use of an everolimus-containing regimen with early stopping of cyclosporine after de novo heart transplantation improves renal function and reduces cardiac allograft vasculopathy, without compromising graft outcomes, new data suggest.
These was among key findings of the randomized, open-label SCHEDULE (Scandinavian Heart Transplant Everolimus De Novo Study with Early Calcineurin Inhibitor Avoidance) reported at the 2014 World Transplant Congress.
"Renal dysfunction and cardiac allograft vasculopathy are markers for increased morbidity and mortality after heart transplantation," lead author Dr. Vilborg Sigurdardottir commented when introducing the study.
Patients in the trial were randomized evenly to a three-drug regimen containing the calcineurin inhibitor cyclosporine (Sandimmune) or to a four-drug regimen also containing the mTOR inhibitor everolimus (Zortress) with discontinuation of cyclosporine at week 7-11. Everolimus is currently approved by the Food and Drug Administration to prevent graft rejection in kidney and liver transplant recipients and, under another brand name, to treat some cancers.
Measured glomerular filtration rate (GFR) at 12 months, the trial’s primary outcome, was 30% better in the everolimus group than in the cyclosporine group (79.8 vs. 61.5 mL/min per 1.73 m2; P less than .001), according to results presented at the congress and recently published (Am. J. Transplant. 2014;14:1828-38).
The urinary albumin-creatinine ratio was higher in the everolimus group, but none of the patients had nephrotic levels of proteinuria.
Rates of adverse events were similar, with the exception that the everolimus group had a lower rate of cytomegalovirus infection (5% vs. 30%) and a higher rate of pneumonia (12% vs. 3%), Dr. Sigurdardottir reported at the congress, which was sponsored by the American Society of Transplant Surgeons.
The incidence of biopsy-proven acute rejection of at least grade 2R was greater with everolimus (40% vs. 18%, P = .01). However, at 12 months, the groups did not differ with respect to left ventricular function as assessed by echocardiography and biomarkers, and, in a cardiac reserve substudy, with respect to cardiac output and pulmonary capillary wedge pressure.
The incidence of cardiac allograft vasculopathy, defined as a mean media-intima thickness of at least 0.5 mm on intravascular ultrasound (IVUS), was lower in the everolimus group (51% vs. 65%, P less than .01), and progression assessed as the change in percent atheroma volume was slower in that group.
"Everolimus initiation and early cyclosporine elimination in de novo heart transplant recipients showed a highly significant improvement of renal function in terms of measured GFR, a reduced incidence of cytomegalovirus [a confirmatory result of previous large-scale studies], similar numbers of adverse and serious adverse events, and an increased incidence of treated acute rejection, however, without hemodynamic compromise and with preserved cardiac function and preserved cardiac reserve," concluded Dr. Sigurdardottir, who is medical director of heart transplantation at the Transplant Institute, Sahlgrenska University Hospital, Gothenburg, Sweden. "We saw also favorable coronary remodeling and less graft vasculopathy, as previously shown."
Among patients whose donor hearts had such disease, the increase in media-intima thickness and percent atheroma volume was less with everolimus than with cyclosporine, Dr. Sigurdardottir said. "Interestingly, we saw here that the total atheroma volume decreased between baseline and 12 months in the everolimus group in the patients who had preexisting donor disease."
An attendee from Norway said, "I am a nephrologist, and if I were to get a new heart, I’d rather have a GFR of 61 and no rejection than a GFR of 73 with rejection. Have you looked at the development of donor-specific antibodies in the ones who had rejection, because I’d like to live for more than a year – I’d like to live 3 years or 5 years or 10 years."
"You are absolutely right. At the time of transplantation, we would be looking at the acute problems, and we often see the kidney dysfunction, so we want to do something about that. But of course these studies need to tell us how patients fare longer term," Dr. Sigurdardottir agreed. None of the patients were found to have donor-specific antibodies, but the trial protocol did not mandate routine measurement, she said.
An attendee from Los Angeles commented, "We tried to do CNI [calcineurin inhibitor] weaning in 2006 and had hemodynamically compromised rejection. Now, I congratulate you on being innovative and having quadruple therapy from the get-go and then taking off the CNI. But the issue of increased rejection is important because ISHLT [International Society for Heart and Lung Transplantation] data show that that does lead to poorer outcome. It is countered by your improvement in renal function, but also your IVUS result, I think, is very important as well."
"Rejection is an important issue, but it is a common issue after transplantation. It was usually manageable. Since we didn’t see any hemodynamic compromise, it was up to each investigator to evaluate what to do. There were nine patients who converted to combination therapy," Dr. Sigurdardottir reported. "The future needs to tell us what the relevance of this rejection is, and we will do a follow-up at 3 and 5 years."
Dr. Sigurdardottir disclosed no relevant conflicts of interest. The trial was sponsored by Novartis, manufacturer of everolimus.
SAN FRANCISCO – Use of an everolimus-containing regimen with early stopping of cyclosporine after de novo heart transplantation improves renal function and reduces cardiac allograft vasculopathy, without compromising graft outcomes, new data suggest.
These was among key findings of the randomized, open-label SCHEDULE (Scandinavian Heart Transplant Everolimus De Novo Study with Early Calcineurin Inhibitor Avoidance) reported at the 2014 World Transplant Congress.
"Renal dysfunction and cardiac allograft vasculopathy are markers for increased morbidity and mortality after heart transplantation," lead author Dr. Vilborg Sigurdardottir commented when introducing the study.
Patients in the trial were randomized evenly to a three-drug regimen containing the calcineurin inhibitor cyclosporine (Sandimmune) or to a four-drug regimen also containing the mTOR inhibitor everolimus (Zortress) with discontinuation of cyclosporine at week 7-11. Everolimus is currently approved by the Food and Drug Administration to prevent graft rejection in kidney and liver transplant recipients and, under another brand name, to treat some cancers.
Measured glomerular filtration rate (GFR) at 12 months, the trial’s primary outcome, was 30% better in the everolimus group than in the cyclosporine group (79.8 vs. 61.5 mL/min per 1.73 m2; P less than .001), according to results presented at the congress and recently published (Am. J. Transplant. 2014;14:1828-38).
The urinary albumin-creatinine ratio was higher in the everolimus group, but none of the patients had nephrotic levels of proteinuria.
Rates of adverse events were similar, with the exception that the everolimus group had a lower rate of cytomegalovirus infection (5% vs. 30%) and a higher rate of pneumonia (12% vs. 3%), Dr. Sigurdardottir reported at the congress, which was sponsored by the American Society of Transplant Surgeons.
The incidence of biopsy-proven acute rejection of at least grade 2R was greater with everolimus (40% vs. 18%, P = .01). However, at 12 months, the groups did not differ with respect to left ventricular function as assessed by echocardiography and biomarkers, and, in a cardiac reserve substudy, with respect to cardiac output and pulmonary capillary wedge pressure.
The incidence of cardiac allograft vasculopathy, defined as a mean media-intima thickness of at least 0.5 mm on intravascular ultrasound (IVUS), was lower in the everolimus group (51% vs. 65%, P less than .01), and progression assessed as the change in percent atheroma volume was slower in that group.
"Everolimus initiation and early cyclosporine elimination in de novo heart transplant recipients showed a highly significant improvement of renal function in terms of measured GFR, a reduced incidence of cytomegalovirus [a confirmatory result of previous large-scale studies], similar numbers of adverse and serious adverse events, and an increased incidence of treated acute rejection, however, without hemodynamic compromise and with preserved cardiac function and preserved cardiac reserve," concluded Dr. Sigurdardottir, who is medical director of heart transplantation at the Transplant Institute, Sahlgrenska University Hospital, Gothenburg, Sweden. "We saw also favorable coronary remodeling and less graft vasculopathy, as previously shown."
Among patients whose donor hearts had such disease, the increase in media-intima thickness and percent atheroma volume was less with everolimus than with cyclosporine, Dr. Sigurdardottir said. "Interestingly, we saw here that the total atheroma volume decreased between baseline and 12 months in the everolimus group in the patients who had preexisting donor disease."
An attendee from Norway said, "I am a nephrologist, and if I were to get a new heart, I’d rather have a GFR of 61 and no rejection than a GFR of 73 with rejection. Have you looked at the development of donor-specific antibodies in the ones who had rejection, because I’d like to live for more than a year – I’d like to live 3 years or 5 years or 10 years."
"You are absolutely right. At the time of transplantation, we would be looking at the acute problems, and we often see the kidney dysfunction, so we want to do something about that. But of course these studies need to tell us how patients fare longer term," Dr. Sigurdardottir agreed. None of the patients were found to have donor-specific antibodies, but the trial protocol did not mandate routine measurement, she said.
An attendee from Los Angeles commented, "We tried to do CNI [calcineurin inhibitor] weaning in 2006 and had hemodynamically compromised rejection. Now, I congratulate you on being innovative and having quadruple therapy from the get-go and then taking off the CNI. But the issue of increased rejection is important because ISHLT [International Society for Heart and Lung Transplantation] data show that that does lead to poorer outcome. It is countered by your improvement in renal function, but also your IVUS result, I think, is very important as well."
"Rejection is an important issue, but it is a common issue after transplantation. It was usually manageable. Since we didn’t see any hemodynamic compromise, it was up to each investigator to evaluate what to do. There were nine patients who converted to combination therapy," Dr. Sigurdardottir reported. "The future needs to tell us what the relevance of this rejection is, and we will do a follow-up at 3 and 5 years."
Dr. Sigurdardottir disclosed no relevant conflicts of interest. The trial was sponsored by Novartis, manufacturer of everolimus.
SAN FRANCISCO – Use of an everolimus-containing regimen with early stopping of cyclosporine after de novo heart transplantation improves renal function and reduces cardiac allograft vasculopathy, without compromising graft outcomes, new data suggest.
These was among key findings of the randomized, open-label SCHEDULE (Scandinavian Heart Transplant Everolimus De Novo Study with Early Calcineurin Inhibitor Avoidance) reported at the 2014 World Transplant Congress.
"Renal dysfunction and cardiac allograft vasculopathy are markers for increased morbidity and mortality after heart transplantation," lead author Dr. Vilborg Sigurdardottir commented when introducing the study.
Patients in the trial were randomized evenly to a three-drug regimen containing the calcineurin inhibitor cyclosporine (Sandimmune) or to a four-drug regimen also containing the mTOR inhibitor everolimus (Zortress) with discontinuation of cyclosporine at week 7-11. Everolimus is currently approved by the Food and Drug Administration to prevent graft rejection in kidney and liver transplant recipients and, under another brand name, to treat some cancers.
Measured glomerular filtration rate (GFR) at 12 months, the trial’s primary outcome, was 30% better in the everolimus group than in the cyclosporine group (79.8 vs. 61.5 mL/min per 1.73 m2; P less than .001), according to results presented at the congress and recently published (Am. J. Transplant. 2014;14:1828-38).
The urinary albumin-creatinine ratio was higher in the everolimus group, but none of the patients had nephrotic levels of proteinuria.
Rates of adverse events were similar, with the exception that the everolimus group had a lower rate of cytomegalovirus infection (5% vs. 30%) and a higher rate of pneumonia (12% vs. 3%), Dr. Sigurdardottir reported at the congress, which was sponsored by the American Society of Transplant Surgeons.
The incidence of biopsy-proven acute rejection of at least grade 2R was greater with everolimus (40% vs. 18%, P = .01). However, at 12 months, the groups did not differ with respect to left ventricular function as assessed by echocardiography and biomarkers, and, in a cardiac reserve substudy, with respect to cardiac output and pulmonary capillary wedge pressure.
The incidence of cardiac allograft vasculopathy, defined as a mean media-intima thickness of at least 0.5 mm on intravascular ultrasound (IVUS), was lower in the everolimus group (51% vs. 65%, P less than .01), and progression assessed as the change in percent atheroma volume was slower in that group.
"Everolimus initiation and early cyclosporine elimination in de novo heart transplant recipients showed a highly significant improvement of renal function in terms of measured GFR, a reduced incidence of cytomegalovirus [a confirmatory result of previous large-scale studies], similar numbers of adverse and serious adverse events, and an increased incidence of treated acute rejection, however, without hemodynamic compromise and with preserved cardiac function and preserved cardiac reserve," concluded Dr. Sigurdardottir, who is medical director of heart transplantation at the Transplant Institute, Sahlgrenska University Hospital, Gothenburg, Sweden. "We saw also favorable coronary remodeling and less graft vasculopathy, as previously shown."
Among patients whose donor hearts had such disease, the increase in media-intima thickness and percent atheroma volume was less with everolimus than with cyclosporine, Dr. Sigurdardottir said. "Interestingly, we saw here that the total atheroma volume decreased between baseline and 12 months in the everolimus group in the patients who had preexisting donor disease."
An attendee from Norway said, "I am a nephrologist, and if I were to get a new heart, I’d rather have a GFR of 61 and no rejection than a GFR of 73 with rejection. Have you looked at the development of donor-specific antibodies in the ones who had rejection, because I’d like to live for more than a year – I’d like to live 3 years or 5 years or 10 years."
"You are absolutely right. At the time of transplantation, we would be looking at the acute problems, and we often see the kidney dysfunction, so we want to do something about that. But of course these studies need to tell us how patients fare longer term," Dr. Sigurdardottir agreed. None of the patients were found to have donor-specific antibodies, but the trial protocol did not mandate routine measurement, she said.
An attendee from Los Angeles commented, "We tried to do CNI [calcineurin inhibitor] weaning in 2006 and had hemodynamically compromised rejection. Now, I congratulate you on being innovative and having quadruple therapy from the get-go and then taking off the CNI. But the issue of increased rejection is important because ISHLT [International Society for Heart and Lung Transplantation] data show that that does lead to poorer outcome. It is countered by your improvement in renal function, but also your IVUS result, I think, is very important as well."
"Rejection is an important issue, but it is a common issue after transplantation. It was usually manageable. Since we didn’t see any hemodynamic compromise, it was up to each investigator to evaluate what to do. There were nine patients who converted to combination therapy," Dr. Sigurdardottir reported. "The future needs to tell us what the relevance of this rejection is, and we will do a follow-up at 3 and 5 years."
Dr. Sigurdardottir disclosed no relevant conflicts of interest. The trial was sponsored by Novartis, manufacturer of everolimus.
FROM THE 2014 WORLD TRANSPLANT CONGRESS
Key clinical point: For post–heart transplant patients, early cessation of cyclosporine when using an everolimus-containing regimen appears to be safe and did not compromise graft outcomes.
Major finding: Compared with patients continued on cyclosporine, patients taken off this agent at 7-11 weeks had a 30% better measured glomerular filtration rate at 12 months.
Data source: A randomized, open-label trial of 115 patients undergoing de novo heart transplantation
Disclosures: Dr. Sigurdardottir disclosed no relevant conflicts of interest. The trial was sponsored by Novartis, manufacturer of everolimus.
Permacol shows low recurrence rates for hernia repair, even in high-risk patients
The collagen-based Permacol surgical implant is safe and feasible for incisional and ventral hernia repair, according to the authors of a study that found hernia recurrence probabilities of 5.8%, 16.6%, and 31.0% at 1, 2, and 3 years, respectively.
Retrospective data from 343 patients with 213 incisional and 130 ventral hernias, treated with the cross-linked porcine collagen product, showed open surgery was associated with a significantly higher rate of recurrence than laparoscopic surgery at 12 months (7.7% vs. 2.5%, P = .047).
Mesh location also affected recurrence rates at 12 months, with onlay (suprafascial) repair associated with an 18.9% recurrence rate, compared with 2.4% for underlay (subfascial, intraperitoneal) repair. But wound classification, wound infection, and seromas did not impact the risk of recurrence at 12 or 24 months (Int. J. Surg. 2014;12:296-303).
Dr. Bipan Chand of the Loyola Center for Metabolic Surgery and Bariatric Care, Loyola University, and colleagues described the study as the largest retrospective multinational study to date evaluating outcomes from hernia repair using Permacol.
"Despite an initially enthusiastic adoption [of collagen-based prosthetics] by the surgical community, clinical data supporting product safety and efficacy and proper indication is needed," the authors wrote.
"The use of biologics is still controversial in class III (contaminated) and IV (infected) wounds and fields with increased collagenase due to potential accelerated breakdown of the collagen-based materials in these more hostile environments and limited evidence of long-term efficacy under those conditions."
At the time of surgery, 8.2% of patients had class III wounds and 6.4% had class IV.
Researchers observed a 1-year hernia recurrence rate of 7.4% in clean wounds and 4.5% in dirty wounds, compared with another study using a non–cross-linked biologic that recorded recurrence rates of 39% in dirty wounds and 5% in clean wounds after 1 year.
There was a 15.2% rate of wound infection and a 19% incidence of seroma. In addition, there was a 3.2% incidence of hematoma and a 0.9% incidence of fistula. One patient required reoperation to remove the mesh, which the authors said was procedure related.
Biologic mesh such as Permacol includes an intact extracellular matrix that supports tissue incorporation, revascularization, and cell repopulation that may also help to clear bacterial contamination, the authors reported.
"Permacol surgical implant was shown to be safe and feasible with low rates of postoperative morbidity even in patients with higher risk of failure," the researchers wrote.
"We recommend optimizing controllable patient conditions, performing these complex operations on an elective basis, reducing the bioburden of the wound, and reapproximating the fascial midline while utilizing Permacol surgical implant as reinforcement."
The study was sponsored and funded by Covidien, who also provided editorial support. Most authors declared a range of honoraria, consultancies, lecture fees, and travel support, including from Covidien.
The collagen-based Permacol surgical implant is safe and feasible for incisional and ventral hernia repair, according to the authors of a study that found hernia recurrence probabilities of 5.8%, 16.6%, and 31.0% at 1, 2, and 3 years, respectively.
Retrospective data from 343 patients with 213 incisional and 130 ventral hernias, treated with the cross-linked porcine collagen product, showed open surgery was associated with a significantly higher rate of recurrence than laparoscopic surgery at 12 months (7.7% vs. 2.5%, P = .047).
Mesh location also affected recurrence rates at 12 months, with onlay (suprafascial) repair associated with an 18.9% recurrence rate, compared with 2.4% for underlay (subfascial, intraperitoneal) repair. But wound classification, wound infection, and seromas did not impact the risk of recurrence at 12 or 24 months (Int. J. Surg. 2014;12:296-303).
Dr. Bipan Chand of the Loyola Center for Metabolic Surgery and Bariatric Care, Loyola University, and colleagues described the study as the largest retrospective multinational study to date evaluating outcomes from hernia repair using Permacol.
"Despite an initially enthusiastic adoption [of collagen-based prosthetics] by the surgical community, clinical data supporting product safety and efficacy and proper indication is needed," the authors wrote.
"The use of biologics is still controversial in class III (contaminated) and IV (infected) wounds and fields with increased collagenase due to potential accelerated breakdown of the collagen-based materials in these more hostile environments and limited evidence of long-term efficacy under those conditions."
At the time of surgery, 8.2% of patients had class III wounds and 6.4% had class IV.
Researchers observed a 1-year hernia recurrence rate of 7.4% in clean wounds and 4.5% in dirty wounds, compared with another study using a non–cross-linked biologic that recorded recurrence rates of 39% in dirty wounds and 5% in clean wounds after 1 year.
There was a 15.2% rate of wound infection and a 19% incidence of seroma. In addition, there was a 3.2% incidence of hematoma and a 0.9% incidence of fistula. One patient required reoperation to remove the mesh, which the authors said was procedure related.
Biologic mesh such as Permacol includes an intact extracellular matrix that supports tissue incorporation, revascularization, and cell repopulation that may also help to clear bacterial contamination, the authors reported.
"Permacol surgical implant was shown to be safe and feasible with low rates of postoperative morbidity even in patients with higher risk of failure," the researchers wrote.
"We recommend optimizing controllable patient conditions, performing these complex operations on an elective basis, reducing the bioburden of the wound, and reapproximating the fascial midline while utilizing Permacol surgical implant as reinforcement."
The study was sponsored and funded by Covidien, who also provided editorial support. Most authors declared a range of honoraria, consultancies, lecture fees, and travel support, including from Covidien.
The collagen-based Permacol surgical implant is safe and feasible for incisional and ventral hernia repair, according to the authors of a study that found hernia recurrence probabilities of 5.8%, 16.6%, and 31.0% at 1, 2, and 3 years, respectively.
Retrospective data from 343 patients with 213 incisional and 130 ventral hernias, treated with the cross-linked porcine collagen product, showed open surgery was associated with a significantly higher rate of recurrence than laparoscopic surgery at 12 months (7.7% vs. 2.5%, P = .047).
Mesh location also affected recurrence rates at 12 months, with onlay (suprafascial) repair associated with an 18.9% recurrence rate, compared with 2.4% for underlay (subfascial, intraperitoneal) repair. But wound classification, wound infection, and seromas did not impact the risk of recurrence at 12 or 24 months (Int. J. Surg. 2014;12:296-303).
Dr. Bipan Chand of the Loyola Center for Metabolic Surgery and Bariatric Care, Loyola University, and colleagues described the study as the largest retrospective multinational study to date evaluating outcomes from hernia repair using Permacol.
"Despite an initially enthusiastic adoption [of collagen-based prosthetics] by the surgical community, clinical data supporting product safety and efficacy and proper indication is needed," the authors wrote.
"The use of biologics is still controversial in class III (contaminated) and IV (infected) wounds and fields with increased collagenase due to potential accelerated breakdown of the collagen-based materials in these more hostile environments and limited evidence of long-term efficacy under those conditions."
At the time of surgery, 8.2% of patients had class III wounds and 6.4% had class IV.
Researchers observed a 1-year hernia recurrence rate of 7.4% in clean wounds and 4.5% in dirty wounds, compared with another study using a non–cross-linked biologic that recorded recurrence rates of 39% in dirty wounds and 5% in clean wounds after 1 year.
There was a 15.2% rate of wound infection and a 19% incidence of seroma. In addition, there was a 3.2% incidence of hematoma and a 0.9% incidence of fistula. One patient required reoperation to remove the mesh, which the authors said was procedure related.
Biologic mesh such as Permacol includes an intact extracellular matrix that supports tissue incorporation, revascularization, and cell repopulation that may also help to clear bacterial contamination, the authors reported.
"Permacol surgical implant was shown to be safe and feasible with low rates of postoperative morbidity even in patients with higher risk of failure," the researchers wrote.
"We recommend optimizing controllable patient conditions, performing these complex operations on an elective basis, reducing the bioburden of the wound, and reapproximating the fascial midline while utilizing Permacol surgical implant as reinforcement."
The study was sponsored and funded by Covidien, who also provided editorial support. Most authors declared a range of honoraria, consultancies, lecture fees, and travel support, including from Covidien.
FROM INTERNATIONAL JOURNAL OF SURGERY
Key clinical point: For hernia repair, consider utilizing Permacol surgical implant in cases where controllable patient conditions can be optimized and the bioburden of the wound can be reduced.
Major finding: The cross-linked porcine collagen surgical implant Permacol is associated with hernia recurrence probabilities of 5.8%, 16.6%, and 31.0% at 1, 2, and 3 years, respectively.
Data source: A retrospective, multinational cohort study
Disclosures: The study was sponsored and funded by Covidien, who also provided editorial support. Most authors declared a range of honoraria, consultancies, lecture fees, and travel support, including from Covidien.