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Update on malpractice trends
Question: Recent developments in malpractice include the following:
A. Severity and frequency rates continue to rise.
B. Apology laws appear to be very effective in reducing claims.
C. Litigation surrounds whether an assistant may obtain a patient’s informed consent on behalf of the doctor.
D. A and B.
E. A, B, and C.
Answer: C. Over the past decade, malpractice claims have in fact diminished, accompanied by a leveling or reduction in premiums.1 Rates have plummeted to roughly half of previous levels, averaging six claims per 100 doctors in 2016.
According to The Doctors Company, internists paid an average premium of $15,853, compared with an average of $19,900 in 2006, general surgeons $52,905 instead of $68,186, and obstetricians $72,999, a drop from $93,230. Even claims-plagued Florida’s Dade County has seen a dramatic drop in internist premiums by some $27,000, down to $47,707.2
The latest attack on MICRA, in 2015, concerned a wrongful death suit brought by a woman whose mother died from hemorrhagic complications related to Coumadin use following heart surgery.4 Her constitutional challenges included violation of equal protection, due process, and the right to a jury trial. But these were essentially all grounded on an entitlement to recover additional noneconomic damages sufficient to cover attorney fees. The trial court had reduced her $1 million noneconomic damages to $250,000 as required by MICRA. A California appeals court rejected her claim as being “contrary to many well-established legal principles.”
Disclosure of medical errors is a relative newcomer as an ethical and effective way of thwarting potential malpractice claims. Many states have enacted so-called “apology laws,” an outgrowth of the communication and resolution programs popularized by the Lexington (Ky.) VA Medical Center, University of Michigan Health System, Harvard’s affiliated institutions, and Colorado’s COPIC Insurance.
Apology laws disallow statements of sympathy from being admitted into evidence. In some cases, these laws may assist the physician. For example, the Ohio Supreme Court has ruled that a surgeon’s comments and alleged admission of guilt (“I take full responsibility for this” regarding accidentally sectioning the common bile duct) were properly shielded from discovery by the state’s apology statute, even though the incident took place before the law went into effect.5
However, apology laws do vary from state to state, and some do not shield admissions regarding causation of error or fault.
A recent study suggests that apology laws don’t work. A Vanderbilt University study published online used a unique dataset covering all malpractice claims for 90% of physicians practicing in a single specialty across the country.6 The findings revealed that, for physicians who do not regularly perform surgery, apology laws actually increased the probability of facing a lawsuit. For surgeons, apology laws do not have a substantial effect on the probability of facing a claim or the average payment made to resolve a claim.
The study’s authors concluded that “apology laws are not substitutes for specific physician disclosure programs, and that the experiences of these types of programs are not generalizable to the physician population at large. In other words, simply being allowed to apologize is not enough to reduce malpractice risk.”
In the informed consent arena, the latest development in the law revolves around whether a physician assistant, in lieu of the surgeon himself, can obtain informed consent from a patient.
In Shinal v. Toms,7 Megan Shinal underwent surgery to remove a craniopharyngioma, but it regrew and required re-exploration by Dr. Steven Toms. Dr. Toms testified that Ms. Shinal had agreed that he would determine during the surgery whether he should remove the entire tumor or perform a partial resection. The operation was complicated by a carotid artery perforation, which left the patient with impaired vision and ambulation.
The complaint asserted that Dr. Toms’s physician assistant, not Dr. Toms himself, had provided the actual discussion during the informed consent process, and thus the patient’s consent was invalid.
The jury was allowed to consider the information provided by the doctor’s support staff, and the Superior Court of Pennsylvania affirmed the validity of the patient’s consent, holding that consent is based on the scope of information relayed rather than the identity of the individual communicating the information. This carefully watched case is now on final appeal before the Supreme Court of Pennsylvania.
At a personal level, physicians dread the stress surrounding medical malpractice litigation. The process frontally attacks their competence and consumes much time and energy, notwithstanding there being little or no exposure of personal assets because of insurance protection. Virtually all doctors practice defensive medicine, which has been defined as “deviation from sound medical practice that is induced primarily by a threat of liability.”
At a societal level, defensive medicine is reported to add substantially to the nation’s medical bill. The figure tossed around is $12 billion to $50 billion a year, based mostly on estimates by the American Medical Association and an older study extrapolating potential Medicare savings from litigation over heart disease.8
A more recent report continues to emphasize the high cost of defensive medicine.9 Jackson Healthcare invited 138,686 physicians to participate in a confidential online survey to quantify the costs and impact of defensive medicine. More than 3,000 physicians spanning all states and medical specialties completed the survey; however, this represented only a 2.21% response rate.
The authors concluded that defensive medicine is a significant force driving the high cost of health care in the United States, and that physicians estimate the cost of defensive medicine to be in the $650 billion to $850 billion range, or between 26% and 34% of annual health care costs.
Skeptics question the way the profession defines defensive medicine, pointing out that malpractice concerns may not be the primary reason, as most interventions add some marginal value to patient care. There may also be conflicting motivations of physicians, such as financial or other personal rewards.
Above all, there is no acceptable method for measuring the extent and use of defensive medicine, and survey reports are apt to be misleading because of bias and the lack of controls and baseline data.
Looking ahead, what can we expect for malpractice law under the Trump administration? Tom Price, MD, a former Republican congressman from Georgia, is an orthopedic surgeon and the new secretary of the Department of Health & Human Services. He has previously spoken passionately about tort reforms such as defensive medicine, damage caps, health tribunals, and practice guidelines. Many states have already incorporated some of these measures into their own tort reforms – with salutary results. It remains to be seen whether HHS will deem any omnibus federal legislation necessary at this point.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the materials have been taken from my earlier columns in Internal Medicine News. For additional information, readers may contact the author at [email protected].
References
1. JAMA. 2014 Nov 26;312(20):2146-55.
2. “Malpractice 2017: Do We Need Reform?” Internal Medicine News, March 1, 2017, page 1.
3. Fein v. Permanente, 38 Cal.3d 137 (1985).
4. Chan v. Curran, 237 CA 4th 601 (2015).
5. Estate of Johnson v. Randall Smith, Inc., 135 Ohio St.3d 440 (2013).
6. Available at https://papers.ssrn.com/sol3/papers2.cfm?abstract_id=2883693.
7. Shinal v. Toms, 122 A. 3d 1066 (Pa. Super. Ct. 2015).
8. Q J Econ. (1996) 111 (2): 353-390.
9. Available at www.jacksonhealthcare.com/media/8968/defensivemedicine_ebook_final.pdf.
Question: Recent developments in malpractice include the following:
A. Severity and frequency rates continue to rise.
B. Apology laws appear to be very effective in reducing claims.
C. Litigation surrounds whether an assistant may obtain a patient’s informed consent on behalf of the doctor.
D. A and B.
E. A, B, and C.
Answer: C. Over the past decade, malpractice claims have in fact diminished, accompanied by a leveling or reduction in premiums.1 Rates have plummeted to roughly half of previous levels, averaging six claims per 100 doctors in 2016.
According to The Doctors Company, internists paid an average premium of $15,853, compared with an average of $19,900 in 2006, general surgeons $52,905 instead of $68,186, and obstetricians $72,999, a drop from $93,230. Even claims-plagued Florida’s Dade County has seen a dramatic drop in internist premiums by some $27,000, down to $47,707.2
The latest attack on MICRA, in 2015, concerned a wrongful death suit brought by a woman whose mother died from hemorrhagic complications related to Coumadin use following heart surgery.4 Her constitutional challenges included violation of equal protection, due process, and the right to a jury trial. But these were essentially all grounded on an entitlement to recover additional noneconomic damages sufficient to cover attorney fees. The trial court had reduced her $1 million noneconomic damages to $250,000 as required by MICRA. A California appeals court rejected her claim as being “contrary to many well-established legal principles.”
Disclosure of medical errors is a relative newcomer as an ethical and effective way of thwarting potential malpractice claims. Many states have enacted so-called “apology laws,” an outgrowth of the communication and resolution programs popularized by the Lexington (Ky.) VA Medical Center, University of Michigan Health System, Harvard’s affiliated institutions, and Colorado’s COPIC Insurance.
Apology laws disallow statements of sympathy from being admitted into evidence. In some cases, these laws may assist the physician. For example, the Ohio Supreme Court has ruled that a surgeon’s comments and alleged admission of guilt (“I take full responsibility for this” regarding accidentally sectioning the common bile duct) were properly shielded from discovery by the state’s apology statute, even though the incident took place before the law went into effect.5
However, apology laws do vary from state to state, and some do not shield admissions regarding causation of error or fault.
A recent study suggests that apology laws don’t work. A Vanderbilt University study published online used a unique dataset covering all malpractice claims for 90% of physicians practicing in a single specialty across the country.6 The findings revealed that, for physicians who do not regularly perform surgery, apology laws actually increased the probability of facing a lawsuit. For surgeons, apology laws do not have a substantial effect on the probability of facing a claim or the average payment made to resolve a claim.
The study’s authors concluded that “apology laws are not substitutes for specific physician disclosure programs, and that the experiences of these types of programs are not generalizable to the physician population at large. In other words, simply being allowed to apologize is not enough to reduce malpractice risk.”
In the informed consent arena, the latest development in the law revolves around whether a physician assistant, in lieu of the surgeon himself, can obtain informed consent from a patient.
In Shinal v. Toms,7 Megan Shinal underwent surgery to remove a craniopharyngioma, but it regrew and required re-exploration by Dr. Steven Toms. Dr. Toms testified that Ms. Shinal had agreed that he would determine during the surgery whether he should remove the entire tumor or perform a partial resection. The operation was complicated by a carotid artery perforation, which left the patient with impaired vision and ambulation.
The complaint asserted that Dr. Toms’s physician assistant, not Dr. Toms himself, had provided the actual discussion during the informed consent process, and thus the patient’s consent was invalid.
The jury was allowed to consider the information provided by the doctor’s support staff, and the Superior Court of Pennsylvania affirmed the validity of the patient’s consent, holding that consent is based on the scope of information relayed rather than the identity of the individual communicating the information. This carefully watched case is now on final appeal before the Supreme Court of Pennsylvania.
At a personal level, physicians dread the stress surrounding medical malpractice litigation. The process frontally attacks their competence and consumes much time and energy, notwithstanding there being little or no exposure of personal assets because of insurance protection. Virtually all doctors practice defensive medicine, which has been defined as “deviation from sound medical practice that is induced primarily by a threat of liability.”
At a societal level, defensive medicine is reported to add substantially to the nation’s medical bill. The figure tossed around is $12 billion to $50 billion a year, based mostly on estimates by the American Medical Association and an older study extrapolating potential Medicare savings from litigation over heart disease.8
A more recent report continues to emphasize the high cost of defensive medicine.9 Jackson Healthcare invited 138,686 physicians to participate in a confidential online survey to quantify the costs and impact of defensive medicine. More than 3,000 physicians spanning all states and medical specialties completed the survey; however, this represented only a 2.21% response rate.
The authors concluded that defensive medicine is a significant force driving the high cost of health care in the United States, and that physicians estimate the cost of defensive medicine to be in the $650 billion to $850 billion range, or between 26% and 34% of annual health care costs.
Skeptics question the way the profession defines defensive medicine, pointing out that malpractice concerns may not be the primary reason, as most interventions add some marginal value to patient care. There may also be conflicting motivations of physicians, such as financial or other personal rewards.
Above all, there is no acceptable method for measuring the extent and use of defensive medicine, and survey reports are apt to be misleading because of bias and the lack of controls and baseline data.
Looking ahead, what can we expect for malpractice law under the Trump administration? Tom Price, MD, a former Republican congressman from Georgia, is an orthopedic surgeon and the new secretary of the Department of Health & Human Services. He has previously spoken passionately about tort reforms such as defensive medicine, damage caps, health tribunals, and practice guidelines. Many states have already incorporated some of these measures into their own tort reforms – with salutary results. It remains to be seen whether HHS will deem any omnibus federal legislation necessary at this point.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the materials have been taken from my earlier columns in Internal Medicine News. For additional information, readers may contact the author at [email protected].
References
1. JAMA. 2014 Nov 26;312(20):2146-55.
2. “Malpractice 2017: Do We Need Reform?” Internal Medicine News, March 1, 2017, page 1.
3. Fein v. Permanente, 38 Cal.3d 137 (1985).
4. Chan v. Curran, 237 CA 4th 601 (2015).
5. Estate of Johnson v. Randall Smith, Inc., 135 Ohio St.3d 440 (2013).
6. Available at https://papers.ssrn.com/sol3/papers2.cfm?abstract_id=2883693.
7. Shinal v. Toms, 122 A. 3d 1066 (Pa. Super. Ct. 2015).
8. Q J Econ. (1996) 111 (2): 353-390.
9. Available at www.jacksonhealthcare.com/media/8968/defensivemedicine_ebook_final.pdf.
Question: Recent developments in malpractice include the following:
A. Severity and frequency rates continue to rise.
B. Apology laws appear to be very effective in reducing claims.
C. Litigation surrounds whether an assistant may obtain a patient’s informed consent on behalf of the doctor.
D. A and B.
E. A, B, and C.
Answer: C. Over the past decade, malpractice claims have in fact diminished, accompanied by a leveling or reduction in premiums.1 Rates have plummeted to roughly half of previous levels, averaging six claims per 100 doctors in 2016.
According to The Doctors Company, internists paid an average premium of $15,853, compared with an average of $19,900 in 2006, general surgeons $52,905 instead of $68,186, and obstetricians $72,999, a drop from $93,230. Even claims-plagued Florida’s Dade County has seen a dramatic drop in internist premiums by some $27,000, down to $47,707.2
The latest attack on MICRA, in 2015, concerned a wrongful death suit brought by a woman whose mother died from hemorrhagic complications related to Coumadin use following heart surgery.4 Her constitutional challenges included violation of equal protection, due process, and the right to a jury trial. But these were essentially all grounded on an entitlement to recover additional noneconomic damages sufficient to cover attorney fees. The trial court had reduced her $1 million noneconomic damages to $250,000 as required by MICRA. A California appeals court rejected her claim as being “contrary to many well-established legal principles.”
Disclosure of medical errors is a relative newcomer as an ethical and effective way of thwarting potential malpractice claims. Many states have enacted so-called “apology laws,” an outgrowth of the communication and resolution programs popularized by the Lexington (Ky.) VA Medical Center, University of Michigan Health System, Harvard’s affiliated institutions, and Colorado’s COPIC Insurance.
Apology laws disallow statements of sympathy from being admitted into evidence. In some cases, these laws may assist the physician. For example, the Ohio Supreme Court has ruled that a surgeon’s comments and alleged admission of guilt (“I take full responsibility for this” regarding accidentally sectioning the common bile duct) were properly shielded from discovery by the state’s apology statute, even though the incident took place before the law went into effect.5
However, apology laws do vary from state to state, and some do not shield admissions regarding causation of error or fault.
A recent study suggests that apology laws don’t work. A Vanderbilt University study published online used a unique dataset covering all malpractice claims for 90% of physicians practicing in a single specialty across the country.6 The findings revealed that, for physicians who do not regularly perform surgery, apology laws actually increased the probability of facing a lawsuit. For surgeons, apology laws do not have a substantial effect on the probability of facing a claim or the average payment made to resolve a claim.
The study’s authors concluded that “apology laws are not substitutes for specific physician disclosure programs, and that the experiences of these types of programs are not generalizable to the physician population at large. In other words, simply being allowed to apologize is not enough to reduce malpractice risk.”
In the informed consent arena, the latest development in the law revolves around whether a physician assistant, in lieu of the surgeon himself, can obtain informed consent from a patient.
In Shinal v. Toms,7 Megan Shinal underwent surgery to remove a craniopharyngioma, but it regrew and required re-exploration by Dr. Steven Toms. Dr. Toms testified that Ms. Shinal had agreed that he would determine during the surgery whether he should remove the entire tumor or perform a partial resection. The operation was complicated by a carotid artery perforation, which left the patient with impaired vision and ambulation.
The complaint asserted that Dr. Toms’s physician assistant, not Dr. Toms himself, had provided the actual discussion during the informed consent process, and thus the patient’s consent was invalid.
The jury was allowed to consider the information provided by the doctor’s support staff, and the Superior Court of Pennsylvania affirmed the validity of the patient’s consent, holding that consent is based on the scope of information relayed rather than the identity of the individual communicating the information. This carefully watched case is now on final appeal before the Supreme Court of Pennsylvania.
At a personal level, physicians dread the stress surrounding medical malpractice litigation. The process frontally attacks their competence and consumes much time and energy, notwithstanding there being little or no exposure of personal assets because of insurance protection. Virtually all doctors practice defensive medicine, which has been defined as “deviation from sound medical practice that is induced primarily by a threat of liability.”
At a societal level, defensive medicine is reported to add substantially to the nation’s medical bill. The figure tossed around is $12 billion to $50 billion a year, based mostly on estimates by the American Medical Association and an older study extrapolating potential Medicare savings from litigation over heart disease.8
A more recent report continues to emphasize the high cost of defensive medicine.9 Jackson Healthcare invited 138,686 physicians to participate in a confidential online survey to quantify the costs and impact of defensive medicine. More than 3,000 physicians spanning all states and medical specialties completed the survey; however, this represented only a 2.21% response rate.
The authors concluded that defensive medicine is a significant force driving the high cost of health care in the United States, and that physicians estimate the cost of defensive medicine to be in the $650 billion to $850 billion range, or between 26% and 34% of annual health care costs.
Skeptics question the way the profession defines defensive medicine, pointing out that malpractice concerns may not be the primary reason, as most interventions add some marginal value to patient care. There may also be conflicting motivations of physicians, such as financial or other personal rewards.
Above all, there is no acceptable method for measuring the extent and use of defensive medicine, and survey reports are apt to be misleading because of bias and the lack of controls and baseline data.
Looking ahead, what can we expect for malpractice law under the Trump administration? Tom Price, MD, a former Republican congressman from Georgia, is an orthopedic surgeon and the new secretary of the Department of Health & Human Services. He has previously spoken passionately about tort reforms such as defensive medicine, damage caps, health tribunals, and practice guidelines. Many states have already incorporated some of these measures into their own tort reforms – with salutary results. It remains to be seen whether HHS will deem any omnibus federal legislation necessary at this point.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the materials have been taken from my earlier columns in Internal Medicine News. For additional information, readers may contact the author at [email protected].
References
1. JAMA. 2014 Nov 26;312(20):2146-55.
2. “Malpractice 2017: Do We Need Reform?” Internal Medicine News, March 1, 2017, page 1.
3. Fein v. Permanente, 38 Cal.3d 137 (1985).
4. Chan v. Curran, 237 CA 4th 601 (2015).
5. Estate of Johnson v. Randall Smith, Inc., 135 Ohio St.3d 440 (2013).
6. Available at https://papers.ssrn.com/sol3/papers2.cfm?abstract_id=2883693.
7. Shinal v. Toms, 122 A. 3d 1066 (Pa. Super. Ct. 2015).
8. Q J Econ. (1996) 111 (2): 353-390.
9. Available at www.jacksonhealthcare.com/media/8968/defensivemedicine_ebook_final.pdf.
VIDEO: Postop troponin T spike flags high mortality risk
WASHINGTON – A rise in the blood level of troponin T immediately after patients underwent noncardiac surgery identified a high risk group with a 30-day mortality rate nearly fivefold higher than that of patients who did not have a postoperative troponin T spike, according to a prospective study of more than 21,000 patients.
For 93% of the patients who have these perioperative spikes in troponin T, a marker of myocardial ischemia, the increased level was the only indicator of a heart problem, P.J. Devereaux, MD, said at the annual meeting of the American College of Cardiology. The painkillers that patients receive following surgery generally mask the chest discomfort they might otherwise feel from their heart damage, he explained. The clinical condition is called myocardial injury after noncardiac surgery.
“We’re seeing more older patients with a high burden of vascular disease undergoing surgery, and surgery is a very significant stress, so a large proportion of these patients will have [myocardial injury after noncardiac surgery] and that affects 30-day survival,” said Dr. Devereaux, professor and director of cardiology at McMaster University in Hamilton, Ont.
Based on the new findings, he recommended performing a baseline assessment of troponin T levels in patients scheduled for noncardiac surgery if they are at least 65 years of age, or if they are age 45-64 years with known vascular disease, followed by repeat testing 1 and 2 days after surgery to check whether a spike in the measure had occurred. The high sensitivity troponin T (hsTnT) test he used in the study is relatively costly (and received Food and Drug Administration approval for U.S. marketing in January 2017), but Dr. Devereaux believed that, used in this way, the cost for testing would be reasonable, given its powerful ability to identify high-risk patients and relative to the cost of other screening tools routinely used in U.S. medical practice.
“It looks very cost-effective,” he said in a video interview.
If the baseline and two follow-up measures of hsTnT showed a postoperative level of at least 20 ng/L that rose above the baseline level by at least 5 ng/L, or if the postoperative level was at least 65 ng/L, Dr. Devereaux recommended starting daily treatment with aspirin and a statin to try to contain any perioperative myocardial damage the patient may have, and follow with comprehensive assessment of the patient by a cardiologist or other internal medicine physician.
“Given the risks associated with a rise in hsTnT in this study, Dr. Devereaux’s recommendations are very reasonable until we collect more data on this,” said Frank W. Sellke, MD, professor of surgery and chief of cardiothoracic surgery at Brown Medical School and the Lifespan Hospitals in Providence, R.I. “What was surprising was how few patients had symptoms” of myocardial ischemia. “You can’t do hsTnT measurements on every patient who goes in for a hernia operation; it’s not practical. But his findings are fairly compelling, and hopefully the cost of this testing will come down,” Dr. Sellke said in an interview.
In the multicenter study of 21,842 patients, 24% had a postoperative hsTnT level of 20 ng/L or greater, including 5% with a level of 65 ng/L or greater. The 30-day mortality rate was 3% among those with a perioperative level of 20-64 ng/L, 9% among patients with perioperative hsTnT levels of 65-999 ng/L, and 30% among the 54 patients (0.2% of the study group) with perioperative levels that reached 1,000 ng/L or greater. Dr. Devereaux reported.
This iteration of the Vascular Events In Noncardiac Surgery Patients Cohort Evaluation Study (VISION) enrolled patients who were at least 45 years of age and underwent noncardiac surgery at 23 centers in 13 countries, including the United States and Canada. All patients underwent hsTnT testing 6-12 hours after surgery and 1, 2, and 3 days after surgery, but only 40% also had a baseline measurement before their surgery began. Full 30-day follow-up occurred for 21,050. The patients’ average age was 63 years. The most common surgery was “low-risk,” in 35%, followed by “major” general surgery in 20%, and “major” orthopedic surgery in 16%. At 30 days, 266 patients (1.2%) had died.
These findings “help define a cutoff for hsTnT that will be clinically useful to change practice,” said Athena Poppas, MD, a cardiologist and director of the Cardiovascular Institute at Rhode Island Hospital in Providence. Dr. Poppas was a designated discussant for Dr. Devereaux’s report at the meeting.
In January 2017, the Canadian Cardiovascular Society issued guidelines for perioperative cardiac risk assessment and management for patients undergoing noncardiac surgery (Can J Cardiol. 2017 Jan;33[1]:17-32). Dr. Devereaux was a member of the writing panel for these guidelines. This is what the guidelines said about using troponin T measurements:
“We recommend obtaining daily troponin measurements for 48-72 hours after noncardiac surgery in patients with a baseline risk greater than 5% for cardiovascular death or nonfatal myocardial infarction at 30 days after surgery (i.e., patients with an elevated NT-proBNP/BNP measurement before surgery or, if there is no NT-proBNP/BNP measurement before surgery, in those who have an RCRI [revised cardiac risk index] score of 1 or greater, age 45-64 years with significant cardiovascular disease, or age 65 years or older).”
The VISION study is sponsored by Roche Diagnostics, which markets the high sensitivity troponin T assay used in the study. Dr. Devereaux has received research funding from Roche Diagnostics and from Abbott Diagnostics and Boehringer Ingelheim. Dr. Sellke and Dr. Poppas had no relevant disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
WASHINGTON – A rise in the blood level of troponin T immediately after patients underwent noncardiac surgery identified a high risk group with a 30-day mortality rate nearly fivefold higher than that of patients who did not have a postoperative troponin T spike, according to a prospective study of more than 21,000 patients.
For 93% of the patients who have these perioperative spikes in troponin T, a marker of myocardial ischemia, the increased level was the only indicator of a heart problem, P.J. Devereaux, MD, said at the annual meeting of the American College of Cardiology. The painkillers that patients receive following surgery generally mask the chest discomfort they might otherwise feel from their heart damage, he explained. The clinical condition is called myocardial injury after noncardiac surgery.
“We’re seeing more older patients with a high burden of vascular disease undergoing surgery, and surgery is a very significant stress, so a large proportion of these patients will have [myocardial injury after noncardiac surgery] and that affects 30-day survival,” said Dr. Devereaux, professor and director of cardiology at McMaster University in Hamilton, Ont.
Based on the new findings, he recommended performing a baseline assessment of troponin T levels in patients scheduled for noncardiac surgery if they are at least 65 years of age, or if they are age 45-64 years with known vascular disease, followed by repeat testing 1 and 2 days after surgery to check whether a spike in the measure had occurred. The high sensitivity troponin T (hsTnT) test he used in the study is relatively costly (and received Food and Drug Administration approval for U.S. marketing in January 2017), but Dr. Devereaux believed that, used in this way, the cost for testing would be reasonable, given its powerful ability to identify high-risk patients and relative to the cost of other screening tools routinely used in U.S. medical practice.
“It looks very cost-effective,” he said in a video interview.
If the baseline and two follow-up measures of hsTnT showed a postoperative level of at least 20 ng/L that rose above the baseline level by at least 5 ng/L, or if the postoperative level was at least 65 ng/L, Dr. Devereaux recommended starting daily treatment with aspirin and a statin to try to contain any perioperative myocardial damage the patient may have, and follow with comprehensive assessment of the patient by a cardiologist or other internal medicine physician.
“Given the risks associated with a rise in hsTnT in this study, Dr. Devereaux’s recommendations are very reasonable until we collect more data on this,” said Frank W. Sellke, MD, professor of surgery and chief of cardiothoracic surgery at Brown Medical School and the Lifespan Hospitals in Providence, R.I. “What was surprising was how few patients had symptoms” of myocardial ischemia. “You can’t do hsTnT measurements on every patient who goes in for a hernia operation; it’s not practical. But his findings are fairly compelling, and hopefully the cost of this testing will come down,” Dr. Sellke said in an interview.
In the multicenter study of 21,842 patients, 24% had a postoperative hsTnT level of 20 ng/L or greater, including 5% with a level of 65 ng/L or greater. The 30-day mortality rate was 3% among those with a perioperative level of 20-64 ng/L, 9% among patients with perioperative hsTnT levels of 65-999 ng/L, and 30% among the 54 patients (0.2% of the study group) with perioperative levels that reached 1,000 ng/L or greater. Dr. Devereaux reported.
This iteration of the Vascular Events In Noncardiac Surgery Patients Cohort Evaluation Study (VISION) enrolled patients who were at least 45 years of age and underwent noncardiac surgery at 23 centers in 13 countries, including the United States and Canada. All patients underwent hsTnT testing 6-12 hours after surgery and 1, 2, and 3 days after surgery, but only 40% also had a baseline measurement before their surgery began. Full 30-day follow-up occurred for 21,050. The patients’ average age was 63 years. The most common surgery was “low-risk,” in 35%, followed by “major” general surgery in 20%, and “major” orthopedic surgery in 16%. At 30 days, 266 patients (1.2%) had died.
These findings “help define a cutoff for hsTnT that will be clinically useful to change practice,” said Athena Poppas, MD, a cardiologist and director of the Cardiovascular Institute at Rhode Island Hospital in Providence. Dr. Poppas was a designated discussant for Dr. Devereaux’s report at the meeting.
In January 2017, the Canadian Cardiovascular Society issued guidelines for perioperative cardiac risk assessment and management for patients undergoing noncardiac surgery (Can J Cardiol. 2017 Jan;33[1]:17-32). Dr. Devereaux was a member of the writing panel for these guidelines. This is what the guidelines said about using troponin T measurements:
“We recommend obtaining daily troponin measurements for 48-72 hours after noncardiac surgery in patients with a baseline risk greater than 5% for cardiovascular death or nonfatal myocardial infarction at 30 days after surgery (i.e., patients with an elevated NT-proBNP/BNP measurement before surgery or, if there is no NT-proBNP/BNP measurement before surgery, in those who have an RCRI [revised cardiac risk index] score of 1 or greater, age 45-64 years with significant cardiovascular disease, or age 65 years or older).”
The VISION study is sponsored by Roche Diagnostics, which markets the high sensitivity troponin T assay used in the study. Dr. Devereaux has received research funding from Roche Diagnostics and from Abbott Diagnostics and Boehringer Ingelheim. Dr. Sellke and Dr. Poppas had no relevant disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
WASHINGTON – A rise in the blood level of troponin T immediately after patients underwent noncardiac surgery identified a high risk group with a 30-day mortality rate nearly fivefold higher than that of patients who did not have a postoperative troponin T spike, according to a prospective study of more than 21,000 patients.
For 93% of the patients who have these perioperative spikes in troponin T, a marker of myocardial ischemia, the increased level was the only indicator of a heart problem, P.J. Devereaux, MD, said at the annual meeting of the American College of Cardiology. The painkillers that patients receive following surgery generally mask the chest discomfort they might otherwise feel from their heart damage, he explained. The clinical condition is called myocardial injury after noncardiac surgery.
“We’re seeing more older patients with a high burden of vascular disease undergoing surgery, and surgery is a very significant stress, so a large proportion of these patients will have [myocardial injury after noncardiac surgery] and that affects 30-day survival,” said Dr. Devereaux, professor and director of cardiology at McMaster University in Hamilton, Ont.
Based on the new findings, he recommended performing a baseline assessment of troponin T levels in patients scheduled for noncardiac surgery if they are at least 65 years of age, or if they are age 45-64 years with known vascular disease, followed by repeat testing 1 and 2 days after surgery to check whether a spike in the measure had occurred. The high sensitivity troponin T (hsTnT) test he used in the study is relatively costly (and received Food and Drug Administration approval for U.S. marketing in January 2017), but Dr. Devereaux believed that, used in this way, the cost for testing would be reasonable, given its powerful ability to identify high-risk patients and relative to the cost of other screening tools routinely used in U.S. medical practice.
“It looks very cost-effective,” he said in a video interview.
If the baseline and two follow-up measures of hsTnT showed a postoperative level of at least 20 ng/L that rose above the baseline level by at least 5 ng/L, or if the postoperative level was at least 65 ng/L, Dr. Devereaux recommended starting daily treatment with aspirin and a statin to try to contain any perioperative myocardial damage the patient may have, and follow with comprehensive assessment of the patient by a cardiologist or other internal medicine physician.
“Given the risks associated with a rise in hsTnT in this study, Dr. Devereaux’s recommendations are very reasonable until we collect more data on this,” said Frank W. Sellke, MD, professor of surgery and chief of cardiothoracic surgery at Brown Medical School and the Lifespan Hospitals in Providence, R.I. “What was surprising was how few patients had symptoms” of myocardial ischemia. “You can’t do hsTnT measurements on every patient who goes in for a hernia operation; it’s not practical. But his findings are fairly compelling, and hopefully the cost of this testing will come down,” Dr. Sellke said in an interview.
In the multicenter study of 21,842 patients, 24% had a postoperative hsTnT level of 20 ng/L or greater, including 5% with a level of 65 ng/L or greater. The 30-day mortality rate was 3% among those with a perioperative level of 20-64 ng/L, 9% among patients with perioperative hsTnT levels of 65-999 ng/L, and 30% among the 54 patients (0.2% of the study group) with perioperative levels that reached 1,000 ng/L or greater. Dr. Devereaux reported.
This iteration of the Vascular Events In Noncardiac Surgery Patients Cohort Evaluation Study (VISION) enrolled patients who were at least 45 years of age and underwent noncardiac surgery at 23 centers in 13 countries, including the United States and Canada. All patients underwent hsTnT testing 6-12 hours after surgery and 1, 2, and 3 days after surgery, but only 40% also had a baseline measurement before their surgery began. Full 30-day follow-up occurred for 21,050. The patients’ average age was 63 years. The most common surgery was “low-risk,” in 35%, followed by “major” general surgery in 20%, and “major” orthopedic surgery in 16%. At 30 days, 266 patients (1.2%) had died.
These findings “help define a cutoff for hsTnT that will be clinically useful to change practice,” said Athena Poppas, MD, a cardiologist and director of the Cardiovascular Institute at Rhode Island Hospital in Providence. Dr. Poppas was a designated discussant for Dr. Devereaux’s report at the meeting.
In January 2017, the Canadian Cardiovascular Society issued guidelines for perioperative cardiac risk assessment and management for patients undergoing noncardiac surgery (Can J Cardiol. 2017 Jan;33[1]:17-32). Dr. Devereaux was a member of the writing panel for these guidelines. This is what the guidelines said about using troponin T measurements:
“We recommend obtaining daily troponin measurements for 48-72 hours after noncardiac surgery in patients with a baseline risk greater than 5% for cardiovascular death or nonfatal myocardial infarction at 30 days after surgery (i.e., patients with an elevated NT-proBNP/BNP measurement before surgery or, if there is no NT-proBNP/BNP measurement before surgery, in those who have an RCRI [revised cardiac risk index] score of 1 or greater, age 45-64 years with significant cardiovascular disease, or age 65 years or older).”
The VISION study is sponsored by Roche Diagnostics, which markets the high sensitivity troponin T assay used in the study. Dr. Devereaux has received research funding from Roche Diagnostics and from Abbott Diagnostics and Boehringer Ingelheim. Dr. Sellke and Dr. Poppas had no relevant disclosures.
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AT ACC 17
Key clinical point:
Major finding: A postoperative high sensitivity troponin T rise of 5 ng/L or more linked with a 4.7-fold increase in 30-day mortality.
Data source: VISION, a prospective, multicenter observational study of 21,842 patients undergoing noncardiac surgery.
Disclosures: The VISION study is sponsored by Roche Diagnostics, which markets the high sensitivity troponin T assay used in the study. Dr. Devereaux has received research funding from Roche Diagnostics and from Abbott Diagnostics and Boehringer Ingelheim.
Intensive ventilation precedes lesser pulmonary complications
Addition of 10 cm H2O to positive end-expiratory volume (PEEP) during mechanical ventilation was followed by significantly lessened pulmonary complications in hospitalized patients who developed hypoxemia after cardiac surgery, participating in a single-center, randomized trial.
This “intensive” alveolar recruitment strategy yielded a median pulmonary complications score of 1.7 (interquartile range, 1.0-2.0), compared with 2.0 (IQR, 1.5-3.0) among patients who underwent ventilation with a PEEP of 20 cm H2O, Alcino Costa Leme, RRT, PhD, said at the International Symposium on Intensive Care and Emergency Medicine. The report was published simultaneously online March 21 in JAMA.
Intensive alveolar recruitment nearly doubled the odds of a lower pulmonary complications score (common odds ratio, 1.9; 95% confidence interval, 1.2-2.8; P = .003), Dr. Leme and his associates reported.
The study comprised 320 adults who developed hypoxemia immediately after undergoing elective cardiac surgery at the Heart Institute (Incor) of the University of São Paulo. The median age of the patients was 62 years, and none had a history of lung disease. Pulmonary complications were scored between 0 (no signs or symptoms) and 5 (death), the investigators noted (JAMA. 2017 Mar 21. doi: 10.1001/jama.2017.2297).
The intensive alveolar recruitment strategy consisted of three 60-second cycles of lung inflation with a positive end-expiratory pressure (PEEP) of 30 cm H2O, pressure-controlled ventilation, driving pressure of 15 cm H2O, respiratory rate of 15/min, inspiratory time of 1.5 seconds, and FIO2 of 0.40. Between and after inflations, patients received assist-controlled or pressure-controlled ventilation, with driving pressures set to achieve a tidal volume of 6 mL/kg of predicted body weight, an inspiratory time of 1 second, PEEP of 13 cm H2O, and minimum respiratory rate to maintain PaCO2 between 35 and 45 mm Hg.
The “moderate strategy” consisted of three 30-second inflations under continuous positive airway pressure mode at 20 cm H2O and FIO2 of 0.60. Between and after inflations, patients received assist or control volume-controlled ventilation (decelerating-flow waveform), tidal volume of 6 mL/kg of predicted body weight, inspiratory time of 1 second, PEEP of 8 cm H2O, and FIO2 of 0.60, at a minimum respiratory rate that maintained PaCO2 at 35-45 mm Hg.
“[The] use of an intensive alveolar recruitment strategy compared with a moderate recruitment strategy resulted in less severe pulmonary complications during the hospital stay,” the investigators wrote. On average, intensively managed patients had shorter stays in the hospital (10.9 vs. 12.4 days; P = .04) and in the intensive care unit (3.8 vs. 4.8 days; P = .01) than did moderately managed patients. Intensive management also was associated with lower rates of hospital mortality and barotrauma, but the differences in these less common outcomes did not reach statistical significance.
“To our knowledge, this is the first study to show a significant effect of lung recruitment maneuvers on clinical outcomes, which objectively resulted in modest reductions in ICU and hospital length of stay,” the researchers wrote. “This is especially noteworthy considering that the control group was also receiving protective lung ventilation with low [tidal volume] and moderate PEEP levels. Thus, the major difference between treatment groups was the intensity of lung recruitment.”
FAPESP (Fundação de Amparo e Pesquisa do Estado de São Paulo) and FINEP (Financiadora de Estudos e Projetos) provided partial funding. Dr. Leme had no disclosures. Senior author Marcelo Britto Passos Amato, MD, PhD, disclosed research funding from Covidien/Medtronics, Dixtal Biomedica Ltd, and Timpel SA.
High PEEP “not only recruits collapsed lung tissue, but can also lead to lung overdistension. If lung collapse is extensive, as in patients with ARDS [acute respiratory distress syndrome], and maybe also in patients with postoperative ARDS, the balance between benefit (i.e., recruitment of lung tissue), and harm (i.e., lung overdistension), tips toward benefit. If there is very little lung collapse, as in critically ill patients without ARDS or patients during surgery, this balance could go in the other direction.”
The clinical trial by Leme and his colleagues “provides another brick in the evidence wall of lung protection. However, it remains unclear which patients benefit most from ventilation with a high [positive end-expiratory pressure] level.”
Ary Serpa Neto, MD, MSc, PhD, and Marcus J. Schultz, MD, PhD, are at the Academic Medical Center, Amsterdam. They reported having no conflicts of interest. These comments are from their editorial (JAMA. 2017 Mar 21. doi: 10.1001/jama.2017.2570).
High PEEP “not only recruits collapsed lung tissue, but can also lead to lung overdistension. If lung collapse is extensive, as in patients with ARDS [acute respiratory distress syndrome], and maybe also in patients with postoperative ARDS, the balance between benefit (i.e., recruitment of lung tissue), and harm (i.e., lung overdistension), tips toward benefit. If there is very little lung collapse, as in critically ill patients without ARDS or patients during surgery, this balance could go in the other direction.”
The clinical trial by Leme and his colleagues “provides another brick in the evidence wall of lung protection. However, it remains unclear which patients benefit most from ventilation with a high [positive end-expiratory pressure] level.”
Ary Serpa Neto, MD, MSc, PhD, and Marcus J. Schultz, MD, PhD, are at the Academic Medical Center, Amsterdam. They reported having no conflicts of interest. These comments are from their editorial (JAMA. 2017 Mar 21. doi: 10.1001/jama.2017.2570).
High PEEP “not only recruits collapsed lung tissue, but can also lead to lung overdistension. If lung collapse is extensive, as in patients with ARDS [acute respiratory distress syndrome], and maybe also in patients with postoperative ARDS, the balance between benefit (i.e., recruitment of lung tissue), and harm (i.e., lung overdistension), tips toward benefit. If there is very little lung collapse, as in critically ill patients without ARDS or patients during surgery, this balance could go in the other direction.”
The clinical trial by Leme and his colleagues “provides another brick in the evidence wall of lung protection. However, it remains unclear which patients benefit most from ventilation with a high [positive end-expiratory pressure] level.”
Ary Serpa Neto, MD, MSc, PhD, and Marcus J. Schultz, MD, PhD, are at the Academic Medical Center, Amsterdam. They reported having no conflicts of interest. These comments are from their editorial (JAMA. 2017 Mar 21. doi: 10.1001/jama.2017.2570).
Addition of 10 cm H2O to positive end-expiratory volume (PEEP) during mechanical ventilation was followed by significantly lessened pulmonary complications in hospitalized patients who developed hypoxemia after cardiac surgery, participating in a single-center, randomized trial.
This “intensive” alveolar recruitment strategy yielded a median pulmonary complications score of 1.7 (interquartile range, 1.0-2.0), compared with 2.0 (IQR, 1.5-3.0) among patients who underwent ventilation with a PEEP of 20 cm H2O, Alcino Costa Leme, RRT, PhD, said at the International Symposium on Intensive Care and Emergency Medicine. The report was published simultaneously online March 21 in JAMA.
Intensive alveolar recruitment nearly doubled the odds of a lower pulmonary complications score (common odds ratio, 1.9; 95% confidence interval, 1.2-2.8; P = .003), Dr. Leme and his associates reported.
The study comprised 320 adults who developed hypoxemia immediately after undergoing elective cardiac surgery at the Heart Institute (Incor) of the University of São Paulo. The median age of the patients was 62 years, and none had a history of lung disease. Pulmonary complications were scored between 0 (no signs or symptoms) and 5 (death), the investigators noted (JAMA. 2017 Mar 21. doi: 10.1001/jama.2017.2297).
The intensive alveolar recruitment strategy consisted of three 60-second cycles of lung inflation with a positive end-expiratory pressure (PEEP) of 30 cm H2O, pressure-controlled ventilation, driving pressure of 15 cm H2O, respiratory rate of 15/min, inspiratory time of 1.5 seconds, and FIO2 of 0.40. Between and after inflations, patients received assist-controlled or pressure-controlled ventilation, with driving pressures set to achieve a tidal volume of 6 mL/kg of predicted body weight, an inspiratory time of 1 second, PEEP of 13 cm H2O, and minimum respiratory rate to maintain PaCO2 between 35 and 45 mm Hg.
The “moderate strategy” consisted of three 30-second inflations under continuous positive airway pressure mode at 20 cm H2O and FIO2 of 0.60. Between and after inflations, patients received assist or control volume-controlled ventilation (decelerating-flow waveform), tidal volume of 6 mL/kg of predicted body weight, inspiratory time of 1 second, PEEP of 8 cm H2O, and FIO2 of 0.60, at a minimum respiratory rate that maintained PaCO2 at 35-45 mm Hg.
“[The] use of an intensive alveolar recruitment strategy compared with a moderate recruitment strategy resulted in less severe pulmonary complications during the hospital stay,” the investigators wrote. On average, intensively managed patients had shorter stays in the hospital (10.9 vs. 12.4 days; P = .04) and in the intensive care unit (3.8 vs. 4.8 days; P = .01) than did moderately managed patients. Intensive management also was associated with lower rates of hospital mortality and barotrauma, but the differences in these less common outcomes did not reach statistical significance.
“To our knowledge, this is the first study to show a significant effect of lung recruitment maneuvers on clinical outcomes, which objectively resulted in modest reductions in ICU and hospital length of stay,” the researchers wrote. “This is especially noteworthy considering that the control group was also receiving protective lung ventilation with low [tidal volume] and moderate PEEP levels. Thus, the major difference between treatment groups was the intensity of lung recruitment.”
FAPESP (Fundação de Amparo e Pesquisa do Estado de São Paulo) and FINEP (Financiadora de Estudos e Projetos) provided partial funding. Dr. Leme had no disclosures. Senior author Marcelo Britto Passos Amato, MD, PhD, disclosed research funding from Covidien/Medtronics, Dixtal Biomedica Ltd, and Timpel SA.
Addition of 10 cm H2O to positive end-expiratory volume (PEEP) during mechanical ventilation was followed by significantly lessened pulmonary complications in hospitalized patients who developed hypoxemia after cardiac surgery, participating in a single-center, randomized trial.
This “intensive” alveolar recruitment strategy yielded a median pulmonary complications score of 1.7 (interquartile range, 1.0-2.0), compared with 2.0 (IQR, 1.5-3.0) among patients who underwent ventilation with a PEEP of 20 cm H2O, Alcino Costa Leme, RRT, PhD, said at the International Symposium on Intensive Care and Emergency Medicine. The report was published simultaneously online March 21 in JAMA.
Intensive alveolar recruitment nearly doubled the odds of a lower pulmonary complications score (common odds ratio, 1.9; 95% confidence interval, 1.2-2.8; P = .003), Dr. Leme and his associates reported.
The study comprised 320 adults who developed hypoxemia immediately after undergoing elective cardiac surgery at the Heart Institute (Incor) of the University of São Paulo. The median age of the patients was 62 years, and none had a history of lung disease. Pulmonary complications were scored between 0 (no signs or symptoms) and 5 (death), the investigators noted (JAMA. 2017 Mar 21. doi: 10.1001/jama.2017.2297).
The intensive alveolar recruitment strategy consisted of three 60-second cycles of lung inflation with a positive end-expiratory pressure (PEEP) of 30 cm H2O, pressure-controlled ventilation, driving pressure of 15 cm H2O, respiratory rate of 15/min, inspiratory time of 1.5 seconds, and FIO2 of 0.40. Between and after inflations, patients received assist-controlled or pressure-controlled ventilation, with driving pressures set to achieve a tidal volume of 6 mL/kg of predicted body weight, an inspiratory time of 1 second, PEEP of 13 cm H2O, and minimum respiratory rate to maintain PaCO2 between 35 and 45 mm Hg.
The “moderate strategy” consisted of three 30-second inflations under continuous positive airway pressure mode at 20 cm H2O and FIO2 of 0.60. Between and after inflations, patients received assist or control volume-controlled ventilation (decelerating-flow waveform), tidal volume of 6 mL/kg of predicted body weight, inspiratory time of 1 second, PEEP of 8 cm H2O, and FIO2 of 0.60, at a minimum respiratory rate that maintained PaCO2 at 35-45 mm Hg.
“[The] use of an intensive alveolar recruitment strategy compared with a moderate recruitment strategy resulted in less severe pulmonary complications during the hospital stay,” the investigators wrote. On average, intensively managed patients had shorter stays in the hospital (10.9 vs. 12.4 days; P = .04) and in the intensive care unit (3.8 vs. 4.8 days; P = .01) than did moderately managed patients. Intensive management also was associated with lower rates of hospital mortality and barotrauma, but the differences in these less common outcomes did not reach statistical significance.
“To our knowledge, this is the first study to show a significant effect of lung recruitment maneuvers on clinical outcomes, which objectively resulted in modest reductions in ICU and hospital length of stay,” the researchers wrote. “This is especially noteworthy considering that the control group was also receiving protective lung ventilation with low [tidal volume] and moderate PEEP levels. Thus, the major difference between treatment groups was the intensity of lung recruitment.”
FAPESP (Fundação de Amparo e Pesquisa do Estado de São Paulo) and FINEP (Financiadora de Estudos e Projetos) provided partial funding. Dr. Leme had no disclosures. Senior author Marcelo Britto Passos Amato, MD, PhD, disclosed research funding from Covidien/Medtronics, Dixtal Biomedica Ltd, and Timpel SA.
FROM ISICEM
Key clinical point: Intensive lung recruitment during mechanical ventilation of hypoxemic cardiac surgery patients was followed by less severe pulmonary complications, compared with moderate lung recruitment.
Major finding: Compared with moderate alveolar recruitment, intensive recruitment nearly doubled the odds that patients had a lower pulmonary complications score (odds ratio, 1.9; 95% confidence interval, 1.2 to 2.8; P = .003).
Data source: A single-center randomized trial of 320 adults with no history of pulmonary disease who developed hypoxemia after undergoing elective cardiac surgery.
Disclosures: FAPESP (Fundação de Amparo e Pesquisa do Estado de São Paulo) and FINEP (Financiadora de Estudos e Projetos) provided partial funding. Dr. Leme had no disclosures. Senior author Marcelo Britto Passos Amato, MD, PhD, disclosed research funding from Covidien/Medtronics, Dixtal Biomedica Ltd, and Timpel SA.
Levosimendan does not improve 30-day mortality following cardiac surgery
Adding a low dose of levosimendan to the standard care for patients on perioperative hemodynamic support does not improve outcomes to any significant extent, according to the findings of a new study presented at the annual congress of the European Society of Intensive Care Medicine and published simultaneously online in the New England Journal of Medicine.
“Levosimendan (Simdax, Orion) is an inotropic agent that has been shown to be associated with a higher rate of survival than other inotropic agents in meta-analyses, especially those involving patients undergoing cardiac surgery,” wrote the authors of the study, led by Giovanni Landoni, MD, of Vita-Salute San Raffaele University in Milan, adding, “Considering the pharmacologic properties of levosimendan and the results of previous studies, we hypothesized that the administration of levosimendan, in addition to standard treatment, might result in lower mortality in this context.”
Dr. Landoni and his colleagues conducted the Levosimendan to Reduce Mortality in High Risk Cardiac Surgery Patients: A Multicenter Randomized Controlled Trial, known more commonly as CHEETAH. Written consent was given by 4,725 patients from 14 centers located in Italy, Russia, and Brazil between November 2009 and April 2016. The investigators recruited a total of 506 patients. All subjects included in the study underwent cardiac surgery and experienced a perioperative cardiovascular dysfunction (N Engl J Med. 2017 Mar 21. doi: 10.1056/NEJMoa1616325).
Subjects were then randomized into a cohort receiving either a placebo or a low dose of levosimendan, which varied between 0.025 to 0.2 mcg/kg of body weight per minute continuously for up to 48 hours. A total of 248 subjects received levosimendan and 258 received placebo. All patients were administered the treatment while in the ICU; patients were taken off their regimen prior to 48 hours if they were discharged from the ICU. Anyone screened for inclusion who already had experienced a negative reaction to levosimendan was excluded from the study.
“We collected preoperative data on baseline characteristics and coexisting conditions, intraoperative and postoperative treatment data, postoperative laboratory values, duration of mechanical ventilation, durations of ICU and hospital stays, and major outcomes,” the authors explained, adding that “telephone follow-up was performed at 30 days and 180 days after randomization by an investigator who was unaware of the trial group assignments.”
The primary outcome of the study was 30-day mortality. The levosimendan cohort experienced 32 deaths (12.9%), while the placebo cohort saw 33 (12.8%), a nonsignificant difference (P = .97) between the two groups. Similarly, the median time spent on mechanical ventilation was 19 hours for those on levosimendan, versus 21 hours for those on placebo (P = .48), and median length of hospital stay was 14 days in both groups (P = .39).
“Previous meta-analyses of randomized, controlled trials showed a higher rate of survival with levosimendan than with other treatment regimens among patients undergoing cardiac surgery,” Dr. Landoni and his coauthors noted. Previous studies also had a number of key differences, such as the number of subjects who underwent coronary artery bypass grafting, the dosing of levosimendan, and inclusion of patients who had reduced preoperative ejection fraction instead of ones with myocardial dysfunction who needed inotropic support, which the current study used.
The study was funded by the Italian Ministry of Health. Dr. Landoni reported receiving nonfinancial support from the Orion Corporation while the study was ongoing; several other coauthors reported similar disclosures.
Adding a low dose of levosimendan to the standard care for patients on perioperative hemodynamic support does not improve outcomes to any significant extent, according to the findings of a new study presented at the annual congress of the European Society of Intensive Care Medicine and published simultaneously online in the New England Journal of Medicine.
“Levosimendan (Simdax, Orion) is an inotropic agent that has been shown to be associated with a higher rate of survival than other inotropic agents in meta-analyses, especially those involving patients undergoing cardiac surgery,” wrote the authors of the study, led by Giovanni Landoni, MD, of Vita-Salute San Raffaele University in Milan, adding, “Considering the pharmacologic properties of levosimendan and the results of previous studies, we hypothesized that the administration of levosimendan, in addition to standard treatment, might result in lower mortality in this context.”
Dr. Landoni and his colleagues conducted the Levosimendan to Reduce Mortality in High Risk Cardiac Surgery Patients: A Multicenter Randomized Controlled Trial, known more commonly as CHEETAH. Written consent was given by 4,725 patients from 14 centers located in Italy, Russia, and Brazil between November 2009 and April 2016. The investigators recruited a total of 506 patients. All subjects included in the study underwent cardiac surgery and experienced a perioperative cardiovascular dysfunction (N Engl J Med. 2017 Mar 21. doi: 10.1056/NEJMoa1616325).
Subjects were then randomized into a cohort receiving either a placebo or a low dose of levosimendan, which varied between 0.025 to 0.2 mcg/kg of body weight per minute continuously for up to 48 hours. A total of 248 subjects received levosimendan and 258 received placebo. All patients were administered the treatment while in the ICU; patients were taken off their regimen prior to 48 hours if they were discharged from the ICU. Anyone screened for inclusion who already had experienced a negative reaction to levosimendan was excluded from the study.
“We collected preoperative data on baseline characteristics and coexisting conditions, intraoperative and postoperative treatment data, postoperative laboratory values, duration of mechanical ventilation, durations of ICU and hospital stays, and major outcomes,” the authors explained, adding that “telephone follow-up was performed at 30 days and 180 days after randomization by an investigator who was unaware of the trial group assignments.”
The primary outcome of the study was 30-day mortality. The levosimendan cohort experienced 32 deaths (12.9%), while the placebo cohort saw 33 (12.8%), a nonsignificant difference (P = .97) between the two groups. Similarly, the median time spent on mechanical ventilation was 19 hours for those on levosimendan, versus 21 hours for those on placebo (P = .48), and median length of hospital stay was 14 days in both groups (P = .39).
“Previous meta-analyses of randomized, controlled trials showed a higher rate of survival with levosimendan than with other treatment regimens among patients undergoing cardiac surgery,” Dr. Landoni and his coauthors noted. Previous studies also had a number of key differences, such as the number of subjects who underwent coronary artery bypass grafting, the dosing of levosimendan, and inclusion of patients who had reduced preoperative ejection fraction instead of ones with myocardial dysfunction who needed inotropic support, which the current study used.
The study was funded by the Italian Ministry of Health. Dr. Landoni reported receiving nonfinancial support from the Orion Corporation while the study was ongoing; several other coauthors reported similar disclosures.
Adding a low dose of levosimendan to the standard care for patients on perioperative hemodynamic support does not improve outcomes to any significant extent, according to the findings of a new study presented at the annual congress of the European Society of Intensive Care Medicine and published simultaneously online in the New England Journal of Medicine.
“Levosimendan (Simdax, Orion) is an inotropic agent that has been shown to be associated with a higher rate of survival than other inotropic agents in meta-analyses, especially those involving patients undergoing cardiac surgery,” wrote the authors of the study, led by Giovanni Landoni, MD, of Vita-Salute San Raffaele University in Milan, adding, “Considering the pharmacologic properties of levosimendan and the results of previous studies, we hypothesized that the administration of levosimendan, in addition to standard treatment, might result in lower mortality in this context.”
Dr. Landoni and his colleagues conducted the Levosimendan to Reduce Mortality in High Risk Cardiac Surgery Patients: A Multicenter Randomized Controlled Trial, known more commonly as CHEETAH. Written consent was given by 4,725 patients from 14 centers located in Italy, Russia, and Brazil between November 2009 and April 2016. The investigators recruited a total of 506 patients. All subjects included in the study underwent cardiac surgery and experienced a perioperative cardiovascular dysfunction (N Engl J Med. 2017 Mar 21. doi: 10.1056/NEJMoa1616325).
Subjects were then randomized into a cohort receiving either a placebo or a low dose of levosimendan, which varied between 0.025 to 0.2 mcg/kg of body weight per minute continuously for up to 48 hours. A total of 248 subjects received levosimendan and 258 received placebo. All patients were administered the treatment while in the ICU; patients were taken off their regimen prior to 48 hours if they were discharged from the ICU. Anyone screened for inclusion who already had experienced a negative reaction to levosimendan was excluded from the study.
“We collected preoperative data on baseline characteristics and coexisting conditions, intraoperative and postoperative treatment data, postoperative laboratory values, duration of mechanical ventilation, durations of ICU and hospital stays, and major outcomes,” the authors explained, adding that “telephone follow-up was performed at 30 days and 180 days after randomization by an investigator who was unaware of the trial group assignments.”
The primary outcome of the study was 30-day mortality. The levosimendan cohort experienced 32 deaths (12.9%), while the placebo cohort saw 33 (12.8%), a nonsignificant difference (P = .97) between the two groups. Similarly, the median time spent on mechanical ventilation was 19 hours for those on levosimendan, versus 21 hours for those on placebo (P = .48), and median length of hospital stay was 14 days in both groups (P = .39).
“Previous meta-analyses of randomized, controlled trials showed a higher rate of survival with levosimendan than with other treatment regimens among patients undergoing cardiac surgery,” Dr. Landoni and his coauthors noted. Previous studies also had a number of key differences, such as the number of subjects who underwent coronary artery bypass grafting, the dosing of levosimendan, and inclusion of patients who had reduced preoperative ejection fraction instead of ones with myocardial dysfunction who needed inotropic support, which the current study used.
The study was funded by the Italian Ministry of Health. Dr. Landoni reported receiving nonfinancial support from the Orion Corporation while the study was ongoing; several other coauthors reported similar disclosures.
Key clinical point:
Major finding: Among other things, 30-day mortality rates between levosimendan (12.9%) and placebo (12.8%) cohorts were not significantly different (P = .97).
Data source: The CHEETAH study is a multicenter, randomized, double-blind, placebo-controlled trial of 506 cardiac surgery patients recommended for perioperative hemodynamic support.
Disclosures: Funded by the Italian Ministry of Health. Several coauthors reported potentially relevant conflicts of interest.
Dexmedetomidine improves sedation in sepsis
Use of dexmedetomidine improved sedation among ventilated patients with sepsis, but did not significantly cut mortality rates or increase ventilator-free days in a multicenter, open-label randomized controlled trial.
Twenty-eight days after the start of mechanical ventilation, cumulative mortality rates were 23% among patients who received dexmedetomidine and 31% among those who did not (hazard ratio, 0.7; 95% confidence interval, 0.4 to 1.2; P = .2), Yu Kawazoe, MD, PhD, and his associates reported at the International Symposium on Intensive Care and Emergency Medicine. The report was simultaneously published in JAMA.
“The study may have identified a clinically important benefit of dexmedetomidine – an 8% reduction in 28-day mortality – that did not demonstrate statistical significance ... ” wrote Dr. Kawazoe of Tohoku University Graduate School of Medicine, Sendai, Japan. “Physicians may consider an 8% difference in 28-day mortality to be clinically significant, but this study was underpowered to detect this difference.” 
Dexmedetomidine often is used for sedation during ventilation, but its effects on mortality and ventilator weaning are poorly understood, the researchers noted. However, this highly selective alpha2-adrenergic agonist has been found to suppress inflammation and to protect organs, and “can improve patients’ ability to communicate pain compared with midazolam and propofol,” the researchers wrote. Therefore, they randomly assigned 201 patients with sepsis at eight intensive care units in Japan to receive sedation with or without dexmedetomidine. Both arms received fentanyl, propofol, and midazolam, dosed to achieve Richmond Agitation-Sedation Scale (RASS) scores of 0 (calm) during the day and –2 (lightly sedated) at night (JAMA. 2017 March 21. doi: 10.1001/jama.2017.2088).
The dexmedetomidine group spent a median of 20 days off the ventilator, compared with 18 days for controls (P = .20), the investigators reported. However, dexmedetomidine led to significantly higher rates of well-controlled sedation. The highest rate of well-controlled sedation (defined as having a RASS scores between –3 and 1 throughout 1 day in the ICU) in treated patients was 58%, while the highest rate of well-controlled sedation in the control group was 39% (P = .01).
Rates of adverse events did not significantly differ between groups. Bradycardia was most common, affecting 7% of the intervention group and 2% of controls (P = .1) the researchers said.
Hospira Japan provided partial funding with a grant to Wakayama Medical University, and helped design the study but was otherwise not involved in the research project. Dr. Kawazoe disclosed ties to Hospira Japan and Pfizer Japan. Three coinvestigators disclosed ties to Pfizer Japan, AbbVie, AstraZeneca, Daiichi Sankyo, and several other pharmaceutical companies. The other coinvestigators had no disclosures.
Use of dexmedetomidine improved sedation among ventilated patients with sepsis, but did not significantly cut mortality rates or increase ventilator-free days in a multicenter, open-label randomized controlled trial.
Twenty-eight days after the start of mechanical ventilation, cumulative mortality rates were 23% among patients who received dexmedetomidine and 31% among those who did not (hazard ratio, 0.7; 95% confidence interval, 0.4 to 1.2; P = .2), Yu Kawazoe, MD, PhD, and his associates reported at the International Symposium on Intensive Care and Emergency Medicine. The report was simultaneously published in JAMA.
“The study may have identified a clinically important benefit of dexmedetomidine – an 8% reduction in 28-day mortality – that did not demonstrate statistical significance ... ” wrote Dr. Kawazoe of Tohoku University Graduate School of Medicine, Sendai, Japan. “Physicians may consider an 8% difference in 28-day mortality to be clinically significant, but this study was underpowered to detect this difference.”
Dexmedetomidine often is used for sedation during ventilation, but its effects on mortality and ventilator weaning are poorly understood, the researchers noted. However, this highly selective alpha2-adrenergic agonist has been found to suppress inflammation and to protect organs, and “can improve patients’ ability to communicate pain compared with midazolam and propofol,” the researchers wrote. Therefore, they randomly assigned 201 patients with sepsis at eight intensive care units in Japan to receive sedation with or without dexmedetomidine. Both arms received fentanyl, propofol, and midazolam, dosed to achieve Richmond Agitation-Sedation Scale (RASS) scores of 0 (calm) during the day and –2 (lightly sedated) at night (JAMA. 2017 March 21. doi: 10.1001/jama.2017.2088).
The dexmedetomidine group spent a median of 20 days off the ventilator, compared with 18 days for controls (P = .20), the investigators reported. However, dexmedetomidine led to significantly higher rates of well-controlled sedation. The highest rate of well-controlled sedation (defined as having a RASS scores between –3 and 1 throughout 1 day in the ICU) in treated patients was 58%, while the highest rate of well-controlled sedation in the control group was 39% (P = .01).
Rates of adverse events did not significantly differ between groups. Bradycardia was most common, affecting 7% of the intervention group and 2% of controls (P = .1) the researchers said.
Hospira Japan provided partial funding with a grant to Wakayama Medical University, and helped design the study but was otherwise not involved in the research project. Dr. Kawazoe disclosed ties to Hospira Japan and Pfizer Japan. Three coinvestigators disclosed ties to Pfizer Japan, AbbVie, AstraZeneca, Daiichi Sankyo, and several other pharmaceutical companies. The other coinvestigators had no disclosures.
Use of dexmedetomidine improved sedation among ventilated patients with sepsis, but did not significantly cut mortality rates or increase ventilator-free days in a multicenter, open-label randomized controlled trial.
Twenty-eight days after the start of mechanical ventilation, cumulative mortality rates were 23% among patients who received dexmedetomidine and 31% among those who did not (hazard ratio, 0.7; 95% confidence interval, 0.4 to 1.2; P = .2), Yu Kawazoe, MD, PhD, and his associates reported at the International Symposium on Intensive Care and Emergency Medicine. The report was simultaneously published in JAMA.
“The study may have identified a clinically important benefit of dexmedetomidine – an 8% reduction in 28-day mortality – that did not demonstrate statistical significance ... ” wrote Dr. Kawazoe of Tohoku University Graduate School of Medicine, Sendai, Japan. “Physicians may consider an 8% difference in 28-day mortality to be clinically significant, but this study was underpowered to detect this difference.”
Dexmedetomidine often is used for sedation during ventilation, but its effects on mortality and ventilator weaning are poorly understood, the researchers noted. However, this highly selective alpha2-adrenergic agonist has been found to suppress inflammation and to protect organs, and “can improve patients’ ability to communicate pain compared with midazolam and propofol,” the researchers wrote. Therefore, they randomly assigned 201 patients with sepsis at eight intensive care units in Japan to receive sedation with or without dexmedetomidine. Both arms received fentanyl, propofol, and midazolam, dosed to achieve Richmond Agitation-Sedation Scale (RASS) scores of 0 (calm) during the day and –2 (lightly sedated) at night (JAMA. 2017 March 21. doi: 10.1001/jama.2017.2088).
The dexmedetomidine group spent a median of 20 days off the ventilator, compared with 18 days for controls (P = .20), the investigators reported. However, dexmedetomidine led to significantly higher rates of well-controlled sedation. The highest rate of well-controlled sedation (defined as having a RASS scores between –3 and 1 throughout 1 day in the ICU) in treated patients was 58%, while the highest rate of well-controlled sedation in the control group was 39% (P = .01).
Rates of adverse events did not significantly differ between groups. Bradycardia was most common, affecting 7% of the intervention group and 2% of controls (P = .1) the researchers said.
Hospira Japan provided partial funding with a grant to Wakayama Medical University, and helped design the study but was otherwise not involved in the research project. Dr. Kawazoe disclosed ties to Hospira Japan and Pfizer Japan. Three coinvestigators disclosed ties to Pfizer Japan, AbbVie, AstraZeneca, Daiichi Sankyo, and several other pharmaceutical companies. The other coinvestigators had no disclosures.
Key clinical point. Use of dexmedetomidine improved sedation but did not significantly cut mortality rates or increase ventilator-free days among hospitalized patients with sepsis.
Major finding: Twenty-eight days after the start of mechanical ventilation, cumulative mortality rates were 23% among patients who received dexmedetomidine and 31% among those who did not (hazard ratio, 0.7; 95% confidence interval, 0.4 to 1.2; P = .2).
Data source: A multicenter, open-label randomized controlled trial of 201 ventilated patients with sepsis.
Disclosures: Hospira Japan provided partial funding with a grant to Wakayama Medical University, and helped design the study but was otherwise not involved. Dr. Kawazoe disclosed ties to Hospira Japan and Pfizer Japan. Three coinvestigators disclosed ties to Pfizer Japan, AbbVie, AstraZeneca, Daiichi Sankyo, and several other pharmaceutical companies. The other coinvestigators had no disclosures.
Reinforcing mesh at ostomy site prevents parastomal hernia
For patients undergoing elective permanent colostomy, prophylactic augmentation of the abdominal wall using mesh at the ostomy site prevents the development of parastomal hernia, according to a report published in the April issue of Annals of Surgery.
The incidence of parastomal hernia is expected to rise because of the increasing number of cancer patients surviving with a colostomy, and the rising number of obese patients who have increased tension on the abdominal wall because of their elevated intra-abdominal pressure and larger abdominal radius. Researchers in the Netherlands performed a prospective randomized study, the PREVENT trial, to assess whether augmenting the abdominal wall at the ostomy site, using a lightweight mesh, would be safe, feasible, and effective at preventing parastomal hernia. They reported their findings after 1 year of follow-up; the study will continue until longer-term results are available at 5 years.
In the intervention group, a retromuscular space was created to accommodate the mesh by dissecting the muscle from the posterior fascia or peritoneum to the lateral border via a median laparotomy. An incision was made in the center of the mesh to allow passage of the colon, and the mesh was placed on the posterior rectus sheath and anchored laterally with two absorbable sutures. “On the medial side, the mesh was incorporated in the running suture closing the fascia, thus preventing contact between the mesh and the viscera,” the investigators said (Ann Surg. 2017;265:663-9).
The primary end point – the incidence of parastomal hernia at 1 year – occurred in 3 patients (4.5%) in the intervention group and 16 (24.2%) in the control group, a significant difference. There were no mesh-related complications such as infection, strictures, or adhesions. “The majority of the parastomal hernias that required surgical repair were in the control group, which supports the concept that if a hernia develops in a patient with mesh, it is smaller and less likely to cause complaints,” Dr. Brandsma and his associates said.
Significantly fewer patients in the mesh group (9%) than in the control group (21%) reported stoma-related complaints such as pain, leakage, and skin problems. Scores on measures of quality of life and pain severity were no different between the two study groups.
“Prophylactic augmentation of the abdominal wall with a retromuscular polypropylene mesh at the ostomy site is a safe and feasible procedure with no adverse events. It significantly reduces the incidence of parastomal hernia,” the investigators concluded.
This study was supported by Canisius Wilhelmina Hospital’s surgery research fund, the Netherlands Organization for Health Research and Development, and Covidien/Medtronic. Dr. Brandsma and his associates reported having no relevant financial disclosures.
For patients undergoing elective permanent colostomy, prophylactic augmentation of the abdominal wall using mesh at the ostomy site prevents the development of parastomal hernia, according to a report published in the April issue of Annals of Surgery.
The incidence of parastomal hernia is expected to rise because of the increasing number of cancer patients surviving with a colostomy, and the rising number of obese patients who have increased tension on the abdominal wall because of their elevated intra-abdominal pressure and larger abdominal radius. Researchers in the Netherlands performed a prospective randomized study, the PREVENT trial, to assess whether augmenting the abdominal wall at the ostomy site, using a lightweight mesh, would be safe, feasible, and effective at preventing parastomal hernia. They reported their findings after 1 year of follow-up; the study will continue until longer-term results are available at 5 years.
In the intervention group, a retromuscular space was created to accommodate the mesh by dissecting the muscle from the posterior fascia or peritoneum to the lateral border via a median laparotomy. An incision was made in the center of the mesh to allow passage of the colon, and the mesh was placed on the posterior rectus sheath and anchored laterally with two absorbable sutures. “On the medial side, the mesh was incorporated in the running suture closing the fascia, thus preventing contact between the mesh and the viscera,” the investigators said (Ann Surg. 2017;265:663-9).
The primary end point – the incidence of parastomal hernia at 1 year – occurred in 3 patients (4.5%) in the intervention group and 16 (24.2%) in the control group, a significant difference. There were no mesh-related complications such as infection, strictures, or adhesions. “The majority of the parastomal hernias that required surgical repair were in the control group, which supports the concept that if a hernia develops in a patient with mesh, it is smaller and less likely to cause complaints,” Dr. Brandsma and his associates said.
Significantly fewer patients in the mesh group (9%) than in the control group (21%) reported stoma-related complaints such as pain, leakage, and skin problems. Scores on measures of quality of life and pain severity were no different between the two study groups.
“Prophylactic augmentation of the abdominal wall with a retromuscular polypropylene mesh at the ostomy site is a safe and feasible procedure with no adverse events. It significantly reduces the incidence of parastomal hernia,” the investigators concluded.
This study was supported by Canisius Wilhelmina Hospital’s surgery research fund, the Netherlands Organization for Health Research and Development, and Covidien/Medtronic. Dr. Brandsma and his associates reported having no relevant financial disclosures.
For patients undergoing elective permanent colostomy, prophylactic augmentation of the abdominal wall using mesh at the ostomy site prevents the development of parastomal hernia, according to a report published in the April issue of Annals of Surgery.
The incidence of parastomal hernia is expected to rise because of the increasing number of cancer patients surviving with a colostomy, and the rising number of obese patients who have increased tension on the abdominal wall because of their elevated intra-abdominal pressure and larger abdominal radius. Researchers in the Netherlands performed a prospective randomized study, the PREVENT trial, to assess whether augmenting the abdominal wall at the ostomy site, using a lightweight mesh, would be safe, feasible, and effective at preventing parastomal hernia. They reported their findings after 1 year of follow-up; the study will continue until longer-term results are available at 5 years.
In the intervention group, a retromuscular space was created to accommodate the mesh by dissecting the muscle from the posterior fascia or peritoneum to the lateral border via a median laparotomy. An incision was made in the center of the mesh to allow passage of the colon, and the mesh was placed on the posterior rectus sheath and anchored laterally with two absorbable sutures. “On the medial side, the mesh was incorporated in the running suture closing the fascia, thus preventing contact between the mesh and the viscera,” the investigators said (Ann Surg. 2017;265:663-9).
The primary end point – the incidence of parastomal hernia at 1 year – occurred in 3 patients (4.5%) in the intervention group and 16 (24.2%) in the control group, a significant difference. There were no mesh-related complications such as infection, strictures, or adhesions. “The majority of the parastomal hernias that required surgical repair were in the control group, which supports the concept that if a hernia develops in a patient with mesh, it is smaller and less likely to cause complaints,” Dr. Brandsma and his associates said.
Significantly fewer patients in the mesh group (9%) than in the control group (21%) reported stoma-related complaints such as pain, leakage, and skin problems. Scores on measures of quality of life and pain severity were no different between the two study groups.
“Prophylactic augmentation of the abdominal wall with a retromuscular polypropylene mesh at the ostomy site is a safe and feasible procedure with no adverse events. It significantly reduces the incidence of parastomal hernia,” the investigators concluded.
This study was supported by Canisius Wilhelmina Hospital’s surgery research fund, the Netherlands Organization for Health Research and Development, and Covidien/Medtronic. Dr. Brandsma and his associates reported having no relevant financial disclosures.
FROM THE ANNALS OF SURGERY
Key clinical point: For patients undergoing permanent colostomy, prophylactic augmentation of the abdominal wall using mesh at the ostomy site prevents the development of parastomal hernia.
Major finding: The primary end point – the incidence of parastomal hernia at 1 year – occurred in 3 patients (4.5%) in the intervention group and 16 (24.2%) in the control group.
Data source: A prospective, multicenter, randomized cohort study comparing prophylactic mesh against standard care in 133 adults undergoing elective end-colostomy during a 3-year period.
Disclosures: This study was supported by Canisius Wilhelmina Hospital’s surgery research fund, the Netherlands Organization for Health Research and Development, and Covidien/Medtronic. Dr. Brandsma and his associates reported having no relevant financial disclosures.
LVADs achieve cardiac palliation in muscular dystrophies
At one time, respiratory failure was the primary cause of death in young men and boys with muscular dystrophies, but since improvements in ventilator support have addressed this problem, cardiac complications such as cardiomyopathy have become the main cause of death in this group, with the highest risk of death in people with Duchenne muscular dystrophy (DMD). Researchers from Rome have reported that the novel use of ventricular assist devices in this population can prolong life.
Gianluigi Perri, MD, PhD, of University Hospital and Bambino Gesù Children Hospital in Rome, and his coauthors, shared their experience treating seven patients with dystrophinopathies and dilated cardiomyopathy (DCM) with left ventricular assist devices (LVADs) from February 2011 to February 2016 (J Thorac Cardiovasc Surg. 2017 March;153:669-74). “Our experience indicates that the use of an LVAD as destination therapy in patients with dystrophinopathies with end-stage DCM is feasible, suggesting that it may be suitable as a palliative therapy for the treatment of these patients with no other therapeutic options,” Dr. Perri and his coauthors said.
Heart transplantation is considered the procedure of choice for children with severe advanced heart failure, but transplantation is contraindicated for children with dystrophinopathies because of the risk of respiratory failure and progression of skeletal myopathy leads to limited functional capacity. Hence, Dr. Perri and his coauthors developed their alternative treatment for end-stage heart failure in these children. They used the Jarvik 2000 LVAD (Jarvik Heart Inc., New York) as destination therapy.
Six of the seven patients they operated on had DMD and one had beta-2 sarcoglycan deficit. Their ages ranged from 14.2 to 23.4 years. Two patients had early complications: retropharyngeal bleeding and cholecystectomy; and abdominal bleeding and splenectomy. Two different patients had late complications: gastrostomy; and osteolysis and infection at the pedestal site. Three patients died after the operation: one of stroke at 15 months; one of severe bleeding about 28 months later; and one of lung infection 45 months afterward. Follow-up for the surviving patients ranged from about 2 months to 40 months. Median hospital stay was 77 days.
Dr. Perri and his coauthors noted that the DMD Care Considerations Working Group expanded acceptable therapies for DMD cardiomyopathy to include novel treatments such as mechanical circulatory support and implantable cardioverter-defibrillators.
“Although the best approach remains unclear, it does seem clear that treatment should be more aggressive,” the researchers said. The limited life expectancy of these patients makes transplantation a complicated choice when a shortage of donors is a concern. “Therefore, the alternative therapeutic option is the use of LVAD,” Dr. Perri and his coauthors said.
These patients need care at centers “with a high level of experience of patients with DMD,” the researchers stated. Common comorbidities such as severe kyphoscoliosis and respiratory muscle weakness in this population increase surgical risks.
Dr. Perri and his coauthors used a surgical technique that involved avoiding the left thoracotomy approach common in adults who undergo VAD implantation, because of respiratory insufficiency in these younger patients. They also used cardiopulmonary bypass in all but one patient who had a minimally invasive off-pump procedure through a left anterior minithoracotomy.
The researchers “strongly suggest” noninvasive ventilation after surgery to assist in pulmonary function often compromised by scoliosis and muscle weakness. “Our experience shows that postoperative care can be extremely challenging and is often burdened by unexpected complications,” they noted.
Kyphoscoliosis poses challenges when placing drains, and complications of these patients should be treated only in a specialized center. “Indeed, one of our patients died in a peripheral hospital because they underwent bronchoscopic examination with an endoscope that caused severe and intractable retropharyngeal bleeding,” they said.
The researchers no relevant financial relationships to disclose.
Almost all young men living with Duchenne muscular dystrophy will develop heart failure, but for many of these patients, continuous-flow left ventricular assist devices can provide “reliable support” for up to a decade, David L. S. Morales, MD, of the Heart Institute at Cincinnati Children’s Hospital Medical Center, said in his invited commentary (J Thorac Cardiovasc Surg. 2017;153:675-6)
“The current series demonstrates, as has been shown at our institute as well as others, that one can provide an effective therapy for certain patients with DMD and heart failure,” Dr. Morales said of the work of Dr. Perri and coauthors. Dr. Morales added that maximizing outcomes in this population hinges on finding the appropriate time point for intervention in the disease process.
While “there is still much to be learned,” Dr. Morales said, Dr. Perri and his coauthors have shown that LVAD therapy is an option in patients with DMD and heart failure who have failed other treatments. “These young men may, therefore, have the option to extend their lives and possibly have the opportunity to benefit from the impressive medical advances being made,” he said. “Perhaps they and their families have been provided hope.”
Dr. Morales disclosed relationships with Berlin Heart, HeartWare and Oregon Total Artificial Heart.
Almost all young men living with Duchenne muscular dystrophy will develop heart failure, but for many of these patients, continuous-flow left ventricular assist devices can provide “reliable support” for up to a decade, David L. S. Morales, MD, of the Heart Institute at Cincinnati Children’s Hospital Medical Center, said in his invited commentary (J Thorac Cardiovasc Surg. 2017;153:675-6)
“The current series demonstrates, as has been shown at our institute as well as others, that one can provide an effective therapy for certain patients with DMD and heart failure,” Dr. Morales said of the work of Dr. Perri and coauthors. Dr. Morales added that maximizing outcomes in this population hinges on finding the appropriate time point for intervention in the disease process.
While “there is still much to be learned,” Dr. Morales said, Dr. Perri and his coauthors have shown that LVAD therapy is an option in patients with DMD and heart failure who have failed other treatments. “These young men may, therefore, have the option to extend their lives and possibly have the opportunity to benefit from the impressive medical advances being made,” he said. “Perhaps they and their families have been provided hope.”
Dr. Morales disclosed relationships with Berlin Heart, HeartWare and Oregon Total Artificial Heart.
Almost all young men living with Duchenne muscular dystrophy will develop heart failure, but for many of these patients, continuous-flow left ventricular assist devices can provide “reliable support” for up to a decade, David L. S. Morales, MD, of the Heart Institute at Cincinnati Children’s Hospital Medical Center, said in his invited commentary (J Thorac Cardiovasc Surg. 2017;153:675-6)
“The current series demonstrates, as has been shown at our institute as well as others, that one can provide an effective therapy for certain patients with DMD and heart failure,” Dr. Morales said of the work of Dr. Perri and coauthors. Dr. Morales added that maximizing outcomes in this population hinges on finding the appropriate time point for intervention in the disease process.
While “there is still much to be learned,” Dr. Morales said, Dr. Perri and his coauthors have shown that LVAD therapy is an option in patients with DMD and heart failure who have failed other treatments. “These young men may, therefore, have the option to extend their lives and possibly have the opportunity to benefit from the impressive medical advances being made,” he said. “Perhaps they and their families have been provided hope.”
Dr. Morales disclosed relationships with Berlin Heart, HeartWare and Oregon Total Artificial Heart.
At one time, respiratory failure was the primary cause of death in young men and boys with muscular dystrophies, but since improvements in ventilator support have addressed this problem, cardiac complications such as cardiomyopathy have become the main cause of death in this group, with the highest risk of death in people with Duchenne muscular dystrophy (DMD). Researchers from Rome have reported that the novel use of ventricular assist devices in this population can prolong life.
Gianluigi Perri, MD, PhD, of University Hospital and Bambino Gesù Children Hospital in Rome, and his coauthors, shared their experience treating seven patients with dystrophinopathies and dilated cardiomyopathy (DCM) with left ventricular assist devices (LVADs) from February 2011 to February 2016 (J Thorac Cardiovasc Surg. 2017 March;153:669-74). “Our experience indicates that the use of an LVAD as destination therapy in patients with dystrophinopathies with end-stage DCM is feasible, suggesting that it may be suitable as a palliative therapy for the treatment of these patients with no other therapeutic options,” Dr. Perri and his coauthors said.
Heart transplantation is considered the procedure of choice for children with severe advanced heart failure, but transplantation is contraindicated for children with dystrophinopathies because of the risk of respiratory failure and progression of skeletal myopathy leads to limited functional capacity. Hence, Dr. Perri and his coauthors developed their alternative treatment for end-stage heart failure in these children. They used the Jarvik 2000 LVAD (Jarvik Heart Inc., New York) as destination therapy.
Six of the seven patients they operated on had DMD and one had beta-2 sarcoglycan deficit. Their ages ranged from 14.2 to 23.4 years. Two patients had early complications: retropharyngeal bleeding and cholecystectomy; and abdominal bleeding and splenectomy. Two different patients had late complications: gastrostomy; and osteolysis and infection at the pedestal site. Three patients died after the operation: one of stroke at 15 months; one of severe bleeding about 28 months later; and one of lung infection 45 months afterward. Follow-up for the surviving patients ranged from about 2 months to 40 months. Median hospital stay was 77 days.
Dr. Perri and his coauthors noted that the DMD Care Considerations Working Group expanded acceptable therapies for DMD cardiomyopathy to include novel treatments such as mechanical circulatory support and implantable cardioverter-defibrillators.
“Although the best approach remains unclear, it does seem clear that treatment should be more aggressive,” the researchers said. The limited life expectancy of these patients makes transplantation a complicated choice when a shortage of donors is a concern. “Therefore, the alternative therapeutic option is the use of LVAD,” Dr. Perri and his coauthors said.
These patients need care at centers “with a high level of experience of patients with DMD,” the researchers stated. Common comorbidities such as severe kyphoscoliosis and respiratory muscle weakness in this population increase surgical risks.
Dr. Perri and his coauthors used a surgical technique that involved avoiding the left thoracotomy approach common in adults who undergo VAD implantation, because of respiratory insufficiency in these younger patients. They also used cardiopulmonary bypass in all but one patient who had a minimally invasive off-pump procedure through a left anterior minithoracotomy.
The researchers “strongly suggest” noninvasive ventilation after surgery to assist in pulmonary function often compromised by scoliosis and muscle weakness. “Our experience shows that postoperative care can be extremely challenging and is often burdened by unexpected complications,” they noted.
Kyphoscoliosis poses challenges when placing drains, and complications of these patients should be treated only in a specialized center. “Indeed, one of our patients died in a peripheral hospital because they underwent bronchoscopic examination with an endoscope that caused severe and intractable retropharyngeal bleeding,” they said.
The researchers no relevant financial relationships to disclose.
At one time, respiratory failure was the primary cause of death in young men and boys with muscular dystrophies, but since improvements in ventilator support have addressed this problem, cardiac complications such as cardiomyopathy have become the main cause of death in this group, with the highest risk of death in people with Duchenne muscular dystrophy (DMD). Researchers from Rome have reported that the novel use of ventricular assist devices in this population can prolong life.
Gianluigi Perri, MD, PhD, of University Hospital and Bambino Gesù Children Hospital in Rome, and his coauthors, shared their experience treating seven patients with dystrophinopathies and dilated cardiomyopathy (DCM) with left ventricular assist devices (LVADs) from February 2011 to February 2016 (J Thorac Cardiovasc Surg. 2017 March;153:669-74). “Our experience indicates that the use of an LVAD as destination therapy in patients with dystrophinopathies with end-stage DCM is feasible, suggesting that it may be suitable as a palliative therapy for the treatment of these patients with no other therapeutic options,” Dr. Perri and his coauthors said.
Heart transplantation is considered the procedure of choice for children with severe advanced heart failure, but transplantation is contraindicated for children with dystrophinopathies because of the risk of respiratory failure and progression of skeletal myopathy leads to limited functional capacity. Hence, Dr. Perri and his coauthors developed their alternative treatment for end-stage heart failure in these children. They used the Jarvik 2000 LVAD (Jarvik Heart Inc., New York) as destination therapy.
Six of the seven patients they operated on had DMD and one had beta-2 sarcoglycan deficit. Their ages ranged from 14.2 to 23.4 years. Two patients had early complications: retropharyngeal bleeding and cholecystectomy; and abdominal bleeding and splenectomy. Two different patients had late complications: gastrostomy; and osteolysis and infection at the pedestal site. Three patients died after the operation: one of stroke at 15 months; one of severe bleeding about 28 months later; and one of lung infection 45 months afterward. Follow-up for the surviving patients ranged from about 2 months to 40 months. Median hospital stay was 77 days.
Dr. Perri and his coauthors noted that the DMD Care Considerations Working Group expanded acceptable therapies for DMD cardiomyopathy to include novel treatments such as mechanical circulatory support and implantable cardioverter-defibrillators.
“Although the best approach remains unclear, it does seem clear that treatment should be more aggressive,” the researchers said. The limited life expectancy of these patients makes transplantation a complicated choice when a shortage of donors is a concern. “Therefore, the alternative therapeutic option is the use of LVAD,” Dr. Perri and his coauthors said.
These patients need care at centers “with a high level of experience of patients with DMD,” the researchers stated. Common comorbidities such as severe kyphoscoliosis and respiratory muscle weakness in this population increase surgical risks.
Dr. Perri and his coauthors used a surgical technique that involved avoiding the left thoracotomy approach common in adults who undergo VAD implantation, because of respiratory insufficiency in these younger patients. They also used cardiopulmonary bypass in all but one patient who had a minimally invasive off-pump procedure through a left anterior minithoracotomy.
The researchers “strongly suggest” noninvasive ventilation after surgery to assist in pulmonary function often compromised by scoliosis and muscle weakness. “Our experience shows that postoperative care can be extremely challenging and is often burdened by unexpected complications,” they noted.
Kyphoscoliosis poses challenges when placing drains, and complications of these patients should be treated only in a specialized center. “Indeed, one of our patients died in a peripheral hospital because they underwent bronchoscopic examination with an endoscope that caused severe and intractable retropharyngeal bleeding,” they said.
The researchers no relevant financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: A left ventricular assist device can be used as destination therapy in patients with Duchenne muscular dystrophy dystrophinopathies and end-stage dilated cardiomyopathy.
Major finding: Four of seven patients who had LVAD survived long term, and survival for the three who died ranged from 15 to 44 months.
Data source: Single-center, retrospective review of seven patients with DMD who had LVAD for DCM from February 2011 to February 2016.
Disclosure: Dr. Perri and his coauthors reported having no relevant financial disclosures.
Preoperative variables can predict prolonged air leak
Prolonged air leak is a well-known complication after lung cancer surgery that can worsen patient outcomes and drive up costs, and while international authors have developed tools to calculate the risk of PAL, their use has been limited in the United States for various reasons. Researchers at the University of Pittsburgh have reported on a predictive model that uses easy-to-obtain patient factors, such as forced expiratory volume and smoking history, to help surgeons identify patients at greatest risk for complications and implement preventative measures.
Adam Attaar and his coauthors reported that their nomogram had an accuracy rate of 76%, with a 95% confidence interval, for predicting PAL after surgery (J Thorac Cardiovasc Surg. 2017 March;153[3]:690-9). “Using readily available candidate variables, our nomogram predicts increasing risk of prolonged air leak with good discriminatory ability,” noted Mr. Attaar, a student at University of Pittsburgh, and his coauthors.
Previously published reports put the incidence of PAL complications at 6%-18%, they noted. In the University of Pittsburgh series of 2,317 patients who had pulmonary resection for lung cancer or nodules from January 2009 to June 2014, the incidence was 8.6%.
In this series, patients with PAL were more likely to be older, men, and smokers, and to have a lower body mass index, peripheral vascular disease, chronic obstructive pulmonary disease, a history of steroid use, a high Zubrod score and lower forced expiratory volume.“They were less likely to have diabetes or to be hospitalized before surgery,” the researchers said. Surgical factors that characterized patients with PAL were resection for primary lung cancer rather than benign or metastatic tumors; lobectomy/segmentectomy or bilobectomy rather than wedge resection; a right-sided resection; thoracotomy; and a surgeon with higher annual caseloads.
Not all those factors made it into the nomogram, however. The nomogram scores each of these 10 variables to calculate the risk of PAL, in order of their weighting: lower forced expiratory volume, procedure type, BMI, right-sided thoracotomy, preoperative hospitalization, annual surgeon caseload, wedge resection by thoracotomy, reoperation, smoking history, and Zubrod score. A second nomogram drops out surgeon volume to make it more generalizable to other institutions.
In explaining higher surgeon volume as a risk factor for PAL, the researchers said that high-volume surgeons may be operating on patients with variables not accounted for in the Society of Thoracic Surgeons General Thoracic Surgery Database. “These unmeasured variables … could reveal modifiable technical factors to reduce the incidence of PAL and require further study,” the researchers said.
Fast-track discharge has gained acceptance in recent years as a way to spare patients a prolonged hospital stay and cut costs, but in this series the median hospital stay for patients with PAL was 10 days vs. 4 days for non-PAL patients (P less than 0.001).
“An accurate and generalizable PAL risk stratification tool could facilitate surgical decision making and patient-specific care” and aid in the design of trials to evaluate air-leak reduction methods such as sealants, buttressed staple lines, and pneumoperitoneum the researchers wrote.
Going forward, further development of the model would involve a multicenter study and inclusion of risk factors not accounted for in the thoracic surgery database, they noted.
The researchers had no relevant financial relationships to disclose.
The authors of this study “have performed a rigorous set of analyses to create this model,” Chi-Fu Jeffrey Yang, MD, of Duke University, Durham, N.C., noted in his invited commentary (J Thorac Cardiovasc Surg. 2017 March;53[3]:700-1). “The strengths of this study include its sound statistical analysis and study design,” Dr. Yang wrote. He gave the authors credit for using bootstrapping to internally validate the model.
However, Dr. Yang said that the database used by the researchers did not account for “numerous important variables,” including presence of pleural adhesions and emphysema status. The analysis also grouped lobectomy and segmentectomy together, and did not consider intraoperative variables such as sealant use, or postoperative management.
While Dr. Yang commended the study authors for developing a “reliable nomogram,” getting it implemented in the clinic is another hurdle. “It is commonly cited that it takes approximately 17 years for research evidence to translate into daily practice,” he said. To shorten that time line, he suggested the authors take a cue from various tech groups: Develop an app that surgeons can use.
Dr. Yang had no relevant financial relationships to disclose.
The authors of this study “have performed a rigorous set of analyses to create this model,” Chi-Fu Jeffrey Yang, MD, of Duke University, Durham, N.C., noted in his invited commentary (J Thorac Cardiovasc Surg. 2017 March;53[3]:700-1). “The strengths of this study include its sound statistical analysis and study design,” Dr. Yang wrote. He gave the authors credit for using bootstrapping to internally validate the model.
However, Dr. Yang said that the database used by the researchers did not account for “numerous important variables,” including presence of pleural adhesions and emphysema status. The analysis also grouped lobectomy and segmentectomy together, and did not consider intraoperative variables such as sealant use, or postoperative management.
While Dr. Yang commended the study authors for developing a “reliable nomogram,” getting it implemented in the clinic is another hurdle. “It is commonly cited that it takes approximately 17 years for research evidence to translate into daily practice,” he said. To shorten that time line, he suggested the authors take a cue from various tech groups: Develop an app that surgeons can use.
Dr. Yang had no relevant financial relationships to disclose.
The authors of this study “have performed a rigorous set of analyses to create this model,” Chi-Fu Jeffrey Yang, MD, of Duke University, Durham, N.C., noted in his invited commentary (J Thorac Cardiovasc Surg. 2017 March;53[3]:700-1). “The strengths of this study include its sound statistical analysis and study design,” Dr. Yang wrote. He gave the authors credit for using bootstrapping to internally validate the model.
However, Dr. Yang said that the database used by the researchers did not account for “numerous important variables,” including presence of pleural adhesions and emphysema status. The analysis also grouped lobectomy and segmentectomy together, and did not consider intraoperative variables such as sealant use, or postoperative management.
While Dr. Yang commended the study authors for developing a “reliable nomogram,” getting it implemented in the clinic is another hurdle. “It is commonly cited that it takes approximately 17 years for research evidence to translate into daily practice,” he said. To shorten that time line, he suggested the authors take a cue from various tech groups: Develop an app that surgeons can use.
Dr. Yang had no relevant financial relationships to disclose.
Prolonged air leak is a well-known complication after lung cancer surgery that can worsen patient outcomes and drive up costs, and while international authors have developed tools to calculate the risk of PAL, their use has been limited in the United States for various reasons. Researchers at the University of Pittsburgh have reported on a predictive model that uses easy-to-obtain patient factors, such as forced expiratory volume and smoking history, to help surgeons identify patients at greatest risk for complications and implement preventative measures.
Adam Attaar and his coauthors reported that their nomogram had an accuracy rate of 76%, with a 95% confidence interval, for predicting PAL after surgery (J Thorac Cardiovasc Surg. 2017 March;153[3]:690-9). “Using readily available candidate variables, our nomogram predicts increasing risk of prolonged air leak with good discriminatory ability,” noted Mr. Attaar, a student at University of Pittsburgh, and his coauthors.
Previously published reports put the incidence of PAL complications at 6%-18%, they noted. In the University of Pittsburgh series of 2,317 patients who had pulmonary resection for lung cancer or nodules from January 2009 to June 2014, the incidence was 8.6%.
In this series, patients with PAL were more likely to be older, men, and smokers, and to have a lower body mass index, peripheral vascular disease, chronic obstructive pulmonary disease, a history of steroid use, a high Zubrod score and lower forced expiratory volume.“They were less likely to have diabetes or to be hospitalized before surgery,” the researchers said. Surgical factors that characterized patients with PAL were resection for primary lung cancer rather than benign or metastatic tumors; lobectomy/segmentectomy or bilobectomy rather than wedge resection; a right-sided resection; thoracotomy; and a surgeon with higher annual caseloads.
Not all those factors made it into the nomogram, however. The nomogram scores each of these 10 variables to calculate the risk of PAL, in order of their weighting: lower forced expiratory volume, procedure type, BMI, right-sided thoracotomy, preoperative hospitalization, annual surgeon caseload, wedge resection by thoracotomy, reoperation, smoking history, and Zubrod score. A second nomogram drops out surgeon volume to make it more generalizable to other institutions.
In explaining higher surgeon volume as a risk factor for PAL, the researchers said that high-volume surgeons may be operating on patients with variables not accounted for in the Society of Thoracic Surgeons General Thoracic Surgery Database. “These unmeasured variables … could reveal modifiable technical factors to reduce the incidence of PAL and require further study,” the researchers said.
Fast-track discharge has gained acceptance in recent years as a way to spare patients a prolonged hospital stay and cut costs, but in this series the median hospital stay for patients with PAL was 10 days vs. 4 days for non-PAL patients (P less than 0.001).
“An accurate and generalizable PAL risk stratification tool could facilitate surgical decision making and patient-specific care” and aid in the design of trials to evaluate air-leak reduction methods such as sealants, buttressed staple lines, and pneumoperitoneum the researchers wrote.
Going forward, further development of the model would involve a multicenter study and inclusion of risk factors not accounted for in the thoracic surgery database, they noted.
The researchers had no relevant financial relationships to disclose.
Prolonged air leak is a well-known complication after lung cancer surgery that can worsen patient outcomes and drive up costs, and while international authors have developed tools to calculate the risk of PAL, their use has been limited in the United States for various reasons. Researchers at the University of Pittsburgh have reported on a predictive model that uses easy-to-obtain patient factors, such as forced expiratory volume and smoking history, to help surgeons identify patients at greatest risk for complications and implement preventative measures.
Adam Attaar and his coauthors reported that their nomogram had an accuracy rate of 76%, with a 95% confidence interval, for predicting PAL after surgery (J Thorac Cardiovasc Surg. 2017 March;153[3]:690-9). “Using readily available candidate variables, our nomogram predicts increasing risk of prolonged air leak with good discriminatory ability,” noted Mr. Attaar, a student at University of Pittsburgh, and his coauthors.
Previously published reports put the incidence of PAL complications at 6%-18%, they noted. In the University of Pittsburgh series of 2,317 patients who had pulmonary resection for lung cancer or nodules from January 2009 to June 2014, the incidence was 8.6%.
In this series, patients with PAL were more likely to be older, men, and smokers, and to have a lower body mass index, peripheral vascular disease, chronic obstructive pulmonary disease, a history of steroid use, a high Zubrod score and lower forced expiratory volume.“They were less likely to have diabetes or to be hospitalized before surgery,” the researchers said. Surgical factors that characterized patients with PAL were resection for primary lung cancer rather than benign or metastatic tumors; lobectomy/segmentectomy or bilobectomy rather than wedge resection; a right-sided resection; thoracotomy; and a surgeon with higher annual caseloads.
Not all those factors made it into the nomogram, however. The nomogram scores each of these 10 variables to calculate the risk of PAL, in order of their weighting: lower forced expiratory volume, procedure type, BMI, right-sided thoracotomy, preoperative hospitalization, annual surgeon caseload, wedge resection by thoracotomy, reoperation, smoking history, and Zubrod score. A second nomogram drops out surgeon volume to make it more generalizable to other institutions.
In explaining higher surgeon volume as a risk factor for PAL, the researchers said that high-volume surgeons may be operating on patients with variables not accounted for in the Society of Thoracic Surgeons General Thoracic Surgery Database. “These unmeasured variables … could reveal modifiable technical factors to reduce the incidence of PAL and require further study,” the researchers said.
Fast-track discharge has gained acceptance in recent years as a way to spare patients a prolonged hospital stay and cut costs, but in this series the median hospital stay for patients with PAL was 10 days vs. 4 days for non-PAL patients (P less than 0.001).
“An accurate and generalizable PAL risk stratification tool could facilitate surgical decision making and patient-specific care” and aid in the design of trials to evaluate air-leak reduction methods such as sealants, buttressed staple lines, and pneumoperitoneum the researchers wrote.
Going forward, further development of the model would involve a multicenter study and inclusion of risk factors not accounted for in the thoracic surgery database, they noted.
The researchers had no relevant financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Preoperative variables can be evaluated to determine patient risk for prolonged air leak (PAL) in lung resection for cancer.
Major finding: A nomogram demonstrated 76% discriminatory accuracy in predicting PAL after lung resection.
Data source: Analysis of 2,522 pulmonary resections performed at eight hospitals within the University of Pittsburgh health system from January 2009 to June 2014.
Disclosures: The researchers had no conflicts of interest to disclose.
ACS launches AHRQ Safety Program for ERAS
The American College of Surgeons (ACS), in collaboration with the Johns Hopkins Medicine Armstrong Institute for Patient Safety and Quality, Baltimore, MD, has launched the AHRQ (Agency for Healthcare Research and Quality) Safety Program for Enhanced Recovery after Surgery (ERAS). This new surgical quality improvement program is funded and guided by AHRQ.
The AHRQ Safety Program for ERAS will support hospitals in implementing perioperative evidence-based protocols to meaningfully improve clinical outcomes, reduce health care utilization, and improve the patient experience. This program aims to enroll at least 750 hospitals throughout the five-year contract. Hospitals within the U.S., Puerto Rico, and the District of Columbia are eligible to participate across five service lines: colorectal, orthopaedic, bariatric, gynecology, and emergency general surgery.
Participating hospitals will have access to the international leaders in ERAS, including representatives of surgery, anesthesiology, and nursing; prototype ERAS protocols developed for five procedures based on up-to-date evidence review; literature to support protocols; tools and educational materials to facilitate implementation; quality improvement specialist support; and coaching calls to support hospital work.
Program enrollment will begin in spring 2017. For more information, contact [email protected].
The American College of Surgeons (ACS), in collaboration with the Johns Hopkins Medicine Armstrong Institute for Patient Safety and Quality, Baltimore, MD, has launched the AHRQ (Agency for Healthcare Research and Quality) Safety Program for Enhanced Recovery after Surgery (ERAS). This new surgical quality improvement program is funded and guided by AHRQ.
The AHRQ Safety Program for ERAS will support hospitals in implementing perioperative evidence-based protocols to meaningfully improve clinical outcomes, reduce health care utilization, and improve the patient experience. This program aims to enroll at least 750 hospitals throughout the five-year contract. Hospitals within the U.S., Puerto Rico, and the District of Columbia are eligible to participate across five service lines: colorectal, orthopaedic, bariatric, gynecology, and emergency general surgery.
Participating hospitals will have access to the international leaders in ERAS, including representatives of surgery, anesthesiology, and nursing; prototype ERAS protocols developed for five procedures based on up-to-date evidence review; literature to support protocols; tools and educational materials to facilitate implementation; quality improvement specialist support; and coaching calls to support hospital work.
Program enrollment will begin in spring 2017. For more information, contact [email protected].
The American College of Surgeons (ACS), in collaboration with the Johns Hopkins Medicine Armstrong Institute for Patient Safety and Quality, Baltimore, MD, has launched the AHRQ (Agency for Healthcare Research and Quality) Safety Program for Enhanced Recovery after Surgery (ERAS). This new surgical quality improvement program is funded and guided by AHRQ.
The AHRQ Safety Program for ERAS will support hospitals in implementing perioperative evidence-based protocols to meaningfully improve clinical outcomes, reduce health care utilization, and improve the patient experience. This program aims to enroll at least 750 hospitals throughout the five-year contract. Hospitals within the U.S., Puerto Rico, and the District of Columbia are eligible to participate across five service lines: colorectal, orthopaedic, bariatric, gynecology, and emergency general surgery.
Participating hospitals will have access to the international leaders in ERAS, including representatives of surgery, anesthesiology, and nursing; prototype ERAS protocols developed for five procedures based on up-to-date evidence review; literature to support protocols; tools and educational materials to facilitate implementation; quality improvement specialist support; and coaching calls to support hospital work.
Program enrollment will begin in spring 2017. For more information, contact [email protected].
Surgical History Group student and resident papers now available online
The Surgical History Group (SHG) of the American College of Surgeons (ACS) has unveiled the inaugural issue of the Bulletin of the Surgical History Group: Papers from the 2016 Poster Competition. This publication is a compendium of articles based on abstracts that medical students and residents submitted for the SHG’s poster competition at Clinical Congress 2016 in Washington, DC.
The SHG sponsors a poster competition at the annual Clinical Congress, featuring the scholarly work of students and residents. Submissions cover a range of surgical history topics.
More than 40 abstracts were submitted for presentation at Clinical Congress 2016 in Washington, DC. A panel of judges led by J. Patrick O’Leary, MD, FACS, and Patrick Greiffenstein, MD, FACS, Chair and Co-Chair, respectively, of the Poster Competition Committee, selected 21 posters for the program and chose two posters among the high-quality entries for top prizes. The SHG decided that the students’ and residents’ scholarship deserved wider distribution in a more permanent format than posters. All participants were invited to submit their work in written form for this collection of articles available for the study and enjoyment of both Fellows and the public interested in the history of surgery.
The e-bulletin can be accessed on the SHG website at facs.org/about-acs/archives/shg.
The Surgical History Group (SHG) of the American College of Surgeons (ACS) has unveiled the inaugural issue of the Bulletin of the Surgical History Group: Papers from the 2016 Poster Competition. This publication is a compendium of articles based on abstracts that medical students and residents submitted for the SHG’s poster competition at Clinical Congress 2016 in Washington, DC.
The SHG sponsors a poster competition at the annual Clinical Congress, featuring the scholarly work of students and residents. Submissions cover a range of surgical history topics.
More than 40 abstracts were submitted for presentation at Clinical Congress 2016 in Washington, DC. A panel of judges led by J. Patrick O’Leary, MD, FACS, and Patrick Greiffenstein, MD, FACS, Chair and Co-Chair, respectively, of the Poster Competition Committee, selected 21 posters for the program and chose two posters among the high-quality entries for top prizes. The SHG decided that the students’ and residents’ scholarship deserved wider distribution in a more permanent format than posters. All participants were invited to submit their work in written form for this collection of articles available for the study and enjoyment of both Fellows and the public interested in the history of surgery.
The e-bulletin can be accessed on the SHG website at facs.org/about-acs/archives/shg.
The Surgical History Group (SHG) of the American College of Surgeons (ACS) has unveiled the inaugural issue of the Bulletin of the Surgical History Group: Papers from the 2016 Poster Competition. This publication is a compendium of articles based on abstracts that medical students and residents submitted for the SHG’s poster competition at Clinical Congress 2016 in Washington, DC.
The SHG sponsors a poster competition at the annual Clinical Congress, featuring the scholarly work of students and residents. Submissions cover a range of surgical history topics.
More than 40 abstracts were submitted for presentation at Clinical Congress 2016 in Washington, DC. A panel of judges led by J. Patrick O’Leary, MD, FACS, and Patrick Greiffenstein, MD, FACS, Chair and Co-Chair, respectively, of the Poster Competition Committee, selected 21 posters for the program and chose two posters among the high-quality entries for top prizes. The SHG decided that the students’ and residents’ scholarship deserved wider distribution in a more permanent format than posters. All participants were invited to submit their work in written form for this collection of articles available for the study and enjoyment of both Fellows and the public interested in the history of surgery.
The e-bulletin can be accessed on the SHG website at facs.org/about-acs/archives/shg.