Official Newspaper of the American College of Surgeons

Top Sections
From the Editor
Palliative Care
The Right Choice?
The Rural Surgeon
sn
Main menu
SN Main Menu
Explore menu
SN Explore Menu
Proclivity ID
18821001
Unpublish
Specialty Focus
Pain
Colon and Rectal
General Surgery
Plastic Surgery
Cardiothoracic
Altmetric
Article Authors "autobrand" affiliation
MDedge News
DSM Affiliated
Display in offset block
Disqus Exclude
Best Practices
CE/CME
Education Center
Medical Education Library
Enable Disqus
Display Author and Disclosure Link
Publication Type
News
Slot System
Top 25
Disable Sticky Ads
Disable Ad Block Mitigation
Featured Buckets Admin
Show Ads on this Publication's Homepage
Consolidated Pub
Show Article Page Numbers on TOC
Display logo in consolidated pubs except when content has these publications
Use larger logo size
Off
publication_blueconic_enabled
Off
Show More Destinations Menu
Disable Adhesion on Publication
Off
Restore Menu Label on Mobile Navigation
Disable Facebook Pixel from Publication
Exclude this publication from publication selection on articles and quiz

ACS-COSECSA Women Scholars Program now accepting applications

Article Type
Changed
Wed, 01/02/2019 - 10:06

 

To help address the severe shortage of surgeons in Sub-Saharan Africa, the American College of Surgeons (ACS) and the College of Surgeons of East, Central, and Southern Africa (COSECSA) have developed a scholarship program to support women in surgical residency, help them complete their training, and encourage other women in medicine to consider surgery as a profession. 

The program is open to senior female surgical residents enrolled in the COSECSA region. Each $2,500 scholarship will go toward educational expenses, including accreditation, the fellowship examination, and five-years of membership dues to COSECSA and the ACS.  Applicants should include a personal statement indicating future goals, a current curriculum vitae, and a letter of support from the surgical training program director.  Completed applications should be sent via e-mail to [email protected] and will be reviewed in conjunction with the Operation Giving Back committee. 

Applications are due no later than April 1.  Contact [email protected] with any questions. 

Publications
Topics
Sections

 

To help address the severe shortage of surgeons in Sub-Saharan Africa, the American College of Surgeons (ACS) and the College of Surgeons of East, Central, and Southern Africa (COSECSA) have developed a scholarship program to support women in surgical residency, help them complete their training, and encourage other women in medicine to consider surgery as a profession. 

The program is open to senior female surgical residents enrolled in the COSECSA region. Each $2,500 scholarship will go toward educational expenses, including accreditation, the fellowship examination, and five-years of membership dues to COSECSA and the ACS.  Applicants should include a personal statement indicating future goals, a current curriculum vitae, and a letter of support from the surgical training program director.  Completed applications should be sent via e-mail to [email protected] and will be reviewed in conjunction with the Operation Giving Back committee. 

Applications are due no later than April 1.  Contact [email protected] with any questions. 

 

To help address the severe shortage of surgeons in Sub-Saharan Africa, the American College of Surgeons (ACS) and the College of Surgeons of East, Central, and Southern Africa (COSECSA) have developed a scholarship program to support women in surgical residency, help them complete their training, and encourage other women in medicine to consider surgery as a profession. 

The program is open to senior female surgical residents enrolled in the COSECSA region. Each $2,500 scholarship will go toward educational expenses, including accreditation, the fellowship examination, and five-years of membership dues to COSECSA and the ACS.  Applicants should include a personal statement indicating future goals, a current curriculum vitae, and a letter of support from the surgical training program director.  Completed applications should be sent via e-mail to [email protected] and will be reviewed in conjunction with the Operation Giving Back committee. 

Applications are due no later than April 1.  Contact [email protected] with any questions. 

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default

Easing into laparoscopic colectomy

Article Type
Changed
Wed, 01/02/2019 - 10:07

Minimally invasive techniques have clear benefits for colectomy, including reduced hospital length of stay, less pain, faster return to work, and reduced incidence of adhesive small bowel obstructions. But the methods are underutilized, in part because they can be challenging to learn.

copyright monkeybusinessimages/Thinkstock
But he believes that the hand-assist technique gets a bad rap because of selection bias. More difficult cases are done with the hand-assist approach, and tend to have worse outcomes. “[Hand assist] is awfully useful for some of these tougher cases,” said Dr. Paquette. In challenging cases, surgeons can convert a laparoscopic surgery to a hand-assist procedure rather than an open procedure, though this requires some practice in keeping your free hand away from the dissection.

One high-volume surgeon showed what happened over time when his practice employed hand-assisted laparoscopy for diverticulitis cases (Dis Colon Rectum. 2014;57[9]1090-7). Initially, most cases were done with the hand-assist technique. Over time, that percentage dropped precipitously and the number that were performed laparoscopically rose sharply. Throughout the study period, the percentage of open procedures remained very low, dropping to almost zero near the conclusion. “They were able to keep their experience of open surgery quite low by using hand-assisted techniques to help with the tough cases of diverticular disease and get over that learning curve,” said Dr. Paquette.

In colon cancer, the study found that laparoscopic procedures hovered around 50%, while open and hand-assisted techniques tended to be around 20%. The higher incidence of open procedures was probably due to the desire of surgeons to be certain that the entire tumor has been excised. “If you’re in doubt, you don’t compromise on oncology. You do an open procedure if you need to,” said Dr. Paquette.

Another tool available to surgeons is single-incision laparoscopic colectomy, as opposed to conventional multiport laparoscopic colectomy. The method results in a very small incision, but can be challenging because the instruments are closer together and it is tricky when the surgeon has to cross the instrument, he said.

Dr. Paquette’s own group also looked at extraction in hand-assisted sigmoid colectomy, in which the surgeon went in laparoscopically, mobilized the colon laterally as would be done in an open procedure, and then performed the colectomy through a small extraction incision. The length of stay was about 15% shorter, there was a lower readmission rate, and gastrointestinal function returned more quickly (Surg Endosc. 2016 Aug;30[8]:3567-72).

Can patients who previously underwent a midline laparotomy be treated laparoscopically? “The answer is possibly yes,” said Dr. Paquette. He noted one study that showed higher rates of minor morbidity, ileotomy, and longer length of stay with laparoscopic treatment (Surg Endosc. 2015;29[3]537-42). “It’s a worth a try if you carefully plan where you’re going to go in through your ports, get in off the midline somewhere if you have to, and just take a look. If you have some adhesions of the omentum to the abdominal wall, it’s really no problem and you can proceed. If you have a frozen abdomen, just do the right thing and open the patient,” said Dr. Paquette.

When it comes to extraction options, Pfannenstiel incisions have the lowest rates of incisional hernias, at 1.9%, according to a survey of 2,148 cases at the Cleveland Clinic. The periumbilical midline incision had the highest frequency at 16.2% (Dis Colon Rectum. 2016 Aug;59[8]:743-50).

“If I’m doing a laparoscopic sigmoid or a laparoscopic low anterior, I do prefer to do a Pfannenstiel incision if I can. If you think that you may need to convert that patient for some reason, don’t do the Pfannenstiel first – nobody wants that big T-shaped incision,” said Dr. Paquette.

Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Paquette has consulted for Ethicon.
 

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

Minimally invasive techniques have clear benefits for colectomy, including reduced hospital length of stay, less pain, faster return to work, and reduced incidence of adhesive small bowel obstructions. But the methods are underutilized, in part because they can be challenging to learn.

copyright monkeybusinessimages/Thinkstock
But he believes that the hand-assist technique gets a bad rap because of selection bias. More difficult cases are done with the hand-assist approach, and tend to have worse outcomes. “[Hand assist] is awfully useful for some of these tougher cases,” said Dr. Paquette. In challenging cases, surgeons can convert a laparoscopic surgery to a hand-assist procedure rather than an open procedure, though this requires some practice in keeping your free hand away from the dissection.

One high-volume surgeon showed what happened over time when his practice employed hand-assisted laparoscopy for diverticulitis cases (Dis Colon Rectum. 2014;57[9]1090-7). Initially, most cases were done with the hand-assist technique. Over time, that percentage dropped precipitously and the number that were performed laparoscopically rose sharply. Throughout the study period, the percentage of open procedures remained very low, dropping to almost zero near the conclusion. “They were able to keep their experience of open surgery quite low by using hand-assisted techniques to help with the tough cases of diverticular disease and get over that learning curve,” said Dr. Paquette.

In colon cancer, the study found that laparoscopic procedures hovered around 50%, while open and hand-assisted techniques tended to be around 20%. The higher incidence of open procedures was probably due to the desire of surgeons to be certain that the entire tumor has been excised. “If you’re in doubt, you don’t compromise on oncology. You do an open procedure if you need to,” said Dr. Paquette.

Another tool available to surgeons is single-incision laparoscopic colectomy, as opposed to conventional multiport laparoscopic colectomy. The method results in a very small incision, but can be challenging because the instruments are closer together and it is tricky when the surgeon has to cross the instrument, he said.

Dr. Paquette’s own group also looked at extraction in hand-assisted sigmoid colectomy, in which the surgeon went in laparoscopically, mobilized the colon laterally as would be done in an open procedure, and then performed the colectomy through a small extraction incision. The length of stay was about 15% shorter, there was a lower readmission rate, and gastrointestinal function returned more quickly (Surg Endosc. 2016 Aug;30[8]:3567-72).

Can patients who previously underwent a midline laparotomy be treated laparoscopically? “The answer is possibly yes,” said Dr. Paquette. He noted one study that showed higher rates of minor morbidity, ileotomy, and longer length of stay with laparoscopic treatment (Surg Endosc. 2015;29[3]537-42). “It’s a worth a try if you carefully plan where you’re going to go in through your ports, get in off the midline somewhere if you have to, and just take a look. If you have some adhesions of the omentum to the abdominal wall, it’s really no problem and you can proceed. If you have a frozen abdomen, just do the right thing and open the patient,” said Dr. Paquette.

When it comes to extraction options, Pfannenstiel incisions have the lowest rates of incisional hernias, at 1.9%, according to a survey of 2,148 cases at the Cleveland Clinic. The periumbilical midline incision had the highest frequency at 16.2% (Dis Colon Rectum. 2016 Aug;59[8]:743-50).

“If I’m doing a laparoscopic sigmoid or a laparoscopic low anterior, I do prefer to do a Pfannenstiel incision if I can. If you think that you may need to convert that patient for some reason, don’t do the Pfannenstiel first – nobody wants that big T-shaped incision,” said Dr. Paquette.

Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Paquette has consulted for Ethicon.
 

Minimally invasive techniques have clear benefits for colectomy, including reduced hospital length of stay, less pain, faster return to work, and reduced incidence of adhesive small bowel obstructions. But the methods are underutilized, in part because they can be challenging to learn.

copyright monkeybusinessimages/Thinkstock
But he believes that the hand-assist technique gets a bad rap because of selection bias. More difficult cases are done with the hand-assist approach, and tend to have worse outcomes. “[Hand assist] is awfully useful for some of these tougher cases,” said Dr. Paquette. In challenging cases, surgeons can convert a laparoscopic surgery to a hand-assist procedure rather than an open procedure, though this requires some practice in keeping your free hand away from the dissection.

One high-volume surgeon showed what happened over time when his practice employed hand-assisted laparoscopy for diverticulitis cases (Dis Colon Rectum. 2014;57[9]1090-7). Initially, most cases were done with the hand-assist technique. Over time, that percentage dropped precipitously and the number that were performed laparoscopically rose sharply. Throughout the study period, the percentage of open procedures remained very low, dropping to almost zero near the conclusion. “They were able to keep their experience of open surgery quite low by using hand-assisted techniques to help with the tough cases of diverticular disease and get over that learning curve,” said Dr. Paquette.

In colon cancer, the study found that laparoscopic procedures hovered around 50%, while open and hand-assisted techniques tended to be around 20%. The higher incidence of open procedures was probably due to the desire of surgeons to be certain that the entire tumor has been excised. “If you’re in doubt, you don’t compromise on oncology. You do an open procedure if you need to,” said Dr. Paquette.

Another tool available to surgeons is single-incision laparoscopic colectomy, as opposed to conventional multiport laparoscopic colectomy. The method results in a very small incision, but can be challenging because the instruments are closer together and it is tricky when the surgeon has to cross the instrument, he said.

Dr. Paquette’s own group also looked at extraction in hand-assisted sigmoid colectomy, in which the surgeon went in laparoscopically, mobilized the colon laterally as would be done in an open procedure, and then performed the colectomy through a small extraction incision. The length of stay was about 15% shorter, there was a lower readmission rate, and gastrointestinal function returned more quickly (Surg Endosc. 2016 Aug;30[8]:3567-72).

Can patients who previously underwent a midline laparotomy be treated laparoscopically? “The answer is possibly yes,” said Dr. Paquette. He noted one study that showed higher rates of minor morbidity, ileotomy, and longer length of stay with laparoscopic treatment (Surg Endosc. 2015;29[3]537-42). “It’s a worth a try if you carefully plan where you’re going to go in through your ports, get in off the midline somewhere if you have to, and just take a look. If you have some adhesions of the omentum to the abdominal wall, it’s really no problem and you can proceed. If you have a frozen abdomen, just do the right thing and open the patient,” said Dr. Paquette.

When it comes to extraction options, Pfannenstiel incisions have the lowest rates of incisional hernias, at 1.9%, according to a survey of 2,148 cases at the Cleveland Clinic. The periumbilical midline incision had the highest frequency at 16.2% (Dis Colon Rectum. 2016 Aug;59[8]:743-50).

“If I’m doing a laparoscopic sigmoid or a laparoscopic low anterior, I do prefer to do a Pfannenstiel incision if I can. If you think that you may need to convert that patient for some reason, don’t do the Pfannenstiel first – nobody wants that big T-shaped incision,” said Dr. Paquette.

Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Paquette has consulted for Ethicon.
 

Publications
Publications
Topics
Article Type
Click for Credit Status
Ready
Sections
Article Source

REPORTING FROM MISS

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default

VIDEO: Dabigatran effective for myocardial injury after noncardiac surgery

Treatment now possible for a new clinical entity
Article Type
Changed
Fri, 06/23/2023 - 16:59

– Treating patients who developed myocardial injury after noncardiac surgery with the anticoagulant dabigatran significantly cut the rate of subsequent major vascular complications in a randomized, multicenter trial with 1,754 patients, a result that gives surgeons and physicians the first evidence-based intervention for treating a common postsurgical condition.

“Because we have not systematically followed noncardiac surgery patients, it’s easy to presume that everyone is okay, but all the epidemiology data show that these patients [who develop myocardial injury after noncardiac surgery] don’t do okay. We need to be aggressive with secondary prophylaxis,” P.J. Devereaux, MD, said at the annual meeting of the American College of Cardiology. “The unfortunate thing is that right now, we don’t do much for these patients,” said Dr. Devereaux, professor of medicine and director of cardiology at McMaster University in Hamilton, Ont.

Results from prior epidemiology studies have shown that, among the roughly 200 million patients who undergo noncardiac surgery worldwide each year, 8% will develop MINS (myocardial injury after noncardiac surgery) (Anesthesiology. 2014 March;120[3]:564-78). The myocardial injury that defines MINS is identified by either an overt MI that meets the universal definition, or an otherwise unexplained rise in serum troponin levels from baseline in the first couple of days after surgery. In the new study, Dr. Devereaux and his associates identified 80% of MINS by a troponin rise and 20% by a diagnosed MI.

The challenge in diagnosing MINS and then administering dabigatran will be implementation of this strategy into routine practice, commented Erin A. Bohula May, MD, a cardiologist at Brigham and Women’s Hospital in Boston. “The problem is, troponin is not routinely measured in postoperative patients. It will be hard to change practice,” she noted.

 

 


Dr. Devereaux agreed that a significant barrier is convincing clinicians, especially surgeons, to routinely measure a patient’s troponin levels just before and immediately after surgery. “People are lulled into a false sense of security because patients [who develop MINS] usually don’t have chest pain,” he said in a video interview. “When we first showed that patients with MINS have bad outcomes, that convinced some [surgeons] to measure troponin after surgery. “Showing we can do something about it” is another important step toward fostering more awareness of and interest in diagnosing and treating MINS.

The Management of Myocardial Injury After Noncardiac Surgery Trial (MANAGE) enrolled 1,754 patients at 82 centers in 19 countries. Researchers randomized patients to treatment with either 110 mg dabigatran b.i.d. or placebo. A majority of patients in both arms also received aspirin and a statin, treatments that Dr. Devereaux should be used along with dabigatran in routine practice, based on observational findings, although the efficacy of these drugs for MINS patients has not been tested in randomized studies. The study’s primary endpoint was the incidence of major vascular complications, a composite that included vascular mortality, nonfatal MI, nonfatal and nonhemorrhagic stroke, peripheral arterial thrombosis, amputation, or symptomatic venous thromboembolism.

After an average follow-up of 16 months, the primary endpoint occurred in 11% of the dabigatran-treated patients and in 15% of controls, which represented a 28% risk reduction that was statistically significant. The study’s primary safety endpoint was a composite of life-threatening, major, and critical organ bleeds, which occurred in 3% of the dabigatran-treated patients and in 4% of controls, a nonsignificant difference. The dabigatran-treated patients showed a significant excess of both minor bleeds – 15% compared with 10% in controls – and “nonsignificant” lower gastrointestinal bleeds, 4% with dabigatran and 1% in the controls. The dabigatran-treated patients also had a significantly higher incidence of dyspepsia.

MANAGE was funded by the Population Health Research Institute and had no commercial funding. Dr. Devereaux has received research support from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, and Roche Diagnostics. Dr. May has been a consultant to Daiichi Sankyo, Merck, and Servier and has received research funding from Eisai.

SOURCE: Devereaux P et al. ACC 18.

Body

 

Dr. Devereaux and his associates are to be congratulated on identifying a new disease entity, MINS (myocardial injury after noncardiac surgery), and now giving us a way to treat it. MINS is extremely common and quite morbid, and there had never before been a trial that studied its treatment. Identifying patients with MINS is extremely important. These are very-high-risk patients, and they are very hard to find. The results from MANAGE give us a way to do something about MINS and an opportunity to improve patient outcomes.

Mitchel L. Zoler/Frontline Medical News
Dr. Pamela S. Douglas
The etiology of MINS puts the responsibility primarily on surgeons to diagnose and treat MINS. I hope the message will reach surgeons about MINS and how it can be treated. It does not seem practical for cardiologists to play a role in most of these cases. I also have some concern that, while surgeons are the logical clinicians to diagnose and treat MINS, they also might feel some disincentive to identify patients who develop an initially asymptomatic complication because of the surgery they have undergone.

Pamela S. Douglas, MD , is a cardiologist and professor of medicine at Duke University in Durham, N.C. She had no disclosures. She made these comments as a discussant for MANAGE and in an interview.

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event
Body

 

Dr. Devereaux and his associates are to be congratulated on identifying a new disease entity, MINS (myocardial injury after noncardiac surgery), and now giving us a way to treat it. MINS is extremely common and quite morbid, and there had never before been a trial that studied its treatment. Identifying patients with MINS is extremely important. These are very-high-risk patients, and they are very hard to find. The results from MANAGE give us a way to do something about MINS and an opportunity to improve patient outcomes.

Mitchel L. Zoler/Frontline Medical News
Dr. Pamela S. Douglas
The etiology of MINS puts the responsibility primarily on surgeons to diagnose and treat MINS. I hope the message will reach surgeons about MINS and how it can be treated. It does not seem practical for cardiologists to play a role in most of these cases. I also have some concern that, while surgeons are the logical clinicians to diagnose and treat MINS, they also might feel some disincentive to identify patients who develop an initially asymptomatic complication because of the surgery they have undergone.

Pamela S. Douglas, MD , is a cardiologist and professor of medicine at Duke University in Durham, N.C. She had no disclosures. She made these comments as a discussant for MANAGE and in an interview.

Body

 

Dr. Devereaux and his associates are to be congratulated on identifying a new disease entity, MINS (myocardial injury after noncardiac surgery), and now giving us a way to treat it. MINS is extremely common and quite morbid, and there had never before been a trial that studied its treatment. Identifying patients with MINS is extremely important. These are very-high-risk patients, and they are very hard to find. The results from MANAGE give us a way to do something about MINS and an opportunity to improve patient outcomes.

Mitchel L. Zoler/Frontline Medical News
Dr. Pamela S. Douglas
The etiology of MINS puts the responsibility primarily on surgeons to diagnose and treat MINS. I hope the message will reach surgeons about MINS and how it can be treated. It does not seem practical for cardiologists to play a role in most of these cases. I also have some concern that, while surgeons are the logical clinicians to diagnose and treat MINS, they also might feel some disincentive to identify patients who develop an initially asymptomatic complication because of the surgery they have undergone.

Pamela S. Douglas, MD , is a cardiologist and professor of medicine at Duke University in Durham, N.C. She had no disclosures. She made these comments as a discussant for MANAGE and in an interview.

Title
Treatment now possible for a new clinical entity
Treatment now possible for a new clinical entity

– Treating patients who developed myocardial injury after noncardiac surgery with the anticoagulant dabigatran significantly cut the rate of subsequent major vascular complications in a randomized, multicenter trial with 1,754 patients, a result that gives surgeons and physicians the first evidence-based intervention for treating a common postsurgical condition.

“Because we have not systematically followed noncardiac surgery patients, it’s easy to presume that everyone is okay, but all the epidemiology data show that these patients [who develop myocardial injury after noncardiac surgery] don’t do okay. We need to be aggressive with secondary prophylaxis,” P.J. Devereaux, MD, said at the annual meeting of the American College of Cardiology. “The unfortunate thing is that right now, we don’t do much for these patients,” said Dr. Devereaux, professor of medicine and director of cardiology at McMaster University in Hamilton, Ont.

Results from prior epidemiology studies have shown that, among the roughly 200 million patients who undergo noncardiac surgery worldwide each year, 8% will develop MINS (myocardial injury after noncardiac surgery) (Anesthesiology. 2014 March;120[3]:564-78). The myocardial injury that defines MINS is identified by either an overt MI that meets the universal definition, or an otherwise unexplained rise in serum troponin levels from baseline in the first couple of days after surgery. In the new study, Dr. Devereaux and his associates identified 80% of MINS by a troponin rise and 20% by a diagnosed MI.

The challenge in diagnosing MINS and then administering dabigatran will be implementation of this strategy into routine practice, commented Erin A. Bohula May, MD, a cardiologist at Brigham and Women’s Hospital in Boston. “The problem is, troponin is not routinely measured in postoperative patients. It will be hard to change practice,” she noted.

 

 


Dr. Devereaux agreed that a significant barrier is convincing clinicians, especially surgeons, to routinely measure a patient’s troponin levels just before and immediately after surgery. “People are lulled into a false sense of security because patients [who develop MINS] usually don’t have chest pain,” he said in a video interview. “When we first showed that patients with MINS have bad outcomes, that convinced some [surgeons] to measure troponin after surgery. “Showing we can do something about it” is another important step toward fostering more awareness of and interest in diagnosing and treating MINS.

The Management of Myocardial Injury After Noncardiac Surgery Trial (MANAGE) enrolled 1,754 patients at 82 centers in 19 countries. Researchers randomized patients to treatment with either 110 mg dabigatran b.i.d. or placebo. A majority of patients in both arms also received aspirin and a statin, treatments that Dr. Devereaux should be used along with dabigatran in routine practice, based on observational findings, although the efficacy of these drugs for MINS patients has not been tested in randomized studies. The study’s primary endpoint was the incidence of major vascular complications, a composite that included vascular mortality, nonfatal MI, nonfatal and nonhemorrhagic stroke, peripheral arterial thrombosis, amputation, or symptomatic venous thromboembolism.

After an average follow-up of 16 months, the primary endpoint occurred in 11% of the dabigatran-treated patients and in 15% of controls, which represented a 28% risk reduction that was statistically significant. The study’s primary safety endpoint was a composite of life-threatening, major, and critical organ bleeds, which occurred in 3% of the dabigatran-treated patients and in 4% of controls, a nonsignificant difference. The dabigatran-treated patients showed a significant excess of both minor bleeds – 15% compared with 10% in controls – and “nonsignificant” lower gastrointestinal bleeds, 4% with dabigatran and 1% in the controls. The dabigatran-treated patients also had a significantly higher incidence of dyspepsia.

MANAGE was funded by the Population Health Research Institute and had no commercial funding. Dr. Devereaux has received research support from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, and Roche Diagnostics. Dr. May has been a consultant to Daiichi Sankyo, Merck, and Servier and has received research funding from Eisai.

SOURCE: Devereaux P et al. ACC 18.

– Treating patients who developed myocardial injury after noncardiac surgery with the anticoagulant dabigatran significantly cut the rate of subsequent major vascular complications in a randomized, multicenter trial with 1,754 patients, a result that gives surgeons and physicians the first evidence-based intervention for treating a common postsurgical condition.

“Because we have not systematically followed noncardiac surgery patients, it’s easy to presume that everyone is okay, but all the epidemiology data show that these patients [who develop myocardial injury after noncardiac surgery] don’t do okay. We need to be aggressive with secondary prophylaxis,” P.J. Devereaux, MD, said at the annual meeting of the American College of Cardiology. “The unfortunate thing is that right now, we don’t do much for these patients,” said Dr. Devereaux, professor of medicine and director of cardiology at McMaster University in Hamilton, Ont.

Results from prior epidemiology studies have shown that, among the roughly 200 million patients who undergo noncardiac surgery worldwide each year, 8% will develop MINS (myocardial injury after noncardiac surgery) (Anesthesiology. 2014 March;120[3]:564-78). The myocardial injury that defines MINS is identified by either an overt MI that meets the universal definition, or an otherwise unexplained rise in serum troponin levels from baseline in the first couple of days after surgery. In the new study, Dr. Devereaux and his associates identified 80% of MINS by a troponin rise and 20% by a diagnosed MI.

The challenge in diagnosing MINS and then administering dabigatran will be implementation of this strategy into routine practice, commented Erin A. Bohula May, MD, a cardiologist at Brigham and Women’s Hospital in Boston. “The problem is, troponin is not routinely measured in postoperative patients. It will be hard to change practice,” she noted.

 

 


Dr. Devereaux agreed that a significant barrier is convincing clinicians, especially surgeons, to routinely measure a patient’s troponin levels just before and immediately after surgery. “People are lulled into a false sense of security because patients [who develop MINS] usually don’t have chest pain,” he said in a video interview. “When we first showed that patients with MINS have bad outcomes, that convinced some [surgeons] to measure troponin after surgery. “Showing we can do something about it” is another important step toward fostering more awareness of and interest in diagnosing and treating MINS.

The Management of Myocardial Injury After Noncardiac Surgery Trial (MANAGE) enrolled 1,754 patients at 82 centers in 19 countries. Researchers randomized patients to treatment with either 110 mg dabigatran b.i.d. or placebo. A majority of patients in both arms also received aspirin and a statin, treatments that Dr. Devereaux should be used along with dabigatran in routine practice, based on observational findings, although the efficacy of these drugs for MINS patients has not been tested in randomized studies. The study’s primary endpoint was the incidence of major vascular complications, a composite that included vascular mortality, nonfatal MI, nonfatal and nonhemorrhagic stroke, peripheral arterial thrombosis, amputation, or symptomatic venous thromboembolism.

After an average follow-up of 16 months, the primary endpoint occurred in 11% of the dabigatran-treated patients and in 15% of controls, which represented a 28% risk reduction that was statistically significant. The study’s primary safety endpoint was a composite of life-threatening, major, and critical organ bleeds, which occurred in 3% of the dabigatran-treated patients and in 4% of controls, a nonsignificant difference. The dabigatran-treated patients showed a significant excess of both minor bleeds – 15% compared with 10% in controls – and “nonsignificant” lower gastrointestinal bleeds, 4% with dabigatran and 1% in the controls. The dabigatran-treated patients also had a significantly higher incidence of dyspepsia.

MANAGE was funded by the Population Health Research Institute and had no commercial funding. Dr. Devereaux has received research support from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, and Roche Diagnostics. Dr. May has been a consultant to Daiichi Sankyo, Merck, and Servier and has received research funding from Eisai.

SOURCE: Devereaux P et al. ACC 18.

Publications
Publications
Topics
Article Type
Sections
Article Source

REPORTING FROM ACC 18

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Vitals

 

Key clinical point: Dabigatran is the first intervention proven to benefit patients with MINS.

Major finding: Major vascular complications occurred in 11% of patients on dabigatran and 15% on placebo.

Study details: MANAGE, a multicenter, randomized trial with 1,754 patients.

Disclosures: MANAGE was funded by the Population Health Research Institute and had no commercial funding. Dr. Devereaux has received research support from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, and Roche Diagnostics. Dr. May has been a consultant to Daiichi Sankyo, Merck, and Servier and has received research funding from Eisai.

Source: Devereaux P et al. ACC 18.

Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

ABS announces new certification exam

Article Type
Changed
Thu, 03/28/2019 - 14:40

 

The American Board of Surgery (ABS) has unveiled a shorter, more flexible assessment to take the place of the dreaded 10-year, pass-fail exam to maintain certification.

The new test, required every other year, consists of a 40-question, open-book assessment that surgeons can take on their own computers within the assessment time frame, according to a March 5 announcement. The previous 10-year exam consisted of nearly 250 questions and had to be completed at a highly secure testing center.

Dr. Mary E. Klingensmith
Of particular interest to diplomates will be the new rules about when those with expiring certificates will be required to participate in the new assessment. Diplomates with general surgery certificates expiring this year may use the new assessment to continue their certification. All general surgery diplomates are required to start taking the new assessment by 2020, regardless of certificate expiration date. So some diplomates will be taking part in the assessment to maintain certification sooner under the new process than they would have under the old rules.



The assessment shift was made to address diplomates’ concerns that the prior exam was burdensome, stressful, and challenging to complete because of its rigid design and location requirements, ABS Chair Mary E. Klingensmith, MD, FACS, said in an interview.

“This new method, which allows a take-from-home or office format, is much less stressful, as both the setting, and the ability to choose the content area, give diplomates much more control,” Dr. Klingensmith said. “Additionally, the testing concepts and references will be provided in advance, should a diplomate desire to know these aspects.”

On March 11, the American College of Surgeons released a statement regarding the new assessment and suggested that, while the new approach is welcomed by the ACS, some details of the process are of concern to surgeons. “The American College of Surgeons (ACS) leadership has heard your concerns both through personal conversations with many of you and through your posts on ACS Communities. In fact, many in leadership share these concerns. We have been in discussions with ABS leadership and can tell you that they are also listening. They want to get this right.”

Of the 40 questions on the new exam, 20 questions will cover core surgical principles, while the other 20 will cover a practice-related area of the diplomate’s choosing. For 2018, diplomates can select from four practice-related areas: general surgery, abdomen, alimentary tract, or breast. More areas are planned based on future feedback from diplomates and surgical societies. Other aspects of the new exam include:

  • Topics and references for the various areas will be published in advance on the ABS website.
  • Diplomates will be provided with immediate feedback, and will have two opportunities to answer a question correctly.
  • A final score of 80% correct will be required to pass.
  • Once the assessment is started, diplomates will have 2 weeks to complete the test, with the ability to save and continue when convenient.

The purpose of the new assessment is to provide practicing surgeons with a timely, relevant, and accessible method to stay current with surgical practice knowledge,” Dr. Klingensmith said.

“By selecting a practice-specific area of their own choosing, surgeons will no longer have to study for and be tested upon the entire breadth of general surgery; instead they can focus on those areas that most reflect their practice,” she said. “By submitting to a learning exercise every 2 years, which is focused in the areas of an individual surgeon’s practice, I expect important aspects of knowledge will be transmitted and integrated into a surgeon’s practice. This new program will provide practicing surgeons with an accessible method for keeping up with the constantly changing landscape of surgical practice.”

The new exam is part of an ongoing effort by ABS to revamp its maintenance of certification requirements after widespread criticism that its past provisions were burdensome and irrelevant. In July, ABS announced that it was extending its continuing medical education reporting cycle from 3 to 5 years and reducing the number of required self-assessment by a third. Surgeons now have to report 150 credits over 5 years, 50 from self-assessment CMEs. Under the old system, it was 90 credits over 3 years, 60 of which had to include self-assessment.

After the July announcement, ABS sent surveys to all diplomates to gather feedback about alternatives to the 10-year exam. Nearly 10,000 surgeons responded, according to an ABS summary. The majority of respondents said they wanted more frequent, lower-stakes, open-book assessments that would be required no frequently than every 2 years. Most surgeons were also in favor of being tested on both surgery concepts and practice-specific content.

For 2019 and beyond, the ABS’ Component Boards – Vascular, Pediatric Surgery, Surgical, and Critical Care – will develop their continuous certification processes, Dr. Klingensmith said. Additional areas for the surgery exam also will be developed in collaboration with specialty societies.

In the meantime, registration for the new general surgery assessment opens Aug. 1. The assessment will be available from Sept. 7 to Nov. 5, during which time diplomates can take the assessment at their convenience.

For more information, go to the continuous certification section on the ABS website.

 

 

Publications
Topics
Sections

 

The American Board of Surgery (ABS) has unveiled a shorter, more flexible assessment to take the place of the dreaded 10-year, pass-fail exam to maintain certification.

The new test, required every other year, consists of a 40-question, open-book assessment that surgeons can take on their own computers within the assessment time frame, according to a March 5 announcement. The previous 10-year exam consisted of nearly 250 questions and had to be completed at a highly secure testing center.

Dr. Mary E. Klingensmith
Of particular interest to diplomates will be the new rules about when those with expiring certificates will be required to participate in the new assessment. Diplomates with general surgery certificates expiring this year may use the new assessment to continue their certification. All general surgery diplomates are required to start taking the new assessment by 2020, regardless of certificate expiration date. So some diplomates will be taking part in the assessment to maintain certification sooner under the new process than they would have under the old rules.



The assessment shift was made to address diplomates’ concerns that the prior exam was burdensome, stressful, and challenging to complete because of its rigid design and location requirements, ABS Chair Mary E. Klingensmith, MD, FACS, said in an interview.

“This new method, which allows a take-from-home or office format, is much less stressful, as both the setting, and the ability to choose the content area, give diplomates much more control,” Dr. Klingensmith said. “Additionally, the testing concepts and references will be provided in advance, should a diplomate desire to know these aspects.”

On March 11, the American College of Surgeons released a statement regarding the new assessment and suggested that, while the new approach is welcomed by the ACS, some details of the process are of concern to surgeons. “The American College of Surgeons (ACS) leadership has heard your concerns both through personal conversations with many of you and through your posts on ACS Communities. In fact, many in leadership share these concerns. We have been in discussions with ABS leadership and can tell you that they are also listening. They want to get this right.”

Of the 40 questions on the new exam, 20 questions will cover core surgical principles, while the other 20 will cover a practice-related area of the diplomate’s choosing. For 2018, diplomates can select from four practice-related areas: general surgery, abdomen, alimentary tract, or breast. More areas are planned based on future feedback from diplomates and surgical societies. Other aspects of the new exam include:

  • Topics and references for the various areas will be published in advance on the ABS website.
  • Diplomates will be provided with immediate feedback, and will have two opportunities to answer a question correctly.
  • A final score of 80% correct will be required to pass.
  • Once the assessment is started, diplomates will have 2 weeks to complete the test, with the ability to save and continue when convenient.

The purpose of the new assessment is to provide practicing surgeons with a timely, relevant, and accessible method to stay current with surgical practice knowledge,” Dr. Klingensmith said.

“By selecting a practice-specific area of their own choosing, surgeons will no longer have to study for and be tested upon the entire breadth of general surgery; instead they can focus on those areas that most reflect their practice,” she said. “By submitting to a learning exercise every 2 years, which is focused in the areas of an individual surgeon’s practice, I expect important aspects of knowledge will be transmitted and integrated into a surgeon’s practice. This new program will provide practicing surgeons with an accessible method for keeping up with the constantly changing landscape of surgical practice.”

The new exam is part of an ongoing effort by ABS to revamp its maintenance of certification requirements after widespread criticism that its past provisions were burdensome and irrelevant. In July, ABS announced that it was extending its continuing medical education reporting cycle from 3 to 5 years and reducing the number of required self-assessment by a third. Surgeons now have to report 150 credits over 5 years, 50 from self-assessment CMEs. Under the old system, it was 90 credits over 3 years, 60 of which had to include self-assessment.

After the July announcement, ABS sent surveys to all diplomates to gather feedback about alternatives to the 10-year exam. Nearly 10,000 surgeons responded, according to an ABS summary. The majority of respondents said they wanted more frequent, lower-stakes, open-book assessments that would be required no frequently than every 2 years. Most surgeons were also in favor of being tested on both surgery concepts and practice-specific content.

For 2019 and beyond, the ABS’ Component Boards – Vascular, Pediatric Surgery, Surgical, and Critical Care – will develop their continuous certification processes, Dr. Klingensmith said. Additional areas for the surgery exam also will be developed in collaboration with specialty societies.

In the meantime, registration for the new general surgery assessment opens Aug. 1. The assessment will be available from Sept. 7 to Nov. 5, during which time diplomates can take the assessment at their convenience.

For more information, go to the continuous certification section on the ABS website.

 

 

 

The American Board of Surgery (ABS) has unveiled a shorter, more flexible assessment to take the place of the dreaded 10-year, pass-fail exam to maintain certification.

The new test, required every other year, consists of a 40-question, open-book assessment that surgeons can take on their own computers within the assessment time frame, according to a March 5 announcement. The previous 10-year exam consisted of nearly 250 questions and had to be completed at a highly secure testing center.

Dr. Mary E. Klingensmith
Of particular interest to diplomates will be the new rules about when those with expiring certificates will be required to participate in the new assessment. Diplomates with general surgery certificates expiring this year may use the new assessment to continue their certification. All general surgery diplomates are required to start taking the new assessment by 2020, regardless of certificate expiration date. So some diplomates will be taking part in the assessment to maintain certification sooner under the new process than they would have under the old rules.



The assessment shift was made to address diplomates’ concerns that the prior exam was burdensome, stressful, and challenging to complete because of its rigid design and location requirements, ABS Chair Mary E. Klingensmith, MD, FACS, said in an interview.

“This new method, which allows a take-from-home or office format, is much less stressful, as both the setting, and the ability to choose the content area, give diplomates much more control,” Dr. Klingensmith said. “Additionally, the testing concepts and references will be provided in advance, should a diplomate desire to know these aspects.”

On March 11, the American College of Surgeons released a statement regarding the new assessment and suggested that, while the new approach is welcomed by the ACS, some details of the process are of concern to surgeons. “The American College of Surgeons (ACS) leadership has heard your concerns both through personal conversations with many of you and through your posts on ACS Communities. In fact, many in leadership share these concerns. We have been in discussions with ABS leadership and can tell you that they are also listening. They want to get this right.”

Of the 40 questions on the new exam, 20 questions will cover core surgical principles, while the other 20 will cover a practice-related area of the diplomate’s choosing. For 2018, diplomates can select from four practice-related areas: general surgery, abdomen, alimentary tract, or breast. More areas are planned based on future feedback from diplomates and surgical societies. Other aspects of the new exam include:

  • Topics and references for the various areas will be published in advance on the ABS website.
  • Diplomates will be provided with immediate feedback, and will have two opportunities to answer a question correctly.
  • A final score of 80% correct will be required to pass.
  • Once the assessment is started, diplomates will have 2 weeks to complete the test, with the ability to save and continue when convenient.

The purpose of the new assessment is to provide practicing surgeons with a timely, relevant, and accessible method to stay current with surgical practice knowledge,” Dr. Klingensmith said.

“By selecting a practice-specific area of their own choosing, surgeons will no longer have to study for and be tested upon the entire breadth of general surgery; instead they can focus on those areas that most reflect their practice,” she said. “By submitting to a learning exercise every 2 years, which is focused in the areas of an individual surgeon’s practice, I expect important aspects of knowledge will be transmitted and integrated into a surgeon’s practice. This new program will provide practicing surgeons with an accessible method for keeping up with the constantly changing landscape of surgical practice.”

The new exam is part of an ongoing effort by ABS to revamp its maintenance of certification requirements after widespread criticism that its past provisions were burdensome and irrelevant. In July, ABS announced that it was extending its continuing medical education reporting cycle from 3 to 5 years and reducing the number of required self-assessment by a third. Surgeons now have to report 150 credits over 5 years, 50 from self-assessment CMEs. Under the old system, it was 90 credits over 3 years, 60 of which had to include self-assessment.

After the July announcement, ABS sent surveys to all diplomates to gather feedback about alternatives to the 10-year exam. Nearly 10,000 surgeons responded, according to an ABS summary. The majority of respondents said they wanted more frequent, lower-stakes, open-book assessments that would be required no frequently than every 2 years. Most surgeons were also in favor of being tested on both surgery concepts and practice-specific content.

For 2019 and beyond, the ABS’ Component Boards – Vascular, Pediatric Surgery, Surgical, and Critical Care – will develop their continuous certification processes, Dr. Klingensmith said. Additional areas for the surgery exam also will be developed in collaboration with specialty societies.

In the meantime, registration for the new general surgery assessment opens Aug. 1. The assessment will be available from Sept. 7 to Nov. 5, during which time diplomates can take the assessment at their convenience.

For more information, go to the continuous certification section on the ABS website.

 

 

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default

FDA issues warning to all duodenoscope manufacturers

Article Type
Changed
Wed, 01/02/2019 - 10:07

 

The Food and Drug Administration on March 9 issued warning letters to all three duodenoscope manufacturers for failing to comply with the requirements of federal law under which they were ordered to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the devices.

The warning is part of an ongoing effort to prevent patient infections associated with the transmission of bacteria from contaminated duodenoscopes. The three manufacturers – Olympus, Fujifilm, and Pentax – are required to conduct studies to sample and culture reprocessed duodenoscopes that are in clinical use to learn more about issues that contribute to contamination, and to study human factors to determine how hospital staff who have had training are following the reprocessing instructions. In 2015, the FDA ordered the companies to conduct a postmarket surveillance study to determine whether health care facilities were able to properly clean and disinfect the devices.

Currently, the Olympus manufacturer has failed to start data collection, while both Pentax and Fujifilm have failed to provide sufficient data required for their respective studies to sample and culture reprocessed duodenoscopes that are in clinical use. In addition, Olympus and Pentax have not complied with requirements to assess how well staff members have followed the reprocessing instructions after the human factors studies and Fujifilm has been meeting its requirements for its human factors study only.

“The FDA has taken important steps to improve the reprocessing of duodenoscopes, and we’ve seen a reduction in reports of patient infections, but we need the required postmarket studies to determine whether these measures are being properly implemented in real-world clinical settings and whether we need to take additional action to further improve the safety of these devices,” said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health in a press release. “We expect these device manufacturers to meet their study obligations to ensure patient safety.”

The companies have until March 24 to submit a plan that outlines how study milestones will be achieved. If the companies fail to respond to the warning letter, the FDA states that they may take additional action, such as seizure, injunction, and civil monetary penalties.

Read the full press release on the FDA’s website.

Publications
Topics
Sections

 

The Food and Drug Administration on March 9 issued warning letters to all three duodenoscope manufacturers for failing to comply with the requirements of federal law under which they were ordered to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the devices.

The warning is part of an ongoing effort to prevent patient infections associated with the transmission of bacteria from contaminated duodenoscopes. The three manufacturers – Olympus, Fujifilm, and Pentax – are required to conduct studies to sample and culture reprocessed duodenoscopes that are in clinical use to learn more about issues that contribute to contamination, and to study human factors to determine how hospital staff who have had training are following the reprocessing instructions. In 2015, the FDA ordered the companies to conduct a postmarket surveillance study to determine whether health care facilities were able to properly clean and disinfect the devices.

Currently, the Olympus manufacturer has failed to start data collection, while both Pentax and Fujifilm have failed to provide sufficient data required for their respective studies to sample and culture reprocessed duodenoscopes that are in clinical use. In addition, Olympus and Pentax have not complied with requirements to assess how well staff members have followed the reprocessing instructions after the human factors studies and Fujifilm has been meeting its requirements for its human factors study only.

“The FDA has taken important steps to improve the reprocessing of duodenoscopes, and we’ve seen a reduction in reports of patient infections, but we need the required postmarket studies to determine whether these measures are being properly implemented in real-world clinical settings and whether we need to take additional action to further improve the safety of these devices,” said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health in a press release. “We expect these device manufacturers to meet their study obligations to ensure patient safety.”

The companies have until March 24 to submit a plan that outlines how study milestones will be achieved. If the companies fail to respond to the warning letter, the FDA states that they may take additional action, such as seizure, injunction, and civil monetary penalties.

Read the full press release on the FDA’s website.

 

The Food and Drug Administration on March 9 issued warning letters to all three duodenoscope manufacturers for failing to comply with the requirements of federal law under which they were ordered to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the devices.

The warning is part of an ongoing effort to prevent patient infections associated with the transmission of bacteria from contaminated duodenoscopes. The three manufacturers – Olympus, Fujifilm, and Pentax – are required to conduct studies to sample and culture reprocessed duodenoscopes that are in clinical use to learn more about issues that contribute to contamination, and to study human factors to determine how hospital staff who have had training are following the reprocessing instructions. In 2015, the FDA ordered the companies to conduct a postmarket surveillance study to determine whether health care facilities were able to properly clean and disinfect the devices.

Currently, the Olympus manufacturer has failed to start data collection, while both Pentax and Fujifilm have failed to provide sufficient data required for their respective studies to sample and culture reprocessed duodenoscopes that are in clinical use. In addition, Olympus and Pentax have not complied with requirements to assess how well staff members have followed the reprocessing instructions after the human factors studies and Fujifilm has been meeting its requirements for its human factors study only.

“The FDA has taken important steps to improve the reprocessing of duodenoscopes, and we’ve seen a reduction in reports of patient infections, but we need the required postmarket studies to determine whether these measures are being properly implemented in real-world clinical settings and whether we need to take additional action to further improve the safety of these devices,” said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health in a press release. “We expect these device manufacturers to meet their study obligations to ensure patient safety.”

The companies have until March 24 to submit a plan that outlines how study milestones will be achieved. If the companies fail to respond to the warning letter, the FDA states that they may take additional action, such as seizure, injunction, and civil monetary penalties.

Read the full press release on the FDA’s website.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default

IBD: When to operate and when to punt

Article Type
Changed
Wed, 01/02/2019 - 10:07

 

– Patients with inflammatory bowel disease who are in need of a surgical intervention can pose a special challenge to surgeons who encounter these patients only occasionally.

The question of whether to perform surgery or refer a patient to a higher-volume specialty center can depend on proximity. In some cases, a specialty center isn’t close, or the patient can’t tolerate the required travel. In fact, a recent study showed that 85.8% of IBD patients are treated surgically in hospitals that treat fewer than 50 patients per year (Am J Gastroenterol. 2008;103:2789-98).

In a presentation at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education, Larry Whelan, MD, FACS, discussed some of the challenges these patients pose and offered guidance on which cases are best referred to high-volume centers, and the best way to proceed in emergencies.

IBD patients at high-volume centers have lower mortality than do those in low-volume centers, but patients treated at lower-volume centers tend to be sicker, and studies have shown no significant difference in complication rate. This suggests that surgeons shouldn’t be afraid to tackle these cases, according to Dr. Whelan, chief of colorectal surgery at Mount Sinai West, New York.

 

 


"If you get an IBD case and you don’t see a lot of those, how do you decide what to do about it, and should you just refer it to a high-volume center?” said Dr. Whelan.

These patients are often under complex medical management, frequently spanning years, and this is an important factor in surgical decisions. They are often on multiple medications, including steroids, and most patients these days are taking monoclonal antibodies, said Dr. Whelan. The latter in particular can lead patients to be susceptible to infections. “These things can all affect decision making,” said Dr. Whelan.

Sometimes the nutritional status of IBD patients is poor, and most of the time, surgery is elective in these patients. So surgery can often be delayed for a month or more to allow time for nutritional status to improve, and this gives time for a patient to go off monoclonal antibodies, and for the physician to arrange for a referral to a high-volume center, if that seems the wisest course.

Surgery should not be considered without a gastrointestinal specialist who is comfortable in managing these patients. “Having someone who knows when to operate and not to operate, and how to handle medication, is really important,” said Dr. Whelan.

Certain cases should definitely be referred out. Ileal pouches are one. Another is a Crohn’s disease patient with multiple points of obstruction. “That may be one that you’re better off to punt,” said Dr. Whelan. Other cases include patients under complex medical management, when there is no experienced GI specialist available to help.
 

 


Emergencies require quicker decisions. In ulcerative colitis, emergency cases may include toxic megacolon, perforated colon, or obstruction from either a stricture or cancer, as well as bleeding in rare cases. Scenarios in Crohn’s disease include perforation with sepsis, inaccessible abscess, and, most commonly, obstruction resulting from fibrous stricture or acute inflammation.

When surgery is required, what’s the best choice? Dr. Whelan emphasized keeping it simple. Redo ileal pouches and ileal pouch excisions should generally be avoided. “Even if you do [pouches] often. It’s not the smartest way to go. These patients are almost all on immunosuppressive medications … to make an operation that’s already big even bigger often doesn’t work out well,” he said.

In emergency chronic ulcerative colitis cases, the safest choice is total abdominal colectomy plus end ileostomy. Dr. Whelan discourages surgeons from considering proctectomy and ileal pouch in emergency cases. A number of studies have shown that delaying pouch surgery is associated with fewer minor and major adverse events, and lower reoperation rates, he said. “If you do these operations on an immunosuppressed population, they don’t do as well,” said Dr. Whelan.

Crohn’s disease emergencies can often be managed nonsurgically. Most patients have phlegmon, fistulae, or a partial obstruction. Intravenous antibiotics, percutaneous drainage, hydration, and boosting nutritional status are good options. In cases where an obstruction requires surgery, and the surgeon isn’t comfortable performing stricturoplasty, “you want to limit the resection as best you can,” he said.

Dr. Whelan disclosed financial relationships with Ethicon Endosurgery and Olympus Corporation. Global Academy for Medical Education and this news organization are owned by the same parent company.”

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

 

– Patients with inflammatory bowel disease who are in need of a surgical intervention can pose a special challenge to surgeons who encounter these patients only occasionally.

The question of whether to perform surgery or refer a patient to a higher-volume specialty center can depend on proximity. In some cases, a specialty center isn’t close, or the patient can’t tolerate the required travel. In fact, a recent study showed that 85.8% of IBD patients are treated surgically in hospitals that treat fewer than 50 patients per year (Am J Gastroenterol. 2008;103:2789-98).

In a presentation at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education, Larry Whelan, MD, FACS, discussed some of the challenges these patients pose and offered guidance on which cases are best referred to high-volume centers, and the best way to proceed in emergencies.

IBD patients at high-volume centers have lower mortality than do those in low-volume centers, but patients treated at lower-volume centers tend to be sicker, and studies have shown no significant difference in complication rate. This suggests that surgeons shouldn’t be afraid to tackle these cases, according to Dr. Whelan, chief of colorectal surgery at Mount Sinai West, New York.

 

 


"If you get an IBD case and you don’t see a lot of those, how do you decide what to do about it, and should you just refer it to a high-volume center?” said Dr. Whelan.

These patients are often under complex medical management, frequently spanning years, and this is an important factor in surgical decisions. They are often on multiple medications, including steroids, and most patients these days are taking monoclonal antibodies, said Dr. Whelan. The latter in particular can lead patients to be susceptible to infections. “These things can all affect decision making,” said Dr. Whelan.

Sometimes the nutritional status of IBD patients is poor, and most of the time, surgery is elective in these patients. So surgery can often be delayed for a month or more to allow time for nutritional status to improve, and this gives time for a patient to go off monoclonal antibodies, and for the physician to arrange for a referral to a high-volume center, if that seems the wisest course.

Surgery should not be considered without a gastrointestinal specialist who is comfortable in managing these patients. “Having someone who knows when to operate and not to operate, and how to handle medication, is really important,” said Dr. Whelan.

Certain cases should definitely be referred out. Ileal pouches are one. Another is a Crohn’s disease patient with multiple points of obstruction. “That may be one that you’re better off to punt,” said Dr. Whelan. Other cases include patients under complex medical management, when there is no experienced GI specialist available to help.
 

 


Emergencies require quicker decisions. In ulcerative colitis, emergency cases may include toxic megacolon, perforated colon, or obstruction from either a stricture or cancer, as well as bleeding in rare cases. Scenarios in Crohn’s disease include perforation with sepsis, inaccessible abscess, and, most commonly, obstruction resulting from fibrous stricture or acute inflammation.

When surgery is required, what’s the best choice? Dr. Whelan emphasized keeping it simple. Redo ileal pouches and ileal pouch excisions should generally be avoided. “Even if you do [pouches] often. It’s not the smartest way to go. These patients are almost all on immunosuppressive medications … to make an operation that’s already big even bigger often doesn’t work out well,” he said.

In emergency chronic ulcerative colitis cases, the safest choice is total abdominal colectomy plus end ileostomy. Dr. Whelan discourages surgeons from considering proctectomy and ileal pouch in emergency cases. A number of studies have shown that delaying pouch surgery is associated with fewer minor and major adverse events, and lower reoperation rates, he said. “If you do these operations on an immunosuppressed population, they don’t do as well,” said Dr. Whelan.

Crohn’s disease emergencies can often be managed nonsurgically. Most patients have phlegmon, fistulae, or a partial obstruction. Intravenous antibiotics, percutaneous drainage, hydration, and boosting nutritional status are good options. In cases where an obstruction requires surgery, and the surgeon isn’t comfortable performing stricturoplasty, “you want to limit the resection as best you can,” he said.

Dr. Whelan disclosed financial relationships with Ethicon Endosurgery and Olympus Corporation. Global Academy for Medical Education and this news organization are owned by the same parent company.”

 

– Patients with inflammatory bowel disease who are in need of a surgical intervention can pose a special challenge to surgeons who encounter these patients only occasionally.

The question of whether to perform surgery or refer a patient to a higher-volume specialty center can depend on proximity. In some cases, a specialty center isn’t close, or the patient can’t tolerate the required travel. In fact, a recent study showed that 85.8% of IBD patients are treated surgically in hospitals that treat fewer than 50 patients per year (Am J Gastroenterol. 2008;103:2789-98).

In a presentation at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education, Larry Whelan, MD, FACS, discussed some of the challenges these patients pose and offered guidance on which cases are best referred to high-volume centers, and the best way to proceed in emergencies.

IBD patients at high-volume centers have lower mortality than do those in low-volume centers, but patients treated at lower-volume centers tend to be sicker, and studies have shown no significant difference in complication rate. This suggests that surgeons shouldn’t be afraid to tackle these cases, according to Dr. Whelan, chief of colorectal surgery at Mount Sinai West, New York.

 

 


"If you get an IBD case and you don’t see a lot of those, how do you decide what to do about it, and should you just refer it to a high-volume center?” said Dr. Whelan.

These patients are often under complex medical management, frequently spanning years, and this is an important factor in surgical decisions. They are often on multiple medications, including steroids, and most patients these days are taking monoclonal antibodies, said Dr. Whelan. The latter in particular can lead patients to be susceptible to infections. “These things can all affect decision making,” said Dr. Whelan.

Sometimes the nutritional status of IBD patients is poor, and most of the time, surgery is elective in these patients. So surgery can often be delayed for a month or more to allow time for nutritional status to improve, and this gives time for a patient to go off monoclonal antibodies, and for the physician to arrange for a referral to a high-volume center, if that seems the wisest course.

Surgery should not be considered without a gastrointestinal specialist who is comfortable in managing these patients. “Having someone who knows when to operate and not to operate, and how to handle medication, is really important,” said Dr. Whelan.

Certain cases should definitely be referred out. Ileal pouches are one. Another is a Crohn’s disease patient with multiple points of obstruction. “That may be one that you’re better off to punt,” said Dr. Whelan. Other cases include patients under complex medical management, when there is no experienced GI specialist available to help.
 

 


Emergencies require quicker decisions. In ulcerative colitis, emergency cases may include toxic megacolon, perforated colon, or obstruction from either a stricture or cancer, as well as bleeding in rare cases. Scenarios in Crohn’s disease include perforation with sepsis, inaccessible abscess, and, most commonly, obstruction resulting from fibrous stricture or acute inflammation.

When surgery is required, what’s the best choice? Dr. Whelan emphasized keeping it simple. Redo ileal pouches and ileal pouch excisions should generally be avoided. “Even if you do [pouches] often. It’s not the smartest way to go. These patients are almost all on immunosuppressive medications … to make an operation that’s already big even bigger often doesn’t work out well,” he said.

In emergency chronic ulcerative colitis cases, the safest choice is total abdominal colectomy plus end ileostomy. Dr. Whelan discourages surgeons from considering proctectomy and ileal pouch in emergency cases. A number of studies have shown that delaying pouch surgery is associated with fewer minor and major adverse events, and lower reoperation rates, he said. “If you do these operations on an immunosuppressed population, they don’t do as well,” said Dr. Whelan.

Crohn’s disease emergencies can often be managed nonsurgically. Most patients have phlegmon, fistulae, or a partial obstruction. Intravenous antibiotics, percutaneous drainage, hydration, and boosting nutritional status are good options. In cases where an obstruction requires surgery, and the surgeon isn’t comfortable performing stricturoplasty, “you want to limit the resection as best you can,” he said.

Dr. Whelan disclosed financial relationships with Ethicon Endosurgery and Olympus Corporation. Global Academy for Medical Education and this news organization are owned by the same parent company.”

Publications
Publications
Topics
Article Type
Click for Credit Status
Ready
Sections
Article Source

EXPERT ANALYSIS FROM MISS

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default

A health plan ‘down payment’ is one way states are retooling individual mandate

Article Type
Changed
Wed, 04/03/2019 - 10:23

 

As President Donald Trump and congressional Republicans tirelessly try to dismantle the Affordable Care Act, a number of states are scrambling to enact laws that safeguard its central provisions.

The GOP tax plan approved by Congress in the last days of 2017 repealed the ACA penalty for people who fail to carry health insurance, a provision called the “individual mandate.” On Jan. 30, in Trump’s first State of the Union address, he claimed victory in killing off this part of the health law, saying Obamacare was effectively dead without it.

But before that federal action kicks in next year, some states are enacting measures to preserve the effects of the mandate by creating their own versions of it.

Maryland is on the cutting edge with legislation moving through both chambers of the Statehouse.

“We’ve been just struggling since Trump became president with how to protect the ACA in our state,” said Vincent DeMarco, president of the Maryland Citizens’ Health Initiative, a nonprofit organization that has been instrumental in pushing the measure.

 

 


Proposals have been discussed or advanced in at least nine states, including California, Washington, Connecticut, and the District of Columbia.

Creating an individual mandate is just one way that states – generally blue states where Democrats control the legislature – seek to ensure that what many lawmakers view as key advances made by the ACA don’t disappear.

They’re looking to one another as test cases to see how state-level legislation can either buttress or alter the ACA, according to Trish Riley, the executive director of the National Academy for State Health Policy.

“One state will try one approach; others will try it,” Riley said. “It’s an experiment, and an important one.”

Time is short, since most states have limited legislative calendars and are fast approaching the deadlines for insurers to file their 2019 rate plans.

Passing and implementing these kinds of measures will be tough, said Sabrina Corlette, a research professor at Georgetown University’s Health Policy Institute. But “I think there’s still a window of opportunity for states to do something and have an impact on 2019 premiums,” she said.
 

 

Maryland’s take on the individual mandate

Maryland’s effort began last April when the state legislature created the Maryland Health Insurance Coverage Protection Commission “both in response to and in anticipation of efforts at the federal level to repeal and replace the ACA,” according to a report by the state’s legislative services department and the commission itself.

The commission, chartered for 3 years, is charged with studying how federal action could affect the state’s health insurance market and Medicaid program and offering recommendations to mitigate any negative impacts. The panel began meeting months before the Maryland General Assembly started its 90-day session in January.

Based on the commission’s initial recommendations, Sen. Brian Feldman and House Del. Joseline Peña-Melnyk introduced the Protect Maryland Health Care Act of 2018, which lays out a framework for preserving an individual mandate in the state.

The federal individual mandate was put in place to make sure that younger, healthier people joined the insurance risk pool, helping to stabilize the market. The idea is that those relatively healthy customers help cover the insurers’ costs for sicker customers’ care, which keeps premium costs manageable for everyone.

 

 


The Congressional Budget Office estimated that 13 million people nationwide would become uninsured without the individual mandate. Some will choose to go without insurance or will not be able to find an affordable plan. Insurers could opt to leave local markets because they could not make money covering only sick patients.

Feldman said insurers and health care experts testified before the commission that Maryland’s insurance exchange would collapse in 2019 if the state didn’t act.

“Because of uncertainty at the federal level, it’s going to be up to states in this arena to pick up the slack and to enact legislation that responds to that uncertainty,” he said.

The federal mandate imposed a tax penalty on people who could afford to but chose not to buy insurance, depositing the money in a general Treasury fund.

In Maryland, the penalty fee will effectively be used, according to advocates, as a “down payment” on an insurance policy.

Beginning in 2020, if someone indicates on their taxes that they’re uninsured, the state would use the fine, plus any tax credits from the federal government, to buy an insurance plan for them.

Maryland would match its residents only with plans that cost nothing more than the fine plus the federal subsidy. So, if such a plan isn’t available in a person’s area, the state will hold on to the money in an interest-bearing account until the next open enrollment season. Then, the person has another chance to buy insurance. If at this time they don’t purchase a plan, the state will deposit the money into an insurance stabilization fund.
 
 

 

Politics and policy on the ground

Maryland is fertile ground for such health care experiments. The ACA remains popular within the state. Polling commissioned by Mr. DeMarco’s group puts the law’s support at 62%.

In addition, about 52% of Marylanders favored a state-based individual mandate, to make up for the federal provision that was repealed.

Democrats control the general assembly, but Gov. Larry Hogan, a Republican, has not offered a specific position on the issue – rather, he alluded to health reform efforts in his State of the State address. “Let’s develop bipartisan solutions to stabilize [health insurance] rates,” he said.

Ed Haislmaier, a senior research fellow at the Heritage Foundation, expressed skepticism about whether this approach will make a difference. The people who are targeted, he argued, are younger, healthier, and generally lower income. They don’t have insurance because they don’t want it, he suggested.

 

 


Jason Levitis, a senior fellow at Yale Law School’s Solomon Center for Health Law and Policy who has been instrumental in helping states craft their own versions of the individual mandate, warned that Maryland’s approach could face administrative challenges.

States that follow an approach more closely modeled after the federal mandate, he said, will have an easier time implementing it because regulators have already had 5 years of experience enforcing it.

Still, Mr. Levitis praised the Maryland plan: “There’s something attractive about the idea there, that you put this money … towards coverage.”

And a sampling of state proposals highlight a common theme.
 

 


“All the mandate efforts are based on the federal one,” Mr. Levitis said. “The variations are what you put on top, [how states] individually keep track of the money people pay and use it for health care services.”


He pointed to Connecticut as an example. It has two bills pending in its legislature – one that closely mirrors the federal mandate, but with slightly lower fines, and another in which the fines would be deposited into health savings accounts for the individuals.

In New Jersey, a Senate panel advanced a two-bill approach on March 5 that would collect a fee from residents who opt against buying health insurance. These fines would then be used to help pay the health care claims of people who are catastrophically ill.

In the District of Columbia, a health care working group recommended an individual mandate nearly identical to the federal one. The plan would require City Council and congressional approval to become law.

 

 


Washington state has convened a group to study how to enforce a mandate, and no legislation has been introduced yet in California.

Meanwhile, Maryland officials also hope to learn from the experiences of other states.

For instance, lawmakers in Maryland are considering the creation of a state-based, basic, low-cost health plan, as well as a fund to help insurers cope with the burden of very high-cost patients.

These efforts also come from the work of the commission.

Stan Dorn, a senior fellow with the pro-Obamacare group Families USA, said Maryland “had the foresight to see threats coming and to try to be proactive about it.”
 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Publications
Topics
Sections

 

As President Donald Trump and congressional Republicans tirelessly try to dismantle the Affordable Care Act, a number of states are scrambling to enact laws that safeguard its central provisions.

The GOP tax plan approved by Congress in the last days of 2017 repealed the ACA penalty for people who fail to carry health insurance, a provision called the “individual mandate.” On Jan. 30, in Trump’s first State of the Union address, he claimed victory in killing off this part of the health law, saying Obamacare was effectively dead without it.

But before that federal action kicks in next year, some states are enacting measures to preserve the effects of the mandate by creating their own versions of it.

Maryland is on the cutting edge with legislation moving through both chambers of the Statehouse.

“We’ve been just struggling since Trump became president with how to protect the ACA in our state,” said Vincent DeMarco, president of the Maryland Citizens’ Health Initiative, a nonprofit organization that has been instrumental in pushing the measure.

 

 


Proposals have been discussed or advanced in at least nine states, including California, Washington, Connecticut, and the District of Columbia.

Creating an individual mandate is just one way that states – generally blue states where Democrats control the legislature – seek to ensure that what many lawmakers view as key advances made by the ACA don’t disappear.

They’re looking to one another as test cases to see how state-level legislation can either buttress or alter the ACA, according to Trish Riley, the executive director of the National Academy for State Health Policy.

“One state will try one approach; others will try it,” Riley said. “It’s an experiment, and an important one.”

Time is short, since most states have limited legislative calendars and are fast approaching the deadlines for insurers to file their 2019 rate plans.

Passing and implementing these kinds of measures will be tough, said Sabrina Corlette, a research professor at Georgetown University’s Health Policy Institute. But “I think there’s still a window of opportunity for states to do something and have an impact on 2019 premiums,” she said.
 

 

Maryland’s take on the individual mandate

Maryland’s effort began last April when the state legislature created the Maryland Health Insurance Coverage Protection Commission “both in response to and in anticipation of efforts at the federal level to repeal and replace the ACA,” according to a report by the state’s legislative services department and the commission itself.

The commission, chartered for 3 years, is charged with studying how federal action could affect the state’s health insurance market and Medicaid program and offering recommendations to mitigate any negative impacts. The panel began meeting months before the Maryland General Assembly started its 90-day session in January.

Based on the commission’s initial recommendations, Sen. Brian Feldman and House Del. Joseline Peña-Melnyk introduced the Protect Maryland Health Care Act of 2018, which lays out a framework for preserving an individual mandate in the state.

The federal individual mandate was put in place to make sure that younger, healthier people joined the insurance risk pool, helping to stabilize the market. The idea is that those relatively healthy customers help cover the insurers’ costs for sicker customers’ care, which keeps premium costs manageable for everyone.

 

 


The Congressional Budget Office estimated that 13 million people nationwide would become uninsured without the individual mandate. Some will choose to go without insurance or will not be able to find an affordable plan. Insurers could opt to leave local markets because they could not make money covering only sick patients.

Feldman said insurers and health care experts testified before the commission that Maryland’s insurance exchange would collapse in 2019 if the state didn’t act.

“Because of uncertainty at the federal level, it’s going to be up to states in this arena to pick up the slack and to enact legislation that responds to that uncertainty,” he said.

The federal mandate imposed a tax penalty on people who could afford to but chose not to buy insurance, depositing the money in a general Treasury fund.

In Maryland, the penalty fee will effectively be used, according to advocates, as a “down payment” on an insurance policy.

Beginning in 2020, if someone indicates on their taxes that they’re uninsured, the state would use the fine, plus any tax credits from the federal government, to buy an insurance plan for them.

Maryland would match its residents only with plans that cost nothing more than the fine plus the federal subsidy. So, if such a plan isn’t available in a person’s area, the state will hold on to the money in an interest-bearing account until the next open enrollment season. Then, the person has another chance to buy insurance. If at this time they don’t purchase a plan, the state will deposit the money into an insurance stabilization fund.
 
 

 

Politics and policy on the ground

Maryland is fertile ground for such health care experiments. The ACA remains popular within the state. Polling commissioned by Mr. DeMarco’s group puts the law’s support at 62%.

In addition, about 52% of Marylanders favored a state-based individual mandate, to make up for the federal provision that was repealed.

Democrats control the general assembly, but Gov. Larry Hogan, a Republican, has not offered a specific position on the issue – rather, he alluded to health reform efforts in his State of the State address. “Let’s develop bipartisan solutions to stabilize [health insurance] rates,” he said.

Ed Haislmaier, a senior research fellow at the Heritage Foundation, expressed skepticism about whether this approach will make a difference. The people who are targeted, he argued, are younger, healthier, and generally lower income. They don’t have insurance because they don’t want it, he suggested.

 

 


Jason Levitis, a senior fellow at Yale Law School’s Solomon Center for Health Law and Policy who has been instrumental in helping states craft their own versions of the individual mandate, warned that Maryland’s approach could face administrative challenges.

States that follow an approach more closely modeled after the federal mandate, he said, will have an easier time implementing it because regulators have already had 5 years of experience enforcing it.

Still, Mr. Levitis praised the Maryland plan: “There’s something attractive about the idea there, that you put this money … towards coverage.”

And a sampling of state proposals highlight a common theme.
 

 


“All the mandate efforts are based on the federal one,” Mr. Levitis said. “The variations are what you put on top, [how states] individually keep track of the money people pay and use it for health care services.”


He pointed to Connecticut as an example. It has two bills pending in its legislature – one that closely mirrors the federal mandate, but with slightly lower fines, and another in which the fines would be deposited into health savings accounts for the individuals.

In New Jersey, a Senate panel advanced a two-bill approach on March 5 that would collect a fee from residents who opt against buying health insurance. These fines would then be used to help pay the health care claims of people who are catastrophically ill.

In the District of Columbia, a health care working group recommended an individual mandate nearly identical to the federal one. The plan would require City Council and congressional approval to become law.

 

 


Washington state has convened a group to study how to enforce a mandate, and no legislation has been introduced yet in California.

Meanwhile, Maryland officials also hope to learn from the experiences of other states.

For instance, lawmakers in Maryland are considering the creation of a state-based, basic, low-cost health plan, as well as a fund to help insurers cope with the burden of very high-cost patients.

These efforts also come from the work of the commission.

Stan Dorn, a senior fellow with the pro-Obamacare group Families USA, said Maryland “had the foresight to see threats coming and to try to be proactive about it.”
 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

 

As President Donald Trump and congressional Republicans tirelessly try to dismantle the Affordable Care Act, a number of states are scrambling to enact laws that safeguard its central provisions.

The GOP tax plan approved by Congress in the last days of 2017 repealed the ACA penalty for people who fail to carry health insurance, a provision called the “individual mandate.” On Jan. 30, in Trump’s first State of the Union address, he claimed victory in killing off this part of the health law, saying Obamacare was effectively dead without it.

But before that federal action kicks in next year, some states are enacting measures to preserve the effects of the mandate by creating their own versions of it.

Maryland is on the cutting edge with legislation moving through both chambers of the Statehouse.

“We’ve been just struggling since Trump became president with how to protect the ACA in our state,” said Vincent DeMarco, president of the Maryland Citizens’ Health Initiative, a nonprofit organization that has been instrumental in pushing the measure.

 

 


Proposals have been discussed or advanced in at least nine states, including California, Washington, Connecticut, and the District of Columbia.

Creating an individual mandate is just one way that states – generally blue states where Democrats control the legislature – seek to ensure that what many lawmakers view as key advances made by the ACA don’t disappear.

They’re looking to one another as test cases to see how state-level legislation can either buttress or alter the ACA, according to Trish Riley, the executive director of the National Academy for State Health Policy.

“One state will try one approach; others will try it,” Riley said. “It’s an experiment, and an important one.”

Time is short, since most states have limited legislative calendars and are fast approaching the deadlines for insurers to file their 2019 rate plans.

Passing and implementing these kinds of measures will be tough, said Sabrina Corlette, a research professor at Georgetown University’s Health Policy Institute. But “I think there’s still a window of opportunity for states to do something and have an impact on 2019 premiums,” she said.
 

 

Maryland’s take on the individual mandate

Maryland’s effort began last April when the state legislature created the Maryland Health Insurance Coverage Protection Commission “both in response to and in anticipation of efforts at the federal level to repeal and replace the ACA,” according to a report by the state’s legislative services department and the commission itself.

The commission, chartered for 3 years, is charged with studying how federal action could affect the state’s health insurance market and Medicaid program and offering recommendations to mitigate any negative impacts. The panel began meeting months before the Maryland General Assembly started its 90-day session in January.

Based on the commission’s initial recommendations, Sen. Brian Feldman and House Del. Joseline Peña-Melnyk introduced the Protect Maryland Health Care Act of 2018, which lays out a framework for preserving an individual mandate in the state.

The federal individual mandate was put in place to make sure that younger, healthier people joined the insurance risk pool, helping to stabilize the market. The idea is that those relatively healthy customers help cover the insurers’ costs for sicker customers’ care, which keeps premium costs manageable for everyone.

 

 


The Congressional Budget Office estimated that 13 million people nationwide would become uninsured without the individual mandate. Some will choose to go without insurance or will not be able to find an affordable plan. Insurers could opt to leave local markets because they could not make money covering only sick patients.

Feldman said insurers and health care experts testified before the commission that Maryland’s insurance exchange would collapse in 2019 if the state didn’t act.

“Because of uncertainty at the federal level, it’s going to be up to states in this arena to pick up the slack and to enact legislation that responds to that uncertainty,” he said.

The federal mandate imposed a tax penalty on people who could afford to but chose not to buy insurance, depositing the money in a general Treasury fund.

In Maryland, the penalty fee will effectively be used, according to advocates, as a “down payment” on an insurance policy.

Beginning in 2020, if someone indicates on their taxes that they’re uninsured, the state would use the fine, plus any tax credits from the federal government, to buy an insurance plan for them.

Maryland would match its residents only with plans that cost nothing more than the fine plus the federal subsidy. So, if such a plan isn’t available in a person’s area, the state will hold on to the money in an interest-bearing account until the next open enrollment season. Then, the person has another chance to buy insurance. If at this time they don’t purchase a plan, the state will deposit the money into an insurance stabilization fund.
 
 

 

Politics and policy on the ground

Maryland is fertile ground for such health care experiments. The ACA remains popular within the state. Polling commissioned by Mr. DeMarco’s group puts the law’s support at 62%.

In addition, about 52% of Marylanders favored a state-based individual mandate, to make up for the federal provision that was repealed.

Democrats control the general assembly, but Gov. Larry Hogan, a Republican, has not offered a specific position on the issue – rather, he alluded to health reform efforts in his State of the State address. “Let’s develop bipartisan solutions to stabilize [health insurance] rates,” he said.

Ed Haislmaier, a senior research fellow at the Heritage Foundation, expressed skepticism about whether this approach will make a difference. The people who are targeted, he argued, are younger, healthier, and generally lower income. They don’t have insurance because they don’t want it, he suggested.

 

 


Jason Levitis, a senior fellow at Yale Law School’s Solomon Center for Health Law and Policy who has been instrumental in helping states craft their own versions of the individual mandate, warned that Maryland’s approach could face administrative challenges.

States that follow an approach more closely modeled after the federal mandate, he said, will have an easier time implementing it because regulators have already had 5 years of experience enforcing it.

Still, Mr. Levitis praised the Maryland plan: “There’s something attractive about the idea there, that you put this money … towards coverage.”

And a sampling of state proposals highlight a common theme.
 

 


“All the mandate efforts are based on the federal one,” Mr. Levitis said. “The variations are what you put on top, [how states] individually keep track of the money people pay and use it for health care services.”


He pointed to Connecticut as an example. It has two bills pending in its legislature – one that closely mirrors the federal mandate, but with slightly lower fines, and another in which the fines would be deposited into health savings accounts for the individuals.

In New Jersey, a Senate panel advanced a two-bill approach on March 5 that would collect a fee from residents who opt against buying health insurance. These fines would then be used to help pay the health care claims of people who are catastrophically ill.

In the District of Columbia, a health care working group recommended an individual mandate nearly identical to the federal one. The plan would require City Council and congressional approval to become law.

 

 


Washington state has convened a group to study how to enforce a mandate, and no legislation has been introduced yet in California.

Meanwhile, Maryland officials also hope to learn from the experiences of other states.

For instance, lawmakers in Maryland are considering the creation of a state-based, basic, low-cost health plan, as well as a fund to help insurers cope with the burden of very high-cost patients.

These efforts also come from the work of the commission.

Stan Dorn, a senior fellow with the pro-Obamacare group Families USA, said Maryland “had the foresight to see threats coming and to try to be proactive about it.”
 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default

Nonendoscopic nonmalignant polyp surgery increasing despite greater risk

Management of complex colon polyps 
Article Type
Changed
Wed, 01/02/2019 - 10:07

 

Rate of nonendoscopic surgeries for nonmalignant colorectal polyps significantly increased from 5.9 to 9.4 per 100,000 people from 2000 to 2014, according to a study in Gastroenterology.

These surgeries are not only associated with a much higher risk to patients than endoscopic procedures, but they are significantly less cost effective, confusing investigators as to the cause of the increase.

“The literature to date is clear that endoscopic resection is the preferred management of nonmalignant colorectal polyps,” Anne Peery, MD, gastroenterologist at the University of North Carolina at Chapel Hill, and colleagues explained. “Among patients who have surgery for a nonmalignant colorectal polyp, 14% will have at least one major short-term postoperative event.”

Data from 1,230,458 surgeries conducted during 2000-2014 and recorded in the Healthcare Cost and Utilization Project National Inpatients Sample were included in this study. Patients who underwent a nonendoscopic procedure for nonmalignant polyps were predominantly non-Hispanic white, covered by Medicare, from the highest household income range, and an average age of 66 years.

 

 


While non-Hispanic white patients had the highest overall rate increase by ethnicity, rising from 5.6 to 10.5 per 100,000 population, rates in non-Hispanic black and Hispanic patients also rose significantly, increasing from 3.5 to 5.8 per 100,000 population, and from 1.1 to 3.7 per 100,000 population, respectively.

Regionally, rates of surgery were higher in the Midwest (10.8 per 100,000) and the South (10.6 per 100,000) than in the Northeast (7.8 per 100,000) and West (7.5 per 100,000). Incidence rates rose equally during the study period for both men and women.

Large urban teaching hospitals were found to have the largest rate increase when data were stratified by teaching status, a finding which caught Dr. Peery and fellow investigators by surprise.

“We had hypothesized that surgery for nonmalignant colorectal polyps would be both uncommon and declining in teaching hospitals where providers are more likely to be familiar with current guidelines and to have access to endoscopic mucosal resection,” wrote the investigators. “Instead, we found that surgery for nonmalignant colorectal polyps is both common and significantly increasing in teaching hospitals.”

 

 


The investigators first hypothesized the increased rate in teaching hospitals could be due to a higher concentration of case referrals to these high-volume centers, following a trend of centralizing cancer procedures. However, there has been no other sign that colon and rectal cancer procedures are following this trend.

Another option considered by Dr. Peery and her colleagues was that increased procedures may stem from a rise in colorectal cancer screening; however, the data indicate screenings did not change from 2010 to 2015, leaving investigators with few final guesses to go on.

“It is also conceivable that increasing production pressure and inadequate reimbursement for endoscopic mucosal resection may persuade endoscopists to refer patients with complex nonmalignant colorectal polyps for surgery,” said Dr. Peery and fellow investigators. “Finally, there is the issue of risk ... for endoscopists without additional training in advanced endoscopic resection, these risks may be perceived as too great, especially when they have the option of referring for a surgical resection.”

There is a possibility that the incidence of surgery was over- or underestimated, as investigators were using ICD-9 codes to identify cases, and patients with diverticulitis were also excluded, which may have affected results.

The investigators reported no relevant financial disclosures.

SOURCE: Peery A et al. Gastroenterology. 2018 Jan 6. doi: 10.1053/j.gastro.2018.01.003.

Body

In this comprehensive analysis, Peery et al. found a rising incidence of surgery for nonmalignant colorectal polyps despite relatively stable colorectal cancer screening rates and with decreasing incidence of colorectal cancer surgery. 

In a separate study, the authors found that 14% of patients who underwent surgical resection of nonmalignant colorectal polyps had a major postoperative event. Other population-based studies have reported similar incidence of surgical complications.  

This report thus raises concern for inappropriate surgical referral. While reimbursement models may play a role, many factors are involved with surgical referral. Complex polypectomy, often using endoscopic mucosal resection techniques to remove large polyps, is associated with higher rates of bleeding, perforation, and incomplete resection, compared with standard polypectomies. The decision to refer to surgery or to attempt endoscopic resection is based on provider experience and polyp characteristics, including suspicion for malignancy.  Current literature suggests that surgical removal is recommended less frequently by specialists in complex polypectomy, compared with nonspecialists. 

Given this study’s findings, health systems should consider including surgical referral rates in their quality measures. Thus, high-quality endoscopy centers would ensure that complex polyps are appropriately characterized and initially managed by endoscopists experienced in complex polypectomy. This is especially important with the increasing repertoire of endoscopic alternatives to surgery that we can offer our patients. 

Gyanprakash A. Ketwaroo, MD, MSc, is an an assistant professor, division of gastroenterology and hepatology, Baylor College of Medicine, Houston. He has no conflicts. 

Publications
Topics
Sections
Body

In this comprehensive analysis, Peery et al. found a rising incidence of surgery for nonmalignant colorectal polyps despite relatively stable colorectal cancer screening rates and with decreasing incidence of colorectal cancer surgery. 

In a separate study, the authors found that 14% of patients who underwent surgical resection of nonmalignant colorectal polyps had a major postoperative event. Other population-based studies have reported similar incidence of surgical complications.  

This report thus raises concern for inappropriate surgical referral. While reimbursement models may play a role, many factors are involved with surgical referral. Complex polypectomy, often using endoscopic mucosal resection techniques to remove large polyps, is associated with higher rates of bleeding, perforation, and incomplete resection, compared with standard polypectomies. The decision to refer to surgery or to attempt endoscopic resection is based on provider experience and polyp characteristics, including suspicion for malignancy.  Current literature suggests that surgical removal is recommended less frequently by specialists in complex polypectomy, compared with nonspecialists. 

Given this study’s findings, health systems should consider including surgical referral rates in their quality measures. Thus, high-quality endoscopy centers would ensure that complex polyps are appropriately characterized and initially managed by endoscopists experienced in complex polypectomy. This is especially important with the increasing repertoire of endoscopic alternatives to surgery that we can offer our patients. 

Gyanprakash A. Ketwaroo, MD, MSc, is an an assistant professor, division of gastroenterology and hepatology, Baylor College of Medicine, Houston. He has no conflicts. 

Body

In this comprehensive analysis, Peery et al. found a rising incidence of surgery for nonmalignant colorectal polyps despite relatively stable colorectal cancer screening rates and with decreasing incidence of colorectal cancer surgery. 

In a separate study, the authors found that 14% of patients who underwent surgical resection of nonmalignant colorectal polyps had a major postoperative event. Other population-based studies have reported similar incidence of surgical complications.  

This report thus raises concern for inappropriate surgical referral. While reimbursement models may play a role, many factors are involved with surgical referral. Complex polypectomy, often using endoscopic mucosal resection techniques to remove large polyps, is associated with higher rates of bleeding, perforation, and incomplete resection, compared with standard polypectomies. The decision to refer to surgery or to attempt endoscopic resection is based on provider experience and polyp characteristics, including suspicion for malignancy.  Current literature suggests that surgical removal is recommended less frequently by specialists in complex polypectomy, compared with nonspecialists. 

Given this study’s findings, health systems should consider including surgical referral rates in their quality measures. Thus, high-quality endoscopy centers would ensure that complex polyps are appropriately characterized and initially managed by endoscopists experienced in complex polypectomy. This is especially important with the increasing repertoire of endoscopic alternatives to surgery that we can offer our patients. 

Gyanprakash A. Ketwaroo, MD, MSc, is an an assistant professor, division of gastroenterology and hepatology, Baylor College of Medicine, Houston. He has no conflicts. 

Title
Management of complex colon polyps 
Management of complex colon polyps 

 

Rate of nonendoscopic surgeries for nonmalignant colorectal polyps significantly increased from 5.9 to 9.4 per 100,000 people from 2000 to 2014, according to a study in Gastroenterology.

These surgeries are not only associated with a much higher risk to patients than endoscopic procedures, but they are significantly less cost effective, confusing investigators as to the cause of the increase.

“The literature to date is clear that endoscopic resection is the preferred management of nonmalignant colorectal polyps,” Anne Peery, MD, gastroenterologist at the University of North Carolina at Chapel Hill, and colleagues explained. “Among patients who have surgery for a nonmalignant colorectal polyp, 14% will have at least one major short-term postoperative event.”

Data from 1,230,458 surgeries conducted during 2000-2014 and recorded in the Healthcare Cost and Utilization Project National Inpatients Sample were included in this study. Patients who underwent a nonendoscopic procedure for nonmalignant polyps were predominantly non-Hispanic white, covered by Medicare, from the highest household income range, and an average age of 66 years.

 

 


While non-Hispanic white patients had the highest overall rate increase by ethnicity, rising from 5.6 to 10.5 per 100,000 population, rates in non-Hispanic black and Hispanic patients also rose significantly, increasing from 3.5 to 5.8 per 100,000 population, and from 1.1 to 3.7 per 100,000 population, respectively.

Regionally, rates of surgery were higher in the Midwest (10.8 per 100,000) and the South (10.6 per 100,000) than in the Northeast (7.8 per 100,000) and West (7.5 per 100,000). Incidence rates rose equally during the study period for both men and women.

Large urban teaching hospitals were found to have the largest rate increase when data were stratified by teaching status, a finding which caught Dr. Peery and fellow investigators by surprise.

“We had hypothesized that surgery for nonmalignant colorectal polyps would be both uncommon and declining in teaching hospitals where providers are more likely to be familiar with current guidelines and to have access to endoscopic mucosal resection,” wrote the investigators. “Instead, we found that surgery for nonmalignant colorectal polyps is both common and significantly increasing in teaching hospitals.”

 

 


The investigators first hypothesized the increased rate in teaching hospitals could be due to a higher concentration of case referrals to these high-volume centers, following a trend of centralizing cancer procedures. However, there has been no other sign that colon and rectal cancer procedures are following this trend.

Another option considered by Dr. Peery and her colleagues was that increased procedures may stem from a rise in colorectal cancer screening; however, the data indicate screenings did not change from 2010 to 2015, leaving investigators with few final guesses to go on.

“It is also conceivable that increasing production pressure and inadequate reimbursement for endoscopic mucosal resection may persuade endoscopists to refer patients with complex nonmalignant colorectal polyps for surgery,” said Dr. Peery and fellow investigators. “Finally, there is the issue of risk ... for endoscopists without additional training in advanced endoscopic resection, these risks may be perceived as too great, especially when they have the option of referring for a surgical resection.”

There is a possibility that the incidence of surgery was over- or underestimated, as investigators were using ICD-9 codes to identify cases, and patients with diverticulitis were also excluded, which may have affected results.

The investigators reported no relevant financial disclosures.

SOURCE: Peery A et al. Gastroenterology. 2018 Jan 6. doi: 10.1053/j.gastro.2018.01.003.

 

Rate of nonendoscopic surgeries for nonmalignant colorectal polyps significantly increased from 5.9 to 9.4 per 100,000 people from 2000 to 2014, according to a study in Gastroenterology.

These surgeries are not only associated with a much higher risk to patients than endoscopic procedures, but they are significantly less cost effective, confusing investigators as to the cause of the increase.

“The literature to date is clear that endoscopic resection is the preferred management of nonmalignant colorectal polyps,” Anne Peery, MD, gastroenterologist at the University of North Carolina at Chapel Hill, and colleagues explained. “Among patients who have surgery for a nonmalignant colorectal polyp, 14% will have at least one major short-term postoperative event.”

Data from 1,230,458 surgeries conducted during 2000-2014 and recorded in the Healthcare Cost and Utilization Project National Inpatients Sample were included in this study. Patients who underwent a nonendoscopic procedure for nonmalignant polyps were predominantly non-Hispanic white, covered by Medicare, from the highest household income range, and an average age of 66 years.

 

 


While non-Hispanic white patients had the highest overall rate increase by ethnicity, rising from 5.6 to 10.5 per 100,000 population, rates in non-Hispanic black and Hispanic patients also rose significantly, increasing from 3.5 to 5.8 per 100,000 population, and from 1.1 to 3.7 per 100,000 population, respectively.

Regionally, rates of surgery were higher in the Midwest (10.8 per 100,000) and the South (10.6 per 100,000) than in the Northeast (7.8 per 100,000) and West (7.5 per 100,000). Incidence rates rose equally during the study period for both men and women.

Large urban teaching hospitals were found to have the largest rate increase when data were stratified by teaching status, a finding which caught Dr. Peery and fellow investigators by surprise.

“We had hypothesized that surgery for nonmalignant colorectal polyps would be both uncommon and declining in teaching hospitals where providers are more likely to be familiar with current guidelines and to have access to endoscopic mucosal resection,” wrote the investigators. “Instead, we found that surgery for nonmalignant colorectal polyps is both common and significantly increasing in teaching hospitals.”

 

 


The investigators first hypothesized the increased rate in teaching hospitals could be due to a higher concentration of case referrals to these high-volume centers, following a trend of centralizing cancer procedures. However, there has been no other sign that colon and rectal cancer procedures are following this trend.

Another option considered by Dr. Peery and her colleagues was that increased procedures may stem from a rise in colorectal cancer screening; however, the data indicate screenings did not change from 2010 to 2015, leaving investigators with few final guesses to go on.

“It is also conceivable that increasing production pressure and inadequate reimbursement for endoscopic mucosal resection may persuade endoscopists to refer patients with complex nonmalignant colorectal polyps for surgery,” said Dr. Peery and fellow investigators. “Finally, there is the issue of risk ... for endoscopists without additional training in advanced endoscopic resection, these risks may be perceived as too great, especially when they have the option of referring for a surgical resection.”

There is a possibility that the incidence of surgery was over- or underestimated, as investigators were using ICD-9 codes to identify cases, and patients with diverticulitis were also excluded, which may have affected results.

The investigators reported no relevant financial disclosures.

SOURCE: Peery A et al. Gastroenterology. 2018 Jan 6. doi: 10.1053/j.gastro.2018.01.003.

Publications
Publications
Topics
Article Type
Click for Credit Status
Ready
Sections
Article Source

FROM GASTROENTEROLOGY

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Vitals

 

Key clinical point: Surgical resections for nonmalignant colorectal polyps are increasing while safer endoscopic procedures are available.

Major finding: Incidence rate of surgery for nonmalignant polyps has increased from 5.9 to 9.4 per 100,000 adults from 2000 to 2014.

Study details: A retrospective study of 1,230,458 surgeries recorded in the Healthcare Cost and Utilization Project National Inpatient Sample from 2000 to 2014.

Disclosures: The authors reported no relevant financial disclosures.

Source: Peery A et al. Gastroenterology. 2018 Jan 6. doi: 10.1053/j.gastro.2018.01.003.

Disqus Comments
Default
Use ProPublica

No clear winner in Pfannenstiel vs. vertical incision for high BMI cesareans

Article Type
Changed
Fri, 01/18/2019 - 17:27

 

No clear winner emerged in a first-ever randomized controlled trial comparing Pfannenstiel with vertical incisions for women with obesity having cesarean delivery, though enrollment difficulties limited study numbers, with almost two-thirds of eligible women declining to participate in the surgical trial.

At 6 weeks postdelivery, 21.1% of women who had a vertical incision experienced wound complications, compared with 18.6% of those who had a Pfannenstiel incision, a nonsignificant difference. This was a smaller difference than was seen at 2 weeks postpartum, when 20% of the vertical incision group had wound complications, compared with 10.4% of those who had a Pfannenstiel, also a nonsignificant difference. Maternal and fetal outcomes didn’t differ significantly with the two surgical approaches.

Dr. Carolyn Marrs
”We were unable to demonstrate a difference in the primary or secondary outcomes in women with class III obesity who received Pfannenstiel versus vertical skin incision,” said Caroline C. Marrs, MD, presenting the study results at the meeting sponsored by the Society for Maternal-Fetal Medicine.

Though there had been several observational studies comparing vertical with Pfannenstiel incisions for cesarean delivery in women with obesity, no randomized, controlled trials had been conducted, and observational study results were mixed, said Dr. Marrs.

 

 


Each approach comes with theoretical pros and cons: For women who have a large pannus, the incision site may lie in a moist environment with a low transverse incision, and oxygen tension may be low. However, a Pfannenstiel incision usually will have better cosmesis than will a vertical incision, and generally will result in less postoperative pain.

On the other hand, said Dr. Marrs, vertical incisions can provide improved exposure of the uterus during delivery, and the moist environment underlying the pannus is avoided. However, wound tension may be higher, and subcutaneous thickness is likely to be higher than at the Pfannenstiel incision site.

The study, conducted at two academic medical centers, enrolled women with a body mass index (BMI) of at least 40 kg/m2 at a gestational age of 24 weeks or greater who required cesarean delivery. Consenting women were then randomized to receive Pfannenstiel or vertical incisions.

Women who had clinical chorioamnionitis, whose amniotic membranes had been ruptured for 18 hours or more, or who had placenta accreta were excluded. Also excluded were women with a private physician and those desiring vaginal delivery, said Dr. Marrs, a maternal-fetal medicine fellow at the University of Texas Medical Branch, Galveston.
 

 


The study’s primary outcome measure was a composite of wound complications seen within 6 weeks of delivery, including surgical site infection, whether superficial, deep, or involving an organ or tissue space; cellulitis; seroma or hematoma; and wound separation. Other maternal outcomes tracked in the study included postoperative length of stay, transfusion requirement, sepsis, readmission, and death.

Cesarean-specific secondary outcomes included operative time and time from skin incision to delivery, estimated blood loss, and any incidence of hysterectomy through a low transverse incision. Neonatal outcomes included a 5-minute Apgar score of less than 7, umbilical cord pH of less than 7, and neonatal ICU admissions.

Dr. Mars said that the goal enrollment for the study was 300 patients, to ensure adequate statistical power. However, they found enrollment a challenge, with low consent rates during the defined time period from October 2013 to May 2017. They shifted their statistical technique to a Bayesian analysis, taking into account the estimated probability of treatment benefit.

Using this approach, they found a 59% probability that a Pfannenstiel incision would lead to a lower primary outcome rate – a better result – than would a vertical incision. This result just missed the predetermined threshold of 60%, said Dr. Marrs.
 

 


Of the 789 women who met the BMI threshold for eligibility assessment, 420 (65%) who passed the screening declined to participate. Of those who consented to participation, an additional 137 women either withdrew consent or failed further screening, leaving 50 women who were randomized to the Pfannenstiel arm and 41 who were randomized to the vertical incision arm.

Baseline characteristics were similar between groups, with a mean maternal age of 30 years in the Pfannenstiel group and 28 years in the vertical incision group. Gestational age at delivery was a mean of 37 weeks in both groups, and mean BMI was 48-50 kg/m2.

Most patients (80%-90%) had public insurance. Diabetes was more common in the Pfannenstiel group (48%) than in the vertical incision cohort (32%). Just over 40% of patients were African American.

Two women in the Pfannenstiel group and three in the vertical incision group did not receive the intended incision. After accounting for patients lost to follow-up by 6 weeks, 43 women who received Pfannenstiel and 38 women who received vertical incisions were available for full evaluation.
 

 


Dr. Marrs said that the study, the first randomized trial to address this issue, had several strengths, including its being conducted at two sites with appropriate stratification for the sites. Also, an independent data safety monitoring board and two chart reviewers helped overcome some of the limitations of a surgical study, where complete blinding is impossible.

The Bayesian analysis allowed ascertainment of the probability of treatment benefit despite the lower-than-hoped-for enrollment numbers. The primary weakness of the study, said Dr. Marrs, centered around the low consent rate, which led to a small study that was prematurely terminated.

“It’s difficult to enroll women in a trial that requires random allocation of skin incision, due to their preference to choose their own incision. A larger trial would likewise be challenging, and unlikely to yield different results,” said Dr. Marrs.

Dr. Marrs reported no conflicts of interest.

 

SOURCE: Marrs CC et al. Am J Obstet Gynecol. 2018 Jan;218:S29.
 

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

 

No clear winner emerged in a first-ever randomized controlled trial comparing Pfannenstiel with vertical incisions for women with obesity having cesarean delivery, though enrollment difficulties limited study numbers, with almost two-thirds of eligible women declining to participate in the surgical trial.

At 6 weeks postdelivery, 21.1% of women who had a vertical incision experienced wound complications, compared with 18.6% of those who had a Pfannenstiel incision, a nonsignificant difference. This was a smaller difference than was seen at 2 weeks postpartum, when 20% of the vertical incision group had wound complications, compared with 10.4% of those who had a Pfannenstiel, also a nonsignificant difference. Maternal and fetal outcomes didn’t differ significantly with the two surgical approaches.

Dr. Carolyn Marrs
”We were unable to demonstrate a difference in the primary or secondary outcomes in women with class III obesity who received Pfannenstiel versus vertical skin incision,” said Caroline C. Marrs, MD, presenting the study results at the meeting sponsored by the Society for Maternal-Fetal Medicine.

Though there had been several observational studies comparing vertical with Pfannenstiel incisions for cesarean delivery in women with obesity, no randomized, controlled trials had been conducted, and observational study results were mixed, said Dr. Marrs.

 

 


Each approach comes with theoretical pros and cons: For women who have a large pannus, the incision site may lie in a moist environment with a low transverse incision, and oxygen tension may be low. However, a Pfannenstiel incision usually will have better cosmesis than will a vertical incision, and generally will result in less postoperative pain.

On the other hand, said Dr. Marrs, vertical incisions can provide improved exposure of the uterus during delivery, and the moist environment underlying the pannus is avoided. However, wound tension may be higher, and subcutaneous thickness is likely to be higher than at the Pfannenstiel incision site.

The study, conducted at two academic medical centers, enrolled women with a body mass index (BMI) of at least 40 kg/m2 at a gestational age of 24 weeks or greater who required cesarean delivery. Consenting women were then randomized to receive Pfannenstiel or vertical incisions.

Women who had clinical chorioamnionitis, whose amniotic membranes had been ruptured for 18 hours or more, or who had placenta accreta were excluded. Also excluded were women with a private physician and those desiring vaginal delivery, said Dr. Marrs, a maternal-fetal medicine fellow at the University of Texas Medical Branch, Galveston.
 

 


The study’s primary outcome measure was a composite of wound complications seen within 6 weeks of delivery, including surgical site infection, whether superficial, deep, or involving an organ or tissue space; cellulitis; seroma or hematoma; and wound separation. Other maternal outcomes tracked in the study included postoperative length of stay, transfusion requirement, sepsis, readmission, and death.

Cesarean-specific secondary outcomes included operative time and time from skin incision to delivery, estimated blood loss, and any incidence of hysterectomy through a low transverse incision. Neonatal outcomes included a 5-minute Apgar score of less than 7, umbilical cord pH of less than 7, and neonatal ICU admissions.

Dr. Mars said that the goal enrollment for the study was 300 patients, to ensure adequate statistical power. However, they found enrollment a challenge, with low consent rates during the defined time period from October 2013 to May 2017. They shifted their statistical technique to a Bayesian analysis, taking into account the estimated probability of treatment benefit.

Using this approach, they found a 59% probability that a Pfannenstiel incision would lead to a lower primary outcome rate – a better result – than would a vertical incision. This result just missed the predetermined threshold of 60%, said Dr. Marrs.
 

 


Of the 789 women who met the BMI threshold for eligibility assessment, 420 (65%) who passed the screening declined to participate. Of those who consented to participation, an additional 137 women either withdrew consent or failed further screening, leaving 50 women who were randomized to the Pfannenstiel arm and 41 who were randomized to the vertical incision arm.

Baseline characteristics were similar between groups, with a mean maternal age of 30 years in the Pfannenstiel group and 28 years in the vertical incision group. Gestational age at delivery was a mean of 37 weeks in both groups, and mean BMI was 48-50 kg/m2.

Most patients (80%-90%) had public insurance. Diabetes was more common in the Pfannenstiel group (48%) than in the vertical incision cohort (32%). Just over 40% of patients were African American.

Two women in the Pfannenstiel group and three in the vertical incision group did not receive the intended incision. After accounting for patients lost to follow-up by 6 weeks, 43 women who received Pfannenstiel and 38 women who received vertical incisions were available for full evaluation.
 

 


Dr. Marrs said that the study, the first randomized trial to address this issue, had several strengths, including its being conducted at two sites with appropriate stratification for the sites. Also, an independent data safety monitoring board and two chart reviewers helped overcome some of the limitations of a surgical study, where complete blinding is impossible.

The Bayesian analysis allowed ascertainment of the probability of treatment benefit despite the lower-than-hoped-for enrollment numbers. The primary weakness of the study, said Dr. Marrs, centered around the low consent rate, which led to a small study that was prematurely terminated.

“It’s difficult to enroll women in a trial that requires random allocation of skin incision, due to their preference to choose their own incision. A larger trial would likewise be challenging, and unlikely to yield different results,” said Dr. Marrs.

Dr. Marrs reported no conflicts of interest.

 

SOURCE: Marrs CC et al. Am J Obstet Gynecol. 2018 Jan;218:S29.
 

 

No clear winner emerged in a first-ever randomized controlled trial comparing Pfannenstiel with vertical incisions for women with obesity having cesarean delivery, though enrollment difficulties limited study numbers, with almost two-thirds of eligible women declining to participate in the surgical trial.

At 6 weeks postdelivery, 21.1% of women who had a vertical incision experienced wound complications, compared with 18.6% of those who had a Pfannenstiel incision, a nonsignificant difference. This was a smaller difference than was seen at 2 weeks postpartum, when 20% of the vertical incision group had wound complications, compared with 10.4% of those who had a Pfannenstiel, also a nonsignificant difference. Maternal and fetal outcomes didn’t differ significantly with the two surgical approaches.

Dr. Carolyn Marrs
”We were unable to demonstrate a difference in the primary or secondary outcomes in women with class III obesity who received Pfannenstiel versus vertical skin incision,” said Caroline C. Marrs, MD, presenting the study results at the meeting sponsored by the Society for Maternal-Fetal Medicine.

Though there had been several observational studies comparing vertical with Pfannenstiel incisions for cesarean delivery in women with obesity, no randomized, controlled trials had been conducted, and observational study results were mixed, said Dr. Marrs.

 

 


Each approach comes with theoretical pros and cons: For women who have a large pannus, the incision site may lie in a moist environment with a low transverse incision, and oxygen tension may be low. However, a Pfannenstiel incision usually will have better cosmesis than will a vertical incision, and generally will result in less postoperative pain.

On the other hand, said Dr. Marrs, vertical incisions can provide improved exposure of the uterus during delivery, and the moist environment underlying the pannus is avoided. However, wound tension may be higher, and subcutaneous thickness is likely to be higher than at the Pfannenstiel incision site.

The study, conducted at two academic medical centers, enrolled women with a body mass index (BMI) of at least 40 kg/m2 at a gestational age of 24 weeks or greater who required cesarean delivery. Consenting women were then randomized to receive Pfannenstiel or vertical incisions.

Women who had clinical chorioamnionitis, whose amniotic membranes had been ruptured for 18 hours or more, or who had placenta accreta were excluded. Also excluded were women with a private physician and those desiring vaginal delivery, said Dr. Marrs, a maternal-fetal medicine fellow at the University of Texas Medical Branch, Galveston.
 

 


The study’s primary outcome measure was a composite of wound complications seen within 6 weeks of delivery, including surgical site infection, whether superficial, deep, or involving an organ or tissue space; cellulitis; seroma or hematoma; and wound separation. Other maternal outcomes tracked in the study included postoperative length of stay, transfusion requirement, sepsis, readmission, and death.

Cesarean-specific secondary outcomes included operative time and time from skin incision to delivery, estimated blood loss, and any incidence of hysterectomy through a low transverse incision. Neonatal outcomes included a 5-minute Apgar score of less than 7, umbilical cord pH of less than 7, and neonatal ICU admissions.

Dr. Mars said that the goal enrollment for the study was 300 patients, to ensure adequate statistical power. However, they found enrollment a challenge, with low consent rates during the defined time period from October 2013 to May 2017. They shifted their statistical technique to a Bayesian analysis, taking into account the estimated probability of treatment benefit.

Using this approach, they found a 59% probability that a Pfannenstiel incision would lead to a lower primary outcome rate – a better result – than would a vertical incision. This result just missed the predetermined threshold of 60%, said Dr. Marrs.
 

 


Of the 789 women who met the BMI threshold for eligibility assessment, 420 (65%) who passed the screening declined to participate. Of those who consented to participation, an additional 137 women either withdrew consent or failed further screening, leaving 50 women who were randomized to the Pfannenstiel arm and 41 who were randomized to the vertical incision arm.

Baseline characteristics were similar between groups, with a mean maternal age of 30 years in the Pfannenstiel group and 28 years in the vertical incision group. Gestational age at delivery was a mean of 37 weeks in both groups, and mean BMI was 48-50 kg/m2.

Most patients (80%-90%) had public insurance. Diabetes was more common in the Pfannenstiel group (48%) than in the vertical incision cohort (32%). Just over 40% of patients were African American.

Two women in the Pfannenstiel group and three in the vertical incision group did not receive the intended incision. After accounting for patients lost to follow-up by 6 weeks, 43 women who received Pfannenstiel and 38 women who received vertical incisions were available for full evaluation.
 

 


Dr. Marrs said that the study, the first randomized trial to address this issue, had several strengths, including its being conducted at two sites with appropriate stratification for the sites. Also, an independent data safety monitoring board and two chart reviewers helped overcome some of the limitations of a surgical study, where complete blinding is impossible.

The Bayesian analysis allowed ascertainment of the probability of treatment benefit despite the lower-than-hoped-for enrollment numbers. The primary weakness of the study, said Dr. Marrs, centered around the low consent rate, which led to a small study that was prematurely terminated.

“It’s difficult to enroll women in a trial that requires random allocation of skin incision, due to their preference to choose their own incision. A larger trial would likewise be challenging, and unlikely to yield different results,” said Dr. Marrs.

Dr. Marrs reported no conflicts of interest.

 

SOURCE: Marrs CC et al. Am J Obstet Gynecol. 2018 Jan;218:S29.
 

Publications
Publications
Topics
Article Type
Sections
Article Source

REPORTING FROM THE PREGNANCY MEETING

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Vitals

 

Key clinical point: Wound complication rates were similar with Pfannenstiel and vertical incisions in women with obesity.

Major finding: At 6 weeks, 21.1% of vertical incision recipients and 18.6% of Pfannenstiel recipients had wound complications.

Study details: Randomized controlled trial of 91 women with obesity receiving cesarean section.

Disclosures: Dr. Marrs reported no conflicts of interest.

Source: Marrs CC et al. Am J Obstet Gynecol. 2018 Jan;218:S29.

Disqus Comments
Default

Strategies to reduce colorectal surgery complications

Article Type
Changed
Fri, 01/18/2019 - 17:27

 

– Colorectal surgery is rife with potential complications, but there are steps that surgeons can take to improve outcomes, and factors to consider to reduce complications. These strategies and considerations were the focus of a talk by Matthew G. Mutch, MD, at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.

Prehabilitation

The approach to improve outcomes can begin with prehabilitation – preparing the patient for the difficult process of surgery. “If somebody is going to fight a 15-round heavyweight bout, they train for 6 or 8 weeks before a fight. Why not bring that concept to surgery?” said Dr. Mutch, chief of colon and rectal surgery at the Washington University, St. Louis.

Prehabilitation can include lifestyle changes, such as quitting smoking, but can also incorporate aerobic and/or resistance exercise, dietary counseling and protein supplementation, anxiety reduction, and medical education to prepare the patient for the challenges ahead. “Preoperatively, we try to identify factors to see if we can make meaningful lifestyle changes, because that’s really the grassroots level where a lot of this [improvement in outcomes] is going to occur,” said Dr. Mutch.
 

Frailty

Frailty is a factor driving complications in colorectal surgery. A meta-analysis of 20 studies showed that frailty and prefrailty were associated with worse all-cause mortality during follow-up among older cancer patients. More striking, it showed that frail patients were nearly five times more likely to be intolerant of cancer treatment (odds ratio, 4.86) and more likely to experience postoperative complications (30-day hazard ratio, 3.19) (Ann Oncol. 2015;26[6]:1091-1101).

 

 

Hemoglobin A1c

Dr. Mutch went on to discuss hemoglobin A1c (HbA1c) levels as a risk factor in colorectal surgery. HbA1c levels higher than 6 are associated with worse outcomes, but tight postoperative control is associated with hypoglycemia. “What you want to do is set that patient up before surgery. HbA1c has a half-life of about a month, so if you start modifying their risk factors 4-6 weeks before you get them into surgery, by 1 month you can see a 50% reduction, and at 2 months a 75% reduction. If you do these things in a preoperative setting it makes a difference,” said Dr. Mutch.

Smoking cessation

Smoking cessation is another key strategy. Two weeks of cessation should lead to a decline in coughing, but a minimum of 4 weeks is needed to significantly reduce overall complications. Lifestyle changes need to be long term. “These are not measures that you’re going to do over a short period of time, and then when surgery is over throw it out the window,” said Dr. Mutch.

Anastomotic leak

Another factor is the detection of anastomotic leak, which can be challenging because its definitions vary significantly, and its causes can be multifactorial. Studies show that predictions of anastomotic leak are not especially successful, Dr. Mutch said, but routine leak testing improves outcomes. In a study of left-side anastomoses in Washington State, hospitals that performed leak tests had lower leak rates at least 90% of the time (OR, 0.23), and hospitals that later implemented leak tests experienced a significant reduction (Arch Surg. 2012:147[4]:345-51).

Venous thromboembolic events

Venous thromboembolic events (VTE), are the leading cause of operative mortality in colorectal surgery patients. This complication can be greatly reduced with prophylaxis, but requires screening for risk factors. Major surgery raises the risk of deep vein thrombosis in 20% of all hospitalized patients to 40%-80%, depending on the surgery type. “We have a lot of room to improve,” said Dr. Mutch.

 

 

copyright monkeybusinessimages/Thinkstock
In cancer patients, VTE risk can also be reduced by prophylaxis with enoxaparin, he said (N Engl J Med. 2002;346[13]:975-80). “All of our patients who get major abdominal surgery, we send home on 21 days of [enoxaparin], he said. He added that all patients who get a major abdominal operation, particularly cancer patients with two or three risk factors, [are sent] home on extended prophylaxis.”
 

Timing

One factor that may have an impact on complications appears to be timing of surgery, at least at Washington University, where Dr. Mutch practices. The institution found that patients who had surgery the same day they were admitted had a 2.5% VTE risk, compared with 11% in patients who had surgery 5 or more days after admission.

Postop ambulation

Postsurgical ambulation was another critical complication factor. Dr. Mutch cited a study showing that ambulation on the day after surgery was associated with a 1% VTE risk, compared to 6.9% in patients who waited until day 2.

Dr. Mutch had no disclosures. Global Academy for Medical Education and this news organization are owned by the same parent company.

 

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

 

– Colorectal surgery is rife with potential complications, but there are steps that surgeons can take to improve outcomes, and factors to consider to reduce complications. These strategies and considerations were the focus of a talk by Matthew G. Mutch, MD, at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.

Prehabilitation

The approach to improve outcomes can begin with prehabilitation – preparing the patient for the difficult process of surgery. “If somebody is going to fight a 15-round heavyweight bout, they train for 6 or 8 weeks before a fight. Why not bring that concept to surgery?” said Dr. Mutch, chief of colon and rectal surgery at the Washington University, St. Louis.

Prehabilitation can include lifestyle changes, such as quitting smoking, but can also incorporate aerobic and/or resistance exercise, dietary counseling and protein supplementation, anxiety reduction, and medical education to prepare the patient for the challenges ahead. “Preoperatively, we try to identify factors to see if we can make meaningful lifestyle changes, because that’s really the grassroots level where a lot of this [improvement in outcomes] is going to occur,” said Dr. Mutch.
 

Frailty

Frailty is a factor driving complications in colorectal surgery. A meta-analysis of 20 studies showed that frailty and prefrailty were associated with worse all-cause mortality during follow-up among older cancer patients. More striking, it showed that frail patients were nearly five times more likely to be intolerant of cancer treatment (odds ratio, 4.86) and more likely to experience postoperative complications (30-day hazard ratio, 3.19) (Ann Oncol. 2015;26[6]:1091-1101).

 

 

Hemoglobin A1c

Dr. Mutch went on to discuss hemoglobin A1c (HbA1c) levels as a risk factor in colorectal surgery. HbA1c levels higher than 6 are associated with worse outcomes, but tight postoperative control is associated with hypoglycemia. “What you want to do is set that patient up before surgery. HbA1c has a half-life of about a month, so if you start modifying their risk factors 4-6 weeks before you get them into surgery, by 1 month you can see a 50% reduction, and at 2 months a 75% reduction. If you do these things in a preoperative setting it makes a difference,” said Dr. Mutch.

Smoking cessation

Smoking cessation is another key strategy. Two weeks of cessation should lead to a decline in coughing, but a minimum of 4 weeks is needed to significantly reduce overall complications. Lifestyle changes need to be long term. “These are not measures that you’re going to do over a short period of time, and then when surgery is over throw it out the window,” said Dr. Mutch.

Anastomotic leak

Another factor is the detection of anastomotic leak, which can be challenging because its definitions vary significantly, and its causes can be multifactorial. Studies show that predictions of anastomotic leak are not especially successful, Dr. Mutch said, but routine leak testing improves outcomes. In a study of left-side anastomoses in Washington State, hospitals that performed leak tests had lower leak rates at least 90% of the time (OR, 0.23), and hospitals that later implemented leak tests experienced a significant reduction (Arch Surg. 2012:147[4]:345-51).

Venous thromboembolic events

Venous thromboembolic events (VTE), are the leading cause of operative mortality in colorectal surgery patients. This complication can be greatly reduced with prophylaxis, but requires screening for risk factors. Major surgery raises the risk of deep vein thrombosis in 20% of all hospitalized patients to 40%-80%, depending on the surgery type. “We have a lot of room to improve,” said Dr. Mutch.

 

 

copyright monkeybusinessimages/Thinkstock
In cancer patients, VTE risk can also be reduced by prophylaxis with enoxaparin, he said (N Engl J Med. 2002;346[13]:975-80). “All of our patients who get major abdominal surgery, we send home on 21 days of [enoxaparin], he said. He added that all patients who get a major abdominal operation, particularly cancer patients with two or three risk factors, [are sent] home on extended prophylaxis.”
 

Timing

One factor that may have an impact on complications appears to be timing of surgery, at least at Washington University, where Dr. Mutch practices. The institution found that patients who had surgery the same day they were admitted had a 2.5% VTE risk, compared with 11% in patients who had surgery 5 or more days after admission.

Postop ambulation

Postsurgical ambulation was another critical complication factor. Dr. Mutch cited a study showing that ambulation on the day after surgery was associated with a 1% VTE risk, compared to 6.9% in patients who waited until day 2.

Dr. Mutch had no disclosures. Global Academy for Medical Education and this news organization are owned by the same parent company.

 

 

– Colorectal surgery is rife with potential complications, but there are steps that surgeons can take to improve outcomes, and factors to consider to reduce complications. These strategies and considerations were the focus of a talk by Matthew G. Mutch, MD, at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.

Prehabilitation

The approach to improve outcomes can begin with prehabilitation – preparing the patient for the difficult process of surgery. “If somebody is going to fight a 15-round heavyweight bout, they train for 6 or 8 weeks before a fight. Why not bring that concept to surgery?” said Dr. Mutch, chief of colon and rectal surgery at the Washington University, St. Louis.

Prehabilitation can include lifestyle changes, such as quitting smoking, but can also incorporate aerobic and/or resistance exercise, dietary counseling and protein supplementation, anxiety reduction, and medical education to prepare the patient for the challenges ahead. “Preoperatively, we try to identify factors to see if we can make meaningful lifestyle changes, because that’s really the grassroots level where a lot of this [improvement in outcomes] is going to occur,” said Dr. Mutch.
 

Frailty

Frailty is a factor driving complications in colorectal surgery. A meta-analysis of 20 studies showed that frailty and prefrailty were associated with worse all-cause mortality during follow-up among older cancer patients. More striking, it showed that frail patients were nearly five times more likely to be intolerant of cancer treatment (odds ratio, 4.86) and more likely to experience postoperative complications (30-day hazard ratio, 3.19) (Ann Oncol. 2015;26[6]:1091-1101).

 

 

Hemoglobin A1c

Dr. Mutch went on to discuss hemoglobin A1c (HbA1c) levels as a risk factor in colorectal surgery. HbA1c levels higher than 6 are associated with worse outcomes, but tight postoperative control is associated with hypoglycemia. “What you want to do is set that patient up before surgery. HbA1c has a half-life of about a month, so if you start modifying their risk factors 4-6 weeks before you get them into surgery, by 1 month you can see a 50% reduction, and at 2 months a 75% reduction. If you do these things in a preoperative setting it makes a difference,” said Dr. Mutch.

Smoking cessation

Smoking cessation is another key strategy. Two weeks of cessation should lead to a decline in coughing, but a minimum of 4 weeks is needed to significantly reduce overall complications. Lifestyle changes need to be long term. “These are not measures that you’re going to do over a short period of time, and then when surgery is over throw it out the window,” said Dr. Mutch.

Anastomotic leak

Another factor is the detection of anastomotic leak, which can be challenging because its definitions vary significantly, and its causes can be multifactorial. Studies show that predictions of anastomotic leak are not especially successful, Dr. Mutch said, but routine leak testing improves outcomes. In a study of left-side anastomoses in Washington State, hospitals that performed leak tests had lower leak rates at least 90% of the time (OR, 0.23), and hospitals that later implemented leak tests experienced a significant reduction (Arch Surg. 2012:147[4]:345-51).

Venous thromboembolic events

Venous thromboembolic events (VTE), are the leading cause of operative mortality in colorectal surgery patients. This complication can be greatly reduced with prophylaxis, but requires screening for risk factors. Major surgery raises the risk of deep vein thrombosis in 20% of all hospitalized patients to 40%-80%, depending on the surgery type. “We have a lot of room to improve,” said Dr. Mutch.

 

 

copyright monkeybusinessimages/Thinkstock
In cancer patients, VTE risk can also be reduced by prophylaxis with enoxaparin, he said (N Engl J Med. 2002;346[13]:975-80). “All of our patients who get major abdominal surgery, we send home on 21 days of [enoxaparin], he said. He added that all patients who get a major abdominal operation, particularly cancer patients with two or three risk factors, [are sent] home on extended prophylaxis.”
 

Timing

One factor that may have an impact on complications appears to be timing of surgery, at least at Washington University, where Dr. Mutch practices. The institution found that patients who had surgery the same day they were admitted had a 2.5% VTE risk, compared with 11% in patients who had surgery 5 or more days after admission.

Postop ambulation

Postsurgical ambulation was another critical complication factor. Dr. Mutch cited a study showing that ambulation on the day after surgery was associated with a 1% VTE risk, compared to 6.9% in patients who waited until day 2.

Dr. Mutch had no disclosures. Global Academy for Medical Education and this news organization are owned by the same parent company.

 

Publications
Publications
Topics
Article Type
Click for Credit Status
Ready
Sections
Article Source

REPORTING FROM MISS

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default