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Official Newspaper of the American College of Surgeons
Open-capsule PPIs linked to faster ulcer healing after Roux-en-Y
The use of proton pump inhibitors in opened instead of closed capsules was associated with a nearly fourfold shorter median healing time among patients who developed marginal ulcers after Roux-en-Y gastric bypass, in a single-center retrospective cohort study.
In contrast, the specific class of proton pump inhibitor (PPI) did not affect healing times, wrote Allison R. Schulman, MD, and her associates at Brigham and Women’s Hospital, Boston. The report is in the April issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2016.10.015). “Given these results and the high prevalence of marginal ulceration in this patient population, further study in a randomized controlled setting is warranted, and use of open-capsule PPIs should be considered as a low-risk, low-cost alternative,” they added.
Roux-en-Y gastric bypass is one of the most common types of gastric bypass surgeries in the world, and up to 16% of patients develop postsurgical ulcers at the gastrojejunal anastomosis, the investigators noted. Acidity is a prime suspect in these “marginal ulcerations” because bypassing the acid-buffering duodenum exposes the jejunum to acid from the stomach, they added. High-dose PPIs are the main treatment, but there is no consensus on the formulation or dose of therapy. Because Roux-en-Y creates a small gastric pouch and hastens small-bowel transit, closed capsules designed to break down in the stomach “even may make their way to the colon before breakdown occurs,” they wrote.
They reviewed medical charts from patients who developed marginal ulcerations after undergoing Roux-en-Y gastric bypass at their hospital from 2000 through 2015. A total of 115 patients received open-capsule PPIs and 49 received intact capsules. All were followed until their ulcers healed.
For the open-capsule group, median time to healing was 91 days, compared with 342 days for the closed-capsule group (P less than .001). Importantly, capsule type was the only independent predictor of healing time (hazard ratio, 6.0; 95% confidence interval, 3.7 to 9.8; P less than .001) in a Cox regression model that included other known correlates of ulcer healing, including age, smoking status, the use of nonsteroidal anti-inflammatory drugs, Helicobacter pylori infection, the length of the gastric pouch, and the presence of fistulae or foreign bodies such as sutures or staples.
The use of sucralfate also did not affect time to ulcer healing, reflecting “many previous studies showing a lack of definitive benefit to this medication,” the researchers said. The findings have “tremendous implications” for health care utilization, they added. Indeed, patients who received open-capsule PPIs needed significantly fewer endoscopic procedures (median, 1.2 versus 1.8; P = .02) and used fewer health care resources overall ($7,206 versus $11,009; P = .05) compared with those prescribed intact PPI capsules.
This study was limited to patients who developed ulcer symptoms and underwent repeated surveillance endoscopies after surgery, the researchers noted. Selection bias is always a concern with retrospective studies, but insurers always covered both types of therapy and the choice of capsule type was entirely up to providers, all of whom consistently prescribed either open- or closed-capsule PPI therapy, they added.
The investigators did not acknowledge external funding sources. Dr. Schulman and four coinvestigators reported having no competing interests. One coinvestigator disclosed ties to Olympus, Boston Scientific, and Covidien.
Proton pump inhibitors (PPIs) are frequently employed to treat marginal ulcers after Roux-en-Y gastric bypass (RYGB). In a retrospective study, Schulman et al. compared intact vs. “open” PPI capsules. 
They state that “this may be overcome by use of a soluble form of PPI,” but don’t state what is meant by “soluble PPI” or how the open-capsule PPI was delivered. Among the PPIs they reported using to compare intact vs. open capsules was Protonix [pantoprazole] which is not produced as a capsule, and soluble Prevacid [lansoprazole], which is an orally disintegrating tablet that should provide characteristics similar to an “open capsule.”
PPI capsules provide PPI in enteric-coated granules, which are designed to protect the PPI from acid degradation in the stomach of individuals with intact gastrointestinal tracts and allow more of the PPI dose to reach the small intestine where it is absorbed. If capsules really fail to release their enteric-coated granules until very distally in RYGB patients, bypassing this step to allow earlier release of PPI makes intuitive sense; formulations such as suspensions and rapidly disintegrating tablets that deliver enteric-coated granules without capsules are currently available.
However, if this is an issue, administering a suspension of uncoated PPI with bicarbonate potentially might be the most attractive option, given more rapid absorption than PPI delivered as enteric-coated granules.
Loren Laine, MD, AGAF, professor of medicine, digestive diseases, Yale University, New Haven, Conn. He has no conflicts of interest.
Proton pump inhibitors (PPIs) are frequently employed to treat marginal ulcers after Roux-en-Y gastric bypass (RYGB). In a retrospective study, Schulman et al. compared intact vs. “open” PPI capsules.
They state that “this may be overcome by use of a soluble form of PPI,” but don’t state what is meant by “soluble PPI” or how the open-capsule PPI was delivered. Among the PPIs they reported using to compare intact vs. open capsules was Protonix [pantoprazole] which is not produced as a capsule, and soluble Prevacid [lansoprazole], which is an orally disintegrating tablet that should provide characteristics similar to an “open capsule.”
PPI capsules provide PPI in enteric-coated granules, which are designed to protect the PPI from acid degradation in the stomach of individuals with intact gastrointestinal tracts and allow more of the PPI dose to reach the small intestine where it is absorbed. If capsules really fail to release their enteric-coated granules until very distally in RYGB patients, bypassing this step to allow earlier release of PPI makes intuitive sense; formulations such as suspensions and rapidly disintegrating tablets that deliver enteric-coated granules without capsules are currently available.
However, if this is an issue, administering a suspension of uncoated PPI with bicarbonate potentially might be the most attractive option, given more rapid absorption than PPI delivered as enteric-coated granules.
Loren Laine, MD, AGAF, professor of medicine, digestive diseases, Yale University, New Haven, Conn. He has no conflicts of interest.
Proton pump inhibitors (PPIs) are frequently employed to treat marginal ulcers after Roux-en-Y gastric bypass (RYGB). In a retrospective study, Schulman et al. compared intact vs. “open” PPI capsules.
They state that “this may be overcome by use of a soluble form of PPI,” but don’t state what is meant by “soluble PPI” or how the open-capsule PPI was delivered. Among the PPIs they reported using to compare intact vs. open capsules was Protonix [pantoprazole] which is not produced as a capsule, and soluble Prevacid [lansoprazole], which is an orally disintegrating tablet that should provide characteristics similar to an “open capsule.”
PPI capsules provide PPI in enteric-coated granules, which are designed to protect the PPI from acid degradation in the stomach of individuals with intact gastrointestinal tracts and allow more of the PPI dose to reach the small intestine where it is absorbed. If capsules really fail to release their enteric-coated granules until very distally in RYGB patients, bypassing this step to allow earlier release of PPI makes intuitive sense; formulations such as suspensions and rapidly disintegrating tablets that deliver enteric-coated granules without capsules are currently available.
However, if this is an issue, administering a suspension of uncoated PPI with bicarbonate potentially might be the most attractive option, given more rapid absorption than PPI delivered as enteric-coated granules.
Loren Laine, MD, AGAF, professor of medicine, digestive diseases, Yale University, New Haven, Conn. He has no conflicts of interest.
The use of proton pump inhibitors in opened instead of closed capsules was associated with a nearly fourfold shorter median healing time among patients who developed marginal ulcers after Roux-en-Y gastric bypass, in a single-center retrospective cohort study.
In contrast, the specific class of proton pump inhibitor (PPI) did not affect healing times, wrote Allison R. Schulman, MD, and her associates at Brigham and Women’s Hospital, Boston. The report is in the April issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2016.10.015). “Given these results and the high prevalence of marginal ulceration in this patient population, further study in a randomized controlled setting is warranted, and use of open-capsule PPIs should be considered as a low-risk, low-cost alternative,” they added.
Roux-en-Y gastric bypass is one of the most common types of gastric bypass surgeries in the world, and up to 16% of patients develop postsurgical ulcers at the gastrojejunal anastomosis, the investigators noted. Acidity is a prime suspect in these “marginal ulcerations” because bypassing the acid-buffering duodenum exposes the jejunum to acid from the stomach, they added. High-dose PPIs are the main treatment, but there is no consensus on the formulation or dose of therapy. Because Roux-en-Y creates a small gastric pouch and hastens small-bowel transit, closed capsules designed to break down in the stomach “even may make their way to the colon before breakdown occurs,” they wrote.
They reviewed medical charts from patients who developed marginal ulcerations after undergoing Roux-en-Y gastric bypass at their hospital from 2000 through 2015. A total of 115 patients received open-capsule PPIs and 49 received intact capsules. All were followed until their ulcers healed.
For the open-capsule group, median time to healing was 91 days, compared with 342 days for the closed-capsule group (P less than .001). Importantly, capsule type was the only independent predictor of healing time (hazard ratio, 6.0; 95% confidence interval, 3.7 to 9.8; P less than .001) in a Cox regression model that included other known correlates of ulcer healing, including age, smoking status, the use of nonsteroidal anti-inflammatory drugs, Helicobacter pylori infection, the length of the gastric pouch, and the presence of fistulae or foreign bodies such as sutures or staples.
The use of sucralfate also did not affect time to ulcer healing, reflecting “many previous studies showing a lack of definitive benefit to this medication,” the researchers said. The findings have “tremendous implications” for health care utilization, they added. Indeed, patients who received open-capsule PPIs needed significantly fewer endoscopic procedures (median, 1.2 versus 1.8; P = .02) and used fewer health care resources overall ($7,206 versus $11,009; P = .05) compared with those prescribed intact PPI capsules.
This study was limited to patients who developed ulcer symptoms and underwent repeated surveillance endoscopies after surgery, the researchers noted. Selection bias is always a concern with retrospective studies, but insurers always covered both types of therapy and the choice of capsule type was entirely up to providers, all of whom consistently prescribed either open- or closed-capsule PPI therapy, they added.
The investigators did not acknowledge external funding sources. Dr. Schulman and four coinvestigators reported having no competing interests. One coinvestigator disclosed ties to Olympus, Boston Scientific, and Covidien.
The use of proton pump inhibitors in opened instead of closed capsules was associated with a nearly fourfold shorter median healing time among patients who developed marginal ulcers after Roux-en-Y gastric bypass, in a single-center retrospective cohort study.
In contrast, the specific class of proton pump inhibitor (PPI) did not affect healing times, wrote Allison R. Schulman, MD, and her associates at Brigham and Women’s Hospital, Boston. The report is in the April issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2016.10.015). “Given these results and the high prevalence of marginal ulceration in this patient population, further study in a randomized controlled setting is warranted, and use of open-capsule PPIs should be considered as a low-risk, low-cost alternative,” they added.
Roux-en-Y gastric bypass is one of the most common types of gastric bypass surgeries in the world, and up to 16% of patients develop postsurgical ulcers at the gastrojejunal anastomosis, the investigators noted. Acidity is a prime suspect in these “marginal ulcerations” because bypassing the acid-buffering duodenum exposes the jejunum to acid from the stomach, they added. High-dose PPIs are the main treatment, but there is no consensus on the formulation or dose of therapy. Because Roux-en-Y creates a small gastric pouch and hastens small-bowel transit, closed capsules designed to break down in the stomach “even may make their way to the colon before breakdown occurs,” they wrote.
They reviewed medical charts from patients who developed marginal ulcerations after undergoing Roux-en-Y gastric bypass at their hospital from 2000 through 2015. A total of 115 patients received open-capsule PPIs and 49 received intact capsules. All were followed until their ulcers healed.
For the open-capsule group, median time to healing was 91 days, compared with 342 days for the closed-capsule group (P less than .001). Importantly, capsule type was the only independent predictor of healing time (hazard ratio, 6.0; 95% confidence interval, 3.7 to 9.8; P less than .001) in a Cox regression model that included other known correlates of ulcer healing, including age, smoking status, the use of nonsteroidal anti-inflammatory drugs, Helicobacter pylori infection, the length of the gastric pouch, and the presence of fistulae or foreign bodies such as sutures or staples.
The use of sucralfate also did not affect time to ulcer healing, reflecting “many previous studies showing a lack of definitive benefit to this medication,” the researchers said. The findings have “tremendous implications” for health care utilization, they added. Indeed, patients who received open-capsule PPIs needed significantly fewer endoscopic procedures (median, 1.2 versus 1.8; P = .02) and used fewer health care resources overall ($7,206 versus $11,009; P = .05) compared with those prescribed intact PPI capsules.
This study was limited to patients who developed ulcer symptoms and underwent repeated surveillance endoscopies after surgery, the researchers noted. Selection bias is always a concern with retrospective studies, but insurers always covered both types of therapy and the choice of capsule type was entirely up to providers, all of whom consistently prescribed either open- or closed-capsule PPI therapy, they added.
The investigators did not acknowledge external funding sources. Dr. Schulman and four coinvestigators reported having no competing interests. One coinvestigator disclosed ties to Olympus, Boston Scientific, and Covidien.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Key clinical point: The use of proton pump inhibitors in opened instead of closed capsules was associated with a nearly fourfold shorter median healing time among patients who developed ulcers at the gastrojejunal anastomosis after Roux-en-Y gastric bypass.
Major finding: The median time to ulcer healing was 91.0 versus 342.0 days for the open- and closed-capsule groups, respectively (P less than .001).
Data source: A single-center retrospective study of 162 patients.
Disclosures: The investigators did not acknowledge external funding sources. Dr. Schulman and four coinvestigators reported having no competing interests. One coinvestigator disclosed ties to Olympus, Boston Scientific, and Covidien.
Point/Counterpoint: Is endograft PAA repair durable?
Endovascular repair is durable
Endovascular repair of popliteal artery aneurysms is vastly superior to all other previous techniques of popliteal aneurysm repair. Half of all popliteal artery aneurysms are bilateral, and 40% are associated with abdominal aortic aneurysm; 1%-2% of patients with abdominal aortic aneurysm have a popliteal aneurysm (ANZ J Surg. 2006 Oct;76[10]:912-5). Less than 0.01% of hospitalized patients have popliteal artery aneurysms, and men are 20 times more prone to them than women are.
Traditional treatment involves either bypass with interval ligation or a direct posterior approach with an interposition graft, but surgery is not without its problems. I think of the retired anesthesiologist who came to me with a popliteal artery aneurysm (PAA) that his primary care doctor diagnosed. “I’m not having any damn femoral popliteal bypass operation,” he told me. “Every single one of those patients dies.”
Endograft repair is a technique that is reaching its prime, as a growing number of reports have shown – although none of these studies has large numbers because the volume just isn’t available. One recent paper compared 52 open and 23 endovascular PAA repairs (Ann Vasc Surg. 2016 Jan;30:253-7) and found both had similarly high rates of reintervention – 50% at 4 years. But it is noteworthy that the endovascular results improved with time.
A University of Pittsburgh study of 186 open and endovascular repairs found that patients with acute presentations of embolization or aneurysm thrombosis did better with open surgery. In addition, while open repair had superior patency initially after surgery, midterm secondary patency and amputation rates of open and endovascular repair were similar (J Vasc Surg. 2016 Jan;63[1]:70-6).
A Netherlands study of 72 PAA treated with endografting showed that 84% had primary patency at 1 year, and 74% had assisted primary patency at 3 years (Eur J Vasc Endovasc Surg. 2016 Jul;52[1]:99-104). Among these patients, 13 had late occlusions, 7 were converted to bypass, and 2 required thrombolysis; but none required limb amputation.
A meta-analysis of 540 patients found no statistically significant difference in outcomes between endovascular and open repair for PAA (Eur J Vasc Endovasc Surg. 2015 Sep;50(3):351-9). Another systematic review and meta-analysis of 14 studies and 514 patients also found no difference in pooled primary and secondary patency at 5 years (J Endovasc Ther. 2015 Jun;22[3]:330-7).
There certainly are contradictory studies, such as one by Dr. Alik Farber’s group in Boston that showed open repair is superior to endovascular surgery (J Vasc Surg. 2015 Mar;61[3]:663-9); but retrospective database mining certainly has its limitations. Their retrospective study queried the Vascular Quality Initiative database and found that 95% of patients who had open elective popliteal aneurysm repair were free from major adverse limb events, vs. 80% for endovascular treatments.
The best outcomes of open repair happen with autologous vein, but there is precious little of that around now. Emergency patients would probably do better with open surgery, but in elective repair there is no clear differential data.
So, if that’s the case, I’m going to take the small incision.
Peter Rossi, MD, FACS, is an associate professor of surgery and radiology, and the clinical director of vascular surgery, at the Medical College of Wisconsin, Milwaukee. He is also on staff at Clement J. Zablocki Veterans Affairs Medical Center in Milwaukee. Dr. Rossi had no financial relationships to disclose.
Endovascular repair may not be durable
Debating the durability of elective endovascular repair of popliteal artery aneurysm raises a question: Who determines durability anyway?
Is it the patients who only want the Band-Aid and no incision? I don’t think so. Is it the interventionalist who only does endovascular repairs? I don’t think so. I’m sure it’s not the insurance companies, who only worry about cost containment, either.
So, who should determine durability of endovascular popliteal artery aneurysm (PAA) repair?
So, the question is, do we have such data?
There are multiple reports looking at how well open repair works. It has been done for decades. In 2008, a Veterans Affairs study of 583 open PAA repairs reported low death rates and excellent rates of limb salvage at 2 years, even in high-risk patients (J Vasc Surg. 2008 Oct;48[4]:845-51). Open surgical repair has excellent documented durability, and that is not the question at hand.
Endovascular repair has some presumed advantages. It’s less invasive and involves less postoperative pain and a quicker recovery. But it is not without problems – graft thrombosis and occlusion, endoleaks, distal limb ischemia, and stent fractures among them.
Surgery, to be clear, is not perfect, either. One of my patients who years ago presented with an occluded PAA underwent open bypass repair – but then went on later to have a pseudoaneurysm of the proximal anastomosis. I repaired this with an endograft, and he has done quite well. So, we all do endograft repairs, walk out, chest bump the Gore rep, and send the patient home that day.
Is it durable, though?
Most of the data on endovascular repair are from single-center studies dating back to 2003. There’s only one prospective trial comparing endovascular vs. open repair (J Vasc Surg. 2005 Aug;42[2]:185-93), but it was a single-center trial with a severe power limitation, because it involved only 30 patients. It found endovascular repair was comparable to open surgery. Also, I suspect a great deal of selection bias is involved in studies of endovascular repair.
A number of studies have found endovascular repair is not inferior to surgical repair. For example, a study by Dr. Audra Duncan, at Mayo Clinic, and her colleagues found that primary and secondary patency rates of elective and emergent stenting were excellent – but the study results only extended out to 2 years (J Vasc Surg. 2013 May;57[5]:1299-305). I don’t think we could hang our hat on that.
A Swedish study that compared open and endovascular surgery in 592 patients reported that endovascular repair has “significantly inferior results compared with open repair,” particularly in those who present with acute ischemia (Eur J Vasc Endovasc Surg. 2015 Sep;50[3]:342-50). A close look at the data shows that primary patency rates were 89% for open repair and 67.4% for stent graft.
Referencing the systematic review and meta-analysis that Dr. Rossi cited, the primary patency of endovascular repair was only 69% and the secondary patency rate was 77% at 5 years (J Endovasc Ther. 2015 Jun;22[3]:330-7). As physicians, I submit that we can do better.
A Netherlands study investigated stent fractures, finding that 17% (13 out of 78 cases) had circumferential fractures (J Vasc Surg. 2010 Jun;51[6]:1413-8). This study only included circumferential stent fractures and excluded localized strut fractures. I think these studies show that endovascular repair is not always durable.
I want to remind you that we are vascular surgeons, so it is appropriate for us to embrace surgical bypass and its known durability, especially when the durability of endovascular repair is still not known.
Patrick Muck, MD, is chief of vascular surgery and director of vascular residency and fellowship at Good Samaritan Hospital, Cincinnati. He is also on staff at Bethesda North Hospital, Cincinnati, and is affiliated with TriHealth Heart Institute in southwestern Ohio. Dr. Muck had no financial relationships to disclose.
Endovascular repair is durable
Endovascular repair of popliteal artery aneurysms is vastly superior to all other previous techniques of popliteal aneurysm repair. Half of all popliteal artery aneurysms are bilateral, and 40% are associated with abdominal aortic aneurysm; 1%-2% of patients with abdominal aortic aneurysm have a popliteal aneurysm (ANZ J Surg. 2006 Oct;76[10]:912-5). Less than 0.01% of hospitalized patients have popliteal artery aneurysms, and men are 20 times more prone to them than women are.
Traditional treatment involves either bypass with interval ligation or a direct posterior approach with an interposition graft, but surgery is not without its problems. I think of the retired anesthesiologist who came to me with a popliteal artery aneurysm (PAA) that his primary care doctor diagnosed. “I’m not having any damn femoral popliteal bypass operation,” he told me. “Every single one of those patients dies.”
Endograft repair is a technique that is reaching its prime, as a growing number of reports have shown – although none of these studies has large numbers because the volume just isn’t available. One recent paper compared 52 open and 23 endovascular PAA repairs (Ann Vasc Surg. 2016 Jan;30:253-7) and found both had similarly high rates of reintervention – 50% at 4 years. But it is noteworthy that the endovascular results improved with time.
A University of Pittsburgh study of 186 open and endovascular repairs found that patients with acute presentations of embolization or aneurysm thrombosis did better with open surgery. In addition, while open repair had superior patency initially after surgery, midterm secondary patency and amputation rates of open and endovascular repair were similar (J Vasc Surg. 2016 Jan;63[1]:70-6).
A Netherlands study of 72 PAA treated with endografting showed that 84% had primary patency at 1 year, and 74% had assisted primary patency at 3 years (Eur J Vasc Endovasc Surg. 2016 Jul;52[1]:99-104). Among these patients, 13 had late occlusions, 7 were converted to bypass, and 2 required thrombolysis; but none required limb amputation.
A meta-analysis of 540 patients found no statistically significant difference in outcomes between endovascular and open repair for PAA (Eur J Vasc Endovasc Surg. 2015 Sep;50(3):351-9). Another systematic review and meta-analysis of 14 studies and 514 patients also found no difference in pooled primary and secondary patency at 5 years (J Endovasc Ther. 2015 Jun;22[3]:330-7).
There certainly are contradictory studies, such as one by Dr. Alik Farber’s group in Boston that showed open repair is superior to endovascular surgery (J Vasc Surg. 2015 Mar;61[3]:663-9); but retrospective database mining certainly has its limitations. Their retrospective study queried the Vascular Quality Initiative database and found that 95% of patients who had open elective popliteal aneurysm repair were free from major adverse limb events, vs. 80% for endovascular treatments.
The best outcomes of open repair happen with autologous vein, but there is precious little of that around now. Emergency patients would probably do better with open surgery, but in elective repair there is no clear differential data.
So, if that’s the case, I’m going to take the small incision.
Peter Rossi, MD, FACS, is an associate professor of surgery and radiology, and the clinical director of vascular surgery, at the Medical College of Wisconsin, Milwaukee. He is also on staff at Clement J. Zablocki Veterans Affairs Medical Center in Milwaukee. Dr. Rossi had no financial relationships to disclose.
Endovascular repair may not be durable
Debating the durability of elective endovascular repair of popliteal artery aneurysm raises a question: Who determines durability anyway?
Is it the patients who only want the Band-Aid and no incision? I don’t think so. Is it the interventionalist who only does endovascular repairs? I don’t think so. I’m sure it’s not the insurance companies, who only worry about cost containment, either.
So, who should determine durability of endovascular popliteal artery aneurysm (PAA) repair?
So, the question is, do we have such data?
There are multiple reports looking at how well open repair works. It has been done for decades. In 2008, a Veterans Affairs study of 583 open PAA repairs reported low death rates and excellent rates of limb salvage at 2 years, even in high-risk patients (J Vasc Surg. 2008 Oct;48[4]:845-51). Open surgical repair has excellent documented durability, and that is not the question at hand.
Endovascular repair has some presumed advantages. It’s less invasive and involves less postoperative pain and a quicker recovery. But it is not without problems – graft thrombosis and occlusion, endoleaks, distal limb ischemia, and stent fractures among them.
Surgery, to be clear, is not perfect, either. One of my patients who years ago presented with an occluded PAA underwent open bypass repair – but then went on later to have a pseudoaneurysm of the proximal anastomosis. I repaired this with an endograft, and he has done quite well. So, we all do endograft repairs, walk out, chest bump the Gore rep, and send the patient home that day.
Is it durable, though?
Most of the data on endovascular repair are from single-center studies dating back to 2003. There’s only one prospective trial comparing endovascular vs. open repair (J Vasc Surg. 2005 Aug;42[2]:185-93), but it was a single-center trial with a severe power limitation, because it involved only 30 patients. It found endovascular repair was comparable to open surgery. Also, I suspect a great deal of selection bias is involved in studies of endovascular repair.
A number of studies have found endovascular repair is not inferior to surgical repair. For example, a study by Dr. Audra Duncan, at Mayo Clinic, and her colleagues found that primary and secondary patency rates of elective and emergent stenting were excellent – but the study results only extended out to 2 years (J Vasc Surg. 2013 May;57[5]:1299-305). I don’t think we could hang our hat on that.
A Swedish study that compared open and endovascular surgery in 592 patients reported that endovascular repair has “significantly inferior results compared with open repair,” particularly in those who present with acute ischemia (Eur J Vasc Endovasc Surg. 2015 Sep;50[3]:342-50). A close look at the data shows that primary patency rates were 89% for open repair and 67.4% for stent graft.
Referencing the systematic review and meta-analysis that Dr. Rossi cited, the primary patency of endovascular repair was only 69% and the secondary patency rate was 77% at 5 years (J Endovasc Ther. 2015 Jun;22[3]:330-7). As physicians, I submit that we can do better.
A Netherlands study investigated stent fractures, finding that 17% (13 out of 78 cases) had circumferential fractures (J Vasc Surg. 2010 Jun;51[6]:1413-8). This study only included circumferential stent fractures and excluded localized strut fractures. I think these studies show that endovascular repair is not always durable.
I want to remind you that we are vascular surgeons, so it is appropriate for us to embrace surgical bypass and its known durability, especially when the durability of endovascular repair is still not known.
Patrick Muck, MD, is chief of vascular surgery and director of vascular residency and fellowship at Good Samaritan Hospital, Cincinnati. He is also on staff at Bethesda North Hospital, Cincinnati, and is affiliated with TriHealth Heart Institute in southwestern Ohio. Dr. Muck had no financial relationships to disclose.
Endovascular repair is durable
Endovascular repair of popliteal artery aneurysms is vastly superior to all other previous techniques of popliteal aneurysm repair. Half of all popliteal artery aneurysms are bilateral, and 40% are associated with abdominal aortic aneurysm; 1%-2% of patients with abdominal aortic aneurysm have a popliteal aneurysm (ANZ J Surg. 2006 Oct;76[10]:912-5). Less than 0.01% of hospitalized patients have popliteal artery aneurysms, and men are 20 times more prone to them than women are.
Traditional treatment involves either bypass with interval ligation or a direct posterior approach with an interposition graft, but surgery is not without its problems. I think of the retired anesthesiologist who came to me with a popliteal artery aneurysm (PAA) that his primary care doctor diagnosed. “I’m not having any damn femoral popliteal bypass operation,” he told me. “Every single one of those patients dies.”
Endograft repair is a technique that is reaching its prime, as a growing number of reports have shown – although none of these studies has large numbers because the volume just isn’t available. One recent paper compared 52 open and 23 endovascular PAA repairs (Ann Vasc Surg. 2016 Jan;30:253-7) and found both had similarly high rates of reintervention – 50% at 4 years. But it is noteworthy that the endovascular results improved with time.
A University of Pittsburgh study of 186 open and endovascular repairs found that patients with acute presentations of embolization or aneurysm thrombosis did better with open surgery. In addition, while open repair had superior patency initially after surgery, midterm secondary patency and amputation rates of open and endovascular repair were similar (J Vasc Surg. 2016 Jan;63[1]:70-6).
A Netherlands study of 72 PAA treated with endografting showed that 84% had primary patency at 1 year, and 74% had assisted primary patency at 3 years (Eur J Vasc Endovasc Surg. 2016 Jul;52[1]:99-104). Among these patients, 13 had late occlusions, 7 were converted to bypass, and 2 required thrombolysis; but none required limb amputation.
A meta-analysis of 540 patients found no statistically significant difference in outcomes between endovascular and open repair for PAA (Eur J Vasc Endovasc Surg. 2015 Sep;50(3):351-9). Another systematic review and meta-analysis of 14 studies and 514 patients also found no difference in pooled primary and secondary patency at 5 years (J Endovasc Ther. 2015 Jun;22[3]:330-7).
There certainly are contradictory studies, such as one by Dr. Alik Farber’s group in Boston that showed open repair is superior to endovascular surgery (J Vasc Surg. 2015 Mar;61[3]:663-9); but retrospective database mining certainly has its limitations. Their retrospective study queried the Vascular Quality Initiative database and found that 95% of patients who had open elective popliteal aneurysm repair were free from major adverse limb events, vs. 80% for endovascular treatments.
The best outcomes of open repair happen with autologous vein, but there is precious little of that around now. Emergency patients would probably do better with open surgery, but in elective repair there is no clear differential data.
So, if that’s the case, I’m going to take the small incision.
Peter Rossi, MD, FACS, is an associate professor of surgery and radiology, and the clinical director of vascular surgery, at the Medical College of Wisconsin, Milwaukee. He is also on staff at Clement J. Zablocki Veterans Affairs Medical Center in Milwaukee. Dr. Rossi had no financial relationships to disclose.
Endovascular repair may not be durable
Debating the durability of elective endovascular repair of popliteal artery aneurysm raises a question: Who determines durability anyway?
Is it the patients who only want the Band-Aid and no incision? I don’t think so. Is it the interventionalist who only does endovascular repairs? I don’t think so. I’m sure it’s not the insurance companies, who only worry about cost containment, either.
So, who should determine durability of endovascular popliteal artery aneurysm (PAA) repair?
So, the question is, do we have such data?
There are multiple reports looking at how well open repair works. It has been done for decades. In 2008, a Veterans Affairs study of 583 open PAA repairs reported low death rates and excellent rates of limb salvage at 2 years, even in high-risk patients (J Vasc Surg. 2008 Oct;48[4]:845-51). Open surgical repair has excellent documented durability, and that is not the question at hand.
Endovascular repair has some presumed advantages. It’s less invasive and involves less postoperative pain and a quicker recovery. But it is not without problems – graft thrombosis and occlusion, endoleaks, distal limb ischemia, and stent fractures among them.
Surgery, to be clear, is not perfect, either. One of my patients who years ago presented with an occluded PAA underwent open bypass repair – but then went on later to have a pseudoaneurysm of the proximal anastomosis. I repaired this with an endograft, and he has done quite well. So, we all do endograft repairs, walk out, chest bump the Gore rep, and send the patient home that day.
Is it durable, though?
Most of the data on endovascular repair are from single-center studies dating back to 2003. There’s only one prospective trial comparing endovascular vs. open repair (J Vasc Surg. 2005 Aug;42[2]:185-93), but it was a single-center trial with a severe power limitation, because it involved only 30 patients. It found endovascular repair was comparable to open surgery. Also, I suspect a great deal of selection bias is involved in studies of endovascular repair.
A number of studies have found endovascular repair is not inferior to surgical repair. For example, a study by Dr. Audra Duncan, at Mayo Clinic, and her colleagues found that primary and secondary patency rates of elective and emergent stenting were excellent – but the study results only extended out to 2 years (J Vasc Surg. 2013 May;57[5]:1299-305). I don’t think we could hang our hat on that.
A Swedish study that compared open and endovascular surgery in 592 patients reported that endovascular repair has “significantly inferior results compared with open repair,” particularly in those who present with acute ischemia (Eur J Vasc Endovasc Surg. 2015 Sep;50[3]:342-50). A close look at the data shows that primary patency rates were 89% for open repair and 67.4% for stent graft.
Referencing the systematic review and meta-analysis that Dr. Rossi cited, the primary patency of endovascular repair was only 69% and the secondary patency rate was 77% at 5 years (J Endovasc Ther. 2015 Jun;22[3]:330-7). As physicians, I submit that we can do better.
A Netherlands study investigated stent fractures, finding that 17% (13 out of 78 cases) had circumferential fractures (J Vasc Surg. 2010 Jun;51[6]:1413-8). This study only included circumferential stent fractures and excluded localized strut fractures. I think these studies show that endovascular repair is not always durable.
I want to remind you that we are vascular surgeons, so it is appropriate for us to embrace surgical bypass and its known durability, especially when the durability of endovascular repair is still not known.
Patrick Muck, MD, is chief of vascular surgery and director of vascular residency and fellowship at Good Samaritan Hospital, Cincinnati. He is also on staff at Bethesda North Hospital, Cincinnati, and is affiliated with TriHealth Heart Institute in southwestern Ohio. Dr. Muck had no financial relationships to disclose.
AT MIDWESTERN VASCULAR 2016
Herbal/dietary supplements linked to liver injury requiring transplant
Herbal or dietary supplements are the fourth most common cause of drug-induced acute hepatic necrosis requiring liver transplantation in the United States, according to a study of liver transplant registry data.
Researchers analyzed registry data for 2,408 adults who underwent urgent liver transplantation for acute hepatic necrosis between 2003 and 2015, 625 of whom were recorded as having drug-induced liver injury. Of these, 21 cases were reportedly due to herbal or dietary supplements, all of which occurred after 2007. Eight cases were attributed to Lipolyze, Hydroxycut, testosterone, and OxyElite Pro, a muscle-building and weight-loss dietary supplement containing a blend of plant-derived extracts. The remaining cases did not list a specific product (Transplantation Proc 2017;49[2]:322-5).
“The potential hepatotoxicity of these HDS [herbal/dietary supplement] agents can result in the need for liver transplantation for irreversible liver failure,” wrote Dr. Linda L. Wong of the University of Hawaii and coauthors, citing two cases in Hawaii where patients needed liver transplant after taking OxyElite Pro.
They also referred to other case reports and case series of liver transplantation occurring in individuals who had taken the supplements usnic acid, Herbalife, Hydroxycut, linoleic acid, black cohosh, Chinese herbs, kava kava, skullcap, ma huang, or bai fang herb. “The benefits of the current regulatory oversight of medications breaks down when patients misuse non-FDA [Food and Drug Administration] approved herbal/dietary supplements (HDS) or ‘natural remedies’ with their inherent unknown side effects, interactions, and complications,” they wrote.
The mean age of individuals for which an herbal/dietary supplement was thought to be the cause of the hepatotoxicity was 36.8 years, 14 of the 21 were female, and the mean waiting time for liver transplantation was 4.7 days. One of the 21 patients died.
Overall, the most common drug associated with drug-induced liver injury was acetaminophen (300 cases), followed by antituberculosis medications (30), and antibiotics (30).
The authors suggested the true figure for HDS-induced liver transplantation may be underestimated, pointing to the fact that in this study, a further 154 cases were recorded as drug-induced injury but no drug was listed.
“Transplant centers and physicians may have difficulty identifying the exact inciting agent because patients do not typically report HDS when queried about medication use,” the authors wrote.
Given this, they recommended that transplant professionals specifically ask potential transplant recipients about their use of HDS, and request a detailed list of these along with the time course of use. They noted that family members and friends may not be privy to this information, and the patients themselves may not be in a position to answer because of decompensation with encephalopathy.
“It is critical to obtain this information as early as possible in the evaluation of the potential liver transplant recipient with an unknown etiology of liver disease or who presents with acute hepatic decompensation,” they wrote.
They also called for transplant professionals to report any information about confirmed HDS use in their patients to the FDA.
“It is imperative that transplant professionals inform the FDA of these dangerous compounds, with the ultimate intent of enforcing regulatory oversight,” they wrote. “This adherence to strict reporting will in turn translate to a reduction in the need for liver transplantation from HDS use.”
No conflicts of interest were declared.
Herbal or dietary supplements are the fourth most common cause of drug-induced acute hepatic necrosis requiring liver transplantation in the United States, according to a study of liver transplant registry data.
Researchers analyzed registry data for 2,408 adults who underwent urgent liver transplantation for acute hepatic necrosis between 2003 and 2015, 625 of whom were recorded as having drug-induced liver injury. Of these, 21 cases were reportedly due to herbal or dietary supplements, all of which occurred after 2007. Eight cases were attributed to Lipolyze, Hydroxycut, testosterone, and OxyElite Pro, a muscle-building and weight-loss dietary supplement containing a blend of plant-derived extracts. The remaining cases did not list a specific product (Transplantation Proc 2017;49[2]:322-5).
“The potential hepatotoxicity of these HDS [herbal/dietary supplement] agents can result in the need for liver transplantation for irreversible liver failure,” wrote Dr. Linda L. Wong of the University of Hawaii and coauthors, citing two cases in Hawaii where patients needed liver transplant after taking OxyElite Pro.
They also referred to other case reports and case series of liver transplantation occurring in individuals who had taken the supplements usnic acid, Herbalife, Hydroxycut, linoleic acid, black cohosh, Chinese herbs, kava kava, skullcap, ma huang, or bai fang herb. “The benefits of the current regulatory oversight of medications breaks down when patients misuse non-FDA [Food and Drug Administration] approved herbal/dietary supplements (HDS) or ‘natural remedies’ with their inherent unknown side effects, interactions, and complications,” they wrote.
The mean age of individuals for which an herbal/dietary supplement was thought to be the cause of the hepatotoxicity was 36.8 years, 14 of the 21 were female, and the mean waiting time for liver transplantation was 4.7 days. One of the 21 patients died.
Overall, the most common drug associated with drug-induced liver injury was acetaminophen (300 cases), followed by antituberculosis medications (30), and antibiotics (30).
The authors suggested the true figure for HDS-induced liver transplantation may be underestimated, pointing to the fact that in this study, a further 154 cases were recorded as drug-induced injury but no drug was listed.
“Transplant centers and physicians may have difficulty identifying the exact inciting agent because patients do not typically report HDS when queried about medication use,” the authors wrote.
Given this, they recommended that transplant professionals specifically ask potential transplant recipients about their use of HDS, and request a detailed list of these along with the time course of use. They noted that family members and friends may not be privy to this information, and the patients themselves may not be in a position to answer because of decompensation with encephalopathy.
“It is critical to obtain this information as early as possible in the evaluation of the potential liver transplant recipient with an unknown etiology of liver disease or who presents with acute hepatic decompensation,” they wrote.
They also called for transplant professionals to report any information about confirmed HDS use in their patients to the FDA.
“It is imperative that transplant professionals inform the FDA of these dangerous compounds, with the ultimate intent of enforcing regulatory oversight,” they wrote. “This adherence to strict reporting will in turn translate to a reduction in the need for liver transplantation from HDS use.”
No conflicts of interest were declared.
Herbal or dietary supplements are the fourth most common cause of drug-induced acute hepatic necrosis requiring liver transplantation in the United States, according to a study of liver transplant registry data.
Researchers analyzed registry data for 2,408 adults who underwent urgent liver transplantation for acute hepatic necrosis between 2003 and 2015, 625 of whom were recorded as having drug-induced liver injury. Of these, 21 cases were reportedly due to herbal or dietary supplements, all of which occurred after 2007. Eight cases were attributed to Lipolyze, Hydroxycut, testosterone, and OxyElite Pro, a muscle-building and weight-loss dietary supplement containing a blend of plant-derived extracts. The remaining cases did not list a specific product (Transplantation Proc 2017;49[2]:322-5).
“The potential hepatotoxicity of these HDS [herbal/dietary supplement] agents can result in the need for liver transplantation for irreversible liver failure,” wrote Dr. Linda L. Wong of the University of Hawaii and coauthors, citing two cases in Hawaii where patients needed liver transplant after taking OxyElite Pro.
They also referred to other case reports and case series of liver transplantation occurring in individuals who had taken the supplements usnic acid, Herbalife, Hydroxycut, linoleic acid, black cohosh, Chinese herbs, kava kava, skullcap, ma huang, or bai fang herb. “The benefits of the current regulatory oversight of medications breaks down when patients misuse non-FDA [Food and Drug Administration] approved herbal/dietary supplements (HDS) or ‘natural remedies’ with their inherent unknown side effects, interactions, and complications,” they wrote.
The mean age of individuals for which an herbal/dietary supplement was thought to be the cause of the hepatotoxicity was 36.8 years, 14 of the 21 were female, and the mean waiting time for liver transplantation was 4.7 days. One of the 21 patients died.
Overall, the most common drug associated with drug-induced liver injury was acetaminophen (300 cases), followed by antituberculosis medications (30), and antibiotics (30).
The authors suggested the true figure for HDS-induced liver transplantation may be underestimated, pointing to the fact that in this study, a further 154 cases were recorded as drug-induced injury but no drug was listed.
“Transplant centers and physicians may have difficulty identifying the exact inciting agent because patients do not typically report HDS when queried about medication use,” the authors wrote.
Given this, they recommended that transplant professionals specifically ask potential transplant recipients about their use of HDS, and request a detailed list of these along with the time course of use. They noted that family members and friends may not be privy to this information, and the patients themselves may not be in a position to answer because of decompensation with encephalopathy.
“It is critical to obtain this information as early as possible in the evaluation of the potential liver transplant recipient with an unknown etiology of liver disease or who presents with acute hepatic decompensation,” they wrote.
They also called for transplant professionals to report any information about confirmed HDS use in their patients to the FDA.
“It is imperative that transplant professionals inform the FDA of these dangerous compounds, with the ultimate intent of enforcing regulatory oversight,” they wrote. “This adherence to strict reporting will in turn translate to a reduction in the need for liver transplantation from HDS use.”
No conflicts of interest were declared.
FROM TRANSPLANTATION PROCEEDINGS
Key clinical point: Herbal or dietary supplements are the fourth most common cause of drug-induced acute hepatic necrosis requiring liver transplantation in the United States.
Major finding: Twenty-one cases of liver transplantation linked to the use of herbal or dietary supplements were recorded between 2003 and 2015.
Data source: Analysis of registry data from 2,408 adults who underwent urgent liver transplantation for acute hepatic necrosis.
Disclosures: No conflicts of interest were declared.
Primary prophylaxis of bleeding in portal hypertension safe in cirrhosis with high-risk varices
Primary prophylaxis of bleeding in children with portal hypertension is safe for treatment of cirrhosis associated with high-risk varices, according to Mathieu Duché, MD, of Hôpital Bicêtre in France, and his associates.
In a study from July 1989 to June 2014, researchers examined 1,300 children with various causes of liver disease, based on the presence of palpable splenomegaly and/or ultrasonographic signs of portal hypertension. During the study, a high-risk pattern – including grade 3 esophageal varices, grade 2 varices with red markings and/or gastric varices along the cardia, or gastric varices with or without esophageal varices – was present in 96% of the 246 children who bled spontaneously and in 11% of the 872 children who did not bleed. Of the 246 children who bled spontaneously, 170 children with high-risk varices underwent primary prophylaxis of bleeding with portal surgery, endoscopic banding/sclerotherapy of varices, or interventional radiology.
In 50 children with noncirrhotic causes of portal hypertension and the high risk varices, those with portal vein obstruction underwent portal surgery (Rex bypass or portosystemic shunt) as primary prophylaxis. Endoscopic banding or sclerotherapy was performed instead in younger children or when angiograms did not favor the surgery. One child who had a severe stenosis of the portal trunk underwent successful interventional radiology. After a mean follow-up of 5.5 years after primary prophylaxis, all these patients are alive.
Of the 120 children with cirrhosis with high risk varices, 10 children with well compensated cirrhosis received a portosystemic shunt; thrombosis of the shunt occurred in 1 child who later underwent liver transplantation, and 1 child with a patent shunt developed portosystemic encephalopathy and underwent liver transplantation. No gastrointestinal bleeding was recorded in these 10 children who were alive at the last follow-up.
Of 110 children who underwent endoscopic banding or sclerotherapy, in 76 children there was eradication of varices; there was a relapse of high-risk varices in 20 children, so further endoscopic was needed. In two children who initially underwent endoscopic treatment and achieved eradication of varices, a protein-losing enteropathy and bleeding from ectopic varices, respectively, required subsequent treatment by a surgical portosystemic shunt. Of the 34 children in whom no eradication was obtained with this primary prophylaxis, 3 died and 29 underwent liver transplantation before eradication could be obtained; 1 was lost to follow-up and 1 received a transjugular intrahepatic portosystemic shunt. After a mean follow-up of 5 years, 8 of the 120 children with cirrhosis who underwent primary prophylaxis have died: 4 children died before transplantation, 2 of septic shock unrelated to endoscopic treatment, and 1 of atrioventricular block during variceal injection of aethoxysklerol. Four other children died after transplantation.
It was noted that no esophageal or gastric perforation was observed as a consequence of endoscopic primary prophylaxis in the pre- or posttransplantation period.
“Although no statistical analysis was performed because this was not a controlled study, the results suggest that, compared with liver transplantation performed directly or with care after a spontaneous bleed, primary prophylaxis of bleeding has a fairly good safety record for the management of children with cirrhosis and high-risk varices,” researchers concluded.
Read the full study in the Journal of Hepatology (doi: 10.1016/j.jhep.2016.09.006).
Primary prophylaxis of bleeding in children with portal hypertension is safe for treatment of cirrhosis associated with high-risk varices, according to Mathieu Duché, MD, of Hôpital Bicêtre in France, and his associates.
In a study from July 1989 to June 2014, researchers examined 1,300 children with various causes of liver disease, based on the presence of palpable splenomegaly and/or ultrasonographic signs of portal hypertension. During the study, a high-risk pattern – including grade 3 esophageal varices, grade 2 varices with red markings and/or gastric varices along the cardia, or gastric varices with or without esophageal varices – was present in 96% of the 246 children who bled spontaneously and in 11% of the 872 children who did not bleed. Of the 246 children who bled spontaneously, 170 children with high-risk varices underwent primary prophylaxis of bleeding with portal surgery, endoscopic banding/sclerotherapy of varices, or interventional radiology.
In 50 children with noncirrhotic causes of portal hypertension and the high risk varices, those with portal vein obstruction underwent portal surgery (Rex bypass or portosystemic shunt) as primary prophylaxis. Endoscopic banding or sclerotherapy was performed instead in younger children or when angiograms did not favor the surgery. One child who had a severe stenosis of the portal trunk underwent successful interventional radiology. After a mean follow-up of 5.5 years after primary prophylaxis, all these patients are alive.
Of the 120 children with cirrhosis with high risk varices, 10 children with well compensated cirrhosis received a portosystemic shunt; thrombosis of the shunt occurred in 1 child who later underwent liver transplantation, and 1 child with a patent shunt developed portosystemic encephalopathy and underwent liver transplantation. No gastrointestinal bleeding was recorded in these 10 children who were alive at the last follow-up.
Of 110 children who underwent endoscopic banding or sclerotherapy, in 76 children there was eradication of varices; there was a relapse of high-risk varices in 20 children, so further endoscopic was needed. In two children who initially underwent endoscopic treatment and achieved eradication of varices, a protein-losing enteropathy and bleeding from ectopic varices, respectively, required subsequent treatment by a surgical portosystemic shunt. Of the 34 children in whom no eradication was obtained with this primary prophylaxis, 3 died and 29 underwent liver transplantation before eradication could be obtained; 1 was lost to follow-up and 1 received a transjugular intrahepatic portosystemic shunt. After a mean follow-up of 5 years, 8 of the 120 children with cirrhosis who underwent primary prophylaxis have died: 4 children died before transplantation, 2 of septic shock unrelated to endoscopic treatment, and 1 of atrioventricular block during variceal injection of aethoxysklerol. Four other children died after transplantation.
It was noted that no esophageal or gastric perforation was observed as a consequence of endoscopic primary prophylaxis in the pre- or posttransplantation period.
“Although no statistical analysis was performed because this was not a controlled study, the results suggest that, compared with liver transplantation performed directly or with care after a spontaneous bleed, primary prophylaxis of bleeding has a fairly good safety record for the management of children with cirrhosis and high-risk varices,” researchers concluded.
Read the full study in the Journal of Hepatology (doi: 10.1016/j.jhep.2016.09.006).
Primary prophylaxis of bleeding in children with portal hypertension is safe for treatment of cirrhosis associated with high-risk varices, according to Mathieu Duché, MD, of Hôpital Bicêtre in France, and his associates.
In a study from July 1989 to June 2014, researchers examined 1,300 children with various causes of liver disease, based on the presence of palpable splenomegaly and/or ultrasonographic signs of portal hypertension. During the study, a high-risk pattern – including grade 3 esophageal varices, grade 2 varices with red markings and/or gastric varices along the cardia, or gastric varices with or without esophageal varices – was present in 96% of the 246 children who bled spontaneously and in 11% of the 872 children who did not bleed. Of the 246 children who bled spontaneously, 170 children with high-risk varices underwent primary prophylaxis of bleeding with portal surgery, endoscopic banding/sclerotherapy of varices, or interventional radiology.
In 50 children with noncirrhotic causes of portal hypertension and the high risk varices, those with portal vein obstruction underwent portal surgery (Rex bypass or portosystemic shunt) as primary prophylaxis. Endoscopic banding or sclerotherapy was performed instead in younger children or when angiograms did not favor the surgery. One child who had a severe stenosis of the portal trunk underwent successful interventional radiology. After a mean follow-up of 5.5 years after primary prophylaxis, all these patients are alive.
Of the 120 children with cirrhosis with high risk varices, 10 children with well compensated cirrhosis received a portosystemic shunt; thrombosis of the shunt occurred in 1 child who later underwent liver transplantation, and 1 child with a patent shunt developed portosystemic encephalopathy and underwent liver transplantation. No gastrointestinal bleeding was recorded in these 10 children who were alive at the last follow-up.
Of 110 children who underwent endoscopic banding or sclerotherapy, in 76 children there was eradication of varices; there was a relapse of high-risk varices in 20 children, so further endoscopic was needed. In two children who initially underwent endoscopic treatment and achieved eradication of varices, a protein-losing enteropathy and bleeding from ectopic varices, respectively, required subsequent treatment by a surgical portosystemic shunt. Of the 34 children in whom no eradication was obtained with this primary prophylaxis, 3 died and 29 underwent liver transplantation before eradication could be obtained; 1 was lost to follow-up and 1 received a transjugular intrahepatic portosystemic shunt. After a mean follow-up of 5 years, 8 of the 120 children with cirrhosis who underwent primary prophylaxis have died: 4 children died before transplantation, 2 of septic shock unrelated to endoscopic treatment, and 1 of atrioventricular block during variceal injection of aethoxysklerol. Four other children died after transplantation.
It was noted that no esophageal or gastric perforation was observed as a consequence of endoscopic primary prophylaxis in the pre- or posttransplantation period.
“Although no statistical analysis was performed because this was not a controlled study, the results suggest that, compared with liver transplantation performed directly or with care after a spontaneous bleed, primary prophylaxis of bleeding has a fairly good safety record for the management of children with cirrhosis and high-risk varices,” researchers concluded.
Read the full study in the Journal of Hepatology (doi: 10.1016/j.jhep.2016.09.006).
FROM JOURNAL OF HEPATOLOGY
Trump lays out principles for ACA replacement
Flexibility and choice were key themes in the health care reform vision President Trump outlined in his first speech to a joint session of Congress on Feb. 28.
Specifically, Americans should be able to “purchase their own coverage through the use of tax credits and expanded health savings accounts, but it must be the plan they want, not the plan forced on them by our government,” Mr. Trump said. They also should be able to purchase insurance across state lines, which “will create a truly competitive national marketplace that will bring costs way down and provide far better care.”
He also advocated providing more flexibility to states to improve Medicaid but did not provide any specifics on how that would be accomplished.
Finally, Mr. Trump called for “legal reforms that protect patients and doctors from unnecessary costs that drive up the price of insurance and work to bring down the artificially high price of drugs and bring them down immediately,” he said, adding that the Food and Drug Administration needs to slash the time to approval for drugs and other medical treatments.
Some of these concepts were mirrored in a talking-points memo from the House Republican leadership earlier in February.
According to the memo, Republican efforts to repeal and replace the ACA will focus on the following areas:
• Repealing the ACA’s Medicaid expansion and allowing states to choose between block grands or per capita grants for Medicaid funding. States could choose to use those grants and per capita grants to keep expansion.
• Rebranding high-risk pools as “state innovation grants” to provide states with flexibility to design coverage that meets the needs of their populations. States could use the innovation grants to reduce patient out-of-pocket costs, lower the cost of providing care, stabilize the individual and small-group markets, provide access to preventive care, and promote participation in private health care plans.
• Promoting health savings accounts tied to high-deductible plans through increasing maximum contribution limits and other administrative fixes to allow for greater flexibility in their use.
• Replacing ACA premium subsides with refundable flat tax credits. Credit would be age-based, with younger recipients receiving smaller credits and older taxpayers being eligible for more. Tax credits would be available to those who are not eligible to receive coverage through other sources, such as an employer or government program.
Many of these provisions were included in a health reform plan known as A Better Way, which was announced in June 2016 by House Speaker Paul Ryan (R-Wis.).
Like Mr. Trump’s outline to Congress, the GOP talking-points memo was light on specifics, including how the bill will be paid for, how much money will be distributed to states for Medicaid, and how these provisions would alter current insurance coverage rates, which government actuaries project would reach 91.5% by 2025 under current law.
The GOP talking-points memo followed a Feb. 10 discussion draft that included the legislative language required to implement these concepts and allowed insurers to charge higher premiums to people with coverage lapses; repealed a number of taxes imposed on insurers, pharmaceutical companies, and device manufacturers; eliminated many of the ACA’s essential benefits; and ended tax penalties on companies that do not provide coverage to their employees.
This proposal, however, is already running into opposition from House Republicans, with reports stating that blocks of Republicans would not approve of the provisions.
It also could run aground in the Senate, where Sen. Lamar Alexander (R-Tenn.), chairman of the Committee on Health, Education, Labor, and Pensions, has expressed his intent to tackle heath care reform in pieces (public programs, the individual market, and employer market) to avoid getting bogged down in one overarching piece of legislation.
Getting Republicans on the same page is going to be a huge hurdle to get any legislation passed long before it comes down to trying to secure any Democratic votes to help pass any replacement legislation.
As former House Speaker John Boehner told physicians and health care IT leaders at the HIMSS annual conference on Feb. 23, “In the 25 years that I served in the Unites States Congress, Republicans never ever one time agreed on what a health care proposal should look like. Not once. … If you repeal without replace, anything that happens is your fault. You broke it. … If you pass repeal without replace, you’ll never pass replace because they will never ever agree on what the [replacement] bill should be.”
Flexibility and choice were key themes in the health care reform vision President Trump outlined in his first speech to a joint session of Congress on Feb. 28.
Specifically, Americans should be able to “purchase their own coverage through the use of tax credits and expanded health savings accounts, but it must be the plan they want, not the plan forced on them by our government,” Mr. Trump said. They also should be able to purchase insurance across state lines, which “will create a truly competitive national marketplace that will bring costs way down and provide far better care.”
He also advocated providing more flexibility to states to improve Medicaid but did not provide any specifics on how that would be accomplished.
Finally, Mr. Trump called for “legal reforms that protect patients and doctors from unnecessary costs that drive up the price of insurance and work to bring down the artificially high price of drugs and bring them down immediately,” he said, adding that the Food and Drug Administration needs to slash the time to approval for drugs and other medical treatments.
Some of these concepts were mirrored in a talking-points memo from the House Republican leadership earlier in February.
According to the memo, Republican efforts to repeal and replace the ACA will focus on the following areas:
• Repealing the ACA’s Medicaid expansion and allowing states to choose between block grands or per capita grants for Medicaid funding. States could choose to use those grants and per capita grants to keep expansion.
• Rebranding high-risk pools as “state innovation grants” to provide states with flexibility to design coverage that meets the needs of their populations. States could use the innovation grants to reduce patient out-of-pocket costs, lower the cost of providing care, stabilize the individual and small-group markets, provide access to preventive care, and promote participation in private health care plans.
• Promoting health savings accounts tied to high-deductible plans through increasing maximum contribution limits and other administrative fixes to allow for greater flexibility in their use.
• Replacing ACA premium subsides with refundable flat tax credits. Credit would be age-based, with younger recipients receiving smaller credits and older taxpayers being eligible for more. Tax credits would be available to those who are not eligible to receive coverage through other sources, such as an employer or government program.
Many of these provisions were included in a health reform plan known as A Better Way, which was announced in June 2016 by House Speaker Paul Ryan (R-Wis.).
Like Mr. Trump’s outline to Congress, the GOP talking-points memo was light on specifics, including how the bill will be paid for, how much money will be distributed to states for Medicaid, and how these provisions would alter current insurance coverage rates, which government actuaries project would reach 91.5% by 2025 under current law.
The GOP talking-points memo followed a Feb. 10 discussion draft that included the legislative language required to implement these concepts and allowed insurers to charge higher premiums to people with coverage lapses; repealed a number of taxes imposed on insurers, pharmaceutical companies, and device manufacturers; eliminated many of the ACA’s essential benefits; and ended tax penalties on companies that do not provide coverage to their employees.
This proposal, however, is already running into opposition from House Republicans, with reports stating that blocks of Republicans would not approve of the provisions.
It also could run aground in the Senate, where Sen. Lamar Alexander (R-Tenn.), chairman of the Committee on Health, Education, Labor, and Pensions, has expressed his intent to tackle heath care reform in pieces (public programs, the individual market, and employer market) to avoid getting bogged down in one overarching piece of legislation.
Getting Republicans on the same page is going to be a huge hurdle to get any legislation passed long before it comes down to trying to secure any Democratic votes to help pass any replacement legislation.
As former House Speaker John Boehner told physicians and health care IT leaders at the HIMSS annual conference on Feb. 23, “In the 25 years that I served in the Unites States Congress, Republicans never ever one time agreed on what a health care proposal should look like. Not once. … If you repeal without replace, anything that happens is your fault. You broke it. … If you pass repeal without replace, you’ll never pass replace because they will never ever agree on what the [replacement] bill should be.”
Flexibility and choice were key themes in the health care reform vision President Trump outlined in his first speech to a joint session of Congress on Feb. 28.
Specifically, Americans should be able to “purchase their own coverage through the use of tax credits and expanded health savings accounts, but it must be the plan they want, not the plan forced on them by our government,” Mr. Trump said. They also should be able to purchase insurance across state lines, which “will create a truly competitive national marketplace that will bring costs way down and provide far better care.”
He also advocated providing more flexibility to states to improve Medicaid but did not provide any specifics on how that would be accomplished.
Finally, Mr. Trump called for “legal reforms that protect patients and doctors from unnecessary costs that drive up the price of insurance and work to bring down the artificially high price of drugs and bring them down immediately,” he said, adding that the Food and Drug Administration needs to slash the time to approval for drugs and other medical treatments.
Some of these concepts were mirrored in a talking-points memo from the House Republican leadership earlier in February.
According to the memo, Republican efforts to repeal and replace the ACA will focus on the following areas:
• Repealing the ACA’s Medicaid expansion and allowing states to choose between block grands or per capita grants for Medicaid funding. States could choose to use those grants and per capita grants to keep expansion.
• Rebranding high-risk pools as “state innovation grants” to provide states with flexibility to design coverage that meets the needs of their populations. States could use the innovation grants to reduce patient out-of-pocket costs, lower the cost of providing care, stabilize the individual and small-group markets, provide access to preventive care, and promote participation in private health care plans.
• Promoting health savings accounts tied to high-deductible plans through increasing maximum contribution limits and other administrative fixes to allow for greater flexibility in their use.
• Replacing ACA premium subsides with refundable flat tax credits. Credit would be age-based, with younger recipients receiving smaller credits and older taxpayers being eligible for more. Tax credits would be available to those who are not eligible to receive coverage through other sources, such as an employer or government program.
Many of these provisions were included in a health reform plan known as A Better Way, which was announced in June 2016 by House Speaker Paul Ryan (R-Wis.).
Like Mr. Trump’s outline to Congress, the GOP talking-points memo was light on specifics, including how the bill will be paid for, how much money will be distributed to states for Medicaid, and how these provisions would alter current insurance coverage rates, which government actuaries project would reach 91.5% by 2025 under current law.
The GOP talking-points memo followed a Feb. 10 discussion draft that included the legislative language required to implement these concepts and allowed insurers to charge higher premiums to people with coverage lapses; repealed a number of taxes imposed on insurers, pharmaceutical companies, and device manufacturers; eliminated many of the ACA’s essential benefits; and ended tax penalties on companies that do not provide coverage to their employees.
This proposal, however, is already running into opposition from House Republicans, with reports stating that blocks of Republicans would not approve of the provisions.
It also could run aground in the Senate, where Sen. Lamar Alexander (R-Tenn.), chairman of the Committee on Health, Education, Labor, and Pensions, has expressed his intent to tackle heath care reform in pieces (public programs, the individual market, and employer market) to avoid getting bogged down in one overarching piece of legislation.
Getting Republicans on the same page is going to be a huge hurdle to get any legislation passed long before it comes down to trying to secure any Democratic votes to help pass any replacement legislation.
As former House Speaker John Boehner told physicians and health care IT leaders at the HIMSS annual conference on Feb. 23, “In the 25 years that I served in the Unites States Congress, Republicans never ever one time agreed on what a health care proposal should look like. Not once. … If you repeal without replace, anything that happens is your fault. You broke it. … If you pass repeal without replace, you’ll never pass replace because they will never ever agree on what the [replacement] bill should be.”
AGA Clinical Practice Update: Using FLIP to assess upper GI tract still murky territory
New clinical practice advice has been issued for use of the functional lumen imaging probe (FLIP) to assess disorders of the upper gastrointestinal tract, with the main takeaway being the device’s potency in diagnosing achalasia.
“Although the strongest data appear to be focused on the management of achalasia, emerging evidence supports the clinical relevance of FLIP in the assessment of disease severity and as an outcome measure in [eosinophilic esophagitis (EoE)] intervention trials,” wrote the authors of the update, led by John E. Pandolfino, MD, of Northwestern University, Chicago. The report is in the March issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2016.
10.022).
In terms of evaluating the LES, however, FLIP can be used during laparoscopic Heller myotomy or peroral endoscopic myotomy (POEM) as a way of monitoring the LES. Using FLIP this way can help clinicians and surgeons personalize the procedure to each patient, even while it’s ongoing. FLIP also can be used with dilation balloons, with the balloon diameter allowing dilation measurement without the need to also use fluoroscopy.
For treating gastroesophageal reflux disease (GERD), the evidence found in existing literature points with less certainty toward use of FLIP.
“The role of FLIP for physiologic evaluation and management in GERD remains appealing; however, the level of evidence is low and currently FLIP should not be used in routine GERD management,” the authors explained. “Future outcome studies are needed to substantiate the utility of FLIP in GERD and to develop metrics that predict severity and treatment response after antireflux procedures.”
FLIP can be used in managing eosinophilic esophagitis, but is recommended only in certain scenarios. According to the authors, FLIP can be used to measure esophageal narrowing and the overall esophageal body. FLIP also can be used to measure esophageal distensibility, and, in the case of at least one study reviewed by the authors, allows “significantly greater accuracy and precision in estimating the effects of remodeling” in certain patients.
Dr. Pandolfino and his colleagues warned that “current recommendations are limited by the low level of evidence and lack of generalized availability of the analysis paradigms.” They noted the need for “further outcome studies that validate the distensibility plateau threshold and further refinements in software analyses to make this methodology more generalizable.”
Overall, the authors concluded, more study still needs to be done to ascertain exactly what FLIP is capable of and when it can be used to greatest effect. In addition to evaluating its benefit in patients with GERD, research should focus on how to make data obtained via FLIP easier to interpret and put to use.
“More work is needed [that] focuses on optimizing data analysis, standardizing protocols, and defining outcome metrics prior to the widespread adoption [of FLIP] into general clinical practice,” the authors wrote.
Dr. Pandolfino disclosed relationships with Medtronic and Sandhill Scientific. Other coauthors did not report any relevant financial disclosures.
*This story updated on 3/9/2017.
New clinical practice advice has been issued for use of the functional lumen imaging probe (FLIP) to assess disorders of the upper gastrointestinal tract, with the main takeaway being the device’s potency in diagnosing achalasia.
“Although the strongest data appear to be focused on the management of achalasia, emerging evidence supports the clinical relevance of FLIP in the assessment of disease severity and as an outcome measure in [eosinophilic esophagitis (EoE)] intervention trials,” wrote the authors of the update, led by John E. Pandolfino, MD, of Northwestern University, Chicago. The report is in the March issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2016.
10.022).
In terms of evaluating the LES, however, FLIP can be used during laparoscopic Heller myotomy or peroral endoscopic myotomy (POEM) as a way of monitoring the LES. Using FLIP this way can help clinicians and surgeons personalize the procedure to each patient, even while it’s ongoing. FLIP also can be used with dilation balloons, with the balloon diameter allowing dilation measurement without the need to also use fluoroscopy.
For treating gastroesophageal reflux disease (GERD), the evidence found in existing literature points with less certainty toward use of FLIP.
“The role of FLIP for physiologic evaluation and management in GERD remains appealing; however, the level of evidence is low and currently FLIP should not be used in routine GERD management,” the authors explained. “Future outcome studies are needed to substantiate the utility of FLIP in GERD and to develop metrics that predict severity and treatment response after antireflux procedures.”
FLIP can be used in managing eosinophilic esophagitis, but is recommended only in certain scenarios. According to the authors, FLIP can be used to measure esophageal narrowing and the overall esophageal body. FLIP also can be used to measure esophageal distensibility, and, in the case of at least one study reviewed by the authors, allows “significantly greater accuracy and precision in estimating the effects of remodeling” in certain patients.
Dr. Pandolfino and his colleagues warned that “current recommendations are limited by the low level of evidence and lack of generalized availability of the analysis paradigms.” They noted the need for “further outcome studies that validate the distensibility plateau threshold and further refinements in software analyses to make this methodology more generalizable.”
Overall, the authors concluded, more study still needs to be done to ascertain exactly what FLIP is capable of and when it can be used to greatest effect. In addition to evaluating its benefit in patients with GERD, research should focus on how to make data obtained via FLIP easier to interpret and put to use.
“More work is needed [that] focuses on optimizing data analysis, standardizing protocols, and defining outcome metrics prior to the widespread adoption [of FLIP] into general clinical practice,” the authors wrote.
Dr. Pandolfino disclosed relationships with Medtronic and Sandhill Scientific. Other coauthors did not report any relevant financial disclosures.
*This story updated on 3/9/2017.
New clinical practice advice has been issued for use of the functional lumen imaging probe (FLIP) to assess disorders of the upper gastrointestinal tract, with the main takeaway being the device’s potency in diagnosing achalasia.
“Although the strongest data appear to be focused on the management of achalasia, emerging evidence supports the clinical relevance of FLIP in the assessment of disease severity and as an outcome measure in [eosinophilic esophagitis (EoE)] intervention trials,” wrote the authors of the update, led by John E. Pandolfino, MD, of Northwestern University, Chicago. The report is in the March issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2016.
10.022).
In terms of evaluating the LES, however, FLIP can be used during laparoscopic Heller myotomy or peroral endoscopic myotomy (POEM) as a way of monitoring the LES. Using FLIP this way can help clinicians and surgeons personalize the procedure to each patient, even while it’s ongoing. FLIP also can be used with dilation balloons, with the balloon diameter allowing dilation measurement without the need to also use fluoroscopy.
For treating gastroesophageal reflux disease (GERD), the evidence found in existing literature points with less certainty toward use of FLIP.
“The role of FLIP for physiologic evaluation and management in GERD remains appealing; however, the level of evidence is low and currently FLIP should not be used in routine GERD management,” the authors explained. “Future outcome studies are needed to substantiate the utility of FLIP in GERD and to develop metrics that predict severity and treatment response after antireflux procedures.”
FLIP can be used in managing eosinophilic esophagitis, but is recommended only in certain scenarios. According to the authors, FLIP can be used to measure esophageal narrowing and the overall esophageal body. FLIP also can be used to measure esophageal distensibility, and, in the case of at least one study reviewed by the authors, allows “significantly greater accuracy and precision in estimating the effects of remodeling” in certain patients.
Dr. Pandolfino and his colleagues warned that “current recommendations are limited by the low level of evidence and lack of generalized availability of the analysis paradigms.” They noted the need for “further outcome studies that validate the distensibility plateau threshold and further refinements in software analyses to make this methodology more generalizable.”
Overall, the authors concluded, more study still needs to be done to ascertain exactly what FLIP is capable of and when it can be used to greatest effect. In addition to evaluating its benefit in patients with GERD, research should focus on how to make data obtained via FLIP easier to interpret and put to use.
“More work is needed [that] focuses on optimizing data analysis, standardizing protocols, and defining outcome metrics prior to the widespread adoption [of FLIP] into general clinical practice,” the authors wrote.
Dr. Pandolfino disclosed relationships with Medtronic and Sandhill Scientific. Other coauthors did not report any relevant financial disclosures.
*This story updated on 3/9/2017.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
AGA Clinical Practice Update: Best practice advice on EBT use released
The AGA Institute has released a series of new best practice statements that gastroenterologists should use when considering a patient for endoscopic bariatric treatments or surgeries (EBTs).
“There is a need for less-invasive weight loss therapies that are more effective and durable than lifestyle interventions alone, less invasive and risky than bariatric surgery, and easily performed at a lower expense than that of surgery, thereby allowing improved access and application to a larger segment of the population with moderate obesity,” wrote the authors of the expert review, led by Barham K. Abu Dayyeh, MD of the Mayo Clinic in Rochester, Minn. The report is in the March issue of Gastroenterology (doi: 10.1053/j.gastro.2017.01.035). “[EBTs] potentially meet these criteria and may provide an effective treatment approach to obesity in selected patients.”
The best practice statements come from a review of relevant studies in the Ovid, MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Scopus databases, among others, that were published between Jan. 1, 2000, and Sept. 30, 2016.
EBTs should be used on patients who have already been unable to lose weight despite lifestyle interventions and more traditional weight loss methods. However, patients that undergo EBTs should also be placed on a weight loss regimen that includes diet, exercise, and lifestyle changes. 
In addition to being used for weight loss, they can also be used to transition a patient to traditional bariatric surgery, or to lower a patient’s weight so that they can undergo a different procedure unrelated to bariatric surgery. Anyone being considered for EBT, or a weight loss regimen involving EBT, should be thoroughly evaluated for comorbidities, behavior, or medical concerns that could lead to adverse effects.
Any patients who are placed on EBT regimens should be followed up regularly by their clinicians, to monitor their progress in terms of weight loss and the development of any adverse effects. Should any adverse outcomes arise, alternative therapies should be implemented as soon as possible. Clinicians are advised to know the ins and outs of risks, contraindications, and potential complications related to EBTs before ever implementing them in their practice, let alone recommending them to a patient.
Finally, it’s imperative that health care institutions with EBT programs make sure there are training protocols clinicians must stringently follow before being allowed to perform EBT procedures.
“Moving ahead, it will be important to better incorporate training in obesity management principles into the GI fellowship curriculum to have a more significant impact,” the authors wrote, adding that it’s important to study the “tandem and sequential use of a combination of EBTs and obesity pharmacotherapies in addition to a comprehensive life-style intervention program.”
Dr. Abu Dayyeh disclosed relationships with Apollo Endosurgery, Metamodix, Aspire Bariatric, and GI Dynamics. Other coauthors also disclosed potential conflicting interests.
The AGA Institute has released a series of new best practice statements that gastroenterologists should use when considering a patient for endoscopic bariatric treatments or surgeries (EBTs).
“There is a need for less-invasive weight loss therapies that are more effective and durable than lifestyle interventions alone, less invasive and risky than bariatric surgery, and easily performed at a lower expense than that of surgery, thereby allowing improved access and application to a larger segment of the population with moderate obesity,” wrote the authors of the expert review, led by Barham K. Abu Dayyeh, MD of the Mayo Clinic in Rochester, Minn. The report is in the March issue of Gastroenterology (doi: 10.1053/j.gastro.2017.01.035). “[EBTs] potentially meet these criteria and may provide an effective treatment approach to obesity in selected patients.”
The best practice statements come from a review of relevant studies in the Ovid, MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Scopus databases, among others, that were published between Jan. 1, 2000, and Sept. 30, 2016.
EBTs should be used on patients who have already been unable to lose weight despite lifestyle interventions and more traditional weight loss methods. However, patients that undergo EBTs should also be placed on a weight loss regimen that includes diet, exercise, and lifestyle changes.
In addition to being used for weight loss, they can also be used to transition a patient to traditional bariatric surgery, or to lower a patient’s weight so that they can undergo a different procedure unrelated to bariatric surgery. Anyone being considered for EBT, or a weight loss regimen involving EBT, should be thoroughly evaluated for comorbidities, behavior, or medical concerns that could lead to adverse effects.
Any patients who are placed on EBT regimens should be followed up regularly by their clinicians, to monitor their progress in terms of weight loss and the development of any adverse effects. Should any adverse outcomes arise, alternative therapies should be implemented as soon as possible. Clinicians are advised to know the ins and outs of risks, contraindications, and potential complications related to EBTs before ever implementing them in their practice, let alone recommending them to a patient.
Finally, it’s imperative that health care institutions with EBT programs make sure there are training protocols clinicians must stringently follow before being allowed to perform EBT procedures.
“Moving ahead, it will be important to better incorporate training in obesity management principles into the GI fellowship curriculum to have a more significant impact,” the authors wrote, adding that it’s important to study the “tandem and sequential use of a combination of EBTs and obesity pharmacotherapies in addition to a comprehensive life-style intervention program.”
Dr. Abu Dayyeh disclosed relationships with Apollo Endosurgery, Metamodix, Aspire Bariatric, and GI Dynamics. Other coauthors also disclosed potential conflicting interests.
The AGA Institute has released a series of new best practice statements that gastroenterologists should use when considering a patient for endoscopic bariatric treatments or surgeries (EBTs).
“There is a need for less-invasive weight loss therapies that are more effective and durable than lifestyle interventions alone, less invasive and risky than bariatric surgery, and easily performed at a lower expense than that of surgery, thereby allowing improved access and application to a larger segment of the population with moderate obesity,” wrote the authors of the expert review, led by Barham K. Abu Dayyeh, MD of the Mayo Clinic in Rochester, Minn. The report is in the March issue of Gastroenterology (doi: 10.1053/j.gastro.2017.01.035). “[EBTs] potentially meet these criteria and may provide an effective treatment approach to obesity in selected patients.”
The best practice statements come from a review of relevant studies in the Ovid, MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Scopus databases, among others, that were published between Jan. 1, 2000, and Sept. 30, 2016.
EBTs should be used on patients who have already been unable to lose weight despite lifestyle interventions and more traditional weight loss methods. However, patients that undergo EBTs should also be placed on a weight loss regimen that includes diet, exercise, and lifestyle changes.
In addition to being used for weight loss, they can also be used to transition a patient to traditional bariatric surgery, or to lower a patient’s weight so that they can undergo a different procedure unrelated to bariatric surgery. Anyone being considered for EBT, or a weight loss regimen involving EBT, should be thoroughly evaluated for comorbidities, behavior, or medical concerns that could lead to adverse effects.
Any patients who are placed on EBT regimens should be followed up regularly by their clinicians, to monitor their progress in terms of weight loss and the development of any adverse effects. Should any adverse outcomes arise, alternative therapies should be implemented as soon as possible. Clinicians are advised to know the ins and outs of risks, contraindications, and potential complications related to EBTs before ever implementing them in their practice, let alone recommending them to a patient.
Finally, it’s imperative that health care institutions with EBT programs make sure there are training protocols clinicians must stringently follow before being allowed to perform EBT procedures.
“Moving ahead, it will be important to better incorporate training in obesity management principles into the GI fellowship curriculum to have a more significant impact,” the authors wrote, adding that it’s important to study the “tandem and sequential use of a combination of EBTs and obesity pharmacotherapies in addition to a comprehensive life-style intervention program.”
Dr. Abu Dayyeh disclosed relationships with Apollo Endosurgery, Metamodix, Aspire Bariatric, and GI Dynamics. Other coauthors also disclosed potential conflicting interests.
FROM GASTROENTEROLOGY
Vascular surgeons underutilize palliative care planning
Investment in advanced palliative care planning has the potential to improve the quality of care for vascular surgery patients, according to investigators from Oregon Health and Science University, Portland.
Dale G. Wilson, MD, and his colleagues performed a retrospective review of electronic medical records for 111 patients, who died while on the vascular surgery service at the OHSU Hospital during 2005-2014.
Almost three-quarters (73%) of patients were transitioned to palliative care; of those, 14% presented with an advanced directive, and 28% received a palliative care consultation (JAMA Surg. 2017;152[2]:183-90. doi: 10.1001/jamasurg.2016.3970).
While palliative care services are increasing in hospitals, accounting for 4% of annual hospital admissions in 2012 according to the study, they are not implemented consistently. “Many teams from various specialties care for patients at end of life; however, we still do not know what prompts end-of-life discussions,” Dr. Wilson said. “There is still no consensus on when to involve palliative services in the care of critically ill patients.”
While the decision to advise a consultation is “variable and physician dependent,” the type of treatment required may help identify when consultations are appropriate.
Of the 14 patients who did not choose comfort care, 11 (79%) required CPR. Additionally, all had to be taken to the operating room and required mechanical ventilation.
Of 81 patients who chose palliative care, 31 did so despite potential medical options. These patients were older – average age, 77 years, as compared with 68 years for patients who did not choose comfort care – with 8 of the 31 (26%) presenting an advanced directive, compared with only 7 of 83 patients (8%) for those who did not receive palliative care.
Dr. Wilson and his colleagues found that patients who chose palliative care were more likely to have received a palliative care consultation, as well: 10 of 31 patients who chose comfort care received a consultation, as opposed to 1 of 83 who chose comfort care but did not receive a consultation.
The nature of the vascular surgery service calls for early efforts to gather information regarding patients’ views on end-of-life care, Dr. Wilson said, noting that 73% of patients studied were admitted emergently and 87% underwent surgery, leaving little time for patients to express their wishes.
“Because the events associated with withdrawal of care are often not anticipated, we argue that all vascular surgical patients should have an advance directive, and perhaps, those at particular high risk should have a preoperative palliative care consultation,” Dr. Wilson wrote.
Limitations to the study included the data abstraction, which was performed by a single unblinded physician. Researchers also gathered patients’ reasons for transitioning to comfort care retrospectively.
The low rate of palliative care consultations found in this study mirrors my own experience, as does the feeling of urgency to shed more light on the issue. The biggest hurdle surgeons face when it comes to palliative care consultations is that, in their minds, seeking these meetings is associated with immediate death care. Many surgeons are shy about bringing palliative care specialists on board because approaching families can be daunting.
Family members who do not know enough about comfort care can be upset by the idea. Addressing this misunderstanding is crucial. Consultations are not just conversations about hospice care but can be emotional and spiritual experiences that prepare both the family and the patient for alternative options when surgical intervention cannot guarantee a good quality of life. I would encourage surgeons to be more proactive and less defensive about comfort care . Luckily, understanding the importance of this issue among professionals is growing.
When I approach these situations, it’s important for me to have a full understanding of what families and patients usually expect. Decisions should not be based on how bad things are now but on the future. What was the patient’s last year like? What is the best-case scenario for moving forward on a proposed intervention? What will the patient’s quality of life be? Answering these questions helps the patient understand his or her situation, without diminishing a surgeon’s ability. If you are honest, the family will usually come to the conclusion that they do not want to subject the patient to ultimately unnecessary treatment.
Palliative care services help patients and their families deal with pain beyond the physical symptoms. Dealing with pain, depression, or delirium is only a part of comfort care – coping with a sense of hopelessness, family disruption, or feelings of guilt also can be a part and, significantly, a part that surgeons are not trained to diagnose or treat.
With more than 70 surgeons certified in hospice care and a growing number of fellowships in palliative care, I am extremely optimistic in the progress we have made and will continue to make.
Geoffrey Dunn, MD, FACS, is the medical director of the Palliative Care Consultation Service at UPMC Hamot Medical Center, Erie, Penn. He currently is Community Editor for the Pain and Palliative Care Community for the ACS’s web portal.
The low rate of palliative care consultations found in this study mirrors my own experience, as does the feeling of urgency to shed more light on the issue. The biggest hurdle surgeons face when it comes to palliative care consultations is that, in their minds, seeking these meetings is associated with immediate death care. Many surgeons are shy about bringing palliative care specialists on board because approaching families can be daunting.
Family members who do not know enough about comfort care can be upset by the idea. Addressing this misunderstanding is crucial. Consultations are not just conversations about hospice care but can be emotional and spiritual experiences that prepare both the family and the patient for alternative options when surgical intervention cannot guarantee a good quality of life. I would encourage surgeons to be more proactive and less defensive about comfort care . Luckily, understanding the importance of this issue among professionals is growing.
When I approach these situations, it’s important for me to have a full understanding of what families and patients usually expect. Decisions should not be based on how bad things are now but on the future. What was the patient’s last year like? What is the best-case scenario for moving forward on a proposed intervention? What will the patient’s quality of life be? Answering these questions helps the patient understand his or her situation, without diminishing a surgeon’s ability. If you are honest, the family will usually come to the conclusion that they do not want to subject the patient to ultimately unnecessary treatment.
Palliative care services help patients and their families deal with pain beyond the physical symptoms. Dealing with pain, depression, or delirium is only a part of comfort care – coping with a sense of hopelessness, family disruption, or feelings of guilt also can be a part and, significantly, a part that surgeons are not trained to diagnose or treat.
With more than 70 surgeons certified in hospice care and a growing number of fellowships in palliative care, I am extremely optimistic in the progress we have made and will continue to make.
Geoffrey Dunn, MD, FACS, is the medical director of the Palliative Care Consultation Service at UPMC Hamot Medical Center, Erie, Penn. He currently is Community Editor for the Pain and Palliative Care Community for the ACS’s web portal.
The low rate of palliative care consultations found in this study mirrors my own experience, as does the feeling of urgency to shed more light on the issue. The biggest hurdle surgeons face when it comes to palliative care consultations is that, in their minds, seeking these meetings is associated with immediate death care. Many surgeons are shy about bringing palliative care specialists on board because approaching families can be daunting.
Family members who do not know enough about comfort care can be upset by the idea. Addressing this misunderstanding is crucial. Consultations are not just conversations about hospice care but can be emotional and spiritual experiences that prepare both the family and the patient for alternative options when surgical intervention cannot guarantee a good quality of life. I would encourage surgeons to be more proactive and less defensive about comfort care . Luckily, understanding the importance of this issue among professionals is growing.
When I approach these situations, it’s important for me to have a full understanding of what families and patients usually expect. Decisions should not be based on how bad things are now but on the future. What was the patient’s last year like? What is the best-case scenario for moving forward on a proposed intervention? What will the patient’s quality of life be? Answering these questions helps the patient understand his or her situation, without diminishing a surgeon’s ability. If you are honest, the family will usually come to the conclusion that they do not want to subject the patient to ultimately unnecessary treatment.
Palliative care services help patients and their families deal with pain beyond the physical symptoms. Dealing with pain, depression, or delirium is only a part of comfort care – coping with a sense of hopelessness, family disruption, or feelings of guilt also can be a part and, significantly, a part that surgeons are not trained to diagnose or treat.
With more than 70 surgeons certified in hospice care and a growing number of fellowships in palliative care, I am extremely optimistic in the progress we have made and will continue to make.
Geoffrey Dunn, MD, FACS, is the medical director of the Palliative Care Consultation Service at UPMC Hamot Medical Center, Erie, Penn. He currently is Community Editor for the Pain and Palliative Care Community for the ACS’s web portal.
Investment in advanced palliative care planning has the potential to improve the quality of care for vascular surgery patients, according to investigators from Oregon Health and Science University, Portland.
Dale G. Wilson, MD, and his colleagues performed a retrospective review of electronic medical records for 111 patients, who died while on the vascular surgery service at the OHSU Hospital during 2005-2014.
Almost three-quarters (73%) of patients were transitioned to palliative care; of those, 14% presented with an advanced directive, and 28% received a palliative care consultation (JAMA Surg. 2017;152[2]:183-90. doi: 10.1001/jamasurg.2016.3970).
While palliative care services are increasing in hospitals, accounting for 4% of annual hospital admissions in 2012 according to the study, they are not implemented consistently. “Many teams from various specialties care for patients at end of life; however, we still do not know what prompts end-of-life discussions,” Dr. Wilson said. “There is still no consensus on when to involve palliative services in the care of critically ill patients.”
While the decision to advise a consultation is “variable and physician dependent,” the type of treatment required may help identify when consultations are appropriate.
Of the 14 patients who did not choose comfort care, 11 (79%) required CPR. Additionally, all had to be taken to the operating room and required mechanical ventilation.
Of 81 patients who chose palliative care, 31 did so despite potential medical options. These patients were older – average age, 77 years, as compared with 68 years for patients who did not choose comfort care – with 8 of the 31 (26%) presenting an advanced directive, compared with only 7 of 83 patients (8%) for those who did not receive palliative care.
Dr. Wilson and his colleagues found that patients who chose palliative care were more likely to have received a palliative care consultation, as well: 10 of 31 patients who chose comfort care received a consultation, as opposed to 1 of 83 who chose comfort care but did not receive a consultation.
The nature of the vascular surgery service calls for early efforts to gather information regarding patients’ views on end-of-life care, Dr. Wilson said, noting that 73% of patients studied were admitted emergently and 87% underwent surgery, leaving little time for patients to express their wishes.
“Because the events associated with withdrawal of care are often not anticipated, we argue that all vascular surgical patients should have an advance directive, and perhaps, those at particular high risk should have a preoperative palliative care consultation,” Dr. Wilson wrote.
Limitations to the study included the data abstraction, which was performed by a single unblinded physician. Researchers also gathered patients’ reasons for transitioning to comfort care retrospectively.
Investment in advanced palliative care planning has the potential to improve the quality of care for vascular surgery patients, according to investigators from Oregon Health and Science University, Portland.
Dale G. Wilson, MD, and his colleagues performed a retrospective review of electronic medical records for 111 patients, who died while on the vascular surgery service at the OHSU Hospital during 2005-2014.
Almost three-quarters (73%) of patients were transitioned to palliative care; of those, 14% presented with an advanced directive, and 28% received a palliative care consultation (JAMA Surg. 2017;152[2]:183-90. doi: 10.1001/jamasurg.2016.3970).
While palliative care services are increasing in hospitals, accounting for 4% of annual hospital admissions in 2012 according to the study, they are not implemented consistently. “Many teams from various specialties care for patients at end of life; however, we still do not know what prompts end-of-life discussions,” Dr. Wilson said. “There is still no consensus on when to involve palliative services in the care of critically ill patients.”
While the decision to advise a consultation is “variable and physician dependent,” the type of treatment required may help identify when consultations are appropriate.
Of the 14 patients who did not choose comfort care, 11 (79%) required CPR. Additionally, all had to be taken to the operating room and required mechanical ventilation.
Of 81 patients who chose palliative care, 31 did so despite potential medical options. These patients were older – average age, 77 years, as compared with 68 years for patients who did not choose comfort care – with 8 of the 31 (26%) presenting an advanced directive, compared with only 7 of 83 patients (8%) for those who did not receive palliative care.
Dr. Wilson and his colleagues found that patients who chose palliative care were more likely to have received a palliative care consultation, as well: 10 of 31 patients who chose comfort care received a consultation, as opposed to 1 of 83 who chose comfort care but did not receive a consultation.
The nature of the vascular surgery service calls for early efforts to gather information regarding patients’ views on end-of-life care, Dr. Wilson said, noting that 73% of patients studied were admitted emergently and 87% underwent surgery, leaving little time for patients to express their wishes.
“Because the events associated with withdrawal of care are often not anticipated, we argue that all vascular surgical patients should have an advance directive, and perhaps, those at particular high risk should have a preoperative palliative care consultation,” Dr. Wilson wrote.
Limitations to the study included the data abstraction, which was performed by a single unblinded physician. Researchers also gathered patients’ reasons for transitioning to comfort care retrospectively.
FROM JAMA SURGERY
Key clinical point:
Major finding: Of the 111 patients studied, 81 died on palliative care, but only 15 presented an advanced directive.
Data source: A retrospective cohort study of the records of patients aged 18-99 years who died in the vascular surgery service at Oregon Health and Science University Hospital from 2005-2014.
Disclosures: The authors reported no financial disclosures.
Palliative care ‘in my hands’
A randomized controlled multicenter study published by Carson et al. in JAMA concluded that, for patients with “chronic critical illness” (defined as requiring 7 days of mechanical ventilation), palliative care team-led informational and emotional support meetings did not reduce anxiety or depression for families and may have increased posttraumatic stress disorder symptoms (2016:316[1]:51-62. doi: 10.1001/jama.2016.8474).
This report may surprise surgeons, as well as practitioners in other specialties, as the disconnect between palliative care and critical care services has been previously perceived as an education and access issue, not an outcome problem.
Carson and colleagues point out that fidelity to some components of the meeting “templates” was low, suggesting that there was some flexibility baked into the study design. However, as Russ and Kaufman aptly described, patients and families vary greatly in their appetite for explicit information about prognosis (Cult Med Psychiatry 2005;29[1]:103-23). Conversely, the hypothesis that direct communication about prognosis will be welcomed by families is a core element of the Carson study. The manuscript supplement reports that discussion of the patient’s condition and prognosis took place in 100% of initial meetings. If the same variability in family receptiveness to this information exists in this population as was described by Russ and Kaufman, it is not hard to see why some families experienced negative consequences because of these discussions.
Furthermore, the authors of the Carson study point out that it was not intended to replicate the components of specialist palliative care (JAMA. 2016;316[15]:1598-9).
Essential elements of specialist palliative care include symptom management, a multidisciplinary approach, and fairly close contact in the acute care setting. These features were lacking in the study protocol. Experienced providers of palliative care will often use symptom assessment and symptom management optimization as a conduit for building rapport and to avoid focusing on prognosis until trust has been established. A period of delay before broaching challenging subjects also allows the palliative care team to develop an understanding of the patient’s or surrogates’ preferences regarding the amount and type of information communicated. Palliative care providers benefit from the deepening of relationships with patients and families over time, as much as or possibly more so than providers of other specialties.
The necessity of the multidisciplinary approach to successful palliative care outcomes cannot be overstated. In many programs, patients seen for specialist palliative care consultation are seen by a physician or advanced practitioner, a chaplain, and a social worker within 24-48 hours of initial referral, and these providers have key roles in addressing the sequelae of anxiety, depression, and stress that were the key outcomes in the JAMA study. In the study, the “support and information team” included a palliative care physician and an advanced practice nurse but not a chaplain or social worker, despite the significance of existential/spiritual and social consequences of ventilator withdrawal or progression to tracheostomy for long-term vent support.
Palliative care providers consider the family meeting to be the “procedure” of their field, a belief that may seem incongruous with a surgical understanding of the nature of procedures but is informative as a framework for understanding the results of the Carson study. Just as surgical procedures carry risk of complications or adverse outcomes, family meetings have risk for worsening instead of improving the coping of families and surrogates. And, as surgical technique can be connected to complications, the family meeting technique applied by Carson et al. may be related to its results. Although there was formalized communication between the ICU team and the palliative care team regarding the patient’s condition, prognosis, and treatment plan, there was not a representative from the critical care team present during the majority of the support and information team led family meetings. This represents a marked deviation from common practice at our institution and many others. Our usual practice is to have a member of the ICU team present for discussions focused on patient prognosis, in order to make sure that there is alignment between the messages of the ICU and palliative care teams and also to prevent the crippling of palliative support that occurs when it becomes the sole repository of unwelcome news.
Because the relief of suffering is a core value of surgery and palliative care, there are countless ways these disciplines can inform one another. The outcome of the Carson study is a cautionary tale about the fallibility of the integration of surgical and palliative care teams, both of which would acknowledge the importance of the multidisciplinary approach, relationships developed over time, and symptom management. As surgeons intuitively understand from their operative experience, the “procedure” (the family meeting) has the potential for both risk and benefit, the outcome of which may be determined “in my hands.”
Dr. Rivet is a colon and rectal surgeon with training and board certification in hospice and palliative medicine. She is an assistant professor, departments of surgery and internal medicine, Virginia Commonwealth University, Richmond. She has no disclosures.
A randomized controlled multicenter study published by Carson et al. in JAMA concluded that, for patients with “chronic critical illness” (defined as requiring 7 days of mechanical ventilation), palliative care team-led informational and emotional support meetings did not reduce anxiety or depression for families and may have increased posttraumatic stress disorder symptoms (2016:316[1]:51-62. doi: 10.1001/jama.2016.8474).
This report may surprise surgeons, as well as practitioners in other specialties, as the disconnect between palliative care and critical care services has been previously perceived as an education and access issue, not an outcome problem.
Carson and colleagues point out that fidelity to some components of the meeting “templates” was low, suggesting that there was some flexibility baked into the study design. However, as Russ and Kaufman aptly described, patients and families vary greatly in their appetite for explicit information about prognosis (Cult Med Psychiatry 2005;29[1]:103-23). Conversely, the hypothesis that direct communication about prognosis will be welcomed by families is a core element of the Carson study. The manuscript supplement reports that discussion of the patient’s condition and prognosis took place in 100% of initial meetings. If the same variability in family receptiveness to this information exists in this population as was described by Russ and Kaufman, it is not hard to see why some families experienced negative consequences because of these discussions.
Furthermore, the authors of the Carson study point out that it was not intended to replicate the components of specialist palliative care (JAMA. 2016;316[15]:1598-9).
Essential elements of specialist palliative care include symptom management, a multidisciplinary approach, and fairly close contact in the acute care setting. These features were lacking in the study protocol. Experienced providers of palliative care will often use symptom assessment and symptom management optimization as a conduit for building rapport and to avoid focusing on prognosis until trust has been established. A period of delay before broaching challenging subjects also allows the palliative care team to develop an understanding of the patient’s or surrogates’ preferences regarding the amount and type of information communicated. Palliative care providers benefit from the deepening of relationships with patients and families over time, as much as or possibly more so than providers of other specialties.
The necessity of the multidisciplinary approach to successful palliative care outcomes cannot be overstated. In many programs, patients seen for specialist palliative care consultation are seen by a physician or advanced practitioner, a chaplain, and a social worker within 24-48 hours of initial referral, and these providers have key roles in addressing the sequelae of anxiety, depression, and stress that were the key outcomes in the JAMA study. In the study, the “support and information team” included a palliative care physician and an advanced practice nurse but not a chaplain or social worker, despite the significance of existential/spiritual and social consequences of ventilator withdrawal or progression to tracheostomy for long-term vent support.
Palliative care providers consider the family meeting to be the “procedure” of their field, a belief that may seem incongruous with a surgical understanding of the nature of procedures but is informative as a framework for understanding the results of the Carson study. Just as surgical procedures carry risk of complications or adverse outcomes, family meetings have risk for worsening instead of improving the coping of families and surrogates. And, as surgical technique can be connected to complications, the family meeting technique applied by Carson et al. may be related to its results. Although there was formalized communication between the ICU team and the palliative care team regarding the patient’s condition, prognosis, and treatment plan, there was not a representative from the critical care team present during the majority of the support and information team led family meetings. This represents a marked deviation from common practice at our institution and many others. Our usual practice is to have a member of the ICU team present for discussions focused on patient prognosis, in order to make sure that there is alignment between the messages of the ICU and palliative care teams and also to prevent the crippling of palliative support that occurs when it becomes the sole repository of unwelcome news.
Because the relief of suffering is a core value of surgery and palliative care, there are countless ways these disciplines can inform one another. The outcome of the Carson study is a cautionary tale about the fallibility of the integration of surgical and palliative care teams, both of which would acknowledge the importance of the multidisciplinary approach, relationships developed over time, and symptom management. As surgeons intuitively understand from their operative experience, the “procedure” (the family meeting) has the potential for both risk and benefit, the outcome of which may be determined “in my hands.”
Dr. Rivet is a colon and rectal surgeon with training and board certification in hospice and palliative medicine. She is an assistant professor, departments of surgery and internal medicine, Virginia Commonwealth University, Richmond. She has no disclosures.
A randomized controlled multicenter study published by Carson et al. in JAMA concluded that, for patients with “chronic critical illness” (defined as requiring 7 days of mechanical ventilation), palliative care team-led informational and emotional support meetings did not reduce anxiety or depression for families and may have increased posttraumatic stress disorder symptoms (2016:316[1]:51-62. doi: 10.1001/jama.2016.8474).
This report may surprise surgeons, as well as practitioners in other specialties, as the disconnect between palliative care and critical care services has been previously perceived as an education and access issue, not an outcome problem.
Carson and colleagues point out that fidelity to some components of the meeting “templates” was low, suggesting that there was some flexibility baked into the study design. However, as Russ and Kaufman aptly described, patients and families vary greatly in their appetite for explicit information about prognosis (Cult Med Psychiatry 2005;29[1]:103-23). Conversely, the hypothesis that direct communication about prognosis will be welcomed by families is a core element of the Carson study. The manuscript supplement reports that discussion of the patient’s condition and prognosis took place in 100% of initial meetings. If the same variability in family receptiveness to this information exists in this population as was described by Russ and Kaufman, it is not hard to see why some families experienced negative consequences because of these discussions.
Furthermore, the authors of the Carson study point out that it was not intended to replicate the components of specialist palliative care (JAMA. 2016;316[15]:1598-9).
Essential elements of specialist palliative care include symptom management, a multidisciplinary approach, and fairly close contact in the acute care setting. These features were lacking in the study protocol. Experienced providers of palliative care will often use symptom assessment and symptom management optimization as a conduit for building rapport and to avoid focusing on prognosis until trust has been established. A period of delay before broaching challenging subjects also allows the palliative care team to develop an understanding of the patient’s or surrogates’ preferences regarding the amount and type of information communicated. Palliative care providers benefit from the deepening of relationships with patients and families over time, as much as or possibly more so than providers of other specialties.
The necessity of the multidisciplinary approach to successful palliative care outcomes cannot be overstated. In many programs, patients seen for specialist palliative care consultation are seen by a physician or advanced practitioner, a chaplain, and a social worker within 24-48 hours of initial referral, and these providers have key roles in addressing the sequelae of anxiety, depression, and stress that were the key outcomes in the JAMA study. In the study, the “support and information team” included a palliative care physician and an advanced practice nurse but not a chaplain or social worker, despite the significance of existential/spiritual and social consequences of ventilator withdrawal or progression to tracheostomy for long-term vent support.
Palliative care providers consider the family meeting to be the “procedure” of their field, a belief that may seem incongruous with a surgical understanding of the nature of procedures but is informative as a framework for understanding the results of the Carson study. Just as surgical procedures carry risk of complications or adverse outcomes, family meetings have risk for worsening instead of improving the coping of families and surrogates. And, as surgical technique can be connected to complications, the family meeting technique applied by Carson et al. may be related to its results. Although there was formalized communication between the ICU team and the palliative care team regarding the patient’s condition, prognosis, and treatment plan, there was not a representative from the critical care team present during the majority of the support and information team led family meetings. This represents a marked deviation from common practice at our institution and many others. Our usual practice is to have a member of the ICU team present for discussions focused on patient prognosis, in order to make sure that there is alignment between the messages of the ICU and palliative care teams and also to prevent the crippling of palliative support that occurs when it becomes the sole repository of unwelcome news.
Because the relief of suffering is a core value of surgery and palliative care, there are countless ways these disciplines can inform one another. The outcome of the Carson study is a cautionary tale about the fallibility of the integration of surgical and palliative care teams, both of which would acknowledge the importance of the multidisciplinary approach, relationships developed over time, and symptom management. As surgeons intuitively understand from their operative experience, the “procedure” (the family meeting) has the potential for both risk and benefit, the outcome of which may be determined “in my hands.”
Dr. Rivet is a colon and rectal surgeon with training and board certification in hospice and palliative medicine. She is an assistant professor, departments of surgery and internal medicine, Virginia Commonwealth University, Richmond. She has no disclosures.
Monofilament suture works best for cesarean closure
LAS VEGAS – A monofilament suture led to substantially fewer wound complications than a braided suture for closing nonemergency cesarean incisions in a head-to-head trial with 520 evaluable women.
Cesarean incision closure with a braided, polyglactin 910 suture (Vicryl) led to 65% more wound complications than the monofilament poliglecaprone 25 suture (Monocryl), Arin M. Buresch, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
This is the first randomized, controlled trial to compare these two suture types, according to Dr. Buresch, and she highlighted the need for caution about changing practice based on results from a single study. But based in large part on these results, which were gathered at Montefiore Medical Center in New York, the obstetrical staff at Montefiore is now primarily using the monofilament, poliglecaprone 25 suture, she said.
The study enrolled 550 pregnant women at 37 weeks’ gestation or greater during May 2015 to July 2016. Participants were either scheduled for an elective cesarean delivery or underwent a nonemergency, indicated cesarean after labor began but without significant maternal or fetal distress. The study excluded emergency cesareans as well as women with a recent urogenital infection, chronic or injected steroid use, or a vertical skin incision. The enrolled women averaged 31 years old, and their average body mass index was 34 kg/m2. The demographic and clinical profile of the two randomized groups closely matched.
The study’s primary endpoint was the incidence of a wound complication during 30 days following delivery. A complication could be a surgical site infection, hematoma, seroma, or wound separation. Of the 550 women randomized, 520 were available for complete 30-day follow-up.
The results showed that wound complications occurred in 9% of the 263 women treated with the poliglecaprone 25 monofilament suture and in 14% of the 257 treated with the polyglactin 910 braided suture, a statistically significant difference, Dr. Buresch reported. The relative risk for a complication increased by 65% with the braided suture, compared with patients treated with monofilament sutures. Treating 18 patients with the monofilament suture prevented one wound complication, on average.
A subgroup analysis showed that the poliglecaprone 25 suture was effective at reducing wound complications in women who underwent elective cesarean deliveries, but among the 17% of participants who had begun labor at the time of their cesarean delivery the monofilament suture conferred no significant advantage, compared with the braided suture. Benefit from the poliglecaprone 25 monofilament occurred about equally across the entire range of body mass index among the women in the study, Dr. Buresch said.
Dr. Buresch had no disclosures.
[email protected]
On Twitter @mitchelzoler
LAS VEGAS – A monofilament suture led to substantially fewer wound complications than a braided suture for closing nonemergency cesarean incisions in a head-to-head trial with 520 evaluable women.
Cesarean incision closure with a braided, polyglactin 910 suture (Vicryl) led to 65% more wound complications than the monofilament poliglecaprone 25 suture (Monocryl), Arin M. Buresch, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
This is the first randomized, controlled trial to compare these two suture types, according to Dr. Buresch, and she highlighted the need for caution about changing practice based on results from a single study. But based in large part on these results, which were gathered at Montefiore Medical Center in New York, the obstetrical staff at Montefiore is now primarily using the monofilament, poliglecaprone 25 suture, she said.
The study enrolled 550 pregnant women at 37 weeks’ gestation or greater during May 2015 to July 2016. Participants were either scheduled for an elective cesarean delivery or underwent a nonemergency, indicated cesarean after labor began but without significant maternal or fetal distress. The study excluded emergency cesareans as well as women with a recent urogenital infection, chronic or injected steroid use, or a vertical skin incision. The enrolled women averaged 31 years old, and their average body mass index was 34 kg/m2. The demographic and clinical profile of the two randomized groups closely matched.
The study’s primary endpoint was the incidence of a wound complication during 30 days following delivery. A complication could be a surgical site infection, hematoma, seroma, or wound separation. Of the 550 women randomized, 520 were available for complete 30-day follow-up.
The results showed that wound complications occurred in 9% of the 263 women treated with the poliglecaprone 25 monofilament suture and in 14% of the 257 treated with the polyglactin 910 braided suture, a statistically significant difference, Dr. Buresch reported. The relative risk for a complication increased by 65% with the braided suture, compared with patients treated with monofilament sutures. Treating 18 patients with the monofilament suture prevented one wound complication, on average.
A subgroup analysis showed that the poliglecaprone 25 suture was effective at reducing wound complications in women who underwent elective cesarean deliveries, but among the 17% of participants who had begun labor at the time of their cesarean delivery the monofilament suture conferred no significant advantage, compared with the braided suture. Benefit from the poliglecaprone 25 monofilament occurred about equally across the entire range of body mass index among the women in the study, Dr. Buresch said.
Dr. Buresch had no disclosures.
[email protected]
On Twitter @mitchelzoler
LAS VEGAS – A monofilament suture led to substantially fewer wound complications than a braided suture for closing nonemergency cesarean incisions in a head-to-head trial with 520 evaluable women.
Cesarean incision closure with a braided, polyglactin 910 suture (Vicryl) led to 65% more wound complications than the monofilament poliglecaprone 25 suture (Monocryl), Arin M. Buresch, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
This is the first randomized, controlled trial to compare these two suture types, according to Dr. Buresch, and she highlighted the need for caution about changing practice based on results from a single study. But based in large part on these results, which were gathered at Montefiore Medical Center in New York, the obstetrical staff at Montefiore is now primarily using the monofilament, poliglecaprone 25 suture, she said.
The study enrolled 550 pregnant women at 37 weeks’ gestation or greater during May 2015 to July 2016. Participants were either scheduled for an elective cesarean delivery or underwent a nonemergency, indicated cesarean after labor began but without significant maternal or fetal distress. The study excluded emergency cesareans as well as women with a recent urogenital infection, chronic or injected steroid use, or a vertical skin incision. The enrolled women averaged 31 years old, and their average body mass index was 34 kg/m2. The demographic and clinical profile of the two randomized groups closely matched.
The study’s primary endpoint was the incidence of a wound complication during 30 days following delivery. A complication could be a surgical site infection, hematoma, seroma, or wound separation. Of the 550 women randomized, 520 were available for complete 30-day follow-up.
The results showed that wound complications occurred in 9% of the 263 women treated with the poliglecaprone 25 monofilament suture and in 14% of the 257 treated with the polyglactin 910 braided suture, a statistically significant difference, Dr. Buresch reported. The relative risk for a complication increased by 65% with the braided suture, compared with patients treated with monofilament sutures. Treating 18 patients with the monofilament suture prevented one wound complication, on average.
A subgroup analysis showed that the poliglecaprone 25 suture was effective at reducing wound complications in women who underwent elective cesarean deliveries, but among the 17% of participants who had begun labor at the time of their cesarean delivery the monofilament suture conferred no significant advantage, compared with the braided suture. Benefit from the poliglecaprone 25 monofilament occurred about equally across the entire range of body mass index among the women in the study, Dr. Buresch said.
Dr. Buresch had no disclosures.
[email protected]
On Twitter @mitchelzoler