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SYNTAX analysis: Making the case for CABG over PCI
Whenever seminal clinical trials report results that challenge conventional thinking, physicians face the challenge of actually applying those findings in the clinic. A team of cardiac surgeons from Baylor University in Plano, Tex., has offered its take on the clinical implications of recent findings from the cause-of-death analysis of the SYNTAX trial that compared coronary artery bypass grafting with stenting: When counseling higher-risk patients with coronary artery disease about revascularization procedures, cardiologists and cardiac surgeons should clearly elucidate the dramatic advantage of coronary artery bypass grafting over stenting that SYNTAX had demonstrated.
Michael Mack, MD, and coauthors made their case in a featured expert opinion in the Journal of Thoracic and Cardiovascular Surgery (2016;152:1237-40).
“In fact, there was a significant survival advantage for CABG in the patients with intermediate and high SYNTAX scores, with the death rate of CABG versus PCI being 9.6% versus 16.3% (P less than .047) and 8.8% versus 17.8% (P less than .02), respectively,” they wrote.
The advantages of surgery “have been most striking for patients with intermediate or high SYNTAX scores, but seem to exist for patients with low scores as well, although requiring more follow-up,” Dr. Mack and colleagues said. But the situation is less clear in other subgroups, particularly in patients with less diffuse distal disease and lower SYNTAX scores, they added.
Complete revascularization after the procedure may explain the better outcomes with CABG, as 43.3% of those in the PCI arm had incomplete revascularization vs. 36.8% in the CABG arm. “Incomplete revascularization was associated with increased risk for major adverse cardiac or cerebrovascular events three years after PCI, but incomplete revascularization in the CABG group could not be identified as a predictor for worse outcomes,” Dr. Mack and colleagues noted.
The expert opinion authors debunk one of the recent criticisms of SYNTAX: that its reliance on first-generation drug-eluting stents is dated and not relevant today. They noted the more recent Bypass Surgery Vs. Everolimus-Eluting Stent Implantation for Multivessel Coronary Artery Disease trial found a similarly higher rate of death, heart attack, and target vessel revascularization occurred more frequently in the PCI group (15.3% vs. 10.6% in the CABG group) (N Engl J Med. 2015;372:1204-12).
Nonetheless, Dr. Mack and coauthors found room for improvement for CABG through increased use of atrial revascularization and appropriate measures to minimize stroke.
The latest SYNTAX findings can inform the approach surgeons take with high-risk patients, they said. This should include “a discussion of these data, particularly in regard to survival.” And physicians should base their therapeutic recommendations on these data. “At present, there are data seeming to indicate that the majority of patients with three-vessel disease receiving invasive treatment in the United States are being treated with PCI, an outcome that is not congruent with these outcome findings,” they said.
Taking into consideration other SYNTAX analyses that have shown that completeness of revascularization is a determining factor in post-PCI outcomes, Dr. Mack and coauthors said that physicians should calculate the degree of coronary artery disease (CAD) left untreated after intervention, “and those patients who are likely to have a high residual SYNTAX score should be strongly considered for CABG.” Doctors should also focus “intensive efforts” on adherence to optimal medical therapy after both CABG and PCI.
“Finally, although there is a strong patient preference for a less-invasive treatment of their CAD, patients with advanced disease should be made aware that the choice of PCI puts them at an increased risk of death relative to CABG, and a full and transparent discussion should occur regarding the implications of their decision,” Dr. Mack and coauthors concluded.
They had no relevant financial relationships to disclose.
In their invited editorial commentary, Saswata Deb, MD, and Stephen E. Fremes, MD, of the Schulich Heart Center at the University of Toronto, concurred with the conclusions of Dr. Mack and colleagues (J Thorac Cardiovasc Surg. 2016;152:1241-2). And Joseph F. Sabik III, MD, of the Cleveland Clinic arrived at a similar conclusion in an accompanying editorial (J. Thorac Cardiovasc Surg. 2016;152:1227-8).
Dr. Deb and Dr. Fremes found noteworthy the point Dr. Mack and coauthors raised about cardiologists and internists continuing to recommend PCI to patients with complex multivessel CAD despite evidence from SYNTAX and other trials. “This raises the importance of having a multidisciplinary heart team,” Dr. Deb and Dr. Fremes said.
But they also raised an important question about the difference in outcomes between CABG and PCI in complex multivessel disease. CABG should be the preferred intervention if the high rates of late fatal myocardial infarction after PCI are due to incomplete revascularization; however, if late stent thrombosis was the cause of this disparity in outcomes, then improvements in PCI could close that gap.
In his editorial, Dr. Sabik attributed the difference in outcomes between PCI and CABG to the ability of the former to both treat existing and prevent future stenosis. PCI can be “difficult, dangerous, and even impossible” when the target vessel is totally occluded or the stenosis is complex, hence leading to incomplete revascularization and residual ischemia. “Performing CABG to these vessels is no more difficult than for an isolated, noncomplex stenosis,” Dr. Sabik said.
Dr. Sabik disclosed he is the principal investigator for an Abbott Laboratories–sponsored trial of left main coronary disease, and is on the scientific advisory board of Medtronic.
Dr. Deb and Dr. Fremes had no relationships to disclose.
In their invited editorial commentary, Saswata Deb, MD, and Stephen E. Fremes, MD, of the Schulich Heart Center at the University of Toronto, concurred with the conclusions of Dr. Mack and colleagues (J Thorac Cardiovasc Surg. 2016;152:1241-2). And Joseph F. Sabik III, MD, of the Cleveland Clinic arrived at a similar conclusion in an accompanying editorial (J. Thorac Cardiovasc Surg. 2016;152:1227-8).
Dr. Deb and Dr. Fremes found noteworthy the point Dr. Mack and coauthors raised about cardiologists and internists continuing to recommend PCI to patients with complex multivessel CAD despite evidence from SYNTAX and other trials. “This raises the importance of having a multidisciplinary heart team,” Dr. Deb and Dr. Fremes said.
But they also raised an important question about the difference in outcomes between CABG and PCI in complex multivessel disease. CABG should be the preferred intervention if the high rates of late fatal myocardial infarction after PCI are due to incomplete revascularization; however, if late stent thrombosis was the cause of this disparity in outcomes, then improvements in PCI could close that gap.
In his editorial, Dr. Sabik attributed the difference in outcomes between PCI and CABG to the ability of the former to both treat existing and prevent future stenosis. PCI can be “difficult, dangerous, and even impossible” when the target vessel is totally occluded or the stenosis is complex, hence leading to incomplete revascularization and residual ischemia. “Performing CABG to these vessels is no more difficult than for an isolated, noncomplex stenosis,” Dr. Sabik said.
Dr. Sabik disclosed he is the principal investigator for an Abbott Laboratories–sponsored trial of left main coronary disease, and is on the scientific advisory board of Medtronic.
Dr. Deb and Dr. Fremes had no relationships to disclose.
In their invited editorial commentary, Saswata Deb, MD, and Stephen E. Fremes, MD, of the Schulich Heart Center at the University of Toronto, concurred with the conclusions of Dr. Mack and colleagues (J Thorac Cardiovasc Surg. 2016;152:1241-2). And Joseph F. Sabik III, MD, of the Cleveland Clinic arrived at a similar conclusion in an accompanying editorial (J. Thorac Cardiovasc Surg. 2016;152:1227-8).
Dr. Deb and Dr. Fremes found noteworthy the point Dr. Mack and coauthors raised about cardiologists and internists continuing to recommend PCI to patients with complex multivessel CAD despite evidence from SYNTAX and other trials. “This raises the importance of having a multidisciplinary heart team,” Dr. Deb and Dr. Fremes said.
But they also raised an important question about the difference in outcomes between CABG and PCI in complex multivessel disease. CABG should be the preferred intervention if the high rates of late fatal myocardial infarction after PCI are due to incomplete revascularization; however, if late stent thrombosis was the cause of this disparity in outcomes, then improvements in PCI could close that gap.
In his editorial, Dr. Sabik attributed the difference in outcomes between PCI and CABG to the ability of the former to both treat existing and prevent future stenosis. PCI can be “difficult, dangerous, and even impossible” when the target vessel is totally occluded or the stenosis is complex, hence leading to incomplete revascularization and residual ischemia. “Performing CABG to these vessels is no more difficult than for an isolated, noncomplex stenosis,” Dr. Sabik said.
Dr. Sabik disclosed he is the principal investigator for an Abbott Laboratories–sponsored trial of left main coronary disease, and is on the scientific advisory board of Medtronic.
Dr. Deb and Dr. Fremes had no relationships to disclose.
Whenever seminal clinical trials report results that challenge conventional thinking, physicians face the challenge of actually applying those findings in the clinic. A team of cardiac surgeons from Baylor University in Plano, Tex., has offered its take on the clinical implications of recent findings from the cause-of-death analysis of the SYNTAX trial that compared coronary artery bypass grafting with stenting: When counseling higher-risk patients with coronary artery disease about revascularization procedures, cardiologists and cardiac surgeons should clearly elucidate the dramatic advantage of coronary artery bypass grafting over stenting that SYNTAX had demonstrated.
Michael Mack, MD, and coauthors made their case in a featured expert opinion in the Journal of Thoracic and Cardiovascular Surgery (2016;152:1237-40).
“In fact, there was a significant survival advantage for CABG in the patients with intermediate and high SYNTAX scores, with the death rate of CABG versus PCI being 9.6% versus 16.3% (P less than .047) and 8.8% versus 17.8% (P less than .02), respectively,” they wrote.
The advantages of surgery “have been most striking for patients with intermediate or high SYNTAX scores, but seem to exist for patients with low scores as well, although requiring more follow-up,” Dr. Mack and colleagues said. But the situation is less clear in other subgroups, particularly in patients with less diffuse distal disease and lower SYNTAX scores, they added.
Complete revascularization after the procedure may explain the better outcomes with CABG, as 43.3% of those in the PCI arm had incomplete revascularization vs. 36.8% in the CABG arm. “Incomplete revascularization was associated with increased risk for major adverse cardiac or cerebrovascular events three years after PCI, but incomplete revascularization in the CABG group could not be identified as a predictor for worse outcomes,” Dr. Mack and colleagues noted.
The expert opinion authors debunk one of the recent criticisms of SYNTAX: that its reliance on first-generation drug-eluting stents is dated and not relevant today. They noted the more recent Bypass Surgery Vs. Everolimus-Eluting Stent Implantation for Multivessel Coronary Artery Disease trial found a similarly higher rate of death, heart attack, and target vessel revascularization occurred more frequently in the PCI group (15.3% vs. 10.6% in the CABG group) (N Engl J Med. 2015;372:1204-12).
Nonetheless, Dr. Mack and coauthors found room for improvement for CABG through increased use of atrial revascularization and appropriate measures to minimize stroke.
The latest SYNTAX findings can inform the approach surgeons take with high-risk patients, they said. This should include “a discussion of these data, particularly in regard to survival.” And physicians should base their therapeutic recommendations on these data. “At present, there are data seeming to indicate that the majority of patients with three-vessel disease receiving invasive treatment in the United States are being treated with PCI, an outcome that is not congruent with these outcome findings,” they said.
Taking into consideration other SYNTAX analyses that have shown that completeness of revascularization is a determining factor in post-PCI outcomes, Dr. Mack and coauthors said that physicians should calculate the degree of coronary artery disease (CAD) left untreated after intervention, “and those patients who are likely to have a high residual SYNTAX score should be strongly considered for CABG.” Doctors should also focus “intensive efforts” on adherence to optimal medical therapy after both CABG and PCI.
“Finally, although there is a strong patient preference for a less-invasive treatment of their CAD, patients with advanced disease should be made aware that the choice of PCI puts them at an increased risk of death relative to CABG, and a full and transparent discussion should occur regarding the implications of their decision,” Dr. Mack and coauthors concluded.
They had no relevant financial relationships to disclose.
Whenever seminal clinical trials report results that challenge conventional thinking, physicians face the challenge of actually applying those findings in the clinic. A team of cardiac surgeons from Baylor University in Plano, Tex., has offered its take on the clinical implications of recent findings from the cause-of-death analysis of the SYNTAX trial that compared coronary artery bypass grafting with stenting: When counseling higher-risk patients with coronary artery disease about revascularization procedures, cardiologists and cardiac surgeons should clearly elucidate the dramatic advantage of coronary artery bypass grafting over stenting that SYNTAX had demonstrated.
Michael Mack, MD, and coauthors made their case in a featured expert opinion in the Journal of Thoracic and Cardiovascular Surgery (2016;152:1237-40).
“In fact, there was a significant survival advantage for CABG in the patients with intermediate and high SYNTAX scores, with the death rate of CABG versus PCI being 9.6% versus 16.3% (P less than .047) and 8.8% versus 17.8% (P less than .02), respectively,” they wrote.
The advantages of surgery “have been most striking for patients with intermediate or high SYNTAX scores, but seem to exist for patients with low scores as well, although requiring more follow-up,” Dr. Mack and colleagues said. But the situation is less clear in other subgroups, particularly in patients with less diffuse distal disease and lower SYNTAX scores, they added.
Complete revascularization after the procedure may explain the better outcomes with CABG, as 43.3% of those in the PCI arm had incomplete revascularization vs. 36.8% in the CABG arm. “Incomplete revascularization was associated with increased risk for major adverse cardiac or cerebrovascular events three years after PCI, but incomplete revascularization in the CABG group could not be identified as a predictor for worse outcomes,” Dr. Mack and colleagues noted.
The expert opinion authors debunk one of the recent criticisms of SYNTAX: that its reliance on first-generation drug-eluting stents is dated and not relevant today. They noted the more recent Bypass Surgery Vs. Everolimus-Eluting Stent Implantation for Multivessel Coronary Artery Disease trial found a similarly higher rate of death, heart attack, and target vessel revascularization occurred more frequently in the PCI group (15.3% vs. 10.6% in the CABG group) (N Engl J Med. 2015;372:1204-12).
Nonetheless, Dr. Mack and coauthors found room for improvement for CABG through increased use of atrial revascularization and appropriate measures to minimize stroke.
The latest SYNTAX findings can inform the approach surgeons take with high-risk patients, they said. This should include “a discussion of these data, particularly in regard to survival.” And physicians should base their therapeutic recommendations on these data. “At present, there are data seeming to indicate that the majority of patients with three-vessel disease receiving invasive treatment in the United States are being treated with PCI, an outcome that is not congruent with these outcome findings,” they said.
Taking into consideration other SYNTAX analyses that have shown that completeness of revascularization is a determining factor in post-PCI outcomes, Dr. Mack and coauthors said that physicians should calculate the degree of coronary artery disease (CAD) left untreated after intervention, “and those patients who are likely to have a high residual SYNTAX score should be strongly considered for CABG.” Doctors should also focus “intensive efforts” on adherence to optimal medical therapy after both CABG and PCI.
“Finally, although there is a strong patient preference for a less-invasive treatment of their CAD, patients with advanced disease should be made aware that the choice of PCI puts them at an increased risk of death relative to CABG, and a full and transparent discussion should occur regarding the implications of their decision,” Dr. Mack and coauthors concluded.
They had no relevant financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Physicians should clearly communicate to patients with complex multivessel artery disease the key findings of the SYNTAX trial.
Major finding: The SYNTAX trials showed the risk of cardiac death from myocardial infarction after percutaneous coronary intervention (PCI) is 10 times greater than that after coronary artery bypass grafting in higher-risk patients.
Data source: A post hoc analysis of causes of death in all 3,075 trial and registry patients in the Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery (SYNTAX) trial.
Disclosures: Dr. Mack and coauthors reported having no financial disclosures.
Early TIPS effective in high-risk cirrhosis patients, but still underutilized
BOSTON – High-risk cirrhosis patients treated early with a transjugular intrahepatic portosystemic shunt (TIPS) showed increased survival rates and reduced rates of adverse events, according to a study.
The data were presented at the American Association for the Study of Liver Diseases by Virginia Hernandez-Gea, MD, a hepatologist at the Hospital Clinic in Barcelona.
In each study arm, three-quarters were men in their mid-50s. Cirrhosis in the non-TIPS group was alcohol-related in 57.4% of the cohort, compared with 71.2% of the group given early TIPS; roughly half of each group mentioned alcohol use in the past 3 months.
Also similar were Model for End-stage Liver Disease (MELD) scores: an average of 15.5 in the non-TIPS group, compared with 15 on average in the TIPS group. Nearly three-quarters of the TIPS group had a Child-Pugh C score, compared with 64% in the non-TIPS group. A Child-Pugh score with active bleeding was recorded in 28.8% of the TIPS group, compared with 36% in the non-TIPS group.
The transplant-free survival rate at 1 year in the standard care group was 61%, compared with 76% in the early TIPS group (P = .0175). The failure and bleeding rate at 1 year was significantly higher in the standard care group: 91%, compared with 68% in the early TIPS group (P = .004). Failure and bleeding rates in the Child-Pugh B and C groups across the study were similar.
Ascites at 1 year was seen in 88% of the standard care group, compared with in 64% of the study group. Rates of hepatic encephalopathy were similar in those with Child-Pugh B with active bleeding, and Child-Pugh C across both groups: 22% in the standard care group vs. 25% in the early TIPS group.
That there was no associated significant risk of hepatic encephalopathy in persons with acute variceal bleeding who were given early TIPS “strongly suggests that early TIPS should be included in clinical practice,” Dr. Hernandez-Gea said, noting that only 10% of the 34 sites in the study had used early TIPS. “We don’t really know why centers are not using this, since it is very difficult to find treatments that extend survival rates in this population.”
[email protected]
On Twitter @whitneymcknight
BOSTON – High-risk cirrhosis patients treated early with a transjugular intrahepatic portosystemic shunt (TIPS) showed increased survival rates and reduced rates of adverse events, according to a study.
The data were presented at the American Association for the Study of Liver Diseases by Virginia Hernandez-Gea, MD, a hepatologist at the Hospital Clinic in Barcelona.
In each study arm, three-quarters were men in their mid-50s. Cirrhosis in the non-TIPS group was alcohol-related in 57.4% of the cohort, compared with 71.2% of the group given early TIPS; roughly half of each group mentioned alcohol use in the past 3 months.
Also similar were Model for End-stage Liver Disease (MELD) scores: an average of 15.5 in the non-TIPS group, compared with 15 on average in the TIPS group. Nearly three-quarters of the TIPS group had a Child-Pugh C score, compared with 64% in the non-TIPS group. A Child-Pugh score with active bleeding was recorded in 28.8% of the TIPS group, compared with 36% in the non-TIPS group.
The transplant-free survival rate at 1 year in the standard care group was 61%, compared with 76% in the early TIPS group (P = .0175). The failure and bleeding rate at 1 year was significantly higher in the standard care group: 91%, compared with 68% in the early TIPS group (P = .004). Failure and bleeding rates in the Child-Pugh B and C groups across the study were similar.
Ascites at 1 year was seen in 88% of the standard care group, compared with in 64% of the study group. Rates of hepatic encephalopathy were similar in those with Child-Pugh B with active bleeding, and Child-Pugh C across both groups: 22% in the standard care group vs. 25% in the early TIPS group.
That there was no associated significant risk of hepatic encephalopathy in persons with acute variceal bleeding who were given early TIPS “strongly suggests that early TIPS should be included in clinical practice,” Dr. Hernandez-Gea said, noting that only 10% of the 34 sites in the study had used early TIPS. “We don’t really know why centers are not using this, since it is very difficult to find treatments that extend survival rates in this population.”
[email protected]
On Twitter @whitneymcknight
BOSTON – High-risk cirrhosis patients treated early with a transjugular intrahepatic portosystemic shunt (TIPS) showed increased survival rates and reduced rates of adverse events, according to a study.
The data were presented at the American Association for the Study of Liver Diseases by Virginia Hernandez-Gea, MD, a hepatologist at the Hospital Clinic in Barcelona.
In each study arm, three-quarters were men in their mid-50s. Cirrhosis in the non-TIPS group was alcohol-related in 57.4% of the cohort, compared with 71.2% of the group given early TIPS; roughly half of each group mentioned alcohol use in the past 3 months.
Also similar were Model for End-stage Liver Disease (MELD) scores: an average of 15.5 in the non-TIPS group, compared with 15 on average in the TIPS group. Nearly three-quarters of the TIPS group had a Child-Pugh C score, compared with 64% in the non-TIPS group. A Child-Pugh score with active bleeding was recorded in 28.8% of the TIPS group, compared with 36% in the non-TIPS group.
The transplant-free survival rate at 1 year in the standard care group was 61%, compared with 76% in the early TIPS group (P = .0175). The failure and bleeding rate at 1 year was significantly higher in the standard care group: 91%, compared with 68% in the early TIPS group (P = .004). Failure and bleeding rates in the Child-Pugh B and C groups across the study were similar.
Ascites at 1 year was seen in 88% of the standard care group, compared with in 64% of the study group. Rates of hepatic encephalopathy were similar in those with Child-Pugh B with active bleeding, and Child-Pugh C across both groups: 22% in the standard care group vs. 25% in the early TIPS group.
That there was no associated significant risk of hepatic encephalopathy in persons with acute variceal bleeding who were given early TIPS “strongly suggests that early TIPS should be included in clinical practice,” Dr. Hernandez-Gea said, noting that only 10% of the 34 sites in the study had used early TIPS. “We don’t really know why centers are not using this, since it is very difficult to find treatments that extend survival rates in this population.”
[email protected]
On Twitter @whitneymcknight
AT THE LIVER MEETING
Key clinical point:
Major finding: At 1 year post procedure, early TIPS was associated with better rates of survival and lower rates of adverse events, compared with those who did not receive early TIPS.
Data source: Multicenter, international observational study between 2011 and 2015 of 671 high-risk patients with cirrhosis managed according to current guidelines.
Disclosures: Dr. Hernandez-Gea did not have any relevant disclosures.
Study shows NJ tube and PEG-J on par for enteral nutrition, but each has complications
CORONADO, CALIF. – Percutaneous gastrostomy with jejunal extension (PEG-J) is an appealing and effective method for delivery of enteral nutrition in necrotizing pancreatitis patients, without the mechanical issues and discomfort associated with nasojejunal (NJ) tube, results from a single-center retrospective study showed.
“The advantages of PEG-J route for enteral nutrition in necrotizing pancreatitis patients must be weighed carefully against the potentially severe complication profile,” study author Alexandra M. Roch, MD, said at the annual meeting of the Western Surgical Association.
Historically, the preferred way to manage patients with necrotizing pancreatitis was via parenteral nutrition with a lack of pancreatic stimulation, said Dr. Roch, of the department of surgery at Indiana University, Indianapolis. However, parenteral nutrition is associated with increased permeability, a lack of peristaltic stimulation, changes in intestinal flora, and an increased risk of infection.
“More recently, enteral nutrition has been used, despite a potential for pancreatic stimulation,” she said. “From 16 randomized, controlled trials with 847 patients, it was associated with decreased mortality, decreased infectious complications, decreased length of hospital stay, and a trend toward decreased rate of organ failure. Based on those findings, enteral nutrition has become the standard of care in acute pancreatitis. The optimal enteral nutrition route, however, is still debated. The traditional route is the nasojejunal [NJ] tube. Its placement is noninvasive, but it is associated with discomfort for the patient, dislodgement in 16%-63% of cases, and potentially sinusitis. Conversely, percutaneous gastrostomy with jejunal extension [PEG-J] is beneficial for patient comfort but has the drawbacks of being an invasive procedure with the risk of cellulitis and more severe complications.”
The aim of the current study was to compare the safety and efficacy of NJ tube and PEG-J enteral nutrition delivery before surgical debridement in patients with necrotizing pancreatitis. Dr. Roch and her associates hypothesized that NJ tube and PEG-J would have a similar complication profile. They retrospectively reviewed the medical records of all patients who underwent surgical debridement for necrotizing pancreatitis at Indiana University Medical Center between 2005 and 2015. Patients with exclusive total parenteral nutrition were excluded from the study, as were those who had incomplete data.
Dr. Roch reported results from 242 patients with a mean age of 54 years. More than half (64%) were men and the main etiology was biliary (47%), followed by alcohol (16%). The median duration of preoperative enteral nutrition was 29 days. Of the 242 patients, 187 had an NJ tube only, 25 had PEG-J only, and 30 patients had an NJ tube followed by PEG-J. More than half of PEG-Js were placed under fluoroscopic guidance, while the remaining 41% were placed endoscopically.
In terms of safety, patients in the NJ tube group had a significantly higher rate of all complications, compared with those in the PEG-J group (52% vs. 27%, respectively; P = .0015). Conversely, there was a significantly higher rate of serious complications among patients in the PEG-J group, compared with the NJ group (11% vs. 0%; P less than .0001). The researchers also found that compared with patients in the PEG-J group, those in the NJ group were more prone to mechanical complications such as difficulty to place (5% vs. 0%, respectively), replacement (30% vs. 5.5%), and repositioning (30% vs. 2%), while PEG-J patients were more prone to infectious complications such as skin infections/cellulitis (4% vs. 0%) and perforation/leakage/peritonitis (11% vs. 0%). When they limited the analysis to grade III or IV complications, the mechanism was always the same: early dislodgement from the GI tract. “The presentation ranged from asymptomatic patients to severe peritonitis,” Dr. Roch said. “Two patients out of the six with severe complications required emergent laparotomy.”
In terms of efficacy, the NJ and PEG-J groups were equivalent in achieving enteral nutrition (67% vs. 68%, respectively). There were also no differences between the two groups in nutritional status when assessed by an increase of serum albumin (38% vs. 36%; P = .87), normalization of serum albumin (9% vs. 16%; P = .14), or in the prevalence of infected necrosis (53% vs. 49%; P = .64).
Dr. Roch acknowledged certain limitations of the study, including its single-center, retrospective design. “Furthermore, we are a tertiary care center, and most patients are referred to us late in the course of their disease,” she said. “Finally, no PEG-Js were placed outside of our institution, raising the question of a selection bias. She reported having no financial disclosures.
CORONADO, CALIF. – Percutaneous gastrostomy with jejunal extension (PEG-J) is an appealing and effective method for delivery of enteral nutrition in necrotizing pancreatitis patients, without the mechanical issues and discomfort associated with nasojejunal (NJ) tube, results from a single-center retrospective study showed.
“The advantages of PEG-J route for enteral nutrition in necrotizing pancreatitis patients must be weighed carefully against the potentially severe complication profile,” study author Alexandra M. Roch, MD, said at the annual meeting of the Western Surgical Association.
Historically, the preferred way to manage patients with necrotizing pancreatitis was via parenteral nutrition with a lack of pancreatic stimulation, said Dr. Roch, of the department of surgery at Indiana University, Indianapolis. However, parenteral nutrition is associated with increased permeability, a lack of peristaltic stimulation, changes in intestinal flora, and an increased risk of infection.
“More recently, enteral nutrition has been used, despite a potential for pancreatic stimulation,” she said. “From 16 randomized, controlled trials with 847 patients, it was associated with decreased mortality, decreased infectious complications, decreased length of hospital stay, and a trend toward decreased rate of organ failure. Based on those findings, enteral nutrition has become the standard of care in acute pancreatitis. The optimal enteral nutrition route, however, is still debated. The traditional route is the nasojejunal [NJ] tube. Its placement is noninvasive, but it is associated with discomfort for the patient, dislodgement in 16%-63% of cases, and potentially sinusitis. Conversely, percutaneous gastrostomy with jejunal extension [PEG-J] is beneficial for patient comfort but has the drawbacks of being an invasive procedure with the risk of cellulitis and more severe complications.”
The aim of the current study was to compare the safety and efficacy of NJ tube and PEG-J enteral nutrition delivery before surgical debridement in patients with necrotizing pancreatitis. Dr. Roch and her associates hypothesized that NJ tube and PEG-J would have a similar complication profile. They retrospectively reviewed the medical records of all patients who underwent surgical debridement for necrotizing pancreatitis at Indiana University Medical Center between 2005 and 2015. Patients with exclusive total parenteral nutrition were excluded from the study, as were those who had incomplete data.
Dr. Roch reported results from 242 patients with a mean age of 54 years. More than half (64%) were men and the main etiology was biliary (47%), followed by alcohol (16%). The median duration of preoperative enteral nutrition was 29 days. Of the 242 patients, 187 had an NJ tube only, 25 had PEG-J only, and 30 patients had an NJ tube followed by PEG-J. More than half of PEG-Js were placed under fluoroscopic guidance, while the remaining 41% were placed endoscopically.
In terms of safety, patients in the NJ tube group had a significantly higher rate of all complications, compared with those in the PEG-J group (52% vs. 27%, respectively; P = .0015). Conversely, there was a significantly higher rate of serious complications among patients in the PEG-J group, compared with the NJ group (11% vs. 0%; P less than .0001). The researchers also found that compared with patients in the PEG-J group, those in the NJ group were more prone to mechanical complications such as difficulty to place (5% vs. 0%, respectively), replacement (30% vs. 5.5%), and repositioning (30% vs. 2%), while PEG-J patients were more prone to infectious complications such as skin infections/cellulitis (4% vs. 0%) and perforation/leakage/peritonitis (11% vs. 0%). When they limited the analysis to grade III or IV complications, the mechanism was always the same: early dislodgement from the GI tract. “The presentation ranged from asymptomatic patients to severe peritonitis,” Dr. Roch said. “Two patients out of the six with severe complications required emergent laparotomy.”
In terms of efficacy, the NJ and PEG-J groups were equivalent in achieving enteral nutrition (67% vs. 68%, respectively). There were also no differences between the two groups in nutritional status when assessed by an increase of serum albumin (38% vs. 36%; P = .87), normalization of serum albumin (9% vs. 16%; P = .14), or in the prevalence of infected necrosis (53% vs. 49%; P = .64).
Dr. Roch acknowledged certain limitations of the study, including its single-center, retrospective design. “Furthermore, we are a tertiary care center, and most patients are referred to us late in the course of their disease,” she said. “Finally, no PEG-Js were placed outside of our institution, raising the question of a selection bias. She reported having no financial disclosures.
CORONADO, CALIF. – Percutaneous gastrostomy with jejunal extension (PEG-J) is an appealing and effective method for delivery of enteral nutrition in necrotizing pancreatitis patients, without the mechanical issues and discomfort associated with nasojejunal (NJ) tube, results from a single-center retrospective study showed.
“The advantages of PEG-J route for enteral nutrition in necrotizing pancreatitis patients must be weighed carefully against the potentially severe complication profile,” study author Alexandra M. Roch, MD, said at the annual meeting of the Western Surgical Association.
Historically, the preferred way to manage patients with necrotizing pancreatitis was via parenteral nutrition with a lack of pancreatic stimulation, said Dr. Roch, of the department of surgery at Indiana University, Indianapolis. However, parenteral nutrition is associated with increased permeability, a lack of peristaltic stimulation, changes in intestinal flora, and an increased risk of infection.
“More recently, enteral nutrition has been used, despite a potential for pancreatic stimulation,” she said. “From 16 randomized, controlled trials with 847 patients, it was associated with decreased mortality, decreased infectious complications, decreased length of hospital stay, and a trend toward decreased rate of organ failure. Based on those findings, enteral nutrition has become the standard of care in acute pancreatitis. The optimal enteral nutrition route, however, is still debated. The traditional route is the nasojejunal [NJ] tube. Its placement is noninvasive, but it is associated with discomfort for the patient, dislodgement in 16%-63% of cases, and potentially sinusitis. Conversely, percutaneous gastrostomy with jejunal extension [PEG-J] is beneficial for patient comfort but has the drawbacks of being an invasive procedure with the risk of cellulitis and more severe complications.”
The aim of the current study was to compare the safety and efficacy of NJ tube and PEG-J enteral nutrition delivery before surgical debridement in patients with necrotizing pancreatitis. Dr. Roch and her associates hypothesized that NJ tube and PEG-J would have a similar complication profile. They retrospectively reviewed the medical records of all patients who underwent surgical debridement for necrotizing pancreatitis at Indiana University Medical Center between 2005 and 2015. Patients with exclusive total parenteral nutrition were excluded from the study, as were those who had incomplete data.
Dr. Roch reported results from 242 patients with a mean age of 54 years. More than half (64%) were men and the main etiology was biliary (47%), followed by alcohol (16%). The median duration of preoperative enteral nutrition was 29 days. Of the 242 patients, 187 had an NJ tube only, 25 had PEG-J only, and 30 patients had an NJ tube followed by PEG-J. More than half of PEG-Js were placed under fluoroscopic guidance, while the remaining 41% were placed endoscopically.
In terms of safety, patients in the NJ tube group had a significantly higher rate of all complications, compared with those in the PEG-J group (52% vs. 27%, respectively; P = .0015). Conversely, there was a significantly higher rate of serious complications among patients in the PEG-J group, compared with the NJ group (11% vs. 0%; P less than .0001). The researchers also found that compared with patients in the PEG-J group, those in the NJ group were more prone to mechanical complications such as difficulty to place (5% vs. 0%, respectively), replacement (30% vs. 5.5%), and repositioning (30% vs. 2%), while PEG-J patients were more prone to infectious complications such as skin infections/cellulitis (4% vs. 0%) and perforation/leakage/peritonitis (11% vs. 0%). When they limited the analysis to grade III or IV complications, the mechanism was always the same: early dislodgement from the GI tract. “The presentation ranged from asymptomatic patients to severe peritonitis,” Dr. Roch said. “Two patients out of the six with severe complications required emergent laparotomy.”
In terms of efficacy, the NJ and PEG-J groups were equivalent in achieving enteral nutrition (67% vs. 68%, respectively). There were also no differences between the two groups in nutritional status when assessed by an increase of serum albumin (38% vs. 36%; P = .87), normalization of serum albumin (9% vs. 16%; P = .14), or in the prevalence of infected necrosis (53% vs. 49%; P = .64).
Dr. Roch acknowledged certain limitations of the study, including its single-center, retrospective design. “Furthermore, we are a tertiary care center, and most patients are referred to us late in the course of their disease,” she said. “Finally, no PEG-Js were placed outside of our institution, raising the question of a selection bias. She reported having no financial disclosures.
AT WSA 2016
Key clinical point:
Major finding: In terms of efficacy, the NJ and PEG-J groups were equivalent in achieving enteral nutrition (67% vs. 68%, respectively).
Data source: A retrospective review of 242 patients who underwent surgical debridement for necrotizing pancreatitis at Indiana University Medical Center between 2005 and 2015.
Disclosures: Dr. Roch reported having no financial disclosures.
VIDEO: HeartMate 3 LVAD solves pump thrombosis
NEW ORLEANS – HeartMate 3, the latest left ventricular assist device in the HeartMate line, appears to have solved the problem of pump thrombosis, a complication that has dogged ventricular pumps since the issue leapt into medical awareness about 3 years ago (New Engl J Med. 2014 Jan 2;370:33-40).
During 6 months of follow-up, none of 152 heart failure patients assigned to receive a HeartMate 3 left ventricular assist device (LVAD) developed suspected or confirmed pump thrombosis, compared with 14 patients (10%) having pump thrombosis out of 138 recipients of the prior-generation HeartMate II LVAD who served as the control group for the study.
“Three years ago, when the issue of pump thrombosis was first revealed, there was a lot of consternation and some drop in LVAD use, especially as destination therapy. We think that seeing no pump thrombosis whatsoever will give people renewed confidence in this technology,” said Dr. Mehra, professor of medicine at Harvard Medical School and medical director of the Heart and Vascular Center of Brigham and Women’s Hospital, both in Boston.
Pump thrombosis has also been a problem for the patients who have received a competitor LVAD, the HeartWare HVAD device (Circulation. 2015 Nov 10;132[suppl 3]:A19675), approved for U.S. use as bridge to transplant. HeartMate II is approved for both bridge to transplant and for destination therapy.
In addition to apparently eliminating pump thrombosis, HeartMate 3’s size and potential implantation approach should make its placement during routine use as quick and minimally invasive as the HeartWare device, features that should further help broader use of HeartMate 3, commented Mark Slaughter, MD, professor and chairman of cardiovascular and thoracic surgery at the University of Louisville (Ky.). But Dr. Slaughter and others were also quick to highlight the shortcomings that remain with both devices that will continue to hamper a broader role for LVAD treatment of patients with advanced heart failure.
“We thought that if there was less pump thrombosis we’d see less stroke, but that is not what the data suggest. It’s the big puzzle we need to figure out before we see widespread acceptance of this treatment,” Dr. Sweitzer said.
“This will not shift LVAD use substantially,” commented Christopher B. Granger, MD, a professor of medicine and a heart failure specialist at Duke University, Durham, N.C. “Reducing the need for reoperation is good for the field, and is an incremental advance, but it is not transformational,” he said in an interview.
The MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3) trial randomized 294 patients at 69 U.S. centers. The study’s primary endpoint of 6-month survival free from disabling stroke or reoperation to repair or replace the LVAD occurred in 86% of 152 patients who received a HeartMate 3 and 77% of 142 patients randomized to HeartMate II, a statistical difference that met the prespecified criteria for both noninferiority and superiority. Concurrently with Dr. Mehra’s report at the meeting, a journal article appeared online (New Engl J Med. 2016 Nov 16. doi: 10.1056/NEJMoa1610426). He stated that as far as he understood, St. Jude would submit the 6-month data he reported to the Food and Drug Administration in an application for marketing approval for HeartMate 3.
“I agree that there are still morbid evens [with HeartMate 3] that need to be surmounted, but this is a confidence-building step in the right direction,” Dr. Mehra said.
[email protected]
On Twitter @mitchelzoler
By eliminating all episodes of pump thrombosis during 6-month follow-up, the HeartMate 3 appeared to resolve one of the major issues that has stood in the way of patients and physicians feeling comfortable with left ventricular assist devices. The smaller size of the HeartMate 3 pump and its ability to be placed with minimally invasive and fairly rapid surgery is another big advance, putting this device on par with the rival pump, the HeartWare HVAD.
But the performance of the HeartMate 3 left ventricular assist device (LVAD) in MOMENTUM 3 also highlighted the shortcomings that still remain for these devices: the unchanged rates of stroke, gastrointestinal bleeds, and infections with HeartMate 3, compared with HeartMate II in this trial, and similar 6-month survival rates in the two arms of the study.
The HeartMate 3 can be implanted without sternotomy, using an 8 cm incision on the lateral chest wall, resulting in a shorter postoperative stay and fewer perisurgical adverse events. Despite the less invasive surgery and absence of pump thrombosis, some patients and physicians will remain hesitant to use an LVAD unless it is unavoidable because of concern about strokes. Until further design and procedural refinements change the rate of serious strokes and other adverse events, LVADs will not be fully competitive with heart transplantation.
The competition between HeartMate and the HeartWare devices will help drive this field forward, leading to further improvements in outcomes and expanded LVAD use.
Mark Slaughter, MD, is professor of surgery and chairman of cardiovascular and thoracic surgery at the University of Louisville (Ky.). He was an investigator in MOMENTUM 3, he has been a consultant to EvaHeart and Oregon Heart, and he has received research support from Carmat and HeartWare. He made these comments as designated discussant for the report and in a video interview.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
By eliminating all episodes of pump thrombosis during 6-month follow-up, the HeartMate 3 appeared to resolve one of the major issues that has stood in the way of patients and physicians feeling comfortable with left ventricular assist devices. The smaller size of the HeartMate 3 pump and its ability to be placed with minimally invasive and fairly rapid surgery is another big advance, putting this device on par with the rival pump, the HeartWare HVAD.
But the performance of the HeartMate 3 left ventricular assist device (LVAD) in MOMENTUM 3 also highlighted the shortcomings that still remain for these devices: the unchanged rates of stroke, gastrointestinal bleeds, and infections with HeartMate 3, compared with HeartMate II in this trial, and similar 6-month survival rates in the two arms of the study.
The HeartMate 3 can be implanted without sternotomy, using an 8 cm incision on the lateral chest wall, resulting in a shorter postoperative stay and fewer perisurgical adverse events. Despite the less invasive surgery and absence of pump thrombosis, some patients and physicians will remain hesitant to use an LVAD unless it is unavoidable because of concern about strokes. Until further design and procedural refinements change the rate of serious strokes and other adverse events, LVADs will not be fully competitive with heart transplantation.
The competition between HeartMate and the HeartWare devices will help drive this field forward, leading to further improvements in outcomes and expanded LVAD use.
Mark Slaughter, MD, is professor of surgery and chairman of cardiovascular and thoracic surgery at the University of Louisville (Ky.). He was an investigator in MOMENTUM 3, he has been a consultant to EvaHeart and Oregon Heart, and he has received research support from Carmat and HeartWare. He made these comments as designated discussant for the report and in a video interview.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
By eliminating all episodes of pump thrombosis during 6-month follow-up, the HeartMate 3 appeared to resolve one of the major issues that has stood in the way of patients and physicians feeling comfortable with left ventricular assist devices. The smaller size of the HeartMate 3 pump and its ability to be placed with minimally invasive and fairly rapid surgery is another big advance, putting this device on par with the rival pump, the HeartWare HVAD.
But the performance of the HeartMate 3 left ventricular assist device (LVAD) in MOMENTUM 3 also highlighted the shortcomings that still remain for these devices: the unchanged rates of stroke, gastrointestinal bleeds, and infections with HeartMate 3, compared with HeartMate II in this trial, and similar 6-month survival rates in the two arms of the study.
The HeartMate 3 can be implanted without sternotomy, using an 8 cm incision on the lateral chest wall, resulting in a shorter postoperative stay and fewer perisurgical adverse events. Despite the less invasive surgery and absence of pump thrombosis, some patients and physicians will remain hesitant to use an LVAD unless it is unavoidable because of concern about strokes. Until further design and procedural refinements change the rate of serious strokes and other adverse events, LVADs will not be fully competitive with heart transplantation.
The competition between HeartMate and the HeartWare devices will help drive this field forward, leading to further improvements in outcomes and expanded LVAD use.
Mark Slaughter, MD, is professor of surgery and chairman of cardiovascular and thoracic surgery at the University of Louisville (Ky.). He was an investigator in MOMENTUM 3, he has been a consultant to EvaHeart and Oregon Heart, and he has received research support from Carmat and HeartWare. He made these comments as designated discussant for the report and in a video interview.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
NEW ORLEANS – HeartMate 3, the latest left ventricular assist device in the HeartMate line, appears to have solved the problem of pump thrombosis, a complication that has dogged ventricular pumps since the issue leapt into medical awareness about 3 years ago (New Engl J Med. 2014 Jan 2;370:33-40).
During 6 months of follow-up, none of 152 heart failure patients assigned to receive a HeartMate 3 left ventricular assist device (LVAD) developed suspected or confirmed pump thrombosis, compared with 14 patients (10%) having pump thrombosis out of 138 recipients of the prior-generation HeartMate II LVAD who served as the control group for the study.
“Three years ago, when the issue of pump thrombosis was first revealed, there was a lot of consternation and some drop in LVAD use, especially as destination therapy. We think that seeing no pump thrombosis whatsoever will give people renewed confidence in this technology,” said Dr. Mehra, professor of medicine at Harvard Medical School and medical director of the Heart and Vascular Center of Brigham and Women’s Hospital, both in Boston.
Pump thrombosis has also been a problem for the patients who have received a competitor LVAD, the HeartWare HVAD device (Circulation. 2015 Nov 10;132[suppl 3]:A19675), approved for U.S. use as bridge to transplant. HeartMate II is approved for both bridge to transplant and for destination therapy.
In addition to apparently eliminating pump thrombosis, HeartMate 3’s size and potential implantation approach should make its placement during routine use as quick and minimally invasive as the HeartWare device, features that should further help broader use of HeartMate 3, commented Mark Slaughter, MD, professor and chairman of cardiovascular and thoracic surgery at the University of Louisville (Ky.). But Dr. Slaughter and others were also quick to highlight the shortcomings that remain with both devices that will continue to hamper a broader role for LVAD treatment of patients with advanced heart failure.
“We thought that if there was less pump thrombosis we’d see less stroke, but that is not what the data suggest. It’s the big puzzle we need to figure out before we see widespread acceptance of this treatment,” Dr. Sweitzer said.
“This will not shift LVAD use substantially,” commented Christopher B. Granger, MD, a professor of medicine and a heart failure specialist at Duke University, Durham, N.C. “Reducing the need for reoperation is good for the field, and is an incremental advance, but it is not transformational,” he said in an interview.
The MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3) trial randomized 294 patients at 69 U.S. centers. The study’s primary endpoint of 6-month survival free from disabling stroke or reoperation to repair or replace the LVAD occurred in 86% of 152 patients who received a HeartMate 3 and 77% of 142 patients randomized to HeartMate II, a statistical difference that met the prespecified criteria for both noninferiority and superiority. Concurrently with Dr. Mehra’s report at the meeting, a journal article appeared online (New Engl J Med. 2016 Nov 16. doi: 10.1056/NEJMoa1610426). He stated that as far as he understood, St. Jude would submit the 6-month data he reported to the Food and Drug Administration in an application for marketing approval for HeartMate 3.
“I agree that there are still morbid evens [with HeartMate 3] that need to be surmounted, but this is a confidence-building step in the right direction,” Dr. Mehra said.
[email protected]
On Twitter @mitchelzoler
NEW ORLEANS – HeartMate 3, the latest left ventricular assist device in the HeartMate line, appears to have solved the problem of pump thrombosis, a complication that has dogged ventricular pumps since the issue leapt into medical awareness about 3 years ago (New Engl J Med. 2014 Jan 2;370:33-40).
During 6 months of follow-up, none of 152 heart failure patients assigned to receive a HeartMate 3 left ventricular assist device (LVAD) developed suspected or confirmed pump thrombosis, compared with 14 patients (10%) having pump thrombosis out of 138 recipients of the prior-generation HeartMate II LVAD who served as the control group for the study.
“Three years ago, when the issue of pump thrombosis was first revealed, there was a lot of consternation and some drop in LVAD use, especially as destination therapy. We think that seeing no pump thrombosis whatsoever will give people renewed confidence in this technology,” said Dr. Mehra, professor of medicine at Harvard Medical School and medical director of the Heart and Vascular Center of Brigham and Women’s Hospital, both in Boston.
Pump thrombosis has also been a problem for the patients who have received a competitor LVAD, the HeartWare HVAD device (Circulation. 2015 Nov 10;132[suppl 3]:A19675), approved for U.S. use as bridge to transplant. HeartMate II is approved for both bridge to transplant and for destination therapy.
In addition to apparently eliminating pump thrombosis, HeartMate 3’s size and potential implantation approach should make its placement during routine use as quick and minimally invasive as the HeartWare device, features that should further help broader use of HeartMate 3, commented Mark Slaughter, MD, professor and chairman of cardiovascular and thoracic surgery at the University of Louisville (Ky.). But Dr. Slaughter and others were also quick to highlight the shortcomings that remain with both devices that will continue to hamper a broader role for LVAD treatment of patients with advanced heart failure.
“We thought that if there was less pump thrombosis we’d see less stroke, but that is not what the data suggest. It’s the big puzzle we need to figure out before we see widespread acceptance of this treatment,” Dr. Sweitzer said.
“This will not shift LVAD use substantially,” commented Christopher B. Granger, MD, a professor of medicine and a heart failure specialist at Duke University, Durham, N.C. “Reducing the need for reoperation is good for the field, and is an incremental advance, but it is not transformational,” he said in an interview.
The MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3) trial randomized 294 patients at 69 U.S. centers. The study’s primary endpoint of 6-month survival free from disabling stroke or reoperation to repair or replace the LVAD occurred in 86% of 152 patients who received a HeartMate 3 and 77% of 142 patients randomized to HeartMate II, a statistical difference that met the prespecified criteria for both noninferiority and superiority. Concurrently with Dr. Mehra’s report at the meeting, a journal article appeared online (New Engl J Med. 2016 Nov 16. doi: 10.1056/NEJMoa1610426). He stated that as far as he understood, St. Jude would submit the 6-month data he reported to the Food and Drug Administration in an application for marketing approval for HeartMate 3.
“I agree that there are still morbid evens [with HeartMate 3] that need to be surmounted, but this is a confidence-building step in the right direction,” Dr. Mehra said.
[email protected]
On Twitter @mitchelzoler
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: During 6 months, suspected or confirmed pump thrombosis occurred in no HeartMate 3 patients and in 10% of HeartMate II recipients.
Data source: The MOMENTUM 3 trial, which randomized 294 patients at 69 U.S. centers.
Disclosures: MOMENTUM 3 was sponsored by St. Jude, the company developing the HeartMate 3 LVAD. Dr. Mehra has received travel reimbursements from St. Jude and has been a consultant to Medtronic, Stealth, and Teva. Dr. Sweitzer was an investigator in MOMENTUM 3 and has been a consultant to Acorda and Medtronic and received research support from Bayer, Corvia, and Novartis. Dr. Granger has been a consultant to Boehringer Ingelheim, and received research support from Medtronic and several other drug and device companies. Dr. Slaughter was an investigator in MOMENTUM 3, has been a consultant to EvaHeart and Oregon Heart, and has received research support from Carmat and HeartWare.
Surgery for bowel obstruction in cancer patients didn’t increase 90-day mortality
CORONADO, CALIF. – Among advanced cancer patients with bowel obstruction, surgery was not an independent predictor of the ability to eat at discharge or survival within 90 days of consultation, results from a long-term retrospective study showed.
“I think this represents the complexity in treating these patients,” lead study author Brian D. Badgwell, MD, said at the annual meeting of the Western Surgical Association. “We need future studies to identify the optimal outcome measures.”
For the current study, the researchers retrospectively reviewed the medical records of 490 patients who required surgical consultation for bowel obstruction at MD Anderson Cancer Center between January 2000 and May 2014. They set out to determine the incidence of obstruction due to intra-abdominal tumor and to identify variables associated with the ability to eat at hospital discharge and 90-day survival. They excluded patients without clinical or radiologic features of mechanical bowel obstruction. Clinical variables of interest included obstruction site, tumor vs. non-tumor cause, laboratory parameters, radiologic extent of malignancy, and the type of treatment performed (surgical, medical, or interventional, defined as interventional radiology or endoscopy). Overall survival was calculated from the date of first surgical evaluation for bowel obstruction to any cause mortality or last follow-up. Univariate and multivariate analyses were performed for ability to eat and a Cox proportional hazards model for 90-day survival.
Dr. Badgwell reported that the most common obstruction site in the 490 patients was the small bowel (64%), followed by large bowel (20%) and gastric outlet (16%). Obstruction etiology was identified as tumor-related in 68% of cases, followed by adhesion-related (20%) and unclear (12%). Nearly half of patients (46%) received chemotherapy within 6 weeks of their surgical consultation, but only 4% were neutropenic. More than half of patients (52%) had an albumin level of less than 3.5 g/dL, 52% had a hemoglobin of 10 g/dL or greater, 36% had lymphadenopathy, 35% had ascites, 34% had peritoneal disease, and 31% had a primary or recurrent tumor in place. In addition, 53% had an abdominal visceral malignancy, 9% had bone metastases, and 14% had lung metastases.
About half of patients (49%) received medical management as their treatment, followed by surgical and procedural treatment (32% and 17%, respectively). Fifteen percent were discharged to in-home hospice or to an inpatient hospice facility. More than two-thirds (68%) were able to eat at the time of discharge, and 43% died within 90 days of surgical consultation.
Multivariate analysis revealed that the following factors were negatively associated with eating at discharge: an intact/primary local recurrence (odds ratio, 0.46), carcinomatosis (OR, 0.34), and albumin level of less than 3.5 g/dL (OR, 0.55). At the same time, variables associated with death within 90 days of consultation included having an intact primary/local recurrence (hazard ratio, 1.75), carcinomatosis (HR, 1.98), and abdominal visceral metastasis (HR, 1.75). Finally, compared with procedural treatment, both medical management and surgical management were negatively associated with death within 90 days (HR of 0.51 and 0.44, respectively).
“There is a high rate of non-mechanical bowel dysfunction in patients undergoing surgical consultation for bowel obstruction,” Dr. Badgwell concluded. “It’s very difficult to categorize these cases preoperatively. They do require a selective approach. Variables associated with outcome measures support caution in patients with carcinomatosis, hypoalbuminemia, and multiple sites of disease on imaging.”
Dr. Badgwell reported having no financial disclosures.
CORONADO, CALIF. – Among advanced cancer patients with bowel obstruction, surgery was not an independent predictor of the ability to eat at discharge or survival within 90 days of consultation, results from a long-term retrospective study showed.
“I think this represents the complexity in treating these patients,” lead study author Brian D. Badgwell, MD, said at the annual meeting of the Western Surgical Association. “We need future studies to identify the optimal outcome measures.”
For the current study, the researchers retrospectively reviewed the medical records of 490 patients who required surgical consultation for bowel obstruction at MD Anderson Cancer Center between January 2000 and May 2014. They set out to determine the incidence of obstruction due to intra-abdominal tumor and to identify variables associated with the ability to eat at hospital discharge and 90-day survival. They excluded patients without clinical or radiologic features of mechanical bowel obstruction. Clinical variables of interest included obstruction site, tumor vs. non-tumor cause, laboratory parameters, radiologic extent of malignancy, and the type of treatment performed (surgical, medical, or interventional, defined as interventional radiology or endoscopy). Overall survival was calculated from the date of first surgical evaluation for bowel obstruction to any cause mortality or last follow-up. Univariate and multivariate analyses were performed for ability to eat and a Cox proportional hazards model for 90-day survival.
Dr. Badgwell reported that the most common obstruction site in the 490 patients was the small bowel (64%), followed by large bowel (20%) and gastric outlet (16%). Obstruction etiology was identified as tumor-related in 68% of cases, followed by adhesion-related (20%) and unclear (12%). Nearly half of patients (46%) received chemotherapy within 6 weeks of their surgical consultation, but only 4% were neutropenic. More than half of patients (52%) had an albumin level of less than 3.5 g/dL, 52% had a hemoglobin of 10 g/dL or greater, 36% had lymphadenopathy, 35% had ascites, 34% had peritoneal disease, and 31% had a primary or recurrent tumor in place. In addition, 53% had an abdominal visceral malignancy, 9% had bone metastases, and 14% had lung metastases.
About half of patients (49%) received medical management as their treatment, followed by surgical and procedural treatment (32% and 17%, respectively). Fifteen percent were discharged to in-home hospice or to an inpatient hospice facility. More than two-thirds (68%) were able to eat at the time of discharge, and 43% died within 90 days of surgical consultation.
Multivariate analysis revealed that the following factors were negatively associated with eating at discharge: an intact/primary local recurrence (odds ratio, 0.46), carcinomatosis (OR, 0.34), and albumin level of less than 3.5 g/dL (OR, 0.55). At the same time, variables associated with death within 90 days of consultation included having an intact primary/local recurrence (hazard ratio, 1.75), carcinomatosis (HR, 1.98), and abdominal visceral metastasis (HR, 1.75). Finally, compared with procedural treatment, both medical management and surgical management were negatively associated with death within 90 days (HR of 0.51 and 0.44, respectively).
“There is a high rate of non-mechanical bowel dysfunction in patients undergoing surgical consultation for bowel obstruction,” Dr. Badgwell concluded. “It’s very difficult to categorize these cases preoperatively. They do require a selective approach. Variables associated with outcome measures support caution in patients with carcinomatosis, hypoalbuminemia, and multiple sites of disease on imaging.”
Dr. Badgwell reported having no financial disclosures.
CORONADO, CALIF. – Among advanced cancer patients with bowel obstruction, surgery was not an independent predictor of the ability to eat at discharge or survival within 90 days of consultation, results from a long-term retrospective study showed.
“I think this represents the complexity in treating these patients,” lead study author Brian D. Badgwell, MD, said at the annual meeting of the Western Surgical Association. “We need future studies to identify the optimal outcome measures.”
For the current study, the researchers retrospectively reviewed the medical records of 490 patients who required surgical consultation for bowel obstruction at MD Anderson Cancer Center between January 2000 and May 2014. They set out to determine the incidence of obstruction due to intra-abdominal tumor and to identify variables associated with the ability to eat at hospital discharge and 90-day survival. They excluded patients without clinical or radiologic features of mechanical bowel obstruction. Clinical variables of interest included obstruction site, tumor vs. non-tumor cause, laboratory parameters, radiologic extent of malignancy, and the type of treatment performed (surgical, medical, or interventional, defined as interventional radiology or endoscopy). Overall survival was calculated from the date of first surgical evaluation for bowel obstruction to any cause mortality or last follow-up. Univariate and multivariate analyses were performed for ability to eat and a Cox proportional hazards model for 90-day survival.
Dr. Badgwell reported that the most common obstruction site in the 490 patients was the small bowel (64%), followed by large bowel (20%) and gastric outlet (16%). Obstruction etiology was identified as tumor-related in 68% of cases, followed by adhesion-related (20%) and unclear (12%). Nearly half of patients (46%) received chemotherapy within 6 weeks of their surgical consultation, but only 4% were neutropenic. More than half of patients (52%) had an albumin level of less than 3.5 g/dL, 52% had a hemoglobin of 10 g/dL or greater, 36% had lymphadenopathy, 35% had ascites, 34% had peritoneal disease, and 31% had a primary or recurrent tumor in place. In addition, 53% had an abdominal visceral malignancy, 9% had bone metastases, and 14% had lung metastases.
About half of patients (49%) received medical management as their treatment, followed by surgical and procedural treatment (32% and 17%, respectively). Fifteen percent were discharged to in-home hospice or to an inpatient hospice facility. More than two-thirds (68%) were able to eat at the time of discharge, and 43% died within 90 days of surgical consultation.
Multivariate analysis revealed that the following factors were negatively associated with eating at discharge: an intact/primary local recurrence (odds ratio, 0.46), carcinomatosis (OR, 0.34), and albumin level of less than 3.5 g/dL (OR, 0.55). At the same time, variables associated with death within 90 days of consultation included having an intact primary/local recurrence (hazard ratio, 1.75), carcinomatosis (HR, 1.98), and abdominal visceral metastasis (HR, 1.75). Finally, compared with procedural treatment, both medical management and surgical management were negatively associated with death within 90 days (HR of 0.51 and 0.44, respectively).
“There is a high rate of non-mechanical bowel dysfunction in patients undergoing surgical consultation for bowel obstruction,” Dr. Badgwell concluded. “It’s very difficult to categorize these cases preoperatively. They do require a selective approach. Variables associated with outcome measures support caution in patients with carcinomatosis, hypoalbuminemia, and multiple sites of disease on imaging.”
Dr. Badgwell reported having no financial disclosures.
AT WSA 2016
Key clinical point:
Major finding: Compared with procedural treatment of bowel obstruction, both medical management and surgical management were negatively associated with death within 90 days (HR of 0.51 and 0.44, respectively).
Data source: A retrospective review of 490 patients with advanced cancer who required surgical consultation for bowel obstruction at MD Anderson Cancer Center, Houston, between January 2000 and May 2014.
Disclosures: Dr. Badgwell reported having no financial disclosures.
Hospital factors play key role in readmission risk after surgery
CORONADO, CALIF. – Variation in readmission risk across hospitals following certain surgical procedures is more attributable to hospital factors than to patient characteristics, results from a large analysis demonstrated.
Such is the impact of the care delivery macro environment (CDM), which Sarah A. Brownlee and coauthors defined as a series of complex interactions between patient characteristics and imposed hospital attributes than can impact patient outcomes postoperatively.
The purpose of the current study was to determine the relative contribution of various aspects of the CDM to 1-year readmission risk after surgery. Working with colleagues Anai Kothari, MD, and Paul Kuo MD, in the One:MAP Section of Clinical informatics and Analytics in the department of surgery at Loyola University Medical Center, Ms. Brownlee analyzed the Healthcare Cost and Utilization Project State Inpatient Databases from Florida, New York, and Washington between 2009 and 2013, which were linked to the American Hospital Association Annual Survey from that same time period.
The researchers used smoothed hazard estimates to determine all-cause readmission in the year after surgery, and multilevel survival models with shared frailty to determine the relative impact of hospital versus patient characteristics on the heterogeneity of readmission risk between hospitals. They limited the analysis to patients aged 18 years and older who underwent one the following procedures: abdominal aortic aneurysm repair, pancreatectomy, colectomy, coronary artery bypass graft, and total hip arthroplasty.
Ms. Brownlee reported results from 502,157 patients who underwent surgical procedures at 347 hospitals. The 1-year readmission rate was 23.5%, and ranged from 12% to 36% across procedures. After controlling for procedure, the researchers observed a 7.9% variation in readmission risk between hospitals. Staffing accounted for 9.8% of variance, followed by hospital structural characteristics such as teaching status and clinical programs (7.5%), patient ZIP code (3.8%), hospital perioperative resources such as inpatient rehab (2.9%), hospital volume (2.8%), and patient clinical characteristics (2.1%). The following hospital characteristics were significantly associated with a lower risk of 1-year readmission: high physician/bed ratio (hazard ratio 0.85; P = .00017); transplant status (HR 0.87; P = .022); high-income ZIP code (HR 0.89; P less than .001); high nurse bed/bed ratio (HR 0.90; P = .047), and cancer center designation (HR 0.93; P = .021).
“Compared to patient clinical characteristics, hospital factors such as staffing ratios, perioperative resources, and structural elements account for more variation in postoperative outcomes,” Ms. Brownlee concluded. “However, it’s important to note that in the present study, over 70% of variation in readmission rates is not explained by the covariates that we analyzed. It’s possible that there are other factors we need to consider. That’s where the direction of this research is going. Much of the variation in readmission risk across hospitals cannot be characterized with currently utilized administrative data.”
The National Institutes of Health provided funding for the study. Ms. Brownlee reported having no financial disclosures.
CORONADO, CALIF. – Variation in readmission risk across hospitals following certain surgical procedures is more attributable to hospital factors than to patient characteristics, results from a large analysis demonstrated.
Such is the impact of the care delivery macro environment (CDM), which Sarah A. Brownlee and coauthors defined as a series of complex interactions between patient characteristics and imposed hospital attributes than can impact patient outcomes postoperatively.
The purpose of the current study was to determine the relative contribution of various aspects of the CDM to 1-year readmission risk after surgery. Working with colleagues Anai Kothari, MD, and Paul Kuo MD, in the One:MAP Section of Clinical informatics and Analytics in the department of surgery at Loyola University Medical Center, Ms. Brownlee analyzed the Healthcare Cost and Utilization Project State Inpatient Databases from Florida, New York, and Washington between 2009 and 2013, which were linked to the American Hospital Association Annual Survey from that same time period.
The researchers used smoothed hazard estimates to determine all-cause readmission in the year after surgery, and multilevel survival models with shared frailty to determine the relative impact of hospital versus patient characteristics on the heterogeneity of readmission risk between hospitals. They limited the analysis to patients aged 18 years and older who underwent one the following procedures: abdominal aortic aneurysm repair, pancreatectomy, colectomy, coronary artery bypass graft, and total hip arthroplasty.
Ms. Brownlee reported results from 502,157 patients who underwent surgical procedures at 347 hospitals. The 1-year readmission rate was 23.5%, and ranged from 12% to 36% across procedures. After controlling for procedure, the researchers observed a 7.9% variation in readmission risk between hospitals. Staffing accounted for 9.8% of variance, followed by hospital structural characteristics such as teaching status and clinical programs (7.5%), patient ZIP code (3.8%), hospital perioperative resources such as inpatient rehab (2.9%), hospital volume (2.8%), and patient clinical characteristics (2.1%). The following hospital characteristics were significantly associated with a lower risk of 1-year readmission: high physician/bed ratio (hazard ratio 0.85; P = .00017); transplant status (HR 0.87; P = .022); high-income ZIP code (HR 0.89; P less than .001); high nurse bed/bed ratio (HR 0.90; P = .047), and cancer center designation (HR 0.93; P = .021).
“Compared to patient clinical characteristics, hospital factors such as staffing ratios, perioperative resources, and structural elements account for more variation in postoperative outcomes,” Ms. Brownlee concluded. “However, it’s important to note that in the present study, over 70% of variation in readmission rates is not explained by the covariates that we analyzed. It’s possible that there are other factors we need to consider. That’s where the direction of this research is going. Much of the variation in readmission risk across hospitals cannot be characterized with currently utilized administrative data.”
The National Institutes of Health provided funding for the study. Ms. Brownlee reported having no financial disclosures.
CORONADO, CALIF. – Variation in readmission risk across hospitals following certain surgical procedures is more attributable to hospital factors than to patient characteristics, results from a large analysis demonstrated.
Such is the impact of the care delivery macro environment (CDM), which Sarah A. Brownlee and coauthors defined as a series of complex interactions between patient characteristics and imposed hospital attributes than can impact patient outcomes postoperatively.
The purpose of the current study was to determine the relative contribution of various aspects of the CDM to 1-year readmission risk after surgery. Working with colleagues Anai Kothari, MD, and Paul Kuo MD, in the One:MAP Section of Clinical informatics and Analytics in the department of surgery at Loyola University Medical Center, Ms. Brownlee analyzed the Healthcare Cost and Utilization Project State Inpatient Databases from Florida, New York, and Washington between 2009 and 2013, which were linked to the American Hospital Association Annual Survey from that same time period.
The researchers used smoothed hazard estimates to determine all-cause readmission in the year after surgery, and multilevel survival models with shared frailty to determine the relative impact of hospital versus patient characteristics on the heterogeneity of readmission risk between hospitals. They limited the analysis to patients aged 18 years and older who underwent one the following procedures: abdominal aortic aneurysm repair, pancreatectomy, colectomy, coronary artery bypass graft, and total hip arthroplasty.
Ms. Brownlee reported results from 502,157 patients who underwent surgical procedures at 347 hospitals. The 1-year readmission rate was 23.5%, and ranged from 12% to 36% across procedures. After controlling for procedure, the researchers observed a 7.9% variation in readmission risk between hospitals. Staffing accounted for 9.8% of variance, followed by hospital structural characteristics such as teaching status and clinical programs (7.5%), patient ZIP code (3.8%), hospital perioperative resources such as inpatient rehab (2.9%), hospital volume (2.8%), and patient clinical characteristics (2.1%). The following hospital characteristics were significantly associated with a lower risk of 1-year readmission: high physician/bed ratio (hazard ratio 0.85; P = .00017); transplant status (HR 0.87; P = .022); high-income ZIP code (HR 0.89; P less than .001); high nurse bed/bed ratio (HR 0.90; P = .047), and cancer center designation (HR 0.93; P = .021).
“Compared to patient clinical characteristics, hospital factors such as staffing ratios, perioperative resources, and structural elements account for more variation in postoperative outcomes,” Ms. Brownlee concluded. “However, it’s important to note that in the present study, over 70% of variation in readmission rates is not explained by the covariates that we analyzed. It’s possible that there are other factors we need to consider. That’s where the direction of this research is going. Much of the variation in readmission risk across hospitals cannot be characterized with currently utilized administrative data.”
The National Institutes of Health provided funding for the study. Ms. Brownlee reported having no financial disclosures.
AT WSA 2016
Key clinical point:
Major finding: Staffing accounted for 9.8% of variance in readmission risk between hospitals, followed by hospital structural characteristics such as teaching status and clinical programs (7.5%).
Data source: Results from 502,157 patients who underwent surgical procedures at 347 hospitals in three states.
Disclosures: The National Institutes of Health provided funding for the study. Ms. Brownlee reported having no financial disclosures.
Recovery path complicated for trauma patients with VTE
CORONADO, CALIF. – Patients who develop a venous thromboembolism (VTE) following severe hemorrhage are more susceptible to complications, compared with their counterparts who do not; they also exhibit hypercoagulability and enhanced platelet function at admission, and have delayed recovery of coagulation and platelet function following injury.
Those are the key findings from a secondary analysis of data from the Pragmatic Randomized Optimal Platelet and Plasma Ratio (PROPPR) trial, which randomized 680 severely injured trauma patients from 12 level I trauma centers to receive 1:1:1 or 1:1:2 ratios of plasma to platelets to red blood cells (JAMA 2015;313[5]:471-82). “The prevention of VTE following traumatic injury is an ongoing challenge,” Belinda H. McCully, PhD, said at the annual meeting of the Western Surgical Association. “Despite prophylaxis, about 25% of patients present with VTE, which is associated with higher complications and an increased risk for mortality. Common risk factors for mortality include age, body mass index, extremity injury, and immobility, but the precise mechanisms that contribute to VTE development are not well understood. We do know that the three main factors contributing to thrombosis include static flow, endothelial injury, and hypercoagulability. Clinically, coagulation is the most feasible factor to assess, mainly through the use of conventional coagulation tests, thromboelastography, platelet levels, and platelet function assays.”
Dr. McCully of the division of trauma, critical care, and acute care surgery in the department of surgery at Oregon Health & Science University, Portland, and her associates hypothesized that enhanced, earlier recovery of coagulation function is associated with increased VTE risk in severely injured trauma patients. To test this hypothesis, they conducted a secondary analysis of the PROPPR database, excluding patients who received anticoagulants, to rule out any bias against VTE development, as well as patients who died within 24 hours, to reduce the survival bias. This left 558 patients: 475 who did not develop a VTE, and 83 who did (defined as those who developed deep vein thrombosis or pulmonary embolism). Patient characteristics of interest included age, sex, BMI, mechanism of injury, and injury severity, as well as the transfusion group, the type of blood products given, and the percentage of patients given procoagulants. The investigators also assessed length of stay and complication incidence previously defined by the trial. During the trial, blood samples were taken from admission up to 72 hours and were used to asses both whole blood coagulation using thromboelastography and platelet function using the Multiplate assay.
Dr. McCully reported that VTE patients and non-VTE patients demonstrated similar admission platelet function activity and inhibition of all platelet function parameters at 24 hours (P less than .05). The onset of platelet function recovery was delayed in VTE patients, specifically for arachidonic acid, adenosine-5’-diphosphate, and collagen. Changes in thromboelastography, clot time to initiation, formation, rate of formation, and strength and index of platelet function from admission to 2 hours indicated increasing hypocoagulability (P less than .05) but suppressed clot lysis in both groups. Compared with patients in the non-VTE group, the VTE group had lower mortality (4% vs. 13%) but increased total hospital days (a mean of 30 vs. 16; P less than .05).
Adverse outcomes were also more prevalent in the VTE group, compared with the non-VTE group, and included systemic inflammatory response syndrome (82% vs. 72%), acute kidney injury (36% vs. 26%), infection (61% vs. 31%), sepsis (60% vs. 28%), and pneumonia (34% vs. 19%; P less than 0.05 for all associations). Conversely, regression analysis showed that VTE was associated only with total hospital days (odds ratio, 1.12), while adverse events were similar between the two groups. “From this we can conclude that VTE development following trauma may be attributed to hypercoagulable thromboelastography parameters and enhanced platelet function at admission, and compensatory mechanisms in response to a delayed recovery of coagulation and platelet function,” Dr. McCully said.
She acknowledged certain limitations of the study, including the fact that it was a secondary analysis of prospectively collected data. “We also plan to assess plasma markers of clot strength and fibrinolysis, which is an ongoing process,” she said. “Despite excluding patients that died within 24 hours, there was still a survival bias in the VTE group.”
The PROPPR study was supported by the National Heart, Lung, and Blood Institute and by the Department of Defense. Dr. McCully reported having no relevant financial disclosures.
CORONADO, CALIF. – Patients who develop a venous thromboembolism (VTE) following severe hemorrhage are more susceptible to complications, compared with their counterparts who do not; they also exhibit hypercoagulability and enhanced platelet function at admission, and have delayed recovery of coagulation and platelet function following injury.
Those are the key findings from a secondary analysis of data from the Pragmatic Randomized Optimal Platelet and Plasma Ratio (PROPPR) trial, which randomized 680 severely injured trauma patients from 12 level I trauma centers to receive 1:1:1 or 1:1:2 ratios of plasma to platelets to red blood cells (JAMA 2015;313[5]:471-82). “The prevention of VTE following traumatic injury is an ongoing challenge,” Belinda H. McCully, PhD, said at the annual meeting of the Western Surgical Association. “Despite prophylaxis, about 25% of patients present with VTE, which is associated with higher complications and an increased risk for mortality. Common risk factors for mortality include age, body mass index, extremity injury, and immobility, but the precise mechanisms that contribute to VTE development are not well understood. We do know that the three main factors contributing to thrombosis include static flow, endothelial injury, and hypercoagulability. Clinically, coagulation is the most feasible factor to assess, mainly through the use of conventional coagulation tests, thromboelastography, platelet levels, and platelet function assays.”
Dr. McCully of the division of trauma, critical care, and acute care surgery in the department of surgery at Oregon Health & Science University, Portland, and her associates hypothesized that enhanced, earlier recovery of coagulation function is associated with increased VTE risk in severely injured trauma patients. To test this hypothesis, they conducted a secondary analysis of the PROPPR database, excluding patients who received anticoagulants, to rule out any bias against VTE development, as well as patients who died within 24 hours, to reduce the survival bias. This left 558 patients: 475 who did not develop a VTE, and 83 who did (defined as those who developed deep vein thrombosis or pulmonary embolism). Patient characteristics of interest included age, sex, BMI, mechanism of injury, and injury severity, as well as the transfusion group, the type of blood products given, and the percentage of patients given procoagulants. The investigators also assessed length of stay and complication incidence previously defined by the trial. During the trial, blood samples were taken from admission up to 72 hours and were used to asses both whole blood coagulation using thromboelastography and platelet function using the Multiplate assay.
Dr. McCully reported that VTE patients and non-VTE patients demonstrated similar admission platelet function activity and inhibition of all platelet function parameters at 24 hours (P less than .05). The onset of platelet function recovery was delayed in VTE patients, specifically for arachidonic acid, adenosine-5’-diphosphate, and collagen. Changes in thromboelastography, clot time to initiation, formation, rate of formation, and strength and index of platelet function from admission to 2 hours indicated increasing hypocoagulability (P less than .05) but suppressed clot lysis in both groups. Compared with patients in the non-VTE group, the VTE group had lower mortality (4% vs. 13%) but increased total hospital days (a mean of 30 vs. 16; P less than .05).
Adverse outcomes were also more prevalent in the VTE group, compared with the non-VTE group, and included systemic inflammatory response syndrome (82% vs. 72%), acute kidney injury (36% vs. 26%), infection (61% vs. 31%), sepsis (60% vs. 28%), and pneumonia (34% vs. 19%; P less than 0.05 for all associations). Conversely, regression analysis showed that VTE was associated only with total hospital days (odds ratio, 1.12), while adverse events were similar between the two groups. “From this we can conclude that VTE development following trauma may be attributed to hypercoagulable thromboelastography parameters and enhanced platelet function at admission, and compensatory mechanisms in response to a delayed recovery of coagulation and platelet function,” Dr. McCully said.
She acknowledged certain limitations of the study, including the fact that it was a secondary analysis of prospectively collected data. “We also plan to assess plasma markers of clot strength and fibrinolysis, which is an ongoing process,” she said. “Despite excluding patients that died within 24 hours, there was still a survival bias in the VTE group.”
The PROPPR study was supported by the National Heart, Lung, and Blood Institute and by the Department of Defense. Dr. McCully reported having no relevant financial disclosures.
CORONADO, CALIF. – Patients who develop a venous thromboembolism (VTE) following severe hemorrhage are more susceptible to complications, compared with their counterparts who do not; they also exhibit hypercoagulability and enhanced platelet function at admission, and have delayed recovery of coagulation and platelet function following injury.
Those are the key findings from a secondary analysis of data from the Pragmatic Randomized Optimal Platelet and Plasma Ratio (PROPPR) trial, which randomized 680 severely injured trauma patients from 12 level I trauma centers to receive 1:1:1 or 1:1:2 ratios of plasma to platelets to red blood cells (JAMA 2015;313[5]:471-82). “The prevention of VTE following traumatic injury is an ongoing challenge,” Belinda H. McCully, PhD, said at the annual meeting of the Western Surgical Association. “Despite prophylaxis, about 25% of patients present with VTE, which is associated with higher complications and an increased risk for mortality. Common risk factors for mortality include age, body mass index, extremity injury, and immobility, but the precise mechanisms that contribute to VTE development are not well understood. We do know that the three main factors contributing to thrombosis include static flow, endothelial injury, and hypercoagulability. Clinically, coagulation is the most feasible factor to assess, mainly through the use of conventional coagulation tests, thromboelastography, platelet levels, and platelet function assays.”
Dr. McCully of the division of trauma, critical care, and acute care surgery in the department of surgery at Oregon Health & Science University, Portland, and her associates hypothesized that enhanced, earlier recovery of coagulation function is associated with increased VTE risk in severely injured trauma patients. To test this hypothesis, they conducted a secondary analysis of the PROPPR database, excluding patients who received anticoagulants, to rule out any bias against VTE development, as well as patients who died within 24 hours, to reduce the survival bias. This left 558 patients: 475 who did not develop a VTE, and 83 who did (defined as those who developed deep vein thrombosis or pulmonary embolism). Patient characteristics of interest included age, sex, BMI, mechanism of injury, and injury severity, as well as the transfusion group, the type of blood products given, and the percentage of patients given procoagulants. The investigators also assessed length of stay and complication incidence previously defined by the trial. During the trial, blood samples were taken from admission up to 72 hours and were used to asses both whole blood coagulation using thromboelastography and platelet function using the Multiplate assay.
Dr. McCully reported that VTE patients and non-VTE patients demonstrated similar admission platelet function activity and inhibition of all platelet function parameters at 24 hours (P less than .05). The onset of platelet function recovery was delayed in VTE patients, specifically for arachidonic acid, adenosine-5’-diphosphate, and collagen. Changes in thromboelastography, clot time to initiation, formation, rate of formation, and strength and index of platelet function from admission to 2 hours indicated increasing hypocoagulability (P less than .05) but suppressed clot lysis in both groups. Compared with patients in the non-VTE group, the VTE group had lower mortality (4% vs. 13%) but increased total hospital days (a mean of 30 vs. 16; P less than .05).
Adverse outcomes were also more prevalent in the VTE group, compared with the non-VTE group, and included systemic inflammatory response syndrome (82% vs. 72%), acute kidney injury (36% vs. 26%), infection (61% vs. 31%), sepsis (60% vs. 28%), and pneumonia (34% vs. 19%; P less than 0.05 for all associations). Conversely, regression analysis showed that VTE was associated only with total hospital days (odds ratio, 1.12), while adverse events were similar between the two groups. “From this we can conclude that VTE development following trauma may be attributed to hypercoagulable thromboelastography parameters and enhanced platelet function at admission, and compensatory mechanisms in response to a delayed recovery of coagulation and platelet function,” Dr. McCully said.
She acknowledged certain limitations of the study, including the fact that it was a secondary analysis of prospectively collected data. “We also plan to assess plasma markers of clot strength and fibrinolysis, which is an ongoing process,” she said. “Despite excluding patients that died within 24 hours, there was still a survival bias in the VTE group.”
The PROPPR study was supported by the National Heart, Lung, and Blood Institute and by the Department of Defense. Dr. McCully reported having no relevant financial disclosures.
AT WSA 2016
Key clinical point:
Major finding: Compared with patients in the non-VTE group, the VTE group had lower mortality (4% vs. 13%) but increased total hospital days (a mean of 30 vs. 16; P less than .05).
Data source: A secondary analysis of 558 patients from the Pragmatic Randomized Optimal Platelet and Plasma Ratio (PROPPR) trial, which randomized severely injured trauma patients from 12 level I trauma centers to receive 1:1:1 or 1:1:2 ratios of plasma to platelets to red blood cells.
Disclosures: The PROPPR study was supported by the National Heart, Lung, and Blood Institute and by the Department of Defense. Dr. McCully reported having no relevant financial disclosures.
REBOA may be a safe alternative to RTACC in the acute care setting
WASHINGTON – Resuscitative endovascular balloon occlusion of the aorta (REBOA) could be an acceptable alternative to thoracotomy in traumatic arrest patients who are hemorrhaging below the diaphragm, according to the results of a small pilot study which were presented by William Teeter, MD, at the annual clinical congress of the American College of Surgeons.
Furthermore, virtual simulation training sufficiently prepares surgeons to safely use the REBOA technique in the acute care setting, a separate study found. Importantly, this training has the potential to allow REBOA to become a widespread tool for surgeons regardless of their endovascular surgical experience.
Dr. Teeter presented the preliminary results of a pilot study involving 19 patients who received RTACC between 2008 and 2013 and 17 patients who received REBOA between 2013 and 2015. All study participants were trauma patients who arrived at the R Adams Cowley Shock Trauma Center in arrest or arrested shortly after arrival.
Age, gender, Glasgow Coma Scale, and injury severity score were the same or similar between the two groups, Dr. Teeter reported. Mean systolic blood pressure at admission was 14 mmHg for the REBOA group and 28 mmHg for the RTACC group; however, the majority of patients (82% of REBOA patients and 73% of RTACC patients) arrived with a blood pressure of 0, reported Dr. Teeter.
Importantly, patients in the RTACC group who had penetrating chest injury were excluded for this analysis, Dr. Teeter noted, adding that there was a slightly higher incidence of blunt trauma within the REBOA group likely due to “a change in practice at the trauma center during this time.”
All resuscitations were captured with real-time videography. Continuous vitals were also collected and analyzed.
While more RTACC patients survived to the operating room (53% vs. 68%), among the REBOA group there were more patients who experienced return of spontaneous circulation (53% vs. 37%). However, neither of these results was statistically significant.
Following occlusion of the aorta, the blood pressure measures, taken from continuous vital signs and averaged over a 15-minute period, were 80 mmHg for the REBOA group and 46 mmHg for the RTACC group. Again, this result was statistically insignificant but trended toward favoring REBOA.
Overall, patient survival was dismal. Only one patient who received REBOA survived.
Following Dr. Teeter’s presentation, the study’s assigned discussant, Nicole A. Stassen, MD, of the University of Rochester Medical Center, N.Y., noted that while post-occlusion blood pressure was higher for the REBOA group it seemed not to matter as the majority of patients did not survive. Dr. Stassen also asked if these preliminary results were sufficient to inform or change clinical practice.
In response, Dr. Teeter explained that the pilot study was conducted at a time when the literature was unclear about how patients would respond to open versus endovascular occlusion, and this data helped guide further research and resuscitation efforts.
“At our center there has been a marked change in practice regarding which patients receive resuscitative thoracotomy and which get REBOA,” he added and concluded that “these and previous data suggest that the time performing thoracotomy for resuscitation purposes may be better spent performing CPR with REBOA.”
At the very least, this pilot study demonstrated that “REBOA may be an acceptable alternative to RTACC.” Further analysis of larger study populations will be published soon and will show that REBOA may be preferred over RTACC, according to Dr. Teeter.
A major hindrance to wider-spread REBOA use in the United States is the lack of endovascular training for surgeons during residency which has resulted in a limited number of surgeons who can perform the REBOA technique and a limited number of surgeons who can teach the procedure to others, said Dr. Hampton.
In lieu of experience, formalized 1- or 2-day endovascular simulation courses, such as BEST, were created to prepare surgeons to use techniques such as REBOA. Prior validation studies, including those conducted by researchers at the University of Maryland, demonstrated that surgeons who participated in these courses improved surgical technique and increased their surgical knowledge base, Dr. Hampton reported.
To further elucidate the benefits of these training courses on the successful use of REBOA in the acute care setting, Dr. Hampton and his associates selected nine acute care surgeons with varying endovascular surgical experience to complete the 1-day BEST course and then compared surgeons’ performances of the REBOA technique after successful course completion.
During the study, a total of 28 REBOA procedures were performed, 17 by the surgeons with no endovascular experience, and the remaining 11 by surgeons with endovascular surgical experience.
Overall, there was no difference in wire placements, sheath insertion, position or localization of balloons, or balloon inflation. In addition, there was no difference in mortality among patients, and there were no known REBOA complications during this study.
In conclusion, endovascular experience during residency is not a prerequisite for safe REBOA placement, Dr. Hampton commented.
Taken together, these two research studies are really helping to break ground on REBOA use in the acute care setting, commented an audience member.
The Department of Defense funded Dr. Teeter’s study. Dr. Teeter and Dr. Hampton both reported having no disclosures.
[email protected]
On Twitter @jessnicolecraig
WASHINGTON – Resuscitative endovascular balloon occlusion of the aorta (REBOA) could be an acceptable alternative to thoracotomy in traumatic arrest patients who are hemorrhaging below the diaphragm, according to the results of a small pilot study which were presented by William Teeter, MD, at the annual clinical congress of the American College of Surgeons.
Furthermore, virtual simulation training sufficiently prepares surgeons to safely use the REBOA technique in the acute care setting, a separate study found. Importantly, this training has the potential to allow REBOA to become a widespread tool for surgeons regardless of their endovascular surgical experience.
Dr. Teeter presented the preliminary results of a pilot study involving 19 patients who received RTACC between 2008 and 2013 and 17 patients who received REBOA between 2013 and 2015. All study participants were trauma patients who arrived at the R Adams Cowley Shock Trauma Center in arrest or arrested shortly after arrival.
Age, gender, Glasgow Coma Scale, and injury severity score were the same or similar between the two groups, Dr. Teeter reported. Mean systolic blood pressure at admission was 14 mmHg for the REBOA group and 28 mmHg for the RTACC group; however, the majority of patients (82% of REBOA patients and 73% of RTACC patients) arrived with a blood pressure of 0, reported Dr. Teeter.
Importantly, patients in the RTACC group who had penetrating chest injury were excluded for this analysis, Dr. Teeter noted, adding that there was a slightly higher incidence of blunt trauma within the REBOA group likely due to “a change in practice at the trauma center during this time.”
All resuscitations were captured with real-time videography. Continuous vitals were also collected and analyzed.
While more RTACC patients survived to the operating room (53% vs. 68%), among the REBOA group there were more patients who experienced return of spontaneous circulation (53% vs. 37%). However, neither of these results was statistically significant.
Following occlusion of the aorta, the blood pressure measures, taken from continuous vital signs and averaged over a 15-minute period, were 80 mmHg for the REBOA group and 46 mmHg for the RTACC group. Again, this result was statistically insignificant but trended toward favoring REBOA.
Overall, patient survival was dismal. Only one patient who received REBOA survived.
Following Dr. Teeter’s presentation, the study’s assigned discussant, Nicole A. Stassen, MD, of the University of Rochester Medical Center, N.Y., noted that while post-occlusion blood pressure was higher for the REBOA group it seemed not to matter as the majority of patients did not survive. Dr. Stassen also asked if these preliminary results were sufficient to inform or change clinical practice.
In response, Dr. Teeter explained that the pilot study was conducted at a time when the literature was unclear about how patients would respond to open versus endovascular occlusion, and this data helped guide further research and resuscitation efforts.
“At our center there has been a marked change in practice regarding which patients receive resuscitative thoracotomy and which get REBOA,” he added and concluded that “these and previous data suggest that the time performing thoracotomy for resuscitation purposes may be better spent performing CPR with REBOA.”
At the very least, this pilot study demonstrated that “REBOA may be an acceptable alternative to RTACC.” Further analysis of larger study populations will be published soon and will show that REBOA may be preferred over RTACC, according to Dr. Teeter.
A major hindrance to wider-spread REBOA use in the United States is the lack of endovascular training for surgeons during residency which has resulted in a limited number of surgeons who can perform the REBOA technique and a limited number of surgeons who can teach the procedure to others, said Dr. Hampton.
In lieu of experience, formalized 1- or 2-day endovascular simulation courses, such as BEST, were created to prepare surgeons to use techniques such as REBOA. Prior validation studies, including those conducted by researchers at the University of Maryland, demonstrated that surgeons who participated in these courses improved surgical technique and increased their surgical knowledge base, Dr. Hampton reported.
To further elucidate the benefits of these training courses on the successful use of REBOA in the acute care setting, Dr. Hampton and his associates selected nine acute care surgeons with varying endovascular surgical experience to complete the 1-day BEST course and then compared surgeons’ performances of the REBOA technique after successful course completion.
During the study, a total of 28 REBOA procedures were performed, 17 by the surgeons with no endovascular experience, and the remaining 11 by surgeons with endovascular surgical experience.
Overall, there was no difference in wire placements, sheath insertion, position or localization of balloons, or balloon inflation. In addition, there was no difference in mortality among patients, and there were no known REBOA complications during this study.
In conclusion, endovascular experience during residency is not a prerequisite for safe REBOA placement, Dr. Hampton commented.
Taken together, these two research studies are really helping to break ground on REBOA use in the acute care setting, commented an audience member.
The Department of Defense funded Dr. Teeter’s study. Dr. Teeter and Dr. Hampton both reported having no disclosures.
[email protected]
On Twitter @jessnicolecraig
WASHINGTON – Resuscitative endovascular balloon occlusion of the aorta (REBOA) could be an acceptable alternative to thoracotomy in traumatic arrest patients who are hemorrhaging below the diaphragm, according to the results of a small pilot study which were presented by William Teeter, MD, at the annual clinical congress of the American College of Surgeons.
Furthermore, virtual simulation training sufficiently prepares surgeons to safely use the REBOA technique in the acute care setting, a separate study found. Importantly, this training has the potential to allow REBOA to become a widespread tool for surgeons regardless of their endovascular surgical experience.
Dr. Teeter presented the preliminary results of a pilot study involving 19 patients who received RTACC between 2008 and 2013 and 17 patients who received REBOA between 2013 and 2015. All study participants were trauma patients who arrived at the R Adams Cowley Shock Trauma Center in arrest or arrested shortly after arrival.
Age, gender, Glasgow Coma Scale, and injury severity score were the same or similar between the two groups, Dr. Teeter reported. Mean systolic blood pressure at admission was 14 mmHg for the REBOA group and 28 mmHg for the RTACC group; however, the majority of patients (82% of REBOA patients and 73% of RTACC patients) arrived with a blood pressure of 0, reported Dr. Teeter.
Importantly, patients in the RTACC group who had penetrating chest injury were excluded for this analysis, Dr. Teeter noted, adding that there was a slightly higher incidence of blunt trauma within the REBOA group likely due to “a change in practice at the trauma center during this time.”
All resuscitations were captured with real-time videography. Continuous vitals were also collected and analyzed.
While more RTACC patients survived to the operating room (53% vs. 68%), among the REBOA group there were more patients who experienced return of spontaneous circulation (53% vs. 37%). However, neither of these results was statistically significant.
Following occlusion of the aorta, the blood pressure measures, taken from continuous vital signs and averaged over a 15-minute period, were 80 mmHg for the REBOA group and 46 mmHg for the RTACC group. Again, this result was statistically insignificant but trended toward favoring REBOA.
Overall, patient survival was dismal. Only one patient who received REBOA survived.
Following Dr. Teeter’s presentation, the study’s assigned discussant, Nicole A. Stassen, MD, of the University of Rochester Medical Center, N.Y., noted that while post-occlusion blood pressure was higher for the REBOA group it seemed not to matter as the majority of patients did not survive. Dr. Stassen also asked if these preliminary results were sufficient to inform or change clinical practice.
In response, Dr. Teeter explained that the pilot study was conducted at a time when the literature was unclear about how patients would respond to open versus endovascular occlusion, and this data helped guide further research and resuscitation efforts.
“At our center there has been a marked change in practice regarding which patients receive resuscitative thoracotomy and which get REBOA,” he added and concluded that “these and previous data suggest that the time performing thoracotomy for resuscitation purposes may be better spent performing CPR with REBOA.”
At the very least, this pilot study demonstrated that “REBOA may be an acceptable alternative to RTACC.” Further analysis of larger study populations will be published soon and will show that REBOA may be preferred over RTACC, according to Dr. Teeter.
A major hindrance to wider-spread REBOA use in the United States is the lack of endovascular training for surgeons during residency which has resulted in a limited number of surgeons who can perform the REBOA technique and a limited number of surgeons who can teach the procedure to others, said Dr. Hampton.
In lieu of experience, formalized 1- or 2-day endovascular simulation courses, such as BEST, were created to prepare surgeons to use techniques such as REBOA. Prior validation studies, including those conducted by researchers at the University of Maryland, demonstrated that surgeons who participated in these courses improved surgical technique and increased their surgical knowledge base, Dr. Hampton reported.
To further elucidate the benefits of these training courses on the successful use of REBOA in the acute care setting, Dr. Hampton and his associates selected nine acute care surgeons with varying endovascular surgical experience to complete the 1-day BEST course and then compared surgeons’ performances of the REBOA technique after successful course completion.
During the study, a total of 28 REBOA procedures were performed, 17 by the surgeons with no endovascular experience, and the remaining 11 by surgeons with endovascular surgical experience.
Overall, there was no difference in wire placements, sheath insertion, position or localization of balloons, or balloon inflation. In addition, there was no difference in mortality among patients, and there were no known REBOA complications during this study.
In conclusion, endovascular experience during residency is not a prerequisite for safe REBOA placement, Dr. Hampton commented.
Taken together, these two research studies are really helping to break ground on REBOA use in the acute care setting, commented an audience member.
The Department of Defense funded Dr. Teeter’s study. Dr. Teeter and Dr. Hampton both reported having no disclosures.
[email protected]
On Twitter @jessnicolecraig
AT THE ACS CLINICAL CONGRESS
Key clinical point:
Major finding: More RTACC patients survived to the operating room (53% vs. 68%), but more REBOA patients experienced return of spontaneous circulation (53% vs. 37%).
Data source: Pilot study involving 36 trauma patients who received either RTACC or REBOA.
Disclosures: The Department of Defense funded Dr. Teeter’s study. Dr. Teeter and Dr. Hampton both reported having no disclosures.
Open, laparoscopic, robotic approaches all sound for distal pancreatectomy
WASHINGTON – The three approaches to distal pancreatectomy – open, laparoscopic, and robotic – are equally safe and oncologically sound methods in properly selected patients, findings from a NSQIP database study show.
“The three approaches have specific indications for use and advantages in well-selected patients; therefore, demonstrating the superiority of one technique over another remains challenging,” said Dimitrios Xourafas, MD, in his presentation at the annual clinical congress of the American College of Surgeons.
Laparoscopic surgeries are more likely to result in open conversions than are robotic surgeries – but robotic surgeries take more time to complete. Open surgeries may be best for advanced disease. But all in all, there are no overriding advantages or disadvantages to any of them, reported Dr. Xourafas, a research fellow in surgery at Brigham and Women’s Hospital, Boston.
He and his colleagues used the American College of Surgeons National Surgical Quality Improvement (NSQIP) database for detailed information on 1,815 distal pancreatectomies performed in 2014. These they separated into three groups: open (921), laparoscopic (694) and robotic (200).
There were no differences in baseline characteristics. Mean age of the patients was 62 years. More than 70% of each group had serious comorbidities. Significantly more in the open surgery group had lost 10% or more of their body weight since diagnosis; this was probably related to a higher rate of preoperative chemotherapy in this group, Dr. Xourafas said. Patients having open surgery also were more likely to have undergone radiation therapy.
There were significant, but mixed, differences in operative outcomes. Surgery was longest in the robotic group (243 minutes vs. 205 minutes in the laparoscopic group and 222 minutes in the open group.) Laparoscopic procedures were more likely to convert to open than were robotic (16% vs. 8%). Blood loss was significantly greater in the open group, with 21% needing transfusion vs. 5% laparoscopic and 6% robotic. Close to 100% of patients in the robotic and open groups needed no vascular resection and no reconstruction. In the open group, fewer patients (88%) had no vascular resection, and 84% required no reconstruction, suggesting that these cases were more advanced disease. This finding was also borne out by the larger percentage of tumors that staged at T3 or higher (34% in the open group vs. about 20% in the other groups). However, about half of each group had a malignant tumor subtype and lesion sizes were similar.
Surgical site infections were more common in the open group (10% vs. 7% of the other groups). The length of stay was longest in the open group (7 days vs. 5 in the other groups). The robotic group had the highest rate of pancreatic fistula (21%) although this was not significantly different from the open and laparoscopic rates (16% and 17%, respectively).
Overall morbidity was 45% in the open group, 36% in the laparoscopic group, and 37% in the robotic group. Mortality was 1.5% in the open group, 1% in the laparoscopic group, and 0.5% in the robotic group – not significantly different.
Dr. Xourafas had no financial disclosures.
[email protected]
On Twitter @Alz_Gal
WASHINGTON – The three approaches to distal pancreatectomy – open, laparoscopic, and robotic – are equally safe and oncologically sound methods in properly selected patients, findings from a NSQIP database study show.
“The three approaches have specific indications for use and advantages in well-selected patients; therefore, demonstrating the superiority of one technique over another remains challenging,” said Dimitrios Xourafas, MD, in his presentation at the annual clinical congress of the American College of Surgeons.
Laparoscopic surgeries are more likely to result in open conversions than are robotic surgeries – but robotic surgeries take more time to complete. Open surgeries may be best for advanced disease. But all in all, there are no overriding advantages or disadvantages to any of them, reported Dr. Xourafas, a research fellow in surgery at Brigham and Women’s Hospital, Boston.
He and his colleagues used the American College of Surgeons National Surgical Quality Improvement (NSQIP) database for detailed information on 1,815 distal pancreatectomies performed in 2014. These they separated into three groups: open (921), laparoscopic (694) and robotic (200).
There were no differences in baseline characteristics. Mean age of the patients was 62 years. More than 70% of each group had serious comorbidities. Significantly more in the open surgery group had lost 10% or more of their body weight since diagnosis; this was probably related to a higher rate of preoperative chemotherapy in this group, Dr. Xourafas said. Patients having open surgery also were more likely to have undergone radiation therapy.
There were significant, but mixed, differences in operative outcomes. Surgery was longest in the robotic group (243 minutes vs. 205 minutes in the laparoscopic group and 222 minutes in the open group.) Laparoscopic procedures were more likely to convert to open than were robotic (16% vs. 8%). Blood loss was significantly greater in the open group, with 21% needing transfusion vs. 5% laparoscopic and 6% robotic. Close to 100% of patients in the robotic and open groups needed no vascular resection and no reconstruction. In the open group, fewer patients (88%) had no vascular resection, and 84% required no reconstruction, suggesting that these cases were more advanced disease. This finding was also borne out by the larger percentage of tumors that staged at T3 or higher (34% in the open group vs. about 20% in the other groups). However, about half of each group had a malignant tumor subtype and lesion sizes were similar.
Surgical site infections were more common in the open group (10% vs. 7% of the other groups). The length of stay was longest in the open group (7 days vs. 5 in the other groups). The robotic group had the highest rate of pancreatic fistula (21%) although this was not significantly different from the open and laparoscopic rates (16% and 17%, respectively).
Overall morbidity was 45% in the open group, 36% in the laparoscopic group, and 37% in the robotic group. Mortality was 1.5% in the open group, 1% in the laparoscopic group, and 0.5% in the robotic group – not significantly different.
Dr. Xourafas had no financial disclosures.
[email protected]
On Twitter @Alz_Gal
WASHINGTON – The three approaches to distal pancreatectomy – open, laparoscopic, and robotic – are equally safe and oncologically sound methods in properly selected patients, findings from a NSQIP database study show.
“The three approaches have specific indications for use and advantages in well-selected patients; therefore, demonstrating the superiority of one technique over another remains challenging,” said Dimitrios Xourafas, MD, in his presentation at the annual clinical congress of the American College of Surgeons.
Laparoscopic surgeries are more likely to result in open conversions than are robotic surgeries – but robotic surgeries take more time to complete. Open surgeries may be best for advanced disease. But all in all, there are no overriding advantages or disadvantages to any of them, reported Dr. Xourafas, a research fellow in surgery at Brigham and Women’s Hospital, Boston.
He and his colleagues used the American College of Surgeons National Surgical Quality Improvement (NSQIP) database for detailed information on 1,815 distal pancreatectomies performed in 2014. These they separated into three groups: open (921), laparoscopic (694) and robotic (200).
There were no differences in baseline characteristics. Mean age of the patients was 62 years. More than 70% of each group had serious comorbidities. Significantly more in the open surgery group had lost 10% or more of their body weight since diagnosis; this was probably related to a higher rate of preoperative chemotherapy in this group, Dr. Xourafas said. Patients having open surgery also were more likely to have undergone radiation therapy.
There were significant, but mixed, differences in operative outcomes. Surgery was longest in the robotic group (243 minutes vs. 205 minutes in the laparoscopic group and 222 minutes in the open group.) Laparoscopic procedures were more likely to convert to open than were robotic (16% vs. 8%). Blood loss was significantly greater in the open group, with 21% needing transfusion vs. 5% laparoscopic and 6% robotic. Close to 100% of patients in the robotic and open groups needed no vascular resection and no reconstruction. In the open group, fewer patients (88%) had no vascular resection, and 84% required no reconstruction, suggesting that these cases were more advanced disease. This finding was also borne out by the larger percentage of tumors that staged at T3 or higher (34% in the open group vs. about 20% in the other groups). However, about half of each group had a malignant tumor subtype and lesion sizes were similar.
Surgical site infections were more common in the open group (10% vs. 7% of the other groups). The length of stay was longest in the open group (7 days vs. 5 in the other groups). The robotic group had the highest rate of pancreatic fistula (21%) although this was not significantly different from the open and laparoscopic rates (16% and 17%, respectively).
Overall morbidity was 45% in the open group, 36% in the laparoscopic group, and 37% in the robotic group. Mortality was 1.5% in the open group, 1% in the laparoscopic group, and 0.5% in the robotic group – not significantly different.
Dr. Xourafas had no financial disclosures.
[email protected]
On Twitter @Alz_Gal
AT THE ACS CLINICAL CONGRESS
Key clinical point:
Major finding: Surgery was longest in the robotic group (243 minutes), but more patients in the open group needed transfusions (21% vs. 5% of the other groups).
Data source: The database review comprised 1,815 patients.
Disclosures: Dr. Xourafas had no financial disclosures.
Chief resident service increased trainees’ confidence and independence
CORONADO, CALIF. – Creation of a surgical chief resident service meant to increase resident autonomy and provide continuity of patient care with appropriate faculty supervision has been successful, results from a small single-center study showed.
“Providing opportunities for autonomy to bolster the development of independence and confidence during surgery residency remains among the most pronounced challenges of the current training paradigm,” Benjamin T. Jarman, MD, said at the annual meeting of the Western Surgical Association. “Prior to 2011, our graduating surgery residents reported a lack of perceived autonomy during their training and a need to improve practice management skills. To be clear, they consistently felt confident in their surgical abilities, but they did not sense that they were routinely engaged in directing all phases of care.”
In an effort to provide chief surgery residents with increased autonomy and full-spectrum continuity of patient care, Dr. Jarman and his associates initiated a chief resident service (CRS) in January of 2011. It was designed as an independent service with call responsibilities, office hours, operative scheduling, procedural coding, and endoscopy time. “We constructed a weekly schedule to be consistent with the practice of a general surgeon in the first year after residency,” Dr. Jarman explained. “We also added administrative time for research, patient coordination, and completion of records. Each class of chief residents was educated about these responsibilities as a group, and individual sit-down sessions occurred before they started the rotation. Expectations were made clear, and the importance of clear communication was stressed. The service was geared to provide excellent exposure to practice management skills.” Members of teaching faculty were assigned to each episode of patient care to meet all supervision guidelines and patients were educated accordingly. “The primary difference of and key to this service is that of patient continuity with the chief resident from preoperative assessment to postoperative care,” he said. “So our faculty had to adapt to the transient role that our residents are accustomed to.”
Dr. Jarman presented results from a study of nine surgeons who completed the CRS between January 2011 and June 2014. Total operative volume during residency was assessed in addition to select procedures for the chief service experience versus the residents’ first year of clinical practice. Residents who pursued fellowship training submitted their operative logs from their first year postfellowship. Graduates were surveyed to assess their current clinical practice, satisfaction with the chief service, and whether they perceived a correlation of the CRS with their clinical practice. Patient evaluations were reviewed as well. The researchers focused on the following procedures for comparison: laparoscopic appendectomy, laparoscopic cholecystectomy, colectomy, ventral/incisional hernia repair, inguinal hernia repair, upper endoscopy, and lower endoscopy.
All nine chief surgery residents completed the chief service and completed case logs. “The first three residents to graduate after implementation of the service spent 2 months each on the rotation, while subsequent graduates spent between 4 and 6 months, depending on how many chiefs we had in a given year,” Dr. Jarman said. The median total case volume was 1,101 during the 5-year residency, 92 during the CRS, and 299 during the first year of practice. When the researchers evaluated overall median case volumes, lower endoscopy volumes were higher during the first year of practice, compared with during the CRS (a median of 71 vs. 10 cases, respectively); otherwise there were similar case volumes across the other procedures selected for evaluation. Next, they determined the mean case volumes by month for the selected general surgical procedures and found similar case volumes with the exception of colectomy, which was more commonly performed during the CRS, compared with during the first year of practice (a mean of 1 vs. 0.4 cases; P=0.016).
All nine graduates completed an electronic survey relaying details about their current practice and degree of satisfaction with the CRS; 100% reported being “very satisfied” with their CRS, and 100% found it “very beneficial” to their practice. In addition, 56% said that their cases on the CRS were “somewhat similar” to their current practice, while 44% said that their cases were “very similar” to their current practice.
Since the inception of the CRS, Dr. Jarman and his associates have made several adjustments to the CRS, including incorporation of endoscopy time, adjusted office hours, the required presence of surgery assistants in the OR, and requiring fourth-year residents to attend the ACS Leadership Conference in preparation for the CRS role. He acknowledged certain limitations of the study, including its small sample size and the fact that its participants had variable clinical experience. “But we’re on the ground running,” Dr. Jarman said of the CRS. “The chief residents are wide-eyed and very engaged in this process, and the impact on their development and respect for all the caveats of independent practice has been significant. The strengths of the service include exposure to practice management skills, whole-spectrum clinical care for a single resident at a time, and operative experience which correlates to that experience of a first-year surgeon.” He reported having no financial disclosures.
CORONADO, CALIF. – Creation of a surgical chief resident service meant to increase resident autonomy and provide continuity of patient care with appropriate faculty supervision has been successful, results from a small single-center study showed.
“Providing opportunities for autonomy to bolster the development of independence and confidence during surgery residency remains among the most pronounced challenges of the current training paradigm,” Benjamin T. Jarman, MD, said at the annual meeting of the Western Surgical Association. “Prior to 2011, our graduating surgery residents reported a lack of perceived autonomy during their training and a need to improve practice management skills. To be clear, they consistently felt confident in their surgical abilities, but they did not sense that they were routinely engaged in directing all phases of care.”
In an effort to provide chief surgery residents with increased autonomy and full-spectrum continuity of patient care, Dr. Jarman and his associates initiated a chief resident service (CRS) in January of 2011. It was designed as an independent service with call responsibilities, office hours, operative scheduling, procedural coding, and endoscopy time. “We constructed a weekly schedule to be consistent with the practice of a general surgeon in the first year after residency,” Dr. Jarman explained. “We also added administrative time for research, patient coordination, and completion of records. Each class of chief residents was educated about these responsibilities as a group, and individual sit-down sessions occurred before they started the rotation. Expectations were made clear, and the importance of clear communication was stressed. The service was geared to provide excellent exposure to practice management skills.” Members of teaching faculty were assigned to each episode of patient care to meet all supervision guidelines and patients were educated accordingly. “The primary difference of and key to this service is that of patient continuity with the chief resident from preoperative assessment to postoperative care,” he said. “So our faculty had to adapt to the transient role that our residents are accustomed to.”
Dr. Jarman presented results from a study of nine surgeons who completed the CRS between January 2011 and June 2014. Total operative volume during residency was assessed in addition to select procedures for the chief service experience versus the residents’ first year of clinical practice. Residents who pursued fellowship training submitted their operative logs from their first year postfellowship. Graduates were surveyed to assess their current clinical practice, satisfaction with the chief service, and whether they perceived a correlation of the CRS with their clinical practice. Patient evaluations were reviewed as well. The researchers focused on the following procedures for comparison: laparoscopic appendectomy, laparoscopic cholecystectomy, colectomy, ventral/incisional hernia repair, inguinal hernia repair, upper endoscopy, and lower endoscopy.
All nine chief surgery residents completed the chief service and completed case logs. “The first three residents to graduate after implementation of the service spent 2 months each on the rotation, while subsequent graduates spent between 4 and 6 months, depending on how many chiefs we had in a given year,” Dr. Jarman said. The median total case volume was 1,101 during the 5-year residency, 92 during the CRS, and 299 during the first year of practice. When the researchers evaluated overall median case volumes, lower endoscopy volumes were higher during the first year of practice, compared with during the CRS (a median of 71 vs. 10 cases, respectively); otherwise there were similar case volumes across the other procedures selected for evaluation. Next, they determined the mean case volumes by month for the selected general surgical procedures and found similar case volumes with the exception of colectomy, which was more commonly performed during the CRS, compared with during the first year of practice (a mean of 1 vs. 0.4 cases; P=0.016).
All nine graduates completed an electronic survey relaying details about their current practice and degree of satisfaction with the CRS; 100% reported being “very satisfied” with their CRS, and 100% found it “very beneficial” to their practice. In addition, 56% said that their cases on the CRS were “somewhat similar” to their current practice, while 44% said that their cases were “very similar” to their current practice.
Since the inception of the CRS, Dr. Jarman and his associates have made several adjustments to the CRS, including incorporation of endoscopy time, adjusted office hours, the required presence of surgery assistants in the OR, and requiring fourth-year residents to attend the ACS Leadership Conference in preparation for the CRS role. He acknowledged certain limitations of the study, including its small sample size and the fact that its participants had variable clinical experience. “But we’re on the ground running,” Dr. Jarman said of the CRS. “The chief residents are wide-eyed and very engaged in this process, and the impact on their development and respect for all the caveats of independent practice has been significant. The strengths of the service include exposure to practice management skills, whole-spectrum clinical care for a single resident at a time, and operative experience which correlates to that experience of a first-year surgeon.” He reported having no financial disclosures.
CORONADO, CALIF. – Creation of a surgical chief resident service meant to increase resident autonomy and provide continuity of patient care with appropriate faculty supervision has been successful, results from a small single-center study showed.
“Providing opportunities for autonomy to bolster the development of independence and confidence during surgery residency remains among the most pronounced challenges of the current training paradigm,” Benjamin T. Jarman, MD, said at the annual meeting of the Western Surgical Association. “Prior to 2011, our graduating surgery residents reported a lack of perceived autonomy during their training and a need to improve practice management skills. To be clear, they consistently felt confident in their surgical abilities, but they did not sense that they were routinely engaged in directing all phases of care.”
In an effort to provide chief surgery residents with increased autonomy and full-spectrum continuity of patient care, Dr. Jarman and his associates initiated a chief resident service (CRS) in January of 2011. It was designed as an independent service with call responsibilities, office hours, operative scheduling, procedural coding, and endoscopy time. “We constructed a weekly schedule to be consistent with the practice of a general surgeon in the first year after residency,” Dr. Jarman explained. “We also added administrative time for research, patient coordination, and completion of records. Each class of chief residents was educated about these responsibilities as a group, and individual sit-down sessions occurred before they started the rotation. Expectations were made clear, and the importance of clear communication was stressed. The service was geared to provide excellent exposure to practice management skills.” Members of teaching faculty were assigned to each episode of patient care to meet all supervision guidelines and patients were educated accordingly. “The primary difference of and key to this service is that of patient continuity with the chief resident from preoperative assessment to postoperative care,” he said. “So our faculty had to adapt to the transient role that our residents are accustomed to.”
Dr. Jarman presented results from a study of nine surgeons who completed the CRS between January 2011 and June 2014. Total operative volume during residency was assessed in addition to select procedures for the chief service experience versus the residents’ first year of clinical practice. Residents who pursued fellowship training submitted their operative logs from their first year postfellowship. Graduates were surveyed to assess their current clinical practice, satisfaction with the chief service, and whether they perceived a correlation of the CRS with their clinical practice. Patient evaluations were reviewed as well. The researchers focused on the following procedures for comparison: laparoscopic appendectomy, laparoscopic cholecystectomy, colectomy, ventral/incisional hernia repair, inguinal hernia repair, upper endoscopy, and lower endoscopy.
All nine chief surgery residents completed the chief service and completed case logs. “The first three residents to graduate after implementation of the service spent 2 months each on the rotation, while subsequent graduates spent between 4 and 6 months, depending on how many chiefs we had in a given year,” Dr. Jarman said. The median total case volume was 1,101 during the 5-year residency, 92 during the CRS, and 299 during the first year of practice. When the researchers evaluated overall median case volumes, lower endoscopy volumes were higher during the first year of practice, compared with during the CRS (a median of 71 vs. 10 cases, respectively); otherwise there were similar case volumes across the other procedures selected for evaluation. Next, they determined the mean case volumes by month for the selected general surgical procedures and found similar case volumes with the exception of colectomy, which was more commonly performed during the CRS, compared with during the first year of practice (a mean of 1 vs. 0.4 cases; P=0.016).
All nine graduates completed an electronic survey relaying details about their current practice and degree of satisfaction with the CRS; 100% reported being “very satisfied” with their CRS, and 100% found it “very beneficial” to their practice. In addition, 56% said that their cases on the CRS were “somewhat similar” to their current practice, while 44% said that their cases were “very similar” to their current practice.
Since the inception of the CRS, Dr. Jarman and his associates have made several adjustments to the CRS, including incorporation of endoscopy time, adjusted office hours, the required presence of surgery assistants in the OR, and requiring fourth-year residents to attend the ACS Leadership Conference in preparation for the CRS role. He acknowledged certain limitations of the study, including its small sample size and the fact that its participants had variable clinical experience. “But we’re on the ground running,” Dr. Jarman said of the CRS. “The chief residents are wide-eyed and very engaged in this process, and the impact on their development and respect for all the caveats of independent practice has been significant. The strengths of the service include exposure to practice management skills, whole-spectrum clinical care for a single resident at a time, and operative experience which correlates to that experience of a first-year surgeon.” He reported having no financial disclosures.
AT WSA 2016
Key clinical point:
Major finding: More than half of general surgery residency graduates (56%) said that their cases on the chief resident service were “somewhat similar” to their current practice, while 44% said that their cases were “very similar” to their current practice.
Data source: An study of nine surgeons who completed the chief resident service between January 2011 and June 2014.
Disclosures: Dr. Jarman reported having no financial disclosures.