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Prosthesis-patient mismatch post TAVR ups death risk 19%
SAN DIEGO – Severe prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) increases risk of adverse outcomes and may be preventable in some cases with careful preprocedural planning, suggests a registry-based retrospective cohort study of 62,125 patients treated in the contemporary era.
The study – the largest to date of this patient population – determined that about one in every eight patients undergoing TAVR ultimately had a severe mismatch between the hemodynamics of the valve prosthesis and the requirements for cardiac output. Compared with counterparts that have moderate or no PPM, these patients with severe PPM had a 12% higher adjusted risk of heart failure rehospitalization and a 19% higher adjusted risk of death, according to results reported at the Transcatheter Cardiovascular Therapeutics annual meeting and simultaneously published online (J Am Coll Cardiol. 2018 Sep 23. doi: 10.1016/j.jacc.2018.09.001).
Notably, some of the predictors of severe PPM, such as use of smaller-diameter valves and performance of a valve-in-valve procedure, were potentially modifiable.
“Our findings suggest that efforts should be made to identify this problem and limit the risk for PPM after TAVR,” concluded lead investigator Howard C. Herrmann, MD, a professor at the University of Pennsylvania and director of the cardiac catheterization laboratories, Hospital of the University of Pennsylvania, both in Philadelphia. “Awareness is really the first step in trying to fix it.”
“We spend a lot of time in the heart-team meetings looking at the CT scans for annular dimensions and the vascular access, but we don’t really talk too much about severe PPM or the risk of that,” he elaborated. “This [study] allows us to start to predict it, based on patient factors and what prosthesis we might be choosing for a patient, and it allows us to have that conversation and think about alternatives.
“There are alternatives to try to avoid PPM, everything from which prosthesis we choose to the size of the prosthesis, to whether we fracture a patient’s valve if we are doing a valve-in-valve procedure. In the future, in some situations, we might even choose a low-risk or low-intermediate-risk patient for surgery with an enlargement operation in order to get a larger effective orifice area. So there are choices that we can make, and we should start thinking about that in the heart-team approach.”
Findings in context
The new study reinforces the message “that hemodynamics matter,” he said. “To the extent that we can get larger valves in and get better results from those valves, it will reduce the frequency of PPM. That’s something as operators we don’t spend as much time focusing on, and this will refocus our attention in trying to prevent PPM by being more diligent in terms of prosthesis choice and some operator characteristics, to try to reduce the gradients and improve the effective orifice areas as much as we can.”
Panelist Jeffrey J. Popma, MD, an interventional cardiologist at Beth Israel Deaconess Medical Center, Boston, noted that he and his colleagues have observed similar trends in their smaller studies but had difficulty teasing out contributors. “It really goes back to the preprocedural planning about what valve you can get in, and larger orifice area is certainly better,” he concurred. “So I do think that this is a phenomenal addition.”
Study details
For the study, Dr. Herrmann and his colleagues analyzed 2014-2107 data from the STS/ACC Transcatheter Valve Therapy Registry, a national surveillance and quality improvement system. They identified enrollees aged 65 years or older at the time of their TAVR procedure who had fee-for-service Medicare and linked them to Centers for Medicare & Medicaid Services claims data to assess outcomes.
Overall, 12.1% of patients had severe PPM, defined as an effective valve orifice area indexed to body surface area of less than 0.65 cm2/m2 on discharge echocardiography, and another 24.6% had moderate PPM, Dr. Herrmann reported at the meeting, sponsored by the Cardiovascular Research Foundation.
The strongest multivariate predictors of severe PPM were small prosthetic valve size (up to 23 mm in diameter) (odds ratio, 2.77), a valve-in-valve procedure (OR, 2.78), larger body surface area (OR, 1.71 per 0.2-U increase), and female sex (OR, 1.46). Odds also increased with decreasing age and were elevated for patients of nonwhite/Hispanic race and those having a lower ejection fraction, atrial fibrillation or flutter, or severe mitral or tricuspid regurgitation.
It was not possible to assess specific valves as predictors of mismatch because the registry prohibits comparisons across manufacturers, according to Dr. Herrmann.
One-year mortality, the study’s primary endpoint, was 17.2% in patients with severe PPM, compared with 15.8% in patients with moderate or no PPM (adjusted hazard ratio, 1.19; P less than .001). Findings were similar across subgroups.
The 1-year rate of heart failure rehospitalization was 14.7% in patients with severe PPM, compared with 12.2% in patients with moderate or no PPM (AHR, 1.12; P = .017).
“I would point out that these [outcome] curves are divergent at 1 year,” Dr. Herrmann noted. “So if we look at low-intermediate-risk and low-risk patients and younger patients, who may be more active and who see the effects of PPM more commonly and who are going to be living more than 1 year, we are going to have to consider this going forward in a more important way.”
Severe PPM did not significantly influence the rate of stroke (which stood at about 4% in each group) or worsen quality of life score at 1 year.
Dr. Herrmann disclosed receiving institutional grant/research support from Abbott Vascular, Bayer, Boston Scientific, Corvia Medical, Edwards Lifesciences, Medtronic, and St. Jude Medical, as well as consulting fees/honoraria from Edwards, Medtronic, and Siemens Healthineers.
SAN DIEGO – Severe prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) increases risk of adverse outcomes and may be preventable in some cases with careful preprocedural planning, suggests a registry-based retrospective cohort study of 62,125 patients treated in the contemporary era.
The study – the largest to date of this patient population – determined that about one in every eight patients undergoing TAVR ultimately had a severe mismatch between the hemodynamics of the valve prosthesis and the requirements for cardiac output. Compared with counterparts that have moderate or no PPM, these patients with severe PPM had a 12% higher adjusted risk of heart failure rehospitalization and a 19% higher adjusted risk of death, according to results reported at the Transcatheter Cardiovascular Therapeutics annual meeting and simultaneously published online (J Am Coll Cardiol. 2018 Sep 23. doi: 10.1016/j.jacc.2018.09.001).
Notably, some of the predictors of severe PPM, such as use of smaller-diameter valves and performance of a valve-in-valve procedure, were potentially modifiable.
“Our findings suggest that efforts should be made to identify this problem and limit the risk for PPM after TAVR,” concluded lead investigator Howard C. Herrmann, MD, a professor at the University of Pennsylvania and director of the cardiac catheterization laboratories, Hospital of the University of Pennsylvania, both in Philadelphia. “Awareness is really the first step in trying to fix it.”
“We spend a lot of time in the heart-team meetings looking at the CT scans for annular dimensions and the vascular access, but we don’t really talk too much about severe PPM or the risk of that,” he elaborated. “This [study] allows us to start to predict it, based on patient factors and what prosthesis we might be choosing for a patient, and it allows us to have that conversation and think about alternatives.
“There are alternatives to try to avoid PPM, everything from which prosthesis we choose to the size of the prosthesis, to whether we fracture a patient’s valve if we are doing a valve-in-valve procedure. In the future, in some situations, we might even choose a low-risk or low-intermediate-risk patient for surgery with an enlargement operation in order to get a larger effective orifice area. So there are choices that we can make, and we should start thinking about that in the heart-team approach.”
Findings in context
The new study reinforces the message “that hemodynamics matter,” he said. “To the extent that we can get larger valves in and get better results from those valves, it will reduce the frequency of PPM. That’s something as operators we don’t spend as much time focusing on, and this will refocus our attention in trying to prevent PPM by being more diligent in terms of prosthesis choice and some operator characteristics, to try to reduce the gradients and improve the effective orifice areas as much as we can.”
Panelist Jeffrey J. Popma, MD, an interventional cardiologist at Beth Israel Deaconess Medical Center, Boston, noted that he and his colleagues have observed similar trends in their smaller studies but had difficulty teasing out contributors. “It really goes back to the preprocedural planning about what valve you can get in, and larger orifice area is certainly better,” he concurred. “So I do think that this is a phenomenal addition.”
Study details
For the study, Dr. Herrmann and his colleagues analyzed 2014-2107 data from the STS/ACC Transcatheter Valve Therapy Registry, a national surveillance and quality improvement system. They identified enrollees aged 65 years or older at the time of their TAVR procedure who had fee-for-service Medicare and linked them to Centers for Medicare & Medicaid Services claims data to assess outcomes.
Overall, 12.1% of patients had severe PPM, defined as an effective valve orifice area indexed to body surface area of less than 0.65 cm2/m2 on discharge echocardiography, and another 24.6% had moderate PPM, Dr. Herrmann reported at the meeting, sponsored by the Cardiovascular Research Foundation.
The strongest multivariate predictors of severe PPM were small prosthetic valve size (up to 23 mm in diameter) (odds ratio, 2.77), a valve-in-valve procedure (OR, 2.78), larger body surface area (OR, 1.71 per 0.2-U increase), and female sex (OR, 1.46). Odds also increased with decreasing age and were elevated for patients of nonwhite/Hispanic race and those having a lower ejection fraction, atrial fibrillation or flutter, or severe mitral or tricuspid regurgitation.
It was not possible to assess specific valves as predictors of mismatch because the registry prohibits comparisons across manufacturers, according to Dr. Herrmann.
One-year mortality, the study’s primary endpoint, was 17.2% in patients with severe PPM, compared with 15.8% in patients with moderate or no PPM (adjusted hazard ratio, 1.19; P less than .001). Findings were similar across subgroups.
The 1-year rate of heart failure rehospitalization was 14.7% in patients with severe PPM, compared with 12.2% in patients with moderate or no PPM (AHR, 1.12; P = .017).
“I would point out that these [outcome] curves are divergent at 1 year,” Dr. Herrmann noted. “So if we look at low-intermediate-risk and low-risk patients and younger patients, who may be more active and who see the effects of PPM more commonly and who are going to be living more than 1 year, we are going to have to consider this going forward in a more important way.”
Severe PPM did not significantly influence the rate of stroke (which stood at about 4% in each group) or worsen quality of life score at 1 year.
Dr. Herrmann disclosed receiving institutional grant/research support from Abbott Vascular, Bayer, Boston Scientific, Corvia Medical, Edwards Lifesciences, Medtronic, and St. Jude Medical, as well as consulting fees/honoraria from Edwards, Medtronic, and Siemens Healthineers.
SAN DIEGO – Severe prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) increases risk of adverse outcomes and may be preventable in some cases with careful preprocedural planning, suggests a registry-based retrospective cohort study of 62,125 patients treated in the contemporary era.
The study – the largest to date of this patient population – determined that about one in every eight patients undergoing TAVR ultimately had a severe mismatch between the hemodynamics of the valve prosthesis and the requirements for cardiac output. Compared with counterparts that have moderate or no PPM, these patients with severe PPM had a 12% higher adjusted risk of heart failure rehospitalization and a 19% higher adjusted risk of death, according to results reported at the Transcatheter Cardiovascular Therapeutics annual meeting and simultaneously published online (J Am Coll Cardiol. 2018 Sep 23. doi: 10.1016/j.jacc.2018.09.001).
Notably, some of the predictors of severe PPM, such as use of smaller-diameter valves and performance of a valve-in-valve procedure, were potentially modifiable.
“Our findings suggest that efforts should be made to identify this problem and limit the risk for PPM after TAVR,” concluded lead investigator Howard C. Herrmann, MD, a professor at the University of Pennsylvania and director of the cardiac catheterization laboratories, Hospital of the University of Pennsylvania, both in Philadelphia. “Awareness is really the first step in trying to fix it.”
“We spend a lot of time in the heart-team meetings looking at the CT scans for annular dimensions and the vascular access, but we don’t really talk too much about severe PPM or the risk of that,” he elaborated. “This [study] allows us to start to predict it, based on patient factors and what prosthesis we might be choosing for a patient, and it allows us to have that conversation and think about alternatives.
“There are alternatives to try to avoid PPM, everything from which prosthesis we choose to the size of the prosthesis, to whether we fracture a patient’s valve if we are doing a valve-in-valve procedure. In the future, in some situations, we might even choose a low-risk or low-intermediate-risk patient for surgery with an enlargement operation in order to get a larger effective orifice area. So there are choices that we can make, and we should start thinking about that in the heart-team approach.”
Findings in context
The new study reinforces the message “that hemodynamics matter,” he said. “To the extent that we can get larger valves in and get better results from those valves, it will reduce the frequency of PPM. That’s something as operators we don’t spend as much time focusing on, and this will refocus our attention in trying to prevent PPM by being more diligent in terms of prosthesis choice and some operator characteristics, to try to reduce the gradients and improve the effective orifice areas as much as we can.”
Panelist Jeffrey J. Popma, MD, an interventional cardiologist at Beth Israel Deaconess Medical Center, Boston, noted that he and his colleagues have observed similar trends in their smaller studies but had difficulty teasing out contributors. “It really goes back to the preprocedural planning about what valve you can get in, and larger orifice area is certainly better,” he concurred. “So I do think that this is a phenomenal addition.”
Study details
For the study, Dr. Herrmann and his colleagues analyzed 2014-2107 data from the STS/ACC Transcatheter Valve Therapy Registry, a national surveillance and quality improvement system. They identified enrollees aged 65 years or older at the time of their TAVR procedure who had fee-for-service Medicare and linked them to Centers for Medicare & Medicaid Services claims data to assess outcomes.
Overall, 12.1% of patients had severe PPM, defined as an effective valve orifice area indexed to body surface area of less than 0.65 cm2/m2 on discharge echocardiography, and another 24.6% had moderate PPM, Dr. Herrmann reported at the meeting, sponsored by the Cardiovascular Research Foundation.
The strongest multivariate predictors of severe PPM were small prosthetic valve size (up to 23 mm in diameter) (odds ratio, 2.77), a valve-in-valve procedure (OR, 2.78), larger body surface area (OR, 1.71 per 0.2-U increase), and female sex (OR, 1.46). Odds also increased with decreasing age and were elevated for patients of nonwhite/Hispanic race and those having a lower ejection fraction, atrial fibrillation or flutter, or severe mitral or tricuspid regurgitation.
It was not possible to assess specific valves as predictors of mismatch because the registry prohibits comparisons across manufacturers, according to Dr. Herrmann.
One-year mortality, the study’s primary endpoint, was 17.2% in patients with severe PPM, compared with 15.8% in patients with moderate or no PPM (adjusted hazard ratio, 1.19; P less than .001). Findings were similar across subgroups.
The 1-year rate of heart failure rehospitalization was 14.7% in patients with severe PPM, compared with 12.2% in patients with moderate or no PPM (AHR, 1.12; P = .017).
“I would point out that these [outcome] curves are divergent at 1 year,” Dr. Herrmann noted. “So if we look at low-intermediate-risk and low-risk patients and younger patients, who may be more active and who see the effects of PPM more commonly and who are going to be living more than 1 year, we are going to have to consider this going forward in a more important way.”
Severe PPM did not significantly influence the rate of stroke (which stood at about 4% in each group) or worsen quality of life score at 1 year.
Dr. Herrmann disclosed receiving institutional grant/research support from Abbott Vascular, Bayer, Boston Scientific, Corvia Medical, Edwards Lifesciences, Medtronic, and St. Jude Medical, as well as consulting fees/honoraria from Edwards, Medtronic, and Siemens Healthineers.
REPORTING FROM TCT 2018
Key clinical point:
Major finding: Patients with severe PPM after TAVR had elevated risks of heart failure rehospitalization (adjusted hazard ratio, 1.12) and death (AHR, 1.19).
Study details: A retrospective cohort study of 62,125 patients aged 65 years or older who underwent TAVR and were captured in the national STS/ACC Transcatheter Valve Therapy Registry.
Disclosures: Dr. Herrmann disclosed receiving institutional grant/research support from Abbott Vascular, Bayer, Boston Scientific, Corvia Medical, Edwards Lifesciences, Medtronic, and St. Jude Medical, as well as consulting fees/honoraria from Edwards, Medtronic, and Siemens Healthineers.
Novel device improves mitral regurgitation 30% in REDUCE-FMR
SAN DIEGO – In patients with heart failure and functional mitral regurgitation, implantation of an investigational device led to reduced MR and improved left ventricular remodeling at 1 year, compared with patients who received sham treatment in the REDUCE-FMR trial.
The device showed promise in this trial, despite a small sample size, and its nature makes it possible to follow up with other procedures if the disease progresses. “The advantage of this technique is that all other options are still open,” Horst Sievert, MD, director of the CardioVascular Center in Frankfurt, said during a press conference at the Transcatheter Cardiovascular Therapeutics annual meeting.
The Carillon Mitral Counter System includes two anchors, one in the great cardiac vein and one in the coronary sinus, connected by a shaping ribbon. The tension of the ribbon bolsters the mitral annulus, which in turn reduces mitral regurgitation.
REDUCE-FMR recruited 120 patients from centers in eight countries and randomized 87 to the Carillon device (73 implanted) and 33 to a sham procedure. Sham patients were sedated and received a coronary sinus angiogram. Patients were included if they had dilated ischemic or nonischemic cardiomyopathy and moderate to severe functional MR, among other requirements. Exclusion criteria included existing coronary artery stents in the implant target zone, severe mitral annular calcification, and significant organic mitral valve pathology.
The primary endpoint was the mean reduction of regurgitant volume at 1 year. The treated patients had a 22% reduction of 7.1 mL, while the sham group on average had an 8% increase of 3.3 mL (P = .03). In the as-treated subpopulation, which comprised 45 patients in the treatment group and 13 controls, the values were –7.5 mL and +3.3 mL (P = .02). A per-protocol analysis, which excluded patients who did not meet protocol criteria, led to an amplification of the effect when the study design was adhered to (–12.5 mL vs. +1.3 mL), though this result did not achieve statistical significance owing to the small sample size.
For the safety endpoints, the researchers examined the frequency of major adverse events (MAE), including death, myocardial infarction, cardiac perforation, device embolism, and surgery or percutaneous coronary intervention related to the device at 1 year. In the treatment group, 16.1% experienced a MAE, compared with 18.2% of control patients, a statistically nonsignificant difference.
A secondary efficacy endpoint of change in left ventricular end-diastolic volume showed improvements in the treatment group at 6 months (–12.4 mL) and 12 months (–8.6 mL), compared with increases in the sham group at 6 months (+5.4 mL) and 12 months (+6.5 mL). A similar trend occurred in left ventricular end-systolic volume (–7.8 mL and –4.8 mL; +3.4 mL and +6.1 mL, respectively).
The study was conducted in a patient population similar to that of the COAPT trial, which examined implantation of Abbott’s MitraClip. That study, presented here at TCT 2018 and simultaneously published in the New England Journal of Medicine, also examined patients with heart failure and secondary MR.
However, in REDUCE-FMR, many of the patients had milder heart failure than the researchers had expected: 44.8% in the treatment group had NYHA class II, as did 48.5% in the sham group. That surprise may help identify an appropriate patient population. “I think this device may have a nice spot in between medical therapy and MitraClip implantation, because we have, by chance, a patient population with mild heart insufficiency and mild MR,” said Dr. Sievert.
The two devices also showed different physiologic effects, Michael Mack, MD, said at a press conference. “One subtle difference is that, in this trial, the difference is due to both positive left ventricular remodeling in the treatment arm and continued progression in the sham control. In COAPT, the difference in improvement that we saw was totally due to prevention of progression of disease. We just stabilized the disease to where it was at. So that’s an intriguing difference here, that you actually were able to demonstrate positive left ventricular remodeling,” noted Dr. Mack, medical director for cardiovascular surgery at Baylor Scott & White Medical Center, Plano, Tex. He was a coinvestigator in the COAPT trial.
REDUCE-FMR was funded by Cardiac Dimensions. Dr. Sievert has received consulting fees, travel expenses, and study honoraria from Cardiac Dimensions, and 35 other companies. Dr. Mack has received grant support or had a research contract with Abbott Vascular, Medtronic, and Edwards Lifesciences.
SAN DIEGO – In patients with heart failure and functional mitral regurgitation, implantation of an investigational device led to reduced MR and improved left ventricular remodeling at 1 year, compared with patients who received sham treatment in the REDUCE-FMR trial.
The device showed promise in this trial, despite a small sample size, and its nature makes it possible to follow up with other procedures if the disease progresses. “The advantage of this technique is that all other options are still open,” Horst Sievert, MD, director of the CardioVascular Center in Frankfurt, said during a press conference at the Transcatheter Cardiovascular Therapeutics annual meeting.
The Carillon Mitral Counter System includes two anchors, one in the great cardiac vein and one in the coronary sinus, connected by a shaping ribbon. The tension of the ribbon bolsters the mitral annulus, which in turn reduces mitral regurgitation.
REDUCE-FMR recruited 120 patients from centers in eight countries and randomized 87 to the Carillon device (73 implanted) and 33 to a sham procedure. Sham patients were sedated and received a coronary sinus angiogram. Patients were included if they had dilated ischemic or nonischemic cardiomyopathy and moderate to severe functional MR, among other requirements. Exclusion criteria included existing coronary artery stents in the implant target zone, severe mitral annular calcification, and significant organic mitral valve pathology.
The primary endpoint was the mean reduction of regurgitant volume at 1 year. The treated patients had a 22% reduction of 7.1 mL, while the sham group on average had an 8% increase of 3.3 mL (P = .03). In the as-treated subpopulation, which comprised 45 patients in the treatment group and 13 controls, the values were –7.5 mL and +3.3 mL (P = .02). A per-protocol analysis, which excluded patients who did not meet protocol criteria, led to an amplification of the effect when the study design was adhered to (–12.5 mL vs. +1.3 mL), though this result did not achieve statistical significance owing to the small sample size.
For the safety endpoints, the researchers examined the frequency of major adverse events (MAE), including death, myocardial infarction, cardiac perforation, device embolism, and surgery or percutaneous coronary intervention related to the device at 1 year. In the treatment group, 16.1% experienced a MAE, compared with 18.2% of control patients, a statistically nonsignificant difference.
A secondary efficacy endpoint of change in left ventricular end-diastolic volume showed improvements in the treatment group at 6 months (–12.4 mL) and 12 months (–8.6 mL), compared with increases in the sham group at 6 months (+5.4 mL) and 12 months (+6.5 mL). A similar trend occurred in left ventricular end-systolic volume (–7.8 mL and –4.8 mL; +3.4 mL and +6.1 mL, respectively).
The study was conducted in a patient population similar to that of the COAPT trial, which examined implantation of Abbott’s MitraClip. That study, presented here at TCT 2018 and simultaneously published in the New England Journal of Medicine, also examined patients with heart failure and secondary MR.
However, in REDUCE-FMR, many of the patients had milder heart failure than the researchers had expected: 44.8% in the treatment group had NYHA class II, as did 48.5% in the sham group. That surprise may help identify an appropriate patient population. “I think this device may have a nice spot in between medical therapy and MitraClip implantation, because we have, by chance, a patient population with mild heart insufficiency and mild MR,” said Dr. Sievert.
The two devices also showed different physiologic effects, Michael Mack, MD, said at a press conference. “One subtle difference is that, in this trial, the difference is due to both positive left ventricular remodeling in the treatment arm and continued progression in the sham control. In COAPT, the difference in improvement that we saw was totally due to prevention of progression of disease. We just stabilized the disease to where it was at. So that’s an intriguing difference here, that you actually were able to demonstrate positive left ventricular remodeling,” noted Dr. Mack, medical director for cardiovascular surgery at Baylor Scott & White Medical Center, Plano, Tex. He was a coinvestigator in the COAPT trial.
REDUCE-FMR was funded by Cardiac Dimensions. Dr. Sievert has received consulting fees, travel expenses, and study honoraria from Cardiac Dimensions, and 35 other companies. Dr. Mack has received grant support or had a research contract with Abbott Vascular, Medtronic, and Edwards Lifesciences.
SAN DIEGO – In patients with heart failure and functional mitral regurgitation, implantation of an investigational device led to reduced MR and improved left ventricular remodeling at 1 year, compared with patients who received sham treatment in the REDUCE-FMR trial.
The device showed promise in this trial, despite a small sample size, and its nature makes it possible to follow up with other procedures if the disease progresses. “The advantage of this technique is that all other options are still open,” Horst Sievert, MD, director of the CardioVascular Center in Frankfurt, said during a press conference at the Transcatheter Cardiovascular Therapeutics annual meeting.
The Carillon Mitral Counter System includes two anchors, one in the great cardiac vein and one in the coronary sinus, connected by a shaping ribbon. The tension of the ribbon bolsters the mitral annulus, which in turn reduces mitral regurgitation.
REDUCE-FMR recruited 120 patients from centers in eight countries and randomized 87 to the Carillon device (73 implanted) and 33 to a sham procedure. Sham patients were sedated and received a coronary sinus angiogram. Patients were included if they had dilated ischemic or nonischemic cardiomyopathy and moderate to severe functional MR, among other requirements. Exclusion criteria included existing coronary artery stents in the implant target zone, severe mitral annular calcification, and significant organic mitral valve pathology.
The primary endpoint was the mean reduction of regurgitant volume at 1 year. The treated patients had a 22% reduction of 7.1 mL, while the sham group on average had an 8% increase of 3.3 mL (P = .03). In the as-treated subpopulation, which comprised 45 patients in the treatment group and 13 controls, the values were –7.5 mL and +3.3 mL (P = .02). A per-protocol analysis, which excluded patients who did not meet protocol criteria, led to an amplification of the effect when the study design was adhered to (–12.5 mL vs. +1.3 mL), though this result did not achieve statistical significance owing to the small sample size.
For the safety endpoints, the researchers examined the frequency of major adverse events (MAE), including death, myocardial infarction, cardiac perforation, device embolism, and surgery or percutaneous coronary intervention related to the device at 1 year. In the treatment group, 16.1% experienced a MAE, compared with 18.2% of control patients, a statistically nonsignificant difference.
A secondary efficacy endpoint of change in left ventricular end-diastolic volume showed improvements in the treatment group at 6 months (–12.4 mL) and 12 months (–8.6 mL), compared with increases in the sham group at 6 months (+5.4 mL) and 12 months (+6.5 mL). A similar trend occurred in left ventricular end-systolic volume (–7.8 mL and –4.8 mL; +3.4 mL and +6.1 mL, respectively).
The study was conducted in a patient population similar to that of the COAPT trial, which examined implantation of Abbott’s MitraClip. That study, presented here at TCT 2018 and simultaneously published in the New England Journal of Medicine, also examined patients with heart failure and secondary MR.
However, in REDUCE-FMR, many of the patients had milder heart failure than the researchers had expected: 44.8% in the treatment group had NYHA class II, as did 48.5% in the sham group. That surprise may help identify an appropriate patient population. “I think this device may have a nice spot in between medical therapy and MitraClip implantation, because we have, by chance, a patient population with mild heart insufficiency and mild MR,” said Dr. Sievert.
The two devices also showed different physiologic effects, Michael Mack, MD, said at a press conference. “One subtle difference is that, in this trial, the difference is due to both positive left ventricular remodeling in the treatment arm and continued progression in the sham control. In COAPT, the difference in improvement that we saw was totally due to prevention of progression of disease. We just stabilized the disease to where it was at. So that’s an intriguing difference here, that you actually were able to demonstrate positive left ventricular remodeling,” noted Dr. Mack, medical director for cardiovascular surgery at Baylor Scott & White Medical Center, Plano, Tex. He was a coinvestigator in the COAPT trial.
REDUCE-FMR was funded by Cardiac Dimensions. Dr. Sievert has received consulting fees, travel expenses, and study honoraria from Cardiac Dimensions, and 35 other companies. Dr. Mack has received grant support or had a research contract with Abbott Vascular, Medtronic, and Edwards Lifesciences.
REPORTING FROM TCT 2018
Key clinical point: The device led to improvement in mitral regurgitation as well as ventricular remodeling.
Major finding:
Study details: REDUCE-FMR, a randomized, sham controlled trial of 120 patients from 8 countries.
Disclosures: REDUCE-FMR was funded by Cardiac Dimensions. Dr. Sievert has received consulting fees, travel expenses, and study honoraria from Cardiac Dimensions, and 35 other companies. Dr. Mack has received grant support or had a research contract with Abbott Vascular, Medtronic, and Edwards Lifesciences.
COAPT: MitraClip prolongs life in selected HF patients
SAN DIEGO – Among a carefully selected subset of heart failure patients and severe secondary mitral regurgitation, transcatheter mitral valve repair with the MitraClip reduced hospitalizations for heart failure by 47%, and death from any cause by 38% over 24 months, compared with maximal medical therapy alone.
That’s according to a randomized, open-label trial presented at the Transcatheter Cardiovascular Therapeutics annual meeting.
The number needed to treat to prevent one heart failure (HF) hospitalization within 2 years was three; the number needed to treat to save one life was six. Only about 3% of patients had a device complication within 12 months of placement in the study, dubbed COAPT (the Heart Failure Patients with Functional Mitral Regurgitation Trial).
COAPT patients had grade 3+ or 4+ secondary mitral regurgitation, with a mean effective regurgitant orifice area (EROA) of 41 mm2. Their left ventricles were dilated, but not huge, with a mean left ventricular end-diastolic volume of 101 mL/m2. “We estimate that’s about 10% of heart failure patients,” said lead investigator and interventional cardiologist Gregg W. Stone, MD, a professor of medicine at Columbia University, New York.
MitraClip placement was performed in high-volume centers by experienced operators, and patients were on maximally tolerated doses of guideline-directed medical therapy, as per the 2013 American College of Cardiology/American Heart Association heart failure management guidelines. There was very little variation in treatment regimens during the 2-year trial (J Am Coll Cardiol. 2017;70:776-803).
Those parameters matter. Among HF patients who did not fit them in the recent Mitra-FR trial in France, MitraClip did not reduce rates of death or unplanned hospitalization (N Engl J Med. 2018 Aug 27. doi: 10.1056/NEJMoa1805374).
COAPT and Mitra-FR investigators said at the meeting that the studies are complimentary, not conflicting, because together, they define secondary mitral regurgitation (MR) patients who will and will not benefit from the device.
MR was less severe in Mitra-FR, with a mean EROA of 31 mm2, but left ventricles were more dilated, with a mean left ventricular end-diastolic volume of 135 mL/m2. Patients were on more real-world drug regimens that varied over the course of the trial. Also, the lower implantation rates and higher complication rates in Mitra-FR “suggests perhaps greater experience of the COAPT operators,” said Dr. Stone, who also is the director of cardiovascular research and education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center.
In short, “they were a different patient population than were enrolled in COAPT,” he said at the meeting, sponsored by the Cardiovascular Research Foundation, which Dr. Stone also codirects.
There was great excitement at TCT about COAPT because there was a startling benefit for patients who previously had few options. But many speakers worried that the hype surrounding the trial will drown out the critically important message about patient selection and that the clip will be used in HF patients who don’t fit the COAPT profile.
They also said that the emerging picture of benefit in patients with less ventricular dilation but more mitral regurgitation needs to be fleshed out and better quantified.
COAPT randomized 302 patients to MitraClip on a background of guideline-directed therapy and 312 to guideline-directed therapy alone. Participants who had mitral regurgitation caused by left ventricular dysfunction, were not surgical candidates, and remained symptomatic despite optimal treatment.
The annualized rate of all hospitalizations for HF within 24 months was 35.8% per patient-year in the device group, as compared with 67.9% per patient-year in the control group, for a relative reduction of 47% (P less than .001).
Death from any cause within 24 months occurred in 29.1% of the patients in the device group and 46.1% in the control group, yielding a reduction of 38% (P less than .001).
“We didn’t cure patients by fixing their MR. They still had 29% 2-year mortality, but we did markedly improve their quality of life. The only subgroup that didn’t benefit were patients that had an EORA of less than 30 mm2 and end diastolic volume greater than the median” of 96 mL/m2, which was “fascinating,” Dr. Stone said, and fit the emerging picture.
Mitral regurgitation grade fell to 1+ or lower in 82% of patients after clip placement and remained there in the majority of survivors at 2 years.
For a long time, “HF experts thought MR was just a marker of severe left ventricular dysfunction. What I think we see here is that secondary MR is not just a bystander. It contributes to the abnormal pathophysiology of these patients,” he said.
The trial was sponsored by MitraClip’s maker, Abbott. The company participated in site selection, management, and data analysis. Dr. Stone disclosed that his employer, Columbia University, receives royalties from Abbott for sale of the clip. Several fellow investigators disclosed grants, fees, and other financial ties to the company.
Simultaneously with the COAPT presentation, the results were published online (N Engl J Med. 2018 Sep 23. doi: 10.1056/NEJMoa1806640).
Mitra-FR was funded by the French Ministry of Health and Research and Abbott.
This is really a blockbuster trial, because you see a statistically significant reduction in cardiovascular endpoints, which is something we almost never see in device-based trials. I think this is going to change clinical practice, but the question of generalizability is tricky. This was such a well-conducted trial; it may be difficult to generalize this to the practicing public. I was impressed by the MitraClip performance: the reduction in MR [mitral regurgitation], the lack of recurrence, and the small number of complications. Perhaps more than anything else, the difference between Mitra-FR and COAPT was the quality of the operators.
Martin B. Leon, MD , is the director of the Center for Interventional Vascular Therapy at Columbia University, N.Y., and the Cardiovascular Research Foundation’s founder and codirector of medical research and education. He was not involved in COAPT, and made his comments after the study presentation.
This is really a blockbuster trial, because you see a statistically significant reduction in cardiovascular endpoints, which is something we almost never see in device-based trials. I think this is going to change clinical practice, but the question of generalizability is tricky. This was such a well-conducted trial; it may be difficult to generalize this to the practicing public. I was impressed by the MitraClip performance: the reduction in MR [mitral regurgitation], the lack of recurrence, and the small number of complications. Perhaps more than anything else, the difference between Mitra-FR and COAPT was the quality of the operators.
Martin B. Leon, MD , is the director of the Center for Interventional Vascular Therapy at Columbia University, N.Y., and the Cardiovascular Research Foundation’s founder and codirector of medical research and education. He was not involved in COAPT, and made his comments after the study presentation.
This is really a blockbuster trial, because you see a statistically significant reduction in cardiovascular endpoints, which is something we almost never see in device-based trials. I think this is going to change clinical practice, but the question of generalizability is tricky. This was such a well-conducted trial; it may be difficult to generalize this to the practicing public. I was impressed by the MitraClip performance: the reduction in MR [mitral regurgitation], the lack of recurrence, and the small number of complications. Perhaps more than anything else, the difference between Mitra-FR and COAPT was the quality of the operators.
Martin B. Leon, MD , is the director of the Center for Interventional Vascular Therapy at Columbia University, N.Y., and the Cardiovascular Research Foundation’s founder and codirector of medical research and education. He was not involved in COAPT, and made his comments after the study presentation.
SAN DIEGO – Among a carefully selected subset of heart failure patients and severe secondary mitral regurgitation, transcatheter mitral valve repair with the MitraClip reduced hospitalizations for heart failure by 47%, and death from any cause by 38% over 24 months, compared with maximal medical therapy alone.
That’s according to a randomized, open-label trial presented at the Transcatheter Cardiovascular Therapeutics annual meeting.
The number needed to treat to prevent one heart failure (HF) hospitalization within 2 years was three; the number needed to treat to save one life was six. Only about 3% of patients had a device complication within 12 months of placement in the study, dubbed COAPT (the Heart Failure Patients with Functional Mitral Regurgitation Trial).
COAPT patients had grade 3+ or 4+ secondary mitral regurgitation, with a mean effective regurgitant orifice area (EROA) of 41 mm2. Their left ventricles were dilated, but not huge, with a mean left ventricular end-diastolic volume of 101 mL/m2. “We estimate that’s about 10% of heart failure patients,” said lead investigator and interventional cardiologist Gregg W. Stone, MD, a professor of medicine at Columbia University, New York.
MitraClip placement was performed in high-volume centers by experienced operators, and patients were on maximally tolerated doses of guideline-directed medical therapy, as per the 2013 American College of Cardiology/American Heart Association heart failure management guidelines. There was very little variation in treatment regimens during the 2-year trial (J Am Coll Cardiol. 2017;70:776-803).
Those parameters matter. Among HF patients who did not fit them in the recent Mitra-FR trial in France, MitraClip did not reduce rates of death or unplanned hospitalization (N Engl J Med. 2018 Aug 27. doi: 10.1056/NEJMoa1805374).
COAPT and Mitra-FR investigators said at the meeting that the studies are complimentary, not conflicting, because together, they define secondary mitral regurgitation (MR) patients who will and will not benefit from the device.
MR was less severe in Mitra-FR, with a mean EROA of 31 mm2, but left ventricles were more dilated, with a mean left ventricular end-diastolic volume of 135 mL/m2. Patients were on more real-world drug regimens that varied over the course of the trial. Also, the lower implantation rates and higher complication rates in Mitra-FR “suggests perhaps greater experience of the COAPT operators,” said Dr. Stone, who also is the director of cardiovascular research and education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center.
In short, “they were a different patient population than were enrolled in COAPT,” he said at the meeting, sponsored by the Cardiovascular Research Foundation, which Dr. Stone also codirects.
There was great excitement at TCT about COAPT because there was a startling benefit for patients who previously had few options. But many speakers worried that the hype surrounding the trial will drown out the critically important message about patient selection and that the clip will be used in HF patients who don’t fit the COAPT profile.
They also said that the emerging picture of benefit in patients with less ventricular dilation but more mitral regurgitation needs to be fleshed out and better quantified.
COAPT randomized 302 patients to MitraClip on a background of guideline-directed therapy and 312 to guideline-directed therapy alone. Participants who had mitral regurgitation caused by left ventricular dysfunction, were not surgical candidates, and remained symptomatic despite optimal treatment.
The annualized rate of all hospitalizations for HF within 24 months was 35.8% per patient-year in the device group, as compared with 67.9% per patient-year in the control group, for a relative reduction of 47% (P less than .001).
Death from any cause within 24 months occurred in 29.1% of the patients in the device group and 46.1% in the control group, yielding a reduction of 38% (P less than .001).
“We didn’t cure patients by fixing their MR. They still had 29% 2-year mortality, but we did markedly improve their quality of life. The only subgroup that didn’t benefit were patients that had an EORA of less than 30 mm2 and end diastolic volume greater than the median” of 96 mL/m2, which was “fascinating,” Dr. Stone said, and fit the emerging picture.
Mitral regurgitation grade fell to 1+ or lower in 82% of patients after clip placement and remained there in the majority of survivors at 2 years.
For a long time, “HF experts thought MR was just a marker of severe left ventricular dysfunction. What I think we see here is that secondary MR is not just a bystander. It contributes to the abnormal pathophysiology of these patients,” he said.
The trial was sponsored by MitraClip’s maker, Abbott. The company participated in site selection, management, and data analysis. Dr. Stone disclosed that his employer, Columbia University, receives royalties from Abbott for sale of the clip. Several fellow investigators disclosed grants, fees, and other financial ties to the company.
Simultaneously with the COAPT presentation, the results were published online (N Engl J Med. 2018 Sep 23. doi: 10.1056/NEJMoa1806640).
Mitra-FR was funded by the French Ministry of Health and Research and Abbott.
SAN DIEGO – Among a carefully selected subset of heart failure patients and severe secondary mitral regurgitation, transcatheter mitral valve repair with the MitraClip reduced hospitalizations for heart failure by 47%, and death from any cause by 38% over 24 months, compared with maximal medical therapy alone.
That’s according to a randomized, open-label trial presented at the Transcatheter Cardiovascular Therapeutics annual meeting.
The number needed to treat to prevent one heart failure (HF) hospitalization within 2 years was three; the number needed to treat to save one life was six. Only about 3% of patients had a device complication within 12 months of placement in the study, dubbed COAPT (the Heart Failure Patients with Functional Mitral Regurgitation Trial).
COAPT patients had grade 3+ or 4+ secondary mitral regurgitation, with a mean effective regurgitant orifice area (EROA) of 41 mm2. Their left ventricles were dilated, but not huge, with a mean left ventricular end-diastolic volume of 101 mL/m2. “We estimate that’s about 10% of heart failure patients,” said lead investigator and interventional cardiologist Gregg W. Stone, MD, a professor of medicine at Columbia University, New York.
MitraClip placement was performed in high-volume centers by experienced operators, and patients were on maximally tolerated doses of guideline-directed medical therapy, as per the 2013 American College of Cardiology/American Heart Association heart failure management guidelines. There was very little variation in treatment regimens during the 2-year trial (J Am Coll Cardiol. 2017;70:776-803).
Those parameters matter. Among HF patients who did not fit them in the recent Mitra-FR trial in France, MitraClip did not reduce rates of death or unplanned hospitalization (N Engl J Med. 2018 Aug 27. doi: 10.1056/NEJMoa1805374).
COAPT and Mitra-FR investigators said at the meeting that the studies are complimentary, not conflicting, because together, they define secondary mitral regurgitation (MR) patients who will and will not benefit from the device.
MR was less severe in Mitra-FR, with a mean EROA of 31 mm2, but left ventricles were more dilated, with a mean left ventricular end-diastolic volume of 135 mL/m2. Patients were on more real-world drug regimens that varied over the course of the trial. Also, the lower implantation rates and higher complication rates in Mitra-FR “suggests perhaps greater experience of the COAPT operators,” said Dr. Stone, who also is the director of cardiovascular research and education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center.
In short, “they were a different patient population than were enrolled in COAPT,” he said at the meeting, sponsored by the Cardiovascular Research Foundation, which Dr. Stone also codirects.
There was great excitement at TCT about COAPT because there was a startling benefit for patients who previously had few options. But many speakers worried that the hype surrounding the trial will drown out the critically important message about patient selection and that the clip will be used in HF patients who don’t fit the COAPT profile.
They also said that the emerging picture of benefit in patients with less ventricular dilation but more mitral regurgitation needs to be fleshed out and better quantified.
COAPT randomized 302 patients to MitraClip on a background of guideline-directed therapy and 312 to guideline-directed therapy alone. Participants who had mitral regurgitation caused by left ventricular dysfunction, were not surgical candidates, and remained symptomatic despite optimal treatment.
The annualized rate of all hospitalizations for HF within 24 months was 35.8% per patient-year in the device group, as compared with 67.9% per patient-year in the control group, for a relative reduction of 47% (P less than .001).
Death from any cause within 24 months occurred in 29.1% of the patients in the device group and 46.1% in the control group, yielding a reduction of 38% (P less than .001).
“We didn’t cure patients by fixing their MR. They still had 29% 2-year mortality, but we did markedly improve their quality of life. The only subgroup that didn’t benefit were patients that had an EORA of less than 30 mm2 and end diastolic volume greater than the median” of 96 mL/m2, which was “fascinating,” Dr. Stone said, and fit the emerging picture.
Mitral regurgitation grade fell to 1+ or lower in 82% of patients after clip placement and remained there in the majority of survivors at 2 years.
For a long time, “HF experts thought MR was just a marker of severe left ventricular dysfunction. What I think we see here is that secondary MR is not just a bystander. It contributes to the abnormal pathophysiology of these patients,” he said.
The trial was sponsored by MitraClip’s maker, Abbott. The company participated in site selection, management, and data analysis. Dr. Stone disclosed that his employer, Columbia University, receives royalties from Abbott for sale of the clip. Several fellow investigators disclosed grants, fees, and other financial ties to the company.
Simultaneously with the COAPT presentation, the results were published online (N Engl J Med. 2018 Sep 23. doi: 10.1056/NEJMoa1806640).
Mitra-FR was funded by the French Ministry of Health and Research and Abbott.
REPORTING FROM TCT 2018
Key clinical point: MitraClip reduced death and heart failure hospitalizations in certain patients, but
Major finding: Among a subset of heart failure patients with moderately dilated left ventricles and severe secondary mitral regurgitation, transcatheter mitral valve repair with the MitraClip reduced hospitalizations for heart failure within 24 months by 47%, and death from any cause within 24 months by 38%, compared with maximal medical therapy alone.
Study details: COAPT, a randomized, open-label trial with 614 subjects
Disclosures: The work was funded by MitraClip maker, Abbott. The company participated in site selection, management, and data analysis. The lead and several other investigators disclosed financial ties to the company.
DIVA results similar for drug-eluting, bare-metal stents
Drug-eluting stents (DESs) and less-expensive bare-metal stents (BMSs) performed equally well in patients with failed saphenous vein grafts after coronary artery bypass graft surgery, based on an analysis of patients in the DIVA trial.
The findings run counter to those of previous clinical trials, which had found drug-eluting stents perform better than bare-metal stents in these situations. “The study results have important economic implications in countries with high DES prices, such as the USA, because they suggest that the lower-cost BMS can be used in SVG [saphenous vein graft] lesions without compromising either safety or efficacy,” lead author Emmanouil S. Brilakis, MD, PhD, of Minneapolis Heart Institute and his coauthors said in reporting the results for the DIVA trial investigators in the Lancet.
The DIVA trial was a randomized, double-blind, controlled trial done at 25 U.S. Department of Veterans Affairs centers. Researchers randomly assigned 599 patients who had previous coronary artery bypass surgery to either the DES or BMS groups, and the study reported data from 597 patients. The combined endpoint comprised cardiac death, target vessel MI, or target vessel revascularization at 12 months and then over the entire length of follow-up, which ranged from 2 to 7 years. Operators used the DES or BMS of their choice.
While BMSs are presumed to be less expensive than DESs, the study authors did not provide prices or price ranges for the stents. Dr. Brilakis and his coauthors acknowledged that the financial implications depend on local stent pricing practices.
The cost-effectiveness of using DESs vs. BMSs has been controversial, with many studies reporting that BMS are cost-effective over the long-term because of the lower incidence of revascularization and later hospitalization. These studies did not differentiate between SVG and native vessels, however. Multiple studies have reported that the overall costs, including the cost for reintervention, are lower for DESs than for BMSs in native vessels. A Wake Forest study reported the average per procedure cost was $1,846 higher for a DES but the cost was offset after 3 years by lower revascularization rates (Circ Cardiovasc Qual Outcomes. 2011. doi: 10.1161/CIRCOUTCOMES.110.960187)
A recent Korean study found the total cost of DESs was about 5% higher (Yonsei Med J. 2014 Nov;55[6]:1533-41). A French study reported BMSs resulted in a cost reduction $217 per case (Open Heart. 2016 Aug 25;3[2]:e000445). But few, if any, studies have directly compared prices hospitals pay for DESs and BMSs.
Pricing aside, Dr. Brilakis and his coauthors reported no statistical differences in terms of outcomes between the DES and BMS groups. Baseline characteristics of both groups were similar, and the vessel failure rates were 17% in the DES group and 19% in the BMS group after 12 months of follow-up. After 2-7 years, “target vessel failure occurred in approximately one in three patients, with no difference between the bare-metal and drug-eluting stents,” Dr. Brilakis and his coauthors said.
There was no significant difference in cardiac death rates – 5% for DES patients and 4% for BMS patients – or in rates of target lesion revascularization, at 9% and 8%, respectively. Postprocedure medication rates were also similar between the two groups. For example, the rates of patients on P2Y12 inhibitors were 89% for both groups at 12 months and, among those who had follow-up at 36 months, 48% for DES and 44% for BMS.
Among the limitations of the study that Dr. Brilakis and his coauthors noted was the high proportion of men in the VA population – only two women, both in the DES group, participated in the study – and the interventionists doing the index SVG intervention were not masked to the type of stent used.
Dr. Brilakis disclosed relationships with Abbott Vascular, Amgen, Asahi, Boston Scientific, Cardinal Health, CSI, Elsevier, GE Healthcare, Medicure, Medtronic, Nitiloop, InfraRedx, and Osprey.
SOURCE: Brilakis ES et al. Lancet. 2018 May 19;391(10134);1997-2007.
The predominant use of second-generation drug-eluting stents in the DIVA study may explain why the researchers found no difference in outcomes for bare metal and drug-eluting stents.
Most patients in previous trials were treated with first-generation drug-eluting stents, but second-generation drug-eluting stents perform better than their first-generation counterparts in native coronary artery disease. One might think that this finding should also apply to saphenous vein bypass graft lesions in which atherosclerosis is more aggressive and the progress of the disease much faster, yet this was not the case in DIVA, and the study authors did not provide an explanation for this finding.
One possible reason for the comparability of outcomes in the drug-eluting stents and bare metal stents groups may be that saphenous vein bypass graft lesions may be more favorably disposed to paclitaxel, commonly used in first-generation drug-eluting stents, than the drugs found in the second-generation stents. The DIVA findings may indicate that the second-generation drug-eluting stents performed worse, not that the bare metal stents performed better.
Studies of only first-generation paclitaxel-eluting stents showed a sustained benefit. Any notion that the pathophysiology of saphenous vein grafts might make them more amenable to a bare metal stent while a drug-eluting stent is better suited for native vessels is purely speculative. Further research comparing the effect of different stent types in saphenous vein bypass graft failure is warranted.
Raban V. Jeger, MD, and Sven Möbius-Winkler, MD, made these remarks in an invited commentary. Dr. Jeger is with the University Hospital Basel (Switzerland), and Dr. Möbius-Winkler is with University Hospital Jena (Germany). Dr. Jeger disclosed he is the principal investigator of the BASKET-SAVAGE trial, which received funding from Boston Scientific Germany. Dr. Möbius-Winkler had no financial relationships to disclose.
The predominant use of second-generation drug-eluting stents in the DIVA study may explain why the researchers found no difference in outcomes for bare metal and drug-eluting stents.
Most patients in previous trials were treated with first-generation drug-eluting stents, but second-generation drug-eluting stents perform better than their first-generation counterparts in native coronary artery disease. One might think that this finding should also apply to saphenous vein bypass graft lesions in which atherosclerosis is more aggressive and the progress of the disease much faster, yet this was not the case in DIVA, and the study authors did not provide an explanation for this finding.
One possible reason for the comparability of outcomes in the drug-eluting stents and bare metal stents groups may be that saphenous vein bypass graft lesions may be more favorably disposed to paclitaxel, commonly used in first-generation drug-eluting stents, than the drugs found in the second-generation stents. The DIVA findings may indicate that the second-generation drug-eluting stents performed worse, not that the bare metal stents performed better.
Studies of only first-generation paclitaxel-eluting stents showed a sustained benefit. Any notion that the pathophysiology of saphenous vein grafts might make them more amenable to a bare metal stent while a drug-eluting stent is better suited for native vessels is purely speculative. Further research comparing the effect of different stent types in saphenous vein bypass graft failure is warranted.
Raban V. Jeger, MD, and Sven Möbius-Winkler, MD, made these remarks in an invited commentary. Dr. Jeger is with the University Hospital Basel (Switzerland), and Dr. Möbius-Winkler is with University Hospital Jena (Germany). Dr. Jeger disclosed he is the principal investigator of the BASKET-SAVAGE trial, which received funding from Boston Scientific Germany. Dr. Möbius-Winkler had no financial relationships to disclose.
The predominant use of second-generation drug-eluting stents in the DIVA study may explain why the researchers found no difference in outcomes for bare metal and drug-eluting stents.
Most patients in previous trials were treated with first-generation drug-eluting stents, but second-generation drug-eluting stents perform better than their first-generation counterparts in native coronary artery disease. One might think that this finding should also apply to saphenous vein bypass graft lesions in which atherosclerosis is more aggressive and the progress of the disease much faster, yet this was not the case in DIVA, and the study authors did not provide an explanation for this finding.
One possible reason for the comparability of outcomes in the drug-eluting stents and bare metal stents groups may be that saphenous vein bypass graft lesions may be more favorably disposed to paclitaxel, commonly used in first-generation drug-eluting stents, than the drugs found in the second-generation stents. The DIVA findings may indicate that the second-generation drug-eluting stents performed worse, not that the bare metal stents performed better.
Studies of only first-generation paclitaxel-eluting stents showed a sustained benefit. Any notion that the pathophysiology of saphenous vein grafts might make them more amenable to a bare metal stent while a drug-eluting stent is better suited for native vessels is purely speculative. Further research comparing the effect of different stent types in saphenous vein bypass graft failure is warranted.
Raban V. Jeger, MD, and Sven Möbius-Winkler, MD, made these remarks in an invited commentary. Dr. Jeger is with the University Hospital Basel (Switzerland), and Dr. Möbius-Winkler is with University Hospital Jena (Germany). Dr. Jeger disclosed he is the principal investigator of the BASKET-SAVAGE trial, which received funding from Boston Scientific Germany. Dr. Möbius-Winkler had no financial relationships to disclose.
Drug-eluting stents (DESs) and less-expensive bare-metal stents (BMSs) performed equally well in patients with failed saphenous vein grafts after coronary artery bypass graft surgery, based on an analysis of patients in the DIVA trial.
The findings run counter to those of previous clinical trials, which had found drug-eluting stents perform better than bare-metal stents in these situations. “The study results have important economic implications in countries with high DES prices, such as the USA, because they suggest that the lower-cost BMS can be used in SVG [saphenous vein graft] lesions without compromising either safety or efficacy,” lead author Emmanouil S. Brilakis, MD, PhD, of Minneapolis Heart Institute and his coauthors said in reporting the results for the DIVA trial investigators in the Lancet.
The DIVA trial was a randomized, double-blind, controlled trial done at 25 U.S. Department of Veterans Affairs centers. Researchers randomly assigned 599 patients who had previous coronary artery bypass surgery to either the DES or BMS groups, and the study reported data from 597 patients. The combined endpoint comprised cardiac death, target vessel MI, or target vessel revascularization at 12 months and then over the entire length of follow-up, which ranged from 2 to 7 years. Operators used the DES or BMS of their choice.
While BMSs are presumed to be less expensive than DESs, the study authors did not provide prices or price ranges for the stents. Dr. Brilakis and his coauthors acknowledged that the financial implications depend on local stent pricing practices.
The cost-effectiveness of using DESs vs. BMSs has been controversial, with many studies reporting that BMS are cost-effective over the long-term because of the lower incidence of revascularization and later hospitalization. These studies did not differentiate between SVG and native vessels, however. Multiple studies have reported that the overall costs, including the cost for reintervention, are lower for DESs than for BMSs in native vessels. A Wake Forest study reported the average per procedure cost was $1,846 higher for a DES but the cost was offset after 3 years by lower revascularization rates (Circ Cardiovasc Qual Outcomes. 2011. doi: 10.1161/CIRCOUTCOMES.110.960187)
A recent Korean study found the total cost of DESs was about 5% higher (Yonsei Med J. 2014 Nov;55[6]:1533-41). A French study reported BMSs resulted in a cost reduction $217 per case (Open Heart. 2016 Aug 25;3[2]:e000445). But few, if any, studies have directly compared prices hospitals pay for DESs and BMSs.
Pricing aside, Dr. Brilakis and his coauthors reported no statistical differences in terms of outcomes between the DES and BMS groups. Baseline characteristics of both groups were similar, and the vessel failure rates were 17% in the DES group and 19% in the BMS group after 12 months of follow-up. After 2-7 years, “target vessel failure occurred in approximately one in three patients, with no difference between the bare-metal and drug-eluting stents,” Dr. Brilakis and his coauthors said.
There was no significant difference in cardiac death rates – 5% for DES patients and 4% for BMS patients – or in rates of target lesion revascularization, at 9% and 8%, respectively. Postprocedure medication rates were also similar between the two groups. For example, the rates of patients on P2Y12 inhibitors were 89% for both groups at 12 months and, among those who had follow-up at 36 months, 48% for DES and 44% for BMS.
Among the limitations of the study that Dr. Brilakis and his coauthors noted was the high proportion of men in the VA population – only two women, both in the DES group, participated in the study – and the interventionists doing the index SVG intervention were not masked to the type of stent used.
Dr. Brilakis disclosed relationships with Abbott Vascular, Amgen, Asahi, Boston Scientific, Cardinal Health, CSI, Elsevier, GE Healthcare, Medicure, Medtronic, Nitiloop, InfraRedx, and Osprey.
SOURCE: Brilakis ES et al. Lancet. 2018 May 19;391(10134);1997-2007.
Drug-eluting stents (DESs) and less-expensive bare-metal stents (BMSs) performed equally well in patients with failed saphenous vein grafts after coronary artery bypass graft surgery, based on an analysis of patients in the DIVA trial.
The findings run counter to those of previous clinical trials, which had found drug-eluting stents perform better than bare-metal stents in these situations. “The study results have important economic implications in countries with high DES prices, such as the USA, because they suggest that the lower-cost BMS can be used in SVG [saphenous vein graft] lesions without compromising either safety or efficacy,” lead author Emmanouil S. Brilakis, MD, PhD, of Minneapolis Heart Institute and his coauthors said in reporting the results for the DIVA trial investigators in the Lancet.
The DIVA trial was a randomized, double-blind, controlled trial done at 25 U.S. Department of Veterans Affairs centers. Researchers randomly assigned 599 patients who had previous coronary artery bypass surgery to either the DES or BMS groups, and the study reported data from 597 patients. The combined endpoint comprised cardiac death, target vessel MI, or target vessel revascularization at 12 months and then over the entire length of follow-up, which ranged from 2 to 7 years. Operators used the DES or BMS of their choice.
While BMSs are presumed to be less expensive than DESs, the study authors did not provide prices or price ranges for the stents. Dr. Brilakis and his coauthors acknowledged that the financial implications depend on local stent pricing practices.
The cost-effectiveness of using DESs vs. BMSs has been controversial, with many studies reporting that BMS are cost-effective over the long-term because of the lower incidence of revascularization and later hospitalization. These studies did not differentiate between SVG and native vessels, however. Multiple studies have reported that the overall costs, including the cost for reintervention, are lower for DESs than for BMSs in native vessels. A Wake Forest study reported the average per procedure cost was $1,846 higher for a DES but the cost was offset after 3 years by lower revascularization rates (Circ Cardiovasc Qual Outcomes. 2011. doi: 10.1161/CIRCOUTCOMES.110.960187)
A recent Korean study found the total cost of DESs was about 5% higher (Yonsei Med J. 2014 Nov;55[6]:1533-41). A French study reported BMSs resulted in a cost reduction $217 per case (Open Heart. 2016 Aug 25;3[2]:e000445). But few, if any, studies have directly compared prices hospitals pay for DESs and BMSs.
Pricing aside, Dr. Brilakis and his coauthors reported no statistical differences in terms of outcomes between the DES and BMS groups. Baseline characteristics of both groups were similar, and the vessel failure rates were 17% in the DES group and 19% in the BMS group after 12 months of follow-up. After 2-7 years, “target vessel failure occurred in approximately one in three patients, with no difference between the bare-metal and drug-eluting stents,” Dr. Brilakis and his coauthors said.
There was no significant difference in cardiac death rates – 5% for DES patients and 4% for BMS patients – or in rates of target lesion revascularization, at 9% and 8%, respectively. Postprocedure medication rates were also similar between the two groups. For example, the rates of patients on P2Y12 inhibitors were 89% for both groups at 12 months and, among those who had follow-up at 36 months, 48% for DES and 44% for BMS.
Among the limitations of the study that Dr. Brilakis and his coauthors noted was the high proportion of men in the VA population – only two women, both in the DES group, participated in the study – and the interventionists doing the index SVG intervention were not masked to the type of stent used.
Dr. Brilakis disclosed relationships with Abbott Vascular, Amgen, Asahi, Boston Scientific, Cardinal Health, CSI, Elsevier, GE Healthcare, Medicure, Medtronic, Nitiloop, InfraRedx, and Osprey.
SOURCE: Brilakis ES et al. Lancet. 2018 May 19;391(10134);1997-2007.
FROM THE LANCET
Key clinical point: Drug-eluting and bare-metal stents had similar outcomes for saphenous vein bypass lesions.
Major finding: Target vessel failure was 17% for drug-eluting stents and 19% for bare metal stents.
Study details: The DIVA trial randomly assigned 599 patients with post-CABG saphenous vein bypass graft failure to drug-eluting or bare metal stents between Jan. 1, 2012, and Dec. 31, 2015.
Disclosures: Dr. Brilakis disclosed relationships with Abbott Vascular, Amgen, Asahi, Boston Scientific, Cardinal Health, CSI, Elsevier, GE Healthcare, Medicure, Medtronic, Nitiloop, InfraRedx, and Osprey.
Source: Brilakis ES et al. Lancet. 2018 May 19;391(10134);1997-2007.
Partial nephrectomies on rise for early-stage RCC
SAN FRANCISCO – Partial nephrectomy for localized renal cell carcinomas (RCCs) is on the rise, but the procedure is still less commonly performed than radical nephrectomy and more commonly performed at high-volume surgical centers.
About half of localized renal tumors are excised through partial nephrectomy, based on results from a new analysis of The National Cancer Database. The study also indicated that patient mortality rates were lower at high volume centers, those in the top 10 percentile of treatment volume, said David Cahn, DO, who presented the results at the annual meeting of the American Urological Association.
The study looked at surgeries among 142,000 patients with pT1a-T2b RCCs (no involvement of lymph nodes or metastases) who underwent procedures during 2004-2014.
Overall, 41% of patients had partial nephrectomies, 58% had radical nephrectomies, and 1% received ablative therapy. The frequency of partial nephrectomies rose markedly over the course of the study, increasing from 24% of cases in 2004 to 53% in 2014. The vast majority of partial nephrectomies, 81%, were performed for pT1a tumors; 24% of pT1b tumors also were excised using partial nephrectomy.
Compared with the reference point of T1a tumors, T1b tumors (odds ratio, 0.22; P less than .0001), T2a (OR, 0.06; P less than .0001), and T2b tumors (OR, 0.03; P less than .0001) were progressively less likely to be treated with partial nephrectomy. A multivariate analysis showed that patients at a high volume center were significantly more likely to undergo partial nephrectomy (OR, 1.89; P less than .0001). Overall mortality was lower at high volume centers (hazard ratio, 0.92; P = .012).
“I think that regionalization of care has ... some benefits to patients, but it comes with many challenges as well. This study really did help show that increased numbers [of procedures performed] makes you more comfortable and willing to offer partial nephrectomy,” said Dr. Cahn, of Fox Chase Cancer Center, Philadelphia.
“Volume tends to show better outcomes. But the concern is: Are you overloading systems? Are you making patients travel farther, and how does that work in terms of follow-up care?” Dr. Cahn said. He cited the example of a patient who may have to travel several hours to get surgery but then returns home and develops a postoperative complication that must be treated in a different facility. That raises issues of transfer of medical records and coordination of care.
The solution, he said, is for some of the procedures and practices common at high-volume centers to be transferred to smaller centers. “For the routine partial nephrectomy ... we need to have well-trained physicians who can offer those all over the country. I think it’s too hard in terms of feasibility to push those patients just towards certain high volume centers.”
SOURCE: AUA Annual Meeting, Abstract PD07-04.
SAN FRANCISCO – Partial nephrectomy for localized renal cell carcinomas (RCCs) is on the rise, but the procedure is still less commonly performed than radical nephrectomy and more commonly performed at high-volume surgical centers.
About half of localized renal tumors are excised through partial nephrectomy, based on results from a new analysis of The National Cancer Database. The study also indicated that patient mortality rates were lower at high volume centers, those in the top 10 percentile of treatment volume, said David Cahn, DO, who presented the results at the annual meeting of the American Urological Association.
The study looked at surgeries among 142,000 patients with pT1a-T2b RCCs (no involvement of lymph nodes or metastases) who underwent procedures during 2004-2014.
Overall, 41% of patients had partial nephrectomies, 58% had radical nephrectomies, and 1% received ablative therapy. The frequency of partial nephrectomies rose markedly over the course of the study, increasing from 24% of cases in 2004 to 53% in 2014. The vast majority of partial nephrectomies, 81%, were performed for pT1a tumors; 24% of pT1b tumors also were excised using partial nephrectomy.
Compared with the reference point of T1a tumors, T1b tumors (odds ratio, 0.22; P less than .0001), T2a (OR, 0.06; P less than .0001), and T2b tumors (OR, 0.03; P less than .0001) were progressively less likely to be treated with partial nephrectomy. A multivariate analysis showed that patients at a high volume center were significantly more likely to undergo partial nephrectomy (OR, 1.89; P less than .0001). Overall mortality was lower at high volume centers (hazard ratio, 0.92; P = .012).
“I think that regionalization of care has ... some benefits to patients, but it comes with many challenges as well. This study really did help show that increased numbers [of procedures performed] makes you more comfortable and willing to offer partial nephrectomy,” said Dr. Cahn, of Fox Chase Cancer Center, Philadelphia.
“Volume tends to show better outcomes. But the concern is: Are you overloading systems? Are you making patients travel farther, and how does that work in terms of follow-up care?” Dr. Cahn said. He cited the example of a patient who may have to travel several hours to get surgery but then returns home and develops a postoperative complication that must be treated in a different facility. That raises issues of transfer of medical records and coordination of care.
The solution, he said, is for some of the procedures and practices common at high-volume centers to be transferred to smaller centers. “For the routine partial nephrectomy ... we need to have well-trained physicians who can offer those all over the country. I think it’s too hard in terms of feasibility to push those patients just towards certain high volume centers.”
SOURCE: AUA Annual Meeting, Abstract PD07-04.
SAN FRANCISCO – Partial nephrectomy for localized renal cell carcinomas (RCCs) is on the rise, but the procedure is still less commonly performed than radical nephrectomy and more commonly performed at high-volume surgical centers.
About half of localized renal tumors are excised through partial nephrectomy, based on results from a new analysis of The National Cancer Database. The study also indicated that patient mortality rates were lower at high volume centers, those in the top 10 percentile of treatment volume, said David Cahn, DO, who presented the results at the annual meeting of the American Urological Association.
The study looked at surgeries among 142,000 patients with pT1a-T2b RCCs (no involvement of lymph nodes or metastases) who underwent procedures during 2004-2014.
Overall, 41% of patients had partial nephrectomies, 58% had radical nephrectomies, and 1% received ablative therapy. The frequency of partial nephrectomies rose markedly over the course of the study, increasing from 24% of cases in 2004 to 53% in 2014. The vast majority of partial nephrectomies, 81%, were performed for pT1a tumors; 24% of pT1b tumors also were excised using partial nephrectomy.
Compared with the reference point of T1a tumors, T1b tumors (odds ratio, 0.22; P less than .0001), T2a (OR, 0.06; P less than .0001), and T2b tumors (OR, 0.03; P less than .0001) were progressively less likely to be treated with partial nephrectomy. A multivariate analysis showed that patients at a high volume center were significantly more likely to undergo partial nephrectomy (OR, 1.89; P less than .0001). Overall mortality was lower at high volume centers (hazard ratio, 0.92; P = .012).
“I think that regionalization of care has ... some benefits to patients, but it comes with many challenges as well. This study really did help show that increased numbers [of procedures performed] makes you more comfortable and willing to offer partial nephrectomy,” said Dr. Cahn, of Fox Chase Cancer Center, Philadelphia.
“Volume tends to show better outcomes. But the concern is: Are you overloading systems? Are you making patients travel farther, and how does that work in terms of follow-up care?” Dr. Cahn said. He cited the example of a patient who may have to travel several hours to get surgery but then returns home and develops a postoperative complication that must be treated in a different facility. That raises issues of transfer of medical records and coordination of care.
The solution, he said, is for some of the procedures and practices common at high-volume centers to be transferred to smaller centers. “For the routine partial nephrectomy ... we need to have well-trained physicians who can offer those all over the country. I think it’s too hard in terms of feasibility to push those patients just towards certain high volume centers.”
SOURCE: AUA Annual Meeting, Abstract PD07-04.
REPORTING FROM THE AUA ANNUAL MEETING
Key clinical point: Many patients who could undergo partial nephrectomy are still receiving radical nephrectomies.
Major finding: In 2014, 53% of patients with pT1a or pT1b RCC underwent partial nephrectomy.
Study details: Retrospective analysis of 142,000 patients.
Disclosures: The study was funded internally. Dr. Cahn reports having no relevant financial disclosures.
Source: Cahn D et al. AUA Annual Meeting, Abstract PD07-04.
GBS in T2DM patients: Study highlights pros and cons, need for better patient selection
ORLANDO – , according to a nationwide, matched, observational cohort study in Sweden.
After 9 years of follow-up, all-cause mortality was 49% lower among 5,321 patients with T2DM compared with 5,321 matched control (183 vs. 351 deaths; hazard ratio, 0.51), as has been reported in prior studies, Vasileios Liakopoulos, MD, of the University of Gothenburg (Sweden) reported at the annual scientific sessions of the American Diabetes Association.
Cardiovascular disease (CVD) risk was 34% lower (108 vs. 150 patients; HR, 0.66), fatal CVD risk was 66% lower (21 vs. 64 patients; HR, 0.34), acute myocardial infarction risk was 45% lower (51 vs. 85 events; HR, 0.55) congestive heart failure risk was 51% lower (109 vs. 225 events; HR, 0.49), and cancer risk was 22% lower (153 vs. 188 cases; HR, 0.78) in cases vs. controls, respectively.
“[As for] the diagnoses that related to diabetes, hyperglycemia was lower by 66%, admission to the hospital due to amputation was 49% lower, and we also found something relatively new – that renal disease was lower by 42%,” Dr. Liakopoulos said.
Renal disease occurred in 105 cases vs. 187 controls (HR, 0.58), with the difference between the groups intensifying after the third year of follow-up, he noted.
However, numerous adverse events occurred more often in case patients, he said.
For example, hospitalizations for psychiatric disorders were increased by 33% (317 vs. 268; HR, 1.33), alcohol-related diagnoses were nearly threefold higher (180 vs. 65; HR, 2.90), malnutrition occurred nearly three times more often (128 vs. 46 patients; HR, 2.81), and anemia occurred nearly twice as often (84 vs. 46 cases; HR, 1.92) in cases vs. controls.
Of course, all the surgery-related adverse events occurred more often in the case patients, but interestingly, those events – which included things like gastrointestinal surgery other than gastric bypass, abdominal pain, gallstones/pancreatitis, gastrointestinal ulcers and reflux, and bowel obstruction – did not occur more often in case patients than in gastric bypass patients without diabetes in other studies, he noted.
The findings were based on merged data from the Scandinavian Obesity Surgery Registry, the Swedish National Diabetes Register, and other national databases, and persons with T2DM who had undergone gastric bypass surgery between 2007 and 2013 were matched by propensity score (based on sex, age, body mass index, and calendar time from the beginning of the study) with obese individuals who were not surgically treated for obesity. The risks of postoperative outcomes were assessed using a Cox regression model adjusted for sex, age, body mass index, and socioeconomic status, Dr. Liakopoulos said.
This study, though limited by its observational nature, minor differences in patient characteristics between the cases and controls, and potential residual confounding, confirms the benefits of gastric bypass surgery in obese patients with T2DM but also characterizes an array of both short- and long-term adverse events after bariatric surgery in these patients, he said.
“The beneficial effects of gastric bypass have been presented in terms of weight reduction, improvements in risk factors and cardiovascular disease, and mortality reduction in people with or without diabetes,” he said, noting, however, that only a few reports have addressed long-term incidence of complications after gastric bypass – and type 2 diabetes has only been addressed in small randomized studies or in low proportions in large prospective studies.
“[Based on the findings] we suggest better selection of patients for bariatric surgery, and we think improved long-term postoperative monitoring might further improve the results of such treatment,” he concluded.
Dr. Liakopoulos reported having no disclosures.
SOURCE: Liakopoulos V et al. ADA 2018, Abstract 131-OR.
ORLANDO – , according to a nationwide, matched, observational cohort study in Sweden.
After 9 years of follow-up, all-cause mortality was 49% lower among 5,321 patients with T2DM compared with 5,321 matched control (183 vs. 351 deaths; hazard ratio, 0.51), as has been reported in prior studies, Vasileios Liakopoulos, MD, of the University of Gothenburg (Sweden) reported at the annual scientific sessions of the American Diabetes Association.
Cardiovascular disease (CVD) risk was 34% lower (108 vs. 150 patients; HR, 0.66), fatal CVD risk was 66% lower (21 vs. 64 patients; HR, 0.34), acute myocardial infarction risk was 45% lower (51 vs. 85 events; HR, 0.55) congestive heart failure risk was 51% lower (109 vs. 225 events; HR, 0.49), and cancer risk was 22% lower (153 vs. 188 cases; HR, 0.78) in cases vs. controls, respectively.
“[As for] the diagnoses that related to diabetes, hyperglycemia was lower by 66%, admission to the hospital due to amputation was 49% lower, and we also found something relatively new – that renal disease was lower by 42%,” Dr. Liakopoulos said.
Renal disease occurred in 105 cases vs. 187 controls (HR, 0.58), with the difference between the groups intensifying after the third year of follow-up, he noted.
However, numerous adverse events occurred more often in case patients, he said.
For example, hospitalizations for psychiatric disorders were increased by 33% (317 vs. 268; HR, 1.33), alcohol-related diagnoses were nearly threefold higher (180 vs. 65; HR, 2.90), malnutrition occurred nearly three times more often (128 vs. 46 patients; HR, 2.81), and anemia occurred nearly twice as often (84 vs. 46 cases; HR, 1.92) in cases vs. controls.
Of course, all the surgery-related adverse events occurred more often in the case patients, but interestingly, those events – which included things like gastrointestinal surgery other than gastric bypass, abdominal pain, gallstones/pancreatitis, gastrointestinal ulcers and reflux, and bowel obstruction – did not occur more often in case patients than in gastric bypass patients without diabetes in other studies, he noted.
The findings were based on merged data from the Scandinavian Obesity Surgery Registry, the Swedish National Diabetes Register, and other national databases, and persons with T2DM who had undergone gastric bypass surgery between 2007 and 2013 were matched by propensity score (based on sex, age, body mass index, and calendar time from the beginning of the study) with obese individuals who were not surgically treated for obesity. The risks of postoperative outcomes were assessed using a Cox regression model adjusted for sex, age, body mass index, and socioeconomic status, Dr. Liakopoulos said.
This study, though limited by its observational nature, minor differences in patient characteristics between the cases and controls, and potential residual confounding, confirms the benefits of gastric bypass surgery in obese patients with T2DM but also characterizes an array of both short- and long-term adverse events after bariatric surgery in these patients, he said.
“The beneficial effects of gastric bypass have been presented in terms of weight reduction, improvements in risk factors and cardiovascular disease, and mortality reduction in people with or without diabetes,” he said, noting, however, that only a few reports have addressed long-term incidence of complications after gastric bypass – and type 2 diabetes has only been addressed in small randomized studies or in low proportions in large prospective studies.
“[Based on the findings] we suggest better selection of patients for bariatric surgery, and we think improved long-term postoperative monitoring might further improve the results of such treatment,” he concluded.
Dr. Liakopoulos reported having no disclosures.
SOURCE: Liakopoulos V et al. ADA 2018, Abstract 131-OR.
ORLANDO – , according to a nationwide, matched, observational cohort study in Sweden.
After 9 years of follow-up, all-cause mortality was 49% lower among 5,321 patients with T2DM compared with 5,321 matched control (183 vs. 351 deaths; hazard ratio, 0.51), as has been reported in prior studies, Vasileios Liakopoulos, MD, of the University of Gothenburg (Sweden) reported at the annual scientific sessions of the American Diabetes Association.
Cardiovascular disease (CVD) risk was 34% lower (108 vs. 150 patients; HR, 0.66), fatal CVD risk was 66% lower (21 vs. 64 patients; HR, 0.34), acute myocardial infarction risk was 45% lower (51 vs. 85 events; HR, 0.55) congestive heart failure risk was 51% lower (109 vs. 225 events; HR, 0.49), and cancer risk was 22% lower (153 vs. 188 cases; HR, 0.78) in cases vs. controls, respectively.
“[As for] the diagnoses that related to diabetes, hyperglycemia was lower by 66%, admission to the hospital due to amputation was 49% lower, and we also found something relatively new – that renal disease was lower by 42%,” Dr. Liakopoulos said.
Renal disease occurred in 105 cases vs. 187 controls (HR, 0.58), with the difference between the groups intensifying after the third year of follow-up, he noted.
However, numerous adverse events occurred more often in case patients, he said.
For example, hospitalizations for psychiatric disorders were increased by 33% (317 vs. 268; HR, 1.33), alcohol-related diagnoses were nearly threefold higher (180 vs. 65; HR, 2.90), malnutrition occurred nearly three times more often (128 vs. 46 patients; HR, 2.81), and anemia occurred nearly twice as often (84 vs. 46 cases; HR, 1.92) in cases vs. controls.
Of course, all the surgery-related adverse events occurred more often in the case patients, but interestingly, those events – which included things like gastrointestinal surgery other than gastric bypass, abdominal pain, gallstones/pancreatitis, gastrointestinal ulcers and reflux, and bowel obstruction – did not occur more often in case patients than in gastric bypass patients without diabetes in other studies, he noted.
The findings were based on merged data from the Scandinavian Obesity Surgery Registry, the Swedish National Diabetes Register, and other national databases, and persons with T2DM who had undergone gastric bypass surgery between 2007 and 2013 were matched by propensity score (based on sex, age, body mass index, and calendar time from the beginning of the study) with obese individuals who were not surgically treated for obesity. The risks of postoperative outcomes were assessed using a Cox regression model adjusted for sex, age, body mass index, and socioeconomic status, Dr. Liakopoulos said.
This study, though limited by its observational nature, minor differences in patient characteristics between the cases and controls, and potential residual confounding, confirms the benefits of gastric bypass surgery in obese patients with T2DM but also characterizes an array of both short- and long-term adverse events after bariatric surgery in these patients, he said.
“The beneficial effects of gastric bypass have been presented in terms of weight reduction, improvements in risk factors and cardiovascular disease, and mortality reduction in people with or without diabetes,” he said, noting, however, that only a few reports have addressed long-term incidence of complications after gastric bypass – and type 2 diabetes has only been addressed in small randomized studies or in low proportions in large prospective studies.
“[Based on the findings] we suggest better selection of patients for bariatric surgery, and we think improved long-term postoperative monitoring might further improve the results of such treatment,” he concluded.
Dr. Liakopoulos reported having no disclosures.
SOURCE: Liakopoulos V et al. ADA 2018, Abstract 131-OR.
REPORTING FROM ADA 2018
Key clinical point: Bariatric surgery lowers mortality, CVD, and renal and other risks in obese T2DM patients but also has high complication rates.
Major finding: All-cause mortality, CVD, and renal disease risks were 49%, 34%, and 42% lower, respectively, in cases vs. controls.
Study details: A matched observational cohort study of 5,321 cases and 5,321 controls.
Disclosures: Dr. Liakopoulos reported having no disclosures.
Source: Liakopoulos V et al. ADA 2018, Abstract 131-OR.
Dr. Valerie W. Rusch to receive ACS Distinguished Service Award
The Board of Regents of the American College of Surgeons (ACS) has selected Valerie W. Rusch, MD, FACS, an esteemed thoracic surgeon in New York, NY, as the recipient of the 2018 Distinguished Service Award (DSA)--the College's highest honor. The Board of Regents will present the award to Dr. Rusch, vice-chair, clinical research, department of surgery; Miner Family Chair in Intrathoracic Cancers; attending surgeon, thoracic service, department of surgery, Memorial Sloan-Kettering Cancer Center; and professor of surgery, Weill Cornell Medical College, New York, NY, at the Convocation ceremony at 6:00 pm October 21 at the Clinical Congress 2018 in Boston, MA.
The Board of Regents is presenting the DSA to Dr. Rusch for "her exemplary leadership of many professional organizations and as a mentor, teacher, and trainer of the next generation of surgeons in clinical trial development and her dedication to expand access to surgical care to underserved global populations," according to the award citation.
The award also is being presented to Dr. Rusch "in admiration of her natural leadership, integrity, vision, and steadfast commitment to the College's initiatives and principles, serving as a role model to surgeons everywhere to always do the right thing for patients."
Leadership in the ACS
An ACS Fellow since 1986, Dr. Rusch has led several prominent ACS bodies, including serving as Chair of the Board of Governors (2006−2008) and Board of Regents (2015−2016). A Regent from 2008 to 2017, she chaired the Central Judiciary Committee (2009–2013), the Program Committee (2011–2017), the Board of Regents Nominating Committee (2011–2012), and the Committee on Global Engagement (2016−2017). She served on the Board of Regents Honors Committee (2012−2016), Executive Committee (2013−2016), and Finance Committee (2014−2016).
In addition, she has been a member of the College’s Advisory Council for Cardiothoracic Surgery (2002−2017), International Relations Committee (2007−2013, Executive Committee, 2009−2012), Commission on Cancer Executive Committee (2012−2017), Scholarships Committee (2008−2012), and Research and Optimal Patient Care Committee (2008−2015).
Renowned thoracic surgeon
Dr. Rusch specializes in the diagnosis and treatment of patients with cancers of the lung, airways (trachea, bronchi), esophagus, mediastinum, chest wall, and pleura (malignant pleural mesothelioma). She was among the first women in the U.S. to be board certified in thoracic surgery.
For more than 30 years, she has emphasized a multidisciplinary approach to treating patients with thoracic malignancy. Her research has focused on the molecular behaviors of asbestos cancers and the genetic tendencies of lung cancer as a means to identify certain cancers in the earlier stages.
Dr. Rusch has been a leader in national and international clinical trials for the treatment of thoracic malignancies and played a pivotal role in establishing the ACS Oncology Group--now the ACS Clinical Research Program. Among her many honors, in 2007, Dr. Rusch received the Thoracic Surgery Foundation for Research and Education Socrates Award, and in 2012, the Association of Women Surgeons awarded her the Nina Starr Braunwald Award for lifetime contributions to the advancement of women in surgery.
She has held 25 visiting professorships and lectureships and given more than 300 major lectures on thoracic cancers at medical conferences around the world. Her curriculum vitae boasts more than 400 peer-reviewed publications.
In addition to the ACS, Dr. Rusch has been a leader of other surgical organizations. More specifically, she served as chair of the American Board of Thoracic Surgery, chair of the Lung and Esophagus Task Force of the American Joint Commission on Cancer, and chair of the Mesothelioma Subcommittee of the International Association for the Study of Lung Cancer Staging Committee.
Dr. Rusch is fluent in both French and English, having graduated from the Lycée Français de New York. She graduated from Vassar College, Poughkeepsie, NY, with a degree in biochemistry. She earned her medical degree from the Columbia University College of Physicians and Surgeons, New York, and she completed surgical residency training in general surgery and thoracic surgery at the University of Washington, Seattle, followed by a fellowship at the University of Texas MD Anderson Cancer Center, Houston.
The Board of Regents of the American College of Surgeons (ACS) has selected Valerie W. Rusch, MD, FACS, an esteemed thoracic surgeon in New York, NY, as the recipient of the 2018 Distinguished Service Award (DSA)--the College's highest honor. The Board of Regents will present the award to Dr. Rusch, vice-chair, clinical research, department of surgery; Miner Family Chair in Intrathoracic Cancers; attending surgeon, thoracic service, department of surgery, Memorial Sloan-Kettering Cancer Center; and professor of surgery, Weill Cornell Medical College, New York, NY, at the Convocation ceremony at 6:00 pm October 21 at the Clinical Congress 2018 in Boston, MA.
The Board of Regents is presenting the DSA to Dr. Rusch for "her exemplary leadership of many professional organizations and as a mentor, teacher, and trainer of the next generation of surgeons in clinical trial development and her dedication to expand access to surgical care to underserved global populations," according to the award citation.
The award also is being presented to Dr. Rusch "in admiration of her natural leadership, integrity, vision, and steadfast commitment to the College's initiatives and principles, serving as a role model to surgeons everywhere to always do the right thing for patients."
Leadership in the ACS
An ACS Fellow since 1986, Dr. Rusch has led several prominent ACS bodies, including serving as Chair of the Board of Governors (2006−2008) and Board of Regents (2015−2016). A Regent from 2008 to 2017, she chaired the Central Judiciary Committee (2009–2013), the Program Committee (2011–2017), the Board of Regents Nominating Committee (2011–2012), and the Committee on Global Engagement (2016−2017). She served on the Board of Regents Honors Committee (2012−2016), Executive Committee (2013−2016), and Finance Committee (2014−2016).
In addition, she has been a member of the College’s Advisory Council for Cardiothoracic Surgery (2002−2017), International Relations Committee (2007−2013, Executive Committee, 2009−2012), Commission on Cancer Executive Committee (2012−2017), Scholarships Committee (2008−2012), and Research and Optimal Patient Care Committee (2008−2015).
Renowned thoracic surgeon
Dr. Rusch specializes in the diagnosis and treatment of patients with cancers of the lung, airways (trachea, bronchi), esophagus, mediastinum, chest wall, and pleura (malignant pleural mesothelioma). She was among the first women in the U.S. to be board certified in thoracic surgery.
For more than 30 years, she has emphasized a multidisciplinary approach to treating patients with thoracic malignancy. Her research has focused on the molecular behaviors of asbestos cancers and the genetic tendencies of lung cancer as a means to identify certain cancers in the earlier stages.
Dr. Rusch has been a leader in national and international clinical trials for the treatment of thoracic malignancies and played a pivotal role in establishing the ACS Oncology Group--now the ACS Clinical Research Program. Among her many honors, in 2007, Dr. Rusch received the Thoracic Surgery Foundation for Research and Education Socrates Award, and in 2012, the Association of Women Surgeons awarded her the Nina Starr Braunwald Award for lifetime contributions to the advancement of women in surgery.
She has held 25 visiting professorships and lectureships and given more than 300 major lectures on thoracic cancers at medical conferences around the world. Her curriculum vitae boasts more than 400 peer-reviewed publications.
In addition to the ACS, Dr. Rusch has been a leader of other surgical organizations. More specifically, she served as chair of the American Board of Thoracic Surgery, chair of the Lung and Esophagus Task Force of the American Joint Commission on Cancer, and chair of the Mesothelioma Subcommittee of the International Association for the Study of Lung Cancer Staging Committee.
Dr. Rusch is fluent in both French and English, having graduated from the Lycée Français de New York. She graduated from Vassar College, Poughkeepsie, NY, with a degree in biochemistry. She earned her medical degree from the Columbia University College of Physicians and Surgeons, New York, and she completed surgical residency training in general surgery and thoracic surgery at the University of Washington, Seattle, followed by a fellowship at the University of Texas MD Anderson Cancer Center, Houston.
The Board of Regents of the American College of Surgeons (ACS) has selected Valerie W. Rusch, MD, FACS, an esteemed thoracic surgeon in New York, NY, as the recipient of the 2018 Distinguished Service Award (DSA)--the College's highest honor. The Board of Regents will present the award to Dr. Rusch, vice-chair, clinical research, department of surgery; Miner Family Chair in Intrathoracic Cancers; attending surgeon, thoracic service, department of surgery, Memorial Sloan-Kettering Cancer Center; and professor of surgery, Weill Cornell Medical College, New York, NY, at the Convocation ceremony at 6:00 pm October 21 at the Clinical Congress 2018 in Boston, MA.
The Board of Regents is presenting the DSA to Dr. Rusch for "her exemplary leadership of many professional organizations and as a mentor, teacher, and trainer of the next generation of surgeons in clinical trial development and her dedication to expand access to surgical care to underserved global populations," according to the award citation.
The award also is being presented to Dr. Rusch "in admiration of her natural leadership, integrity, vision, and steadfast commitment to the College's initiatives and principles, serving as a role model to surgeons everywhere to always do the right thing for patients."
Leadership in the ACS
An ACS Fellow since 1986, Dr. Rusch has led several prominent ACS bodies, including serving as Chair of the Board of Governors (2006−2008) and Board of Regents (2015−2016). A Regent from 2008 to 2017, she chaired the Central Judiciary Committee (2009–2013), the Program Committee (2011–2017), the Board of Regents Nominating Committee (2011–2012), and the Committee on Global Engagement (2016−2017). She served on the Board of Regents Honors Committee (2012−2016), Executive Committee (2013−2016), and Finance Committee (2014−2016).
In addition, she has been a member of the College’s Advisory Council for Cardiothoracic Surgery (2002−2017), International Relations Committee (2007−2013, Executive Committee, 2009−2012), Commission on Cancer Executive Committee (2012−2017), Scholarships Committee (2008−2012), and Research and Optimal Patient Care Committee (2008−2015).
Renowned thoracic surgeon
Dr. Rusch specializes in the diagnosis and treatment of patients with cancers of the lung, airways (trachea, bronchi), esophagus, mediastinum, chest wall, and pleura (malignant pleural mesothelioma). She was among the first women in the U.S. to be board certified in thoracic surgery.
For more than 30 years, she has emphasized a multidisciplinary approach to treating patients with thoracic malignancy. Her research has focused on the molecular behaviors of asbestos cancers and the genetic tendencies of lung cancer as a means to identify certain cancers in the earlier stages.
Dr. Rusch has been a leader in national and international clinical trials for the treatment of thoracic malignancies and played a pivotal role in establishing the ACS Oncology Group--now the ACS Clinical Research Program. Among her many honors, in 2007, Dr. Rusch received the Thoracic Surgery Foundation for Research and Education Socrates Award, and in 2012, the Association of Women Surgeons awarded her the Nina Starr Braunwald Award for lifetime contributions to the advancement of women in surgery.
She has held 25 visiting professorships and lectureships and given more than 300 major lectures on thoracic cancers at medical conferences around the world. Her curriculum vitae boasts more than 400 peer-reviewed publications.
In addition to the ACS, Dr. Rusch has been a leader of other surgical organizations. More specifically, she served as chair of the American Board of Thoracic Surgery, chair of the Lung and Esophagus Task Force of the American Joint Commission on Cancer, and chair of the Mesothelioma Subcommittee of the International Association for the Study of Lung Cancer Staging Committee.
Dr. Rusch is fluent in both French and English, having graduated from the Lycée Français de New York. She graduated from Vassar College, Poughkeepsie, NY, with a degree in biochemistry. She earned her medical degree from the Columbia University College of Physicians and Surgeons, New York, and she completed surgical residency training in general surgery and thoracic surgery at the University of Washington, Seattle, followed by a fellowship at the University of Texas MD Anderson Cancer Center, Houston.
Senators unveil legislation to protect patients against surprise medical bills
With frustration growing among Americans who are being charged exorbitant prices for medical treatment, a bipartisan group of senators unveiled a plan on Sept. 18 to protect patients from surprise bills and high charges from hospitals or doctors who are not in their insurance networks.
The draft legislation, which sponsors said is designed to prevent medical bankruptcies, targets three key consumer concerns:
- Treatment for an emergency by a doctor who is not part of the patient’s insurance network at a hospital that is also outside that network. The patients would be required to pay out of pocket the amount required by their insurance plans. The hospital or doctor could not bill the patient for the remainder of the bill, a practice known as “balance billing.” The hospital and doctor could seek additional payments from the patient’s insurer under state regulations or through a formula established in the legislation.
- Treatment by an out-of-network doctor or other provider at a hospital that is in the patient’s insurance network. Patients would pay only what is required by their plans. Again, the doctors could seek more payments from the plans based on formulas set up by state rules or through the federal formula.
- Mandated notification to emergency patients, once they are stabilized, that they could run up excess charges if they are in an out-of-network hospital. The patients would be required to sign a statement acknowledging that they had been told their insurance might not cover their expenses, and they could seek treatment elsewhere.
“Our proposal protects patients in those emergency situations where current law does not, so that they don’t receive a surprise bill that is basically uncapped by anything but a sense of shame,” Sen. Bill Cassidy (R-La.) said in his announcement about the legislation.
Kevin Lucia, a senior research professor at Georgetown University’s Center on Health Insurance Reforms who had not yet read the draft legislation, said the measure was aimed at a big problem.
“Balance billing is ripe for a federal solution,” he said. States regulate only some health plans and that “leaves open a vast number of people that aren’t covered by those laws.”
Federal law regulates health plans offered by many larger companies and unions that are “self-funded.” Sixty-one percent of privately insured employees get their insurance this way. Those plans pay claims out of their own funds, rather than buying an insurance policy. Federal law does not prohibit balance billing in these plans.
Sen. Cassidy’s office said, however, that this legislation would plug that gap.
In addition to Sen. Cassidy, the legislation is being offered by Sens. Michael Bennet (D-Colo.), Chuck Grassley (R-Iowa), Tom Carper (D-Del.), Todd Young (R-Ind.), and Claire McCaskill (D-Mo.).
Sen. Cassidy’s announcement cited two recent articles from Kaiser Health News and NPR’s “Bill of the Month” series, including a $17,850 urine test and a $109,000 bill after a heart attack.
In a statement to Kaiser Health News, Sen. Bennet said, “In Colorado, we hear from patients facing unexpected bills with astronomical costs even when they’ve received a service from an in-network provider. That’s why Senator Cassidy and I are leading a bipartisan group of senators to address this all-too-common byproduct of limited price transparency.”
Emergency rooms and out-of-network hospitals aren’t the only sources of balance bills, Mr. Lucia said. He mentioned that both ground and air ambulances can leave patients responsible for surprisingly high costs as well.
Mr. Lucia said he was encouraged that both Democrats and Republicans signed on to the draft legislation. “Any effort at the federal level is encouraging because this has been a challenging issue at the state level to make progress on,” he said.
KHN reporter Carmen Heredia Rodriguez contributed to this article. KHN is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
With frustration growing among Americans who are being charged exorbitant prices for medical treatment, a bipartisan group of senators unveiled a plan on Sept. 18 to protect patients from surprise bills and high charges from hospitals or doctors who are not in their insurance networks.
The draft legislation, which sponsors said is designed to prevent medical bankruptcies, targets three key consumer concerns:
- Treatment for an emergency by a doctor who is not part of the patient’s insurance network at a hospital that is also outside that network. The patients would be required to pay out of pocket the amount required by their insurance plans. The hospital or doctor could not bill the patient for the remainder of the bill, a practice known as “balance billing.” The hospital and doctor could seek additional payments from the patient’s insurer under state regulations or through a formula established in the legislation.
- Treatment by an out-of-network doctor or other provider at a hospital that is in the patient’s insurance network. Patients would pay only what is required by their plans. Again, the doctors could seek more payments from the plans based on formulas set up by state rules or through the federal formula.
- Mandated notification to emergency patients, once they are stabilized, that they could run up excess charges if they are in an out-of-network hospital. The patients would be required to sign a statement acknowledging that they had been told their insurance might not cover their expenses, and they could seek treatment elsewhere.
“Our proposal protects patients in those emergency situations where current law does not, so that they don’t receive a surprise bill that is basically uncapped by anything but a sense of shame,” Sen. Bill Cassidy (R-La.) said in his announcement about the legislation.
Kevin Lucia, a senior research professor at Georgetown University’s Center on Health Insurance Reforms who had not yet read the draft legislation, said the measure was aimed at a big problem.
“Balance billing is ripe for a federal solution,” he said. States regulate only some health plans and that “leaves open a vast number of people that aren’t covered by those laws.”
Federal law regulates health plans offered by many larger companies and unions that are “self-funded.” Sixty-one percent of privately insured employees get their insurance this way. Those plans pay claims out of their own funds, rather than buying an insurance policy. Federal law does not prohibit balance billing in these plans.
Sen. Cassidy’s office said, however, that this legislation would plug that gap.
In addition to Sen. Cassidy, the legislation is being offered by Sens. Michael Bennet (D-Colo.), Chuck Grassley (R-Iowa), Tom Carper (D-Del.), Todd Young (R-Ind.), and Claire McCaskill (D-Mo.).
Sen. Cassidy’s announcement cited two recent articles from Kaiser Health News and NPR’s “Bill of the Month” series, including a $17,850 urine test and a $109,000 bill after a heart attack.
In a statement to Kaiser Health News, Sen. Bennet said, “In Colorado, we hear from patients facing unexpected bills with astronomical costs even when they’ve received a service from an in-network provider. That’s why Senator Cassidy and I are leading a bipartisan group of senators to address this all-too-common byproduct of limited price transparency.”
Emergency rooms and out-of-network hospitals aren’t the only sources of balance bills, Mr. Lucia said. He mentioned that both ground and air ambulances can leave patients responsible for surprisingly high costs as well.
Mr. Lucia said he was encouraged that both Democrats and Republicans signed on to the draft legislation. “Any effort at the federal level is encouraging because this has been a challenging issue at the state level to make progress on,” he said.
KHN reporter Carmen Heredia Rodriguez contributed to this article. KHN is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
With frustration growing among Americans who are being charged exorbitant prices for medical treatment, a bipartisan group of senators unveiled a plan on Sept. 18 to protect patients from surprise bills and high charges from hospitals or doctors who are not in their insurance networks.
The draft legislation, which sponsors said is designed to prevent medical bankruptcies, targets three key consumer concerns:
- Treatment for an emergency by a doctor who is not part of the patient’s insurance network at a hospital that is also outside that network. The patients would be required to pay out of pocket the amount required by their insurance plans. The hospital or doctor could not bill the patient for the remainder of the bill, a practice known as “balance billing.” The hospital and doctor could seek additional payments from the patient’s insurer under state regulations or through a formula established in the legislation.
- Treatment by an out-of-network doctor or other provider at a hospital that is in the patient’s insurance network. Patients would pay only what is required by their plans. Again, the doctors could seek more payments from the plans based on formulas set up by state rules or through the federal formula.
- Mandated notification to emergency patients, once they are stabilized, that they could run up excess charges if they are in an out-of-network hospital. The patients would be required to sign a statement acknowledging that they had been told their insurance might not cover their expenses, and they could seek treatment elsewhere.
“Our proposal protects patients in those emergency situations where current law does not, so that they don’t receive a surprise bill that is basically uncapped by anything but a sense of shame,” Sen. Bill Cassidy (R-La.) said in his announcement about the legislation.
Kevin Lucia, a senior research professor at Georgetown University’s Center on Health Insurance Reforms who had not yet read the draft legislation, said the measure was aimed at a big problem.
“Balance billing is ripe for a federal solution,” he said. States regulate only some health plans and that “leaves open a vast number of people that aren’t covered by those laws.”
Federal law regulates health plans offered by many larger companies and unions that are “self-funded.” Sixty-one percent of privately insured employees get their insurance this way. Those plans pay claims out of their own funds, rather than buying an insurance policy. Federal law does not prohibit balance billing in these plans.
Sen. Cassidy’s office said, however, that this legislation would plug that gap.
In addition to Sen. Cassidy, the legislation is being offered by Sens. Michael Bennet (D-Colo.), Chuck Grassley (R-Iowa), Tom Carper (D-Del.), Todd Young (R-Ind.), and Claire McCaskill (D-Mo.).
Sen. Cassidy’s announcement cited two recent articles from Kaiser Health News and NPR’s “Bill of the Month” series, including a $17,850 urine test and a $109,000 bill after a heart attack.
In a statement to Kaiser Health News, Sen. Bennet said, “In Colorado, we hear from patients facing unexpected bills with astronomical costs even when they’ve received a service from an in-network provider. That’s why Senator Cassidy and I are leading a bipartisan group of senators to address this all-too-common byproduct of limited price transparency.”
Emergency rooms and out-of-network hospitals aren’t the only sources of balance bills, Mr. Lucia said. He mentioned that both ground and air ambulances can leave patients responsible for surprisingly high costs as well.
Mr. Lucia said he was encouraged that both Democrats and Republicans signed on to the draft legislation. “Any effort at the federal level is encouraging because this has been a challenging issue at the state level to make progress on,” he said.
KHN reporter Carmen Heredia Rodriguez contributed to this article. KHN is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
FDA issues new REMS for immediate-release opioids
Opioid prescribers will need to be mindful of a new, expanded Risk Evaluation and Mitigation Strategy issued Sept. 18 by the Food and Drug Administration, covering immediate-release opioid analgesics used in the outpatient setting. The strategy also applies to extended-release and long-acting opioids, which have been subject to REMS since 2012.
The new REMS program requires for the first time that training be made available to health care providers who are involved in pain management. For the purposes of this REMS program, the training is not limited to just the prescriber, but includes nurses and pharmacists.
, including alternatives to opioids for pain management.
The FDA said it is in the process of approving a new label for opioids that will contain information about health care provider education that is now a part of the REMS.
“Our new effort is aimed at arming providers with the most current and comprehensive information on the appropriate management of pain,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Appropriate prescribing practices and education are important steps that we are prioritizing to help address the human and financial toll of this crisis.”
Dr. Gottlieb added that the goal of the new REMS is to help prescribers with the latest evidence on the appropriate amount of doses that should be prescribed for a given condition and that the “aim is to reduce overall dispensing as a way to further reduce exposure to these drugs. Our goal is to help prevent patients from becoming addicted by decreasing unnecessary or inappropriate exposure to opioids and fostering rational prescribing to enable appropriate access to those patients who have legitimate medical need for these medicines.”
The FDA also approved a new guidance document that includes updated educational content.
Opioid prescribers will need to be mindful of a new, expanded Risk Evaluation and Mitigation Strategy issued Sept. 18 by the Food and Drug Administration, covering immediate-release opioid analgesics used in the outpatient setting. The strategy also applies to extended-release and long-acting opioids, which have been subject to REMS since 2012.
The new REMS program requires for the first time that training be made available to health care providers who are involved in pain management. For the purposes of this REMS program, the training is not limited to just the prescriber, but includes nurses and pharmacists.
, including alternatives to opioids for pain management.
The FDA said it is in the process of approving a new label for opioids that will contain information about health care provider education that is now a part of the REMS.
“Our new effort is aimed at arming providers with the most current and comprehensive information on the appropriate management of pain,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Appropriate prescribing practices and education are important steps that we are prioritizing to help address the human and financial toll of this crisis.”
Dr. Gottlieb added that the goal of the new REMS is to help prescribers with the latest evidence on the appropriate amount of doses that should be prescribed for a given condition and that the “aim is to reduce overall dispensing as a way to further reduce exposure to these drugs. Our goal is to help prevent patients from becoming addicted by decreasing unnecessary or inappropriate exposure to opioids and fostering rational prescribing to enable appropriate access to those patients who have legitimate medical need for these medicines.”
The FDA also approved a new guidance document that includes updated educational content.
Opioid prescribers will need to be mindful of a new, expanded Risk Evaluation and Mitigation Strategy issued Sept. 18 by the Food and Drug Administration, covering immediate-release opioid analgesics used in the outpatient setting. The strategy also applies to extended-release and long-acting opioids, which have been subject to REMS since 2012.
The new REMS program requires for the first time that training be made available to health care providers who are involved in pain management. For the purposes of this REMS program, the training is not limited to just the prescriber, but includes nurses and pharmacists.
, including alternatives to opioids for pain management.
The FDA said it is in the process of approving a new label for opioids that will contain information about health care provider education that is now a part of the REMS.
“Our new effort is aimed at arming providers with the most current and comprehensive information on the appropriate management of pain,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Appropriate prescribing practices and education are important steps that we are prioritizing to help address the human and financial toll of this crisis.”
Dr. Gottlieb added that the goal of the new REMS is to help prescribers with the latest evidence on the appropriate amount of doses that should be prescribed for a given condition and that the “aim is to reduce overall dispensing as a way to further reduce exposure to these drugs. Our goal is to help prevent patients from becoming addicted by decreasing unnecessary or inappropriate exposure to opioids and fostering rational prescribing to enable appropriate access to those patients who have legitimate medical need for these medicines.”
The FDA also approved a new guidance document that includes updated educational content.
Tracking 90-day vascular surgery outcomes: The coming new normal?
The Centers for Medicare and Medicaid Services is test driving a new quality measurement model that pushes hospital readmissions measures out from 30 to 90 days.
Previous research has identified vascular surgery as having twice as high rates of 90-day readmissions, compared with 30-day readmissions (Am J Manag Care. 2014;20[9]:e432-e438), and this could prove problematic in light of the CMS pilot project currently underway, according to Donald E. Fry, MD, of MPA Healthcare Solutions, Chicago, and his colleagues.
They performed a study that found a high level of adverse outcomes for common vascular procedures and that there was a significant variability in risk-adjusted outcomes among best- and poorest-performing hospitals in all major vascular procedures, indicating that a large opportunity exists for improvement in results.
Medicare’s value-based care Readmissions Reduction Model developed financial penalties for hospitals that fail to achieve acceptable performance scores, and in doing so shifted some of the financial risks of care to the providers based on a 30-day readmission model. In contrast, the pilot Bundled Payments for Care Improvement (BPCI) Advanced Program, which the CMS plans to launch in October 2018, will follow a 90-day period of postoperative care as its duration of financial accountability.
“While BPCI Advanced, has, until now, focused upon orthopedics, cardiovascular procedures, and high-volume medical admissions areas, it is anticipated that vascular surgery will be included in the future,” according to the investigators. Therefore, the researchers performed an in-depth analysis to examine the 90-day outcomes of common vascular surgeries across hospitals as a prelude to the vascular surgery field having to potentially confront this new CMS model (Surgery 2018 Jun 22 doi: 10.1016/j.surg.2018.03.025).
Dr. Fry and his colleagues used the Medicare Limited Data Set for 2012-2014 to follow the outcomes of major vascular surgery beginning with the inpatient stay and on through 90 days of postoperative care. A pool of more than 500 aggregated and individual candidate risk factors, including age and sex, was used in model development, based upon data from 359 hospitals with 10,815 patients in the Medicare Limited Data Set.
The researchers examined the risk-adjusted outcomes of four major groupings of vascular surgery procedures: elective open aortic; open peripheral vascular procedures; endovascular aortic; and percutaneous angioplasty procedures.
They found that the total adverse-outcome rate (AO) was 27.8% for open aortic procedures, 31.5% for open peripheral vascular procedures, 19.6% for endovascular aortic procedures, and 36.4% for percutaneous angioplasty procedures. The difference in risk-adjusted adverse-outcome rates between the best- and the poorest- performing deciles was 32.2% for open aortic procedures, 29.5% for open peripheral vascular procedures, 21.5% for endovascular aortic procedures, and 37.1% for percutaneous angioplasty procedures.
The model determined significant risk factors (P less than .001) for inpatient death (including malnutrition, intestinal ischemia, supplemental oxygen, and age greater than or equal to 85 years); prolonged length of stay (including supplemental oxygen, peritoneal adhesions, and chronic lung obstructive disease); 90-day postdischarge death (including heart failure, chronic infection, psychosis, and primary head/neck cancer); and 90-day postdischarge readmission (malnutrition, chronic obstructive lung disease, upper aerodigestive tract cancer, and skin ulceration) for these procedures.
For all cases, the total 90-day postdischarge mortality rate exceeded the inpatient death rate, and readmissions were the major driver of the total AO. They found that 22% of all patients readmitted across the entire 90-day interval had not seen a physician for follow-up after discharge. [This] “begs the question of whether more frequent physician or physician-extender follow-up can reduce this AO,” according to Dr. Fry and his colleagues. “Importantly, first readmissions during days 31-90 following discharge were almost as common as those occurring during the initial 30 days. Over 20% of total readmissions were subsequently repeat events during the 90-day interval,” they added.
They also found that the variability in risk-adjusted outcomes among the best and poorest performing hospitals was over 20% in all of the major vascular procedures and indicates a large opportunity for improvement in results.
“Understanding variables associated with higher risk can be used as a decision support tool to identify which patients will need increased vigilance to avoid AOs. Identification of very high risk may become a consideration in the assessment of the appropriateness of the surgical intervention. If providers know their outcomes and those outcomes are benchmarked against the whole population of hospitals, then clinical performance can be improved by specific care redesign initiatives,” the researchers concluded.
Dr. Fry is executive vice president of MPA Healthcare Solutions, which funded the research.
SOURCE: Fry DE et al. Surgery 2018 Jun 22. doi: 10.1016/j.surg.2018.03.025.
The Centers for Medicare and Medicaid Services is test driving a new quality measurement model that pushes hospital readmissions measures out from 30 to 90 days.
Previous research has identified vascular surgery as having twice as high rates of 90-day readmissions, compared with 30-day readmissions (Am J Manag Care. 2014;20[9]:e432-e438), and this could prove problematic in light of the CMS pilot project currently underway, according to Donald E. Fry, MD, of MPA Healthcare Solutions, Chicago, and his colleagues.
They performed a study that found a high level of adverse outcomes for common vascular procedures and that there was a significant variability in risk-adjusted outcomes among best- and poorest-performing hospitals in all major vascular procedures, indicating that a large opportunity exists for improvement in results.
Medicare’s value-based care Readmissions Reduction Model developed financial penalties for hospitals that fail to achieve acceptable performance scores, and in doing so shifted some of the financial risks of care to the providers based on a 30-day readmission model. In contrast, the pilot Bundled Payments for Care Improvement (BPCI) Advanced Program, which the CMS plans to launch in October 2018, will follow a 90-day period of postoperative care as its duration of financial accountability.
“While BPCI Advanced, has, until now, focused upon orthopedics, cardiovascular procedures, and high-volume medical admissions areas, it is anticipated that vascular surgery will be included in the future,” according to the investigators. Therefore, the researchers performed an in-depth analysis to examine the 90-day outcomes of common vascular surgeries across hospitals as a prelude to the vascular surgery field having to potentially confront this new CMS model (Surgery 2018 Jun 22 doi: 10.1016/j.surg.2018.03.025).
Dr. Fry and his colleagues used the Medicare Limited Data Set for 2012-2014 to follow the outcomes of major vascular surgery beginning with the inpatient stay and on through 90 days of postoperative care. A pool of more than 500 aggregated and individual candidate risk factors, including age and sex, was used in model development, based upon data from 359 hospitals with 10,815 patients in the Medicare Limited Data Set.
The researchers examined the risk-adjusted outcomes of four major groupings of vascular surgery procedures: elective open aortic; open peripheral vascular procedures; endovascular aortic; and percutaneous angioplasty procedures.
They found that the total adverse-outcome rate (AO) was 27.8% for open aortic procedures, 31.5% for open peripheral vascular procedures, 19.6% for endovascular aortic procedures, and 36.4% for percutaneous angioplasty procedures. The difference in risk-adjusted adverse-outcome rates between the best- and the poorest- performing deciles was 32.2% for open aortic procedures, 29.5% for open peripheral vascular procedures, 21.5% for endovascular aortic procedures, and 37.1% for percutaneous angioplasty procedures.
The model determined significant risk factors (P less than .001) for inpatient death (including malnutrition, intestinal ischemia, supplemental oxygen, and age greater than or equal to 85 years); prolonged length of stay (including supplemental oxygen, peritoneal adhesions, and chronic lung obstructive disease); 90-day postdischarge death (including heart failure, chronic infection, psychosis, and primary head/neck cancer); and 90-day postdischarge readmission (malnutrition, chronic obstructive lung disease, upper aerodigestive tract cancer, and skin ulceration) for these procedures.
For all cases, the total 90-day postdischarge mortality rate exceeded the inpatient death rate, and readmissions were the major driver of the total AO. They found that 22% of all patients readmitted across the entire 90-day interval had not seen a physician for follow-up after discharge. [This] “begs the question of whether more frequent physician or physician-extender follow-up can reduce this AO,” according to Dr. Fry and his colleagues. “Importantly, first readmissions during days 31-90 following discharge were almost as common as those occurring during the initial 30 days. Over 20% of total readmissions were subsequently repeat events during the 90-day interval,” they added.
They also found that the variability in risk-adjusted outcomes among the best and poorest performing hospitals was over 20% in all of the major vascular procedures and indicates a large opportunity for improvement in results.
“Understanding variables associated with higher risk can be used as a decision support tool to identify which patients will need increased vigilance to avoid AOs. Identification of very high risk may become a consideration in the assessment of the appropriateness of the surgical intervention. If providers know their outcomes and those outcomes are benchmarked against the whole population of hospitals, then clinical performance can be improved by specific care redesign initiatives,” the researchers concluded.
Dr. Fry is executive vice president of MPA Healthcare Solutions, which funded the research.
SOURCE: Fry DE et al. Surgery 2018 Jun 22. doi: 10.1016/j.surg.2018.03.025.
The Centers for Medicare and Medicaid Services is test driving a new quality measurement model that pushes hospital readmissions measures out from 30 to 90 days.
Previous research has identified vascular surgery as having twice as high rates of 90-day readmissions, compared with 30-day readmissions (Am J Manag Care. 2014;20[9]:e432-e438), and this could prove problematic in light of the CMS pilot project currently underway, according to Donald E. Fry, MD, of MPA Healthcare Solutions, Chicago, and his colleagues.
They performed a study that found a high level of adverse outcomes for common vascular procedures and that there was a significant variability in risk-adjusted outcomes among best- and poorest-performing hospitals in all major vascular procedures, indicating that a large opportunity exists for improvement in results.
Medicare’s value-based care Readmissions Reduction Model developed financial penalties for hospitals that fail to achieve acceptable performance scores, and in doing so shifted some of the financial risks of care to the providers based on a 30-day readmission model. In contrast, the pilot Bundled Payments for Care Improvement (BPCI) Advanced Program, which the CMS plans to launch in October 2018, will follow a 90-day period of postoperative care as its duration of financial accountability.
“While BPCI Advanced, has, until now, focused upon orthopedics, cardiovascular procedures, and high-volume medical admissions areas, it is anticipated that vascular surgery will be included in the future,” according to the investigators. Therefore, the researchers performed an in-depth analysis to examine the 90-day outcomes of common vascular surgeries across hospitals as a prelude to the vascular surgery field having to potentially confront this new CMS model (Surgery 2018 Jun 22 doi: 10.1016/j.surg.2018.03.025).
Dr. Fry and his colleagues used the Medicare Limited Data Set for 2012-2014 to follow the outcomes of major vascular surgery beginning with the inpatient stay and on through 90 days of postoperative care. A pool of more than 500 aggregated and individual candidate risk factors, including age and sex, was used in model development, based upon data from 359 hospitals with 10,815 patients in the Medicare Limited Data Set.
The researchers examined the risk-adjusted outcomes of four major groupings of vascular surgery procedures: elective open aortic; open peripheral vascular procedures; endovascular aortic; and percutaneous angioplasty procedures.
They found that the total adverse-outcome rate (AO) was 27.8% for open aortic procedures, 31.5% for open peripheral vascular procedures, 19.6% for endovascular aortic procedures, and 36.4% for percutaneous angioplasty procedures. The difference in risk-adjusted adverse-outcome rates between the best- and the poorest- performing deciles was 32.2% for open aortic procedures, 29.5% for open peripheral vascular procedures, 21.5% for endovascular aortic procedures, and 37.1% for percutaneous angioplasty procedures.
The model determined significant risk factors (P less than .001) for inpatient death (including malnutrition, intestinal ischemia, supplemental oxygen, and age greater than or equal to 85 years); prolonged length of stay (including supplemental oxygen, peritoneal adhesions, and chronic lung obstructive disease); 90-day postdischarge death (including heart failure, chronic infection, psychosis, and primary head/neck cancer); and 90-day postdischarge readmission (malnutrition, chronic obstructive lung disease, upper aerodigestive tract cancer, and skin ulceration) for these procedures.
For all cases, the total 90-day postdischarge mortality rate exceeded the inpatient death rate, and readmissions were the major driver of the total AO. They found that 22% of all patients readmitted across the entire 90-day interval had not seen a physician for follow-up after discharge. [This] “begs the question of whether more frequent physician or physician-extender follow-up can reduce this AO,” according to Dr. Fry and his colleagues. “Importantly, first readmissions during days 31-90 following discharge were almost as common as those occurring during the initial 30 days. Over 20% of total readmissions were subsequently repeat events during the 90-day interval,” they added.
They also found that the variability in risk-adjusted outcomes among the best and poorest performing hospitals was over 20% in all of the major vascular procedures and indicates a large opportunity for improvement in results.
“Understanding variables associated with higher risk can be used as a decision support tool to identify which patients will need increased vigilance to avoid AOs. Identification of very high risk may become a consideration in the assessment of the appropriateness of the surgical intervention. If providers know their outcomes and those outcomes are benchmarked against the whole population of hospitals, then clinical performance can be improved by specific care redesign initiatives,” the researchers concluded.
Dr. Fry is executive vice president of MPA Healthcare Solutions, which funded the research.
SOURCE: Fry DE et al. Surgery 2018 Jun 22. doi: 10.1016/j.surg.2018.03.025.
FROM SURGERY
Key clinical point: The variability in risk-adjusted outcomes among the best and poorest performing hospitals was over 20% in all of the major vascular procedures.
Major finding: The total adverse-outcome rate was 27.8% for open aortic procedures, 31.5% for open peripheral artery, 19.6% for endovascular aortic, and 36.4% for percutaneous angioplasty.
Study details: The Medicare Limited Data Set for 2012-2014 was used to follow the outcomes of major vascular surgery beginning with the inpatient stay and on through 90 days of postop care.
Disclosures: Dr. Fry is executive vice president of MPA Healthcare Solutions, which funded the research.
Source: Fry DE et al. Surgery 2018 Jun 22. doi: 10.1016/j.surg.2018.03.025.