Acquired Cardiovascular Disease

CHICAGO – One-year results of a pivotal European trial of the percutaneous Cardioband mitral valve reconstruction system show a stable, consistent, and clinically meaningful reduction in mitral regurgitation coupled with significant quality of life improvements and a safety profile equivalent to that of other transcatheter valve procedures.

“The results are quite impressive. Ladies and gentlemen, I can tell you that I’ve used almost all the devices for direct and indirect annuloplasty, and this is the only device that works in a reproducible fashion,” Dr. Karl-Heinz Kuck said at the annual meeting of the American College of Cardiology.

Bruce Jancin/Fronteline Medical News

He presented the results for the first 50 patients to reach 12 months of follow-up after undergoing the Cardioband procedure in a multicenter prospective study in which participants served as their own before-and-after controls. On the strength of these results, the Cardioband device has been approved by European Union regulatory authorities for the nonsurgical treatment of symptomatic moderate to severe secondary, or functional, mitral regurgitation. In Germany, the Cardioband procedure is now routinely reimbursed at a level similar to that of the MitraClip, according to Dr. Kuck, president of the German Cardiac Society and head of cardiology at St. Georg Hospital in Hamburg, Germany.

The Cardioband procedure essentially entails percutaneous implantation of an adjustable surgical ring designed to remodel a severely dysfunctional mitral valve by repairing the valve annulus. The implantation procedure features transfemoral venous access, which the TAVR experience has shown to be safer than transapical access. As in surgery, the percutaneous procedure utilizes supra-annular fixation. And it accomplishes a significant reduction in annular dimensions, comparable to what is achieved with a size 28 surgical ring.

“And the most important thing: Because we are not interfering with the leaflets or any other part of the mitral valve, the procedure leaves all options open for the future by preserving the native anatomy,” Dr. Kuck noted.

The procedure entails a transseptal puncture, insertion of the system, deployment of the implant, and adjustment of its size by cinching it down under echocardiographic guidance in order to reduce the septolateral valve dimension. The whole thing takes about 75 minutes.

The connection of the implant to the annulus is achieved in sutureless fashion using a series of screw-in anchors.

All 50 participants in the consecutive series were deemed by a heart team to be at unacceptably high surgical risk. They averaged 71 years of age, with an left ventricular ejection fraction of 33% and a left ventricular end diastolic diameter of 61 mm. Among them, 31 had ischemic heart disease, 11 had chronic obstructive pulmonary disease, 38 were in moderate or severe renal failure, 39 had atrial fibrillation, 12 had severe pulmonary hypertension, and 16 had previously undergone CABG surgery.

The 30-day safety adverse events consisted of one hemorrhagic stroke, a single major bleeding complication, two cases of acute renal failure, and one of cardiac tamponade. There were no MIs, and neither of the two deaths were related to the procedure.

In terms of efficacy, at baseline three-quarters of patients had grade 3-4 mitral regurgitation (MR). At discharge that was true for only 12%. At 1 year of follow-up, 90% of subjects had MR grade 2 or less, and roughly two-thirds of patients had MR grade 0-1.

The procedure did what it was designed to do: The mean valve septolateral dimension decreased by 30%, from 37 mm at baseline to 26 mm at discharge.

Dr. Kuck provided 6-month data on functional improvement. The mean 6-minute walk distance improved from 262 to 339 meters. At baseline, 87% of subjects were NYHA class III or IV; at 6 months, 77% were NYHA class I or II. Scores on the Minnesota Living with Heart Failure Questionnaire improved from a mean of 39 to 16 at follow-up.

A much larger European postmarketing commercial use study of the Cardioband system is now underway.

The Cardioband procedure addresses a major unmet need, Dr. Kuck observed. More than 4 million patients in the United States alone have mitral valve disease. When medically managed, patients with severe secondary mitral regurgitation have a poor prognosis, with 1- and 5-year mortality rates of 20% and 50%, and an extremely high rate of rehospitalization for heart failure. And yet multiple surveys have shown only a minority of these patients undergo surgery.

Discussant Dr. Spencer B. King III called the transcatheter mitral valve reconstruction system “quite fascinating.” He wondered what happens if the operator accidentally grabs the nearby circumflex artery with one of the device anchors. The answer, Dr. Kuck replied, is that the anchors can be unscrewed and repositioned at any point during the procedure.

Dr. King, president of the Heart and Vascular Institute at Saint Joseph’s Health System in Atlanta, has developed several devices widely used in interventional cardiology. He shook his head in amazement at the speed at which the European regulatory agency operated in this case, noting that EU marketing approval for the Valtech Cardioband device was granted and a payment structure was almost immediately established on the basis of a 50-patient, first-in-man study.

“The data are very consistent. I think that‘s what made the difference,” Dr. Kuck said.

The study was funded by Valtech. Dr. Kuck reported serving as a consultant to Biosense Webster, Edwards, and St. Jude, and on a speakers’ bureau for Medtronic.

[email protected]

CHICAGO – One-year results of a pivotal European trial of the percutaneous Cardioband mitral valve reconstruction system show a stable, consistent, and clinically meaningful reduction in mitral regurgitation coupled with significant quality of life improvements and a safety profile equivalent to that of other transcatheter valve procedures.

“The results are quite impressive. Ladies and gentlemen, I can tell you that I’ve used almost all the devices for direct and indirect annuloplasty, and this is the only device that works in a reproducible fashion,” Dr. Karl-Heinz Kuck said at the annual meeting of the American College of Cardiology.

Bruce Jancin/Fronteline Medical News

He presented the results for the first 50 patients to reach 12 months of follow-up after undergoing the Cardioband procedure in a multicenter prospective study in which participants served as their own before-and-after controls. On the strength of these results, the Cardioband device has been approved by European Union regulatory authorities for the nonsurgical treatment of symptomatic moderate to severe secondary, or functional, mitral regurgitation. In Germany, the Cardioband procedure is now routinely reimbursed at a level similar to that of the MitraClip, according to Dr. Kuck, president of the German Cardiac Society and head of cardiology at St. Georg Hospital in Hamburg, Germany.

The Cardioband procedure essentially entails percutaneous implantation of an adjustable surgical ring designed to remodel a severely dysfunctional mitral valve by repairing the valve annulus. The implantation procedure features transfemoral venous access, which the TAVR experience has shown to be safer than transapical access. As in surgery, the percutaneous procedure utilizes supra-annular fixation. And it accomplishes a significant reduction in annular dimensions, comparable to what is achieved with a size 28 surgical ring.

“And the most important thing: Because we are not interfering with the leaflets or any other part of the mitral valve, the procedure leaves all options open for the future by preserving the native anatomy,” Dr. Kuck noted.

The procedure entails a transseptal puncture, insertion of the system, deployment of the implant, and adjustment of its size by cinching it down under echocardiographic guidance in order to reduce the septolateral valve dimension. The whole thing takes about 75 minutes.

The connection of the implant to the annulus is achieved in sutureless fashion using a series of screw-in anchors.

All 50 participants in the consecutive series were deemed by a heart team to be at unacceptably high surgical risk. They averaged 71 years of age, with an left ventricular ejection fraction of 33% and a left ventricular end diastolic diameter of 61 mm. Among them, 31 had ischemic heart disease, 11 had chronic obstructive pulmonary disease, 38 were in moderate or severe renal failure, 39 had atrial fibrillation, 12 had severe pulmonary hypertension, and 16 had previously undergone CABG surgery.

The 30-day safety adverse events consisted of one hemorrhagic stroke, a single major bleeding complication, two cases of acute renal failure, and one of cardiac tamponade. There were no MIs, and neither of the two deaths were related to the procedure.

In terms of efficacy, at baseline three-quarters of patients had grade 3-4 mitral regurgitation (MR). At discharge that was true for only 12%. At 1 year of follow-up, 90% of subjects had MR grade 2 or less, and roughly two-thirds of patients had MR grade 0-1.

The procedure did what it was designed to do: The mean valve septolateral dimension decreased by 30%, from 37 mm at baseline to 26 mm at discharge.

Dr. Kuck provided 6-month data on functional improvement. The mean 6-minute walk distance improved from 262 to 339 meters. At baseline, 87% of subjects were NYHA class III or IV; at 6 months, 77% were NYHA class I or II. Scores on the Minnesota Living with Heart Failure Questionnaire improved from a mean of 39 to 16 at follow-up.

A much larger European postmarketing commercial use study of the Cardioband system is now underway.

The Cardioband procedure addresses a major unmet need, Dr. Kuck observed. More than 4 million patients in the United States alone have mitral valve disease. When medically managed, patients with severe secondary mitral regurgitation have a poor prognosis, with 1- and 5-year mortality rates of 20% and 50%, and an extremely high rate of rehospitalization for heart failure. And yet multiple surveys have shown only a minority of these patients undergo surgery.

Discussant Dr. Spencer B. King III called the transcatheter mitral valve reconstruction system “quite fascinating.” He wondered what happens if the operator accidentally grabs the nearby circumflex artery with one of the device anchors. The answer, Dr. Kuck replied, is that the anchors can be unscrewed and repositioned at any point during the procedure.

Dr. King, president of the Heart and Vascular Institute at Saint Joseph’s Health System in Atlanta, has developed several devices widely used in interventional cardiology. He shook his head in amazement at the speed at which the European regulatory agency operated in this case, noting that EU marketing approval for the Valtech Cardioband device was granted and a payment structure was almost immediately established on the basis of a 50-patient, first-in-man study.

“The data are very consistent. I think that‘s what made the difference,” Dr. Kuck said.

The study was funded by Valtech. Dr. Kuck reported serving as a consultant to Biosense Webster, Edwards, and St. Jude, and on a speakers’ bureau for Medtronic.

[email protected]

CHICAGO – One-year results of a pivotal European trial of the percutaneous Cardioband mitral valve reconstruction system show a stable, consistent, and clinically meaningful reduction in mitral regurgitation coupled with significant quality of life improvements and a safety profile equivalent to that of other transcatheter valve procedures.

“The results are quite impressive. Ladies and gentlemen, I can tell you that I’ve used almost all the devices for direct and indirect annuloplasty, and this is the only device that works in a reproducible fashion,” Dr. Karl-Heinz Kuck said at the annual meeting of the American College of Cardiology.

Bruce Jancin/Fronteline Medical News

He presented the results for the first 50 patients to reach 12 months of follow-up after undergoing the Cardioband procedure in a multicenter prospective study in which participants served as their own before-and-after controls. On the strength of these results, the Cardioband device has been approved by European Union regulatory authorities for the nonsurgical treatment of symptomatic moderate to severe secondary, or functional, mitral regurgitation. In Germany, the Cardioband procedure is now routinely reimbursed at a level similar to that of the MitraClip, according to Dr. Kuck, president of the German Cardiac Society and head of cardiology at St. Georg Hospital in Hamburg, Germany.

The Cardioband procedure essentially entails percutaneous implantation of an adjustable surgical ring designed to remodel a severely dysfunctional mitral valve by repairing the valve annulus. The implantation procedure features transfemoral venous access, which the TAVR experience has shown to be safer than transapical access. As in surgery, the percutaneous procedure utilizes supra-annular fixation. And it accomplishes a significant reduction in annular dimensions, comparable to what is achieved with a size 28 surgical ring.

“And the most important thing: Because we are not interfering with the leaflets or any other part of the mitral valve, the procedure leaves all options open for the future by preserving the native anatomy,” Dr. Kuck noted.

The procedure entails a transseptal puncture, insertion of the system, deployment of the implant, and adjustment of its size by cinching it down under echocardiographic guidance in order to reduce the septolateral valve dimension. The whole thing takes about 75 minutes.

The connection of the implant to the annulus is achieved in sutureless fashion using a series of screw-in anchors.

All 50 participants in the consecutive series were deemed by a heart team to be at unacceptably high surgical risk. They averaged 71 years of age, with an left ventricular ejection fraction of 33% and a left ventricular end diastolic diameter of 61 mm. Among them, 31 had ischemic heart disease, 11 had chronic obstructive pulmonary disease, 38 were in moderate or severe renal failure, 39 had atrial fibrillation, 12 had severe pulmonary hypertension, and 16 had previously undergone CABG surgery.

The 30-day safety adverse events consisted of one hemorrhagic stroke, a single major bleeding complication, two cases of acute renal failure, and one of cardiac tamponade. There were no MIs, and neither of the two deaths were related to the procedure.

In terms of efficacy, at baseline three-quarters of patients had grade 3-4 mitral regurgitation (MR). At discharge that was true for only 12%. At 1 year of follow-up, 90% of subjects had MR grade 2 or less, and roughly two-thirds of patients had MR grade 0-1.

The procedure did what it was designed to do: The mean valve septolateral dimension decreased by 30%, from 37 mm at baseline to 26 mm at discharge.

Dr. Kuck provided 6-month data on functional improvement. The mean 6-minute walk distance improved from 262 to 339 meters. At baseline, 87% of subjects were NYHA class III or IV; at 6 months, 77% were NYHA class I or II. Scores on the Minnesota Living with Heart Failure Questionnaire improved from a mean of 39 to 16 at follow-up.

A much larger European postmarketing commercial use study of the Cardioband system is now underway.

The Cardioband procedure addresses a major unmet need, Dr. Kuck observed. More than 4 million patients in the United States alone have mitral valve disease. When medically managed, patients with severe secondary mitral regurgitation have a poor prognosis, with 1- and 5-year mortality rates of 20% and 50%, and an extremely high rate of rehospitalization for heart failure. And yet multiple surveys have shown only a minority of these patients undergo surgery.

Discussant Dr. Spencer B. King III called the transcatheter mitral valve reconstruction system “quite fascinating.” He wondered what happens if the operator accidentally grabs the nearby circumflex artery with one of the device anchors. The answer, Dr. Kuck replied, is that the anchors can be unscrewed and repositioned at any point during the procedure.

Dr. King, president of the Heart and Vascular Institute at Saint Joseph’s Health System in Atlanta, has developed several devices widely used in interventional cardiology. He shook his head in amazement at the speed at which the European regulatory agency operated in this case, noting that EU marketing approval for the Valtech Cardioband device was granted and a payment structure was almost immediately established on the basis of a 50-patient, first-in-man study.

“The data are very consistent. I think that‘s what made the difference,” Dr. Kuck said.

The study was funded by Valtech. Dr. Kuck reported serving as a consultant to Biosense Webster, Edwards, and St. Jude, and on a speakers’ bureau for Medtronic.

[email protected]

Reporting of outcomes has grown in importance as clinical registries collect data and establish benchmarks for quality care, but exactly what those data report can vary depending on the definition of a specific outcome, even for an outcome as seemingly straightforward as death after an intervention.

Dr. Steven Maximus of the University of California Irvine Medical Center, and colleagues reported on this phenomenon in the April issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:1101-10). Specifically, they showed how rates of postoperative mortality after five different cardiac interventions can vary within the same data set depending on the definition of postoperative mortality.

“A significant percentage of procedural deaths occur after transfer or discharge from the index hospital,” Dr. Maximus and colleagues said. “These findings illustrate the importance of the definition of ‘operative’ mortality and the need to ensure accuracy in the reporting of data to volunteer clinical registries.”

They calculated outcomes based on five different definitions of postoperative mortality for five different cardiac interventions, depending on when and where the patient died, each of which showed slightly different results. The five different definitions of postoperative mortality are: during the index hospitalization only; during the index hospitalization or in a hospital the patient was transferred to on the same day or within 24 hours of discharge; during the index hospitalization or within 30 days after the procedure; during the index hospitalization or transfer hospitalization or during readmission within 30 days; and during the index hospitalization, transfer, and within 30 days after the procedure regardless of readmission.

As an example, mortality rates for percutaneous coronary intervention (PCI) with acute coronary syndrome (ACS) ranged from 3.25% for the first definition listed to 4.51% for the fifth definition. For isolated coronary artery bypass grafting, the rates ranged from 1.71% for the first definition to 2.15% for the fifth.

The fifth definition “is the most encompassing and is the current definition used by the STS [Society of Thoracic Surgeons] and should be applied to other clinical registries, such as the American College of Cardiology National Cardiovascular Data Registry,” Dr. Maximus and colleagues said.

The study noted that the Society of Thoracic Surgeons National Database (STS-NDB) has revised its definition of operative mortality to more accurately measure outcomes. Originally, the STS-NDB definition included all deaths during the index hospitalization, even those after 30 days, and postdischarge deaths within 30 days unless the cause of death was not related to the operation. In 2011, the definition was updated to include patients transferred to other acute care facilities. STS-NDB updated the definition again in 2014 to include all deaths, regardless of cause, during the index hospitalization, even if after 30 days, and including patients transferred to other acute care facilities, and all deaths, again regardless of cause, after discharge and within 30 days of the operation.

The analyses by Dr. Maximus and colleagues used data from the California Office of Statewide Health Planning and Development hospitalized patient discharge database for the year 2009. The first analysis the researchers performed did not exclude any patients and found a significant number of cardiac procedural deaths occurred after transfer at discharge from the index hospitalization, 17% in the surgical group vs. 31% in the PCI group. In the second analysis, which excluded untrackable patients, hospital deaths included 12% for PCI and 4% for surgery.

“PCI mortality was more dependent on the method used to define mortality, compared with the surgical patients, and a larger percentage of deaths occurred after hospital discharge and within 30 days of the procedure,” Dr. Maximus and colleagues said.

Another key factor in calculating mortality rates was the ability of hospitals to follow patients. “We found that up to 20% of hospitals were not able to track their patients long-term,” Dr. Maximus and coauthors said.

Study coauthor Dr. Junaid Kahn disclosed consulting fees from Edwards Lifesciences. The other authors have no financial relationships to disclose.

Reporting of outcomes has grown in importance as clinical registries collect data and establish benchmarks for quality care, but exactly what those data report can vary depending on the definition of a specific outcome, even for an outcome as seemingly straightforward as death after an intervention.

Dr. Steven Maximus of the University of California Irvine Medical Center, and colleagues reported on this phenomenon in the April issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:1101-10). Specifically, they showed how rates of postoperative mortality after five different cardiac interventions can vary within the same data set depending on the definition of postoperative mortality.

“A significant percentage of procedural deaths occur after transfer or discharge from the index hospital,” Dr. Maximus and colleagues said. “These findings illustrate the importance of the definition of ‘operative’ mortality and the need to ensure accuracy in the reporting of data to volunteer clinical registries.”

They calculated outcomes based on five different definitions of postoperative mortality for five different cardiac interventions, depending on when and where the patient died, each of which showed slightly different results. The five different definitions of postoperative mortality are: during the index hospitalization only; during the index hospitalization or in a hospital the patient was transferred to on the same day or within 24 hours of discharge; during the index hospitalization or within 30 days after the procedure; during the index hospitalization or transfer hospitalization or during readmission within 30 days; and during the index hospitalization, transfer, and within 30 days after the procedure regardless of readmission.

As an example, mortality rates for percutaneous coronary intervention (PCI) with acute coronary syndrome (ACS) ranged from 3.25% for the first definition listed to 4.51% for the fifth definition. For isolated coronary artery bypass grafting, the rates ranged from 1.71% for the first definition to 2.15% for the fifth.

The fifth definition “is the most encompassing and is the current definition used by the STS [Society of Thoracic Surgeons] and should be applied to other clinical registries, such as the American College of Cardiology National Cardiovascular Data Registry,” Dr. Maximus and colleagues said.

The study noted that the Society of Thoracic Surgeons National Database (STS-NDB) has revised its definition of operative mortality to more accurately measure outcomes. Originally, the STS-NDB definition included all deaths during the index hospitalization, even those after 30 days, and postdischarge deaths within 30 days unless the cause of death was not related to the operation. In 2011, the definition was updated to include patients transferred to other acute care facilities. STS-NDB updated the definition again in 2014 to include all deaths, regardless of cause, during the index hospitalization, even if after 30 days, and including patients transferred to other acute care facilities, and all deaths, again regardless of cause, after discharge and within 30 days of the operation.

The analyses by Dr. Maximus and colleagues used data from the California Office of Statewide Health Planning and Development hospitalized patient discharge database for the year 2009. The first analysis the researchers performed did not exclude any patients and found a significant number of cardiac procedural deaths occurred after transfer at discharge from the index hospitalization, 17% in the surgical group vs. 31% in the PCI group. In the second analysis, which excluded untrackable patients, hospital deaths included 12% for PCI and 4% for surgery.

“PCI mortality was more dependent on the method used to define mortality, compared with the surgical patients, and a larger percentage of deaths occurred after hospital discharge and within 30 days of the procedure,” Dr. Maximus and colleagues said.

Another key factor in calculating mortality rates was the ability of hospitals to follow patients. “We found that up to 20% of hospitals were not able to track their patients long-term,” Dr. Maximus and coauthors said.

Study coauthor Dr. Junaid Kahn disclosed consulting fees from Edwards Lifesciences. The other authors have no financial relationships to disclose.

Reporting of outcomes has grown in importance as clinical registries collect data and establish benchmarks for quality care, but exactly what those data report can vary depending on the definition of a specific outcome, even for an outcome as seemingly straightforward as death after an intervention.

Dr. Steven Maximus of the University of California Irvine Medical Center, and colleagues reported on this phenomenon in the April issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:1101-10). Specifically, they showed how rates of postoperative mortality after five different cardiac interventions can vary within the same data set depending on the definition of postoperative mortality.

“A significant percentage of procedural deaths occur after transfer or discharge from the index hospital,” Dr. Maximus and colleagues said. “These findings illustrate the importance of the definition of ‘operative’ mortality and the need to ensure accuracy in the reporting of data to volunteer clinical registries.”

They calculated outcomes based on five different definitions of postoperative mortality for five different cardiac interventions, depending on when and where the patient died, each of which showed slightly different results. The five different definitions of postoperative mortality are: during the index hospitalization only; during the index hospitalization or in a hospital the patient was transferred to on the same day or within 24 hours of discharge; during the index hospitalization or within 30 days after the procedure; during the index hospitalization or transfer hospitalization or during readmission within 30 days; and during the index hospitalization, transfer, and within 30 days after the procedure regardless of readmission.

As an example, mortality rates for percutaneous coronary intervention (PCI) with acute coronary syndrome (ACS) ranged from 3.25% for the first definition listed to 4.51% for the fifth definition. For isolated coronary artery bypass grafting, the rates ranged from 1.71% for the first definition to 2.15% for the fifth.

The fifth definition “is the most encompassing and is the current definition used by the STS [Society of Thoracic Surgeons] and should be applied to other clinical registries, such as the American College of Cardiology National Cardiovascular Data Registry,” Dr. Maximus and colleagues said.

The study noted that the Society of Thoracic Surgeons National Database (STS-NDB) has revised its definition of operative mortality to more accurately measure outcomes. Originally, the STS-NDB definition included all deaths during the index hospitalization, even those after 30 days, and postdischarge deaths within 30 days unless the cause of death was not related to the operation. In 2011, the definition was updated to include patients transferred to other acute care facilities. STS-NDB updated the definition again in 2014 to include all deaths, regardless of cause, during the index hospitalization, even if after 30 days, and including patients transferred to other acute care facilities, and all deaths, again regardless of cause, after discharge and within 30 days of the operation.

The analyses by Dr. Maximus and colleagues used data from the California Office of Statewide Health Planning and Development hospitalized patient discharge database for the year 2009. The first analysis the researchers performed did not exclude any patients and found a significant number of cardiac procedural deaths occurred after transfer at discharge from the index hospitalization, 17% in the surgical group vs. 31% in the PCI group. In the second analysis, which excluded untrackable patients, hospital deaths included 12% for PCI and 4% for surgery.

“PCI mortality was more dependent on the method used to define mortality, compared with the surgical patients, and a larger percentage of deaths occurred after hospital discharge and within 30 days of the procedure,” Dr. Maximus and colleagues said.

Another key factor in calculating mortality rates was the ability of hospitals to follow patients. “We found that up to 20% of hospitals were not able to track their patients long-term,” Dr. Maximus and coauthors said.

Study coauthor Dr. Junaid Kahn disclosed consulting fees from Edwards Lifesciences. The other authors have no financial relationships to disclose.

WASHINGTON – In patients with coronary artery disease, there is no increased risk of angina 1 year after percutaneous coronary intervention for bare metal stents relative to drug-eluting metal stents, according to data presented at Cardiovascular Research Technologies 2016.

“Angina pectoris in the first year after PCI [percutaneous coronary intervention] is remarkably common, affecting 32.3% of patients,” but “metallic stent type is not independently associated with the occurrence of angina,” reported Dr. Michael A. Gaglia Jr., an interventional cardiologist at MedStar Heart and Vascular Institute in Washington.

©Suze777/ thinkstockphotos.com

This conclusion was based on a study in which 8,804 patients who underwent PCI with metal stents were questioned about angina and its severity. The incidence of angina was compared for bare-metal stents relative to five drug-eluting metal stents: Cypher (sirolimus-eluting, Johnson & Johnson), Taxus Express2 (paclitaxel, Boston Scientific), Xience V (everolimus, Abbott Vascular), Promus Element (everolimus, Boston Scientific), and Resolute Integrity (zotarolimus, Medtronic).

For nearly 3 months, the cumulative incidence of angina remained tightly grouped at 5% or less across stent types. Incidence rates began climbing slowly through the first 9 months of follow-up and then more steeply at about 10 months. When depicted graphically, the incidence of angina appeared higher after placement of the Cypher stent, which was discontinued in 2011, but multivariate analysis found “no significant association between stent type and angina at 1 year after PCI,” Dr. Gaglia reported.

Although risk of angina was not correlated with type of metal stent, angina was highly correlated with risk of a major adverse cardiovascular event (MACE). When angina severity was stratified by the Canadian Cardiovascular Society system, MACE, defined as a composite of all-cause mortality, target vessel revascularization, and Q-wave myocardial infarction, occurred in 6.8% of those without angina, 10.0% of those with class 1 or 2 angina, and 19.7% of those with class 3 or 4 angina (P less than .001 for this trend) over the course of follow-up.

Independent of stent type, angina was more common in patients with a history of severe angina prior to PCI, a prior PCI, or prior coronary artery bypass grafting. A reduced likelihood of angina was independently associated with older age, male sex, a presentation of acute coronary syndrome, and a longer stented length.

Other studies have also shown that angina after PCI is associated with an increased risk of MACE relative to the absence of ischemia, but the contribution of this study is that it is the first set of data to suggest that drug eluting stents provide no advantage over bare metal stents for controlling angina, according to the authors. In the graphic representation of angina incidence for different stent types over 1-year of follow-up, four of the six lines, including the line representing bare metal stents, were essentially superimposable. In addition to the line representing angina incidence in those receiving the Cypher stent, the line representing angina incidence on the Promus Element stent climbed higher at 9 months relative to the remaining four stent types, but this line had rejoined the others at 12 months.

“Metallic coronary stents alter vessel geometry, shear stress, and hemodynamics. Stents also vary in design and architecture,” Dr. Gaglia observed. Although protection from angina is one of the major indications for the placement of stents, Dr. Gaglia emphasized that data comparing different metallic stents in regards to the incidence of angina pectoris at long-term follow-up have until this study “been lacking.”

The meeting was sponsored by the Cardiovascular Research Institute at Washington Hospital Center. Dr. Gaglia reports no relevant financial relationships. Abbott Vascular funded the study.

WASHINGTON – In patients with coronary artery disease, there is no increased risk of angina 1 year after percutaneous coronary intervention for bare metal stents relative to drug-eluting metal stents, according to data presented at Cardiovascular Research Technologies 2016.

“Angina pectoris in the first year after PCI [percutaneous coronary intervention] is remarkably common, affecting 32.3% of patients,” but “metallic stent type is not independently associated with the occurrence of angina,” reported Dr. Michael A. Gaglia Jr., an interventional cardiologist at MedStar Heart and Vascular Institute in Washington.

©Suze777/ thinkstockphotos.com

This conclusion was based on a study in which 8,804 patients who underwent PCI with metal stents were questioned about angina and its severity. The incidence of angina was compared for bare-metal stents relative to five drug-eluting metal stents: Cypher (sirolimus-eluting, Johnson & Johnson), Taxus Express2 (paclitaxel, Boston Scientific), Xience V (everolimus, Abbott Vascular), Promus Element (everolimus, Boston Scientific), and Resolute Integrity (zotarolimus, Medtronic).

For nearly 3 months, the cumulative incidence of angina remained tightly grouped at 5% or less across stent types. Incidence rates began climbing slowly through the first 9 months of follow-up and then more steeply at about 10 months. When depicted graphically, the incidence of angina appeared higher after placement of the Cypher stent, which was discontinued in 2011, but multivariate analysis found “no significant association between stent type and angina at 1 year after PCI,” Dr. Gaglia reported.

Although risk of angina was not correlated with type of metal stent, angina was highly correlated with risk of a major adverse cardiovascular event (MACE). When angina severity was stratified by the Canadian Cardiovascular Society system, MACE, defined as a composite of all-cause mortality, target vessel revascularization, and Q-wave myocardial infarction, occurred in 6.8% of those without angina, 10.0% of those with class 1 or 2 angina, and 19.7% of those with class 3 or 4 angina (P less than .001 for this trend) over the course of follow-up.

Independent of stent type, angina was more common in patients with a history of severe angina prior to PCI, a prior PCI, or prior coronary artery bypass grafting. A reduced likelihood of angina was independently associated with older age, male sex, a presentation of acute coronary syndrome, and a longer stented length.

Other studies have also shown that angina after PCI is associated with an increased risk of MACE relative to the absence of ischemia, but the contribution of this study is that it is the first set of data to suggest that drug eluting stents provide no advantage over bare metal stents for controlling angina, according to the authors. In the graphic representation of angina incidence for different stent types over 1-year of follow-up, four of the six lines, including the line representing bare metal stents, were essentially superimposable. In addition to the line representing angina incidence in those receiving the Cypher stent, the line representing angina incidence on the Promus Element stent climbed higher at 9 months relative to the remaining four stent types, but this line had rejoined the others at 12 months.

“Metallic coronary stents alter vessel geometry, shear stress, and hemodynamics. Stents also vary in design and architecture,” Dr. Gaglia observed. Although protection from angina is one of the major indications for the placement of stents, Dr. Gaglia emphasized that data comparing different metallic stents in regards to the incidence of angina pectoris at long-term follow-up have until this study “been lacking.”

The meeting was sponsored by the Cardiovascular Research Institute at Washington Hospital Center. Dr. Gaglia reports no relevant financial relationships. Abbott Vascular funded the study.

WASHINGTON – In patients with coronary artery disease, there is no increased risk of angina 1 year after percutaneous coronary intervention for bare metal stents relative to drug-eluting metal stents, according to data presented at Cardiovascular Research Technologies 2016.

“Angina pectoris in the first year after PCI [percutaneous coronary intervention] is remarkably common, affecting 32.3% of patients,” but “metallic stent type is not independently associated with the occurrence of angina,” reported Dr. Michael A. Gaglia Jr., an interventional cardiologist at MedStar Heart and Vascular Institute in Washington.

©Suze777/ thinkstockphotos.com

This conclusion was based on a study in which 8,804 patients who underwent PCI with metal stents were questioned about angina and its severity. The incidence of angina was compared for bare-metal stents relative to five drug-eluting metal stents: Cypher (sirolimus-eluting, Johnson & Johnson), Taxus Express2 (paclitaxel, Boston Scientific), Xience V (everolimus, Abbott Vascular), Promus Element (everolimus, Boston Scientific), and Resolute Integrity (zotarolimus, Medtronic).

For nearly 3 months, the cumulative incidence of angina remained tightly grouped at 5% or less across stent types. Incidence rates began climbing slowly through the first 9 months of follow-up and then more steeply at about 10 months. When depicted graphically, the incidence of angina appeared higher after placement of the Cypher stent, which was discontinued in 2011, but multivariate analysis found “no significant association between stent type and angina at 1 year after PCI,” Dr. Gaglia reported.

Although risk of angina was not correlated with type of metal stent, angina was highly correlated with risk of a major adverse cardiovascular event (MACE). When angina severity was stratified by the Canadian Cardiovascular Society system, MACE, defined as a composite of all-cause mortality, target vessel revascularization, and Q-wave myocardial infarction, occurred in 6.8% of those without angina, 10.0% of those with class 1 or 2 angina, and 19.7% of those with class 3 or 4 angina (P less than .001 for this trend) over the course of follow-up.

Independent of stent type, angina was more common in patients with a history of severe angina prior to PCI, a prior PCI, or prior coronary artery bypass grafting. A reduced likelihood of angina was independently associated with older age, male sex, a presentation of acute coronary syndrome, and a longer stented length.

Other studies have also shown that angina after PCI is associated with an increased risk of MACE relative to the absence of ischemia, but the contribution of this study is that it is the first set of data to suggest that drug eluting stents provide no advantage over bare metal stents for controlling angina, according to the authors. In the graphic representation of angina incidence for different stent types over 1-year of follow-up, four of the six lines, including the line representing bare metal stents, were essentially superimposable. In addition to the line representing angina incidence in those receiving the Cypher stent, the line representing angina incidence on the Promus Element stent climbed higher at 9 months relative to the remaining four stent types, but this line had rejoined the others at 12 months.

“Metallic coronary stents alter vessel geometry, shear stress, and hemodynamics. Stents also vary in design and architecture,” Dr. Gaglia observed. Although protection from angina is one of the major indications for the placement of stents, Dr. Gaglia emphasized that data comparing different metallic stents in regards to the incidence of angina pectoris at long-term follow-up have until this study “been lacking.”

The meeting was sponsored by the Cardiovascular Research Institute at Washington Hospital Center. Dr. Gaglia reports no relevant financial relationships. Abbott Vascular funded the study.

Workers performing fluoroscopically guided cardiovascular procedures are at significantly higher risk of a diverse array of health disorders compared with nonexposed subjects, according to a survey.

Though cancers and ocular, skin, and thyroid disorders are recognized risks of working with low-dose radiation, as are orthopedic problems associated with wearing heavy lead aprons, the new study, published online April 12 in Circulation: Cardiovascular Interventions, adds weight to emerging concerns about lesser-known risks.

In addition to higher prevalence of skin lesions, cataracts, thyroid disorders, cancer, and orthopedic problems, exposed workers saw significantly higher prevalence of hypertension, hypercholesterolemia, and depression or anxiety, compared with controls.

Maria Grazia Andreassi, Ph.D., of the CNR Institute of Clinical Physiology, in Pisa, Italy, led the study, which used questionnaires to collect health, exposure, and demographic information from 466 workers in cardiac catheterization laboratories in Italy: 218 interventional cardiologists and electrophysiologists, 191 nurses, and 57 technicians. Radiation exposure was estimated based on subjects’ occupational radiological risk score (ORRS), which takes into consideration years of work, caseloads, and proximity to the radiation source in the lab.

Genetics Unit of CNR Institute of Clinical Physiology in Italy

The researchers administered the same questionnaires to 280 health workers who did not have occupational radiation exposure. The two groups were well matched for age, sex, education level, alcohol use, and body mass index, though current smoking differed significantly (27% of lab staff vs. 23% of unexposed workers).

As expected, orthopedic injuries were markedly higher among the lab workers, with 30% reporting disorders compared with 5% of controls (P less than .001). Nearly 5% of the lab workers had cataracts, compared with less than 1% of the nonexposed (P = .003), and risk increased for subjects with more years in the lab. Cancer was higher among exposed participants (2.6% vs. 0.7%), a difference that did not reach statistical significance. However, a significant trend was seen for cancer risk increasing across duration of exposure (Circ Cardiovasc Interv. 2016;9:e003273).

In the composite endpoint of cataract and cancer, a surrogate for disease associated with occupational exposure to radiation, the researchers found that the interventional cardiologists and electrophysiologists had a significantly higher prevalence than did the nurses and technicians (69% vs. 22% and 9%, respectively; P = .03).

Furthermore, the cancer in physicians occurred more often in the left side, when laterality was applicable, in 67% of cases, whereas the malignancy was left-sided in 33% of cancers occurring in nurses and technicians.

No significant differences in cardiovascular events were seen between the groups. However, hypertension and high cholesterol were more prevalent in cath lab workers, with adjusted odds ratios of 1.7 (95% confidence interval, 1-3; P = .05) and 2.9 (CI, 1-5; P = .004), respectively, for highly exposed subjects, compared with controls.

Last year, in a separate study, Dr. Andreassi’s group reported that exposure to low-dose radiation over time may increase carotid intima-media thickness, an early indicator of vascular injury, among cath lab workers (J Am Coll Cardiol Intv. 2015;8:616-27).

Anxiety and depression occurred in 12% of exposed subjects, compared with 2% of controls. The finding could reflect high occupational stress, the researchers wrote in their analysis, or may be an effect of radiation, “which is especially relevant on the unprotected head of the first operator and at chronic low doses may impact detrimentally on hippocampal neurogenesis and neuronal plasticity.”

The researchers acknowledged the possibility of selection bias in their study, favoring “a possible disproportionate contribution of respondents with existing health issues, who may reasonably think that their complaints are occupationally related,” they wrote. They also noted that the study was not designed to directly assess radiation dose, in part because dosimeters were not regularly worn in some of the settings where subjects worked. Finally, the radiation-exposed group had more cardiovascular risk factors. Nonetheless, the findings highlight the need to “spread the culture of safety” in cardiac cath labs, the researchers wrote.

There is now “more than enough information for us to conclude that the interventional catheterization laboratory is not a healthy workplace,” Dr. Lloyd W. Klein and Dr. Mugurel Bazavan of Advocate Illinois Masonic Medical Center, and Rush Medical College in Chicago, wrote in an accompanying editorial.

Finding “the courage to change business practice,” they wrote, “is the only path to innovative cath laboratory design and shielding techniques that can prevent these occupational hazards” (Circ Cardiovasc Interv. 2016;9:e003742).

Dr. Andreassi and colleagues disclosed no conflicts of interest related to their study, and Dr. Klein and Dr. Bazavan disclosed no conflicts related to their editorial.

Workers performing fluoroscopically guided cardiovascular procedures are at significantly higher risk of a diverse array of health disorders compared with nonexposed subjects, according to a survey.

Though cancers and ocular, skin, and thyroid disorders are recognized risks of working with low-dose radiation, as are orthopedic problems associated with wearing heavy lead aprons, the new study, published online April 12 in Circulation: Cardiovascular Interventions, adds weight to emerging concerns about lesser-known risks.

In addition to higher prevalence of skin lesions, cataracts, thyroid disorders, cancer, and orthopedic problems, exposed workers saw significantly higher prevalence of hypertension, hypercholesterolemia, and depression or anxiety, compared with controls.

Maria Grazia Andreassi, Ph.D., of the CNR Institute of Clinical Physiology, in Pisa, Italy, led the study, which used questionnaires to collect health, exposure, and demographic information from 466 workers in cardiac catheterization laboratories in Italy: 218 interventional cardiologists and electrophysiologists, 191 nurses, and 57 technicians. Radiation exposure was estimated based on subjects’ occupational radiological risk score (ORRS), which takes into consideration years of work, caseloads, and proximity to the radiation source in the lab.

Genetics Unit of CNR Institute of Clinical Physiology in Italy

The researchers administered the same questionnaires to 280 health workers who did not have occupational radiation exposure. The two groups were well matched for age, sex, education level, alcohol use, and body mass index, though current smoking differed significantly (27% of lab staff vs. 23% of unexposed workers).

As expected, orthopedic injuries were markedly higher among the lab workers, with 30% reporting disorders compared with 5% of controls (P less than .001). Nearly 5% of the lab workers had cataracts, compared with less than 1% of the nonexposed (P = .003), and risk increased for subjects with more years in the lab. Cancer was higher among exposed participants (2.6% vs. 0.7%), a difference that did not reach statistical significance. However, a significant trend was seen for cancer risk increasing across duration of exposure (Circ Cardiovasc Interv. 2016;9:e003273).

In the composite endpoint of cataract and cancer, a surrogate for disease associated with occupational exposure to radiation, the researchers found that the interventional cardiologists and electrophysiologists had a significantly higher prevalence than did the nurses and technicians (69% vs. 22% and 9%, respectively; P = .03).

Furthermore, the cancer in physicians occurred more often in the left side, when laterality was applicable, in 67% of cases, whereas the malignancy was left-sided in 33% of cancers occurring in nurses and technicians.

No significant differences in cardiovascular events were seen between the groups. However, hypertension and high cholesterol were more prevalent in cath lab workers, with adjusted odds ratios of 1.7 (95% confidence interval, 1-3; P = .05) and 2.9 (CI, 1-5; P = .004), respectively, for highly exposed subjects, compared with controls.

Last year, in a separate study, Dr. Andreassi’s group reported that exposure to low-dose radiation over time may increase carotid intima-media thickness, an early indicator of vascular injury, among cath lab workers (J Am Coll Cardiol Intv. 2015;8:616-27).

Anxiety and depression occurred in 12% of exposed subjects, compared with 2% of controls. The finding could reflect high occupational stress, the researchers wrote in their analysis, or may be an effect of radiation, “which is especially relevant on the unprotected head of the first operator and at chronic low doses may impact detrimentally on hippocampal neurogenesis and neuronal plasticity.”

The researchers acknowledged the possibility of selection bias in their study, favoring “a possible disproportionate contribution of respondents with existing health issues, who may reasonably think that their complaints are occupationally related,” they wrote. They also noted that the study was not designed to directly assess radiation dose, in part because dosimeters were not regularly worn in some of the settings where subjects worked. Finally, the radiation-exposed group had more cardiovascular risk factors. Nonetheless, the findings highlight the need to “spread the culture of safety” in cardiac cath labs, the researchers wrote.

There is now “more than enough information for us to conclude that the interventional catheterization laboratory is not a healthy workplace,” Dr. Lloyd W. Klein and Dr. Mugurel Bazavan of Advocate Illinois Masonic Medical Center, and Rush Medical College in Chicago, wrote in an accompanying editorial.

Finding “the courage to change business practice,” they wrote, “is the only path to innovative cath laboratory design and shielding techniques that can prevent these occupational hazards” (Circ Cardiovasc Interv. 2016;9:e003742).

Dr. Andreassi and colleagues disclosed no conflicts of interest related to their study, and Dr. Klein and Dr. Bazavan disclosed no conflicts related to their editorial.

Workers performing fluoroscopically guided cardiovascular procedures are at significantly higher risk of a diverse array of health disorders compared with nonexposed subjects, according to a survey.

Though cancers and ocular, skin, and thyroid disorders are recognized risks of working with low-dose radiation, as are orthopedic problems associated with wearing heavy lead aprons, the new study, published online April 12 in Circulation: Cardiovascular Interventions, adds weight to emerging concerns about lesser-known risks.

In addition to higher prevalence of skin lesions, cataracts, thyroid disorders, cancer, and orthopedic problems, exposed workers saw significantly higher prevalence of hypertension, hypercholesterolemia, and depression or anxiety, compared with controls.

Maria Grazia Andreassi, Ph.D., of the CNR Institute of Clinical Physiology, in Pisa, Italy, led the study, which used questionnaires to collect health, exposure, and demographic information from 466 workers in cardiac catheterization laboratories in Italy: 218 interventional cardiologists and electrophysiologists, 191 nurses, and 57 technicians. Radiation exposure was estimated based on subjects’ occupational radiological risk score (ORRS), which takes into consideration years of work, caseloads, and proximity to the radiation source in the lab.

Genetics Unit of CNR Institute of Clinical Physiology in Italy

The researchers administered the same questionnaires to 280 health workers who did not have occupational radiation exposure. The two groups were well matched for age, sex, education level, alcohol use, and body mass index, though current smoking differed significantly (27% of lab staff vs. 23% of unexposed workers).

As expected, orthopedic injuries were markedly higher among the lab workers, with 30% reporting disorders compared with 5% of controls (P less than .001). Nearly 5% of the lab workers had cataracts, compared with less than 1% of the nonexposed (P = .003), and risk increased for subjects with more years in the lab. Cancer was higher among exposed participants (2.6% vs. 0.7%), a difference that did not reach statistical significance. However, a significant trend was seen for cancer risk increasing across duration of exposure (Circ Cardiovasc Interv. 2016;9:e003273).

In the composite endpoint of cataract and cancer, a surrogate for disease associated with occupational exposure to radiation, the researchers found that the interventional cardiologists and electrophysiologists had a significantly higher prevalence than did the nurses and technicians (69% vs. 22% and 9%, respectively; P = .03).

Furthermore, the cancer in physicians occurred more often in the left side, when laterality was applicable, in 67% of cases, whereas the malignancy was left-sided in 33% of cancers occurring in nurses and technicians.

No significant differences in cardiovascular events were seen between the groups. However, hypertension and high cholesterol were more prevalent in cath lab workers, with adjusted odds ratios of 1.7 (95% confidence interval, 1-3; P = .05) and 2.9 (CI, 1-5; P = .004), respectively, for highly exposed subjects, compared with controls.

Last year, in a separate study, Dr. Andreassi’s group reported that exposure to low-dose radiation over time may increase carotid intima-media thickness, an early indicator of vascular injury, among cath lab workers (J Am Coll Cardiol Intv. 2015;8:616-27).

Anxiety and depression occurred in 12% of exposed subjects, compared with 2% of controls. The finding could reflect high occupational stress, the researchers wrote in their analysis, or may be an effect of radiation, “which is especially relevant on the unprotected head of the first operator and at chronic low doses may impact detrimentally on hippocampal neurogenesis and neuronal plasticity.”

The researchers acknowledged the possibility of selection bias in their study, favoring “a possible disproportionate contribution of respondents with existing health issues, who may reasonably think that their complaints are occupationally related,” they wrote. They also noted that the study was not designed to directly assess radiation dose, in part because dosimeters were not regularly worn in some of the settings where subjects worked. Finally, the radiation-exposed group had more cardiovascular risk factors. Nonetheless, the findings highlight the need to “spread the culture of safety” in cardiac cath labs, the researchers wrote.

There is now “more than enough information for us to conclude that the interventional catheterization laboratory is not a healthy workplace,” Dr. Lloyd W. Klein and Dr. Mugurel Bazavan of Advocate Illinois Masonic Medical Center, and Rush Medical College in Chicago, wrote in an accompanying editorial.

Finding “the courage to change business practice,” they wrote, “is the only path to innovative cath laboratory design and shielding techniques that can prevent these occupational hazards” (Circ Cardiovasc Interv. 2016;9:e003742).

Dr. Andreassi and colleagues disclosed no conflicts of interest related to their study, and Dr. Klein and Dr. Bazavan disclosed no conflicts related to their editorial.

In patients with moderate ischemic mitral regurgitation, adding mitral valve repair to coronary artery bypass graft did not significantly affect the extent of left ventricular remodeling at 2 years, according to a randomized multicenter trial.

Compared with revascularization alone, the combined procedure was associated with a two-thirds lower rate of moderate to severe mitral regurgitation at the end of year 2, reported Dr. Robert Michler at Albert Einstein College of Medicine, New York, together with his associates. But improved durability did not translate to better survival or lower rates of major adverse cardiac and cerebrovascular events, heart failure, or hospital readmissions, they said. Furthermore, adding mitral valve repair to CABG was linked to higher rates of postoperative neurologic events and supraventricular arrhythmias than for CABG alone, the investigators reported at the annual meeting of the American College of Cardiology and simultaneously online April 3 in the New England Journal of Medicine.

Surgeons have debated whether to add restrictive mitral annuloplasty to CABG in patients with moderate ischemic mitral regurgitation. The combined approach requires open-heart exposure and longer aortic cross-clamping and cardiopulmonary bypass time, all of which increase perioperative risk, the researchers noted. To explore the risk-benefit balance of these approaches, they randomly assigned 301 patients to either revascularization alone or to the combined procedure, and assessed clinical and echocardiographic outcomes over 2 years (New Engl. J. Med. 2016 April 3 doi: 10.1056/NEJMoa1602003).

At year 1, the arms resembled each other in terms of survival, rates of major adverse cardiac or cerebrovascular events (MACCEs), and left ventricular reverse remodeling, as measured by left ventricular end-systolic volume index (LVESVI), said the investigators. At year 2, the extent of remodeling remained similar between the arms, with mean LVESVIs of 41.2 mL (standard deviation, 20.0 mL) per square meter of body surface area in the CABG-only group and 43.2 mL (SD, 20.6 mL) in the combined procedure group, for a mean decrease from baseline of 14.1 and 14.6 mL, respectively. About two-thirds of improvements in LVESI occurred during year 1 regardless of procedure type, the researchers noted.

About a third of CABG-only patients had moderate to severe mitral regurgitation at 2 years, compared with only 11% of patients who underwent the combined procedure (P less than .001). Patients who had mild or no mitral regurgitation had more than twice the percentage improvement in the global wall motion index and in the inferior-posterior-lateral regional wall motion score, compared with patients with moderate to severe regurgitation. Although both groups improved on several quality-of-life indices, the combined-procedure group scored more than 5 points higher on the Duke Activity Status Index, which measures self-reported exercise capacity. That difference was not only clinically meaningful, but resembled the increase in peak myocardial oxygen consumption in a similar, smaller trial (New Engl. J. Med. 2016 Jan. 28 doi: 10.1056/NEJMoa151291), the investigators noted.

However, mortality rates were similar between the arms at 2 years – 10.6% for CABG only and 10% for the combined procedure, for a non-significant hazard ratio of 0.9. Likewise, rates of heart failure and other serious adverse events were similar between the arms, while the combined-procedure arm had more than three times more postoperative neurologic events and more than twice as many occurrences of supraventricular arrhythmia. Therefore, treatment choice requires “balancing the risks of adverse perioperative events against the uncertain benefits of a lower incidence of postoperative moderate or severe mitral regurgitation,” said the researchers. “Effective revascularization, as reflected in improved regional and global left ventricular function, plays an important role independent of mitral valve repair.”

The National Institutes of Health and the Canadian Institutes of Health Research funded the study. Disclosures were reported separately at nejm.org.

In patients with moderate ischemic mitral regurgitation, adding mitral valve repair to coronary artery bypass graft did not significantly affect the extent of left ventricular remodeling at 2 years, according to a randomized multicenter trial.

Compared with revascularization alone, the combined procedure was associated with a two-thirds lower rate of moderate to severe mitral regurgitation at the end of year 2, reported Dr. Robert Michler at Albert Einstein College of Medicine, New York, together with his associates. But improved durability did not translate to better survival or lower rates of major adverse cardiac and cerebrovascular events, heart failure, or hospital readmissions, they said. Furthermore, adding mitral valve repair to CABG was linked to higher rates of postoperative neurologic events and supraventricular arrhythmias than for CABG alone, the investigators reported at the annual meeting of the American College of Cardiology and simultaneously online April 3 in the New England Journal of Medicine.

Surgeons have debated whether to add restrictive mitral annuloplasty to CABG in patients with moderate ischemic mitral regurgitation. The combined approach requires open-heart exposure and longer aortic cross-clamping and cardiopulmonary bypass time, all of which increase perioperative risk, the researchers noted. To explore the risk-benefit balance of these approaches, they randomly assigned 301 patients to either revascularization alone or to the combined procedure, and assessed clinical and echocardiographic outcomes over 2 years (New Engl. J. Med. 2016 April 3 doi: 10.1056/NEJMoa1602003).

At year 1, the arms resembled each other in terms of survival, rates of major adverse cardiac or cerebrovascular events (MACCEs), and left ventricular reverse remodeling, as measured by left ventricular end-systolic volume index (LVESVI), said the investigators. At year 2, the extent of remodeling remained similar between the arms, with mean LVESVIs of 41.2 mL (standard deviation, 20.0 mL) per square meter of body surface area in the CABG-only group and 43.2 mL (SD, 20.6 mL) in the combined procedure group, for a mean decrease from baseline of 14.1 and 14.6 mL, respectively. About two-thirds of improvements in LVESI occurred during year 1 regardless of procedure type, the researchers noted.

About a third of CABG-only patients had moderate to severe mitral regurgitation at 2 years, compared with only 11% of patients who underwent the combined procedure (P less than .001). Patients who had mild or no mitral regurgitation had more than twice the percentage improvement in the global wall motion index and in the inferior-posterior-lateral regional wall motion score, compared with patients with moderate to severe regurgitation. Although both groups improved on several quality-of-life indices, the combined-procedure group scored more than 5 points higher on the Duke Activity Status Index, which measures self-reported exercise capacity. That difference was not only clinically meaningful, but resembled the increase in peak myocardial oxygen consumption in a similar, smaller trial (New Engl. J. Med. 2016 Jan. 28 doi: 10.1056/NEJMoa151291), the investigators noted.

However, mortality rates were similar between the arms at 2 years – 10.6% for CABG only and 10% for the combined procedure, for a non-significant hazard ratio of 0.9. Likewise, rates of heart failure and other serious adverse events were similar between the arms, while the combined-procedure arm had more than three times more postoperative neurologic events and more than twice as many occurrences of supraventricular arrhythmia. Therefore, treatment choice requires “balancing the risks of adverse perioperative events against the uncertain benefits of a lower incidence of postoperative moderate or severe mitral regurgitation,” said the researchers. “Effective revascularization, as reflected in improved regional and global left ventricular function, plays an important role independent of mitral valve repair.”

The National Institutes of Health and the Canadian Institutes of Health Research funded the study. Disclosures were reported separately at nejm.org.

In patients with moderate ischemic mitral regurgitation, adding mitral valve repair to coronary artery bypass graft did not significantly affect the extent of left ventricular remodeling at 2 years, according to a randomized multicenter trial.

Compared with revascularization alone, the combined procedure was associated with a two-thirds lower rate of moderate to severe mitral regurgitation at the end of year 2, reported Dr. Robert Michler at Albert Einstein College of Medicine, New York, together with his associates. But improved durability did not translate to better survival or lower rates of major adverse cardiac and cerebrovascular events, heart failure, or hospital readmissions, they said. Furthermore, adding mitral valve repair to CABG was linked to higher rates of postoperative neurologic events and supraventricular arrhythmias than for CABG alone, the investigators reported at the annual meeting of the American College of Cardiology and simultaneously online April 3 in the New England Journal of Medicine.

Surgeons have debated whether to add restrictive mitral annuloplasty to CABG in patients with moderate ischemic mitral regurgitation. The combined approach requires open-heart exposure and longer aortic cross-clamping and cardiopulmonary bypass time, all of which increase perioperative risk, the researchers noted. To explore the risk-benefit balance of these approaches, they randomly assigned 301 patients to either revascularization alone or to the combined procedure, and assessed clinical and echocardiographic outcomes over 2 years (New Engl. J. Med. 2016 April 3 doi: 10.1056/NEJMoa1602003).

At year 1, the arms resembled each other in terms of survival, rates of major adverse cardiac or cerebrovascular events (MACCEs), and left ventricular reverse remodeling, as measured by left ventricular end-systolic volume index (LVESVI), said the investigators. At year 2, the extent of remodeling remained similar between the arms, with mean LVESVIs of 41.2 mL (standard deviation, 20.0 mL) per square meter of body surface area in the CABG-only group and 43.2 mL (SD, 20.6 mL) in the combined procedure group, for a mean decrease from baseline of 14.1 and 14.6 mL, respectively. About two-thirds of improvements in LVESI occurred during year 1 regardless of procedure type, the researchers noted.

About a third of CABG-only patients had moderate to severe mitral regurgitation at 2 years, compared with only 11% of patients who underwent the combined procedure (P less than .001). Patients who had mild or no mitral regurgitation had more than twice the percentage improvement in the global wall motion index and in the inferior-posterior-lateral regional wall motion score, compared with patients with moderate to severe regurgitation. Although both groups improved on several quality-of-life indices, the combined-procedure group scored more than 5 points higher on the Duke Activity Status Index, which measures self-reported exercise capacity. That difference was not only clinically meaningful, but resembled the increase in peak myocardial oxygen consumption in a similar, smaller trial (New Engl. J. Med. 2016 Jan. 28 doi: 10.1056/NEJMoa151291), the investigators noted.

However, mortality rates were similar between the arms at 2 years – 10.6% for CABG only and 10% for the combined procedure, for a non-significant hazard ratio of 0.9. Likewise, rates of heart failure and other serious adverse events were similar between the arms, while the combined-procedure arm had more than three times more postoperative neurologic events and more than twice as many occurrences of supraventricular arrhythmia. Therefore, treatment choice requires “balancing the risks of adverse perioperative events against the uncertain benefits of a lower incidence of postoperative moderate or severe mitral regurgitation,” said the researchers. “Effective revascularization, as reflected in improved regional and global left ventricular function, plays an important role independent of mitral valve repair.”

The National Institutes of Health and the Canadian Institutes of Health Research funded the study. Disclosures were reported separately at nejm.org.