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Five-year outcomes favor on- versus off-pump CABG
Compared with adults who underwent off-pump coronary-artery bypass grafting surgery, those who underwent on-pump CABG had significantly lower rates of mortality and major adverse cardiovascular events at 5 years, results from a large randomized trial demonstrated.
“Given the results, it appears that innovative surgical approaches – such as the more technically demanding off-pump procedure – may not always provide superior clinical outcomes,” researchers led by A. Laurie Shroyer, PhD, wrote (N Engl J Med. 2017 Aug 17;377:623-32). “Additional long-term follow-up, evaluating these same outcomes rigorously at 10 years after CABG, appears to be warranted. Future research may identify the risk factors of the patients and the cardiac surgical processes of care that affect longer-term outcomes of coronary revascularization procedures, with the goal of increasing the rate of long-term event-free survival.”
Dr. Shroyer, of the Northport (N.Y.) VA Medical Center, and her associates conduced a 5-year follow-up study of patients who had participated in the original Randomized On/Off Bypass (ROOBY) trial, which compared the effectiveness of the two surgical approaches (N Engl J Med 2009 Nov 5;361:1827-37). During February 2002–June 2007, 2,203 patients at 18 medical centers were randomly assigned to either on-pump or off-pump CABG, with 1-year assessments completed by May 2008. The primary outcomes were the rates mortality and major adverse cardiovascular events at 5 years, while the secondary 5-year outcomes included death from cardiac causes, repeat revascularization, and nonfatal myocardial infarction.
The mean age of patients was 63 years, nearly all were male, 46% were between the ages of 55 and 64, and about 21% had chronic obstructive pulmonary disease. The researchers found that at 5 years, the rate of death was 15.2% in the off-pump group, compared with 11.9% in the on-pump group, which translated into a relative risk of 1.28 (P = .02). In addition, the rate of major cardiovascular events at 5 years was 31% in the off-pump group, compared with 27.1% in the on-pump group, which translated into a relative risk of 1.14 (P = .046). None of the secondary outcomes at 5 years met the prespecified threshold of a P value of .01 or less for statistical significance, when the off-pump and on-pump groups were compared. This included the rates of nonfatal myocardial infarction (12.1% vs. 9.6%, respectively; P = .05); death from cardiac causes (6.3% vs. 5.3%; P = .29); repeat vascularization (13.1% vs. 11.9%; P = .39), and repeat CABG (1.4% vs. 0.5%; P = .02).
“In combination with findings from other randomized trials and a 2012 Cochrane systematic review [Cochrane Database Syst Rev. 2012;14:CD007224], the 5-year outcomes in our study support the conclusion that off-pump CABG does not offer any substantial advantages over on-pump CABG except possibly in unusual situations such as, for example, in patients with an extensively calcified (porcelain) aorta, in whom the off-pump technique may result in less manipulation of the aorta, potentially decreasing the risk of aortic emboli or stroke,” the researchers wrote. “In light of the low rates of use of off-pump CABG in the United States, the findings in our trial may provide more of a real-world experience than those in the CORONARY and GOPCABE trials, which required surgeons with a very high volume of experience with off-pump procedures, as compared with the ROOBY trial and with most other surgeons who are based in the United States.”
They acknowledged certain limitations of the study, including the fact that the study population comprised mostly males who had multiple coexisting conditions, “so the findings may not be applicable to female patients or to patients who are not veterans.”
The study was supported by a grant from the Department of Veterans Affairs. Dr. Shroyer reported having received grants from the VA Cooperative Studies Program during the conduct of the study. Her coauthors reported having no financial disclosures.
Compared with adults who underwent off-pump coronary-artery bypass grafting surgery, those who underwent on-pump CABG had significantly lower rates of mortality and major adverse cardiovascular events at 5 years, results from a large randomized trial demonstrated.
“Given the results, it appears that innovative surgical approaches – such as the more technically demanding off-pump procedure – may not always provide superior clinical outcomes,” researchers led by A. Laurie Shroyer, PhD, wrote (N Engl J Med. 2017 Aug 17;377:623-32). “Additional long-term follow-up, evaluating these same outcomes rigorously at 10 years after CABG, appears to be warranted. Future research may identify the risk factors of the patients and the cardiac surgical processes of care that affect longer-term outcomes of coronary revascularization procedures, with the goal of increasing the rate of long-term event-free survival.”
Dr. Shroyer, of the Northport (N.Y.) VA Medical Center, and her associates conduced a 5-year follow-up study of patients who had participated in the original Randomized On/Off Bypass (ROOBY) trial, which compared the effectiveness of the two surgical approaches (N Engl J Med 2009 Nov 5;361:1827-37). During February 2002–June 2007, 2,203 patients at 18 medical centers were randomly assigned to either on-pump or off-pump CABG, with 1-year assessments completed by May 2008. The primary outcomes were the rates mortality and major adverse cardiovascular events at 5 years, while the secondary 5-year outcomes included death from cardiac causes, repeat revascularization, and nonfatal myocardial infarction.
The mean age of patients was 63 years, nearly all were male, 46% were between the ages of 55 and 64, and about 21% had chronic obstructive pulmonary disease. The researchers found that at 5 years, the rate of death was 15.2% in the off-pump group, compared with 11.9% in the on-pump group, which translated into a relative risk of 1.28 (P = .02). In addition, the rate of major cardiovascular events at 5 years was 31% in the off-pump group, compared with 27.1% in the on-pump group, which translated into a relative risk of 1.14 (P = .046). None of the secondary outcomes at 5 years met the prespecified threshold of a P value of .01 or less for statistical significance, when the off-pump and on-pump groups were compared. This included the rates of nonfatal myocardial infarction (12.1% vs. 9.6%, respectively; P = .05); death from cardiac causes (6.3% vs. 5.3%; P = .29); repeat vascularization (13.1% vs. 11.9%; P = .39), and repeat CABG (1.4% vs. 0.5%; P = .02).
“In combination with findings from other randomized trials and a 2012 Cochrane systematic review [Cochrane Database Syst Rev. 2012;14:CD007224], the 5-year outcomes in our study support the conclusion that off-pump CABG does not offer any substantial advantages over on-pump CABG except possibly in unusual situations such as, for example, in patients with an extensively calcified (porcelain) aorta, in whom the off-pump technique may result in less manipulation of the aorta, potentially decreasing the risk of aortic emboli or stroke,” the researchers wrote. “In light of the low rates of use of off-pump CABG in the United States, the findings in our trial may provide more of a real-world experience than those in the CORONARY and GOPCABE trials, which required surgeons with a very high volume of experience with off-pump procedures, as compared with the ROOBY trial and with most other surgeons who are based in the United States.”
They acknowledged certain limitations of the study, including the fact that the study population comprised mostly males who had multiple coexisting conditions, “so the findings may not be applicable to female patients or to patients who are not veterans.”
The study was supported by a grant from the Department of Veterans Affairs. Dr. Shroyer reported having received grants from the VA Cooperative Studies Program during the conduct of the study. Her coauthors reported having no financial disclosures.
Compared with adults who underwent off-pump coronary-artery bypass grafting surgery, those who underwent on-pump CABG had significantly lower rates of mortality and major adverse cardiovascular events at 5 years, results from a large randomized trial demonstrated.
“Given the results, it appears that innovative surgical approaches – such as the more technically demanding off-pump procedure – may not always provide superior clinical outcomes,” researchers led by A. Laurie Shroyer, PhD, wrote (N Engl J Med. 2017 Aug 17;377:623-32). “Additional long-term follow-up, evaluating these same outcomes rigorously at 10 years after CABG, appears to be warranted. Future research may identify the risk factors of the patients and the cardiac surgical processes of care that affect longer-term outcomes of coronary revascularization procedures, with the goal of increasing the rate of long-term event-free survival.”
Dr. Shroyer, of the Northport (N.Y.) VA Medical Center, and her associates conduced a 5-year follow-up study of patients who had participated in the original Randomized On/Off Bypass (ROOBY) trial, which compared the effectiveness of the two surgical approaches (N Engl J Med 2009 Nov 5;361:1827-37). During February 2002–June 2007, 2,203 patients at 18 medical centers were randomly assigned to either on-pump or off-pump CABG, with 1-year assessments completed by May 2008. The primary outcomes were the rates mortality and major adverse cardiovascular events at 5 years, while the secondary 5-year outcomes included death from cardiac causes, repeat revascularization, and nonfatal myocardial infarction.
The mean age of patients was 63 years, nearly all were male, 46% were between the ages of 55 and 64, and about 21% had chronic obstructive pulmonary disease. The researchers found that at 5 years, the rate of death was 15.2% in the off-pump group, compared with 11.9% in the on-pump group, which translated into a relative risk of 1.28 (P = .02). In addition, the rate of major cardiovascular events at 5 years was 31% in the off-pump group, compared with 27.1% in the on-pump group, which translated into a relative risk of 1.14 (P = .046). None of the secondary outcomes at 5 years met the prespecified threshold of a P value of .01 or less for statistical significance, when the off-pump and on-pump groups were compared. This included the rates of nonfatal myocardial infarction (12.1% vs. 9.6%, respectively; P = .05); death from cardiac causes (6.3% vs. 5.3%; P = .29); repeat vascularization (13.1% vs. 11.9%; P = .39), and repeat CABG (1.4% vs. 0.5%; P = .02).
“In combination with findings from other randomized trials and a 2012 Cochrane systematic review [Cochrane Database Syst Rev. 2012;14:CD007224], the 5-year outcomes in our study support the conclusion that off-pump CABG does not offer any substantial advantages over on-pump CABG except possibly in unusual situations such as, for example, in patients with an extensively calcified (porcelain) aorta, in whom the off-pump technique may result in less manipulation of the aorta, potentially decreasing the risk of aortic emboli or stroke,” the researchers wrote. “In light of the low rates of use of off-pump CABG in the United States, the findings in our trial may provide more of a real-world experience than those in the CORONARY and GOPCABE trials, which required surgeons with a very high volume of experience with off-pump procedures, as compared with the ROOBY trial and with most other surgeons who are based in the United States.”
They acknowledged certain limitations of the study, including the fact that the study population comprised mostly males who had multiple coexisting conditions, “so the findings may not be applicable to female patients or to patients who are not veterans.”
The study was supported by a grant from the Department of Veterans Affairs. Dr. Shroyer reported having received grants from the VA Cooperative Studies Program during the conduct of the study. Her coauthors reported having no financial disclosures.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point:
Major finding: At 5 years, the rate of death was 15.2% in the off-pump group, compared with 11.9% in the on-pump group, which translated into a relative risk of 1.28 (P = .02).
Data source: A 5-year follow-up study of 2,203 patients who had participated in the original Randomized On/Off Bypass (ROOBY) trial.
Disclosures: The study was supported by a grant from the Department of Veterans Affairs. Dr. Shroyer reported having received grants from the Department of Veterans Affairs Cooperative Studies Program during the study. The other coauthors reported having no financial disclosures.
New-onset AF after aortic valve replacement did not affect long-term survival
New-onset atrial fibrillation after aortic valve replacement was not an independent risk factor for decreased long-term survival, according to the results of a single-center, retrospective study reported by Ben M. Swinkels, MD, of St Antonius Hospital, Nieuwegein, and his colleagues in the Netherlands.
Key to this success, however, is restoring normal sinus rhythm before hospital discharge, they said.
In this retrospective, longitudinal cohort study, 569 consecutive patients with no history of AF who underwent AVR with or without concomitant coronary artery bypass grafting during 1990-1993 were followed for a mean of 17.8 years (J Thorac Cardiovasc Surg. 2017;154:492-8).
Thirty-day and long-term survival rates were determined in the 241 patients (42%) with and the 328 patients (58%) without new-onset postoperative atrial fibrillation (POAF), which was defined as electrocardiographically documented AF lasting for at least several hours, and occurring after AVR while the patient was still admitted. Standard therapy to prevent new onset POAF was the use of sotalol in patients who were not on beta-blocker therapy, and continuation of beta-blocker therapy for those who were already on it.
There were no significant differences between the two groups in demographic characteristics. There were also no significant differences between the two groups in operative characteristics, postoperative in-hospital adverse events, and postoperative hospital lengths of stay until discharge home, except for mechanical ventilation time, which was significantly longer in the patients with new-onset POAF (P = .011).
Thirty-day mortality was 1.2% in the patients with POAF, and 2.7% in those without, a nonsignificant difference. There was no statistically significant difference between the two survival curves and the Kaplan-Meier overall cumulative survival rates at 15 years of follow-up in the patients with new-onset POAF vs. those without were not statistically different (41.5% vs. 41.3%, respectively).
In addition, the 18-year probability of long-term first adverse events, including recurrent AF, transient ischemic attack, ischemic or hemorrhagic stroke, peripheral venous thromboembolism, or major or minor bleeding was not significantly different between the two groups.
“New-onset POAF after AVR does not affect long-term survival when treatment is aimed to restore sinus rhythm before the patient is discharged home. Future studies with a prospective, randomized design should be done to confirm this finding in patients undergoing different kinds of cardiac surgery,” the researchers concluded.
The study was funded by the authors’ home institution; the authors reported they had nothing to disclose.
The incidence of atrial fibrillation after valve surgery has been described to be as high as 50%, Manuel J. Antunes, MD, said in an editorial commentary. “The adverse effect on long-term survival may not be related to the short-lived new-onset AF but rather to the underlying pathology associated to the arrhythmia, especially pathology that affects the myocardium, principally in atherosclerotic coronary artery disease,” he wrote. “It is not survival alone, however, that should be cause for concern; AF, even in episodes of limited duration, may result in transient ischemic attacks, ischemic, or hemorrhagic strokes, and peripheral thromboembolism, which is why affected patients should immediately be anticoagulated.”
This study, however, is at odds with previously published studies, with opposite conclusions, according to Dr. Antunes. Swinkels and his colleagues suggest that one of the reasons for the discrepancy was the homogeneous character of their series, which consisted almost entirely of patients who had isolated AVR. Dr. Antunes also adds that another important aspect to consider is that the antiarrhythmic drugs used prophylactically or therapeutically for this patient cohort (treated during 1990-1993) are no longer used or have been replaced by new and more efficacious pharmacologic agents.
Manuel J. Antunes, MD, of the University Hospital and Faculty of Medicine, Coimbra, Portugal, made these remarks in an invited editorial (J Thorac Cardiovasc Surg. 2017;154:490-1). He reported having nothing to disclose.
The incidence of atrial fibrillation after valve surgery has been described to be as high as 50%, Manuel J. Antunes, MD, said in an editorial commentary. “The adverse effect on long-term survival may not be related to the short-lived new-onset AF but rather to the underlying pathology associated to the arrhythmia, especially pathology that affects the myocardium, principally in atherosclerotic coronary artery disease,” he wrote. “It is not survival alone, however, that should be cause for concern; AF, even in episodes of limited duration, may result in transient ischemic attacks, ischemic, or hemorrhagic strokes, and peripheral thromboembolism, which is why affected patients should immediately be anticoagulated.”
This study, however, is at odds with previously published studies, with opposite conclusions, according to Dr. Antunes. Swinkels and his colleagues suggest that one of the reasons for the discrepancy was the homogeneous character of their series, which consisted almost entirely of patients who had isolated AVR. Dr. Antunes also adds that another important aspect to consider is that the antiarrhythmic drugs used prophylactically or therapeutically for this patient cohort (treated during 1990-1993) are no longer used or have been replaced by new and more efficacious pharmacologic agents.
Manuel J. Antunes, MD, of the University Hospital and Faculty of Medicine, Coimbra, Portugal, made these remarks in an invited editorial (J Thorac Cardiovasc Surg. 2017;154:490-1). He reported having nothing to disclose.
The incidence of atrial fibrillation after valve surgery has been described to be as high as 50%, Manuel J. Antunes, MD, said in an editorial commentary. “The adverse effect on long-term survival may not be related to the short-lived new-onset AF but rather to the underlying pathology associated to the arrhythmia, especially pathology that affects the myocardium, principally in atherosclerotic coronary artery disease,” he wrote. “It is not survival alone, however, that should be cause for concern; AF, even in episodes of limited duration, may result in transient ischemic attacks, ischemic, or hemorrhagic strokes, and peripheral thromboembolism, which is why affected patients should immediately be anticoagulated.”
This study, however, is at odds with previously published studies, with opposite conclusions, according to Dr. Antunes. Swinkels and his colleagues suggest that one of the reasons for the discrepancy was the homogeneous character of their series, which consisted almost entirely of patients who had isolated AVR. Dr. Antunes also adds that another important aspect to consider is that the antiarrhythmic drugs used prophylactically or therapeutically for this patient cohort (treated during 1990-1993) are no longer used or have been replaced by new and more efficacious pharmacologic agents.
Manuel J. Antunes, MD, of the University Hospital and Faculty of Medicine, Coimbra, Portugal, made these remarks in an invited editorial (J Thorac Cardiovasc Surg. 2017;154:490-1). He reported having nothing to disclose.
New-onset atrial fibrillation after aortic valve replacement was not an independent risk factor for decreased long-term survival, according to the results of a single-center, retrospective study reported by Ben M. Swinkels, MD, of St Antonius Hospital, Nieuwegein, and his colleagues in the Netherlands.
Key to this success, however, is restoring normal sinus rhythm before hospital discharge, they said.
In this retrospective, longitudinal cohort study, 569 consecutive patients with no history of AF who underwent AVR with or without concomitant coronary artery bypass grafting during 1990-1993 were followed for a mean of 17.8 years (J Thorac Cardiovasc Surg. 2017;154:492-8).
Thirty-day and long-term survival rates were determined in the 241 patients (42%) with and the 328 patients (58%) without new-onset postoperative atrial fibrillation (POAF), which was defined as electrocardiographically documented AF lasting for at least several hours, and occurring after AVR while the patient was still admitted. Standard therapy to prevent new onset POAF was the use of sotalol in patients who were not on beta-blocker therapy, and continuation of beta-blocker therapy for those who were already on it.
There were no significant differences between the two groups in demographic characteristics. There were also no significant differences between the two groups in operative characteristics, postoperative in-hospital adverse events, and postoperative hospital lengths of stay until discharge home, except for mechanical ventilation time, which was significantly longer in the patients with new-onset POAF (P = .011).
Thirty-day mortality was 1.2% in the patients with POAF, and 2.7% in those without, a nonsignificant difference. There was no statistically significant difference between the two survival curves and the Kaplan-Meier overall cumulative survival rates at 15 years of follow-up in the patients with new-onset POAF vs. those without were not statistically different (41.5% vs. 41.3%, respectively).
In addition, the 18-year probability of long-term first adverse events, including recurrent AF, transient ischemic attack, ischemic or hemorrhagic stroke, peripheral venous thromboembolism, or major or minor bleeding was not significantly different between the two groups.
“New-onset POAF after AVR does not affect long-term survival when treatment is aimed to restore sinus rhythm before the patient is discharged home. Future studies with a prospective, randomized design should be done to confirm this finding in patients undergoing different kinds of cardiac surgery,” the researchers concluded.
The study was funded by the authors’ home institution; the authors reported they had nothing to disclose.
New-onset atrial fibrillation after aortic valve replacement was not an independent risk factor for decreased long-term survival, according to the results of a single-center, retrospective study reported by Ben M. Swinkels, MD, of St Antonius Hospital, Nieuwegein, and his colleagues in the Netherlands.
Key to this success, however, is restoring normal sinus rhythm before hospital discharge, they said.
In this retrospective, longitudinal cohort study, 569 consecutive patients with no history of AF who underwent AVR with or without concomitant coronary artery bypass grafting during 1990-1993 were followed for a mean of 17.8 years (J Thorac Cardiovasc Surg. 2017;154:492-8).
Thirty-day and long-term survival rates were determined in the 241 patients (42%) with and the 328 patients (58%) without new-onset postoperative atrial fibrillation (POAF), which was defined as electrocardiographically documented AF lasting for at least several hours, and occurring after AVR while the patient was still admitted. Standard therapy to prevent new onset POAF was the use of sotalol in patients who were not on beta-blocker therapy, and continuation of beta-blocker therapy for those who were already on it.
There were no significant differences between the two groups in demographic characteristics. There were also no significant differences between the two groups in operative characteristics, postoperative in-hospital adverse events, and postoperative hospital lengths of stay until discharge home, except for mechanical ventilation time, which was significantly longer in the patients with new-onset POAF (P = .011).
Thirty-day mortality was 1.2% in the patients with POAF, and 2.7% in those without, a nonsignificant difference. There was no statistically significant difference between the two survival curves and the Kaplan-Meier overall cumulative survival rates at 15 years of follow-up in the patients with new-onset POAF vs. those without were not statistically different (41.5% vs. 41.3%, respectively).
In addition, the 18-year probability of long-term first adverse events, including recurrent AF, transient ischemic attack, ischemic or hemorrhagic stroke, peripheral venous thromboembolism, or major or minor bleeding was not significantly different between the two groups.
“New-onset POAF after AVR does not affect long-term survival when treatment is aimed to restore sinus rhythm before the patient is discharged home. Future studies with a prospective, randomized design should be done to confirm this finding in patients undergoing different kinds of cardiac surgery,” the researchers concluded.
The study was funded by the authors’ home institution; the authors reported they had nothing to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point:
Major finding: Cumulative 15-year survival rates were similar in the patients with new-onset postop AF (41.5%) to those without (41.3%).
Data source: A retrospective longitudinal cohort study of 569 consecutive patients without a history of AF who were followed for a mean of 17.8 years after AVR with or without concomitant CABG.
Disclosures: The study was funded by the authors’ home institution and the authors reported they had nothing to disclose.
Bailout stenting for coronary bifurcations brings ‘unacceptable’ hazards
PARIS – Bailout stenting during percutaneous coronary intervention for coronary bifurcations doubled the risk of major adverse cardiovascular events in the world’s largest registry of patients with these often-challenging lesions treated using bioactive stents, Marco Zimarino, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
Indeed, resort to bailout stenting stood out as the major potentially modifiable risk factor for adverse outcomes among the 4,306 participants in the P2BiTO registry, an international collaboration supported by members of the EuroBifurcation Club. Most of the other independent risk factors identified in a multivariate regression analysis of the P2BiTO database were beyond operator control, including diabetes, advanced age, and presentation with an acute coronary syndrome, according to Dr. Zimarino of the University of Chieti (Italy).
Bailout stenting is largely avoidable through meticulous procedural planning, the interventional cardiologist added.
“Careful planning is always mandatory because bailout stenting is associated with an unacceptably higher risk of both in-hospital and 1-year adverse outcomes,” Dr. Zimarino emphasized. “It’s much better to leave a degraded side branch instead of using bailout stenting to get an excellent angiographic outcome that’s a predictor of a worse clinical outcome.”
Conventional wisdom holds that single stenting of either the main artery or a side branch in a patient with coronary bifurcation is safer than double stenting of both. However, that wasn’t really borne out in the P2BiTO registry provided the operator’s plan was for double stenting. The difference in 1-year major adverse cardiovascular events (MACE) between patients treated using a single- or double-stenting strategy wasn’t statistically significant, provided bailout stenting wasn’t utilized. If bailout stenting was employed, though, the risk of MACE was 2.2-fold greater than if the cardiologist stuck with the plan.
Ninety-eight percent of patients in the P2BiTO registry received drug-eluting stents. The other 2% got the Absorb bioabsorbable vascular scaffold. The percutaneous coronary intervention access site, treatment strategy, choice of stent, and duration of dual-antiplatelet therapy were left up to the operator’s discretion.
The risk of MACE was reduced by 39% in patients on dual-antiplatelet therapy for 6-12 months, compared with less than 6 months.
Discussant Graham Cassel, MD, director of the heart transplant unit at Milpark Hospital in Johannesburg, commented, “The message comes through very clearly that, if you plan your procedure well, the chance of bailout is far less – and if you do have to bail out, the results are uniformly bad. If you can avoid putting in two or three stents, that’s beneficial.”
Dr. Zimarino reported having no financial conflicts of interest regarding his presentation.
PARIS – Bailout stenting during percutaneous coronary intervention for coronary bifurcations doubled the risk of major adverse cardiovascular events in the world’s largest registry of patients with these often-challenging lesions treated using bioactive stents, Marco Zimarino, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
Indeed, resort to bailout stenting stood out as the major potentially modifiable risk factor for adverse outcomes among the 4,306 participants in the P2BiTO registry, an international collaboration supported by members of the EuroBifurcation Club. Most of the other independent risk factors identified in a multivariate regression analysis of the P2BiTO database were beyond operator control, including diabetes, advanced age, and presentation with an acute coronary syndrome, according to Dr. Zimarino of the University of Chieti (Italy).
Bailout stenting is largely avoidable through meticulous procedural planning, the interventional cardiologist added.
“Careful planning is always mandatory because bailout stenting is associated with an unacceptably higher risk of both in-hospital and 1-year adverse outcomes,” Dr. Zimarino emphasized. “It’s much better to leave a degraded side branch instead of using bailout stenting to get an excellent angiographic outcome that’s a predictor of a worse clinical outcome.”
Conventional wisdom holds that single stenting of either the main artery or a side branch in a patient with coronary bifurcation is safer than double stenting of both. However, that wasn’t really borne out in the P2BiTO registry provided the operator’s plan was for double stenting. The difference in 1-year major adverse cardiovascular events (MACE) between patients treated using a single- or double-stenting strategy wasn’t statistically significant, provided bailout stenting wasn’t utilized. If bailout stenting was employed, though, the risk of MACE was 2.2-fold greater than if the cardiologist stuck with the plan.
Ninety-eight percent of patients in the P2BiTO registry received drug-eluting stents. The other 2% got the Absorb bioabsorbable vascular scaffold. The percutaneous coronary intervention access site, treatment strategy, choice of stent, and duration of dual-antiplatelet therapy were left up to the operator’s discretion.
The risk of MACE was reduced by 39% in patients on dual-antiplatelet therapy for 6-12 months, compared with less than 6 months.
Discussant Graham Cassel, MD, director of the heart transplant unit at Milpark Hospital in Johannesburg, commented, “The message comes through very clearly that, if you plan your procedure well, the chance of bailout is far less – and if you do have to bail out, the results are uniformly bad. If you can avoid putting in two or three stents, that’s beneficial.”
Dr. Zimarino reported having no financial conflicts of interest regarding his presentation.
PARIS – Bailout stenting during percutaneous coronary intervention for coronary bifurcations doubled the risk of major adverse cardiovascular events in the world’s largest registry of patients with these often-challenging lesions treated using bioactive stents, Marco Zimarino, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
Indeed, resort to bailout stenting stood out as the major potentially modifiable risk factor for adverse outcomes among the 4,306 participants in the P2BiTO registry, an international collaboration supported by members of the EuroBifurcation Club. Most of the other independent risk factors identified in a multivariate regression analysis of the P2BiTO database were beyond operator control, including diabetes, advanced age, and presentation with an acute coronary syndrome, according to Dr. Zimarino of the University of Chieti (Italy).
Bailout stenting is largely avoidable through meticulous procedural planning, the interventional cardiologist added.
“Careful planning is always mandatory because bailout stenting is associated with an unacceptably higher risk of both in-hospital and 1-year adverse outcomes,” Dr. Zimarino emphasized. “It’s much better to leave a degraded side branch instead of using bailout stenting to get an excellent angiographic outcome that’s a predictor of a worse clinical outcome.”
Conventional wisdom holds that single stenting of either the main artery or a side branch in a patient with coronary bifurcation is safer than double stenting of both. However, that wasn’t really borne out in the P2BiTO registry provided the operator’s plan was for double stenting. The difference in 1-year major adverse cardiovascular events (MACE) between patients treated using a single- or double-stenting strategy wasn’t statistically significant, provided bailout stenting wasn’t utilized. If bailout stenting was employed, though, the risk of MACE was 2.2-fold greater than if the cardiologist stuck with the plan.
Ninety-eight percent of patients in the P2BiTO registry received drug-eluting stents. The other 2% got the Absorb bioabsorbable vascular scaffold. The percutaneous coronary intervention access site, treatment strategy, choice of stent, and duration of dual-antiplatelet therapy were left up to the operator’s discretion.
The risk of MACE was reduced by 39% in patients on dual-antiplatelet therapy for 6-12 months, compared with less than 6 months.
Discussant Graham Cassel, MD, director of the heart transplant unit at Milpark Hospital in Johannesburg, commented, “The message comes through very clearly that, if you plan your procedure well, the chance of bailout is far less – and if you do have to bail out, the results are uniformly bad. If you can avoid putting in two or three stents, that’s beneficial.”
Dr. Zimarino reported having no financial conflicts of interest regarding his presentation.
AT EUROPCR
Key clinical point:
Major finding: Bailout stenting during PCI for coronary bifurcations doubles the risk of major adverse cardiovascular events.
Data source: The P2BiTO registry includes 4,306 patients who received one or more drug-eluting stents or bioabsorbable vascular scaffolds for treatment of coronary bifurcations.
Disclosures: The study presenter reported having no financial conflicts of interest.
VA cohort study: Individualize SSI prophylaxis based on patient factors
The combined use of vancomycin and a beta-lactam antibiotic for prophylaxis against surgical site infections is associated with both benefits and harms, according to findings from a national propensity-score–adjusted retrospective cohort study.
For example, the combination treatment reduced surgical site infections (SSIs) 30 days after cardiac surgical procedures but increased the risk of postoperative acute kidney injury (AKI) in some patients, Westyn Branch-Elliman, MD, of the VA Boston Healthcare System and her colleagues reported online July 10 in PLOS Medicine.
Among cardiac surgery patients, the incidence of surgical site infections was significantly lower for the 6,953 patients treated with both drugs vs. the 12,834 treated with a single agent (0.95% vs. 1.48%), the investigators found (PLOS Med. 2017 Jul 10. doi: 10.1371/journal.pmed.1002340).
SSI benefit with combination therapy
“After controlling for age, diabetes, ASA [American Society of Anesthesiologists] score, mupirocin administration, current smoking status, and preoperative MRSA [methicillin-resistant Staphylococcus aureus] colonization status, receipt of combination antimicrobial prophylaxis was associated with reduced SSI risk following cardiac surgical procedures (adjusted risk ratio, 0.61),” they wrote, noting that, when combination therapy was compared with either of the agents alone, the associations were similar and that no association between SSI reduction and the combination regimen was seen for the other types of surgical procedures assessed.
Secondary analyses showed that, among the cardiac patients, differences in the rates of SSIs were seen based on MRSA status in patients undergoing cardiac surgery. Among MRSA-colonized patients, SSIs occurred in 8 of 346 patients (2.3%) who received combination prophylaxis vs. 4 of 100 patients (4%) who received vancomycin alone (aRR, 0.53), and, among MRSA-negative and MRSA-unknown cardiac surgery patients, SSIs occurred in 58 of 6,607 patients (0.88%) receiving combination prophylaxis and 146 of 10,215 patients (1.4%) receiving a beta-lactam alone (aRR, 0.60).
“Among MRSA-colonized patients undergoing cardiac surgery, the associated absolute risk reduction for SSI was approximately triple that of the absolute risk reduction in MRSA-negative or -unknown patients, with a [number needed to treat] to prevent 1 SSI of 53 for the MRSA-colonized group, compared with 176 for the MRSA-negative or -unknown groups,” they wrote.
The incidence of Clostridium difficile infection was similar in both exposure groups (0.72% and 0.81% with combination and single agent prophylaxis, respectively).
Higher AKI risk with combination therapy
“In contrast, combination versus single prophylaxis was associated with higher relative risk of AKI in the 7-day postoperative period after adjusting for prophylaxis regimen duration, age, diabetes, ASA score, and smoking,” they said.
The rate of AKI was 23.75% among patients receiving combination prophylaxis, compared with 20.79% and 13.93% among those receiving vancomycin alone and a beta-lactam alone, respectively.
Significant associations between absolute risk of AKI and receipt of combination regimens were seen across all types of procedures, the investigators said.
“Overall, the NNH [number needed to harm] to cause one episode of AKI in cardiac surgery patients receiving combination therapy was 22, and, for stage 3 AKI, 167. The NNH associated with one additional episode of any postoperative AKI after receipt of combination therapy was 76 following orthopedic procedures and 25 following vascular surgical procedures,” they said.
The optimal approach for preventing SSIs is unclear. Although the multidisciplinary Clinical Practice Guidelines for Antimicrobial Prophylaxis in Surgery recommend single agent prophylaxis most often, with a beta-lactam antibiotic, for most surgical procedures, the use of vancomycin alone is a consideration in MRSA-colonized patients and in centers with a high MRSA incidence, and combination prophylaxis with a beta-lactam plus vancomycin is increasing. However, the relative risks and benefit of this strategy have not been carefully studied, the investigators said.
Thus, the investigators used a propensity-adjusted, log-binomial regression model stratified by type of surgical procedure among the cases identified in the Veterans Affairs cohort to assess the association between SSIs and receipt of combination prophylaxis versus single agent prophylaxis.
Though limited by the observational study design and by factors such as a predominantly male and slightly older and more rural population, the findings suggest that “clinicians may need to individualize prophylaxis strategy based on patient-specific factors that influence the risk-versus-benefit equation,” they said, concluding that “future studies are needed to evaluate the utility of MRSA screening protocols for optimizing and individualizing surgical prophylaxis regimen.”
This study was funded by Veterans Affairs Health Services Research and Development. Dr. Branch-Elliman reported having no disclosures. One other author, Eli Perencevich, MD, received an investigator initiated Grant from Merck Pharmaceuticals in 2013.
The combined use of vancomycin and a beta-lactam antibiotic for prophylaxis against surgical site infections is associated with both benefits and harms, according to findings from a national propensity-score–adjusted retrospective cohort study.
For example, the combination treatment reduced surgical site infections (SSIs) 30 days after cardiac surgical procedures but increased the risk of postoperative acute kidney injury (AKI) in some patients, Westyn Branch-Elliman, MD, of the VA Boston Healthcare System and her colleagues reported online July 10 in PLOS Medicine.
Among cardiac surgery patients, the incidence of surgical site infections was significantly lower for the 6,953 patients treated with both drugs vs. the 12,834 treated with a single agent (0.95% vs. 1.48%), the investigators found (PLOS Med. 2017 Jul 10. doi: 10.1371/journal.pmed.1002340).
SSI benefit with combination therapy
“After controlling for age, diabetes, ASA [American Society of Anesthesiologists] score, mupirocin administration, current smoking status, and preoperative MRSA [methicillin-resistant Staphylococcus aureus] colonization status, receipt of combination antimicrobial prophylaxis was associated with reduced SSI risk following cardiac surgical procedures (adjusted risk ratio, 0.61),” they wrote, noting that, when combination therapy was compared with either of the agents alone, the associations were similar and that no association between SSI reduction and the combination regimen was seen for the other types of surgical procedures assessed.
Secondary analyses showed that, among the cardiac patients, differences in the rates of SSIs were seen based on MRSA status in patients undergoing cardiac surgery. Among MRSA-colonized patients, SSIs occurred in 8 of 346 patients (2.3%) who received combination prophylaxis vs. 4 of 100 patients (4%) who received vancomycin alone (aRR, 0.53), and, among MRSA-negative and MRSA-unknown cardiac surgery patients, SSIs occurred in 58 of 6,607 patients (0.88%) receiving combination prophylaxis and 146 of 10,215 patients (1.4%) receiving a beta-lactam alone (aRR, 0.60).
“Among MRSA-colonized patients undergoing cardiac surgery, the associated absolute risk reduction for SSI was approximately triple that of the absolute risk reduction in MRSA-negative or -unknown patients, with a [number needed to treat] to prevent 1 SSI of 53 for the MRSA-colonized group, compared with 176 for the MRSA-negative or -unknown groups,” they wrote.
The incidence of Clostridium difficile infection was similar in both exposure groups (0.72% and 0.81% with combination and single agent prophylaxis, respectively).
Higher AKI risk with combination therapy
“In contrast, combination versus single prophylaxis was associated with higher relative risk of AKI in the 7-day postoperative period after adjusting for prophylaxis regimen duration, age, diabetes, ASA score, and smoking,” they said.
The rate of AKI was 23.75% among patients receiving combination prophylaxis, compared with 20.79% and 13.93% among those receiving vancomycin alone and a beta-lactam alone, respectively.
Significant associations between absolute risk of AKI and receipt of combination regimens were seen across all types of procedures, the investigators said.
“Overall, the NNH [number needed to harm] to cause one episode of AKI in cardiac surgery patients receiving combination therapy was 22, and, for stage 3 AKI, 167. The NNH associated with one additional episode of any postoperative AKI after receipt of combination therapy was 76 following orthopedic procedures and 25 following vascular surgical procedures,” they said.
The optimal approach for preventing SSIs is unclear. Although the multidisciplinary Clinical Practice Guidelines for Antimicrobial Prophylaxis in Surgery recommend single agent prophylaxis most often, with a beta-lactam antibiotic, for most surgical procedures, the use of vancomycin alone is a consideration in MRSA-colonized patients and in centers with a high MRSA incidence, and combination prophylaxis with a beta-lactam plus vancomycin is increasing. However, the relative risks and benefit of this strategy have not been carefully studied, the investigators said.
Thus, the investigators used a propensity-adjusted, log-binomial regression model stratified by type of surgical procedure among the cases identified in the Veterans Affairs cohort to assess the association between SSIs and receipt of combination prophylaxis versus single agent prophylaxis.
Though limited by the observational study design and by factors such as a predominantly male and slightly older and more rural population, the findings suggest that “clinicians may need to individualize prophylaxis strategy based on patient-specific factors that influence the risk-versus-benefit equation,” they said, concluding that “future studies are needed to evaluate the utility of MRSA screening protocols for optimizing and individualizing surgical prophylaxis regimen.”
This study was funded by Veterans Affairs Health Services Research and Development. Dr. Branch-Elliman reported having no disclosures. One other author, Eli Perencevich, MD, received an investigator initiated Grant from Merck Pharmaceuticals in 2013.
The combined use of vancomycin and a beta-lactam antibiotic for prophylaxis against surgical site infections is associated with both benefits and harms, according to findings from a national propensity-score–adjusted retrospective cohort study.
For example, the combination treatment reduced surgical site infections (SSIs) 30 days after cardiac surgical procedures but increased the risk of postoperative acute kidney injury (AKI) in some patients, Westyn Branch-Elliman, MD, of the VA Boston Healthcare System and her colleagues reported online July 10 in PLOS Medicine.
Among cardiac surgery patients, the incidence of surgical site infections was significantly lower for the 6,953 patients treated with both drugs vs. the 12,834 treated with a single agent (0.95% vs. 1.48%), the investigators found (PLOS Med. 2017 Jul 10. doi: 10.1371/journal.pmed.1002340).
SSI benefit with combination therapy
“After controlling for age, diabetes, ASA [American Society of Anesthesiologists] score, mupirocin administration, current smoking status, and preoperative MRSA [methicillin-resistant Staphylococcus aureus] colonization status, receipt of combination antimicrobial prophylaxis was associated with reduced SSI risk following cardiac surgical procedures (adjusted risk ratio, 0.61),” they wrote, noting that, when combination therapy was compared with either of the agents alone, the associations were similar and that no association between SSI reduction and the combination regimen was seen for the other types of surgical procedures assessed.
Secondary analyses showed that, among the cardiac patients, differences in the rates of SSIs were seen based on MRSA status in patients undergoing cardiac surgery. Among MRSA-colonized patients, SSIs occurred in 8 of 346 patients (2.3%) who received combination prophylaxis vs. 4 of 100 patients (4%) who received vancomycin alone (aRR, 0.53), and, among MRSA-negative and MRSA-unknown cardiac surgery patients, SSIs occurred in 58 of 6,607 patients (0.88%) receiving combination prophylaxis and 146 of 10,215 patients (1.4%) receiving a beta-lactam alone (aRR, 0.60).
“Among MRSA-colonized patients undergoing cardiac surgery, the associated absolute risk reduction for SSI was approximately triple that of the absolute risk reduction in MRSA-negative or -unknown patients, with a [number needed to treat] to prevent 1 SSI of 53 for the MRSA-colonized group, compared with 176 for the MRSA-negative or -unknown groups,” they wrote.
The incidence of Clostridium difficile infection was similar in both exposure groups (0.72% and 0.81% with combination and single agent prophylaxis, respectively).
Higher AKI risk with combination therapy
“In contrast, combination versus single prophylaxis was associated with higher relative risk of AKI in the 7-day postoperative period after adjusting for prophylaxis regimen duration, age, diabetes, ASA score, and smoking,” they said.
The rate of AKI was 23.75% among patients receiving combination prophylaxis, compared with 20.79% and 13.93% among those receiving vancomycin alone and a beta-lactam alone, respectively.
Significant associations between absolute risk of AKI and receipt of combination regimens were seen across all types of procedures, the investigators said.
“Overall, the NNH [number needed to harm] to cause one episode of AKI in cardiac surgery patients receiving combination therapy was 22, and, for stage 3 AKI, 167. The NNH associated with one additional episode of any postoperative AKI after receipt of combination therapy was 76 following orthopedic procedures and 25 following vascular surgical procedures,” they said.
The optimal approach for preventing SSIs is unclear. Although the multidisciplinary Clinical Practice Guidelines for Antimicrobial Prophylaxis in Surgery recommend single agent prophylaxis most often, with a beta-lactam antibiotic, for most surgical procedures, the use of vancomycin alone is a consideration in MRSA-colonized patients and in centers with a high MRSA incidence, and combination prophylaxis with a beta-lactam plus vancomycin is increasing. However, the relative risks and benefit of this strategy have not been carefully studied, the investigators said.
Thus, the investigators used a propensity-adjusted, log-binomial regression model stratified by type of surgical procedure among the cases identified in the Veterans Affairs cohort to assess the association between SSIs and receipt of combination prophylaxis versus single agent prophylaxis.
Though limited by the observational study design and by factors such as a predominantly male and slightly older and more rural population, the findings suggest that “clinicians may need to individualize prophylaxis strategy based on patient-specific factors that influence the risk-versus-benefit equation,” they said, concluding that “future studies are needed to evaluate the utility of MRSA screening protocols for optimizing and individualizing surgical prophylaxis regimen.”
This study was funded by Veterans Affairs Health Services Research and Development. Dr. Branch-Elliman reported having no disclosures. One other author, Eli Perencevich, MD, received an investigator initiated Grant from Merck Pharmaceuticals in 2013.
FROM PLOS MEDICINE
Key clinical point:
Major finding: The SSI incidence was 0.95% vs. 1.48% with combination vs. single agent–therapy in cardiac surgery patients. Acute kidney injuries occurred in 23.75% of all surgery patients receiving combination prophylaxis, compared with 20.79% and 13.93% with vancomycin or a beta-lactam, respectively.
Data source: A retrospective cohort study of more than 70,000 surgical procedures.
Disclosures: This study was funded by Veterans Affairs Health Services Research and Development. Dr. Branch-Elliman reported having no disclosures. One other author, Eli Perencevich, MD, received an investigator initiated grant from Merck Pharmaceuticals in 2013.
Outcomes/costs similar for minimally invasive vs. sternotomy-based mitral surgery
NEW YORK – Minimally invasive mitral valve surgery provides outcomes that match those of conventional sternotomy without increasing use of resources, and lower costs after surgery offset potentially higher operation costs, according to a single-center, propensity-matched analysis of almost 500 patients presented at the meeting sponsored by the American Association for Thoracic Surgery.
“Minimally invasive mitral surgery has excellent outcomes with fewer transfusions and less time ventilated in this representative cohort,” said Robert Hawkins, MD, of the University of Virginia, Charlottesville, in reporting the results.
“While operative times were longer, surgical costs remained statistically similar, and minimally invasive mitral surgery was associated with similar total costs in more complex mitral cases.”
Dr. Hawkins said this study included higher risk patients to attempt to overcome shortcomings of previously published reports that skewed toward lower-risk, highly selective mitral repairs for degenerative mitral disease. “They’re not really representative of the current state of minimally invasive mitral valve surgery as it currently stands in the higher risk patient population,” he said of previous studies.
Major outcomes were similar in both groups. “The mitral valve repair rate was about 81% for both groups, and the tricuspid valve repair rate was 8.8%,” Dr. Hawkins said. “About 35% had atrial fibrillation surgery, including both ablation and left atrial appendage ligation.”
Dr. Hawkins characterized outcomes in both surgical groups as “excellent,” and added, “The operative mortality rate was 1.3% and the major morbidity rate was 11% and not different between groups.”
Some key operative characteristics differed between the two groups. “As expected the cross clamp times and bypass times for the minimally invasive approaches were longer,” Dr. Hawkins said. Also, those who had minimally invasive mitral surgery had a “dramatic decrease” in transfusion rates.
With regard to resource utilization, minimally invasive surgery had longer operative times – an average of 291 minutes vs. 222 minutes (P less than .0001) – but similar or improved use of postoperative resources. “We see that the minimally invasive approach leads to decreased treatment and ancillary costs without a statistically significant difference in surgical costs despite the longer operative times,” Dr. Hawkins said.
However, he noted the high variability of total hospital costs in higher-risk populations complicate any head-to-head comparisons of resource utilization between the conventional and minimally invasive approaches, so the researchers attempted to drill down to identify predictors of resource use. Using a regression model, they found that minimally invasive approach may actually save money, although this finding was not statistically significant (–$1,524; P = 0.83).
“We see that the major drivers of costs are complications,” Dr. Hawkins said. “Morbidity and mortality led to a $54,000 cost increase, and the addition of tricuspid repair also led to about $60,000 higher costs, which is more likely related to higher risk and thus complications. The costs of higher-acuity cases are driven by the complications and not the approach.”
Dr. Hawkins reported no financial relationships. Dr. Ailawadi disclosed consulting agreements with Edwards Lifesciences, Abbott, Medtronic, and AtriCure.
NEW YORK – Minimally invasive mitral valve surgery provides outcomes that match those of conventional sternotomy without increasing use of resources, and lower costs after surgery offset potentially higher operation costs, according to a single-center, propensity-matched analysis of almost 500 patients presented at the meeting sponsored by the American Association for Thoracic Surgery.
“Minimally invasive mitral surgery has excellent outcomes with fewer transfusions and less time ventilated in this representative cohort,” said Robert Hawkins, MD, of the University of Virginia, Charlottesville, in reporting the results.
“While operative times were longer, surgical costs remained statistically similar, and minimally invasive mitral surgery was associated with similar total costs in more complex mitral cases.”
Dr. Hawkins said this study included higher risk patients to attempt to overcome shortcomings of previously published reports that skewed toward lower-risk, highly selective mitral repairs for degenerative mitral disease. “They’re not really representative of the current state of minimally invasive mitral valve surgery as it currently stands in the higher risk patient population,” he said of previous studies.
Major outcomes were similar in both groups. “The mitral valve repair rate was about 81% for both groups, and the tricuspid valve repair rate was 8.8%,” Dr. Hawkins said. “About 35% had atrial fibrillation surgery, including both ablation and left atrial appendage ligation.”
Dr. Hawkins characterized outcomes in both surgical groups as “excellent,” and added, “The operative mortality rate was 1.3% and the major morbidity rate was 11% and not different between groups.”
Some key operative characteristics differed between the two groups. “As expected the cross clamp times and bypass times for the minimally invasive approaches were longer,” Dr. Hawkins said. Also, those who had minimally invasive mitral surgery had a “dramatic decrease” in transfusion rates.
With regard to resource utilization, minimally invasive surgery had longer operative times – an average of 291 minutes vs. 222 minutes (P less than .0001) – but similar or improved use of postoperative resources. “We see that the minimally invasive approach leads to decreased treatment and ancillary costs without a statistically significant difference in surgical costs despite the longer operative times,” Dr. Hawkins said.
However, he noted the high variability of total hospital costs in higher-risk populations complicate any head-to-head comparisons of resource utilization between the conventional and minimally invasive approaches, so the researchers attempted to drill down to identify predictors of resource use. Using a regression model, they found that minimally invasive approach may actually save money, although this finding was not statistically significant (–$1,524; P = 0.83).
“We see that the major drivers of costs are complications,” Dr. Hawkins said. “Morbidity and mortality led to a $54,000 cost increase, and the addition of tricuspid repair also led to about $60,000 higher costs, which is more likely related to higher risk and thus complications. The costs of higher-acuity cases are driven by the complications and not the approach.”
Dr. Hawkins reported no financial relationships. Dr. Ailawadi disclosed consulting agreements with Edwards Lifesciences, Abbott, Medtronic, and AtriCure.
NEW YORK – Minimally invasive mitral valve surgery provides outcomes that match those of conventional sternotomy without increasing use of resources, and lower costs after surgery offset potentially higher operation costs, according to a single-center, propensity-matched analysis of almost 500 patients presented at the meeting sponsored by the American Association for Thoracic Surgery.
“Minimally invasive mitral surgery has excellent outcomes with fewer transfusions and less time ventilated in this representative cohort,” said Robert Hawkins, MD, of the University of Virginia, Charlottesville, in reporting the results.
“While operative times were longer, surgical costs remained statistically similar, and minimally invasive mitral surgery was associated with similar total costs in more complex mitral cases.”
Dr. Hawkins said this study included higher risk patients to attempt to overcome shortcomings of previously published reports that skewed toward lower-risk, highly selective mitral repairs for degenerative mitral disease. “They’re not really representative of the current state of minimally invasive mitral valve surgery as it currently stands in the higher risk patient population,” he said of previous studies.
Major outcomes were similar in both groups. “The mitral valve repair rate was about 81% for both groups, and the tricuspid valve repair rate was 8.8%,” Dr. Hawkins said. “About 35% had atrial fibrillation surgery, including both ablation and left atrial appendage ligation.”
Dr. Hawkins characterized outcomes in both surgical groups as “excellent,” and added, “The operative mortality rate was 1.3% and the major morbidity rate was 11% and not different between groups.”
Some key operative characteristics differed between the two groups. “As expected the cross clamp times and bypass times for the minimally invasive approaches were longer,” Dr. Hawkins said. Also, those who had minimally invasive mitral surgery had a “dramatic decrease” in transfusion rates.
With regard to resource utilization, minimally invasive surgery had longer operative times – an average of 291 minutes vs. 222 minutes (P less than .0001) – but similar or improved use of postoperative resources. “We see that the minimally invasive approach leads to decreased treatment and ancillary costs without a statistically significant difference in surgical costs despite the longer operative times,” Dr. Hawkins said.
However, he noted the high variability of total hospital costs in higher-risk populations complicate any head-to-head comparisons of resource utilization between the conventional and minimally invasive approaches, so the researchers attempted to drill down to identify predictors of resource use. Using a regression model, they found that minimally invasive approach may actually save money, although this finding was not statistically significant (–$1,524; P = 0.83).
“We see that the major drivers of costs are complications,” Dr. Hawkins said. “Morbidity and mortality led to a $54,000 cost increase, and the addition of tricuspid repair also led to about $60,000 higher costs, which is more likely related to higher risk and thus complications. The costs of higher-acuity cases are driven by the complications and not the approach.”
Dr. Hawkins reported no financial relationships. Dr. Ailawadi disclosed consulting agreements with Edwards Lifesciences, Abbott, Medtronic, and AtriCure.
AT THE 2017 MITRAL VALVE CONCLAVE
Key clinical point: Outcomes and costs of minimally invasive mitral surgery are similar to that of conventional sternotomy for mitral valve surgery.
Major finding: Mortality rates of 1.3% and major morbidity rates of 11% were similar in both groups.
Data source: Propensity-matched analysis of 479 patients who had a primary mitral valve operation from January 2010 to June 2016 at the University of Virginia.
Disclosures: Dr. Hawkins reported no financial disclosures. Coauthor Dr. Gorav Ailawadi disclosed consulting agreements with Edwards Lifesciences, Abbott, Medtronic, and AtriCure.
Concomitant MIMV-TVS no worse than MIMV alone
NEW YORK – Concurrent mitral-tricuspid valve surgery has similar outcomes to isolated minimally invasive mitral valve surgery, according to results of a 12-year review reported at the 2017 Mitral Valve Conclave, sponsored by the American Association for Thoracic Surgery.
Indications for minimally invasive tricuspid valve surgery done at the same time of mitral valve surgery have not been well established, in part because the outcomes of such combined procedures have been underreported.
Dr. Kilic noted that patients who had concomitant TVS were typically higher risk at baseline. “The concomitant group was older, had a higher percentage of female patients, and higher rates of chronic lung disease and cerebrovascular disease as well,” Dr. Kilic said. In comparing the isolated MIMV surgery and MIMV-TVS groups in the unmatched analysis, 9% vs. 14% had chronic lung disease (P = .05), 12% vs. 16% had coronary artery disease (P = .15), 7% vs. 12% had cerebrovascular disease (P = .04), and 93% vs. 90% had elective surgery (P = .18). The majority of tricuspid repairs were for severe tricuspid regurgitation (TR) or moderate TR with a dilated annulus of 40 mm or greater.
The operative characteristics differed significantly between the two groups. “As one might expect, the cardiopulmonary bypass time and aortic occlusion times were longer in the concomitant group; and balloon aortic occlusion was used in more than 70% in each cohort,” Dr. Kilic said. Those differences were similar in the propensity-matched cohort: bypass times were 147.5 minutes for isolated MIMV surgery and 174.6 minutes for MIMV-TVS (P less than .001); and aortic occlusion time 104.8 vs. 128 minutes (P less than .001), respectively.
Operative mortality was 3% for isolated MIMV surgery and 4% for concurrent MIMV-TVS (P = .73), but the isolated MIMV surgery group required fewer permanent pacemakers, 1% vs. 6% (P = .03).
“Aside from permanent pacemaker implantation, the rates of every other complication were similar, including stoke, limb ischemia, atrial fibrillation, gastrointestinal complications, respiratory complications, blood product transfusions as well as discharge to home rates,” Dr. Kilic said. Median hospital length of stays were also similar: 7 days for isolated MIMV surgery vs. 8 days for MIMV-TVS (P = .13).
One limitation of the study Dr. Kilic pointed out was that the decision to perform concomitant MIMV-TVS was surgeon dependent.
Dr. Kilic reported having no financial disclosures.
NEW YORK – Concurrent mitral-tricuspid valve surgery has similar outcomes to isolated minimally invasive mitral valve surgery, according to results of a 12-year review reported at the 2017 Mitral Valve Conclave, sponsored by the American Association for Thoracic Surgery.
Indications for minimally invasive tricuspid valve surgery done at the same time of mitral valve surgery have not been well established, in part because the outcomes of such combined procedures have been underreported.
Dr. Kilic noted that patients who had concomitant TVS were typically higher risk at baseline. “The concomitant group was older, had a higher percentage of female patients, and higher rates of chronic lung disease and cerebrovascular disease as well,” Dr. Kilic said. In comparing the isolated MIMV surgery and MIMV-TVS groups in the unmatched analysis, 9% vs. 14% had chronic lung disease (P = .05), 12% vs. 16% had coronary artery disease (P = .15), 7% vs. 12% had cerebrovascular disease (P = .04), and 93% vs. 90% had elective surgery (P = .18). The majority of tricuspid repairs were for severe tricuspid regurgitation (TR) or moderate TR with a dilated annulus of 40 mm or greater.
The operative characteristics differed significantly between the two groups. “As one might expect, the cardiopulmonary bypass time and aortic occlusion times were longer in the concomitant group; and balloon aortic occlusion was used in more than 70% in each cohort,” Dr. Kilic said. Those differences were similar in the propensity-matched cohort: bypass times were 147.5 minutes for isolated MIMV surgery and 174.6 minutes for MIMV-TVS (P less than .001); and aortic occlusion time 104.8 vs. 128 minutes (P less than .001), respectively.
Operative mortality was 3% for isolated MIMV surgery and 4% for concurrent MIMV-TVS (P = .73), but the isolated MIMV surgery group required fewer permanent pacemakers, 1% vs. 6% (P = .03).
“Aside from permanent pacemaker implantation, the rates of every other complication were similar, including stoke, limb ischemia, atrial fibrillation, gastrointestinal complications, respiratory complications, blood product transfusions as well as discharge to home rates,” Dr. Kilic said. Median hospital length of stays were also similar: 7 days for isolated MIMV surgery vs. 8 days for MIMV-TVS (P = .13).
One limitation of the study Dr. Kilic pointed out was that the decision to perform concomitant MIMV-TVS was surgeon dependent.
Dr. Kilic reported having no financial disclosures.
NEW YORK – Concurrent mitral-tricuspid valve surgery has similar outcomes to isolated minimally invasive mitral valve surgery, according to results of a 12-year review reported at the 2017 Mitral Valve Conclave, sponsored by the American Association for Thoracic Surgery.
Indications for minimally invasive tricuspid valve surgery done at the same time of mitral valve surgery have not been well established, in part because the outcomes of such combined procedures have been underreported.
Dr. Kilic noted that patients who had concomitant TVS were typically higher risk at baseline. “The concomitant group was older, had a higher percentage of female patients, and higher rates of chronic lung disease and cerebrovascular disease as well,” Dr. Kilic said. In comparing the isolated MIMV surgery and MIMV-TVS groups in the unmatched analysis, 9% vs. 14% had chronic lung disease (P = .05), 12% vs. 16% had coronary artery disease (P = .15), 7% vs. 12% had cerebrovascular disease (P = .04), and 93% vs. 90% had elective surgery (P = .18). The majority of tricuspid repairs were for severe tricuspid regurgitation (TR) or moderate TR with a dilated annulus of 40 mm or greater.
The operative characteristics differed significantly between the two groups. “As one might expect, the cardiopulmonary bypass time and aortic occlusion times were longer in the concomitant group; and balloon aortic occlusion was used in more than 70% in each cohort,” Dr. Kilic said. Those differences were similar in the propensity-matched cohort: bypass times were 147.5 minutes for isolated MIMV surgery and 174.6 minutes for MIMV-TVS (P less than .001); and aortic occlusion time 104.8 vs. 128 minutes (P less than .001), respectively.
Operative mortality was 3% for isolated MIMV surgery and 4% for concurrent MIMV-TVS (P = .73), but the isolated MIMV surgery group required fewer permanent pacemakers, 1% vs. 6% (P = .03).
“Aside from permanent pacemaker implantation, the rates of every other complication were similar, including stoke, limb ischemia, atrial fibrillation, gastrointestinal complications, respiratory complications, blood product transfusions as well as discharge to home rates,” Dr. Kilic said. Median hospital length of stays were also similar: 7 days for isolated MIMV surgery vs. 8 days for MIMV-TVS (P = .13).
One limitation of the study Dr. Kilic pointed out was that the decision to perform concomitant MIMV-TVS was surgeon dependent.
Dr. Kilic reported having no financial disclosures.
AT THE 2017 MITRAL VALVE CONCLAVE
Key clinical point: Outcomes of isolated minimally invasive mitral valve surgery (MIMV) and MIMV with concomitant tricuspid valve surgery (TVS) are similar.
Major finding: Operative mortality was 3% for isolated MIMV and 4% for concurrent MIMV-TVS.
Data source: Single-center review of 1,158 patients who underwent either isolated MIMV or MIMV-TVS from 2002 to 2014, including a propensity-matched cohort.
Disclosures: Dr. Kilic reported having no financial disclosures.
MV disease in children requires modified strategies
NEW YORK – Repairing mitral valves in pediatric patients must overcome two issues: the wide variability in their anatomy and their growth. Using strategies and techniques common in adult mitral surgery can accomplish good mitral valve function in children, but some techniques in children differ, like using combined resorbable material with autologous tissue or transferring native chords instead of placing artificial chords to a malfunctioning leaflet.
Pedro del Nido, MD, of Boston Children’s Hospital, said the spectrum of mitral valve pathology in children goes from congenital mitral stenosis with a thick annulus with leaflet immobility to leaflet hypermobility that involves anterior leaflet prolapse and can involve a cleft that causes regurgitation. Dr. del Nido explained his surgical approaches for mitral valve disease in children at the 2017 Mitral Conclave, sponsored by the American Association of Thoracic Surgery.
Accessing the mitral valve in children requires a different approach than in adults, Dr. del Nido said. “Going through the left atrium is generally difficult, so we often enter through a trans-septal incision,” he said. “The main reason for that is because the tricuspid valve is often associated with the mitral valve problem and this gives us the most direct exposure.”
Once the surgeon gains exposure, the surgical analysis for a diseased adult or child valve is almost identical, with the exception that adult disease is acquired whereas childhood disease tends to be congenital, Dr. del Nido said. “In the congenital patient, we often find fibroelastic tissue that the child is born with,” he said. “We see this in neonates and young infants. It thickens over time; it doesn’t often calcify, but it does often restrict the leaflets and it tends to fuse the chords, so in essence you have direct attachments of the leaflets to the papillaries.”
He explained that this pathology requires an approach similar to that for rheumatic mitral disease in adults. “Start splitting the commissures and start resecting the tissue off the chords creating fenestrations in order to improve the inflow.” Dr. del Nido added, “If you don’t do this, the child will always have a gradient, and if you think about an adult having problems and symptoms with a gradient, think about a 10-year-old running around trying to do athletics; it’s impossible.”
Dysfunctional chords also require a somewhat different approach in children than they require in adults. “We find elongation of the chords and the anterior support structure is abnormal; the secondary chords are totally intact,” Dr. del Nido said. When confronting a torn-edge chord, resection is often an option in adults, but is uncommon in children. “We don’t usually have very much leaflet tissue,” he said. Artificial chords do not accommodate growth.
“We tend to use native tissue,” said Dr. del Nido. “You can transfer the strut chord; you can transfer the secondary chord in order to achieve support for the edge of that prolapsed leaflet.”
Leaflet problems are probably the biggest single source of recurrence in children, Dr. del Nido said. A cleft on the anterior leaflet can be particularly vexing. For example, cleft edges attached to the septum can prevent the valve leaflet from coaptation with the posterior leaflet. “If you don’t recognize that on 3-D echocardiography, you’re going to have a problem; that leaflet will never create the coaptation surface that you want,” he said.
The solution may lie underneath the leaflet. Said Dr. del Nido, “We tend to want to close a cleft, and, yes, that will get you relief of regurgitation in the central portion, but if you end up with immobility of that leaflet, then look underneath. Most often there are very abnormal attachments to the edges of that cleft to the septum. You have to get rid of that; if you don’t resect all that, you’ll never have a leaflet that truly floats up to coapt against the posterior leaflet.”
Annular dilation in children can also challenge a cardiothoracic surgeon’s skill.
In rare cases, a suture commissuroplasty may correct the problem. Sometimes Dr. del Nido will use the DeVega suture annuloplasty – “even though it is very much user dependent; it’s very easy in pediatrics to create stenosis with the DeVega.” As an alternative, synthetic ring annuloplasties can confine valve growth and are rarely used.
Dr. del Nido’s preference is to use a hybrid approach of tissue and resorbable material. “The advantage of the resorbable material is that it will go away, but that’s also the problem with the resorbable material,” he said. “Once it does go away, there’s nothing there to support the annulus, so a combination of tissue and resorbable suture is probably the best answer.”
In posterior leaflet deficiency, a patch of pericardium posteriorly can augment the dysfunctional leaflet. You can also use pericardium as an annuloplasty ring. “You can use it circumferentially,” Dr. del Nido said. “It’s a soft ring; you can certainly use this material which is autologous; it does provide strength to the fibrous annulus; it does support that valve; and you do see growth.” He added that bovine pericardium is not ideal for this use.
Dr. del Nido reported no relevant financial relationships.
NEW YORK – Repairing mitral valves in pediatric patients must overcome two issues: the wide variability in their anatomy and their growth. Using strategies and techniques common in adult mitral surgery can accomplish good mitral valve function in children, but some techniques in children differ, like using combined resorbable material with autologous tissue or transferring native chords instead of placing artificial chords to a malfunctioning leaflet.
Pedro del Nido, MD, of Boston Children’s Hospital, said the spectrum of mitral valve pathology in children goes from congenital mitral stenosis with a thick annulus with leaflet immobility to leaflet hypermobility that involves anterior leaflet prolapse and can involve a cleft that causes regurgitation. Dr. del Nido explained his surgical approaches for mitral valve disease in children at the 2017 Mitral Conclave, sponsored by the American Association of Thoracic Surgery.
Accessing the mitral valve in children requires a different approach than in adults, Dr. del Nido said. “Going through the left atrium is generally difficult, so we often enter through a trans-septal incision,” he said. “The main reason for that is because the tricuspid valve is often associated with the mitral valve problem and this gives us the most direct exposure.”
Once the surgeon gains exposure, the surgical analysis for a diseased adult or child valve is almost identical, with the exception that adult disease is acquired whereas childhood disease tends to be congenital, Dr. del Nido said. “In the congenital patient, we often find fibroelastic tissue that the child is born with,” he said. “We see this in neonates and young infants. It thickens over time; it doesn’t often calcify, but it does often restrict the leaflets and it tends to fuse the chords, so in essence you have direct attachments of the leaflets to the papillaries.”
He explained that this pathology requires an approach similar to that for rheumatic mitral disease in adults. “Start splitting the commissures and start resecting the tissue off the chords creating fenestrations in order to improve the inflow.” Dr. del Nido added, “If you don’t do this, the child will always have a gradient, and if you think about an adult having problems and symptoms with a gradient, think about a 10-year-old running around trying to do athletics; it’s impossible.”
Dysfunctional chords also require a somewhat different approach in children than they require in adults. “We find elongation of the chords and the anterior support structure is abnormal; the secondary chords are totally intact,” Dr. del Nido said. When confronting a torn-edge chord, resection is often an option in adults, but is uncommon in children. “We don’t usually have very much leaflet tissue,” he said. Artificial chords do not accommodate growth.
“We tend to use native tissue,” said Dr. del Nido. “You can transfer the strut chord; you can transfer the secondary chord in order to achieve support for the edge of that prolapsed leaflet.”
Leaflet problems are probably the biggest single source of recurrence in children, Dr. del Nido said. A cleft on the anterior leaflet can be particularly vexing. For example, cleft edges attached to the septum can prevent the valve leaflet from coaptation with the posterior leaflet. “If you don’t recognize that on 3-D echocardiography, you’re going to have a problem; that leaflet will never create the coaptation surface that you want,” he said.
The solution may lie underneath the leaflet. Said Dr. del Nido, “We tend to want to close a cleft, and, yes, that will get you relief of regurgitation in the central portion, but if you end up with immobility of that leaflet, then look underneath. Most often there are very abnormal attachments to the edges of that cleft to the septum. You have to get rid of that; if you don’t resect all that, you’ll never have a leaflet that truly floats up to coapt against the posterior leaflet.”
Annular dilation in children can also challenge a cardiothoracic surgeon’s skill.
In rare cases, a suture commissuroplasty may correct the problem. Sometimes Dr. del Nido will use the DeVega suture annuloplasty – “even though it is very much user dependent; it’s very easy in pediatrics to create stenosis with the DeVega.” As an alternative, synthetic ring annuloplasties can confine valve growth and are rarely used.
Dr. del Nido’s preference is to use a hybrid approach of tissue and resorbable material. “The advantage of the resorbable material is that it will go away, but that’s also the problem with the resorbable material,” he said. “Once it does go away, there’s nothing there to support the annulus, so a combination of tissue and resorbable suture is probably the best answer.”
In posterior leaflet deficiency, a patch of pericardium posteriorly can augment the dysfunctional leaflet. You can also use pericardium as an annuloplasty ring. “You can use it circumferentially,” Dr. del Nido said. “It’s a soft ring; you can certainly use this material which is autologous; it does provide strength to the fibrous annulus; it does support that valve; and you do see growth.” He added that bovine pericardium is not ideal for this use.
Dr. del Nido reported no relevant financial relationships.
NEW YORK – Repairing mitral valves in pediatric patients must overcome two issues: the wide variability in their anatomy and their growth. Using strategies and techniques common in adult mitral surgery can accomplish good mitral valve function in children, but some techniques in children differ, like using combined resorbable material with autologous tissue or transferring native chords instead of placing artificial chords to a malfunctioning leaflet.
Pedro del Nido, MD, of Boston Children’s Hospital, said the spectrum of mitral valve pathology in children goes from congenital mitral stenosis with a thick annulus with leaflet immobility to leaflet hypermobility that involves anterior leaflet prolapse and can involve a cleft that causes regurgitation. Dr. del Nido explained his surgical approaches for mitral valve disease in children at the 2017 Mitral Conclave, sponsored by the American Association of Thoracic Surgery.
Accessing the mitral valve in children requires a different approach than in adults, Dr. del Nido said. “Going through the left atrium is generally difficult, so we often enter through a trans-septal incision,” he said. “The main reason for that is because the tricuspid valve is often associated with the mitral valve problem and this gives us the most direct exposure.”
Once the surgeon gains exposure, the surgical analysis for a diseased adult or child valve is almost identical, with the exception that adult disease is acquired whereas childhood disease tends to be congenital, Dr. del Nido said. “In the congenital patient, we often find fibroelastic tissue that the child is born with,” he said. “We see this in neonates and young infants. It thickens over time; it doesn’t often calcify, but it does often restrict the leaflets and it tends to fuse the chords, so in essence you have direct attachments of the leaflets to the papillaries.”
He explained that this pathology requires an approach similar to that for rheumatic mitral disease in adults. “Start splitting the commissures and start resecting the tissue off the chords creating fenestrations in order to improve the inflow.” Dr. del Nido added, “If you don’t do this, the child will always have a gradient, and if you think about an adult having problems and symptoms with a gradient, think about a 10-year-old running around trying to do athletics; it’s impossible.”
Dysfunctional chords also require a somewhat different approach in children than they require in adults. “We find elongation of the chords and the anterior support structure is abnormal; the secondary chords are totally intact,” Dr. del Nido said. When confronting a torn-edge chord, resection is often an option in adults, but is uncommon in children. “We don’t usually have very much leaflet tissue,” he said. Artificial chords do not accommodate growth.
“We tend to use native tissue,” said Dr. del Nido. “You can transfer the strut chord; you can transfer the secondary chord in order to achieve support for the edge of that prolapsed leaflet.”
Leaflet problems are probably the biggest single source of recurrence in children, Dr. del Nido said. A cleft on the anterior leaflet can be particularly vexing. For example, cleft edges attached to the septum can prevent the valve leaflet from coaptation with the posterior leaflet. “If you don’t recognize that on 3-D echocardiography, you’re going to have a problem; that leaflet will never create the coaptation surface that you want,” he said.
The solution may lie underneath the leaflet. Said Dr. del Nido, “We tend to want to close a cleft, and, yes, that will get you relief of regurgitation in the central portion, but if you end up with immobility of that leaflet, then look underneath. Most often there are very abnormal attachments to the edges of that cleft to the septum. You have to get rid of that; if you don’t resect all that, you’ll never have a leaflet that truly floats up to coapt against the posterior leaflet.”
Annular dilation in children can also challenge a cardiothoracic surgeon’s skill.
In rare cases, a suture commissuroplasty may correct the problem. Sometimes Dr. del Nido will use the DeVega suture annuloplasty – “even though it is very much user dependent; it’s very easy in pediatrics to create stenosis with the DeVega.” As an alternative, synthetic ring annuloplasties can confine valve growth and are rarely used.
Dr. del Nido’s preference is to use a hybrid approach of tissue and resorbable material. “The advantage of the resorbable material is that it will go away, but that’s also the problem with the resorbable material,” he said. “Once it does go away, there’s nothing there to support the annulus, so a combination of tissue and resorbable suture is probably the best answer.”
In posterior leaflet deficiency, a patch of pericardium posteriorly can augment the dysfunctional leaflet. You can also use pericardium as an annuloplasty ring. “You can use it circumferentially,” Dr. del Nido said. “It’s a soft ring; you can certainly use this material which is autologous; it does provide strength to the fibrous annulus; it does support that valve; and you do see growth.” He added that bovine pericardium is not ideal for this use.
Dr. del Nido reported no relevant financial relationships.
AT THE 2017 MITRAL VALVE CONCLAVE
Key clinical point: Operating on mitral valves in pediatric patients must overcome the wide variability in anatomy among young patients and accommodate growth.
Major finding: Strategies that involve a combination of resorbable material with autologous tissue can accomplish repair in most of these patients.
Data source: Review based on Dr. del Nido’s experience.
Disclosures: Dr. del Nido reported having no relevant financial disclosures.
High TAVR rates linked to fewer readmissions
WASHINGTON – Hospitals with a higher volume of transcatheter aortic valve replacements (TAVRs) have significantly lower 30-day readmission rates, according to an observational study.
In a study of 129 hospitals, those that performed more than 100 TAVR procedures had a 24% and 25% lower readmission rate compared with hospitals that performed 50 to100 TAVRs (P less than .001) and hospitals that performed fewer that 50 TAVRs (P = .007) respectively (JAMA Cardiol. 2017 May 11. doi: 10.1001/jamacardio.2017.1630).
This finding could have serious financial and medical implications for hospitals that are deciding whether or not to focus on this minimally invasive procedure, according to Sahil Khera, MD, MPH, chief resident and cardiology fellow at New York Medical College, Valhalla, and his colleagues.
“Lower readmission rates at high-volume hospitals substantially reduce health care expenditure,” said Dr. Khera and colleagues. “As new TAVR programs open across the country, these data will guide policymakers to identify targets for optimizing and standardizing TAVR outcomes across hospitals.”
To study the correlation between TAVR procedures and readmission rates, the investigators gathered records on hospitals that performed at least five TAVRs in 2014, which were then categorized into high-, medium-, or low-volume categories, and cross-referenced with the 2014 Nationwide Readmissions Database.
Of the 16,252 TAVR procedures conducted in 2014, 663 (4%), 3,067 (19%), and 12,522 (77%) were performed at low-, medium-, and high-volume hospitals, respectively, according to the investigators.
Patients undergoing these procedures were on average 81 years of age, with an average of four Elixhauser comorbidities, most commonly dyslipidemia (64%), hypertension (80%), heart failure (75%), and known coronary artery disease (69%), with a majority having undergone an endovascular procedure (83%).
However, the researchers found the population of TAVR patients of high volume hospitals were slightly younger, had fewer women, were more likely to be in a higher income household, and were less likely to undergo a transapical procedure than in low volume hospitals, which Dr. Khera and fellow researchers believe may have some impact on their findings.
“Low-volume hospitals were more likely to operate on patients with a higher number of comorbidities compared with high-volume hospitals and were more likely to use the TA approach,” according to investigators, “Transapical TAVR is associated with poorer short- and intermediate-term mortality, increased use of skilled nursing care facilities, longer hospital stays, and readmissions when compared with transfemoral TAVR.”
Overall, there were 2,667 readmissions reported, among which high volume hospitals reported a 30-day readmission rate of 15.6%, while low- and medium-volume hospitals reported similarly higher rates of 19.5% and 19%.
When looking into the causes for these readmissions, the investigators found that 1,619 (61%) were due to noncardiac causes, which appeared in all three hospitals, despite a larger proportion present in low-volume hospitals as opposed to medium and high-volume hospitals (65.6% vs. 60.1% and 60.6%, respectively).
“Infection, respiratory, endocrine/metabolic, renal, and trauma problems were more common in low-volume hospitals,” according to the researchers. “Whereas gastrointestinal and TIA/stroke issues were more common in medium and high volume hospitals.”
While price and length of stay did not differ among the volume categories, the investigators estimate the lower rate of readmissions saved high-volume hospitals approximately $6.5 million.
They found that while the difference of readmissions between hospital classifications narrowed when controlling for experience, the margin was still significant. They admitted, however, that the possibility of greater access to more technologically advanced TAVR in high-volume hospitals may affect the findings.
This study was limited by administrative nature of the database used, which does not make available information such as valve type, patient risk scores, or medications.
One investigator has received personal fees from Edwards Lifesciences and Medtronic; another has received grants and personal fees from various pharmaceutical companies, educational institutions, and publications; and a third has consulted for Medtronic.
[email protected]
On Twitter @eaztweets
Considering the idea of using readmissions in comparison to rate of TAVR procedures is interesting, the number of confounds are too great to give any kind of accurate representation of medical practice. While the authors of this study do address its limitations, including a learning curve as it relates to the risk of inpatient mortality, the number of adjustments that must be made to account for the additional confounding factors are simply too insurmountable to give an accurate estimate of statistical and clinical importance.
For example, researchers found TAVR readmissions were associated with certain baseline comorbidities, access sites, and complications. However, association does not mean causation and so the categorization of cardiac-related vs. noncardiac-related readmissions must be approached with some caution.
If one were to try to use readmission rates after TAVR to argue for reimbursement of the procedure, one would need to determine a well established, validated reimbursement rate for TAVR readmissions, which has not been done.
Also, the advancing nature of this procedure, combined with a constant focus from hospitals to reduce readmission rates means any baseline for readmissions used would most likely be out of date.
It would be unlikely for investigators to factor in the cause of reduced readmission rates, which could be a factor of increased technology, more experienced physicians, lower-risk patients, or any combination thereof.
Holding TAVR sites accountable for quality of care is of course important, but using readmission rates to determine something like funding is not appropriate when the measurement being used is so complex.
Perhaps a better approach would be to widen access for low volume hospitals to resources that would improve the TAVR processes and encourage using financial incentives.
Evaluations by physical therapists or a similar procedure should be put into place before discharge to assess a patient’s risk of readmission.
Overall, this is a multifaceted issue that would be better helped by promoting TAVR best practices and encouraging hospitals to compare themselves against each other to reduce unnecessary readmissions.
John D. Carroll, MD, is professor of medicine and director of the Cardiac and Vascular Center at the University of Colorado, Denver. He made his remarks in an editorial in JAMA Cardiology ( doi: 10.1001/jamacardio.2017.1650 ).
Considering the idea of using readmissions in comparison to rate of TAVR procedures is interesting, the number of confounds are too great to give any kind of accurate representation of medical practice. While the authors of this study do address its limitations, including a learning curve as it relates to the risk of inpatient mortality, the number of adjustments that must be made to account for the additional confounding factors are simply too insurmountable to give an accurate estimate of statistical and clinical importance.
For example, researchers found TAVR readmissions were associated with certain baseline comorbidities, access sites, and complications. However, association does not mean causation and so the categorization of cardiac-related vs. noncardiac-related readmissions must be approached with some caution.
If one were to try to use readmission rates after TAVR to argue for reimbursement of the procedure, one would need to determine a well established, validated reimbursement rate for TAVR readmissions, which has not been done.
Also, the advancing nature of this procedure, combined with a constant focus from hospitals to reduce readmission rates means any baseline for readmissions used would most likely be out of date.
It would be unlikely for investigators to factor in the cause of reduced readmission rates, which could be a factor of increased technology, more experienced physicians, lower-risk patients, or any combination thereof.
Holding TAVR sites accountable for quality of care is of course important, but using readmission rates to determine something like funding is not appropriate when the measurement being used is so complex.
Perhaps a better approach would be to widen access for low volume hospitals to resources that would improve the TAVR processes and encourage using financial incentives.
Evaluations by physical therapists or a similar procedure should be put into place before discharge to assess a patient’s risk of readmission.
Overall, this is a multifaceted issue that would be better helped by promoting TAVR best practices and encouraging hospitals to compare themselves against each other to reduce unnecessary readmissions.
John D. Carroll, MD, is professor of medicine and director of the Cardiac and Vascular Center at the University of Colorado, Denver. He made his remarks in an editorial in JAMA Cardiology ( doi: 10.1001/jamacardio.2017.1650 ).
Considering the idea of using readmissions in comparison to rate of TAVR procedures is interesting, the number of confounds are too great to give any kind of accurate representation of medical practice. While the authors of this study do address its limitations, including a learning curve as it relates to the risk of inpatient mortality, the number of adjustments that must be made to account for the additional confounding factors are simply too insurmountable to give an accurate estimate of statistical and clinical importance.
For example, researchers found TAVR readmissions were associated with certain baseline comorbidities, access sites, and complications. However, association does not mean causation and so the categorization of cardiac-related vs. noncardiac-related readmissions must be approached with some caution.
If one were to try to use readmission rates after TAVR to argue for reimbursement of the procedure, one would need to determine a well established, validated reimbursement rate for TAVR readmissions, which has not been done.
Also, the advancing nature of this procedure, combined with a constant focus from hospitals to reduce readmission rates means any baseline for readmissions used would most likely be out of date.
It would be unlikely for investigators to factor in the cause of reduced readmission rates, which could be a factor of increased technology, more experienced physicians, lower-risk patients, or any combination thereof.
Holding TAVR sites accountable for quality of care is of course important, but using readmission rates to determine something like funding is not appropriate when the measurement being used is so complex.
Perhaps a better approach would be to widen access for low volume hospitals to resources that would improve the TAVR processes and encourage using financial incentives.
Evaluations by physical therapists or a similar procedure should be put into place before discharge to assess a patient’s risk of readmission.
Overall, this is a multifaceted issue that would be better helped by promoting TAVR best practices and encouraging hospitals to compare themselves against each other to reduce unnecessary readmissions.
John D. Carroll, MD, is professor of medicine and director of the Cardiac and Vascular Center at the University of Colorado, Denver. He made his remarks in an editorial in JAMA Cardiology ( doi: 10.1001/jamacardio.2017.1650 ).
WASHINGTON – Hospitals with a higher volume of transcatheter aortic valve replacements (TAVRs) have significantly lower 30-day readmission rates, according to an observational study.
In a study of 129 hospitals, those that performed more than 100 TAVR procedures had a 24% and 25% lower readmission rate compared with hospitals that performed 50 to100 TAVRs (P less than .001) and hospitals that performed fewer that 50 TAVRs (P = .007) respectively (JAMA Cardiol. 2017 May 11. doi: 10.1001/jamacardio.2017.1630).
This finding could have serious financial and medical implications for hospitals that are deciding whether or not to focus on this minimally invasive procedure, according to Sahil Khera, MD, MPH, chief resident and cardiology fellow at New York Medical College, Valhalla, and his colleagues.
“Lower readmission rates at high-volume hospitals substantially reduce health care expenditure,” said Dr. Khera and colleagues. “As new TAVR programs open across the country, these data will guide policymakers to identify targets for optimizing and standardizing TAVR outcomes across hospitals.”
To study the correlation between TAVR procedures and readmission rates, the investigators gathered records on hospitals that performed at least five TAVRs in 2014, which were then categorized into high-, medium-, or low-volume categories, and cross-referenced with the 2014 Nationwide Readmissions Database.
Of the 16,252 TAVR procedures conducted in 2014, 663 (4%), 3,067 (19%), and 12,522 (77%) were performed at low-, medium-, and high-volume hospitals, respectively, according to the investigators.
Patients undergoing these procedures were on average 81 years of age, with an average of four Elixhauser comorbidities, most commonly dyslipidemia (64%), hypertension (80%), heart failure (75%), and known coronary artery disease (69%), with a majority having undergone an endovascular procedure (83%).
However, the researchers found the population of TAVR patients of high volume hospitals were slightly younger, had fewer women, were more likely to be in a higher income household, and were less likely to undergo a transapical procedure than in low volume hospitals, which Dr. Khera and fellow researchers believe may have some impact on their findings.
“Low-volume hospitals were more likely to operate on patients with a higher number of comorbidities compared with high-volume hospitals and were more likely to use the TA approach,” according to investigators, “Transapical TAVR is associated with poorer short- and intermediate-term mortality, increased use of skilled nursing care facilities, longer hospital stays, and readmissions when compared with transfemoral TAVR.”
Overall, there were 2,667 readmissions reported, among which high volume hospitals reported a 30-day readmission rate of 15.6%, while low- and medium-volume hospitals reported similarly higher rates of 19.5% and 19%.
When looking into the causes for these readmissions, the investigators found that 1,619 (61%) were due to noncardiac causes, which appeared in all three hospitals, despite a larger proportion present in low-volume hospitals as opposed to medium and high-volume hospitals (65.6% vs. 60.1% and 60.6%, respectively).
“Infection, respiratory, endocrine/metabolic, renal, and trauma problems were more common in low-volume hospitals,” according to the researchers. “Whereas gastrointestinal and TIA/stroke issues were more common in medium and high volume hospitals.”
While price and length of stay did not differ among the volume categories, the investigators estimate the lower rate of readmissions saved high-volume hospitals approximately $6.5 million.
They found that while the difference of readmissions between hospital classifications narrowed when controlling for experience, the margin was still significant. They admitted, however, that the possibility of greater access to more technologically advanced TAVR in high-volume hospitals may affect the findings.
This study was limited by administrative nature of the database used, which does not make available information such as valve type, patient risk scores, or medications.
One investigator has received personal fees from Edwards Lifesciences and Medtronic; another has received grants and personal fees from various pharmaceutical companies, educational institutions, and publications; and a third has consulted for Medtronic.
[email protected]
On Twitter @eaztweets
WASHINGTON – Hospitals with a higher volume of transcatheter aortic valve replacements (TAVRs) have significantly lower 30-day readmission rates, according to an observational study.
In a study of 129 hospitals, those that performed more than 100 TAVR procedures had a 24% and 25% lower readmission rate compared with hospitals that performed 50 to100 TAVRs (P less than .001) and hospitals that performed fewer that 50 TAVRs (P = .007) respectively (JAMA Cardiol. 2017 May 11. doi: 10.1001/jamacardio.2017.1630).
This finding could have serious financial and medical implications for hospitals that are deciding whether or not to focus on this minimally invasive procedure, according to Sahil Khera, MD, MPH, chief resident and cardiology fellow at New York Medical College, Valhalla, and his colleagues.
“Lower readmission rates at high-volume hospitals substantially reduce health care expenditure,” said Dr. Khera and colleagues. “As new TAVR programs open across the country, these data will guide policymakers to identify targets for optimizing and standardizing TAVR outcomes across hospitals.”
To study the correlation between TAVR procedures and readmission rates, the investigators gathered records on hospitals that performed at least five TAVRs in 2014, which were then categorized into high-, medium-, or low-volume categories, and cross-referenced with the 2014 Nationwide Readmissions Database.
Of the 16,252 TAVR procedures conducted in 2014, 663 (4%), 3,067 (19%), and 12,522 (77%) were performed at low-, medium-, and high-volume hospitals, respectively, according to the investigators.
Patients undergoing these procedures were on average 81 years of age, with an average of four Elixhauser comorbidities, most commonly dyslipidemia (64%), hypertension (80%), heart failure (75%), and known coronary artery disease (69%), with a majority having undergone an endovascular procedure (83%).
However, the researchers found the population of TAVR patients of high volume hospitals were slightly younger, had fewer women, were more likely to be in a higher income household, and were less likely to undergo a transapical procedure than in low volume hospitals, which Dr. Khera and fellow researchers believe may have some impact on their findings.
“Low-volume hospitals were more likely to operate on patients with a higher number of comorbidities compared with high-volume hospitals and were more likely to use the TA approach,” according to investigators, “Transapical TAVR is associated with poorer short- and intermediate-term mortality, increased use of skilled nursing care facilities, longer hospital stays, and readmissions when compared with transfemoral TAVR.”
Overall, there were 2,667 readmissions reported, among which high volume hospitals reported a 30-day readmission rate of 15.6%, while low- and medium-volume hospitals reported similarly higher rates of 19.5% and 19%.
When looking into the causes for these readmissions, the investigators found that 1,619 (61%) were due to noncardiac causes, which appeared in all three hospitals, despite a larger proportion present in low-volume hospitals as opposed to medium and high-volume hospitals (65.6% vs. 60.1% and 60.6%, respectively).
“Infection, respiratory, endocrine/metabolic, renal, and trauma problems were more common in low-volume hospitals,” according to the researchers. “Whereas gastrointestinal and TIA/stroke issues were more common in medium and high volume hospitals.”
While price and length of stay did not differ among the volume categories, the investigators estimate the lower rate of readmissions saved high-volume hospitals approximately $6.5 million.
They found that while the difference of readmissions between hospital classifications narrowed when controlling for experience, the margin was still significant. They admitted, however, that the possibility of greater access to more technologically advanced TAVR in high-volume hospitals may affect the findings.
This study was limited by administrative nature of the database used, which does not make available information such as valve type, patient risk scores, or medications.
One investigator has received personal fees from Edwards Lifesciences and Medtronic; another has received grants and personal fees from various pharmaceutical companies, educational institutions, and publications; and a third has consulted for Medtronic.
[email protected]
On Twitter @eaztweets
FROM JAMA CARDIOLOGY
Key clinical point:
Major finding: Hospitals that performed more than 100 TAVR procedures reported significantly lower 30-day readmission rates, compared with those that performed 50-100 procedures and hospitals that performed less than 50.
Data source: Observational study of 129 hospitals that performed at least five TAVRs in 2015, and documents gathered from the 2014 Nationwide Readmissions Database.
Disclosures: One investigator has received personal fees from Edwards Lifesciences and Medtronic; another has received grants and personal fees from various pharmaceutical companies, educational institutions, and publications; and a third has consulted for Medtronic.
Surgeon volume tied to mitral valve surgery outcomes
CHICAGO – A total annual surgeon volume of fewer than 25 operations was associated with increased 1-year mortality and reoperation rates, according to a study presented at the 2017 American Association for Thoracic Surgery Centennial.
Improvements in repair rates, survival, and freedom from reoperation increased with increasing surgeon case volumes, Joanna Chikwe, MD, and her colleagues at the Icahn School of Medicine at Mount Sinai, New York, stated.
The researchers compared repair rates, long-term survival, and risk of postrepair reoperation in patients with degenerative disease according to total annual surgeon volume, which was defined as any mitral valve operation for any cause during the study period. The study was simultaneously published in the Journal of the American College of Cardiology (2017 May 16;69[19]:2397-406).
Mitral valve repair is the preferred treatment, compared with valve replacement, for the treatment of severe mitral valve regurgitation in patients who have degenerative valve disease with mitral valve prolapse, and both U.S. and European guidelines strongly recommend valve repair whenever possible, according to Dr. Chikwe and her colleagues.
But, “mitral valve replacement unfortunately remains relatively common in patients with degenerative valve disease,” they stated.
A total of 313 surgeons from 41 institutions met the study eligibility criteria, according to the researchers. They performed a median of 10 mitral valve operations per year (range, 1-230). The median annual institutional mitral valve volume was 59 mitral valve operations, ranging from a minimum of 6 to a maximum of 310 operations. Repair rates for primary mitral valve operations for any cause at all 41 institutions varied from 15% to 83%, and repair rates for degenerative mitral valve operations varied from 25% to 100%.
In the study cohort, surgeons with a total annual volume of less than 25 operations carried out 25% of procedures.
After multivariable adjustment, total annual surgeon volume was independently associated with the probability of mitral valve repair. The chance of repair increased significantly by 13% for every 10-case increment in total annual surgeon volume (P less than .001).
In addition, compared with patients operated on by surgeons with a total annual surgeon volume of 10 or fewer operations, patients operated on by surgeons with a total annual surgeon volume of greater than 50 operations were more than three times as likely to undergo mitral valve repair rather than replacement.
A total annual surgeon volume of less than 25 operations was associated with lower mitral valve repair rates and with increased 1-year mortality and mitral valve reoperation rates. Improvements in repair rates, survival, and freedom from reoperation increased with increasing surgeon case volumes.
After 1 year of repair or replacement, the actuarial survival of patients with degenerative mitral valve disease who were operated on by surgeons performing greater than 50 operations per year was 97.8%, compared with 94.1% for patients operated on by surgeons performing less than or equal to 10 operations a year.
Compared with replacement, mitral repair was significantly associated with better survival, but total annual surgeon volume still remained a significant independent predictor (P less than .001). In addition, for those patients who underwent mitral valve repair, total annual surgeon volume was a significant independent predictor of late death.
The results are important, the investigators noted, given that the median number of mitral valve operations performed annually by individual surgeons in the United States was five, according to an analysis of the Society of Thoracic Surgeons database – and that, in New York state, most surgeons actually performed less than one mitral operation per month.
There were significant differences seen in the patient characteristics across surgeons’ case volume groups. The prevalence of congestive heart failure was significantly higher in patients operated on by surgeons with lower volumes, and the proportion of patients undergoing urgent surgery was also significantly higher for lower-volume surgeons.
“This leads to a double jeopardy, where sicker patients are adversely affected by the lower repair rates and poorer outcomes seen with lower-volume surgeons, and it underscores the need to refer the highest-risk patients to high-volume surgeons,” said Dr. Chickwe and her colleagues.
However, “even among high-volume surgeons, there was an observed variability of degenerative disease repair rates, ranging from 19% to nearly 100%,” they added. “This finding reflects that surgeon volume is not the only factor for better outcomes, and it emphasizes the need for more transparency of surgeon-related factors and outcomes of degenerative mitral valve surgery for patients and referring cardiologists.
“Considering that there was an incremental improvement in survival and probability of repair with increasing volume over 25 operations, one could make the argument that a minimum volume target of 50, or even more, operations would be optimal,” the researchers noted. “Developing more very high-volume surgeons experienced in mitral valve repair would likely be particularly beneficial for patients with complex but repairable mitral valve disease, and for asymptomatic patients whose repair feasibility would optimally approach 100%.”
Dr. David Adams is the national coprincipal investigator of the Core Valve United States Pivotal Trial, supported by Medtronic. Dr. Chikwe received speaker honoraria from Edwards Lifesciences. The other coauthors had no disclosures to report.
CHICAGO – A total annual surgeon volume of fewer than 25 operations was associated with increased 1-year mortality and reoperation rates, according to a study presented at the 2017 American Association for Thoracic Surgery Centennial.
Improvements in repair rates, survival, and freedom from reoperation increased with increasing surgeon case volumes, Joanna Chikwe, MD, and her colleagues at the Icahn School of Medicine at Mount Sinai, New York, stated.
The researchers compared repair rates, long-term survival, and risk of postrepair reoperation in patients with degenerative disease according to total annual surgeon volume, which was defined as any mitral valve operation for any cause during the study period. The study was simultaneously published in the Journal of the American College of Cardiology (2017 May 16;69[19]:2397-406).
Mitral valve repair is the preferred treatment, compared with valve replacement, for the treatment of severe mitral valve regurgitation in patients who have degenerative valve disease with mitral valve prolapse, and both U.S. and European guidelines strongly recommend valve repair whenever possible, according to Dr. Chikwe and her colleagues.
But, “mitral valve replacement unfortunately remains relatively common in patients with degenerative valve disease,” they stated.
A total of 313 surgeons from 41 institutions met the study eligibility criteria, according to the researchers. They performed a median of 10 mitral valve operations per year (range, 1-230). The median annual institutional mitral valve volume was 59 mitral valve operations, ranging from a minimum of 6 to a maximum of 310 operations. Repair rates for primary mitral valve operations for any cause at all 41 institutions varied from 15% to 83%, and repair rates for degenerative mitral valve operations varied from 25% to 100%.
In the study cohort, surgeons with a total annual volume of less than 25 operations carried out 25% of procedures.
After multivariable adjustment, total annual surgeon volume was independently associated with the probability of mitral valve repair. The chance of repair increased significantly by 13% for every 10-case increment in total annual surgeon volume (P less than .001).
In addition, compared with patients operated on by surgeons with a total annual surgeon volume of 10 or fewer operations, patients operated on by surgeons with a total annual surgeon volume of greater than 50 operations were more than three times as likely to undergo mitral valve repair rather than replacement.
A total annual surgeon volume of less than 25 operations was associated with lower mitral valve repair rates and with increased 1-year mortality and mitral valve reoperation rates. Improvements in repair rates, survival, and freedom from reoperation increased with increasing surgeon case volumes.
After 1 year of repair or replacement, the actuarial survival of patients with degenerative mitral valve disease who were operated on by surgeons performing greater than 50 operations per year was 97.8%, compared with 94.1% for patients operated on by surgeons performing less than or equal to 10 operations a year.
Compared with replacement, mitral repair was significantly associated with better survival, but total annual surgeon volume still remained a significant independent predictor (P less than .001). In addition, for those patients who underwent mitral valve repair, total annual surgeon volume was a significant independent predictor of late death.
The results are important, the investigators noted, given that the median number of mitral valve operations performed annually by individual surgeons in the United States was five, according to an analysis of the Society of Thoracic Surgeons database – and that, in New York state, most surgeons actually performed less than one mitral operation per month.
There were significant differences seen in the patient characteristics across surgeons’ case volume groups. The prevalence of congestive heart failure was significantly higher in patients operated on by surgeons with lower volumes, and the proportion of patients undergoing urgent surgery was also significantly higher for lower-volume surgeons.
“This leads to a double jeopardy, where sicker patients are adversely affected by the lower repair rates and poorer outcomes seen with lower-volume surgeons, and it underscores the need to refer the highest-risk patients to high-volume surgeons,” said Dr. Chickwe and her colleagues.
However, “even among high-volume surgeons, there was an observed variability of degenerative disease repair rates, ranging from 19% to nearly 100%,” they added. “This finding reflects that surgeon volume is not the only factor for better outcomes, and it emphasizes the need for more transparency of surgeon-related factors and outcomes of degenerative mitral valve surgery for patients and referring cardiologists.
“Considering that there was an incremental improvement in survival and probability of repair with increasing volume over 25 operations, one could make the argument that a minimum volume target of 50, or even more, operations would be optimal,” the researchers noted. “Developing more very high-volume surgeons experienced in mitral valve repair would likely be particularly beneficial for patients with complex but repairable mitral valve disease, and for asymptomatic patients whose repair feasibility would optimally approach 100%.”
Dr. David Adams is the national coprincipal investigator of the Core Valve United States Pivotal Trial, supported by Medtronic. Dr. Chikwe received speaker honoraria from Edwards Lifesciences. The other coauthors had no disclosures to report.
CHICAGO – A total annual surgeon volume of fewer than 25 operations was associated with increased 1-year mortality and reoperation rates, according to a study presented at the 2017 American Association for Thoracic Surgery Centennial.
Improvements in repair rates, survival, and freedom from reoperation increased with increasing surgeon case volumes, Joanna Chikwe, MD, and her colleagues at the Icahn School of Medicine at Mount Sinai, New York, stated.
The researchers compared repair rates, long-term survival, and risk of postrepair reoperation in patients with degenerative disease according to total annual surgeon volume, which was defined as any mitral valve operation for any cause during the study period. The study was simultaneously published in the Journal of the American College of Cardiology (2017 May 16;69[19]:2397-406).
Mitral valve repair is the preferred treatment, compared with valve replacement, for the treatment of severe mitral valve regurgitation in patients who have degenerative valve disease with mitral valve prolapse, and both U.S. and European guidelines strongly recommend valve repair whenever possible, according to Dr. Chikwe and her colleagues.
But, “mitral valve replacement unfortunately remains relatively common in patients with degenerative valve disease,” they stated.
A total of 313 surgeons from 41 institutions met the study eligibility criteria, according to the researchers. They performed a median of 10 mitral valve operations per year (range, 1-230). The median annual institutional mitral valve volume was 59 mitral valve operations, ranging from a minimum of 6 to a maximum of 310 operations. Repair rates for primary mitral valve operations for any cause at all 41 institutions varied from 15% to 83%, and repair rates for degenerative mitral valve operations varied from 25% to 100%.
In the study cohort, surgeons with a total annual volume of less than 25 operations carried out 25% of procedures.
After multivariable adjustment, total annual surgeon volume was independently associated with the probability of mitral valve repair. The chance of repair increased significantly by 13% for every 10-case increment in total annual surgeon volume (P less than .001).
In addition, compared with patients operated on by surgeons with a total annual surgeon volume of 10 or fewer operations, patients operated on by surgeons with a total annual surgeon volume of greater than 50 operations were more than three times as likely to undergo mitral valve repair rather than replacement.
A total annual surgeon volume of less than 25 operations was associated with lower mitral valve repair rates and with increased 1-year mortality and mitral valve reoperation rates. Improvements in repair rates, survival, and freedom from reoperation increased with increasing surgeon case volumes.
After 1 year of repair or replacement, the actuarial survival of patients with degenerative mitral valve disease who were operated on by surgeons performing greater than 50 operations per year was 97.8%, compared with 94.1% for patients operated on by surgeons performing less than or equal to 10 operations a year.
Compared with replacement, mitral repair was significantly associated with better survival, but total annual surgeon volume still remained a significant independent predictor (P less than .001). In addition, for those patients who underwent mitral valve repair, total annual surgeon volume was a significant independent predictor of late death.
The results are important, the investigators noted, given that the median number of mitral valve operations performed annually by individual surgeons in the United States was five, according to an analysis of the Society of Thoracic Surgeons database – and that, in New York state, most surgeons actually performed less than one mitral operation per month.
There were significant differences seen in the patient characteristics across surgeons’ case volume groups. The prevalence of congestive heart failure was significantly higher in patients operated on by surgeons with lower volumes, and the proportion of patients undergoing urgent surgery was also significantly higher for lower-volume surgeons.
“This leads to a double jeopardy, where sicker patients are adversely affected by the lower repair rates and poorer outcomes seen with lower-volume surgeons, and it underscores the need to refer the highest-risk patients to high-volume surgeons,” said Dr. Chickwe and her colleagues.
However, “even among high-volume surgeons, there was an observed variability of degenerative disease repair rates, ranging from 19% to nearly 100%,” they added. “This finding reflects that surgeon volume is not the only factor for better outcomes, and it emphasizes the need for more transparency of surgeon-related factors and outcomes of degenerative mitral valve surgery for patients and referring cardiologists.
“Considering that there was an incremental improvement in survival and probability of repair with increasing volume over 25 operations, one could make the argument that a minimum volume target of 50, or even more, operations would be optimal,” the researchers noted. “Developing more very high-volume surgeons experienced in mitral valve repair would likely be particularly beneficial for patients with complex but repairable mitral valve disease, and for asymptomatic patients whose repair feasibility would optimally approach 100%.”
Dr. David Adams is the national coprincipal investigator of the Core Valve United States Pivotal Trial, supported by Medtronic. Dr. Chikwe received speaker honoraria from Edwards Lifesciences. The other coauthors had no disclosures to report.
FROM THE AATS ANNUAL MEETING AND THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Key clinical point:
Major finding: Mitral valve reoperation rates steadily decreased with increasing surgeon volume until 25 operations per year, coupled to an improved 1-year survival for every 10 additional operations more than that.
Data source: A mandatory New York state database containing 5,475 patients who underwent mitral valve repair between 2002 and 2013.
Disclosures: Dr. David Adams is the national coprincipal investigator of the Core Valve United States Pivotal Trial, supported by Medtronic. Dr. Joanna Chikwe received speaker honoraria from Edwards Lifesciences. The other coauthors had no disclosures to report.
Shift to minimally invasive MV surgery picks up
NEW YORK – An analysis of a Society of Thoracic Surgeons database has identified a significant increase in volumes for isolated mitral valve surgery and leaflet prolapse this decade, with a shift toward minimally invasive approaches, according to a study of trends in mitral valve surgery in the United States presented here at the American Association for Thoracic Surgery Mitral Conclave 2017.
James Gammie, MD, of the University of Maryland School of Medicine, Baltimore, reported on the analysis of the STS Adult Cardiac Surgery Database in which more than 90% of the adult cardiac surgery centers in North America participate.
“Degenerative disease remains the most common reason patients are referred for surgery,” Dr. Gammie said, noting that 60.7% of patients with an identified etiology had degenerative leaflet prolapse (etiology was unknown in 31% of the patients in the dataset).
“The operative approach has changed and continues to shift toward a less invasive approach,” Dr. Gammie said. Overall, 74.1% of operations involved sternotomy, but only 67.5% of those in the leaflet prolapse subgroup, with less invasive operations comprising 23% of all operations and 29.1% of those in the leaflet prolapse subgroup. From 2011 to 2016, total mitral surgical volume grew at a rate of 1.1% annually, but the volume for isolated MV operations grew 4.4% annually while leaflet prolapse procedures increased 7.6% annually, Dr. Gammie said.
Dr. Gammie described surgeons’ decision to perform ablation for preoperative AF during MV surgery a “coin toss.” One-third (34%) had AF, but only 51.2% of patients with AF in the total cohort and 54.4% of those in the leaflet prolapse subgroup got ablation. The overall MV repair rate was 65% for the total cohort but 83% for those with leaflet prolapse. For those who had MV replacement, the share of bioprosthetic devices increased steadily through the study period, from around 65% to 75.8%, Dr. Gammie said.
In the leaflet prolapse subgroup, 96.1% had annuloplasty and 29.2% had artificial chords implanted, with an average of two chords per operation. “There’s an increasing use of artificial ePTFE chords,” Dr. Gammie said. He noted the leaflet prolapse subgroup was composed of low-risk healthy patients. The mean ejection fraction (EF) for the cohort was 57%, and 47% of patients had EF of less than 60%. The overwhelming majority of patients (88%) had Class I indications for surgery with the remainder having Class IIa indications.
Dr. Gammie noted a few other emerging trends of MV surgery during the study period. “Patients with functional mitral regurgitation are rarely referred for operation: these patients made up fewer than 5% of patients undergoing mitral valve operations during the study period,” he said.;
With regard to outcomes, Dr. Gammie said, “There remain substantial differences between repair and replacement.” Replacement had almost twice the rate of reoperation for bleeding than repair (4.1% vs. 2.1%) and renal failure (3.4% vs. 1.4%).
“We observed that a substantial number of patients have an unsuccessful attempt at mitral valve repair before undergoing replacement – 16 % of the overall replacement group and 27% of patients having replacement for degenerative leaflet prolapse,” he said. “This does not appear to penalize patients in terms of outcome.”
The rate of permanent pacemaker was also significantly higher in the replacement cohort, 9.8% vs. 3.8% for repair operations, as was operative mortality, 3.7% vs. 1.1%. Said Dr. Gammie.
“This is something to think about as we move to less invasive approaches and overall operative mortality remains over threefold higher for replacement than repair.”
The leaflet prolapse subgroup showed similar disparities between replacement and repair groups. “The increased application of repair when feasible will be of value to improve outcomes, as will referral of patients earlier in the disease process ,” Dr. Gammie said.
“In our own STS database, about one-third of patients who were coded as having AF had no evidence of it, and that’s why in our institution they don’t get treated.” He added, “I’m not that surprised at the low repair rate when the average surgeon in the United States does five mitral repairs a year.”
Dr. Gammie disclosed that he is a consultant to Edwards Lifesciences and has an ownership interest in Harpoon Medical. Dr. Damiano disclosed that he is a speaker for LivaNova and a consultant to and a research grant recipient of Atricure.
NEW YORK – An analysis of a Society of Thoracic Surgeons database has identified a significant increase in volumes for isolated mitral valve surgery and leaflet prolapse this decade, with a shift toward minimally invasive approaches, according to a study of trends in mitral valve surgery in the United States presented here at the American Association for Thoracic Surgery Mitral Conclave 2017.
James Gammie, MD, of the University of Maryland School of Medicine, Baltimore, reported on the analysis of the STS Adult Cardiac Surgery Database in which more than 90% of the adult cardiac surgery centers in North America participate.
“Degenerative disease remains the most common reason patients are referred for surgery,” Dr. Gammie said, noting that 60.7% of patients with an identified etiology had degenerative leaflet prolapse (etiology was unknown in 31% of the patients in the dataset).
“The operative approach has changed and continues to shift toward a less invasive approach,” Dr. Gammie said. Overall, 74.1% of operations involved sternotomy, but only 67.5% of those in the leaflet prolapse subgroup, with less invasive operations comprising 23% of all operations and 29.1% of those in the leaflet prolapse subgroup. From 2011 to 2016, total mitral surgical volume grew at a rate of 1.1% annually, but the volume for isolated MV operations grew 4.4% annually while leaflet prolapse procedures increased 7.6% annually, Dr. Gammie said.
Dr. Gammie described surgeons’ decision to perform ablation for preoperative AF during MV surgery a “coin toss.” One-third (34%) had AF, but only 51.2% of patients with AF in the total cohort and 54.4% of those in the leaflet prolapse subgroup got ablation. The overall MV repair rate was 65% for the total cohort but 83% for those with leaflet prolapse. For those who had MV replacement, the share of bioprosthetic devices increased steadily through the study period, from around 65% to 75.8%, Dr. Gammie said.
In the leaflet prolapse subgroup, 96.1% had annuloplasty and 29.2% had artificial chords implanted, with an average of two chords per operation. “There’s an increasing use of artificial ePTFE chords,” Dr. Gammie said. He noted the leaflet prolapse subgroup was composed of low-risk healthy patients. The mean ejection fraction (EF) for the cohort was 57%, and 47% of patients had EF of less than 60%. The overwhelming majority of patients (88%) had Class I indications for surgery with the remainder having Class IIa indications.
Dr. Gammie noted a few other emerging trends of MV surgery during the study period. “Patients with functional mitral regurgitation are rarely referred for operation: these patients made up fewer than 5% of patients undergoing mitral valve operations during the study period,” he said.;
With regard to outcomes, Dr. Gammie said, “There remain substantial differences between repair and replacement.” Replacement had almost twice the rate of reoperation for bleeding than repair (4.1% vs. 2.1%) and renal failure (3.4% vs. 1.4%).
“We observed that a substantial number of patients have an unsuccessful attempt at mitral valve repair before undergoing replacement – 16 % of the overall replacement group and 27% of patients having replacement for degenerative leaflet prolapse,” he said. “This does not appear to penalize patients in terms of outcome.”
The rate of permanent pacemaker was also significantly higher in the replacement cohort, 9.8% vs. 3.8% for repair operations, as was operative mortality, 3.7% vs. 1.1%. Said Dr. Gammie.
“This is something to think about as we move to less invasive approaches and overall operative mortality remains over threefold higher for replacement than repair.”
The leaflet prolapse subgroup showed similar disparities between replacement and repair groups. “The increased application of repair when feasible will be of value to improve outcomes, as will referral of patients earlier in the disease process ,” Dr. Gammie said.
“In our own STS database, about one-third of patients who were coded as having AF had no evidence of it, and that’s why in our institution they don’t get treated.” He added, “I’m not that surprised at the low repair rate when the average surgeon in the United States does five mitral repairs a year.”
Dr. Gammie disclosed that he is a consultant to Edwards Lifesciences and has an ownership interest in Harpoon Medical. Dr. Damiano disclosed that he is a speaker for LivaNova and a consultant to and a research grant recipient of Atricure.
NEW YORK – An analysis of a Society of Thoracic Surgeons database has identified a significant increase in volumes for isolated mitral valve surgery and leaflet prolapse this decade, with a shift toward minimally invasive approaches, according to a study of trends in mitral valve surgery in the United States presented here at the American Association for Thoracic Surgery Mitral Conclave 2017.
James Gammie, MD, of the University of Maryland School of Medicine, Baltimore, reported on the analysis of the STS Adult Cardiac Surgery Database in which more than 90% of the adult cardiac surgery centers in North America participate.
“Degenerative disease remains the most common reason patients are referred for surgery,” Dr. Gammie said, noting that 60.7% of patients with an identified etiology had degenerative leaflet prolapse (etiology was unknown in 31% of the patients in the dataset).
“The operative approach has changed and continues to shift toward a less invasive approach,” Dr. Gammie said. Overall, 74.1% of operations involved sternotomy, but only 67.5% of those in the leaflet prolapse subgroup, with less invasive operations comprising 23% of all operations and 29.1% of those in the leaflet prolapse subgroup. From 2011 to 2016, total mitral surgical volume grew at a rate of 1.1% annually, but the volume for isolated MV operations grew 4.4% annually while leaflet prolapse procedures increased 7.6% annually, Dr. Gammie said.
Dr. Gammie described surgeons’ decision to perform ablation for preoperative AF during MV surgery a “coin toss.” One-third (34%) had AF, but only 51.2% of patients with AF in the total cohort and 54.4% of those in the leaflet prolapse subgroup got ablation. The overall MV repair rate was 65% for the total cohort but 83% for those with leaflet prolapse. For those who had MV replacement, the share of bioprosthetic devices increased steadily through the study period, from around 65% to 75.8%, Dr. Gammie said.
In the leaflet prolapse subgroup, 96.1% had annuloplasty and 29.2% had artificial chords implanted, with an average of two chords per operation. “There’s an increasing use of artificial ePTFE chords,” Dr. Gammie said. He noted the leaflet prolapse subgroup was composed of low-risk healthy patients. The mean ejection fraction (EF) for the cohort was 57%, and 47% of patients had EF of less than 60%. The overwhelming majority of patients (88%) had Class I indications for surgery with the remainder having Class IIa indications.
Dr. Gammie noted a few other emerging trends of MV surgery during the study period. “Patients with functional mitral regurgitation are rarely referred for operation: these patients made up fewer than 5% of patients undergoing mitral valve operations during the study period,” he said.;
With regard to outcomes, Dr. Gammie said, “There remain substantial differences between repair and replacement.” Replacement had almost twice the rate of reoperation for bleeding than repair (4.1% vs. 2.1%) and renal failure (3.4% vs. 1.4%).
“We observed that a substantial number of patients have an unsuccessful attempt at mitral valve repair before undergoing replacement – 16 % of the overall replacement group and 27% of patients having replacement for degenerative leaflet prolapse,” he said. “This does not appear to penalize patients in terms of outcome.”
The rate of permanent pacemaker was also significantly higher in the replacement cohort, 9.8% vs. 3.8% for repair operations, as was operative mortality, 3.7% vs. 1.1%. Said Dr. Gammie.
“This is something to think about as we move to less invasive approaches and overall operative mortality remains over threefold higher for replacement than repair.”
The leaflet prolapse subgroup showed similar disparities between replacement and repair groups. “The increased application of repair when feasible will be of value to improve outcomes, as will referral of patients earlier in the disease process ,” Dr. Gammie said.
“In our own STS database, about one-third of patients who were coded as having AF had no evidence of it, and that’s why in our institution they don’t get treated.” He added, “I’m not that surprised at the low repair rate when the average surgeon in the United States does five mitral repairs a year.”
Dr. Gammie disclosed that he is a consultant to Edwards Lifesciences and has an ownership interest in Harpoon Medical. Dr. Damiano disclosed that he is a speaker for LivaNova and a consultant to and a research grant recipient of Atricure.
AT THE AATS MITRAL CONCLAVE 2017
Key clinical point: The volume of mitral valve surgery has increased substantially, according to an analysis of the Society for Thoracic Surgery database, and an increasing percentage of procedures are minimally invasive in nature.
Major finding: Sternotomy continues to be the most widely used approach for mitral valve surgery, but less invasive options most recently comprised 23% of the overall group and 29.1% of those with isolated leaflet prolapse.
Data source: Retrospective study of 15,360 isolated mitral valve operations performed from July 2011 to September 2016 in the Society of Thoracic Surgeons database.
Disclosures: Dr. Gammie reported being a consultant to Edwards Lifesciences and having an ownership interest in Harpoon Medical.