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Early risks outweighed at 1 year
For patients undergoing transcatheter aortic valve replacement (TAVR), adverse outcomes are more common in those who are in cardiogenic shock than those who are not, but the greater risks appear to be completely concentrated in the early period of recovery, suggests a propensity-matched study.
reported Abhijeet Dhoble, MD, associate professor and an interventional cardiologist at McGovern Medical School, University of Texas Health Science Center, Houston.
Their results were presented at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.
The study, which drew data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Replacement (STS/ACC TVR) Registry, looked only at patients who underwent TAVR with the Sapien3 or Sapience3 Ultra device. Patients with CS were propensity matched to Sapien device-treated patients in the registry without CS.
Taken from a pool of 9,348 patients with CS and 299,600 patients without, the matching included a large array of clinically relevant covariates, including age, gender, prior cardiovascular events, left ventricular ejection fraction (LVEF), and New York Heart Association (NYHA) class.
After matching, there were 4,952 patients in each arm. The baseline Society of Thoracic Surgeons (STS) risk score was approximately 10.0 in both arms. About half had atrial fibrillation and 90% were in NYHA class III or IV. The median LVEF in both groups was 39.9%.
Mortality more than twofold higher in CS patients
At 30 days, outcomes were worse in patients with CS, including the proportion who died (12.9% vs. 4.9%; P < .0001) and the proportion with stroke (3.3% vs. 1.9%; P < .0001).
The only major study endpoint not significantly different, although higher in the CS group, was the rate of readmission (12.0% vs. 11.0%; P = .25).
At 1 year, the differences in the rates of mortality (29.7% vs. 22.6%; P < .0001) and stroke (4.3% vs. 3.1%; P = .0004) had narrowed modestly but remained highly significant. A closer analysis indicated that almost all of the difference in the rate of events occurred prior to hospital discharge.
In fact, mortality (9.9% vs. 2.7%; P < .0001), stroke (2.9% vs. 1.5%; P < .0001), major vascular complications (2.3% vs. 1.9%; P = .0002), life-threatening bleeding (2.5% vs. 0.7%; P < .0001), new dialysis (3.5% vs. 1.1%; P < .0001) and new onset atrial fibrillation (3.8% vs. 1.6%; P < .0001) were all significantly higher in the CS group in this very early time period. By hazard ratio (HR), the risk of a major event prior to leaving the hospital was nearly threefold higher (HR 2.3; P < .0001) in the CS group.
Yet, there was no significant difference in the accumulation of adverse events after discharge. When compared for major events in the landmark analysis, the event curves were essentially superimposable from 30 days to 1 year. During this period, event rates were 19.3% versus 18.5% for CS and non-CS patients (HR 1.07; P = .2640).
The higher rate of events was unrelated to procedural complications, which were very low in both groups and did not differ significantly. Transition to open surgery, annular disruption, aortic dissection, coronary occlusion, and device embolization occurred in < 1% of patients in both groups.
Predictors of a poor outcome identified
On multivariate analysis, the predictors of events in the CS patients were comorbidities. Despite propensity matching, being on dialysis, having a permanent pacemaker, or having a mechanical assist device were all independent predictors of mortality risk specific to the CS group.
Age and baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) score were not predictors.
These risk factors deserve consideration when evaluating CS candidates for TAVR, but Dr. Dhoble said that none are absolute contraindications. Rather, he advised that they should be considered in the context of the entire clinical picture, including the expected benefit from TAVR. Indeed, the benefit-to-risk ratio generally favors TAVR in CS patients, particularly those with obstructive CS caused by aortic stenosis, according to Dr. Dhoble.
“Efforts should be made not only to avoid delaying TAVR in such patients but also to prevent CS by early definitive treatment of patients with aortic stenosis,” he said.
These data are useful and important, said Jonathan Schwartz, MD, medical director, interventional cardiology, Atrium Health, Charlotte, N.C.
CS candidates for TAVR “are some of the sickest patients we treat. It is nice to finally have some data for this group,” he said. He agreed that CS patients can derive major benefit from TAVR if appropriately selected.
While many CS patients are already considered for TAVR, one source of hesitation has been the exclusion of CS patients from major TAVR trials, said Dr. Dhoble. He hopes these data will provide a framework for clinical decisions.
Ironically, the first TAVR patient and half of the initial series of 38 TAVR patients had CS, noted Alain G. Cribier, MD, director of cardiology, Charles Nicolle Hospital, University of Rouen, France. As the primary investigator of that initial TAVR study, conducted more than 20 years ago, he said he was not surprised by the favorable results of the propensity analysis.
“There is an almost miraculous clinical improvement to be achieved when you succeed with the procedure,” said Dr. Cribier, recounting his own experience. Improvements in LVEF of up to 30% can be achieved “within a day or two or even the first day,” he said.
Dr. Dhoble reports financial relationships with Abbott Vascular and Edwards Lifesciences. Dr. Schwartz reports that he has financial relationships with Abbott Vascular, Boston Scientific, Cordis, Edwards Lifesciences and Medtronic. Dr. Cribier reports a financial relationship with Edwards Lifesciences.
Early risks outweighed at 1 year
Early risks outweighed at 1 year
For patients undergoing transcatheter aortic valve replacement (TAVR), adverse outcomes are more common in those who are in cardiogenic shock than those who are not, but the greater risks appear to be completely concentrated in the early period of recovery, suggests a propensity-matched study.
reported Abhijeet Dhoble, MD, associate professor and an interventional cardiologist at McGovern Medical School, University of Texas Health Science Center, Houston.
Their results were presented at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.
The study, which drew data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Replacement (STS/ACC TVR) Registry, looked only at patients who underwent TAVR with the Sapien3 or Sapience3 Ultra device. Patients with CS were propensity matched to Sapien device-treated patients in the registry without CS.
Taken from a pool of 9,348 patients with CS and 299,600 patients without, the matching included a large array of clinically relevant covariates, including age, gender, prior cardiovascular events, left ventricular ejection fraction (LVEF), and New York Heart Association (NYHA) class.
After matching, there were 4,952 patients in each arm. The baseline Society of Thoracic Surgeons (STS) risk score was approximately 10.0 in both arms. About half had atrial fibrillation and 90% were in NYHA class III or IV. The median LVEF in both groups was 39.9%.
Mortality more than twofold higher in CS patients
At 30 days, outcomes were worse in patients with CS, including the proportion who died (12.9% vs. 4.9%; P < .0001) and the proportion with stroke (3.3% vs. 1.9%; P < .0001).
The only major study endpoint not significantly different, although higher in the CS group, was the rate of readmission (12.0% vs. 11.0%; P = .25).
At 1 year, the differences in the rates of mortality (29.7% vs. 22.6%; P < .0001) and stroke (4.3% vs. 3.1%; P = .0004) had narrowed modestly but remained highly significant. A closer analysis indicated that almost all of the difference in the rate of events occurred prior to hospital discharge.
In fact, mortality (9.9% vs. 2.7%; P < .0001), stroke (2.9% vs. 1.5%; P < .0001), major vascular complications (2.3% vs. 1.9%; P = .0002), life-threatening bleeding (2.5% vs. 0.7%; P < .0001), new dialysis (3.5% vs. 1.1%; P < .0001) and new onset atrial fibrillation (3.8% vs. 1.6%; P < .0001) were all significantly higher in the CS group in this very early time period. By hazard ratio (HR), the risk of a major event prior to leaving the hospital was nearly threefold higher (HR 2.3; P < .0001) in the CS group.
Yet, there was no significant difference in the accumulation of adverse events after discharge. When compared for major events in the landmark analysis, the event curves were essentially superimposable from 30 days to 1 year. During this period, event rates were 19.3% versus 18.5% for CS and non-CS patients (HR 1.07; P = .2640).
The higher rate of events was unrelated to procedural complications, which were very low in both groups and did not differ significantly. Transition to open surgery, annular disruption, aortic dissection, coronary occlusion, and device embolization occurred in < 1% of patients in both groups.
Predictors of a poor outcome identified
On multivariate analysis, the predictors of events in the CS patients were comorbidities. Despite propensity matching, being on dialysis, having a permanent pacemaker, or having a mechanical assist device were all independent predictors of mortality risk specific to the CS group.
Age and baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) score were not predictors.
These risk factors deserve consideration when evaluating CS candidates for TAVR, but Dr. Dhoble said that none are absolute contraindications. Rather, he advised that they should be considered in the context of the entire clinical picture, including the expected benefit from TAVR. Indeed, the benefit-to-risk ratio generally favors TAVR in CS patients, particularly those with obstructive CS caused by aortic stenosis, according to Dr. Dhoble.
“Efforts should be made not only to avoid delaying TAVR in such patients but also to prevent CS by early definitive treatment of patients with aortic stenosis,” he said.
These data are useful and important, said Jonathan Schwartz, MD, medical director, interventional cardiology, Atrium Health, Charlotte, N.C.
CS candidates for TAVR “are some of the sickest patients we treat. It is nice to finally have some data for this group,” he said. He agreed that CS patients can derive major benefit from TAVR if appropriately selected.
While many CS patients are already considered for TAVR, one source of hesitation has been the exclusion of CS patients from major TAVR trials, said Dr. Dhoble. He hopes these data will provide a framework for clinical decisions.
Ironically, the first TAVR patient and half of the initial series of 38 TAVR patients had CS, noted Alain G. Cribier, MD, director of cardiology, Charles Nicolle Hospital, University of Rouen, France. As the primary investigator of that initial TAVR study, conducted more than 20 years ago, he said he was not surprised by the favorable results of the propensity analysis.
“There is an almost miraculous clinical improvement to be achieved when you succeed with the procedure,” said Dr. Cribier, recounting his own experience. Improvements in LVEF of up to 30% can be achieved “within a day or two or even the first day,” he said.
Dr. Dhoble reports financial relationships with Abbott Vascular and Edwards Lifesciences. Dr. Schwartz reports that he has financial relationships with Abbott Vascular, Boston Scientific, Cordis, Edwards Lifesciences and Medtronic. Dr. Cribier reports a financial relationship with Edwards Lifesciences.
For patients undergoing transcatheter aortic valve replacement (TAVR), adverse outcomes are more common in those who are in cardiogenic shock than those who are not, but the greater risks appear to be completely concentrated in the early period of recovery, suggests a propensity-matched study.
reported Abhijeet Dhoble, MD, associate professor and an interventional cardiologist at McGovern Medical School, University of Texas Health Science Center, Houston.
Their results were presented at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.
The study, which drew data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Replacement (STS/ACC TVR) Registry, looked only at patients who underwent TAVR with the Sapien3 or Sapience3 Ultra device. Patients with CS were propensity matched to Sapien device-treated patients in the registry without CS.
Taken from a pool of 9,348 patients with CS and 299,600 patients without, the matching included a large array of clinically relevant covariates, including age, gender, prior cardiovascular events, left ventricular ejection fraction (LVEF), and New York Heart Association (NYHA) class.
After matching, there were 4,952 patients in each arm. The baseline Society of Thoracic Surgeons (STS) risk score was approximately 10.0 in both arms. About half had atrial fibrillation and 90% were in NYHA class III or IV. The median LVEF in both groups was 39.9%.
Mortality more than twofold higher in CS patients
At 30 days, outcomes were worse in patients with CS, including the proportion who died (12.9% vs. 4.9%; P < .0001) and the proportion with stroke (3.3% vs. 1.9%; P < .0001).
The only major study endpoint not significantly different, although higher in the CS group, was the rate of readmission (12.0% vs. 11.0%; P = .25).
At 1 year, the differences in the rates of mortality (29.7% vs. 22.6%; P < .0001) and stroke (4.3% vs. 3.1%; P = .0004) had narrowed modestly but remained highly significant. A closer analysis indicated that almost all of the difference in the rate of events occurred prior to hospital discharge.
In fact, mortality (9.9% vs. 2.7%; P < .0001), stroke (2.9% vs. 1.5%; P < .0001), major vascular complications (2.3% vs. 1.9%; P = .0002), life-threatening bleeding (2.5% vs. 0.7%; P < .0001), new dialysis (3.5% vs. 1.1%; P < .0001) and new onset atrial fibrillation (3.8% vs. 1.6%; P < .0001) were all significantly higher in the CS group in this very early time period. By hazard ratio (HR), the risk of a major event prior to leaving the hospital was nearly threefold higher (HR 2.3; P < .0001) in the CS group.
Yet, there was no significant difference in the accumulation of adverse events after discharge. When compared for major events in the landmark analysis, the event curves were essentially superimposable from 30 days to 1 year. During this period, event rates were 19.3% versus 18.5% for CS and non-CS patients (HR 1.07; P = .2640).
The higher rate of events was unrelated to procedural complications, which were very low in both groups and did not differ significantly. Transition to open surgery, annular disruption, aortic dissection, coronary occlusion, and device embolization occurred in < 1% of patients in both groups.
Predictors of a poor outcome identified
On multivariate analysis, the predictors of events in the CS patients were comorbidities. Despite propensity matching, being on dialysis, having a permanent pacemaker, or having a mechanical assist device were all independent predictors of mortality risk specific to the CS group.
Age and baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) score were not predictors.
These risk factors deserve consideration when evaluating CS candidates for TAVR, but Dr. Dhoble said that none are absolute contraindications. Rather, he advised that they should be considered in the context of the entire clinical picture, including the expected benefit from TAVR. Indeed, the benefit-to-risk ratio generally favors TAVR in CS patients, particularly those with obstructive CS caused by aortic stenosis, according to Dr. Dhoble.
“Efforts should be made not only to avoid delaying TAVR in such patients but also to prevent CS by early definitive treatment of patients with aortic stenosis,” he said.
These data are useful and important, said Jonathan Schwartz, MD, medical director, interventional cardiology, Atrium Health, Charlotte, N.C.
CS candidates for TAVR “are some of the sickest patients we treat. It is nice to finally have some data for this group,” he said. He agreed that CS patients can derive major benefit from TAVR if appropriately selected.
While many CS patients are already considered for TAVR, one source of hesitation has been the exclusion of CS patients from major TAVR trials, said Dr. Dhoble. He hopes these data will provide a framework for clinical decisions.
Ironically, the first TAVR patient and half of the initial series of 38 TAVR patients had CS, noted Alain G. Cribier, MD, director of cardiology, Charles Nicolle Hospital, University of Rouen, France. As the primary investigator of that initial TAVR study, conducted more than 20 years ago, he said he was not surprised by the favorable results of the propensity analysis.
“There is an almost miraculous clinical improvement to be achieved when you succeed with the procedure,” said Dr. Cribier, recounting his own experience. Improvements in LVEF of up to 30% can be achieved “within a day or two or even the first day,” he said.
Dr. Dhoble reports financial relationships with Abbott Vascular and Edwards Lifesciences. Dr. Schwartz reports that he has financial relationships with Abbott Vascular, Boston Scientific, Cordis, Edwards Lifesciences and Medtronic. Dr. Cribier reports a financial relationship with Edwards Lifesciences.
FROM EUROPCR 2023