Transfemoral TAVR Edges Surgery on Quality of Life Factors

SAN FRANCISCO – The relative impact of transcatheter aortic valve replacement on patients’ quality of life depends on which access site is used for the procedure, suggest new data from Cohort A of the randomized PARTNER trial.

The trial compared transcatheter aortic valve replacement (TAVR) with surgical valve replacement among nearly 700 patients at high surgical risk. Lead investigator Dr. David J. Cohen presented its key quality of life findings – notably as perceived by patients themselves – at Transcatheter Cardiovascular Therapeutics 2011.

These findings showed that patients having TAVR by transfemoral access had better summary scores on the Kansas City Cardiomyopathy Questionnaire at 1 month than their surgical counterparts, with a difference between groups of about 10 points on the 100-point scale. The difference disappeared thereafter.

In contrast, patients having TAVR by transapical access had worse scores than their surgical counterparts at 6 months, with a difference between groups of about 8 points, although this difference likewise abated with longer follow-up.

"Taken together with previous data that have been reported, these findings demonstrate that for patients suitable for a transfemoral approach, TAVR provides important benefits compared with surgical aortic valve replacement from the patients’ perspective," Dr. Cohen said in a press conference. "The lack of benefit and suggestion of worse quality of life among patients who were ineligible for the transfemoral approach suggest the transapical approach may not be preferable to surgical aortic valve replacement in such patients."

"Whether further experience and refinements in the transapical approach can overcome these limitations should be the subject of future investigation," he added.

The findings provide reassurance about the transfemoral approach, according to Dr. Michael J. Mack, medical director of cardiovascular surgery at the Baylor Health Care System, Heart Hospital Baylor Plano, in Plano, Tex.

The trial "does validate that transfemoral does improve quality of life over surgery, especially early on. It’s a less invasive procedure, and patients recover quicker. That’s kind of what we always hoped and thought [that] clinically" that would be the case, he commented.

But the findings regarding transapical TAVR are not as worrisome as the data might suggest in light of certain aspects of the trial; in fact, "it’s very dangerous to go down that route to say it" is worse than surgery, he asserted.

Dr. Mack noted that transfemoral TAVR "got a head start," and many centers in the trial were just beginning to use transapical TAVR by the end of the trial. "It is clear there is a learning curve to it, and you had to think of this as a feasibility trial in the United States," he commented. Moreover, transfemoral access was attempted first in patients; thus, "the worst of the worst got left for transapical." A final factor to consider was the better-than-expected performance of surgery in the trial.

"So not to ignore the message and not to say there aren’t some concerns here, but I think that the data everywhere else in the world on transapical, with ... [rare exceptions] all is positive for transapical," he concluded at the meeting, which was sponsored by the Cardiovascular Research Foundation. "So I think, yes, concern. And yes, it should be noted. But I am not as concerned about it as the data may speak."

The trial data that Dr. Cohen reported came out of a prospective, preplanned quality of life substudy within Cohort A of the PARTNER trial, which enrolled 699 patients with severe, symptomatic aortic stenosis who had a high risk for surgical complications.

The patients were randomized 1:1 to undergo TAVR (with an Edwards Sapien valve, Edwards Lifesciences, either transfemoral or transapical) vs. surgical aortic valve replacement (with any other valve).

Previously reported safety and efficacy results for Cohort A indicated that TAVR and surgical aortic valve replacement yielded similar rates of 1-year survival (N. Engl. J. Med. 2011;364:2187-98). The former was associated with a higher rate of major vascular complications, whereas the latter was associated with higher rates of major bleeding and new-onset atrial fibrillation.

Patients’ health-related quality of life was assessed with the Kansas City Cardiomyopathy Questionnaire. Dr. Cohen stressed that this questionnaire captures quality of life data from the patient’s perspective, differentiating it from the New York Heart Association class, which instead reflects the physician’s perspective.

The primary quality of life end point was the summary score on this questionnaire. "This has been shown to predict mortality and cost among patients with heart failure," he noted. "And just to give you some reference, a minimum clinically important difference on this specific scale is 5 points."

Preliminary results showed a significant interaction between treatment effect and access site used for TAVR – transfemoral vs. transapical – and trial outcomes, according to Dr. Cohen, who is director of cardiovascular research at Saint Luke’s Mid-America Heart and Vascular Institute, University of Missouri–Kansas City. Therefore, analyses considered these subgroups separately.

Patients undergoing transfemoral TAVR had better scores on the Kansas City Cardiomyopathy Questionnaire at 1 month than their surgical counterparts (difference, 9.9 points; P less than .001). But there was no longer a significant difference at 6 or 12 months.

Patients undergoing transapical TAVR had worse scores than their surgical counterparts at 6 months (difference, 7.9 points; P = .04). But there was no significant difference at 1 or 12 months.

The findings were much the same for the individual subscales of the Kansas City Cardiomyopathy Questionnaire, and for additional, generic measures of health and quality of life assessed in the trial (the Short Form-12 Health Survey and the EQ-5D questionnaire), according to Dr. Cohen.

Furthermore, the findings held up in sensitivity analyses that were restricted to only patients who actually had attempted valve replacement, that used worst-case values for patients with missing data, and that instead categorized outcomes dichotomously.

The trial was sponsored by Edwards Lifesciences. Dr. Cohen reported that he receives research or grant support from Abbott Vascular, Boston Scientific, Medtronic, AstraZeneca, and Edwards Lifesciences; and is a consultant to, is a speaker for, or receives honoraria from Daiichi-Sankyo/Eli Lilly and Medtronic. Dr. Mack reported that he had no relevant conflicts of interest.

SAN FRANCISCO – The relative impact of transcatheter aortic valve replacement on patients’ quality of life depends on which access site is used for the procedure, suggest new data from Cohort A of the randomized PARTNER trial.

The trial compared transcatheter aortic valve replacement (TAVR) with surgical valve replacement among nearly 700 patients at high surgical risk. Lead investigator Dr. David J. Cohen presented its key quality of life findings – notably as perceived by patients themselves – at Transcatheter Cardiovascular Therapeutics 2011.

These findings showed that patients having TAVR by transfemoral access had better summary scores on the Kansas City Cardiomyopathy Questionnaire at 1 month than their surgical counterparts, with a difference between groups of about 10 points on the 100-point scale. The difference disappeared thereafter.

In contrast, patients having TAVR by transapical access had worse scores than their surgical counterparts at 6 months, with a difference between groups of about 8 points, although this difference likewise abated with longer follow-up.

"Taken together with previous data that have been reported, these findings demonstrate that for patients suitable for a transfemoral approach, TAVR provides important benefits compared with surgical aortic valve replacement from the patients’ perspective," Dr. Cohen said in a press conference. "The lack of benefit and suggestion of worse quality of life among patients who were ineligible for the transfemoral approach suggest the transapical approach may not be preferable to surgical aortic valve replacement in such patients."

"Whether further experience and refinements in the transapical approach can overcome these limitations should be the subject of future investigation," he added.

The findings provide reassurance about the transfemoral approach, according to Dr. Michael J. Mack, medical director of cardiovascular surgery at the Baylor Health Care System, Heart Hospital Baylor Plano, in Plano, Tex.

The trial "does validate that transfemoral does improve quality of life over surgery, especially early on. It’s a less invasive procedure, and patients recover quicker. That’s kind of what we always hoped and thought [that] clinically" that would be the case, he commented.

But the findings regarding transapical TAVR are not as worrisome as the data might suggest in light of certain aspects of the trial; in fact, "it’s very dangerous to go down that route to say it" is worse than surgery, he asserted.

Dr. Mack noted that transfemoral TAVR "got a head start," and many centers in the trial were just beginning to use transapical TAVR by the end of the trial. "It is clear there is a learning curve to it, and you had to think of this as a feasibility trial in the United States," he commented. Moreover, transfemoral access was attempted first in patients; thus, "the worst of the worst got left for transapical." A final factor to consider was the better-than-expected performance of surgery in the trial.

"So not to ignore the message and not to say there aren’t some concerns here, but I think that the data everywhere else in the world on transapical, with ... [rare exceptions] all is positive for transapical," he concluded at the meeting, which was sponsored by the Cardiovascular Research Foundation. "So I think, yes, concern. And yes, it should be noted. But I am not as concerned about it as the data may speak."

The trial data that Dr. Cohen reported came out of a prospective, preplanned quality of life substudy within Cohort A of the PARTNER trial, which enrolled 699 patients with severe, symptomatic aortic stenosis who had a high risk for surgical complications.

The patients were randomized 1:1 to undergo TAVR (with an Edwards Sapien valve, Edwards Lifesciences, either transfemoral or transapical) vs. surgical aortic valve replacement (with any other valve).

Previously reported safety and efficacy results for Cohort A indicated that TAVR and surgical aortic valve replacement yielded similar rates of 1-year survival (N. Engl. J. Med. 2011;364:2187-98). The former was associated with a higher rate of major vascular complications, whereas the latter was associated with higher rates of major bleeding and new-onset atrial fibrillation.

Patients’ health-related quality of life was assessed with the Kansas City Cardiomyopathy Questionnaire. Dr. Cohen stressed that this questionnaire captures quality of life data from the patient’s perspective, differentiating it from the New York Heart Association class, which instead reflects the physician’s perspective.

The primary quality of life end point was the summary score on this questionnaire. "This has been shown to predict mortality and cost among patients with heart failure," he noted. "And just to give you some reference, a minimum clinically important difference on this specific scale is 5 points."

Preliminary results showed a significant interaction between treatment effect and access site used for TAVR – transfemoral vs. transapical – and trial outcomes, according to Dr. Cohen, who is director of cardiovascular research at Saint Luke’s Mid-America Heart and Vascular Institute, University of Missouri–Kansas City. Therefore, analyses considered these subgroups separately.

Patients undergoing transfemoral TAVR had better scores on the Kansas City Cardiomyopathy Questionnaire at 1 month than their surgical counterparts (difference, 9.9 points; P less than .001). But there was no longer a significant difference at 6 or 12 months.

Patients undergoing transapical TAVR had worse scores than their surgical counterparts at 6 months (difference, 7.9 points; P = .04). But there was no significant difference at 1 or 12 months.

The findings were much the same for the individual subscales of the Kansas City Cardiomyopathy Questionnaire, and for additional, generic measures of health and quality of life assessed in the trial (the Short Form-12 Health Survey and the EQ-5D questionnaire), according to Dr. Cohen.

Furthermore, the findings held up in sensitivity analyses that were restricted to only patients who actually had attempted valve replacement, that used worst-case values for patients with missing data, and that instead categorized outcomes dichotomously.

The trial was sponsored by Edwards Lifesciences. Dr. Cohen reported that he receives research or grant support from Abbott Vascular, Boston Scientific, Medtronic, AstraZeneca, and Edwards Lifesciences; and is a consultant to, is a speaker for, or receives honoraria from Daiichi-Sankyo/Eli Lilly and Medtronic. Dr. Mack reported that he had no relevant conflicts of interest.

SAN FRANCISCO – The relative impact of transcatheter aortic valve replacement on patients’ quality of life depends on which access site is used for the procedure, suggest new data from Cohort A of the randomized PARTNER trial.

The trial compared transcatheter aortic valve replacement (TAVR) with surgical valve replacement among nearly 700 patients at high surgical risk. Lead investigator Dr. David J. Cohen presented its key quality of life findings – notably as perceived by patients themselves – at Transcatheter Cardiovascular Therapeutics 2011.

These findings showed that patients having TAVR by transfemoral access had better summary scores on the Kansas City Cardiomyopathy Questionnaire at 1 month than their surgical counterparts, with a difference between groups of about 10 points on the 100-point scale. The difference disappeared thereafter.

In contrast, patients having TAVR by transapical access had worse scores than their surgical counterparts at 6 months, with a difference between groups of about 8 points, although this difference likewise abated with longer follow-up.

"Taken together with previous data that have been reported, these findings demonstrate that for patients suitable for a transfemoral approach, TAVR provides important benefits compared with surgical aortic valve replacement from the patients’ perspective," Dr. Cohen said in a press conference. "The lack of benefit and suggestion of worse quality of life among patients who were ineligible for the transfemoral approach suggest the transapical approach may not be preferable to surgical aortic valve replacement in such patients."

"Whether further experience and refinements in the transapical approach can overcome these limitations should be the subject of future investigation," he added.

The findings provide reassurance about the transfemoral approach, according to Dr. Michael J. Mack, medical director of cardiovascular surgery at the Baylor Health Care System, Heart Hospital Baylor Plano, in Plano, Tex.

The trial "does validate that transfemoral does improve quality of life over surgery, especially early on. It’s a less invasive procedure, and patients recover quicker. That’s kind of what we always hoped and thought [that] clinically" that would be the case, he commented.

But the findings regarding transapical TAVR are not as worrisome as the data might suggest in light of certain aspects of the trial; in fact, "it’s very dangerous to go down that route to say it" is worse than surgery, he asserted.

Dr. Mack noted that transfemoral TAVR "got a head start," and many centers in the trial were just beginning to use transapical TAVR by the end of the trial. "It is clear there is a learning curve to it, and you had to think of this as a feasibility trial in the United States," he commented. Moreover, transfemoral access was attempted first in patients; thus, "the worst of the worst got left for transapical." A final factor to consider was the better-than-expected performance of surgery in the trial.

"So not to ignore the message and not to say there aren’t some concerns here, but I think that the data everywhere else in the world on transapical, with ... [rare exceptions] all is positive for transapical," he concluded at the meeting, which was sponsored by the Cardiovascular Research Foundation. "So I think, yes, concern. And yes, it should be noted. But I am not as concerned about it as the data may speak."

The trial data that Dr. Cohen reported came out of a prospective, preplanned quality of life substudy within Cohort A of the PARTNER trial, which enrolled 699 patients with severe, symptomatic aortic stenosis who had a high risk for surgical complications.

The patients were randomized 1:1 to undergo TAVR (with an Edwards Sapien valve, Edwards Lifesciences, either transfemoral or transapical) vs. surgical aortic valve replacement (with any other valve).

Previously reported safety and efficacy results for Cohort A indicated that TAVR and surgical aortic valve replacement yielded similar rates of 1-year survival (N. Engl. J. Med. 2011;364:2187-98). The former was associated with a higher rate of major vascular complications, whereas the latter was associated with higher rates of major bleeding and new-onset atrial fibrillation.

Patients’ health-related quality of life was assessed with the Kansas City Cardiomyopathy Questionnaire. Dr. Cohen stressed that this questionnaire captures quality of life data from the patient’s perspective, differentiating it from the New York Heart Association class, which instead reflects the physician’s perspective.

The primary quality of life end point was the summary score on this questionnaire. "This has been shown to predict mortality and cost among patients with heart failure," he noted. "And just to give you some reference, a minimum clinically important difference on this specific scale is 5 points."

Preliminary results showed a significant interaction between treatment effect and access site used for TAVR – transfemoral vs. transapical – and trial outcomes, according to Dr. Cohen, who is director of cardiovascular research at Saint Luke’s Mid-America Heart and Vascular Institute, University of Missouri–Kansas City. Therefore, analyses considered these subgroups separately.

Patients undergoing transfemoral TAVR had better scores on the Kansas City Cardiomyopathy Questionnaire at 1 month than their surgical counterparts (difference, 9.9 points; P less than .001). But there was no longer a significant difference at 6 or 12 months.

Patients undergoing transapical TAVR had worse scores than their surgical counterparts at 6 months (difference, 7.9 points; P = .04). But there was no significant difference at 1 or 12 months.

The findings were much the same for the individual subscales of the Kansas City Cardiomyopathy Questionnaire, and for additional, generic measures of health and quality of life assessed in the trial (the Short Form-12 Health Survey and the EQ-5D questionnaire), according to Dr. Cohen.

Furthermore, the findings held up in sensitivity analyses that were restricted to only patients who actually had attempted valve replacement, that used worst-case values for patients with missing data, and that instead categorized outcomes dichotomously.

The trial was sponsored by Edwards Lifesciences. Dr. Cohen reported that he receives research or grant support from Abbott Vascular, Boston Scientific, Medtronic, AstraZeneca, and Edwards Lifesciences; and is a consultant to, is a speaker for, or receives honoraria from Daiichi-Sankyo/Eli Lilly and Medtronic. Dr. Mack reported that he had no relevant conflicts of interest.