Transcatheter Aortic Valves Boost Quality of Life

CHICAGO – Transcatheter aortic valve implantation produced a dramatic improvement in quality of life scores, compared with standard medical management, in patients with inoperable, severe aortic stenosis in a pivotal trial with 358 randomized patients.

The primary end point of the trial, which was first reported in September and then published in October, showed that transcatheter aortic valve implantation (TAVI) significantly improved the rate of all-cause death, compared with medical care, in patients who were judged to be unable to undergo conventional surgical aortic valve replacement (N. Engl. J. Med. 2010;363:1597-607). Additional results in the new report showed a sharp improvement in the quality of life of these patients, with 62% having a 20-point or greater rise in their KCCQ (Kansas City Cardiomyopathy Questionnaire) summary scores, compared with baseline. That increase translates into an improvement of two classes on the New York Heart Association heart failure scale, Dr. David J. Cohen said at the annual scientific sessions of the American Heart Association.

"These findings add further support to the concept that TAVI should be considered an emerging standard of care for patients with severe aortic stenosis who are not candidates for surgical aortic valve replacement," said Dr. Cohen, professor and director of cardiovascular research at Saint Luke’s Mid America Heart Institute in Kansas City.

The substantial quality of life improvement seen in most patients who are treated with TAVI adds an important dimension to the study’s outcome because "these patients care far more about how they feel than how long they live," Dr. Cohen said in an interview. "If patients lived longer but didn’t feel any better than they felt at baseline – which was lousy – it wouldn’t be much of an accomplishment." Patients who seek care for severe aortic stenosis usually put a high value on treatment that produces an improved quality of life, he said.

"The impact of TAVI on health status [quality of life] is as important as any other outcome," including survival, commented Dr. John S. Rumsfeld, a cardiologist at the Denver VA Medical Center and the University of Colorado, Denver. It is an efficacy outcome that is very meaningful to patients, he said.

Based on the benefits for both survival and quality of life now reported from the PARTNER (Placement of Aortic Transcatheter Valves) study, staffers from Edwards Lifesciences Corp. announced in November that the company submitted an application to the Food and Drug Administration for marketing approval of the Sapien valve and delivery system used in the study. A report on the results from the second portion of the study, which randomized patients to surgical valve replacement or TAVI, is expected during the first half of 2011, a company spokeswoman said in an interview.

The PARTNER trial enrolled 358 patients with severe aortic stenosis who were judged inoperable by two independent surgeons. Their average age was 83 years, and slightly more than half the patients were women. Assessment using the KCCQ occurred in 81%-91% of the participants at baseline and at 1, 6, and 12 months following the start of the study. At baseline, the average KCCQ summary score among patients in both treatment arms was 35, and 70% of the patients in both arms had a score of 45 or less. A KCCQ score at that level indicates that the patient’s health status is comparable to someone with class IV New York Heart Association heart failure.

At 12 months after entry, patients who underwent TAVI had a KCCQ summary score that averaged 25 points higher than the score of those on medical therapy. The TAVI patients also had higher scores in four elements of the KCCQ assessment: symptoms, physical limitations, social limitations, and quality of life. The TAVI patients also showed substantial improvements at 12 months in three secondary measures of health status: the SF-12 physical scale, the SF-12 mental scale, and the Euro quality of life measure. For example, on the SF-12 physical scale, the average improvement with TAVI was 5 points better than with medical management. On this scale, an increase of at least 2 points reflects a clinically important difference, Dr. Cohen said.

Further analysis tallied the percentage of patients who had an "excellent" outcome, defined as those who survived to a particular follow-up interval and had a 20-point or better rise in their KCCQ summary score, compared with baseline. At all follow-up intervals, substantially more patients who were treated with TAVI met the excellent outcome criteria (see box), with a number-needed-to-treat of 3.5 to achieve one excellent outcome at 12 months.

A series of subgroup analyses showed no interaction of these effects by TAVI with age, sex, surgical risk score, aortic valve gradient pressure, or the severity of comorbid chronic obstructive pulmonary disease.

Inoperable patients make up a small portion – about 5%-10% – of all patients with severe aortic stenosis, Dr. Cohen said. Other patients with severe aortic stenosis don’t undergo surgical valve replacement for other, unknown reasons; thus, about one-fifth to one-quarter of U.S. aortic stenosis patients with disease that is severe enough to warrant valve replacement surgery don’t get it, he added. Although truly inoperable patients are uncommon, they stand to gain markedly when the transcatheter valve system becomes routinely available. They have "the biggest unmet need," Dr. Cohen said.

The PARTNER study was funded by Edwards Lifesciences. Dr. Cohen said that he has received research funding from Edwards Lifesciences.

CHICAGO – Transcatheter aortic valve implantation produced a dramatic improvement in quality of life scores, compared with standard medical management, in patients with inoperable, severe aortic stenosis in a pivotal trial with 358 randomized patients.

The primary end point of the trial, which was first reported in September and then published in October, showed that transcatheter aortic valve implantation (TAVI) significantly improved the rate of all-cause death, compared with medical care, in patients who were judged to be unable to undergo conventional surgical aortic valve replacement (N. Engl. J. Med. 2010;363:1597-607). Additional results in the new report showed a sharp improvement in the quality of life of these patients, with 62% having a 20-point or greater rise in their KCCQ (Kansas City Cardiomyopathy Questionnaire) summary scores, compared with baseline. That increase translates into an improvement of two classes on the New York Heart Association heart failure scale, Dr. David J. Cohen said at the annual scientific sessions of the American Heart Association.

"These findings add further support to the concept that TAVI should be considered an emerging standard of care for patients with severe aortic stenosis who are not candidates for surgical aortic valve replacement," said Dr. Cohen, professor and director of cardiovascular research at Saint Luke’s Mid America Heart Institute in Kansas City.

The substantial quality of life improvement seen in most patients who are treated with TAVI adds an important dimension to the study’s outcome because "these patients care far more about how they feel than how long they live," Dr. Cohen said in an interview. "If patients lived longer but didn’t feel any better than they felt at baseline – which was lousy – it wouldn’t be much of an accomplishment." Patients who seek care for severe aortic stenosis usually put a high value on treatment that produces an improved quality of life, he said.

"The impact of TAVI on health status [quality of life] is as important as any other outcome," including survival, commented Dr. John S. Rumsfeld, a cardiologist at the Denver VA Medical Center and the University of Colorado, Denver. It is an efficacy outcome that is very meaningful to patients, he said.

Based on the benefits for both survival and quality of life now reported from the PARTNER (Placement of Aortic Transcatheter Valves) study, staffers from Edwards Lifesciences Corp. announced in November that the company submitted an application to the Food and Drug Administration for marketing approval of the Sapien valve and delivery system used in the study. A report on the results from the second portion of the study, which randomized patients to surgical valve replacement or TAVI, is expected during the first half of 2011, a company spokeswoman said in an interview.

The PARTNER trial enrolled 358 patients with severe aortic stenosis who were judged inoperable by two independent surgeons. Their average age was 83 years, and slightly more than half the patients were women. Assessment using the KCCQ occurred in 81%-91% of the participants at baseline and at 1, 6, and 12 months following the start of the study. At baseline, the average KCCQ summary score among patients in both treatment arms was 35, and 70% of the patients in both arms had a score of 45 or less. A KCCQ score at that level indicates that the patient’s health status is comparable to someone with class IV New York Heart Association heart failure.

At 12 months after entry, patients who underwent TAVI had a KCCQ summary score that averaged 25 points higher than the score of those on medical therapy. The TAVI patients also had higher scores in four elements of the KCCQ assessment: symptoms, physical limitations, social limitations, and quality of life. The TAVI patients also showed substantial improvements at 12 months in three secondary measures of health status: the SF-12 physical scale, the SF-12 mental scale, and the Euro quality of life measure. For example, on the SF-12 physical scale, the average improvement with TAVI was 5 points better than with medical management. On this scale, an increase of at least 2 points reflects a clinically important difference, Dr. Cohen said.

Further analysis tallied the percentage of patients who had an "excellent" outcome, defined as those who survived to a particular follow-up interval and had a 20-point or better rise in their KCCQ summary score, compared with baseline. At all follow-up intervals, substantially more patients who were treated with TAVI met the excellent outcome criteria (see box), with a number-needed-to-treat of 3.5 to achieve one excellent outcome at 12 months.

A series of subgroup analyses showed no interaction of these effects by TAVI with age, sex, surgical risk score, aortic valve gradient pressure, or the severity of comorbid chronic obstructive pulmonary disease.

Inoperable patients make up a small portion – about 5%-10% – of all patients with severe aortic stenosis, Dr. Cohen said. Other patients with severe aortic stenosis don’t undergo surgical valve replacement for other, unknown reasons; thus, about one-fifth to one-quarter of U.S. aortic stenosis patients with disease that is severe enough to warrant valve replacement surgery don’t get it, he added. Although truly inoperable patients are uncommon, they stand to gain markedly when the transcatheter valve system becomes routinely available. They have "the biggest unmet need," Dr. Cohen said.

The PARTNER study was funded by Edwards Lifesciences. Dr. Cohen said that he has received research funding from Edwards Lifesciences.

CHICAGO – Transcatheter aortic valve implantation produced a dramatic improvement in quality of life scores, compared with standard medical management, in patients with inoperable, severe aortic stenosis in a pivotal trial with 358 randomized patients.

The primary end point of the trial, which was first reported in September and then published in October, showed that transcatheter aortic valve implantation (TAVI) significantly improved the rate of all-cause death, compared with medical care, in patients who were judged to be unable to undergo conventional surgical aortic valve replacement (N. Engl. J. Med. 2010;363:1597-607). Additional results in the new report showed a sharp improvement in the quality of life of these patients, with 62% having a 20-point or greater rise in their KCCQ (Kansas City Cardiomyopathy Questionnaire) summary scores, compared with baseline. That increase translates into an improvement of two classes on the New York Heart Association heart failure scale, Dr. David J. Cohen said at the annual scientific sessions of the American Heart Association.

"These findings add further support to the concept that TAVI should be considered an emerging standard of care for patients with severe aortic stenosis who are not candidates for surgical aortic valve replacement," said Dr. Cohen, professor and director of cardiovascular research at Saint Luke’s Mid America Heart Institute in Kansas City.

The substantial quality of life improvement seen in most patients who are treated with TAVI adds an important dimension to the study’s outcome because "these patients care far more about how they feel than how long they live," Dr. Cohen said in an interview. "If patients lived longer but didn’t feel any better than they felt at baseline – which was lousy – it wouldn’t be much of an accomplishment." Patients who seek care for severe aortic stenosis usually put a high value on treatment that produces an improved quality of life, he said.

"The impact of TAVI on health status [quality of life] is as important as any other outcome," including survival, commented Dr. John S. Rumsfeld, a cardiologist at the Denver VA Medical Center and the University of Colorado, Denver. It is an efficacy outcome that is very meaningful to patients, he said.

Based on the benefits for both survival and quality of life now reported from the PARTNER (Placement of Aortic Transcatheter Valves) study, staffers from Edwards Lifesciences Corp. announced in November that the company submitted an application to the Food and Drug Administration for marketing approval of the Sapien valve and delivery system used in the study. A report on the results from the second portion of the study, which randomized patients to surgical valve replacement or TAVI, is expected during the first half of 2011, a company spokeswoman said in an interview.

The PARTNER trial enrolled 358 patients with severe aortic stenosis who were judged inoperable by two independent surgeons. Their average age was 83 years, and slightly more than half the patients were women. Assessment using the KCCQ occurred in 81%-91% of the participants at baseline and at 1, 6, and 12 months following the start of the study. At baseline, the average KCCQ summary score among patients in both treatment arms was 35, and 70% of the patients in both arms had a score of 45 or less. A KCCQ score at that level indicates that the patient’s health status is comparable to someone with class IV New York Heart Association heart failure.

At 12 months after entry, patients who underwent TAVI had a KCCQ summary score that averaged 25 points higher than the score of those on medical therapy. The TAVI patients also had higher scores in four elements of the KCCQ assessment: symptoms, physical limitations, social limitations, and quality of life. The TAVI patients also showed substantial improvements at 12 months in three secondary measures of health status: the SF-12 physical scale, the SF-12 mental scale, and the Euro quality of life measure. For example, on the SF-12 physical scale, the average improvement with TAVI was 5 points better than with medical management. On this scale, an increase of at least 2 points reflects a clinically important difference, Dr. Cohen said.

Further analysis tallied the percentage of patients who had an "excellent" outcome, defined as those who survived to a particular follow-up interval and had a 20-point or better rise in their KCCQ summary score, compared with baseline. At all follow-up intervals, substantially more patients who were treated with TAVI met the excellent outcome criteria (see box), with a number-needed-to-treat of 3.5 to achieve one excellent outcome at 12 months.

A series of subgroup analyses showed no interaction of these effects by TAVI with age, sex, surgical risk score, aortic valve gradient pressure, or the severity of comorbid chronic obstructive pulmonary disease.

Inoperable patients make up a small portion – about 5%-10% – of all patients with severe aortic stenosis, Dr. Cohen said. Other patients with severe aortic stenosis don’t undergo surgical valve replacement for other, unknown reasons; thus, about one-fifth to one-quarter of U.S. aortic stenosis patients with disease that is severe enough to warrant valve replacement surgery don’t get it, he added. Although truly inoperable patients are uncommon, they stand to gain markedly when the transcatheter valve system becomes routinely available. They have "the biggest unmet need," Dr. Cohen said.

The PARTNER study was funded by Edwards Lifesciences. Dr. Cohen said that he has received research funding from Edwards Lifesciences.