TY - JOUR
T1 - Health-related quality of life after transcatheter or surgical aortic valve replacement in high-risk patients with severe aortic stenosis
T2 - Results from the PARTNER (Placement of AoRTic TraNscathetER Valve) trial (Cohort A)
AU - Reynolds, Matthew R.
AU - Magnuson, Elizabeth A.
AU - Wang, Kaijun
AU - Thourani, Vinod H.
AU - Williams, Mathew
AU - Zajarias, Alan
AU - Rihal, Charanjit S.
AU - Brown, David L.
AU - Smith, Craig R.
AU - Leon, Martin B.
AU - Cohen, David J.
N1 - Funding Information:
Supported by Edwards Lifesciences, Inc. Dr. Reynolds receives research grant support from Edwards Lifesciences ; and is a consultant for Medtronic and St. Jude Medical. Dr. Cohen receives research grants from Edwards Lifesciences , Medtronic , Abbott Vascular , Boston Scientific , AstraZeneca , and Eli Lilly ; is a consultant for Medtronic and Abbott Vascular; and has received speaking honoraria from Eli Lilly. Dr. Leon has received reimbursement from Edwards Lifesciences for travel expenses related to his unpaid participation as a member of the Executive Committee for the PARTNER Trial; in addition, his institution (Columbia University) has received grant support from Edwards for educational programs. Dr. Thourani is a member of advisory boards for Edwards Lifescience, Sorin Medical, and St. Jude. Dr. Williams is a consultant/proctor for Edwards Lifesciences; and his institution (Columbia University) has received grant support from Edwards for educational programs. Dr. Zajarias is a consultant/proctor for Edwards Lifesciences; and has received travel reimbursement from Edwards as a member of the PARTNER Steering Committee. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
PY - 2012/8/7
Y1 - 2012/8/7
N2 - Objectives: This study sought to compare health status and quality-of-life outcomes for patients with severe aortic stenosis (AS) and high surgical risk treated with either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (AVR). Background: For high-risk patients with severe AS, TAVR has been shown to result in similar 12-month survival but differing adverse events compared with AVR. Methods: We evaluated the health status of 628 patients with severe, symptomatic AS at high risk of surgical complications who were randomized to either TAVR or AVR in the PARTNER Trial. Health status was assessed at baseline and 1, 6, and 12 months using the Kansas City Cardiomyopathy Questionnaire, the Short Form-12, and the EuroQol-5D. Results: The primary outcome, the Kansas City Cardiomyopathy Questionnaire summary score, improved more rapidly with TAVR, but was similar for the 2 groups at 6 and 12 months. However, there was a significant interaction between the benefit of TAVR and access site (transapical vs. transfemoral). Patients eligible for transfemoral TAVR demonstrated significant health status benefits with TAVR versus AVR at 1 month (difference, 9.9 points; 95% confidence interval: 4.9 to 14.9; p < 0.001), whereas patients treated via the TA approach demonstrated no benefits with TAVR compared with AVR at any time point. Results for Kansas City Cardiomyopathy Questionnaire subscales and generic measures demonstrated similar patterns. Conclusions: In high-risk patients with severe AS, health status improved substantially between baseline and 1 year after either TAVR or AVR. TAVR via the transfemoral, but not the transapical route, was associated with a short-term advantage compared with surgery. (Placement of AoRTic TraNscathetER Valve [PARTNER] trial; NCT00530894)
AB - Objectives: This study sought to compare health status and quality-of-life outcomes for patients with severe aortic stenosis (AS) and high surgical risk treated with either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (AVR). Background: For high-risk patients with severe AS, TAVR has been shown to result in similar 12-month survival but differing adverse events compared with AVR. Methods: We evaluated the health status of 628 patients with severe, symptomatic AS at high risk of surgical complications who were randomized to either TAVR or AVR in the PARTNER Trial. Health status was assessed at baseline and 1, 6, and 12 months using the Kansas City Cardiomyopathy Questionnaire, the Short Form-12, and the EuroQol-5D. Results: The primary outcome, the Kansas City Cardiomyopathy Questionnaire summary score, improved more rapidly with TAVR, but was similar for the 2 groups at 6 and 12 months. However, there was a significant interaction between the benefit of TAVR and access site (transapical vs. transfemoral). Patients eligible for transfemoral TAVR demonstrated significant health status benefits with TAVR versus AVR at 1 month (difference, 9.9 points; 95% confidence interval: 4.9 to 14.9; p < 0.001), whereas patients treated via the TA approach demonstrated no benefits with TAVR compared with AVR at any time point. Results for Kansas City Cardiomyopathy Questionnaire subscales and generic measures demonstrated similar patterns. Conclusions: In high-risk patients with severe AS, health status improved substantially between baseline and 1 year after either TAVR or AVR. TAVR via the transfemoral, but not the transapical route, was associated with a short-term advantage compared with surgery. (Placement of AoRTic TraNscathetER Valve [PARTNER] trial; NCT00530894)
KW - AVR
KW - TAVR
KW - aortic stenosis
KW - quality of life
UR - http://www.scopus.com/inward/record.url?scp=84864774776&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84864774776&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2012.03.075
DO - 10.1016/j.jacc.2012.03.075
M3 - Article
C2 - 22818074
AN - SCOPUS:84864774776
SN - 0735-1097
VL - 60
SP - 548
EP - 558
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 6
ER -