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Author Notes:

Address for correspondence: David J Cohen, MD, MSc, Saint Luke’s Mid America Heart Institute, University of Missouri-Kansas City School of Medicine, 4401 Wornall Road, Kansas City, MO 64111, Phone: 816-931-1883, dcohen@saint-lukes.org.

Disclosures: Dr. Cohen has received grant support from Edwards Lifesciences, Medtronic, Boston Scientific, Abbott Vascular, MedRad, Merck/Schering-Plough, and Eli Lilly-Daiichi Sankyo, consulting fees from Schering-Plough, Eli Lilly, Medtronic, and Cordis, and speaking honoraria from Eli Lilly, The Medicines Company, and St. Jude Medical. Dr. Reynolds has received research support from Edwards Lifesciences and Medtronic, and consulting fees from Medtronic. Dr. Williams has received consulting fees from Edwards Lifesciences. Dr. Kodali has received consulting fees from Edwards Lifesciences and serves on the advisory board for the Thubrikar Aortic Valve. Dr. Leon has been an unpaid member of the PARTNER Trial Executive Committee. Dr. Thourani has received research support from Edwards Lifesciences and Sorin Medical, consulting fees from DirectFlow Medical, St. Jude, and Sorin Medical, and royalties/intellectual property rights from Apica. Dr. Szeto has received consulting fees from MicroInterventional Devices. All other co-authors have no relevant disclosures.

Subjects:

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Cardiac & Cardiovascular Systems
  • Cardiovascular System & Cardiology
  • aortic valve
  • follow-up studies
  • quality of life
  • transcatheter aortic valve replacement
  • transapical
  • HIGH-RISK PATIENTS
  • CITY CARDIOMYOPATHY QUESTIONNAIRE
  • HEALTH-STATUS
  • POSTTHORACOTOMY PAIN
  • COST-EFFECTIVENESS
  • LEARNING-CURVE
  • HEART-FAILURE
  • IMPLANTATION
  • STENOSIS
  • ANALGESIA

Temporal Trends in Quality of Life Outcomes After Transapical Transcatheter Aortic Valve Replacement: A Placement of AoRTic TraNscathetER Valve (PARTNER) Trial Substudy

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Journal Title:

Circulation Cardiovascular Quality and Outcomes

Volume:

Volume 8, Number 4

Publisher:

, Pages 338-346

Type of Work:

Article | Post-print: After Peer Review

Abstract:

Background - In the Placement of AoRTic TraNscathetER Valve (PARTNER) randomized controlled trial (RCT), which represented the first exposure to transapical transcatheter aortic valve replacement (TA-TAVR) for many clinical sites, high-risk patients undergoing TA-TAVR derived similar health-related quality of life (HRQoL) outcomes when compared with surgical aortic valve replacement (SAVR). With increasing experience, it is possible that HRQoL outcomes of TA-TAVR may have improved. Methods and Results - We evaluated HRQoL outcomes at 1-, 6-, and 12-month follow-ups among 875 patients undergoing TA-TAVR in the PARTNER nonrandomized continued access (NRCA) registry and compared these outcomes with those of the TA-TAVR and SAVR patients in the PARTNER RCT. HRQoL was assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Medical Outcomes Study Short-Form 12, and the EuroQoL-5D, with the KCCQ overall summary score serving as the primary end point. The NRCA TA-TAVR and RCT TA-TAVR and SAVR groups were generally similar. The primary outcome, the KCCQ summary score, did not differ between the NRCA TA-TAVR and the RCT TA-TAVR group at any follow-up timepoints, although there were small differences in favor of the NRCA cohort on several KCCQ subscales at 1 month. There were no significant differences in follow-up HRQOL between the NRCA-TAVR and the RCT SAVR cohorts on the KCCQ overall summary scale or any of the disease-specific or generic subscales. Conclusions - Despite greater experience with TA-TAVR in the NRCA registry, HRQoL outcomes remained similar to those of TA-TAVR in the original RCT cohort and no better than those with SAVR. These findings have important implications for patient selection for TAVR when transfemoral access is not an option.

Copyright information:

© 2015 American Heart Association, Inc.

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