Author + information
- Received November 16, 2018
- Revision received February 5, 2019
- Accepted March 5, 2019
- Published online May 27, 2019.
- John G. Webb, MDa,∗ (, )@PPibarot,
- Dale J. Murdoch, MBBSa,
- Maria C. Alu, MSb,
- Anson Cheung, MDa,
- Aaron Crowley, MAc,
- Danny Dvir, MDd,
- Howard C. Herrmann, MDe,
- Susheel K. Kodali, MDb,
- Jonathon Leipsic, MDa,
- D. Craig Miller, MDf,
- Philippe Pibarot, PhD, DVMg,
- Rakesh M. Suri, MD, DPhilh,
- David Wood, MDa,
- Martin B. Leon, MDb,c and
- Michael J. Mack, MDi
- aSt. Paul’s Hospital, Vancouver, British Columbia, Canada
- bColumbia University Medical Center, New York, New York
- cCardiovascular Research Foundation, New York, New York
- dUniversity of Washington, Seattle, Washington
- eUniversity of Pennsylvania, Philadelphia, Pennsylvania
- fStanford University, Stanford, California
- gLaval University, Quebec, Quebec, Canada
- hCleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates
- iBaylor Scott & White Health, Plano, Texas
- ↵∗Address for correspondence:
Dr. John G. Webb, St. Paul’s Hospital, 1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada.
Background Transcatheter aortic valve replacement (TAVR) for degenerated surgical bioprosthetic aortic valves is associated with favorable early outcomes. However, little is known about the durability and longer-term outcomes associated with this therapy.
Objectives The aim of this study was to examine late outcomes after valve-in-valve TAVR.
Methods Patients with symptomatic degeneration of surgical aortic bioprostheses at high risk (≥50% major morbidity or mortality) for reoperative surgery were prospectively enrolled in the multicenter PARTNER (Placement of Aortic Transcatheter Valves) 2 valve-in-valve and continued access registries. Three-year clinical and echocardiographic follow-up was obtained.
Results Valve-in-valve procedures were performed in 365 patients. The mean age was 78.9 ± 10.2 years, and the mean Society of Thoracic Surgeons score was 9.1 ± 4.7%. At 3 years, the overall Kaplan-Meier estimate of all-cause mortality was 32.7%. Aortic valve re-replacement was required in 1.9%. Mean transaortic gradient was 35.0 mm Hg at baseline, decreasing to 17.8 mm Hg at 30-day follow-up and 16.6 mm Hg at 3-year follow-up. Baseline effective orifice area was 0.93 cm2, increasing to 1.13 and 1.15 cm2 at 30 days and 3 years, respectively. Moderate to severe aortic regurgitation was reduced from 45.1% at pre-TAVR baseline to 2.5% at 3 years. Importantly, moderate or severe mitral and tricuspid regurgitation also decreased (33.7% vs. 8.6% [p < 0.0001] and 29.7% vs. 18.8% [p = 0.002], respectively). Baseline left ventricular ejection fraction was 50.7%, increasing to 54.7% at 3 years (p < 0.0001), while left ventricular mass index was 136.4 g/m2, decreasing to 109.1 g/m2 at 3 years (p < 0.0001). New York Heart Association functional class improved, with 90.4% in class III or IV at baseline and 14.1% at 3 years (p < 0.0001), and Kansas City Cardiomyopathy Questionnaire overall score increased (43.1 to 73.1; p < 0.0001).
Conclusions At 3-year follow-up, TAVR for bioprosthetic aortic valve failure was associated with favorable survival, sustained improved hemodynamic status, and excellent functional and quality-of-life outcomes. (The PARTNER II Trial: Placement of Aortic Transcatheter Valves II - PARTNER II - Nested Registry 3/Valve-in-Valve [PII NR3/ViV]; NCT03225001)
The PARTNER 2 trial was sponsored by Edwards Lifesciences. Dr. Webb is a consultant for Edwards Lifesciences; and is a member of the PARTNER trial executive committee. Dr. Mack is a member of the PARTNER trial executive committee. Dr. Dvir is a consultant for Edwards Lifesciences. Dr. Herrmann has received grants from and is a consultant for Edwards Lifesciences. Dr. Blanke is a consultant for Edwards Lifesciences. Drs. Blanke and Leipsic provide computed tomographic core laboratory services for Edwards Lifesciences. Dr. Pibarot provides echocardiography core laboratory services for Edwards Lifesciences. Dr. Kodali has received grants from Edwards Lifesciences; and is a member of the PARTNER trial executive committee. Drs. Miller and Leon are members of the PARTNER trial executive committee. Dr. Wood has served as a consultant to Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received November 16, 2018.
- Revision received February 5, 2019.
- Accepted March 5, 2019.
- 2019 American College of Cardiology Foundation
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