Journal
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Volume 69, Issue 18, Pages 2253-2262Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jacc.2017.02.057
Keywords
6-min walk test; aortic stenosis; mortality; registry; regurgitation
Categories
Funding
- Edwards Lifesciences
- St. Jude Medical
- Medtronic
- Boston Scientific
- Abbott Vascular
- Gore
- Siemens
- Cardiokinetix
- Mitraspan
- National Heart Lung Blood Institute [HL67025]
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BACKGROUND Early experience with transcatheter aortic valve replacement (TAVR) within failed bioprosthetic surgical aortic valves has shown that valve-in-valve (VIV) TAVR is a feasible therapeutic option with acceptable acute procedural results. OBJECTIVES The authors examined 30-day and 1-year outcomes in a large cohort of high-risk patients undergoing VIV 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 VIV trial and continued access registries. RESULTS Valve-in-valve procedures were performed in 365 patients (96 initial registry, 269 continued access patients). Mean age was 78.9 +/- 10.2 years, and mean Society of Thoracic Surgeons score was 9.1 +/- 4.7%. At 30 days, all-cause mortality was 2.7%, stroke was 2.7%, major vascular complication was 4.1%, conversion to surgery was 0.6%, coronary occlusion was 0.8%, and new pacemaker insertion was 1.9%. One-year all-cause mortality was 12.4%. Mortality fell from the initial registry to the subsequent continued access registry, both at 30 days (8.2% vs. 0.7%, respectively; p = 0.0001) and at 1 year (19.7% vs. 9.8%, respectively; p = 0.006). At 1 year, mean gradient was 17.6 mm Hg, and effective orifice area was 1.16 cm(2), with greater than mild paravalvular regurgitation of 1.9%. Left ventricular ejection fraction increased (50.6% to 54.2%), and mass index decreased (135.7 to 117.6 g/m(2)), with reductions in both mitral (34.9% vs. 12.7%) and tricuspid (31.8% vs. 21.2%) moderate or severe regurgitation (all p < 0.0001). Kansas City Cardiomyopathy Questionnaire score increased (mean: 43.1 to 77.0) and 6-min walk test distance results increased (mean: 163.6 to 252.3 m; both p < 0.0001). CONCLUSIONS In high-risk patients, TAVR for bioprosthetic aortic valve failure is associated with relatively low mortality and complication rates, improved hemodynamics, and excellent functional and quality-of-life outcomes at 1 year. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves [PARTNER II]; NCT01314313) (C) 2017 by the American College of Cardiology Foundation.
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