Transcatheter Aortic Valve Implantation Within Degenerated Aortic Surgical Bioprostheses: PARTNER 2 Valve-in-Valve Registry

• Published in: Journal of the American College of Cardiology 2017-05, Vol.69 (18), p.2253-2262
• Main Authors: Webb, John G, Mack, Michael J, White, Jonathon M, Dvir, Danny, Blanke, Philipp, Herrmann, Howard C, Leipsic, Jonathon, Kodali, Susheel K, Makkar, Raj, Miller, D Craig, Pibarot, Philippe, Pichard, Augusto, Satler, Lowell F, Svensson, Lars, Alu, Maria C, Suri, Rakesh M, Leon, Martin B
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Aortic Valve; Bioprosthesis - adverse effects; Cardiology; Cardiomyopathy; Catheters; Coronary vessels; Degeneration; Early experience; Follow-Up Studies; Heart; Heart surgery; Heart Valve Prosthesis; Heart valves; Hemodynamics; Humans; Implantation; Medical personnel; Mercury; Morbidity; Mortality; Occlusion; Patients; Placement; Prospective Studies; Prostheses; Prosthesis Failure; Quality of Life; Registries; Regurgitation; Reoperation; Risk; Risk groups; Stroke; Studies; Surgery; Thorax; Transcatheter Aortic Valve Replacement; Transplants & implants; Ventricle
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2017.02.057

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. The authors examined 30-day and 1-year outcomes in a large cohort of high-risk patients undergoing VIV TAVR. 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. 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 , 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 ), 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). 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).