Durability and Clinical Outcomes of Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses

Author:

Dauerman Harold L.1,Deeb G. Michael2,O’Hair Daniel P.34,Waksman Ron5,Yakubov Steven J.6,Kleiman Neal S.7,Chetcuti Stanley J.8,Hermiller James B.9,Bajwa Tanvir3,Khabbaz Kamal10,de Marchena Eduardo11,Salerno Tomas11,Dries-Devlin Jessica L.12,Li Shuzhen12,Popma Jeffrey J.10,Reardon Michael J.7

Affiliation:

1. University of Vermont Larner College of Medicine, Burlington (H.L.D.).

2. Department of Cardiac Surgery, University of Michigan, Ann Arbor (G.M.D.).

3. Departments of Cardiac Surgery and Cardiology, Aurora Healthcare, Milwaukee, WI (D.P.O., T.B.).

4. Current address: Boulder Heart, CO (D.P.O.).

5. Section of Interventional Cardiology, MedStar Washington Hospital Center, DC (R.W.).

6. Department of Cardiology, Riverside Methodist Hospital, Columbus, OH (S.J.Y.).

7. Departments of Cardiology and Cardiothoracic Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, TX (N.S.K., M.J.R.).

8. Division of Cardiology, University of Michigan, Ann Arbor (S.J.C.).

9. Division of Cardiovascular Medicine, St Vincent’s Medical Center, IN (J.B.H.).

10. Departments of Cardiovascular Surgery and Internal Medicine, Cardiovascular Division, Beth Israel Deaconess Medical Center, Boston, MA (K.K., J.J.P.).

11. Divisions of Cardiology and Cardiothoracic Surgery, University of Miami Miller School of Medicine, Miami, FL (E.d.M., T.S.).

12. Coronary and Structural Heart Clinical Operations, Medtronic, Mounds View, MN (J.L.D.-D., S.L.).

Abstract

Background: Valve-in-valve transcatheter aortic valve replacement (TAVR) is an option when a surgical valve demonstrates deterioration and dysfunction. This study reports 3-year results following valve-in-valve with self-expanding TAVR. Methods: The CoreValve US Expanded Use Study is a prospective, nonrandomized, single-arm study that evaluates safety and effectiveness of TAVR in extreme risk patients with symptomatic failed surgical biologic aortic valves. Study end points include all-cause mortality, need for valve reintervention, hemodynamic changes over time, and quality of life through 3 years. Patients were stratified by presence of preexisting surgical valve prosthesis-patient mismatch. Results: From March 2013 to May 2015, 226 patients deemed extreme risk (STS-PROM [Society of Thoracic Surgeons Predicted Risk of Mortality] 9.0±7%) had attempted valve-in-valve TAVR. Preexisting surgical valve prosthesis-patient mismatch was present in 47.2% of the cohort. At 3 years, all-cause mortality or major stroke was 28.6%, and 93% of patients were in New York Heart Association I or II heart failure. Valve performance was maintained over 3 years with low valve reintervention rates (4.4%), an improvement in effective orifice area over time and a 2.7% rate of severe structural valve deterioration. Preexisting severe prosthesis-patient mismatch was not associated with 3-year mortality but was associated with significantly less improvement in quality of life at 3-year follow-up ( P =0.01). Conclusions: Self-expanding TAVR in patients with failed surgical bioprostheses at extreme risk for surgery was associated with durable hemodynamics and excellent clinical outcomes. Preexisting surgical valve prosthesis-patient mismatch was not associated with mortality but did limit patient improvement in quality of life over 3-year follow-up. Clinical Trial Registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01675440.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Cardiology and Cardiovascular Medicine

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