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

Harold L. Dauerman, G. Michael Deeb, Daniel P. O'Hair, Ron Waksman, Steven J. Yakubov, Neal S. Kleiman, Stanley J. Chetcuti, James B. Hermiller, Tanvir Bajwa, Kamal Khabbaz, Eduardo De Marchena, Tomas Salerno, Jessica L. Dries-Devlin, Shuzhen Li, Jeffrey J. Popma, Michael J. Reardon

Research output: Contribution to journalArticle

3 Scopus citations

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.

Original languageEnglish (US)
Article numbere008155
JournalCirculation: Cardiovascular Interventions
Volume12
Issue number10
DOIs
StatePublished - Oct 1 2019

Keywords

  • aortic valve
  • aortic valve stenosis
  • bioprosthesis
  • transcatheter aortic valve replacement

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Dauerman, H. L., Deeb, G. M., O'Hair, D. P., Waksman, R., Yakubov, S. J., Kleiman, N. S., Chetcuti, S. J., Hermiller, J. B., Bajwa, T., Khabbaz, K., De Marchena, E., Salerno, T., Dries-Devlin, J. L., Li, S., Popma, J. J., & Reardon, M. J. (2019). Durability and Clinical Outcomes of Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses. Circulation: Cardiovascular Interventions, 12(10), [e008155]. https://doi.org/10.1161/CIRCINTERVENTIONS.119.008155