Ten-year outcomes of surgical aortic valve replacement with a contemporary supra-annular porcine valve in a Medicare population

Robert J Wiechmann; Leonard Y Lee; Yang Yu; Julie B Prillinger; Dan Gutfinger; Bradford Blakeman

doi:10.1016/j.xjon.2022.08.002

Ten-year outcomes of surgical aortic valve replacement with a contemporary supra-annular porcine valve in a Medicare population

JTCVS Open. 2022 Aug 17:12:84-102. doi: 10.1016/j.xjon.2022.08.002. eCollection 2022 Dec.

Authors

Robert J Wiechmann¹, Leonard Y Lee², Yang Yu³, Julie B Prillinger³, Dan Gutfinger³, Bradford Blakeman⁴

Affiliations

¹ Mayo Clinic Health System, Cardiothoracic Surgery, Eau Claire, Wis.
² Division of Cardiothoracic Surgery, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ.
³ Abbott, Santa Clara, Calif.
⁴ UP Health System-Marquette, Cardiovascular Surgery, Marquette, Mich.

Abstract

Objective: Bioprosthetic surgical aortic valve replacement remains an important treatment option in the era of transcatheter interventions. Real-world outcomes are not well characterized because of limited prospective follow-up studies. We present the 10-year clinical outcomes of Medicare beneficiaries undergoing surgical aortic valve replacement with a contemporary supra-annular porcine valve.

Methods: This is a single-arm observational study using Medicare fee-for-service claims data. De-identified patients undergoing surgical aortic valve replacement with the Epic Supra valve (Abbott) in the United States between January 1, 2008, and December 31, 2019, were selected by International Classification of Diseases 9^th and 10^th Revision procedure codes and then linked to a manufacturer device tracking database. All-cause mortality, heart failure rehospitalization, and aortic valve reintervention (surgical or transcatheter valve-in-valve) were evaluated at 10 years using the Kaplan-Meier method.

Results: Among 272,591 Medicare beneficiaries undergoing surgical aortic valve replacement during the study period, 11,685 received the Epic Supra valve, of whom 51.6% (6029) had underlying heart failure. Mean age was 76 ± 7 years. Survival at 10 years in patients without preoperative heart failure was 43.5% (95% confidence interval, 41.8-45.2) compared with 24.1% (95% confidence interval, 22.6-25.5) for patients with heart failure (P < .001). The 10-year freedom from heart failure rehospitalization was 64.0% (95% confidence interval, 62.6-65.3). Freedom from aortic valve reintervention was 94.6% (95% confidence interval, 93.8-95.3) at 10 years.

Conclusions: This real-world nationwide study of US Medicare beneficiaries receiving the Epic Supra valve demonstrates more than 94% freedom from all-cause valve reintervention and 64% freedom from heart failure rehospitalization at 10 years postimplant. Long-term survival and heart failure rehospitalization in this population with aortic valve disease undergoing surgical aortic valve replacement were found to be impacted by underlying heart failure.

Keywords: CABG, coronary artery bypass grafting; CI, confidence interval; CMS, Centers for Medicare & Medicaid Service; FFS, fee-for-service; HF, heart failure; HR, hazard ratio; ICD-10, International Classification of Diseases, Tenth Revision; ICD-9, International Classification of Diseases, Ninth Revision; LVAD, left ventricular assist device; SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve implantation; VIV, valve-in-valve; aortic valve replacement; durability; heart failure; porcine valve; survival.