Long‑term outcomes of transcatheter self-expanding aortic valve implantations in inoperable and high surgical–risk patients with severe aortic stenosis: a single-center single-valve registry

Abstract

Background: Transcatheter aortic valve implantation (TAVI) is being increasingly used in patients with longer life expectancy. Data on long‑term outcomes are still limited.

Aims: The aim of the study was to assess the clinical outcomes of patients treated with TAVI and identify baseline and procedure‑related factors influencing long‑term survival.

Methods: Symptomatic patients with critical aortic stenosis who were inoperable or had high surgical risk were qualified for TAVI. Between August 2012 and December 2017, 248 consecutive patients treated with self ‑expanding Medtronic valve implantation at American Heart of Poland in Bielsko‑Biała were prospectively enrolled. Patients were followed for 30 days after the procedure and subsequently annually. All events were classified according to the Valve Academic Research Consortium‑2 (VARC‑2) criteria and assessed. Survival was compared between the subgroups defined by the EuroSCORE II (European System for Cardiac Operative Risk Evaluation II) and with matched representatives from the general population.

Results: The median (interquartile range) follow‑up was 3.4 (2.5–4.6) years, and the longest follow‑up lasted 7.8 years. A total of 92 patients (37.1%) died during the follow‑up. The Kaplan–Meier estimates for cumulative mortality at 1, 3, 5, and 7 years were: 11.3%, 26.8%, 42.1%, and 60.6%. Patients with EuroSCORE II greater than 6% experienced worse survival compared with those with EuroSCORE II 6% or less (P = 0.008). Patients with EuroSCORE II 6% or less had similar survival to the general population. Male sex, baseline eGFR of less than 50 ml/min/1.73 m2, chronic obstructive pulmonary disease, moderate / severe paravalvular leak, absence of postdilatation, major vascular complication, and stroke at 30 days were independently associated with long‑term mortality.

Conclusions: TAVI with a self‑expanding Medtronic valve implantation according to a consistent protocol was associated with favorable outcomes. Patients with lower EuroSCORE II scores had the same prognosis as the actuarial survival of the general population.