Five-year Clinical Outcomes and Durability of a Self-Expanding Transcatheter Heart Valve with Intra-annular leaflets

S. Fichtlscherer (Bad Segeberg)¹, R. Puri (Cleveland)², H. Thiele (Leipzig)³, D. Westermann (Freiburg im Breisgau)⁴, R. Makkar (Californien)⁵, R. Waksman (Washington)⁶, S. Hakmi (Hamburg)⁷, L. Sondergaard (Westfield)⁸, M. Groh (Asheville)⁹, J. Kempfert (Berlin)¹⁰, F. Maisano (Milan)¹¹, H. Möllmann (Dortmund)^12
1Segeberger Kliniken GmbH Herz- und Gefäßzentrum Bad Segeberg, Deutschland; ²Cleveland Clinic Foundation Mailbox 569 Cleveland, USA; ³Herzzentrum Leipzig - Universität Leipzig Klinik für Innere Medizin/Kardiologie Leipzig, Deutschland; ⁴Universitäts-Herzzentrum Freiburg - Bad Krozingen Innere Medizin III, Kardiologie und Angiologie Freiburg im Breisgau, Deutschland; ⁵Cedars-Sinai Medical Center Californien, USA; ⁶MedStar Washington Hospital Center Washington, USA; ⁷Asklepios Klinik St. Georg Abteilung Herzchirurgie Hamburg, Deutschland; ⁸Abbott Structural Heart Westfield, USA; ⁹Ashville Heart Asheville, USA; ¹⁰Deutsches Herzzentrum der Charite (DHZC) Klinik für Herz-, Thorax- und Gefäßchirurgie Berlin, Deutschland; ¹¹San Raffaele Hospital IRCCS Ospedale San Raffaele Milan, Italien; ¹²Kath. St. Paulus Gesellschaft Klinik für Innere Medizin I Dortmund, Deutschland

Background

There is a paucity of data regarding longer-term durability of transcatheter heart valves (THV) using standardized definitions. The self-expanding Portico THV with intra-annular leaflet position was iterated to the current Navitor THV system, however the leaflet technology across the two systems remains identical.

Objectives

To describe the 5-year clinical outcomes and valve durability for patients treated with the Portico THV across three studies harmonized in their prospective enrolment, inclusion/exclusion criteria, centralized core laboratory echocardiographic analysis, and independent clinical events committee adjudication.

Methods

Patient-level data from the PORTICO IDE randomized controlled trial, the PORTICO I post-market study and PORTICO continued access datasets were pooled. All three studies collected follow-up data at discharge, 30 days, and annually through 5-years. Adverse events and paired echocardiographic data were assessed using VARC-2 definitions. Durability definitions were adapted from VARC-3 and EAPCI/ESC/EACTS Consensus guidelines.

Results

Between April 2013 and December 2019, 1464 patients with severe symptomatic aortic stenosis and high or extreme surgical risk were treated at 111 sites across 14 countries. Mean age at implant was 82.7 years, 61.7% were women with a mean STS score of 5.97%. At 5-years, all-cause mortality and stroke rates were 47.3% and 12.5%, respectively. Mean transvalvular gradient and EOA at 5-years were 6.8 mmHg and 1.85 cm², respectively, with paravalvular leak (PVL) ≥moderate severity occurring in 1.9%, with decreasing severity over time. The 5-year bioprosthetic valve failure (BVF) rate was 3.0%, comprised of 1.2% valve-related death rate and a 1.8% valve re-intervention rate, but no patients with severe hemodynamic structural valve deterioration (HSVD). Moderate HSVD occurred in 0.3% of the patients at 5 years. Hemodynamic performance and THV durability did not differ according to small (≤23 mm) or large (>23 mm) aortic annulus diameter.

Conclusions

The use of Portico THV system in patients at high or extreme surgical risk demonstrated favorable clinical outcomes and hemodynamic performance with low trans-valvular pressure gradients and rate of clinically relevant PVL. Furthermore, BVF rates were low with no incidence of severe HSVD at 5 years, irrespective of annulus size.