Balloon-Expandable TAVR Bioprostheses: Area or Perimeter Sizing? A Prospective Pilot Study

Overview

Journal J Interv Cardiol

Publisher Wiley

Specialty Cardiology & Vascular Diseases

Date 2022 Nov 2

PMID 36320718

Authors

Jonathan Halim

Peter den Heijer

Jeroen Vos

Bas E Scholzel

Martijn Meuwissen

Ben van den Branden

Andreas Baumbach

Alexander J J IJsselmuiden

Affiliations

Soon will be listed here.

Abstract

Objective: In TAVR, area sizing is used for balloon-expandable (BE) valves, whereas self-expanding valves are sized to annulus perimeter. For BE valves, this seems illogical: these frames force a circular shape even on an ellipsoid annulus. This can potentially lead to relative undersizing when area sizing is being applied. We developed a perimeter-based sizing algorithm to evaluate the safety and feasibility of perimeter sizing for the Myval BE valve.

Methods: In this prospective single-center study, 60 patients with severe aortic stenosis treated with the Myval BE valve were included. Perimeter sizing was used with limited oversizing of 3.7% ± 1.3% compared to the annulus perimeter. After TAVR, clinical outcomes were evaluated at 30 days and 1 year. An echocardiographic follow-up took place at 30 days.

Results: At 30 days, the need for PPI and stroke occurred in 2% and 3% of the patients, respectively. Moreover, cardiac death and moderate-severe PVL were absent. At 1-year, cardiac death and stroke were observed in 3% and 8% of the patients, respectively. In 33.3% of the patients, a larger valve size was implanted compared to the valve size calculated by area sizing.

Conclusions: Perimeter sizing with the Myval BE valve leads to substantial use of larger valve sizes and favorable clinical outcomes, with low PPI and the absence of significant PVL. A randomized controlled trial is being planned to prove the superiority of this alternative sizing method.

Citing Articles

Myval Transcatheter Heart Valve: The Future of Transcatheter Valve Replacement and Significance in Current Timeline.

Kilic T, Coskun S, Mirzamidinov D, Yilmaz I, Yavuz S, Sahin T J Clin Med. 2024; 13(22).

PMID: 39598000 PMC: 11594825. DOI: 10.3390/jcm13226857.

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