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Multicenter Study
. 2024 Apr 9;83(14):1310-1321.
doi: 10.1016/j.jacc.2024.02.010.

Early Outcomes From a Multicenter Transcatheter Self-Expanding Pulmonary Valve Replacement Registry

Bryan H Goldstein  1 , Doff B McElhinney  2 , Matthew J Gillespie  3 , Jamil A Aboulhosn  4 , Daniel S Levi  4 , Brian H Morray  5 , Allison K Cabalka  6 , Barry A Love  7 , Jeffrey D Zampi  8 , David T Balzer  9 , Mark A Law  10 , Mary D Schiff  11 , Arvind Hoskoppal  12 , Athar M Qureshi  13
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Free article
Multicenter Study

Early Outcomes From a Multicenter Transcatheter Self-Expanding Pulmonary Valve Replacement Registry

Bryan H Goldstein et al. J Am Coll Cardiol. .
Free article

Abstract

Background: Transcatheter pulmonary valve replacement (TPVR) with the self-expanding Harmony valve (Medtronic) is an emerging treatment for patients with native or surgically repaired right ventricular outflow tract (RVOT) pulmonary regurgitation (PR). Limited data are available since U.S. Food and Drug Administration approval in 2021.

Objectives: In this study, the authors sought to evaluate the safety and short-term effectiveness of self-expanding TPVR in a real-world experience.

Methods: This was a multicenter registry study of consecutive patients with native RVOT PR who underwent TPVR through April 30, 2022, at 11 U.S.

Centers: The primary outcome was a composite of hemodynamic dysfunction (PR greater than mild and RVOT mean gradient >30 mm Hg) and RVOT reintervention.

Results: A total of 243 patients underwent TPVR at a median age of 31 years (Q1-Q3: 19-45 years). Cardiac diagnoses were tetralogy of Fallot (71%), valvular pulmonary stenosis (21%), and other (8%). Acute technical success was achieved in all but 1 case. Procedural serious adverse events occurred in 4% of cases, with no device embolization or death. Hospital length of stay was 1 day in 86% of patients. Ventricular arrhythmia prompting treatment occurred in 19% of cases. At a median follow-up of 13 months (Q1-Q3: 8-19 months), 98% of patients had acceptable hemodynamic function. Estimated freedom from the composite clinical outcome was 99% at 1 year and 96% at 2 years. Freedom from TPVR-related endocarditis was 98% at 1 year. Five patients died from COVID-19 (n = 1), unknown causes (n = 2), and bloodstream infection (n = 2).

Conclusions: In this large multicenter real-world experience, short-term clinical and hemodynamic outcomes of self-expanding TPVR therapy were excellent. Ongoing follow-up of this cohort will provide important insights into long-term outcomes.

Keywords: Harmony transcatheter pulmonary valve; native right ventricular outflow tract; pulmonary regurgitation; pulmonary stenosis; tetralogy of Fallot.

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Conflict of interest statement

Funding Support and Author Disclosures Dr Goldstein is a consultant, proctor, and investigator for Medtronic; is a consultant and investigator for Edwards Lifesciences; is a consultant and proctor for W.L. Gore and Associates; is a consultant and advisory board member for Mezzion Pharmaceuticals; and is a consultant for PECA Labs. Dr McElhinney is a consultant and proctor for Medtronic and Edwards Lifesciences. Dr Gillespie is a consultant and proctor for Medtronic and W.L. Gore and Associates. Dr Aboulhosn is a consultant, advisory board member, and proctor for Medtronic; and is a consultant and proctor for Edwards Lifesciences. Dr Levi is a consultant for Medtronic and Edwards Lifesciences. Dr Cabalka is a consultant and investigator for Medtronic and Edwards Lifesciences; and is a consultant for B. Braun. Dr Zampi is a consultant and proctor for Medtronic and W.L. Gore and Associates; and is on the data safety monitoring board for Encore Medical. Dr Balzer is a consultant and proctor for Medtronic, Edwards Lifesciences, and Abbott. Dr Law is a proctor for Medtronic, Edwards Lifesciences, and W.L. Gore and Associates. Dr Qureshi is a consultant and proctor for Medtronic, W.L. Gore and Associates, and B. Braun. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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