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. 2024 Jan 22;17(2):231-244.
doi: 10.1016/j.jcin.2023.10.065.

Transcatheter Pulmonary Valve Replacement With Balloon-Expandable Valves: Utilization and Procedural Outcomes From the IMPACT Registry

Ada C Stefanescu Schmidt  1 , Aimee K Armstrong  2 , Jamil A Aboulhosn  3 , Kevin F Kennedy  4 , Thomas K Jones  5 , Daniel S Levi  6 , Doff B McElhinney  7 , Ami B Bhatt  8
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Free article

Transcatheter Pulmonary Valve Replacement With Balloon-Expandable Valves: Utilization and Procedural Outcomes From the IMPACT Registry

Ada C Stefanescu Schmidt et al. JACC Cardiovasc Interv. .
Free article

Abstract

Background: Transcatheter pulmonary valve replacement (TPVR) has expanded and evolved since its initial commercial approval in the United States in 2010.

Objectives: This study sought to characterize real-world practice, including patient selection, procedural outcomes, complications, and off-label usage.

Methods: Characteristics and outcomes for patients undergoing balloon-expandable TPVR were collected from the American College of Cardiology National Cardiovascular Data Registry IMPACT (Improving Pediatric and Adult Congenital Treatment) Registry.

Results: Between April 2016 and March 2021, 4,513 TPVR procedures were performed in patients with a median age of 19 years, 57% with a Melody (Medtronic Inc) and 43% with a SAPIEN (Edwards Lifesciences) valve. Most implanting centers performed <10 cases annually. One-third of transcatheter pulmonary valve implants were into homograft conduits, one-third were into bioprosthetic valves (BPVs), 25% were in native or patched right ventricular outflow tracts (RVOTs), and 6% were into Contegra (Medtronic Inc) conduits. Over the course of the study period, SAPIEN valve use grew from ∼25% to 60%, in large part because of implants in patients with a native/patched RVOT. Acute success was achieved in 95% of patients (95.7% in homografts, 96.2% in BPVs, 94.2% in native RVOTs, and 95.4% in Contegra conduits). Major adverse events occurred in 2.4% of procedures, more commonly in patients with a homograft (2.9%) or native RVOT (3.4%) than a prior BPV (1.4%; P = 0.004).

Conclusions: This study describes novel population data on the use and procedural outcomes of TPVR with balloon-expandable valves. Over time, there has been increasing use of TPVR to treat regurgitant native RVOT anatomy, with the SAPIEN valve more commonly used for this application.

Keywords: adult congenital heart disease; cardiac catheterization; pulmonary regurgitation; tetralogy of Fallot; transcatheter valve.

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Conflict of interest statement

Funding Support and Author Disclosures A portion of this work was supported by the National Institutes of Health (T32HL007604) to Dr Stefanescu Schmidt. The manuscript contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health. Dr Stefanescu Schmidt is an investigator for Occlutech. Dr Armstrong is a consultant and proctor for Medtronic and Edwards Lifesciences and an investigator for Edwards Lifescience. Dr Aboulhosn is a consultant and proctor for Medtronic and Edwards Lifesciences. Dr Jones is an investigator, consultant, proctor, and Clinical Event Committee member for Medtronic; and is an investigator and consultant for Edwards Lifesciences. Dr Levi is a consultant for Medtronic and Edwards Lifesciences. Dr McElhinney is a consultant and proctor for Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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