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

Ada C Stefanescu Schmidt; Aimee K Armstrong; Jamil A Aboulhosn; Kevin F Kennedy; Thomas K Jones; Daniel S Levi; Doff B McElhinney; Ami B Bhatt

doi:10.1016/j.jcin.2023.10.065

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

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

Authors

Ada C Stefanescu Schmidt¹, Aimee K Armstrong², Jamil A Aboulhosn³, Kevin F Kennedy⁴, Thomas K Jones⁵, Daniel S Levi⁶, Doff B McElhinney⁷, Ami B Bhatt⁸

Affiliations

¹ Heart Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA. Electronic address: ada.stefanescu@mgh.harvard.edu.
² Nationwide Children's Hospital, Columbus, Ohio, USA.
³ Ahmanson/University of California, Los Angeles Adult Congenital Heart Center, David Geffen School of Medicine at University of California-Los Angeles, Los Angeles, California, USA.
⁴ Saint Luke's Hospital, Kansas City, Missouri, USA.
⁵ Seattle Children's Hospital, University of Washington, Seattle, Washington, USA.
⁶ Mattel Children's Hospital at University of California-Los Angeles, Los Angeles, California, USA.
⁷ Stanford University School of Medicine, Palo Alto, California, USA.
⁸ Heart Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA; American College of Cardiology, Washington, DC, USA.

PMID: 38267137
DOI: 10.1016/j.jcin.2023.10.065

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.

MeSH terms

Adult
Child
Heart Valve Prosthesis*
Humans
Pulmonary Valve* / diagnostic imaging
Pulmonary Valve* / surgery
Registries
Transcatheter Aortic Valve Replacement*
Treatment Outcome
Young Adult