Transcatheter pulmonary valve replacement with a self-expanding valve showed excellent short-term outcomes, with 99% estimated freedom from hemodynamic dysfunction and RVOT reintervention at 1 year.
Observational (n=243)
Yes
Does transcatheter self-expanding pulmonary valve replacement improve hemodynamic function and prevent RVOT reintervention in patients with native or surgically repaired RVOT pulmonary regurgitation?
In a real-world multicenter registry, self-expanding TPVR demonstrated excellent short-term clinical and hemodynamic outcomes with 99% freedom from hemodynamic dysfunction or reintervention at 1 year.
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.
“The Harmony TPV therapy finally offered a non-surgical option to treat severe PR and restore pulmonary valve competence.”
Goldstein et al. (2024) conducted an observational in Native right ventricular outflow tract pulmonary regurgitation (n=243). Transcatheter pulmonary valve replacement with self-expanding Harmony valve was evaluated on Composite of hemodynamic dysfunction (PR greater than mild and RVOT mean gradient >30 mm Hg) and RVOT reintervention. Transcatheter pulmonary valve replacement with a self-expanding valve showed excellent short-term outcomes, with 99% estimated freedom from hemodynamic dysfunction and RVOT reintervention at 1 year.