Key result
Harmony transcatheter pulmonary valve replacement achieves ~99% procedural success, exceeding the regulatory performance target.
Why the study?
Although the Harmony TPV is FDA-approved for severe pulmonary regurgitation in the native or surgically repaired right ventricular outflow tract, a rigorous quantitative synthesis of outcomes across trial and real-world settings had not been performed.
Does transcatheter pulmonary valve replacement with the Harmony valve achieve procedural success exceeding the 95% regulatory benchmark and acceptable clinical safety in patients with severe pulmonary regurgitation in the native or surgically repaired right ventricular outflow tract?
Meta-Analysis (n=742)
Yes
Does transcatheter pulmonary valve replacement with the Harmony valve achieve procedural success exceeding the 95% regulatory benchmark and acceptable clinical safety in patients with severe pulmonary regurgitation in the native or surgically repaired right ventricular outflow tract?
This meta-analysis demonstrates that Harmony transcatheter pulmonary valve replacement achieves a 98.9% procedural success rate exceeding regulatory benchmarks with low mortality (1.6%) and transient peri-implant ventricular arrhythmias (26.0%) that resolve by 6 months.
Answers are grounded in this paper and cite their sources.
Supports Harmony TPVR for severe pulmonary regurgitation; confirms benchmark exceedance and extends pooled evidence across cohorts.
Background: The Harmony transcatheter pulmonary valve (TPV; Medtronic) is the first FDA-approved device for severe pulmonary regurgitation in the native or surgically repaired right ventricular outflow tract. A rigorous quantitative synthesis of outcomes across trial and real-world settings has not been performed. Methods: A systematic review identified independent studies reporting outcomes after Harmony TPV implantation through 2025. Overlapping cohorts were deduplicated retaining the most mature report. Three independent primary studies contributed to pooled analyses (Morray 2025, n=86, median follow-up 3-5 years; Goldstein 2024, n=243, median follow-up 13 months; Yang 2025, n=54, median follow-up 22 months); the Armstrong 2026 SERVE Registry Harmony arm (n=359) contributed to arrhythmia analyses. Freeman-Tukey double arcsine transformation with DerSimonian-Laird random-effects modeling was applied to all proportion outcomes. Pooled procedural success was tested against the pre-specified regulatory performance target of 95%. Results: Pooled procedural success across three independent studies was 98.9% (95% CI: 95.9-100%; I 2 =0%), significantly exceeding the 95% regulatory performance benchmark (p=0.016). Pooled all-cause mortality across four studies was 1.6% (95% CI: 0.3-3.9%; I 2 =0%), with no device-related deaths adjudicated in any cohort. Peri-implant nonsustained ventricular tachycardia or ventricular arrhythmia was identified in a pooled 26.0% of patients (95% CI: 17.7-35.3%; I 2 =39.2%) across four studies, with moderate between-study heterogeneity attributable to differences in telemetry review methodology and arrhythmia definitions. Across all studies with structured post-discharge rhythm monitoring, arrhythmia burden diminished rapidly after discharge and returned to pre-implant baseline by 6 months. Conclusions: Harmony TPV replacement achieves procedural success significantly exceeding regulatory benchmarks, with low all-cause mortality and no device-related deaths across trial and real-world populations. Peri-implant ventricular arrhythmias occur in approximately one-quarter of patients but are transient. The small number of independent studies limits pooling for several clinically important outcomes; longer-term multicenter registry data are needed to characterize valve durability and late adverse events.
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Haroun et al. (2026) conducted a meta-analysis in Severe pulmonary regurgitation in the native or surgically repaired right ventricular outflow tract (n=742). Transcatheter pulmonary valve replacement with the Harmony valve vs. Pre-specified regulatory performance target of 95% was evaluated on Pooled procedural success (95% CI 95.9-100%, p=0.016). Harmony transcatheter pulmonary valve replacement achieved 98.9% pooled procedural success (95% CI 95.9-100%; p=0.016 vs 95% target) and 1.6% all-cause mortality.
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