Valvular & structural heart disease
Midterm Outcomes in a Pooled Cohort of Harmony Transcatheter Pulmonary Valve Recipients
Authors' conclusion
At 3 to 5 years, Harmony TPV replacement resulted in sustained valve competence, beneficial cardiac remodeling, and improved quality of life. Continued monitoring is needed to assess long-term outcomes and valve performance.
Study context
- Population
- Patients with severe pulmonary regurgitation in the native or surgically repaired right ventricular (RV) outflow tract who received a commercially available TPV22 or TPV25 Harmony devicecatheterized, 86 successfully implanted with a Harmony transcatheter pulmonary valve (TPV)
- Participants
- 89 patients
- Exposure
- TPV22 vs TPV25
- Outcome
- ≤mild pulmonary regurgitation
- Follow-up
- 3 years
Methodological detailspooled cohort, Native Outflow Tract Early Feasibility Study, Harmony Pivotal Trial, and Continued Access Study
- Pooled cohort
- Native Outflow Tract Early Feasibility Study, Harmony Pivotal Trial, and Continued Access Study
Main finding
As reported in the abstract
TPV22
all patients
TPV25
96%
Observational data: associations, not effects.
Further findings
Duration of follow-up
RV end-diastolic volume index, RV to left ventricular end-diastolic volume ratio, effective RV stroke volume (magnetic resonance imaging) · preimplant to 2 years
- Significant improvements
- all P <0.001
SF-36 quality-of-life scores · over 3 years
- Improved after Harmony implantation and sustained
Arrhythmias
- Early cases of ventricular tachycardia resolved; no new arrhythmias
Safety
Adverse events · up to 5 years
- Deaths unrelated to the device or procedure
- 3
- Endocarditis, treated (1 medically, 1 transcatheter debulking of a vegetation) and resolved
- 2
- Patients with RV outflow tract obstruction or thrombosis resulting in valve-in valve procedures
- 6
- Major stent fracture resulting in surgical explant
- 1
Original publication
Midterm Outcomes in a Pooled Cohort of Harmony Transcatheter Pulmonary Valve Recipients. Circ Cardiovasc Interv. Published 16 July 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →