Valvular & structural heart diseaseMeta-analysis
1-Year Outcomes in a Pooled Cohort of Harmony Transcatheter Pulmonary Valve Clinical Trial Participants
- Pooled analysis of prospective clinical trials
- 19 patients with a discontinued early device iteration evaluated separately
Authors' conclusion
The Harmony TPV device demonstrated favorable clinical and hemodynamic outcomes across studies and valve types through 1 year.
Study context
- Population
- Patients with severe pulmonary regurgitation (PR) (echocardiography) or PR fraction ≥ 30% (cardiac MRI) and clinical indications for pulmonary valve replacement, native or surgically repaired right ventricular outflow tract (RVOT)primary analysis
- Participants
- 87 patients
- Comparison
- TPV22 vs TPV25 Harmony transcatheter pulmonary valve
- TPV22n = 42
- TPV25n = 45
Pooled result
As reported in the abstract
Freedom from PR, stenosis and reintervention · 1 year
Further pooled results
| Outcome | TPV22 | TPV25 |
|---|---|---|
| None/trace or mild PR · 1 year | Not reported in the abstract | 97% |
Death · 1 year
- No deaths
Safety
Nonsustained VT
- Nonsustained VT, all patients
- 16%
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
1-Year Outcomes in a Pooled Cohort of Harmony Transcatheter Pulmonary Valve Clinical Trial Participants. JACC Cardiovasc Interv. Published 17 May 2023. doi:10.1016/j.jcin.2023.03.002
Summarised from the published abstract; every number is checked against it