Early Outcomes of Harmony™ Transcatheter Pulmonary Valve Implantation in the Middle East: A Single-Center Experience from Saudi Arabia

Background Significant pulmonary regurgitation (PR) is a common late complication following repair of right ventricular outflow tract (RVOT) lesions, potentially leading to right ventricular failure. The Harmony™ transcatheter pulmonary valve (TPV) was developed for large, native or patched RVOTs. While multicenter studies have shown favorable results, regional single-center data, particularly from the Middle East, are scarce. This study reports our initial single-center experience with Harmony™ TPV implantation, focusing on procedural success, safety, and 1-year outcomes. Methods We conducted a retrospective analysis of 10 consecutive patients who underwent Harmony™ TPV implantation at our institution. Data were collected on baseline characteristics, procedural details, and outcomes. Procedural success, complications, and hemodynamic performance were assessed. Results The median age of our population was 15.5 years, and 70% of patients were males. The most common underlying diagnosis was post-tetralogy of Fallot repair (50%). All patients had severe PR at baseline. Technical success was achieved in all patients. There was no mortality. Minor periprocedural complications occurred in 4 patients, including minor femoral vein avulsion, fever, ecchymosis, and frequent premature ventricular contractions, all managed conservatively. At 1-year follow-up, freedom from death, moderate/severe PR, mean RVOT gradient >40 mmHg, or reintervention was 100%. No endocarditis, valve thrombosis, or stent fracture was observed. Conclusion This single-center experience from the Middle East demonstrates that Harmony™ TPV implantation is a feasible and safe procedure with excellent early clinical and echocardiographic outcomes. These findings are consistent with previously published international series and support the adoption of this technology in specialized centers for managing severe PR in patients with complex RVOT anatomy.