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Peer-reviewedCC BY-NC-NDCJC pediatric and congenital heart disease

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

  • Abdullghany M Dowaikh1
  • Amr A Arafat2
  • Sameh F Ahmed1
  • Ahmed A Ismail3,4
  • Atif H Alsahari1
  • Abdulmajeed A Alotay1
  • Tarek S Momenah1,5
5 affiliations
  1. 1Pediatric Cardiology Department, Prince Sultan Cardiac Center, Riyadh, Kingdom of Saudi Arabia.
  2. 2Cardiac Surgery Department, Prince Sultan Cardiac Center, Riyadh, Kingdom of Saudi Arabia.
  3. 3Cardiac Anesthesia Department, Prince Sultan Cardiac Center, Riyadh, Kingdom of Saudi Arabia.
  4. 4Anesthesia Department, Faculty of Medicine, Cario University, Cario, Egypt.
  5. 5College of Medicine, Alfaisal University, Riyadh, Kingdom of Saudi Arabia.
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Abstract

Background

Significant pulmonary regurgitation (PR) is a common late complication after 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. Although 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 male. 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 mm Hg, or reintervention was 100%. No endocarditis, valve thrombosis, or stent fracture was observed.Conclusions

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.

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Cite

BibTeXRIS
BibTeX
@article{dowaikh2026early,
  title = {{Early Outcomes of Harmony Transcatheter Pulmonary Valve Implantation in the Middle East: A Single-Center Experience From Saudi Arabia.}},
  author = {Abdullghany M Dowaikh and Amr A Arafat and Sameh F Ahmed and Ahmed A Ismail and Atif H Alsahari and Abdulmajeed A Alotay and Tarek S Momenah},
  journal = {CJC pediatric and congenital heart disease},
  year = {2026},
  month = may,
  doi = {10.1016/j.cjcpc.2026.05.001},
  url = {https://europepmc.org/article/MED/42948774},
  note = {CC BY-NC-ND},
}
RIS
TY  - JOUR
TI  - Early Outcomes of Harmony Transcatheter Pulmonary Valve Implantation in the Middle East: A Single-Center Experience From Saudi Arabia.
AU  - Abdullghany M Dowaikh
AU  - Amr A Arafat
AU  - Sameh F Ahmed
AU  - Ahmed A Ismail
AU  - Atif H Alsahari
AU  - Abdulmajeed A Alotay
AU  - Tarek S Momenah
PY  - 2026
DA  - 2026/05/14
JO  - CJC pediatric and congenital heart disease
DO  - 10.1016/j.cjcpc.2026.05.001
UR  - https://europepmc.org/article/MED/42948774
AB  - Background  Significant pulmonary regurgitation (PR) is a common late complication after 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. Although 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 male. 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 mm Hg, or reintervention was 100%. No endocarditis, valve thrombosis, or stent fracture was observed.Conclusions  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.
SN  - 2772-8129
ER  -