Self-Expanding Pulmonary Valve Replacement Registry Outcomes

Quick Takes

  • Transcatheter pulmonary valve replacement with self-expanding valves was associated with excellent procedural success rates and excellent short-term hemodynamics.
  • Ventricular arrhythmias prompting treatment occurred in 19% of cases.
  • Freedom from endocarditis was 98% at 1 year.

Study Questions:

What are the short-term outcomes for patients with native or surgically repaired right ventricular outflow tract (RVOT) undergoing transcatheter pulmonary valve replacement (TPVR) with a self-expanding valve?


A multicenter registry of consecutive patients with native RVOT pulmonary regurgitation (PR) was used for this study. The primary outcome was a composite of hemodynamic dysfunction (PR greater than mild and RVOT mean gradient >30 mm Hg) and RVOT reintervention.


A total of 243 patients underwent TPVR with a median age of 31 years. The underlying cardiac diagnosis was tetralogy of Fallot (TOF) in 71% of patients, valvular pulmonary stenosis in 21%, and other in 8%. Acute technical success was achieved in all but one case. Procedural serious events occurred in 4% of patients with no device embolization or death. Ventricular arrhythmia requiring treatment occurred in 19% of cases. At median follow-up of 13 months, 98% of patients had acceptable hemodynamic function. Freedom from TPVR-related endocarditis was 98% at 1 year. Five patients died during the follow-up period (one with COVID-19, two unknown causes, and two with bloodstream infections).


The authors conclude that in this large multicenter real-world experience, short-term clinical and hemodynamic outcomes of self-expanding TPVR therapy were excellent.


The development of self-expanding transcatheter pulmonary valves has significantly expanded the pool of patients who are candidates for transcatheter therapies for pulmonary valve regurgitation. This study shows excellent short-term outcomes for TPVR in native RVOTs. There was a relatively high rate of ventricular arrhythmia requiring treatment (19%). Interestingly, this was more common in patients with an underlying diagnosis of valvular pulmonary stenosis than in those with TOF. The authors postulate that the ventricular arrhythmias are due to contact between the proximal end of the device and the myocardium of the RVOT. Patients with TOF were more likely to have valves placed in the supra-annular position, which decreases this contact. These arrhythmias appear to dissipate over time, although further study is required. Very little endocarditis of this valve type had been reported in initial studies. This study showed a rate of 2% at a median follow-up of 13 months. Endocarditis risk will require continued study moving forward.

Clinical Topics: Congenital Heart Disease and Pediatric Cardiology, Valvular Heart Disease, Congenital Heart Disease

Keywords: Pulmonary Valve Insufficiency, Tetralogy of Fallot

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