Long-Term Outcomes After Transcatheter Pulmonary Valve Replacement

Quick Takes

  • The overall reintervention rate at 8 years was 25.1% with a surgical reintervention rate of 14.1%.
  • Risk factors for surgical reintervention included younger age, prior endocarditis, placement of transcatheter pulmonary valve replacement into a stented bioprosthetic valve, and elevated post-implant gradient.

Study Questions:

What are the mid- and long-term outcomes after transcatheter pulmonary valve replacement (TPVR) in a large multicenter cohort?

Methods:

An international registry was used for this study. Patients were eligible for entry into the registry if they had undergone TPVR with a Melody valve or any type of Sapien Valve. The primary outcomes of the study were death, any transcatheter pulmonary valve (TPV) reintervention, or TPV explant.

Results:

Data were submitted for 2,476 patients with a median follow-up of 2.8 years (interquartile range, 0.8-5.4; mean ± standard deviation, 3.4 ± 2.9 years). Median age at implant was 20.5 with a range from 10 months to 79 years. A total of 95 patients died after TPVR with a cumulative incidence of death of 8.9% 8 years after TPVR. On multivariable analysis, age at TPVR (hazard ratio [HR], 1.04 per year), a prosthetic valve in other positions (HR, 2.1), and an existing transvenous pacemaker/implantable cardioverter-defibrillator (HR, 2.1) were associated with death. At 8 years, the cumulative incidence of TPV reintervention was 25.1% and of surgical reintervention was 14.4%. Risk factors for surgical reintervention included younger age (HR, 0.95 per year), prior endocarditis (HR, 2.5), TPVR into a stented bioprosthetic valve (HR, 1.7), and post-implant gradient (HR, 1.4 per 10 mm Hg).

Conclusions:

The authors concluded that survival and freedom from reintervention or surgery after TPVR are generally comparable to outcomes of surgical conduit/valve replacement across a wide age range.

Perspective:

TPVR has become an important tool in the management of patients with postoperative right ventricular outflow tract obstruction or pulmonary regurgitation. Endocarditis remains a significant concern in this patient group, with a recent study from the same dataset reporting cumulative incidence of 9.5% at 5 years and 16.9% at 8 years (McElhinney DB, et al., J Am Coll Cardiol 2021). This study reports on the intermediate-term outcomes and reintervention rates of a large dataset from an international registry and demonstrates reintervention rates similar to what would be expected for surgical pulmonary valve replacement. The follow-up in this study was relatively short with a median of 2.8 years, suggesting the need for additional longer-term studies moving forward.

Keywords: Cardiac Surgical Procedures, Defibrillators, Implantable, Endocarditis, Heart Defects, Congenital, Heart Valve Diseases, Heart Valve Prosthesis, Pacemaker, Artificial, Pediatrics, Pulmonary Valve Insufficiency, Stents, Tetralogy of Fallot, Transcatheter Aortic Valve Replacement


< Back to Listings