Long-Term Outcomes After Transcatheter Pulmonary Valve Replacement
- 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.
What are the mid- and long-term outcomes after transcatheter pulmonary valve replacement (TPVR) in a large multicenter cohort?
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.
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).
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.
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
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