Patients undergoing transcatheter pulmonary valve replacement (TPVR) using a Sapien valve had satisfactory short-term clinical outcomes, according to a study published in the Journal of the American College of Cardiologists.

In this study, data from patients (N=774; median age, 24 years) who underwent TPVR at 23 centers between 2008 and 2019 were retrospectively collected. All procedures in which a Sapien device was used were included (Sapien S3, 78%; Sapien XT, 22%). In this cohort, 51% of patients had native or patched right ventricular outflow tract, and 25% and 24% had dysfunctional a bioprosthetic valve and right ventricle-to-pulmonary artery conduit, respectively. Patients were assessed for procedure success and clinical outcomes at a median of 12 months.

Stratified by procedure type, patients differed significantly for cardiac diagnosis (P <.001), history of endocarditis (P <.001), baseline echocardiogram (P <.001), indication for TPVR (P <.001), age group (P =.010), gender (P =.001), and weight (P =.022).

Most procedures (93%) were accessed through the femoral vein. A majority of patients received a 29 mm valve (39%) or a 26 mm valve (34%).


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Valve implantation was deemed successful in 97.4% of patients. The remaining 20 procedures were deemed unsuccessful (removal within 24 hours, n=14; not implanted, n=4; procedure-related death, n=2). Stratified by body weight, patients who were <30 kg vs ≥30 kg had a lower success rate (90.4% vs 97.9%, respectively; P =.008).

Serious adverse events were observed in 67 patients (10%), and included malposition of the valve (n=21) or pre-stent (n=9), emergency surgery due to malposition of the TPV (n=11) or pre-stent (n=1), and requirement for additional valve implantation (n=5), aortic surgery (n=1), and coronary artery compression surgery (n=1).

Acute surgery postprocedure was higher among patients who had native/patched (2.5%) vs with conduit (1.1%) or bioprosthetic valve (1.0%) procedures. Patients weighing <30 kg vs ≥30 kg were more likely to have post-procedure acute surgery (7.7% vs 1.4%, respectively; P =.011).

A total of 46% of patients had follow-up data with a median of 12 months. Few patients (5.5%) had new moderate (n=15) or severe (n=4) pulmonary regurgitation and 3 patients had worsening of previous symptoms. The median peak Doppler gradient was 18 mmHg. Endocarditis was diagnosed in 9 patients, 2 of whom had a known history. Twenty patients required reintervention surgery.

A total of 14 patients (1.8%) died (native/patched, n=10; conduit, n=3; BPV, n=1). None of these deaths were associated with the TPVR procedure.

Study limitations include the lack of core laboratory evaluations postprocedure.

The study authors concluded that TPVR procedures with Sapien XT or S3 devices had positive outcomes, especially among patients undergoing conduit or bioprosthetic valve procedures. This registry will continue to monitor these patients for long-term clinical outcomes associated with the use of Sapien devices.

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

Reference

Shahanavaz S, Zahn E M, Levi D S, et al. Transcatheter Pulmonary Valve Replacement With the Sapien Prosthesis. J Am Coll Cardiol. 2020;76(24):2847-2858. doi:10.1016/j.jacc.2020.10.04