Transcatheter Pulmonary Valve Replacement With the Sapien Prosthesis

Abstract

Background: There are limited published data focused on outcomes of transcatheter pulmonary valve replacement (TPVR) with either a Sapien XT or Sapien 3 (S3) valve.

Objectives: This study sought to report short-term outcomes in a large cohort of patients who underwent TPVR with either a Sapien XT or S3 valve.

Methods: Data were entered retrospectively into a multicenter registry for patients who underwent attempted TPVR with a Sapien XT or S3 valve. Patient-related, procedural, and short-term outcomes data were characterized overall and according to type of right ventricular outflow tract (RVOT) anatomy.

Results: Twenty-three centers enrolled a total of 774 patients: 397 (51%) with a native/patched RVOT; 183 (24%) with a conduit; and 194 (25%) with a bioprosthetic valve. The S3 was used in 78% of patients, and the XT was used in 22%, with most patients receiving a 29-mm (39%) or 26-mm (34%) valve. The implant was technically successful in 754 (97.4%) patients. Serious adverse events were reported in 67 patients (10%), with no difference between RVOT anatomy groups. Fourteen patients underwent urgent surgery. Nine patients had a second valve implanted. Among patients with available data, tricuspid valve injury was documented in 11 (1.7%), and 9 others (1.3%) had new moderate or severe regurgitation 2 grades higher than pre-implantation, for 20 (3.0%) total patients with tricuspid valve complications. Valve function at discharge was excellent in most patients, but 58 (8.5%) had moderate or greater pulmonary regurgitation or maximum Doppler gradients >40 mm Hg. During limited follow-up (n = 349; median: 12 months), 9 patients were diagnosed with endocarditis, and 17 additional patients underwent surgical valve replacement or valve-in-valve TPVR.

Conclusions: Acute outcomes after TPVR with balloon-expandable valves were generally excellent in all types of RVOT. Additional data and longer follow-up will be necessary to gain insight into these issues.

Keywords: Sapien S3; Sapien XT; tetralogy of Fallot.

Conflict of interest statement

Author Disclosures This study received funding from Edwards Lifesciences, Inc., to support data management and analysis, but there was no direct participation by employees of Edwards Lifesciences, Inc. Drs. Aboulhosn, Asnes, and Torres have served as proctors for Edwards Lifesciences. Dr. Balzer has served as a proctor for Edwards Lifesciences and Medtronic. Drs. Berman and Zahn have served as a proctor and consultant for Edwards Lifesciences, Abbott, and Medtronic. Dr. Gillespie has served as a consultant for Medtronic. Dr. Goldstein has served as a consultant for Medtronic; has served as a consultant and proctor for W.L. Gore & Associates; and has served on the PECA Labs Advisory Board. Dr. Levi has served as a consultant and proctor for Edwards Lifesciences. Dr. McElhinney has served as a consultant and proctor for Medtronic. Dr. Morgan has served as a consultant and proctor for Edwards Lifesciences; and has served as a consultant for Medtronic. Dr. Murray has served as a consultant for Medtronic and Abbott. Dr. Shahanavaz has served as a proctor for Edwards Lifesciences and Medtronic. Dr. Sathanandam has served as a proctor and consultant for Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.