Intermediate outcomes of transcatheter pulmonary valve replacement with the Edwards Sapien 3 valve - German experience

Expert Rev Med Devices. 2019 Sep;16(9):829-834. doi: 10.1080/17434440.2019.1653180. Epub 2019 Aug 30.

Abstract

Background: After encouraging results with the Edwards Sapien and XT valves, this study aimed to review procedural data and early outcomes for the Sapien 3 valves for transcatheter pulmonary valve replacement (TPVR). Methods: We performed a multicenter, retrospective analysis of cases who underwent a Sapien 3 TPVR between 2015 and 2017 in 7 centers in Germany with a follow-up of up to 2 years. Results: 56 patients could be enrolled (weight 58,5 ± 25,0 kg; 53% Tetralogy of Fallot, 45% native RVOT). Most procedures were two-stage procedures (82,1%) with 100% prestenting. Valve sizes were 20 mm (n = 1), 23 mm (n = 15), 26 mm (n = 27), 29 mm (n = 13). Procedural success rate was 96.4%. Two patients underwent surgical valve implantation after balloon rupture during TPVR. Follow-up data were available up to 24-month post TPVR. The rate of patients with ? moderate and severe pulmonary regurgitation decreased to 0% after TPVR, peak systolic gradient decreased from 24,2 (SD±20,9) mmHg to 7,1 mmHg (SD±5,0). There were no endocarditis, severe tricuspid valve impairment or stent fractures. Conclusions: With the Edwards Sapien 3 valve, the patient pool for TPVR can be substantially extended. Continued data collection is necessary to verify long-term results.

Keywords: Edwards Sapien® valve; Transcatheter pulmonary valve replacement; catheter intervention; congenital heart disease; new devices.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Cardiac Catheterization*
  • Child
  • Child, Preschool
  • Female
  • Follow-Up Studies
  • Germany
  • Heart Valve Prosthesis Implantation*
  • Hemodynamics
  • Humans
  • Male
  • Middle Aged
  • Pulmonary Valve / physiopathology
  • Pulmonary Valve / surgery*
  • Retrospective Studies
  • Systole
  • Treatment Outcome
  • Young Adult