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

Lehner, Anja; Dashkalova, Tsvetina; Ulrich, Sarah; Rodriguez, Silvia Fernandez; Mandilaras, Guido; Jakob, Andre; Dalla-Pozza, Robert; Fischer, Marcus; Schneider, Heike; Tarusinov, Gleb; Kampmann, Christoph; Hofbeck, Michael; Daehnert, Ingo; Kanaan, Majed und Haas, Nikolaus A. (2019): Intermediate outcomes of transcatheter pulmonary valve replacement with the Edwards Sapien 3 valve - German experience. In: Expert Review of Medical Devices, Bd. 16, Nr. 9: S. 829-834

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.

• Dokumententyp: Zeitschriftenartikel
• Fakultät: Medizin
• Themengebiete: 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit
• ISSN: 1743-4440
• Sprache: Englisch