Intermediate outcomes of transcatheter pulmonary valve replacement with the Edwards Sapien 3 valve - German experience
2019-09 | journal article. A publication with affiliation to the University of Göttingen.
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Intermediate outcomes of transcatheter pulmonary valve replacement with the Edwards Sapien 3 valve - German experience
Lehner, A.; Dashkalova, T.; Ulrich, S.; Fernandez Rodriguez, S.; Mandilaras, G.; Jakob, A. & Dalla-Pozza, R. et al. (2019)
Expert Review of Medical Devices, 16(9) pp. 829-834-834. DOI: https://doi.org/10.1080/17434440.2019.1653180
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Details
- Authors
- Lehner, Anja; Dashkalova, Tsvetina; Ulrich, Sarah; Fernandez Rodriguez, Silvia; Mandilaras, Guido; Jakob, André; Dalla-Pozza, Robert; Fischer, Marcus; Schneider, Heike E. ; Tarusinov, Gleb; Kampmann, Christoph; Hofbeck, Michael; Dähnert, Ingo; Kanaan, Majed; Haas, Nikolaus A.
- 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.
- Issue Date
- September-2019
- Journal
- Expert Review of Medical Devices
- ISSN
- 1743-4440; 1745-2422
- eISSN
- 1745-2422
- Language
- English