Thorac Cardiovasc Surg 2016; 64 - OP21
DOI: 10.1055/s-0036-1571489

Sapien XT versus Sapien 3 Prosthesis: Preliminary Results of a Meta-analysis

F. Pollari 1, F. Biancari 2, M. Pol 2, F. Vogt 1, G. Santarpino 1, T. Fischlein 1, S. Pfeiffer 1
  • 1Klinikum Nürnberg - Paracelsus Medical University, Herzchirurgie, Nürnberg, Germany
  • 2Oulu University Hospital, Department of Surgery, Oulu, Finland

Objectives: The wide application of transcatheter aortic valve implantation (TAVI) is currently limited from its complications rate, such as postoperative pacemaker implantation and paravalvular leaks. The aim of this analysis was to pool and compare the results of the new Sapien-3 and its predecessor Sapien-XT valve prosthesis.

Methods: We performed a systematic review, meta-analysis and meta-regression of data on TAVIs with Sapien-XT versus Sapien-3 valve prosthesis. Articles were retrieved from PubMed. Outcome end-points were defined according to the VARC-2 definition criteria.

Results: Nine studies reported on 795 Sapien-XT patients and 331 Sapien-3 with similar baseline characteristics (logistic EuroSCORE: Sapien-XT, 18.7% versus Sapien-3, 19.4%, p = 0.549; Society of Thoracic Surgery score: Sapien-XT, 8.0% versus Sapien-3, 8.9%, p = 0.525). Thirty-day mortality (Sapien-XT, 3.0% versus Sapien-3, 2.9%, p = 0.694), vascular complications (Sapien-XT, 10.3% versus Sapien-3, 8.3%, p = 0.812) and major bleeding (Sapien-XT, 7.1% versus Sapien-3, 7.0%, p = 0.930) were similar in the study groups. The risk of life threatening bleeding was lower in the Sapien-3 group (Sapien-XT, 5.2% versus Sapien-3, 2.1%, p = 0.01). A permanent pacemaker was more frequently implanted in the Sapien-3 group (Sapien-XT, 6.8% versus Sapien-3, 13.1%, p = 0.119). The incidence of mild-to-severe paravalvular regurgitation was similar in the study groups (Sapien-XT, 19.6% versus Sapien-3, 17.7%, p = 0.840), but the rate of moderate-to-severe paravalvular regurgitation tended to be lower in the Sapien-3 group (Sapien-XT, 2.5% versus Sapien-3, 1.4%, p = 0.335; absolute proportion: Sapien-XT 16/458 patients, 3.5% versus Sapien-3 4/331 patients, 1.2%, p = 0.06).

Conclusions: Current data suggest that the results with Sapien-3 valve prosthesis are not markedly different from its predecessor Sapien-XT. However, a trend toward lower risk of moderate-to-severe paravalvular regurgitation was observed with Sapien-3 prosthesis. Further comparative analyses are needed to evaluate whether development in TAVI technology has translated into improved clinical results.