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Comparison of procedural and clinical outcomes with Evolut R versus Medtronic CoreValve: a Swiss TAVI registry analysis

1. Cardiology Division, University Hospital, Geneva, Switzerland; 2. Cardiology and Cardiovascular Surgery Departments, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland; 3. Clinical Research Department, Clinical Trials Unit and Institute of Social and Preventive Medicine, Bern University, Bern, Switzerland; 4. Triemli Hospital Zurich, Zurich, Switzerland; 5. Cardiology Department, Basel University Hospital, Basel, Switzerland; 6. Kantonsspital, Luzern, Switzerland; 7. Cardiology Department, Cardiocentro Ticino, Lugano, Switzerland; 8. Cardiology and Cardiovascular Surgery Departments, University Hospital, Zurich, Switzerland; 9. Hirslanden Clinic Zurich, Zurich, Switzerland; 10. Applied Health Research Centre, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, and Department of Medicine, University of Toronto, Toronto, Canada; 11. Cardiology Department, Klinik im Park, Zurich, Switzerland

Aims: Data on procedural and clinical outcomes after transcatheter aortic valve implantation (TAVI) with the new-generation self-expanding Medtronic Evolut R prosthesis in comparison with its predecessor, the Medtronic CoreValve, are scarce. The aim of this study was to assess the safety and efficacy of the Evolut R device compared with the former-generation CoreValve.

Methods and results: In a nationwide, prospective, multicentre cohort study (Swiss TAVI registry, NCT01368250), outcomes of consecutive transfemoral TAVI patients treated with the new-generation Medtronic Evolut R (September 2014 - February 2016) and the Medtronic CoreValve (February 2011 - February 2016) were investigated. Events were reported according to VARC-2 and adjudicated by a clinical events committee. During the study period, 317 and 678 consecutive patients underwent TAVI with the Evolut R and the CoreValve bioprosthesis, respectively. Baseline clinical characteristics between the groups were comparable, although Evolut R patients were lower risk according to the STS score (4.8±3.4% vs. 6.9±5.0%, p<0.001) and logistic EuroSCORE (17.3±13% vs. 20.1±13%, p=0.009). Implantation of the Evolut R was associated with a lower use of predilatation (48.1% vs. 72.4%, p<0.001), a shorter procedure time (67.9±36 min vs. 76.7±42 min, p=0.002), and less contrast dye use during the procedure (155.2±98 ml vs. 208.0±117 ml, p<0.001). Post-procedural mean gradient was comparable (7.4±4.7 mmHg vs. 7.5±5.0 mmHg), as were the 30-day rates of moderate to severe aortic regurgitation (8.5% vs. 10.5%), major vascular (9.8% vs. 10.3%) and life-threatening bleeding complications (5.4% vs. 5.3%), disabling stroke (1.9% vs. 1.6%), all-cause mortality (3.2% vs. 3.4%) as well as permanent pacemaker implantation (22.1% vs. 23.4%).

Conclusions: Thirty-day clinical outcomes were favourable and comparable between the Evolut R and the CoreValve bioprosthesis.

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