Author + information
- Gennaro Giustino1,
- Didier Tchetche2,
- Nicolas Van Mieghem3,
- Nicolas Dumonteil2,
- Raphael Philippart4,
- Nahid El Faquir5,
- Chiara De Biase6,
- Zouhair Rahhab7,
- Peter P.T. De Jaegere8,
- Antonio Colombo9 and
- Alaide Chieffo10
- 1Icahn School of Medicine at Mount Sinai, New York, New York, United States
- 2Clinique Pasteur, Toulouse, France
- 3Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands
- 4CHU Trousseau TOURS, TOURS, France
- 5Department of Cardiology, Erasmus MC, Rotterdam, Netherlands
- 6UNIVERSITà FEDEREICO II, NAPLES, Italy
- 7Erasmus MC, Rotterdam, Netherlands
- 8Erasmus MC, Rotterdam, The Netherlands, Rotterdam, Netherlands
- 9San Raffaele Scientific Institute, Milan, Italy
- 10Interventional Cardiology Institute San Raffaele Hospital, Milan, Milan, Italy
The impact of TAVR device iterations on procedural outcomes in a real-world setting remains unclear.
We pooled patient-level data from 3 tertiary European institutions with significant TAVR expertise. All consecutive patients treated with any new-generation (NG) TAVR device through any vascular access between January 2011 until December 2015 were included. NG-TAVR device was defined as any device developed after the Sapien XT (SXT) and the Medtronic CoreValve (MCV) and approved for commercial use in Europe or United States. Primary endpoint was the VARC-2 early composite safety endpoint (CSE) at hospital discharge. Outcomes with new-generation TAVR were compared with the historical PRAGMATIC-I registry cohort (N=1,062) including early-generation (EG) TAVR devices.
A total of 822 patients treated with NG-TAVR devices were included. NG-TAVR devices included the Sapien 3 valve (N=331), the Evolut R valve (N=120), the Lotus valve (N=192), the Portico valve (N=35) and the Direct Flow Medical valve (N=144). Transfemoral access was used in 93.8% of cases and mean STS score was 6.1%. Device success was 94.1% across all valve types. Overall rate of the primary CSE at hospital discharge was 13.2% (95% confidence interval: 11.0% to 15.8%) which did not vary across quintiles of time of enrolment during the study period (ptrend=0.87). Rates of adverse events are illustrated in the Figure. Additional data will be presented.
Contemporary TAVR in a real-world setting with newer generation devices seems to be associated with significantly improved procedural safety.
STRUCTURAL: Valvular Disease: Aortic