Thirty-day Outcome Following CoreValve Evolut R Transcatheter Aortic Valve Implantation: An All-comers Prospective Study.

There are scarce clinical outcomes data on the new generation recapturable and repositionable CoreValve Evolut R. Data on all-comer patients undergoing transcatheter aortic valve implantation (TAVI) with the Evolut R for severe symptomatic aortic stenosis at a single center were prospectively collected between February 2015 and April 2016. Clinical endpoints were independently adjudicated according to the Valve Academic Research Consortium-2 criteria. Primary outcomes consisted of early safety composite endpoints and 30-day device success. The incidence of new permanent pacemaker implantation was recorded. Among the 83 patients undergoing TAVI during this period, 71 (85.5% of the population; median age, 83.0 [interquartile range, 80.0-87.0] years; Society of Thoracic Surgeons scores, 4.8±3.5%) were suitable for Evolut R implantation and were included in the analysis. Repositioning was performed in 26.8% of the procedures. The early safety composite endpoint was observed in 11.3% of patients at 30 days, with 2.8% all-cause mortality. Device success was documented in 90.1% of patients. Paravalvular leakage was less than grade II in 98.4% of patients. The mean transvalvular aortic gradient was reduced from 42.5±14.5mmHg at baseline to 7.7±4.0mmHg at discharge (P<.0001 vs baseline). New permanent pacemaker implantation was required in 23.9% of patients. The new generation Evolut R is suitable for most patients and shows high device success and acceptable mortality in an unbiased, consecutive, all-comer population at a single center performing TAVI exclusively with Medtronic valves.

Perrin N ，Roffi M ，Frei A ，Hachulla AL ，Ellenberger C ，Müller H ，Cikirikcioglu M ，Licker M ，Noble S ... -  《-》

Comparative Matched Outcome of Evolut-R vs CoreValve Transcatheter Aortic Valve Implantation.

Landes U ，Bental T ，Barsheshet A ，Assali A ，Vaknin Assa H ，Levi A ，Orvin K ，Kornowski R ... -  《-》

Transcathether aortic valve implantation with the new repositionable self-expandable Evolut R versus CoreValve system: A case-matched comparison.

Despite promising results following transcatheter aortic valve implantation (TAVI), several relevant challenges still remain. To overcome these issues, new generation devices have been developed. The purpose of the present study was to determine whether TAVI with the new self-expanding repositionable Evolut R offers potential benefits compared to the preceding CoreValve, using propensity matching. Between June 2007 and November 2015, 2148 consecutive patients undergoing TAVI either CoreValve (n=1846) or Evolut R (n=302) were prospectively included in the Italian TAVI ClinicalService® project. For the purpose of our analysis 211 patients treated with the Evolut R were matched to 211 patients treated with the CoreValve. An independent core laboratory reviewed all angiographic procedural data and an independent clinical events committee adjudicated all events. Patients treated with Evolut R experienced higher 1-year overall survival (log rank test p=0.045) and a significantly lower incidence of major vascular access complications, bleeding events and acute kidney injury compared to patients treated with the CoreValve. Recapture manoeuvres to optimize valve deployment were performed 44 times, allowing a less implantation depth for the Evolut R. As a consequence, the rate of more than mild paravalvular leak and new permanent pacemaker was lower in patients receiving the Evolut R. In this matched comparison of high surgical risk patients undergoing TAVI, the use of Evolut R was associated with a significant survival benefit at 1year compared with the CoreValve. This was driven by lower incidence of periprocedural complications and higher rates of correct anatomic positioning.

Giannini C ，De Carlo M ，Tamburino C ，Ettori F ，Latib AM ，Bedogni F ，Bruschi G ，Presbitero P ，Poli A ，Fabbiocchi F ，Violini R ，Trani C ，Giudice P ，Barbanti M ，Adamo M ，Colombo P ，Benincasa S ，Agnifili M ，Petronio AS ... -  《-》

1-Year Outcomes With the Evolut R Self-Expanding Transcatheter Aortic Valve: From the International FORWARD Study.

This study sought to report the 1-year safety and efficacy outcomes in the FORWARD (CoreValve Evolut R FORWARD) study following transcatheter aortic valve replacement (TAVR) with the next-generation Evolut R device (Medtronic, Minneapolis, Minnesota) in routine clinical practice. The FORWARD study reported low incidences of mortality, disabling stroke, and significant paravalvular leak following TAVR in routine clinical practice at 30 days. Longer-term results in large patient populations with the Evolut R self-expanding, repositionable transcatheter heart valve (THV) are lacking. This was a prospective, single-arm, multinational, multicenter, observational study investigating efficacy and safety following TAVR with the next-generation self-expanding THV. Between January and December 2016, 1,040 patients underwent attempted implant of the Evolut R self-expanding repositionable valve at 53 sites worldwide. An independent Clinical Events Committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms. The mean age was 81.8 ± 6.2 years, 64.8% were women, and patients had a mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 5.5 ± 4.5% and EuroSCORE II of 5.7 ± 5.0%. The 1-year all-cause mortality rate was 8.9%, with a cardiovascular mortality rate of 6.9%. At 1 year, the incidence of disabling stroke was 2.1%, and a pacemaker was implanted in 19.7% of patients. The incidence of more than mild paravalvular leak was 1.2%. The FORWARD study demonstrated good safety and efficacy profiles for the next-generation Evolut R THV up to 1-year follow-up, with very low mortality and adverse events. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369).

Manoharan G ，Van Mieghem NM ，Windecker S ，Bosmans J ，Bleiziffer S ，Modine T ，Linke A ，Scholtz W ，Chevalier B ，Gooley R ，Zeng C ，Oh JK ，Grube E ... -  《-》

Initial Experience of a Second-Generation Self-Expanding Transcatheter Aortic Valve: The UK & Ireland Evolut R Implanters' Registry.

The authors present the UK and Irish real-world learning curve experience of the Evolut R transcatheter heart valve. The Evolut R is a self-expanding, repositionable, and fully recapturable second-generation transcatheter heart valve with several novel design features to improve outcomes and reduce complications. Clinical, procedural, and 30-day outcome data were prospectively collected for the first 264 patients to receive the Evolut R valve in the United Kingdom and Ireland. A total of 264 consecutive Evolut R implantations were performed across 9 centers. The mean age was 81.1 ± 7.8 years, and the mean logistic European System for Cardiac Operative Risk Evaluation score was 19.9 ± 13.7%. Procedural indications included aortic stenosis (72.0%), mixed aortic valve disease (17.4%), and failing aortic valve bioprostheses (10.6%). Conscious sedation was used in 39.8% of patients and transfemoral access in 93.6%. The procedural success rate was 91.3%, and paravalvular leak immediately after implantation was mild or less in 92.3%. Major complications were rare: cardiac tamponade in 0.4%, conversion to sternotomy in 0.8%, annular rupture in 0.0%, coronary occlusion in 0.8%, major vascular in 5.3%, acute kidney injury in 6.1%, new permanent pacemaker implantation in 14.7%, and procedure-related death in 0.0%. At 30-day follow-up, survival was 97.7%, paravalvular leak was mild or less in 92.3%, and the stroke rate was 3.8%. This registry represents the largest published real-world experience of the Evolut R valve. The procedural success rate was high and safety was excellent, comparable with previous studies of the Evolut R valve and other second-generation devices. The low rate of complications represents an improvement on first-generation devices.

Kalra SS ，Firoozi S ，Yeh J ，Blackman DJ ，Rashid S ，Davies S ，Moat N ，Dalby M ，Kabir T ，Khogali SS ，Anderson RA ，Groves PH ，Mylotte D ，Hildick-Smith D ，Rampat R ，Kovac J ，Gunarathne A ，Laborde JC ，Brecker SJ ... -  《-》