Nils Perrin1, Marco Roffi2, Angela Frei2, Anne-Lise Hachulla3, Christoph Ellenberger4, Hajo Müller2, Mustafa Cikirikcioglu5, Marc Licker4, Stephane Noble2. 1. Division of Cardiology, University Hospital of Geneva, Geneva, Switzerland. Electronic address: nils.perrin@bluewin.ch. 2. Division of Cardiology, University Hospital of Geneva, Geneva, Switzerland. 3. Department of Radiology, University Hospital of Geneva, Geneva, Switzerland. 4. Department of Anesthesiology, University Hospital of Geneva, Geneva, Switzerland. 5. Division of Cardiovascular Surgery, University Hospital of Geneva, Geneva, Switzerland.
Abstract
INTRODUCTION AND OBJECTIVES: There are scarce clinical outcomes data on the new generation recapturable and repositionable CoreValve Evolut R. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
INTRODUCTION AND OBJECTIVES: There are scarce clinical outcomes data on the new generation recapturable and repositionable CoreValve Evolut R. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
Authors: Nils Perrin; Amir Fassa; Antoine Baroz; Caroline Frangos; Stephane Mock; Angela Frei; Murat Cimci; Sophie Degrauwe; Marco Roffi; Juan Fernando Iglesias; Stephane Noble Journal: Cardiol J Date: 2020-05-21 Impact factor: 2.737