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Transcathether aortic valve implantation with the new repositionable self-expandable Medtronic Evolut R vs. CoreValve system

evidence on the benefit of a meta-analytical approach

Kowalewski, Mariusza,b,c,*; Gozdek, Mirosławb,d,*; Raffa, Giuseppe Mariac,e; Słomka, Arturf; Zieliński, Kamilg; Kubica, Jacekd; Anisimowicz, Lechh; Kowalewski, Januszi; Landes, Urij; Kornowski, Ranj; Lorusso, Robertoc; Suwalski, Piotra,k

Journal of Cardiovascular Medicine: April 2019 - Volume 20 - Issue 4 - p 226–236
doi: 10.2459/JCM.0000000000000757
Research articles: Structural heart intervention
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Aims To compare transcatheter aortic valve replacement TAVR with self-expandable first-generation Medtronic CoreValve with new-generation Evolut R devices in patients with aortic stenosis.

Methods Multiple databases were screened for all available reports directly or indirectly comparing CoreValve vs Evolut R. Primary endpoint was device success. Procedural, functional and clinical outcomes were assessed as well.

Results Ten retrospective series including 12 294 pts. were found. Overall device success rate was 95.5% and was statistically higher in the Evolut R treated patients as compared with CoreValve: 96.6 vs. 94.8%, respectively; RR (risk ratio) 95%CIs (confidence intervals): 1.02 (1.00-1.04); P = 0.01. There were no statistical differences with regard to postoperative mean aortic gradients 8.5 +/- 5.3 vs 7.9 +/- 4.6 with Evolut R and CoreValve. Evolut R valve demonstrated nearly 50% reduction of the risk for moderate-to-severe paravalvilar leak 0.55 (0.39-0.79); P = 0.001; 60% statistically significant lower risk of developing myocardial injury 0.40 (0.22-0.72); P = 0.002 and numerical reductions in the risk of acute kidney injury, vascular complications and bleeding. Together with significantly reduced risk of permanent pacemaker implantation (0.80 [0.67-0.96]; P = 0.02) the above benefits were associated with 40% reduction in the risk of 30-day all-cause mortality with Evolut R as compared to CoreValve: 0.60 (0.37-1.00); P = 0.05.

Conclusions The use of new-generation Evolut R was associated with improved procedural, functional and clinical outcomes compared with the CoreValve device.

aClinical Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior in Warsaw, Warsaw

bCardiothoracic Research Centre, Innovative Medical Forum, Bydgoszcz, Poland

cCardio-Thoracic Surgery Department, Heart and Vascular Centre, Maastricht University Medical Centre, Maastricht, The Netherlands

dDepartment of Cardiology and Internal Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland

eDepartment for the Treatment and Study of Cardiothoracic Diseases and Cardiothoracic Transplantation, IRCCS—ISMETT (Istituto Mediterraneo per I Trapianti e Terapie ad alta specializzazione), Palermo, Italy

fChair and Department of Pathophysiology, Collegium Medicum UMK in Bydgoszcz, Bydgoszcz

gMedical University of Warsaw, Warsaw

hDepartment of Cardiac Surgery, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz

iLung Cancer and Thoracic Surgery Department, Collegium Medicum, Nicolaus Copernicus University, Toruń, Poland

jDepartment of Cardiology, Institute of Interventional Cardiology, Rabin Medical Center, Petach Tikva and Tel Aviv University, Tel Aviv, Israel

kDepartment of Cardiac Surgery, Centre of Postgraduate Medical Education, Warsaw, Poland

Correspondence to Mariusz Kowalewski, MD, Clinical Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior, Centre of Postgraduate Medical Education, Warsaw, Wołoska Str 137, Warsaw 02507, Poland Tel: +48 502269240; fax: +48 22 508 12 70; e-mail: kowalewskimariusz@gazeta.pl

Received 14 March, 2018

Revised 20 December, 2018

Accepted 20 December, 2018

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© 2019 Italian Federation of Cardiology. All rights reserved.