Mariusz Kowalewski1,2,3, Mirosław Gozdek2,4, Giuseppe Maria Raffa3,5, Artur Słomka6, Kamil Zieliński7, Jacek Kubica4, Lech Anisimowicz8, Janusz Kowalewski9, Uri Landes10, Ran Kornowski10, Roberto Lorusso3, Piotr Suwalski1,11. 1. Clinical Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior in Warsaw, Warsaw. 2. Cardiothoracic Research Centre, Innovative Medical Forum, Bydgoszcz, Poland. 3. Cardio-Thoracic Surgery Department, Heart and Vascular Centre, Maastricht University Medical Centre, Maastricht, The Netherlands. 4. Department of Cardiology and Internal Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland. 5. Department 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. 6. Chair and Department of Pathophysiology, Collegium Medicum UMK in Bydgoszcz, Bydgoszcz. 7. Medical University of Warsaw, Warsaw. 8. Department of Cardiac Surgery, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz. 9. Lung Cancer and Thoracic Surgery Department, Collegium Medicum, Nicolaus Copernicus University, Toruń, Poland. 10. Department of Cardiology, Institute of Interventional Cardiology, Rabin Medical Center, Petach Tikva and Tel Aviv University, Tel Aviv, Israel. 11. Department of Cardiac Surgery, Centre of Postgraduate Medical Education, Warsaw, Poland.
Abstract
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.
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.
Authors: Mirosław Gozdek; Kamil Zieliński; Michał Pasierski; Matteo Matteucci; Dario Fina; Federica Jiritano; Paolo Meani; Giuseppe Maria Raffa; Pietro Giorgio Malvindi; Michele Pilato; Domenico Paparella; Artur Słomka; Jacek Kubica; Dariusz Jagielak; Roberto Lorusso; Piotr Suwalski; Mariusz Kowalewski Journal: J Clin Med Date: 2020-02-01 Impact factor: 4.241