TY - JOUR
T1 - Transcathether aortic valve implantation with the new repositionable self-expandable Medtronic Evolut R vs. CoreValve system
T2 - Evidence on the benefit of a meta-analytical approach
AU - Kowalewski, Mariusz
AU - Gozdek, Mirosław
AU - Raffa, Giuseppe Maria
AU - Słomka, Artur
AU - Zieliński, Kamil
AU - Kubica, Jacek
AU - Anisimowicz, Lech
AU - Kowalewski, Janusz
AU - Landes, Uri
AU - Kornowski, Ran
AU - Lorusso, Roberto
AU - Suwalski, Piotr
N1 - Publisher Copyright:
© 2019 Italian Federation of Cardiology - I.F.C. All rights reserved.
PY - 2019/4
Y1 - 2019/4
N2 - 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 U 0.01. There were no statistical differences with regard to postoperative mean aortic gradients 8.5 R/- 5.3 vs 7.9 R/- 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 U 0.001; 60% statistically significant lower risk of developing myocardial injury 0.40 (0.22-0.72); P U 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 U 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 U 0.05. Conclusions The use of new-generation Evolut R was associated with improved procedural, functional and clinical outcomes compared with the CoreValve device.
AB - 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 U 0.01. There were no statistical differences with regard to postoperative mean aortic gradients 8.5 R/- 5.3 vs 7.9 R/- 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 U 0.001; 60% statistically significant lower risk of developing myocardial injury 0.40 (0.22-0.72); P U 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 U 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 U 0.05. Conclusions The use of new-generation Evolut R was associated with improved procedural, functional and clinical outcomes compared with the CoreValve device.
KW - Meta-analysis
KW - Self-expandable valve
KW - Transcatheter aortic valve implantation
KW - Transcatheter aortic valve replacement
UR - http://www.scopus.com/inward/record.url?scp=85062405689&partnerID=8YFLogxK
U2 - 10.2459/JCM.0000000000000757
DO - 10.2459/JCM.0000000000000757
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C2 - 30829877
AN - SCOPUS:85062405689
SN - 1558-2027
VL - 20
SP - 226
EP - 236
JO - Journal of Cardiovascular Medicine
JF - Journal of Cardiovascular Medicine
IS - 4
ER -