Transcatheter aortic valve implantation with the new-generation Evolut R™

Objective To compare procedural outcomes of transcatheter aortic valve implantation (TAVI) patients who were implanted with older versus newer generation valves. Background The current evidence base for improved safety of the newer commercially available TAVI valves is limited. Methods A retrospective analysis of the Israeli multicenter TAVI registry was performed. Patients were stratified by valve generation of four commercially available devices: Edwards Sapien (ESX) Edwards Sapien S3 (ES3), Medtronic CoreValve (MCV), and Medtronic Evolut R (MER). Results The cohort consisted of 737 patients with new generation valves (NGVs; ES3 n = 223; MER n = 514) and 1,869 with old generation valves (OGVs; MCV n = 1,181; ESX n = 688). Device success rates were significantly higher in NGV (97.5 versus 95.4%), with less post‐procedural paravalvular leak (3 versus 5.8%), and valve mal‐positioning (1.2 versus 3.4%); all P‐values<0.05. There were no differences in rates of permanent pacemaker implantation, stroke or acute kidney injury (AKI) of any stage between the groups, although stage ≥2 AKI was more prevalent in NGV. After adjustment to significant differences in baseline patient and procedural characteristics, device success was higher (OR 1.86, 95% confidence interval (CI) 1.09–3.18, P = 0.023) and the 1‐month safety outcome was significantly lower (OR 0.72, 95% CI 0.55–0.96, P = 0.025) for NGV. Device success was driven mainly by improved rates of PVL of ES3, while the safety outcome was mainly driven by improved rates of life‐threatening bleeding and valve mal‐positioning of MER. Conclusion As compared to OGV, use of NGV for TAVI was associated with higher rates of device success and lower rates of adverse events.

Section: Discussionsupporting

confidence: 82%

Safety outcomes of new versus old generation transcatheter aortic valves

Finkelstein

Rozenbaum

Zhitomirsky

et al. 2018

“…To our knowledge, this is the first study that compares individually the new large size self‐expandable 34 mm valve with its 31 mm predecessor. To date, studies comparing all‐size Evolut‐R with older CoreValve, demonstrated comparable 30‐day clinical outcomes, while a small single‐center cohort has shown reduced rates of more‐than‐mild PVR and higher device success with the new‐generation Evolut‐R device …”

Section: Discussionmentioning

confidence: 99%

Real‐world comparison of the new 34 mm self‐expandable transcatheter aortic prosthesis Evolut R to its 31 mm core valve predecessor

Kalogeras

Kabir

Mittal

et al. 2018

Objectives The aim of the present study was to compare the incidence of periprocedural complications and short‐term outcomes between the second‐generation recapturable 34 mm Evolut‐R and its first‐generation 31 mm predecessor. Background Although already in extensive clinical use in real world patients, the periprocedural complications and clinical outcomes of the new 34 mm device have not been investigated yet. Methods Consecutive patients who had undergone transcatheter aortic valve implantation in two centers with either a 31 mm CoreValve or a 34 mm Evolut‐R device were retrospectively studied. Periprocedural complications of malpositioning, valve‐in‐valve implantation, conversion to full sternotomy or percutaneous coronary intervention and vascular complications were compared between the two groups. Short‐term outcomes at discharge were compared using Valve Academic Research Consortium (VARC‐2) criteria. Results The study group included 106 patients (35 Evolut‐R 34 mm; 71 CoreValve 31 mm). Significantly lower rates of valve‐in‐valve implantation were demonstrated for the 34 mm group compared to the first‐generation device (0% vs. 11.9%, respectively, P = 0.036). All other periprocedural complications were similar between groups. At discharge, the rates of new pacemaker implantation (5.7% vs. 26.8%, P = 0.037) and bleeding complications (2.9% vs. 19.6%, P = 0.025) were statistically significantly lower among the 34 mm group. With regards to VARC‐2 defined combined endpoints, rates of early safety were significantly improved among the 34 mm group compared to 31 mm group (0% vs. 27.9%, respectively, P = 0.004). Conclusions The recently introduced 34 mm Evolut‐R seems to demonstrate an improved safety profile, as evidenced by the reduced bleeding rates, lower rates of valve‐in‐valve implantation and lower PPM rates compared to its 31 mm predecessor.

“…However, contradictory results from different studies have been reported comparing both types of prostheses. Although those studies have demonstrated a reduction in the PPI rate with the new generation of the CoreValve, 19,20 others have reported similar results [21][22][23][24][25] (Table 5). In our study, the abnormalities of conduction were frequent after TAVI, with a PPI rate that significantly decreased in the patients treated with Evolut R (45, 21.6% vs. 15, 10.9%; p = 0.01).…”

Section: Procedural Datamentioning

confidence: 77%

Impact of the repositionable Evolut R CoreValve system on the need for a permanent pacemaker after transcatheter aortic valve implantation in patients with severe aortic stenosis

Ojeda

Hidalgo

Romero

et al. 2019

Objectives To compare the incidence of permanent pacemaker implantation (PPI) with the CoreValve and Evolut R prostheses, to evaluate the implantation depth with both types of prostheses, and to study factors predicting the need for PPI. Background The Evolut R CoreValve can be recaptured and repositioned during deployment, allowing a more precise implantation. Methods A total of 208 patients treated with CoreValve and 137 patients treated with Evolut R were analyzed. The depth of the prosthesis in the LVOT was measured by angiography in the annular perpendicular view projection after deploymen in all patients. Results Baseline conduction abnormalities were comparable between the groups (85/208, 40.9% vs. 53/137, 38.7%; p = 0.69). The mean prosthesis depth was 10.3 ± 8.6 mm in the CoreValve group and 5.5 ± 2.7 mm in the Evolut R group; p < 0.0001. Conduction disturbances after valve implantation were more frequent with the CoreValve (new‐onset left bundle branch block: 93, 44.7% vs. 16, 11.7%; p < 0.05, first‐degree atrioventricular block: 23, 11.1% vs. 5, 3.6%; p < 0.05). In addition, the incidence of PPI was significantly lower with Evolut R (45, 21.6% vs. 15, 10.9%; p = 0.01). The predictors of the need for PPI were the mean depth of the prosthesis (OR: 1.13, 95% CI: 1.06–1.21; p < 0.0001) and prior right bundle branch block (OR 10.22, 95% CI: 4.62–22.63; p < 0.0001). Conclusions The recapturable capability of the Evolut R system allowed for higher and precise valve implantation. This fact had an impact on the reduction in the need for PPI.