The ACURATE <i>neo</i> transcatheter aortic valve system

Choudhury, Tawfiq; Solomonica, Amir; Bagur, Rodrigo

doi:10.1080/17434440.2018.1526675

Cited by 17 publications

(10 citation statements)

References 14 publications

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“…In the matched cohort there were no significant differences according to baseline characteristics between the both groups. According to the (VARC)-2 criteria 13 a device success rate of 98.3% was observed for the ACURATE neo™ in studies performed by Choudhury et al 15 and Möllmann et al 16 The same authors were able to show that this device demonstrated excellent procedural success since the results so far are promising due to the low mortality rate in a medium-risk population in both, the short and medium-term, which is consistent with our results. 15,16 Similar results were also found in other studies for device success after TAVR.…”

Section: Baseline Characteristics and Periprocedural Datasupporting

confidence: 91%

“…According to the (VARC)-2 criteria 13 a device success rate of 98.3% was observed for the ACURATE neo™ in studies performed by Choudhury et al 15 and Möllmann et al 16 The same authors were able to show that this device demonstrated excellent procedural success since the results so far are promising due to the low mortality rate in a medium-risk population in both, the short and medium-term, which is consistent with our results. 15,16 Similar results were also found in other studies for device success after TAVR. [17][18][19] Therefore, in both groups (CoreValve ® and ACURATE neo™) in our study it can be stated that the device success does not differ post-procedurally between the valve prostheses with comparable initial characteristics.…”

Section: Baseline Characteristics and Periprocedural Datasupporting

confidence: 91%

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Clinical results and 30-day outcomes of self-expanding transcatheter aortic valves: comparative case-matched analysis of CoreValve^® versus ACURATE neo™

et al. 2021

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Background: Transcatheter aortic valve replacement (TAVR) is associated with excellent results in patients with severe aortic stenosis. In highly calcified aortic anuli with increased risk of annulus rupture and in favor of the supra-annular design, self-expandable prostheses are frequently used. In this regard, we aimed to perform a comparative analysis of clinical and 30-day outcomes after TAVR using the self-expanding CoreValve® Evolut R or ACURATE neo™ prosthesis. Methods: Out of 343 consecutive patients treated with either CoreValve® Evolut R or ACURATE neo™ from January 2014 to December 2017, 76 patients were assigned each per group after 1:1 propensity score matching in regard of preoperative characteristics. Pre- and periprocedural outcomes were retrospectively collected and assessed. Outcomes at 30 days are reported according to the established Valve Academic Research Consortium (VARC-2) criteria. Results: Device success and 30-day survival accounted for 93.4% ( n = 71), respectively 97.4% ( n = 74) in both groups (p = 1.00). No statistically significant differences regarding clinical parameters were observed. The combined safety endpoint at 30 days was comparable (84.2% ( n = 64) CoreValve® vs 85.5% ( n = 65) ACURATE neo™; p = 0.848). Except a trend toward higher stroke (p = 0.08) and pacemaker (p = 0.07) rate in the CoreValve® group, major vascular complications, incidence of life-threatening or disabling bleeding, and incidence of postoperative acute kidney injury were comparable. Postoperative hemodynamic parameters showed no significant differences between the implanted valves. Conclusion: Both self-expandable prostheses showed good postoperative hemodynamic performance with a low incidence of severe paravalvular leakage, all- cause mortality, and comparable clinical outcomes.

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Section: Baseline Characteristics and Periprocedural Datasupporting

confidence: 91%

Section: Baseline Characteristics and Periprocedural Datasupporting

confidence: 91%

Clinical results and 30-day outcomes of self-expanding transcatheter aortic valves: comparative case-matched analysis of CoreValve^® versus ACURATE neo™

et al. 2021

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“…Secondly, one study [15] reports on outcomes with both transfemoral ACURATE neo and transapical ACURATE TA systems. While similar in stent design and technological features, there are certain, albeit minor, differences in delivery system and biological tissue used in both devices [42]. Thirdly, only half of included studies reported follow-up longer than one month; paucity of data regarding long-term clinical and functional outcomes significantly impedes interpretation of ACURATE neo and SAPIEN 3 clinical suitability.…”

Section: Discussionmentioning

confidence: 99%

Transcatheter Aortic Valve Replacement with Self-Expandable ACURATE neo as Compared to Balloon-Expandable SAPIEN 3 in Patients with Severe Aortic Stenosis: Meta-Analysis of Randomized and Propensity-Matched Studies

Gozdek

Zieliński

Pasierski

et al. 2020

JCM

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Frequent occurrence of paravalvular leak (PVL) after transcatheter aortic valve replacement (TAVR) was the main concern with earlier-generation devices. Current meta-analysis compared outcomes of TAVR with next-generation devices: ACURATE neo and SAPIEN 3. In random-effects meta-analysis, the pooled incidence rates of procedural, clinical and functional outcomes according to VARC-2 definitions were assessed. One randomized controlled trial and five observational studies including 2818 patients (ACURATE neo n = 1256 vs. SAPIEN 3 n = 1562) met inclusion criteria. ACURATE neo was associated with a 3.7-fold increase of moderate-to-severe PVL (RR (risk ratio): 3.70 (2.04–6.70); P < 0.0001), which was indirectly related to higher observed 30-day mortality with ACURATE valve (RR: 1.77 (1.03–3.04); P = 0.04). Major vascular complications, acute kidney injury, periprocedural myocardial infarction, stroke and serious bleeding events were similar between devices. ACURATE neo demonstrated lower transvalvular pressure gradients both at discharge (P < 0.00001) and at 30 days (P < 0.00001), along with lower risk of patient–prosthesis mismatch (RR: 0.29 (0.10–0.87); P = 0.03) and pacemaker implantation (RR: 0.64 (0.50–0.81); P = 0.0002), but no differences were observed regarding composite endpoints early safety and device success. In conclusion, ACURATE neo, as compared with SAPIEN 3, was associated with higher rates of moderate-to-severe PVL, which were indirectly linked with increased observed 30-day all-cause mortality.

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“…The device at full deployment protrudes only minimally into the left ventricular outflow tract; thus, the risk of coronary obstruction and abnormalities of the conduction system are minimized. 38 Due to the supra-annular design with predictable top-down deployment, ACURATE neo is also suitable for patients with conduction abnormalities. 14,21 The manufacturer suggests balloon predilatation as common practice during the procedure, mostly driven by the comparatively moderate radial force.…”

Section: Discussionmentioning

confidence: 99%

Study Level Meta-Analysis of Transcatheter Aortic Valve Implantation With the ACURATE neo Self-Expanding Transcatheter Heart Valve

Koliastasis

Doundoulakis

Kokkinidis

et al. 2023

Cardiology in Review

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The ACURATE neo transcatheter aortic valve is a self-expanding device. Several studies have investigated safety and efficacy, but meta-analysis and pooled data are lacking. We aimed to provide a comprehensive systematic review and meta-analysis on the clinical outcomes of transcatheter aortic valve implantation with the ACURATE neo valve. A systematic literature search for eligible records was conducted. The primary endpoint was device success as designated by Valve Academic Research Consortium-2 criteria. The secondary endpoints (time frame: 30 days) were all-cause mortality, stroke, myocardial infarction, need for new permanent pacemaker, major vascular complications, major bleeding, acute kidney injury stage II or III, and paravalvular regurgitation grade moderate or severe (II or III). Our search yielded a total of 355 records, 20 of those (n = 5858 ACURATE neo receivers) were included in our meta-analysis. Device success was achieved in 94.5% (95% confidence interval [CI], 91.4–96.5%) of the patients. The 30-day all-cause mortality incidence proportion was 1.8% (95% CI, 1.3–2.4%). New pacemaker implantation was required in 7.7% (95% CI, 6.4–9.2%) of the patients, stroke occurred in 1.9% (95% CI, 1.6–2.3%), myocardial infarction in 0.5% (95% CI, 0.3–0.7%), major bleeding in 5.0% (95% CI, 3.9–6.5%), major vascular complication in 5.6% (95% CI, 4.0–7.8%), acute kidney injury stage ≥2 in 2.5% (95% CI, 1.8–3.4%), and paravalvular leak grade ≥moderate was observed in 4.3% (95% CI, 3.0–6.2%). Balloon predilatation and postdilatation incidence was 93.9% (95% CI, 87.0–97.3%) and 43.2% (95% CI, 37.9–48.6%), respectively. ACURATE neo appears to be safe and effective in our analysis with high device success incidence, low mortality, and low new pacemaker implantations.

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The ACURATE neo transcatheter aortic valve system

Cited by 17 publications

References 14 publications

Clinical results and 30-day outcomes of self-expanding transcatheter aortic valves: comparative case-matched analysis of CoreValve^® versus ACURATE neo™

Clinical results and 30-day outcomes of self-expanding transcatheter aortic valves: comparative case-matched analysis of CoreValve^® versus ACURATE neo™

Transcatheter Aortic Valve Replacement with Self-Expandable ACURATE neo as Compared to Balloon-Expandable SAPIEN 3 in Patients with Severe Aortic Stenosis: Meta-Analysis of Randomized and Propensity-Matched Studies

Study Level Meta-Analysis of Transcatheter Aortic Valve Implantation With the ACURATE neo Self-Expanding Transcatheter Heart Valve

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The ACURATE neo transcatheter aortic valve system

Cited by 17 publications

References 14 publications

Clinical results and 30-day outcomes of self-expanding transcatheter aortic valves: comparative case-matched analysis of CoreValve® versus ACURATE neo™

Clinical results and 30-day outcomes of self-expanding transcatheter aortic valves: comparative case-matched analysis of CoreValve® versus ACURATE neo™

Transcatheter Aortic Valve Replacement with Self-Expandable ACURATE neo as Compared to Balloon-Expandable SAPIEN 3 in Patients with Severe Aortic Stenosis: Meta-Analysis of Randomized and Propensity-Matched Studies

Study Level Meta-Analysis of Transcatheter Aortic Valve Implantation With the ACURATE neo Self-Expanding Transcatheter Heart Valve

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Clinical results and 30-day outcomes of self-expanding transcatheter aortic valves: comparative case-matched analysis of CoreValve^® versus ACURATE neo™

Clinical results and 30-day outcomes of self-expanding transcatheter aortic valves: comparative case-matched analysis of CoreValve^® versus ACURATE neo™