Prospective comparison between three TAVR devices: ACURATE neo vs. CoreValve vs. SAPIEN XT. A single heart team experience in patients with severe aortic stenosis

Jatene, Tannas; Castro-Filho, Antonio de; Meneguz‐Moreno, Rafael Alexandre; Siqueira, Dimytri; Abizaid, Alexandre; Ramos, Ana; Arrais, Magaly; Bihan, David Costa de Souza Le; Barretto, Rodrigo B M; Moreira, Adriana; Sousa, Amanda G. M. R.; Sousa, J. Eduardo

doi:10.1002/ccd.26837

Cited by 14 publications

(18 citation statements)

References 24 publications

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“…4–7,21–36 Twenty studies (5670 patients) reported data on 30-day need for new PPI post-TAVI with a cumulative incidence of 7.7% (95% CI, 6.4–9.2%) (Figure 4). 4–7,21–36 In total, 20 studies (5478 patients) reported data on PVL, with a cumulative incidence of moderate/severe PVL of 4.3% (95% CI, 3.0–6.2%) (Figure 5). 4–7,21–36 Among 18 studies and 5617 patients with data on 30-day stroke rates, the cumulative incidence was 1.9% (95% CI, 1.6–2.3%) (Supplemental Figures, http://links.lww.com/CIR/A42).…”

Section: Resultsmentioning

confidence: 99%

“…4–7,21,23–36 The postdilatation incidence proportion, respectively, was 43.2% (95% CI, 37.9–48.6%) as evaluated from 19 studied (5808 patients) (Supplementary Figures, http://links.lww.com/CIR/A42). 4–7,21–36…”

Section: Resultsmentioning

confidence: 99%

“…[14][15][16][17][18][19][20] Finally, 20 studies (n = 5858 ACURATE neo receivers) were included in the meta-analysis (Table 1). [4][5][6][7][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36] Mean age was 81.32 years and 37.5% were females.…”

Section: Overview Of Studiesmentioning

confidence: 99%

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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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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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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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“…Полученные нами результаты демонстрируют высокий профиль клинической эффективности и безопасности использования биопротеза Acurate neo в течение 30 сут. после ТИАК, что соответствует опубликованным в зарубежной литературе данным [4][5][6].…”

Section: Discussionunclassified

First experience of transcatheter implantation of new-generation self-expanding bioprosthesis Acurate neo

et al. 2019

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Aim. To evaluate immediate single-center results of transcatheter aortic valve implantation (TAVI) with use of novel self-expanding bioprosthesis Acurate neo.Material and methods. TAVI procedure was performed in 69 high-tointermediate surgical risk patients (mean age 76,8±6,1years, 31 males, 68 females) with severe calcified aortic stenosis and diverse comorbidity. Concomitant coronary artery disease was observed in 43 (62%), atrial fibrillation in 23 (33%), diabetes mellitus type 2 in 26 (38%) patients. Median Euroscore II was 4,9 (2,8; 9,0). VARC-2 criteria were applied to assess early effectiveness and safety of the procedure.Results. There were no all-cause mortality, surgical conversion, acute coronary syndrome and stroke in the study group. In-hospital and 30-day mortality was also 0%. Duration of the procedure was 100 min (75;120), hospital stay — 7 (6;8) days. Patient’s haemodynamics and clinical status were significantly improved after TAVI. Mean aortic valve pressure gradient significantly decreased from 57,4±17,6 to 11,8±4,4 mm Hg, effective aortic valve area increased from 0,65±0,17 up to 1,8±0,41 mm Hg (p<0,001). Left ventricle ejection fraction increased from 54,5±13,2 mm Hg to 57,7±12,3 before discharge (p<0,001). Moderate paravalvular aortic regurgitation was observed in only 13% of patients. Permanent pacemaker rate was 5,8%. NYHA class reduced from 2,9 to 2,0 (p<0,001).Conclusion. First Russian prospective study of TAVI with use of Acurate neo showed satisfactory hemodynamic characteristics, safety indicators and clinical efficacy of this device. Relative disadvantages of this non-repositionable valve could be generally overcome due to its distinctive features allowing precise planning, adequate navigation and accurate implantation.

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“…[5][6][7] Generally, the Edwards SAPIEN 3 valve has shown favorable results in studies comparing clinical outcomes by valve type. 8,9 Researchers hypothesize that trauma to, and impingement upon, conduction bundles may be responsible for subsequent need for PPM after TAVR, given the location of the valve prosthesis near the aortic annulus and into the left ventricular outflow tract. 10 This is supported by the fact that several groups have uncovered preexisting right bundle branch block (RBBB) as a predictor of PPM.…”

Section: Introductionmentioning

confidence: 99%

Novel Method for Implantation of Balloon Expandable Transcatheter Aortic Valve Replacement to Reduce Pacemaker Rate—Line of Lucency Method

et al. 2020

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Prospective comparison between three TAVR devices: ACURATE neo vs. CoreValve vs. SAPIEN XT. A single heart team experience in patients with severe aortic stenosis

Abstract: In a "real world" registry, ACT compared favorably against the well-studied SXT and MCV devices in both safety and efficacy. MCV implantation was associated with lower device success rates and higher rates of new permanent pacemaker implantation. © 2016 Wiley Periodicals, Inc.

Cited by 14 publications

References 24 publications

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

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

First experience of transcatheter implantation of new-generation self-expanding bioprosthesis Acurate neo

Novel Method for Implantation of Balloon Expandable Transcatheter Aortic Valve Replacement to Reduce Pacemaker Rate—Line of Lucency Method

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