Self-expandable transcatheter heart valves for aortic stenosis. Short-term outcome and matched hemodynamic performance

Vera, Silvio; Nombela‐Franco, Luis; Santos‐Martínez, Sandra; Moreno, Raúl; Jiménez-Díaz, Víctor Alfonso; Rodríguez‐Gabella, Tania; Catalá, Pablo; Castro-Mejía, Alex F.; Galeote, Guillermo; Baz, José Antonio; Gutiérrez, Hipólito; Serrador, Ana; García-Gómez, Mario; Redondo, Alfredo; Baladrón, Carlos; Arnold, Román; Jiménez‐Quevedo, Pilar; Carrasco‐Moraleja, Manuel; Gómez-Salvador, Itziar; Román, José Alberto San; Amat‐Santos, Ignacio J.

doi:10.1016/j.rec.2020.09.014

Cited by 3 publications

(14 citation statements)

References 31 publications

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“…On the one hand, apart from the supra‐annular position of the valves, the flexible commissural fixation points for pericardium stress reduction, and the concave form that avoids leaflets to touch the stent frame during opening face, allow to obtain very low gradients and high effective orifice area after implantation 10 . In one study, this valve showed the lowest gradients and the largest effective orifice area post‐implantation among different self‐expandable valves 11 . On the other hand, the valve frame has six radio‐opaque gold markers that facilitate obtaining a correct valve position contributing to reduce valve gradients after the procedure.…”

Section: Discussionmentioning

confidence: 99%

“…The Allegra device (Biosensors, Morges, Switzerland) is a novel transcatheter aortic self‐expandable valve with supra‐annular position of the valves, flexible commissural fixation points for pericardium stress reduction, and concave form that avoids leaflets to touch the stent frame during opening face, all this designed to obtain very low gradients and high effective orifice area after implantation 10 . In one study, this valve showed the lowest gradients and the largest effective orifice area post‐implantation among self‐expandable valves 11 …”

Section: Introductionmentioning

confidence: 99%

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Transcatheter aortic valve implantation for degenerated aortic valves: Experience with a new supra‐annular device. The Spanish Allegra valve‐in‐valve (SAVIV) registry

Moreno

Baz

Moreu

et al. 2021

Cathet Cardio Intervent

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Objectives The objective was to evaluate the results of valve‐in‐valve procedures performed with the Allegra device. Background Transcatheter aortic valve implantation to treat degenerated biological aortic valves (valve‐in‐valve) is an established procedure in most catheterization laboratories, but the results are poorer than procedures done in native aortic stenosis. The Allegra device (Biosensors, Morges, Switzerland) has an excellent design to treat these patients. Methods All patients with severely degenerated biological aortic valve treated with the Allegra device in centers from Spain until December 2020 were included (n = 29). Hemodynamic results and 30‐day clinical outcomes were evaluated. The predominant hemodynamic failure was stenosis in 15, regurgitation in 11, and a combination of both in 3 cases. Time from aortic valve replacement to valve‐in‐valve procedure was 8.4 ± 3.9 years (range 3.3–22.1). Results After the procedure, maximum and mean trans‐valvular gradients were 17.4 ± 12.3 and 8.4 ± 6.1 mmHg, respectively. Device success was obtained in 28 patients (96.6%). In one patient with a degenerated 19 mm prosthetic valve, mean gradient after the procedure was 22 mmHg. No patients had a para‐valvular leak grade >1. There were no deaths during the hospitalization or at 30 days and one patient suffered a stroke. Conclusions The Allegra trans‐catheter aortic valve offers optimal hemodynamic results in patients with severely degenerated biological aortic valve.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Transcatheter aortic valve implantation for degenerated aortic valves: Experience with a new supra‐annular device. The Spanish Allegra valve‐in‐valve (SAVIV) registry

Moreno

Baz

Moreu

et al. 2021

Cathet Cardio Intervent

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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%

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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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Transcatheter aortic valve implantation with Allegra: procedural and mid-term outcomes according to experience phase in a high-volume center

Corcione¹,

Ferraro²,

Morello³

et al. 2023

Minerva Cardiol Angiol

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Self-expandable transcatheter heart valves for aortic stenosis. Short-term outcome and matched hemodynamic performance

Cited by 3 publications

References 31 publications

Transcatheter aortic valve implantation for degenerated aortic valves: Experience with a new supra‐annular device. The Spanish Allegra valve‐in‐valve (SAVIV) registry

Transcatheter aortic valve implantation for degenerated aortic valves: Experience with a new supra‐annular device. The Spanish Allegra valve‐in‐valve (SAVIV) registry

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

Transcatheter aortic valve implantation with Allegra: procedural and mid-term outcomes according to experience phase in a high-volume center

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