Impact of Accidental High or Low Implantation Depth on Peri-Procedural Outcomes after Implantation with the Self-Expanding ACURATE neo2

Author:

Eckel Clemens12,Kim Won-Keun34,Schlüter Judith1,Renker Matthias35ORCID,Bargon Sophie1,Grothusen Christina16,Elsässer Albrecht2,Dohmen Guido7ORCID,Choi Yeong-Hoon5ORCID,Charitos Efstratios I.5ORCID,Hamm Christian W.34,Sossalla Samuel34ORCID,Möllmann Helge1,Blumenstein Johannes12

Affiliation:

1. Department of Cardiology, St. Johannes Hospital, 44137 Dortmund, Germany

2. School VI—School of Medicine and Health Sciences, Carl von Ossietzky Universität Oldenburg, 26129 Oldenburg, Germany

3. Department of Cardiology, Kerckhoff Heart Center, 61231 Bad Nauheim, Germany

4. Department of Cardiology, Justus-Liebig University of Giessen, 35390 Giessen, Germany

5. Department of Cardiac Surgery, Kerckhoff Heart Center, 61231 Bad Nauheim, Germany

6. Department of Cardiac Surgery, University of Kiel, 24118 Kiel, Germany

7. Department of Cardiac Surgery, St. Johannes Hospital, 44137 Dortmund, Germany

Abstract

Background: Precise implantation could play a crucial role in the technical success of transcatheter aortic valve replacement (TAVR) for some prostheses. The impact of an accidental implantation depth (ID) outside the recommended range has not been assessed for the ACURATE neo2 (NEO2). Methods: Data from 1839 patients with severe native aortic stenosis treated with the NEO2 prosthesis were evaluated. We compared the results of prostheses implanted in an ID both inside and outside the recommendations. The outcome assessment followed the Valve Academic Research Consortium-3 criteria. Results: Patients were retrospectively divided into high (<3 mm; n = 412), optimal (3–7 mm; n = 1236), and low (>7 mm; n = 169) implantations. Technical success (94.7% vs. 94.7% vs. 91.7%, p = 0.296) and device success were high (90.1% vs. 89.3% vs. 84.6%, p = 0.112) without differences between groups. Rates of relevant paravalvular regurgitation (PVL; >mild or VinV due to PVL) were comparable (1.2% vs. 1.8% vs. 1.2%, p = 0.759). Even when hemodynamics were superior in the high-implantation group, with greater iEOA (1.01 cm2/m2 vs. 0.95 cm2/m2 vs. 0.92 cm2/m2, p < 0.001), spontaneous embolization or after post-dilatation was more common. Low implantation was associated with a higher rate of associated pacemaker implantation (PPI) (6.1% vs. 8.8% vs. 14.8%, p = 0.001). Conclusions: Implantation with the ACURATE neo2 showed excellent hemodynamic results, including low gradients and a small number of relevant PVL, in line with a high technical success rate that was irrespective of the ID. A favorable outcome can also be achieved in accidental low or high positions. Low implantation was associated with a higher rate of associated pacemaker implantation. Deliberately high implantation should be avoided due to the risk of embolization.

Publisher

MDPI AG

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