Background: Self-expanding transcatheter valves (THV) seem superior to balloon-expanding valves in regard to the incidence of prosthesis-patient mismatch (PPM). Data on the occurrence of PPM with the ACURATE system as a representative of self-expanding prostheses in very small annuli, even below the applicable instructions for use (IFU), are scarce.
Methods: Data from 654 patients with severe native aortic stenosis treated with the smallest size ACURATE valve (size S, 23 mm) at two German high-volume centers from 06/2012 to 12/2021 were evaluated. We compared clinical and hemodynamic outcomes among patients with implantation in adherence to the recommended sizing (on-label = 529) and below the recommended sizing range (off-label = 125) and identified predictors for PPM in the overall population. BMI-adjusted PPM was defined according to VARC-3 recommendations.
Results: Post-procedure, the mean gradient (10.0 mmHg vs. 9.0 mmHg, = 0.834) and the rate of paravalvular leakage (PVL) ≥ moderate (3.2% vs. 2.8%, = 0.770) were similar between on-label and off-label implantations. The rate of moderate to severe PPM (24%) was comparably low in ACURATE S, with a very low proportion of severe PPM whether implanted off- or on-label (4.9% vs. 3.8%, = 0.552). Thirty-day all-cause mortality was higher among patients with off-label implantations (6.5% vs. 2.3%, = 0.036). In the subgroup of these patients, no device-related deaths occurred, and cardiac causes did not differ (each 5). Besides small annulus area and high BMI, a multivariate analysis identified a greater cover index (OR 3.26), deep implantation (OR 2.25) and severe calcification (OR 2.07) as independent predictors of PPM.
Conclusions: The ACURATE S subgroup shows a convincing hemodynamic outcome according to low mean gradient even outside the previous IFUs without a relevant increase in the rate of PVL or PPM. In addition to known factors such as annulus area and BMI, potential predictors for PPM are severe annulus calcification and implantation depth. Nevertheless, the ACURATE system seems to be a reliable option in patients with very small annuli.
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http://dx.doi.org/10.3390/jcm11185313 | DOI Listing |
Catheter Cardiovasc Interv
December 2024
Cardiology Department, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
Background: The management of Transcatheter Aortic Valve Implantation (TAVI) patients with a small aortic annulus (SAA) postures a substantial challenge, increasing the risk of patient- prosthesis mismatch (PPM) and overall mortality.
Aims: This study aimed to compare the hemodynamic and clinical outcomes of transcatheter balloon-expandable valve (BEV) versus transcatheter self-expandable valve (SEV) in SAA.
Methods: We conducted propensity score matching (PSM) of severe AS patients with SAA who underwent trans-femoral TAVR and enrolled to the Israeli TAVR registry between the years 2008 and 2023.
Little is known about the diversity and systematics of nematodes from intertidal sands of the Sea of Japan (East Sea). Here, nematodes of the rare genus Gairleanema and two new species of the family Xyalidae are described and illustrated. Metadesmolaimus innii sp.
View Article and Find Full Text PDFCardiovasc Interv Ther
November 2024
Department of Cardiac Surgery, National Cerebral and Cardiovascular Center, Osaka, Japan.
Despite the widespread adoption of valve-in-valve transcatheter aortic valve replacement (VIV-TAVR) for patients with failed aortic bioprosthesis, the effectiveness of this treatment for Japanese patients frequently associated with small aortic annuli remains unclear. From December-2011 to October-2022, 41 consecutive patients undergoing VIV-TAVR were enrolled in this study. The endpoints were technical success, device success, early safety, and two-year mortality according to implanted surgical valve size (small valves: 19-mm and 21-mm, n = 23; large valves: 23-mm and 25-mm, n = 18).
View Article and Find Full Text PDFAm J Cardiol
November 2024
Department of Cardiology, University Heart and Vascular Center Hamburg, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Lübeck/Kiel, Germany; Department of Cardiology and Angiology, BG University Hospital Bergmannsheil, Ruhr University Bochum, Germany.
Prosthesis-patient mismatch (PPM) is a common phenomenon after transcatheter aortic valve implantation (TAVI), especially in patients with small aortic annuli. Whether factors during implantation, such as the implantation depth, have an impact on the occurrence of PPM is currently unclear. The objectives of our study were to (1) investigate the influence of procedure planning- and implantation-related factors on the occurrence of PPM and (2) evaluate the impact of PPM on long-term mortality after TAVI.
View Article and Find Full Text PDFZoological Lett
October 2024
Department of Biosphere-Geosphere Science, Okayama University of Science, Ridai-Cho 1-1, Kita-Ku, Okayama, 700005, Japan.
The osteohistology of Andrias spp. is a pivotal analogue for large fossil non-amniotes (e.g.
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