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Transcatheter Heart Valve Implantation in Bicuspid Patients with Self-Expanding Device.

ABSTRACT: Bicuspid aortic valve (BAV) patients are conventionally not treated by transcathether aortic valve implantation (TAVI) because of anatomic constraint with unfavorable outcome. Patient-specific numerical simulation of TAVI in BAV may predict important clinical insights to assess the conformability of the transcathether heart valves (THV) implanted on the aortic root of members of this challenging patient population. We aimed to develop a computational approach and virtually simulate TAVI in a group of n.6 stenotic BAV patients using the self-expanding Evolut Pro THV. Specifically, the structural mechanics were evaluated by a finite-element model to estimate the deformed THV configuration in the oval bicuspid anatomy. Then, a fluid-solid interaction analysis based on the smoothed-particle hydrodynamics (SPH) technique was adopted to quantify the blood-flow patterns as well as the regions at high risk of paravalvular leakage (PVL). Simulations demonstrated a slight asymmetric and elliptical expansion of the THV stent frame in the BAV anatomy. The contact pressure between the luminal aortic root surface and the THV stent frame was determined to quantify the device anchoring force at the level of the aortic annulus and mid-ascending aorta. At late diastole, PVL was found in the gap between the aortic wall and THV stent frame. Though the modeling framework was not validated by clinical data, this study could be considered a further step towards the use of numerical simulations for the assessment of TAVI in BAV, aiming at understanding patients not suitable for device implantation on an anatomic basis.

SUBMITTER: Pasta S

PROVIDER: S-EPMC8301021 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundSevere calcification of the ascending aorta increases the peri-operative risk for neurological complications in patients with severe aortic stenosis. Transcatheter aortic valve implantation (TAVI) seems to be an optimal treatment option in these patients. However, the impact of the extent of aortic calcification on procedural and neurological outcomes during TAVI is unclear.MethodsData from 3010 patients with severe native aortic valve stenosis treated with ACURATE neo/neo2 from May 2012 to July 2022 were evaluated and matched by 2-to-1 nearest-neighbor matching to identify one patient with porcelain aorta (PA) (n = 492) compared with two patients without PA (n = 984). PA was additionally subdivided into circumferential (classic PA) (n = 89; 3.0%) and non-circumferential (partial PA) (n = 403; 13.4%) calcification. We compared outcomes according to VARC-3 criteria among patients with and without PA and identified predictors for occurrence of stroke in the overall population.ResultsTechnical success (88.5% vs. 87.4%, p = 0.589) and device success at 30 days (82.3% vs. 81.5%, p = 0.755) after transcatheter ACURATE neo/neo2 implantation according to VARC-3 definition was high and did not differ between non-calcified aortas or PA. The rate of in-hospital complications according to VARC-3-definitions was low in both groups. Rates of all stroke (3.2% (n = 31) vs. 2.6% (n = 13), p = 0.705) or transitory ischemic attacks (1.1% vs. 1.2%, p = 1.000) did not differ significantly. Thirty-day all-cause mortality did not differ (3.0% vs. 3.2%, RR 1.1; p = 0.775). Overall device migration/embolization (OR 5.0 [2.10;11.87]), severe bleeding (OR 1.79 [1.11;2.89]), and major structural cardiac complications (OR 3.37 [1.32;8.57]) were identified as independent predictors for in-hospital stroke in a multivariate analysis after implantation of ACURATE neo/neo2.ConclusionA porcelain aorta does not increase the risk of neurological complications after transfemoral ACURATE neo/neo2 implantation. Based on these findings, transfemoral ACURATE neo/neo2 implantation is safe in these particularly vulnerable patients.

Project description:BackgroundBicuspid aortic valve (BAV) is common congenital malformation, bicuspid aortic stenosis accounts for a substantial proportion of patients with aortic valve stenosis (AS). Bicuspid AS are more likely to have aortic dilatation with slightly less elliptical annuli, which might lead to paravalvular aortic valve regurgitation (AR) and permanent pacemaker implantation (PPM) after TAVI with higher mortality. Our study aims to understand the therapeutic efficacy and safety of transcatheter aortic valve implantation (TAVI) with a supra-annular structure-based sizing strategy in Chinese AS patients with BAV versus tricuspid aortic valve (TAV).MethodsSeventy-four consecutive tricuspid AS patients and 44 bicuspid AS patients were included and enrolled in the study for analysis. Both groups underwent TAVI performed using balloon sizing less than mild paravalvular AR to assess the proper prosthesis size. The myocardial function within 1 year postoperative were sequentially evaluated using the New York Heart Association (NYHA) class, and echocardiography measurements. The incidence rates of complications at 30 days and 1 year were analyzed. During the 1-year follow-up, the time of death from any cause or complications in both groups was recorded.ResultsThe study found that the percentage of patients with class III-IV of NYHA dropped after TAVI in both groups, and no significant difference between both groups at 1 year. Compared with the tricuspid AS group patients, Bicuspid group patients had more improvement in mean aortic valve gradient from baseline to 1year (-47.47±13.38 vs. -50.22±19.25 mmHg, P<0.05). There were no significant differences in 30-day and one-year compliance outcomes except a lower incidence of AR at post-procedure and 30 days in the tricuspid AS group as the Bicuspid AS group. There were no statistically significant differences in the time of death from any cause or significant complications between groups.ConclusionsTAVI has acceptable therapeutic efficacy and safety and is feasible for AS patients with BAV in China.

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Transcatheter Heart Valve Implantation in Bicuspid Patients with Self-Expanding Device.

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