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Efficacy and safety of transcatheter aortic valve implantation in patients with severe bicuspid aortic stenosis.

ABSTRACT: Background:Bicuspid 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). Methods:Seventy-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. Results:The 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. Conclusions:TAVI has acceptable therapeutic efficacy and safety and is feasible for AS patients with BAV in China.

SUBMITTER: Fu B

PROVIDER: S-EPMC7396751 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Efficacy and safety of transcatheter aortic valve implantation in patients with severe bicuspid aortic stenosis.

Fu Bo B Chen Qingliang Q Zhao Feng F Guo Zhigang Z Jiang Nan N Wang Xu X Wang Wei W Han Jiange J Yang Li L Zhu Yanbo Y Ma Yanhe Y

Annals of translational medicine 20200701 14

<h4>Background</h4>Bicuspid 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 transcat ...[more]

PMID: 32793717

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Project description:ImportanceThe outcomes of transcatheter aortic valve replacement (TAVR) in low-risk patients with bicuspid aortic valve stenosis have not been studied in a large scale, multicentered, prospective fashion.ObjectiveTo evaluate the procedural safety, efficacy, and 30-day outcomes of TAVR in patients with bicuspid aortic stenosis at low surgical risk.Design, setting, and participantsThe Low Risk Bicuspid Study is a prospective, single-arm trial study with inclusion/exclusion criteria developed from the Evolut Low Risk Randomized Trial. Follow-up is planned for 10 years. Patients underwent TAVR at 25 centers in the United States who were also participating in the Evolut Low Risk Randomized Trial from December 2018 to October 2019. Eligible patients had severe bicuspid aortic valve stenosis and met American Heart Association/American College of Cardiology guideline indications for aortic valve replacement.InterventionsPatients underwent attempted implant of an Evolut or Evolut PRO transcatheter aortic valve, with valve size based on annular measurements.Main outcomes and measuresThe prespecified primary end point was the incidence of all-cause mortality or disabling stroke at 30 days. The prespecified primary efficacy end point was device success defined as the absence of procedural mortality, the correct position of 1 bioprosthetic heart valve in the proper anatomical location, and the absence of more than mild aortic regurgitation postprocedure.ResultsA total of 150 patients underwent an attempted implant. Baseline characteristics include mean age of 70.3 (5.5) years, 48.0% female (n = 72), and a mean Society of Thoracic Surgeons score of 1.4 (0.6%). Most patients (136; 90.7%) had Sievers type I valve morphology. The incidence of all-cause mortality or disabling stroke was 1.3% (95% CI, 0.3%-5.3%) at 30 days. The device success rate was 95.3% (95% CI, 90.5%-98.1%). At 30 days, the mean (SD) AV gradient was 7.6 (3.7) mm Hg and effective orifice area was 2.3 (0.7) cm2. A new permanent pacemaker was implanted in 22 patients (15.1%). No patients had greater than mild paravalvular leak.Conclusions and relevanceTranscatheter aortic valve replacement in low-surgical risk patients with bicuspid aortic valve stenosis achieved favorable 30-day results, with low rates of death and stroke and high device success rate.Trial registrationClinicalTrials.gov Identifier: NCT03635424.

Dataset Information

Efficacy and safety of transcatheter aortic valve implantation in patients with severe bicuspid aortic stenosis.

Publications

Efficacy and safety of transcatheter aortic valve implantation in patients with severe bicuspid aortic stenosis.

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