Dataset Information

Long-Term Mortality After TAVI for Bicuspid vs. Tricuspid Aortic Stenosis: A Propensity-Matched Multicentre Cohort Study.

ABSTRACT:

Objectives

Patients with bicuspid aortic valve (BAV) stenosis were excluded from the pivotal trials of transcatheter aortic valve implantation (TAVI). We compared the in-hospital and long-term outcomes between patients undergoing TAVI for bicuspid and tricuspid aortic valve (TAV) stenosis.

Methods

We performed a retrospective registry-based analysis on patients who underwent TAVI for BAV and TAV at five different centers between January 2009 and August 2017. The primary outcome was long-term all-cause mortality. Secondary outcomes were in-hospital mortality, procedural complications, and valve performance.

Results

Of 1,451 consecutive patients who underwent TAVI, two propensity-matched cohorts consisting of 130 patients with BAV and 390 patients with TAV were analyzed. All-cause mortality was comparable in both groups up to 10 years following TAVI (HR 1.09, 95% CI: 0.77-1.51). Device success and in-hospital mortality were comparable between the groups (96 vs. 95%, p = 0.554 and 2.3 vs. 2.1%, p = 0.863, respectively). Incidence of procedural complications was similar in both groups, with a trend toward a higher rate of stroke in patients with BAV (5 vs. 2%, p = 0.078). Incidence of moderate or severe paravalvular leak (PVL) at discharge was comparable in both groups (2 vs. 2%, p = 0.846). Among patients with BAV, all-cause mortality was similar in self-expanding and balloon-expandable prostheses (HR 1.02, 95% CI: 0.52-1.99) and lower in new-generation devices compared to old-generation valves (HR 0.27, 95% CI 0.12-0.62).

Conclusion

Patients who had undergone TAVI for BAV had comparable mortality to patients with TAV up to 10 years after the procedure. The device success, in-hospital mortality, procedural complications, and PVL rate were comparable between the groups. The high rate of neurological complications (5%) in patients with BAV warrants further investigation.

SUBMITTER: Gasecka A

PROVIDER: S-EPMC9253589 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceTranscatheter aortic valve replacement (TAVR) indications are expanding, leading to an increasing number of patients with bicuspid aortic stenosis undergoing TAVR. Pivotal randomized trials conducted to obtain US Food and Drug Administration approval excluded bicuspid anatomy.ObjectiveTo compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis.Design, setting, and participantsRegistry-based prospective cohort study of patients undergoing TAVR at 552 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapies Registry from June 2015 to November 2018.ExposuresTAVR for bicuspid vs tricuspid aortic stenosis.Main outcomes and measuresPrimary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications, valve hemodynamics, and quality of life assessment.ResultsOf 81 822 consecutive patients with aortic stenosis (2726 bicuspid; 79 096 tricuspid), 2691 propensity-score matched pairs of bicuspid and tricuspid aortic stenosis were analyzed (median age, 74 years [interquartile range {IQR}, 66-81 years]; 39.1%, women; mean [SD] STS-predicted risk of mortality, 4.9% [4.0%] and 5.1% [4.2%], respectively). All-cause mortality was not significantly different between patients with bicuspid and tricuspid aortic stenosis at 30 days (2.6% vs 2.5%; hazard ratio [HR], 1.04, [95% CI, 0.74-1.47]) and 1 year (10.5% vs 12.0%; HR, 0.90 [95% CI, 0.73-1.10]). The 30-day stroke rate was significantly higher for bicuspid vs tricuspid aortic stenosis (2.5% vs 1.6%; HR, 1.57 [95% CI, 1.06-2.33]). The risk of procedural complications requiring open heart surgery was significantly higher in the bicuspid vs tricuspid cohort (0.9% vs 0.4%, respectively; absolute risk difference [RD], 0.5% [95% CI, 0%-0.9%]). There were no significant differences in valve hemodynamics. There were no significant differences in moderate or severe paravalvular leak at 30 days (2.0% vs 2.4%; absolute RD, 0.3% [95% CI, -1.3% to 0.7%]) and 1 year (3.2% vs 2.5%; absolute RD, 0.7% [95% CI, -1.3% to 2.7%]). At 1 year there was no significant difference in improvement in quality of life between the groups (difference in improvement in the Kansas City Cardiomyopathy Questionnaire overall summary score, -2.4 [95% CI, -5.1 to 0.3]; P = .08).Conclusions and relevanceIn this preliminary, registry-based study of propensity-matched patients who had undergone transcatheter aortic valve replacement for aortic stenosis, patients with bicuspid vs tricuspid aortic stenosis had no significant difference in 30-day or 1-year mortality but had increased 30-day risk for stroke. Because of the potential for selection bias and the absence of a control group treated surgically for bicuspid stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis.

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