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Comparing outcomes after transcatheter aortic valve replacement in patients with stenotic bicuspid and tricuspid aortic valve: A systematic review and meta-analysis.

ABSTRACT: BACKGROUND:Transcatheter aortic valve replacement (TAVR) has become an alternative treatment to surgery in patients with severe aortic stenosis. However, patients with bicuspid aortic stenosis (BAV) are usually excluded from major TAVR studies. The aim of this study is to reexamine current evidence of TAVR in patients with severe aortic stenosis and BAV compared with tricuspid aortic valve (TAV). HYPOTHESIS:There might be differences in outcomes post TAVR between patients with BAV comparing to TAV. METHOD:Databases were systematically searched for relevant articles featuring cohort studies that included patients with BAV and TAV who underwent TAVR studies, of which reported outcomes of interest included mortality and complications in both groups. Pooled effect size was calculated with a random-effect model and weighted for the inverse of variance, to compare outcomes post-TAVR between BAV and TAV. RESULTS:Nine studies were included in the meta-analysis. There was no difference in 30-day mortality rate in patients with BAV compared with TAV (OR: 1.27, 95% CI: 0.84-1.93, I2 = 0). Patients with BAV were more likely to have a moderate to severe paravalvular leak (9 studies; OR: 1.42, 95% CI: 1.08-1.87, I2 = 0) and conversion to surgery (5 studies; OR: 5.48, 95% CI: 1.74-17.27, I2 = 0), and less likely to have device success compared with patients with TAV (5 studies; OR: 0.57, 95% CI: 0.40-0.81, I2 = 0%). CONCLUSIONS:There was no difference in mortality post-TAVR in patients with BAV compared with TAV. Further randomized studies should be done in newer-generation prostheses to assess this association.

SUBMITTER: Kanjanahattakij N

PROVIDER: S-EPMC6489988 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Comparing outcomes after transcatheter aortic valve replacement in patients with stenotic bicuspid and tricuspid aortic valve: A systematic review and meta-analysis.

Kanjanahattakij Napatt N Horn Benjamin B Vutthikraivit Wasawat W Biso Sylvia Marie SM Ziccardi Mary Rodriguez MR Lu Marvin Louis Roy MLR Rattanawong Pattara P

Clinical cardiology 20180718 7

<h4>Background</h4>Transcatheter aortic valve replacement (TAVR) has become an alternative treatment to surgery in patients with severe aortic stenosis. However, patients with bicuspid aortic stenosis (BAV) are usually excluded from major TAVR studies. The aim of this study is to reexamine current evidence of TAVR in patients with severe aortic stenosis and BAV compared with tricuspid aortic valve (TAV).<h4>Hypothesis</h4>There might be differences in outcomes post TAVR between patients with BAV ...[more]

PMID: 29896777

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Project description:BackgroundThere is a lack of available data on specific prognostic comparisons between transcatheter aortic valve replacement (TAVR) using self-expandable valves (SEV) in patients with stenotic Type 0, Type 1 bicuspid aortic valve (BAV) and tricuspid aortic valve (TAV).ObjectivesTo evaluate the association between aortic valve morphology and outcomes following self-expandable TAVR.MethodsConsecutive patients with aortic stenosis(AS) undergoing self-expandable TAVR were enrolled and categorized into three groups (Type 0/Type 1 BAV or TAV) according to the Sievers classification. The primary endpoint was a composite of all-cause mortality and rehospitalization for heart failure (HF) within 2 years. Secondary outcomes included procedural complications and major cardiovascular events observed in clinical follow-ups. Clinical outcomes at 2 years following TAVR were compared among three groups using Kaplan-Meier curve and multivariable Cox proportional hazards regression models.ResultsA total of 344 AS patients (Type 0: 86; Type 1: 109; TAV: 149) were enrolled. The presence of moderate or severe paravalvular leak (PVL) was significantly higher in patients with Type 0 and Type 1 BAV versus TAV (10.47% vs. 16.51% vs. 6.71%, p = 0.043). All-cause 30-day mortality (2.33% vs. 0.92% vs. 2.68%, p = 0.626) and 2-year mortality (3.49% vs. 5.50% vs. 6.71%, p = 0.657) was comparable among the three groups. However, rehospitalization for HF within 2 years was significantly higher in Type 1 BAV (11.63% vs. 20.18% vs. 8.72%, p = 0.020). Multivariate Cox analysis showed that a higher STS score, Type 1 BAV morphology and excess leaflet calcification (≥ median calcium volume (CV) of the entire population) were independent predictors for HF rehospitalization. Additional intragroup Kaplan‒Meier analysis showed that excess leaflet calcification could predict higher long-term mortality and rehospitalization risk for HF(HR (95% CI): 3.430 (1.166-10.090), log rank p = 0.017) in Type 1 BAV patients.ConclusionOutcomes of self-expandable TAVR in BAV-AS patients might vary depending on valve subtypes. BAV patients with excess leaflet calcification and a raphe, especially calcified, had an increased risk of moderate PVL and HF readmission in mid-to-long term follow-ups.

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.

Dataset Information

Comparing outcomes after transcatheter aortic valve replacement in patients with stenotic bicuspid and tricuspid aortic valve: A systematic review and meta-analysis.

Publications

Comparing outcomes after transcatheter aortic valve replacement in patients with stenotic bicuspid and tricuspid aortic valve: A systematic review and meta-analysis.

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