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Comparative Study
. 2019 Jun 11;321(22):2193-2202.
doi: 10.1001/jama.2019.7108.

Association Between Transcatheter Aortic Valve Replacement for Bicuspid vs Tricuspid Aortic Stenosis and Mortality or Stroke

Raj R Makkar  1 , Sung-Han Yoon  1 , Martin B Leon  2 , Tarun Chakravarty  1 , Michael Rinaldi  3 , Pinak B Shah  4 , Eric R Skipper  3 , Vinod H Thourani  5 , Vasilis Babaliaros  6 , Wen Cheng  1 , Alfredo Trento  1 , Sreekanth Vemulapalli  7 , Samir R Kapadia  8 , Susheel Kodali  2 , Michael J Mack  9 , Gilbert H L Tang  10 , Tsuyoshi Kaneko  4
Affiliations
Comparative Study

Association Between Transcatheter Aortic Valve Replacement for Bicuspid vs Tricuspid Aortic Stenosis and Mortality or Stroke

Raj R Makkar et al. JAMA. .

Abstract

Importance: Transcatheter 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.

Objective: To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis.

Design, setting, and participants: Registry-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.

Exposures: TAVR for bicuspid vs tricuspid aortic stenosis.

Main outcomes and measures: Primary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications, valve hemodynamics, and quality of life assessment.

Results: Of 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 relevance: In 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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Conflict of interest statement

Conflict of Interest Disclosures: Dr Makkar reported receiving research grants, consulting and speaker fees from Edwards LifeSciences, Abbott, Medtronic, and Boston Scientific during the course of the study. Dr Leon reported receiving grants and other support from Edwards Lifesciences, Medtronic, and Boston Scientific outside the submitted work. Dr Chakravarty reported receiving support from Edwards Lifesciences, Medtronic, and Abbott during the conduct of the study. Dr Rinaldi reported receiving personal fees from Edwards Lifesciences, Abbott Vascular, Boston Scientific, and Cordis outside the submitted work. Dr Shah reported receiving support from Edwards Lifesciences outside the submitted work. Dr Skipper reported receiving support from Edwards Lifesciences and Medtronic outside the submitted work. Dr Thourani reported receiving grants and personal fees from Edwards Lifesciences outside the submitted work. Dr Babaliaros reported receiving consulting fees from Edwards Lifesciences and Abbott Vascular and having equity in Transmural Systems. Dr Vemulapalli reported receiving grants and personal fees from Boston Scientific; grants from Abbott Vascular, the National Institutes of Health, the Society of Thoracic Surgeons, and the American College of Cardiology; and personal fees from Zafgen, Premiere, and Novella outside the submitted work. Dr Kodali reported receiving grants from Edwards Lifesciences, Medtronic, and Boston Scientific; grants and personal fees from Abbott Vascular; personal fees from Claret Medical, Admedus, and Meril Lifesciences; and nonfinancial support from Dura Biotech and Thubrikar Aortic Valve Inc outside the submitted work. Dr Mack reported receiving nonfinancial support from Edwards Lifesciences, Abbott, and Medtronic outside the submitted work. Dr Tang reported receiving personal fees from Edwards Lifesciences and Medtronic outside the submitted work. Dr Kaneko reported receiving personal fees from Edwards Lifesciences and Medtronic during the conduct of the study and from Abbott Structural Heart and Baylis outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Study Flowchart of Patients Who Underwent Transcatheter Aortic Valve Replacement Therapy
TAVR indicates transcatheter aortic valve replacement.
Figure 2.
Figure 2.. One-Year Cumulative Event Rates of All-Cause Mortality or Stroke Among Patients With Bicuspid and Tricuspid Aortic Stenosis in Unadjusted and Propensity-Matched Cohorts
The P values were obtained from Cox proportional hazards models. In the unadjusted cohort, the median follow-up for the bicuspid group was 44 days (interquartile range [IQR], 31-365 days) and for the tricuspid group, 55 days (IQR, 32-365 days). In the propensity score–matched cohort, the median follow-up for the bicuspid group was 44 days (IQR, 31-365 days) and for the tricuspid, 53 days (IQR, 32-365 days). This is a continuous registry in which all patients will not have reached the 1-year follow-up at any given time point. At 1 year, there were missing data from 1586 patients in the bicuspid group (660 had not completed their first year of follow-up at the time of the analysis; 926, unknown) and 1514 patients in the tricuspid group (684 had not completed their first year of follow-up at the time of the analysis; 830, unknown), which were further assessed in the Centers for Medicare & Medicaid Services linked sensitivity analyses (eFigure 3 in the Supplement).
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