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

Educational Objective
To learn about transcatheter aortic valve replacement for patients with aortic stenosis.
1 Credit CME
Key Points

Question  Are there differences in mortality and stroke between patients who undergo transcatheter aortic valve replacement (TAVR) for bicuspid compared with tricuspid aortic stenosis?

Findings  In this registry-based cohort study that included 2691 propensity-score matched pairs of patients undergoing TAVR for bicuspid vs tricuspid aortic stenosis, there was no statistically significant difference in 30-day mortality (2.6% vs 2.5%; respectively) or 1-year mortality (10.5% vs 12.0%). However, the 30-day risk of stroke was significantly greater among those with bicuspid aortic stenosis (2.5% vs 1.6%).

Meaning  Patients who underwent TAVR for bicuspid aortic stenosis compared with tricuspid aortic stenosis had no significant difference in mortality, but had increased 30-day risk of stroke; because of the potential for selection bias, randomized trials would be needed to adequately assess the efficacy and safety of TAVR for bicuspid aortic stenosis.

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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Article Information

Corresponding Author: Raj R. Makkar, MD, Smidt Heart Institute, Cedars-Sinai Medical Center, 8700 Beverly Blvd, Los Angeles, CA 90048 (Raj.Makkar@cshs.org).

Accepted for Publication: May 9, 2019.

Author Contributions: Dr Makkar had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Makkar, Yoon, Leon, Rinaldi, Shah, Skipper, Thourani, Cheng, Trento, Tang, Kaneko.

Acquisition, analysis, or interpretation of data: Makkar, Yoon, Chakravarty, Shah, Babaliaros, Vemulapalli, Kapadia, Kodali, Mack, Tang.

Drafting of the manuscript: Makkar, Yoon, Chakravarty, Shah, Skipper, Tang.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Makkar, Yoon, Chakravarty.

Administrative, technical, or material support: Shah, Vemulapalli, Tang.

Supervision: Makkar, Leon, Rinaldi, Skipper, Thourani, Babaliaros, Cheng, Trento, Kapadia.

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.

Funding/Support: The Transcatheter Valve Therapy Registry is an initiative of the Society of Thoracic Surgeons and the American College of Cardiology. This research was supported by Edwards Lifesciences.

Role of the Funder/Sponsor: Edwards Lifesciences had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The statistical analysis of the data was supported by the sponsor.

Disclaimer: The views or opinions presented herein are solely those of authors and do not represent those of the American College of Cardiology, the Society of Thoracic Surgeons, or the STS/ACC TVT Registry.

Additional Contributions: We thank Faouzi Kallel, PhD (Edwards Lifesciences) for ensuring technical accuracy of the manuscript; Ke Xu, PhD (Edwards Lifesciences) and Heidi Gransar, MS (Smidt Heart Institute at Cedars-Sinai Medical Center) for assistance with the statistical analysis; and Angila Sewal, PhD (Edwards Lifesciences) for formatting tables and figures for the manuscript. No one received compensation for their role in this study.

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