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

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          <div class="section"> <a class="named-anchor" id="ab-jpc190005-1"> <!-- named anchor --> </a> <h5 class="section-title" id="d730072e471">Question</h5> <p id="d730072e473">Are there differences in mortality and stroke between patients who undergo transcatheter aortic valve replacement (TAVR) for bicuspid compared with tricuspid aortic stenosis? </p> </div><div class="section"> <a class="named-anchor" id="ab-jpc190005-2"> <!-- named anchor --> </a> <h5 class="section-title" id="d730072e476">Findings</h5> <p id="d730072e478">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%). </p> </div><div class="section"> <a class="named-anchor" id="ab-jpc190005-3"> <!-- named anchor --> </a> <h5 class="section-title" id="d730072e481">Meaning</h5> <p id="d730072e483">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. </p> </div><div class="section"> <a class="named-anchor" id="ab-jpc190005-4"> <!-- named anchor --> </a> <h5 class="section-title" id="d730072e488">Importance</h5> <p id="d730072e490">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. </p> </div><div class="section"> <a class="named-anchor" id="ab-jpc190005-5"> <!-- named anchor --> </a> <h5 class="section-title" id="d730072e493">Objective</h5> <p id="d730072e495">To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis. </p> </div><div class="section"> <a class="named-anchor" id="ab-jpc190005-6"> <!-- named anchor --> </a> <h5 class="section-title" id="d730072e498">Design, Setting, and Participants</h5> <p id="d730072e500">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. </p> </div><div class="section"> <a class="named-anchor" id="ab-jpc190005-7"> <!-- named anchor --> </a> <h5 class="section-title" id="d730072e503">Exposures</h5> <p id="d730072e505">TAVR for bicuspid vs tricuspid aortic stenosis.</p> </div><div class="section"> <a class="named-anchor" id="ab-jpc190005-8"> <!-- named anchor --> </a> <h5 class="section-title" id="d730072e508">Main Outcomes and Measures</h5> <p id="d730072e510">Primary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications, valve hemodynamics, and quality of life assessment. </p> </div><div class="section"> <a class="named-anchor" id="ab-jpc190005-9"> <!-- named anchor --> </a> <h5 class="section-title" id="d730072e513">Results</h5> <p id="d730072e515">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]; <i>P</i> = .08). </p> </div><div class="section"> <a class="named-anchor" id="ab-jpc190005-10"> <!-- named anchor --> </a> <h5 class="section-title" id="d730072e521">Conclusions and Relevance</h5> <p id="d730072e523">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. </p> </div><p class="first" id="d730072e526">This registry-based cohort study compared mortality and stroke rates among patients with bicuspid and tricuspid aortic stenosis who had undergone TAVR to determine whether advances in technology and in valve devices improved outcomes for patients with bicuspid aortic anatomy. </p>

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          Most cited references18

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          A classification system for the bicuspid aortic valve from 304 surgical specimens.

          In general, classification of a disease has proven to be advantageous for disease management. This may also be valid for the bicuspid aortic valve, because the term "bicuspid aortic valve" stands for a common congenital aortic valve malformation with heterogeneous morphologic phenotypes and function resulting in different treatment strategies. We attempted to establish a classification system based on a 5-year data collection of surgical specimens. Between 1999 and 2003 a precise description of valve pathology was obtained from operative reports of 304 patients with a diseased bicuspid aortic valve. Several different characteristics of bicuspid aortic valves were tested to generate a pithy and easily applicable classification system. Three characteristics for a systematic classification were found appropriate: (1) number of raphes, (2) spatial position of cusps or raphes, and (3) functional status of the valve. The first characteristic was found to be the most significant and therefore termed "type." Three major types were identified: type 0 (no raphe), type 1 (one raphe), and type 2 (two raphes), followed by two supplementary characteristics, spatial position and function. These characteristics served to classify and codify the bicuspid aortic valves into three categories. Most frequently, a bicuspid aortic valve with one raphe was identified (type 1, n = 269). This raphe was positioned between the left (L) and right (R) coronary sinuses in 216 (type 1, L/R) with a hemodynamic predominant stenosis (S) in 119 (type 1, L/R, S). Only 21 patients had a "purely" bicuspid aortic valve with no raphe (type 0). A classification system for the bicuspid aortic valve with one major category ("type") and two supplementary categories is presented. This classification, even if used in the major category (type) alone, might be advantageous to better define bicuspid aortic valve disease, facilitate scientific communication, and improve treatment.
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            Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study.

            Subclinical leaflet thrombosis of bioprosthetic aortic valves after transcatheter valve replacement (TAVR) and surgical aortic valve replacement (SAVR) has been found with CT imaging. The objective of this study was to report the prevalence of subclinical leaflet thrombosis in surgical and transcatheter aortic valves and the effect of novel oral anticoagulants (NOACs) on the subclinical leaflet thrombosis and subsequent valve haemodynamics and clinical outcomes on the basis of two registries of patients who had CT imaging done after TAVR or SAVR.
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              Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves

              A finding of reduced aortic-valve leaflet motion was noted on computed tomography (CT) in a patient who had a stroke after transcatheter aortic-valve replacement (TAVR) during an ongoing clinical trial. This finding raised a concern about possible subclinical leaflet thrombosis and prompted further investigation.

                Author and article information

                American Medical Association (AMA)
                June 11 2019
                June 11 2019
                : 321
                : 22
                : 2193
                [1 ]Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California
                [2 ]Columbia University Medical Center, New York, New York
                [3 ]Sanger Heart and Vascular Institute, Carolinas Medical Center, Charlotte, North Carolina
                [4 ]Brigham and Women’s Hospital, Boston, Massachusetts
                [5 ]Medstar Heart and Vascular Institute, Washington, DC
                [6 ]Emory University School of Medicine, Atlanta, Georgia
                [7 ]Duke Clinical Research Institute, Durham, North Carolina
                [8 ]Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
                [9 ]Baylor Scott and White Health, Plano, Texas
                [10 ]Mount Sinai Health System, New York, New York
                © 2019


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