Transcatheter Aortic Valve Replacement in Bicuspid Aortic Valve Disease

Mylotte, Darren; Lefèvre, Thierry; Søndergaard, Lars; Watanabe, Yusuke; Modine, Thomas; Dvir, Danny; Bosmans, Johan; Tchétché, Didier; Kornowski, Ran; Sinning, Jan‐Malte; Thériault-Lauzier, Pascal; O’Sullivan, Cróchán J.; Barbanti, Marco; Debry, Nicolas; Buithieu, Jean; Codner, Pablo; Dorfmeister, Magdalena; Martucci, Giuseppe; Nickenig, Georg; Wenaweser, Peter; Tamburino, Corrado; Grube, Eberhard; Webb, John G.; Windecker, Stephan; Lange, Rüediger; Piazza, Nicolò

doi:10.1016/j.jacc.2014.09.039

Cited by 288 publications

(134 citation statements)

References 42 publications

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“…A multicenter registry of 108 patients reported 30‐day and 1‐year mortality rates of 8.3% and 16.9%, respectively 35. An analysis of 139 low‐ and intermediate‐risk patients (mean STS score 4.9±3.4%) in 12 European centers corroborated these findings with 1‐year mortality of 17.5% 36. Another multicenter observational study comparing TAVR in patients with bicuspid versus tricuspid aortic valves did not demonstrate any difference in 30‐day mortality 40.…”

Section: Do Clinical Trials Of Tavr In Low‐risk Patients Herald the Ementioning

confidence: 84%

“…First, the rate of moderate or severe PVL could be higher. Observational studies have reported PVL rates in bicuspid valves to range from 9.6% to 28.4% 35, 36. However, careful valve sizing using cardiac computed tomography angiography can reduce the incidence of PVL substantially 36.…”

Section: Do Clinical Trials Of Tavr In Low‐risk Patients Herald the Ementioning

confidence: 99%

“…Observational studies have reported PVL rates in bicuspid valves to range from 9.6% to 28.4% 35, 36. However, careful valve sizing using cardiac computed tomography angiography can reduce the incidence of PVL substantially 36. Use of newer‐generation valves that incorporate features to reduce PVL may be particularly advantageous in the setting of bicuspid AS.…”

Section: Do Clinical Trials Of Tavr In Low‐risk Patients Herald the Ementioning

confidence: 99%

“…Use of newer‐generation valves that incorporate features to reduce PVL may be particularly advantageous in the setting of bicuspid AS. Second, the rate of valve embolization could be higher, although the same observational studies suggest that embolization with conversion to open chest surgery occurs rarely in bicuspid AS (2.2–4.0%) 36, 37. Third, the rate of prosthesis–patient mismatch could be higher because the abnormal aortic valve morphology could prevent full expansion of the transcatheter valve 38.…”

Section: Do Clinical Trials Of Tavr In Low‐risk Patients Herald the Ementioning

confidence: 99%

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Transcatheter Aortic Valve Replacement in Intermediate‐ and Low‐Risk Patients

Rogers

Thourani

Waksman

2018

JAHA

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Section: Do Clinical Trials Of Tavr In Low‐risk Patients Herald the Ementioning

confidence: 84%

Section: Do Clinical Trials Of Tavr In Low‐risk Patients Herald the Ementioning

confidence: 99%

Section: Do Clinical Trials Of Tavr In Low‐risk Patients Herald the Ementioning

confidence: 99%

Section: Do Clinical Trials Of Tavr In Low‐risk Patients Herald the Ementioning

confidence: 99%

See 2 more Smart Citations

Transcatheter Aortic Valve Replacement in Intermediate‐ and Low‐Risk Patients

Rogers

Thourani

Waksman

2018

JAHA

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“…BAV disease was an exclusion criterion in fundamental clinical trials to test the safety and efficacy of TAVI, largely because of the unique morphological features and associated aortic pathology of this condition 2, 3. Limited data exist for outcomes from TAVI in BAV and, despite promising single‐center series,4, 5 a recently published multi‐center series raised concerns about the excess of paravalvular regurgitation 6…”

Section: Introductionmentioning

confidence: 99%

Transcatheter aortic valve implantation in an orthotopic heart transplant recipient with bicuspid aortic valve

Akleh

Bandali

Edwards

2018

Clinical Case Reports

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

Makkar

Yoon

Leon

et al. 2019

JAMA

233

143

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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 propensitymatched 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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Transcatheter Aortic Valve Replacement in Bicuspid Aortic Valve Disease

Cited by 288 publications

References 42 publications

Transcatheter Aortic Valve Replacement in Intermediate‐ and Low‐Risk Patients

Transcatheter Aortic Valve Replacement in Intermediate‐ and Low‐Risk Patients

Transcatheter aortic valve implantation in an orthotopic heart transplant recipient with bicuspid aortic valve

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

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