John K Forrest1, Ryan K Kaple2, Basel Ramlawi3, Thomas G Gleason4, Christopher U Meduri5, Steven J Yakubov6, Hasan Jilaihawi7, Fang Liu8, Michael J Reardon9. 1. Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut. Electronic address: john.k.forrest@yale.edu. 2. Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut. 3. Department of Cardiothoracic Surgery, Valley Health System, Winchester, Virginia. 4. Department of Cardiothoracic Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. 5. Department of Interventional Cardiology, Piedmont Heart Institute, Atlanta, Georgia. 6. Department of Interventional Cardiology, Riverside Methodist-Ohio Health, Columbus, Ohio. 7. Heart Valve Center, New York University Langone Health, New York, New York. 8. Department of Statistics, Medtronic, Minneapolis, Minnesota. 9. Department of Cardiothoracic Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.
Abstract
OBJECTIVES: This study sought to compare outcomes in patients with bicuspid versus tricuspid anatomy undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: TAVR has shown excellent safety and efficacy in patients with tricuspid aortic valve stenosis, but limited data are available on the use of self-expanding valves in patients with bicuspid valves. METHODS: The Society of Thoracic Surgeons/American College of Cardiology TVT Registry was used to analyze patients who underwent TAVR with the Evolut R or Evolut PRO valves. Clinical and echocardiographic outcomes were analyzed through 1-year follow-up. RESULTS: Between July 2015 and September 2018 a total of 932 patients with bicuspid aortic valve stenosis underwent elective TAVR with the self-expanding Evolut R or Evolut PRO valve. These patients were compared with a group of 26,154 patients with tricuspid aortic stenosis who underwent TAVR during that same time period. At baseline, patients with bicuspid valves were younger, had fewer cardiac comorbidities, and had lower Society of Thoracic Surgeons Predicted Risk of Mortality scores (5.3 ± 4.2% vs. 6.9 ± 4.8%; p < 0.001). To account for these differences, propensity matching was performed, which resulted in 929 matched pairs. Within these match groups, the rates of all-cause mortality at 30 days (2.6% vs. 1.7%; p = 0.18) and 1 year (10.4% vs. 12.1%; p = 0.63), as well the rate of stroke at 30 days (3.4% vs. 2.7%; p = 0.41) and 1 year (3.9% vs. 4.4%; p = 0.93), were comparable. CONCLUSIONS: All-cause mortality, stroke, and valve hemodynamics did not differ at 30 days or 1 year between patient groups. In patients at increased surgical risk, TAVR for bicuspid aortic valve stenosis indicates acceptable safety outcomes with low complications rates.
OBJECTIVES: This study sought to compare outcomes in patients with bicuspid versus tricuspid anatomy undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: TAVR has shown excellent safety and efficacy in patients with tricuspid aortic valve stenosis, but limited data are available on the use of self-expanding valves in patients with bicuspid valves. METHODS: The Society of Thoracic Surgeons/American College of Cardiology TVT Registry was used to analyze patients who underwent TAVR with the Evolut R or Evolut PRO valves. Clinical and echocardiographic outcomes were analyzed through 1-year follow-up. RESULTS: Between July 2015 and September 2018 a total of 932 patients with bicuspid aortic valve stenosis underwent elective TAVR with the self-expanding Evolut R or Evolut PRO valve. These patients were compared with a group of 26,154 patients with tricuspid aortic stenosis who underwent TAVR during that same time period. At baseline, patients with bicuspid valves were younger, had fewer cardiac comorbidities, and had lower Society of Thoracic Surgeons Predicted Risk of Mortality scores (5.3 ± 4.2% vs. 6.9 ± 4.8%; p < 0.001). To account for these differences, propensity matching was performed, which resulted in 929 matched pairs. Within these match groups, the rates of all-cause mortality at 30 days (2.6% vs. 1.7%; p = 0.18) and 1 year (10.4% vs. 12.1%; p = 0.63), as well the rate of stroke at 30 days (3.4% vs. 2.7%; p = 0.41) and 1 year (3.9% vs. 4.4%; p = 0.93), were comparable. CONCLUSIONS: All-cause mortality, stroke, and valve hemodynamics did not differ at 30 days or 1 year between patient groups. In patients at increased surgical risk, TAVR for bicuspid aortic valve stenosis indicates acceptable safety outcomes with low complications rates.
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