Sam Brusco, Associate Editor05.19.21
Edwards Lifesciences released real-world study results comparing outcomes for bicuspid aortic stenosis (AS) patients treated with SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Aortic Valve Replacement (TAVR) and at low risk for surgery. The data show excellent outcomes at one year, with low rates of death and stroke, and no significant differences in the primary outcomes compared with the overall cohort, or those with tricuspid aortic valve disease.
The analysis comparing real-world data of bicuspid and tricuspid AS patients collected from the Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry was presented during the EuroPCR 2021 late-breaking clinical trials hotline session by Raj Makkar, M.D., Director, Interventional Cardiology, Associate Director, Smidt Heart Institute at Cedars Sinai Medical Center.
"I am encouraged to see these data reflect the favorable outcomes we've witnessed to date in bicuspid patients treated with SAPIEN 3 TAVR, including very low rates of death and stroke, significant and similar improvements in functional status and quality of life, and high procedural success rates," Makkar told the press. "With bicuspid aortic valve disease as another anatomical consideration in the treatment of TAVR patients, these SAPIEN 3 data are encouraging and crucial for guiding treatment, particularly for younger patients."
The all-cause mortality rate for bicuspid valves was low and similar at 1 year when compared to those with tricuspid valve disease (4.6 versus 6.6 percent) as were stroke rates at 1 year (2.0 versus 2.1 percent). Outcomes data from the TVT Registry also demonstrated a low rate of significant paravalvular leak, as well as significant and similar improvements in functional status and quality of life measures.
"These SAPIEN 3 data provide further evidence and confidence for physicians in treating their patients with bicuspid valves who prefer TAVR as an option to open-heart surgery," said Larry L. Wood, Edwards' corporate vice president, transcatheter aortic valve replacement. "This supports recent American College of Cardiology/American Heart Association guidelines that recommend the importance of shared decision-making with patients based on the robust clinical evidence that show both TAVR and surgical treatment options should be considered for all patients 65 years and older."
The analysis comparing real-world data of bicuspid and tricuspid AS patients collected from the Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry was presented during the EuroPCR 2021 late-breaking clinical trials hotline session by Raj Makkar, M.D., Director, Interventional Cardiology, Associate Director, Smidt Heart Institute at Cedars Sinai Medical Center.
"I am encouraged to see these data reflect the favorable outcomes we've witnessed to date in bicuspid patients treated with SAPIEN 3 TAVR, including very low rates of death and stroke, significant and similar improvements in functional status and quality of life, and high procedural success rates," Makkar told the press. "With bicuspid aortic valve disease as another anatomical consideration in the treatment of TAVR patients, these SAPIEN 3 data are encouraging and crucial for guiding treatment, particularly for younger patients."
The all-cause mortality rate for bicuspid valves was low and similar at 1 year when compared to those with tricuspid valve disease (4.6 versus 6.6 percent) as were stroke rates at 1 year (2.0 versus 2.1 percent). Outcomes data from the TVT Registry also demonstrated a low rate of significant paravalvular leak, as well as significant and similar improvements in functional status and quality of life measures.
"These SAPIEN 3 data provide further evidence and confidence for physicians in treating their patients with bicuspid valves who prefer TAVR as an option to open-heart surgery," said Larry L. Wood, Edwards' corporate vice president, transcatheter aortic valve replacement. "This supports recent American College of Cardiology/American Heart Association guidelines that recommend the importance of shared decision-making with patients based on the robust clinical evidence that show both TAVR and surgical treatment options should be considered for all patients 65 years and older."