John K Forrest1, Abeel A Mangi2, Jeffrey J Popma3, Kamal Khabbaz3, Michael J Reardon4, Neal S Kleiman4, Steven J Yakubov5, Daniel Watson5, Susheel Kodali6, Isaac George6, Peter Tadros7, George L Zorn7, John Brown8, Robert Kipperman8, Sara Saul9, Hongyan Qiao9, Jae K Oh10, Mathew R Williams11. 1. Departments of Internal Medicine (Cardiology) and Surgery (Cardiac Surgery), Yale University School of Medicine, New Haven, Connecticut. Electronic address: john.k.forrest@yale.edu. 2. Departments of Internal Medicine (Cardiology) and Surgery (Cardiac Surgery), Yale University School of Medicine, New Haven, Connecticut. 3. Departments of Internal Medicine (Cardiovascular Division) and Surgery (Cardiovascular Surgery), Beth Israel Deaconess Medical Center, Boston, Massachusetts. 4. Departments of Cardiothoracic Surgery and Cardiology, Houston Methodist DeBakey Heart & Vascular Center, Houston, Texas. 5. Departments of Cardiac Surgery and Interventional Cardiology, Riverside Methodist Hospital, Columbus, Ohio. 6. Departments of Cardiology and Cardiac Surgery, Columbia University-New York Presbyterian, New York, New York. 7. Departments of Cardiology and Cardiac Surgery, University of Kansas, Kansas City, Missouri. 8. Departments of Cardiology and Cardiac Surgery, Morristown Hospital, Morristown, New Jersey. 9. Department of Statistical Services, Medtronic, Minneapolis, Minnesota. 10. Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota. 11. Department of Cardiothoracic Surgery, New York University-Langone Medical Center, New York, New York.
Abstract
OBJECTIVES: This study sought to evaluate the Medtronic Evolut PRO Transcatheter Aortic Valve System in patients with severe symptomatic aortic stenosis. BACKGROUND: A next-generation self-expanding transcatheter aortic valve was designed with an external pericardial wrap with the intent to reduce paravalvular leak while maintaining the benefits of a low-profile, self-expanding, and repositionable supra-annular valve. METHODS: The Medtronic Evolut PRO Clinical Study included 60 patients undergoing transcatheter aortic valve replacement with the Evolut PRO valve at 8 investigational sites in the United States. Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria. The 2 primary safety endpoints were the incidence of all-cause mortality at 30 days and the incidence of disabling stroke at 30 days. The primary efficacy endpoint was the proportion of patients with no or trace prosthetic valve regurgitation at 30 days. An independent echocardiographic core laboratory (Mayo Clinic, Rochester, Minnesota) was used to adjudicate all echocardiographic assessments. RESULTS: All 60 patients received the Evolut PRO valve. At 30 days, 1 patient (1.7%) died and 1 patient (1.7%) experienced a nonfatal disabling stroke. Paravalvular regurgitation at 30 days was absent or trace in 72.4% of patients and was mild in the remainder of patients, with no patients having worse than mild paravavlular leak. The mean atrioventricular gradient was 6.4 ± 2.1 mm Hg and effective orifice area was 2.0 ± 0.5 cm2 at 30 days. CONCLUSIONS: The safety and efficacy results of this study support the use of the Evolut PRO System for the treatment of severe symptomatic aortic stenosis in patients who are at increased surgical risk, resulting in excellent hemodynamics and minimal paravalvular leak (The Medtronic TAVR 2.0 US Clinical Study; NCT02738853).
OBJECTIVES: This study sought to evaluate the Medtronic Evolut PRO Transcatheter Aortic Valve System in patients with severe symptomatic aortic stenosis. BACKGROUND: A next-generation self-expanding transcatheter aortic valve was designed with an external pericardial wrap with the intent to reduce paravalvular leak while maintaining the benefits of a low-profile, self-expanding, and repositionable supra-annular valve. METHODS: The Medtronic Evolut PRO Clinical Study included 60 patients undergoing transcatheter aortic valve replacement with the Evolut PRO valve at 8 investigational sites in the United States. Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria. The 2 primary safety endpoints were the incidence of all-cause mortality at 30 days and the incidence of disabling stroke at 30 days. The primary efficacy endpoint was the proportion of patients with no or trace prosthetic valve regurgitation at 30 days. An independent echocardiographic core laboratory (Mayo Clinic, Rochester, Minnesota) was used to adjudicate all echocardiographic assessments. RESULTS: All 60 patients received the Evolut PRO valve. At 30 days, 1 patient (1.7%) died and 1 patient (1.7%) experienced a nonfatal disabling stroke. Paravalvular regurgitation at 30 days was absent or trace in 72.4% of patients and was mild in the remainder of patients, with no patients having worse than mild paravavlular leak. The mean atrioventricular gradient was 6.4 ± 2.1 mm Hg and effective orifice area was 2.0 ± 0.5 cm2 at 30 days. CONCLUSIONS: The safety and efficacy results of this study support the use of the Evolut PRO System for the treatment of severe symptomatic aortic stenosis in patients who are at increased surgical risk, resulting in excellent hemodynamics and minimal paravalvular leak (The Medtronic TAVR 2.0 US Clinical Study; NCT02738853).
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