Author + information
- Received September 15, 2017
- Revision received October 5, 2017
- Accepted October 10, 2017
- Published online January 15, 2018.
- John K. Forrest, MDa,∗ (, )
- Abeel A. Mangi, MDa,
- Jeffrey J. Popma, MDb,
- Kamal Khabbaz, MDb,
- Michael J. Reardon, MDc,
- Neal S. Kleiman, MDc,
- Steven J. Yakubov, MDd,
- Daniel Watson, MDd,
- Susheel Kodali, MDe,
- Isaac George, MDe,
- Peter Tadros, MDf,
- George L. Zorn III, MDf,
- John Brown, MDg,
- Robert Kipperman, MDg,
- Sara Saul, PhDh,
- Hongyan Qiao, PhDh,
- Jae K. Oh, MDi and
- Mathew R. Williams, MDj
- aDepartments of Internal Medicine (Cardiology) and Surgery (Cardiac Surgery), Yale University School of Medicine, New Haven, Connecticut
- bDepartments of Internal Medicine (Cardiovascular Division) and Surgery (Cardiovascular Surgery), Beth Israel Deaconess Medical Center, Boston, Massachusetts
- cDepartments of Cardiothoracic Surgery and Cardiology, Houston Methodist DeBakey Heart & Vascular Center, Houston, Texas
- dDepartments of Cardiac Surgery and Interventional Cardiology, Riverside Methodist Hospital, Columbus, Ohio
- eDepartments of Cardiology and Cardiac Surgery, Columbia University–New York Presbyterian, New York, New York
- fDepartments of Cardiology and Cardiac Surgery, University of Kansas, Kansas City, Missouri
- gDepartments of Cardiology and Cardiac Surgery, Morristown Hospital, Morristown, New Jersey
- hDepartment of Statistical Services, Medtronic, Minneapolis, Minnesota
- iDepartment of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota
- jDepartment of Cardiothoracic Surgery, New York University-Langone Medical Center, New York, New York
- ↵∗Address for correspondence:
Dr. John K. Forrest, 789 Howard Avenue, Dana 3-Cardiology Section, New Haven, Connecticut 06519.
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)
Funded by Medtronic, Minneapolis, Minnesota. Dr. Forrest has received grant support/research contracts and consultant fees/honoraria/speakers bureau fees from Edwards Lifesciences and Medtronic. Dr. Mangi has received speaking fees and consulting fees from Thoratec Corporation; and speaking, training, and proctoring fees from Medtronic Corporation and Edwards LifeSciences. Dr. Popma has received grants from Medtronic, Boston Scientific, Abbott Vascular, and Direct Flow Medical; and serves on the medical advisory board of Boston Scientific and Cordis. Dr. Reardon serves on an advisory board for Medtronic. Dr. Kleiman has received fees for providing educational services from Medtronic. Dr. Yakubov has received institutional research grants from Medtronic, Direct Flow Medical, and Boston Scientific; and serves on an advisory board for Medtronic and Boston Scientific. Dr. Watson serves on the speakers bureau and is a proctor for Boston Scientific, Edwards, Medtronic, and Liva Nova. Dr. Kodali has received grant/research support from Boston Scientific, Claret Medical, Edwards Lifesciences, and Medtronic; serves on the steering committee for Claret Medical, Edwards Lifesciences, and Meril; holds equity in Thubrikar Aortic Valve and Dura Biotech; and received honoraria from Claret Medical and St. Jude Medical. Dr. George is a consultant for Medtronic. Dr. Tadros is a consultant and proctor and has received research support from Medtronic and St. Jude Medical. Dr. Zorn receives consulting fees from Medtronic. Dr. Kipperman is a consultant for Medtronic. Dr. Saul is an employee and shareholder of Medtronic. Dr. Qiao is an employee and shareholder of Medtronic. Dr. Williams serves as a consultant for Edwards Lifesciences and Medtronic; as a speaker for Abbott Laboratories; and has received research grants from Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 15, 2017.
- Revision received October 5, 2017.
- Accepted October 10, 2017.
- 2018 American College of Cardiology Foundation