Author + information
- Received February 4, 2020
- Accepted February 4, 2020
- Published online May 4, 2020.
- Ron Waksman, MDa,∗ (, )
- Paige E. Craig, MPHa,
- Rebecca Torguson, MPHa,
- Federico M. Asch, MDb,
- Gaby Weissman, MDc,
- Daniel Ruiz, MDa,
- Paul Gordon, MDd,
- Afshin Ehsan, MDe,
- Puja Parikh, MDf,
- Thomas Bilfinger, MDg,
- Robert Levitt, MDh,
- Chiwon Hahn, MDi,
- David Roberts, MDj,
- Michael Ingram, MDj,
- Nicholas Hanna, MDk,
- George Comas, MDl,
- Cheng Zhang, PhDa,
- Itsik Ben-Dor, MDa,
- Lowell F. Satler, MDa,
- Hector M. Garcia-Garcia, MD, PhDa,
- Christian Shults, MDm and
- Toby Rogers, MD, PhDa,n
- aSection of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia
- bMedStar Health Research Institute, MedStar Washington Hospital Center, Washington, District of Columbia
- cDepartment of Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia
- dDivision of Cardiology, The Miriam Hospital, Providence, Rhode Island
- eDivision of Cardiothoracic Surgery, Lifespan Cardiovascular Institute, Providence, Rhode Island
- fDepartment of Medicine, Stony Brook Hospital, Stony Brook, New York
- gDepartment of Surgery, Stony Brook Hospital, Stony Brook, New York
- hDepartment of Cardiology, Henrico Doctors’ Hospital, Richmond, Virginia
- iDepartment of Cardiothoracic Surgery, Henrico Doctors’ Hospital, Richmond, Virginia
- jSutter Medical Center, Sacramento, Sutter Heart and Vascular Institute, Research, Sacramento, California
- kSt. John Heart Institute Cardiovascular Consultants, St. John Health System, Tulsa, Oklahoma
- lSt. John Clinic Cardiovascular Surgery, St. John Heart Institute Cardiovascular Consultants, St. John Health System, Tulsa, Oklahoma
- mDepartment of Cardiac Surgery, MedStar Washington Hospital Center, Washington, District of Columbia
- nCardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland
- ↵∗Address for correspondence:
Dr. Ron Waksman, MedStar Washington Hospital Center, 110 Irving Street, NW, Suite 4B-1, Washington, DC 20010.
Objectives The aim of this study was to evaluate clinical outcomes and transcatheter heart valve hemodynamic parameters after transcatheter aortic valve replacement (TAVR) in low-risk patients with bicuspid aortic stenosis (AS).
Background TAVR is approved for low-risk patients in the United States. However, patients with bicuspid AS were excluded from the randomized cohorts of the pivotal low-risk trials.
Methods The LRT (Low Risk TAVR) trial was an investigator-initiated, prospective, multicenter study and was the first and only U.S. Food and Drug Administration–approved investigational device exemption trial to evaluate the feasibility of TAVR with either balloon-expandable or self-expanding valves in low-risk patients with bicuspid AS. The primary endpoint was all-cause mortality at 30 days. Baseline and follow-up echocardiography and computed tomography to detect leaflet thickening were analyzed in an independent core laboratory.
Results Sixty-one low-risk patients with symptomatic, severe AS and bicuspid aortic valves (78.3% Sievers type 1 morphology) underwent TAVR at 6 centers from 2016 to 2019. The mean age was 68.6 years, and 42.6% were men. At 30 days, there was zero mortality and no disabling strokes. The rate of new permanent pacemaker implantation was 13.1%; just 1 patient had a moderate paravalvular leak at 30 days. Hypoattenuated leaflet thickening was observed in 10% of patients at 30 days.
Conclusions TAVR appears to be safe in patients with bicuspid AS, with short length of hospital stay, zero mortality, and no disabling strokes at 30 days. Subclinical leaflet thrombosis was observed in a minority of patients at 30 days but did not appear to be associated with clinical events.
The LRT trial (NCT02628899) was funded by MedStar Health Research Institute. Dr. Waksman is a consultant for Abbott Vascular, Biosensors International, Biotronik, Boston Scientific, Medtronic Vascular, Symetis, and Lifetech; is a member of the Speakers Bureau for AstraZeneca, Boston Scientific, Biotronik, and Abbott Vascular; and has received grant support from Biosensors International, Biotronik, Boston Scientific, Edwards Lifesciences, and Abbott Vascular. Dr. Asch is director of an academic cardiovascular imaging core laboratory with institutional contracts with Edwards Lifesciences, Medtronic, Boston Scientific, Biotronik, LivaNova, and Abbott. Dr. Weissman is director of an academic cardiovascular imaging core laboratory with institutional contracts with Boston Scientific, Ancora Heart, LivaNova, and HDL Therapeutics. Dr. Parikh is a consultant for Medtronic. Dr. Roberts is a consultant and proctor for Edwards Lifesciences. Dr. Hanna is a speaker for Edwards Lifesciences. Dr. Satler is a member of the Speakers Bureau for AstraZeneca. Dr. Rogers is a consultant and proctor for Edwards Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.
- Received February 4, 2020.
- Accepted February 4, 2020.
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