Author + information
- Received February 4, 2020
- Accepted February 4, 2020
- Published online February 24, 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 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, RI
- eDivision of Cardiothoracic Surgery, Lifespan Cardiovascular Institute, Providence, RI
- fDepartment of Medicine, Stony Brook Hospital, Stony Brook, NY
- gDepartment of Surgery, Stony Brook Hospital, Stony Brook, NY
- hDepartment of Cardiology, Henrico Doctors’ HospitalRichmond, VA
- iDepartment of Cardiothoracic Surgery, Henrico Doctors’ Hospital, Richmond, VA
- jSutter Medical Center, Sacramento, Sutter Heart and Vascular Institute, Research, Sacramento, CA
- kSt. John Heart Institute Cardiovascular Consultants, St. John Health System, Tulsa, OK
- lSt. John Clinic Cardiovascular Surgery, St. John Heart Institute Cardiovascular Consultants, St. John Health System, Tulsa, OK
- mDepartment of Cardiac Surgery, MedStar Washington Hospital Center, Washington, DC
- nCardiovascular Branch, Division of Intramural Research, National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland
- ↵∗∗Address for Correspondence: Ron Waksman, MD MedStar Washington Hospital Center 110 Irving St., NW, Suite 4B-1 Washington, DC 20010 Phone: 202-877-2812 Fax: 202-877-2715
Background Transcatheter aortic valve replacement (TAVR) is approved for low-risk patients in the US. However, patients with bicuspid aortic stenosis (AS) were excluded from the randomized cohorts of the pivotal low-risk trials.
Objectives We aimed to evaluate clinical outcomes and transcatheter heart valve hemodynamics after TAVR in low-risk bicuspid AS patients.
Methods The Low Risk TAVR (LRT) trial was an investigator-initiated, prospective, multicenter study and was the first and only Food and Drug Administration-approved Investigational Device Exemption trial to evaluate feasibility of TAVR with either balloon-expandable or self-expanding valve in low-risk bicuspid AS patients. 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 7 centers from 2016 to 2019. Mean age was 68.6 years and 42.6% were male. At 30 days, there was zero mortality and zero disabling stroke. New permanent pacemaker implantation rate was 13.1%; just one patient had 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 bicuspid AS patients, with short hospital length of stay, zero mortality, and zero disabling stroke 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 Low Risk TAVR (LRT) trial, NCT02628899, was funded by MedStar Health Research Institute, Washington, DC.
Ron Waksman: Consultant: Abbott Vascular, Biosensors International, Biotronik, Boston Scientific, Medtronic Vascular, Symetis, Lifetech; Speakers Bureau: AstraZeneca, Boston Scientific, Biotronik, Abbott Vascular; Grant Support: Biosensors International, Biotronik, Boston Scientific, Edwards Lifesciences, Abbott Vascular.
Federico Asch – Director of an academic cardiovascular imaging core lab with institutional contracts with Edwards, Medtronic, Boston Scientific, Biotronik and Abbott. Gaby Weissman – Director of an academic cardiovascular imaging core lab with institutional contracts with Boston Scientific, Ancora Heart. LivaNova, and HDL Therapeutics.
Nicholas Hanna – Speaker: Edwards.
Lowell Satler: Speakers Bureau: AstraZeneca.
Toby Rogers: Consultant and Proctor: Edwards Lifesciences, Medtronic
All other authors have no conflicts to disclose.
Tweet/handle: @ron_waksman; LRT trial shows TAVR is safe in low-risk bicuspid patients with symptomatic severe AS, with zero mortality and zero disabling stroke at 30 days
- Received February 4, 2020.
- Accepted February 4, 2020.
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