Author + information
- Received July 27, 2018
- Revision received August 3, 2018
- Accepted August 3, 2018
- Published online August 28, 2018.
- Ron Waksman, MDa,∗ (, )@ron_waksman@MedstarHealth,
- Toby Rogers, MD, PhDa,
- Rebecca Torguson, MPHa,
- Paul Gordon, MDb,
- Afshin Ehsan, MDb,
- Sean R. Wilson, MDc,
- John Goncalves, MDc,
- Robert Levitt, MDd,
- Chiwon Hahn, MDd,
- Puja Parikh, MDe,
- Thomas Bilfinger, MD, ScDe,
- David Butzel, MDf,
- Scott Buchanan, MDf,
- Nicholas Hanna, MDg,
- Robert Garrett, MDg,
- Federico Asch, MDa,
- Gaby Weissman, MDa,
- Itsik Ben-Dor, MDa,
- Christian Shults, MDa,
- Roshni Bastian, MPH, MBAa,
- Paige E. Craig, MPHa,
- Hector M. Garcia-Garcia, MDa,
- Paul Kolm, PhDa,
- Quan Zou, PhDa,
- Lowell F. Satler, MDa and
- Paul J. Corso, MDa
- aMedStar Washington Hospital Center, Washington, DC
- bThe Miriam Hospital, Providence, Rhode Island
- cThe Valley Hospital, Ridgewood, New Jersey
- dHenrico Doctors’ Hospital, Richmond, Virginia
- eStony Brook Hospital, Stony Brook, New York
- fMaine Medical Center, Portland, Maine
- gSt. John Health System, Tulsa, Oklahoma
- ↵∗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 now standard of care for patients with symptomatic severe aortic stenosis who are extreme, high or intermediate risk for surgical aortic valve replacement (SAVR).
Objectives To evaluate TAVR in a prospective multicenter trial involving low-risk patients.
Methods The Low Risk TAVR trial was the first FDA-approved Investigational Device Exemption trial to enroll in the US. This investigator-led trial was a prospective, multicenter, unblinded, comparison to historical controls from the Society of Thoracic Surgeons (STS) database. The primary endpoint was all-cause mortality at 30 days.
Results We enrolled 200 low-risk patients with symptomatic severe aortic stenosis at 11 centers to undergo TAVR. We compared outcomes with an inverse probability weighting adjusted control cohort of 719 patients who underwent SAVR at the same institutions using the STS database. At 30 days, there was zero all-cause mortality in the TAVR group versus 1.7% mortality in the SAVR group. There was zero in-hospital stroke in the TAVR group versus 0.6% stroke in the SAVR group. Permanent pacemaker implantation rates were similar between TAVR and SAVR (5.0% versus 4.5%). The rates of new onset atrial fibrillation (3.0%) and length of stay (2.0±1.1days) were low in the TAVR group. One patient (0.5%) in the TAVR group had >mild paravalvular leak at 30 days. Fourteen percent of TAVR patients had evidence of subclinical leaflet thrombosis at 30 days.
Conclusions TAVR is safe in low-risk patients with symptomatic severe aortic stenosis, with low procedural complication rates, short hospital length of stay, zero mortality, and zero disabling stroke at 30 days. Subclinical leaflet thrombosis was observed in a minority of TAVR patients at 30 days.
Funding: Funded by MedStar Health Research Institute, Washington, DC; NCT 02628899.
Disclosures: Waksman: Advisory Board: Abbott Vascular, Amgen, Boston Scientific, Medtronic, Philips Volcano, Pi-Cardia Ltd., Cardioset; Consultant: Abbott Vascular, Amgen, Biosensors, Biotronik, Boston Scientific, Medtronic, Philips Volcano, Pi-Cardia Ltd., Cardioset; Grant Support: Abbott Vascular, AstraZeneca, Biosensors, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance; Rogers: Consultant & Proctor: Medtronic; Proctor: Edwards Lifesciences; Goncalves: Proctor: Medtronic; Hanna: Speaker: Edwards. Asch: Director of an academic cardiovascular imaging core lab with institutional contracts with Edwards, Medtronic, Boston Scientific, Biotronik and Abbott; Weissman: Director of an academic cardiovascular imaging core lab with institutional contracts with Boston Scientific, Ancora Heart. LivaNova, and HDL Therapeutics. All other authors have no relationships with industry to disclose.
Proposed tweet: ‘LRT trial shows TAVR is safe in low-risk patients with symptomatic severe aortic stenosis, with zero mortality and zero disabling stroke at 30 days’
Clinical Trial: NCT 02628899
- Received July 27, 2018.
- Revision received August 3, 2018.
- Accepted August 3, 2018.