Author + information
- Ron Waksman, MDa,∗ (, )
- Paul J. Corso, MDb,
- Rebecca Torguson, MPHa,
- Paul Gordon, MDc,
- Afshin Ehsan, MDd,
- Sean R. Wilson, MDe,
- John Goncalves, MDf,
- Robert Levitt, MDg,
- Chiwon Hahn, MDh,
- Puja Parikh, MDi,
- Thomas Bilfinger, MD, ScDj,
- David Butzel, MDk,
- Scott Buchanan, MDk,
- Nicholas Hanna, MDl,
- Robert Garrett, MDm,
- Maurice Buchbinder, MDn,
- Federico Asch, MDo,
- Gaby Weissman, MDp,
- Itsik Ben-Dor, MDa,
- Christian Shults, MDb,
- Roshni Bastian, MPH, MBAa,
- Paige E. Craig, MPHa,
- Syed Ali, MBBSa,
- Hector M. Garcia-Garcia, MDa,
- Paul Kolm, PhDa,
- Quan Zou, PhDa,
- Lowell F. Satler, MDa and
- Toby Rogers, MD, PhDa
- aSection of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC
- bDepartment of Cardiac Surgery, MedStar Washington Hospital Center, Washington, DC
- cDivision of Cardiology, The Miriam Hospital, Providence, RI
- dDivision of Cardiothoracic Surgery, Lifespan Cardiovascular Institute, Providence, RI
- eDepartment of Medicine, The Valley Hospital, Ridgewood, NJ
- fCardiac Surgery Program, The Valley Hospital, Ridgewood, NJ
- gDepartment of Cardiology, Henrico Doctors’ Hospital, Richmond, VA
- hDepartment of Cardiothoracic Surgery, Henrico Doctors’ Hospital, Richmond, VA
- iDepartment of Medicine, Stony Brook Hospital, Stony Brook, NY
- jDepartment of Surgery, Stony Brook Hospital, Stony Brook, NY
- kCardiovascular Service Line, Maine Medical Center, Portland, ME
- lSt. John Heart Institute Cardiovascular Consultants, St. John Health System, Tulsa, OK
- mSt. John Clinic Cardiovascular Surgery, St. John Heart Institute Cardiovascular Consultants, St. John Health System, Tulsa, OK
- nFoundation for Cardiovascular Medicine, Stanford University, Stanford, CA
- oMedStar Health Research Institute, MedStar Washington Hospital Center, Washington, DC
- pDepartment of Cardiology, MedStar Washington Hospital Center, Washington, DC
- ↵∗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
Objectives To evaluate clinical outcomes and transcatheter heart valve hemodynamics at 1 year after transcatheter aortic valve replacement (TAVR) in low-risk patients.
Background Early results from the Low Risk TAVR (LRT) trial demonstrated that TAVR is safe in patients with symptomatic severe aortic stenosis (AS) who are low risk for surgical valve replacement.
Methods The LRT trial was an investigator-initiated, prospective, multicenter study and was the first Food and Drug Administration-approved Investigational Device Exemption trial to evaluate feasibility of TAVR in low-risk patients. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included clinical outcomes and valve hemodynamics at 1 year.
Results The LRT trial enrolled 200 low-risk patients with symptomatic severe AS to undergo TAVR at 11 centers. Mean age was 73.6 years and 61.5% were male. At 30 days, there was zero mortality, zero disabling stroke, and low permanent pacemaker implantation rate (5.0%), At 1-year follow-up, mortality was 3.0%, stroke rate was 2.1%, and permanent pacemaker implantation rate was 7.3%. Two subjects (1.0%) underwent surgical reintervention for endocarditis. Of the 14% of TAVR subjects who had evidence of hypoattenuated leaflet thickening at 30 days, there was no impact on valve hemodynamics at 1 year, but the stroke rate was numerically higher (3.8% vs. 1.9%, p=0.53).
Conclusions TAVR in low-risk patients with symptomatic severe AS appears to be safe at 1 year. Hypoattenuated leaflet thickening, observed in a minority of TAVR patients at 30 days, did not impact valve hemodynamics in the longer term.
- Low Risk
- Aortic Stenosis
- Transcatheter Aortic Valve Replacement
- Subclinical Leaflet Thrombosis
- Hypoattenuated Leaflet Thickening
Ron 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.
Toby Rogers – Consultant & Proctor: Medtronic; Proctor: Edwards Lifesciences.
John Goncalves – Proctor: Medtronic.
Nicholas Hanna – Speaker: Edwards.
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.
All other authors have no relationships with industry to disclose.
- Received January 31, 2019.
- Revision received March 7, 2019.
- Accepted March 7, 2019.
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