Author + information
- Received January 31, 2019
- Revision received March 7, 2019
- Accepted March 7, 2019
- Published online May 20, 2019.
- 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, Miriam Hospital, Providence, Rhode Island
- dDivision of Cardiothoracic Surgery, Lifespan Cardiovascular Institute, Providence, Rhode Island
- eDepartment of Medicine, Valley Hospital, Ridgewood, New Jersey
- fCardiac Surgery Program, Valley Hospital, Ridgewood, New Jersey
- gDepartment of Cardiology, Henrico Doctors’ Hospital, Richmond, Virginia
- hDepartment of Cardiothoracic Surgery, Henrico Doctors’ Hospital, Richmond, Virginia
- iDepartment of Medicine, Stony Brook Hospital, Stony Brook, New York
- jDepartment of Surgery, Stony Brook Hospital, Stony Brook, New York
- kCardiovascular Service Line, Maine Medical Center, Portland, Maine
- lSt. John Heart Institute Cardiovascular Consultants, St. John Health System, Tulsa, Oklahoma
- mSt. John Cardiovascular Surgery, St. John Heart Institute Cardiovascular Consultants, St. John Health System, Tulsa, Oklahoma
- nFoundation for Cardiovascular Medicine, Stanford University, Stanford, California
- oMedStar Health Research Institute, MedStar Washington Hospital Center, Washington, DC
- pDepartment of Cardiology, MedStar Washington Hospital Center, Washington, DC
- ↵∗Address for correspondence:
Dr. Ron Waksman, MedStar Washington Hospital Center, 110 Irving Street, NW, Suite 4B-1, Washington, DC 20010.
Objectives This study sought 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 LRT (Low Risk TAVR) trial demonstrated that TAVR is safe in patients with symptomatic severe aortic stenosis who are at 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 men. 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 (1.0%) subjects 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 aortic stenosis appears to be safe at 1 year. Hypoattenuated leaflet thickening, observed in a minority of TAVR patients at 30 days, did not have an impact on valve hemodynamics in the longer term.
- aortic stenosis
- hypoattenuated leaflet thickening
- low risk
- subclinical leaflet thrombosis
- transcatheter aortic valve replacement
Dr. Waksman has served on the advisory board for Abbott Vascular, Amgen, Boston Scientific, Medtronic, Philips Volcano, Pi-Cardia, and Cardioset; served as a consultant for Abbott Vascular, Amgen, Biosensors, Biotronik, Boston Scientific, Medtronic, Philips Volcano, Pi-Cardia, and Cardioset; has received grant support from Abbott Vascular, AstraZeneca, Biosensors, Biotronik, Boston Scientific, and Chiesi; has served on the Speakers Bureau for AstraZeneca and Chiesi; and is an investor in MedAlliance. Dr. Goncalves has served as a proctor for Medtronic. Dr. Parikh has served on the scientific advisory board for AstraZeneca; and as a consultant for Medtronic. Dr. Hanna has served as a speaker for Edwards Lifesciences. Dr. Asch has served as the director of an academic cardiovascular imaging core lab with institutional contracts with Edwards, Medtronic, Boston Scientific, Biotronik, and Abbott. Dr. Weissman has served as the director of an academic cardiovascular imaging core lab with institutional contracts with Boston Scientific, Ancora Heart, Medtronic, LivaNova, and HDL Therapeutics. Dr. Rogers has served as a consultant for Medtronic; and as a proctor for Medtronic and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received January 31, 2019.
- Revision received March 7, 2019.
- Accepted March 7, 2019.
- 2019 American College of Cardiology Foundation
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