Transcatheter aortic valve replacement (TAVR) is safe in low-risk patients with symptomatic severe aortic stenosis, based on new research published in the Journal of the American Cardiology and presented Aug. 28 during ESC Congress 2018. Researchers reported low procedural complication rates, short hospital length of stay, zero mortality, and zero disabling stroke at 30 days.

The "Low Risk TAVR Trial" involved 200 low-risk patients with symptomatic severe aortic stenosis undergoing TAVR at 11 U.S. centers. Outcomes from these patients were compared to a cohort of 719 patients from the STS database who underwent SAVR at the same centers.

Findings at 30 days showed zero all-cause mortality in the TAVR group compared with 1.7 percent mortality in the SAVR group. Similarly, there was zero in-hospital stroke in the TAVR group vs. 0.6 percent in the SAVR group. The rates of new onset atrial fibrillation (3.0 percent) and length of stay (2.0±1.1days) were low in the TAVR group. One patient in the TAVR group had >mild paravalvular leak at 30 days, while 14 percent of TAVR patients had evidence of subclinical leaflet thrombosis at 30 days. Permanent pacemaker implantation rates were similar across both groups.

"This study is the first prospective study of TAVR in low-risk patients conducted in the U.S. utilizing historical cohort from a major national database as the control group," noted the study authors. With the ability to randomize patients to surgery likely to become more difficult in the future, this methodology could be increasingly used to evaluate new devices.

Keywords: ESC18, ESC Congress, Heart Valve Diseases, Transcatheter Aortic Valve Replacement, Prospective Studies, Aortic Valve Stenosis, Heart Valve Prosthesis, Aortic Valve

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