TAVR in Low-Risk Patients With Severe Aortic Stenosis

Study Questions:

What is the safety and short-term efficacy of transcatheter aortic valve replacement (TAVR) in low-risk patients (Society of Thoracic Surgeons–Predicted Risk of Mortality [STS-PROM] <3%) with severe aortic stenosis?

Methods:

This investigator-led trial was a prospective, multicenter, unblinded trial of low-risk patients with severe aortic stenosis undergoing TAVR compared to historical controls undergoing surgical AVR (SAVR) from the STS database. The primary endpoint was all-cause mortality at 30 days.

Results:

A total of 200 patients (mean age 74 years) with low surgical risk were enrolled and outcomes were compared to a matched cohort undergoing SAVR from the same institutions. At 30 days, TAVR patients had 0% all-cause mortality (vs. 1.7% for SAVR), 0% stroke (vs. 0.6% for SAVR), and 5.0% permanent pacemaker rate (vs. 4.5% for SAVR); 14% of TAVR patients were noted to have subclinical leaflet thrombosis at 30 days.

Conclusions:

Low-risk patients undergoing TAVR had excellent 30-day outcomes. There was evidence of subclinical leaflet thrombosis in a proportion (14%) of patients at 30 days.

Perspective:

This was a feasibility, nonrandomized trial to evaluate the safety of transfemoral TAVR for low-risk patients. There were several restrictions to enrollment in both TAVR and historical SAVR groups. Given the non-adjudicated comparator, confounding bias cannot be fully excluded. Nonetheless, TAVR appears to be associated with zero mortality and disabling stroke at 30 days. In addition, TAVR in low-risk patients is associated with shorter lengths of hospital stay, lower rates of atrial fibrillation and paravalvular leak, and similar rates of needing a permanent pacemaker. There continues to be a signal for subclinical leaflet thrombosis in TAVR patients, with one in seven patients having computed tomography or transesophageal echocardiography evidence at 30 days. Despite reassuring short-term results, longer-term outcomes (>1 year) should determine eventual use of TAVR in low-risk cohorts. Results of the PARTNER 3 low-risk trial and Medtronic EVOLUT TAVR in low-risk patients are eagerly awaited.

Keywords: ESC Congress, ESC18, Aortic Valve Stenosis, Atrial Fibrillation, Cardiac Surgical Procedures, Echocardiography, Transesophageal, Geriatrics, Heart Valve Diseases, Heart Valve Prosthesis, Risk, Pacemaker, Artificial, Stroke, Thrombosis, Transcatheter Aortic Valve Replacement, Vascular Diseases


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