Transcatheter aortic valve replacement (TAVR) is now the standard of care for patients with symptomatic severe aortic stenosis who are at extreme, high, or intermediate risk for surgery.
This multicenter, prospective study (Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis) included low-risk patients and was approved by the United States Food and Drug Administration (FDA) to enroll patients in its country.
The primary endpoint was all-cause mortality at 30 days and results were compared to historical controls from the Society of Thoracic Surgeons (STS) database.
The trial included 200 low-risk patients with symptomatic severe aortic stenosis undergoing TAVR at 11 sites. These patients were compared to 719 patients who underwent surgery at the same institutions according to the STS database.
At 30 days, there was zero all-cause mortality (the primary endpoint) in the TAVR group vs. 1.7% mortality in the surgical group. There was also 0% in-hospital stroke rate in the TAVR group vs. 0.6% in the surgical group.
Permanent pacemaker implantation rates were similar between strategies, 5% vs. 4.5%, which is a great step forward for TAVR.
New-onset atrial fibrillation (3%) and length of hospital stay (2.0 ± 1.1 days) rates were lower in the TAVR group.
One patient (0.5%) in the TAVR group had mild paravalvular leak and 14% of TAVR patients had evidence of subclinical leaflet thrombosis, both at 30 days.
This last figure is troublesome, since leaflet thrombosis, even if it is subclinical, might cause early device malfunction in a patient with more prolonged life expectancy. This is not the first time we hear about leaflet thrombosis and we should verify its impact over time, and whether it warrants a modification of antiplatelet/antithrombotic therapy regimes at discharge.
Transcatheter aortic valve replacement in low-risk patients has very low procedural complication rates, short length of hospital stay, zero mortality, and zero disabling stroke. A minority of patients experienced subclinical leaflet thrombosis, whose progress should be studied over time.
Original title: Transcatheter Aortic Valve Replacement in Low-Risk Patients with Symptomatic Severe Aortic Stenosis.
Reference: Ron Waksman et al. J Am Coll Cardiol 2018;72:2095-105.
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