In the TVT registry, around 40% of the patients eligible for transcatheter aortic valve replacement (TAVR) had atrial fibrillation, and there were high levels of adverse events after starting anticoagulant treatment, especially with oral anticoagulants (VKAs), primarily due to bleeding.
The purpose of this study was to assess the feasibility, safety, and efficacy of combined TAVR and left atrial appendage closure (LAAC) using the Watchman 2.5 device compared with TAVR plus conventional medical treatment (TM). A prospective multicenter study with a 1:1 random allocation was conducted in 34 centers in the United States.
The study included a total of 349 patients with a follow-up of up to 24 months. The primary endpoint (PEP) was defined as a combination of all-cause mortality, stroke, and major bleeding. Patients in the left atrial appendage closure group required 6 weeks of Warfarin treatment and post-procedure antiplatelet therapy, followed by 6 months of dual antiplatelet therapy (DAPT).
The average patient age was 80.8 years; 39% of subjects were female and approximately 80% had heart failure. When classifying atrial fibrillation (AF), most patients had paroxysmal AF (47.5%) or persistent AF (23.5%).
The average CHA2DS2-Vasc score was 4.8±1.2, and the average HAS-BLED score was 3.0±1.2. The average time required for the TAVR procedure was 52 minutes, with 43 additional minutes for the placement of the Watchman device. In comparison, the average time for the medical treatment group was 60.3 minutes. In-hospital mortality rate was very low, 0.6%, and the average hospitalization stay was 3.5±2.7 days for the left atrial appendage closure group and 4.0±5.0 days for the medical treatment group.
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The PEP rate was lower for the group receiving the combination of TAVR and left atrial appendage closure, with a hazard ratio (HR) of 0.86 (95% confidence interval [CI], 0.60-1.22; non-inferiority P < 0.001). Furthermore, this group also had lower mortality (HR, 0.86; 95% CI, 0.55-1.34) and fewer cases of stroke (HR, 0.76; 95% CI, 0.33-1.77), although the incidence of bleeding among these patients actually increased (HR, 1.1; 95% CI, 0.67-1.79). When assessing safety, it is important to note a significant increase in the incidence of thrombosis or arterial and venous embolic events (HR, 5.3; 95% CI, 1.47-17.26).
In summary, the authors conclude that left atrial appendage closure with the Watchman 2.5 device during the TAVR procedure was noninferior to conventional medical treatment followed by TAVR in terms of the primary endpoint at two years in patients with atrial fibrillation and severe symptomatic aortic stenosis.
Dr. Omar Tupayachi.
Member of the Editorial Board of SOLACI.org.
Presented by Dr. Samir Kapadia in Late-Breaking Clinical Trials at TCT 2023, San Francisco, October 23, 2023.
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