Concomitant left atrial appendage occlusion, TAVR an option for some with AF: WATCH-TAVR
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Key takeaways:
- Atrial fibrillation is associated with increased risk for bleeding and stroke in patients undergoing TAVR.
- Left atrial appendage occlusion at the time of TAVR has not been extensively studied.
SAN FRANCISCO — Left atrial appendage occlusion at the time of transcatheter aortic valve replacement provides a noninferior treatment option to TAVR plus medical therapy in patients with severe aortic stenosis and atrial fibrillation.
In the WATCH-TAVR study, presented at TCT 2023 and simultaneously published in Circulation, concomitant left atrial appendage occlusion (LAAO) with the Watchman 2.5 device (Boston Scientific) and TAVR was noninferior to TAVR plus chronic oral anticoagulation for the primary endpoint of all-cause mortality, stroke and major bleeding at 2 years among patients with severe symptomatic aortic stenosis and AF.
At 2-year follow-up, the primary noninferiority endpoint occurred in 33.9% of patients who received LAAO and TAVR compared with 37.2% who received TAVR plus medical therapy (HR = 0.86; 95% CI, 0.6-1.22; P for noninferiority < .001).
“The implication is that [concomitant LAAO and TAVR vs. TAVR and medical therapy] are similar, and the concomitant therapy can be performed with low hospital mortality. It can be viewed as an alternative, considering the complexity of the procedure, and few complications were listed,” Samir R. Kapadia, MD, chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute at Cleveland Clinic and professor of medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, said during a press conference.
Separately, the rate of all-cause mortality was 20.9% with concomitant LAAO and TAVR vs. 22.7% with TAVR and medical therapy (HR = 0.86; 95% CI, 0.55-1.34), the rate of all strokes was 5.7% vs. 7% (HR = 0.76; 95% CI, 0.33-1.77) and the rate of major bleeding was 19.8% vs. 17.4% (HR = 1.1; 95% CI, 0.67-1.79). Bleeding occurred more frequently in the first 180 days but did not differ significantly at 2 years, according to the researchers.
In other results, CV mortality and rehospitalization were similar between the two groups, Kapadia said. Arterial or venous thrombosis or embolism was more frequent in the LAAO and TAVR group (9% vs. 1.7%; HR = 5.03; 95% CI, 1.47-17.26), driven by venous thrombosis. In-hospital mortality was low at 0.6% in both groups, with a similar length of stay and acute kidney injury, Kapadia said. A moderate or large pericardial effusion was observed in 2.4% of the LAAO and TAVR group compared with 0.5% in TAVR and medical therapy group.
There were no differences in medical treatments between groups at the time of the procedure. At 2 years, dual antiplatelet was used in 7.3% of the LAAO and TAVR group and 5% of the TAVR and medical therapy group; antiplatelet therapy was used in 82.5% and 50.8%, respectively; and anticoagulation was used in 13.9% and 66.7%, respectively.
Mean procedure time for LAAO was 38 minutes.
The WATCH-TAVR study was conducted to evaluate feasibility, safety and effectiveness of concomitant LAAO and TAVR in AF patients with severe AS compared with contemporary medical therapy.
“Nonrandomized, observational studies have demonstrated the relative safety of concomitant TAVR and LAAO. However, WATCH-TAVR is the first prospectively conducted trial of concomitant LAAO during TAVR and demonstrated that the combined procedure was accomplished without an increased risk of complications,” the researchers wrote in Circulation.
The study enrolled 349 patients undergoing transfemoral TAVR at 34 centers in North America. Patients randomly assigned to concomitant LAAO received anticoagulation for 45 days followed by DAPT until 6 months. In the TAVR-only group, medical therapy was based upon the treating physicians’ discretion. At baseline, 85.4% of patients were taking anticoagulation and 71.3% were on antiplatelet therapy.
The current study does not account for differences between the groups beyond 2 years, Kapadia said during the press conference. In addition, the study was limited to use of only the Watchman 2.5 device. Kapadia noted that the current-generation Watchman FLX device is safer and requires less aggressive adjunctive pharmacology, which may further reduce risk for bleeding after the combined procedures compared with the Watchman 2.5 device.
Reference:
Perspective
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Poonam Velagapudi, MD, FACC
The WATCH-TAVR trial demonstrated that combined TAVR and a LAAO procedure was non-inferior to performing TAVR alone with anticoagulation for AF.
When TAVR and LAAO are performed as two separate procedures, patients have to make two trips to the hospital, receive anesthesia twice, and perhaps need an additional day or two of hospitalization. By combining TAVR and LAAO, there is an increase in the procedure time, but it saves patients from a second procedure and additional hospitalization, which is particularly important in older patients. These data also support the safety of performing this combined procedure, and will benefit patients with severe aortic stenosis and atrial fibrillation with high-risk of bleeding.
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Kapadia SR, et al. Late-breaking clinical trials: Session I, in collaboration with The New England Journal of Medicine. Presented at: TCT Scientific Symposium; Oct. 23-26, 2023; San Francisco (hybrid meeting).
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