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TAVR With LAAO vs. TAVR Plus Medical Therapy Study Results

Core Concepts
TAVR with LAAO is non-inferior to TAVR plus medical therapy in patients with AF and severe aortic stenosis.
The study compared the outcomes of left atrial appendage occlusion (LAAO) during transcatheter aortic valve replacement (TAVR) using the WATCHMAN 2.5 device to TAVR followed by medical therapy in patients with atrial fibrillation (AF) and severe aortic stenosis. Here are the key highlights and insights from the content: Feasibility and non-inferiority of TAVR with LAAO compared to TAVR plus medical therapy. Increased thromboembolism risk in the combined procedure group. Duration of WATCHMAN procedure was 45 minutes. Similar hospital stay and acute kidney injury rates between the groups. Non-inferiority study involving 349 patients from 34 centers in North America. Primary endpoint included all-cause mortality, stroke, and major bleeding within 24 months. TAVR + LAAO group showed reduced primary outcome compared to TAVR + medical therapy. Trends favored TAVR + LAAO in terms of mortality and strokes. Major bleeding occurred more often in the TAVR + LAAO group. Higher risk of thrombosis or embolism in the TAVR + LAAO arm. Study limitations include the use of WATCHMAN 2.5 and a 2-year duration.
AF typically present in 33%–40% of patients undergoing TAVR. Hospital stay was 3.5 days for the combined procedure vs 4 days for TAVR alone. Major or life-threatening bleeding risk was 35% greater in the first 6 months post-TAVR + LAAO.
"The duration of WATCHMAN was only 45 minutes added to the procedure." - Samir Kapadia, MD "A limitation of the trial is that it does not involve the more modern devices and practice." - Samir Kapadia, MD "It means that the comparator is not terrible. It's not, you know, unacceptably worse." - Megan Coylewright, MD, MPH

Key Insights Distilled From

by Daniel M. Ke... at 10-25-2023
TAVR With LAAO Non-inferior to TAVR Plus Medical Therapy

Deeper Inquiries

How might the use of more modern devices impact the outcomes observed in the study?

The use of more modern devices, such as the WATCHMAN FLX, could potentially impact the outcomes observed in the study in several ways. These newer devices may offer improved features, such as better sealing and reduced risk of complications like thromboembolism. The WATCHMAN FLX, for example, may require less anticoagulation therapy, which could help mitigate bleeding complications seen in the study. Additionally, advancements in device design and technology may lead to better procedural outcomes, reduced procedure times, and potentially lower rates of adverse events. Therefore, the adoption of more modern devices could potentially enhance the overall effectiveness and safety of procedures like TAVR with LAAO.

What are the implications of poor adherence to anticoagulant therapy on the study results?

Poor adherence to anticoagulant therapy among patients in the study could have significant implications on the results. Non-adherence to anticoagulation therapy may lead to an increased risk of thromboembolic events, such as strokes, which are critical endpoints in the study. If a substantial portion of patients in the TAVR + medical therapy group were not compliant with anticoagulant therapy, it could potentially skew the results and impact the overall interpretation of the study findings. Poor adherence could introduce bias and confound the outcomes, making it challenging to accurately assess the true efficacy and safety of the interventions being studied. Therefore, ensuring high adherence to anticoagulant therapy is crucial for the validity and reliability of the study results.

How can national registries be utilized to provide continued evidence for procedural developments in the future?

National registries can play a vital role in providing continued evidence for procedural developments in the future by serving as repositories of real-world data on patient outcomes, treatment patterns, and procedural techniques. By leveraging national registries, researchers and clinicians can track long-term outcomes, monitor trends in practice, and evaluate the effectiveness and safety of evolving procedures over time. These registries can help identify areas for improvement, assess the impact of new technologies or interventions, and guide clinical decision-making based on robust, population-level data. Furthermore, national registries can facilitate post-market surveillance, comparative effectiveness research, and quality improvement initiatives, ultimately contributing to the advancement of evidence-based practice and the optimization of patient care. Leveraging national registries in this manner can provide valuable insights into the real-world effectiveness and safety of procedural developments, guiding future research and clinical decision-making.