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The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Safety and Efficacy of Mini-Invasive Left Atrial Appendage Closure: A Propensity-Score Analysis
Catherine Denis1, Guillaume Clerfond2, Aurélie Chalard1
1Cardiology Department, CHU Clermont-Ferrand, F-63000 Clermont-Ferrand, France.
Insights
A mini-invasive left atrial appendage closure (LAAC) strategy using micro-transesophageal echocardiography (micro-TEE) under sedation is safe and effective, offering shorter procedures and hospital stays compared to standard general anesthesia approaches.
Area of Science:
- Cardiology
- Medical Devices
- Interventional Procedures
Background:
- Left atrial appendage closure (LAAC) prevents stroke in nonvalvular atrial fibrillation (NVAF) patients unsuitable for anticoagulation.
- General anesthesia (GA) for transesophageal echocardiography (TEE) guidance in LAAC can be challenging.
- Evaluating a less invasive LAAC approach is crucial for broader patient applicability.
Purpose of the Study:
- To assess the safety and midterm efficacy of a mini-invasive LAAC strategy.
- To compare micro-TEE under procedural sedation with standard 3D TEE under GA for LAAC.
Main Methods:
- Propensity score matching compared two LAAC cohorts: standard TEE-guided (GA) and mini-invasive (sedation).
- The primary endpoint included embolic/bleeding events, procedural complications, and cardiovascular deaths within 3 months.
- Mini-invasive LAAC was defined as using micro-TEE under procedural sedation.
Main Results:
- The mini-invasive strategy was successful in 96.1% of planned patients.
- The primary endpoint occurred in 11.2% (mini-invasive) vs. 10.3% (standard) (P=0.76).
- Procedural times, fluoroscopy, and hospital stays were significantly shorter with the mini-invasive approach (P<0.001).
Conclusions:
- The mini-invasive LAAC strategy demonstrates comparable safety and efficacy to the standard approach.
- This approach may expand LAAC accessibility as indications grow.
- Micro-TEE under sedation offers a viable alternative for LAAC guidance.
Background:
Left atrial appendage closure (LAAC) for prevention of stroke is validated in patients with nonvalvular atrial fibrillation (NVAF) contraindicated to oral anticoagulation. General anaesthesia (GA) is often used for procedural guidance by transesophageal echocardiography (TEE); however, its use may be challenging in some patients. The aim of the study was to evaluate the safety and the midterm efficacy of a mini-invasive LAAC strategy using micro-TEE under procedural sedation.
Methods:
Comparison by propensity score of 2 cohorts of consecutive patients who underwent LAAC: standard TEE-guided LAAC (3-dimensional [3D] TEE under GA) and mini-invasive LAAC strategy (micro-TEE under procedural sedation). The primary endpoint was a composite of embolic or bleeding events, significant per procedural complication, and cardiovascular deaths within 3 months after LAAC.
Results:
In total, 432 patients were included (78.7 ± 8 years old, 32.4% of women, CHA2DS2VASC score: 4.9 ± 1.1); 127 patients underwent mini-invasive LAAC strategy and were compared with 305 patients standard TEE-guided LAAC. The mini-invasive strategy was achieved in 122 of 127 (96.1%) planned patients. The primary endpoint occurred in 11.2% of patients from the mini-invasive LAAC strategy group and in 10.3% of patients from the standard TEE group (absolute difference = 0.9% [-6.4; 4.5], hazard ratio = 1.11 [0.56; 2.19], P = 0.76). Procedural times, fluoroscopy duration, and hospital stays were shorter in the mini-invasive LAAC strategy group (P < 0.001).
Conclusions:
The mini-invasive LAAC strategy is safe and effective compared with the standard TEE-guided LAAC strategy. A mini-invasive LAAC strategy may also be an important tool to help physicians to treat more patients as LAAC indications evolve in the future.

