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Left atrial appendage closure device implantation in patients at very high risk for stroke
Erika Hutt1, Oussama M Wazni2, Simrat Kaur1
1Department of Internal Medicine, Cleveland Clinic Foundation, Cleveland, Ohio.
Insights
Left atrial appendage closure with the Watchman device is safe and effective for high-stroke-risk patients. This study shows a 2.8% annual ischemic stroke risk, lower than traditional anticoagulation methods.
Area of Science:
- Cardiology
- Medical Devices
- Interventional Cardiology
Background:
- Left atrial appendage closure (LAAC) using the Watchman device is a crucial intervention for stroke prevention.
- Limited data exists on its efficacy in patients at very high risk of stroke.
Purpose of the Study:
- To evaluate the safety and effectiveness of the Watchman device in patients with a CHA2DS2-VASc score of 5 or higher.
- To assess the role of LAAC in a population with elevated stroke and bleeding risks.
Main Methods:
- A prospective registry of 104 consecutive patients receiving Watchman implantation for LAAC.
- Patients had a CHA2DS2-VASc score ≥5, with indications including prior bleeding or unacceptable bleeding risk.
- Follow-up included transesophageal echocardiogram at 45 days and clinical assessment at 1 year.
Main Results:
- Watchman implantation was successful in all patients.
- No significant peridevice leak was observed at 45 days.
- At 1-year follow-up, the annual ischemic stroke rate was 2.8% (3 patients).
Conclusions:
- Watchman implantation is a safe and effective option for patients with very high stroke risk (CHA2DS2-VASc ≥5).
- The observed 2.8% annual ischemic stroke risk is significantly lower than estimated risks with oral anticoagulation in similar populations.
Background:
Little is known about the role of left atrial appendage closure using the Watchman device (Boston Scientific) in patients who are at very high risk for stroke.
Objective:
The purpose of this study was to assess the role of Watchman in patients with CHA2DS2-VASc ≥5.
Methods:
All patients undergoing procedures for Watchman implant at our institution were enrolled in a prospective registry. All 104 consecutive recipients with CHA2DS2-VASc ≥5 were included.
Results:
Median patient age was 78.5 ± 6.4 years, 56% were male, mean CHA2DS2-VASc was 5.7 ± 0.9, and mean HASBLED was 4.0 ± 1.0. Indications for implantation were significant prior bleeding (73%), unacceptable bleeding risk (21%), and unacceptable stroke and bleeding risk (6%). Watchman implantation was successful in all patients. All but 2 patients completed 45 days of postprocedural anticoagulation; 56% used warfarin and 44% used a novel oral anticoagulant. Transesophageal echocardiogram at 45 days revealed no significant peridevice leak. One patient was found to have a small mobile, filamentous echodensity attached on the medial aspect of the Watchman device. This resolved with longer anticoagulation with dabigatran and did not result in adverse outcome. At 1-year follow up, ischemic stroke had occurred in 3 patients (2.8%) at 96, 119, and 276 days after the procedure.
Conclusion:
In a population of patients with mean CHA2DS2-VASc of 5.7, Watchman implantation seemed to be safe and efficacious, with a residual annual ischemic stroke risk of 2.8%. In an atrial fibrillation population with a similar CHA2DS2-VASc score, the estimated annual risk of stroke is ≈12% off anticoagulation and >4% on warfarin.
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