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Updated: Dec 8, 2025
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Use of a Novel Septal Occluder Device for Left Atrial Appendage Closure in Patients With Postsurgical and Postlariat
Domenico G Della Rocca1, Rodney P Horton1,2, Nicola Tarantino3
1Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin (D.G.D.R., R.P.H., C.T., Q.C., S.M., A.A., C.G., M.B., A.A.-A., J.D.B., G.J.G., L.D.B., A.N.).
Insights
The Gore Cardioform Septal Occluder effectively closes the left atrial appendage (LAA) in patients with incomplete ligation or unsuitable anatomy for other devices, offering a new stroke prevention option.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Left atrial appendage (LAA) exclusion is an alternative to oral anticoagulation for stroke risk reduction.
- Incomplete LAA closure and unsuitable anatomy limit current device efficacy.
- A need exists for alternative thromboembolic prevention strategies.
Purpose of the Study:
- To evaluate the feasibility of LAA closure using the Gore Cardioform Septal Occluder.
- To assess the device's efficacy in patients with incomplete LAA ligation.
- To determine suitability for patients with anatomy not meeting Watchman device criteria.
Main Methods:
- Twenty-one patients with high thromboembolic risk were included.
- Transesophageal echocardiography was used for LAA patency assessment.
- The Gore Cardioform Septal Occluder was deployed in all cases.
Main Results:
- Successful deployment was achieved in all 21 patients.
- No peri-procedural complications were observed.
- Complete LAA closure was confirmed by echocardiography at follow-up.
Conclusions:
- The Cardioform Septal Occluder is a feasible option for LAA closure.
- It provides a solution for patients with residual leaks or challenging anatomy.
- This device expands transcatheter LAA closure alternatives.
Background:
Interventional therapies aiming at excluding the left atrial appendage (LAA) from systemic circulation have been established as a valid alternative to oral anticoagulation in patients at high thromboembolic risk. However, their efficacy on stroke prophylaxis may be compromised owing to incomplete LAA closure. Additionally, the need for an alternative thromboembolic prevention may remain unmet in patients with contraindications to oral anticoagulation whose appendage anatomy is unsuitable for some conventional devices commercially available. We aimed at evaluating the feasibility of LAA closure with the novel Gore Cardioform Septal Occluder in patients with incomplete appendage ligation or anatomic features which do not meet the manufacturer's requirements for Watchman deployment.
Methods:
Twenty-one consecutive patients (mean age: 72±6 years; 85.7% males; CHA2DS2-VASc: 4.5±1.4; HAS-BLED: 3.6±1.0) were included. Transesophageal echocardiography was performed within 2 months to assess for residual LAA patency.
Results:
Fourteen patients had incomplete LAA closure following surgical (n=6) or Lariat ligation (n=8). In 7 patients with an appendage anatomy unsuitable for Watchman deployment, the mean maximal landing zone size and LAA depth were 14.4±1.3 and 18.6±2.8 mm. Successful Cardioform Septal Occluder deployment was achieved in all patients. No peri-procedural complications were documented. Procedure and fluoroscopy times were 46±13 and 14±5 minutes. Follow-up transesophageal echocardiography after 58±9 days revealed complete LAA closure in all patients.
Conclusions:
Transcatheter LAA closure via a Cardioform Septal Occluder device might be a valid alternative in patients with residual leaks following failed appendage ligation or whose LAA anatomy does not meet the minimal anatomic criteria to accommodate a Watchman device. Graphic Abstract: A graphic abstract is available for this article.
