Key result
Transcatheter LAA closure using the Gore Cardioform Septal Occluder achieved successful deployment and complete LAA closure at follow-up in 100% of patients with residual leaks or unsuitable anatomy.
Why the study?
Stroke prophylaxis can be compromised by incomplete LAA closure, and patients with contraindications to oral anticoagulation may have appendage anatomy unsuitable for conventional percutaneous devices.
Does the Gore Cardioform Septal Occluder achieve complete LAA closure in patients with postsurgical/postlariat leaks or anatomies unsuitable for conventional occlusion?
Observational (n=21)
Does the Gore Cardioform Septal Occluder achieve complete LAA closure in patients with postsurgical/postlariat leaks or anatomies unsuitable for conventional occlusion?
The Gore Cardioform Septal Occluder is a feasible and effective alternative for LAA closure in patients with residual leaks after prior ligation or anatomies unsuitable for standard devices.
May support off-label use for residual LAA leaks; leaves open safety and durability confirmation in prospective trials.
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: -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.
No takes yet. Share an insight, caveat, or question.
Rocca et al. (2020) conducted an observational in Incomplete LAA closure or anatomy unsuitable for Watchman deployment (n=21). Gore Cardioform Septal Occluder was evaluated on Successful deployment and complete LAA closure. Transcatheter LAA closure using the Gore Cardioform Septal Occluder achieved successful deployment and complete LAA closure at follow-up in 100% of patients with residual leaks or unsuitable anatomy.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: