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Published on: February 26, 2013
Left Atrial Appendage Closure With the New Occlutech® Device: First in Man Experience and Neurological Outcome
Barbara Bellmann1, Steffen Schnupp2, Peter Kühnlein3
1Department of Cardiology, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Insights
Percutaneous left atrial appendage closure (LAAC) using the Occlutech device is safe and effective for stroke prevention in atrial fibrillation patients. High procedural success and no reported strokes or deaths demonstrate its value.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Percutaneous left atrial appendage closure (LAAC) offers stroke prevention for atrial fibrillation patients with high bleeding risk (HAS-BLED-Score ≥3).
- The safety and neurological outcomes associated with the Occlutech device (OD) for LAAC require further elucidation.
Purpose of the Study:
- To evaluate the procedural safety and neurological outcomes of LAAC using the Occlutech device (OD).
- To assess the acute and short-term efficacy of the Occlutech device in preventing stroke.
Main Methods:
- A prospective study involving 30 patients undergoing LAAC with the Occlutech device (OD) between 2012 and 2016.
- Neurological examinations and transesophageal echocardiography were conducted pre-procedure and at 1, 3, and 12 months post-procedure.
Main Results:
- Successful implantation of the Occlutech device (OD) was achieved in 93% of patients (28/30).
- Minor complications included pericardial effusion in two patients and small leaks (<3 mm) in four, with only two persistent at 3 months.
- No patients experienced clinically apparent stroke or death during the follow-up period.
Conclusions:
- LAAC using the Occlutech device (OD) demonstrated high acute and 3-month follow-up success rates in this study.
- The procedure was associated with no significant neurological deficits, highlighting its safety profile.
Aims:
Percutaneous left atrial appendage closure (LAAC) is a valuable treatment option for stroke prevention in patients with atrial fibrillation and a HAS-BLED-Score ≥3. Determinants of procedural safety events and neurological outcome of the patients with the Occlutech device (OD) are not established yet.
Methods And Results:
Between 2012 and 2016, 30 patients underwent LAAC using the OD. This is a prospective study. Neurological examination and transesophageal echocardiography was performed directly before and after the procedure and after 1, 3, and 12 months. The OC was successfully implanted in 28 of the 30 enrolled patients (93%). Two patients presented a hemodynamic relevant pericardial effusion. A leak <3 mm could be documented direct after implantation in 4 patients. After 3 months, there were only 2/4 patients with persistent LAA leakage with a maximum leakage of <3 mm. The correct position of the device was confirmed in 27/28 patients during 3-month follow-up. In 2 patients, there was a thrombus at the OC. In 12 patients, a transoesophageal echocardiography was performed after 12 months. All patients (12/12) showed a correct placement of the device. None of the patients developed a clinically apparent stroke or died during follow-up.
Conclusion:
In this uncontrolled, nonrandomized study, acute and 3-month follow-up success of LAAC using OD was high. No patient showed significant neurological deficits.
