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A review of the LARIAT device: insights from the cumulative clinical experience
Mukta C Srivastava1, Vincent Y See1, Murtaza Y Dawood1
1University of Maryland School of Medicine, 110 S. Paca Street; 7N-121, Baltimore, MD 21201 USA.
Insights
Atrial fibrillation (AF) stroke risk is high. The LARIAT device offers percutaneous left atrial appendage exclusion (LAAO) as an alternative to anticoagulation, but more data on its safety and efficacy is needed.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Atrial fibrillation (AF) is the most common heart arrhythmia, significantly increasing stroke risk.
- Managing stroke risk in AF patients is challenging due to anticoagulation intolerance and warfarin management difficulties.
- The left atrial appendage (LAA) is a primary source of thrombus in AF-related embolic events.
Purpose of the Study:
- To review the history, patient selection, procedural technique, and complications of LARIAT LAAO.
- To discuss insights and procedural improvements from clinical experience with the LARIAT device.
- To evaluate the LARIAT device as a percutaneous LAA exclusion therapy for stroke prevention in AF.
Main Methods:
- Review of historical data, pre-clinical canine studies, and published clinical series of LARIAT LAAO.
- Analysis of procedural techniques, including combined pericardial and trans-septal access for epicardial LAA exclusion.
- Evaluation of device safety, efficacy, and potential complications.
Main Results:
- Surgical LAA exclusion (LAAO) is common but limited by incomplete closure and open-heart morbidity.
- Percutaneous LAAO approaches, like the LARIAT device, offer an alternative.
- The LARIAT device enables percutaneous suture ligation of the LAA via an epicardial approach.
Conclusions:
- The LARIAT device provides a unique epicardial approach for percutaneous LAA exclusion.
- While FDA cleared for soft-tissue ligation, further data on LARIAT's safety and efficacy is required.
- More evidence is needed for the LARIAT to become an established stroke prevention therapy in AF patients.
Abstract:
Atrial fibrillation (AF) is the most common arrhythmic disorder world-wide, accounting for 15 % of all strokes. Management of stroke risk in AF is complicated by intolerance of anti-coagulation (AC) therapy and difficulty maintaining therapeutic range in patients treated with warfarin. The left atrial appendage (LAA) is a source of thrombus in AFrelated thrombo-embolic events and surgical LAA exclusion (LAAO) is commonly performed during cardiac surgery in AF patients. Surgical approaches are limited by a high incidence of incomplete closure with a potential for consequent thrombo-embolic events as well as the morbidity of an open-heart procedure. More recently, percutaneous approaches to LAAO have been developed. The LARIAT device is an epicardial LAA exclusion system that enables percutaneous suture ligation of the LAA via combined, pericardial and trans-septal access. The device has 510k Federal Drug Administration (FDA) clearance for soft-tissue ligation and has been studied in canine models in pre-clinical studies as well as published series of clinical experience with LARIAT LAAO. The history, patient selection, procedural technique and complications of LARIAT LAAO are reviewed here. Additionally, insights and procedural improvements that have been elucidated from clinical series and outcomes from the collective experience are discussed. The LARIAT's epicardial approach to LAA ligation is unique compared with other percutaneous LAA exclusion devices, however more data regarding device safety and efficacy is needed for the LARIAT to emerge as an established therapy for stroke prevention in AF.
