Peri-Device Leaks after Percutaneous Left Atrial Appendage Closure: Clinical Significance and Unmet Diagnostic Needs

ABSTRACT

Oral anticoagulation reduces the ischemic stroke risk in patients with nonvalvular atrial fibrillation (NVAF) but inherently increases the bleeding risk. Percutaneous left atrial appendage occlusion (LAAO) offers an alternative to long-term anticoagulation in patients at risk for cardioembolic events due to underlying atrial fibrillation. Although long-term clinical data remain limited, percutaneous LAAO appears to be a safe and effective means of reducing hemorrhagic stroke and non-procedural-related bleeding events compared to warfarin. Incomplete closure of the LAA resulting in a peri-device leak (PDL) is common after interventions targeting the LAA and has been variably associated with an increased risk of embolic stroke in patients following LAAO. However, the clinical significance of PDL remains unclear, in part, due to variability in the definitions used for PDL, modalities used for the detection of PDL, and the confounding impact of continuing therapeutic anticoagulation in patients found to have PDL on surveillance imaging. In the current review, we examine the association of PDL with ischemic stroke and systemic embolization and explore mechanistic considerations in the development of PDL as they pertain to the unmet need for improving the diagnostic assessment of PDL from an anatomic and physiologic perspective.

KEYWORDS:

• left atrial appendage occlusion (LAAO)
• peri-device leak (PDL)
• imaging

Acknowledgments

We would like to acknowledge the support of Mr. Cassio Lynm of Amino Creative, LLC in the design of our figure graphics.

Disclosure statement

Mazen Albaghdadi MD MSc – Consultant and grant support from CSI, Inc. Grant support from Boston Scientific, Consultant for K2 Medical, Inc. Andrew O. Kadlec, MD, PhD – Consultant to K2 Medical. Andrew Adler – Consultant to K2 Medical. Alexander Romanov, MD PhD, FEHRA, FHRS, FESC – Nothing to disclose. Usman R Siddiqui MD FHRS – Consultant to K2 Medical. Karl-Heinz Kuck, MD – Consultant to K2 Medical. Horst Sievert, MD – Study honoraria to institution, travel expenses, consulting: 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Append Medical, Axon, Bavaria Medizin Technologie GmbH, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Cardiac Success, Cardimed, Celonova, Comed B.V., Contego, CVRx, Dinova, Edwards, Endologix, Endomatic, Hemoteq, Hangzhou Nuomao Medtech, Holistick Medical, K2, Lifetech, Maquet Getinge Group, Medtronic, Mokita, Occlutech, Recor, Renal Guard, Terumo, Trisol, Vascular Dynamics, Vectorious Medtech, Venus, Venock, Vivasure Medical. Martin B. Leon, MD – Nothing to disclose. Torsten Vahl, MD – Abbott Laboratories: Grant/Research Support, Consulting Fees. Boston Scientific: Grant/Research Support, Consulting Fees. Edwards Lifesciences: Grant/Research Support, JenaValve Technology: Grant/Research Support, Consulting Fees, Medtronic: Grant/Research Support, Siemens Healthineers: Grant/Research Support, Consulting Fees.

Additional information

Funding

K2 Medical provided funding in support of this paper.