Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints and data collection requirements for clinical studies

Abstract

The increasing interest in left atrial appendage occlusion (LAAO) for ischaemic stroke prevention in atrial fibrillation (AF) fuels the need for more clinical data on the safety and effectiveness of this therapy. Besides an assessment of the effectiveness of the therapy in specific patient groups, comparisons with pharmacological stroke prophylaxis, surgical approaches and other device-based therapies are warranted. This paper documents the consensus reached among clinical experts in relevant disciplines from Europe and North America, European cardiology professional societies and representatives from the medical device industry regarding definitions for parameters and endpoints to be assessed in clinical studies. Adherence to these definitions is proposed in order to achieve a consistent approach across clinical studies on LAAO among the involved stakeholders and various clinical disciplines and thereby facilitate continued evaluation of therapeutic strategies available.

A 79‐year‐old woman with atrial fibrillation and new onset of heart failure

“…13 Because natriuretic peptides play an important role in fluid regulation and volume homeostasis, LAA closure may impede the physiological regulation in heart failure. 16 In a recent publication, rehospitalizations for heart failure were reported in 17% of the patients after interventional LAA closure; however, the development of heart failure was attributed to pre-existing cardiac disease in this study. 14,15 Up to now, there is only one randomized trial comparing LAA closure with OAC.…”

Left atrial appendage occlusion for stroke prevention in diabetes mellitus patients with atrial fibrillation: Long‐term results

“…Adverse events reported during follow‐up visits, based on the Munich consensus document, included mortality (cardiovascular, non‐cardiovascular, procedural mortality, immediate procedural mortality), thromboembolic events (stroke, transient ischemic attack [TIA], systemic embolism) and bleeding (life‐threating or disabling, major bleeding, minor bleeding). Procedure efficacy to prevent thromboembolic events (stroke, TIA, systemic embolism, thrombus in the heart chamber) was also evaluated by comparing the actual event rate at follow‐up with the event rate predicted by the CHA 2 DS 2 ‐VASc score .…”

Usable implantation depth for watchman left atrial appendage occlusion is greater with appendage angiography than transesophageal echocardiography

“…Three cases were aborted due to an LAA that was too large for the device. There were no device‐related complications . Two patients had clinically relevant pericardial effusions that resolved with pericardial drains and were the only procedure‐related complications.…”