Clinical outcomes of patients undergoing percutaneous left atrial appendage occlusion in general anaesthesia or conscious sedation: data from the prospective global Amplatzer Amulet Occluder Observational Study

Abstract

Objective: To evaluate the safety and efficacy of percutaneous left atrial appendage occlusion (LAAO) using conscious sedation (CS).

Background: Several percutaneous structural heart disease interventions are safely and efficiently performed using CS instead of general anaesthesia (GA). This concept has not been evaluated in a large multicenter cohort of patients undergoing LAAO.

Methods: Patients from the prospective, global Amplatzer Amulet Occluder Observational Study were divided into two groups (GA vs CS). Baseline information, periprocedural and postprocedural efficacy and complications, as well as outcomes through 7 days post implant were compared.

Results: Patients undergoing transesophageal-guided implants were categorised by GA (n=607, 64%) or CS (n=342, 36%) usage. Mean age was 75 years in both groups. LAAO technical success was achieved in 99% of both groups. The procedure duration (GA: 35±22 min vs CS: 27±19 min, p<0.001), total amount of contrast medium (GA: 105±81 mL vs CS: 86±66 mL, p<0.001) and fluoroscopic time (GA: 13±9 min vs CS: 12±13 min, p<0.001) were less in CS cases. Procedure-related or device-related serious adverse events during the first 7 days were numerically higher in the CS group (GA: 4.9% vs CS: 7.6%, p=0.114). Peridevice residual flow was absent or ≤5 mm 1-3 months after the procedure in 99.7% of the GA and in 100% of the CS group (p=1.000).

Conclusions: In a large global study, LAAO with the Amplatzer Amulet occluder is safe and feasible using CS. Procedure duration and total amount of contrast were less with CS than GA cases.

Trial registration number: NCT02447081; Results.

Keywords: cardiology; stroke medicine; thromboembolism.

Conflict of interest statement

Competing interests: Dr Nielsen-Kudsk has served as a proctor for Abbott and is a consultant for Abbott and Boston Scientific. Dr Schmidt has served as a consultant for Boston Scientific and Medtronic. Dr Mazzone has served as a consultant for Abbott, Boston Scientific, and Medtronic. Dr Berti has served as a proctor for Abbott. Dr Fischer has served as a proctor for Biotronik and Boston Scientific and is a consultant for Abbott. Dr Lund has served as a proctor for Abbott. Dr Montorfano has served as a proctor for Abbott, Boston Scientific, and Edwards Lifesciences. Dr Della Bella has served as a proctor and consultant for Abbott. Mr Gage is an employee of Abbott and was involved in data review and analysis. Dr Zeus has received consulting fees, travel expenses or study honorariums from Medtronic and Edwards Lifesciences outside of this work. All other authors have nothing to disclose with regard to this project.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

Patient selection process and study design. Of 949 subjects undergoing transesophageal echocardiography-guided implant attempt in the Amulet Observational Study, those managed with general anaesthesia (n=607, 64%) or conscious sedation (n=342, 36%) were analysed in regards of baseline characteristics, in-hospital data and 7-day follow-up. ICE, intracardiac echocardiography.

Figure 2

Intrahospital outcome of patients undergoing left atrial appendage occlusion (LAAO) in general anaesthesia (GA) versus conscious sedation (CS). (A) The procedure duration—defined as the duration from the first delivery system in to the removal of the dilator/delivery system—(GA: 35 min±22 vs CS: 27 min±19, p

Figure 3

Heat map of anaesthetic method in the Amplatzer Amulet Occluder Observational Study. Countries performing transoesophageal echocardiography-guided implants in the Amplatzer Amulet Observational Study are color-coded based on their anaesthesiologic method of choice: shades of blue represent countries where conscious sedation is the method of choice, whereas shades of red stand for countries where general anaesthesia is most often used during left atrial appendage occlusion procedure.

Figure 4

Short-term follow-up. (A) The overall mortality rate at 7 days did not differ (general anaesthesia (GA): 0.3% vs conscious sedation (CS): 0.3%, p=1.000). (B) An ischaemic stroke occurred in 0.2% of GA, and in 0.9% of CS patients (p=0.136) and (C) major bleeding events occurred numerically more often in the CS group (GA: 2.3% vs CS: 4.1%, p=0.160) 7 days post implant. (D) Peridevice residual flow ≤5 mm was evenly distributed (GA: 99.7% vs CS: 100%, p=1.000). LAAO, left atrial appendage occlusion.