Observational studyBMJ open2021
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.
Observational study in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02447081 (Amplatzer™Amulet™ Observational Post-Market Study), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Amplatzer™Amulet™ Observational Post-Market Study
Who cites it
3 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.
- Sedation versus general anesthesia on all-cause mortality in patients undergoing percutaneous procedures: a systematic review and meta-analysis.BMC anesthesiology · 2024Pooled it
- Left Atrial Appendage Occlusion in the Era of Minimalist Approaches: Anesthesia and Imaging Considerations.Journal of clinical medicine · 2026Review
- Clinical Outcomes of Percutaneous Left-Atrial Appendage Occlusion with Conscious Sedation without an Anesthesiologist on Site: Results from a Multicenter Study.Medicina (Kaunas, Lithuania) · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 8 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the safety and efficacy of percutaneous left atrial appendage occlusion (LAAO) using conscious sedation (CS).
backgroundSeveral 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.
methodsPatients 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.
resultsPatients 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).
conclusionsIn 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.
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