AIMS: No standard practice exists with respect to anaesthesiologist-directed sedation (ADS) vs. sedation by proceduralist (PDS) for defibrillation threshold (DT) testing. We aimed to evaluate adverse events and safety outcomes with ADS vs. PDS for DT testing. METHODS AND RESULTS: A post hoc analysis of the Shockless Implant Evaluation (SIMPLE) study was performed among the 1242 patients who had DT testing (624 ADS and 618 PDS). We evaluated both intraoperative and in-hospital adverse composite events and two safety composite outcomes at 30-days of the main trial. Propensity score adjusted models were used to compute odds ratio (OR) and 95% confidence interval (CI) to evaluate the association between adverse and safety outcomes with method of sedation and independent predictors for use of ADS. Compared to PDS, patients who received ADS were younger (62 ± 12 years vs. 64 ± 12 years, P = 0.01), had lower ejection fraction (left ventricular ejection fraction 0.31 ± 13 vs. 0.33 ± 13, P = 0.03), were more likely to receive inhalational anaesthesia, propofol, or narcotics (P < 0.001, respectively) and receive an arterial line (43% vs. 8%, P = <0.0001). Independent predictors for ADS sedation were presence of coronary artery disease (OR 1.69, 95% CI 1.0-2.72; P = 0.03) and hypertrophic cardiomyopathy (OR 2.64, 95% CI 1.19-5.85; P = 0.02). Anaesthesiologist directed sedation had higher intraoperative adverse events (2.2% vs. 0.5%; OR 4.47, 95% CI 1.25-16.0; P = 0.02) and higher primary safety outcomes at 30 days (8.2% vs. 4.9%; OR 1.72 95% CI 1.06-2.80; P = 0.03) and no difference in other outcomes compared to PDS. CONCLUSION: Proceduralist-directed sedation is safe, however, this could be result of selection bias. Further research is needed.

Boston Scientific Brussels Belgium

Boston Scientific Minneapolis MN USA

Centre Hospitalier Universitaire Rennes France

Hospital de Santa Creu i Sant Pau Barcelona Spain

Hungary Semmelweis Univ Sch Med Budapest Hungary

Institut Universitaire de Cardiologie et de Pneumologie de Québec QC Canada

Institute for Clinical and Experimental Medicine Prague Czech Republic

JW Goethe University Frankfurt Germany

Karolinska Institute Stockholm Sweden

Klinikum Kassel Kassel Germany

Leiden University Medical Center Leiden the Netherlands

Leviev Heart Center Sheba Medical Center Tel Hashomer Israel

Mazankowski Alberta Heart Institute University of Alberta 8440 112 Street 2C2 WMC Edmonton AB Canada

Population Health Research Institute McMaster University Hamilton ON Canada

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