Sedation strategies for defibrillation threshold testing: safety outcomes with anaesthesiologist compared to proceduralist-directed sedation: an analysis from the SIMPLE study.

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.

ILEEM-survey on the Heart Team approach and team training for lead extraction procedures.

BACKGROUND: The Heart Team approach has become an integral part of modern cardiovascular medicine. To evaluate current opinions and real-world practice among lead extraction practitioners, an online survey was created and distributed among a pool of lead extraction specialists participating in the International Lead Extraction Expert Meeting (ILEEM) 2018. METHODS: The online survey consisted of 10 questions and was performed using an online survey tool (www.surveymonkey.com). The collector link was sent to 48 lead extraction experts via email. RESULTS: A total of 43 answers were collected (89% return rate) from lead extraction experts in 16 different countries. A great majority (83.7%) of the respondents performed more than 30 lead extraction procedures per year. The most common procedural environment in this survey was the hybrid operating room (67.4%). Most procedures were performed by electrophysiologists and cardiologists (80.9%). Important additional members of the current lead extraction teams were cardiac surgeons (79.1%), anesthesiologists (95.3%) and operating room scrub nurses (76.7%). An extended Heart Team is regarded beneficial for patient care by 86.0%, with potential further members being infectious diseases specialists, intensivists and radiologists. Team training activities are performed in 48.8% of participating centers. CONCLUSIONS: This survey supports the importance of establishing lead extraction Heart Teams in specialized lead extraction centers to potentially improve patient outcomes. The concept of a core and an extended Heart Team approach in lead extraction procedures is introduced.

Implantable cardioverter-defibrillator therapy in hypertrophic cardiomyopathy: A SIMPLE substudy.

BACKGROUND: Patients with hypertrophic cardiomyopathy (HCM) are considered to be at high risk for elevated defibrillation thresholds, periprocedural complications, and failed appropriate shocks. OBJECTIVE: The purpose of this study was to determine the value of defibrillation testing (DT) in HCM patients undergoing implantable cardioverter-defibrillator (ICD) insertion. METHODS: Defibrillation thresholds, perioperative complications, and long-term outcomes were compared between patients with HCM and those with ischemic cardiomyopathy (ICM) or dilated cardiomyopathy (DCM) enrolled in the SIMPLE (Shockless IMPLant Evaluation) trial (Clinialtrials.gov Identifier: NCT00800384). In patients with HCM, outcomes were also compared between those randomized to DT vs no DT. RESULTS: Adequate defibrillation safety margin without system change was achieved in 46 of 52 (88.5%) HCM and 948 of 1047 (90.5%) ICM/DCM patients (P = .63). Perioperative complications occurred in 1 of 52 (1.9%) HCM patients with DT compared to 67 of 1047 (6.4%) ICM/DCM patients with DT (P = .37) or 3 of 42 (7.1%) HCM patients without DT (P = .32). During follow-up, there was no significant difference between HCM vs ICM/DCM patients in terms of all-cause mortality (adjusted hazard ratio [HR] 1.02, 95% confidence interval [CI] 0.45-2.34), composite of arrhythmic death or failed appropriate shock (adjusted HR 0.33, 95% CI 0.04-2.42), inappropriate shocks (adjusted HR 1.64, 95% CI 0.69-3.89), or system complications (adjusted HR 1.93, 95% CI 0.88-4.27). All-cause mortality (HR 0.26, 95% CI 0.03-2.20), appropriate (HR 0.24, 95% CI 0.03-2.05), and inappropriate shocks (HR 2.13, 95% CI 0.51-8.94) were similar in HCM patients without or those with DT. CONCLUSION: We did not find any difference in intraoperative defibrillation efficacy, perioperative complications, and long-term outcomes between patients with HCM and those with ICM/DCM. DT did not improve intraoperative or clinical shock efficacy in HCM patients.