Prospectively collected data of patients who underwent S-ICD implantation with MAC from 2015 to 2016 were analyzed retrospectively. The efficacy endpoints were the provision of an optimal depth of sedation and analgesia to facilitate S-ICD implantation without intra-procedure patient discomfort or awareness, and the absence of “severe” pain at the lead tunneling and the generator insertion sites post-procedure. The safety endpoints included: (1) periprocedural hypotension, as defined by a mean arterial pressure (MAP)<60 mmHg refractory to conventional pharmacotherapy, (2) heart rate (HR)<45 bpm requiring pharmacologic support, and (3) sedation-induced airway compromise requiring endotracheal intubation.
MAP and HR were recorded during S-ICD implantation and DFT testing. The maximum and minimum infusion rates of propofol, supplemental sedatives, and analgesics, and doses of vasopressor and/or inotropic agents administered intra-procedurally were recorded. Post-procedure pain scores also were noted.
Ten patients underwent S-ICD implantation with MAC (mean age, 56 years; 50% men; mean left ventricular ejection fraction was 39%). Implantation of the S-ICD system using MAC was successful in all patients without any major adverse events. The mean baseline MAP was 92.8 mmHg, and the mean end-procedure MAP was 88 mmHg (p = 0.26). When compared to baseline and end-procedure, the mean lowest intra-procedure MAP was significantly lower (67.4 mmHg; p = 0.0001). The mean baseline HR was 65.7 bpm, and the mean end-procedure HR was 70.1 bpm (p = 0.28). When compared to baseline and end-procedure, the mean lowest intra-procedure HR was significantly lower (55.8 bpm; p<0.001). MAC was not associated with airway compromise in any patient, and post-procedure pain was rated as no greater than “mild”.
Among a heterogeneous patient population undergoing S-ICD implantation and DFT testing, the use of MAC is efficacious, feasible, and safe.