Phrenic nerve stimulation in patients with central sleep apnea: a single­center experience from pilot and pivotal trials evaluating the remede System.

BACKGROUND: Patients with central sleep apnea (CSA) have recently been shown to have improved sleep metrics and quality of life (QoL) with phrenic nerve stimulation (PNS). AIMS: The aim of this study was to report the results of a partnership between cardiology, sleep medicine, and electrophysiology in a single clinical center as well as the enrollment, implantation, and follow­up experience demonstrating both the safety and efficacy of PNS. METHODS: This analysis included data from the pilot and pivotal trials investigating the effect of PNS using an implantable transvenous system in patients with CSA. We present our experience and data on the enrollment processes, implantation feasibility and safety, sleep indices, and QoL at 6 and 12 months of follow­up. RESULTS: Between June 2010 and May 2015, cardiology patients were prescreened and 588 of them were sent for in­home sleep test. Ninety­six patients were referred for polysomnographic studies, and 33 were enrolled and had an implant attempt, with 31 successfully receiving an implant. The apnea-hypopnea index was reduced in the pilot trial (mean [SD] of 48.7 [15.5] events/h to 22.5 [13.2] events/h; P <0.001) and in the pivotal trial (mean [SD] of 48.3 [18.8] events/h to 26.0 [21.9] events/h; P <0.001). Improvement in QoL was also observed. CONCLUSIONS: We showed that PNS improved sleep metrics and QoL in patients with CSA, which is a result of multiple factors, including a comprehensive coordination between cardiology, sleep medicine, and electrophysiology. This ensures appropriate patient identification leading to safe implantation and full patient compliance during follow­up visits.

Seat belts-related behaviors in car drivers with cardiac implantable electronic devices.

BACKGROUND: Seat belt use is the single most effective means of reducing fatal injuries in road traffic accidents. The presence of a cardiac implantable electronic device (CIED) might influence seat belt-related behaviors due to the physical proximity of the seat belt and left subclavian area in which the device is usually implanted. Understanding the underlying mechanisms of improper seat belt use may improve safety of these patients. METHODS: We performed a prospective study using a structured questionnaire with 120 CIED recipients (age, 63.9 ± 10.9 years) attending a pacing outpatient clinic. All study participants were active drivers and predominantly male. The majority of patients (79%) had undergone high-energy device implantation. RESULTS: We found that 18% of study participants do not fasten seat belts on a regular basis or use the seat belt in an atypical fashion (such as under the armpit). Moderate or high level of discomfort from the interaction between seat belt and CIED was present in 27%, while more than half (51%) were afraid of seat belt-induced CIED damage. In multifactorial analysis, we found the following independent predictors of improper seat belt use: (1) at least moderate level of discomfort at the CIED site (P = 0.02); (2) fear of CIED damage (P = 0.009); and (3) irregular seat belt use prior to CIED implantation (P = 0.037). CONCLUSIONS: Improper seat belt-related behaviors are common in CIED recipients. They arise from previous habits and from CIED-related physical and psychological factors. Patients' education regarding the importance and safety of proper seat belt use is a priority.