No abstract

Background Central sleep apnea (CSA) is a breathing disorder caused by the intermittent absence of central respiratory drive. Transvenous phrenic nerve stimulation is a new therapeutic option, recently approved by the FDA , for the treatment of CSA. Objective To describe the technique used to implant the transvenous phrenic nerve stimulation system (the remedē System, Respicardia, Inc). Methods The remedē System is placed in the pectoral region, typically on the right side. A single stimulation lead is placed in either the left pericardiophrenic vein (PPV) or the right brachiocephalic vein (RBC). A sensing lead is placed into the azygous vein to detect respiration. Results In the remedē System Pivotal trial, 147 of 151 (97%) patients were successfully implanted with the system. Sixty‐two percent of stimulation leads were placed in the PPV and 35% in the RBC. Mean procedure time was 2.7 ± 0.8 hours and 94% of patients were free from implant‐related serious adverse events through 6 months. Conclusion In patients with CSA, transvenous phrenic nerve stimulation is an effective and safe therapy with an implant procedure similar to that of cardiac implantable electronic devices.

Introduction The novel two‐lead cardiac resynchronization therapy (CRT)‐DX system utilizes a floating atrial dipole on the implantable cardioverter‐defibrillator lead, and when implanted with a left ventricular (LV) lead, offers a two‐lead CRT system with AV synchrony. This study compared complication rates and CRT response among subjects implanted with a two‐lead CRT‐DX system to those subjects implanted with a standard three‐lead CRT‐D system. Methods and Results A total of 240 subjects from the Sentus QP—Extended CRT Evaluation with Quadripolar Left Ventricular Leads postapproval study were selected to identify 120 matched pairs based on similar demographic characteristics using a Greedy algorithm. The complication‐free rate was evaluated as the primary endpoint. All‐cause mortality, heart failure hospitalizations, device diagnostic data, New York Heart Association (NYHA) class improvement, and defibrillator therapy were evaluated from clinical data, in‐office interrogations, and remote monitoring throughout the follow‐up period. Complication‐free survival favored the CRT‐DX group with 92.5% without a major complication compared to 85.0% in the CRT‐D cohort ( P = .0495; 95% confidence interval: 0.1%‐14.9%) over a mean follow‐up of 1.3 and 1.4 years, respectively. Incidence of all‐cause mortality, heart failure hospitalizations, NYHA changes at 6 months postimplant, and percent of LV pacing during CRT therapy were similar in both device cohorts. Inappropriate shocks were more frequent in the CRT‐D cohort with 5.8% of subjects receiving an inappropriate shock vs 0.8% in the CRT‐DX cohort. Conclusion The results of this subanalysis demonstrate that the CRT‐DX system can provide similar CRT responses and significantly fewer complications when compared to a similar cohort with a conventional three‐lead CRT‐D system.

Background: Multisite LV stimulation therapy allows for stimulation of two different left ventricular pacing vectors within a single LV lead and may improve responsiveness to cardiac resynchronization therapy (CRT). This study prospectively evaluated the safety and efficacy of the MultiPole Pacing (MPP) feature in CRT non-responder patients. Methods and Results: CRT non-responders with a standard CRT-D indication were eligible for enrollment into the MPP Sub-Study. Patient status, NYHA classification, Patient Global Assessment (PGA), and adverse events were collected at follow-up. A clinical composite score (CCS) was determined at the 6 month follow-up visit. The primary objective was defined as the proportion of patients with an improved CCS. Safetywas evaluated as freedom from MPP system related adverse events requiring additional invasive intervention to resolve. A total of 53 patients were enrolled across 26 U.S. centers. The cumulative follow-up duration was 24.1 years. CCS was improved in 35.6% of patients (p < .0001 when compared to a performance goal of 3%) after 6 months of MPP therapy. When incorporating patient feedback into a modified CCS, 60.0% of patients showed an improvement. Three patients (5.7%) experienced hospitalization for heart failure, and three patient deaths occurred over the follow-up period. No MPP system-related events were reported for an AE-free rate of 100% (95% CI 93.28% to 100.0%). Conclusions:The results of this small, non-randomized study suggest that the MPP feature is safe, and may be effective at converting a percentage of CRT non-responders to responders. Larger, randomized studies are needed to confirm this result.