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Purpose: Phrenic nerve stimulation (PNS) was approved by the Food and Drug Administration (FDA) to treat moderate to severe central sleep apnea. We report here, results of a retrospective study regarding our institutional outcomes at one year. In this study we evaluated the change in the apnea hypopnea index, epworth sleepiness score, and functional outcomes of sleep score at one year post implant., Methods: This is a retrospective analysis of patients ≥ 18 years of age who had PNS implanted for moderate to severe CSA at the Ohio State University Wexner Medical Center apnea between Feb 1, 2018 to July 1, 2021. Sleep disordered breathing parameters and objective sleepiness as measured by the Epworth Sleepiness Scale (ESS) scores, and Functional Outcomes of Sleep Questionnaire (FOSQ) scores were assessed at baseline and one-year post-implant., Results: Twenty-two patients were implanted with PNS at OSU between February 1, 2018 and May, 31, 2022. The AHI showed a statistically significant decrease from a median of 40 events/hour at baseline to 18 at follow-up (p-value = 0.003). The CAI decreased from 16 events/hour to 2 events/hour (p-value of 0.001). The obstructive apnea index, mixed apnea index, and hypopnea index did not significantly change. The ESS scores had a statistically significant improvement from a median score of 12 to 9 (p-value = 0.028). While the FOSQ showed a trend to improvement from 15.0 to 17.8, it was not statistically significant (p-value of 0.086)., Conclusion: Our study found that PNS therapy for moderate to severe CSA improves overall AHI and CAI. Objective sleepiness as measured by the ESS also improved at one-year post implant., (© 2024. The Author(s).)

Background: Central sleep apnea (CSA) is a form of sleep-disordered breathing caused by a lack of the drive to breathe during sleep. Phrenic nerve stimulation (PNS) was approved in 2017 for treatment of moderate to severe CSA. However, information on setting up a successful PNS program is lacking. We describe our institution's program to provide a framework to bridge the gap between clinical research and clinical application for PNS therapy., Methods: The PNS program was created as a joint program between cardiology and sleep medicine. The program team included cardiologists, sleep medicine specialists, advanced practice providers, clinic managers, and staff who worked together in the evaluation, implantation, and management of patients., Results: Thus far, 33 patients have been implanted at our institution. We have noted resolution of central apneas with PNS and improvement in patient sleep symptoms. The multidisciplinary clinic with cardiology and sleep medicine has led to high patient satisfaction and has facilitated a cohesive relationship between implant and management teams., Conclusions: PNS therapy is an effective treatment option for CSA. While the therapy treats central apneas, it will not affect upper airway obstruction. Proper patient identification is important and cooperative management between cardiology and sleep medicine enhances patient care and experience. Challenges of establishing a multidisciplinary program include identification of providers, clinic space, and scheduling. Once established, the program provides an important service to a vulnerable patient population., (© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Background: Central sleep apnea is common in heart failure patients. Transvenous phrenic nerve stimulation (TPNS) requires placing a lead to stimulate the phrenic nerve and activate the diaphragm. Data are lacking concerning the safety and efficacy of TPNS in patients with concomitant cardiovascular implantable electronic devices (CIEDs)., Objective: To report the safety and efficacy of TPNS in patients with concomitant CIEDs., Methods: In the remedē System Pivotal Trial, 151 patients underwent TPNS device implant. This analysis compared patients with concomitant CIEDs to those without with respect to safety, implant metrics, and efficacy of TPNS. Safety was assessed using incidence of adverse events and device-device interactions. A detailed interaction protocol was followed. Implant metrics included overall TPNS implantation success. Efficacy endpoints included changes in the apnea-hypopnea index (AHI) and quality of life., Results: Of 151 patients, 64 (42%) had a concomitant CIED. There were no significant differences between the groups with respect to safety. There were 4 CIED oversensing events in 3 patients leading to 1 inappropriate defibrillator shock and delivery of antitachycardia pacing. There was no difference in efficacy between the CIED and non-CIED subgroups receiving TPNS, with both having similar percentages of patients who achieved ≥50% reduction in AHI and quality-of-life improvement., Conclusion: Concomitant CIED and TPNS therapy is safe. The presence of a concomitant CIED did not seem to impact implant metrics, implantation success, and TPNS efficacy. A detailed interaction protocol should be followed to minimize the incidence of device-device interaction., (Copyright © 2020 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Study Objectives: Early evidence with transvenous phrenic nerve stimulation (PNS) demonstrates improved disease severity and quality of life (QOL) in patients with central sleep apnea (CSA). The goal of this analysis is to evaluate the complete prospective experience with PNS in order to better characterize its efficacy and safety, including in patients with concomitant heart failure (HF)., Methods: Using pooled individual data from the pilot (n = 57) and pivotal (n = 151) studies of the remedē System in patients with predominant moderate to severe CSA, we evaluated 12-month safety and 6- and 12-month effectiveness based on polysomnography data, QOL, and cardiac function., Results: Among 208 combined patients (June 2010 to May 2015), a remedē device implant was successful in 197 patients (95%), 50/57 pilot study patients (88%) and 147/151 pivotal trial patients (97%). The pooled cohort included patients with CSA of various etiologies, and 141 (68%) had concomitant HF. PNS reduced apnea-hypopnea index (AHI) at 6 months by a median of -22.6 episodes/h (25th and 75th percentile; -38.6 and -8.4, respectively) (median 58% reduction from baseline, P < .001). Improvement in sleep variables was maintained through 12 months of follow-up. In patients with HF and ejection fraction ≤ 45%, PNS was associated with improvement in systolic function from 27.0% (23.3, 36.0) to 31.1% (24.0, 41.5) at 12 months (P = .003). In the entire cohort, improvement in QOL was concordant with amelioration of sleep measures., Conclusions: Transvenous PNS significantly improves CSA severity, sleep quality, ventricular function, and QOL regardless of HF status. Improvements, which are independent of patient compliance, are sustained at 1 year and are associated with acceptable safety., (© 2019 American Academy of Sleep Medicine.)

Study Objective: To evaluate long-term efficacy and safety of phrenic nerve stimulation (PNS) in patients with moderate-to-severe central sleep apnea (CSA) through 3 years of therapy., Methods: Patients in the remedē System Pivotal Trial were observed every 3 months after implant until US Food and Drug Administration approval. At the time of approval and study closure, all patients completed 24 months of follow-up; 33 patients had not reached the 36-month visit. Sleep metrics (polysomnography) and echocardiographic parameters are reported at baseline, 12, 18, and 24 months, in addition to available 36-month sleep results from polygraphy. Safety was assessed through 36 months; however, analysis focused through 24 months and available 36-month results are provided., Results: Patients were assessed at 24 (n = 109) and 36 (n = 60) months. Baseline characteristics included mean age 64 years, 91% male, and mean apnea-hypopnea index 47 events per hour. Sleep metrics (apnea-hypopnea index (AHI), central apnea index, arousal index, oxygen desaturation index, rapid eye movement sleep) remained improved through 24 and 36 months with continuous use of PNS therapy. At least 60% of patients in the treatment group achieved at least 50% reduction in AHI through 24 months. Serious adverse events (SAEs) related to the remedē System implant procedure, device, or therapy through 24 months were reported by 10% of patients, no unanticipated adverse device effects or deaths, and all events resolved. No additional related SAEs were reported between 24 and 36 months., Conclusion: These data suggest beneficial effects of long-term PNS in patients with CSA appear to sustain through 36 months with no new safety concerns., Trial Registration: NCT01816776., (© Sleep Research Society 2019. Published by Oxford University Press [on behalf of the Sleep Research Society].)

Aims: The presence of central sleep apnoea (CSA) is associated with poor prognosis in patients with heart failure (HF). The aim of this analysis was to evaluate if using phrenic nerve stimulation to treat CSA in patients with CSA and HF was associated with changes in HF-specific metrics., Methods and Results: All patients randomized in the remedē System Pivotal Trial and identified at baseline with HF were included (n = 96). Effectiveness data from treatment and former control groups were pooled based on months since therapy activation. Changes from baseline to 6 and 12 months in sleep metrics, Epworth Sleepiness Scale, patient global assessment health-related quality of life, Minnesota Living with Heart Failure Questionnaire (MLHFQ), and echocardiographic parameters are reported. HF hospitalization, cardiovascular death, and the composite of HF hospitalization or cardiovascular death within 6 months are reported by the original randomized group assignment for safety assessment. Sleep metrics and quality of life improved from baseline to 6 and 12 months. At 12 months, MLHFQ scores changed by -6.8 ± 20.0 (P = 0.005). The 6-month rate of HF hospitalization was 4.7% in treatment patients (standard error = 3.3) and 17.0% in control patients (standard error = 5.5) (P = 0.065). Reported adverse events were as expected for a transvenous implantable system., Conclusions: Phrenic nerve stimulation reduces CSA severity in patients with HF. In parallel, this CSA treatment was associated with benefits on HF quality of life., (© 2018 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Transvenous phrenic nerve stimulation improved sleep metrics and quality of life after 6 months versus control in the remedē System Pivotal Trial. This analysis explored the effectiveness of phrenic nerve stimulation in patients with central sleep apnea after 12 months of therapy. Reproducibility of treatment effect was assessed in the former control group in whom the implanted device was initially inactive for the sixth month and subsequently activated when the randomized control assessments were complete. Patients with moderate-to-severe central sleep apnea implanted with the remedē System were randomized to therapy activation at 1 month (treatment) or after 6 months (control). Sleep indices were assessed from baseline to 12 months in the treatment group and from 6 to 12 months in former controls. In the treatment group, a ≥50% reduction in apnea-hypopnea index occurred in 60% of patients at 6 months (95% confidence interval [CI] 47% to 64%) and 67% (95% CI 53% to 78%) at 12 months. After 6 months of therapy, 55% of former controls (95% CI 43% to 67%) achieved ≥50%reduction in apnea-hypopnea index. Patient Global Assessment was markedly ormoderately improved at 6 and 12 months in 60% of treatment patients.Improvements persisted at 12 months. A serious adverse event within 12 months occurred in 13 patients (9%). Phrenic nerve stimulation produced sustained improvements in sleep indices and quality of life to at least 12 months in patients with central sleep apnea. The similar improvement of former controls after 6 months of active therapy confirms benefits are reproducible and reliable., (Copyright © 2018 Respicardia, Inc. Published by Elsevier Inc. All rights reserved.)

Aims: Patients with central sleep apnoea (CSA) often have poor quality of life and are at increased risk of morbidity and mortality. This study sought to evaluate the 12-month clinical outcomes of patients with CSA treated with unilateral transvenous phrenic nerve stimulation in the prospective, multicentre, non-randomized remedē ® System pilot study., Methods and Results: Forty-seven patients with CSA were treated with the remedē ® System (Respicardia Inc., Minnetonka, MN, USA) for a minimum of 3 months. Sleep-disordered breathing parameters were evaluated by polysomnography (PSG) at 3, 6, and 12-month follow-up. Sleep symptoms and quality of life were also evaluated. Forty-one patients completed all follow-up PSGs and were included in the analysis. At 12 months, there was sustained improvement compared with baseline in the apnoea-hypopnoea index (49.9 ± 15.1 vs. 27.5 ± 18.3 events/h, P < 0.001) and central apnoea index (28.2 ± 15.0 vs. 6.0 ± 9.2 events/h, P < 0.001). Sustained improvement in the oxygen desaturation index (46.1 ± 19.1 vs. 26.9 ± 18.0 events/h, P < 0.001), rapid eye movement sleep (11.4 ± 6.1% vs. 17.1 ± 8.0%, P < 0.001), and sleep efficiency (69.3 ± 16.9% vs. 75.6 ± 17.1%, P = 0.024) were also observed. There were also continued favourable effects on sleepiness and quality of life. Three deaths unrelated to remedē ® System therapy and five serious adverse events occurred over 12 months of follow-up., Conclusion: The present study demonstrates that in patients with CSA, unilateral transvenous phrenic nerve stimulation is associated with sustained improvement in key sleep parameters, sleep symptoms, and quality of life over 12 months of follow-up., (© 2016 The Authors. European Journal of Heart Failure © 2016 European Society of Cardiology.)

Background: Central sleep apnea is common in patients with cardiovascular disease and worsens outcomes. There is a lack of established therapies for central sleep apnea, and those available are limited by poor patient adherence and potentially adverse cardiovascular effects, at least in a subset of patients. The remedē System (Respicardia, Minnetonka, Minnesota) is a new physiologic treatment that uses transvenous phrenic nerve stimulation to contract the diaphragm, thereby stabilizing gas exchange and restoring normal breathing throughout the sleep period., Methods: This is a prospective multicenter randomized trial with blinded end points evaluating the safety and efficacy of the remedē System. Up to 173 patients with central sleep apnea will be randomized 1:1 to remedē System therapy initiated at 1 month after implantation (treatment) or to an implanted remedē System that will remain inactive for 6 months (control). Primary efficacy end point is the percentage of patients who experience a reduction in apnea-hypopnea index by a ≥ 50% at 6 months (responder analysis). Primary safety end point is freedom from serious adverse events through 12 months. Secondary end points include sleep-disordered breathing parameters, sleep architecture, Epworth Sleepiness Scale score, and Patient Global Assessment., Conclusions: This is the 1st randomized controlled trial of the safety and efficacy of the remedē System for the treatment of central sleep apnea., (Copyright © 2015. Published by Elsevier Inc.)

Central sleep apnea (CSA) is a common, though often unrecognized, finding in congestive heart failure (HF) patients that is associated with poor quality of life and increased morbidity and mortality. While various treatment strategies, including continuous positive airway pressure (CPAP) therapy, have been devised and tested to treat CSA in HF, none thus far have been proven effective over the long term or been shown to improve survival. Adaptive pressure support servo-ventilation (ASV) is a promising potential new therapy for CSA, but like its predecessor, CPAP, it is often not well tolerated by patients, and results from clinical trials evaluating its long-term effectiveness in reducing morbidity and mortality are still a number of years off. Recently, a new therapy utilizing unilateral transvenous phrenic nerve stimulation has been introduced to treat CSA in HF. As a totally implantable, device-based therapy, it may be better tolerated than CPAP or ASV in HF patients and, thus, improve patient compliance with treatment. Early studies using this therapy have been encouraging, with patients demonstrating significant improvement in major indices of CSA severity.