Transvenous phrenic nerve stimulation to treat idiopathic central sleep apnea

Abstract Introduction Some subjects with central sleep apnea (CSA) complain of subjective excessive daytime sleepiness (EDS), as assessed by the Epworth Sleepiness Score (ESS). However, there is considerable variability in the level of chances of dozing for each of the 8 ESS questions, as each reflects a different situation. The aim of this analysis was to examine individual situations of the ESS and determine if transvenous phrenic nerve stimulation (TPNS) resulted in improvements of individual ESS situations which were scored moderate to high (2 and 3) at baseline. Patient Global Assessment (PGA) was also assessed. Methods All 151 subjects enrolled in the randomized (Treatment vs Control) remedē System pivotal trial were included in the analysis. All subjects were implanted, but activation in Control arm was delayed 6 months. Results Greater than or equal to 50% of patients scored moderate-high on several individual ESS situations: chance of dozing while sitting and reading (57%), watching television (62%), while lying down to rest in the afternoon when circumstances permit (76%). In the active arm, 68%, 44% and 29% of patients with moderate-high at baseline, respectively, for sitting and reading, watching television, and lying down to rest in the afternoon shifted to less than moderate at 6 months. Respective shifts for the control arm were 29%, 23% and 13%. Seventy-two percent of treated subjects with baseline ESS>10 shifted to ≤10 at 6 months compared to 26% of control patients. Additionally, 72% of treated compared to 7% of control subjects with baseline ESS>10 reported markedly or moderately improved QoL. Conclusion Results of this randomized controlled trial shows that compared to the control arm, TPNS leads to improvements in various situations of the ESS as well as QoL. The most improved situations were less chance of dozing while reading and watching television. Support Respicardia

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TCT-134 Transvenous Phrenic Nerve Stimulation in the Treatment of Central Sleep Apnea in Patients with Reduced Ejection Fraction: A Report from the remede(r) System Pilot Study

Journal of the American College of Cardiology ◽

10.1016/j.jacc.2013.08.865 ◽

2013 ◽

Vol 62 (18) ◽

pp. B43 ◽

Cited By ~ 1

Author(s):

Piotr Ponikowski ◽

Dariusz Jagielski ◽

Olaf Oldenburg ◽

Ralph Augostini ◽

...

Keyword(s):

Sleep Apnea ◽

Pilot Study ◽

Ejection Fraction ◽

Nerve Stimulation ◽

Phrenic Nerve ◽

Central Sleep Apnea ◽

Phrenic Nerve Stimulation ◽

Reduced Ejection Fraction

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Transvenous Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea: Five-Year Safety and Efficacy Outcomes

Nature and Science of Sleep ◽

10.2147/nss.s300713 ◽

2021 ◽

Vol Volume 13 ◽

pp. 515-526

Author(s):

Maria Rosa Costanzo ◽

Shahrokh Javaheri ◽

Piotr Ponikowski ◽

Olaf Oldenburg ◽

Ralph Augostini ◽

...

Keyword(s):

Sleep Apnea ◽

Nerve Stimulation ◽

Phrenic Nerve ◽

Central Sleep Apnea ◽

Phrenic Nerve Stimulation ◽

Safety And Efficacy

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Phrenic nerve stimulation in patients with central sleep apnea: a single‑center experience from pilot and pivotal trials evaluating the remedē System

Kardiologia Polska ◽

10.5603/kp.a2019.0061 ◽

2019 ◽

Vol 77 (5) ◽

pp. 553-560 ◽

Cited By ~ 1

Author(s):

Dariusz Jagielski ◽

Adam Kołodziej ◽

Randy Westlund ◽

Bartosz Biel ◽

Krzysztof Nowak ◽

...

Keyword(s):

Sleep Apnea ◽

Nerve Stimulation ◽

Phrenic Nerve ◽

Central Sleep Apnea ◽

Single Center ◽

Phrenic Nerve Stimulation ◽

Single Center Experience

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Transvenous Phrenic Nerve Stimulation Improves Central Sleep Apnea in Heart Failure Patients

Journal of Cardiac Failure ◽

10.1016/j.cardfail.2020.09.196 ◽

2020 ◽

Vol 26 (10) ◽

pp. S67

Author(s):

Lee R. Goldberg ◽

Loreena Hill ◽

Maria Rosa Costanzo ◽

Ovidiu Chioncel ◽

Mitja Lainscak ◽

...

Keyword(s):

Heart Failure ◽

Sleep Apnea ◽

Nerve Stimulation ◽

Phrenic Nerve ◽

Central Sleep Apnea ◽

Phrenic Nerve Stimulation ◽

Heart Failure Patients

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Phrenic Nerve Stimulation Improves Physical Performance and Hypoxemia in Heart Failure Patients with Central Sleep Apnea

Journal of Clinical Medicine ◽

10.3390/jcm10020202 ◽

2021 ◽

Vol 10 (2) ◽

pp. 202

Author(s):

Max Potratz ◽

Christian Sohns ◽

Daniel Dumitrescu ◽

Philipp Sommer ◽

Henrik Fox

Keyword(s):

Heart Failure ◽

Sleep Apnea ◽

Physical Performance ◽

Nerve Stimulation ◽

Phrenic Nerve ◽

Central Sleep Apnea ◽

Phrenic Nerve Stimulation ◽

Performance Capacity ◽

Physical Performance Capacity

Background: Central sleep apnea (CSA) is a common comorbidity in patients with heart failure (HF) and has been linked to increased morbidity and mortality risk. In addition, CSA is associated with impaired quality of life, reduced physical performance capacity, and hypoxemia. Phrenic nerve stimulation (PNS) is a novel approach to the treatment of CSA and has been shown to be safe and effective in this indication. However, there are currently no data on the effects of PNS on physical performance and hypoxia in CSA HF patients, both of which have been shown to be linked to mortality in HF. Methods: This prospective study enrolled patients with HF and CSA diagnosed using polysomnography. All were implanted with a PNS system (remedē® system, Respicardia Inc., Minnetonka, MN, USA) for the treatment of CSA. Examinations included polysomnography (to determine hypoxemic burden), echocardiography and a standardized 6-min walk test prior to device implantation (baseline) and after 6 months of follow-up. Results: A total of 24 patients were enrolled (mean age 67.1 ± 11.2 years, 88% male). The 6-min walk distance was 369.5 ± 163.5 m at baseline and significantly improved during follow-up (to 410 ± 169.7 m; p = 0.035). Hypoxemic burden, determined based on time with oxygen saturation < 90% improved from 81 ± 55.8 min at baseline to 27.9 ± 42.8 min during PNS therapy (p < 0.01). Conclusion: In addition to safely and effectively treating CSA, PNS is also associated with improved physical performance capacity and reduced hypoxemic burden in patients with HF.

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Long-term efficacy and safety of phrenic nerve stimulation for the treatment of central sleep apnea

SLEEP ◽

10.1093/sleep/zsz158 ◽

2019 ◽

Vol 42 (11) ◽

Cited By ~ 8

Author(s):

Henrik Fox ◽

Olaf Oldenburg ◽

Shahrokh Javaheri ◽

Piotr Ponikowski ◽

Ralph Augostini ◽

...

Keyword(s):

Sleep Apnea ◽

Nerve Stimulation ◽

Phrenic Nerve ◽

Central Sleep Apnea ◽

Apnea Hypopnea Index ◽

Efficacy And Safety ◽

Phrenic Nerve Stimulation ◽

Study Objective ◽

Term Efficacy

Abstract 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.

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