Transvenous neurostimulation for central sleep apnoea: a randomised controlled trial

Costanzo, María Rosa; Ponikowski, Piotr; Javaheri, Shahrokh; Augostini, Ralph; Goldberg, Lee R.; Holcomb, Richard; Kao, Andrew; Khayat, Rami; Oldenburg, Olaf; Stellbrink, Christoph; Abraham, William T.

doi:10.1016/s0140-6736(16)30961-8

Cited by 156 publications

(144 citation statements)

References 32 publications

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“…Future randomised control trials with unilateral transvenous neurostimulation for HF should be powered to determine cardiovascular outcomes. n 59 …”

Section: Resultsmentioning

confidence: 99%

“…In the HF group, tolerability and safety were similar to those of the overall population. 59 The results of this trial indicate that transvenous neurostimulation produces significant improvements in reducing the severity of central sleep apnea, as measured by several pre-specified sleep indices obtained during polysomnography and scored by masked investigators in a core laboratory. Improvements were observed with use of the device in the arousal index, REM sleep, PGA scores, and ESS quality of life measures at 6 months of follow up.…”

Section: Phrenic Nerve Stimulationmentioning

confidence: 89%

“…All prespecified hierarchically tested secondary sleep and quality of life measure endpoints were improved in the treatment group compared to control. 59 Exploratory evaluation of the 64 % of the study subjects who had underlying HF revealed that, compared to HF controls, the HF treatment group included a greater percentage of patients who had a reduction in AHI>50 % at 6 months (63 % versus 4 %, p<0.0001). In the HF group, tolerability and safety were similar to those of the overall population.…”

Section: Phrenic Nerve Stimulationmentioning

confidence: 98%

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Sleep-Disordered Breathing During Congestive Heart Failure: To Intervene or Not to Intervene?

Valika¹,

Costanzo²

2017

Cardiac Failure Review

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Sleep-disordered breathing is common in heart failure patients and is associated with increased morbidity and mortality. Central sleep apnea occurs more commonly in heart failure-reduced ejection fraction, and obstructive sleep apnea occurs more frequently in heart failure with preserved ejection fraction. Although the two types of sleep-disordered breathing have distinct pathophysiologic mechanisms, both contribute to abnormal cardiovascular consequences. Treatment with continuous positive airway pressure for obstructive sleep apnea in heart failure has been well defined, whereas treatment strategies for central sleep apnea in heart failure continue to evolve. Unilateral transvenous neurostimulation has shown promise for the treatment of central sleep apnea. In this paper, we examine the current state of knowledge of treatment options for sleep-disordered breathing in heart failure.

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“…Future randomised control trials with unilateral transvenous neurostimulation for HF should be powered to determine cardiovascular outcomes. n 59 …”

Section: Resultsmentioning

confidence: 99%

Section: Phrenic Nerve Stimulationmentioning

confidence: 89%

Section: Phrenic Nerve Stimulationmentioning

confidence: 98%

See 1 more Smart Citation

Sleep-Disordered Breathing During Congestive Heart Failure: To Intervene or Not to Intervene?

Valika¹,

Costanzo²

2017

Cardiac Failure Review

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“…Remarkable efficacy was observed in these patients (15). A large multicenter study conducted in Europe and the USA found therapeutic efficacy, with elimination of CSA events and elevation of SpO 2 compared with no PNS during long-term follow-up of 151 HF patients (24). A prospective randomized controlled study of 173 patients is underway.…”

Section: Pathogenesis Of Csamentioning

confidence: 92%

Transvenous phrenic nerve stimulation, a novel therapeutic approach for central sleep apnea

Ding¹,

Zhang²

2018

J. Thorac. Dis.

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Central sleep apnea (CSA) is common in heart failure (HF) patients. Traditional treatment of CSA, including continuous positive airway pressure (CPAP), adaptive servo ventilation (ASV), oxygen therapy, and CO 2 inhalation, has respective limitations. Transvenous phrenic nerve stimulation (PNS), a novel therapeutic approach for CSA, was proved to be effective and safe. The remedē ® system and related transvenous PNS methods was approved by FDA in 2017, for treating moderate to severe CSA.

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“…It is possible that a stronger recommendation for this therapeutic approach could have been included in recent guidelines had the data been available earlier. [41] The future of CSA therapy Central sleep apnoea is of paramount importance to the HF clinician. Without treatment, HF patients continue to be at risk for the devastating consequences of CSA.…”

Section: Treatment Options For Csamentioning

confidence: 99%

The Management of Co-Morbidities in Patients with Heart Failure – Central Sleep Apnoea

Coats¹,

Shewan²,

Abraham³

2017

ICFJ

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Despite many therapeutic advances, heart failure (HF) remains challenging to treat and continues to be associated with high rates of morbidity and mortality. There is an ongoing need to identify co-morbidities that either contribute to the progression of heart failure or limit the therapeutic response to treatment. One area under active investigation is the treatment of central sleep apnoea (CSA). CSA has consistently been shown to be associated with a worse prognosis in HF patients. Thus, understanding how to diagnose and treat CSA is of paramount importance to the HF clinician. Without treatment, HF patients continue to be at risk for the devastating consequences of CSA. Prognosis is very poor with studies consistently demonstrating poor outcomes among HF patients with CSA. Over the course of the night, each discrete event contributes to increased nor- epinephrine levels and hypoxia which are associated with progressive heart failure and arrhythmias. Initial therapeutic options utilized therapies which were developed for obstructive sleep apnoea with limited success or even harm. ASV is now contraindicated in HF patients with an EF < 45% leaving only 2 potential treatment options: CPAP and transvenous phrenic nerve stimulation. Data from the recently presented (post ESC guidelines) trial on transvenous phrenic nerve stimulation demonstrated efficacy without the need for patient compliance or any safety concerns. It is expected that additional studies in CSA will continue to demonstrate the full impact of treating this important co-morbidity on patients with HF.

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Transvenous neurostimulation for central sleep apnoea: a randomised controlled trial

Cited by 156 publications

References 32 publications

Sleep-Disordered Breathing During Congestive Heart Failure: To Intervene or Not to Intervene?

Sleep-Disordered Breathing During Congestive Heart Failure: To Intervene or Not to Intervene?

Transvenous phrenic nerve stimulation, a novel therapeutic approach for central sleep apnea

The Management of Co-Morbidities in Patients with Heart Failure – Central Sleep Apnoea

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