Neuromodulation for Drug-Refractory Epilepsy and Chronic Heart Failure: Targets, Delivery, Composition and Titration

S, Anand Inder; A, Konstam Marvin; L, Ardell Jeffrey; Libbus, Imad; A, DiCarlo Lorenzo; L, Mann Douglas

doi:10.23937/2378-3001/1410091

Cited by 4 publications

(5 citation statements)

References 47 publications

(79 reference statements)

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“…The functional difference between these leads is in the polarity of the electrodes. In DRE and TRD, the cathode is positioned cranially, and in HF, the cathode is positioned caudally (Anand, Konstam, Ardell, Libbus, & DiCarlo, 2019;Ben-Menachem, 2002).…”

Section: Discussionmentioning

confidence: 99%

Long-Term Lead Performance for Vagus Nerve Stimulation: Low Rate of Complications and Failures

Anand

Libbus

DiCarlo

2020

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Background: Vagus nerve stimulation (VNS) has been shown to improve cardiac function and heart failure symptoms. The VITARIA System provides chronic stimulation through a self-sizing, atraumatic lead placed around the cervical vagus nerve. The lead is identical to the predecessor M304 lead, which has been implanted in patients since 2009 for treatment of epilepsy and depression. Its long-term performance has not been previously reported. Methods: All leads implanted in the United States for any indication were included in this analysis. All available data on lead explants, replacements, and customer complaints were used to identify failures. Lead survival was defined as likelihood of the implanted lead remaining implanted and performing as intended. Results: The M304 lead has been part of 31,000 implantations, with 72,100 device-years of patient exposure. In 11,000 patients, 99.4% of leads remained implanted and performing as intended after 1 year. At 7 years, 95.7% of leads performed as intended. Lead failure is rare, with common causes being infection (0.87%) and vocal cord dysfunction (0.68%). Conclusions: The M304 VNS lead has been used for neuromodulation in over 30,000 patients for over 70,000 device-years. Cumulative lead survival has exceeded design requirements and has low rates of complications and failures.

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Section: Discussionmentioning

confidence: 99%

Long-Term Lead Performance for Vagus Nerve Stimulation: Low Rate of Complications and Failures

Anand

Libbus

DiCarlo

2020

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“…The therapies also differ in the frequency, pulse width, duty cycle, and current outputs that are utilized. Titration of VNS for epilepsy is empiric while a biomarker of autonomic nervous system engagement and cardiac control is used to guide titration of VNS for HF ( Inder S et al, 2019 ).…”

Section: Administration Of Autonomic Regulation Therapy Using Vagus N...mentioning

confidence: 99%

“…VNS can be delivered clinically using open-loop stimulation with a programmable pulse generator and an electrode lead that surrounds the cervical vagus nerve and requires no intraoperative mapping for placement ( Figure 2 ) ( Inder S et al, 2019 ).…”

Section: Administration Of Autonomic Regulation Therapy Using Vagus N...mentioning

confidence: 99%

Advances in Our Clinical Understanding of Autonomic Regulation Therapy Using Vagal Nerve Stimulation in Patients Living With Heart Failure

et al. 2022

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The ANTHEM-HF, INOVATE-HF, and NECTAR-HF clinical studies of autonomic regulation therapy (ART) using vagus nerve stimulation (VNS) systems have collectively provided dose-ranging information enabling the development of several working hypotheses on how stimulation frequency can be utilized during VNS for tolerability and improving cardiovascular outcomes in patients living with heart failure (HF) and reduced ejection fraction (HFrEF). Changes in heart rate dynamics, comprising reduced heart rate (HR) and increased HR variability, are a biomarker of autonomic nerve system engagement and cardiac control, and appear to be sensitive to VNS that is delivered using a stimulation frequency that is similar to the natural operating frequency of the vagus nerve. Among prior studies, the ANTHEM-HF Pilot Study has provided the clearest evidence of autonomic engagement with VNS that was delivered using a stimulation frequency that was within the operating range of the vagus nerve. Achieving autonomic engagement was accompanied by improvement from baseline in six-minute walk duration (6MWD), health-related quality of life, and left ventricular EF (LVEF), over and above those achieved by concomitant guideline-directed medical therapy (GDMT) administered to counteract harmful neurohormonal activation, with relative freedom from deleterious effects. Autonomic engagement and positive directional changes have persisted over time, and an exploratory analysis suggests that improvement in autonomic tone, symptoms, and physical capacity may be independent of baseline NT-proBNP values. Based upon these encouraging observations, prospective, randomized controlled trials examining the effects on symptoms and cardiac function as well as natural history have been warranted. A multi-national, large-scale, randomized, controlled trial is well underway to determine the outcomes associated with ART using autonomic nervous system engagement as a guide for VNS delivery.

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“…Though the mechanisms of VNS for epilepsy are poorly characterized, reduction in seizure frequency and use of anti-epileptic drugs has been noted across trials (Ben-Menachem et al, 2015). The Food and Drug Administration has already approved implantable pulse generators and leads for safe and effective treatment of epilepsy, facilitating the adaptation of similar technology to alternate diseases (Ben-Menachem et al, 2015;Anand et al, 2019). Given the relevance of autonomic dysregulation in the development and progression of heart failure and arrhythmias, trials exploring the efficacy and safety of VNS for cardiovascular disease have received significant national attention since the initial report of its use for heart failure in 2008 (Schwartz et al, 2008;De Ferrari et al, 2011;Premchand et al, 2014;Gold et al, 2016;De Ferrari et al, 2017).…”

Section: Vns For Treatment Of Cardiovascular Disease: Clinical Trialsmentioning

confidence: 99%

Autonomic Modulation for Cardiovascular Disease

Hadaya

Ardell

2020

Front. Physiol.

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Dysfunction of the autonomic nervous system has been implicated in the pathogenesis of cardiovascular disease, including congestive heart failure and cardiac arrhythmias. Despite advances in the medical and surgical management of these entities, progression of disease persists as does the risk for sudden cardiac death. With improved knowledge of the dynamic relationships between the nervous system and heart, neuromodulatory techniques such as cardiac sympathetic denervation and vagal nerve stimulation (VNS) have emerged as possible therapeutic approaches for the management of these disorders. In this review, we present the structure and function of the cardiac nervous system and the remodeling that occurs in disease states, emphasizing the concept of increased sympathoexcitation and reduced parasympathetic tone. We review preclinical evidence for vagal nerve stimulation, and early results of clinical trials in the setting of congestive heart failure. Vagal nerve stimulation, and other neuromodulatory techniques, may improve the management of cardiovascular disorders, and warrant further study.

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Neuromodulation for Drug-Refractory Epilepsy and Chronic Heart Failure: Targets, Delivery, Composition and Titration

Cited by 4 publications

References 47 publications

Long-Term Lead Performance for Vagus Nerve Stimulation: Low Rate of Complications and Failures

Long-Term Lead Performance for Vagus Nerve Stimulation: Low Rate of Complications and Failures

Advances in Our Clinical Understanding of Autonomic Regulation Therapy Using Vagal Nerve Stimulation in Patients Living With Heart Failure

Autonomic Modulation for Cardiovascular Disease

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