Long-term vagal stimulation for heart failure: Eighteen month results from the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) trial

Ferrari, Gaetano M. De; Stolen, Craig M.; Tuinenburg, Anton E.; Wright, David J.; Brugada, Josép; Butter, Christian; Klein, Helmut U.; Neužil, Petr; Botman, Cornelis J.; Castel, María Ángeles; D’Onofrio, Antonio; Borst, Gert J. de; Solomon, Scott D.; Steín, Kenneth M.; Schubert, Bernd; Stalsberg, Kevin; Wold, Nicholas; Ruble, Stephen B.; Zannad, Faı̈ez

doi:10.1016/j.ijcard.2017.06.036

Cited by 121 publications

(136 citation statements)

References 22 publications

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“…Although the long‐term safety profile was favourable, no improvement in the efficacy endpoints was seen with the VNS dose that was delivered. A detailed analysis demonstrated that in the majority of patients, the VNS protocol used in that study generated no significant change in parameters of heart rate variability indicative of autonomic modulation …”

Section: Discussionmentioning

confidence: 88%

“…Six months after completion of titration, heart rate decreased significantly, and standard deviation in normal‐to‐normal R‐R intervals (SDNN) increased significantly in ANTHEM‐HF . Heart rate and SDNN were reported to be unchanged in INOVATE‐HF and NECTAR‐HF . Comparisons of available data for symptomatic and functional outcomes are summarized in Figure .…”

Section: Resultsmentioning

confidence: 99%

“…11 Heart rate and SDNN were reported to be unchanged in INOVATE-HF and NECTAR-HF. 12,13,22 Comparisons of available data for symptomatic and functional outcomes are summarized in Figure 5. When NECTAR-HF and ANTHEM-HF were compared, greater improvements in heart The remainder of the abbreviations are described in the text and the other tables.…”

Section: Resultsmentioning

confidence: 99%

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Comparison of symptomatic and functional responses to vagus nerve stimulation in ANTHEM‐HF, INOVATE‐HF, and NECTAR‐HF

et al. 2020

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Aims Clinical studies of vagal nerve stimulation (VNS) for heart failure with reduced ejection fraction have had mixed results to date. We sought to compare VNS delivery and associated changes in symptoms and function in autonomic regulation therapy via left or right cervical vagus nerve stimulation in patients with chronic heart failure (ANTHEM‐HF), increase of vagal tone in heart failure (INOVATE‐HF), and neural cardiac therapy for heart failure (NECTAR‐HF) for hypothesis generation. Methods and results Descriptive statistics were used to analyse data from the public domain for differences in proportions using Pearson's chi‐square test, differences in mean values using Student's unpaired t‐test, and differences in changes of mean values using two‐sample t‐tests. Guideline‐directed medical therapy recommendations were similar across studies. Fewer patients were in New York Heart Association 3, and baseline heart rate (HR) was higher in ANTHEM‐HF. In INOVATE‐HF, VNS was aimed at peripheral neural targets, using closed‐loop delivery that required synchronization of VNS to R‐wave sensing by an intracardiac lead. Pulse frequency was low (1–2 Hz) because of a timing schedule allowing ≤3 pulses of VNS following at most 25% of detected R waves. NECTAR‐HF and ANTHEM‐HF used open‐loop VNS delivery (i.e. independent of any external signal) aimed at both central and peripheral targets. In NECTAR‐HF, VNS delivery at 20 Hz caused off‐target effects that limited VNS up‐titration in a majority of patients. In ANTHEM‐HF, VNS delivery at 10 Hz allowed up‐titration until changes in HR dynamics were confirmed. Six months after VNS titration, significant improvements in both HR and HR variability occurred only in ANTHEM‐HF. When ANTHEM‐HF and NECTAR‐HF were compared, greater improvements from baseline were observed in ANTHEM‐HF in standard deviation in normal‐to‐normal R‐R intervals (94 ± 26 to 111 ± 50 vs. 146 ± 48 to 130 ± 52 ms; P < 0.001), left ventricular ejection fraction (32 ± 7 to 37 ± 0.4 vs. 31 ± 6 to 33 ± 6; P < 0.05), and Minnesota Living with Heart Failure mean score (40 ± 14 to 21 ± 10 vs. 44 ± 22 to 36 ± 21; P < 0.002). When compared with INOVATE‐HF, greater improvement in 6‐min walk distance was observed in ANTHEM‐HF (287 ± 66 to 346 ± 78 vs. 304 ± 111 to 334 ± 111 m; P < 0.04). Conclusions In this post‐hoc analysis, differences in patient demographics were seen and may have caused the differential responses in symptoms and function observed in association with VNS. Major differences in technology platforms, neural targets, VNS delivery, and HR and HR variability responses could have also potentially played a very important role. Further study is underway in a randomized controlled trial with these considerations in mind.

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Section: Discussionmentioning

confidence: 88%

Section: Resultsmentioning

confidence: 99%

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Comparison of symptomatic and functional responses to vagus nerve stimulation in ANTHEM‐HF, INOVATE‐HF, and NECTAR‐HF

et al. 2020

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“…117 However, the NECTAR-HF study failed to demonstrate an improvement in left ventricular endsystolic diameter with vagal stimulation in a randomized trial design. 118 A much larger randomized study (INNO-VATE HF) is currently underway and the ventricular arrhythmia outcomes, if reported, will be of particular interest to electrophysiologists. 119 Vasovagal syncope is a common disorder faced by internists, cardiologists, and electrophysiologists alike.…”

Section: Novel Targets For Catheter Ablationmentioning

confidence: 99%

Innovations in Clinical Cardiac Electrophysiology: Challenges and Upcoming Solutions in 2018 and Beyond

Vaidya¹,

Sugure²,

Asirvatham³

2017

J Innov Cardiac Rhythm Manage

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“…Chronic VNS was proposed as a new potential therapy in patients with heart failure. Results of preclinical animal studies and early clinical trials have demonstrated the safety and efficacy of these therapies in heart failure [2].…”

Section: Introductionmentioning

confidence: 99%

Vague nerve stimulation in chronic heart failure: is it worth it?

Floria¹,

Grecu²,

Tinică³

2017

Arch Clin Cases

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In heart failure the major pathophysiology changes are enhanced sympathetic nervous system activity and reduced parasympathetic activation. Despite advances in pharmacologic treatment and interventional therapies such as implantable devices, mortality and morbidity in patients with advanced heart failure is still higher. In the last three decades the novel interventional and device-based therapies aim to restore cardiac autonomic balance by neuromodulation. Chronic vague nerve stimulation (VNS) is a neuromodulator method proposed as a new potential therapy in patients with heart failure. Results of preclinical animal studies and early clinical trials have demonstrated the safety and efficacy of this therapy in heart failure. Although a favorable long-term safety profile was found in human, improvements in the efficacy endpoints in patients with heart failure by VNS are controversially, as demonstrated by one of the largest recently published trial. Despite that VNS does not reduce left ventricular end-systolic volume index, the rate of death or heart failure events in chronic heart failure patients, this new treatment improved quality of life, NYHA functional class, and 6-min walking distance. Large randomized clinical studies are necessary to evaluate the clinical role of this new therapeutic approach in chronic heart failure.

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Long-term vagal stimulation for heart failure: Eighteen month results from the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) trial

Cited by 121 publications

References 22 publications

Comparison of symptomatic and functional responses to vagus nerve stimulation in ANTHEM‐HF, INOVATE‐HF, and NECTAR‐HF

Comparison of symptomatic and functional responses to vagus nerve stimulation in ANTHEM‐HF, INOVATE‐HF, and NECTAR‐HF

Innovations in Clinical Cardiac Electrophysiology: Challenges and Upcoming Solutions in 2018 and Beyond

Vague nerve stimulation in chronic heart failure: is it worth it?

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