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Rationale and study design of the NEuroCardiac TherApy foR Heart Failure Study: NECTAR-HF.

De Ferrari GM, Tuinenburg AE, Ruble S, Brugada J, Klein H, Butter C, Wright DJ, Schubert B, Solomon S, Meyer S, Stein K, Ramuzat A, Zannad F - Eur. J. Heart Fail. (2014)

Bottom Line: Increased sympathetic activation and reduced parasympathetic tone are important pathophysiological contributors to the progression of heart failure, and are associated with poor outcome in patients.The study is powered to detect differences in the primary efficacy endpoint of change in left ventricular end systolic diameter.Secondary endpoints include ejection fraction, left ventricular volumes, quality of life scores, functional capacity, and changes in biomarkers.

View Article: PubMed Central - PubMed

Affiliation: Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

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Related in: MedlinePlus

The NECTAR-HF (NEural Cardiac TherApy foR Heart Failure) implant location. The lead is placed around the cervical vagus nerve and then tunnelled across the clavicle and connected to the pulse generator, which is located in a pectoral pocket.
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fig02: The NECTAR-HF (NEural Cardiac TherApy foR Heart Failure) implant location. The lead is placed around the cervical vagus nerve and then tunnelled across the clavicle and connected to the pulse generator, which is located in a pectoral pocket.

Mentions: The investigational vagal cuff lead is implanted in all patients by exposing approximately 4–6 cm of the vagus nerve on the right side of the neck. The lead is then tunnelled over the clavicle and connected to a pulse generator (Figure 2). The procedure can be performed under general or local anaesthesia by an appropriately trained and experienced vascular/cardiovascular surgeon or neurosurgeon. Although the recommendation is to use general anaesthesia, the surgical team may decide to use local anaesthesia if there is concern about patient safety. Based upon the clinical experience of vagal nerve implants to treat epilepsy, the procedure will take 90 minutes or less to implant in most cases.


Rationale and study design of the NEuroCardiac TherApy foR Heart Failure Study: NECTAR-HF.

De Ferrari GM, Tuinenburg AE, Ruble S, Brugada J, Klein H, Butter C, Wright DJ, Schubert B, Solomon S, Meyer S, Stein K, Ramuzat A, Zannad F - Eur. J. Heart Fail. (2014)

The NECTAR-HF (NEural Cardiac TherApy foR Heart Failure) implant location. The lead is placed around the cervical vagus nerve and then tunnelled across the clavicle and connected to the pulse generator, which is located in a pectoral pocket.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4288987&req=5

fig02: The NECTAR-HF (NEural Cardiac TherApy foR Heart Failure) implant location. The lead is placed around the cervical vagus nerve and then tunnelled across the clavicle and connected to the pulse generator, which is located in a pectoral pocket.
Mentions: The investigational vagal cuff lead is implanted in all patients by exposing approximately 4–6 cm of the vagus nerve on the right side of the neck. The lead is then tunnelled over the clavicle and connected to a pulse generator (Figure 2). The procedure can be performed under general or local anaesthesia by an appropriately trained and experienced vascular/cardiovascular surgeon or neurosurgeon. Although the recommendation is to use general anaesthesia, the surgical team may decide to use local anaesthesia if there is concern about patient safety. Based upon the clinical experience of vagal nerve implants to treat epilepsy, the procedure will take 90 minutes or less to implant in most cases.

Bottom Line: Increased sympathetic activation and reduced parasympathetic tone are important pathophysiological contributors to the progression of heart failure, and are associated with poor outcome in patients.The study is powered to detect differences in the primary efficacy endpoint of change in left ventricular end systolic diameter.Secondary endpoints include ejection fraction, left ventricular volumes, quality of life scores, functional capacity, and changes in biomarkers.

View Article: PubMed Central - PubMed

Affiliation: Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

Show MeSH
Related in: MedlinePlus