Feature | November 20, 2013

Nerve Stimulation in Neck May Reduce Heart Failure Symptoms

Doctors at Mount Sinai Hospital testing heart failure therapy

clinical trial study cath lab ep heart failure treatments cardiofit biocontrol

A team of Mount Sinai Hospital doctors are testing the benefit of vagus nerve stimulation in heart failure patients using the surgically implantable CardioFit system.

November 20, 2013 — A multidisciplinary team of experts in heart failure, cardiac arrhythmia and neurosurgery at Mount Sinai Hospital in New York City are testing nerve stimulation in the neck as a therapy for heart failure patients to potentially help relieve their debilitating symptoms of fatigue, shortness of breath and heart arrhythmias while reducing their hospitalizations.
 
The global, multicenter randomized clinical trial called "Increase of Vagal Tone in Chronic Heart Failure" (INOVATE-HF) is investigating the safety and efficacy of an implantable vagus nerve electrical stimulation device called CardioFit to improve the heart’s function and the quality of life of heart failure patients.
 
Mount Sinai’s multidisciplinary team of clinical trial investigators includes principal investigator Vivek Reddy, M.D, electrophysiologist and director of Arrhythmia Services; Brian Kopell, M.D., neurosurgeon and director of the Center for Neuromodulation; and Ajith Nair, M.D., heart failure specialist and director, Pulmonary Hypertension Program, Advanced Heart Failure and Transplantation Program.
 
The device is a three-part system consisting of a “stimulator” about the size of a pacemaker and two connecting leads. The stimulator is implanted under the skin of the chest with a “sensor lead” implanted inside the right ventricle of the heart and a “stimulation lead” implanted around the vagus nerve in the right side of the neck.
 
The large vagus nerve runs from the brain stem down to the abdomen on both the left and right side of the body. It sends signals throughout the body and directly to and from the brain to regulate multiple bodily functions including heart rate.
 
Once activated by doctors, the stimulator in the chest sends mild electrical pulses up to the vagus nerve to help reduce heart rate, stress and workload on the cardiac muscle to improve overall heart function. The sensor lead in the right ventricle monitors for any abnormal changes in electrical activity and provides feedback to the stimulator enabling it to react.
 
“This novel use of vagus nerve stimulation may be the therapy we have long been waiting for to bring relief to heart failure patients with chronic symptoms and protect them from dangerous and potentially fatal arrhythmias,” said Reddy. “The results of this study testing the simple electrical stimulation of the body’s powerful vagus nerve may unlock a future promising therapy for heart failure. I am excited that by working with our heart failure and neurosurgery colleagues, we can offer this potentially transformative therapy to our patients.”
 
“Our clinical trial will compare the benefits of vagus nerve stimulation to the standard treatment of combination medication which is currently our first line of defense against heart failure,” said Nair. “Our study will also test vagus nerve stimulation therapy’s ability to reduce hospitalization, a major issue for heart failure patients, as well as its capability to reduce mortality in this high-risk population.”
 
“At Mount Sinai, we have successfully used vagus nerve stimulation for refractory epilepsy in patients with uncontrollable seizures and to treat patients with major depression who don’t have good responses to medication therapy,” said Kopell. “This trial represents the first time VNS is being tested in heart failure patients in the United States.”
 
Recent international studies investigating the CardioFit device have shown that patients with the nerve stimulation device can experience sustained improvement in heart function and structure, heart rate, improvement in quality of life and increased exercise tolerance. Research shows patients may start to experience improvement in their heart failure symptoms after several weeks and months of gradually increased nerve stimulation therapy.
 
Patients eligible for enrollment in the INOVATE-HF clinical trial are those diagnosed with New York Heart Association (NYHA) stage III “moderate” heart failure who, despite treatment with several combination medications, continue to have debilitating symptoms including fatigue, shortness of breath and abnormal heart arrhythmias.
 
For more information: www.mountsinai.org

Related Content

Sci-image, Scimage, CVIS, CIIMS, Cpacs c-pacs, cardiovascular information system

Today's cardiovascular information systems need to incorporate all facets of the cardiology department, including subspecialties, to allow a complete picture of a patient's record. These data also need to be able to be shared with enterprise data systems, such as the electronic medical record (EMR). This image is from ScImage, illustrating the various aspects that integrate to make up a complete CVIS. 

 

Feature | September 29, 2016 | Val Kapitula, RT(R), PMP, CIIP
Cardiovascular Information and Imaging Systems (CVIS) have existed for many years in the dedicated sub-specialty area
Keystone Heart, TriGuard Embolic Protection Device, real-world results, PCR London Valves Conference 2016
News | Embolic Protection Devices| September 29, 2016
Keystone Heart Ltd. recently announced the safety and efficacy of the TriGuard Cerebral Embolic Protection device...
CardioKinetix, Parachute device, Heart Failure device therapy

The CardioKinetix Parachute device implant shown deployed in the left ventricle of a heart failure patient. The device helps remodel the ventricle to improve the heart's ability to pump blood more efficiently. 

Feature | Heart Failure| September 29, 2016 | Abha Mishra
New cardiovascular device therapies for atrial fibrillation (AF) and heart failure (HF) are rapidly evolving with the
Neuravi, EmboTrap II stent retriever, thrombectomy device, acute stroke, European launch, CE Mark
News | Thrombectomy Devices| September 28, 2016
Neuravi recently announced Conformité Européenne (CE) Mark approval and launch of the company’s newly available...
Infinix 4D CT

Toshiba's Infinix 4D CT, which combines CT with angiography in the interventional lab.

Feature | Angiography| September 28, 2016 | Tom Watson BS, RCVT, Clinical Analyst, MD Buyline
One of the more significant advancements for interventional X-ray (IXR) in the past few years has been a significantl
TCT 2016, TCT.16, main arena, late breaking trials
Feature | Cath Lab| September 28, 2016
September 28, 2016 — The Cardiovascular Research Foundation (CRF) has announced the 11 late-breaking trials and 16 fi
Avinger, U.S. Department of Veterans Affairs, VA, Lumivascular technology, FSS Contract Award
News | Optical Coherence Tomography (OCT)| September 27, 2016
Avinger Inc. recently announced the company has received an FSS Contract Award from the U.S. Department of Veterans...
European Heart Rhythm Association, EHRA White Book 2016, EP Europace supplement, cardiac rhythm device use, Europe
News | EP Lab| September 27, 2016
In August, the European Heart Rhythm Association (EHRA) and EP Europace journal announced the release of the supplement...
News | Pharmaceuticals| September 26, 2016
Nearly 2 out of 5 people with diabetes who could benefit from statin therapy to lower their risk of future heart attack...
Bard, Lutonix 014 DCB, drug-coated balloon, six-month endpoint, FDA IDE trial
Technology | Drug-Eluting Balloons| September 26, 2016
C. R. Bard Inc. announced the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE...
Overlay Init