Revolutionary UK-first operation to tackle heart failure

Posted by pt91 at Aug 23, 2012 04:40 PM |
University of Leicester researchers used an innovative nerve-stimulating implant to treat the condition for the first time today.

The operation is the first to take place in the UK, and was undertaken at Glenfield Hospital. It is part of a clinical trial called INOVATE-HF, and could pave the way for a revolutionary treatment of a condition that scientists say has reached “epidemic proportions.”

In patients with heart failure, the nervous system is out of balance. This imbalance leads to added stress on the heart and progressive deterioration of cardiovascular function. The CardioFit system is intended to restore balance by activating a specific part of the nervous system (called the 'parasympathetic' nervous system) to reduce stress on the heart, thereby alleviating heart failure symptoms and reversing heart failure deterioration. It operates by stimulating the vagus nerve on the right side of the neck.

The UK chief investigator, and also the study’s principal investigator at the site, is Dr. André Ng, senior lecturer in cardiology in the Department of Cardiovascular Sciences and consultant cardiologist at Glenfield Hospital. This is not the first time Dr Ng has pioneered a new technique – he carried out the world's first remote heart procedure using a robotic arm alongside 3-D mapping in 2010.

The INOVATE-HF study team at the University of Leicester includes Matt Bown, senior lecturer in vascular surgery; Iain Squire, professor in cardiovascular medicine; Kieran Brack, BHF intermediate basic science research fellow and research coordinator for the trial; and other members of the University Hospitals of Leicester. The study is sponsored by BioControl Medical (Yehud, Israel), the developer of the CardioFit device.

Heart failure significantly impacts the NHS due to the level of treatment required and the increased incidence of death. It is a common condition in which the heart's pumping function is compromised, leading to a cascade of limiting symptoms and poor overall body function. It is also associated with increased mortality from sudden death as a result of dangerous heart rhythm disturbances.

Pre-clinical data suggest that vagus nerve stimulation for the treatment of heart failure improves the function of the heart and reverses negative changes to the body associated with the condition.  Moreover, the safety and performance of the CardioFit have been validated in a 32-patient, multi-centre, pilot clinical study conducted in Germany, Italy, The Netherlands and Serbia. Study data showed that patients experienced significant improvements across key clinical measures, including left ventricular function and structure, heart rate variability, and resting heart rate.