Health City Cayman Islands introduces new device to treat heart failure

For the first time in the Caribbean, Central and South America, Dr. Ravi Kishore, Chief Interventional Cardiologist and Electrophysiologist at Health City Cayman Islands, has implanted a Cardiac Contractility Modulation (CCM) device to treat heart failure in a Cayman Islands resident.

Dr. Kishore implanted the device in late August, thereby making medical history in the region. The device used is the Optimizer IVs Active Implantable Pulse Generator (IPG) by Impulse Dynamics, intended for the treatment of heart failure through delivery of CCM signals.

“What we are proud of is this is the first time we have introduced this device in the entire Caribbean, and even in the US it’s an investigational device so it’s not routinely implanted in patients in the US and none of them have been implanted in Central America and South America. In that sense, I think we have introduced yet another novel therapy in the region,” Dr. Kishore said.

CCM device implantation is currently conducted only on an investigational basis in the United States, however CCM devices are approved and available for clinical use in all European Union countries and in Australia, Turkey, India and Hong Kong. While CCM therapy is not approved for clinical use in the United States, a study has been initiated in order to obtain FDA approval.

Cardiac contractility modulation (CCM) is a treatment for patients with moderate to severe left ventricular systolic heart failure. The short- and long-term use of CCM therapy enhances both the strength of ventricular contraction and the heart’s pumping capacity by modulating the myocardial contractility.

In contrast to other electrical stimulation treatments for heart failure, such as pacemaker therapy or implantable cardioverter defibrillators (ICD), CCM does not affect the cardiac rhythm directly. Rather, the aim is to enhance the heart’s natural contraction sustainably over long periods of time.

In several device trials, CCM treatment has been shown to positively impact quality of life in patients. Preliminary long-term survival data shows that CCM is associated with lower long-term mortality in heart failure patients when compared with expected rates among similar patients not treated with CCM.

CCM therapy is an alternative for patients who are not eligible for traditional cardiac resynchronization therapy (CRT; also known as biventricular pacing.) Approximately 30-40% of all heart failure patients are good candidates for CRT, and therefore between 60-70% of patients are not eligible for traditional CRT.

Until recently, the only other option for such patients were medical therapy eventually leading on to Heart transplant or a LVAD as a bridge. Current research results suggest that this therapeutic gap described could now be closed by CCM therapy.

Heart failure is a chronic disease that usually progresses gradually. The rate of progression and the degree of symptoms of the disease varies between different patients. CCM therapy aims to treat heart failure through a medium- to long-term treatment, over the course of weeks and months.

After the CCM device implantation wound is healed, the lifestyle of a patient is not restricted by the implanted device. The patient can return to normal, physical activity – including travel, leisure activities and exercise without ill effects, and may perceive an improved capacity for these activities.

Development of cardiac contractility modulation began in the late 1990s. An implantable CCM device was received by a patient for the first time in 2001. The first study on the therapeutic effects of CCM in humans was presented in 2004. To date, more than 2,000 heart failure patients have been treated with CCM worldwide.

Source: Freddy Abi-Samra and David Gutterman, Cardiac contractility modulation: a novel approach for the treatment of heart failure, Heart Fail Rev. 2016; 21(6): 645–660. Published online 2016 Jul 9. doi:  10.1007/s10741-016-9571-6.