October 15, 2018

Saving lives by monitoring chronic heart failure at home

Chronic congestive heart failure (CHF), which involves a weakening of the heart’s pumping power, is the primary cause of hospitalization in people older than 65, affecting about 26 million people globally. The related cost in the United States alone is estimated at up to $40 billion. About half of that amount stems from hospital readmissions — 25 percent of heart-failure patients are readmitted within a month, and half within six months.

Israeli devices such as Impulse Dynamics’ Optimizer III and BioControl Medical’s CardioFit already offer novel treatment options for CHF. But other Israeli companies also are developing better ways to manage and monitor this progressive condition, to improve patients’ quality of life and avoid repeated hospitalizations.

Vectorious Medical Technologies of Tel Aviv recently closed a $5 million financing round for the development of its miniature wireless hemodynamic monitoring sensory implant toward first human trials. Among the investors is the Global Cardiovascular Innovation Center of the Cleveland Clinic in Ohio.

“Our solution will make daily monitoring a routine activity for congestive heart failure patients and their physicians, similar to glucose monitoring for diabetes patients,” said co-founder and CEO Oren Goldshtein.

With the push of a button, patients with the Vectorious implant would get a pressure reading from their heart’s left atrium, enabling a better adjustment of their medical treatment. Goldshtein said left atrial pressure provides earlier and more specific indication of cardiac deterioration than does the CardioMEMS device approved by the U.S. Food and Drug Administration (FDA) last May for measuring pulmonary (lung) artery pressure. That breakthrough American device is reducing readmissions by up to 40 percent, and Goldshtein believes Vectorious can be even more effective.

It took about four years to develop the first working model of the Vectorious device, expected to be tested this coming year in collaboration with American and Israeli cardiologists. The 10-person company has a subsidiary in Ohio to oversee this next stage. Goldshtein believes the technology infrastructure will have additional applications ahead.

While atrial pressure cannot be adequately measured from outside the body, several Israeli companies are taking a different tack by developing noninvasive devices to monitor congestion in the lungs.

Most hospital readmissions of CHF patients are due to lung edema (swelling) caused by excess fluid, so it makes sense to identify and treat fluid buildup before edema sets in.

Last year, Sensible Medical Innovations of Kfar Neter received Europe’s CE mark for its ReDS Wearable System for measuring and monitoring lung fluid in hospitals, clinics and homes. The system will be introduced via commercial pilots in Europe together with Boston Scientific Corporation.

“Worsening congestion is a key driver of hospital admission and mortality in patients with heart failure. Identifying and appropriately managing congestion is challenging,” said Dr. John Cleland, chairman of clinical cardiology at the National Heart and Lung Institute of Royal Brompton and Harefield hospitals in London, and a member of Sensible’s physician steering committee. “We look forward to seeing how treatment based on accurate lung fluid measurement may help keep patients safe at home and potentially reduce hospitalizations and perhaps even mortality.”

Kyma Medical Technologies in Kfar Saba recently received CE approval for its next-generation µCor System, a platform to monitor a patient’s chest fluids, along with other vital signs, in clinical and home environments.

The NICaS (NonInvasive Cardiac System) from NI Medical in Kfar Mallal is being used in many countries to facilitate diagnosis and guide therapeutic management of patients with heart failure and other conditions before, during and after surgery.

“We will primarily focus on heart failure patients as they represent the most costly group of patients in the entire health care system,” the company states. “The number of these patients is increasing, and data from NI Medical’s Whole Body Impedance technology can lead to significant improvements in patient outcomes and cost of care.”

RS Medical Monitoring (RSMM) in Bnei Brak is developing the Edema Guard Monitor for noninvasive in-hospital and home monitoring of lung fluid accumulation in CHF patients. Avner Amir, vice president for business development, said clinical studies have shown Edema Guard alerts an impending pulmonary edema about two weeks before the patient feels any symptoms. 

“And by the time a patient feels it, it’s too late to avoid hospitalization,” Amir said.

Clinical trials conducted over the past six years at Hillel Yaffe Medical Center in Hadera show usage of Edema Guard at home reduces CHF hospitalizations by 55 percent and heart-failure mortality by 42 percent. In-hospital monitoring during acute myocardial infarction demonstrated reduction of 51 percent in post-discharge mortality rate and 64 percent reduction in new CHF events.

RSMM’s device monitors lung fluid buildup noninvasively by measuring the body’s impedance, or resistance, to alternating current. 

“The more fluid is there, the more conductive to electricity, so by transferring a very small electrical current, we can get a reading that is highly accurate and extremely sensitive to changes in lung fluid,” Amir explained.

Its unique algorithm determines the patient’s baseline impedance and compares it to the present reading. This algorithm was developed using data accumulated from more than 1,000 patients treated and monitored in the CHF Unit at Hillel Yaffe, which is headed by RSMM founder and chief medical officer Michael Shochat.

“If you have a patient who has some level of fluid accumulation but you don’t know the person’s baseline, you don’t know how severe his situation is,” Amir said. “You couldn’t do this without our unique big data, and that’s very important for home monitoring.”

Within the next year, the company expects to fine-tune its technology and apply for FDA and CE approval to market the device and disposable electrodes for home use through distributors and strategic partners.