Policlinico Gemelli IRCCS di Roma

Heart: under special surveillance (even remotely) in case of heart failure

Monday, June 1, 2020

Original article: Cuore: sorvegliato speciale (anche da remoto) in caso di insufficienza cardiaca - Policlinico Universitario A. Gemelli IRCCS (policlinicogemelli.it)

The Cardiology Team

Patients with heart failure are always under special surveillance because their condition can easily turn into dangerous life-threatening flare-ups, generating frequent emergency room visits and hospitalizations.

However, in times of emergency, such as those that have occurred in recent months, it becomes very difficult to follow these patients on an outpatient or inpatient basis, because this in the COVID era can be very risky indeed.

Technology and telehealth can meet the needs of patients and caregivers: making a virtue of necessity in such difficult times, experimental pathways have been implemented that are likely to be routine in the near future.

For months already, a trial of a special heart failure monitoring system, developed by Israeli start-up Vectorious Medical Technologies, has been underway in several countries including our own. It is the V-LAP, a real microcomputer (weighs 5 grams and measures about 3 mm) that looks like a spinning top of twisted metal wires.

V-Lap is implanted in the heart at the level of the interatrial septum (the thin wall separating the two atria) with its antennae 'looking' toward the left atrium.

The cardiologist ascends to the heart, starting at the femoral vein, with a special catheter on the tip of which V-LAP is placed.

The implantation technique is the same as that used for 'umbrellas' that close congenital heart cavity defects. The procedure is performed under sedation and lasts less than an hour.


A sentinel in the heart

V-LAP is a sentinel that promptly reports what is happening in the patient's heart and promptly alerts the physician to increases in left atrium pressure that may precede, even by weeks, symptoms such as wheezing or palpitations.

Before this occurs, the physician can contact his patient and modify his therapy, such as by increasing the dose of diuretics. This will avert the crisis and save the patient a trip to the emergency room and subsequent hospitalization.

This technological gem is a sensor, which communicates left atrium pressure readings to a special belt worn by the patient, which acts at the same time as a receiver of the signal from the heart and as a battery (V-LAP charging from outside by induction).

By pushing a special button on the belt, the patient sends the information received from the sensor once a day to the cloud, from where his or her cardiologist reads it.

The physician is thus able to assess his patient's degree of compensation at any time, even from his cell phone day by day, without having him come to the clinic, but by reading his data remotely and can intervene quickly to change his therapy, before heart failure flares up again.

"This technology," comments Dr Domenico D'Amario, medical director at the UOC of Cardiology at the Agostino Gemelli IRCCS University Polyclinic Foundation (directed by Professor Filippo Crea) and a member of the European Society of Cardiology-Health Association on Heart Failure (ESC-HFA) Committee on Training and Implementation of Telemedicine and e-health, "allows us to have direct measurements from the left atrium, something that until now was only possible by resorting to an invasive test such as cardiac catheterization. Having these measurements available is important because increased pressure in the left atrium precedes the onset of symptoms by a few days. The other advantage is that this system does not run on internal batteries (which would become difficult to replace), but is recharged by induction from the outside. It is connected to a cloud platform, from where the cardiologist can check daily how the pressure in his patient's heart is doing and then modify his therapy as needed. This is a very important innovation, especially for frail patients; this also helped us a lot during the pandemic emergency, when having these patients come to the hospital would have been really risky. But also in the future, monitoring these patients remotely will offer great advantages, decreasing the number of medical contacts within the hospital and envisioning a more shared management of complex chronic diseases between high speciality centres, the patient and the territory. Tools such as V-LAP will allow us to remotely manage and treat these patients outside the hospital, activating a network with family physicians and home care, thus limiting hospital access to only the most serious cases requiring hospitalization."

Evaluation of the safety and accuracy of the data sent by V-LAP is ongoing in four countries around the world (Italy, Israel, Germany, and Great Britain) within the VECTOR-HF study; this is the first time this sensor is being tested in humans, on about 20 patients.

"At Gemelli," Dr D'Amario reveals, "two have already been implanted (on two patients aged 75 and 60), but we already have others waiting. The results obtained so far will be presented on June 26 as a late-breaking clinical trial, in the part dedicated to innovations, at the Euro-PCR congress, which is the European Society of Cardiology (ESC) congress dedicated to interventional cardiology."

What is heart failure and how to treat it

Heart failure is a very common condition, especially in the elderly population and causes frequent hospitalizations for flare-ups.

The patient presents with air hunger, and swelling of the ankles and legs, reports great exhaustion, does not breathe well at night when lying down, may experience digestive disturbances, and complains of decreased appetite.

All this is due to the fact that the heart muscle, weakened by the failure, can no longer pump oxygenated blood to the organs, and this causes a buildup of fluid not only in the legs but also in the lungs, leading to what is known as acute pulmonary oedema, which is the emergency that brings these patients to the emergency room.

This condition is treated with a variety of drugs (ACE inhibitors, beta-blockers, anti-aldosteronics, neprilysin/valsartan inhibitors, dapagliflozin, diuretics) and with special anti-blood pacemakers. Fundamental is careful monitoring of the patient's condition and weight (sudden weight gain should suggest fluid accumulation and thus risk of pulmonary edema).

The extent of the problem

It is estimated that at least one million Italians (1.7 percent of the population) suffer from heart failure (worldwide 27 million patients, 7 percent of the elderly population). This condition is the culmination of a range of heart diseases, from heart attack to valve disease, to congenital heart disease. In our country, heart failure is the leading cause of death from cardiovascular disease (one in two patients dies within 5 years of diagnosis) and is the leading cause of hospitalization, generating 190,000 hospitalizations a year, at an estimated cost of 3 billion euros.

"This condition," Dr. D'Amario concludes, "has a prognosis overlapping with that of advanced cancer, but people, and patients themselves, are not aware of this risk. The consequence is that these patients often come to us late and in poor condition."

Gemelli Rome Triangle


Gemelli Rome Triangle