Boston Scientific VIGILANT Device Helps Survive a Heart Attack
On a June day in 2021 in Pompano Beach, Florida, a man was walking across a condo’s parking lot. Suddenly, he collapsed to the ground. Within seconds, his body convulsed. Then, he picked himself up and walked off as if nothing happened.
The man’s name is Robert, an active, healthy 70-year-old—except for one previous heart attack. He was lucky. Unlike millions of people who suffer heart attacks, he survived.
This brief yet shocking incident was captured on a CCTV video and the video was played during a session at the 3DEXPERIENCE Conference by Boston Scientific, the company that made the medical device that saved Robert.
Surviving a heart attack is remarkable and miraculous in itself, but what is even more remarkable is how Robert was saved using new innovations.
The Prevalence of Heart Attacks and Cardiac Arrests
Innovations are always in demand for treating cardiovascular diseases; heart attacks and cardiac arrests have long been a serious public health problem in the U.S. and worldwide.
In 2020, there are more than 19.1 million cardiovascular deaths globally, and the prevalence of coronary heart disease is increasing. In the same year, about 697,000 people in the United States died from heart disease in 2020, which is 1 in every 5 deaths—more than from cancer, COVID and accidents.
More than half of cardiovascular deaths occur suddenly. Deaths related to heart disease occur when patients have a heart attack or cardiac arrest outside of the hospital (pre-hospital setting) or in a hospital (in-hospital setting). The pre-hospital survival rate is much lower than the in-hospital survival rate, likely due to lower availability of medical equipment and personnel. In addition, out-of-hospital cardiac arrests occur more frequently than in-hospital ones, making their treatment even more challenging.
Due to the sudden nature of a cardiac arrest, its optimal treatment needs to happen within an hour after the onset of symptoms (also known as “the golden hour”). For example, the “door-to-balloon” time, which refers to the timeframe within which a procedure called angioplasty needs to be performed to stretch open a narrowed or blocked artery, is 90 minutes.
The patient needs to be discovered by somebody who can correctly diagnose his or her condition or recognize the severity of the situation. Then, first-aid such as cardiopulmonary resuscitation (CPR) or treatment with an automated external defibrillator (AED) needs to be administered. Next, the patient needs to be transported to a hospital promptly and treated by a doctor in the emergency room within an hour.
A delay in any or several of these steps will subtract from the golden hour.
While CPR improves the survival rate of patients undergoing out-of-hospital cardiac arrests, it works best for the first 20 minutes; beyond that window of opportunity it becomes much less effective. In addition, the frequency of bystanders performing CPR (10 – 65 percent) and resultant survival (3 – 22 percent) in the United States varies significantly due to socioeconomic and demographic factors, to the disadvantage of low-income and minority communities.
In addition, while AEDs are life-saving and can achieve a 95 percent success rate, they are hard for a person to carry around. Therefore, they are often set up at home or installed in public spaces. Occupational Health and Safety Administration estimated that 30 million are needed to cover 70 percent of the population, which lives in urbanized areas and another 10 million to cover the population living in non-urbanized areas. However, only about 4.5 million AEDs are in use. As a result, AEDs are rarely used by bystanders to treat cardiac arrests.
There are other technologies that can help reduce the occurrence of cardiac arrests. For example, pacemakers are small, implanted devices which can help prevent cardiovascular abnormalities by regulating heart rhythm with emitted electrical pulses.
Another example is telemetry, in which dedicated personnel collect and monitor measurements from patients and identify ones who are having issues. But telemetry is more applicable for patients who have cardiac arrests in a hospital.
Taken together, most preventive technologies cannot be used to treat cardiac arrest when it happens outside of a healthcare facility and there is a need for technologies that can address one or several of the bottlenecks in the process of identifying, triaging, transporting and treating patients who suffer heart attacks while out in the world.
How VIGILANT Works
VIGILANT, the device made by Boston Scientific that saved Robert’s life in the video, is an example of a class of disruptive devices called cardiac resynchronization therapy defibrillator (CRT-D), which can address several of these pain points.
A CRT-D is similar to an implantable cardioverter-defibrillator (ICD), an electrical device that constantly monitors a patient’s heart rhythm to detect and stop irregular heartbeats. ICD shocks the heart if it senses a dangerous heart rhythm. However, CRT-D differs from ICDs in that it has an additional lead (ICDs have two leads) passed through a vein traveling behind the heart to pace the heart from the left-hand side, helping the heart’s lower chambers—the ventricles—work in tandem. As a result, CRT-Ds increase the effectiveness of a diseased heart and elevate blood flow, thus improving heart failure symptoms like fatigue, shortness of breath and exercise intolerance, and reducing the patient’s risk of dying due to cardiac events.
Also, patients with ICD are at risk of electrical storm occurrences that are associated with mortality and poor quality of life. CRT-D minimizes the number of inappropriate ICD shocks, lowering the risk of electrical storms and the risk of mortality, and improving a patient’s quality of life. Moreover, CRT-Ds have a longer battery life than ICDs. For example, ICD batteries last around six years and the VIGILANT CRT-D’s battery lasts from 7 to 14.7 years. ICDs and CRT-Ds both require surgery to be implanted into patients, so a longer battery life will reduce the need and frequency for additional surgery and lower the cost of care.
In addition to longer battery life and improving heart failure symptoms, the VIGILANT device contains HeartLogic, a highly sensitive heart failure diagnostic technology that provides weeks of advanced notice and a low-alert burden for detecting early signs of worsening heart failure.
With the combined functionalities, the VIGILANT device circumvents the many bottlenecks in the process of treating patients having a heart attack. The patient no longer depends on being found and diagnosed by a passerby, whether the passerby knows how to administer CPR properly or can find an AED nearby and operate it, or call for an ambulance so the patient can reach the emergency room in time for treatment. The patient can be diagnosed by the HeartLogic function and administered appropriate electric pulses on the spot.
In Robert’s video, there were only ten seconds between his collapse and the activation of the VIGILANT device to deliver electrical pulses to his heart. The time of detection, diagnosis and treatment has shrunk from tens of minutes to ten seconds. Because the resuscitation happened so quickly, Robert was able to not only get up and walk off in no time but also feel fine afterward.
He recalled, “Honestly, if I hadn’t known that I’d collapsed, I never would have thought anything happened…I felt completely normal.” After double-checking his health in the hospital, he has gone on to live his usual, active lifestyle. The effects of delayed treatment on health and well-being, prevalent in many patients suffering from a heart attack and who unfortunately did not receive treatment promptly, are nearly impossible to detect in Robert.
CRT-Ds, such as the VIGILANT device, are not without a downside.
Aside from having risks similar to those associated with implanted ICDs, such as infection at the implant site, swelling or bleeding, blood vessel damage, bleeding around the heart, blood leakage, collapsed lung and shifting of the device, the main issue for CRT-D is cost. On average, CRT-Ds are significantly more expensive, at more than $36,000, compared to ICDs which cost around $23,000. In addition, CRT-Ds are suitable only for a specific section of the population of patients with cardiovascular issues.
Moreover, while many more lives could be saved if defibrillators were implanted prophylactically in patients at increased risk of sudden death, one can argue that the cost of implanting CRT-Ds in a certain number of patients can be used to cover a much bigger potential patient population in a longer timeframe.
However, if we stop looking at disease in terms of populations and statistics and instead look at each patient as a person, we can see each implanted device is worth it.
It certainly is to Robert. “The VIGILANT CRT-D gives me peace of mind,” he said, “I feel confident working, going to the gym and exercising, knowing that my device works. It is very comforting.”
Every life saved also means a great deal to the people who develop life-saving technologies. As Matt Sheldov, the Senior R & D Manager at Boston Scientific, puts it, knowing the impact of VIGILANT on patients like Robert is an “emotional paycheck.”