CardioMEMS device detects heart failure early, saving lives


“Heart failure remains the leading cause of hospitalization and deaths, affecting about 45 million people worldwide, including 5-to-6 million in the United States,” said Dr. Raghavendra Makam, a cardiologist with Cleveland Clinic Indian River Hospital. That’s more than all the victims of all cancers put together, and the disease affects all genders, ethnicities and economic strata, sparing no one.

“The prevalence of heart failure has been on the rise with associated increase in hospitalizations, morbidity and mortality,” according to the National Institutes of Health.

“These hospitalizations have led to increasingly more cost on and decreased quality of life for patients.”

Fortunately, Dr. Makam has at his disposal CardioMEMS, which NIH calls “one of the newer devices designed to help tackle this condition by allowing for better monitoring of heart failure patients.” The device senses pressure increases in the pulmonary artery and alerts doctors when intervention is needed to prevent a crisis.

“Once you get heart failure, it’s all about how to optimize it. If you don’t do anything about it or treat it symptomatically you may get better, but if the underlying cause is not addressed it can lead to worsening of the cardiomyopathy, making further treatment very difficult,” Dr. Makam said. “The survival rate for patients with heart failure is worse than those of patients with cancer, but it doesn’t have to be a death sentence. With appropriate care it can be stabilized.

“This is a reasonably resistant condition,” Dr. Makam continued. “We can only manage the condition and not cure it. Each patient must be seen in a personalized manner even if they have the same type of heart failure because everyone has a different recovery.”

Heart failure patients typically exhibit classic symptoms like shortness of breath, especially on exertion, weight gain and swelling of the feet. Often symptoms are attributed to age and the patient will simply limit their activities, without seeking diagnosis or treatment for a heart condition.

Patients at Cleveland Clinic Indian River Hospital are treated with multi-disciplinary resources that can diagnose patients early to ensure timely interventions. The first step in diagnosis is telling your primary care physician about any changes in your physical ability or condition, including the onset of symptoms mentioned above.

If your doctor sees signs of cardiomyopathy, he will refer you to a cardiologist for further evaluation. After evaluation the cardiologist will determine if the condition can be managed or if it requires more intensive investigation to come up with a comprehensive treatment plan. Heart failure is not like a heart attack, which has a more acute presentation. There is lead time to catch it early on, and since not all heart failures are the same, seeing a cardiologist early is important.

Diagnosing the type of heart failure the patient is experiencing is the first step to formulating a treatment plan. According to the American Heart Association, there are two types of left-side heart failure and drug treatments are different for each of them.

Heart failure with reduced ejection fraction, also called systolic failure, occurs when the left ventricle loses its ability to contract normally. The pumping action of the heart is weak and can’t pump with enough force to push enough blood into circulation.

Heart failure with preserved ejection fraction, also called diastolic failure, occurs when the left ventricle loses its elasticity and becomes stiff. The heart can’t properly fill with blood during the resting period between each beat.

Right-side or right ventricular heart failure usually occurs as a result of left-sided failure.

When the left ventricle fails, the fluid pressure transfers back through the lungs, damaging the heart’s right side. As blood flow from the heart slows, the blood returning to the heart through the veins backs up, causing congestion in the body’s tissues that results in swelling.

“The way we manage each case is different,” Dr. Makam said. “About half of the cases with reduced ejection in the pumping function is caused by ischemic heart disease or coronary heart disease. Significant blockage of the blood lining the heart causes the heart muscle to become weak. We may do an angiogram or place a stint to open up the blood vessel, or perform bypass surgery if the heart blockage is causing the heart failure.

“The other half is caused by cardiomyopathy because of inflammation in the system. Once we have a diagnosis, we can initiate a treatment plan. We have to counter the weak heart in four or five different pathways, and constantly monitor and regulate the doses of medication. If intervention isn’t done in the first six months or so, the patient might survive but the heart muscle is now hard and the healing is difficult from here.”

Scientists trying find a way to predict heart failure before symptoms appear discovered that pressures inside the heart begin building up about two weeks before symptoms appeared on the outside. Initially they monitored heart pressure by inserting a catheter in the heart, but since a patient can’t walk around with a catheter in their heart, doctors and scientists developed a micro-electromechanical system (MEMS) device which is implanted in the heart to monitor the pressure.

The CardioMEMS device, which was approved by the FDA in 2014 and has been improved since then, “is proven through clinical trial data to reduce heart failure hospitalizations and mortality, as well as improve quality of life for patients,” according to Abbott, which manufactures the device.

Last year the FDA approved “an expanded indication for the CardioMEMS system to support the care of more people living with heart failure. With the expanded indication, an additional 1.2 million U.S. patients are now eligible to benefit from advanced monitoring, which marks a significant increase over the current addressable population.

The sensor provides an early warning system enabling doctors to protect against worsening heart failure.”

“The small remote monitoring device is implanted within the pulmonary artery that comes from the right side of the heart and goes to the left,” Dr. Makam explained. “It is a small pressure sensor with no batteries attached to it so it does not require replacement, and once you have it, you have it for life. It senses the pressure in the heart even before the patient starts having symptoms. Pressure readings are automatically transmitted to the doctor’s office. When the doctor gets an elevated reading, it becomes a trigger that something needs to be done.

“Normally the device is implanted when the patient is in ideal health so that the sensor has a normal benchmark pressure reading. Anytime the pressure reading goes beyond the benchmark limit, it indicates the pressure inside the heart is building up and if something isn’t done now, then in 7-to-10 days the patient will start having symptoms. This is purely a monitoring device and it does not assist in the pumping blood. By intervening early, we can often avoid hospitalization. Studies have shown that it does prevent worsening of heart failure, decreases the mortality rate and improves the quality of life.”

If none of the interventional procedures has helped and the patient enters advanced heart failure, there are three options left:

The first is to evaluate the patient for a left ventricular assist device, which is a pump that takes over the pumping function of the heart. It is implanted into your heart with open heart surgery. A charging cable comes out of the abdomen wall and needs to be connected to batteries to recharge every day. It can add up to a decade of quality life.

Second, if a patient meets all of the qualifications, a successful heart transplant done with open heart surgery could potentially add up to 15 years of life.

Finally, a patient who is unable to tolerate major heart failure surgeries will most likely choose palliative care.

Dr. Makam said he is proud to be part of Cleveland Clinic Indian River Hospital’s progressive heart failure and cardiomyopathy program that has been awarded a gold-plus certification by the American Heart Association. He was awarded fellowships in cardiac critical care from John Hopkins Hospital; in cardiology from University of Massachusetts Medical Center; and in advanced heart transplants from Jackson Memorial Hospital/University of Miami. He can be reached at his office located at the Welsh Heart Center, 3450 11th Court, Suite 102, in Vero Beach or by phone at 772-778-8687.

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