Cleveland: A top American hospital, Cleveland Clinic, reports that a small implantable medical device has transformed the lives of more than 1,000 of its high-stroke-risk patients by offering them an effective alternative to blood thinners.
The device, about the size of a small coin, is implanted into the heart’s left atrial appendage in a one-time minimally invasive procedure. The left atrial appendage is where 90% of stroke-causing clots form in patients with atrial fibrillation, the most common type of cardiac arrhythmia, or heart rhythm disorder. After around 45 days, a patient’s heart tissue grows over the device, sealing off the area.
“There are two major benefits to using the left atrial appendage-blocking device,” explains Oussama Wazni, M.D., Section Head for Electrophysiology in the Heart, Vascular & Thoracic Institute at Cleveland Clinic. “First, the patients can lower their stroke risk and, second, they can avoid pitfalls of taking anticoagulants [a type of blood thinner], which are the traditional treatment in cases of atrial fibrillation, but not suitable for all patients and with serious potential side effects.”
The procedure is performed under general anesthesia and takes around an hour. A small cut is made in the groin and the device is inserted using a catheter, or small tube, running through the recipient’s vein into the heart’s left atrial appendage. Once the body’s tissue has grown over and sealed off the device, patients will need to take only a daily aspirin to prevent stroke risk from other areas of the body says Dr. Wazni.
The development and increasing use of the device is significant as more than three million new cases of atrial fibrillation worldwide were registered in the Global Health Data Exchange database during 2017, according to a review published in the International Journal of Stroke this year. Furthermore, prevalence of atrial fibrillation is increasing, with the estimated incidence rate for 2017 being 31% higher than the corresponding incidence in 1997.
Dr. Wazni says that Cleveland Clinic began performing the implant procedure in 2009, as part of the clinical trials prior to FDA approval. It crossed the 1,000 implant mark this year, meaning that the hospital has performed more of these operations than any other in the U.S.
Explaining why anticoagulants are not suitable for all patients, Dr. Wazni says that because they work by making blood clot more slowly than normal, the risks of bleeding problems are increased. This could occur in and around the brain, potentially causing a stroke, or in the stomach and intestines, as well as serious rashes. Patients also need to be extremely careful to avoid situations that could lead to falls or injury as these would result in heavy bruising and bleeding.
He adds that people with other health issues such as uncontrolled high blood pressure, kidney or liver disease and high alcohol consumption have additional risks and are not able to take anticoagulants.
Dr. Wazni was part of a Cleveland Clinic team of researchers on a recent study of the device’s effectiveness in atrial fibrillation patients who had very high risk for stroke and a high risk of bleeding as they had already had a major bleeding event in the past. “In our small study of these high-risk patients who could not take anticoagulants, we found that their residual annual ischemic stroke risk decreased from an estimated 12% down to 2.8%. This is an excellent result as the risk is lower than it would have been if the patients were on anticoagulants.”
Another benefit the physicians at Cleveland Clinic have seen in their use of the device is that in around 200 cases, the procedure was easily combined with catheter ablation, which is used to control the symptoms of atrial fibrillation, thus enhancing a patient’s quality of life. “We have developed a series of best practices for this simultaneous procedure, which hospitals were initially reluctant to perform,” says Dr. Wazni.
Similar to the implant procedure, in ablation, thin tubes, or catheters, are led from a cut in the groin via blood vessels to the heart, where heart tissue is scarred to prevent to help break up the electrical signals that cause irregular heartbeat.
“Minimally invasive techniques such as these are the future of stroke care. They can be performed on a one-off basis and last a lifetime, offering our patients the chance to lead a more active and better quality of life as well as providing greater peace of mind,” concludes Dr. Wazni.
About Cleveland Clinic:
Cleveland Clinic – now in its centennial year – is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S. News & World Report consistently names Cleveland Clinic as one of the nation’s best hospitals in its annual “America’s Best Hospitals” survey. Among Cleveland Clinic’s 70,800 employees worldwide are more than 4,660 salaried physicians and researchers, and 18,500 registered nurses and advanced practice providers, representing 140 medical specialties and subspecialties. Cleveland Clinic is a 6,500-bed health system that includes a 173-acre main campus near downtown Cleveland, 19 hospitals, more than 220 outpatient facilities, and locations in southeast Florida; Las Vegas, Nevada; Toronto, Canada; Abu Dhabi, UAE; and London, England. In 2020, there were 8.7 million total outpatient visits, 273,000 hospital admissions and observations, and 217,000 surgical cases throughout Cleveland Clinic’s health system. Patients came for treatment from every state and 185 countries.
