Cleveland Clinic researchers concluded that using a heart implant after treatment for an irregular heartbeat is as effective as using blood thinners in preventing blood clots that could lead to stroke, while also lowering a risk of bleeding.
An irregular heartbeat, also known as heart arrhythmia, causes the heart to beat too slow, too fast or in an irregular way. Nearly 3 million people nationally have an irregular heartbeat, which can cause an increased risk of stroke, heart failure and cardiac arrest.
A report published in the New England Journal of Medicine on Nov. 16 examined a Cleveland Clinic randomized trial of 1,600 patients across 114 global sites between Nov. 6, 2019 and June 28, 2021. The trial examined the difference between participants who used blood thinners and those who used a heart implant that closes off a small part of the heart where blood typically pools, leading to blood clots.
Dr. Oussama Wazni, the study’s lead author and section head of cardiac electrophysiology and pacing at Cleveland Clinic, said the heart implants are as effective as blood thinners and patients will see additional benefits.
“They can expect that they will have a reduced amount of needing to seek a doctor to get attention for bleeding and they won't have to take a blood thinner on a daily basis," he said.
The study found 18.1% of study participants who used blood thinners experienced bleeding, including nose bleeds and gastrointestinal bleeding, compared with 8.5% who used implants.
The lower risk of bleeding is significant, Wazni said.
"It's not something trivial because, like we saw in this study, 18.1% had to go and seek medical help for bleeding," he said. "So, I think (using the device) is good for their overall quality of life."
While the device is approved by the Food and Drug Administration for use when a patient has a problem with bleeding that precludes use of blood thinners, it has not been approved as an alternative treatment when there is not a pre-existing problem with bleeds, Wazni said.
Cleveland Clinic will now share the results of this study with the FDA so that it can decide whether to expand use of the device as an alternative to blood thinners, he said.
The FDA should make a decision within a year, Wazni said.
