The risks and benefits of devices for patients with pulmonary embolism.
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Little data suggest the use of novel interventional devices that remove or dissolve clots in the lungs are safer and more effective than the use of traditional anticoagulants, a scientific statement from the American Heart Association led by Penn Medicine said.
Researchers developed the statement to raise awareness of the novel treatment approaches, advise of the potential benefits and risks of endovascular pulmonary embolism intervention and outline appropriate uses, including identifying which patients would benefit the most.
“While the emergence of these interventional devices offers a new approach to treat pulmonary embolism, questions exist about when they should be administered and which patients would benefit the most,” said Jay Giri, M.D., MPH, an assistant professor of cardiovascular medicine in the Perelman School of Medicine at the University of Pennsylvania. “This statement aims to help stratify the risks associated with these approaches and guide clinical practice.”
Traditionally, patients with pulmonary embolism treat the condition with blood thinners to prevent new clots from forming. This method does not eliminate existing clot and can lead to adverse outcomes. Such events prompted the manufacturing of novel therapeutics like catheter-directed thrombolysis and catheter-based embolectomy.
Technology to manage acute intermediate- and high-risk pulmonary embolism is evolving, the authors stated. But as of right now, only two devices for the interventional treatment of pulmonary embolism have been cleared by the U.S. Food and Drug Administration.
While the regulator cleared the devices, there is limited evidence that supports the safety of the therapies against conservative and more traditional approaches, the authors wrote.
Patients with the highest risk of dying of pulmonary embolism and lowest risk for bleeding benefit the most from more invasive therapies, the researchers concluded. The primary use of technology for these patients is to reduce rapidly reverse hemodynamic compromise and gas exchange abnormalities.
Those considered low risk should just use anticoagulants. Interventional therapies should not be used routinely on patients at intermediate risk, the research team added. For these patients, the primary goal of advanced therapies is to avert possible hemodynamic collapse and death resulting from progressive right-sided heart failure and to expedite symptom resolution.
“Given the minimal short-term risk and low cost associated with anticoagulation alone, these interventional therapy devices must prove safety and effectiveness compared to anticoagulants in randomized clinical trials,” Giri said. “As we move forward, it’s critical to design randomized trials that enable us to measure clinically meaningful differences in patient outcomes and quality of life.”
The research team presented the information at the 5th Annual Pulmonary Embolism Symposium in Boston.
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