‘Catastrophic’ PE associated with very high in-hospital mortality rate
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Key takeaways:
- Patients with “catastrophic” pulmonary embolism, defined as hemodynamic collapse, had an in-hospital mortality rate of more than 40%.
- Improvements in care of this population are urgently needed.
The subset of patients with high-risk pulmonary embolism who had hemodynamic collapse had an in-hospital mortality rate of 42%, according to a retrospective analysis of a large registry.
This group, defined as having “catastrophic” PE, died in the hospital at more than twice the rate of patients who had high-risk but not catastrophic PE, researchers wrote in the Journal of the American College of Cardiology.
“There are a lot of goals for us to achieve in pulmonary embolism care, but the single most important one is decreasing mortality, especially short-term mortality in the sickest patients,” Jay Giri, MD, MPH, FACC, FAHA, FSCAI, director of the cardiovascular catheterization laboratories at the Hospital of the University of the Pennsylvania, told Healio. “The grand majority of mortality is driven by a small subset of patients that come into the hospital with pulmonary embolism. This group is characterized as so-called high-risk pulmonary embolism patients. We estimate they represent about 5% to 10% of the total population of patients that come to the hospital with pulmonary embolism. We wanted to look at these sickest patients to start to get some information on what they really look like now in modern practice.”
Guidelines for treatment of these patients recommend lytic therapy above all other options, but that is based on one trial from about 30 years ago, so a better understanding of who these patients are and how their condition can be improved is necessary, Giri told Healio, adding that previous analyses have been in smaller populations.
Large registry analysis
The researchers conducted an analysis of 5,790 patients included in the Pulmonary Embolism Response Team (PERT) Consortium registry from 35 sites, including 2,976 presenting with intermediate-risk PE (mean age, 62 years; 50% men) and 1,442 presenting with high-risk PE (mean age, 63 years; 50% men). Of the high-risk group, 197 (13.7%) had hemodynamic collapse and were categorized as having catastrophic PE. Hemodynamic collapse was defined as current or prior cardiac arrest or at risk for pending cardiac arrest, “which usually meant rapid escalation of vasopressor use,” Giri said.
“It’s technically a 10-year window, but most of the patients were coming in over the last 5 years, so it’s relatively modern,” Giri told Healio. “We can lay the groundwork for what studies need to be performed using this data as a baseline of what to expect in modern practice at experienced centers.”
Compared with the intermediate-risk group, the high-risk group were more often treated with advanced therapies (41.9% vs. 30.2%) and were more likely to die in the hospital (20.6% vs. 3.7%) or experience major bleeding (10.5% vs. 3.5%; P < .001 for all), according to the researchers.
The 20.6% mortality rate in the high-risk group was lower than that seen in previous trials and meta-analyses, likely due to modern treatments and care in specialized PE centers, Giri told Healio. “It’s a little bit of an optimistic finding, but it’s nowhere near good enough,” he said.
Factors independently associated with in-hospital mortality included vasopressor use (OR = 4.56; 95% CI, 3.27-6.38; P < .01), extracorporeal membrane oxygenation (ECMO) use (OR = 2.86; 95% CI, 1.12-7.3; P = .03), clot-in-transit (OR = 2.26; 95% CI, 1.13-4.52; P = .02) and malignancy (OR = 1.7; 95% CI, 1.13-2.56; P = .01), Giri and colleagues found.
Compared with patients with high-risk but not catastrophic PE, those with catastrophic PE had higher rates of in-hospital mortality (42.1% vs. 17.2%; P < .001), and were more likely to have ECMO (13.3% vs. 4.8%; P < .001) and systemic thrombolysis (25% vs. 11.3%; P < .001), the researchers wrote.
“This is delineating risk in a more nuanced fashion,” Giri told Healio.
He said the researchers were surprised that systemic thrombolysis was not used often in this cohort.
“These centers will have protocols for use of systemic thrombolysis,” Giri told Healio. “But there probably is not a lot of confidence among these U.S. experts in a European Society of Cardiology guideline level I recommendation to use systemic thrombolysis in these patients. Advanced therapies, including systemic thrombolysis, catheter-directed approaches, surgical embolectomy [and] mechanical circulatory support with ECMO, were used in roughly 40% of patients. That is higher than what modern guidelines are recommending, but those guidelines are based on opinion, not on hard data. The U.S. PERT centers are making their own decisions on how they want to treat these patients. But it is still only a minority of [high-risk] patients that are being treated with anything more than anticoagulation alone. We have got to prove things with well-designed studies going forward, but it looks there is a lot of like room for improvement in these sick patients. We have got to be more aggressive with these patients if they are dying at high rates.”
Moving forward
The analysis has “laid out what the playing field is with this group of patients,” Giri told Healio. “We have information with which to move forward and do more rigorous study designs, including potentially randomized trials.”
Randomized trials in intermediate-risk patients are ongoing, and were launched first because the patient population is larger, he said. “But [randomized trials of high-risk patients] is the next step forward for the field. The time for that is soon, especially as the data from the intermediate-risk trials come in, which will give us more information on what we expect these devices — catheter-directed lytic devices, catheter embolectomy devices — to do. The field and the technology are moving very fast and this is a baseline study to lay the groundwork.”
In the meantime, “the current guidelines as they are laid out are giving systemic thrombolysis an inappropriate position of primacy,” Giri told Healio. “That doesn't mean nobody should have systematic thrombolysis; we use it when we need to. But should it stand on its own as the only class I recommendation compared to all these other therapies? I would argue that there is not evidence to justify it having a class I recommendation on its own right now. The data are poor and are based on a single randomized trial from 3 decades ago. PERTs are barely using it even in the highest-risk patients. It’s at least time to put systemic thrombolysis to the test in a more rigorous way. We don’t have enough evidence to upgrade the other options, but I can’t say they deserve to be on a lower playing field. Current guidelines encourage hospitals to use algorithms that say push the lytics first and ask questions later. It doesn’t feel like that’s the right thing to do with the data that is coming out across various contemporary studies.”
For more information:
Jay Giri, MD, MPH, FACC, FAHA, FSCAI, can be reached at jay.giri@pennmedicine.upenn.edu. X (Twitter): @jaygirimd.
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