Tag: pulmonary embolism

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Endovascular Catheter Safely Treats Acute Pulmonary Embolism

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Credit: Scientific Animations CC4.0

The BASHIR™ Endovascular Catheter (THROMBOLEX, Inc.), recently approved by the US Food and Drug Administration (FDA), is paving the way to more effective and safe treatment for acute pulmonary embolism. Already demonstrated to be effective for reducing blockages in lung arteries, a new study in JACC: Advances shows that the BASHIR™ catheter also reduces blockages in the smaller segmental pulmonary artery branches. These branches are ultimately responsible for oxygenating the blood in the lungs.

The new study from Temple University which was part of the National Institutes of Health-sponsored multicentre RESCUE clinical trial, further showed a correlation between decreased numbers of blockages in the small lung arteries and functional recovery of the right ventricle of the heart, which pumps blood into the main pulmonary artery of the lungs.

Compared to other devices, the BASHIR™ catheter also had significantly lower bleeding rates, a key advance in acute pulmonary embolism treatment.

“Blockages in these smaller, distal pulmonary arteries have never previously been explored in patients treated for acute pulmonary embolism,” explained Riyaz Bashir, MD, FACC, Professor of Medicine, Director of Vascular and Endovascular Medicine in the Section of Cardiology, Department of Medicine at the Lewis Katz School of Medicine and Temple University Hospital, co-inventor of the BASHIR™ Endovascular Catheter, and first author on the new report.

The BASHIR™ catheter is a small tube-like device that consists of a helical basket with six mini-infusion catheters at its farthest end.

When the infusion basket is expanded within a clot in a large blood vessel, new channels open, enabling blood to flow through the clot. The blood carries the body’s clot-dissolving chemicals into the channels, accelerating clot breakdown.

Researchers at THROMBOLEX™ Inc. were involved in developing and commercialising this platform technology.

The occlusion of small lung arteries is the major reason for the reduction in blood flow in patients with acute pulmonary embolism.

“The more occlusions a patient has, the lower their survival,” Dr Bashir said.

“Among the treatment goals is relieving obstructions in both large and small arteries.”

Patients who survive may, over more extended periods, be at high risk of developing chronic thromboembolic pulmonary hypertension (CTEPH), which is a life-threatening condition caused by increased blood pressure in the lungs.

In the new study, Dr Bashir and colleagues observed reductions in occlusions in segmental and proximal branches of the pulmonary artery 48 hours following treatment with the BASHIR™ catheter.

The blockages decreased even in those arteries that were distant from where the infusion basket was located, enabling improved blood flow and healing of the right ventricle.

“We suspect that the improvements in blood flow are due to both the expansion of the basket and the flow of the body’s clot dissolving molecules into the clot, which cause the blockage to shrink,” Dr. Bashir said.

“As the volume of blood flow improved, right ventricular function also improved, which could translate to better survival.”

In future work, Dr Bashir and colleagues plan to investigate mechanisms behind the observed reductions in arterial blockage.

Further trials are also needed to understand better the impact of treatment with the BASHIR™ catheter on patient survival and incidence of CTEPH.

Source: Temple University Health System

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Consider More People with PE for Surgery, AHA Statement Urges

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Credit: American Heart Association

A new American Heart Association scientific statement suggests surgery be considered for more people with high-risk pulmonary embolism (PE). The statement, published in the journal Circulation, also calls for data quality registries for high-risk patients with pulmonary embolism and more research to better understand the disease process and effective treatments.

Nearly 45% of patients experiencing PE will progress to severe symptoms, where the clot causes high pressure in the lungs and subsequent damage to the right heart chamber, with a high risk of death. Even therapy following current guideline-directed treatment has a high rate of death, estimated at approximately 40% of cases in some groups.

Treatment options for patients with severe pulmonary embolism include anticoagulation therapy or thrombolysis (either intravenously or via catheter procedure), or advanced surgical interventions such as surgical embolectomy and mechanical circulatory support. Often, surgical techniques are a last resort after other treatments are unsuccessful. The statement suggests that considering surgery earlier may help improve survival for patients with severe PE.

“This statement demonstrates that modern surgical management strategies and mechanical circulatory support results in excellent survival (97%) even among the sickest patients, including those who present with cardiac arrest and have had CPR,” said Joshua B. Goldberg, MD, chair of the statement writing group. 

“Modern surgical strategies and mechanical circulatory support are drastically underutilised,” he said. “It is the hope of the multidisciplinary group of authors that this scientific statement will provide a greater awareness of the safety and efficacy of modern surgical management and mechanical circulatory support in treating the most unstable patients so that lives may be saved. In addition, we hope this statement will facilitate improved understanding of the disease process and effective treatments and encourage future research to improve the survival of patients with this common and deadly disease.”  

The writing group proposes strategies to determine risk more accurately and identify earlier which PE patients may benefit from surgical intervention. They also suggest increased education for clinicians to encourage the use and integration of surgical strategies earlier in PE treatment. Additionally, the statement supports the development of patient registries, particularly focused on data that provides useful context for clinicians and surgeons to understand the progression from intermediate to high-risk pulmonary embolism and treatment outcomes across patients at various risk levels.

Source: American Heart Association

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Aspirin as Effective as Heparin for Clot Prevention in Bone Fracture Hospitalisation

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Source: Mat Napo on Unsplash

Patients hospitalised with fractures typically receive low-molecular-weight heparin to prevent life-threatening blood clots. A new clinical trial, however, found that inexpensive over-the-counter aspirin is just as effective. The findings, published today in the New England Journal of Medicine, may lead surgeons to change their practice and administer aspirin to these patients.

With more than 12 000 patients, the multi-centre randomised clinical trial is the largest trial ever conducted on orthopaedic trauma patients. This multidisciplinary collaboration between orthopaedic surgeons and trauma surgeons points to the importance of evaluating techniques used to prevent post-surgical complications, like blood clots and infections, through high-quality, head-to-head comparison studies.

“Many patients with fractures will likely strongly prefer to take a daily aspirin over receiving injections after we found that both give them similar outcomes for prevention of the most serious outcomes from blood clots,” said the study’s principal investigator Robert V. O’Toole, MD. “We expect our findings from this large-scale trial to have an important impact on clinical practice that may even alter the standard of care.”

Patients who experience fractures that require surgery are at increased risk of developing blood clots, including life-threatening pulmonary embolisms. Current guidelines recommend prescribing low-molecular-weight heparin (enoxaparin) to prevent these clots, although smaller clinical trials in total joint replacement surgery suggested a potential benefit of aspirin as a less-expensive, widely available option.

The study enrolled 12 211 patients with leg or arm fractures that necessitated surgery or pelvic fractures regardless of the treatment. Half were randomised to 30mg of injectable enoxaparin twice daily. The other half received 81mg of aspirin twice daily. Patients were followed for 90 days to measure health outcomes from the two treatments.

The main finding of the study was that aspirin was “non-inferior,” or no worse than low molecular-weight heparin in preventing death from any cause – 47 patients in the aspirin group died, compared with 45 patients in the heparin group. For other important complications, the researchers also found no differences in pulmonary embolisms between the two groups. The incidence of bleeding complications, infection, wound problems, and other adverse events from the treatments was also similar in both groups.

Of all the outcomes studied, the only potential difference noted was in deep vein thrombosis. This condition was relatively uncommon in both groups as it occurred in 2.5% of patients in the aspirin group, and in 1.7% of patients in the heparin group.

“This relatively small difference was driven by clots lower in the leg, which are thought to be of less clinical significance and often do not require treatment,” said study co-principal investigator Deborah Stein, MD, MPH.

“Many patients don’t like giving themselves injections. It’s not fun in terms of giving the actual injection because it burns, and your stomach tends to bruise more easily compared to aspirin,” said Debra Marvel, a 53-year-old from Columbia, MD, who served as a patient advisor on the study. She received Lovenox (low-molecular-weight heparin) after her legs were crushed in a 2015 pedestrian accident, requiring multiple surgeries at the University of Maryland Shock Trauma Center. “Patients also prefer aspirin because Lovenox can be expensive based on insurance.”

“An estimated one million Americans are hospitalised each year with extremity fractures, and this new finding could help prevent potentially fatal blood clots in these patients using a medication that is cheaper and far easier to administer,” said Mark T. Gladwin, MD, Vice President for Medical Affairs, University of Maryland, Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor and Dean, University of Maryland School of Medicine. “Given these important results, we can expect the guidelines for the prevention of blood clots to be revised to include the option of aspirin for patients with traumatic bone fractures.”

Source: University of Maryland School of Medicine