Research examines safety of treatments for deep vein thrombosis
Patients who have a clot in their legs and are considering whether to be treated with traditional blood-thinning medication or undergo a minimally-invasive catheter-based clot removal procedure should feel comfortable that there is no difference in death rates between the two treatments, although there are more bleeding risks with the catheter procedure, according to a study by Temple University School of Medicine researchers. The study involved a review of more than 90,000 cases nationwide.
Riyaz Bashir, MD, a specialist in interventional cardiology and vascular disease at Temple Heart & Vascular Center, directed the study, which was aimed at figuring out the best way to treat a painful and potentially deadly condition called deep vein thrombosis (DVT).
The study, to be published by JAMA Internal Medicine, compared two approaches: catheter-based thrombolysis, which involves inserting a catheter to deliver clot-dissolving medication directly into the leg clot; and medical therapy using a blood-thinning medication (anticoagulation). The study found that the in-hospital mortality rate was similar for the two groups. However, the catheter-based procedure was associated with higher rates of bleeding. The catheter procedure also was more costly than the medical therapy and involved more days in the hospital.
It is estimated that about 6 percent of DVT patients die within one month of the diagnosis. The study should help inform an ongoing medical debate over the safest and most effective way to treat DVT, which is the third most common cause of cardiovascular morbidity and death after coronary artery disease and stroke. When a blood clot develops in a vein in the leg, it can break loose and travel to the lungs, causing a deadly condition called pulmonary embolism. DVT, which occurs in about 1 out of every 1,000 people per year, can have a long-lasting effect on a person's well-being.
About 20 to 50 percent of patients with above-knee DVT will go on to develop a condition called post-thrombotic syndrome (PTS) even when treated with anticoagulation therapy and compression stockings. Patients with PTS experience pain, swelling, itching, skin discoloration and heaviness in the legs, and, in severe cases, skin ulcers.
"These patients can end up very disabled. They sometimes are unable to work and they lose their job," said Dr. Bashir, Associate Professor of Medicine. "Post-thrombotic syndrome places a huge economic burden ($2.4 billion and 200 million work days lost annually in the U.S.) on the health-care system."
Several studies had shown that early removal of the clot using catheter-directed thrombolysis (CDT) leads to a significant reduction in the incidence of PTS along with improvement in patients' quality of life.
The studies were too small, however, to draw any conclusions about the safety of the catheter-based procedure versus medical therapy alone using blood-thinning medications, and doctors are divided on which approach is better.
The American Heart Association recommends the catheter-based procedure (CDT) as the first-line therapy for patients at low risk for bleeding, while the American College of Chest Surgeons recommends against the use of CDT because of safety concerns and the complexity of the procedure.
Dr. Bashir and his research team used a national database called Nationwide Inpatient Sample to study outcomes for patients who were hospitalized for DVT between January 2005 and December 2010.
They identified 90,618 cases overall. They then compared 3,594 patients who underwent the catheter-based procedure to deliver clot-busting medication to the same number of patients who received anticoagulation alone.
Among the findings were:
The researchers found that rate of CDT utilization for treating DVT went from 2.3 percent in 2005 to 5.9 percent in 2010. Over that same period, the mortality rate for patients who had CDT went down, which is probably a reflection in a refinement in catheter based technologies and increased operator experience. However the rate of bleeding continued to remain higher in this group of patients. Patients who had the procedure at a higher-volume center tended to do better, the study found.
Dr. Bashir said that some patients with DVT clearly benefit from the catheter based procedure, but he said patients needed to be carefully selected. His team concluded that more research is needed to sort out the risks versus the benefits of the procedure.
"In light of the findings of this study, it is imperative that the magnitude of benefit from CDT has to be substantiated in order to justify the increased upfront resource utilization and bleeding risk of this therapy," the researchers wrote. "In the absence of such data, it may be reasonable to restrict this form of therapy to those patients who have a low bleeding risk and have a high risk of PTS," such as patients with clots at or above their groins.
"I think all patients with leg clots should be informed about the risks of developing PTS and its consequences and the risks of catheter-based clot removal so that they can truly participate in shared decision-making," Dr. Bashir said.
Dr. Bashir conducted the study with three other Temple University School of Medicine researchers: Chad Zack, MD, Huaqing Zhao, PhD, and Alfred Bove, MD. Anthony Comerota, MD, of ProMedica Toledo Hospital in Ohio was also on the research team.
The study was funded by Temple University Hospital's Cardiovascular Division, which is a nationally-recognized leader in research on cardiovascular diseases and their treatments.
About Temple Health
Temple Health refers to the health, education and research activities carried out by the affiliates of Temple University Health System and by Temple University School of Medicine.
Temple University Health System (TUHS) is a $1.4 billion academic health system dedicated to providing access to quality patient care and supporting excellence in medical education and research. The Health System consists of Temple University Hospital (TUH), ranked among the "Best Hospitals" in the region by U.S. News & World Report; TUH-Episcopal Campus; TUH-Northeastern Campus; Fox Chase Cancer Center, an NCI-designated comprehensive cancer center; Jeanes Hospital, a community-based hospital offering medical, surgical and emergency services; Temple Transport Team, a ground and air-ambulance company; and Temple Physicians, Inc., a network of community-based specialty and primary-care physician practices. TUHS is affiliated with Temple University School of Medicine.
Temple University School of Medicine (TUSM), established in 1901, is one of the nation's leading medical schools. Each year, the School of Medicine educates approximately 840 medical students and 140 graduate students. Based on its level of funding from the National Institutes of Health, Temple University School of Medicine is the second-highest ranked medical school in Philadelphia and the third-highest in the Commonwealth of Pennsylvania. According to U.S. News & World Report, TUSM is among the top 10 most applied-to medical schools in the nation.
Kathleen Duffy | Eurek Alert!
Penn researchers use network science to help pinpoint source of seizures
29.01.2016 | University of Pennsylvania
Automobiles increase the mobility of their users. However, their maneuverability is pushed to the limit by cramped inner city conditions. Those who need to...
Advance in biomedical imaging: The University of Würzburg's Biocenter has enhanced fluorescence microscopy to label and visualise up to nine different cell structures simultaneously.
Fluorescence microscopy allows researchers to visualise biomolecules in cells. They label the molecules using fluorescent probes, excite them with light and...
NASA's follow-on to the successful ICESat mission will employ a never-before-flown technique for determining the topography of ice sheets and the thickness of sea ice, but that won't be the only first for this mission.
Slated for launch in 2018, NASA's Ice, Cloud and land Elevation Satellite-2 (ICESat-2) also will carry a 3-D printed part made of polyetherketoneketone (PEKK),...
In the last decades, sea level has been rising continuously – about 3.3 mm per year. For reef islands such as the Maldives or the Marshall Islands a sinister picture is being painted evoking the demise of the island states and their cultures. Are the effects of sea-level rise already noticeable on reef islands? Scientists from the ZMT have now answered this question for the Takuu Atoll, a group of Pacific islands, located northeast of Papua New Guinea.
In the last decades, sea level has been rising continuously – about 3.3 mm per year. For reef islands such as the Maldives or the Marshall Islands a sinister...
The ‘Internet of Things’ is growing rapidly. Mobile phones, washing machines and the milk bottle in the fridge: the idea is that minicomputers connected to these will be able to process information, receive and send data. This requires electrical power. Transistors that are capable of switching information with a single electron use far less power than field effect transistors that are commonly used in computers. However, these innovative electronic switches do not yet work at room temperature. Scientists working on the new EU research project ‘Ions4Set’ intend to change this. The program will be launched on February 1. It is coordinated by the Helmholtz-Zentrum Dresden-Rossendorf (HZDR).
“Billions of tiny computers will in future communicate with each other via the Internet or locally. Yet power consumption currently remains a great obstacle”,...
02.02.2016 | Event News
26.01.2016 | Event News
26.01.2016 | Event News
05.02.2016 | Life Sciences
05.02.2016 | Materials Sciences
05.02.2016 | Physics and Astronomy