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Two patients: two types of DVT

“Isn’t there something else we should be doing?”

That’s the question Chuck Lange, 60, repeatedly asked physicians in Cape Girardeau, Mo., as he experienced intense pain and swelling in his legs over a period of several months early in 2014.

After days of severe pain and swelling in her left leg in July 2013, St. Louisan Ann-Marie Stagoski, 46, found herself in a Kansas City, Mo., hospital awaiting an ultrasound to confirm a suspected diagnosis. 

“Could it be anything else?” she asked a nurse. “Oh, honey, you have a blood clot,” came the reply.

 

Both Lange and Stagoski were experiencing deep vein thrombosis (DVT), a condition estimated to affect between 350,000 and 600,000 Americans annually. 

They sought help and were eventually treated successfully by Mallinckrodt Institute of Radiology interventional radiologists who are leading a landmark study funded by the National Institutes of Health (NIH) to determine the definitive treatment for DVT.

 

A history of blood clots

DVT results from a blood clot that forms in a vein deep in the body, usually in the lower leg or thigh. These blood clots — especially those within the thigh — can break off and travel through the bloodstream. A pulmonary embolism (PE) develops when the clot travels to an artery in the lungs and blocks blood flow. This serious condition can damage the lungs, cause heart failure, and even end in death.

DVTs are classified as acute when diagnosed within 14 days of the clot forming or chronic when the clot is more than a month old. Chronic DVT can lead to post-thrombotic syndrome (PTS), a condition with leg symptoms that include aching or cramping, a feeling of heaviness, itching or tingling, swelling, skin discoloration, and ulcers on the skin.

That’s the type of DVT Lange was experiencing. He had a history of DVTs dating to hip replacement surgeries in 2004 and 2008, one of which resulted in a PE. To help prevent a recurrence, a surgeon had implanted a filter in Lange’s inferior vena cava. The device acts as a sieve to block blood clots from reaching the lungs. 

“I was fine until January of this year, when I developed viral pneumonia and was hospitalized for 16 days,” says Lange. “Then a couple of weeks after leaving the hospital, I herniated a disc in my back. I could hardly move: I was in excruciating pain, and my legs swelled up immediately.”

Following another four-day stay in the hospital, Lange returned home. His back injury improved, but his legs remained swollen.

 “After about a month, the doctors ordered an ultrasound and found clots in my legs and abdomen. Although I was taking a blood thinner, it wasn’t helping my condition,” says Lange.

Lange’s physicians suggested he see a vascular surgeon, but an almost six-week wait in Cape Girardeau prompted him to travel to the emergency department at Barnes-Jewish Hospital. There he was referred to Nael E. A. Saad, MD, assistant professor of radiology and Mallinckrodt interventional radiologist.

“Mr. Lange’s filter was blocked, causing a large clot to form at the filter and extend down into his abdomen and pelvis,” says Saad. “Since he had chronic DVT, the blood clots were hardened and impossible to dissolve. The only way for us to re-establish blood flow was to place stents throughout his inferior vena cava and iliac veins.”

Saad used balloon angioplasty to penetrate and push the clots open. Along the same pathway, he threaded 11 stents — small mesh tubes — to areas where the veins were narrowed. 

“Relief from the pain was immediate, and overnight the swelling in my legs began to subside,” says Lange.

Over time, the hardening of blood clots damages the delicate valves within veins, and for that reason Lange’s legs will never be back to full capacity. But he is pleased with his progress and his ability to resume chores on the 20 acres of property he calls home with his partner, Teresa.

“I know I’ll be on a blood thinner for the rest of my life, and that’s OK,” he says. “My goal is to stay healthy, and thanks to Dr. Saad, I’m feeling good.”

 

A rare anatomic variant

Not all DVTs are alike. In another example, Stagoski was returning from a family vacation in July 2013, a trip during which she spent eight hours in a car barely moving due to a severe case of poison ivy. The next morning she awoke with severe pain on her left side and running down her outer left thigh. A trip to a doctor several days later for both the poison ivy and her leg pain resulted in a diagnosis of sciatica.

“The next weekend I traveled to Kansas City for my daughter’s soccer tournament, and the pain and swelling in my leg kept getting worse. A dad at the games who had experienced a blood clot told me to go to the hospital,” says Stagoski. “I really fought that idea, but after talking with my insurance company, my doctor’s nurse, and finally my doctor, I was convinced I needed to go to the emergency room.”

An ultrasound showed Stagoski had a blood clot extending from her groin down to her mid-calf. She spent three days in the hospital on blood thinners.

“Once I got home to St. Louis, I continued on a blood thinner, but the pain and swelling didn’t get better,” she says.

 

 

ABOVE: Chuck Lange and Ann-Marie Stagoski (shown with her daughter)

 

At the recommendation of a friend, Stagoski made an appointment with Suresh Vedantham, MD, professor of radiology and MIR interventional radiologist. Stagoski was diagnosed with May-Thurner syndrome, a rare condition that develops when the crossing right iliac artery compresses the left iliac vein, increasing the risk of DVT in the left leg.

“Ms. Stagoski had an acute DVT, which means her blood clot still had a jello-like consistency. This allowed us to perform pharmacomechanical catheter-directed thrombolysis (PCDT),” says Vedantham. 

PCDT involves inserting a catheter into the blood clot and injecting it with the clot-busting drug tissue plasminogen activator t-PA. For Stagoski, the catheter was inserted into the blood clot and the t-PA was allowed to drip overnight. By the next day, the clot had dissolved, enabling Vedantham to insert two stents. Stagoski experienced immediate relief from the pain. After six months on a blood thinner, she now takes a daily dose of baby aspirin.

“Dr. Vedantham thinks there may be some valve damage, but I’ve noticed only minimal swelling when I exercise,” says Stagoski. “With daughters aged 15 and 17, I lead an active life, and I’ve been able to fully return to it.”

 

Attract: a landmark study

Vedantham is the national principal investigator of the NIH-funded ATTRACT Study, a multicenter, randomized, controlled clinical trial designed to determine the best way to treat patients with proximal DVT (large blood clots of the leg). Saad serves as a co-investigator.

“For 60 years, the treatment for DVT has remained consistent — prescribe blood-thinning drugs to prevent new episodes and to stop the clot from moving,” says Vedantham. “Removing the existing clot hasn’t been considered an element of standard care; t-PA has been used only in select patients.”

Advances in how t-PA can be administered have raised the question of whether removing blood clots in patients with acute DVT while continuing them on blood thinners should become routine care. 

“In the past, t-PA was delivered through a vein in the arm, which meant giving patients a very large dose of this powerful drug. As a result, bleeding events occurred,” says Vedantham. “We now have the technology to inject t-PA directly into the clot, which means we can inject lower doses while achieving a better target effect.”

The two-arm ATTRACT Study has one group of patients who receive the standard treatment for DVT, which consists of blood-thinning drugs and the use of elastic compression stockings. The other group receives the standard treatment as well as the PCDT clot-busting procedure. Each patient is followed for two years. The study began in 2009 and will conclude in 2016.

“Statistics show that 25 to 50 percent of patients — between 50,000 and 100,000 a year — with a first episode of DVT will develop post-thrombotic syndrome,” says Patty Nieters, RN, BSN, the ATTRACT study coordinator. “That’s a significant number of patients who will be debilitated to some degree for the rest of their lives. Once PTS develops, there is no consistently effective treatment to help patients fully recover.”

The study aims to determine if PCDT prevents PTS, improves quality of life, is safe enough, and is cost-effective. The study also has the goal of determining the mechanism by which PCDT prevents PTS.

 “Currently there are two schools of thought in regard to using PCDT; some think it should be used only in very few, selected cases, while others think it should be used routinely,” says Vedantham. “This study — with leading researchers from across the nation on its steering committee and an endorsement from the U.S. Surgeon General — will give us the definitive answer about the care we need to provide to patients with DVT in the United States and throughout the world.” 

 

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