Tampa is only site on Florida’s west coast for the large-scale, NIH-funded clinical trial

Tampa, FL (June 9, 2014) — A new clinical trial at USF Health is evaluating the ability of a common antibiotic, doxycycline, to slow the growth of small abdominal aortic aneurysms, possibly preventing or delaying the need for surgery.

USF Health is one of only two sites in Florida, and 16 nationwide, participating in the $12.2-million study sponsored by the National Institutes of Health.  The other Florida site is Baptist Health Medical Center in Miami.

“The intent is to test if doxycycline — which is widely available, relatively inexpensive, and has minimal side effects — can reduce inflammation in the abdominal aorta and prevent small aneurysms from becoming larger,” said local principal investigator Murray Shames, MD, a vascular surgeon at USF Health Morsani College of Medicine and Tampa General Hospital.

“If drug treatment can do that, we could potentially improve care and reduce the costs of surveillance and operations needed to fix large aneurysms.”

USF Health/TGH vascular surgeon Dr. Murray Shames leads the local NIH-sponsored trial testing the effects of the common antibiotic doxycycline on the growth of abdominal aortic aneurysms.

An abdominal aortic aneurysm is a ballooning or bulge in the lower part of the aorta, a major blood vessel running from the heart through the center of the chest and abdomen. Since the aorta is the body’s main supplier of blood, a ruptured abdominal aortic aneurysm can cause life-threatening bleeding.  If an aortic aneurysm bursts, it is fatal more than half the time.

When aortic aneurysms are small and low risk, less than 5 cm. or about the size of a plum, doctors closely monitor with ultrasound any changes in the aneurysm’s size and rate of growth.  Surgery is performed to fix the aneurysm only when it reaches a size at which the risk of rupture outweighs the risk of surgery.

USF expects to enroll 25 patients, ages 55 and older who have been diagnosed with small abdominal aortic aneurysms, in the local trial.  Nationwide, 248 men and women will be enrolled.

Abdominal aortic aneurysms typically grow slowly, no more than a half-centimeter each year, and predicting which ones will enlarge rapidly is difficult, Dr. Shames said. “Right now we watch and wait until the aneurysm gets bigger to intervene, because there’s nothing else to do. That waiting can create a lot of anxiety for patients.”

Bernard Remas, 82, of Fort Myers, was one of the first patients enrolled in the randomized, double-blind, placebo-controlled trial at USF Health.  Remas’s abdominal aortic aneurysm was diagnosed about two years ago.  Like many people, he experienced no symptoms and his aneurysm was diagnosed by doctors when he underwent an imaging test for another reason.

Patients are randomized to receive either two doses of doxycycline a day, or a placebo. They will be followed for two years, getting their blood drawn and CT scans every six months.

Remas doesn’t know if he’s taking the tested drug or a placebo, but he says “the study seemed like a good thing to do…it’s pretty easy and painless.” If taking a medication could safely help him avoid an operation to repair an aneurysm, that would be preferable, he said.

USF Health’s Dr. Shames was involved in some earlier rat studies showing that doxycycline and similar anti-inflammatory drugs helped block the enzymes that weaken aortic walls.  Now, he’s part of a comprehensive trial that will determine whether the promising data gained from years of animal studies for slowing aneurysm growth can be replicated in humans.

“If treatment with this medication proves effective, it could become the gold standard for treating small abdominal aortic aneurysms,” he said.

Adominal aortic aneurysm is more common in men and those age 65 or older. Risk factors include family history, smoking, high blood pressure, high cholesterol and atherosclerosis (hardening of arteries).  The U.S. Preventive Services Task Force recommends ultrasound screening for abdominal aortic aneurysms for men ages 65 to 75 who have ever smoked, even if they have no symptoms.

For more information about the Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial at USF Health, please contact Stephenie Yapchanyk, vascular surgery research coordinator at (813) 259-0683, or Syapchan@health.usf.edu

  -USF Health-
USF Health’s mission is to envision and implement the future of health. It is the partnership of the USF Health Morsani College of Medicine, the College of Nursing, the College of Public Health, the College of Pharmacy, the School of Biomedical Sciences and the School of Physical Therapy and Rehabilitation Sciences; and the USF Physician’s Group. The University of South Florida is a Top 50 research university in total research expenditures among both public and private institutions nationwide, according to the National Science Foundation. For more information, visit www.health.usf.edu

-Tampa General Hospital-
Tampa General is a 1018-bed academic medical center on the west coast of Florida that serves as the region’s only center for Level l trauma, comprehensive burn care, and adult solid organ transplants. It is the primary teaching hospital for the USF Health Morsani College of Medicine. TGH is a comprehensive stroke center and a state-certified spinal cord and brain injury rehabilitation center.

Media contacts:
Anne DeLotto Baier, USF Health Communications, (813) 974-3303, or abaier@health.usf.edu
Ellen Fiss, Tampa General Hospital, (813) 844-6397, or efiss@tgh.org

Photo by Eric Younghans, USF Health Communications

When a subject line of an email reads “your patient Heather Glenday — Univ. of Tampa Swimmer” you pause.

Could this be sad news?

Luckily, it was wonderful news when Karl Illig, MD, professor of surgery and director of the USF Division of Vascular Surgery, opened such an email from his patient’s mother.

***

Photo by Andy Meng, UT

Last year, Heather Glenday, a swimmer for the University of Tampa, had a national title on the line when an odd feeling in her right arm slowed her training. A team trainer knew immediately by the swelling that the UT swimmer needed to get to the emergency room right away. At Tampa General Hospital, it was USF vascular surgeon Karl Illig, MD, who knew that Heather was experiencing Paget-Schroetter syndrome, a condition that causes a vein to be pinched off at the collarbone and upper rib. If left untreated, the vein could potentially clot off as the bone continues to crush the vein. For Heather, immediate surgery was necessary, which included removing that first rib.

Also called venous thoracic outlet syndrome (VTOS) and effort thrombosis, the uncommon condition affects only about 5,000 Americans every year, but is more common in high-performance athletes.

“It’s not unusual, and there is great success after treatment,” Dr. Illig said. “Surgery corrects the problem, with 95 percent of patients living a symptom-free life.”

***

After her surgery last year, Heather spent her summer recuperating at home in New York.

“I’m incredibly lucky to have connected with Dr. Illig, who had already treated patients with this,” she said. “When I went for follow-up exams back home to check the incisions, the doctor there said ‘Oh, you’re the first patient I’ve seen with Paget-Schroetter’s,’ which wasn’t too comforting. I’m so lucky to have found Dr. Illig.”

By fall, Heather returned to UT – she’s a junior studying accounting – and was back in the pool.

And that brings us back to Dr. Illig’s email.

Heather’s mother, Maureen Glenday, was sharing the good news with Dr. Illig that the young swimmer had not only recovered and returned to the pool, but that she was fast enough to help UT earn four NCAA trophies: two for relays and two for individual events.

Here’s what Maureen wrote to Dr. Illig in March.

***

Heather saw Dr. Illig’s this April at the Morsani Center for Advanced Healthcare for her one-year follow-up exam. The ultrasound showed all was well and he gave her a full release, although annual check-ups for the next couple of years are expected.

As a thank you, Heather presented Dr. Illig with a University of Tampa Spartans hat.

***

As if a story of a patient succeeding in life isn’t enough, another caveat is that Heather’s story ties together so many areas of expertise found in Tampa. It’s a story of a community of expert institutions coming together and providing the best care possible. Here are the players:

– University of Tampa has a title-winning swim team.

– Well trained athletic trainer recognizes symptoms and acts quickly to get the student to emergency room.

– Tampa General Hospital is affiliated with the USF Morsani College of Medicine, the region’s only academic medical center.

– Dr. Karl Illig has seen and treated this condition before in his training at academic medical centers.

***

To see Heather Glenday winning a 800 yard freestyle relay title for UT post-surgery, check out this video.  Choose the 2013 DII Swimming & Diving Day 3, Evening Session: Full Replay (2:47:18) option and go to about 132/167.1.

Story by Sarah A. Worth, photos by Eric Younghans, USF Health Office of Communications

Under the bright lights of the surgical skills laboratory at the USF Health Center for Advanced Medical Learning and Simulation (CAMLS), medical students and surgical residents practice together.  Two learners to each life-sized operating room table, they focus on honing their suturing techniques using cryopreserved aortas.

In another surgical lab, course faculty evaluate vascular surgery fellows as they work through all the tasks needed to repair an abdominal aortic aneurysm, including threading a tiny catheter through a simulated femoral artery.

In the trauma operating room, another group of trainees gathers around a large monitor to observe as an instructor inserts a central line into an endovascular simulator.

Dr. Ian Nordon, a vascular surgery fellow from England, watches the monitor as he uses a simulator to work through some of the critical steps required to repair an abdominal aortic aneurysm.

“This place is unique,” said Dr. Ian Nordon, a vascular surgery fellow who works at a university hospital in London, England.  “I’ve never seen anything like it, certainly not in the United Kingdom system where most of our training is still very much on patients rather than on simulators.”

“Amazing,” said Dr. Erica Mitchell, associate professor of vascular surgery at Oregon Health and Science University.  “A facility with all this space dedicated to learning and assessment of competency is impressive.”

Drs. Nordon and Mitchell were among the participants for one of the first programs offered at CAMLS, a 90,000-square-foot facility encompassing three floors of innovative simulation technology and experiences with education and research excellence under one roof.  The Introduction to Academic Vascular Surgery course, which drew more than 45 medical students and vascular surgeons from across the United States as well as Canada, included simulation exercises and demonstrations on the first day.

Dr. Erica Mitchell observes as a medical student and general surgery resident practice suturing an aorta.

Such tools are needed both to measure the effectiveness of simulation training and optimize its use, Dr. Mitchell said.

Dr. Mitchell holds the rating instrument developed by the Association of Program Directors in Vascular Surgery to assess the performance of basic vascular surgery skills across different levels of trainees.

“The beauty of simulation is that it allows a medical student or junior resident to practice and make mistakes on a machine where no one is hurt, instead of on a human being,” said Dr. Karl Illig, director of the USF Health Division of Vascular Surgery, who co-directed the course with USF’s Dr. Murray Shames.

“But, there’s still a gap between simulation as it exists today and what it could be,” Dr. Illig said. “CAMLS will be a leader in determining how to make simulation training work as well as possible in improving physician competency and patient safety.”

Medical students practice ultrasound-guided central venous catheter placement on a "Blue Phantom" simulator.

While more research is needed to determine whether learning augmented by simulation training is superior to more traditional educational methods, simulation appears to help shorten the learning curve for acquiring competency in basic skills, said Dr. Jason Lee, associate professor and director of the Vascular Surgery Residency and Fellowship Program at Stanford University.

“Simulation seems to accelerate the process of getting trainees from novice to an acceptable skill level” before they begin operating on patients, said Lee, who is studying whether a simulation-based endovascular curriculum improves residents’ performance and clinical outcomes.

USF Health's Dr. Karl Illig (above) and Dr. Murray Shames (below) were course co-directors.

Dr. Pushpinder Sivia, a USF senior vascular surgery fellow who will graduate in July, has visited CAMLS several times since it opened.  In his experience, Dr. Sivia said, simulation is valuable because it allows surgeons to practice complex or new procedures repeatedly. “You can do dry runs in a (risk-free) place like this before tackling a complicated case in the operating room,” he said.

Whether someone is an inexperienced medical student or a physician with years of expertise who needs to update his or her skills, simulation “is the future,” APDVS’s Dr. Mitchell said. “With limits on time for residency training, the increasing emphasis on patient safety and unprecedented public demand for better health outcomes, simulation is becoming increasingly integrated into medical school training programs.”

Course participants gather for a demonstration of central line insertion using a high-fidelity simulator at CAMLS.

More than 30,000 health professionals from around the world are expected to visit USF Health CAMLS each year for education and training activities, from courses on advanced surgical techniques (using state-of-the-art simulators and robots) and interprofessonal team training, to research and innovation for the next generation of medical devices and simulation technology.

Medical students, residents and faculty gown up before entering the CAMLS Surgical Skills Laboratory for simulation exercises.

Photos by Eric Younghans, USF Health Communications