eCancer Consult, November, 2012

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New Definitions For CLABSI A Game – Changer

A multidisciplinary task force examines our practice and experience in light of CLABSIs with the goal of improved patient safety and practice. Read about how the results will lead to updates to the NHSN Patient Safety Component Manual.

Hospital-acquired infections that result from cancer treatments – which suppress the immune system, are at present classified the same as other CLABSIs.

That will change early in 2013, due in part to the work of a team at Cleveland Clinic, who worked to prove national guidelines on infection control should be changed to reflect the nuances in cancer treatments.

“The clinical definition is more descriptive of a catheter-related infection, but the terminology has become a catheter-associated infection,” says Dr. Thomas G. Fraser, Vice Chairman of Cleveland Clinic’s Department of Infectious Disease. Thus, the fact that a patient has a central line and a bloodstream infection does not take into account the type of treatment the patient is receiving.

The difference in the two is not only semantic. It’s hugely relevant to catheter-related infections that are acquired due to treatment for hematologic malignancies.

A New Definition

Hospital-acquired infections are a well-known cause of morbidity and mortality in the U.S. A quarter of those infections are related to catheters that unintentionally facilitate bloodstream infections.

Infection prevention and surveillance programs in place across the country are based on a framework of standard definitions that are promulgated by the Centers for Disease Control through the work of the National Health and Safety Network (NHSN). Surveillance methodology for CLABSIs is a major discussion in the oncology community nationwide. This topic was taken up at Cleveland Clinic, as a result of a conversation Dr. Fraser had in July 2010 with Taussig Cancer Institute Chairman Brian J. Bolwell, MD. The decision was made to assemble a multidisciplinary task force to examine our practice and experience in light of CLABSIs. Improved patient safety and practice are the goals of the task force.

The task force includes Matt Kalaycio, MD, Department Chair of Hematologic Oncology and Blood Disorders, Mikkael Sekeres, MD, MS, Director of the Leukemia Program and chair of the CLABSI task force, Megan DiGiorgio, MSN, RN of infection control and the lead author of the study, and direct care nurses.

“From the start, we knew that part of the issue was the current NHSN CLABSI definitions lack specificity for complex and heterogeneous patient populations and required modification,” says Dr. Fraser. “We knew that we needed to collect the data and compile the arguments to try to change the definitions. A better definition complements efforts to improve patient care.”

“Infection control is vital to quality patient care. That’s why the CLABSI task force chose to study the types of infections experienced during treatment for hematologic malignancies,” adds Dr. Bolwell.

Assembling the Case for Change

“We wanted to separate the source of the infection from the treatment itself,” says Dr. Mikkael Sekeres. “This knowledge could inform our practice and allow us to provide better care to patients. For example, we could see fewer catheter removals as a result of knowing more about the sources of infections that stem from use of those devices.”

The current NHSN definition of CLABSI was originally intended for the general medical-surgical population. This definition does not take into account how the infections are acquired, what bacteria are involved, and if other circumstances related to treatment could be contributing factors. Bone marrow transplant (BMT) recipients and leukemia patients, who by definition have compromised immune function to facilitate treatment and to stave off graft-versus-host disease, undergo treatment that carries risk for hospital-acquired blood stream infections as a result of the conditioning regimens and chemotherapy. These treatments cause severe neutropenia and disrupt protective mucous membranes that increase the likelihood of a bacterial infection of blood.

The task force members developed a modified surveillance definition of CLABSIs (mCLABSI) specific to patients with hematologic malignancies to better support ongoing improvements. The group studied outcomes from patients seen at both the 22-bed BMT unit, and the 22-bed leukemia unit at Cleveland Clinic.

“We expect bloodstream infections as a result of our therapies,” says Dr. Kalaycio. “Our patients are immunosuppressed as part of their therapy, so there’s opportunity for infection – but different types of infections, from different sources, than most other CLABSIs.”

The task force reviewed historical data on more than 1,400 patients and found that when using the old NHSN guidelines, the incidence of CLABSI on the BMT unit was 6 per 1,000 central line-days and 14.4 per 1,000 central line-days on the leukemia unit. Using the mCLABSI definition, the BMT unit saw two infections per 1,000 central line-days, and the leukemia unit recorded 8.2 infections per 1,000 central line-days.

Also as a result of the task force’s work, specific classes of bacteria were also identified as responsible for CLABSIs that occur in patients with hematologic malignancies. Infections in those patients most often resulted from coagulase-negative staphylococcus, Staphylococcus aureus and Pseudomonas aeruginosa. The top three bacteria responsible for CLABSIs in the existing NHSN definition were Enterococcus species, Klebsiella species and Escherichia coli.

“These infections most certainly result from different types of organisms than other hospital-acquired infections, particularly CLABSIs, “says Dr. Sekeres. “Infections in leukemia and bone marrow transplant patients result largely from other flora, particularly gram-negative bacteria in the gut.”

Changing the Rulebook

This new definition was then brought to the attention of the CDC. After gathering input from organizations across the country, the NHSN definition on CLABSIs called “Mucosal Barrier Injury”, or MBI, will change in January 2013.

Teresa Horan, Team Leader, National Healthcare Safety Network Education and Data Quality Assurance Team at the CDC, says that a work group was convened to study the issue. The group reviewed the published work of Dr. Fraser and Cleveland Clinic’s CLABSI task force. Subsequently, the CDC conducted a pilot test of the new criteria ahead of a decision to implement the recommendations and came to the realization that the national guidelines did not mirror the realities of daily practice in hematology.

The NHSN Patient Safety Component Manual will have the 2013 updates posted on the NHSN website sometime in December. “Cleveland Clinic’s work was important in quantifying the problem and adding to the body of evidence needed to make a change to the national Healthcare-Acquired Infection surveillance system,” says Ms. Horan.

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Honing In On Tough Tumors

Rectal cancer patients with recurrent or locally advanced tumors can benefit from a direct radiation ‘boost’ during surgery.

Intraoperative radiation therapy gives patients with recurrent or locally advanced tumors a boost and better surgical outcomes, thanks to advanced radiation systems that target tumors while minimizing dose to normal tissues. The INTRABEAM (photon radiosurgery system) and recently acquired Mobetron system are part of Cleveland Clinic Taussig Institute’s multi-disciplinary approach to delivering personalized cancer care.

Surgery isn’t always enough to control a recurrent or aggressive tumor. But rectal cancer patients with tough-to-treat tumors can get a “boost” in the operating room thanks to intraoperative radiation therapy. Patient outcomes are improved when a higher dose of radiation is applied directly to the tumor bed, and radiation exposure to normal tissue is minimized.

“One of the major advantages about intraoperative radiation therapy is that you can visualize the tumor bed at the time of the operation,” says John Suh, MD, Chairman of the Department of Radiation Oncology at Cleveland Clinic Taussig Cancer Institute. “And, you can exclude all or part of the normal structures that are present. This allows us to deliver a high dose of radiation directly to the area most likely for tumor recurrence, which should result in better outcomes."

Cleveland Clinic’s Taussig Cancer Institute has been using the INTRABEAM radiosurgery system for more than a decade, and is one of 15 cancer centers in the United States to introduce an even more adaptable technology called the Mobetron system, which uses high-energy electrons. In fact, Cleveland Clinic was the second center to get the latest Mobetron model, which gives surgeons and radiation oncologists even more flexibility in the operating room.

Both systems advance the level of cancer care that recurrent and locally advanced rectal cancer patients can receive during surgery. And, they can be used successfully to treat patients with brain, breast and gynecological cancers.

INTRABEAM Technology: How It Works

The INTRABEAM radiosurgery system emits low-energy X-rays using spherical applicators (available in various sizes) to treat the tumor bed closer to the surface, explains Dr. Suh. Applicators are applied to the tumor bed following surgery in the operating room. The applicator treats the area of microscopic or residual disease. Prior to and during the procedure, a medical physicist is present to assure that the system is properly calibrated. The process can take up to 30 minutes, and it's truly a multi-disciplinary effort involving surgeons, oncologists, medical physicists and a team of support staff, Dr. Suh emphasizes.

Mobetron: Advancing IntraOp Therapy

The Mobetron uses high-energy radiation (electrons) to directly treat larger areas and deeper tumors. This system's electron energy can be adjusted on a case-by-case basis to deliver radiation to the correct size and depth of the actual tumor bed. The process can take just a few minutes using this advanced system.

Dr. Suh says in the future, the Mobetron’s use will be expanded beyond rectal cancer to treat cancers of the pancreas, breast, and soft tissue sarcomas. Currently, an in-house protocol is being finalized for pancreatic cancer patients. “This intraoperative radiation therapy system that we obtained earlier this year gives us more versatility and represents another valuable treatment option for cancer patients undergoing surgery,” Dr. Suh says of the Mobetron.

Dr. Suh and staff are optimistic about the potential for the Mobetron system and its ability to treat a range of cancers in patients with recurrent or locally advanced tumors. It has been proven to be an effective, efficient and safe treatment option, he says.

Plus, the Mobetron system’s design allows the machine to stay in a dedicated operating room. The accessibility of this machine during surgery gives surgeons and staff the ability to deliver the best multi-disciplinary care possible for patients. “Our intraoperative radiation therapy program advances the personalized, multi-disciplinary care that we offer and provides another powerful treatment option for cancer patients,” Dr. Suh says.

For more information about the Taussig Cancer Institute and intraoperative radiation therapy as an option for rectal cancer patients, contact:

Taussig Cancer Institute Clinical Trials

Taussig Cancer Institute provides world-class care to patients with cancer and is at the forefront of new and emerging clinical, translational and basic cancer research. Taussig annually enrolls over 1300 patients in over 240 clinical trials.

Please read more about our featured trials this month:

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