Duke Anesthesiology Plays Critical Role in Rare Transplant Surgery

Dr. Joshua Dooley with the first hand transplant patient at DukeDURHAM, N.C. — A Duke Health team has performed the first hand transplant in North Carolina, attaching the limb to a 54-year-old patient from Laredo, Texas, whose hand was severed in a childhood accident.

The highly complex, 12-hour procedure was performed May 27, 2016, by a team of surgeons, anesthesiologists, nurses, operating room staff and technicians, and was led by Linda Cendales, M.D., associate professor of surgery at Duke University School of Medicine and director of Duke’s hand transplant program.

The transplant marks the inauguration of a clinical trial at Duke to determine the safety and efficacy of hand transplantation, and the efficacy of a new anti-rejection drug called belatacept.

“This is an exciting time for our patient, his family, and Duke,” Cendales said. “The patient is doing very well and is recovering from his surgery. He is excited about the possibilities that await him as he continues his rehabilitation.”

The patient, Rene Chavez, was flown to Duke on May 26 after a deceased donor was identified as a match (the donor remains anonymous). A construction worker and automobile dealer, Chavez became one of fewer than 90 people worldwide who have received a transplanted hand.

“I am so grateful to the family of the donor and I want them to know I will do all I can to honor their loved one,” Chavez said, adding that he feels he has already had some sensation in the new limb. Chavez lost his dominant, left hand at the age of 4 when he reached into a meat grinder and his brother accidently turned on the power. Through the years, he said through a translator, he learned to compensate, playing soccer and even riding motorcycles.

But he said he became determined to have a hand transplant after learning three years ago that the procedure was becoming more widely available with advances in surgical techniques and anti-rejection drugs.

Chavez said he looks forward to relearning all that he taught himself to do without his hand – a process that will take months of intensive physical therapy sessions.

“I want to take the experience so people can see that you can overcome adversity if you strive for a goal,” Chavez said.

Duke is one of only about 10 hospitals in the U.S. that has performed a hand transplant. The surgery is difficult, involving an intricate process of connecting bone, blood vessels, muscle, nerve, tendons, and skin. Matching the limb from a deceased donor is also complex, as is the control of rejection, adding to the rarity of the procedure.

Duke’s hand transplantation program was formed in 2014 after Cendales joined Duke’s Department of Surgery faculty from Emory University, where she served as the director of the Vascularized Composite Allotransplantation program and the Laboratory of Microsurgery.

Prior to Emory, Cendales trained at the Christine M. Kleinert Institute for Hand and Microsurgery in Louisville, Ky., where she helped establish the first hand transplant program in the country, and was among the team that performed the first two cases in the United States in 1999 and in 2001.

“This case highlights all that is special about Duke,” said Allan D. Kirk, M.D., Ph.D., chair of the Department of Surgery at Duke. “It is so gratifying to witness the selfless collaboration among the health care providers, researchers and administrators, all for the benefit of this most deserving patient, and conducted in the context of a clinical trial that will help countless patients, including members of the armed services, whom we may never meet.”

Article Source: Duke Medicine News and Communications

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Photos Courtesy of: Duke Health Photography

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Duke Researchers Discover Promising Pain Treatment

Wolfgang Liedtke, M.D., Ph.D.A research team at Duke University has discovered a potential new class of small-molecule drugs that simultaneously block two sought-after targets in the treatment of pain.

These proof-of-concept experiments, published June 1 in Scientific Reports, could lead to the development of a new drug to treat conditions including skin irritation and itching, headaches, jaw pain, and abdominal pain stemming from the pancreas and colon.

More than 100 million people suffer from chronic pain in the United States, according to a report from the Institute of Medicine, and new medicines are badly needed.

“We are very pleased with what is a first chapter in a highly promising story,” said Wolfgang Liedtke, M.D., Ph.D., a professor of neurology, anesthesiology and neurobiology at Duke University School of Medicine, who treats patients with head and face pain and other sensory disorders. “We hope to be able to develop these compounds for clinical use in humans or animals.”

In the new study, the researchers initially aimed to develop more effective blockers of TRPV4, a molecule their previous research had shown transmits skin irritation elicited by sunburn, and painful sensations coming from the head and face. Liedtke and his Duke collaborator Farshid Guilak used a prototype TRPV4 blocker in a 2009 study and then set out to develop more potent versions.

Compared to the prototype, one of the new candidate drugs, called “16-8,” worked 10 times more effectively in cells with active TRPV4 that are key for the development of osteoarthritis. It also worked well in another cell type involved in nerve cell injury, stroke and epilepsy.

But to their surprise, when assessing the specificity of 16-8, the scientists discovered that it also blocked TRPA1, which is a promising target in pain and itch research.

“As a physician, I soon realized the enormous potential that these compounds might have, given how beneficial dual-target molecules can be in clinical medicine,” Liedtke said.

Both TRPV4 and TRPA1 are members of the family of TRP ion channels, which function in sensory nerve cells to directly sense painful stimuli. Other research groups are now targeting these channels in clinical trials for pain relief.

In this study, the drug 16-8 also quelled pain in living animals, including abdominal aches in mice with pancreas inflammation. So-called pancreatitis is extremely painful and difficult to treat, and new cases are on the rise globally, said study co-author Rodger Liddle, M.D., of the Duke University School of Medicine and a member of the Duke Institute for Brain Sciences.

Liedtke sees potential for the 16-8 drug to treat osteoarthritis and other types of joint pain as well as head, face and jaw pain. In general, it might also treat aches radiating from internal organs or resulting from nerve cell injury.

The group’s preclinical work will focus on understanding the compound’s potential use in these conditions as well as learning more about how it works. They also hope to explore topical applications to mucous membranes, which are present throughout the body and skin.

The study was supported by the National Institutes of Health (DE018549, AR48182, AR48182-S1, AR48852, AG15768, AR50245, AG46927, DK064213, DK091946, DK098796, F33DE024668, K12DE022793, K12CA100639, the U.S. Department of Defense (W81XWH-13-1-0299), the U.S. Department of Veterans Affairs, the National Science Foundation (1445792), the Arthritis Foundation, and the Harrington Discovery Institute Scholar-Innovator Award. Duke’s Office of Licensing and Ventures is pursuing patent applications on this work.

CITATION: ” Small molecule dual-inhibitors of TRPV4 and TRPA1 for attenuation of inflammation and pain,” Patrick Kanju, Yong Chen, Whasil Lee, Michele Yeo, Suk Hee Lee, Joelle Romac, Rafiq Shahid, Ping Fan, David M. Gooden, Sidney A. Simon, Ivan Spasojevic,
Robert A. Mook, Rodger A. Liddle, Farshid Guilak and Wolfgang B. Liedtke. Scientific Reports, June 1, 2016. DOI: 10.1038/srep26894

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Duke’s POET Targets Spine Patients with a Unique Launch

Duke POET Team

Diabetes is the seventh leading cause of death in the United States. While it’s a common condition among patients presenting for elective surgery, it often predicts poor postsurgical outcomes. As the prevalence of diabetes continues to increase, and the global cost to treat and prevent diabetes complications is expected to exceed $490 billion in the next fifteen years, optimal screening, management and timing of elective surgery for this group of patients has become increasingly important and remains a population health challenge – a challenge Duke is meeting head-on.

After Duke Anesthesiology’s successful launch of the Preoperative Anemia Clinic (PAC) in September of 2014, serving as a multidisciplinary anemia management program to improve surgical outcomes for patients with chronic anemia, the department’s Perioperative Enhancement Team (POET) is taking yet another step toward redefining their role in perioperative medicine. This time, the team is targeting patients with uncontrolled diabetes scheduled to have spine surgery. On April 7, POET launched the Preoperative Diabetes Management Program and expanded the Preoperative Anemia Clinic for patients seen in the Duke Spine Center. It’s a collaborative effort between anesthesiologists, surgeons, endocrinologists and internal medicine with one common goal – improving glucose control before surgery to enhance the outcomes of Duke spine patients.

“This group of patients is of particular interest because when glucose is not controlled there is an increased risk for postoperative infection,” says anesthesiologist, Dr. Erin Manning. “These patients typically have substantial incisions and hardware placed inside their bodies which put them at higher risk of infections to begin with; combine that with poor glucose control and they don’t always heal well.”

“It’s crucially important that our patients are well prepared for the stress of surgery,” adds spine surgeon, Dr. Sergio Mendoza-Lattes. “It’s more than just surgical skills. This program is a way of getting patients safely through the experience with a good outcome.”

POET is the Department of Anesthesiology’s way to address the new reality in health care of managing risk in a volume-to-value transition. With the same principle that underscored the launch of the anemia clinic, POET wanted to expand to other sites of service to include the Duke Spine Center. “Our efforts are ways for the department to be more directly and proactively involved in the upstream identification of patients who would otherwise be high-risk – active participation in the management of modifiable risk factors so they no longer pose a threat to an adverse outcome downstream,” says Dr. Sol Aronson, anesthesiologist and medical director of POET who oversees its 54 projects.

The Preoperative Diabetes Management Program was developed for nearly ten months before its official launch with the involvement of about three dozen medical experts. “Part of the reason it took so long with what looks on the surface to be a pretty simple idea is because all team members had to be touched, connected and integrated into this new work stream and new process,” adds Dr. Aronson. “It’s quite methodical and there is a lot of necessary detail to ensure this program runs smoothly and effectively. The hope and expectation is by optimizing these modifiable risk factors before patients come to surgery, then the risk associated with them during surgery will be mitigated and outcomes will be improved.”

To make that happen, the team’s first tactic is to identify patients who are at risk of poor glycemic control. This alone requires multiple steps (see workflow diagrams below): once a patient is determined to be a surgical candidate at Duke, a nurse will review their chart to check for diabetes and A1C levels. If their most recent A1C test was performed in the last three months and is over 7.5, they are referred to a preoperative diabetes clinic with the expectation that they would go into surgery with a less likely chance of having an adverse outcome, including infection and poor wound healing (both of which are related to increased lengths of hospital stays and an increased expense to manage). According to Dr. Aronson, this alternative preoperative pathway leads patients into some significant lifestyle and perhaps medication modifications which could take between four and eight weeks to prepare themselves for surgery.

Endocrinologist, Dr. Tracy Setji, is the medical director for Duke’s inpatient endocrine consultation service. She notes that while four to eight weeks may sound like a delay, this program is actually an opportunity to optimize patient care in the fastest way possible. Dr. Setji helped develop protocol for both the screening criteria (A1C levels – the marker for glycemic control) and the identification of high-risk patients. She worked with POET to develop both the inpatient and outpatient protocols.

According to Dr. Setji, the protocol within this new program is also designed to capture the large number of patients with undiagnosed diabetes, which is just over eight million people, according to the latest research from the Centers for Disease Control and Prevention. Patients who are unaware of their diabetes have an even higher risk of perioperative mortality compared to patients who are aware of their condition. “In the past, there hasn’t been as much attention paid to glycemic control during hospitalizations or in the perioperative period, but over time, we’ve seen the associations of poor glycemic control and less optimal outcomes. Trying to target glucoses as a tangible way to improve outcomes is becoming an increasing recognized target,” she says.

Anesthesiology, in general, is heading into the field of perioperative medicine which is exciting for Dr. Manning because she says it provides a way for anesthesiologists to be involved with surgical and other medical colleagues to help patients overall, not just inside the operating room. In Dr. Manning’s role, she is helping to change the way patients’ glucose is managed in the OR. Working with endocrinology, anesthesiology developed a protocol that focuses on how they monitor glucose based on preoperative levels, ultimately changing interoperative management.

“It’s like air traffic control. We won’t land planes on the runway until we know all the wheels are down,” says Dr. Aronson. “In the past, we weren’t meticulously checking to make sure the wheels were down before we told the plane it was okay to land. Now, we’re proactively making certain that this is the case. Therefore, the need for communication becomes a significant part of this equation. And, the need for great air traffic control becomes quite obvious, quite quickly.”

According to Dr. Susan Spratt, endocrinologist and director of diabetes services for the Duke University Health System, 25 percent of Americans over the age of 65 have diabetes. The Duke Spine Center has about 1,200 spine cases each year – a large percentage of those patients are considered older Americans. Dr. Manning believes this new diabetes management program has the potential to help a significant number of Duke spine patients.

“Spine surgery is a team sport and we need all the right players,” adds Dr. Mendoza-Lattes. “It’s an endocrinologist’s dream that surgeons want to tackle this problem before surgery,” says Dr. Spratt. She built the order set that providers and the health system’s nursing staff use to tee-up orders to access glucose control and refer patients to Duke’s endocrinology clinic. “That’s one of the unique parts of this program. Often times, we’re called in late, after surgery, when patients’ blood sugars are high and they want to be discharged. Or, worse case scenario, they come back with an infection. So, we are thrilled that we are able to be proactive in this endeavor instead of reactive.”

The collaboration at the Duke Spine Center extends beyond diabetes. It will also impact patients with chronic anemia. According to Dr. Manning, spine patients are a good population to work with Duke’s Preoperative Anemia Clinic because there can be significant blood loss in the larger spine surgeries. The goal of the “anemia arm” is to have the patients optimized regarding hemoglobin levels with the expected outcome of giving them fewer blood transfusions in the OR and after surgery.

With the point of care testing already in place, the launch of these programs at the Duke Spine Center means patients now have expedited access to the necessary expertise to handle these specific health issues quickly and in advance of operations. So, what does the future hold for POET? Pain and nutrition are next in line in what the team hopes to be a series of other clinics and patient populations undergoing specific surgical procedures who can benefit from having their preoperative risk of anemia and diabetes identified and managed, according to Dr. Aronson. “It’s very rewarding and particularly, a year into the PAC, we can look back at our efforts and see the positive impact we’ve had on our patients. I’m very proud of everyone on this team.”

“We’re all very enthused about these programs and we hope to contribute and make them grow. At the end of the day, it’s not just the skill of the surgeons; it’s the whole team that contributes to the results and to the safety of the procedures,” says Dr. Mendoza-Lattes. “This is key – the Duke difference is a team approach.”

View the complete Duke Spine Center preoperative anemia workflow diagram and the diabetes management collaboration workflow diagram.

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