Over the past 20 years, more than 85 amputees around the world have received a hand or bilateral hand transplant – including two adults and one child here at Penn Medicine and Children’s Hospital of Philadelphia (CHOP). For a great majority, this rare gift has been transformative.
Lindsay Ess, the first patient at Penn to undergo a bilateral hand transplant in 2011, is a perfect example. “I drive. I live on my own. I have a dog. House, to take care of. Cleaning. Dishes. Cooking,” Ess, who lost all four limbs due to sepsis three years before her transplant, told ABC News in 2016. She has even competed in CrossFit competitions.
Today, “she’s doing beautifully,” said L. Scott Levin, MD, FACS, chairman of Orthopaedic Surgery and a professor of Plastic Surgery at Penn Medicine, a leading expert in the specialized field of vascularized composite allotransplantation (VCA) who led the three transplant surgeries at Penn and CHOP. The revolutionary procedure – which comes with a host of physical and psychological factors unlike other transplants – involves first reattaching the forearm bones, then the arteries and veins, muscles, tendons, nerves, and finally the skin.
“Most patients who have undergone VCA have gotten back incredible function,” Levin said. “Where they were fully disabled and dependent, they now live independently.”
Those successes are what’s driving many leaders to push the field even further. Now is the time, Levin said, to move it from an experimental operation to a mainstream part of reconstructive surgery, so more amputees who lose upper extremity limbs can gain access to it.
“We believe this should be standard of care for certain patients,” Levin said. “But we need scientific evidence from validated research that these operations, which are complex and expensive, make a profound difference in somebody’s life.”
L. Scott Levin, MD, FACS
A new project supported by the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense* aims to show just that.
The effort will be led by a trio of VCA researchers and physicians, including Levin, Scott Tintle, MD, chief of Hand Surgery and the associate research director of the department of Orthopaedic Surgery at Walter Reed National Military Medical Center, and David Tulsky, PhD, a professor in the departments of Physical Therapy and Psychological and Brain Sciences at the University of Delaware (UD).
Over three years, the principal investigators and their clinical research teams, will study quality-of-life and psychosocial factors to not only better understand and demonstrate the impact and effectiveness of the procedure, but also to identify the factors that make someone a good candidate.
Because most of the research conducted on VCA over the past 15 years has focused on the basic science of immunosuppression and function of the new limbs, the science behind which patients are ideal candidates for such a complex procedure also remains unclear. Researchers know more about the physiology, but less about how patients feel about their limbs. And since VCA is considered a quality-of-life procedure rather than a life-saving one, psychosocial outcomes, like well-being and independence, are critical to assess whether a transplant has been a “success.”
“We are going to do an extensive battery of testing, questioning, examining, and analyzing of the patients who have had this done to get their perspective,” Levin said. “We’ll look to each center that performs these surgeries around the country to provide data, so we can evaluate more patients and determine what outcomes are important to this population.”
Demonstrating an improvement in psychosocial experiences would also help justify reimbursement from insurers and third-party payers to cover the procedure, he added.
It’s important to note that the procedure differs from other types of transplantation, like the liver or lungs. This patient population faces unique needs and challenges, which need to be taken into consideration to fully evaluate their outcomes.
For one, VCA is a different emotional and physical experience. After surgery, patients must undergo intense physical therapy to optimize function of the new limb or limbs, which can mean up to four to six hours of rehabilitation every day for several years. Solid organ transplant patients need follow-up medical care, but long-term physical therapy is not typically required. And VCA patients actually see their new organs – which can add another layer to the recovery.
Once their donor arms are physiologically accepted, recipients have to integrate their new limbs into their everyday lives physically, psychologically, and socially. It takes a resilient, highly-motivated, and determined person to endure such a journey, the researchers said.
The team plans to use the study results to develop a standardized screening process, as well as practice guidelines to help inform institutions and reinforce their own screening procedures, and expand these techniques to other sites in the United States and abroad.
The first phase of the project kicked off in November at the American Society for Reconstructive Transplantation meeting in Chicago, where approximately 30 experts in transplant surgery gave their input on what they see as the most important psychosocial considerations and challenges for patients undergoing VCA procedures.
From there, the researchers will begin holding focus groups with the clinical teams at the three sites – Penn, UD, and Walter Reed – and interviewing other VCA clinicians and patients (both military and civilian) who have undergone the procedure, as well as those who have been screened and are eligible, and those who have not been selected for transplant.
“The hopes are that this information will validate the ongoing efforts to develop new field of hand transplant,” Levin said. “That it’s here to stay, has a dramatic influence on patients and their quality of life, and it can be done safely with patients who are so adversely affected by limb loss.”
Editor’s Note: This work was supported by the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, through the Reconstructive Transplant Research Program (RTRP) Qualitative Research Award(W81XWH18-2-0067). Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense. This support is part of a larger grant shared with researchers from Walter Reed National Military Medical Center and the University of Delaware.