Keck MD 2017 Issue 1

Published by the University of Southern California

FEATURES

Total ankle replacement, Bladder cancer and biological mesh, Co-managing MS

CASE STUDIES

Stem cell therapy for spinal cord injuries, Robotic tumor resection

2017 - Issue 1

Seamless Care USC Adult Congenital Heart Disease Center ensures

for heart patients on the verge of adulthood

DEPARTMENTS

News briefs, Clinical trials, Continuing Medical Education calendar

Published by the University of Southern California

Keck Medicine of USC is the University of Southern California’s medical enterprise, one of only two university-based medical systems in the Los Angeles area. Encompassing academic, research and clinical excellence, the medical system attracts internationally renowned experts who teach and practice at the Keck School of Medicine of USC, the region’s first medical school; includes the renowned USC Norris Comprehensive Cancer Center, one of the first comprehensive cancer centers established by the National Institutes of Health (NIH) in the United States; has a medical faculty practice, the USC Care Medical Group; operates the Keck Medical Center of USC, which includes two acute care hospitals: 401-licensed bed Keck Hospital of USC and 60-licensed bed USC Norris Cancer Hospital; and owns USC Verdugo Hills Hospital, a 158-licensed bed community hospital. It also includes more than 40 outpatient facilities, some at affiliated hospitals, in Los Angeles, Orange, Kern, Tulare and Ventura counties.

Editor Amanda Busick Contributing Writers Mary Dacuma, Hope Hamashige, Robin Heffler, Matthew Kredell, Candace Pearson, Sherri Snelling, Zen Vuong Graphic Design Julie Matzaganian Printer ColorGraphics

©2017 Keck Medicine of USC Permission to reprint articles is available upon request. No artwork may be reproduced without the artist’s consent. Our mailing list comes from several sources. If you receive duplicate copies of this magazine, please send us all the label information and we will strive to eliminate the duplication. Direct inquiries to Keck Medicine of USC Marketing and Communications, SST-2830, 2011 N. Soto Ave., Los Angeles, CA 90032. Phone: (323) 442-2830. Fax: (323) 442-2832. Email: prmarketing@med.usc.edu

Keck Medicine of USC complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. Keck Medicine of USC does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex.

ATTENTION: If you speak Spanish, Chinese, Vietnamese, Tagalog, Korean, Armenian, Persian-Farsi, Russian, Japanese, Arabic, Punjabi, Cambodian, Hmong, Hindi, or Thai—call the number below for free language assistance services: (800) 872.2273.

ATENCIÓN: Si habla español, tiene a su disposición servicios gratuitos de asistencia lingüística.

Llame al (800) 872-2273.

注意：如果您使用繁體中文，您可以免費獲得語言援助服務。請致電 (800) 872-2273.

2

• 2017 - Issue 1

FEATURES

4

On the Cover:

USC Adult Congenital Heart Disease Center ensures seamless care for heart patients on the verge of adulthood

10 6 8 11 9 7 Total Ankle Replacements increase as techniques and devices evolve

Epilepsy Care

Partnering with physicians for better epilepsy care

Case Study

Robotic spinal tumor resection

Case Study

A promising therapy to treat spinal cord trauma

DEPARTMENTS

Robotic Surgery

Biologic Mesh

Clinical trial tests preventive power of biologic mesh after bladder cancer surgery

offers alternative for HPV-related oral cancer treatment

12 News Briefs

Childhood head trauma and brain structure changes; new treatment for glaucoma; groundbreaking robotic surgery for kidney cancer.

15 Clinical Trials

Discover the latest Keck Medicine of USC clinical trials and studies in cervical cancer; breast cancer; chronic pelvic pain; oral cancer; GERD; MS.

16 Continuing Medical Education Calendar

• 2017 - Issue 1

3

Ted Pang

It wasn’t too many years ago that children born with heart defects rarely survived into adulthood. Today, with more effective treatments for congenital heart disease, most can look forward to experiencing the many important milestones of adult life.

USC Adult Congenital Heart Disease Center ensures seamless care for heart patients on the verge of adulthood

BY HOPE HAMASHIGE

4

• 2017 - Issue 1

The number of patients with adult congenital heart disease (ACHD) continues to grow, and the team of heart specialists at Keck Medicine of USC has created the USC Adult Congenital Heart Disease Center to meet the special needs of this group of patients.

Some ACHD patients have survived into adulthood with undiagnosed or untreated defects which will need repair. Some have complex defects that need to be monitored throughout their lives. Many others had surgeries as children that permanently altered either the structure or function of their hearts in ways that even seasoned cardiologists may not fully understand. One of the goals of the ACHD Center is to help adults with congenital heart disease understand their condition, take care of their heart health, and establish an appropriate follow-up plan for their unique conditions.

TWO TEAMS ON A MISSION Part of the mission of the USC Adult Congenital Heart Disease Center is to help young patients with congenital heart disease transition from pediatric care at Children’s Hospital Los Angeles (CHLA) to adult care at Keck Medicine.

David Laughrun, MD, assistant professor of clinical medicine at the Keck School of Medicine of USC, and a new member of Keck Medicine’s ACHD Center team, is one of only a few doctors in Southern California who is board certified in ACHD, now recognized by the American Board of Internal Medicine as a subspecialty within cardiology. The center’s surgical director, Craig Baker, MD, professor of clinical surgery (educational scholar) at the Keck School, and chief of the division of cardiac surgery, completed additional training in congenital heart disease at Children’s Hospital Los Angeles (CHLA).

“The USC ACHD Center offers the important subspecialty services necessary for adults with congenital heart disease,” says Laughrun. “When a patient transitions to adulthood, it’s important that this framework for their care is in place, in order to provide seamless treatment at a crucial time.”

Keck Medicine is also fortunate to have advanced imaging specialists in CT, MRI and angiography, very experienced interventional and electrophysiologic cardiologists and, if necessary, highly

skilled surgeons and advanced heart failure specialists experienced in the care of ACHD patients.

The program also benefits by cultivating relationships with other research institutes and treatment centers. The team has a close, collaborative relationship with the Heart Institute at CHLA, a recognized worldwide leader in treating congenital heart disease in children. The team also has access to the latest devices and novel techniques in part through Keck Medicine’s participation in clinical trials of new cardiac devices and through consulting with the USC Center for Body Computing.

“We have access to outstanding resources at Keck Medicine,” says Baker. “Our team is world class, and the ability to collaborate with both CHLA and other centers at USC enables us to help ACHD patients achieve a quality of life that is beyond compare.”

For more information or to refer a patient, call (323) 442-5849.

Many ACHD patients do not receive proper care as they get older even though they need it. Many develop arrhythmias for which they will need ongoing treatment. Some will develop other serious problems, such as heart failure, or may need additional surgeries in adulthood.

The team from the USC Adult Congenital Heart Disease Center routinely meets with patients who are preparing to transfer their care from CHLA to Keck Medicine. They delve deeply into old charts and records to thoroughly understand the unique medical histories and experiences of their young patients while they are still receiving their care at CHLA. A tremendous amount of time is invested to prepare families for the future as these children grow to be young adults living with congenital heart disease. The doctors discuss transfer of care to Keck Medicine and educate these patients, and their parents, about their ongoing medical needs based on their heart conditions. This detailed approach helps patients avoid gaps in care, keeping them healthier for their whole lives.

• 2017 - Issue 1

5

Total ankle replacements increase as techniques and devices evolve

BY CANDACE PEARSON

Total ankle arthroplasty, also known as a total ankle replacement (TAR), can give patients relief from pain while often preserving or even increasing range of motion in the joint.

Total ankle replacement, preoperative (left) and postoperative (right) lateral views. (Images/Eric W. Tan, MD)

“As newer implants and surgical techniques emerge, TARs are on the rise. Our understanding is evolving daily,” says Eric W. Tan, MD, clinical professor of orthopaedic surgery at the Keck School of Medicine of USC. Historically, the “gold standard” solution for a degenerative ankle joint was thought to be an ankle fusion. However, since that procedure eliminates the joint’s up-anddown motion, research has demonstrated that many patients subsequently develop progressive arthritis around the fused ankle because of increased pressure on surrounding bones and tissue.

As an academic medical institution, Keck Medicine of USC offers a higher level of training and experience in intricate procedures such as total ankle replacements.

The field of TARs is about 10 to 15 years behind hip and knee replacements, but has progressed significantly over the past few decades. “As we get better at

6

• 2017 - Issue 1

these replacements, their indications are expanding,” says Tan. TAR may be performed in two ways, either from the front or the outside of the ankle, depending on the implant chosen.

The surgeon first shapes the ankle joint to accept the implant, which involves removing damaged cartilage and correcting any pre-existing deformity. If the patient has a tight tendon or Achilles heel, the surgeon releases these and makes any other necessary corrections.

Next, the metal-and-plastic implant — or a series of implants of different sizes — is positioned and checked for the perfect alignment. This step in particular calls on the surgeon’s experience.

Most patients stay overnight, and must avoid putting weight on the ankle for two weeks to a month. While the TAR typically preserves or even increases motion, doctors recommend that patients forgo impact sports after surgery.

Long term, there may be more biologic solutions on the horizon. Tan, whose research focuses in part on improving clinical outcomes in cartilage repair, is collaborating with stem cell scientists on how to stimulate cartilage growth. “The holy grail remains an injection that will help rebuild the ankle cartilage,” he says. “We’re not there yet, but biological solutions are the future.”

For more information or to refer a patient, call (323) 442-5860.

Clinical trial tests preventive power of biologic mesh after bladder cancer surgery

BY CANDACE PEARSON

A first-of-its-kind clinical trial at Keck Medicine of USC may hold the key to preventing parastomal hernia (PSH) — a common complication for patients with bladder cancer who undergo radical cystectomy and urinary diversion.

The randomized Phase 3 trial asks whether biologic mesh inserted following surgical removal of the bladder can prevent a hernia from occurring in the future.

Biologic mesh is already used as treatment for a hernia that develops at a stoma in the abdominal surface created for an ileal conduit system urinary drainage. “What’s exciting about this trial is the prophylactic usage of the mesh, which has never been done,” says principal investigator Hooman Djaladat, MD, MS, associate professor of clinical urology at the Keck School of Medicine of USC. Earlier research led by Djaladat and published in the Journal of Urology in September 2016, showed that 20-25 percent of patients undergoing radical cystectomy and ileal conduit develop a PSH, and the median time to development is 13 months post-surgery.

At Keck Medicine, the most common solution for urinary diversion after radical cystectomy is to create a new bladder out of tissue from the small intestine and connect it to the urethra. However, that procedure requires advanced surgical techniques.

As a result, worldwide the more common solution is an ileal conduit.

The clinical trial, which is actively enrolling, will involve 146 patients, half in a control group and half receiving the preventive mesh. Participants will be followed for two years.

Exclusions include previous scars or mesh at the level of ileal conduit, predicted post-surgical survival rates of fewer than 12 months and those with a history of allergic reactions to similar materials.

Researchers are utilizing a biological mesh which has already been approved by the Food and Drug Administration for breast augmentation and abdominal repairs. “We think we will be able to use this mesh to augment the abdominal wall and prevent PSH,” says Djaladat.

The forward-thinking clinical trial is just one example of the exceptional care available at Keck Medicine, says Djaladat. “Our worldclass, multidisciplinary team available to manage bladder cancer sets us apart.”

Candidates for the procedure have bladder cancer and are undergoing radical cystectomy with ileal conduit diversion.

To refer a patient for enrollment in this trial, contact Ileana.Aldana@med.usc.edu.

• 2017 - Issue 1

7

Care partnerships for epilepsy treatment: A team approach

BY HOPE HAMASHIGE

No matter their age or the severity of their condition, all epilepsy patients have one thing in common — they want their seizures to stop.

Most will succeed by taking medication and having regular checkups. Others, however, will need more advanced treatments that their local neurologist may not offer.

uncontrolled seizures, suffer severe side effects from medication, want to get pregnant or have other related complex issues.

Keck Medicine of USC is making this problem a thing of the past by reaching out to community hospitals and doctors across Southern California to establish care partnerships for patients with complex epilepsy treatment needs. The goal: Giving as many patients as possible access to the expertise and resources of the USC Comprehensive Epilepsy Center, while also maintaining the important relationships with their home team.

“Patients come to us because they need a higher level of care, but then they keep coming to us for their regular check-ups when they should be seeing their doctor in the community who referred them,” explains Christi Heck, MD, professor of clinical neurology at the Keck School of Medicine of USC, and medical director of the center.

The USC Comprehensive Epilepsy Center is accredited as a Level 4 specialist center (the highest designation) by the National Association of Epilepsy Centers. The center employs a multidisciplinary medical team with the full complement of subspecialties needed to provide the most advanced care available for patients that experience

With care partnerships, the patient’s local neurologist again becomes the main point of contact. These physicians perform regular, routine checkups, but also have the advantage of complete access to the worldclass medical and surgical facilities of Keck Medical Center when a patient’s treatment requires resources that aren’t available at a community medical center.

To help facilitate this collaboration between Keck Medicine and community health care providers, the USC Comprehensive Epilepsy Consortium has been established.

The consortium holds weekly joint surgical conferences and allows for a more flexible system where patients can move easily from one facility to another as treatment needs dictate.

“The consortium has created a team of doctors who are doing everything they can for each patient,” says Charles Liu, MD, professor of clinical neurological surgery at the Keck School and surgical director of the epilepsy center. “When a community doctor has access to the resources of Keck Medicine, they know that when their patient needs advanced care, they will get it. We believe that this is the only way the true public health needs of epilepsy can be addressed. Our goal is to make it so as many people as possible can benefit.”

These benefits include access to the latest technological advancements, including imaging studies and procedures that accurately pinpoint the source of the seizures. Advanced research protocols and clinical trials are easily accessible when necessary, as well as nutritionists, psychologists and other specialists that may not be available closer to home.

“This approach is a bit unique,” says Heck about the consortium and the network that has developed from these efforts. “I think it is a model of how centers of excellence, not only in neurology, might better serve patients.”

For more information or to refer a patient, call (323) 442-5710.

8

• 2017 - Issue 1

Robotic surgery offers alternative for HPV-related oral cancer treatment

BY MATTHEW KREDELL

Cancer of the tonsils and tongue is on the rise primarily due to human papillomavirus (HPV). The Keck School of Medicine of USC is leading the treatment of such tongue and throat cancers with robot-assisted surgery.

Niels Kokot, MD, associate professor of clinical otolaryngology – head and neck surgery, and residency program director at the USC Tina and Rick Caruso Department of Otolaryngology – Head and Neck Surgery, was a fellow at the University of Pennsylvania when doctors there adapted the da Vinci robotic surgical system — previously used primarily for abdominal, pelvic and thoracic surgery — for head and neck surgery. The FDA approved the procedure in 2009, and Keck Medicine of USC became the first center on the West Coast to offer the procedure in 2010.

Because the robotic arms are much smaller than human hands, transoral robotic surgery (TORS) allows surgeons to remove tumors without having to make a disfiguring incision through the chin and jawline.

“The fact that it’s minimally invasive, going only through the mouth, avoids reconstructive operations, making it advantageous over traditional

approaches,” Kokot says. “The job is faster and easier for surgeons and patients.”

Tumors caused by HPV often are smaller, making them good candidates for robotassisted surgery.

During the procedure, the surgeon sits at a console from which the da Vinci system provides three-dimensional images with 10-times magnification and maneuvers four robotic arms modeled after the human wrist for greater flexibility. Each of the arms has a surgical function, and they reduce the tremors from a human hand. The only exterior incision needed is in the neck to remove lymph nodes for biopsies.

TORS may allow patients to avoid radiation therapy or chemotherapy. If they do need radiation, Keck Medicine radiologists have the capability to administer lower and more targeted doses, leading to fewer side effects.

The link between oral sex, HPV and cancer has been receiving more attention in recent

years, since actor Michael Douglas made public that it likely was the cause of his tongue cancer. Men get these HPV-related tumors at a rate three times greater than women. There can be a latent period of many years between HPV infection and development of tumor.

“Patients who undergo transoral robotic surgery have an improved prognosis and live longer,” Kokot says. “Thus, being able to minimize surgical and treatment morbidity is paramount to preserving quality of life for patients.”

To avoid HPV-related cancer, men and women should employ safe sex practices.

Studies are underway to determine whether the vaccine that is given to girls and women ages 11 to 26 to prevent cervical cancer might also be beneficial for preventing throat cancer.

For more information or to refer a patient, call (323) 442-5790.

• 2017 - Issue 1

9

C ASE STUDY

ROBOTIC TUMOR RESECTION A PARTNERSHIP BETWEEN THE KECK SCHOOL OF MEDICINE OF USC’S DEPARTMENT OF NEUROLOGICAL SURGERY AND THE USC INSTITUTE OF UROLOGY RECENTLY ENABLED A PATIENT TO UNDERGO A FIRSTOF-ITS-KIND MINIMALLY INVASIVE PROCEDURE TO REMOVE A SPINAL TUMOR.

By Patrick Hsieh, MD, associate professor of neurological surgery, specialist in neurology and spinal oncology

CASE PRESENTATION A team of doctors was monitoring a patient with neuromatosis, a genetic disorder that caused multiple tumors to grow in her brain and spinal cord, when a new tumor was discovered deep within her abdomen adjacent to her spine.

The 71-year-old woman had developed a rapidly growing tumor outside her spinal canal, next to the spine and abutting the aorta and kidneys in the L3-L4 spinal section. It’s a relatively unusual location for some of these tumors, but not so rare that we never see it: The tumors tend to grow along the nerve pathways, so they can occur anywhere from the head to toe.

Tumors like this can grow and cause pressure on the brain or spinal cord; they can cause local destruction of bone and tissue; and they can cause pain, discomfort and loss of nerve function depending on the size and location. If they grow very rapidly, as in this case, there is also concern about transformation of these tumors to cancer cells.

MANAGEMENT AND OUTCOME The patient’s ongoing condition meant she had already had a number of tumors removed throughout her life and we determined that this tumor was eligible for a minimally invasive procedure, either laparoscopically or robotically.

10

• 2017 - Issue 1

Hsieh’s team at work in the OR (Image/Ricardo Carrasco III)

The advantage of the robotic procedure is that there is a much smaller incision with very little disruption of the soft tissue and minimal blood loss. I enlisted the help of Andrew J. Hung, MD, assistant professor of clinical urology and director of robotic simulation and education at the USC Institute of Urology, who looked at the patient’s film and agreed that a robotic procedure would be a favorable treatment approach.

The patient was scheduled for a robotic paraspinal tumor resection using the da Vinci robotic surgical system. We approached the deep-seated spinal tumor through multiple smaller ports and, because of the robot’s ability to work in confined spaces, quickly were

able to dissect the tumor from the nerves and organs before removing the mass. While the patient has underlying health problems that delayed her release from the hospital, I believe healthier patients could be discharged as soon as the next day. With refinement of techniques and experience, I believe that we will ultimately be able to remove these tumors as outpatient procedures.

By teaming up with various disciplines and combining specialties, we at Keck Medicine of USC are developing innovative ways to deal with complex diseases and the multidisciplinary approach allows us to do things that each of us would not be able to do separately.

C ASE STUDY

A PROMISING THERAPY FOR SPINAL CORD TRAUMA KECK MEDICINE OF USC IS ONE OF SIX SITES IN THE UNITED STATES CONDUCTING CLINICAL TRIALS OF STEM-CELL INJECTIONS AIMED AT RESTORING FUNCTION IN PATIENTS WITH SPINAL CORD INJURIES. EARLY RESULTS ARE ENCOURAGING.

By Charles Liu, MD, professor of clinical neurological surgery at the Keck School of Medicine of USC and director of the USC Neurorestoration Center

CASE PRESENTATION On a wet road in Bakersfield, California in March 2016, a 20-year-old man suffered a traumatic injury to his cervical spine during a car accident, resulting in paralysis from the neck down. At the local hospital, the neurosurgeon fused his neck bones and stabilized his spine. Later, he called me about whether the young man might be a candidate for a new, potential treatment to restore function, injecting AST-OPC1, oligodendrocyte progenitor cells, directly into the spinal cord.

MANAGEMENT AND OUTCOME In early April, the surgical team injected a dose of 10 million AST-OPC1 cells, the amount found effective in preclinical trials, directly into his cervical spinal cord. The surgery was within the window of time in which the injection could potentially be most effective when inflammation was reduced but before scarring had occurred.

The patient showed significant improvement in his motor function 90 days after surgery. With the help of rehabilitation therapy, he uses his hands to open a bottle, feed himself, text on a cell phone, send e-mails, play video games, lift weights, and operate a motorized wheelchair. The significance of this level of functional independence cannot be overstated.

The treatment he received is part of a Phase 1/2A clinical trial to evaluate the safety and efficacy of escalating doses of AST-OPC1 cells developed by Fremont, California-based Asterias Biotherapeutics to help people with spinal cord injuries gain independence.

It is believed that the stem cells not only fix the damaged insulation, but also invite blood vessels back into the injury site, and help nourish nerves, potentially reviving nerves that were nearly dead.

The clinical trial is for patients with severe spinal cord injury at the c5-c7 level. To qualify for the trial, enrollees must be between the age of 18 and 69, and their condition must be stable enough to receive the injection between the 14th and 30th days following injury.

Researchers next will examine the effectiveness of doubling the dose of the cells. In addition, patients with less severe injuries will also be the subject of future studies. I believe we’re possibly at the beginning of something really remarkable in restoring function to patients with spinal cord injuries.

For more information or to refer a patient, call (562) 401-7020.

Additional reporting by Robin Heffler

• 2017 - Issue 1

11

NEWS BRIEFS: HEAD INJURIES IN KIDS APPEAR TO CAUSE STRUCTURAL CHANGES IN BRAIN Children with delayed visual perception as a result of head injuries may end up with structural changes in their brains that interrupt normal development, a new Keck School of Medicine of USC study shows.

This finding is the first step to creating targeted treatments for a subpopulation of children with traumatic brain injuries (TBIs), the leading cause of disability among the young. The goal is to save their brains from further deterioration as a consequence of the initial injury.

The team examined the brain scans of 21 children in Los Angeles County who were diagnosed with a TBI from a fall or a car accident. Study participants were 8 to 18 years old when they incurred the TBI. Twenty children without a brain injury served as the control group.

“We found that children who had delayed information transfer times between the two brain hemispheres had widespread regions of white matter disorganization and progressive loss of white matter volume,” said Emily Dennis, PhD, lead author of the study and a postdoctoral scholar at

USC ROSKI EYE INSTITUTE OPHTHALMOLOGISTS ARE FIRST TO USE XEN GEL STENT TO TREAT GLAUCOMA PATIENTS IN LOS ANGELES

the Imaging Genetics Center, USC Mark and Mary Stevens Neuroimaging and Informatics Institute. “In children, this disruption to myelin — the insulation that facilitates information transfer — is compounded because the brain is still maturing. Myelination typically continues beyond age 30.”

The preliminary study published on March 15 in Neurology found that children who took more than 18 milliseconds to transfer information between the brain hemispheres did not recover as well from TBI compared to their similarly injured counterparts.

• 2017 - Issue 1

The study was supported by the National Institutes of Health, UCLA Brain Injury Research Center, UCLA Steve Tisch BrainSPORT Program, Easton Foundation and the UCLA Staglin IMHRO Center for Cognitive Neuroscience.

— ZEN VUONG

Scientists took diffusion-weighted MRI scans of the young study participants two to five months after their injury and again about a year later. The children took thinking and memory skills tests.

They also had EEGs done while they completed a computerized pattern-matching task, enabling researchers to examine how quickly information was transferred from one brain hemisphere to the other.

Researchers tracked brain activity as it transferred

A team from the USC Gayle and Edward Roski Eye Institute became the first in Los Angeles County to implant the XEN gel stent in glaucoma patients in early March of this year.

The XEN gel stent was approved by the U.S. Food and Drug Administration in November 2016. It became available for implantation in patients nationwide in February.

The half-dozen glaucoma stent implant procedures for Los Angeles-area patients were performed by USC Roski Eye Institute ophthalmologists Alena Reznik, MD, and Sahar Bedrood, MD, PhD, both assistant professors of clinical ophthalmology at the Keck School of Medicine of USC.

12

information through the hemispheres via the corpus callosum. During the initial evaluation, half of the injured kids had a transfer time of more than 18 milliseconds while the other half were in the normal range between 7 to 10 milliseconds — more than 30 times the speed of the blink of an eye.

The XEN gel stent is made of non-degradable soft collagen-derived gelatin and is a minimally invasive, outpatient surgical option for glaucoma patients whose intra-ocular pressure cannot be managed by medications or laser treatment. It allows glaucoma patients to avoid more invasive surgical procedures. The XEN gel stent lets eye fluid drain from inside the eye, reducing elevated eye pressure that can eventually lead to blindness if not alleviated.

“The XEN gel stent is a unique device that conforms to the ocular tissue and is successful at fluid drainage and reducing eye pressure while also being extremely

DOCTORS PERFORM THE FIRST ROBOTIC SURGERY TO REMOVE KIDNEY CANCER EXTENDING INTO THE HEART A surgical team at Keck Medicine of USC pushed the boundaries of clinical care by performing the first-ever robotic, minimally invasive surgical removal of a stage IV tumor thrombus — the removal of a kidney cancer tumor that extends into the heart.

The nearly 10-hour procedure required painstaking precision from three renowned surgeons, a critical care anesthesiologist and a radiologist. In doing the procedure, the team reduced the patient’s risk of sudden death from the tumor breaking off into the heart and lungs.

Typically, the surgery for a stage IV tumor thrombus is both traumatic and risky. It requires major open surgery in which the patient’s chest and abdomen are opened completely while the anesthesiologist monitors the patient and the thrombus. The aim is to remove the tumor and thrombus from the inferior vena cava and the heart while ensuring it does not break. Several quarts of blood are needed for transfusion and patients have a 1 in 20 chance of dying during the procedure.

comfortable for the patient,” said Reznik.

“Since it is a less invasive procedure than other traditional glaucoma surgical options, there are fewer side effects and the patients recover more quickly.”

Reznik added that USC Roski Eye Institute was proud to be the first in Los Angeles to implant the XEN device since Rohit Varma, MD, MPH, dean of the Keck School and director of the USC Roski Eye Institute, had worked with AqueSys Inc. to design the device and analyze the outcomes data over several years of clinical trials conducted in refractory glaucoma patients.

The use of robotic surgery techniques significantly reduced trauma to the patient and minimized blood loss by more than fivefold. By using small incisions, the patient’s hospital stay was just six days, as opposed to the typical two to three weeks after open surgery. Overall recovery time was also reduced significantly. Such multidisciplinary collaboration lays the groundwork for using advanced technology to build higher standards of patient care, even in the most complex cases.

“This exciting feat promises to redefine the boundaries of what is surgically possible through skill, collaboration and technology,” said Inderbir Gill, MD, chair and Distinguished Professor of Urology, founding executive director of the USC Institute of Urology and associate dean for clinical innovation at the Keck School of Medicine of USC. Gill led the multidisciplinary team that performed the surgery. “Our hope is that we can now propel the field at large to turn such futuristic robotic surgery into our present standard-of-care.”

Before the surgery, Vinay Duddalwar, MD, associate professor of clinical radiology, created three-dimensional animated maps of the patient’s chest and abdomen so that surgeons could pre-plan their entire surgical strategy with millimeter precision. The

“The XEN device is a game changer for patients with primary open-angle glaucoma, pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy,” Varma said. “In addition to offering a minimally invasive option for glaucoma patients that was successful in reducing eye pressure, our analysis also showed it helped reduce the study participant’s medications.”

procedure began with Namir Katkhouda, MD, PhD, professor of surgery, performing a surgical maneuver to control blood flow to the patient’s liver. Next, Gill used the latest-generation Xi da Vinci surgical robot to completely dissect the tumor-bearing kidney through small keyhole incisions in the patient’s abdomen to control various blood vessels, which allowed him access around and into the inferior vena cava where the cancer had spread. Then Mark Cunningham, MD, associate professor of clinical surgery, put the patient on a heartlung bypass machine to create a bloodless environment for tumor removal. He opened the patient’s heart using a minimally invasive incision through the rib cage.

Cunningham and Gill then worked quickly and simultaneously from the chest and abdomen to remove the tumor thrombus from the heart and inferior vena cava, respectively, with Cunningham working from the chest downward and Gill working from the abdomen upward. All the while, Duraiyah Thangathurai, MD, professor of clinical anesthesiology and chief of critical care medicine, monitored the patient’s organ function, keeping a close eye on the patient’s heart using an esophageal echo probe.

— MARY DACUMA

“Glaucoma does not have to lead to blindness,” Varma said. “The disease progresses slowly, usually without any symptoms, so an annual dilated eye exam for early detection and treatment, especially after the age of 50, is essential to prevent blindness.”

— SHERRI SNELLING

Varma’s data analysis during clinical trials showed that one year after the implant, eye pressure was reduced by 44 percent from baseline and IOP medications, including eye drops, were reduced by 65 percent.

• 2017 - Issue 1

13

CLINICAL TRIALS There are hundreds of clinical trials and studies currently taking place at Keck Medicine of USC, giving participants access to novel and potentially promising therapies that generally are not available elsewhere.

For more information on these and other open clinical trials, visit clinicaltrials.KeckMedicine.org.

CERVICAL CANCER

MEN’S HEALTH

WOMEN’S HEALTH

Title: Eribulin Mesylate in Treating Patients with Advanced or Recurrent Cervical Cancer

Title: Sensorimotor Impairments in Men with Chronic Prostatitis/Chronic Pelvic Pain Syndrome: Relationship of RestingState Brain Activity to Pelvic Floor Muscle Activation

Title: A Prospective Validation Study of a Rapid Point-of-Care Breath Test for Breast Cancer

Purpose: Cervical cancer is the second most common cancer in women worldwide; and it is the leading cause of death by cancer for women in developing countries. Treatment for advanced disease after the use of platinum based therapy yields low response and survival rates, therefore there is a huge need for the identification of active agents. Eribulin is a targeted agent that inhibits cell growth in multiple types of cancers. Previous studies have shown that it improves response and survival rates. This study is a phase 2, single arm, two-stage study using eribulin in patients with advanced cervical cancer.

The primary objective of this study is to evaluate the effectiveness of eribulin in these patients ClinicalTrials.gov Identifier: NCT01676818 Keck School of Medicine of USC investigator: Lynda Roman, MD, associate professor of obstetrics and gynecology and division chief of gynecologic oncology Contact: Gangothri Namasivayam, MS, gnamasiv@usc.edu, (213) 740-5075

14

• 2017 - Issue 1

Purpose: Pelvic floor muscles provide support and control necessary for voluntary and involuntary movement. Millions of men suffer from chronic uncontrollable pain in the region of the pelvic muscles — impacting everything from bowel/bladder function to sexual function to physical activity — causing a greatly reduced quality of life. In this project, we will test the hypothesis that men with chronic pelvic pain have changes in resting brain function associated with changes in muscle control underlying the dysfunction in this disorder, laying the groundwork for future treatment studies.

USC investigator: Jason J. Kutch, PhD, assistant professor of biokinesiology and physical therapy Contact: Jason Kutch, PhD, kutch@usc.edu, (323) 442-1945

Purpose: This is a multicenter, blinded prospective study of 2,000 women undergoing mammography for breast -related symptoms or signs. Breath tests will be performed in order to demonstrate that the outcome of mammography results combined with breast test results improves clinical sensitivity and specificity in a group that has an increased prior probability of cancer. Breath will be collected and analyzed with a rapid point-of-care instrument (BreathLink™) and also with a laboratory-based assay of samples collected into an inflatable bag (BreathBag™).

ClinicalTrials.gov identifier: NCT02888366 Keck School of Medicine of USC investigator: Linda Hovanessian-Larsen, MD, associate professor of clinical radiology, director of the division of women’s imaging and director, radiology research in women’s health Contact: Ruth Vergara, ruth.vergara@med.usc.edu, (323) 865-3203

ORAL CANCER

GASTROESOPHAGEAL REFLUX DISEASE

MULTIPLE SCLEROSIS

Title: IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity (INSPIRE)

Title: An Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Reflux

Title: A Non-randomized, Exploratory, Study to Assess Clinical Response to Gilenya® (Fingolimod) in a Cohort of Relapsing Remitting Hispanic MS Forms

Purpose: The purpose of this investigation is to demonstrate the safety and effectiveness of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System in the treatment of subjects with gastroesophageal reflux disease (GERD). This investigation is a multicenter, randomized, double-blind, shamcontrolled clinical investigation. After the implant procedure, subjects will be randomized to either the Treatment Group (immediate stimulation) or Control Group (delayed stimulation) for a 6-month, double-blind phase followed by an additional open-label treatment phase in which all subjects will receive electrical stimulation therapy for a total of 12 months. Subjects continue on stimulation treatment and an extended open-label follow-up phase includes an 18 month post-stimulation phone interview followed by annual visits through five years poststimulation.

Purpose: The primary objective of this study is to determine the success of Gilenya® (fingolimod) treatment in patients with MS of Hispanic descent relative to their ancestral background. Therapeutic success will be determined by annualized relapse rate (ARR; defined as the number of relapses divided by the person-years followed) after initiation of treatment with Gilenya® (fingolimod)in comparison to the relapse rate in the previous 12 months.

This will be determined based on medical chart extraction, in-person assessment and regular clinical follow-up. A secondary objective of this study is to investigate whether the efficacy of Gilenya® (fingolimod) is superior or equal in HW which have higher loads of Amerindian versus Caucasian background with opticospinal MS (OSMS-NMO neg) versus classical MS (CMS) in the first 12 months using radiological and clinical parameters.

Purpose: This study will assess the activity and safety of the IRX Regimen in participants with newly diagnosed, untreated, surgically resectable squamous cell cancer of the oral cavity. Participants will be randomly assigned to receive either Regimen 1: IRX-2 + cyclophosphamide + indomethacin + zinc + omeprazole, or Regimen 2: cyclophosphamide + indomethacin + zinc + omeprazole. The primary study hypothesis is that the Regimen 1 with IRX-2 prolongs eventfree survival and overall survival when compared to Regimen 2 without IRX-2.

Subjects will be randomized to either Regimen 1 or Regimen 2 on a 2:1 basis and treated prior to surgery.

ClinicalTrials.gov Identifier: NCT02609386 Keck School of Medicine of USC investigator: Jorge Nieva, MD associate professor of clinical medicine Contact: Gina Tse, RN, tse_g@med.usc.edu, (323) 865-0514

ClinicalTrials.gov Identifier: NCT02749071 Keck School of Medicine of USC investigator: John Lipham, MD, associate professor of clinical surgery, division chief of upper GI and general surgery, director of the foregut cancer program Contact: Michelle Hernandez, michelle.hernandez@med.usc.edu, (323) 442-6252

ClinicalTrials.gov Identifier: NCT01592097 Keck School of Medicine of USC investigator: Lilyana Amezcua, MD, assistant professor of clinical neurology Contact: Andrea Martinez, MPH, andrea.martinez@med.usc.edu, (323) 442-6817

• 2017 - Issue 1

15

UPCOMING CONTINUING MEDICAL EDUCATION 21ST ANNUAL MAX R. GASPAR, MD SYMPOSIUM: VASCULAR SURGERY EMERGENCIES Date: September 7, 2017 Location: Millennium Biltmore Hotel, Los Angeles, CA Fees: MD, DO: $100.00; RN, PA, Allied Health: $50.00 Credit: 6.25 AMA PRA Category 1 Credits™

INNOVATIONS IN CARDIOVASCULAR DIAGNOSIS AND THERAPY Date: October 14, 2017 Location: Millennium Biltmore Hotel, Los Angeles, CA Fees: MD, DO: $140.00; RN, PA, Allied Health: $100.00; Credit: 8.5 AMA PRA Category 1 Credits™

4TH ANNUAL DHS DIABETES DAY Date: October 2, 2017 Location: California Endowment Center Fees: MD, DO: $50.00; RN, PA, Allied Health: $50.00; Fellows, Residents, Students: $50.00; Credit: 7.25 AMA PRA Category 1 Credits™

2017 CEREBROVASCULAR DISEASE SYMPOSIUM Date: October 14, 2017 Location: USC Health Sciences Campus, Mayer Auditorium Fees: MD, DO: $100.00; RN, PA, Allied Health: $50.00; Credit: 6.5 AMA PRA Category 1 Credits™

USC CLINICAL RHEUMATOLOGY UPDATE: FOCUS ON RA, LUPUS AND PSORIATIC ARTHRITIS Date: October 7, 2017 Location: USC Health Sciences Campus, Aresty Conference Center Fees: Industry: $200.00 MD, DO: $100.00; RN, PA, Allied Health: $50.00; Credit: 5.75 AMA PRA Category 1 Credits™

For more information, visit keck.usc.edu/cme/

NON-PROFIT ORGANIZATION

Keck Medicine of USC Marketing and Communications SST-2830 2011 N. Soto St. Los Angeles, CA 90032

US POSTAGE PAID UNIVERSITY OF SOUTHERN CALIFORNIA