Daily Archives: November 10, 2015

Head Start Fetal myelomeningocele repair prevents spinal cord damage and improves neurologic function

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CIC_heads1It was a day Kasey Hilton had been anticipating from the beginning of her pregnancy – finding out whether she was having a boy or girl. But the ultrasound appointment in June, 2014 brought news she and her husband Mike weren’t ever expecting to hear. They were having a baby boy, but he had a serious spinal cord defect called myelomeningocele that is associated with lifelong disabilities.

There was, however, hopeful news. University of Michigan’s C.S. Mott Children’s Hospital had recently become the only hospital in the region and among just over a dozen in the country to offer fetal surgery to correct the defect months before birth. The procedure prevents further damage to the spinal cord and improves neurologic function.

The Hiltons spent the day meeting with many experts from the Fetal Diagnosis & Treatment Center at C.S. Mott Children’s Hospital and Von Voigtlander Women’s Hospital.  After extensive testing, doctors determined that Kasey and the baby were potential candidates for the procedure. The Hiltons then underwent multi-disciplinary counseling by the team to understand the relative maternal and fetal risks and benefits.

It takes a team

“A prenatal diagnosis of myelomeningocele can be overwhelming for families, but this new procedure offers hope for better outcomes,” says Marcie Treadwell, M.D., director of U-M’s Fetal Diagnostic Center.

“Although not a cure, fetal surgery prevents ongoing damage to the spinal cord and is associated with improved neurologic outcomes,” says Cormac Maher, M.D., associate professor of pediatric neurosurgery.

Last July, when Carter was only 23.5 weeks gestation, Kasey underwent open fetal surgery with the hope of improving her baby’s outcome.  This procedure required an experienced multi-disciplinary team working seamlessly together.  Maternal anesthesia was provided by Dr. Baskar Rajala, pediatric anesthesia by Dr. Paul Reynolds, and fetal monitoring by Drs. Sarah Gelehrter and Rebecca Jane Vartanian. Five surgeons were involved in the procedure – Treadwell, Maher, pediatric surgeon George Mychaliska, M.D. and maternal fetal medicine specialists Deborah Berman, M.D., and Clark Nugent, M.D.

The doctors performed open fetal surgery which involved deep maternal anesthesia, hemostatic hysterotomy, extensive maternal and fetal monitoring and partial exposure of the fetus. Once they had access to the one-pound fetus, Dr. Maher performed the delicate, 30-minute operation to repair his spinal canal and cover the defect with skin.  The uterus was closed using a specialized technique to incorporate the membranes and ensure a watertight seal.

Hilton was closely monitored in the hospital by the maternal fetal medicine team and then sent home on bed rest.  She underwent serial ultrasound examinations and for signs of preterm labor.

At 34 weeks, Carter Hilton was born via C-section. Although Carter did require a ventriculoperitoneal shunt, he is currently six months old and doing well.

Innovative and promising

“Fetal surgery for myelomeningocele is innovative and promising,” says Mychaliska, director of the Fetal Diagnosis and Treatment Center. CIC_heads2“Although fetal surgery improved outcomes, children with myelomeningocele still require long-term care. In addition, the potential fetal benefits must be weighed with an understanding of the potential maternal and fetal risks.”

For nearly a decade, U-M doctors have been working together to develop the Fetal Diagnosis and Treatment Center which provides comprehensive prenatal diagnosis and cutting edge fetal surgery for carefully selected patients.  “We are fortunate to have a talented and experienced team dedicated to our maternal and fetal patients,” says  Mychaliska.

“The team carefully explained to us the risks involved for both me and my unborn son but we did not hesitate to say yes in light of the potential to improve his quality of life,” Kasey Hilton says. “I had concerns, as anyone would, but knew I was in good hands.

“We’ll have to watch Carter for various milestones in his life and we won’t know if he will have challenges with things like walking or with his bowels and bladder until he’s old enough to walk and potty train. For now, he’s doing great and we are grateful to the entire fetal team at U-M for a procedure that could help give him a better future.”

The MOMs trial

The landmark randomized prospective clinical trial comparing prenatal versus postnatal repair of myelomeningocele, known as the MOMS trial, closed early due to efficacy, and the results were published in the New England Journal of Medicine. By 12 months, children who had fetal surgery had a decreased need for shunting and less hindbrain herniation.  At 30 months of age, those who received fetal surgery also scored better on mental and motor function tests and were more likely to walk independently. However, fetal surgery was also associated with an increased risk of preterm delivery and uterine dehiscence at delivery.

Inclusion Criteria

  • Mothers ≥ 18 years of age
  • T1—S1 with hindbrain herniation
  • Normal fetal karyotype
  • Gestational age between 19 to 25 weeks

Exclusion Criteria

  • Fetal anomaly unrelated to myelomeningocele
  • History of spontaneous preterm birth
  • Maternal BMI > 35
  • Maternal co-morbidities
  • Inability to comply with follow-up

Michigan’s Comprehensive Stroke Center Helping patients achieve best level of function

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The most advanced stroke treatments and equipment in the world won’t make a difference in an environment that can’t support their use.

Fortunately, the University of Michigan’s Comprehensive Stroke Center can meet stroke head on. Accredited by the Joint Commission, all physicians are board certified. And as they offer care for patients—from straightforward conditions through the most complex cases—they have the latest technologies readily available.

“Our teams of physicians, nurses and therapists are set up to ensure all of our patients receive the highest level of care, from their emergency department (ED) stay until their discharge,” says neurologist Eric E. Adelman, M.D. Adelman co-leads the Center with neurosurgeon Aditya S. Pandey, M.D., and emergency medicine physician William Meurer, M.D.

“We have a strong focus on quality improvement and continually work to improve the care we provide.” The Center treats patients before, during and after stroke, through preventive, emergent and rehabilitative care, and can accept new patients at any point throughout the care continuum.

The Team
Eric Adelman, M.D.

Eric Adelman, M.D.

Patients at U-M are treated by a multidisciplinary team of emergency medicine, neurology, neurosurgery and neurointerventional radiology physicians who are specially trained in stroke care. Vascular surgeons, cardiologists, internal medicine and physical medicine and rehabilitation physicians are also part of the care team.

The Center always keeps in mind that just as no two strokes are the same, neither are any two patients the same.

“Our goal is to design a team specific to the patient and disease,” says Aditya Pandey, M.D.

Cerebral aneurysms and AVMs can also cause significant neurological disability and even death, and U-M has a multidisciplinary approach to treating such individuals with such difficult conditions as well.

Aditya S. Pandey, M.D.

Aditya S. Pandey, M.D.

“Our radiologists and neurosurgeons use the latest techniques in providing cutting-edge treatments in the safest manner. We have three dual trained cerebrovascular neurosurgeons who treat diseases with both minimally invasive endovascular techniques as well as open microsurgery techniques,” Pandey says.

After any type of stroke procedure, patients go to either the Stroke Unit or the Neuro ICU. “Our state-of-the-art Stroke Unit and Neuro ICU ensure that patients can be safely monitored by nursing staff and have ready access to  rehabilitation,” Adelman says.

Clot-busting Stent Retrievers

In one of Michigan’s unique surgical rooms, a CT scan of the head can be performed in the same room where doctors can remove clots from vessels or repair brain aneurysms, saving critical time for the stroke patient.

“Here, we are able to use neurointerventional radiology to enable endovascular image-guided treatment of brain aneurysms, brain bleeds and opening of blocked brain vessels,” says Neeraj Chaudhary, M.D., MRCS, FRCR. “Our endovascular practitioners are extremely well-trained in the use of all the state-of-the-art medical devices. And their expertise is supported by a robust setup of regular monitoring of clinical outcomes to ensure the best for our patients.”

Among the newest generation devices are stent retrievers. They resemble the wire stents often used to keep coronary arteries open but function more like a trap. When a catheter containing a collapsed stent retriever reaches a clot blocking a cerebral artery, the stent moves out of the catheter, unfolds to form a 3-D mesh tube, ensnares the clot and retracts back into the catheter with its catch. Surgeons then thread the catheter with the clot back out of the body.

In the meantime, the artery is cleared and blood flows back into the brain, replenishing its vital supply of oxygen and glucose.

Neurosurgical Intensive Care Unit (NICU)

CIC_stroke3The Neuro ICU is a 15-bed unit that cares for critically ill neurosurgery and neurology patients, including stroke patients. The unit is led by neurointensivist Venkatakrishna Rajajee, MBBS, and staffed by four board-certified neurointensivists, which is relatively rare.

“We add value in different ways,” says Rajajee. “For the neurosurgery patient, the Neuro ICU allows particularly high-risk, complicated procedures to be performed. Yes, you know you can provide treatment and surgery, but you want to be certain that there is the ability to provide care afterwards if there are complications. You want the ability to monitor the patient extremely closely afterwards. You can lose all the benefits from the surgery if you don’t have the ability to provide the care afterwards.”

Stroke Rehabilitation—Individualized Treatment Plans

Rehabilitation Physician Edward S. Claflin, M.D., leads the U-M Acute Stroke Rehabilitation Program for patients who have significant disabilities because of stroke.

Once again, state-of-the-art equipment and technologies—such as the Lokomat robotic exoskeleton, BioEx gait training with biofeedback, Bioness technologies, Saebo hand and foot functional tone management, graded UE biking, and neuromuscular and functional electric stimulation—are backed up by the knowledge and expertise of a truly interdisciplinary and collaborative team.

Their team of experts includes a physical medicine and rehabilitation physician (a physiatrist), physical therapists, occupational therapists, speech language pathologists, neuropsychologists, rehab engineers, exercise technicians/personal trainers, orthotists/prothetists and a case manager.

“The medical or surgical team asks for rehabilitation assessments by therapists as soon as it is deemed safe—usually within hours of a patient’s admission. These therapists will continue to see patients in the hospital until they move to the next level of rehab,” says Claflin. After assessment, the team develops specific rehab goals and a timeline for transitioning to another rehab setting or back home. The team even develops home exercise plans so that patients can maintain their level of function.

“Our goal is to help patients achieve their best level of function after stroke,” Claflin says.

Working Together

“A truly comprehensive stroke care setup cannot function unless there is genuine collaboration among its different components,” says Chaudhary. “Here at the University of Michigan, all the components of such a comprehensive stroke center work in perfect harmony.”

“We appreciate the privilege of treating all of these patients and appreciate each referring physician’s important contribution in allowing us these opportunities,” Pandey says.

New Hope for Multiple Sclerosis

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CIC_MS1Since the University of Michigan created its Multiple Sclerosis Center in 2007, Michigan has been fighting a good fight against MS. Under the direction of Benjamin Segal, M.D., the center has grown from 400 patients and one physician to 3,000 patients and six specialty physicians. This growth represents an all-out war against MS, with clinical, translational and clinical research arms. The strategy is working so well that the center was designated a Center of Excellence for Comprehensive MS Care by the National Multiple Sclerosis Society (NMSS).

The center takes a multidisciplinary approach, collaborating with physical medicine, pain specialists, urologists and neurologists. “All in the interest of helping our patients in the most expert way,” says Segal.

In addition to providing patient care in the outpatient clinic, the center is conducting several clinical trials for both relapsing remitting and secondary progressive MS to further the treatment options for the disease.

Siponimod Phase III – Largest Trial in the World

Dr. Yang Mao-Draayer is principal investigator and Segal is co-investigator on a Phase III trial to see how the drug siponimod impacts the immune system in patients with secondary progressive MS. Siponimod is a variation of fingolimod, a drug that is used in relapsed or remitting MS patients but was designed to have fewer side effects.

The study involves more than 300 centers around the world, is the largest secondary progressive MS trial ever conducted and includes nearly 1,600 subjects worldwide. “Our study is the first in-depth immunological study of its kind for MS and involves a unique collaboration among 19 US academic centers, Novartis and the National Institutes of Health,” says Yang.

Surprising Connections Between Sleep Disorders and MS

Dr. Tiffany J. Braley is interested in the causes of fatigue in MS and how to better treat it.

“It turns out that a good portion of people with MS have a sleep disorder that is contributing to their fatigue,” says Braley.

Obstructive sleep apnea (OSA) is underdiagnosed in MS patients, and Braley has found that such sleep disorders are more common in patients with MS than the general population. She is studying whether the effects of the disease itself as well as the treatments given to patients to decrease relapse rates impact patients’ sleep hygiene and put them at a higher risk for OSA.

She has started an MS/sleep and fatigue subspecialty clinic—the first of its kind in the country—where she and Dr. Ronald Chervin, director of the U-M Sleep Medicine Division, evaluate and treat MS patients with severe fatigue, tiredness and sleep disorders.

“In addition, I am looking at whether or not some medications that are used to treat MS may help alleviate sleep apnea in the general population,” Braley says. “We continue to find connections between the two conditions.”

Extracorporeal Photophereresis – Enrolling for Trial Now
“ Compared to other MS treatments, it is relatively low risk. If this works, it will be a huge advancement in the management of progressive MS.” —Benja min M. Segal , M.D., Director, U-M Multiple Sclerosis Center

“ Compared to other
MS treatments, it
is relatively low
risk. If this works,
it will be a huge
advancement in
the management of
progressive MS.”
—Benjamin M. Segal , M.D., Director,
U-M Multiple Sclerosis Center

“I am one of the people who believes inflammation plays a role during all stages of MS. However, every patient is unique,” says Segal. “The type of inflammation that causes damage may vary between individuals. This may be why there is no immunoregulatory drug that is effective across all patient subsets.”

There are now 13 FDA-approved medications that decrease risk of clinical exacerbation in patients in the relapsing-remitting stage of MS. “However, we do not have a cure, and there are no highly effective medications that slow, let alone reverse, the accumulation of disability in patients in the progressive stages of MS,” he says.

So Segal has tried a different approach, concentrating on the idea of combating inflammation in progressive MS, but coming at it from a different direction. “One of my colleagues, Dr. Daniel Couriel, chief of the Bone Marrow Transplant unit, uses a technique called extracorporeal photopheresis (ECP) to treat graft versus host disease—an inflammatory disease of multiple organs that occurs in some patients following bone marrow transplantation. In a way, it’s like an autoimmune disease,” he says.

ECP is a relatively safe procedure involving removal of some white blood cells from a patient, exposing those cells to UV light in the presence of a photosensitizing agent and then reinfusing those cells.

Segal and Couriel used ECP on a father of two with progressive MS who had not responded well to other treatments, even chemotherapy.

“He went from spending most of the day in a motorized scooter to walking with a cane. A second patient could stand in the shower for the first time in years. A third did not make gains but she did not deteriorate either.”

“As far as I know, we’re the only site in the world that’s doing this procedure in this way to treat progressive MS,” Segal says.

“Compared to other MS treatments, it is relatively low risk. And if this works, it will be a huge advancement in the management of progressive MS,” Segal says.

FOR REFERRING PHYSICIANS
ECP – Enrolling for Trial Now

Patients with secondary progressive MS not currently treated with disease modifying therapies may be eligible for the ECP trial. Trial candidates should have experienced disability accumulation over the past 1-2 years. Please contact Amanda Rasnake, clinical trial coordinator, at (734) 232-2452 if you would like to refer a patient to the trial.

MS/OSA Trial

This clinical trial will evaluate the effects of Positive Airway Pressure (PAP) on cognitive function in multiple sclerosis patients who have obstructive sleep apnea. MS patients who have concerns about their cognitive function or who are at risk for obstructive sleep apnea may be eligible.

Please contact study coordinator Nancy Kessler (734) 647-9067, nrypkows@med.umich.edu, if you would like to refer a patient to this trial.