March 25, 2017

Helping Paraplegics Walk Again with Robotic Exoskeleton Systems

By: John Robb, CPO, Reach Orthotic & Prosthetic Services

You’ve probably seen it in the news: paraplegics standing upright and walking again with the aid of robotic exoskeleton systems.  No longer the make believe flaunt of a science fiction movie, these real-life bionic devices have made their way into the everyday world of modern healthcare.  And with the exoskeleton market expected to gain popularity across the globe, multiple vendors are joining in to offer their versions of the latest technology.

Initially developed for military soldiers in the 1960s by the US armed forces and General Electric, exoskeleton technology is now available to the general population.  This modern, wearable technology is a marriage of computer systems and robotics, resulting in a powerful external structure for the human body.

These bionic walking systems utilize a battery, motors and controls that allow wearers to replicate a wide range of movements, detecting and enhancing the user’s own abilities. Spinal cord injury patients may lose all or some of the muscle function in their lower extremities: these devices are secured externally along the lower back and lower extremities, providing movement to the hip, knee and ankle joints similar to normal ambulation. This allows paraplegics to stand up, walk and even climb stairs.  Training is needed to learn skills and adapt to the device, and while exoskeletons fall short of normal function, the ongoing technology has a promising future.

Exoskeletons are also extremely helpful in rehabilitation environments, where they provide patients with valuable exercise and therapy treatment options.  Physical Therapists can utilize a broad range of parameters for each patient and make adjustments as training progresses.

The Benefits are Widespread:
• Increases physical capabilities and independence

• Offers support for standing, walking, and carrying objects

• Can be utilized for rehabilitation of stroke or spinal cord injury

• Provides mobility which can reduce the disabling effects of some diseases

One of the biggest challenges facing designers of exoskeletons is the power supply.  Power sources have to be light enough for the wearer to accommodate, and there are currently only a small number of power sources that can sustain a powered exoskeleton for more than a few hours.  With any new technology there is a sizeable price tag, and this carries a hefty one: powered exoskeletons can cost $70,000 or more, and getting insurance coverage is challenging due to lack of long-term outcomes data.

With more and more new players entering the market, the technology continues to advance and evidence of its benefits continues to be collected. In the meantime, we can expect to see more of this technology come off of the big screen and out into the marketplace.

What To Do If You Are Accused of Patent Infringment

What To Do If You Are
Accused of Patent Infringment
By Matthew R. Osenga – Goodman Allen Donnelly, PLLC

 

Being accused of patent infringement is serious and can have grave consequences.  You could be liable for damages, including lost profits or reasonable royalties – maybe even attorneys’ fees or treble damages.  You could even be subject to an injunction.  There are, however, a number of defenses to such an accusation.

Medical Activity Defense
One defense of particular importance to medical professionals is contained in § 287(c) of the Patent Act.  This provision provides that no remedy shall apply to certain charges of patent infringement by listed medical professionals.  Specifically, for qualifying activities, no damages, no injunction, no award of attorney’s fees, and no civil action for infringement are available to the patent owner.  Like many provisions in the law, this defense was the result of a compromise, so it is important to study the various provisions and requirements to determine the parameters of the defense.

The defense is available to “a medical practitioner’s performance of a medical activity” that would otherwise constitute an infringement.  If the defense applies, the remedies for patent infringement do not apply against “the medical practitioner or against a related health care entity.”

The first issue to consider is to whom this defense is available.  The statute defines a medical practitioner as “any natural person who is licensed by a State to provide the medical activity . . . or who is acting under the direction of such person in the performance of the medical activity.”  This definition seems to cover physicians, surgeons, nurses, and related health care practitioners.  The statute also defines a related health care entity as “an entity with which the medical practitioner has a professional affiliation under which the medical practitioner performs the medical activity.”  Examples include nursing homes, hospitals, universities, medical schools, HMOs, group medical practices, or medical clinics.  The statute also defines professional affiliation as generally requiring some type of contractual or employment relationship, staff privilege or membership.

Next, what type of medical activity falls within the defense?  The statute defines medical activity as “performance of a medical or surgical procedure on a body,” but then makes several very big exclusions from the definition.  The defense does not apply to methods of use of a patented machine, manufacture, or composition of matter; nor does the defense cover the practice of a process in violation of a biotechnology patent.

The bottom line is that the defense applies to a relatively small number of patents directed to pure surgical or diagnostic procedures that are performed on a patient and that do not involve drugs or reagents to accomplish the result.

What Should You Do?
If you are accused of infringing another party’s patent, it’s advisable to speak with a patent attorney, who can assist you in determining the types of defenses that may be available, as well as an appropriate response to the party making the accusation.

The patent system can be a complicated and intricate experience.  It is usually best to obtain advice from a patent attorney at an early stage in the process.

Matt Osenga is a registered patent attorney with Goodman Allen Donnelly. His practice includes all aspects of patent prosecution before the US Patent & Trademark Office, as well as other aspects of patent law, including foreign patenting, patent infringement, and patent opinions. www.goodmanallen.com

Rotator Cuff Repair

Rotator Cuff Repair:
Advances in non-surgical care and the operating room benefit patients of all ages
By Samuel Brown, MD

Effective repair of rotator cuff tears is frequently possible in most patients, no matter how major their injury or advanced their age.

However, the best results depend on prompt and accurate diagnosis, effective use of non-invasive therapies or surgery, and carefully managed rehabilitation. Specialized care can help almost all patients return to their favorite activities and avoid long term shoulder pain and arthritis.

Tears of the rotator cuff – a group of four muscles and their tendons that converge at the greater tuberosity of the humerus in the shoulder – are extremely common. Tears can be acute or degenerative, caused by falls, repetitive stresses in athletics or normal wear-and-tear of age. They are often preceded by a condition called shoulder impingement syndrome, which is compression of the rotator cuff in the narrow subacromial space.

One common misconception is that everyone with a rotator cuff “tear” requires surgery. In fact, many patients with partial tears or worn, fraying areas of a tendon can improve without surgery. Non-steroidal anti-inflammatory medications, strengthening exercises and physical therapy may help. Others with more serious tears will benefit from arthroscopic surgery, a minimally-invasive outpatient procedure.

Full-thickness tears, in which the tendon is torn away from the bone, are more significant. New suture anchors and techniques have reduced surgical times, minimized the rate of complications and allowed us to fix injuries once considered “untreatable”.

The rehabilitation period remains significant, requiring gradual but steady strengthening without risking another tear. Physical therapy may range from six to eight weeks up to two to three months, depending on a patient’s injury and age. Since each individual is different, long-term success is best achieved with close coordination between a surgeon and physical therapy team. Every case is different.

Early diagnosis and intervention is critical. Symptoms of rotator cuff injury include night pain and pain with activity; discomfort when raising or lowering the arm, weakness when lifting or rotating the arm and a grinding sensation with shoulder movement also may occur.

If left untreated, damage can progress to adhesive capsulitis, or frozen shoulder syndrome, which is marked by extreme stiffness and pain, limited range of motion and the development of scar tissue that complicates any future attempt at repair and rehabilitation. Unrepaired patients also might suffer from cuff tear arthropathy, a debilitating form of shoulder arthritis.

As a result, we encourage primary care physicians to refer patients of all ages – not just the young or athletic – to a specialist. Even patients in their 80s and 90s can see a dramatic improvement in their daily lives with proper care. Our philosophy is that a patient doesn’t have to be a professional athlete to be treated like one!

Dr. Brown is an Orthopaedic Surgeon and specialist in Sports Medicine, with fellowship training in shoulder disorder.  He is one of the original members of Sports Medicine & Orthopaedic Center, Inc., and recently became President of the Southern Orthopaedic Association. smoc-pt.com

 

Understanding Your Patient

Understanding Your Patient
…a new column dedicated to easing the administrative burdens on physicians and their staffs


As the shift to value-based reimbursement continues, payers are more and more tying a portion of reimbursement to patient satisfaction scores, measurement of quality of care and the values it brings to the patient and ultimately to the health care system – all of which is requiring physicians and their staffs to place an even greater emphasis on understanding each patient’s unique personal and healthcare needs.  Even in the era of savvy younger patients who readily access reliable medical information on the Internet and routinely monitor their own health through medical portals and practice websites, this can be an onerous task for physicians and their staffs.

In the case of older patients, who can be notoriously poor historians, it’s even more of a time-consuming challenge for the physician to fully understand each patient’s personal profile.

For a particular subset of this population, at least, the United States government is offering some much needed help.  Dr. Scott Kruger of Virginia Oncology Associates, explains:

“The biggest change that’s happening nationwide is the Oncology Care Model, or OCM project,” Dr. Kruger says. “There are roughly 195 oncology groups participating across the U.S.  For the first time, Medicare is giving us access to something they’ve never, ever given any group of doctors before:  Medicare claims data.”  In short, Medicare is letting these physicians know how many times their patients visit an emergency room or are admitted to the hospital, for whatever reason.  “It’s a huge data base that we’ve never seen before,” Dr. Kruger says, “so I’m learning that some of our patients are going to the emergency department for non-oncology related reasons.  Now I can look at whether that might have anything to do with our care, or with the medications we’re giving. Unfortunately, unless they tell us specifically, we don’t really know who our patients are seeing, why they’re seeing someone, or what they’re doing.”

Essentially, Medicare wants OCM participants to make an oncology home for these people.  They want to work with oncologists to see why patients are going to the hospital, why to the emergency room, and how oncologists can coordinate together with other caregivers to improve quality care.  “Medicare is working with us to develop a new model of patient care,” Dr. Kruger says.

There are a host of requirements to participate in the OCM, including ensuring a nurse navigator is available to each patient, and recruiting and training record-keeping personnel.  But there too, Medicare is offering financial support.

OCM incorporates a two-part payment system for participating practices, creating incentives to improve the quality of care and furnish enhanced services for beneficiaries who undergo chemotherapy treatment for a cancer diagnosis. The two forms of payment include a per-beneficiary Monthly Enhanced Oncology Services (MEOS) payment for the duration of the episode and the potential for a performance-based payment for episodes of chemotherapy care. The $160 MEOS payment assists participating practices in effectively managing and coordinating care for oncology patients during episodes of care, while the potential for performance-based payment incentivizes practices to lower the total cost of care and improve care for beneficiaries during treatment episodes.

“Now, in addition to knowing the oncology piece of each patient’s care, we have access to information about heart disease, vascular disease, diabetes, and other conditions,” Dr. Kruger says.  “This is giving us a much clearer snapshot of who each patient is.  And when we understand the whole patient, we can decrease complications in those with major diseases.  Knowing what’s going on can help us devise programs to help the patient access the health care system earlier, before complications come up.”

The OCM project has only been in place since July, but Dr. Kruger notes, “I honestly think this is the medicine of the future.”

How Colon Cancer Treatment Redefined Preventable Blindness Worldwide

By Kapil G. Kapoor, MD,  Wagner Macula and Retina Center

In 2013, a group of prominent historians were surveyed and asked to compile a list of the greatest breakthroughs of all time.  While some items on the list were clearly revolutionary – such as electricity (#2) and the Internet (#9) others seemed humdrum by comparison (paper at #6!), but clearly chosen for the ripple effects they would have on history and society.

If we similarly compiled a list of the greatest breakthroughs in retinal medicine, we would need go no further than the topic of colon cancer to unveil one of the true gems. Perhaps the single most dramatic therapeutic change in retinal medicine had its origins in colorectal cancer treatment.

In 2004, the FDA approved bevacizumab (Avastin) for the treatment of metastatic colon cancer.  Bevacizumab is a humanized monoclonal antibody that inhibits vascular endothelial growth factor (VEGF) by shrinking blood vessels. Bevacizumab proved a potent chemotherapeutic adjunct, inducing tumor regression by inhibiting growth of the very blood vessels tumors critically rely on for their own growth.

New blood vessel growth is a significant source of pathology in retinal disease, most notably in wet age-related macular degeneration (AMD). With advancing age, the retinal basement membrane degenerates, and a lack of oxygen and nutrients signals development of new blood vessels. Rather than recruiting oxygen and improving the nutrient stores, these new blood vessels, or choroidal neovascular membranes, break through the retinal surface and leak blood and fluid into the retinal layers, often resulting in a severe disruption of central vision.  This quickly compounds when we realize how quickly wet AMD can lead to legal blindness, and how prevalent AMD is – affecting over 20 million Americans!

Just over a decade ago, the only reasonable treatment for these blood vessels was laser treatment that often just slowed blood vessel growth, with ineffectual lasting effect. There was no known way to reverse vision loss – all treatment focused on preventing or slowing the inevitable vision loss.

Anti-VEGF heralded an entire new era, with impressive results. Randomized controlled trials have revealed that nearly half of patients are able to significantly reverse vision loss, improving vision by at least three lines on the eye chart. Additionally, approximately 95 percent can successfully prevent further significant loss of vision

– a huge improvement!

It soon became apparent that this treatment would work in several other cancers by inhibiting VEGF, thus gaining multiple other FDA approvals. Similarly, in retinal medicine, bevacizumab and its cohort of other anti-VEGF teammates have expanded their scope to a range of retinal pathologies, prominently diabetic retinopathy and retinal vascular occlusions – that similarly produce new blood vessels intent on stealing vision.

Whereas wet AMD was a nearly irreversible source of vision loss a decade ago, it now has superb treatments that can keep patients with wet AMD driving, reading, and continuing their day-to-day activities for years!

It’s easy to take our present outcomes for granted, and even easier to forget the critical need for continued innovation. Research and development have always been the foundation of progress in medicine, the cornerstone upon which we expand our patient outcomes. The jump from using anti-VEGF in colorectal cancer to using it in the eye was one of those breakthrough moments.

The very next innovation may be developing as we speak.  Currently, multiple clinical trials are ongoing at our research center, investigating treatments across a breadth of retinal pathology, notably the dry and wet forms of age-related macular degeneration and diabetic retinopathy – the leading causes of blindness in adults in the United States today.  These innovative treatments no longer require a trek out of town, and we look forward to your collaboration in expanding and communicating the availability of these research opportunities to your patients and colleagues.

Kapil G. Kapoor, MD  is a Board certified ophthalmologist specializing in vitreoretinal surgery.   wagnerretina.com

World Class Weaponry

Stereotactic Radiosurgery offers cutting-edge precision in the battle against cancer
By Biral S. Amin, MD

Stereotactic Radiosurgery has changed the outlook for many cancer patients once at a high risk of complications from radiation treatment – or with little chance of recovery at all.

Two remarkable systems at the Radiosurgery Center, the Leksell Gamma Knife and Synergy S, can deliver high doses of radiation to abnormal tissues in the brain and body in an extremely precise manner.

These non-invasive therapies increase the concentration of radiation we can deliver to unhealthy tissue yet spare surrounding healthy tissue from damage. With no incisions involved, they also limit blood loss and pain, promote quicker healing and offer new hope to patients who have undergone previous cancer treatments without success.

The Gamma Knife

The Gamma Knife simultaneously aims 194 powerful beams of cobalt radiation at a single site inside the brain. The outpatient procedure has evolved into the gold standard for treatment of metastatic brain tumors and also can target primary small primary tumors, arteriovenous malformations (AVM), trigeminal neuralgia (TN), vestibular neuroma (VN) and other benign conditions.

As a result, patients who once faced grueling open surgery, lengthy hospital stays and taxing recovery periods can return almost immediately to their pretreatment activities. They also demonstrate improved long-term cognitive function compared to those who undergo whole-brain radiation.

Synergy S, meanwhile, can be effective on cancers throughout the body, including the lung, breast, prostate, pancreas, spine and liver, as well as on brain tumors not accessible by the Gamma Knife. The system pairs a linear accelerator with real-time visualization of internal structures, including soft tissues, in a three-dimensional format. The combination allows surgeons to blast cancerous growths and lesions with incredible accuracy, even if tumors or organs shift during radiation treatment.

Synergy S

Synergy S can help patients who are not surgical candidates and/or have difficult-to-reach cancers such as tiny lung tumors or a small metastasis away from the original disease site. By dramatically narrowing the treatment field, the system also benefits patients who have had previous doses of conventional radiation that have already impacted nearby tissues.

Stereotactic Radiation has constantly evolved since its initial introduction in 1951. In the last five years alone, we have made significant progress in our ability to immobilize patients during treatment; pinpoint, map and track cancers; and instantly switch radiation beams on and off based on even the most incremental tumor movement during surgery.

This innovative technology, made possible by a partnership between Riverside Health System, the University of Virginia Health System and Chesapeake Regional Medical Center, will continue to change the lives of cancer patients in Hampton Roads well into the future.

Dr. Amin practices at the Radiosurgery Center at Riverside Regional Medical Center in Newport News. He is Board certified by the American Board of Radiation/Radiation Oncology and treats all cancer sites, with a special interest in head and neck tumors and prostate brachytherapy. riversideonline.com/cancer

 

Medical Update Winter 2017

Colorectal Cancer

Despite advances made in the diagnosis and treatment of colorectal cancer, the disease continues to maintain its hold as the second leading cause of cancer-related deaths in the United States, and the third most common cancer in both men and women.  Unfortunately, the statistics are even worse in Hampton Roads.  Bruce Waldholtz, MD, a gastroenterologist with Gastroenterology & Liver Specialists of Tidewater, cites a 2015 study published by epidemiologist Rebecca Siegel, MPH in Cancer Epidemiology, Biomarkers & Prevention, reporting that the Eastern Virginia/Northeast North Carolina region is one of three hot spots in the United States for colorectal cancer, with a nine percent higher mortality rate than the rest of the country.

And yet it remains a fact that half of all U.S. colon cancer deaths a year could be prevented if everyone 50 and older were screened. And even when not prevented, colon cancer in its early stages is highly curable, with a five-year survival rate of 90 percent. However, only 39 percent of colon cancers are detected at this stage.

The main reason, of course, is that people aren’t getting screened.  “Colon cancer screening right now is at about 50 to 55 percent,” says Marybeth Hughes, MD, Chief of the Division of Surgical Oncology at EVMS.  “It’s woefully inadequate.”

So inadequate, in fact, that the National Colorectal Cancer Roundtable has launched the “80% by 2018” initiative.

80% by 2018 – An Ambitious But Achievable Goal
Hundreds of organizations and care providers across the country have committed to substantially reducing colorectal cancer as a major public health problem for those 50 and older (45 for African Americans).These organizations are working toward the shared goal of 80 percent of adults aged 50 and older being regularly screened for colorectal cancer by 2018. The initiative is led by the American Cancer Society (ACS), the Centers for Disease Control and Prevention (CDC) with the NCCR.  The 80% by 2018 website states that “If we can achieve 80% by 2018, 277,000 cases and 203,000 colorectal cancer deaths would be prevented by 2030.”

All of the physicians interviewed for this article believe it’s an achievable goal, and all are involved in the initiative.  “Bon Secours received a grant from NIH, which we used to hire personnel to visit primary care physicians’ offices and go through patient charts to identify those who need colonoscopy,” says Joseph Frenkel, MD, a colorectal surgeon with Bon Secours Maryview Medical Center, “and then trying to navigate them to a gastroenterologist or colorectal specialist for that screening.”  Similarly, reports Sentara Cancer Network colorectal surgeon William Rudolph, MD, “Sentara Medical Group physicians are leveraging the power of the electronic medical record to proactively trigger screening reminders.”

“We do a lot of outreach on 80% by 18, monthly lectures, speaking with church and civic groups and the like,” says Brian Billings, MD, a colorectal surgeon with Riverside Health System. “We’ll screen any appropriate patient who comes through our doors.”

The initiative is aimed not just at the general public, Dr. Hughes says, “but also at primary care physicians.  When patients come in for regular checkups – cholesterol, blood pressure, etc. – or indeed, for any office visit, these physicians should be asking about colonoscopy, and urging their eligible patients to schedule them.”

The gold standard for screening, of course, is colonoscopy, which unfortunately many patients simply refuse for a variety of reasons, not the least of which is the prep.  It’s the number one complaint patients have.  “We’re better with preps than we used to be,” says Dr. Billings.    “We’re using Miralax, a low volume prep that’s easily tolerated.”  And it may soon get more palatable, Dr. Waldholtz explains:  a Boston-based company, ColonaryConcepts, is developing bowel-cleaning food bars and drinks that taste more like fruit smoothies and chocolate.  “These have shown good results thus far,” Dr. Waldholtz says.  “They’re not commercially available yet, but ColonaryConcepts is scheduled to begin phase 3 trials in early 2017, so we might see them enter the market by 2018.”

Noncolonoscopy Screenings
Fifteen years ago, virtual colonography was introduced, looking for a less invasive way to diagnose patients, and select out those who actually needed the full colonoscopy for follow up.  While effective at finding polyps a centimeter or greater, it can’t determine which are simply polyps and which are cancer.  Another problem with colonography is that it was developed “in an era when we weren’t really looking at flat polyps,” Dr. Billings says.  “These are subtle, and easily missed by the CT.  But for patients whose anatomy won’t allow colonoscopy, or who can’t tolerate it, there is an application for virtual colonography.”

The newest iterations of screening tests include the Fecal Immunochemical Test (FIT) and stool DNA tests.  These are attractive to patients because they can be done at home, and while better than no screening at all, both of these can miss many polyps and some cancers.  The FIT test can produce false positive test results.  In both cases, if the results are abnormal, colonoscopy screening is indicated. Dr. Frenkel explains, “The biggest problem with these tests is they’re just not as accurate or therapeutic as colonoscopy.  They’re good at ruling out cancer, and for someone who can’t have a colonoscopy, that’s promising.  So there’s a place for them with very elderly or highly comorbid patients, but beyond that, I don’t use them.”

“These screening tests are better than the stool tests we’ve had in the past,” says Ray Ramirez, MD, a colon and rectal surgeon with Chesapeake Surgical Specialists.  “But they are not indicated for people with a history of polyps or a first degree relative with a history of colon cancer.”

These newer screening tests are included in the recently published Recommendations of the U.S. Multi-Society Task Force on Colorectal Cancer, which again confirm the primacy of the colonoscopy, Dr. Hughes says.  The new guidelines have expanded, she says: “If you have a first degree family member, you should have your first screening when you are 10 years younger than that relative was diagnosed.  For instance, if your sister got colon cancer at 45, your colonoscopies should start when you are 35.”

“It’s true that a DNA or FIT test is better than nothing,” Dr. Rudolph says, but cautions, “These tests are adequate at picking up cancers – we’re talking about 70 to 90 percent sensitivity – but advanced adenomas, precancerous polyps, aren’t picked up by the standard DNA test.  And getting the polyps out before they turn into cancers has made a huge impact.”

David Z. Chang, MD, a medical oncologist with Virginia Oncology Associates, confirms.  “With screening colonoscopy, when polyps are found, we can actually prevent cancer by taking out the polyp.  Even if it is cancer, it’s very curable in its early stages. For example, in Stage I, 95 percent of patients can be cured by surgery alone.  Unfortunately, without screening colonoscopy, by the time people present with symptoms and come to see surgical oncologists, they likely already have cancer, likely beyond Stage I.”

Genetic Tests
“There are colon cancers that act differently,” Dr. Hughes says.  “Some are well differentiated, some poorly.  And there are other markers, like BRAF, KRAS mutations that can help us guide the biologic behavior of these tumors.”

Knowing that wouldn’t dictate the type of surgery performed, she adds.  A lot of that information is gleaned after the specimen is removed.  “We’re also looking at micro-satellite instability, in the subset of patients who have problems with their repair genes.  In these patients, when a cell divides, it makes a mistake, and the four repair genes that we look at are compromised, so these patients are at higher risk for another cancer.  They don’t respond as well to chemotherapy.”

“The discovery of micro-satellite instability in colorectal tumors has increased our awareness of the diversity of colorectal cancers,” Dr. Chang adds, “and their implications for specialized management of patients, for example, using the modern immunotherapy.”

There are other genetic abnormalities that can occur as well, Dr. Rudolph notes, including Lynch Syndrome and familial polyposis.  “We have standard genetic tests, looking for these conditions,” he says.  “In fact, for three years, nearly 100 percent of cancer specimens obtained from Sentara’s colonoscopy or surgery patients have undergone testing,” giving patients’ family members the opportunity to be tested and seek treatment.  For example, if a family member tests positive for Lynch Syndrome, one of the options is either to screen the colon on a yearly basis, or to have a partial colectomy.  And some women, if they are beyond childbearing years, may choose to undergo prophylactic oophorectomy or hysterectomy.

“We’re starting to see some of the fruits of our genetic work,” Dr. Billings says, “and really starting to understand the genetic mutations that are driving these tumors.  So the future is going to see us more and more tailoring therapy to individuals.”  Tumors are different, he explains, some slow growing and easy to treat, while others are very aggressive and fast.  “We can’t really tell the difference between them, other than that some patients do well and some poorly.  Now we’re starting to be able to take these tumors apart genetically, and look for markers that can tell us if the patient has an aggressive tumor.”

Colorectal Surgeries
The procedure the surgeon chooses depends on where the tumor is, each patient’s unique presentation and anatomy, whether there have been multiple prior surgeries, and other conditions, including obesity.

For Stage I, II and even III, surgery is always an essential part of treatment, Dr. Chang says.  And staging determines the prognosis.  “In Stage IV, when cancer has spread to other organs like the liver or lungs, it has traditionally not been curable.  But today, chemotherapy has become so effective that we are sometimes able to shrink cancer in the liver to allow surgery to remove it.  Looking at the data from M. D. Anderson and other institutes, between 40 and 60 percent of these patients can become long-term survivors after liver metastasis resection, basically cured and living relatively comfortable lives.”

Among the most significant advances in the field of colorectal cancer are the new surgical techniques that are being employed today, and especially those being contemplated.  “It’s acceptable to do an open colon with an old-fashioned incision,” Dr. Hughes says, “although more surgeons are doing laparoscopic colectomies, which make it easier on the patient to recover.  More and more minimally invasive procedures will be done in the future.”  Nationally, only about a third of colon cancer surgery is now being done minimally invasive, adds Dr. Ramirez, who teaches the technique to residents and surgeons several times a year.  “That, to me, is one area where we can improve, because of the many benefits to the patient.”

Today, some surgeons believe robotic surgery affords better visualization in the pelvis, especially in men with their smaller pelvises, because the magnification on the camera is better than laparoscopic, especially for low rectal surgery.

Robotic surgery solves one of the persistent problems with traditional laparoscopic surgery, says Dr. Rudolph, who performs robotic colorectal procedures at his home base at Sentara Virginia Beach General Hospital, and also at Bon Secours DePaul Medical Center, both of which house a daVinci Xi® system.  “The generation of the Xi robot at DePaul was specifically designed – in part, at least – for colorectal surgery,” Dr. Frenkel says, “because unlike some of the other surgeries that are done robotically, colorectal surgeons sometimes need to be in more than one corner of the abdominal cavity.  For example, in a patient having rectal cancer surgery, we may need to remove a portion of their sigmoid colon.  It was difficult for the older robot to go into different areas because of the way it was built.  With the newer Xi, we can go to different areas more easily.  I love the greater visualization and the ease it allows me to dissect the rectum.”  That matters, he adds, because in rectal cancer surgery, the quality of the dissection is extremely important as it relates to patient outcomes oncologically.

“Fine movements and the ability to dissect very precisely just aren’t possible with straight laparoscopy,” Dr. Rudolph explains.  “It’s like using chopsticks.”  But with the daVinci robot, he says, “we have fully articulated motions with our instruments, allowing us to get into areas we normally wouldn’t be able to get into, with precision we normally wouldn’t have.”  Since employing the Xi, Dr. Rudolph confirms that robotic surgery has improved his patients’ recovery, significantly reduced hospital stays and lessened complications.

Dr. Frenkel, a proponent of single incision surgery, has recently begun doing surgeries robotically as well, and agrees wholeheartedly.  And with the recent installation of a new daVinci Xi® system at Bon Secours Maryview Medical Center, there is now a third location where surgeons can perform the procedure.

What’s Next?
Colorectal Cancer Treatment 5-10-15 Years From Now.
Colorectal cancer is being studied across the country with a view toward prevention and cure.  An ongoing local research project is an Alliance trial: N1048, looking at patients with rectal cancer who are candidates for curative intent sphincter-sparing surgery – without high risk features such as tumor encroaching upon the mesorectal fascia or distal tumors.

“The biggest hope I have in terms of treating colon cancer is immunotherapy,” says Dr. Chang.  “It’s been around for many years, but becoming more popular recently as we see more effective immunotherapy agents approved for various cancers, e.g., melanoma, lung cancer, kidney cancer, bladder cancer, etc.  However, other than for micro satellite instable colon cancer, immunotherapy hasn’t been as effective in most colon cancer because of the cancer’s different biology. It’s being studied extensively, and I foresee that in 10 years, immunotherapy will be used for colon cancer.  We’re also seeing encouraging results for cancer control from radioembolization in patients whose colon cancer has spread to the liver.”

“There are major advances in the way we treat rectal cancer,” Dr. Rudolph says, “one is the idea that we can treat it locally, or transanally.” Dr. Rudolph emphasizes that transanal surgery is not the standard of care in the United States – yet – but explains: “Normally what we worry about with colorectal cancer is ensuring that we get an adequate sampling of lymph nodes, to ensure that the cancer staging is complete and that there is no residual cancer left. Particularly in rectal cancer, there’s a high risk of recurrence. Because of this, for many rectal cancers we give preoperative chemotherapy and radiation therapy, followed by resection through the abdomen. In some countries, they are now taking out the cancers locally through the anus, sparing patients a very big surgery and possible colostomy. Although we do not have large randomized studies at this point to be able to make this approach the standard of care in the US, in the future this may be a tremendous advantage to our patients.”

Preliminary results outside of the United States are good, but it won’t be available in the US until sufficient data is accrued to ensure equivalency between a transabdominal and a transanal resection.  There are several trials going on in America, but it will take a while to accrue the data.

Perhaps the most dramatic potential change in the treatment of colorectal cancer is the advent of the transanal total mesorectal excision.  “The pioneers in our field are working on ways to do the entire rectal cancer surgery from the anal area,” Dr. Frenkel says, “removing both the tumor and the surrounding lymph nodes, just as it would be done transabdominally.  Many people feel that, as opposed to rectal dissection from the abdomen, which can be challenging when you’re dealing with the prostate or the vagina and uterus, that dissection might become the standard.  We’re only a couple of years into this now, but it’s on the horizon.”

Postsurgical Innovation
A new post-operative protocol being introduced throughout the country is ERAS, Dr. Ramirez says.  “It stands for Enhanced Recovery After Surgery, and the goal is to minimize post-operative pain without the use of narcotics.  The actual prep for surgery is totally different.”  It’s a very involved prep, Dr. Billings notes, that includes having the patient drink a carbohydrate rich drink the night before and the morning of the surgery.  “The patient is given a spinal injection before surgery, and nonnarcotic pain medicine during and immediately after surgery.”

The NIH website defines the key principles of the ERAS protocol as “pre-operative counseling, preoperative nutrition, avoidance of perioperative fasting and carbohydrate loading up to two hours preoperatively,” and calls ERAS “an important focus of perioperative management after colorectal surgery.”

The Bottom Line
Colon and rectal cancers, while not 100 percent preventable, can be treated when detected early, and for that to happen, patients are going to have to make screening – at the age appropriate to their particular medical profile – a priority.  And physicians are going to have to even more aggressively prevail upon their patients to take this life-saving step.

“Don’t fear the scope,” Dr. Hughes urges patients.  “It saves lives.”

And if they won’t have a colonoscopy?  As Dr. Waldholtz says, quoting the American Cancer Society, “The best test is the one that gets done.”

Finding Solutions for Cervical Whiplash

By Scott Bradley, MD, Hampton Roads Orthopaedics & Sports Medicine

Although cervical whiplash is a common injury, the condition is often misdiagnosed and overlooked in patients who might suffer frustrating or debilitating symptoms for months or years.

With specialized training, advanced diagnostic equipment and tailored therapies, we can offer a range of treatment options to erase or ease mild to severe pain.

Whiplash injuries occur with rapid acceleration and deceleration of the head, most often during car accidents. That force can stretch and tear muscles, ligaments and joints between the vertebrae of the neck.

Studies have shown more than 80 percent of people in a car accident sustain some degree of whiplash, while crashes at speeds of as little as five miles per hour can induce a cervical injury. Symptoms can appear weeks or months after an accident.

While mild cases might present with minor neck discomfort and stiffness, moderate to severe cases may include multiple complaints, including headache, dizziness, vision changes, tinnitus and pain or numbness in the neck, shoulder, arm or jaw. Without relief, these patients also are at risk for developing depression, anxiety and insomnia.

Unfortunately, cervical whiplash injuries can be difficult to diagnose because damage to structures in the neck may not appear on imaging tests, and because reported pain may be located away from the neck. By the time many patients reach us, they have consulted with multiple doctors in emergency room and community settings. Frequently, they have received ineffective medication or been told there is nothing physically wrong with them; some have been dismissed as drug-seekers.

By listening closely to clinical symptoms, we often can match pain in a certain area of the body to a specific structure in the neck. In many cases, pain arises from the facet joints, small synovial joints between and behind adjacent vertebrae that provide spinal column stability and allow for proper movement.

Generally, our treatment plans begin with conservative approaches such as anti-inflammatory medications, muscle relaxants and application of heat or ice, along with physical therapy and stretches to loosen and repair shocked muscles. Precise medication management and individualized exercise regimens can relieve many mild cases of whiplash.

For patients with moderate to severe injuries, we can offer advanced diagnostic tests such as nuclear medicine studies and discuss more aggressive therapies. Our goal is to address the source of each person’s pain – not mask it temporarily or rely on a single-angle treatment.

Options include epidural steroid injections or facet joint injections to reduce inflammation. Another promising treatment is radiofrequency ablation (RFA), which burns the nerves that enervate damaged joints. RFA has the potential to block pain for eight to 10 months, giving muscles time to reset and freeing patients to participate fully in physical therapy.

The improvements we see can have a major quality-of-life impact. Many patients greet us with smiles, hugs and joyful stories of finally returning to their regular activities. With patience and persistence, we can find solutions for cervical whiplash.

Dr. Bradley is Board certified in Physical Medicine and Rehabilitation and specializes in disorders of the spine, musculoskeletal system and acute sports-related injuries. He will join Hampton Roads Orthopaedic & Sports Medicine in February 2017, practicing at the New Town office in Williamsburg. www.hrosm.com.

Advanced Practice Provider Winter 2017

Sally Carr, NP-C

Three years ago, after nearly thirty-five years in obstetrics and gynecology – first as a nurse and later as a Certified Nurse Practitioner – Sally Carr knew it was time for a change.  She saw a notice on one of the professional websites she frequented, advertising for a bariatric NP.  “I didn’t really know what that meant,” Carr remembers now, “but the ad mentioned dealing with bioidentical hormones in the female patient, and I had been doing that for 30 years, so I thought I’d apply and at least talk with the physician.”

When Dr. Jennifer Pagador, the founder and medical director of Seriously Weight Loss, reviewed Carr’s resume, she immediately contacted her for an interview.  The physician was so impressed at the interview, she offered Carr the position of Bariatric Nurse Practitioner.  Carr accepted, and found a second career equally satisfying in terms of helping a population of patients with very specific health issues and and needs.

Helping people with health needs has always been at the forefront of Carr’s career decisions.  As a high school student with a decided interest in the sciences, she worked in a pharmacy in her small town of Pittsboro, North Carolina.  She attended pharmacy school, but after two years, she realized that “organic chemistry was never going to be my friend.”  She decided to apply the two years toward a Bachelor of Science in Nursing.  She completed her final two years and earned her BS from Atlantic Christian (now Barton) College.

She worked as a staff nurse at New Hanover Memorial Hospital in Wilmington, as well as at what was then Obici Memorial Hospital.  Just as she was realizing she didn’t care for the constantly changing shifts and weekend work, a fellow nurse suggested they investigate the nurse practitioner program that was coming to Hampton Institute.  They attended the lecture and decided to apply.  Carr graduated in 1982 as a Certified OB/GYN Nurse Practitioner, and worked in the field exclusively until 2013, when she noticed Dr. Pagador’s ad.

The two practices – OB/GYN and bariatric – both involve dealing with bioidentical hormones, but otherwise, Carr’s daily routine is far different working with Dr. Pagador’s Seriously Weight Loss patients.  Where she spent most of her days doing complete physical exams and ordering tests for obstetric and gynecology patients, today she spends more of her one-on-one time with patients counseling them.  “Now I mostly give dietary counseling, encouraging physical activity,” she says.  “Where I was used to standing a lot, and going constantly, now I’m spending time sitting and talking with patients, reviewing how their diet is going, how their exercise regimen is going, how much they’re sleeping, how much stress there is in their lives.”

Patients do have blood tests, and Carr works to help them improve their numbers.  And because Seriously Weight Loss is a medically managed office, patients are administered an EKG.  “Some of the medications we use can affect the heart,” Carr says, “so we have to ensure they’re not going to cause any more problems.  Some patients rarely get EKGs, so we’ve even picked up some problems they weren’t aware of.  We refer them for appropriate care before admitting them to the program.”

The best part of the switch to bariatric practice, Carr says, is that her work is “more rewarding, because these patients actually want to hear what I have to say.”  She explains: “I talked to patients for years and years about health and nutrition, trying to encourage them to lose weight, to become healthier, and nobody listened to me.  Today, my patients listen.  And in return, they regain their health.”

Good Deeds Winter 2017

Ian Persaud, MD, MPH
Medical Director of Cardiology & Specialty Care JenCare Medical Centers

When Dr. Ian Persaud came to Hampton Roads in 2013 to join JenCare Medical Centers, he brought with him a history of volunteerism and service that extended far beyond the borders of the Brooklyn community, where he was a fellow at State University of New York Downstate Medical Center.  Throughout his fellowship, he participated in many of the local and international outreach activities and missions of the Brooklyn Tabernacle and the International Presbyterian Church.

It was only natural, therefore, that he would seek out volunteer and outreach opportunities when he came to Hampton Roads.  These he has found in a number of places.

Since June of 2014, he has been an active member of the Soup Kitchen Ministry at First Presbyterian Church in the Ghent section of Norfolk.  “I really love to cook,” Dr. Persaud says, “it’s a real stress reliever.”  But more importantly, he says, it’s an opportunity to meet people living in the community who, whether just down on their luck or truly impoverished, have interesting stories to tell.  And it’s an opportunity to help them.

Dr. Persaud also participates in the Church’s Video Mission Ministry.  “This was something I got interested in during my fellowship,” he says.  “I worked with the inmates at Riker’s Island.  In New York, many of the families lived close by, so they could visit the inmates regularly.  But locally, many of the inmates’ families are eight hours away or more, so it’s impractical to visit.”  The Video Ministry works with prisons to facilitate on-screen conferences between inmates and their families, much like a Skype session.  “There are inmates who haven’t laid eyes on their family members in years,” Dr. Persaud says.  “Allowing them to have that connection can be very emotional at times, but always gratifying.”

Dr. Persaud also devotes time at the HOPES Clinic, supervising and teaching the medical students who volunteer there.  HOPES, which stands for Health Outreach Partnership of EVMS Students, has served uninsured citizens of Norfolk with long term and specialty care since its founding in 2011.  Until recently, there wasn’t a cardiac clinic at HOPES, and many of the patients who regularly use the clinic have sought attention from area emergency rooms for chest pain, heart failure, or other cardiac conditions.  “Once these patients leave the ER, it’s hard for them to get the necessary follow-up studies like echocardiograms or EKGs,” Dr. Persaud explains.  “So we’ve been identifying the subset of these patients with multiple admissions for heart failure or uncontrolled blood pressure who have been coming to the HOPES clinic, to get them into a specialty clinic, where we can manage them more closely, even doing echocardiogram studies so they don’t have to go elsewhere.”  Dr. Persaud will serve as Medical Director of the Cardiac Specialty Care Clinic, which he anticipated would be fully operational in January 2017.

In all of his community service work, Dr. Persaud likes having time with individuals who might otherwise pass under the radar – to give them some much needed attention.  Whether he’s cooking and serving meals with the soup kitchen ministry, facilitating family video conferences for prisoners, or supervising students who are providing much needed medical care to underserved members of the community, he says, “It’s nice to have a specific skill set that allows me to help them in a particular way.”