December 2015 â€˘ Volume 13 Number 12
Prostate Cancer Samith Kochuparambil, MD
Corneal Inlays By Richard L. Lindstrom, MD, and David R. Hardten, MD
Spinal Surgery H.R. Abbasi, MD, PhD
rehabilitate T oowith rehabilitate aa body, body, we we start start with the the mind mind and and soul. soul.
If you or someone you know needs rehabilitation after an accident, surgery, illness or stroke, we have a If you or someone you know needs rehabilitation after an accident, surgery, illness or stroke, we have a simple premise for you to consider: To recover physically, you need support mentally and emotionally. How simple premise for you to consider: To recover physically, you need support mentally and emotionally. How positive and how determined someone is can make all the difference. We believe the most effective therapy positive and how determined someone is can make all the difference. We believe the most effective therapy treats your body, mind and soul. That’s our approach. treats your body, mind and soul. That’s our approach. Post-acute rehabilitation services from the Good Samaritan Society are offered at multiple inpatient and Post-acute rehabilitation services from the Good Samaritan Society are offered at multiple inpatient and outpatient locations throughout Minnesota and the Minneapolis/St. Paul area. outpatient locations throughout Minnesota and the Minneapolis/St. Paul area. To make a referral or for more information, call us at To make a referral or for more information, call us at (888) GSS-CARE or visit www.good-sam.com/minnesota. (888) GSS-CARE or visit www.good-sam.com/minnesota.
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Minnesota Health care news December 2015
December 2015 • Volume 13 Number 12
4 7 8 10 12 14
Jim Abeler, DC Registered Lobbyist
Maria D. Tudor, MD Fridley Medical Center
By Richard L. Lindstrom,
MD, and David R. Hardten, MD, FACS
Behavioral Health Cyberbullying LPCC
Prostate cancer By Samith Kochuparambil, MD
KAMRA corneal inlays
By Chris Ochocki, MA,
MINNesOTa HeaLTH CaRe ROUNdTabLe
Medical Innovation vs. Medical economics When payment policies limit quality of life
By H.R. Abbasi, MD, PhD,
R espiratory Therapy
Thursday, April 21, 2016 • 1:00-4:00 PM
Downtown minneapolis Hilton and Towers
By Jenny Kratochvil, RRT,
background and focus: The pace of innovation in medical science is rapidly escalating. From more accurate diagnostic equipment, to the use of genomic data, to better surgical techniques and medical devices, to new and more efﬁcacious pharmaceuticals, breakthroughs occur nearly every day. These advances face many challenges when incorporated into medical practice. Several signiﬁcant factors limit this adoption, including the economic models around how patient use of new science will be utilized. Twentieth century health insurance, medical risk management, and reimbursement models are controlling 21st century medical care and patients are the losers.
and Sara Erickson, MD
Walking in the Minnesota winter By Wendy Rader, PT
Rotator cuff injuries By Jason Dieterle, DO, MS
Publisher Mike Starnes | email@example.com Editor Lisa McGowan | firstname.lastname@example.org Associate Editor Richard Ericson | email@example.com Acquisitions Editor Patricia Mata Starnes | firstname.lastname@example.org Art Director Joe Pfahl | email@example.com Office Administrator Amanda Marlow | firstname.lastname@example.org Account Executive Stacey Bush | email@example.com Account Executive Kylie Engle | firstname.lastname@example.org Minnesota Heath Care News is published once a month by Minnesota Physician Publishing, Inc. Our address is 2812 East 26th Street, Minneapolis, MN 55406; phone 612.728.8600; fax 612.728.8601; email mpp@mppub. com. We welcome the submission of manuscripts and letters for possible publication. All views and opinions expressed by authors of published articles are solely those of the authors and do not necessarily represent or express the views of Minnesota Physician Publishing, Inc., or this publication. The contents herein are believed accurate but are not intended to replace medical, legal, tax, business, or other professional advice and counsel. No part of this publication may be reprinted or reproduced without written permission of the publisher. Annual subscriptions (12 copies) are $36.00/ Individual copies are $4.00.
objectives: We will review examples of recent scientiﬁc advances and the difﬁculties they face when becoming part of best medical practice, despite their clear superiority over existing norms. We will look at prevailing thinking behind economic models that govern how health care is paid for today. our panel of industry experts will explore potential solutions to these problems. We will look at ways to create balance between payment models, new technology, and increased quality of life. Please send me tickets at $95.00 per ticket. Tickets may be ordered by phone at (612) 728-8600, by fax at (612) 728-8601, on our website (mppub. com), or by mail. make checks payable to minnesota Physician Publishing. mail orders to mPP, 2812 east 26th Street, mpls, mN 55406. Please note: tickets are non-refundable. Name company Address city, State, ZIP Telephone/FAX card #
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December 2015 Minnesota Health care news
Most Infant Deaths Due to Unsafe Sleep Situations
not being placed on a firm surface like a crib mattress to sleep.
“Data has clarified our message to parents and improved our understanding of what babies need to The Minnesota Department of Human Services (DHS) and Department sleep safely,” said Ed Ehlinger, MD, of Health (MDH) are pushing infant Minnesota commissioner of health. “We can save dozens of infants a sleep recommendations to reduce unexpected infant deaths in the state. year by supporting communities, retailers, parents, grandparents, and They recommend no co-sleeping caregivers in their efforts to have with infants and for infants to sleep infants sleep alone on their backs in without blankets or pillows nearby safety-approved cribs free of pillows after conducting an analysis that and blankets.” showed unsafe sleep environments account for almost all unexpected From August 2002 –2012, 83 infant deaths in Minnesota. Minnesota children died in family child care homes —75 percent died Officials looked at all cases of while in an unsafe sleep situation. sudden unexpected infant deaths in 2014 and discovered that 52 of the 56 babies who died suddenly and unexpectedly were in an unsafe sleep environment. About half of those were sharing a sleep surface, like a bed, couch, or recliner with another person and the other half were in an unsafe sleep position, such as being on their side or stomach, having loose objects like pillows or blankets around them, or
“These prevention measures save lives,” said Jerry Kerber, DHS inspector general. “Since we’ve increased training in safe sleep practices for child care providers, Minnesota has seen a dramatic decrease in infant deaths in licensed child care. In 2013, that number fell to three infant deaths in family child care and in 2014 there was one infant death— which is still one too many.”
Minnesota Health care news December 2015
Guidelines Published on Sharing DNA Information with Relatives A group of researchers has published the first set of consensus guidelines for how researchers should share genomic research results with relatives of those who may share a genetic risk. “These recommendations will have an impact on future human subject protection policies when genetic research is performed,” said Gloria Petersen, PhD, of Mayo Clinic and co-author of the guidelines alongside Susan Wolf, JD, of the University of Minnesota and Barbara Koenig, PhD, of the University of California, San Francisco. The study, funded with a fiveyear, $2.5 million grant from the National Cancer Institute and the National Human Genome Research Institute in 2011, analyzed the legal and ethical issues of providing genetic research results from tissue donated to research bio banks to relatives of the donor. Researchers
consulted with experts in medical genetics and genomics, genetic counseling, genomic research, biobanks and repositories, human research protection, and law. The researchers then developed recommendations offering direction on sharing information before and after the death of an individual research participant. The authors say that until now, researchers have had no guidance on how to balance individual privacy against family members’ need to know crucial information about their potential health conditions. “What makes these issues so challenging is current bioethics, law, and research rules focus on protecting individuals, but genetics is about families,” said Wolf. The authors recommend that researchers should anticipate requests from relatives for results and seek participants’ preferences about sharing results and who should act as their representative after their death, and strive to protect the choices of research participants regarding what information is shared. They also
recommend that relatives, rather than researchers, should be the ones to raise the question of sharing individual results. The authors note that in unusual cases where sharing is likely to avert imminent harm, researchers may be ethically justified in reaching out to the participant’s relatives to offer genomic information.
Summit Orthopedics Announces Merger, Expansion Plans Woodbury-based Summit Orthopedics and Bloomington-based Institute for Low Back and Neck Care (ILBNC) have announced plans to merge practices. Summit Orthopedics has about 650 employees at 16 locations in the east metro area. ILBNC has about 80 employees at its primary clinics in Plymouth and Minneapolis, 11 clinics in greater Minnesota, and a surgery center in Plymouth. Together, the combined practice will have about 720 employees in January 2016 when officials expect the merger to be completed. All of the Summit Orthopedics and ILBNC clinic locations will remain open and the physicians will continue to practice at their current facilities. However, some of ILBNC’s employees at its corporate headquarters will relocate to Summit Orthopedics’ main office in Woodbury in mid-2016. “Today’s spine care environment is fragmented by practices offering either surgical or non-surgical care, with nothing in between that provides a comprehensive yet responsible approach for the well-being of the patient,” said Jack Drogt, MD, president of Summit Orthopedics. “The goal in bringing Summit and ILBNC together is to create more integrated, multidisciplinary spine care services than what currently exists in the Twin Cities health care market.” In addition, Summit Orthopedics has announced plans to break ground on a 65,000-square-foot surgery and treatment center in Eagan in spring 2016. The facility will house “care suites” for advanced spine and total joint replacements, which officials say offer 25 percent lower costs and dramatically
reduced infection rates than traditional hospitals. “Patients undergoing surgery at the Eagan facility will never stay in a hospital, which reduces the cost of orthopedic surgery and improves the overall experience for those patients,” said Adam Berry, CEO of Summit Orthopedics. “Summit’s approach is unique because patients aren’t transported to an off-site building following surgery.”
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Wisconsin-Based Behavioral Health Firm to Open Eden Prairie Location Rogers Behavioral Health System, based in Oconomowoc, Wis., has announced plans to open a treatment center in Eden Prairie in spring 2016. Rogers plans to lease a 10,400- square-foot second-floor space on City West Parkway. “Planned treatment areas include obsessivecompulsive disorder (OCD) and related anxiety disorders, eating disorders, depression and other mood disorders, and post-traumatic stress disorder,” according to a news release. “All programs will serve adults, while the OCD and anxiety programs will also serve children and adolescents. A mix of partial hospital and intensive outpatient programs offering treatment several hours a day is projected.”
The behavioral health firm currently has three hospital campuses and six outpatient locations in Wisconsin. The new facility in Eden Prairie is the fourth regional location Rogers has opened since September 2014, in addition to outpatient programs in Tampa, the Chicago area, and Nashville. “There continues to be a growing demand for mental health services,” said James Ledbetter, vice president of regional partial hospital operations at Rogers Behavioral Health System. “We believe we offer an expertise and commitment to specialized services that can help fill needs in each of the markets we’ve entered.”
H2462_92682 Accepted 10/14/2015 HealthPartners is a Cost plan with a Medicare contract. Enrollment in HealthPartners depends on contract renewal. ©2015 HealthPartners
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December 2015 Minnesota Health care news
News from page 5
State Receives Behavioral Health Planning Grant The Minnesota Department of Human Services has received a $982,000 federal grant to support community-based treatment for mental and substance use disorders in an effort to improve behavioral health care. This is the first phase of a two-phase process that supports planning for certified community behavioral health clinics, including soliciting input from stakeholders, establishing prospective payment systems for demonstration reimbursable services, and preparing an application to participate in the demonstration program. “The planning grants will help the state strengthen payment for behavioral health services for Medicaid and CHIP beneficiaries, and will help individuals with mental and substance abuse disorders obtain the health care they need to maintain their health and
well-being,” said Vikki Wachino, deputy director of the Centers for Medicare & Medicaid Services (CMS) and director of the Center for Medicaid and CHIP Services. The planning phase will end in October 2016, at which point grantees will have the opportunity to apply to participate in the two-year demonstration program that will begin January 2017. These grants are part of a comprehensive effort to integrate behavioral health homes with physical health care. “We see this program as a game changer in our efforts to improve care, quality, and access to services,” said Kana Enomoto, acting administrator at the Substance Abuse and Mental Health Services Administration (SAMHSA). “Today’s awards will assist states in working closely with community clinics to bring together essential behavioral health services, integrate primary care services, and improve quality and data reporting systems.” In total, $22.9 million in grants were awarded to 24 states to
Don’t Suffer Alone
certify community behavioral health clinics through the SAMHSA, in conjunction with CMS and the Assistant Secretary of Planning and Evaluation.
and specialty services, same-day surgery center, radiology services, an outpatient pharmacy, and a comprehensive cancer center. It is expected to open in 2018.
HCMC Expanding, Consolidating in Downtown Minneapolis
“Right now our primary care and specialty care clinics downtown are spread across nine buildings that we own or lease. Bringing them together into one building will make it more convenient for our patients and more efficient for our staff,” Jon Pryor, HCMC CEO said when the plan was announced.
Hennepin County Medical Center (HCMC) broke ground on construction of a new 377,000-square-foot clinic and specialty center on Nov. 12 in downtown Minneapolis. HCMC has been planning for this new building since 2013. The $220.8 million ambulatory outpatient specialty center will consolidate 40 clinics and specialty services currently spread across nine buildings within the five blocks of its downtown campus into one location with six floors and 377,000 square feet. It will house a combination of clinics and services, including 27 outpatient clinics for primary care
In addition to the groundbreaking, HCMC saw the inaugural helicopter land on its new helistop, located on the roof of the building that houses the emergency department, operating rooms, and intensive care units. The new $3.8 million helistop doubles the capacity to receive trauma patients by air and reduces transport time to the hospital, according to officials. The original helistop, located on top of a nearby parking ramp, will remain available for when multiple patients are being transported to the hospital by air.
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Minnesota Health care news December 2015
People Kim McConnell, MD, neurodevelopmental pediatrician at Gillette Children’s Specialty Healthcare, has received the Family Voices of Minnesota Family Champion Award for her commitment to family-centered care. She was chosen from a group of health care providers and professionals from across Minnesota that were nominated by families. Kim McConnell, McConnell specializes in the early diagnosis and MD treatment of developmental conditions; cerebral palsy; abnormalities in muscle tone; developmental brain abnormalities; Down syndrome; autism spectrum disorders; behavioral and learning difficulties associated with children who have disabilities; and prenatal drug effects. McConnell graduated from the Medical College of Wisconsin and completed her pediatric residency at Children’s Hospital Medical Center in Cincinnati, Ohio. She completed her fellowship in child development and developmental disabilities at the Child Development Center at Rhode Island Hospital. Mariam Anwar, MBBS, has joined Hennepin County Medical Center (HCMC). Anwar earned her medical degree at Aga Khan University in Karachi, Pakistan. She completed an internal medicine residency and a fellowship in geriatric medicine at HCMC. She then worked in a community clinic with a large group of Somali patients before returnMariam Anwar, ing to HCMC. Anwar has a special interest in the MBBS care of the elderly, polypharmacy, osteoporosis, mental health, and chronic medical conditions including diabetes, heart failure, and chronic kidney disease. Ronald Holmgren, MD, president and CEO of Affiliated Community Medical Centers (ACMC) and physician at its Willmar clinic, has received the 2015 ACMC Physician Excellence Award. Holmgren earned his medical degree from the University of Minnesota, completed his internship in family practice at St. Paul Ramsey Hospital, and Ronald completed his residency in family practice at North Holmgren, MD Memorial Hospital. Holmgren has been a part of the ACMC leadership team for most of his time with the organization, serving on the board of directors for many years, as medical director, and now as president and CEO since 2000. He is also the president of Affiliated Community Health Foundation. Holmgren plans to step down from his role as president and CEO when he retires at the end of 2015. Natalia Dorland, MD, has joined the Minneapolis Clinic of Neurology’s Maple Grove location. She also provides neurology consultations at Maple Grove Hospital and North Memorial Medical Center. Dorland earned her medical degree at St. Petersburg State I.P. Pavlov Medical University in the Russian Federation. She completed her neuroloNatalia Dorland, gy residency and clinical neurophysiology fellowship MD at the Medical College of Wisconsin. She provides general neurology services in addition to specializing in epilepsy and EEG interpretation.
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P e r s pect i v e
Shaping health care legislation How you can be involved
he thought of engaging in today’s political process is daunting enough to make many citizens consider getting a root canal instead. But you can affect the legislative process, protecting your future, and even your present.
Jim Abeler, DC Abeler Chiropractic Clinic Dr. Abeler is a former Republican member of the Minnesota House of Representatives, representing District 35A, the cities of Anoka and Ramsey. He served from 1999 to 2015. He chaired the House Health Care Cost Containment Division and the Health and Human Services Finance Committee. Dr. Abeler practices at Abeler Chiropractic in Anoka. He is currently a registered lobbyist, working on health- and education-related topics. He recently announced his candidacy for the Minnesota State Senate (District 35).
Everyday citizens helped Minnesota to enact its own health care reforms years before the federal Affordable Care Act, and provided input on laws governing lead paint exposure, public health in the schools, workplace safety, second-hand smoke, and air quality, to name just a few. You might have your own concerns: health care standards at the salon or tattoo parlor, special needs of the elderly, playground safety, public accessibility, the special needs of your business or profession…concerns that ought to find a way into state law.
thoughts ahead of time. This is important whether you are representing yourself, a community organization, or a company or association with a paid lobbyist. Working with lobbyists has its advantages, since they know processes, who your profession’s friends are, and, even more importantly, who the enemies are. The Minnesota Campaign Finance and Public Disclosure Board lists lobbyists representing associations and subject areas at www.cfboard. state.mn.us/lob_lists.html; if you have never worked with a lobbyist and wish to do so, you might start there. But if you have to go it alone, not to worry. Most legislative staffers are used to that and will attempt to guide you.
Don’t fear the process.
The problem: Most legislators hail from across the state, with wildly divergent backgrounds and little if any practical experience in your particular interests. They rely on other elected officials to make remarkably far-reaching decisions for them, or base decisions on brief, staff-provided summaries. The few legislators who are close to the process often get a near blank check to write most anything they want. The rest often vote for or against what amounts to a slogan. One simple answer: more people should engage with each and every elected official in the country. The good news is that it starts with a single contact.
Some tips on working with legislators: Don’t fear the process. It’s no more scary than raising kids, sifting through business files, or satisfying cranky customers. Pick up the phone or head down to the Capitol building. They really are waiting to meet you, and will be glad you came. You might want to call ahead for an appointment; look for your legislator’s contact information at www.leg.state.mn.us/ leg/legdir.aspx. (Unsure of your legislative district? Visit www.leg.state.mn.us/leg/districtfinder.aspx.)
Come prepared. You might enjoy reading repair manuals on vacations, but most legislators appreciate a brief executive summary of your thoughts. Ask what they know about your topic so you can know where to spend your time. This is your chance to shape their thinking, and you may pave the way for future meetings. You can be their expert on one or more topics, and they will come to trust you. Plan to follow up from time to time. Again, this is vital whether you work with a lobbyist or as an individual. Lobbyists often publish a list of pending legislation that they deem positive, neutral, or negative to the organizations they represent. As you review these lists, your opinions may diverge from what your lobbyist or professional organization is saying. Engage your colleagues in dialogue. There is a chance they never considered your perspective and will welcome the input. However, keep your head low, since in too many cases these servants of your cause don’t want any advice and will rebel at your impertinence. If you’re going it alone, do your homework, read the paper, pay attention to the news, and stay engaged. It’s more difficult if you’re a team of one, but you can still do it. Join forces with others. Your profession, community group, or like-minded neighbors could all form legislative committees. Join up—or organize them on your own—and advocate for your own perspectives. It takes some work, but at the end of all this effort, you will see some fruit for your labor. More dangerous yet, you might just decide to run for office.
Enjoy the meeting. The legislator will look surprisingly like the people you see everyday; you may even know their family or acquaintances. While some have egos the size of Mount Rushmore, most are surprisingly pleased you are visiting and will want to hear what you have to say. You may discover that you are one of the few from your community or profession who has come calling, and you could be a valuable resource.
There ought to be a law
Be polite and relaxed, but get to the point. The average meeting is just 15 minutes, so organize your
Your family, your community, your profession, and your future are depending on you.
Minnesota Health care news December 2015
Done well, engaging in the political process is an interesting, invigorating, beneficial way to invest some of your precious hours. Bring a friend or colleague, and watch your influence make a difference.
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Stroke — a vascular malfunction in the brain Maria D. Tudor, MD Dr. Tudor practices internal medicine at Multicare Associates’ Fridley Medical Center. What is a stroke? A stroke is a condition resulting from a sudden interruption of the blood supply (either due to a blockage or to a bleeding) to an organ, in most cases, the brain. When blood flow to an area of the brain is cut off, brain cells are deprived of oxygen and begin to die. This is why patients who experience a stroke often have lasting issues with memory and muscle control. In 2014, 5 percent of all deaths in Minnesota were related to strokes. Some 2,172 total people died of strokes in 2014, making it the fifth leading cause of death. Roughly 90,000 Minnesotans have experienced a stroke. What are the symptoms of a stroke? The symptoms of a stroke depend on the site of the brain affected. Common symptoms of stroke are the sudden onset of one or more of the following: weakness, numbness or an inability to move the face, arm, or leg, especially if on one side of the body; slurred speech or confusion or the inability to understand speech; loss of vision in one or both eyes; severe headache without a known cause; and trouble walking, dizziness, and loss of balance or coordination. Some simple ways to identify a stroke in a loved one include asking them to smile and noticing if one side of the face droops. If you ask them to repeat a sentence, do they look confused or slur their speech? If yes, act immediately and call 911. Sometimes the symptoms of stroke can disappear in time. Other times they are permanent, even with treatment.
Minnesota Health care news December 2015
What is a Transient Ischemic Attack (TIA)? A Transient Ischemic Attack is a brief strokelike attack due to a temporary artery blockage in the brain. The TIA symptoms typically resolve within 24 hours. Generally a TIA doesn’t cause permanent damage, but it is a warning sign of a potential full blown stroke. Medical attention should be sought if this occurs. What should you do if you believe you are having a stroke? Seek immediate medical attention. Time is of uttermost importance, because certain treatments for stroke are applicable only in the first few hours (three to four and one-half hours) from the occurrence of initial symptoms. The length and where the stroke occurs in the brain are large factors in how much of the brain is damaged. Immediate treatment may minimize the long-term effects of a stroke and prevent death. How are strokes treated? Treatment depends on the type of stroke. There are two types of strokes: hemorrhagic or ischemic. An ischemic stroke is the most common and occurs as a result of an obstruction within a blood vessel supplying blood to the brain. If detected soon enough, a medication called tPA (tissue plasminogen activator) works by dissolving the clot and improving blood flow to the part of the brain being deprived of blood flow. A significant number of stroke victims don’t get to the hospital in time for tPA treatment; this is why it’s so important to identify a stroke immediately. Surgery may also be needed, in which a surgeon will use a wire-like device to break up the blood clot. A hemorrhagic stroke occurs when a weakened blood vessel ruptures and spills blood into brain tissue. In this case surgery is needed to stop the source of bleeding and decompress the brain.
What are the risk factors for strokes, both preventable and unpreventable? Risk factors that are not controllable include age, gender, ethnicity, genetics, and prior heart conditions. Controllable risk factors include lifestyle issues like healthy diet, cigarette smoking, physical inactivity, illicit drug use, and obesity. Working with your primary doctor to properly manage chronic diseases through lifestyle changes and medications such as those for high blood pressure, diabetes, artery disease, and cholesterol will help reduce your risk of having a stroke. Do genetics play a role in stroke risk? Yes, they do, but these are mostly related to secondary risk factors.
activated with the emergency room staff. The stroke team will get a very targeted medical history to determine if the patient will be a candidate for the blood clot dissolving medication tPA (if it is an ischemic stroke). Imaging of the brain will be done immediately with a CT scan, along with heart rhythm monitoring and standard blood work. The goal is to make a determination as to the kind of stroke so the proper treatment can be given as quickly as possible. Rehabilitation from a stroke can cover a wide range of conditions and outcomes. What can you tell us about this? Rehabilitation from a stroke can vary widely depending on how much of the brain was affected and damaged. Patients may be able to leave the hospital in a few days, receiving some outpatient and home-based therapies, or they may need to be admitted to a rehabilitation unit where they receive more in-depth physical, speech, and occupational therapy. Roughly 35 percent of patients recover completely or have minor impairments from a stroke, 50 percent have moderate to severe impairments that require special care, and 15 percent die shortly after a stroke. A healthy lifestyle, along with proper management of other health problems, greatly reduces the risk of having a stroke. It is often quoted that 80 percent of strokes can be avoided. If we combine education about the early warning signs and symptoms of strokes—which leads to better identification of when people are having strokes—and early medical intervention, we can significantly impact the severity and incidence of strokes.
Immediate treatment may minimize the long-term effects.
If you have had one stroke, what can you do to lower your risk of future strokes? Modifying the underlying risk factors discussed previously, whether lifestyle changes or working with your primary doctor to control other related conditions such as blood pressure, are important. Being compliant with medical advice and taking appropriate medications will go a long way to preventing another stroke.
If you accompany a stroke victim to the hospital or emergency room, what elements of care should you be certain are being provided? The stroke patient will be assessed by emergency medical technicians when the ambulance arrives on scene. These technicians often will relay information ahead to the hospital, where a stroke team is activated; this team can also be
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Prostate cancer Early detection is key By Samith Kochuparambil, MD
rostate cancer is the most common form of cancer among men in the U.S. It is expected to be the most diagnosed cancer in men in the U.S. this year. An estimated 220,800 men will be diagnosed with prostate cancer in 2015, and nearly 27,540 men will die from the disease this year. Early detection has led to a decrease in death rates among men with prostate cancer in recent years.
Background The disease starts in the prostate gland, a small, walnut-sized structure that makes up part of a manâ€™s reproductive system. It wraps around the urethra, the tube that carries urine out of the body. Prostate cancer occurs when some of the cells in the prostate reproduce far more rapidly than normal, resulting in a tumor. If left untreated, prostate cancer cells may eventually spread from the prostate and invade distant parts of the body, particularly the lymph nodes and bones, producing secondary tumors in a process known as metastasis. Because prostate cancer grows slowly, it doesnâ€™t always immediately cause health problems. One of the most worrying aspects of the disease is that most prostate cancers develop without men experiencing any symptoms in the early stages. Most prostate cancers are confined to the prostate gland itself and have not spread beyond it. About 70 percent of men with these cancers can be cured with surgery to remove the gland or with radiation directed precisely at it. In the remaining 30 percent of men, prostate cancer will recur within 10 years of their initial treatment. Most men with these recurrent cancers cannot be cured, but their lives can be extended and their cancers can be put into remission with palliative treatments. These treatments do not aim to cure, but rather to improve the quality and length of life. Risk factors A number of risk factors, taken individually or in combination, can affect the likelihood of prostate cancer: Age. The majority of prostate cancer cases are found in men over the age of 65. Race. African American men are 56 percent more likely than Caucasian men to develop prostate cancer. Family history. The chance of developing prostate cancer rises when immediate family members have the disease.
Nationality. Prostate cancer occurs more in North American and in northwestern European countries. Minnesota Health care news December 2015
Diet. A diet that includes a lot of red meat and/or high-fat dairy products can yield a greater risk of prostate cancer.
Surgery removes the cancerous tissue. The type of surgery required depends on the stage of the cancer.
Exercise. Men over the age of 65 who do not regularly exercise may have increased risks of prostate cancer.
Radical retropubic prostatectomy is the surgical removal of some or all of the surrounding lymph nodes and the prostate gland through the lower abdomen. This is the most common type of prostate cancer surgery.
Signs and symptoms The early stages of prostate cancer are often asymptomatic, or without obvious symptoms. However, any of the symptoms listed below should be viewed as a potential warning sign requiring a doctor visit:
Transurethral resection of the prostate (TURP) trims away excess tissue in the urethra to relieve urinary difficulties associated with prostate cancer. This procedure is not intended to remove the cancer.
• Trouble having or keeping an erection (impotence) • Blood in urine • Persistent dull achy pain in the spine, hips, ribs, or other bones • Weakness or numbness in the legs or feet
Advanced prostate cancer At initial diagnosis, 16 percent of patients have prostate cancer that has spread to a different part of the body. This means that the cancer is already in the advanced stage. Most of the time, it spreads to the bones first. Prostate cancer spreads to bones in nine out of 10 men with advanced prostate cancer.
Treatment options differ for each prostate cancer patient.
• Loss of bladder or bowel control Screening Screening tests are performed to determine the presence of abnormal or cancerous cells in the prostate. The American Society of Clinical Oncology (ASCO) recommends PSA (prostate-specific antigen) screening in men with a life expectancy greater than 10 years. This blood test measures levels of PSA, a protein produced by the prostate and present in all men. Elevated PSA levels may indicate the presence of prostate cancer, and a biopsy may be performed to confirm the diagnosis. It is recommended that physicians discuss with their patients whether PSA testing for prostate cancer screening is appropriate for them.
When tests indicate that a prostate cancer patient’s PSA level is rising or imaging scans indicate cancer in other areas of the body, doctors often first prescribe hormone therapies (androgen Prostate cancer to page 19
Staging If cancer is found, an oncologist will need to determine its progression. This classification, called staging, allows the health care provider to properly identify a treatment plan and to determine the prognosis. All cancers are staged on a Roman numeral scale, I-IV (1-4), where the higher stage represents a more advanced cancer. Treatment Treatment options differ for each prostate cancer patient, but may include surgery, radiation therapy, or chemotherapy. Each of the following treatment options may be used alone or in combination: Chemotherapy uses drugs to kill cancer cells. The drugs, administered orally or infused directly into the bloodstream, travel throughout the body, reaching cancer cells that may have spread beyond the prostate. Radiation therapy uses high-energy rays to kill cancer cells in the treated area. It is usually administered from a machine outside the body; however, it can be administered internally through small radioactive pellets. Hormone therapy lowers the levels of male hormones that allow prostate cancer cells to grow. Treatment can include orchiectomy (removal of testicles) and the use of specialized drugs.
December 2015 Minnesota Health care news
Tips for preventing falls By Wendy Rader, PT
Telephone Equipment Distribution (TED) Program
t happens every year: the air grows colder, leaves fall, and soon snowflakes begin to fly. Winter is coming, bringing the promise of skiing, skating, and other cold-weather sports. Along with that, we’ll get the inevitable snow and ice on our sidewalks and driveways, and the risk of falls. Winter lasts too long here in Minnesota to stay inside and wait it out. Fortunately, there are ways to decrease your risk of falling and continue to get outdoors, even in the coldest weather.
Do you have patients with trouble using their telephone due to hearing loss, speech or physical disability? If so…the TED Program provides assistive telephone equipment at NO COST to those who qualify. Please contact us, or have your patients call directly, for more information.
1-800-657-3663 www.tedprogram.org Duluth • Mankato • Metro Moorhead • St. Cloud The Telephone Equipment Distribution Program is funded through the Department of Commerce Telecommunications Access Minnesota (TAM) and administered by the Minnesota Department of Human Services
Minnesota Health care news December 2015
Fall risk No one is immune when it comes to fall risk: falls occur in all age groups and are one of the leading causes of injury, disability, and death. The elderly and immobile are at higher risk. According to 2013 data collected by the Centers for Disease Control and Prevention, the majority of injuries treated at the emergency room were caused by an unintentional fall. One in three adults over the age of 65 fall in a given year, and 20 to 30 percent of these fallers sustain injuries that potentially limit their mobility. Fall statistics are very similar in this state. Falls are the leading cause of injury in children and in adults aged 35 and older, according to Minnesota Falls Prevention, a partnership of the Minnesota Board on Aging and several public and private organizations. Some 40 percent of all hospital admissions in older adults were due to fall-related injuries. Minnesota ranks fifth in the U.S. for number of fatal falls, with 86 percent of these occurring in the 65 and older age group. There are a number of factors that increase risk of falls across age and demographic lines. Risky behaviors or occupations increase the likelihood of a fall. Construction workers are more likely than any other occupational group to suffer a fatal fall. Playgrounds are the location of many fall-related injuries in children. But it remains that adults over the age of 65 are the most likely group to fall, and that risk increases with each passing decade. You are at a higher risk of falling if you meet any of the following criteria: have fallen twice in the last year, have sustained any fall-related injury, have one or more chronic health conditions, are fearful of falling, have poor nutrition status, or take more than four prescription medications. Some of these risk factors can be changed. You can visit your physician to discuss current medications, and be sure your health is well managed. Your physician can also refer you to other health care professionals to address nutrition and mobility concerns. A physical therapist is qualified to evaluate many aspects of mobility, and can assist with improving balance and strength. They can also make specific recommendations to reduce your particular risk. Tips for all seasons The best falls prevention starts early, long before the first flakes fall from the sky, even before the leaves change color. Maintaining a
basic level of fitness improves mobility and decreases your risk of falling. According to Minnesota Falls Prevention, increasing your physical activity is a key factor in reducing falls risk. It is best to find an activity you enjoy and that you can do regularly, at least three to five times per week. Golfing, gardening, and walking are all activities that can be enjoyed at any age. Evidence shows that prolonged sitting increases risk of disease and reduces mobility, so any activity that gets you off your seat and on your feet is beneficial. To kick it up a notch, add strength training. Health clubs often have reduced membership rates for seniors, and offer personal training services you can access for an individualized strength program. Some insurance companies will offer discounts as well. Silver Sneakers (a group strength and flexibility program for seniors available to many group retirees and Medicare enrollees), yoga, and Pilates classes are other possibilities.
service. Scouting clubs or local churches may also offer snow removal for those unable to manage on their own. Keep a bucket of ice melt and salt at your front and back entryway. Even the most fastidious cannot completely clear sidewalks, and melting or blowing snow can cause ice formation on a previously cleared sidewalk. Apply the ice melt frequently, to avoid dangerous build up. On those sub-zero days when the ice won’t melt, and we are bound to get a few, sprinkle sand instead. It won’t melt the ice, but it can help reduce slips. People of all ages should also exercise caution while hanging holiday lights or building outdoor displays. Make sure that ladders are sturdy and secure, take your time, and consider hiring outside help if necessary.
Minnesota ranks fifth in the U.S. for number of fatal falls.
Get that snow under control Winter presents an extra wrinkle in preventing falls. Even those of us with no specific risk factors can slip on the ice. Removing snow promptly is key to reducing ice formation. Don’t wait until a big storm is over; you may have better luck keeping the steps clear if you remove the snow a few times throughout the storm. If you cannot shovel the snow yourself, consider purchasing a snow blower, or hiring a snow removal
Getting outside safely The most obvious way to avoid a fall on the ice is to stay indoors! Plan your trips outdoors around the weather, and postpone activities until the weather and your pathways are clear. But let’s say you’re out of milk, or are just plain sick of being stuck inside and need some outdoors time. Here are some safety tips:
Wear shoes with good traction. Now is not the time for fashion forward footwear! Shoe traction devices slip on over your existing shoes or boots and may provide more grip on slippery surfaces. Walking in the Minnesota winter to page 34
Minnesota Optometric Association
Doctors on the frontline of eye and vision care Did you know?
• Diabetic retinopathy can be controlled and diabetic patients need regular eye exams to maintain vision and good eye health. • Diabetes Type ll can also cause vision changes. • Glaucoma must be diagnosed in early stages in order to prevent vision loss. • All children entering school need a comprehensive eye exam, because vision screenings do not detect a number of eye disorders. • To maintain eye health, everybody from babies to boomers to older adults needs a regular eye exam by a family eye doctor. To locate an optometrist near you and find comprehensive information about eye health visit http://Minnesota.aoa.org December 2015 Minnesota Health care news
Rotator cuff injuries A range of treatment options By Jason Dieterle, DO, MS
houlder pain is common across all age groups. One of the most common causes of shoulder pain is inflammation of or injury to the rotator cuff. Your rotator cuff is four muscles around your shoulder blade that combine to form a “cuff” of tendon over the top of your arm bone in your shoulder. The purpose of your rotator cuff is to position your arm in place and help keep the ball centered in the socket of your shoulder joint. Your rotator cuff gets used almost constantly in daily life. Every time you move your arm, you are engaging the help of your rotator cuff. Unfortunately, the tendons of the rotator cuff live in a small
If you have diabetes, controlling your blood pressure can help protect you from heart attack, stroke, blindness and kidney disease
• Track your blood pressure and share with your doctor
if you take them
• Eat healthy and be active • Avoid salt • Do not smoke
Minnesota Diabetes & Heart Health Collaborative
The Minnesota Diabetes and Heart Health Collaborative: Working together to keep you informed
www.mn-dc.org Adapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard
Daily motions Anytime you lift your arm away from your body, especially when raising your arm above your head, the tendons of the rotator cuff are pinched between the top of your arm bone and your acromion—the part of your shoulder blade that you feel on the top and outside part of your shoulder. A cushion, known as a bursa, softens blows in this area. When this area of tendon and bursa becomes inflamed, it becomes painful to move your arm. This condition is called impingement syndrome, rotator cuff tendinopathy, or shoulder bursitis. This is really three ways to say the same thing. This condition is normally brought on by a change in activity, such as a new workout regimen or a repetitive overhead activity, such as painting. Like any part of the body, your rotator cuff tendon will wear with time, so older people can be more prone to this condition. Your tendon will rub across your bone like a rope that is rubbed across a sharp corner. Over time the tendon will start to fray and will often show up on an MRI (magnetic resonance imaging) as a partial tear. Often there is no single injury or inciting event to this ailment.
PUT THE SQUEEZE ON HIGH BLOOD PRESSURE
• Medicines can make a
space between the bones of your shoulder, making it particularly vulnerable to irritation or injury.
Minnesota Health care news December 2015
Symptoms usually consist of sharp pain that runs down the side of your arm during certain movements, such as reaching out or behind. A throbbing pain often occurs at night. The pattern of pain is caused by the way your nerves run across your shoulder and down your arm. Rotator cuff pain is usually not pain in your shoulder blade or neck, nor does it travel past your elbow. Your doctor may perform physical tests. If there is no specific injury, physical therapy is the first step. Physical therapy strengthens other muscles in your shoulder to take the pressure off the rotator cuff muscles. When pain subsides, strengthening the rotator cuff itself can help reduce the chance of reoccurrence. Cortisone shots are another option. Cortisone, a strong anti- inflammatory medicine, is injected directly into the site of inflammation in the bursa, quickly reducing your pain. If inflammation of the bursa or tendon is the cause of pain and dysfunction, the shot itself can often cure the condition. In impingement syndrome there is no anatomic damage, so “covering” the pain is not harmful. You are not causing further damage by continued use of the arm, and it
is actually better to use the arm, as pain allows, so the shoulder joint does not become stiff. If these treatments fail, an MRI is indicated. You cannot see the rotator cuff on an X-ray. The MRI will best show the anatomy of the rotator cuff. If you cannot have an MRI, a CT (computerized tomography) scan or ultrasound can also be used to evaluate the tendon. If less than 50 percent of the tendon is torn, the tendon usually does not need to be fixed. Surgical repairs If the tendon itself is not torn enough to warrant reattachment, and conservative measures fail, a minimally invasive decompression surgery can be done. Under this arthroscopic procedure, narrow tubes are inserted through small incisions. Through these tubes, the inflamed bursa is surgically removed, and the bone is ground down to allow more room for the tendon.
A full tear of the rotator cuff is treated quite differently. A full tear is where the tendon is completely detached from the bone, usually as the result of injury. Falling and trying to catch yourself on an outstretched arm, falling directly on your shoulder, or lifting a heavy weight away from your body are examples of common rotator cuff tearing injuries.
Your rotator cuff gets used almost constantly.
If surgery consists of a decompression and not a rotator cuff repair, recovery is much faster. Usually a sling is worn only for comfort, as there is no repair to protect with the sling. Physical therapy can start right away. You can expect to have good use of your arm and less pain in four to six weeks.
A full tear is usually more painful than an inflamed tendon. It is not true that you will not be able to lift your arm out to the side if it’s a full tear. There are accessory muscles that will help lift your arm. However, there is usually noticeable weakness, especially when tested by a trained health care provider. The weakness is worst in the first movements away from your body. When your arm is raised past 30 degrees out, your big shoulder muscle, the deltoid, takes over the lifting.
Full thickness rotator cuff tears cannot heal on their own. Once detached, the muscle connected to the tendon will continue to contract, pulling the tendon farther away from its intended attachment point. Generally the pain will eventually go away, but you will always have a degree of weakness. If the tear is not repaired, the muscle will atrophy and turn into fat, and your body will start to resorb the tendon. Rotator cuff injuries to page 32
If you’re a Baby Boomer age 65 or older, it’s time to find your groove with Medicare. UCare is ready with health plans that are as flexible and forward-thinking as you are.
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UCare for SeniorsSM lets you choose from plans that cover prescription drugs, travel, eyewear, dental, fitness programs like Healthways SilverSneakers® Fitness and more. There are low or no co-pays for primary care visits with most plans. And you’ll get to talk to a real person 24/7 when you call customer service. It’s just what you’d expect from health care that starts with you. Learn more about the benefits of UCare for Seniors in our new eGuide to Medicare at ucareplans.org. Or call (toll free) 1-877-523-1518 (TTY) 1-800-688-2534, 8 a.m. to 8 p.m. daily.
UCare for Seniors is an HMO-POS plan with a Medicare contract. Enrollment in UCare for Seniors depends on contract renewal. ©2015, UCare H2459_101512 CMS Accepted (10202012) UC693 2015 Boomer MPP MN Health Care News_Hippie.indd 1
December 2015 Minnesota Health care news 17 9/14/15 9:03 AM
Calendar Dec. 2015-Jan. 2016 Dec.9 Stroke Support Group
HealthPartners hosts this monthly support group for people who have had a stroke and their care partners. Meetings are facilitated by therapists who will address problems of social isolation and barriers to community reentry. For more information, call (651) 254-2053. Wednesday, Dec. 9, 4–5:30 p.m., Regions Hospital Rehabilitation Institute, 640 Jackson St., St. Paul
Women’s Cardiac Support Group
Allina Health offers this support group for women who are living with heart disease. Join other women to discuss your experiences, strategies for living healthy, and solutions to challenges. For more information, call (612) 775-3074.
Monday, Dec. 14, 5–6:30 p.m., Minneapolis Heart Institute Foundation Building— Dining Rm., 920 E. 28th St., Minneapolis
Tourette Syndrome Support Group
The Tourette Syndrome Association of Minnesota offers this free support group for people living with Tourette syndrome. Come meet others with this disorder to share experiences, challenges, and strategies for success. Call (612) 759-7112 for more information. Saturday, Dec. 19, 1:30–3 p.m., University of Minnesota, Coffman Memorial Union, Rm. 213, 300 Washington Ave. SE, Minneapolis
Memory Loss Support Group
HealthEast hosts this support group for individuals who provide care to someone with memory loss. For this meeting, attendees may bring their loved one suffering from memory loss for a recreational respite group taking place at the same time as the support group. For more information, contact Lynn at (651) 232-2202. Tuesday, Dec. 22, 10 a.m.–12 p.m., Bethesda Hospital, 559 N. Capitol Blvd., St. Paul
Send us your news: We welcome your input. If you have an event you would like to submit for our calendar, please send your submission to MPP/Calendar, 2812 E. 26th St., Minneapolis, MN 55406. Email submissions to firstname.lastname@example.org or fax them to (612) 728-8601. Please note: We cannot guarantee that all submissions will be used. CME, CE, and symposium listings will not be published.
December 1, 2015:
World AIDS Day An estimated 1.2 million people in the U.S. are living with HIV, and nearly one in eight of those are not aware that they are infected, according to the Centers for Disease Control and Prevention (CDC). About 50,000 more people are diagnosed each year, and about one in four of those are among youth ages 13 to 24. The rate of new infections has remained relatively stable in recent years due to prevention efforts. World AIDS Day efforts aim to raise awareness about HIV and AIDS to reduce the rates of new infections and AIDS-related deaths. HIV testing is an important first step to ending the epidemic. The earlier someone is tested and receives their results, the sooner they can take action. If the results are negative, they can modify any risky behaviors to help them stay uninfected. If the results are positive, they can start life-saving treatment to prevent the disease from progressing to AIDS and prevent transmitting it to others. The sooner someone with HIV begins medication and treatment, the more effective it can be. A 2011 study showed that people with HIV who began taking anti-HIV medications early—before their immune systems were significantly weakened—saw a 96 percent reduction in their risk of transmitting the disease to their sexual partners, according to the CDC.
The Minnesota AIDS Project offers free, confidential HIV testing. An HIV educator will conduct a brief risk assessment, answer any questions you may have, and conduct the test, which involves a quick, relatively painless fingerstick. Testing sessions take about 30 minutes and you will receive your results the same day. For more information, call (612) 373-AIDS or visit www. mnaidsproject.org.
Diabetes Support Group
Fairview Health Services hosts this support for anyone with diabetes. Come learn helpful tips about living well with diabetes from certified diabetes educators and health coaches and discuss strategies from others living with the disease. Friends and family members are welcome. For more information, call (763) 502-4877. Wednesday, Jan. 6, 4–5 p.m., Fairview Clinics—Blaine, 10961 Club W. Pkwy. NE, Blaine
Anxiety & Panic Attack Support Group
The Minnesota Chapter of the National Alliance on Mental Illness offers this support group for anyone living with anxiety or panic disorder. Come gain emotional support, learn coping strategies, and meet others who understand. Call Judy at (612) 600-2134 for more information. Tuesday, Jan. 12, 1–2:30 p.m., Southdale Library—Conference Rm., 701 York Ave. S., Edina
Winter Wellness Class
Hennepin County Library hosts this class for winter nutrition and self-care strategies in collaboration with Radiant Life Chiropractics. Come learn ways to stay happy and healthy this winter from a local holistic health expert. To sign up, call (612) 543-8425 or alee@ namimn.org. Tuesday, Jan. 12, 6:30–7:30 p.m., East Lake Library, 2727 E. Lake St., Minneapolis
Depression & Bipolar Disorder Support Group
Mental Health Minnesota offers this support group for individuals living with depression or bipolar disorder. Come meet others living with similar conditions to gain understanding and coping strategies. Other dates and locations available. For more information, call Bobby at (952) 938-8941. Thursday, Jan. 14, 7–9 p.m., Park Nicollet Melrose Center, 3525 Monterey Dr., St. Louis Park
Mondays, Wednesdays, and Thursdays: 9:30 a.m.-4:30 p.m.; Tuesdays: 1-8 p.m., Minnesota AIDS Project, 1400 Park Ave., Minneapolis
America’s leading source of health information online 18
Minnesota Health care news December 2015
Prostate cancer from page 13
deprivation therapy or ADT) that block the male sex hormone testosterone, which fuels prostate cancer cells. These therapies work for some time, but most men will eventually develop what’s commonly called “hormone-resistant” prostate cancer, which doesn’t respond to standard hormone therapy anymore. In the last decade, the U.S. Food and Drug Administration has approved six new drugs for this type of advanced cancer, five of them in the last five years. They include two therapies called enzalutamide and abiraterone, which target testosterone. Other approved therapies are sipuleucel-T, which uses the body’s immune system to fight prostate cancer cells; an injectable, liquid radiotherapy called radium-223 that binds to the bone where prostate cancer often spreads; and the chemotherapy drugs, cabazitaxel and docetaxel.
from different angles. For example, abiraterone blocks testosterone produced by the adrenal glands and the tumor cells themselves, and enzalutamide blocks the connection between proteins on the surface of prostate cancer cells and testosterone. If you are currently living with advanced prostate cancer, ask yourself these questions: re you having trouble doing regular • A activities? re you taking more medicine for pain or • A discomfort? re you living with aches, discomfort, or • A pain you can’t explain?
African American men are 56 percent more likely than Caucasian men to develop prostate cancer.
When men become resistant to hormone therapy, it’s because prostate cancer cells engineer ways to make their own fuel source—testosterone—or change their structure to absorb as much available testosterone as possible. Since cancers are constantly evolving new ways to fuel their growth, many of the recently approved therapies aim to block this process
In the next issue...
You may think these things are occurring because of your age, a busy day, or a simple change in routine. You also may think that over-the-counter or prescription pain medicine is the only solution to treat these symptoms. But these aches, pains, and lifestyle changes could be a sign or symptom of your prostate cancer spreading to bone.
Samith Kochuparambil, MD, is a medical oncologist and hematologist with Minnesota Oncology in Minneapolis.
Don’t be afraid.
Your Guide to Consumer Information Jones-Harrison Assisted Living is committed to the whole being of our residents, providing them with the best possible opportunity to continue to lead full and independent lives.
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Call today at , for a tour of our beautiful home beside Cedar Lake, or visit us at 3700 Cedar Lake Avenue, Minneapolis, Minnesota 55416 December 2015 Minnesota Health care news
corneal inlays Correcting age-related vision loss By Richard L. Lindstrom, MD, and David R. Hardten, MD, FACS
hy is my near vision changing?” This is a common question for many individuals as they near the age of 40 and beyond. They may begin to notice their reading, or “up close,” vision beginning to get blurry. Perhaps they squint, turn on a brighter light, or extend their arm to bring an object into focus. The technical term for this condition is presbyopia (prez-bee-OH-peeah). It is a frustratingly natural condition that eventually happens to everyone.
Focusing on age In our 20s and 30s, our eye’s natural lens is elastic and flexible. Like a camera lens, it automatically adjusts and focuses our vision, allowing us to switch our gaze from something near to something far away. Over time, the natural lens in your eye begins to stiffen. It can’t bend into the right shapes to bring close objects into focus. Presbyopia progresses over time. For example, someone who is 45 may only notice it when trying to read tiny print in low light. However, someone who is 50 may depend more and more on reading glasses or contact lenses throughout the day for near vision tasks. Presbyopia is different from another common refractive error: myopia, or nearsightedness. Nearsighted individuals typically have problems seeing well at a distance and are forced to wear glasses or contact lenses. The nearsighted eye is usually longer than a normal eye, and its front portion, or cornea, may also be steeper. Therefore, when light passes through the cornea and lens, it is focused in front of the retina. This will make distant images appear blurred.
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Minnesota Health care news December 2015
Reading glasses are a part of growing older, but many people who start wearing them in their later years find them downright awkward and uncomfortable. A new corneal inlay device, approved by the Food and Drug Administration (FDA) in April 2015, may provide a solution. A “pinhole” inlay The KAMRA inlay (developed by AcuFocus) is implanted into the cornea of the patient’s non-dominant eye, leaving the second eye untouched. Smaller and thinner than a contact lens, the inlay is a mini-ring with a tiny opening in its center. Implanted in the first few layers of the cornea, the inlay uses the pinhole effect to focus light coming into the eye, restoring near vision while maintaining distance vision—much like squinting. It also offers long-term performance to help you continue to enjoy clear vision over time. The device is essentially a 3.8 millimeter ring with a 1.6 millimeter aperture in the center. Just like a diaphragm in a camera, this narrow opening for light increases image focus. Of course, a lot of the peripheral unfocused light is blocked by the implant, but because
only one of the eyes receives the implant, patients will maintain distance vision without losing depth perception. Unlike other refractive surgeries, distance vision remains binocular. To help the device stay in place without causing unnecessary irritation to corneal tissue, it has thousands of holes within its body that allow oxygen and nutrients to pass through. Inlay vs. onlay Corneal inlays, developed to surgically correct presbyopia, are typically implanted within one-third to one-half the depth of the cornea, using a laser to create a “pocket” for the device. Corneal onlays, on the other hand, were intended to be a less invasive means to correct corneal refracting power. Onlays are implanted closer to the front of the cornea, just under the outer layer or epithelium, which comprises about 10 percent of the overall thickness of the cornea. The epithelium acts as a protective barrier to keep bacteria, dust, and other foreign substances from penetrating the eye. The epithelium also absorbs oxygen and nutrients from the tear film so they can nourish the rest of the cornea.
from the laser during the creation of the flap, but should experience no pain and little discomfort. There are no stiches or bandages, but patients will need to use eye drops for a period of time to ensure proper healing. The goal of the inlay is to restore everyday near vision, so the patient can once again see text messages, computer screens, and wristwatches, without the frustration of reading glasses or contact lenses. As with any eye surgery, healing is a process. The recovery time (when patients will notice an improvement in near vision) will depend on their personal healing patterns. While some patients see an improvement within the first week to a month, others may require additional time. FDA approval and outcomes
The entire inlay procedure typically takes less than 20 minutes.
Many ophthalmologists now consider corneal inlays to be the preferred method for corneal implants designed for vision correction.
To evaluate the safety and efficacy of the inlay, the FDA reviewed the results of three clinical studies. The main study showed that 83.5 percent of the evaluable 478 participants achieved uncorrected near visual acuity of 20/40 or better at 12 months. This is the level of vision needed to read most text in magazines and newspapers. KAMRA corneal inlays to page 25
Inlay vs. other refractive procedures The KAMRA inlay is not to be confused with LASIK or other refractive procedures that use lasers to reshape the curvature of the cornea, altering the way light rays enter the eye. Artificial lenses surgically inserted into the eye can also refocus light rays to sharpen vision. “Monovision” LASIK corrects one eye for near vision and one eye for distance. Near vision improves, but distance vision diminishes over time. Also, people who have LASIK with monovision report increased night glare, a sense of feeling off balance, and loss of depth perception. Further, the improved near vision decreases in the long term.
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In the KAMRA inlay procedure, a device is implanted in the cornea, but the cornea is not reshaped, as it is in LASIK. Procedure and recovery The inlay is ideal for people hoping to reduce their dependency on reading glasses. The device is indicated for people 45 to 60 years old that have not had previous eye surgery, who have normal distance vision but require reading glasses between +1 and +2.5 diopters of power. Ideal candidates do not suffer from dry eye. The entire inlay procedure typically takes less than 20 minutes, with numbing drops used to ensure the patient’s comfort. Using a laser, the surgeon creates a small pocket in the first few layers of the cornea. The surgeon then places the inlay into the pocket and centers it over the pupil. Patients will feel a slight pressure
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Cyberbullying A significant and growing problem By Chris Ochocki, MA, LPCC
magine a playground where bullies could strike without any real fear of retaliation, where the taunts could extend beyond an immediate circle of onlookers to be witnessed by an entire community. Imagine a single instance of bullying that lives on not just by word of mouth, but through endless replays to an expanding audience, encouraging other youth—even those who had never
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Minnesota Health care news December 2015
considered themselves to be bullies—to join in on the fun, serving up attacks that are almost impossible for victims to escape, even in the privacy of their own homes. That playground is real for every young person with a computer, tablet, or cell phone, and it’s called cyberbullying. A new twist on an old issue Bullying, in one form or another, has been with us forever. In its Understanding Bullying 2015 Fact Sheet, the Centers for Disease Control and Prevention (CDC) presents a formal definition of bullying as “unwanted aggressive behavior…that involves an observed or perceived power imbalance and is repeated multiple times or is highly likely to be repeated.” In the past, this “unwanted aggressive behavior” meant fistfights or verbal attacks. Now it could be as simple as a snide text message, as pervasive as a vicious broadcast email, or as devastating as a sabotaged image posted to the world via social media. It starts early, with some 9 percent of students in grades six through 12 reporting that they have experienced cyberbullying, according to a report from the National Center for Education Statistics and Bureau of Justice Statistics. For older students in grades nine through 12, the numbers grow, with 15 percent reporting instances in 2012, according to the CDC’s 2013 Youth Risk Behavior Report. Here in Minnesota, instances of all forms of bullying—physical and electronic—are more prevalent among Pacific Islanders (22 percent), multi-racial youth (19 percent), and those identifying as gay and lesbian (33 percent), according to the 2013 Minnesota Student Survey, a report prepared by the Minnesota Department of Health. No escape Why can’t victims just turn off their electronic devices or ignore messages from cyberbullies? Today’s youth tap into all forms of online media. Living without some or all of these social platforms—from text messages to Twitter feeds to Facebook posts to chat rooms to public websites—would be like living without a telephone. It could even lead their peers to attack them for their electronic isolation.
Unfortunately, that means that the cyberbully never goes away. In the past, youth who were bullied face-to-face could escape from the torment while they were at home or out of proximity from a bully. Under our always accessible and interconnected social media, this same amount of torture and its devastating effects can occur 24 hours a day, seven days a week, each day of the year. When the devices are shut down, the attacks simply lurk in cyberspace, waiting for the next logon. When the attacks arrive, they take many forms: online fights, making fun of someone, excluding peers from chats and online groups intentionally, sharing personal secrets online, tricking someone to reveal personal information or photos and sharing these with others, pretending to be someone else, repeatedly sending explicit and harassing messages, and continued threats of harm.
Bullying can also impact education, both in attendance and academics. The Minnesota Student Survey for 2013 suggests that a large majority of students who experienced bullying at least one time weekly had grades that were mostly Ds, Fs, and Incompletes. The incidents of school refusal and truancy also seem to be connected with experiences of repeated bullying.
The Attorney General’s office has developed tips for parents to address cyberbullying.
They can also take more benign forms. Facebook users regularly click a thumbs-up “Like” button to indicate support for a friend’s posting. Stemming in part from requests from older users, the site is rolling out a “Dislike” button for those who wish to show empathy for a friend in need—as a response to a post about the anniversary of a death, for example. Mature users will appreciate this option, but for those of us who work with youth, it seems like a bad idea, one that could allow young people to become more distanced in negative messaging and create more instances of “keyboard courage”: the tendency to attack impulsively with a single click.
The most challenging statistics and largest concerns involve parental awareness of cyberbullying. Research indicates that 7 to 10 percent of parents are aware of cyberbullying, know how they could intercede, and have, in many instances, put a quick end to the attacks. The remaining majority of parents might be able to help, but much of the literature shows that young people are reluctant to share experiences of bullying with their parents. Only one-fourth to one-third feel comfortable talking with their parents about being cyberbullied.
Parents and educators can respond in a broader context. Starting in 2007 and under the direction of the Minnesota Attorney General’s office, each school district is now required to put policies in place that address cyberbullying, and to provide resolutions to Cyberbullying to page 24
The vulnerability of youth For any person, these cyber attacks would be hurtful. They have an even greater impact on young people because of their emotional, physical, and social developmental phase of life. Young people are not equipped with the emotional tools to manage such harassment, and the on-going nature of cyberbullying can lead to unexpected consequences for the bully, the bystander, and the victim. Young people may be unaware that what is said in cyberspace is very difficult to erase. Inappropriate pictures, comments, or acts do not just disappear when a window is closed or a computer is turned off. Many social media sites keep records of all forms of messaging that is transmitted through their servers, and these can be retrieved and used in negative ways in the future. Cyberbullying poses the same risks as face-to-face bullying. Repeated harassing experiences decrease self-esteem and can lead to other emotional difficulties, such as depression and anxiety. Bullying also impacts the physical health of young people, causing loss of sleep and appetite, panic episodes, and other physical symptomology. Victims may become more socially withdrawn and isolated, and may report feelings of being alone. This can lead to higher rates of suicidal thoughts and can trigger suicide attempts. According to research by Espelage and Holt, published in The Journal of Adolescent Health (2013), “youth victimized by their peers were 2.4 times more likely to report suicidal thinking and 3.3 times more likely to make a suicide attempt than youth who did not report that they were bullied.”
December 2015 Minnesota Health care news
Cyberbullying from page 23
problem bullying behaviors. The Attorney General’s office has developed tips for parents to address cyberbullying, which include talking with children about online abuses, reporting known misconduct immediately to schools, and saving offensive images or messages as evidence for future reporting. The office urges parents to share their expectations regarding online behaviors and to ensure that their children follow these expectations. We know from brain development research that young people do not fully think through their actions during their teen years, so it is important for parents to stress the permanency and public nature of putting any information online, in text, or in emails, and to share with them the long-term consequences of their posts and pictures. Young people need to be taught that once they hit send/upload, it is considered public information regardless of privacy settings.
Standing up to cyberbullies You can give your children the tools to address cyberbullying head on, whether they are victims or observers/bystanders. Research shows that bystanders of bullying who intervene positively by telling adults what they are seeing and hearing have a greater impact on ending bullying episodes and positively impacting their community. Teach your child that he or she can be that powerful voice for change. If the cyberbullying takes place on the Web, you may also contact the site administrator, since most sites have specific policies to address this activity. Visit www.wordswound. org for a list of contacts to report online offensive behaviors.
Repeated harassing experiences decrease self-esteem.
There are many other resources for parents and communities to address cyberbullying, both online and in published research and books. Visit www.nobullying.com, www.stopbullying. gov, www.cyberbullying.org, or read books on these topics by researchers and authors such as Justin W. Patchin, PhD, and Sameer Hinduja, PhD. Chris Ochocki, MA, LPCC, works as a school-based therapist for Headway Emotional Health Services.
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Minnesota Health care news December 2015
KAMRA corneal inlays from page 21
The device is not intended for patients who have had cataract surgery or patients with severe dry eye; an active eye infection or inflammation; corneal abnormalities related to thinning and irregular shape of the surface of their eyes; insufficient corneal thickness to withstand the procedure; a recent or recurring herpes eye infection or problems resulting from past infection; uncontrolled glaucoma; uncontrolled diabetes; or active autoimmune or connective tissue disease.
The KAMRA corneal inlay is a very favorable option for individuals interested in maintaining a natural range of vision—from near to far. As the only presbyopia procedure utilizing small aperture optics, it offers treatment for near, or reading, vision. With the inlay, patients receive:
It is important to understand that there may be times when additional magnification is needed to read small print in dim light or to perform a near task for an extended period of time.
Recovery time…will depend on personal healing patterns.
Before considering the procedure, you should have a complete eye examination. Talk to your eye surgeon about the potential benefits, complications, risks, and healing time. It is important to know that some KAMRA inlay patients may still require reading glasses for activities such as reading tiny print or reading in low light and that if the inlay is not centered properly or the effects are not ideal, it can be surgically removed.
S afe, proven, sustainable near vision solution
Complete uninterrupted range of vision
M inimally invasive procedure
reatment that leaves the natural T lens in place
Lasting vision treatment
Richard L. Lindstrom, MD, a board-certified ophthalmologist, is the founder and attending surgeon at Minnesota Eye Consultants and adjunct professor emeritus at the University of Minnesota Department of Ophthalmology. David R. Hardten, MD, FACS, is a board-certified ophthalmologist and founding partner of Minnesota Eye Consultants, where he serves as director of the Clinical Research Department.
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December 2015 Minnesota Health care news
The future of spinal fusion By H.R. Abbasi, MD, PhD, FACS, FAANS
t’s an ailment that 80 percent of the population will experience at some time in their lives. It is also the number one reason for disability in the U.S., and chances are you or someone you know is suffering with it right now. We’re talking about back pain. Back pain and its related diseases represent one of the top reasons patients make appointments with their family doctors, and the pain does not discriminate, affecting everyone from high school athletes to the elderly. A new, minimally invasive surgical procedure may provide relief for many of these patients, without the lengthy recovery times associated with traditional surgery.
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Minnesota Health care news December 2015
Traditional forms of treatment Back pain can originate from multiple diseases, including degenerative disk disease (age-related changes in the soft, compressible disks that separate the spine’s interlocking bones, or vertebrae), herniated disks (in which disk material emerges from the spaces between vertebrae), scoliosis (curvature of the spine), spinal stenosis (a narrowing of the bone channel), and spondylolisthesis (in which vertebrae slip out of place). Back pain may also be caused by accidents or injuries. Many sufferers find relief through non-surgical methods, which may include physical therapy, medication management, and changes in lifestyle. These non-surgical methods may not be sufficient for some patients, though, and it may be deemed medically necessary for them to find treatment and pain relief through spinal fusion surgery, which permanently connects two or more vertebrae in the spine, eliminating motion between them. Spinal fusion involves techniques designed to mimic the normal healing process of broken bones. During spinal fusion, a surgeon places a spacer made of bone-like material within the space between two spinal vertebrae. Titanium screws and rods are used to hold the vertebrae together and in place, so the vertebrae can heal into one solid unit. Traditional spinal surgery often requires large incisions. Depending upon the surgeon’s technique, these incisions may be made in the abdomen, with additional necessary incisions performed on the back. These incisions permit access to the damaged disk and the spinal anatomy, including the vertebrae and subparts. During the surgery, the patient may be moved to allow access to the abdomen
or the back. Gaining this desired access requires that muscle and ligaments be removed from their connection to the spine. Unlike other joint surgery techniques, there is no means to reconnect these muscles to their original location in the spine once the affected disk is removed and spinal implants are placed. The muscles will eventually shrink, because the nerves connecting to them are separated and turn into scar tissue, and the muscle is no longer available to support and stabilize the spine. The result is weakened or missing muscle anatomy that no longer can optimally support the spine, presenting new concerns for the patient. Since muscle in the spine traverses multiple segments above and below, detaching muscle in one location will negatively affect the biomechanics of many levels. Though relief can be found for the patient after surgery and healing is completed, the patient is now at greater risk for future back pain.
over on the back and belly during surgery, and there is no need for large incision scars on the abdomen or on the patient’s back. The reduction in tissue damage can also greatly reduce surgical site infections, a proven leading cause of hospital-acquired harm to patients. These smaller incisions result in surgical procedure times as short as 45 minutes, with many patients able to walk within two hours after surgery and be discharged the same day. It is typical to see a patient return to low-stress daily activities (driving, extended walks, and work) in one to two weeks; some patients require only three days. A 2015 Minnesota-based study published by the National Institutes of Health (Economic Performance of Oblique Lateral Lumbar Interbody Fusion) documented these shorter surgical times, noting that some patients have their procedures performed at same-day ambulatory surgery centers. The study also highlighted reductions in blood loss. Because the OLLIF procedure does not require the detachment or cutting of muscle from the spine, blood loss was observed at levels as little as one-tenth that of traditional spinal surgical procedures.
Incisions … are no larger than 10 millimeters.
Traditional one-segment spinal surgery typically takes a minimum of three to four hours, hospitalization for up to five days or more, and, in some cases, a clinically significant loss of blood. The length of a hospital stay is usually determined by the size of the incisions, the amount of muscle that has been removed from the spine, and the amount of blood loss. Upon discharge from the hospital, a patient may have a doctor’s order to recover from the procedure for up to three months. This recuperation involves rest, limited physical activity, and leave from work. Failing to follow the prescribed recommendations for this lengthy period of healing may be detrimental to the overall success of the procedure. A half-inch alternative Some patients find these traditional surgical procedures too disruptive, and may be candidates for less invasive procedures. Because of its anatomical and technical complexity, spinal surgery is decades behind general surgery in adapting minimally invasive techniques, and most spinal surgeons still offer these traditional procedures as the only surgical options for their patients. However, there is an advanced minimally invasive procedure that reduces, and in some cases eliminates, what could have been a patient’s difficult spinal surgery experience. Oblique Lateral Lumbar Interbody Fusion (OLLIF) utilizes advanced surgical instrument technology and surgical skills to work with the damaged spine through incisions that are no larger than 10 millimeters in width. While traditional spine surgery requires direct viewing of the spine, this minimally invasive approach utilizes diagnostic X-ray imaging in the operating room during the procedure. As with traditional surgery, spinal implants and fixation devices are still used. However, the OLLIF spinal devices (known as cage, rods, and screws) are implanted through small 10-millimeter incisions. Access to the patient’s damaged disk is made from the side, or oblique, area of the back. There is no requirement to turn the patient
OLLIF surgery to page 31
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December 2015 Minnesota Health care news
Pulmonary rehabilitation Treating victims of breathing disorders By Jenny Kratochvil, RRT, and Sara Erickson, MD
eople suffering from chronic breathing problems—as well as those facing or recovering from lung surgery—often find relief under the latest advances in pulmonary rehabilitation therapy. While many in the U.S. are not receiving proper respiratory care, either because they are unaware of the progress that has been made in the field or because they have not yet been referred to a therapy program, growing numbers benefit from these outpatient programs intended to build physical fitness and teach breathing techniques and strategies. The therapy cannot cure existing
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Minnesota Health care news December 2015
problems, but it can relieve symptoms and comfortably maintain the patient’s prior life style. History and new developments Pulmonary rehabilitation therapy is less than 50 years old, quite “new” when compared to some other treatment protocols. One of the many reasons for this lack of attention to pulmonary problems was that pulmonologists historically had only autopsied tissue to examine. In the very early days, the chest cavity was traditionally closed to surgeons; some people considered it to be the residence of the soul and therefore untouchable. That changed with the advent of open-heart surgery, pioneered by the University of Minnesota’s C. Walton Lillehei, MD, in 1956. Pulmonologists could now observe living, breathing lungs, allowing the study of trauma, muscle failure, shocks, disintegration, and other ordeals of living tissue. Further research helped to develop appropriate treatments for non-malignant health problems such as pneumonia, asthma, dyspnea (difficult or labored breathing), pulmonary fibrosis (in which lung tissue becomes damaged and scarred), sarcoidosis (an inflammatory disease that can affect the lungs), and, perhaps most important, the two conditions now defined under the rubric of chronic obstructive pulmonary disease (COPD): emphysema and chronic bronchitis. COPD is a progressive disease often characterized by coughing with large volumes of mucus, wheezing, shortness of breath, and tightness in the chest. Some 12 million people in the U.S. are diagnosed with the disease, which is listed as the third leading cause of death by the National Institutes of Health. Caused by long-term smoking or exposure to pollutants, it can include damage to the airways and air sacs in the lungs, with the airways becoming inflamed or clogged with mucus. Emphysema and chronic bronchitis are the two main conditions associated with COPD, and some patients suffer from both of these. There is no cure for COPD, but the past several decades have seen rapid growth in treatment. From the 1960s into the 1990s, the pioneer era of pulmonary rehabilitation, clinicians recognized that breathing techniques; resistance training; walking, biking, swimming, and other aerobic exercises; oxygen therapy; nutritional
counseling; and education were the keys to pulmonary rehabilitation, but there was not yet a structured therapy regimen or medically supported programs, since there appeared to be no scientific cure for any of these maladies. The four decades from 1960 to 2000 saw intermittent but steady progress toward the construction of these programs and the universal acceptance of pulmonary rehabilitation therapy as the gold standard of treatment for COPD care. The eventual development of structured twomonth outpatient programs, with accompanying educational presentations, psychological counseling, and support groups to bring people facing similar issues together, would provide the patient with the necessary exercise training, education, nutritional material, and coping skills to control the disease.
The therapy cannot cure existing problems, but it can relieve symptoms.
In “A History of Pulmonary Rehabilitation: Back to the Future,” Richard ZuWallack, MD, associate chief of pulmonary and critical care medicine at Saint Francis Hospital and Medical Center in Hartford, Conn., describes this therapy as “the most effective care for patients with COPD,” and urges its continued expansion for all patients suffering from COPD and other respiratory conditions.
Minnesota offers some of the most effective programs available in the country, with some 42 hospital-based outpatient programs, seven of which are in the Twin Cities. Smaller hospitals that cannot afford the staff, equipment, and facilities required by a complete program may take advantage of the American Lung Association’s (ALA) free Better Breathers Club initiative, which organizes small groups of pulmonary disease patients and families to share the support of other patients and health care professionals. Hospitals may contact the ALA for assistance in establishing their own Better Breathers Club. Based on the original curriculum offered at Regions Hospital in St. Paul, several additional HealthPartners facilities are also offering therapy programs in the St. Croix Valley. The program at Lakeview Hospital in Stillwater, Minn., provides an example of what patients might expect. The Lakeview Hospital program After being referred to the outpatient program by a doctor, the new Stillwater Medical Group patient will be interviewed by a respiratory therapist, who will determine the presence and extent of the disease, examining closely the following symptoms: • Shortness of breath • Fatigue
After this analysis, they will discuss a program outline for the next two months. The respiratory therapist also uses screening tools to assess emotional health and quality of life. Patients and therapists work together to set realistic goals and determine the patient’s greatest needs, focusing on the primary objective to maintain the current level of lung function, increase muscle strength, and improve daily living activities. The patient will then complete a six-minute walk test while breathing, pulse rate, blood pressure, oxygen saturation, and energy expenditure are measured and tabulated. The Borg Scale of Perceived Exertion is then used to assess shortness of breath and exertion. Comparative numbers will be examined at the end of the course.
Much of the two-month course time (a minimum of 16 hours) is spent concentrating on exercising the many muscles that control breathing in a completely equipped workroom or exercise laboratory. As a “warm-up,” patients are led through a 10-minute resistance exercise program, gripping variable-sized weights in each hand. Equipment used most often by the patients includes the treadmill, the recumbent stepper, the arm
Pulmonary rehabilitation to page 30
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• Coughing • Chest discomfort • Wheezing • Change in sputum color or amount December 2015 Minnesota Health care news
Pulmonary rehabilitation from page 29
ergometer, and the stationery bicycle. Timed exercise periods on each piece of equipment are monitored by exercise physiologists and pulmonary therapists, who take each patientâ€™s pulse rate, blood pressure, and oxygen saturation at regular intervals, entering the data into the session file for course-long analytical and comparative purposes. Only a registered therapist or a registered nurse is qualified by licensure to sign off on these records. Each week there is an educational presentation in an adjoining lecture room. The first such presentation outlines the course work to be followed and discusses lung anatomy and physiology. During one of the following weeks a dietician reviews food groups beneficial to COPD patients, as well as foods and liquids that may be harmful. Other subjects covered during this educational period include stress management, the emotional aspects of chronic lung disease, oxygen uses, and the prevention of lung diseases. The last educational session focuses on the medical aspects of the disease, and tells patients how they can participate in their own recovery.
The hospital also hosts its own monthly ALA Better Breathers Club. Former patients attend this post-treatment group to help improve coping skills, reduce stress and anxiety, and improve their outlook. A few months after this treatment, patients complete follow-up forms assessing individual outcomes. These forms are designed to measure the patientâ€™s functional status, but they also request information about the patientâ€™s emotional health, quality of life status, and the nutrition outcome they receive at the diet and nutrition lecture. Hospital therapists are also designing a telephone survey program, which will provide ongoing, complete reporting at regular intervals.
Patients and therapists work together to set realistic goals.
Minnesota Health care news December 2015
Conclusion Pulmonary rehabilitation therapy programs are available all over the country operated by many health care providers. It is no longer necessary for any patient to suffer the discomforts and threats of COPD that have menaced us for centuries.
Jenny Kratochvil, RRT, a registered respiratory therapist, is manager of pulmonary services at Lakeview Hospital in Stillwater, Minn. Sara Erickson, MD, is board-certified in internal medicine-pulmonary disease and internal medicine-critical care medicine and practices at HealthPartners facilities in St. Paul and Stillwater, Minn.
OLLIF surgery from page 27
This absence of significant muscle trauma is credited to the surgical instrumentation. Instruments are placed through the muscle fiber, spreading muscles apart in order to gain access to the damaged disk and the spine. By gently working through the muscle tissue’s easily separating fibers, the approach greatly reduces tissue trauma, resulting in significantly reduced healing time of skin and muscle tissue and enabling patients to return to work and enjoyment of their new, pain-free life. The study also demonstrates that this advanced minimally invasive procedure is effective in treating diseases of all levels of the lumbar spine that have historically been treated through traditional spinal surgery procedures. These treated spinal diseases include degenerative disk disease, scoliosis, stenosis, severe disk herniation, and spondylolisthesis.
Conclusion OLLIF is a medically proven surgical procedure that can treat the many ailments at the root of back pain. It offers the latest in spine treatment advancements intended to minimize discomfort and disruption while maximizing high-quality clinical results. Given these benefits over traditional spinal surgery, why aren’t more spinal surgeons offering their patients this procedure as a treatment option? Advanced minimally invasive spinal surgery is on the leading edge of new advancements in spinal treatment. This new technique requires a sharp learning curve to develop proficiency in the procedure. OLLIF operations are best practiced and adopted by neurosurgeons that have an in-depth knowledge of spinal anatomy, with particular attention placed on nerve placement, and extensive surgical experience.
Many patients (are) able to walk within two hours after surgery.
Read more about the procedure at www.backachedoctor.com.
H.R. Abbasi, MD, PhD, FACS, FAANS, is a Minnesota-based neurosurgeon with medical practices in Alexandria and the Twin Cities. Dr. Abbasi is one of the few surgeons worldwide to perform the OLLIF procedure. He has performed the procedure more than 250 times, the most professionally reported both nationally and internationally.
RemaRkable caRe when it counts we realize that any surgery is a major event in your life. that’s why we make every effort to make you feel at ease. when you visit specialists in General surgery, you’ll receive care that is tailored to you as an individual. From discussing the details of your surgery in familiar terms to helping answer any questions, our coordinated team of surgeons and staff will be with you every step of the way. at specialists in General surgery, you can count on us to provide you the surgical expertise you need and the remarkable care you deserve.
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To schedule an appointment at any of our 13 locations, please call 763-780-6699 or visit www.sgsmn.com December 2015 Minnesota Health care news
Rotator cuff injuries from page 17
That is why old rotator cuff tears cannot be fixed. The tendon will not hold suture to repair it, and the muscle will not contract to pull the tendon. This process takes place over a few months. That is why it’s important to get evaluated, and, if torn, to have surgery to repair the tendon in the first two to three months after injury. The surgery to repair a torn rotator cuff is usually a same-day surgery that does not require overnight hospitalization. The repair can be done either through an incision or arthroscopically, as determined by the surgeon. The repair consists of placing an anchor in your bone at the attachment point of the tendon that has suture attached. The suture is passed through the tendon and tied down, bringing the tendon back to the bone. Sometimes, if indicated, a decompression will be performed at the same time as the repair. The point of the surgery is to reattach the tendon so that it heals back to the bone. The anchor and suture are not meant to hold the repair forever.
starts with regaining the motion in your shoulder. This takes six to eight weeks after surgery. Then you will gradually start to strengthen your shoulder and rotator cuff. This is a slow progression, and it can take up to six to eight months to regain full strength. It is a long recovery, but the hope is that you will have regained the full use of your arm that would have not been possible without surgery. Summing up If you have pain that runs down the side of your arm that is worse when reaching out or lifting away from your body, it’s likely rotator cuff-associated pain. If the pain does not subside in a few days, it’s best to be evaluated by a health care professional. Conservative treatments such as physical therapy and cortisone injections can usually cure your pain if there is no tear. An MRI may be performed if there is question of a tear. If a full tear is noted, surgery is required for full functional recovery. Recent techniques, including all-arthroscopic repair of the tendon, have decreased the pain of recovery associated with rotator cuff surgery.
Pain that runs down the side of your arm that is worse when reaching out (is) likely rotator cuff-associated.
Because there is a healing process that takes place, the recovery after surgery is longer. The repair is protected by wearing a sling for four to six weeks after surgery. Physical therapy can start before or after this time frame, depending on the size of the repair and your surgeon’s preference. The shoulder can become stiff, and therapy
Jason Dieterle, DO, MS, practices at St. Croix Orthopaedics clinics in Minnesota and Wisconsin. He is board-certified with the American Osteopathic Board of Orthopedic Surgery and is a member of the American Academy of Orthopaedic Surgeons.
November 2015 Survey
M I N N E S OTA H E A LT H C A R E
CO N S U M E R A S S O C I AT I O N
Each month, members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system. There is no charge to join the association, and everyone is invited. 1. I, or someone I know, have been victimized by cyberbullying (attacks delivered by cell phone or electronic media). 35%
4. Parents should intervene if their children are attacked by cyberbullies. 70% 60 50
5. I support efforts by schools and communities to curb cyberbullying. 70%
3. Social media sites such as Facebook have a responsibility to remove destructive messages posted by cyberbullies. 40%
10 Strongly agree
Selected survey comments:
“ This is such a new area to try to govern. As soon as we parents figure out some sites and apps, the kids move on to new ones!” “I have not experienced cyber attacks, nor have my grandchildren. Bullying has been going on forever. The only difference is they now do it over social media. It will never stop and it is the parents’ job to deal with it.”
60 50 40 30
“Adults can be targeted as well as children and all ages need to be protected.”
“Asking a child about bullying should be on the checklist of every medical practitioner... is it?”
2. I believe that cyberbullying can be as destructive as physical or verbal bullying.
“Bullying has led to committing suicide in my family.” Strongly agree
For more information, please visit www.mnhcca.org. We are pleased to present results of the most recent survey.
Minnesota Health care news December 2015
Be heard in debates and discussions that shape the future of health care policy. There is no cost to join this informed and informative online community. Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys.
www.mnhcca.org December 2015 Minnesota Health care news
Walking in the Minnesota winter from page 15
• Don’t rush! Leave yourself plenty of time to arrive at your destination.
These are available at some of the better retail shoe stores or sporting goods stores.
• Ask for help when crossing the street or navigating an icy path.
Carry a bag of sand in your bag or pocket. If you encounter ice along the way this can provide some extra traction.
• Advocate. If a business location is poorly groomed, let a manager know so they can clear the area. • B e alert. Watch for slick areas, and for cars sliding in parking lots and streets.
Do the penguin walk. Slow down and walk flat-footed; this reduces the chance of a slip on the ice.
• Keep your hands free and out of your pockets.
Step down from your car. Turn your body and place both feet flat on the ground, and hold on to the frame of the car for support.
• Avoid carrying heavy loads.
Take care on curbs. Step down, not out, and land flat footed, not on your heel. If you use a cane, purchase a retractable ice grip tip. These flip up when not in use, and when engaged provide some extra traction on ice and snow. You can usually purchase these at a local pharmacy.
Falls occur in all age groups.
Buddy up. Don’t leave the house alone. Take a family member along who is capable of helping if needed. Read up Search the Web for more tips from the Minnesota Department of Administration (www.mn.gov/admin/government/risk/safety-losscontrol/slips-trips-falls/) and Minnesota Falls Prevention (www. mnfallsprevention.org). Denver Health offers these additional recommendations:
If despite all your care you do fall there are some things you can do to reduce injury. Relax and roll with it: try to land sequentially: thigh, hip, and shoulder. Don’t put your arm out to break a fall; you may break your arm instead. Curl up, to avoid hitting your head if you slip.
Be prepared Whether you love it or not, winter in Minnesota is a fact of life. We hardy Minnesotans tend to embrace it with pride. A little care and planning can help us all enjoy it safely. Wendy Rader, PT, is a physical therapist at the National Dizzy and Balance Center in Edina, specializing in balance, fall prevention, and vestibular rehabilitation.
Now accepting new patients
A unique perspective on cardiac care Preventive Cardiology Consultants is founded on the fundamental belief that much of heart disease can be avoided in the vast majority of patients, and significantly delayed in the rest, by prudent modification of risk factors and attainable lifestyle measures. Elizabeth Klodas, M.D., F.A.S.C.C is a preventive cardiologist. She is the founding Editor in Chief of CardioSmart for the American College of Cardiology www.cardiosmart.org, a published author and medical editor for webMD. She is a member of several national committees on improving cardiac health and a frequent lecturer on the topic.
We are dedicated to creating a true partnership between doctor and patient working together to maximize heart health. We spend time getting to know each patient individually, learning about their lives and lifestyles before customizing treatment programs to maximize their health. Whether you have experienced any type of cardiac event, are at risk for one, or
are interested in learning how to prevent one, we can design a set of just-for-you solutions. Among the services we provide • One-on-one consultations with cardiologists • In-depth evaluation of nutrition and lifestyle factors • Advanced and routine blood analysis • Cardiac imaging including (as required) stress testing, stress echocardiography, stress nuclear imaging, coronary calcium screening, CT coronary angiography • Vascular screening • Dietary counseling/Exercise prescriptions
To schedule an appointment or to learn more about becoming a patient, please contact: Preventive Cardiology Consultants 6545 France Avenue, Suite 125, Edina, MN 55435 phone. 952.929.5600 fax. 952.929.5610 www.pccmn.com
Minnesota Health care news December 2015
Victoza® (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY. Please consult package insert for full prescribing information. WARNING: RISK OF THYROID C-CELL TUMORS: Liraglutide causes dose-dependent and treatmentduration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions].
for neutralizing effect against native GLP-1, and thus the potential for clinically significant neutralization of native GLP-1 was not assessed. Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 2.3% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 1.0% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. Among Victoza®-treated patients who developed anti-liraglutide antibodies, the most common category of adverse events was that of infections, which occurred among 40% of these patients compared to 36%, 34% and 35% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. The specific infections which occurred with greater frequency among Victoza®-treated antibody-positive patients were primarily nonserious upper respiratory tract infections, which occurred among 11% of Victoza®-treated antibody-positive patients; and among 7%, 7% and 5% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Among Victoza®-treated antibody-negative patients, the most common category of adverse events was that of gastrointestinal events, which occurred in 43%, 18% and 19% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Antibody formation was not associated with reduced efficacy of Victoza® when comparing mean HbA1c of all antibody-positive and all antibody-negative patients. However, the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victoza® treatment. In the five double-blind clinical trials of Victoza®, events from a composite of adverse events potentially related to immunogenicity (e.g. urticaria, angioedema) occurred among 0.8% of Victoza®-treated patients and among 0.4% of comparator-treated patients. Urticaria accounted for approximately one-half of the events in this composite for Victoza®-treated patients. Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies. Injection site reactions: Injection site reactions (e.g., injection site rash, erythema) were reported in approximately 2% of Victoza®-treated patients in the five double-blind clinical trials of at least 26 weeks duration. Less than 0.2% of Victoza®-treated patients discontinued due to injection site reactions. Papillary thyroid carcinoma: In clinical trials of Victoza®, there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victoza® and 1 case in a comparator-treated patient (1.5 vs. 0.5 cases per 1000 patient-years). Most of these papillary thyroid carcinomas were <1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound. Hypoglycemia :In the eight clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients (2.3 cases per 1000 patient-years) and in two exenatidetreated patients. Of these 11 Victoza®-treated patients, six patients were concomitantly using metformin and a sulfonylurea, one was concomitantly using a sulfonylurea, two were concomitantly using metformin (blood glucose values were 65 and 94 mg/dL) and two were using Victoza® as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treatment during a hospital stay). For these two patients on Victoza® monotherapy, the insulin treatment was the likely explanation for the hypoglycemia. In the 26-week open-label trial comparing Victoza® to sitagliptin, the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose <56 mg/ dL was comparable among the treatment groups (approximately 5%). Table 5: Incidence (%) and Rate (episodes/patient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials Victoza® Treatment Active Comparator Placebo Comparator None Monotherapy Victoza® (N = 497) Glimepiride (N = 248) Patient not able to self-treat 0 0 — Patient able to self-treat 9.7 (0.24) 25.0 (1.66) — Not classified 1.2 (0.03) 2.4 (0.04) — ® Add-on to Metformin Victoza + Metformin Glimepiride + Placebo + Metformin (N = 724) Metformin (N = 242) (N = 121) Patient not able to self-treat 0.1 (0.001) 0 0 Patient able to self-treat 3.6 (0.05) 22.3 (0.87) 2.5 (0.06) ®+ ® None Insulin detemir + Continued Victoza Add-on to Victoza Metformin Victoza® + Metformin + Metformin alone (N = 158*) (N = 163) Patient not able to self-treat 0 0 — Patient able to self-treat 9.2 (0.29) 1.3 (0.03) — Rosiglitazone + Placebo + Add-on to Glimepiride Victoza® + Glimepiride (N = 695) Glimepiride (N = 231) Glimepiride (N = 114) Patient not able to self-treat 0.1 (0.003) 0 0 Patient able to self-treat 7.5 (0.38) 4.3 (0.12) 2.6 (0.17) Not classified 0.9 (0.05) 0.9 (0.02) 0 Placebo + Metformin Add-on to Metformin + Victoza® + Metformin None + Rosiglitazone + Rosiglitazone Rosiglitazone (N = 175) (N = 355) Patient not able to self-treat 0 — 0 Patient able to self-treat 7.9 (0.49) — 4.6 (0.15) Not classified 0.6 (0.01) — 1.1 (0.03) Add-on to Metformin + Victoza® + Metformin Insulin glargine Placebo + Metformin + Glimepiride + Metformin + Glimepiride + Glimepiride (N = 114) Glimepiride (N = 232) (N = 230) Patient not able to self-treat 2.2 (0.06) 0 0 Patient able to self-treat 27.4 (1.16) 28.9 (1.29) 16.7 (0.95) Not classified 0 1.7 (0.04) 0 *One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat. This patient had a history of frequent hypoglycemia prior to the study. In a pooled analysis of clinical trials, the incidence rate (per 1,000 patient-years) for malignant neoplasms (based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label study periods) was 10.9 for Victoza®, 6.3 for placebo, and 7.2 for active comparator. After excluding papillary thyroid carcinoma events [see Adverse Reactions], no particular cancer cell type predominated. Seven malignant neoplasm events were reported beyond 1 year of exposure to study medication, six events among Victoza®-treated patients (4 colon, 1 prostate and 1 nasopharyngeal), no events with placebo and one event with active comparator (colon). Causality has not been established. Laboratory Tests: In the five clinical trials of at least 26 weeks duration, mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 4.0% of Victoza®-treated patients, 2.1% of placebo-treated patients and 3.5% of active-comparator-treated patients. This finding was not accompanied by abnormalities in other liver tests. The significance of this isolated finding is unknown. Vital signs: Victoza® did not have adverse effects on blood pressure. Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victoza® compared to placebo. The long-term clinical effects of the increase in pulse rate have not been established. Post-Marketing Experience: The following additional adverse reactions have been reported during post-approval use of Victoza®. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Dehydration resulting from nausea, vomiting and diarrhea; Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis; Angioedema and anaphylactic reactions; Allergic reactions: rash and pruritus; Acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death. OVERDOSAGE: Overdoses have been reported in clinical trials and post-marketing use of Victoza®. Effects have included severe nausea and severe vomiting. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. More detailed information is available upon request. For information about Victoza® contact: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536, 1−877-484-2869 Date of Issue: April 16, 2013 Version: 6 Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark Victoza® is covered by US Patent Nos. 6,268,343, 6,458,924, 7,235,627, 8,114,833 and other patents pending. Victoza® Pen is covered by US Patent Nos. 6,004,297, RE 43,834, RE 41,956 and other patents pending. © 2010-2013 Novo Nordisk 0513-00015682-1 5/2013
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INDICATIONS AND USAGE: Victoza® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. The concurrent use of Victoza® and prandial insulin has not been studied. CONTRAINDICATIONS: Do not use in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components. WARNINGS AND PRECAUTIONS: Risk of Thyroid C-cell Tumors: Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice. Malignant thyroid C-cell carcinomas were detected in rats and mice. A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls. It is unknown whether Victoza® will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies. In the clinical trials, there have been 6 reported cases of thyroid C-cell hyperplasia among Victoza®-treated patients and 2 cases in comparator-treated patients (1.3 vs. 1.0 cases per 1000 patient-years). One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations >1000 ng/L suggesting pre-existing disease. All of these cases were diagnosed after thyroidectomy, which was prompted by abnormal results on routine, protocol-specified measurements of serum calcitonin. Five of the six Victoza®-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One Victoza® and one non-Victoza®-treated patient developed elevated calcitonin concentrations while on treatment. Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. The serum calcitonin assay used in the Victoza® clinical trials had a lower limit of quantification (LLOQ) of 0.7 ng/L and the upper limit of the reference range was 5.0 ng/L for women and 8.4 ng/L for men. At Weeks 26 and 52 in the clinical trials, adjusted mean serum calcitonin concentrations were higher in Victoza®-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator. At these timepoints, the adjusted mean serum calcitonin values (~1.0 ng/L) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 0.1 ng/L or less. Among patients with pre-treatment serum calcitonin below the upper limit of the reference range, shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victoza® 1.8 mg/day. In trials with on-treatment serum calcitonin measurements out to 5-6 months, 1.9% of patients treated with Victoza® 1.8 mg/day developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 0.8-1.1% of patients treated with control medication or the 0.6 and 1.2 mg doses of Victoza®. In trials with on-treatment serum calcitonin measurements out to 12 months, 1.3% of patients treated with Victoza® 1.8 mg/day had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range, compared to 0.6%, 0% and 1.0% of patients treated with Victoza® 1.2 mg, placebo and active control, respectively. Otherwise, Victoza® did not produce consistent dose-dependent or time-dependent increases in serum calcitonin. Patients with MTC usually have calcitonin values >50 ng/L. In Victoza® clinical trials, among patients with pre-treatment serum calcitonin <50 ng/L, one Victoza®-treated patient and no comparator-treated patients developed serum calcitonin >50 ng/L. The Victoza®-treated patient who developed serum calcitonin >50 ng/L had an elevated pre-treatment serum calcitonin of 10.7 ng/L that increased to 30.7 ng/L at Week 12 and 53.5 ng/L at the end of the 6-month trial. Follow-up serum calcitonin was 22.3 ng/L more than 2.5 years after the last dose of Victoza®. The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 19.3 ng/L at baseline to 44.8 ng/L at Week 65 and 38.1 ng/L at Week 104. Among patients who began with serum calcitonin <20 ng/L, calcitonin elevations to >20 ng/L occurred in 0.7% of Victoza®-treated patients, 0.3% of placebo-treated patients, and 0.5% of active-comparator-treated patients, with an incidence of 1.1% among patients treated with 1.8 mg/ day of Victoza®. The clinical significance of these findings is unknown. Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea or persistent hoarseness). It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC, and such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza®, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation. Pancreatitis: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with Victoza®. After initiation of Victoza®, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Victoza® should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Victoza® should not be restarted. Consider antidiabetic therapies other than Victoza® in patients with a history of pancreatitis. In clinical trials of Victoza®, there have been 13 cases of pancreatitis among Victoza®-treated patients and 1 case in a comparator (glimepiride) treated patient (2.7 vs. 0.5 cases per 1000 patient-years). Nine of the 13 cases with Victoza® were reported as acute pancreatitis and four were reported as chronic pancreatitis. In one case in a Victoza®-treated patient, pancreatitis, with necrosis, was observed and led to death; however clinical causality could not be established. Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. Use with Medications Known to Cause Hypoglycemia: Patients receiving Victoza® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin Renal Impairment: Victoza® has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza®-treated patients. Some of these events were reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status. Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents, including Victoza®. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with Victoza®. If a hypersensitivity reaction occurs, the patient should discontinue Victoza® and other suspect medications and promptly seek medical advice. Angioedema has also been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to angioedema with Victoza®. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. ADVERSE REACTIONS: Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Victoza® has been evaluated in 8 clinical trials: A double-blind 52-week monotherapy trial compared Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, and glimepiride 8 mg daily; A double-blind 26 week add-on to metformin trial compared Victoza® 0.6 mg once-daily, Victoza® 1.2 mg once-daily, Victoza® 1.8
mg once-daily, placebo, and glimepiride 4 mg once-daily; A double-blind 26 week add-on to glimepiride trial compared Victoza® 0.6 mg daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and rosiglitazone 4 mg once-daily; A 26 week add-on to metformin + glimepiride trial, compared double-blind Victoza® 1.8 mg once-daily, double-blind placebo, and open-label insulin glargine once-daily; A doubleblind 26-week add-on to metformin + rosiglitazone trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily and placebo; An open-label 26-week add-on to metformin and/or sulfonylurea trial compared Victoza® 1.8 mg once-daily and exenatide 10 mcg twice-daily; An open-label 26-week add-on to metformin trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, and sitagliptin 100 mg once-daily; An open-label 26-week trial compared insulin detemir as add-on to Victoza® 1.8 mg + metformin to continued treatment with Victoza® + metformin alone. Withdrawals: The incidence of withdrawal due to adverse events was 7.8% for Victoza®-treated patients and 3.4% for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer. This difference was driven by withdrawals due to gastrointestinal adverse reactions, which occurred in 5.0% of Victoza®-treated patients and 0.5% of comparator-treated patients. In these five trials, the most common adverse reactions leading to withdrawal for Victoza®-treated patients were nausea (2.8% versus 0% for comparator) and vomiting (1.5% versus 0.1% for comparator). Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials. Common adverse reactions: Tables 1, 2, 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer. Most of these adverse reactions were gastrointestinal in nature. In the five double-blind clinical trials of 26 weeks duration or longer, gastrointestinal adverse reactions were reported in 41% of Victoza®-treated patients and were dose-related. Gastrointestinal adverse reactions occurred in 17% of comparator-treated patients. Common adverse reactions that occurred at a higher incidence among Victoza®-treated patients included nausea, vomiting, diarrhea, dyspepsia and constipation. In the five double-blind and three open-label clinical trials of 26 weeks duration or longer, the percentage of patients who reported nausea declined over time. In the five double-blind trials approximately 13% of Victoza®-treated patients and 2% of comparator-treated patients reported nausea during the first 2 weeks of treatment. In the 26-week open-label trial comparing Victoza® to exenatide, both in combination with metformin and/or sulfonylurea, gastrointestinal adverse reactions were reported at a similar incidence in the Victoza® and exenatide treatment groups (Table 3). In the 26-week open-label trial comparing Victoza® 1.2 mg, Victoza® 1.8 mg and sitagliptin 100 mg, all in combination with metformin, gastrointestinal adverse reactions were reported at a higher incidence with Victoza® than sitagliptin (Table 4). In the remaining 26-week trial, all patients received Victoza® 1.8 mg + metformin during a 12-week run-in period. During the run-in period, 167 patients (17% of enrolled total) withdrew from the trial: 76 (46% of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9% of withdrawals) doing so due to other adverse events. Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued, unchanged treatment with Victoza® 1.8 mg + metformin. During this randomized 26-week period, diarrhea was the only adverse reaction reported in ≥5% of patients treated with Victoza® 1.8 mg + metformin + insulin detemir (11.7%) and greater than in patients treated with Victoza® 1.8 mg and metformin alone (6.9%). Table 1: Adverse reactions reported in ≥5% of Victoza®-treated patients in a 52-week monotherapy trial All Victoza® N = 497 Glimepiride N = 248 (%) (%) Adverse Reaction Nausea 28.4 8.5 Diarrhea 17.1 8.9 Vomiting 10.9 3.6 Constipation 9.9 4.8 Headache 9.1 9.3 Table 2: Adverse reactions reported in ≥5% of Victoza®-treated patients and occurring more frequently with Victoza® compared to placebo: 26-week combination therapy trials Add-on to Metformin Trial All Victoza® + Metformin Placebo + Metformin Glimepiride + Metformin N = 724 N = 121 N = 242 (%) (%) (%) Adverse Reaction Nausea 15.2 4.1 3.3 Diarrhea 10.9 4.1 3.7 Headache 9.0 6.6 9.5 Vomiting 6.5 0.8 0.4 Add-on to Glimepiride Trial ® Placebo + Glimepiride Rosiglitazone + All Victoza + Glimepiride N = 695 N = 114 Glimepiride N = 231 (%) (%) (%) Adverse Reaction Nausea 7.5 1.8 2.6 Diarrhea 7.2 1.8 2.2 Constipation 5.3 0.9 1.7 Dyspepsia 5.2 0.9 2.6 Add-on to Metformin + Glimepiride ® Victoza 1.8 + Metformin Placebo + Metformin + Glargine + Metformin + + Glimepiride N = 230 Glimepiride N = 114 Glimepiride N = 232 (%) (%) (%) Adverse Reaction Nausea 13.9 3.5 1.3 Diarrhea 10.0 5.3 1.3 Headache 9.6 7.9 5.6 Dyspepsia 6.5 0.9 1.7 Vomiting 6.5 3.5 0.4 Add-on to Metformin + Rosiglitazone ® Placebo + Metformin + Rosiglitazone All Victoza + Metformin + Rosiglitazone N = 355 N = 175 (%) (%) Adverse Reaction Nausea 34.6 8.6 Diarrhea 14.1 6.3 Vomiting 12.4 2.9 Headache 8.2 4.6 Constipation 5.1 1.1 Table 3: Adverse Reactions reported in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Exenatide Exenatide 10 mcg twice daily + Victoza® 1.8 mg once daily + metformin and/or sulfonylurea metformin and/or sulfonylurea N = 232 N = 235 (%) (%) Adverse Reaction Nausea 25.5 28.0 Diarrhea 12.3 12.1 Headache 8.9 10.3 Dyspepsia 8.9 4.7 Vomiting 6.0 9.9 Constipation 5.1 2.6 Table 4: Adverse Reactions in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Sitagliptin All Victoza® + metformin Sitagliptin 100 mg/day + N = 439 metformin N = 219 (%) (%) Adverse Reaction Nausea 23.9 4.6 Headache 10.3 10.0 Diarrhea 9.3 4.6 Vomiting 8.7 4.1 Immunogenicity: Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with Victoza® may develop anti-liraglutide antibodies. Approximately 50-70% of Victoza®-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment. Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 8.6% of these Victoza®-treated patients. Sampling was not performed uniformly across all patients in the clinical trials, and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies. Cross-reacting antiliraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 6.9% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 4.8% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. These cross-reacting antibodies were not tested
Victoza —a force for change in type 2 diabetes. A change with powerful, long-lasting benefits
Reductions up to -1.1%a
Weight loss up to 5.5 lba,b
Low rate of hypoglycemiac
1.8 mg dose when used alone for 52 weeks. Victoza® is not indicated for the management of obesity. Weight change was a secondary end point in clinical trials. c In the 8 clinical trials of at least 26 weeks’ duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients. a
A 52-week, double-blind, double-dummy, active-controlled, parallel-group, multicenter study. Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victoza® 1.2 mg (n=251), Victoza® 1.8 mg (n=246), or glimepiride 8 mg (n=248). The primary outcome was change in A1C after 52 weeks.
The change begins at VictozaPro.com. Indications and Usage
Victoza (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as firstline therapy for patients who have inadequate glycemic control on diet and exercise. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. Victoza® has not been studied in combination with prandial insulin. ®
Important Safety Information
Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors. Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components. Postmarketing reports, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Discontinue promptly if pancreatitis is suspected. Do not restart if Victoza® is a registered trademark of Novo Nordisk A/S. © 2013 Novo Nordisk All rights reserved.
pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis. When Victoza® is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia. Renal impairment has been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Serious hypersensitivity reactions (e.g. anaphylaxis and angioedema) have been reported during postmarketing use of Victoza®. If symptoms of hypersensitivity reactions occur, patients must stop taking Victoza® and seek medical advice promptly. There have been no studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. The most common adverse reactions, reported in ≥5% of patients treated with Victoza® and more commonly than in patients treated with placebo, are headache, nausea, diarrhea, dyspepsia, constipation and anti-liraglutide antibody formation. Immunogenicity-related events, including urticaria, were more common among Victoza®-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials. Victoza® has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patients. There is limited data in patients with renal or hepatic impairment. In a 52-week monotherapy study (n=745) with a 52-week extension, the adverse reactions reported in ≥ 5% of patients treated with Victoza® 1.8 mg, Victoza® 1.2 mg, or glimepiride were constipation (11.8%, 8.4%, and 4.8%), diarrhea (19.5%, 17.5%, and 9.3%), flatulence (5.3%, 1.6%, and 2.0%), nausea (30.5%, 28.7%, and 8.5%), vomiting (10.2%, 13.1%, and 4.0%), fatigue (5.3%, 3.2%, and 3.6%), bronchitis (3.7%, 6.0%, and 4.4%), influenza (11.0%, 9.2%, and 8.5%), nasopharyngitis (6.5%, 9.2%, and 7.3%), sinusitis (7.3%, 8.4%, and 7.3%), upper respiratory tract infection (13.4%, 14.3%, and 8.9%), urinary tract infection (6.1%, 10.4%, and 5.2%), arthralgia (2.4%, 4.4%, and 6.0%), back pain (7.3%, 7.2%, and 6.9%), pain in extremity (6.1%, 3.6%, and 3.2%), dizziness (7.7%, 5.2%, and 5.2%), headache (7.3%, 11.2%, and 9.3%), depression (5.7%, 3.2%, and 2.0%), cough (5.7%, 2.0%, and 4.4%), and hypertension (4.5%, 5.6%, and 6.9%). Please see brief summary of Prescribing Information on adjacent page. 1013-00018617-1
Published on Dec 9, 2015