News and Trends—November 2015

| November 1, 2015

35 Medical Societies Gather for Second Annual National Obesity Summit
GAINESVILLE, Florida— Representatives from 35 major health and medical organizations including, the American Diabetes Association (ADA), American Medical Association (AMA), American Heart Association (AHA), American Academy of Orthopaedic Surgeons (AAOS), and American Society of Clinical Oncology (ASCO) convened for a second annual summit in Chicago to identify opportunities for collaboration in treating obesity. “The National Obesity Summit on the Provision of Care for the Obese Patient” was hosted by the American Society for Metabolic and Bariatric Surgery (ASMBS).

“We represent many different specialties, backgrounds and perspectives, but we’re all really treating the same disease,” said John M. Morton, MD, MPH, ASMBS President, who served as moderator for the Summit, which was held in September. “That’s why there is intense and growing interest in how we can work together to better help our patients with obesity and related diseases. Obesity is the medical equivalent of economic inflation – obesity increases costs and decreases the effectiveness of medical interventions. We are paying for obesity already. Let’s coordinate and provide care the right way.”

Specialists in obesity medicine, bariatric surgery, orthopaedics, diabetes, heart disease, reproductive medicine, sleep medicine, anesthesiology, nutrition, behavioral health, dentistry and oncology discussed prevention and treatment strategies for obesity, patient access to treatment, care coordination and how to further engage patients themselves in the treatment of obesity. Representatives from the insurance industry also participated.

“Treating obesity is central to the management of type 2 diabetes,” said William Herman, MD, MPH, who represented the American Diabetes Association. “Medical care is so siloed. We need to move from a piecemeal approach to one that is more comprehensive.”

Recently the American Diabetes Association and the American Heart Association issued a joint scientific statement on cardiovascular disease in adults with type 2 diabetes, which for the first time includes discussion and recommendations on bariatric and metabolic surgery, focuses on blood pressure and blood glucose control, cholesterol management, aspirin therapy, and weight management through lifestyle, pharmacological and surgical approaches.

Another group that is becoming increasingly focused on obesity treatment is the American Society of Clinical Oncology (ASCO), the world’s leading professional organization representing physicians who care for people with cancer. Last October, ASCO called for increased education, research and advocacy “to reduce the toll of obesity, both as a leading cause of cancer and complication in the care of cancer patients.”

Jennifer Ligibel, MD, who leads the ASCO Energy Balance Working Group, presented data at the Summit that illustrated a strong connection between obesity and cancer, a connection she says is not well recognized, especially in the general population.
“Over the next 20 years, obesity is likely to be the most preventable cause of cancer,” Dr. Ligibel said. Dr. Ligibel told the group she envisions potential collaborations in research, education and policy activities.

Collaboration was the key word as the group discussed how they could work together to improve patient care through a multidisciplinary, comprehensive approach to obesity.
“The AASM recognizes that healthy sleep helps prevent obesity, and that helping our patients with obesity lose weight is an integral part of sleep apnea treatment. This conference is a great step towards whole person healthcare,” said Timothy I. Morgenthaler, MD, Mayo Clinic Center for Sleep Medicine and past president, American Academy of Sleep Medicine (AASM).

“We are thankful to be included in the Summit. The dental office can play an important role in assessing for and monitoring chronic diseases like diabetes and hypertension, which are significantly linked to obesity,” said Lindsey Robinson, DDS, who represented the American Dental Association. “Dental care professionals can be an important part of the multi-disciplinary care team to manage patients with chronic diseases and reduce obesity prevalence in society.”

Many said the AMA’s classification of obesity as a disease brings a new critical focus and sense of urgency regarding obesity prevention and treatment to the general public, healthcare professionals, payers and policymakers.

“It’s important we work together with physicians at all levels,” said Mary Anne McCaffree, MD, a member of the AMA Board of Trustees, who said the AMA will focus on prediabetes detection and treatment, as well as detecting hypertension at its early states, as part of a strategic initiative. “We do none of this alone, but in a collaborative effort.”

Stacy Brethauer, MD and Shanu Kothari, MD from the ASMBS served as co-chairs of the summit. Other ASMBS representatives in attendance included Raul Rosenthal, MD, Ninh Nguyen, MD, Alfons Pomp, MD Chris Bauer, MSN, RN, CBN and Karen Flanders, MSN, ARNP, CBN.

Planned activities from the Summit include the development of joint guidelines and symposia, a Healthy Hospital Initiative, an obesity treatment app, an educational curriculum, and collaboration on a legislative agenda, among other initiatives.

National Obesity Summit on the Provision of Care for the Obese Patient Participating Organizations
•    Academy of Nutrition and Dietetics (AND)
•    American Academy of Orthopaedic Surgeons (AAOS)
•    American Academy of Physician Assistants (AAPA)
•    American Academy of Sleep Medicine (AASM)
•    American Association for the Study of Liver Disease (AASLD)
•    American Association of Clinical Endocrinologist (AACE)
•    American Association of Nurse Practitioners (AANP)
•    American College of Gastroenterology (ACG)
•    American College of Occupational and Environmental Medicine (ACOEM)
•    American College of Sports Medicine (ACSM)
•    American College of Surgeons (ACS)
•    American College of Obstetricians and Gynecologists (ACOG)
•    American Dental Association (ADA)
•    American Diabetes Association (ADA)
•    American Heart Association (AHA)
•    American Medical Association (AMA)
•    American Psychological Association (APA)
•    American Sleep Apnea Association (ASAA)
•    American Society for Bariatric Physicians (ASBP)
•    American Society for Gastrointestinal Endoscopy (ASGE)
•    American Society for Metabolic and Bariatric Surgery (ASMBS)
•    American Society for Reproductive Medicine (ASRM)
•    American Society of Anesthesiologists (ASA)
•    American Society of Clinical Oncology (ASCO)
•    American Society of Plastic Surgeons (ASPS)
•    Endocrine Society
•    International Society for the Perioperative Care of the Obese Patient (ISPCOP)
•    National Lipid Association (NLA)
•    Obesity Action Coalition (OAC)
•    Strategies to Overcome & Prevent Obesity Alliance (STOP)
•    The Obesity Society (TOS)
•    Blue Cross Blue Shield
•    Optum
•    Pacific Business Group on Health
•    Willis-Towers Watson

About Obesity. Studies have shown individuals with a body mass index (BMI) greater than 30 have a 50 to 100 percent increased risk of premature death compared to healthy weight individuals, as well as an increased risk of developing more than 30 obesity-related diseases and conditions including Type 2 diabetes, heart disease and certain cancers.

About the ASMBS. The ASMBS is the largest organization for bariatric surgeons in the nation. It is a non-profit organization that works to advance the art and science of bariatric surgery and is committed to educating medical professionals and the lay public about bariatric surgery as an option for the treatment of morbid obesity, as well as the associated risks and benefits. It encourages its members to investigate and discover new advances in obesity, while maintaining a steady exchange of experiences and ideas that may lead to improved outcomes for morbidly obese patients. For more information, visit www.asmbs.org.

SAGES Launches SMART™ Enhanced Recovery Program
The SAGES SMART (Surgical Multimodal Accelerated Recovery Trajectory) Task Force provides the education and materials needed for surgeons to adopt a strong, evidence-based Enhanced Recovery Program (ERP) into their practices.
As such, SAGES has developed the following SMART Enhanced Recovery Program resources:

•    The SAGES SMART Enhanced Recovery Program website, a living resource of best ERP practices and guidelines for SAGES members.
•    The SAGES/ERAS Society Manual of Enhanced Recovery Programs for Gastrointestinal Surgery, a companion to the website, provides more in-depth guidance on implementation of ERP concepts.
•    The SAGES/ERAS Society Canada course, ERAS 2015: Creating a Culture of Enhanced Recovery, a one-day symposium which will address the issues related to the organization of ERPs for surgery from a multidisciplinary point of view.

Additional SMART ERP courses will follow at SAGES 2016 at the Hynes Veterans Memorial Convention Center, Boston, MA on March 16–19, 2016.

TransEnterix Acquires the ALF-X Surgical Robotic System
RESEARCH TRIANGLE PARK, North Carolina and MILAN, Italy—TransEnterix, Inc., a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, announced today that it has acquired the surgical robotics division of SOFAR S.p.A., an Italian health care company, in a cash and stock transaction with total consideration of $99.8 million. SOFAR has developed the TELELAP ALF-X® advanced robotic system for minimally invasive surgery, which has an active CE Mark.

“The combination of SurgiBot™ and AL-FX® will allow TransEnterix to address a larger market opportunity with compelling patient, surgeon and hospital value,” said Todd M. Pope, President and CEO of TransEnterix. “We believe this combination accelerates our commercialization timeline and revenue ramp as we can immediately begin selling the ALF-X in many markets globally.”

“We believe joining with TransEnterix will make our vision to create the next wave of robotic surgery a reality.” said Andrea Biffi, CEO of SOFAR, who has been appointed to the TransEnterix Board of Directors. “Our decision to become a significant shareholder reflects our belief that the company has built a strong team and will execute on this compelling opportunity.”

Strategic Rationale. The combination with SOFAR’s surgical robotics division supports and accelerates TransEnterix’s fundamental strategies:

•    Accelerate the migration of traditional laparoscopic procedures to robotically assisted laparoscopy: Both robotic surgical systems are designed to leverage the experience and motion of traditional laparoscopic surgery. Laparoscopic procedures represent over 10 times the number of existing robotic surgery procedures. New robotic systems that leverage laparoscopic experience and techniques should facilitate the continued growth of robotically enhanced laparoscopy.
•    Address the trade-offs required of surgeons when using currently available robots: Both the SurgiBot and ALFX systems are designed to address trade-offs that currently-available robotic systems require of surgeons, such as loss of haptic feedback, being disengaged from the surgical field, the increased size of required trocar incisions, the inability to easily reposition patients once docked, and the requirement to interrupt operating and disengage instrument controls in order to move the camera.
•    Eliminate cost barriers to adoption with compelling pricing models: Both robotic systems are designed to present a compelling economic value to hospitals. Whether through reduced capital acquisition cost or reduced per-procedure costs, each system will lower the economic barriers for hospitals to engage in robotic surgery. This should make robotic surgery a possibility for many more hospitals around the world.

About TransEnterix. TransEnterix is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the economic and clinical challenges associated with current laparoscopic and robotic options. The company is focused on the development and commercialization of the SurgiBot™ System, a robotically enhanced laparoscopic surgical platform that allows the surgeon to be patient-side within the sterile field. The SurgiBot System is not yet available for sale in any market.

For more information, visit the TransEnterix website at www.transenterix.com.

About TELELAP ALF-X. TELELAP ALF-X is a next generation robotic surgical system. The system is the result of years of advanced research by SOFAR S.p.A, in collaboration with the European Commission’s Joint Research Centre (JRC). TELELAP ALF-X is a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative new technology such as eye tracking and haptics. Utilizing reusable instruments, the system will allow hospitals to offer the most advanced technology with low operational costs. The ALF-X is not available for sale in the U.S.

Read the full release at: http://www.businesswire.com/news/home/20150921006346/en/TransEnterix-Acquires-ALF-X-Surgical-Robotic-System

Bariatric Patients Can Now Use CareCredit for all Bariatric Surgical Procedures
COSTA MESA, California—CareCredit, a leading healthcare credit card, can now be used by patients to pay for ALL bariatric procedures.

CareCredit has always been a convenient payment option for patients seeking minimally invasive procedures such as Lap-band. But now patients can use the healthcare credit card for ALL surgical procedures including gastric bypass, gastric sleeve and the balloon system.

Many patients today face high deductibles and large out-of-pocket costs that may stop them from moving forward with recommended treatment or care. To address patient cost concerns, many practices have added the CareCredit healthcare credit care as a payment option. CareCredit offers a variety of special financing options* that patients can use to pay for care with convenient monthly payments that fit into their lifestyle and budget.

CareCredit can help practices attract more patients, enhance treatment acceptance, increase cash-flow and reduce accounts receivable. Plus, the practice gets paid in two business days and patients have a financial resource for additional or follow-up care.
About CareCredit. For nearly 30 years, CareCredit, from Synchrony Financial (NYSE: SYF), has helped millions of patients receive needed and desired care. CareCredit is a health, wellness and beauty credit card that can be used as a financing option for certain expenses not covered by insurance or to bridge payment when desired care exceeds insurance coverage. CareCredit is accepted at more than 185,000 healthcare practices nationwide.

For more information on CareCredit, call 800-300-3046, option 5 or visit www.carecredit.com.
*Subject to credit approval. Minimum monthly payments required. See carecredit.com for details.

Obstructive Sleep Apnea associated with Incident Heart Failure, Death In Women
In women, sleep apnea associated with higher levels of troponin, a marker for heart injury
BOSTON, Massachusetts—Risk factors for obstructive sleep apnea (OSA) and the development of subsequent cardiovascular (CV) complications differ by sex, but it is not clear from prior research whether the effects of sleep apnea on heart disease is similar for men and women.

To evaluate whether sex-based differences exist in the relationship between OSA and CV disease, researchers at Brigham and Women’s Hospital (BWH) evaluated the links among sleep apnea, cardiac bio-markers that provide early evidence of heart disease, and occurrence of adverse heart outcomes in 1,625 individuals who were free of heart disease when first studied, and followed for an average of almost 14 years.

Results of the research, published in Circulation in October, found that sex-specific differences exist in the relationship between OSA and CV disease and that, in women, sleep apnea was associated with higher blood levels of troponin (hs-TnT), a marker that provides information on early evidence of heart injury.

“The finding that sleep apnea is associated with evidence of early heart injury and an elevation in long term risk of heart failure, coronary heart disease, enlargement of the heart muscle, and death in women highlights the importance of sleep apnea screening and treatment for women, a group who often are not routinely screened for sleep apnea,” said co-author Susan Redline, MD, MPH, associate clinical director, in the Division of Sleep and Circadian Disorders at BWH.

The study examined post-menopausal women, who are at a greater risk for sleep apnea and heart disease.  Researchers found that older women may be at relatively greater risk of sleep apnea related heart disease compared to men.

At the beginning of the study, when participants were an average age of approximately 63 years, 23 percent of men and 10 percent of women had undiagnosed moderate to severe sleep apnea. Over a 14 year follow up, 46 percent of men and 32 percent of women experienced a significant adverse cardiac event, death, or had an enlarged heart. Women with moderate to severe sleep apnea were more than 30 percent likely to experience these adverse heart problems compared to women without sleep apnea. This relationship was not statistically significant in men, suggesting that factors such as age, obesity, hypertension and diabetes explained most of the observed heart disease risk in the men studied.

“We hope these results focus attention on the importance of sleep apnea in women, who historically are under-diagnosed in this area,” Redline noted.
This research was supported by National Heart, Lung, and Blood Institute.

Risk of Suicide Appears to Increase after Bariatric Surgery
The JAMA Network Journals—A study of a large group of adults who underwent bariatric surgery finds that the risk for self-harm emergencies increased after the surgery, according to a study published online by JAMA Surgery.

Junaid A. Bhatti, M.B.B.S., M.Sc., Ph.D., of the Sunnybrook Research Institute, Toronto, and colleagues studied 8,815 adults from Ontario, Canada, who underwent bariatric surgery to compare the risk of self-harm behaviors before and after surgery. Follow-up for each patient was 3 years prior to surgery and 3 years after surgery. The researchers categorized 4 distinct mechanisms of self-harm behaviors: medications, alcohol, poisoning by toxic chemicals, and physical trauma.

A total of 111 patients had 158 self-harm emergencies during follow-up. The researchers write that although a few patients had self-harm emergencies, the risk of these emergencies increased significantly (by approximately 50 percent) after surgery. Nearly all events occurred in patients who had a history of a mental health disorder. Intentional self-poisoning by medications was the most common mechanism of attempted suicide.
The authors write that the published literature provides differing reasons for the association between bariatric surgery and the subsequent risk of self-harm, including changes in alcohol metabolism after surgery; surgery might lead to a substitution of substance misuse for food; increased stress and anxiety in postoperative patients; and the effect of surgery on the levels of neurohormones, possible mediators of the likelihood of depression and suicidal behaviors. “Findings from this study advocate a better understanding of these and other theories through future research of potential mechanisms of self-harm in patients undergoing bariatric surgery.”

“These adverse events undermine the overall benefits of bariatric surgery. The study findings could be useful for bariatric surgeons and emergency physicians in postoperative follow-up. Additional clinical implications include active postoperative screening for self-harm risk among patients who have undergone bariatric surgery and are presenting for follow up. Patient and surgery factors could help identify vulnerable patients. Overall, these findings imply that more work is needed to understand why self-harm behaviors increase in the postoperative period and how these risks might be reduced.”
Source: JAMA Surgery. Published online October 7, 2015. doi:10.1001/jamasurg.2015.3414.

Commentary: Bariatric Surgery—More Than Just an Operation.
“The study has 2 important findings. First, the preoperative incidence of self-harm emergencies in patients undergoing bariatric surgery is twice the population average and increases by an additional 50 percent in the postoperative period. The identification of patients with an increased risk of such adverse outcomes remains an elusive goal,” write Amir A. Ghaferi, M.D., M.S., and Carol Lindsay-Westphal, Ph.D., of the Ann Arbor Veterans Administration Healthcare System, Ann Arbor, Mich.

“Second, most self-harm emergencies occur in the second and third postoperative years. There is currently no minimum standard for psychological follow-up. Although stringent criteria are in place for insurance and programmatic approval to undergo surgery, the postoperative follow-up rates in general have been poor.”
“The study by Bhatti and colleagues underscores the unique vulnerability of patients undergoing bariatric surgery and forces us to look closely at why suicide rates are more than 4 times higher in these patients than the general population. Bariatric surgery is more than just an operation—it is time we recognize and treat it is as such.”

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