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We never forget they’re your patients. Connect instantly to patient updates through Mayo Clinic’s Online Services for Referring Physicians Esophageal Diseases For specialized care related to benign and malignant diseases of the esophagus, look to Mayo Clinic in Florida — an internationally recognized leader in the diagnosis and treatment of gastrointestinal disorders.

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Use of state-of-the art imaging techniques, including high resolution endoscopy with narrow band imaging, confocal laser endomicroscopy and other advanced systems.

A comprehensive Barrett’s program providing all FDA-approved treatments — photodynamic therapy, endoscopic resection, radiofrequency ablation, cryotherapy and surgical resection.

Esophagectomy using conventional and laparoscopic minimally invasive techniques.

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DCMS online . org


VOLUME 65, NUMBER 1 Cardiovascular Disease and Limb Saving Spring 2014

Spring 2014

EDITOR IN CHIEF Raed Assar, MD (Chair)

Contents

MANAGING EDITOR Laura Townsend ASSOCIATE EDITORS Kim Barbel-Johnson, MD Mark Fleisher, MD Ruple Galani, MD James Joyce, MD

Spring CMEs

Daniel Kantor, MD

(Earn up to 4.5 credits)

Joseph Sabato, Jr., MD James St. George, MD

EXECUTIVE DIRECTOR Bryan Campbell DCMS FOUNDATION BOARD OF DIRECTORS President: Todd Sack, MD President-elect: Guy Benrubi, MD Secretary: Allen Seals, MD Treasurer: Malcom Foster, MD At Large Seat 1: Ruple Galani, MD At Large Seat 2: Eli Lerner, MD

2013 DCMS FOUNDATION DONORS Todd Sack, MD James Borland, MD Karen Ostergren, MD Marianne McEuen, MD J. Eugene Glenn, MD George Mayer, MD Jefferson Edwards, MD James St. George, MD R. Jay Cummings, MD Janet Betchkal, MD Jack Giddings, MD Cesar Gorospe, MD J. Timothy Walsh, MD H. Wade Barnes, MD David Boyd, MD Joe Ebbinghouse, MD Troy Guthrie, MD James Townsend, MD Kenneth Horn, MD N. H. Tucker, MD Chalermchai Punya, MD Allen Marks, MD

Northeast Florida Medicine is published by the DCMS Foundation, Jacksonville, Florida, on behalf of the County Medical Societies of Duval, Clay, Nassau, Putnam, and St. Johns. Except for official announcements from the County Medical Societies, no material or advertisements published in NEFM are to be seen as representing the policy or views of the DCMS Foundation or its colleague Medical Societies. All advertising is subject to acceptance by the Editor in Chief. Address correspondence and advertising to: 1301 Riverplace Blvd. Suite 1638, Jacksonville, FL 32207 (904-355-6561), or email: ltownsend@dcmsonline.org.

DCMS online . org

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Domestic Violence and the Physician’s Role Leo Alonso, DO

Domestic violence is a subject that most physicians would probably prefer not to discuss with patients. Similar to end-of-life conversations, it creates a tension between the physician and the patient that most of us want to avoid. As physicians, however, our duty and obligation is to defend patients’ rights and physical wellbeing, not just from invisible pathogens, but also from the physical and psychological injuries that can arise from domestic violence.

43 ACO Forum CME William Carriere, MD Jonathan B. Gavras, MD Chad Greeno Kenyatta Lee, MD and Pam Maxwell

Introduction by Eli Lerner, MD Topics include the future of health care in Northeast Florida, defining accountable care, starting an ACO, the experience of the pioneer ACO in North Florida, the payer’s perspective on integrated health systems, employer-based ACOs and the the role of the Patient Centered Medical Home and Ambulatory Intensive Care Unit in ACOs.

Features

Peripheral Artery Disease (PAD) 9 & Advances in Endovascular Medicine Yazan Khatib, MD, FACC, FSCAI, FABVM, FSVM Guest Editor

18

PAD Facts and Myths Desmond Bell, DPM, CWS

Imaging in PAD: The Role of the 23 Non-Invasive Vascular Department Jason Roberts DHSc, RVT and Yazan Khatib, MD, FACC, FSCAI, FABVM, FSVM

27

A Physician’s Personal Experience with PAD

Nicholas H. Bancks MD, FACR

Endovascular Management of Lower Extremity PAD

29

Omer Zuberi, MD, FACC, FSCAI and Yazan Khatib, MD, FACC, FSCAI, FABVM, FSVM

Acute Limb Ischemia

37

Juzar Lokhandwala, MD

Wake Up Call: How I Began My Leadership Journey

56

Meridith Farrow, MD 2013 Philip H. Gilbert Young Physician Leadership Award Recipient

4 5 7 8 57 58

Departments Patient Page From the Editor’s Desk From the President’s Desk From the Executive Vice President’s Desk Residents’ Corner Trends in Public Health

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Patient Page

Peripheral Arterial Disease (PAD) in the Legs or lower extremities is the narrowing or blockage of the vessels that carry blood from the heart to the legs. It is primarily caused by the buildup of fatty plaque in the arteries, which is called atherosclerosis. PAD can occur in any blood vessel, but it is more common in the legs than the arms.

Risk Factors for PAD • Smoking • High blood pressure • Atherosclerosis • Diabetes • High cholesterol • Older than age 60

Approximately 8 million people in the United States have PAD, including 12-20% of individuals older than age 60. General population awareness of PAD is estimated at 25%, based on prior studies.1

Signs and Symptoms of PAD The classic symptom of PAD is pain in the legs with exertion such as walking, which is relieved by resting. However, up to 40% of individuals with PAD have no leg pain. Symptoms of pain, ache, or cramp with walking (claudication) can occur in the buttock, hip, thigh, or calf.2 Physical signs in the leg that may indicate peripheral arterial disease include muscle atrophy, hair loss, smooth shiny skin, skin that is cool to the touch especially if accompanied by pain while walking (which is relieved by stopping walking), decreased or absent pulses in the feet, non-healing ulcers or sores in the legs or feet, and cold or numb toes.2,3

Diagnosis and Treatment of PAD In patients with symptoms of PAD, the ankle-brachial index (ABI) is a non-invasive test that measures the blood pressure in the ankles and compares it with the blood pressure in the arms at rest and after exercise. Imaging tests such as ultrasound, magnetic resonance angiography (MRA), and computed tomographic (CT) angiography can provide additional information in diagnosing PAD.1-3 • Individuals with PAD are at risk for developing coronary artery disease and cerebrovascular disease, which could lead to a heart attack or stroke.4 • Aspirin or other similar anti-platelet medications may prevent the development of serious complications from PAD and associated atherosclerosis.2,4 • All efforts must be made to stop smoking. • Severe cases may require surgery to bypass blocked arteries. References: (1) Roger VL, Go AS, Lloyd-Jones DM, et. al. Heart Disease and Stroke Statistics 2011 Update: A Report From the American Heart Association. Circulation 2011;123:e18-e209. (2) Creager MA, Loscalzo J. Vascular Diseases of the Extremities. In: Fauci AS, Braunwald E, Kasper DL, et al., eds. Harrison’s Principles of Internal Medicine. 17e ed. New York: McGraw Hill, 2008. (3) Rooke TW, Wennberg PW. Diagnosis and Management of Diseases of the Peripheral Arteries and Veins. In: Walsh RA, Simon DI, Hoit BD, et al., eds.: Hurst’s The Heart. 12e ed. New York: McGraw Hill, 2007. (4) Hirsch AT, Haskal ZJ, Hertzer NR, et al. ACC/AHA 2005 Practice guidelines for the management of patients withi peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): Circulation. 2006;113:e463-654.

Add For more information, call 1-800-CDC-INFO or visit www.cdc.gov.

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From the Editor’s Desk

DCMS and Community Health Education In 2012, the Duval County Medical Society (DCMS) updated its mission statement and adopted a Strategic Plan to help guide the organization in the future. The mission statement “Helping physicians care for the health of our community,” reflects the passion of DCMS physicians, not just for their patients, but for improving the overall health of the population in North Florida. Executing this mission is the focus of the DCMS Journal and Communications Committee as it oversees the publishing the Northeast Florida Medicine journal and the DCMS Membership Directory, manages the development of the DCMS website dcmsonline.org, as well as directs any other communication initiatives or projects. As a result, DCMS has Raed Assar, MD, MBA taken an active role in edEditor-in-Chief ucating the community on Northeast Florida Medicine healthcare issues through the Florida Times-Union newspaper and a column entitled “Doctors On Call.” In 2013, DCMS published more than 25 valuable articles on a variety of health care topics varying from preventive health to relevant seasonal issues to education on end of life discussions. A list of the article library is available via the Managing Editor. DCMS also utilized television and radio as ways to better disseminate medical information. In 2013, DCMS had more than 40 radio and TV spots highlighting a variety of health care topics and health care policy issues. Special thanks go to Dr. Daniel Kantor for six interviews and Dr. Sunil Joshi for three. Additionally, Drs. Gary Evans, Neel Karnani, Ashley Norse, and Alan Marks all contributed greatly to this process. There are definite benefits to the community, physicians, and DCMS through the published news column and electronic media appearances. All help promote the overall mission of DCMS. This approach is aligned with the vision of the Department of Health and Human Services (HHS) for “public health quality to build better systems to give all people what they need to reach their full potential for health.” DCMS does so by ensuring that public health education is accessible at all levels of understanding in North Florida. The documents are available for review at: http://www.hhs. gov/ash/initiatives/quality/quality/#public.

Educating the public has a positive impact on health care outcomes. An Agency for Healthcare Research and Quality (AHRQ) report published in January 2004, indicated low literacy is associated with several adverse health outcomes including low health knowledge, increased incidence of chronic illness, poorer disease markers, and less than optimal use of preventive health services. Interventions to alleviate the effects of low literacy have been studied and some have shown promise for improving patient health and receipt of health care services. This report on literacy and health outcomes was requested by the American Medical Association and funded by AHRQ. http://archive.ahrq.gov/downloads/ pub/evidence/pdf/literacy/literacy.pdf The newspaper column and other media initiatives will promote the delivery of high quality medical care, a major component of DCMS mission. The DCMS Board of Directors wants to extend DCMS activities to other print media and to television and radio stations to educate the community-at-large on health issues. The Society’s engagement in this media campaign with newspapers, television stations, and radio stations will highlight the value DCMS brings to the medical community and the public. Several DCMS physicians have already volunteered to represent the society in such educational efforts. In addition, as non-member physicians become interested in publishing articles and supporting community education, they will join DCMS. In fact, several physicians have recently joined DCMS in order to participate. Adding to our membership makes DCMS a stronger organization that is more capable of achieving its mission. DCMS needs your help to continue this effort. Please let us know if you would like to represent DCMS in this important activity. Not only would you be able to share information that would help prevent disease and better inform patients so they can make more informed decisions about their health issues, but your practice would gain exposure through this media publicity. Please contact Laura Townsend, the DCMS Communications Coordinator, at ltownsend@dcmsonline.org or by phone at: 904.355.6561 ext. 101 if you are interested in participating. She can provide the overall guidelines and suggest beneficial topics. Please indicate the areas of your interest whether it is writing newspaper articles or conducting television or radio interviews. There is a need for more physicians who are willing to accommodate television station requests for health care experts to address national, local or seasonal issues. The DCMS Journal and Communication Committee will guide this effort to ensure consistency, validity, and responsiveness. Your contributions are welcomed and greatly encouraged.

Dr. Assar is Aetna’s Medical Director for North Florida. Articles or opinions provided by Dr. Assar do not necessarily reflect the views of Aetna. DCMS online . org

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Rehabilitation Hospital • Outpatient Clinics • Home Health • Senior Services • Medical Group Practice • Research • Community Programs

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DCMS online . org


From the President’s Desk

Dear Colleagues,

health, the system will weaken substantially.

Happy New Year to you, your families and your loved ones. I hope and pray that this New Year brings you much happiness and success.

Mobeen H. Rathore, MD 2014 DCMS President

As we start this New Year our profession is faced with many challenges, however, these challenges also bring with it many opportunities. I am certain that we, as individuals and as a profession, are up to meeting these challenges. Our society was born out of meeting such challenges.

I hope to work toward achieving my and our Society’s “TRIPLE AIMS”: 1. Opportunity for each individual physician to have a practice environment that allows for the provision of best healthcare for her/his patients. 2. Improving the health of our community at large. 3. Focusing on the health of the community of physicians. I believe each of these goals is important for the success of our Society and that of the individual members of the Society. These aims are inter-related, and successful achievement of one without the other will achieve only partial success. We must have the ability to focus on and provide the best possible service for each and every one of our patients, however, if our physician community is not healthy we lose something critical in our mission. Similarly, if our individual patient and the community are healthy, but we fail to take care of our own

DCMS online . org

Your Society with your support will work hard to achieve all these aims. With regards to our ability to have an environment where we can provide the best healthcare for our patients, your Society is working with our partners in organized medicine to seek legislation that would require managed care organizations to provide “real time” eligibility for their subscribers and reimburse physicians for any patient services rendered whereby subscriber eligibility has been confirmed prior to the delivery of care, so that we do not face the unnecessary hurdles of getting to the best option for our patients quickly. This will be one of our top priorities in the upcoming legislative session. For the better health of our community we will advocate to make sure that all our patients have access to physician services. Realizing the shortage of physicians, we are advocating for an effective telemedicine program in the State of Florida. We want to assure that not only appropriately licensed Florida physicians practice telemedicine in Florida, but also that there is parity in payments for these services. In addition our EVP Bryan Campbell is leading the Mayor’s Council on Fitness and Wellbeing, and we will work closely with the City of Jacksonville to face the challenge of the “obesity epidemic.” Last, but not least, we must take care of ourselves. For our own health we - the DCMS - will organize activities that would help us improve our physical, mental and financial health. Too often we are so focused on care of our patients and the day-to-day activities that are necessary to achieve this most important goal that we tend to neglect ourselves. We must change this. Stay tuned for more information on these activities that I hope will be very beneficial to all of us. I wish you all the best of luck and look forward to another great year. Mobeen H. Rathore, M.D.

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From the Executive Vice President

Preserving History, Preparing for the Future When the Duval County Medical Society moved its headquarters in October of 2013, this was just the most recent in a number of relocations over the course of time. However, the move into the Gate Riverplace Tower (formerly the Gulf Life Building) brings the Medical Society directly across the river from where it all began back in 1853. When Dr. Abel Baldwin, Dr. H.D. Holland, Dr. Charles Byrne, Dr. Richard Daniel, Dr. James Dell and Dr. James Murdoch met on May 25, 1853 at the office of Dr. William L’Engle, they probably could not have imagined that 161 years later their small group of physicians would be 2,000 strong, headquartered in a building that practically touches the sky. All they were trying to do was come together to solve the malaria and small pox outbreaks in the region. They probably didn’t realize they were founding organized medicine in Florida. Bryan Campbell DCMS Executive Vice President

A plaque was dedicated in commemoration of the founding at the site of Dr. L’Engle’s office at the corner of Market and Bay Streets. If that intersection sounds familiar, it’s because that’s where the Duval County Courthouse Annex stands… today.

Saving a Landmark E. Russell Jackson is one of the leaders in organized medicine, not just in North Florida, but in the entire state and even the country. Last year he was honored by the American Medical Association with the Medical Executive Lifetime Achievement Award. “Russ” has spent his entire life in service to organized medicine, and if you’ve ever spoken with him, he knows more about the history of medicine in Florida than probably anyone. Russ knew that the Courthouse Annex is slated for demolition, and knew that he had to save the DCMS plaque. So he headed down to the building with his wife, Sharon, to see if he could find the plaque and get some details. Sharon waited outside while Russ scoured the inside of the lobby for any sign of the plaque. Nothing. Exasperated, he went back outside to check in with Sharon, who was resting against the concrete building sign. When Russ got to her, he looked over her shoulder, into the bushes, and saw a plaque – tarnished and nearly completely covered by bushes. It was the DCMS Founding plaque! Russ took pictures of the plaque and brought them to my attention. After more than a year of government bureaucracy, State Rep. Mia Jones stepped up and helped connect me with the right people to save this monument. Last fall, with no pomp and no circumstance, a crew from Public Works brought their drills and saws to help dislodge the plaque. It took some work to restore the old plaque, but it now has a prominent spot directly inside the door of our new office space. Russ recently had the chance to visit the new office 8 Vol. 65, No. 1 2014

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and for the first time truly see the history he helped to save. His only comment: “It’s Beautiful.” The plaque sits across from the DCMS logo and our Mission Statement “Helping physicians care for the health of our community.” Nearly 161 years later, the core values of the Medical Society remain the same. We are glad you are a part of this history, and look forward to making more with each and every one of you in the future. DCMS online . org


Guest Editorial

Peripheral Artery Disease (PAD) & Advances in Endovascular Medicine It is my distinct privilege to be the Guest Editor of this edition of Northeast Florida Medicine. It was most exciting to see the Editor-in-Chief agree to give the topic of PAD the importance it needs. For decades, our patients have struggled with the horrific complications of PAD and late diagnosis of atherosclerotic cardiovascular disease. Our communities and businesses continue to bear the high cost of such delay in diagnosis. Locally and nationally I find it quite sobering that Yazan Khatib, MD, FACC, most providers assumed FSCAI, FABVM, FSVM Guest Editor cancer mortality is higher than that of PAD. In fact, breast and prostate cancer mortality rates are far lower than that of PAD. Only lung and colorectal cancers have a higher mortality rate than PAD.1 These startling statistics reaffirm the need to educate all physicians about the importance of checking every patient for signs of PAD. The first article of this issue is a domestic violence CME article by Dr. Leo Alonso. Domestic violence CME is required for license renewal in the state of Florida, so I strongly encourage everyone to take advantage of this opportunity. In the next article, “PAD: Facts and Myths,” Dr. Desmond Bell updates us on the statistics of PAD. He provides information on disparity in access and outcomes. He also provides practical approaches to address missed opportunities for early detection and treatment. While the diagnosis of PAD is mostly clinical, Dr. Jason Roberts and I set out to explain the basics of vascular sonography and the importance of accreditation to ensure quality use of this cost effective tool. Duplex ultrasound and the ankle brachial index are explained, as well as their

DCMS online . org

respective roles in diagnosing and grading the extent of PAD in the article “Imaging in PAD: The Role of the Non-Invasive Vascular Department.” Dr. Nicholas Bancks’ testimony as a physician and patient provides insight into a patient’s life after diagnosis. He attests first hand to how the chronicity of disease progression and lack of knowledge about endovascular low risk treatment options can lead to the patient and physician to acquiesce to medical management only. This would be an adequate option for some patients, but not in many active young patients. He describes the life changing event of endovascular revascularization. This serves as an introduction into Dr. Omer Zuberi and my piece “Endovascular Management of Lower Extremity Peripheral Artery Disease (PAD),” which sums up the revolution in endovascular medicine. I felt this article, with the attached “before and after” radiographs, is beneficial for physicians to get an update about the tools available and adopted by the vascular surgeon, the radiologist and the cardiologist in battling advanced cases of PAD, especially when revascularization is indicated. Most PAD presentations are chronic, yet in few patients acute cold leg is the first sign of a larger problem. Dr. Juzar Lokhandwala in his article “Acute Limb Ischemia,” shares an abstract presentation of such cases treated successfully in a local outpatient endovascular lab, thus allowing tremendous cost savings, without jeopardizing safety or outcome. In Summary I hope this edition will promote better understanding of PAD and the importance of early detection and aggressive medical therapy of the risk factors. This issue also provides information regarding the endovascular options available to patients with advanced symptoms. Most importantly, I hope that it serves a reminder to prompt us all to check the pedal pulses on all our patients. References: 1- Armstrong DG. Int Wound J. 2007;4(4):286-287.

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Domestic Violence CME

Domestic Violence and the Physician’s Role Background:

The Duval County Medical Society (DCMS) is proud to provide its members with free continuing medical education (CME) opportunities in subject areas mandated and suggested by the State of Florida Board of Medicine to obtain and retain medical licensure. The DCMS would like to thank the St. Vincent’s Healthcare Committee on CME for reviewing and accrediting this activity in compliance with the Accreditation Council on Continuing Medical Education (ACCME). This issue of Northeast Florida Medicine includes an article, “Domestic Violence and the Physician’s Role” authored by Leo Alonso, D.O., which has been approved for 2 AMA PRA Category 1 credits.TM For a full description of CME requirements for Florida physicians, please visit www.dcmsonline.org.

Faculty/Credentials:

Faculty/Credentials: Leo Alonso, D.O., is Chairman of the Department of Emergency Medicine at Orange Park Medical Center.

Objectives: 1.

Quantify the prevalence of domestic violence in the community.

2.

Identify and address specific questions directed at patients to identify victims of domestic violence.

3.

Understand the high risk scenarios and presentations of intimate partner violence.

Date of release: Feb. 1, 2014

Date Credit Expires: Expires: Feb. 1, 2016

Estimated Completion Time: 2 hours

How to Earn this CME Credit: 1.

Read the “Domestic Violence and the Physician’s Role” article, complete posttest following the article and email your test to Patti Ruscito at patti@dcmsonline.org or mail it to 1301 Riverplace Blvd. Suite 1638, Jacksonville, FL 32207.

2.

Go to www.dcmsonline.org to read the article and take the CME test online.

3.

All non-members must submit payment for their CME before their test can be graded.

CME Credit Eligibility:

A minimum passing grade of 70% must be achieved. Only one re-take opportunity will be granted. A certificate of credit/completion will be emailed within four to six weeks of submission. If you have any questions, please contact Patti Ruscito at 904.355.6561 or patti@dcmsonline.org.

Faculty Disclosure:

Leo Alonso, D.O., reports no significant relations to disclose, financial or otherwise with any commercial supporter or product manufacturer associated with this activity.

Disclosure of Conflicts of Interest:

St. Vincent’s Healthcare (SVHC) requires speakers, faculty, CME Committee and other individuals who are in a position to control the content of this educations activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity. All identified conflicts of interest are thoroughly evaluated by SVHC for fair balance, scientific objectivity of studies mentioned in the presentation and educational materials used as basis for content, and appropriateness of patient care recommendations.

Joint Sponsorship Accreditation Statement

This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of St. Vincent’s Healthcare and the Duval County Medical Society. St. Vincent’s Healthcare designates this educational activity for a maximum of 2 AMA PRA Category 1 credits.TM Physicians should only claim credit commensurate with the extent of their participation in the activity.

DCMS online . org

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Domestic Violence CME

Domestic Violence and the Physician’s Role Leo Alonso, DO

Medical Director of the Emergency Department, Orange Park Medical Center

Domestic violence is a subject that most physicians would probably prefer not to discuss with patients. Similar to endof-life conversations, it creates a tension between the physician and the patient that most of us want to avoid. As physicians, however, our duty and obligation is to defend patients’ rights and physical wellbeing, not just from invisible pathogens, but also from the physical and psychological injuries that can arise from domestic violence. Below are statistics that give perspective to domestic violence against women and men. According to a CDC survey conducted in 2010:1 For women:

Table 12 Statistics on domestic violence for those that believe it is just not part of their practice. • Every 9 seconds in the US a woman is assaulted or beaten. • Around the world, at least one in every three women has been beaten, coerced into sex or otherwise abused during her lifetime. Most often, the abuser is a member of her own family.

• High rates of sexual violence, stalking and intimate partner violence were reported by women.

• Domestic violence is the leading cause of injury to women—more than car accidents, muggings, and rapes combined.

• Nearly one in five women has been raped at some time in her life.

• Studies suggest that up to 10 million children witness some form of domestic violence annually.

• One in four women has been a victim of severe physical violence by an intimate partner in her lifetime.

• Nearly 1 in 5 teenage girls who have been in a relationship said a boyfriend threatened violence or self-harm if presented with a breakup.

• One in six women has experienced stalking victimization during her lifetime in which she felt very fearful or believed that she or someone close to her would be harmed or killed. Much of stalking victimization was facilitated by technology, such as unwanted phone calls and text messages. • Almost 70 percent of female victims experienced some form of intimate partner violence for the first time before the age of 25. • Approximately 80 percent of female victims of rape were first raped before age 25. • Female victims of violence (sexual violence, stalking, intimate partner violence) were significantly more likely to report physical and mental health problems than female non–victims. • Across all forms of violence (sexual violence, stalking, intimate partner violence), the vast majority of victims knew their perpetrator (often an intimate partner or acquaintance and seldom a stranger).

Address correspondence: Leo Alonso, D.O., Medical Director of the Emergency Department, Orange Park Medical Center, 2001 Kingsley Avenue, Orange Park, FL. 32073 12 Vol. 65, No. 1 2014

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• Every day in the US, more than three women are murdered by their husbands or boyfriends. • Ninety-two percent of women surveyed listed reducing domestic violence and sexual assault as their top concern. • Domestic violence victims lose nearly 8 million days of paid work per year in the US alone—the equivalent of 32,000 full-time jobs. • Based on reports from 10 countries, between 55 percent and 95 percent of women who had been physically abused by their partners had never contacted non-governmental organizations, shelters, or the police for help. • The costs of intimate partner violence in the US alone exceed $5.8 billion per year: $4.1 billion are for direct medical and health care services, while productivity losses account for nearly $1.8 billion. Men who as children witnessed their parents’ domestic violence were twice as likely to abuse their own wives as sons of nonviolent parents.

DCMS online . org


Domestic Violence CME Men can also be victims of domestic violence.2 Some statistics on domestic violence against men include: • About one in seven men has experienced severe physical violence by an intimate partner at some point in their lifetime. • One in 19 men has experienced stalking victimization at some point during their lifetime in which they felt very fearful or believed that they or someone close to them would be harmed or killed. • Almost 53 percent of male victims experienced some form of intimate partner violence for the first time before age of 25. • More than one-quarter of male rape victims were first raped when they were 10 years old or younger. • Male victims of violence (sexual violence, stalking, intimate partner violence) were significantly more likely to report physical and mental health problems than male non-victims. Domestic violence is a major public health burden and the negative impact can have consequences that last a lifetime. Due to the prevalence, physicians engaged in clinical practice routinely manage patients with undisclosed domestic violence issues. Studies demonstrate that female victims of violence have a significantly higher prevalence of long-term health problems, including irritable bowel syndrome, diabetes, frequent headaches, chronic pain and difficulty sleeping. Nearly twice as many women who were victims of violence reported having asthma, compared to women who did not report violence victimization.3 Next time you have a patient with intractable pain and multiple somatic complaints consider broaching the subject about the possibility of domestic violence. Nicole Brown, the murdered wife of O.J. Simpson, is a famous high profile case of domestic violence. She called 911 eleven times to report her attacks before she successfully separated from her husband. Police officers responded to her home on those occasions, sometimes making formal reports of their visits and often, when Nicole herself declined to press charges, left without reporting. At no point did anyone in her family or in law enforcement facilitate a successful intervention. O.J. Simpson was never arrested for assault, and his wife’s murder is still considered unsolved. Despite decades of research, we do not know why victims stay with abusers. Many who do not work and have no other means of support are crippled by the lack of options available to them when they try to leave. But these crimes happen in every racial, ethnic and socioeconomic class. Some capable of supporting themselves tell us that they love the offender so deeply that they are unable to separate, believing that the abusive behavior will change, or that they did something to provoke the attack. In many instances, the partner apologizes and begs for forgiveness. The dynamic of power and control over the victim is reinforced and the victim remains in place. What is clear from the numbers is that the two most dangerous times for a person in an abusive relationship are when he or she attempts to separate from the perpetrator without a successful plan, and when a woman is pregnant.4

DCMS online . org

Searching for Physical Evidence Healthcare professionals need to be vigilant for subtle physical and psychological clues of domestic violence. Unwitnessed head, neck or facial injuries are significant markers for intimate partner violence.5 Look for symmetrical bruises on the upper arms, wrists and neck where a person might physically attempt to stop the victim from walking away. Check for nail marks or a swatch of hair missing from the head, which may be hidden under a hat or under long bangs. Victims often have bruises in various stages of healing. Old fractures and injuries inconsistent with an explanation of how they occurred should trigger suspicion; for example, a patient reporting that symmetrical injuries resulted from “bumping into the bathroom sink.” Fractured mandibles, black eyes, ruptured tympanic membranes, lacerations around the eyes and lips, subdural hematomas, rib fractures, and bruises on the breasts or genitalia can indicate abuse. Observation is the key to recognizing patterns of abuse. Minor injuries often become extreme emergencies to a victim of abuse, while severe trauma may barely raise a concern. A victim may watch a partner for signs of approval before answering questions, or edge toward the opposite side of the stretcher when the partner walks near. A nurse may notice the patient’s heart rate accelerate when the abusive partner enters the room and moves closer. None of these observations alone indicate abuse, but their presence warrants further exploration Since perpetrators of domestic violence use power and control to manipulate their partners, they often continue with a subdued version in public. The abuser may object to a male nurse caring for his or her partner or may interrupt questions and answer for their partner. Many abusers refuse to allow their victims to be alone with healthcare professionals, therapists or physicians, even for a few minutes. Strong objection to leaving the patient alone in your care by the partner, when you already suspect abuse, is a warning sign.

Just Ask the Question In most Emergency Departments (ED), all patients are routinely asked about the possibility of domestic violence and whether they feel safe at home. Unfortunately the question often becomes a mindless checkbox in a litany of computer generated questions and screens that must be completed in order to arrive at the reason the patient is in the ED. Victims will often not volunteer spontaneously that they are in an abusive relationship, especially if the partner is next to them. Asking about abuse in front of a possible abuser may trigger an abusive episode. Physicians should attempt to broach the subject in private. One example of getting the abuser out of the room is to ask the registration clerk or a nurse to call the partner out of the exam room for additional information which allows private time to discuss the possibility of abuse. Many healthcare professionals shy away from asking about abuse because of a lack of time, their own beliefs about asking such personal questions or they might have been in a similar situation.6 It is important to keep the patient’s wellbeing first in mind as you may be the last person standing between that person staying alive or their premature death. When a woman discloses abuse, give her time to talk about it, particularly before beginning a physical assessment. It is not uncomNortheast Florida Medicine Vol. 65, No. 1 2014 13


AmericAn college of cArdiology FoundAtion

Presented by: north Florida CardiovasCular eduCation Foundation 11th Annual

m a r r i ot t s aWg r a s s h ot e l Ponte vedra beaCh, Florida

Co-sPonsored by: ameriCan College oF Cardiology Foundation Florida ChaPter, ameriCan College oF Cardiology

saturday, april 12, 2014

SCHEDULE 7:00 am 8:15 am

Registration and Breakfast Welcome

A Cardiovascular Education Opportunity

anything neW in ChF? 8:30 am 8:40 am 9:10 am 9:40 am 10:00 am

Introduction of Speakers and Case Presentation Drug Therapy Update – Kirkwood Adams, Jr., MD Device Therapy Update – Philip Adamson, MD Panel Discussion Break

heart disease – are the seXes diFFerent? 10:30 am 10:40 am 11:10 am

11:40 am 12:15 pm

Introduction of Speakers and Case Presentation Yes! Woman Are Different – Joanne Foody, MD Yes! Men Are Different – Kevin Billups, MD • Management of Heart Disease in Men • Potential Role and Impact of Testosterone Panel Discussion Lunch and Presentation ACC – Its Relevance to All Cardiologists – Patrick O’Gara, MD

hyPertension: drugs versus “tugs” 1:30 pm 1:40 pm 2:10 pm 2:40 pm 3:00 pm

Introduction of Speakers and Case Presentation Drugs Are Here to Stay – George Bakris, MD Renal Denervation – A New Option in Severe Hypertension? – Deepak Bhatt, MD Panel Discussion Break

Guest Faculty includes:

Kirkwood F. Adams, MD, FACC Philip B. Adamson, MD, FACC George L. Bakris, MD, FASH Deepak Bhatt, MD, FACC Kevin L. Billups, MD JoAnn M. Foody, MD, FACC Morten J. Kern, MD, FAHA Patrick O’Gara, MD, FACC Habib Samady, MD, FACC Co-Directors: Pamela rama, md and michael Koran, md Featuring the latest information from faculty experts on the topics of:

• • • •

What is new in Congestive heart Failure heart disease – differences between the sexes hypertension – drugs versus “tugs” ischemic heart disease

isChemiC heart disease 3:30 pm 3:40 pm 4:10 pm 4:40 pm 5:00 pm

Introduction of Speakers and Case Presentation Bioabsorbable Stents – Now You See Them… – Habib Samady, MD Physiological Evaluation of Coronary Artery Disease…Go with the Flow – Morton Kern, MD Panel Discussion Reception for All Attendees

Featuring Luncheon Presentation by:

Patrick o’gara, md, FaCC, President-elect, american College of Cardiology Discussing the ACC and its relevance to all cardiologists in today’s environment.

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For more information and to register visit www.pvcardiacsymposium.com.


Domestic Violence CME Table 24 How to Ask using SAFE Questions Asking indirectly • How are things going at home? • What about stress levels? How are things going at work? At home? • How do you feel about the relationships in your life? • How does your partner treat you? • Are you having any problems with your partner?

Framing the question • Because unfortunately violence is so common in our society, I have started asking all of my patients about it. • Because domestic violence has so many effects on health, I now ask all my patients about it. • From past experience with other patients, I’m concerned that some of your medical problems may be the result of someone hurting you. Is that happening? • I don’t know if this is a problem for you, but many of the women I see as patients are dealing with abusive relationships. Some are too afraid or uncomfortable to bring it up themselves, so I’ve started asking about it routinely. • Violence affects many families. Violence in the home may result in physical and emotional problems for you and your child. We are offering services to anyone who may be concerned about violence in their home.

Asking directly • Are you afraid of your partner? Do you feel you are in danger? • You mentioned your partner’s problem with temper/ stress/drinking. When that happens, has he ever threatened or hurt you? • Every couple fights at times – what are your fights like at home? Do the fights ever become physical? • Have you been hit or scared since the last time I saw you? • Has anyone at home hit you or tried to injure you in any way? • What kinds of experiences with violence have you had in your life? • Do you feel controlled or isolated by your partner? • Does your partner ever try to control you by threatening to hurt you or your family? • Has anyone close to you ever threatened or hurt you? • Does your partner ever hit, kick, hurt or threaten you? • Have you ever been slapped, pushed or shoved by your partner? • Have you ever been touched in a way that made you feel uncomfortable? • Has anyone ever made you to do something sexual when you did not want to? • Has your partner ever refused to practice safe sex?

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mon for a woman to understate or minimize the frequency and intensity of battering and its effects on her and the family. She may blame herself or indicate that the abuser could not help himself because of alcohol or other circumstances in his life. Always reassure the woman that she is not responsible for the perpetrator’s abusive behavior, nor does she deserve such treatment. Do not allow any beliefs you may have about what she should or should not do enter into the conversation or thought process. The decision is hers alone and any hint of disapproval may keep a victim silent.

Where to Seek Help in Northeast Florida Once you have identified a victim of domestic violence what do you do next? What advice can you offer the victim? First and foremost, if the victim believes they are in imminent danger, you must counsel them to call the law enforcement authorities and/or seek shelter in a safe haven. A remarkable facility in Duval that offers 24 hours a day service is Hubbard House. They shelter approximately 90 victims and their children each day and provide services to 5,000 victims per year. Their 24 hour hotline is 904-354-3114. Serving the Clay County area is Quigley House with a 24 hour hotline of 904-284-0061. I encourage everyone to donate to these non-profit institutions serving our community. They also provide counseling and advice you may not be able to render in your busy practice. Additionally, the National Domestic Violence Hotline is 1-800-799-7233 and their website is www.TheHotline.org. To be effective in diagnosis and prevention of domestic violence, physicians should remain attentive to the plausibility that humans are capable of committing violent acts. It is the social and civil constructs of our modern society that no longer tolerate a degree of violence that only a century ago was considered normal and acceptable. As healers and health professionals, physicians must advocate for the safety and wellbeing of our patients. Be vigilant for signs of intimate partner and domestic violence and intervene to make a difference. You may save someone’s life! v

References 1. Centers for Disease Control and Prevention. Violence Prevention [Internet]. Data and Statistics [updated & reviewed Dec. 4, 2013; cited 2014, Jan.14] Available from: http://www.cdc.gov/violenceprevention/data_stats/index.html 2. Domestic Violence Statistics. [Internet] [cited 2013, Jan.14] Available from: http://domesticviolencestatistics.org/domestic-violence-statistics/ 3. Theodora B. Aggeles, RN, BA: Nurse.com. [Internet].Domestic Violence Advocacy;60133 Continuing Education Unit page. [cited 2013, Jan 11] Available from: http://ce.nurse.com/course/60133/ domestic-violence-advocacy-florida-update-2007/ 4. Make it Our Business. [Internet] Domestic violence-is there a risk of death page, [cited 2013, Dec. 20], Available from: http://www. makeitourbusiness.com/index.php?option=com_content&view=article&id=&Itemid=50 5. Wu et al, Pattern of Physical Injury Associated with IPV in Women Presenting to the Emergency Department: A Systematic Review and Meta-Analysis; Trauma Violence & Abuse April 2010 11:71-82 6. Stanford School of Medicine resource page [Internet], Domestic Abuse, Screening/ How to Ask subsection [cited 2013, Dec. 12] Available from: http://domesticabuse.stanford.edu/screening/how.html Northeast Florida Medicine Vol. 65, No. 1 2014 15


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 http://bit.ly/CEBroker

“Domestic Violence & The Physician’s Role” CME Questions & Answers (circle one answer)/Free to DCMS Members/$50.00 charge non-members*

(Return by February 1, 2016 by FAX: 904-353-5848, by mail: 1301 Riverplace Blvd. Suite 1638, Jacksonville, FL 32207 or online: www.dcmsonline.org.)

1. According to a 2010 CDC study, how many women have been raped at some time in their lives? a. Nearly one in five women b. Nearly two in seven women c. Nearly three in four women d. Nearly one in four women 2. What percentage of female victims experience some form of intimate partner violence for the first time before the age of 25? a. Almost 50 percent b. Almost 60 percent c. Almost 70 percent d. Almost 80 percent 3. How many men have experienced severe physical violence by an intimate partner? a. One in five men b. One in seven men c. Two in nine men d. Three in 10 men 4. When is the most dangerous time for a person in an abusive relationship? a. When he or she attempts to separate from the perpetrator without a successful plan b. When a woman is pregnant c. None of the above d. Both A and B

5. Unwitnessed head, neck or facial injuries are significant marker for intimate partner violence. a. True b. False 6. Asking about abuse in front of a possible abuser may trigger an abusive episode. a. True b. False 7. Strong objection to leaving the patient alone in your care by the partner, when you already suspect abuse, should not be seen as a warning sign. a. True b. False 8. Studies demonstrate that female victims of violence have a ________ higher prevalence of long-term health problems, including irritable bowel syndrome, diabetes, frequent headaches, chronic pain and difficulty sleeping. a. Moderately b. Somewhat c. Significantly d. None of the above

Evaluation questions & CME Credit Information (Please evaluate this article. Circle one number using this scale: 1= Strongly Agree to 5= Strongly Disagree) The article met the stated objectives: 1 2 3 4 5 The article was appropriate to my practice: 1 2 3 4 5 The topic was current and well presented: 1 2 3 4 5 Comments:   Name (Print) Email  Address/City/State/Zip  Phone Fax

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Peripheral Arterial Disease Section

Peripheral Arterial Disease “PAD”, Facts and Myths Desmond Bell, DPM, CWS

PAD Defined

Abstract: It has long been wrongly accepted in the medical community that Peripheral Arterial Disease (PAD) is a disease of men and a disease of the old. The mortality of PAD far exceeds that of most cancers. Such mortality is largely reversible, but only with early diagnosis. This article provides a review and update of the pertinent issues surrounding PAD, its unrecognized prevalence and poor, but reversible, prognosis.

Simply stated, PAD refers to the systemic disease of atherosclerosis as it affects the arteries throughout the body, especially those of the pelvis and legs. When atherosclerosis plaque formation and progression affects the carotid arteries, decreased blood flow to the brain can result in transient ischemic attack (TIA), stroke or death. Atherosclerosis of the renal arteries can result in resistant hypertension and chronic kidney disease (CKD). There may be additional complications such as myocardial infarction, stroke, dialysis, amputation of toes or legs, pain, suffering and a loss of independence that is accompanied by the mental anguish of becoming a burden to loved ones, in addition to the potential loss of dignity that accompanies life of the chronically ill.

Address correspondence to: Desmond Bell, DPM, CWS 8833 Perimeter Park Blvd., Suite 501, Jacksonville, FL 32216 Email: dr.desmond.bell@gmail.com Dr. Desmond Bell is the co-founder and Executive Board member of the “Save A Leg, Save A Life” Foundation, a multidisciplinary non-profit organization dedicated to the reduction in lower extremity amputations and improving wound healing outcomes through evidence based methodology and community outreach. To learn more about this non-profit organization, please visit www.savealegsavealife.org

Often, PAD screening might be overlooked due to the toes, feet and legs being hidden within socks, shoes or pants. Another

The search for yield is more difficult than ever. Unless you know where to look. Thankfully, we know where to look.

You have goals. We have strategies. Let’s get busy. C O N TA C T U S : 9 0 4 . 8 2 4 . 5 6 5 6 |

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Peripheral Arterial Disease Section important reason for such a vicious disease to evade diagnosis is the frequently insidious nature of symptom progression to where patients assume them to be a natural part of the aging process. The lack of awareness among the public and providers is leading to many preventable amputations, complications and deaths. People are suffering; yet often they are suffering in silence. Approximately one half of the lower limb amputations that are performed in the United States are done without even a simple, non-invasive test to check for arterial circulation.1 Procedures such as angioplasty, stenting and bypass are well-recognized terms and procedures when discussing coronary arterial disease. The same procedures are available to those with advanced PAD of the lower extremities, and despite this, the first line treatment offered to many is amputation based on this author’s experience.

Recognizing PAD Patients often do not know they have PAD. More alarming is the fact that quite frequently the medical providers are not aware either. The PARTNERS study is a community survey of 6,979 patients with one or more risk factors for PAD in 350 primary care clinics across America. Results show that 29 percent of the patients had PAD, yet only 49 percent of providers were aware of those patients. Only 11 percent of those PAD patients had classic claudication. Overall, less than half of the PAD patients were vigorously treated to reduce risk factors (anti-platelet, lipid lowering and anti-hypertension therapies).2 Also notable is the fact that PAD was equally prevalent between men and women. This data suggests that clinicians who only utilize a classic history of claudication to detect PAD are likely to miss 85 to 90 percent of the PAD diagnoses. Since many patients who are afflicted with PAD also suffer from

diabetes and peripheral neuropathy, it is important to recognize the similarities and overlapping symptoms. Neuropathy may mask symptoms of PAD. Conversely, symptoms of PAD may be mistaken for those of neuropathy. PAD in the Asymptomatic State Unfortunately the vast majority of PAD patients present with no symptoms and are only detected on physical examination when the pedal pulses are specifically checked and the Ankle Brachial Index (ABI) is performed. Claudication Intermittent Claudication is a dull cramping or pain most commonly in the calf muscles, but sometimes in the hips and thighs while walking, climbing stairs or exercising. It is relieved by cessation of activity. Claudication may also be characterized by fatigue in the legs, which may require a patient to stop and rest while walking. Patients may also exhibit a slow or antalgic gait and may have difficulty keeping up with others when ambulating. An example of claudication would be that of someone being able to walk for two city blocks, but then having to stop to rest due to pain in the calves. After resting for a few minutes, the pain subsides and the person is able to walk again for about the same distance, with the cycle repeating. The distance threshold for discomfort is specific to the individual and fairly predictable. One person may be able to walk five blocks while another person may only be able to walk 50 yards. Classic claudication as detailed above was only present in 11 to 15 percent of PAD patients in the PARTNERS study.2 The differential diagnosis for claudication includes the following etiologies: The author does not list or discuss the differential. There should be discussion regarding other etiologies that mimic claudication; e.g. neurogenic claudication, venous insufficiency, etc. (Table I)

Table 1 Differentiating Leg Pain Symptoms Pain Symptoms

PAD Claudication

Pain from other causes “Pseudo-claudication”

Description

Fatigue to severe pain, less commonly weakness. No sensory deficits

Frequent occurrence of weakness, tingling, or numbness Same, yet pain frequently extends to the middle of the back

Location

Most common in calf & feet, may also affect buttocks, hip and thigh

Exercise Related

Always

May also occur at rest or with prolonged sitting

Distance to Claudication

Same each time. May vary with speed.

Quite variable

Effect of Standing

Brings Relief

Frequently elicits the pain

Relief

Stop walking for few minutes

Most often can only be obtained by sitting or changing body position

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Peripheral Arterial Disease Section Figure 1

Other Symptoms of PAD Forty-five to 60 percent have atypical leg pain. Many patients simply do not complain as they assume the difficulties and symptoms are a part of aging. 2

Critical Limb Ischemia CLI As PAD severity increases, patients complain of pain at rest even without walking. In more advanced cases, ulcerations or gangrene may develop. Ischemic Pain at Rest or Tissue Loss When PAD is advanced, elevation of the lower extremities will further decrease blood flow to the feet and toes. This results in pain that is relieved by using gravity to assist blood flow back to the feet, whether by dangling feet from the side of the bed or getting up from sleep for a short walk. Rest pain is most noticeable at night when the patient is supine in bed. On exam the feet and toes may appear red, dusky or purplish-blue, especially when in the dependent or seated position. Decreased blood flow to the extremities, and the lack of oxygen creates what is referred to as either dependent rubor (red) or cyanosis (purple-blue). (Figure 1) Non-Healing ulcerations In more advanced cases of CLI, patients may develop non-healing ulceration(s) or gangrene, predominantly of the toes and heel. These ulcers are typically exquisitely painful, even in cases where patients are afflicted with concomitant decreased sensation due to neuropathy. Threatened limb or tissue loss is impending. Sores related to advanced PAD typically have atrophic edges and dry eschars, unless concomitant heart failure, venous insufficiency or other congestive states are present.

Ischemic changes in foot with significant PAD

Table 2 Non-Healing Ulcerations 0: Asymptomatic CLAUDICATION

2: Moderate 3: Severe

The Rutherford-Becker Categorization of lower extremity PAD

4: Ischemic Rest Pain

The Rutherford-Becker classification specifies the extent of symptoms from asymptomatic to those seen in Critical Limb Ischemia (Rutherford-Becker Category 4-6).3 (Table 2) Erectile Dysfunction Equals Endothelial Dysfunction Impotence can be a frustrating complication for diabetic men, but many non-diabetic men share the same underlying vascular dysfunction. Impotence may be a sign of PAD. The underlying reduction in blood flow by way of the fine arterial supply to the male genitalia should not be overlooked as the “normal aging process.� PAD should be considered in the differential diagnosis in any man experiencing impotence. This is especially true for men at high-risk such as diabetics and smokers.4

PAD Risk Factors Age, race/ethnicity, elevated levels of inflammatory markers (C-reactive protein, fibrinogen, leukocytes, interleukin-6), chronic renal disease, family history, and hypercoagulable states (altered

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1: Mild

CRITICAL LIMB ISCHEMIA

5: Minor tissue loss, e.g. non-healing ulcer, focal gangrene 6: Major tissue loss, i.e. above transmetatarsal level

levels of D-dimer, homocysteine, lipoprotein [a]) are important irreversible risk factors. The incidence of atherosclerosis increases with age. A pivotal study known as the National Health and Nutrition Examination Survey (NHANES) performed under the direction of the Centers for Disease Control found that patients 40 years of age and older had a PAD prevalence of 4.3 percent while patients who were older than 70 years had a prevalence of 14.5 percent.5 This translates into one in every seven patients

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Peripheral Arterial Disease Section older than the age of 70. Reversible risk factors for PAD include diabetes, smoking, hypertension, and hyperlipidemia. Smoking increases the risk of PAD four times and accelerates the onset by nearly ten years. Additionally, a dose response relationship between pack year history and PAD risk has been established.6 Smoking is the single most important modifiable risk factor for the prevention of PAD.6 Diabetes also increases the risk for developing PAD via elevated blood pressure, increased triglycerides and increased cholesterol, in addition to the frequent concurrence of low HDL levels. Diabetics also appear to have greater vascular inflammation, increased endothelial cell dysfunction, abnormalities in vascular smooth muscle cells, increased platelet aggregation and impaired fibrinolytic function when compared to non-diabetics.6 Diabetes is also associated with a 1.5 to four fold increased risk of cardiovascular events and the development of PAD Among diabetics, there is an early mortality among those with PAD. Diabetics are also at higher risk for developing ischemic ulcerations and gangrene, which is often the end stage symptom leading to lower extremity amputation.7

Figure 2

It is also believed that an abnormal waist to hip ratio, and a sedentary lifestyle are independent risk factors. When we factor in the sobering statistics of at least 30 percent five year mortality and cardiovascular severe morbidity associated with the diagnosis of PAD, it becomes a call for action. Acute Limb Ischemia While PAD usually presents with chronic and insidious symptoms, a minority of patients may present with acute ischemia and a threatened limb. Acute arterial occlusion of a lower extremity is a medical emergency, to an acute myocardial infarction, where every hour of delay of treatment translates into a higher risk of limb and function loss. The “6 P’s of acute limb ischemia” may also be observed. •

Pulselessness

Pain

Pallor

Poikilothermy (cold)

Paresthesia (indicates impending irreversible damage)

Paralysis

The evolution to paresthesia and especially to paralysis reflects the presence of severe and potentially irreversible ischemia.

Discrepancies In Access To Care Baser, Verpillat, et al conducted an analysis of critical limb ischemia (CLI) and PAD in Medicare recipients during a two year period. 68,074 new patients with CLI were identified for their retrospective analysis. They examined ICD-9 codes for rest pain, ulceration and gangrene (440.22, 440.23 and 440.24, respectively).8 Among their findings, diabetics had 7.6 times CLI risk compared to non-diabetics. Diabetic black males between the ages of 65 and 69 had the highest overall amputation rates. Non-diabetic white males between the ages of 65 and 69 had a higher likelihood of undergoing revascularization. Diabetic black females 85 years of age or older were the least likely to undergo revascularization.8 While technology is improving to address the complications of PAD, prevention remains the best way to address the overall problem. A greater understanding of PAD and CLI by all healthcare providers through greater awareness, early recognition, and knowledge of treatment options can have an enormous benefit to individual patients and society as a whole. Amputation reduction, heart attack and stroke prevention, and improved quality of life are benefits of greater PAD awareness and detection.

Ischemic gangrene of lower extremity, secondary to extensive tobacco use, without prior vascular intervention

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With these issues in mind, five steps are highlighted to improve PAD treatment and outcomes per the Prevention of Atherothrombotic Disease Network (PAD Network) an international, multidisciplinary network, adjoined by the mutual goal of increasing awareness, detection, and treatment rates of peripheral arterial

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Peripheral Arterial Disease Section disease (PAD) and increasing awareness of the interrelationship between PAD and the risk of ischemic events.9 1. Increase awareness of PAD and its consequences 2. Identify people with symptomatic PAD 3. Screen for patients at high risk 4. Improve treatment for symptomatic PAD cases 5. Increase early detection of asymptomatic cases The PAD Network also references the American Diabetes Association’s recommendation that people with diabetes who are 50 years of age or older be regularly screened for PAD, as well as have an annual foot exam.10 Screening for PAD is also recommended for those 70 years of age or older, or those 50 years of age or older with tobacco exposure. • Less than 50 percent of all amputees regain the ability to

ambulate after the loss of a lower extremity. Among this group, less than 50 percent of below knee amputees and less than 25 percent of above knee amputees will ambulate with the use of a prosthesis.11

• 5-10 percent of below knee amputations and 15-20 percent of above knee amputations die in the hospital after amputation.12 • Associated costs of amputation are between $10-20 billion annually in the U.S.13 • Lower extremity amputations are the most common treatment for CLI, instead of revascularization.13 • Fifty percent of amputations are performed without prior angiography or ABI.13 • An ABI value of 0.78 portends an approximate 30 percent five-year risk of MI or ischemicstroke.14,15,16 • One out of 23 patients 40 years of age or older has PAD (most are asymptomatic) 16

Conclusion Unfortunately, PAD is often overlooked and under-diagnosed. It is a highly preventable condition. Waiting until those with PAD present with outward symptoms, such as purple toes or ischemic ulcers, increases the likelihood of complications. One simple tip to increase PAD detection is to perform regular foot inspections and palpate pedal pulses. These additional simple steps can help better detect PAD and increase patients’ quality of life. v

References: 1. “Emerging Vascular Approaches for Healing Diabetic Foot Ulcers”. Allie DE. Podiatry Today. July 2007. (20) 44-54. 2. “Peripheral arterial disease detection, awareness, and treatment in primary care”. Hirsch AT, Criqui MH, Treat-Jacobson D, et al. JAMA. 2001 Sep 19;286(11):1317-24 3. “Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Norgren L, Hiatt WR, Dormandy JA, et al. J Vasc Surg. Jan 2007. S5A-S67A. 4. “Peripheral Arterial Disease Overview Update”. Bell D. Podiatry Management. January 2013. 175-187. 5. h t t p : / / w w w. a m e r i c a n h e a r t . o r g / d ow n l o a d a b l e / heart/1136822690283PAD06 percent20REVdoc.pdf 6. “Guidelines for the Management of Patients with Peripheral Arterial Disease (Lower extremity, renal, Mesenteric, and Abdominal Aortic)”. Hirsch AT, Haskal ZJ, Hertzer NR, et al.: ACC/AHA. Journal of the American College of Cardiology. ©2006 by the American College of Cardiology Foundation and the American Heart Association, Inc. 7. American Diabetes Association: National Diabetes Fact Sheet, 2005. 8. “Prevalence, Incidence, and Outcomes of Critical Limb Ischemia in the US Medicare Population”. Baser O, Verpillat P, et al. Vascular Disease Mgt 2013 10(2): E26-E36 9. “Critical Issues in Peripheral Arterial Disease Detection and Management: a Call to Action”. Belch JJ, Topol EJ, Agnelli G, et al. JAMA (formerly Arch Intern Med). 2003;163(8):884-892. doi:10.1001/archinte.163.8.884. 10. American Diabetes Association: Preventative foot care in people with diabetes. Diabetes Care 26(Suppl. 1):S78–S79, 2003 11. “The Staggering Clinical and Economic Cost of CLI”. New Advances in Critical Limb Ischemia. Allie DE. Lecture. New Cardio Vascular Horizons. CLI Summit. Miami, FL. 2006 12. “The Economic Impact of Amputation”. Yost M. The Sage Group. Radio Interview, “The Save A Leg, Save A Life Show.” July 8, 2012. WOKV, Jacksonville, FL. 13. Newman AB, Tyrrell KS, Kuller LH. Mortality over four years in SHEP participants with a low ankle-arm index. J Am Geriatr Soc.1997;45:1472-1478. 14. McDermott MM. Ankle brachial index as a predictor of outcomes in peripheral arterial disease. J Lab Clin Med. 1999;133:33-40. 15. McKenna M, Wolfson S, Kuller L. The ratio of ankle and arm arterial pressure as an independent predictor of mortality. Atherosclerosis.1991;87:119-128. 16. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, et al. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) J Vascular Surgery. Jan. 2007

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Peripheral Arterial Disease Section

Imaging in Peripheral Arterial Disease: The Role of the Non-Invasive Vascular Department Jason Roberts DHSc, RVT and Yazan Khatib, MD, FACC, FSCAI, FABVM, FSVM

Abstract: The purpose of this paper is to introduce the non-invasive

vascular laboratories (NIVL) role in the detection of peripheral arterial disease (PAD), and why vascular accredited facilities and staff are essential. This paper will also explain why the ankle brachial index (ABI) is not always reliable, how to avoid erroneous data collection, and the ten year mortality rates of cardiovascular patients associated with lower score ABI’s. Also, the demonstrated sensitivities are examined in the detection of cerebrovascular and lower extremity arterial disease when compared to angiography, computed tomography, and magnetic resonance angiography, and why the NIVL is more cost effective and safer for the health system as a first order modality. Finally, the new Medicare guidelines regarding reimbursement of in-office vascular testing and how this may impact facilities outsourcing vascular services will be discussed

Introduction The successful management of peripheral arterial disease (PAD) is a concert of clinical and professional collaboration. At the heart of any vascular program are dedicated credentialed vascular professionals and vascular laboratories. Accreditation may be obtained through the Intersocietal Accreditation Commission of Vascular Laboratories (IAC), or the American College of Radiology simply stated, accreditation ensures high quality patient care through strict accountability, guidelines and standardization of patient care.1 These standards are based on Non-Invasive Vascular Laboratory (NIVL) protocols which are correlated against the gold standards in arterial imaging such as angiography, computed tomography angiography (CTA) and magnetic resonance angiography (MRA). In many cases, ultrasound prevails not only economically, but also qualitatively. It is increasingly common for the peripheral arterial anatomy and pathology to be depicted noninvasively utilizing ultrasound in conjunction or adjunctively with angiography, CTA, and MRA.2 The ultrasonic evaluation of PAD requires astute knowledge of advanced pathological states, along with normal, collateral and variant anatomy of the periphery.2 Some of the more notable NIVL studies are ankle brachial index, lower extremity arterial duplex ultrasound, abdominal aortic ultrasound, and extracranial carotid duplex ultrasound. While many institutions broker these services over various departments, it is common for these institutions to not have an accredited vascular laboratory, regis-

Send correspondence to: Jason Roberts, 3900 University Blvd, South, Jacksonville, Fl, 32216

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tered vascular sonographers or properly credentialed interpreting physicians. Sonographers are credentialed as Registered Vascular Technologists (RVT) or a Registered Vascular Sonographer (RVS.) Physicians are credentialed as Registered Physician Vascular Interpreter (RPVI.) Many ultrasound departments can have great disparity in diagnostic reproducibility, especially in non-accredited facilities performing vascular studies. These disparities happen for a multitude of reasons including inaccurate collection of diagnostic information, inaccurately interpreting diagnostic reports, poor standards of quality assurance, and inaccurate protocols. This results in testing redundancy, misdiagnoses, under as well as over estimating the extent of vascular disease, and unnecessary procedures/surgeries.3 This can be problematic on many levels and only adds to the economic footprint and meaningful use guidelines. In 2008, Congress enacted the Medicare Improvements for Patients and Providers Act (MIPPA), and starting in 2012 advanced imaging centers must be accredited.4 The NIVL is not exempt as many of today’s testing reimbursements are based on the testing facility being IAC accredited and/or all sonographers registered in vascular technology. Moreover, vascular duplex ultrasound is highly technologist dependent; therefore, varying technological skills become amplified with inexperience. In contrast to this statement, with registered and competent technologist, the sensitivity and specificity of ultrasound is very specific in the detection of disease, less expensive than CTA, or MRA, and in some cases nearing the gold standard in imaging. It is no surprise as such that many of leading institutions in the nation have reduced the use of more expensive technology with and incorporated accredited vascular labs and technologists as an integral part of their vascular departments. What is a Vascular Duplex Ultrasound As vascular testing evolved, two vascular testing modalities were incorporated together into today’s vascular ultrasound thus creating a “duplex.” These two modalities are: • 2-D Imaging (two-dimensional imaging) This affords us a very good assessment of the morphologic features of the vessel and plaque. We can see if the plaque is ulcerated or not, which makes it more likely to cause embolic complications. We can also see how calcified it is. We can measure the vessel size and define any aneurysmal dilation with accuracy to the level one millimeter. This is Northeast Florida Medicine Vol. 65, No. 1 2014 23


Peripheral Arterial Disease Section the ultrasound equivalent of X-ray or CT scan imaging. However, just like X-ray and CT scan imaging, it does not define the functional significance of the plaques that we identify when used alone. • Doppler Evaluation This has many different modes and is a functional evaluation of the blood flow characteristics. By measuring the velocity of blood flow through different segments in the artery, we can get a very good assessment of vessel narrowing. Typically, the more narrowed the artery segment is the higher the blood flow velocity in that segment. This is a very important feature of the duplex ultrasound which helps us to define the physiologic impact of the plaque visualized on 2-D imaging. Doppler ultrasound adds more value without increasing cost, as compared to most x-ray and CT scan based imaging techniques, which are for most part strictly morphologic evaluations. Testing and Peripheral Arterial Disease Lower Arterial Testing and the Ankle Brachial Index It is recognized that aortoiliac disease is a key concern for the treatment of patients with claudication. Generally these patients are referred for some modality of testing once the diagnosis of claudication is suggested. In most patients an ankle brachial index (ABI) is the front line screening method for PAD given its simplicity, reproducibility, and cost effectiveness. The ABI is calculated utilizing a blood pressure cuff and handle held Doppler. The ABI compares the ankle (posterior tibial and anterior tibial arteries) vessel pressures to the highest arm (brachial artery) pressures. There are numerous studies which report the ABI, when compared to angiography having a sensitivity of more than 90 percent and a specificity of more than 95 percent in diagnosing >50 percent stenosis of the lower extremity arteries.6 With such a high sensitivity in detecting PAD, the ABI is also a peek at the patients overall cardiovascular health. As Khan et.al explain there is up to a fourfold increase in cardiovascular disease and mortality in patients with severely abnormal ABI’s.6 The patient is diagnosed with PAD when the ABI is ≤ 0.9. PAD is graded as mild to moderate if the ABI is between 0.4 and 0.9, and an ABI less than 0.40 is suggestive of severe PAD. An ABI value greater than 1.3 is also considered abnormal, suggestive of non-compressible vessels. Also reported by Khan et.al, the mortality rates from atherosclerotic heart disease doubled with each 0.5 units drop in the ABI.6 The ten year mortality rates of CVD in patients with an ABI < 0.5 was 37 percent, compared to a 27 percent ABI values ranging between 0.5- 0.7, 22 percent in patients with ABI 0.7- 0.9 and 17 percent in patients with ABI values >0.9. Relative risk for all-cause mortality was higher in subjects with ABI < 0.5 compared to subjects with ABI values ranging between 0.51-0.7.6 Also of significant note, there is a published twofold increase in acute coronary syndrome in patients with clinical and sub clinical PAD.6 There is however a caveat to the ABI, diabetes. Given the natural progression of diabetes in the peripheral arterial circulation, the artery’s intima becomes stiff (arterial stiffness) to the point of non-compressibility, and this can be a pitfall for many clinicians when collecting and reporting ABI data. Since there is no specific criteria for mild to moderate 24 Vol. 65, No. 1 2014

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arterial stiffness in ABI data collection, severe PAD can be missed altogether. ABI collection should be coupled with an audible continuous wave (CW) Doppler and an astute appreciation to the audible signals. For this reason alone ABI data collection should be two parts, one part audible and one part pressure. Audible signals are classified as triphasic (normal), biphasic (mild-moderate), monophasic (severe), absent (occluded), and generally quantified by a vascular professional. The next logical step in testing would be lower arterial duplex further define the anatomy pinpointing the arterial blockage. (Figure 1) Aortoiliac Duplex There are two parts to the lower extremities arterial system: the aortoiliac (inflow) and femoropopliteal (outflow) segments. The aortoiliac (AI) segments are more difficult to examine indirectly or through an ABI. This area has to be imaged, and duplex ultrasound (DU) is a logical first step. While atherosclerosis is a major concern of the AI segments, so are AI aneurysms which are not assessed with an ABI. Aortic and iliac aneurysms are easily detected by ultrasound. (Figures 2 and 3) When compared to CTA, duplex ultrasound is noted to have a sensitivity and specificity of close to 100 percent when compared with operative findings.7 MRA is usually not routinely utilized for the detection of abdominal aortic aneurysm (AAA.) Given the lack of dye, radiation and cost, DU for can be the initial evaluation for patients with renal insufficiency, stents or pacemakers. The American College of Radiology (ACR) Appropriateness Criteria recommends that DU ultrasound be used as an adjunct to CTA imaging for AAA.8 Conventional duplex ultrasound scanning has proven to be a cost effective and accurate diagnostic tool in the assessment of peripheral vascular disease. In the lower extremity arterial system, duplex ultrasound (DU) has a reported sensitivity of 83 percent and a specificity of 96 percent for detecting severe stenosis in

Figure 1

Arterial Embolization of Great Toe from Bypass Graft Occlusion

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Peripheral Arterial Disease Section Figure 2

Right Common Iliac Aneurysm

Figure 4

Figure 3

Aortic Penetrating Ulceration with Aneurysm

Internal Carotid Artery Severe Stenosis

Figure 5 the aortoiliac tract.5 DU coupled with the ABI can further and accurately pinpoint the exact location of the arterial blockage, giving to a more detailed interventional approach if needed. DU is also performed when contraindications arise, such as ulcerations, grafts, stents and other post procedural interventions where cuff compression is contraindicated. Given the degree of difficulty in accurately performing and interpreting arterial DUâ&#x20AC;&#x2122;s, this should only be performed by a registered vascular technologist in an accredited facility. In Northeast Florida, lower arterial, and most other vascular DU must be performed by a registered vascular technologist according to First Coast Service Options (FCSO) and Medicare Policy Guidelines for reimbursement.9 Therefore, billing and collecting reimbursements in many clinical settings may be problematic given the lack of credentialed vascular technologists and non-vascular credential physicians.

Internal Carotid Artery Disection

Extracranial Carotid Duplex Extracranial (carotid artery) duplex has become the initial standard of care in carotid artery imaging. The fourth highest cause of death is stroke, killing more than 137,000 people annually, and affecting another 795,000 Americans.10 Extracranial testing must be cost effective and accurate to help control the annual $74 billion for stroke related medical costs.10 When performed by accredited vascular professionals in accredited facilities, carotid artery duplex has demonstrated a sensitivity of 98 percent and specificity of 88 percent for detecting greater than 50 percent internal carotid artery (ICA) stenosis; and 94 percent and 90 percent respectively for detecting greater than 70 percent ICA stenosis.11 This should be considered first line testing. In an acute stroke, CTA is the appropriate first choice exam as it adds the needed imaging of the brain itself.11 (Figures 4 and 5) If significant stenosis of the internal carotid artery (ICA) is detected by DU, the patient can be considered amendable to mechanical repair, and CTA or MRA is a discretionary step. The sensitivity and specificity of duplex ultrasound for severe (greater than 70 percent) ICA stenosis when compared to MRA is 85 percent and 46-88 percent, respectively.11 When compared to MRA and DU, CTA is noted to have a similar sensitivity of 85 percent and specificity of 93 percent for severe ICA stenosis of over 70 percent. DCMS online . org

Furthermore, given the frequency of carotid artery stenosis and stroke, reliable and affordable imaging is critical. Initial imaging is with high-quality DUS. If abnormal, MRA or CTA may be helpful in providing comprehensive anatomic information to aid in planning therapeutic strategies, but it can be costly. DU has proven to be sensitive and specific in the detection of ICA stenosis; however, skill and experience of the operators and interpreters are critical in providing reproducible outcomes.

Conclusion In conclusion vascular duplex ultrasound has been proven and well documented to be cost effective, safe and accurate. We must reemphasize however, that this is an operator driven modality and is prone to technical errors, and skill level inequities. This can be overcome by seeking vascular facilities which are accredited by IAC or ACR in vascular testing, and the studies interpreted by properly credentialed vascular professionals Is ultrasound the best modality in every case? No, but it is a cost effective and accurate starting point for the vast majority of patients when evaluating PAD, carotid disease, AAA, renal and mesenteric artery stenosis. Also, DU is a proven cost effective and reliable modality to manage post-procedure patient care to ensure stent or bypass continued patency. v

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Peripheral Arterial Disease Section References 1. Intersocietal Accreditation Commission. What is accreditation?(2013) [cited 2013 Nov 14]. Available from http:// intersocietal.org/vascular/main/what_is_accreditation.htm 2. Pellerito, J.S., Polak, J.F. Introduction to vascular sonography (2012). (6th ed.). Philadelphia, PA. Elsevier. 3. What patients should know. Intersocietal Accreditation Commission (2013). [cited 2013 Nov 14]. Available from http://intersocietal.org/vascular/main/patients.htm 4. Whats happening with lab accreditation process and requirements. Orenstien, B.W. (2011). [cited 2013 Nov 10]. Availible from http://www.sdms.org/members/news/ NewsWave/NW-March-2011.pdf 5. Allard, L., Cloutier, G., Druand , G.L., Roderer, G.O, Langlois, Y.E. Limitations of ultrasonic duplex scanning for diagnosing lower limb arterial stenoses in the presence of adjacent segment disease (1993). [cited 2013, Nov 14]. Available from http://www.jvascsurg.org/article/ PIIS0741521494700389/fulltext 6. Khan, H.T., Farooqui, F.A., Niaz, K. Critical review of the ankle brachial index (2008). [cited 2013 Nov 15]. doi: 10.2174/157340308784245810

7. Abdominal aortic Aneurysm: interventional planning and follow-up. American College of Radiology. ACR Appropriateness Criteria (2010) [cited 2013 Nov 16]. Available from http://www.acr.org/quality safety/~/media/C551BC29AC144772A4C2ECBFA4384382.pdf 8. Silverstein, M.D., Pitts, S.R., Chaikof, E.L., Ballard, D.J Abdominal aortic aneurysm (AAA): cost-effectiveness of screening, surveillance of intermediate-sized AAA, and management of symptomatic AAA (2005) [cited 2013 Nov 16]. Available from http://www.ncbi.nlm.nih.gov/ pubmed/16252027 9. LCD look up. First Coast Service Options (2013) [cited 2013 Nov 15]. Available from http://medicare.fcso.com/ Fee_lookup/LCDDisplay.asp?id=L29158 10. Impact of stroke. Stroke statistics American Stroke Association (2013) Retrieved from http://www.strokeassociation.org/STROKEORG/AboutStroke/Impact-ofStroke_UCM_310728_Article.jsp 11. Jaff, M.R., Goldmaker, G.V., Lev, M.H., Romero, J.M. Imaging of the carotid arteries.: the role of duplex ultrasonography, magnetic resonance arteriography, and computerized tomographic arteriography (2008) [cited 2013 Nov 16]. Available from http://vmj.sagepub.com/ content/13/4/281.full.pdf

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Peripheral Arterial Disease Section

A Physician’s Personal Experience with Peripheral Arterial Disease Nicholas H. Bancks MD, FACR

I have been asked to give my perspective on peripheral arterial disease (PAD) as a physician and a long term sufferer of the disease. I first became aware I had PAD while doing a routine stress test which I had to stop due to leg pain. A lower extremity angiogram showed a total right superficial femoral artery occlusion with a few native collaterals. A guide wire wouldn’t pass the lesion, but as I had a warm intact limb and could stroll four or five blocks at a time, my physician and I agreed to treat it with benign neglect. Fast forward four years. I am walking up one of the innumerable hills in Greece when I get severe bilateral calf pain. Another angiogram showed the chronic right sided lesion and a new 95 percent lesion on the left. Even at this point I still had a left foot pulse, an equivocal right foot pulse, and warm feet, and did my “routine” activities pain free. The left leg stenosis was stented, and in a display of masterful catheter technique, the chronic total occlusion of my right femoral artery was crossed using what is called the “sub-intimal technique,” and a covered stent graft was placed, bypassing the otherwise impassable chronic total occlusion. I returned to work the very next day. Everything has remained patent and I am as happy as can be with the results and here lies the point of this article. During the years between my first symptoms and ultimate intervention, I thought I was doing fine, but I have a sedentary job and I live in urban America and did not have to walk more than a block or so at any given time.

Address Correspondence to: Nicholas H. Bancks M.D. F.A.C.R., 1748 Lord Byron Lane, Jacksonville, FL 32223

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Any real exercise I had was voluntary, and I had gradually and unconsciously accommodated to my progressive disease. I had stopped my weekend walks, going to the gym, doing yard work, and squatting to pull weeds had become a killer. I had gradually stopped doing anything requiring much leg use. What I was able to do, I did slower. I rationalized this with excuses of being busy and exercising being boring and age. The less I did, the harder it was to do anything and so I would do even less still. As a consequence my weight increased, I became deconditioned and most importantly my attitude suffered. If I had not been forced out of my usual zone of comfort by that hill in Greece, who knows how bad things might have gotten before I had the cold foot, rest pain or inability to walk at all which would have forced intervention. Happily, I am more active now than I have been in a dozen years: back to the gym, doing my own yard work and doing things much faster. The more I do, the more I can do and the more I want to do. My weight, blood pressure and pulse are down. Most important, life in general is just more fun when you can get up and live it. Our routine exams are designed to prevent limb loss and they may suffice for that, but given the sedentary lifestyles of so many of us, by the time we get to that point we may already be suffering the multitude of co-morbidities associated with progressive inactivity. The leg lends itself to multiple non-invasive techniques such as the ankle-brachial index (ABI) or arterial duplex scan to pick up and quantify the disease. My request is for us to be more proactive on PAD. The benefits might be greater and more far reaching than you think. We all owe it to our patients to prevent the cycle of disability. v

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Peripheral Arterial Disease Section

Endovascular Management of Lower Extremity Peripheral Artery Disease (PAD) Omer Zuberi, MD, FACC, FSCAI and Yazan Khatib, MD, FACC, FSCAI, FABVM, FSVM

Abstract: In the past, most patients with significant limb ischemia

have been treated with open surgical revascularization. With the evolution of endovascular catheter based techniques, and evolving patient preferences, more and more patients with symptomatic PAD are now treated by endovascular means. This article focuses on the rapid advances in endovascular options available to treat symptomatic PAD. Other aspects of this very prevalent and high risk disease are addressed elsewhere in this edition.

Introduction Technological advances in the past decade, along with patient preference, have shifted revascularization strategies from open surgical approaches towards percutaneous endovascular treatments. The availability of stents, more than any other advance, has fueled the growth of catheter-based procedures by improving safety, durability and predictability of percutaneous revascularization. Endovascular therapy offers distinct advantages over surgical revascularization for selected lesions.1,2 It is performed with local anesthesia, which enables treatment of patients who are at high risk for general anesthesia. The morbidity and mortality from catheter-based therapy is low, especially compared with surgical revascularization. After successful percutaneous intervention, patients are ambulatory on the day of treatment, and can return to normal activity within 24 to 48 hours of an uncomplicated procedure. Endovascular therapies generally do not preclude or alter subsequent surgical options and may be repeated if necessary. It is notable that endovascular techniques have not only been embraced by interventional cardiologists and interventional radiologists, but also by the vascular surgeons, to the extent that endovascular training is now a formal part of most accredited fellowships in all three of those specialties.

Address Correspondence to: Omer Zuberi, MD, FACC, FSCAI First Coast Cardiovascular Institute, 3900 University Boulevard South, Jacksonville, FL 32216 | Email: ozuberi1@mac.com

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Revascularization Options: TASC Classification The guidelines for the Trans-Atlantic inter-Society Consensus (TASC) for the management of PAD were created to provide some uniformity to the treatment of PAD. 3 It presents a scheme that classifies iliac and femoropopliteal lesions as type A, B, C and D based on overall success rates of treating the lesion using endovascular and surgical means. General Class A lesions have high success rate with endovascular techniques, while class D are felt to be better suited for surgical bypass and mostly comprise long or multi-level occlusions. TASC remains the most frequently quoted guideline despite many operators and authors questioning its current applicability in todayâ&#x20AC;&#x2122;s world of vascular medicine. We mention it here for reference understanding its limitations. Revascularization options will be addressed based on the three major anatomic subsets: aorto-iliac, femoro-popliteal and tibio-peroneal arteries. Aorto-iliac Disease Revascularization options for patients with infra-renal aortic and iliac obstructive PAD are open surgery or percutaneous repair. Aorto-iliac and aorto-femoral bypass procedures are associated with 74 percent to 95 percent 5-year patency rates, respectively, which are comparable but not superior to percutaneous therapies.4,5 Morbidity (e.g. infection and bleeding) and mortality can be significant because many of these operations require an extensive abdominal incision. The availability of endovascular stents has significantly increased the number of aorto-iliac lesions treated percutaneously by providing a larger acute gain in luminal diameter, scaffolding the lumen to prevent vascular recoil and embolization of debris, and enhancing long-term patency compared with balloon angioplasty alone.6,7 For common iliac bifurcation lesions, kissing-balloons â&#x20AC;&#x201C; expandable stents have become the preferred option (Figure 1, page 30).8 In one series of 48 patients, there were no major complications. All of the patients experienced symptomatic improvement. Twoyear patency rate was 87 percent.9

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Peripheral Arterial Disease Section

Figure 1

Bilateral severe common iliac artery stenosis, left image show baseline anatomy. Right image shows final angiogram following “kissing” stent implants on purely outpatient basis. Courtesy O. Zuberi, MD

Endovascular treatment for infra-renal aorta disease can be performed with lower morbidity than open surgery with equal durability; there is, however, no randomized controlled trial data to compare. Figure 2 shows an example of an abdominal aortic occlusion that was repaired by endovascular stents. Trials comparing surgery with percutaneous intervention for iliac occlusive disease include a randomized comparison of balloon angioplasty versus surgery for 157 iliac lesions. This comparison found no difference in the three-year cumulative rate for death, amputation or revascularization failure.10 On the basis of these and other trial data, current recommendations favor endovascular procedures for TASC A and B lesions and for selected C lesions. Patients with TASC D lesions generally will be considered surgical candidates, but with newer technology these patients increasingly are considered for endovascular therapy on a case-by-case basis.1 When data from several trials were combined, 873 patients had an iliac stent acute procedural success rate greater than 90 percent, with 3±1-year primary patency rates of 74 to 87 percent, and secondary patency of 84 to 95 percent, which compares favorably with reported surgical patency rates.5,10–12 The 30-day mortality risk was 0.5 percent which is lower than the 4 percent weighted mortality risk for aortofemoral bypass (Figure 3).5 Variables that correlate with reduced patency after iliac stent placement include occlusions rather than stenoses, longer lesions, female gender, and external iliac stent placement. The current American Heart Association class I guideline recommendation is for primary stent placement in the iliac arteries. This is supported by a meta-analysis that reviewed 2,000 patients.13 Procedural success was higher in the primary stent group, and there was a 43 percent reduction in long-term (four-year) failures for aorto-iliac stent placement compared with balloon angioplasty alone.

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Figure 2

Abdominal aortic occlusion extending into the iliac arteries bilaterally, successfully repaired on outpatient basis with stents. Courtesy Y. Khatib, MD

Figure 3

Iliac Stent vs. Aorto-Fem Bypass mortality difference, while secondary patency is equal.

Femoro-popliteal Disease The same vessel that extends from the pelvic rim to the knee crease, despite been one contiguous vessel, has been labeled into three different segments: 1. The Common Femoral Artery (CFA) refers to the few centimeters of femoral artery at the groin level. Author needs to better define—the CFA is defined as the segment from the inguinal ligament to the superficial and profunda femoral artery bifurcation. 2. The Superficial Femoral Artery (SFA) is the length of the vessel extending from the common femoral artery origin to the adductor canal. 3. The Popliteal artery is the segment from the adductor canal to the origins of the three tibioperoneal vessels.

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Peripheral Arterial Disease Section There are different anatomic and functional considerations to each of these segments that affect revascularization decision-making. The CFA and popliteal segments are at highly flexible locations (the groin and the knee), making them imperfect candidates for stenting due to increased risk of stent fracture with recurrent flexion/extention cycles. As a result, different strategies have been adopted in different segments. Given the fact that femoral-popliteal PAD frequently involves all three of the above mentioned territories, it is not unusual in todayâ&#x20AC;&#x2122;s endovascular interventions to employ more than one technique in the same procedure (e.g. angioplasty, Stents and atherectomy).

Figure 4

Common Femoral Artery The need for vascular access and the highly flexible nature of this artery due to the movement of the hip led physicians to avoid stenting when severe stenosis is present. Surgical Endarterectomy with or without pericardial patch angioplasty is the preferred surgical technique to treat the CFA.14-16 The immediate technical success rate exceeds 90 percent, but postoperative morbidity is significant, with wound infections, hematomas, and seromas affecting greater than 15 percent of the patients. The one-year primary patency rate exceeds 80 percent. Stenting of the CFA has been performed on occasions because of the aforementioned complications. In a trial of 20 patients, CFA stenting17 showed sustained clinical improvement in 90 percent of the subjects. However, data regarding safety and efficacy for the longer term is lacking and therefore stenting of the CFA remains controversial. Atherectomy offers the ability to extract plaque percutaneously, much like in surgical endarterectomy, without the complications associated with open surgical approach. (Figure 4) However, long-term clinical data is inconclusive and this approach remains controversial to a certain extent. The SFA and Popliteal Artery Disease In claudicants cost-effectiveness and quality-of-life outcomes favor the performance of percutaneous therapy as a more effective treatment than exercise alone.18 Revascularization was more effective than medical therapy for improvement in physical function, bodily pain and walking distance.19 SFA lesions tend to be fairly long. They are frequently totally occluded vessels, and disease frequently extends up to the CFA. While stents proved advantageous in almost all vascular territories, the SFA has been one challenging vascular territory prone to a fairly high rate of re-stenosis following stent placement. Nonetheless, SFA stenting has yielded better functional improvement and walking distance than PTA.20 Factors associated with increased intra-stent restenosis were stent fractures, length of the lesion treated, the presence of diabetes chronic limb ischemia.21, 22 Additionally when stenosis extended into the popliteal segment behind the very mobile and very flexible knee joint, stents have a higher risk of fracture and failure. As a result, atherectomy/debulking was introduced to reduce reliance on stents in the SFA.34 Drug eluting stents, as well as covered endovascular stent grafts, have been shown to have much less restenosis in the SFA compared to bare metal stents.

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Heavily calcified common femoral artery stenosis on Left, s/p successful atherectomy & angioplasty on Right. Courtesy O. Zuberi, MD

Atherectomy & Debulking Strategies Atherectomy is performed with the goal of reducing plaque burden, and avoiding long lengths of implanted stents within the SFA (a practice associated with higher incidence of stent fracture and restenosis). The pros and cons are summarized for each device with the understanding that most of these devices have limited outcome data. There are four different types of atherectomy devices available Laser Atherectomy: A small fiber optic catheter is positioned at the top of the blockage, or occlusion, it then starts transmitting short, pulsed bursts of ultraviolet energy through the catheter, penetrating the blockage. The laser catheter moves slowly through the occlusion, one millimeter per second, vaporizing the blockage in its path. Excimer laser light breaks chemical bonds at the molecular level and vaporizes intracellular water, dissolving the occlusion into tiny by-products that are smaller than a red blood cell and easily absorbed into the bloodstream. The PELA (Peripheral Excimer Laser Angioplasty) trial randomized 251 patients with claudication and a total SFA occlusion to either PTA or laser-assisted PTA. There was no difference in clinical events or patency rates at one year of follow-up. There is no evidence that laser-assisted angioplasty adds any benefit to conventional therapy.23 Its current use is limited to certain anatomic subsets as a facilitating procedure. Excisional Atherectomy: This technology has been around since 2004 with many improvements. This is a minimally invasive treatment method

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Peripheral Arterial Disease Section during which an atherectomy catheter is directed toward an area of plaque buildup to remove the plaque from the body hence restoring blood flow. Definitive Le is the largest peripheral atherectomy study conducted and presented to date publication is awaited. A total of 1,022 lesions (up to 20 cm in length) were treated with the Covidien SilverHawk or TurboHawk Plaque Excision device. Clinical outcomes were improved by 30 days, and sustained through 12 months of follow-up with patency results that were comparable to those reported in stent studies for short lesions. Diabetics fared as well as non-diabetics with this device. 35

Figure 5 Vascular Stenting in Diabetics

Rotational Excisional Atherectomy: Jetstream Atherectomy is a new device that has gained momentum in its ability to extract atherosclerotic, as well as thrombotic components of plaque but the level of evidence is still limited. Diamond Back Atherectomy: This device rotates at speeds exceeding 100,000 RPM. The rotating element is equipped with micro blades made of diamond designed to shave off the calcific plaque in heavily calcific segments. It has gained momentum among many interventionalists, but the level of evidence is still limited.

Drug-Eluting Stents Initial attempts at transferring the benefits of drug elution stents achieved in the coronary arteries for stents placed in the femoral-popliteal arteries were not successful.25 A 2-phase randomized controlled trial of sirolimus-eluting nitinol stents compared with bare-metal nitinol stents in de novo femoral arteries with an average lesion length of 8.5 cm was performed in patients in European centers. After 18 months of follow-up, there appeared to be no advantage for the restenosis rate of the drug-eluting stent (20.7 percent) over the bare-metal nitinol stent (17.9 percent).31 In the initial phase of the trial, failure of the drug-coated stent was attributed to stent fractures, seen in 18 percent of cases, but in the second phase of the trial, stent fractures were only seen in 8 percent of cases and were not associated with restenosis. The drug eluting stent ZILVER PTX trial (PTX stands for Paclitaxol which is the same drug used in some of the coronary drug eluting stents) compared primary placement of drug eluting stents with angioplasty in superficial femoral artery lesions. While the primary outcome of significantly improved patency in the drug eluting stent group, the analysis showing that drug eluting stents appear to neutralize the well-known negative impact of diabetes on stent patency (Figure 5). The study also showed that using a drug eluting stent had significantly better three-year primary patency rates compared with bare metal stents (80 percent versus 56 percent), and was associated with sustained clinical benefit (Figure 6).

Covered Stents Grafts Covered stents are made up of a metal stent skeleton covered with the very same ePTFE graft material used for surgical by32 Vol. 65, No. 1 2014

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Right graph representing markedly increased risk for restenosis in diabetics compared to non-diabetics. Left shows marked improvement in patency in diabetics with the drug eluting stents. Reprinted with permission from Cook medical.31-32

pass. The main benefit of this type of stent is that in-growth of tissue between the stent struts is prevented, and the only place a covered stent graft may develop restenosis is at the edges. The diffuse SFA in-stent restenosis is prevented; however, stent edge restenosis remains an issue, and stent graft thrombosis is a concern once critical edge restenosis occurs. Additionally, these stent grafts have a significantly higher cost.36 Recent advances in reshaping the covered stent edges, adding heparin bonding to the graft material, as well as better operator technique have been associated with marked improvement in outcome data.26 The VIPER trial-treating moderate to long-segment stenosis and occlusions of the Femoropopliteal artery showed a one-year primary patency after stent graft implantation of 73 percent. These findings are comparable to patency of femoral-popliteal artery bypass using synthetic graft. The previously described concern of acute limb ischemia and thrombotic occlusion of stent graft was not supported by VIPER trial when optimal implantation techniques were used.27 Similarly, the randomized VIASTAR trial demonstrated higher efficacy of Viabhan stent graft endoprosthesis than bare metal stent in the treatment of long superficial femoral artery occlusive disease (78 percent vs. 53.5 percent).28

Tibial and Peroneal Artery Disease Below-knee angioplasty has traditionally been reserved for patients with chronic limb ischemia (CLI) because of the fear of limb loss should a complication occur. Current practice standards have broadened in that patients with severe claudication who have extensive, multilevel disease may have this intervention performed to improve â&#x20AC;&#x153;outflowâ&#x20AC;? in their infrapopliteal vessels; however, no systematic study data exist to support this indication for intervention. Isolated tibioperoneal disease does not generally cause lifestyle-limiting claudication unless it occurs in the DCMS online . org


Peripheral Arterial Disease Section proximal tibioperoneal trunk and affects the common inflow to all three vessels. The adaptation of coronary equipment has improved the results of tibioperoneal interventions. Current procedural success rates for below-knee intervention in limb-salvage patients range from 60 percent for occlusions to greater than 90 percent for simple stenosis. Limb-salvage rates at two to five years are 80 to 90 percent with modern endovascular techniques.29-30

Figure 6

Optimal treatment of tibio-peroneal disease requires appropriate patient and lesion selection for treatment. Stenosis fares better than occlusions and long-term patency drops off as the lesion length increases. Strategically, straight-line, pulsatile flow to the foot is the goal of therapy in patients with CLI. Recently the concept of “angiosome” tailored revascularization has been advocated. According to the “angiosome theory” the anterior tibial/dorsalis pedis artery are deemed to be the lifeline for the forefoot, and the posterior tibial artery the lifeline for the heel. Yet there is well-established data in the surgical literature that a generic single vessel runoff is adequate for more than 80 percent of CLI patients.37-38

Three year patency of bare-metal vs. drug eluting femoral stents. Reprinted with permission from Cook medical.33

Figure 7

In Tibio-Peroneal intervention, success is measured more by relief of rest pain, healing of ulcers and avoidance of amputation, and less by long-term vessel patency. When trying to heal ischemic ulcers, the basic principle is that it takes more oxygenated blood flow to heal a wound than it does to maintain tissue integrity once the wound is healed. Alternative techniques such as accessing the dorsalis pedis artery retrograde has allowed interventionalists to tackle more challenging below knee PAD for critical limb ischemia. Here a micro catheter is advanced through one of the arteries in the foot to facilitate crossing occluded vessels that could not be crossed coming from the groin. (Figure 8, page 34)

Future Therapies Four year prospective randomized fem-pop bypass vs covered stent graft data.

24

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Frequently, the severity of infrapopliteal disease abolishes most if not all of the named vasculature, and revascularization is simply not possible. Although theoretically promising, trials to date have failed to prove the clinical value of therapeutic angiogenesis with growth factors or stem cell therapy.

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Peripheral Arterial Disease Section Figure 8

3. Norgren L, Hiatt WR, Dormandy JA. Inter-Society Consensus for the Management of Peripheral Arterial Disease(TASC II). J Vasc Surg. 2007; 45: S5–S67. 1993; 88: 1534–1557. 4. Murphy TP, Ariaratnam NS. Long-term experience with stent placement for treatment. Radiology. 2004; 231: 243–249. 5. Sullivan TM, Childs MB. Percutaneous transluminal angioplasty and primary stenting of the iliac arteries in 288 patients. J Vasc Surg. 1997; 25: 829–838.

Severe tibio-peroneal severe PAD on Left. Following successful atherectomy and angioplasty on the right in a patient with CLI. Courtesy Y. Khatib, MD

Summary The endovascular treatment of lower-extremity PAD continues to evolve with the expectation of improvement in acute success rates and safety, and the anticipation of improving long-term durability with newer technologies ranging from drug eluting stents to stent grafts. Aorto-iliac blockages are most commonly repaired with stents with equal long term patency to surgical options. As for Femoro-popliteal blockages, we are at a stage where the negative impact of diabetes and long lesions on patency seems to be neutralized by the new drug eluting femoral stents and the better application of covered stent implants, to a point nearing bypass patency at a much lower risk. Large scale utilization of such advanced stent technologies will be hampered by the current gap between their high cost and low reimbursement. We must also keep in mind the coincident CAD and carotid disease in this patient population, so that we reduce their morbidity and mortality. v

6. De Vries JP, van Den Heuvel DA, et al. Freedom from secondary interventions to treat stenotic disease after percutaneous transluminal angioplasty of infrarenal aorta: long-term results. J Vasc Surg. 2004; 39: 427–431. 7. Scheinert D, Schroder M, Balzer JO. Stent-supported reconstruction of the aortoiliac bifurcation with the kissing balloon technique. Circulation. 1999; 100 (suppl II): II-295–II-300. 8. White CJ, Ramee SR, Collins TJ, Procter CD, Hollier LH. Initial results of peripheral vascular angioplasty performed by experienced interventional cardiologists. Am J Cardiol. 1992; 69: 1249–1250. 9. Dierk Scheinert, MD ET AL. Stent-Supported Reconstruction of the Aortoiliac Bifurcation With the Kissing Balloon Technique. Circulation1999; 100: II-295-Ii-300 10. Wilson SE, Wolf GL, Cross AP. Percutaneous transluminal angioplasty versus operation for peripheral arteriosclerosis: report of a prospective randomized trial in a selected group of patients. J Vasc Surg. 1989; 9: 1–9. 11. Park KB, Do YS, Kim JH. Stent placement for chronic iliac arterial occlusive disease: the results of 10 years experience in a single institution. Korean J Radiol. 2005; 6: 256–266. 12. Vorwerk D, Gunther RW, Schurmann K, Wendt G. Aortic and iliac stenoses: follow-up results of stent placement after insufficient balloon angioplasty in 118 cases. Radiology. 1996; 198: 45–48.

References:

13. Bosch JL, Hunink MG. Meta-analysis of the results of percutaneous transluminal angioplasty and stent placement for aortoiliac occlusive disease. Radiology. 1997; 204: 87–96.

1. O’Keeffe ST, Woods BO, Beckmann CF. Percutaneous transluminal angioplasty of the peripheral arteries. Cardiol Clin. 1991; 9: 515–522.

14. Springhorn ME, Kinney M, Littooy FN, Saletta C, Greisler HP. Inflow atherosclerotic disease localized to the common femoral artery: treatment and outcome. Ann Vasc Surg. 1991; 5: 234–240.

2. Isner J, Rosenfield K. Redefining the treatment of peripheral artery disease: role of percutaneous revascularization. Circulation 1993; 88: 1534–1557

15. Mukherjee D, Inahara T. Endarterectomy as the procedure of choice for atherosclerotic occlusive lesions of the common femoral artery. Am J Surg. 1989; 157: 498–500.

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Peripheral Arterial Disease Section 16. McGovern PJ Jr, Stark KR, Kaufman JL, Rosenberg N. Management of common femoral artery occlusion: a report of ten cases. J Cardiovasc Surg (Torino). 1987; 28: 38–42 17. Silva JA, White CJ, Quintana H, Collins TJ, Jenkins JS, Ramee SR. Percutaneous revascularization of the common femoral artery for limb ischemia. Catheter Cardiovasc Interv. 2004; 62: 230–233. 18. De Vries SO, Visser K, de Vries JA. Intermittent claudication: cost-effectiveness of revascularization versus exercise therapy. Radiology. 2002; 222: 25–36. 19. Feinglass J, McCarthy WJ, Slavensky R, Manheim LM, Martin GJ. Functional status and walking ability after lower extremity bypass grafting or angioplasty for intermittent claudication: results from a prospective outcomes study. J Vasc Surg. 2000; 31: 93–103. 20. Muradin GS, Bosch JL. Balloon dilation and stent implantation for treatment of femoropopliteal arterial disease: meta-analysis. Radiology. 2001; 221: 137–145. 21. Schillinger M, Sabeti S, Loewe C, Dick P. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006; 354: 1879–1888. 22. Schlager O, Dick P, Sabeti S. Long-segment SFA stenting: the dark sides: in-stent restenosis, clinical deterioration, and stent fractures. J Endovasc Ther. 2005; 12: 676–684. 23. Steinkamp HJ, Rademaker J, Wissgott C, Scheinert D, Werk M. Percutaneous transluminal laser angioplasty versus balloon dilation for treatment of popliteal artery occlusions. J Endovasc Ther. 2002; 9: 882–888. 24. McQuade K, Gable D, Pearl G, Theune B, Black S. Four-year randomized prospective comparison of percutaneous ePTFE/nitinol self-expanding stent graft versus prosthetic femoral-popliteal bypass in the treatment of superficial femoral artery occlusive disease. J Vasc Surg. 2010 Sep;52(3):584-90; discussion 590-1, 591.e1-591. e7. doi: 10.1016/j.jvs.2010.03.071. 25. Stone GW, Ellis SG, et al. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004; 350: 221–231. 26. Fischer M, Schwabe C, Schulte KL. Value of the Hemobahn/Viabahn endoprosthesis in the treatment of long chronic lesions of the superficial femoral artery: 6 years of experience. J Endovasc Ther. 2006; 13: 281–290 27. Saxon RR, Chervu A, Jones PA, Bajwa TK. Heparin-bonded, expanded polytetrafluoroethylene-lined stent graft in the treatment of femoropopliteal artery disease: 1-year results of the VIPER (Viabahn Endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease) trial. Journal of Vascular Surgery, Volume 52, Issue 3 , Pages 584-591. e7, September 2010

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28. Lammer J, Zeller T ET AL. Heparin-bonded covered stents versus bare-metal stents for complex femoropopliteal artery lesions: the randomized VIASTAR trial (Viabahn endoprosthesis with PROPATEN bioactive surface [VIA] versus bare nitinol stent in the treatment of long lesions in superficial femoral artery occlusive disease). J Am Coll Cardiol. 2013 Oct 8;62(15):1320-7. doi: 10.1016/j. jacc.2013.05.079. Epub 2013 Jul 10 29. Soder HK, Manninen HI, Jaakkola P, Matsi PJ, Rasanen HT, Kaukanen E, Loponen P, Soimakallio S. Prospective trial of infrapopliteal artery balloon angioplasty for critical limb ischemia: angiographic and clinical results. J Vasc Interv Radiol. 2000; 11: 1021–1031 30. Dorros G, Lewin RF, Jamnadas P, Mathiak LM. Belowthe-knee angioplasty: tibioperoneal vessels, the acute outcome. Cathet Cardiovasc Diagn. 1990; 19: 170–178. Oliva VL, Soulez G. Sirolimus-eluting stents versus the superficial femoral artery: second round. J Vasc Interv Radiol. 2005; 16: 313–315. 31. Greenen GPJ, Zilver PTX stenting: effective treatment of PAD in the diabetic patient population. Presented at The 26th Annual Meeting of the CArdiovascular and Interventional Radiological Society of Eruope (CIRSE); Oct 2010; Valencia Spain. 32. Sabeti S, Mlekush W, Amighi J, Minar E, Schillinger M. Primary patency of long segment self-expanding nitinol stents in the femoropopiteal arteries. J Endovasc Ther. 2005;12:6-12 33. Dake MD, on behalf of the Investigators. The Zilver PTX® randomized trial of paclitaxel-eluting stents for femoropoliteal disease: 3 year results. Presented at The 10th Annual Vascular Interventional Advances (VIVA) Meeting: Oct 2012; Las Vegas, NV 34. Zeller T, Rastan A, Percutaneous peripheral atherectomy of femoropopliteal stenoses using a new-generation device: six-month results from a single-center experience. J Endovasc Ther. 2004 Dec;11(6):676-85 35. Lawrence Garcia MD. Definitive LE Trial. Abstract Presented at VIVA October 2012. Las Vegas NV 36. Bauermeister, G. Endovascular stent-grafting in the treatment of superficial femoral artery occlusive disease. J Endovasc Ther. 2001;8:315-320. 37. Brodmann M. The angiosome concept in clinical practice: implications for patient-specific recanalization procedures. J Cardiovasc Surg (Torino). 2013 Oct;54(5):567-71 38. Attinger CE, Evans KK, Bulan E, et al. Angiosomes of the foot and ankle and clinical implications for limb salvage: reconstruction, incisions, and revascularization. Plast Reconstr Surg. 2006;117(7 suppl):261S-293S

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Peripheral Arterial Disease Section

Acute Limb Ischemia Advances in Endovascular management and a report of our initial experience of effective management in an outpatient catheterization lab setting. Juzar Lokhandwala, MD Special thanks to Debra Kilpatrick RCIS, BHSc in assisting with data collection.

Abstract: Acute limb ischemia (ALI) is a condition associated with significant risk for limb loss and mortality. It requires prompt diagnosis and treatment to improve outcomes. Given that it is most often associated with significant cardiac disease, advances in endovascular management of ALI has the potential to not only achieve the desired outcome of limb salvage but to also decrease perioperative mortality and morbidity associated with conventional vascular surgery in patients with significant cardiac disease. ALI has typically been associated with an average hospital stay of three to 10 days. We report our initial experience of successful treatment of acute limb ischemia in an outpatient catheterization laboratory setting which provides a dramatic reduction in costs of treatment by reducing the length of stay while achieving the desired outcome of limb salvage. While such approach has likely been implemented in some pioneering outpatient cardiovascular catheterization laboratories across the nation, to our knowledge, there is no published reports of such cases.

Introduction Acute limb ischemia (ALI) is characterized by sudden and complete cessation of blood flow to a limb. While the initial response is the shift in metabolism from aerobic to anaerobic, uncorrected it leads to cell death and eventually tissue and function loss. Clinically it is characterized by a painful, pulseless, pale, poikilothermic extremity with progressive parasthesia and paralysis. While fortunately not the most common presentation of peripheral arterial disease, it is a potentially dangerous one associated with morbidity of limb loss and mortality. It requires prompt recognition and eventual rapid restoration of blood flow to the ischemic extremity. The incidence of ALI is estimated to be 14 per 100,000. Hospitalization for ALI is frequently associated with a high cost, placing a significant financial burden on the healthcare system. In the past, surgical methods were the only available options, including open thrombectomy and extra-anatomic bypass. In current practice, mainstays of therapy involve urgent angiography with inpatient endovascular revascu-

Address Correspondence to: Juzar Lokhandwala MD 3900 University Blvd. South, Jacksonville, FL 32216 Email: jlokhand@firstcoastcardio.com

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larization, typically with 24 to 48 hours of thrombolytic therapy in the setting of intensive care unit monitoring.1,2,3 Given that ALI is most often associated with significant cardiac disease, endovascular management not only achieves the desired outcome of limb salvage, but also decreases perioperative mortality and morbidity associated with conventional vascular surgery in patients with significant cardiac disease. New thrombectomy devices and techniques have allowed for more effective thrombus management in the vast majority of such patients allowing outpatient treatment and thereby avoiding prolonged hospital stay, decreasing the bleeding risk associated with thrombolytic infusion and lowering the cost. We report on our series of such patients presenting with ALI, and treated effectively in a purely outpatient setting.

ALI Classification Unlike the well-known Rutherford-Becker classification for chronic peripheral arterial disease (PAD) into six levels, the classification more commonly used for acute limb ischemia is the one reported by Rutherford et al and delineated in Table 1.4 (page 38) One word of caution when dealing with the class III patients is that while revascularization might not yield limb salvage prompt revascularization could alter the level of amputation to a less disabling one.

Clinical Subgroups of ALI: 1. Embolic ALI: This is the most common etiology. Seventy-five percent of emboli are cardiac. Cardiac sources include left atrial or left atrial appendage thrombus due to atrial fibrillation or thrombi associated with left ventricular aneurysms from prior myocardial infarction. Twenty-five percent of emboli come from abdominal aortic, or popliteal artery aneurysms or from atheromatous plaque. Embolic ALI is most likely to present with Rutherford class IIb or III limb ischemia, given the acute onset and lack of pre-existing collaterals.3 These patients require prompt revascularization typically less than six hours from onset to prevent permanent neurologic deficits or tissue loss.

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Peripheral Arterial Disease Section Table 1: Classification of ALI4 Category

Description

Motor loss

Sensory Loss

None

I

Viable

None

IIa

Marginally threatened limb

None None/ minimal (toes)

Endovascular Revascularization

As soon as feasible

Urgent

IIb

Immediately threatned

Mild/ moderate

More than toes, rest pain

Within 6 hours

III

Irreversible

Profound (paralysis)

Profound (anasthetic)

Typically does not achieve limb salvage, but may alter level of amputation

2. In situ thrombosis: This occurs when there is a thrombotic occlusion at the site of an underlying severe stenosis and existing peripheral arterial disease. In this case, if there are well-developed collaterals to provide some limb perfusion, ALI is typically class I or IIa. In patients with previous revascularization procedures for peripheral arterial disease, such as bypass grafting or peripheral artery stents, thrombotic occlusion of revascularized segments can lead to ALI. In treating this sub group of patients endovascular therapy is the preferred therapy. In addition to extraction or lysis of the thrombus, an important goal with these patients is to identify and treat the underlying stenosis that led to the thrombosis in the first place. This is typically either in the bypass graft or in the distal outflow vessel. 3. Other rare etiologies include traumatic disruption, acute extrinsic compression or dissection.

Figure 1

A

B

C

D

Shows various endovascular devices available for treatment of acute limb ischemia in the outpatient cath lab setting. Jetstream device (a) has a series of rotating blades which pulverize atherothrombotic material and these are continuously aspirated. Angiojet device (b) releases high speed saline jets that create a low pressure and eventual suction in to the catheter. A filter (c and d) may be used if there is high risk of distal embolization. The images of JETSTREAM and AngioJet have been reproduced with the permission of Bayer HealthCare LLC. JETSTREAM and AngioJet are registered trademarks of Bayer.

Basic Principles of Management: 1. Evaluate for associated metabolic disturbances including assessment of renal function, basic chemistry and blood count, and in select cases creatinine kinase, and hypercoagulable tests (especially in cases that are otherwise unexplained). 2. Anticoagulation with IV heparin 3. Finally, a decision should be promptly made regarding viability of affected limb. If the patient has irreversible tissue loss (Class III) then amputation is considered. The vast majority of patients, however, typically present early enough to be candidates for urgent revascularization. Prior to revascularization an angiogram is typically performed to delineate the extent of occlusion and collateralization and feasibility of ad-hoc endovascular 38 Vol. 65, No. 1 2014

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revascularization. Rarely surgical approaches such as open embolectomy or extra-anatomical bypass are considered. It is strongly recommended to urgently consult a vascular or endovascular specialist early on, and let them make the decision on the next course of action. It is recommended to defer the decision on any contrast based imaging tests to the vascular specialist, especially in patients whose renal function is compromised or borderline. A CT angiogram, for example, typically requires 150 cc of contrast injection, which in a patient with chronic kidney disease may significantly increase the risk of contrast nephropathy if urgent angiography and revascularization are needed. To provide a similar anatomic vascular diagnosis, invasive DCMS online . org


Peripheral Arterial Disease Section Figure 2

Figure 3

Occlusion of the entire Fem pop Bypass graft

A

B Widely patent Fem pop Bypass post thrombectomy

C

D

Fifty-nine year old male with sudden onset right leg pain and coolness due to acute occlusion of the right femoropopliteal bypass graft (a). He underwent successful thrombectomy with a Jetstream device, restoring flow in the graft (b). There was still a 100 percent occlusion of the distal right popliteal artery beyond the anastomosis of the bypass graft (c), which likely was the culprit lesion for causing thrombosis of the bypass graft. This was successfully treated as well with Jetstream atherectomy and angioplasty to restore brisk flow down the right leg (d).

angiography uses considerably less contrast dye when compared to CT angiography and provides much more information to guide immediate endovascular treatment.

Baseline occlusion of the femoral artery

Post thombectomy and stenting

Eighty-three year old female without any prior diagnosis of peripheral arterial disease presented with acute onset of rest pain and coolness in right leg. Urgent outpatient angiography identified complete occlusion of flow in the right common femoral artery with poor collateralization and also a subsequent occlusion of the right superficial femoral artery. Both lesions were treated successfully using Angiojet thrombectomy followed by angioplasty and stent placement in the superficial femoral artery with restoration of brisk flow down the right leg. She is ambulatory without any claudication symptoms on six month follow up.

Endovascular Reperfusion Techniques: 1. Catheter directed thrombolysis: In this technique a multi-hole catheter is advanced over a guidewire into the thrombosed artery or bypass graft and tissue plasminogen activator (or other lytic agents) is infused over 12 to 24 hours. After this the patient is brought back for a relook angiogram to verify the adequacy of thrombus removal, and to identify arterial stenoses that may need endovascular treatment. This requires hospitalization and close monitoring of the patient for bleeding in the intensive care unit. It is contraindicated with any active bleeding, prior cerebral hemorrhage, recent major surgery, uncontrolled hypertension or other usual contraindications of thrombolytic therapy. 2. Mechanical thrombectomy: Mechanical devices have the advantage of being immediately effective in restoring perfusion when compared to infusion therapy and this is particularly useful in clinical situations when even waiting a few hours can result in irreversible tissue loss. It is a useful tool to enable treatment of acute limb ischemia as an outpatient. Devices available include AngioJet rheolytic thrombectomy (Figure 1a), Jetstream atherothrombectomy device (Figure 1b) and Trelis device. In essence all of these devices extract thrombus through a process of

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either maceration, suction, or stirring the vascular lumen or a combination thereof. Coupled with low dose, focally infused thrombolytic agent, these techniques can achieve rapid thrombus removal. 3. Other endovascular considerations: A temporary filter may be placed distal to the thrombotic segment prior to mechanical thrombectomy, in certain situations, to avoid distal embolization (Figure 1c and 1d). Also, initial thrombectomy frequently reveals underlying stenosis which precipitated the occlusion and this may also need to be adequately treated (Figure 2c and 2d)

Our Initial Experience of the Management of ALI in an Outpatient Catheterization Lab Setting: â&#x20AC;˘ Methods: We analyzed cases of acute limb ischemia done at our outpatient catheterization laboratory for baseline variables and outcomes, done over the last 10 months who had symptom onset/ sudden worsening over a period of less than seven days. These were sent for urgent

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Peripheral Arterial Disease Section Figure 4

pre

Baseline occlusion of the right iliac artery

Figure 5

post

Post thombectomy and angioplasty

Seventy-two year old male with ongoing tobacco abuse and with prior history of iliac stent placements, who presented with acute onset progressive discoloration of the right leg for the past few days. Angiography identified complete occlusion of flow on the right at the level of the common iliac artery. Angiojet thrombectomy was performed with additional angioplasty. Patient also had occlusion of right superficial femoral artery stents, which were also intervened on in the same setting with good restoration of flow down the right foot.

angiography and intervention to our outpatient catheterization lab at the clinical discretion of their cardiovascular physician. As such, no criteria were pre-specified to the clinicians for inpatient versus outpatient treatment and this remains purely a retrospective review of our initial experience. Generally, majority of these patients would be clinically classified under category I and IIa as defined in Table 1(page 38). We only included those patients who were found to have a complete vessel occlusion with evidence of thrombus. Angiograms of some of these patients before and after revascularization are shown in Figures 2-5. â&#x20AC;˘ Results: Initially thirteen cases were identified, by retrospective review of our outpatient catheterization lab cases where thrombectomy was used in the lower extremities for complete vascular occlusions. Four patients were excluded because the time period from either symptom onset or acute worsening to presentation was greater than seven days putting them more in the critical limb ischemia rather than acute limb ischemia category. Therefore, a total of nine cases were included in this analysis. Baseline characteristics (Table2) and results (Table 3) are tabulated. Level of occlusion ranged from common iliac to popliteal and involved both native vessels as well as bypass grafts. Overall, all patients underwent successful revascularization and the

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pre

post

Baseline occlusion of Left Femoral artery

Post thombectomy and stenting

Seventy-four year old female presented with acute occlusion of the left common femoral artery stent. Post intervention there was good restoration of flow with Angiojet thrombectomy and angioplasty. Five months later, arterial duplex has identified widely patent treatment site with good healing of left leg wounds.

outcome of limb salvage was achieved in all patients. None of these patients required additional vascular surgery or inpatient admission. One patient had an inconsequential hematoma post sheath pull and was discharged without event. All patients were successfully discharged to home post revascularization (or to an extended care facility if they were there previously). Arteriotomy closure device use in patients with suitable anatomy also helped expedite discharge. Additionally, preliminary satisfaction surveys were positive. Six to nine month follow up was available for eight of the nine patients. Two patients had recurrent occlusion at two months and five months respectively and these were again successfully treated in the outpatient catheterization lab setting. Two other patients presented with restenosis detected by serial arterial duplex evaluation, without any thrombosis or occlusion, and underwent outpatient intervention to these lesions successfully. â&#x20AC;˘ Discussion: Acute limb ischemia is a serious condition that requires prompt diagnosis and therapy to prevent limb loss with its inherent morbidity and mortality. There has been a natural shift towards endovascular management of acute limb ischemia as it has for all other clinical subsets of peripheral arterial disease. Inpatient endovascular management has been shown to be an effective alternative

DCMS online . org


Peripheral Arterial Disease Section Table 2: Baseline characteristics Range Number of patients Average Age Average creatinine Males Presence of ulceration or tissue loss

9

NA

70.4 years

59-83

1.21

0.8 - 1.7

7

NA

2 pts

NA

to surgical therapies in trials.2,3 This is the first report describing successful treatment of acute limb ischemia in an outpatient cardiovascular catheterization laboratory. Overall, the main advantage, at least in theory, is reduced costs that are associated with inpatient treatment as well as decrease in bleeding complications by obviating the need for routine prolonged thrombolytic infusions. This approach needs to be studied in larger cohorts with an eye towards safety and cost effectiveness. Admittedly this is a retrospective review with the inherent flaws of such methodology. We intend to prospectively collect such data in the future to reduce the potential for bias.

Conclusion: Endovascular therapies have revolutionized the outcomes of patients with acute limb ischemia. Our initial experience in treating acute limb ischemia in an outpatient cardiovascular catheterization laboratory shows that this is safe, feasible and effective with a potential of significantly reducing health care costs associated with traditional inpatient treatment of this condition. This may hold great promise for the future as our health care system continues to focus on therapies with the best cost benefit ratio for our patients. v

DCMS online . org

Table 3: Results Average duration of procedure

2.4 hours

Average stay post procedure in recovery

3.67 hours

Average contrast use

260 ml

Disposition post procedure

All discharged without hospitalization

Complications

1 (inconsequential hematoma post sheath pull, stable at discharge to home)

References: 1. Kasirajan K, Marek JM, Longsfeld M. Mechanical thrombectomy as a first-line treatment for arterial occlusion. Semin Vasc Surg. 2001;14(2):123-131. 2. Ouriel K, Veith FJ, Sasahara AA, for the Thrombolysis or Peripheral Arterial Surgery (TOPAS) investigators. A comparison of recombinant urokinase with vascular surgery as initial treatment for acute arterial occlusion of the legs. N Engl J Med. 1998;338(16):1105-1111. 3. The STILE Trial: results of a prospective randomized trial evaluating Surgery versus Thrombolysis for Ischemia of the Lower Extremity. Ann Surg. 1994;220:251-266. 4. Rutherford RB. Clinical staging of acute limb ischemia as the basis for choice of revascularization method: when and how to intervene. Semin Vasc Surg. 2009 Mar;22(1):5-9. 5. Sedghi Y, Collins TJ, White CJ. Endovascular management of acute limb ischemia. Vasc Med. 2013 Oct;18(5):30713.

Northeast Florida Medicine Vol. 65, No. 1 2014 41


Thank you to our 2013 Caring Award Sponsors Diamond

Gold Dr. Scot and Alexandra Ackerman Rick and Susan Sontag

Silver

Bronze

Patron GATE Foundation Haskell Haven Hospice Hunter & Associates Dr. David and Jeanne Moomaw Drs. Michael and Sue Nussbaum Dr. Francis and Mrs. Carmencita Ong Drs. Todd Sack and Barbara Sharp Dr. George and Mrs. Ann Trotter Shirley Weinstein 42 Vol. 65, No. 1 2014

Northeast Florida Medicine

Media

Donor American Enterprise Bank of Florida Baymeadows MRI DCMS Alliance James G. Lemley and Beverly Cheveallier John Giehrl, CPA Smoak, Davis & Nixon, LLP Wally and Alyson Lee Dr. Stanton Longenecker T.R. Lowe, R.Ph, C.Ph Metro Diner Teresa Myers Sherry Murray

Dr. Phil Perry Life Planning Partners Platinum Cutts Unlimited Barber & Beauty

In Kind AB-Brewmaster, Steve Foppee and Gary Parker Deborah DeAngelo Dr. Jeffrey and Mrs. Kathy Harris Mrs. Ann Trotter Wingard Creative

DCMS online . org


ACO Forum CME

The Future of Healthcare and the ACOs For several years as I saw the beginnings of Obamacare arise from its primordial broth of words to its present status as the medical law of the land, it became painfully apparent to me that we needed to know more about it. It became even more apparent that this legislation would become one of the most far-reaching pieces of medical legislation in the history of the United States with implications effecting every patient and physician either directly or indirectly in the United States. It was apparent that change would happen within the law itself and medical upheavals would occur across the country. Eli Lerner, MD, FACS DCMS Immediate Past President

Yet we know very little about Obamacare. Unfortunately, much of the administration of the law has once again been given to non-medical people who have very little understanding of the problems we face daily in the care of our patients. I believe that a lot of this disconnect is because of us. With increasing clinical responsibilities and diminishing reimbursement, who has time to try to read and understand legislation that continues to change on a daily basis, much less work with it? We are boxed in by responsibilities to our patients, our clinic or practice obligations, our CME’s, and our families. Our time is a finite resource.

DCMS online . org

I thought that we could serve our membership by establishing a conference that would try to help us understand on a local level how Accountable Care Organizations, the basic structure of the health care interface, would affect the practice of medicine in the Northeast Florida Medical community. It took almost two years to get the conference going but it fills the need for local education on how to relate to the ACOs. Initial topics covered the future of health care in Northeast Florida, defining accountable care, starting an ACO, the experience of the pioneer ACO in North Florida, the payer’s perspective on integrated health systems, employer-based ACOs and the Ambulatory Intensive Care Unit’s place in ACOs. Attendance was very good, and attendees and participants left knowing more about the ACOs than they did before the meeting. The meeting dovetailed nicely with the Annual Caring Community Conference three months’ earlier and the Jacksonville University Health Care Conference a few weeks earlier. All three together form a very complete primer on Obamacare’s local effects and how they would be accomplished. I welcome you to this issue of our journal which reviews our conference on PPACA and lessons learned. – Eli Lerner MD, FACS

Northeast Florida Medicine Vol. 65, No. 1 2014 43


ACO Forum CME

Getting Started in an ACO Background:

The Duval County Medical Society (DCMS) is proud to provide its members with free continuing medical education (CME) opportunities in subject areas mandated and suggested by the State of Florida Board of Medicine to obtain and retain medical licensure. The DCMS would like to thank the St. Vincent’s Healthcare Committee on CME for reviewing and accrediting this activity in compliance with the Accreditation Council on Continuing Medical Education (ACCME). This issue of Northeast Florida Medicine includes an article, “Getting Started in an ACO” authored by Pam Maxwell which has been approved for .5 AMA PRA Category 1 credit.TM For a full description of CME requirements for Florida physicians, please visit www.dcmsonline.org.

Faculty/Credentials:

Pam Maxwell is the Vice President of Provider Development for Orange Health Solutions.

Objectives: 1.

To educate healthcare providers about what it takes to create and manage a successful ACO.

2.

Provide insight into how successful ACOs positively impact the triple aim of healthcare.

3.

Stimulate providers into thinking about how and why they would become part of an ACO.

Date of release: Feb. 1, 2014

Date Credit Expires: Expires: Feb. 1, 2016

Estimated Completion Time: 1/2 hr

How to Earn this CME Credit: 1.

Read the “Getting Started in an ACO” article, complete posttest (page 55) and email your test to Patti Ruscito at patti@dcmsonline.org or 904.353.5848.

2.

Go to www.dcmsonline.org to read the article and take the CME test online.

3.

All non-members must submit payment for their CME before their test can be graded.

CME Credit Eligibility:

A minimum passing grade of 70% must be achieved. Only one re-take opportunity will be granted. A certificate of credit/completion will be emailed within four to six weeks of submission. If you have any questions, please contact Patti Ruscito at 904.355.6561 or patti@dcmsonline.org.

Faculty Disclosure:

Pam Maxwell reports no significant relations to disclose, financial or otherwise with any commercial supporter or product manufacturer associated with this activity.

Disclosure of Conflicts of Interest:

St. Vincent’s Healthcare (SVHC) requires speakers, faculty, CME Committee and other individuals who are in a position to control the content of this educations activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity. All identified conflicts of interest are thoroughly evaluated by SVHC for fair balance, scientific objectivity of studies mentioned in the presentation and educational materials used as basis for content, and appropriateness of patient care recommendations.

Joint Sponsorship Accreditation Statement

This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of St. Vincent’s Healthcare and the Duval County Medical Society. St. Vincent’s Healthcare designates this educational activity for a maximum of 1 AMA PRA Category 1 credit.TM Physicians should only claim credit commensurate with the extent of their participation in the activity.

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DCMS online . org


ACO Forum CME

Getting Started in an Accountable Care Organization Pam Maxwell

VP Provider Development, Orange Health Solutions

The increased cost of healthcare in the United States is the driving force of change within the industry. The Accountable Care Organization (ACO) strategy, an important component of the Patient Protection and Affordable Care Act (PPACA), will be effective when opportunities to reduce healthcare costs are taken while maintaining or improving quality and patient satisfaction. As healthcare is evolving away from the traditional pay-for-volume to more pay-for-performance, the primary care provider role has emerged as a leader of patient care management affecting outcomes and driving costs. ACOs are groups of doctors, hospitals and other health care providers who come together voluntarily to give coordinated high quality care to their Medicare patients. The goal of coordinated care is to ensure that patients, especially the chronically ill, get the right care at the right time, while avoiding unnecessary duplication of services and preventing medical errors. As of August 2013, almost 500 ACO’s nationwide existed, with more than half of these aligned under the Medicare Shared Savings Program (MSSP). Begun in 2011 with the 23 “Pioneer” ACO’s, the program has expanded as independent physicians groups, hospitals and hospital physicians groups have formed to take advantage of Medicare incentives. What’s in it for Providers? The Center for Medicare and Medicaid Services (CMS) has guidelines for establishing an ACO that include a minimum number of 5,000 patients attributed. Based on average benchmark costs at $55 million for the annual treatment of patients (Part A&B) a six percent savings in Medicare expenses can result in approximately $1.7 million revenue shared with the ACO. Realities for ACO startups from the trenches Reality #1 – It Takes Money The estimated cost to fund the operations for 18 months can be as much as $1.5 million or more. These costs include:

Reality #2 – You Need Providers The majority of the participants in a MSSP ACO must be primary care providers, as they will manage the patients. An average of 25 to 50 providers is needed to meet the 5,000 Medicare Fee-for-Service lives. CMS approves which patients are attributed to the providers. Reality #3 – Financial Incentives are Key An ACO will need contracts that include aligned incentives to reward providers for achieving the goals of the contract and ACO. An easy place to start is with the MSSP since it is readily available; however, contracts for commercial payers are becoming more common. Reality #4 – You Must Create Sustainable Results Sustainable results require a reasonable investment in infrastructure to support the goals of the ACO and its contracts. Even ACOs who have tried to make minimal investments have seen the need for technology and analytics, some basic care coordination, and the required governance and administration of the CMS contract. The ACO must remain a viable entity throughout the three-year MSSP contract, which requires a laser focus on reducing medical costs and achieving shared savings. Those who don’t reduce cost don’t receive payment from CMS. Reducing costs must not mean withholding care, but focusing on identifying where cost-savings can be made by reducing overutilization and waste. The data showing where spending is high will direct an ACO into actions that will have the most impact. Developing programs that make a difference in how doctors make decisions will lead to minor changes with major cost savings. Sharing best practices across providers within the ACO is encouraged so all participants have a stake in making changes. The 8 Rules of ACO Medical Cost 1. High costs tend to be high costs

• Executive leadership and administration of the ACO

2. Understand the numbers

• Software and analytics capabilities to effectively interpret the claims data CMS will share about the ACO’s patient population

3. Be aware of benchmarks

• Resources to support patient engagement including outreach communication and the possible addition of care coordinators

5. Hospitals tend to be expensive sites of care

4. Do the math 6. Big groups of cost are easier to work with than small ones 7. Don’t lose time 8. Remember the patient in the numbers v

Address correspondence to: info@orangehealth.net

DCMS online . org

Northeast Florida Medicine Vol. 65, No. 1 2014 45


ACO Forum CME

A Pioneer ACO in North Florida Background:

The Duval County Medical Society (DCMS) is proud to provide its members with free continuing medical education (CME) opportunities in subject areas mandated and suggested by the State of Florida Board of Medicine to obtain and retain medical licensure. The DCMS would like to thank the St. Vincent’s Healthcare Committee on CME for reviewing and accrediting this activity in compliance with the Accreditation Council on Continuing Medical Education (ACCME). This issue of Northeast Florida Medicine includes an article, “The Pioneer ACO in North Florida” authored by William Carriere, M.D., which has been approved for .5 AMA PRA Category 1 credit.TM For a full description of CME requirements for Florida physicians, please visit www.dcmsonline.org.

Faculty/Credentials:

William Carriere, M.D., is the CEO of Family Care Partners.

Objectives: 1.

Understand the healthcare industry evolution that lead to the formation of Accountable Care Partners ACO.

2.

Understand how the financial incentives align with delivering coordinated higher quality, lower cost healthcare.

3.

Understand the infrastructure created in order to achieve success as an ACO.

Date of release: Feb. 1, 2014

Date Credit Expires: Expires: Feb. 1, 2016

Estimated Completion Time: 1/2 hr

How to Earn this CME Credit: 1.

Read the “The Pioneer ACO in North Florida” article, complete posttest (page 55) and email your test to Patti Ruscito at patti@dcmsonline.org or 904.353.5848.

2.

Go to www.dcmsonline.org to read the article and take the CME test online.

3.

All non-members must submit payment for their CME before their test can be graded.

CME Credit Eligibility:

A minimum passing grade of 70% must be achieved. Only one re-take opportunity will be granted. A certificate of credit/completion will be emailed within four to six weeks of submission. If you have any questions, please contact Patti Ruscito at 904.355.6561 or patti@dcmsonline.org.

Faculty Disclosure:

William Carriere, M.D., reports no significant relations to disclose, financial or otherwise with any commercial supporter or product manufacturer associated with this activity.

Disclosure of Conflicts of Interest:

St. Vincent’s Healthcare (SVHC) requires speakers, faculty, CME Committee and other individuals who are in a position to control the content of this educations activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity. All identified conflicts of interest are thoroughly evaluated by SVHC for fair balance, scientific objectivity of studies mentioned in the presentation and educational materials used as basis for content, and appropriateness of patient care recommendations.

Joint Sponsorship Accreditation Statement

This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of St. Vincent’s Healthcare and the Duval County Medical Society. St. Vincent’s Healthcare designates this educational activity for a maximum of 1 AMA PRA Category 1 credit.TM Physicians should only claim credit commensurate with the extent of their participation in the activity.

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ACO Forum CME

A Pioneer ACO in North Florida William Carriere, MD

VP Provider Development, Orange Health Solutions

Overview Accountable Care Organizations (ACOs) are an important part of healthcare reform. As the first ACO formed in Jacksonville, Accountable Care Partners (ACP) led by Dr. William Carriere, had a unique opportunity to develop and implement strategies for navigating through the complexities of overhauling the healthcare system. Their journey has led them to a set of components vital to the success of ACOs. ACP believes their recipe for success gives physicians the greatest opportunity to seize control of their own destiny in the years to come. Component I: Recognizing How We Got Here Many would agree that achieving universal healthcare is a noble and altruistic effort, but a major flaw is that the Affordable Care Act (ACA) merely floods more people into a system that is currently broken and inefficient. ACOs are only a portion of the ACA. It is designed to control healthcare costs while improving the quality of healthcare given to patients. In order to fully appreciate the ACO’s goals, there must be an understanding of the factors that led the United States healthcare into a compromised position. Medical rates are mostly paid by governmental and commercial insurances, or “payers.” As the level of medical and technological advancements increased throughout time, the rates for performing them also increased. Providers are the main purchasing agents of these services. As costs began to significantly rise, payers implemented controls by cutting the amount they would pay for each service. Rarely, providers compensated for the cuts by performing more tasks and services, to make up for their revenue shortfalls. As the cycle continued, adversarial relationships developed between payers and the providers. The spending and cutting cycle is not the only culprit for increased financial strain on the healthcare industry. Spending analysis indicates anywhere from 30 to 50 percent of healthcare dollars are attributed to waste producing activities such as duplication of procedures and tests, overutilization, medication errors and increased hospital admissions.1 Component II: Information Technology Physicians in an ACO are held accountable for the entire range of care their patients receive. They must solve failures in the areas of communication, coordination, quality and cost effectiveness. The use of Information Technology (IT) in ACOs ensures accurate tracking of value-based measurements for this payment model. IT provides data gathering and analytic capabilities to stratify

populations of patients, determine cost effectiveness of services, and assist with appropriate clinical decisions. Component III: The Physician Team Support is necessary to coordinate the overall care of a patient. Patient outreach, education, engagement, case management, improved access and monitoring of care quality all require attention. In no other way can a physician accomplish all of their new responsibilities without the help of a team. Essentially, these teams support the physician by fulfilling a multitude of background tasks in order to free the physician to concentrate on the most critical decisions necessary for patients. A growing standard for this form of practicing medicine is called the Patient Centered Medical Home (PCMH). Sponsored by the NCQA, PCMH recognition in a practice comes to those who can prove they are providing the type of coordinated care required to achieve a set standard of quality metrics in patient populations. Component IV: Payment Reform to Incentivize Change Finally, physicians must understand that payment based on outcomes, cost effectiveness, and value rather than volume is the theme of many new incentive models. ACP operates in a shared savings model. At its most basic level, the ACO works with a specific population of patients. Those patients are assigned a budgeted amount of dollars for their annual care among any and all healthcare providers. Payment for services to patients are still made by Fee-For-Service, but if the ACO can satisfactorily achieve a set of evidence-based quality care measures, and do it for less than the overall budgeted amount, a portion of the total savings is then distributed back to the members of the ACO. The remaining savings is held by the payer (in this case, Medicare). The Challenge and The Opportunity The obvious challenge for physicians in the coming years is to survive in the old format of Fee-For-Services, or “Volume Based” payment, while implementing the steps necessary for the new “Value-Based” format. The opportunity for physicians, however, lies in the fact that those who can arm themselves with the necessary data and team can take advantage of the transition and prosper in the savings created by eliminating waste. v References: 1.

Robert Kelley, VP Healthcare Analytics, Thomson Reuters. “Where Can $700 Billion in Waste Be Cut Annually From the U.S. Healthcare System?” October 2009.

Address correspondence to Dr. William Carriere, 6520 Ft. Caroline Road, Jacksonville FL 32277

DCMS online . org

Northeast Florida Medicine Vol. 65, No. 1 2014 47


ACO Forum CME

Integrated Health Systems – A Payer’s Perspective Background:

The Duval County Medical Society (DCMS) is proud to provide its members with free continuing medical education (CME) opportunities in subject areas mandated and suggested by the State of Florida Board of Medicine to obtain and retain medical licensure. The DCMS would like to thank the St. Vincent’s Healthcare Committee on CME for reviewing and accrediting this activity in compliance with the Accreditation Council on Continuing Medical Education (ACCME). This issue of Northeast Florida Medicine includes an article, “Integrated Health Systems – A Payer’s Perspective” authored by Jonathan B. Gavras, M.D., which has been approved for .5 AMA PRA Category 1 credit.TM For a full description of CME requirements for Florida physicians, please visit www.dcmsonline.org.

Faculty/Credentials:

Jonathan Gavras, MD is the Senior Vice President of Delivery Systems and Chief Medical Officer for Florida Blue.

Objectives: 1.

Understand why payer industry is move to value-based integrated healthcare.

2.

Understand value-based programs that have been implemented at Florida Blue.

3.

Discussion of lessons learned from developing value-based models.

Date of release: Feb. 1, 2014

Date Credit Expires: Expires: Feb. 1, 2016

Estimated Completion Time: 1/2 hr

How to Earn this CME Credit: 1.

Read the “Integrated Health Systems – A Payer’s Perspective” article, complete posttest (page 55) and email your test to Patti Ruscito at patti@dcmsonline.org or 904.353.5848.

2.

Go to www.dcmsonline.org to read the article and take the CME test online.

3.

All non-members must submit payment for their CME before their test can be graded.

CME Credit Eligibility:

A minimum passing grade of 70% must be achieved. Only one re-take opportunity will be granted. A certificate of credit/completion will be emailed within four to six weeks of submission. If you have any questions, please contact Patti Ruscito at 904.355.6561 or patti@dcmsonline.org.

Faculty Disclosure:

Jonathan Gavras, MD reports no significant relations to disclose, financial or otherwise with any commercial supporter or product manufacturer associated with this activity.

Disclosure of Conflicts of Interest:

St. Vincent’s Healthcare (SVHC) requires speakers, faculty, CME Committee and other individuals who are in a position to control the content of this educations activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity. All identified conflicts of interest are thoroughly evaluated by SVHC for fair balance, scientific objectivity of studies mentioned in the presentation and educational materials used as basis for content, and appropriateness of patient care recommendations.

Joint Sponsorship Accreditation Statement

This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of St. Vincent’s Healthcare and the Duval County Medical Society. St. Vincent’s Healthcare designates this educational activity for a maximum of 1 AMA PRA Category 1 credit.TM Physicians should only claim credit commensurate with the extent of their participation in the activity.

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ACO Forum CME

Florida Blue Integrated Health Systems - A Payer’s Perspective Jonathan B. Gavras, MD

SVP, Delivery System and Chief Medical Officer

The United States Delivery System is going through many changes. No one is sure what the full impacts of healthcare reform will be or how the current system of care will evolve. Tremendous anxiety abounds which has led to consolidation and previously unthinkable alliances. One thing is for certain, the changes in healthcare delivery are not fleeting in nature. Healthcare is local to most people. Their physician remains the anchor and navigator for their care. In the future, quality will be tied to revenue and payment, and will therefore be important in any model moving forward. Patients are more “consumers” of healthcare. They will look for what they perceive as the best value in healthcare. Payment methodologies are evolving from strictly FeeFor-Service to more value-based care. The previous way of managing costs has not been effective or sustainable. Medical cost trends continue to outpace the Corporate Performance Indicator (CPI). New payment and care delivery models are essential to support coordinated, efficient, and quality-driven healthcare. Some payment innovation domains consist of Patient Centered Medical Homes (PCMH), Accountable Care Organizations (ACO), episode-based/bundled payments, and pay-for performance/quality based incentive programs. Two models have become particularly widespread recently. The PCMH is a model founded on the patient-physician relationship. The physician is a navigator of members’ care. Models have shown promising results from a cost and quality standpoint. Florida Blue’s PCMH is one of the largest PCMHs in the nation. It consists of more than 700,000 members touched and more than 2,200 Primary Care Physicians participating in Florida. PCMH physicians performed same or better than non-participating peers in 100 percent of 29 clinical quality metrics. The utilization of emergency rooms

was reduced by 12 percent. Utilization of inpatient stays was reduced by nine percent, and the overall per-member permonth cost reduction was greater than four percent. ACOs are population-based models which focus on the cost and quality of populations of patients. Patients attributed to these models are handled holistically and increased efforts to improve wellness and condition management are paramount. This system is based upon setting a target for quality and cost for a population of patients assigned to a provider entity. Delivery Systems are incentivized to surpass these targets to share in the savings from better overall outcomes in care. Most ACOs are for total cost of care members, but some specialty ACOs exist. An example of this type of model is the Miami-Dade Accountable Oncology Program. Oncology costs are very high in Florida, and this program was an attempt to see if it could reduce the medical cost trend. Baptist Health South Florida (BHSF), Advanced Medical Specialties (AMS), and Florida Blue partnered to manage attributed oncology patients. Oncology pathways, after hour care, and increased clinical coordination were the focus. After one year, ER use readmissions decreased and pathway adherence improved. A second oncology ACO was started in Tampa with Moffitt Cancer Center and Florida Blue. Moffitt Cancer Center is a designated National Cancer Institute (NCI) Comprehensive Cancer Center. Moffitt Medical Group contains 330 oncology practitioners in Florida dedicated to cancer care. Similar parameters and structure apply to this program as the BHSF/AMS program. Over time, the magnitude of U.S. Delivery System will be value-based. This will be essential to a sustainable health care value solution. There are many opportunities to improve the quality and cost of these healthcare models. Improve member engagement, physician satisfaction, and standardized care will continue to evolve and be on the forefront of change within the delivery system. v

Address correspondence to Jonathan B. Gavras, MD SVP, Delivery System and Chief Medical Officer 4800 Deerwood Campus Parkway, Bldg 100, 8th Floor Jacksonville, FL 32246

DCMS online . org

Northeast Florida Medicine Vol. 65, No. 1 2014 49


ACO Forum CME

An Employer’s Approach to Improving Health Background:

The Duval County Medical Society (DCMS) is proud to provide its members with free continuing medical education (CME) opportunities in subject areas mandated and suggested by the State of Florida Board of Medicine to obtain and retain medical licensure. The DCMS would like to thank the St. Vincent’s Healthcare Committee on CME for reviewing and accrediting this activity in compliance with the Accreditation Council on Continuing Medical Education (ACCME). This issue of Northeast Florida Medicine includes an article, “An Employer’s Approach to Improving Health” authored by Chad Greeno which has been approved for .5 AMA PRA Category 1 credit.TM For a full description of CME requirements for Florida physicians, please visit www.dcmsonline.org.

Faculty/Credentials:

Chad Greeno is the Managing Director for the Healthcare Reform Business Unit at Cerner.

Objectives: 1.

Describe the journey that Cerner has taken in improving the health of our associates while decreasing our annual healthcare spend.

2.

Present trends in the employer market that are relative to the formation of ACOs combining technology and strategy.

3.

Thoughts for partnering directly with employers to achieve outstanding health outcomes at a reduced cost.

Date of release: Feb. 1, 2014

Date Credit Expires: Expires: Feb. 1, 2016

Estimated Completion Time: 1/2 hr

How to Earn this CME Credit: 1.

Read the “An Employer’s Approach to Improving Health” article, complete posttest (page 55) and email your test to Patti Ruscito at patti@dcmsonline.org or 904.353.5848.

2.

Go to www.dcmsonline.org to read the article and take the CME test online.

3.

All non-members must submit payment for their CME before their test can be graded.

CME Credit Eligibility:

A minimum passing grade of 70% must be achieved. Only one re-take opportunity will be granted. A certificate of credit/completion will be emailed within four to six weeks of submission. If you have any questions, please contact Patti Ruscito at 904.355.6561 or patti@dcmsonline.org.

Faculty Disclosure:

Chad Greeno reports no significant relations to disclose, financial or otherwise with any commercial supporter or product manufacturer associated with this activity.

Disclosure of Conflicts of Interest:

St. Vincent’s Healthcare (SVHC) requires speakers, faculty, CME Committee and other individuals who are in a position to control the content of this educations activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity. All identified conflicts of interest are thoroughly evaluated by SVHC for fair balance, scientific objectivity of studies mentioned in the presentation and educational materials used as basis for content, and appropriateness of patient care recommendations.

Joint Sponsorship Accreditation Statement

This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of St. Vincent’s Healthcare and the Duval County Medical Society. St. Vincent’s Healthcare designates this educational activity for a maximum of 1 AMA PRA Category 1 credit.TM Physicians should only claim credit commensurate with the extent of their participation in the activity.

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DCMS online . org


ACO Forum CME

Employer-based ACOs: How Employers are Systematically Managing the Health of Their Populations Chad Greeno, Cerner Corporation At its core, an Accountable Care Organization (ACO) is a network of healthcare providers with shared financial responsibility for providing high-quality, coordinated care to a member population. Employers have a defined member population (their employees), and they hold some level of financial responsibility for the health of their employees. However, aside from healthcare organizations like hospitals, not many employers have the resources to close the loop by providing healthcare to their employees. That is changing. As a direct response to increasing health care costs and changing healthcare policy, United States employers are taking a more active role in their employees’ healthcare. Employers are implementing worksite wellness programs, onsite clinics and are directly contracting to provide value-based care to their workforces. They are, in effect, developing their own ACOs. Many employer-based ACOs are decreasing health care costs and improving the quality of care received by their employees by employing a data-driven, systematic approach to managing the health of their populations. Worksite Wellness One of the most common entry points for employers into direct healthcare engagement is through worksite wellness programs. Most worksite wellness programs consist of health risk assessments combined with biometric screening data to identify risks across a population. The wellness initiatives introduce health education, behavior modification programs, and changes to the physical environment to present more opportunities for making healthy decisions and to create a “culture of health.” The Affordable Care Act has created additional incentives for employers to implement and increase their investment in worksite wellness programs. A review of literature found workplace wellness programs decrease employer healthcare costs, including medical savings ranging from $11 to $626 per year.1 Healthcare providers are playing a larger role in these worksite wellness programs by providing the assessment and screening systems and staff, and by lending their healthcare brand to the worksite wellness program. This often times improves the employees’ trust and participation in the program. Onsite Clinics Worksite wellness programs have benefits, but they also fall short of being able to affect the experience and outcomes related to the delivery of care. Hence, many employers are investing directly in facilities to provide care for their employees and covered lives. Today, these clinics are being developed to provide primary care, as well as some specialized services. Toyota’s recent investment in a primary care onsite clinic at one of its US locations saw a 33 percent reduction in specialty care costs and a 16 percent reduction in its premium trend. The clinic is now saving the company $3 million per year in health care costs and will realize its return on investment in just two years. According to a 2012 survey of employers from the National Business Group on Health, 46 percent of large employers offered at least one Address correspondence to chad.greeno@cerner.com DCMS online . org

onsite clinic to their employees – nearly a 10 percent increase from 2011.2 Additionally, another 10 to 20 percent of large employers have plans to add clinics in the next two years.3 Healthcare providers who are developing clinic and staffing strategies are well-positioned to participate in these important new facets of employer-based ACOs. Direct Contracts Despite onsite clinics, a considerable amount of employer healthcare spending still happens in the community. In order to improve the value generated through those community healthcare interactions many employers are turning to direct contracts with providers. These contracts attempt to help shape the quality side of the value equation by establishing measures for member experience, process and outcomes. Some employers seek to establish value-based contracts with providers based on specialty services lines, while some larger employers are contracting directly for total healthcare services. Walmart and Lowe’s have a set of cardiac-specific programs with Cleveland Clinic, while healthcare technology company Cerner Corporation recently announced a first-of-its-kind maternity program for its employees in Kansas City.4,5 Intel is one of a handful of employers who have announced direct contracts with local health systems for narrow-network ACOs (Intel’s partnership with Presbyterian Healthcare Services is called “Connected Care”). A 2013 survey by Oliver Wyman Health & Life Sciences Practice of more than 1,300 employers revealed that nearly 40 percent of employers say they would be interested in contracting directly with provider organizations for a value-based network. Healthcare providers should view their local employers, regardless of size, as an aggregator of prospective patients who are looking for value-oriented relationships. Without willing partners in their communities, these employers are developing independent ACO-like initiatives to engage their employees not only in health, but also in care. Those employers who are demonstrating success in improving health outcomes and controlling costs are taking a systematic approach to managing the health of their populations, and represent a lower risk opportunity for healthcare providers to participate in an ACO arrangement. v

References: 1.

RAND Health. 2013. Workplace Wellness Programs Study. Retrieved December 2013, from DHHS, Office of the Assistant Secretary for Planning and Evaluation: http://aspe.hhs.gov/hsp/13/WorkplaceWellness/rpt_wellness.cfm

2.

Ferro,S. (2012, August 7). On-site healthcare a growing corporate trend. Retrieved on December 2013, from Treasury & Risk: http://www.treasuryandrisk.com/2012/08/07/on-site-healthcare-a-growing-corporate-trend?t=retirement-benefits

3.

Anderson,C. (2013, March 13). More large employers adding onsite health clinics. Retrieved on December 2013, from Healthcare Finance News: http://www.healthcarefinancenews.com/news/more-large-employers-adding-site-health-clinics

4.

Cleveland. (2012, October 11). Cleveland Clinic adds Walmart to Bundled Payment Program for Employees. Retrieved on December 2013, from Cleveland Clinic: http://my.clevelandclinic.org/media_relations/library/2012/2012-10-11cleveland-clinic-adds-walmart-to-bundled-payment-program-for-employees.aspx

5.

Cerner. (2013, October 2). Cerner to Offer New Maternity Benefit Program for Kansas City Associates. Retrieved on December 2013, from Cerner: http://www. cerner.com/Cerner_to_Offer_New_Maternity_Benefit_Program/

Northeast Florida Medicine Vol. 65, No. 1 2014 51


ACO Forum CME

The Role of the Patient Centered Medical Home and Ambulatory Intensive Care Unit in the Accountable Care Organization Background:

The Duval County Medical Society (DCMS) is proud to provide its members with free continuing medical education (CME) opportunities in subject areas mandated and suggested by the State of Florida Board of Medicine to obtain and retain medical licensure. The DCMS would like to thank the St. Vincent’s Healthcare Committee on CME for reviewing and accrediting this activity in compliance with the Accreditation Council on Continuing Medical Education (ACCME). This issue of Northeast Florida Medicine includes an article, “The Role of the Patient Centered Medical Home and Ambulatory Intensive Care Unit in the Accountable Care Organization” authored by Kenyatta Lee, M.D., which has been approved for .5 AMA PRA Category 1 credit.TM For a full description of CME requirements for Florida physicians, please visit www.dcmsonline.org.

Faculty/Credentials:

Kenyatta Lee, M.D., is the Assistant Dean of Medical Management and Metrics and Associate Medical Director at First Coast Advantages.

Objectives: 1.

Understand the history of Ambulatory Intensive Care Unit A-ICU.

2.

Review the data demonstrating the effectiveness of the A-ICU.

3.

Discuss the future of the A-ICU and role in the ACO.

Date of release: Feb. 1, 2014

Date Credit Expires: Expires: Feb. 1, 2016

Estimated Completion Time: 1/2 hr

How to Earn this CME Credit: 1.

Read the “The Role of the Patient Centered Medical Home and Ambulatory Intensive Care Unit in the Accountable Care Organization” article, complete posttest (page 55) and email your test to Patti Ruscito at patti@dcmsonline.org or 904.353.5848.

2.

Go to www.dcmsonline.org to read the article and take the CME test online.

3.

All non-members must submit payment for their CME before their test can be graded.

CME Credit Eligibility:

A minimum passing grade of 70% must be achieved. Only one re-take opportunity will be granted. A certificate of credit/completion will be emailed within four to six weeks of submission. If you have any questions, please contact Patti Ruscito at 904.355.6561 or patti@dcmsonline.org.

Faculty Disclosure:

Kenyatta Lee, M.D., reports no significant relations to disclose, financial or otherwise with any commercial supporter or product manufacturer associated with this activity.

Disclosure of Conflicts of Interest:

St. Vincent’s Healthcare (SVHC) requires speakers, faculty, CME Committee and other individuals who are in a position to control the content of this educations activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity. All identified conflicts of interest are thoroughly evaluated by SVHC for fair balance, scientific objectivity of studies mentioned in the presentation and educational materials used as basis for content, and appropriateness of patient care recommendations.

Joint Sponsorship Accreditation Statement

This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of St. Vincent’s Healthcare and the Duval County Medical Society. St. Vincent’s Healthcare designates this educational activity for a maximum of 1 AMA PRA Category 1 credit.TM Physicians should only claim credit commensurate with the extent of their participation in the activity.

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ACO Forum CME

The Role of the Patient Centered Medical Home and Ambulatory Intensive Care Unit in the Accountable Care Organization Kenyatta Lee, MD

Assistant Dean of Medical Management and Metrics and the Associate Medical Director at First Coast Advantage

According to Medicare, Accountable Care Organizations (ACOs) are groups of doctors, hospitals and other health care providers who come together voluntarily to give coordinated high quality care to their Medicare patients. The goal of coordinated care is to ensure that patients, especially the chronically ill, get the right care at the right time, while avoiding unnecessary duplication of services and preventing medical errors. The Patient Centered Medical Home (PCMH) has been described as central to ACO functionality because of its demonstrated ability to improve quality and lower the cost of care for patients particularly those with chronic disease. The PCMH model has been in the literature for more than 40 years and promotes the Evidence Based Management of the Ambulatory Practice. The key components of medical homes are improved access, registries, care management, self-management support, referral tracking and continuous quality improvement. Groups that decide to move forward with participation in an ACO will have to develop robust and dynamic medical homes. The reality, however, is that the medical home model is a significant departure from the current ambulatory model because its focus is value and not volume. Value is described as

Address correspondence to kenyatta.lee@jax.ufl.edu

DCMS online . org

quality per unit of cost. Our definition of quality is borrowed directly from the (Institute of Organization Managementâ&#x20AC;&#x2122;s (IOM) six domains of quality. To be successful at value management, practices within an ACO model will have to make the transition from feeders to facilitators of improved quality at lower cost. Consistent with complexity theory, this transition can take some practices two to three years of rigorous and deep practice transformations under the best of circumstances. Most ACO failures occur because they underestimated the time and complexity associated with transformation of volume based practices into well-integrated value producing practices. This underestimation is exacerbated by the fact that many ACO contracts require that the ACO demonstrate measurable savings within the first year. To overcome this challenge many health systems have developed Ambulatory Intensive Care Units (A-ICU) within the ambulatory network. The A-ICU is a model that was developed as a physical location that concentrates resources in one location. The A-ICU leverages the Pareto principle which states that 20 percent of the patients generate 80 percent of the utilization. The A-ICU works centrally as a hub of the larger PCMH network to provide care for this 20 percent. In this location patients are given full access to providers, social workers and clinical pharmacist that work closely with each patient to decrease emergency room and hospital utilization. v

Northeast Florida Medicine Vol. 65, No. 1 2014 53


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ACO Forum CME

CME Questions & Answers (circle one answer)/Free to DCMS Members/$50.00 charge non-members* (Return by February 1, 2016 by FAX: 904-353-5848, by mail: 1301 Riverplace Blvd. Suite 1638, Jacksonville, FL 32207 or online: www.dcmsonline.org.)

Getting Started in an ACO (page 45) 1. What are the typical costs involved in starting an ACO? a. Executive leadership and staff salaries, software, analytics, data management, care coordination, and business administration of the ACO. b. Costs to start up are based on the number of participants in the ACO, and increase as additional participants join. c. There is minimal cost to start an ACO, as shared savings are paid up-front, and prior to the reporting period. 2. How do hospitals affect cost savings in the MSSP? a. Hospitals share in cost savings efforts, and discourage use of hospital admissions for PCP patients. b. Hospitals incent ACOs to use their facilities in the form of kick-backs and bribes, so participants are not concerned with Medicare savings. c. ER visits and hospital services tend have higher overall costs compared to other care settings, and can hinder the cost savings for the ACO. 3. How do data analytics affect participants in managing medical costs? a. Electronic Health Records provide enough information about how to treat individual patients, and each participant makes their own decisions about care spending. b. Having data identifying where spending is high can direct the ACO into actions that will have the most impact. Programs that lead practices to make minor changes can have major impacts on cost savings. c. Participants who are creating the highest cost per patient need to be identified by the data analytics so they can be expelled from the ACO.

The Pioneer ACO in North Florida (page 47) 4. Approximately what percentage of healthcare dollars is considered wasted by the current inefficient system? a. 10% -20% b. 30% -50% c. 25% - 30% d. 5% - 10% 5. What activities are NOT necessary for survival in a Value-Based payment system? a. Care Coordination b. Meeting Quality Measures c. Engaging Patients in their own healthcare d. Duplicating Procedures 6. In a Medicare Shared Savings ACO model, physicians are exclusively paid Fee-For-Service for the services they provide to patients throughout the year. a. True b. False Integrated Health Systems (page 49) 7. All of the following apply to the current U.S. Healthcare system except for: a. Consolidation b. Integration c. Move to value based models d. Not changing 8. Patient Centered Medical Homes are physician directed. a. True b. False 9. ACOs value cost over quality. a. True b. False Employer-based ACOs (page 51) 10. Employers are using which of the following strategies to create their own accountable care organizations: a. Worksite wellness programs b. Onsite clinics c. Direct provider contracts d. All of the above

11. Employers are seeking value-based contracts with providers for service lines and total healthcare services. A cornerstone of these value based contracts is defined a. Hours of operation b. Quality measures c. Staffing ratios d. Provider lab coat color 12. Employer investment in onsite clinics is projected to ___________ in the next two years a. Double b. Increase 10 to 20 percent c. Increase 40 percent d. Decrease five percent Roles in ACOs (page 53) 13. The goal of coordinated care is to ensure that patients, especially the chronically ill, get the right care at the right time, while avoiding unnecessary duplication of services and preventing medical errors. a. True b. False 14. The medical home model is primarily based on the current ambulatory model. a. True b. False 15. To be successful at value management, practices within an ACO model will have to make the transition from feeders to facilitators of improved quality at lower cost. a. True b. False 16. The A-ICU leverages the Pareto principle which states that 20 percent of the patients generate 80 percent of the utilization. a. True b. False

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Evaluation questions & CME Credit Information (Please evaluate this article. Circle one number using this scale: 1= Strongly Agree to 5= Strongly Disagree) The articles met the stated objectives: 1 2 3 4 5 The articles were appropriate to my practice: 1 2 3 4 5 The topics were current and well presented: 1 2 3 4 5 Comments:   Name (Print) Email  Address/City/State/Zip  Phone Fax

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Northeast Florida Medicine Vol. 65, No. 1 2014 55


Philip H. Gilbert Invited Editorial

Wake Up Call: How I Began My Leadership Journey Meridith Farrow, MD 2013 Philip H. Gilbert Young Physician Leadership Award Recipient For the years after medical school I was primarily concerned with learning obstetrics and gynecology. I think all physicians can relate to the grueling hours of work followed by study followed by testing…and then repeat. Then you graduate from residency and try to keep your head above water while practicing medicine on your own for the first time. This is followed by taking written boards and, before you know it, preparing for oral boards in some cases. I put almost all of my attention into training to become the best obstetrician gynecologist I could be without paying much attention to what was happening to the profession that I had worked so hard to be a part of. I had a wake-up call the year after I passed my oral boards which changed all of that, and it occurred at a Florida Medical Association (FMA) meeting. Unfortunately, I don’t think I am alone in my seeming lack of concern for the future of our profession, particularly among young physicians. My wake-up call occurred while attending a practice management course at an FMA meeting. The last portion of the course consisted of a review of the newly passed Accountable Care Act by an attorney from the University of Miami. He started his talk by pointing out that only about 17 percent of physicians (at that time) belong to the American Medical Association (AMA), our primary lobby. He then asked the group, “How many lawyers belong to and contribute to their lobby?” I was assuming their participation to be higher than ours, but not to be essentially 100 percent! Their lobby is called The Bar Association. Every lawyer is automatically enrolled in the bar association for a year the first time they pass a bar. I was quite taken aback. Furthermore, I was informed that there are 55 lawyers in the Senate and 156 in the House while only 17 physicians serve in the House and two in the Senate. How could I not have known this? Again I plead the intensity of medical school, residency and board training. As the leader of the class proceeded to outline the basics of the Accountable Care Act, my heart sunk. But I had to think, there is no one to blame but myself. I have rested comfortably in the cushion of a career that was made spiritually and financially rewarding by the physicians that came before me. My next thought…what can I do? Where do I start? I was already a member of the Duval County Medical Society, but not an active one…the same for my specialty board. I looked around me for the remainder of the meeting and noticed how few young physicians there were at the meeting and in the House of Delegates. I decided to make my participation in organized medicine a priority, and

56 Vol. 65, No. 1 2014

Northeast Florida Medicine

Immediate Past President Dr. Eli Lerner presents Dr. Meridith Farrow with the 2013 Philip H. Gilbert Young Physician Leadership Award.

to become more educated and involved in the legislative process. Physicians have been community leaders for many years, and have put their patients’ lives ahead of their own for many more. The worries that face us now on a national level are serious, but not insurmountable. The Native American Chief Tecumseh said “a single twig breaks, but the bundle of twigs is strong.” I believe that organized medicine provides us this strength in numbers, and I plan to support it and the cause of physicians until I have attended as many DCMS and FMA meetings and affected as much positive change as Dr. Jerry Scheibeler! v

DCMS online . org


Residents’ Corner: St. Vincent’s

St. Vincent’s Medical Center We are creating folders containing patients’ health information, including their medications, diagnoses, surgeries, and allergies. We are also including blood glucose and blood pressure logs in these packets. Randomly selected diabetic patients are being given these documents, and they are being surveyed with regard to their knowledge of their own diagnoses, medications, and health goals (like A1c). After several months, we will re-survey these patients and see if their knowledge has improved. Also, we are comparing these patients to a control group, and analyzing for differences in improvement of A1c and blood pressure. - Kyle Contini, MD PGY2 Drs. Jessica McCain, MD (PGY2) and Sally Tran, MD (PGY1) are recognizing that as primary care providers they can directly combat the pediatric population’s most common disease, dental cavities. As part of their scholarly project, they plan to educate staff and parents about preventative measures, and institute Fluoride Varnish treatments as a valuable service provided during the routine Well Child visit. Our faculty pediatrician, John W. Waidner MD joined the program 5 years ago after a 10 year stay in private practice here in Jacksonville. He currently serves as the Chief of Pediatrics at St. Vincent’s Riverside Campus. He and various colleagues recently completed the University of Florida/AAP Pediatric Medical Home Demonstration project. We were the only practice in NE FL that was represented throughout the project and it has brought improvements to our practice including the implementation of routine standardized tools for developmental screening and tools to more objectively assess asthma control in pediatric patients. He is involved with several ongoing projects including improved pediatric dental health, obesity screening and intervention, and an active study on the timing of newborn circumcision and its effects on breastfeeding. Dr. Waidner serves on the Wolfson Children’s Hospital CME committee, the St. Vincent’s Medical Center CME Committee, the St. Vincent’s Medical Center Breast Feeding Task Force, and is the general pediatric representative on the State of Florida Newborn Screening Advisory Committee. v Jessica McCain, MD Family Medicine Resident St. Vincent’s Medical Center

2013 DCMS Foundation Donors Todd Sack, MD

James St. George, MD

Joe Ebbinghouse, MD

James Borland, MD

R. Jay Cummings, MD

Troy Guthrie, MD

Karen Ostergren, MD

Janet Betchkal, MD

James Townsend, MD

Marianne McEuen, MD

Jack Giddings, MD

Kenneth Horn, MD

J. Eugene Glenn, MD

Cesar Gorospe, MD

N. H. Tucker, MD

George Mayer, MD

J. Timothy Walsh, MD

Chalermchai Punya, MD

Jefferson Edwards, MD

H. Wade Barnes, MD

Allen Marks, MD

David Boyd, MD

DCMS online . org

Northeast Florida Medicine Vol. 65, No. 1 2014 57


Trends in Public Health

On the Horizon: Hopes and Dreams of Current Healthcare Paradigms Wells, Kelli MD; Konkwo, Ikechi MD; Lukens-Bull, Katryne, MPH and Remo, Radley, MPH Healthcare expenditures in the US continue to grow at an alarming rate. Currently, the bill is about $2.7 trillion, accounting for about 18 percent of the Gross Domestic Product (GDP) and expected to increase to 34 percent of the GDP by 2040. The per capita cost is about $8,680, twice the average of other developed countries and one half more than the next ranked developed country. In the U.S. we do have better cancer survival rates, but we have lower overall life expectancy in spite of the lofty expenditures. The consensus is that the current trends and the healthcare model that is driving it are definitely not sustainable. Let’s consider that healthcare model.

Table1: Emergency Room Visits for Ambulatory Care Sensitive Conditions (ASC) in Florida, 2011 (HCUPnet) First-listed diagnosis Total # category and name of Visits

Rate of Visits per Admitted to 100,000 persons hospital from ED

19,854

105.4

1,412 (7.11%)

Diabetes mellitus with complication

52,311

277.6

32,915 (62.92%)

Asthma

117,631

624.3

26,718 (22.71%)

Congestive Heart Failure

68,956

365.9

61,819 (89.65%)

Coronary Artery Disease

39,249

208.3

28,410 (72.38%)

COPD

133,524

708.6

Epilepsy/Grand Mal

71,469

379.3

Essential hypertension

61,701

327.4

Diabetes mellitus without complication

Hypertension with complications and secondary hypertension

21,040

Total

585,735

111.7

Table 2: Burden of readmissions for select ASCs in the US, 2011 (HCUPnet) Clinical Classification Asthma

14,718

$99,155,166

Hypertension with complications (not essential)

8511

$91,467,717

49,638 (37.18%)

Congestive

74,897

$943,851,994

19,047 (26.65%)

CAD

17,434

$315,904,080

7,803 ( 12.65%)

Diabetes

42,098

$384,017,956

16,167 (76.84%)

Epilepsy

10,505

$99,324,775

168,163

$1,933,721,688

Total 3,109

227,762 (38.9%)

The model that brought us thus far was based on a resource based relative value scale that essentially paid for healthcare by estimating the expertise, geographical location and risk (malpractice insurance) associated with the care. This led to a lot of variation in healthcare costs as regional preferences and laws (or law suits) affected healthcare delivery. In essence, medical specialists ruled the day and primary care became de-emphasized. The top-heavy healthcare system was born, with significant impact upon resident physician training preferences. Doctors with high student loans wanted lucrative practices, and hospitals, the typical site of specialist care, demanded more specialists. It is not all bad news; our vast consumption of hospital equipment has paid off with the best cancer outcomes among developed countries. Prevention services received only lip service. With a primary care workforce on the endangered species list, emergency care and hospitalizations ruled (see table1). With jammed emergency rooms and equally overflowing hospital wards, healthcare errors became rampant with abundant loss of life and limb. Readmissions within 30 days for the same principal diagnosis was a huge burden, especially for Medicaid/Medicare patients (see table 2). When last evaluated, there was an estimated 440,000 fatal errors every year in the U.S. (50deaths/hour!). Hospitals were recently dubbed the most dangerous place on earth. The Institute of Medicine has addressed the U.S. healthcare system with a series of landmark reports. The first of these was the now famous “To Err is Human” which highlighted the high cost of lives and money from healthcare errors. “Crossing the Quality Chasm” showed the huge disparity between healthcare spending and healthcare quality in the U.S. as compared with other countries with a recommendation to adopt IT, change payment models and emphasize quality of care through standardization. The recent series on “The Learning Healthcare System” seeks to develop a toolkit for utilizing best practices and Information Technology to hardwire already proven knowledge management practices into healthcare for process improvement. The result of these publications and the workshops that preceded them has been a shift away from volume based purchasing to the value-based 58 Vol. 65, No. 1 2014

Northeast Florida Medicine

Readmissions within 30 days Total costs of for same Principal Diagnosis readmissions

purchasing framework for healthcare reimbursements. With this shift in emphasis from procedures and gross resources to outcomes and relative resource use, the Accountable Care payment platform has gathered momentum. The appropriate information technology infrastructure necessary for the depth of reporting that makes accountable care feasible has been encouraged by the ‘Meaningful Use’ program and the other ONC funded initiatives around interoperable health records and Health Information Exchanges. The environment of care has also seen significant changes away from the traditional physician/hospital centered practice to the still evolving “Patient-Centered Medical Homes”. Celebrating quality and cost-savings is now encouraged by transparent quality of care reporting and published patient-satisfaction surveys. The health insurance market place with published physician performance profile and patient satisfaction further constrains physicians to go the extra mile in actually studying the patients they serve to provide efficient, effective, equitable, safe and timely care in the spirit of the triple aim of health care: better health, better healthcare and lower costs. It is understandable that changes on these huge scales will take time and the concurrent happenings are causing some consternation, even outright bewilderment in the healthcare industry. Navigating these choppy waters will take a new kind of healthcare provider. The fact that quality of care is a team effort will require collaborative leadership skills in physicians and excellent team building in healthcare administrators. The patient’s total experience is flavored by a gamut of issues from the front desk to check out. Advocating for the patient is another, multifactorial new realm. For example, city transportation infrastructure affects no-show rates and compliance with referrals. Understanding why a particular subset of the patient population appears consistently below average in outcomes and how to affect that population will force every accountable health system to become a patient-centered outcomes research center to maximize reimbursements and reduce penalties or adverse ratings in the health plan market place. Progress toward the triple aim is slow, but utilization and outcomes data speaks to the value of our efforts. v DCMS online . org


Your Compassionate Guide leads to quality time.

®

Your patients have a guide to walk with, listen to and help them find quality time through all stages of advanced illness—Community Hospice of Northeast Florida. Ask us how we can help your patients find that quality time. Call Community Hospice today.

904.407.6500 • 866.253.6681 toll free • CommunityHospice.com Community Focused • Community Supported DCMS online . org Serving Baker, Clay, Duval, Nassau and St. Johns Northeast Florida Medicine Vol. 65, No. 1 counties since 1979

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Northeast Florida Medicine -Spring 2014 - Peripheral Arterial Disease  

Our Spring 2014 issue on Peripheral Arterial Disease & Limb Saving is guest edited by DCMS member Dr. Yazan Khatib. It offers several CME cr...

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