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FOCUS TOPIC CARDIOLOGY

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FEBRUARY 2020 / $5

CARDIOLOGY

ON ROUNDS

Birmingham Physician Develops Revolutionary Protective Device By ann B. DeBelliS

Interventional cardiology is ranked as the occupation with the highest level of radiation exposure in the world, with providers facing levels that are typically three times higher than those faced by workers in nuclear power plants. As a result, physicians and staff are required to wear lead aprons during surgical procedures, and while this equipment provides some protection, it has a number of drawbacks. “We wear lead aprons for radiation protection, but they only protect the areas of the body that are covered – namely the torso,” Robert Foster, MD said. “Our brains, our eyes, our arms and any uncovered parts of the body are not protected. I do a lot of peripheral work, and many of our cases can take several hours. As a result, our radiation exposure continues to climb.” In addition to potential health hazards that can result

Birmingham Heart Clinic Adopts Pedal First Approach to Arteriograms When performing an arteriogram for treating peripheral artery disease (PAD), the cardiologists at Birmingham Heart Clinic have adopted a “pedal first” approach, in which the pedal vessels are entered around the ankle ... 3

Easing the Suffering of Serious Illnesses For physicians who went into medicine to save lives and heal people, one of the greatest frustrations they face is when they run out of options for a patient’s cure. ... 9

(CONTINUED ON PAGE 10)

Tim Livingston (left) and Dr. Robert Foster pose with the Rampart IC.

Statewide Collaborative Works to Prevent Premature Births Alabama Third From Last in Premature Births

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By ann DeBelliS

dence of premature births.” The Alabama March of Dimes program is enAlabama has earned an “F” on the 2019 March gaged in advocacy work with several issues related of Dimes Report Card for its pre-term birth rate, to childbirth, such as improving workplace accoma key indicator of maternal and infant health. Alamodations for pregnant women, addressing the bama’s pre-term birth rate increased to 12.5 percent treatment of pregnant women in prison, and assurfrom 12 percent in 2018, ranking Alabama as the ing access to care. third-worst state in the country in this category of “This year, we want to make sure that the state maternal health. appropriately funds the Maternal Mortality Re“In an effort to lower our number of prema- Britta Cedergren, MPH, MPA view Committee,” Cedergren says. “The purpose ture births, we are looking for ways to mitigate of the committee is to determine the major conthe social impact of issues like structural racism,” says Britta tributing factors to maternal mortality by reviewing the case of Cedergren, MPH, MPA, the Alabama March of Dimes Dievery woman who dies within a year of pregnancy. Right now, rector for Maternal Child Health and Government Affairs. we don’t have an accurate count of these deaths or a way to “Poverty can also contribute to stress and increase the inci(CONTINUED ON PAGE 8)

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Birmingham Medical News


CARDIOLOGY

Birmingham Heart Clinic Adopts Pedal First Approach to Arteriograms By Marti Webb Slay

When performing an arteriogram for treating peripheral artery disease (PAD), the cardiologists at Birmingham Heart Clinic have adopted a “pedal first” approach, in which the pedal vessels are entered around the ankle. While this procedure is not unique in Birmingham, Robert H. Yoe, IV, MD, FACC, says that it is still relatively rare for cardiologists to adopt pedal access as the first choice. “This procedure is the radial equivalent of a heart cath,” he said. “It is easier for the patient when we enter pedal first because we can remove the access sheath immediately after the procedure and place a small sealing band around the ankle which results in less bleeding risk. And the patient can leave two to four hours after the procedure. “We have found the pedal access to be as effective as femoral access. Pretty much anything you can treat from the femoral area can be treated using pedal access. There aren’t long hospital trials yet, but everything is looking quite positive.” When BHC patients present with PAD symptoms, the physicians check the ankle-brachial index (ABI), which should be less than 0.9. “If it’s not normal, we typically follow that up with an arterial ultrasound, to look at the flow through the superficial femoral, and popliteal arteries. We can see if there are any abnormalities,” Yoe said. Yoe also performs peripheral angiograms with the pedal approach. “We insert a small catheter in the right radial wrist and a catheter in the aorta though an abdominal aortagram. We have found that the pictures we get from the radial angiogram are much clearer than with a computed tomography angiography or magnetic resonance angiography. We can use smaller amounts of contrast so we can see all the runoff vessels really well. “Most cardiologists would follow up at this point with femoral arterial access. That’s uncomfortable for patients because they have to lie flat for four to six hours after the procedure, but there’s also an increased risk for retroperitoneal

Robert Yoe, IV, MD in surgery.

bleeds. Through the medical literature, we discovered how much better radial access can be. We use ultrasound access to achieve pedal access. We take the images from the wrist. It allows us to do procedures more quickly, with less risk for bleeding, and patients can walk off the table and sit in a chair afterwards and leave the cath lab in one to two hours.”

In most cases, Yoe will get pictures in one procedure and schedule the arteriogram later. “We can show the patients the pictures before, show them where we will be entering in their ankle, and then pursue the case,” he said. While BHC is having success with arterial pedal intervention, Yoe points out that the first line of defense for treating PAD is getting a referral and diagnosis to begin with. “It’s amazing how many physicians don’t refer their patients with PAD or even check for it,” he said. “Once patients are in the critical limb ischemia territory, their mortality at one year is nearing 25 percent. That’s pretty high. Up to 50 percent of PAD patients don’t even know they have it. It’s really important to do an ABI on patients who have ever smoked cigarettes or are diabetics or are over the age of 50. If the ABI is less than 0.9, or if a pulse volume recording (measuring the pressure going through the limb) looks abnormal, they should be referred to a PAD special-

ist. Most of these patients have coronary artery disease as well. “We are pretty aggressive about treating patients with critical limb ischemia to prevent amputation. We are also aggressive about patients with claudication, using guideline directed medical therapy such as aspirin, statin therapy, and controlling blood sugars and blood pressure.” Yoe particularly emphasized the importance of exercise for these patients. “Exercise is critical. Even without treatment, it will help a lot if you get these patients on good guideline directed medical therapy and exercise them,” he said. He also stressed the importance of PAD specialists working with other physicians for patients who may be diabetic or who need wound care. “We are all one group working together,” he said. “It’s paramount that we restore the blood flow while other physicians are helping with wound care and the endocrinologist is helping control the diabetes. It’s all integrated.” Yoe said BHC is doing 80 percent of interventions pedal access first. Based on results in medical literature and his own experience, he estimates that within five years most cardiologists will have moved to this approach.

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FEBRUARY 2020 • 3


CARDIOLOGY

Enhanced Bioprinter Engineers Tissue to Prevent Heart Failure By Ann B. DeBellis

An innovative bioprinter designed by a University of Alabama at Birmingham student is speeding tissue engineering and the manufacturing of human tissue for organ regeneration and replacement. Wesley LaBarge, a fifth-year PhD student in the Biomedical Engineering Department, developed the idea of speeding computerWesley LaBarge controlled creation of human tissue. “Previously, commercial bioprinters could build tissue only one spheroid at a time. This system’s efficiency is 100 times greater,” LaBarge says. “The new bioprinter can pick up numerous spheroids at one time and place them simultaneously on a matrix of pins.” The bioprinting process uses 3D cell aggregates, called spheroids, and growth factors without the use of scaffold material to create structures that imitate natural tissues. The required cells, such

as kidney or skin cells, are taken from a patient and are cultivated to create stem cells specific to the patient. These stem cells are then used to make the spheroids which are loaded into the printer. Printed onto the pins a full layer at a time, the spheroids fuse together until there is a single tissue layer. The bioprinter is designed to build multiple layers of engineered tissue, depending on the desired dimensions needed. “This scaffoldfree bioprinter is unique and can print large tissues,” says Jianyi “Jay” Zhang, MD, PhD, Chair of Jianyi “Jay” Zhang, MD, PhD the UAB Department of Biomedical Engineering, lead researcher and a corresponding author. “We will be able to build larger and more precise tissues more quickly with this method. We use the cell fusion feature where cells attach and fuse together. One cell becomes two, two cells become four and so forth, so we can have 100,000 cells fused to-

gether to fabricate or engineer the building blocks of the tissue.” Zhang’s lab research focuses on proteins and cardiac stem cells. Currently, the researchers are examining the mechanisms of congestive heart failure and the development of therapy to prevent it. “We don’t have good therapy to cure heart failure, but we can develop new approaches to prevent it from occurring,” Zhang says. “When a patient suffers a heart attack and we are able to save him, the patient can develop severe heart contractile dysfunction followed by heart failure, which is irreversible. Today, caring for patients with that condition costs a trillion dollars a year worldwide. We want to study the mechanisms of heart failure and find out why the heart muscle fails to pump and support needed oxygen for the human body.” The engineered tissues produced by the new bioprinter are being used in the lab to determine new techniques to help prevent heart failure. “We are using an engineered, functional myocardium to examine the mechanism of heart failure, and we are developing

technology to therapeutically treat and prevent heart failure,” Zhang says. “We have also used it to examine the disease further in hopes that we will discover a drug that can help these patients. That is one major direction of our lab.” Zhang and his team are collaborating with Auburn University to use a high-yield magnet to enable them to see the mechanics of a beating heart. “We also want to understand cardiac muscle cell proliferation,” Zhang says. “We want to examine why the myocyte muscle cells were not delivered to the organ system. We want to find the regulators that can turn off the muscle cell proliferation shortly after birth. If we succeed in finding these regulators, we can manipulate them to make the cells turn back the clock, reproduce and heal the damaged heart muscle.” Zhang says their goal is to fabricate a functional myocardium that runs completely by a computer so that there is no human error involved. “LaBarge and his team have completed the fabrication piece of this project,” Zhang says. “Now we have to make everything automatic.”

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CARDIOLOGY

In a Specialty of Mostly Men, Sarah Sandberg is Rare By Laura Freeman

When you look at the class picture from almost any medical school, you can see how far women have come as physicians. However, cardiology is one specialty where you rarely see a female doctor. This is especially true of electrophysiology. In welcoming Sarah Sandberg MD, FACC to Birmingham, Cardiovascular Associates and Brookwood Baptist Health are breaking that stereotype. “Cardiology is such an interesting area of medicine. I’m surprised there aren’t more women in the field,” Sandberg said. Sarah Sandberg MD, FACC “I was drawn to the specialty from the start, and thought I’d probably work in transplants. I hadn’t really considered electrophysiology until I had two female mentors who were electrophysiologists. Right away, I knew this was the field for me.

“One of the things I like best is that this is an area where it’s possible to actually cure a patient with one procedure. With a catheter ablation, I can eliminate a problem like supraventricular tachycardia so it doesn’t bother the patient anymore. Even though common conditions like atrial fibrillation may be more of a matter of treating rather than curing, we can make a real difference in the patient’s health and quality of life.” In some conditions, electrophysiologists can make a difference that is truly life saving. “Some patients are walking around with dangerous heart rhythms like ventricular fibrillation that put them at risk for sudden death,” Sandberg said. “This can happen even in young athletes. If we can detect the dangerous rhythm in time and intervene with a procedure and/or implantation of a defibrillator, we can give them an opportunity to live a longer, fuller life.” Electophysiologists work with the body’s electrical system, particularly the nerves in and around the heart that govern the rhythm of the pulse.

Using equipment attached to catheters threaded through the vascular system, they can correct a number of heart rhythm problems without leaving a scar and without the need for open heart surgery. A pulse through the catheter can eliminate a rogue nerve that is triggering a dangerously accelerated heart beat or a chaotic rhythm. Since Sandberg seems to be the first female electrophysiologist in Birmingham and perhaps the only one in Alabama, the question that comes to mind is whether there are differences in how women physicians might approach this work or their interactions with patients. “You might be able to generalize that some patients could find it more comfortable to deal with a physician of one or the other gender. However, each person is an individual. I can only say how I approach patient care,” Sandberg said. “Communicating with patients is very important for me. I also like to take the broader view of helping patients participate in improving the quality of their own health. I can help them with as a physician, and teach them how they can

help themselves with lifestyle changes like finding new ways to manage stress, eating better, becoming more active and stopping smoking. Sometimes it’s just a matter of educating them that it’s possible for them to take ownership of their own health and to show them how they can make it better.” After completing her studies in electrophysiology at Washington University in St. Louis, Sandberg worked in Missouri before coming to Birmingham in January. “This is a wonderful opportunity to work with a highly respected team of cardiologists,” she said. “It’s also good to be back in the South again. I grew up in the Carolinas, and my husband is looking forward to warmer weather this spring.” Whether she’s meeting with new patients at the Colonnade office of Cardiovascular Associates, or performing procedures at Brookwood Baptist Health or Grandview Medical Center, Sarah Sandberg, MD, is one of a kind— and an inspiring example of how women physicians are contributing to yet another field of medicine.

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Birmingham Medical News

FEBRUARY 2020 • 5


CARDIOLOGY

Ifetroban for Treating DMD-Associated Cardiomyopathy Cumberland Pharmaceuticals Gears up for Phase II Clinical Trial By CINDY SANDERS

Last fall, the U.S. Food and Drug Administration (FDA) announced $15 million in grant funding in support of 12 new clinical trials through the Orphan Products Clinical Trials Grant Program funded by Congress. The grants aim to determine the benefit of various treatment options for patients with rare diseases. Cumberland Pharmaceuticals, a Nashville-based specialty pharmaceutical company, received $1 million as one of the 12 recipients to help fund a new Phase II clinical trial studying the use of ifetroban to treat cardiomyopathy associated with Duchenne Muscular Dystrophy (DMD). Ifetroban is a potent antagonist of the thromboxane prostanoid (TP) receptor, which has various functions including smooth muscle contraction, platelet aggregation and inflammation. “It is not currently approved by the FDA but is a candidate for orphan drug status because DMD meets the U.S. definition of

a rare diseased,” explained Ines MaciasPerez, PhD, principal scientist for Cumberland Pharmaceuticals. She added the drug is being developed for several other indications recog- Ines Macias-Perez, nized as unmet mediPhD cal needs, as well. “We were studying it originally for pulmonary arterial hypertension, or PAH,” Macias-Perez continued, “and found ifetroban could prevent fibrosis in the heart.” That observation led the publicly traded company, which has successfully brought a number of other drugs to market to treat a range of unmet needs, to consider ifetroban as a possible therapy for DMD patients. Affecting one in 3,500 to 5,000 male children, DMD is a fatal neuromuscular disease caused by a genetic mutation preventing the body from producing dystrophin, which is

critical for muscles to function properly. Characterized by muscle weakness and the progressive loss of muscle, cardiomyopathy leading to arrhythmias and heart failure has emerged as the leading cause of death in DMD patients. “DMD is a devastating X-linked disease affecting primarily boys and leads to losing their ability to walk between ages eight and 12, respiratory failure and cardiomyopathy at any age, and inevitably premature death in their 20s or early 30s,” explained Macias-Perez. “Many other drug development efforts are focused on restoring dystrophin and prolonging ambulation. With no specific cardiac treatments to extend life, our study aims to address this unmet need using a new therapeutic strategy for patients with DMD.” Cumberland Pharmaceuticals is working in collaboration with scientists at Vanderbilt University Medical Center to evaluate ifetroban in mouse models of DMD. They believed TP signaling contributes to DMD-associated cardio-

myopathy since activation of TP could create fibrosis in the heart. Therefore, blocking TP signaling with ifetroban might decrease the cardiac fibrosis and dysfunction, thereby helping those with the disease live longer. Results of the preclinical studies affirmed those conclusions with all mice in the ifetroban arm surviving to the end of the study compared to 60 percent, 43 percent and 90 percent in the various mouse models treated with placebo. Additionally, TPr antagonism improved cardiac output in two models of severe DMD and increased ejection fraction while decreasing fibrosis in the third. The team from Vanderbilt, Cumberland Pharmaceuticals and Indiana University School of Medicine – where Larry Markham, MD, primary investigator on the ifetroban trial is located – recently published these successful results. “Antagonism of the Thromboxane-Prostanoid Receptor as a Potential Therapy for Cardiomyopathy of Muscu(CONTINUED ON PAGE 12)

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Birmingham Medical News


Is the CON Physician Office Exemption in Jeopardy? By Kelli Fleming

There is an ongoing discussion among healthcare provider associations regarding the appropriateness of the Physician Office Exemption (“POE”) under the Certificate of Need (“CON”) Program. For years, the State Health Planning and Development Agency (“SHPDA”), the state agency overseeing the CON process, has allowed for an exemption to CON review for services performed by a physician office meeting certain statutory requirements. In its current form, in order to take advantage of the POE, the following requirements must be satisfied: The services are provided, and related equipment used, exclusively by the physicians identified as owners or employees of the physicians’ practice for the care of their patients; The services are provided, and related equipment used, at the office of such physicians; All patient billings related to such services are through, or expressly on behalf of, the physicians’ practice; and The equipment is not used for inpa-

tient care, nor by, through, or on behalf of a healthcare facility. Over the past few years, the POE has been used more frequently by physician offices seeking Letters of Non-Reviewability confirming that the performance of interventional and therapeutic procedures within the office is not subject to CON review, as long as the above-stated requirements are satisfied. In September, by way of a letter to SHPDA, the Alabama Hospital Association (“AlaHA”) expressed concerns with physician offices utilizing the POE to perform interventional/therapeutic procedures within their offices. In its letter, AlaHA expressed concerns with patient safety and quality when such procedures are performed in a physician office, as opposed to a general acute care setting. According to AlaHA, the trend of requesting Letters of Non-Reviewability for interventional procedures performed within a physician office “blurs the lines between diagnostic procedures that can be safely performed within a physician’s office setting and more risk based interventional/therapeutic procedures that

originally could only be performed in a hospital setting.” In October, by way of a letter to SHPDA, the Medical Association of the State of Alabama (“MASA”), and 450 of its member physicians, filed a response to the concerns expressed by AlaHA in its September letter. MASA’s response noted that the POE needs no adjustment, as it is established statutory law. Further, MASA responded that the Alabama Board of Medical Examiners, the state physician licensing body, has the authority to address potential safety concerns for services offered in a physician office, not SHPDA. In response to these filings, SHPDA and the Certificate of Need Review Board (“CONRB”) requested an update on the discussions between AlaHA and MASA on the use of the POE for interventional/therapeutic procedures. Representatives from AlaHA and MASA appeared at a recent CONRB meeting to provide an update “for informational purposes only.” At the recent meeting, the CONRB expressed that it has become increasingly concerned by the intensity level

of care provided in physicians’ offices. Further, it has concerns that the Letter of Non-Reviewability process and the POE is being used in a manner not contemplated by the exemption. MASA and AlaHA were encouraged by the CONRB to come to a consensus on adding a patient safety/quality measure to the POE or to the applicable CON regulations.  However, as of the writing of this article, nothing has been agreed upon or formalized. Thus, for now, the POE remains intact, and no action has been taken with regard to the use of the POE for interventional/therapeutic procedures performed within a physician’s office. However, all physician practices currently providing services pursuant to the POE, or desiring to provide such services in the near future, should stay tuned. The recent actions may signal future regulatory action concerning the POE. Kelli Fleming is a Partner at Burr & Forman LLP practicing exclusively in the firm’s healthcare industry group.

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Statewide Collaborative Works to Prevent Premature Births, continued from page 1 determine the primary causes of death. We know that the health of a mother is vital to the health of a pregnancy, and we can’t improve outcomes for one without improving them for the other. We are trying to determine the biological factors that are causing these mothers to die. Is it hypertension or drug abuse? What are the bigger societal issues?” Cedergren represents the March of Dimes on the Alabama Perinatal Quality Collaborative, a group of health care representatives who are working to address the causes of pre-term birth rates and the high number of mother and child mortalities. Sara Mazzoni, MD, MPH, Associate Professor of Obstetrics and Gynecology at UAB, is the OB/GYN lead for the Perinatal Quality Collaborative. She was not surprised at Alabama’s failing report card. “In Alabama, access to medical care is a

big problem,” Mazzoni says. “We haven’t expanded Medicaid, and we have a huge number of women who are uninsured. These women don’t have access to contraception, which can Sara Mazzoni, MD, help delay pregnancy MPH until the woman is ready. And they aren’t able to access medical care to optimize health conditions such as diabetes and high blood pressure before becoming pregnant. So many women are entering pregnancy sooner than they might want and they are unhealthy. That presents a host of problems that usually lead to pre-term birth.” Mazzoni also believes racism is an issue. “Black women are more likely to have a pre-term birth than her white

r u o y s Doe tine Valen

counterparts,” she says. “Even a collegeeducated, wealthy black woman is more likely to have a pre-term birth than a white woman of lower socioeconomic status. We keep wringing our hands and saying we don’t know why, but we do. It’s racism. Regardless of the situation, being a black woman in the United States is stressful. “We need to provide these women access to health care. Medicaid expansion is the easiest, but no one wants to talk about that in Alabama because it has become a political issue instead of a health care issue. As long as we continue to value our politics more than we value our women and children, we will continue to fight about it. “Women need access to contraception. The Alabama Department of Public Health is doing a fabulous job in this area. They have expanded their family planning efforts, and Jefferson County is

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working hard on the issue too. If the state won’t expand Medicaid, these women need access to health care via health insurance somehow.” Donald Williamson, MD, president of the Alabama Hospital Association, is also a proponent of expanding Medicaid. “States that have expanded Medicaid have seen a statistically significant Donald Williamson, MD decline in infant mortality compared to the non-expansion states,” Williamson says. “For women who are currently in that inter-pregnancy gap without coverage, Medicaid would provide them with access to regular care to control their blood pressure and diabetes, and provide earlier diagnosis for these and other serious conditions. Expanding Medicaid is the foundational change we need in order to improve our bad outcomes. “And although there are up-front costs with Medicaid expansion, the taxes generated down the road from the two billion dollars of the new federal revenue and the state savings that will occur will provide significant revenue to offset those costs. “And we’ve never factored in the economic benefit of a healthy workforce. If we can provide care that helps to prevent delivering pre-term, underweight babies, then in the long run, we will have a much healthier work force.” The stakeholders of the Alabama Perinatal Collaborative are working together to address these problems. Sitting on the collaborative are members of the Alabama Hospital Association, Alabama Medicaid Agency, Alabama Department of Public Health, March of Dimes, and Blue Cross and Blue Shield along with neonatologists, general pediatricians and obstetricians. The group chooses quality initiative projects and works together to address state challenges. The Collaborative just completed a birth certificate data project and is launching a Maternal Hypertension project and a Neonatal Opioid Withdrawal Syndrome project. “Working on these programs has brought stakeholders together and has opened communication between all the players in the state,” Mazzoni says. The people involved in the initiative are excited to donate their time because they want to provide these women and children a chance for good medical care. “The United States is the only country in the world besides Sudan and Afghanistan where maternal mortality is rising,” Mazzoni says. “That’s embarrassing, and it’s time we consider how we value women and children and how we’re going to solve this problem. If we aren’t going to give women access to health care and give them the best opportunity to thrive before, during and after pregnancy, then we will continue to get an “F” and continue to watch women die in childbirth.”


Pathways Improve Patient Care while Increasing the Bottom Line for UCA By Marti Webb Slay

women,” said Cassidy Henningsen, female health navigator. “There is this train of thought that this is what happens as you get older. But it’s not true. There are treatments for OAB. It’s common, but it’s not normal.” The program maps treatment options and shows the patient what to expect upfront, so even if the first choice of treatment isn’t successful, patients know there will be other treatments to try. “The best thing about the pathway is it sets expectations. They know we are going to start with some medicine and exercise, but if those don’t work, they don’t have to get frustrated or give up,” Hen-

When Urology Centers of Alabama started a data analytics program last year, they discovered that over 50 percent of their overactive bladder (OAB) and benign prostatic hyperplasia (BPH) patients never showed back up for a second visit. That was clearly a problem, both from a patient care perspective as well as the practice’s bottom line. With this difficulty in mind, Urology Centers established patient care pathways and hired patient navigators to moni- Navigation team from left to right: Jessica Durrah (Prostate Cancer), Cassidy Henningsen (Female Health), Jason Biddy (CEO), Peyton Muskett (Data Analysis), and Jared Ball (BPH). tor patient compliance with those pathways. By all measures, the program has been a sucningsen said. even get it because it’s too expensive. And cess. New patients are entered into the if they didn’t make another appointment “The first treatment for OAB and program, and if they don’t return for before they leave the first time, there was BPH is usually medicine,” said Jason scheduled follow ups, the program alerts no follow up. They often think the sympBiddy, chief executive officer. “But paPeyton Muskett, the data analyst. She toms are just something they have to live tients may not take their medicine corthen sends the name to a navigator who with.” rectly, or long enough. Or they may not will call the patient. “I find that’s particularly true with

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“The pathway is like lines on the road,” Biddy said. “As long as the patient stays between the lines, they will not show up on a list. If they get outside of the lines -- they miss the first follow up, for instance -- they will show up on a list and our data analyst will send their file to a navigator for follow-up. It creates a uniform approach to make sure every patient is getting the appropriate follow-up care.” Henningsen said most patients come as the result of referrals from other physicians, and they have usually tried one medicine already, which is not working. After they see a specialist in the practice, she will call the patient in a week or two to go over a questionnaire and see how they are doing. In addition to assessing the effectiveness of the medicine, she will ask about side effects. “There are a shocking number of patients who won’t say anything about the side effects of medicine,” she said. “They just deal with it. But this is about quality of life, and we want the patients to be able to do whatever they want to do. I act as an advocate for my patients. They can ask me questions they may be embarrassed to ask the doctor. If I don’t (CONTINUED ON PAGE 10)

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Birmingham Physician Develops Revolutionary Device, continued fom page 1

from radiation exposure, providers are also prone to spinal issues because of the weight of the lead aprons. Statistics from the Society of Cardiac Angiography Intervention show that when providers work in a catheterization lab for more than 20 years, approximately 60 percent begin to exhibit chronic spinal problems, resulting in the need to reduce case volumes or avoid the lab altogether. “The aprons weigh between 15 and 30 pounds. Everybody in the lab has to wear one,” Foster says. “For the first 15 years of my career, I was in the lab eight to 10 hours a day wearing about 20 to 30 pounds of lead. I ruptured the first disc in my spine when I was 45, and another disc ruptured five years ago in my early 50s. The second rupture caused paralysis in my leg which resulted in a second surgery. I swore I would never wear a lead apron again.” So Foster, a cardiologist at St. Vincent’s East, decided to find a solution. In 2014, he met with several local engineers and together they came up with a revolutionary device that protects providers from radiation without the heavy aprons. They named it the Rampart IC M1128 because a rampart is a barrier that protects a community, thus reducing the need to wear body armor, and M1128 comes from the Bible verse, Matthew 11:28 – ‘Come to me all who are weary and heavy burdened and I

will give you rest.’ Tom Livingston, president and COO of Rampart IC, is Foster’s partner in the design and an engineer himself. “The Rampart IC is sophisticated but simple. The solution was to transfer the weight of the protection to a support structure and the floor,” Livingston says. “The difficulty was engineering a device that is configurable to the many procedures these physicians do and allowing multiple access sites to the body.” The Rampart IC is made of clear, lead-infused acrylic panels that block the radiation from reaching the operator. Physicians and technicians are protected from radiation scatter behind the device. It has a mobile base that allows the device to be moved as needed. Because of this protection, interventionalists may be able to perform more procedures safely and with more comfort. “Our occupational risks are extremely high, but we are patient-focused and would place ourselves at risk in order to perform our skills in the cath lab,” Foster says. “The Rampart IC mitigates the orthopedic risk by reducing the need for heavy aprons. If we can reduce the spine issues caused by the weight on our shoulders, this will be a huge improvement to the cath lab environment for physicians and their teams. Also, it will allow us to help more patients and possibly extend our careers.

“I couldn’t have created this by myself. It involved some special people who have a lot of skill. I believe this product will change every lab in the world to the point where we will look back 10 years from now and say we can’t believe we wore 30 pounds of lead on our bodies.” Suzannah Campbell, President of St. Vincent’s East, praises the work of Foster and his colleagues in the development of

the device. “The safety of our patients is always a top priority and so is the safety of our providers,” she says. “We have received good feedback about the Rampart IC. The ease of use has had a positive impact on our physicians and radiology techs. I am excited for Dr. Foster and our team.” For more information, visit RampartIC. com.

Pathways Improve, continued from page 9 know the answer, I’ll find it out and get back with them. I’m not a doctor, so I talk about their condition and medications in layman’s terms.” Pathways have also been set up for prostate cancer patients. “That pathway is more complicated,” Biddy said. “But it shows a patient all the options available to them at the right time. At least they hear all the options as they progress through the different stages.” Muskett is the single data analyst for the practice and feeds information to four navigators, who can effectively serve 700 to 800 patients at a time. Biddy stresses the importance of using data to ensure patients don’t fall through the cracks. “Before we started analyzing data, our doctors thought we were doing follow-up well,” he said. “But doctors don’t always know the

quality of patient compliance. They didn’t notice how many patients fell off, because new ones came in, and they were still busy.” Now with the pathway program, UCA is seeing the metrics improve considerably. And while that’s good for their patients, it has also proven to be good for the bottom line. “When you look at the financial value of retaining those patients, the return on investment has been incredible,” Biddy said. While improvement to the bottom line is an important factor, it’s the improvement to patient care that is the ultimate reason UCA is satisfied with their move to patient pathways. Navigators are now seeing more referrals from patients as well as physicians, a sign that patients are satisfied with the quality of care they receive.

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Easing the Suffering of Serious Illnesses By Laura Freeman

For physicians who went into medicine to save lives and heal people, one of the greatest frustrations they face is when they run out of options for a patient’s cure. When everything that can be done has been done with medical and surgical interventions, it’s difficult to see your patients still suffering and their families struggling to cope. Fortunately, palliative care offers another pathway to help patients deal with life-threatening and life-altering conditions. “It’s about helping patients live a better quality of life when they are facing a serious illness,” Rodney Tucker, MD, director of UAB’s Center for Palliative and Supportive Care, said. “For 20 years our center has been building and refining a palliative care model that can help Rodney Tucker, MD ease suffering and reduce the stress for both patients and the people who love them.” Public perception sometimes confuses palliative care with hospice, but its purpose is helping patients live better

Hand in Paw therapy dog visits palliative patient.

while undergoing treatment for serious illnesses like cancer and heart disease, or dealing with painful chronic neuromuscular illnesses, HIV and other long term conditions that may go on for years. “Together, we work as a care team to aggressively manage distressing symptoms. That includes pain, anxiety, depression, as well as the stresses that can burden caregivers,” Tucker said. “Doctors, nurses, counselors, social workers,

physical and occupational therapists, and pastoral care providers come together to address the specific needs of each patient and the type of support that would be helpful to families. Caregivers also need care. Their role can be exhausting and can create both emotional and financial stress.” In a palliative care situation, the first step in helping is to understand the patient’s goals for care and to make sure

the family has been heard. It’s a time when important decisions are made, and the patient may need information and the perspective of experience to make the best decision for her circumstance. “Does the patient want to continue living in his home, and would house calls, a visiting nurse and other services like transportation and meal delivery be necessary to make that possible? Would moving to a retirement community or assisted living facility better fit the patient’s needs and how will they get their home ready for sale and manage the financial arrangements to make the transition? When is a nursing home necessary, and how do you know when it’s time to consider hospice care? Simply understanding the different levels of care can be difficult. It helps to have someone with experience who you can call on for answers,” Tucker said. Since its inception, the UAB Palliative and Supportive Care center has achieved remarkable results in improving and expanding its care model to help with issues ranging from helping patients with transportation to their appointments to using the arts to improve their quality of life. However, access to palliative care for Alabama as a whole is an issue that (CONTINUED ON PAGE 12)

Picture a world where underserved populations get the health care they need. At Wexford Health, we are always striving to achieve that world. As a leading provider of correctional care services, we understand the importance of proper medical and mental health treatment and how it can impact the health status of our patients. Making a difference in the lives of these patients is what our dedicated employees do every day. And you can do the same. We are now offering fulfilling opportunities for physicians and nurse practitioners across the State of Alabama. If you chose medicine because you want to help people change for the better, join our Wexford Health team today and grow with an industry leader where we are raising the standard of correctional medicine.

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Ifetroban for Treating DMD-Associated Cardiomyopathy, continued from page 6 lar Dystrophy” appeared in the December 2019 issue of the Journal of American Heart Association. Although the Phase II trial hasn’t yet begun recruiting, Macias-Perez said the first site at Children’s National in Washington, D.C., will begin this month. The plan, she continued, is to have six to nine sites across the country participate to quickly enroll 48 DMD patients. The boys in the study must be at least seven years old and have stable heart disease. Although this is the first ifetroban trial for DMD patients, Macias-Perez noted the safety profile of ifetroban is well established with more than two dozen clinical trials, including Cumberland Pharmaceutical’s ongoing trials in scleroderma and aspirin-exacerbated respiratory disease (AERD). “We worked with families, patient

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advocacy groups and caregivers to help us design a study that focuses most importantly on the patient and their families,” Macias-Perez said. For this reason, she continued, study participants only have to visit the clinician at least three times within a 12-month period to minimize the burden of travel. Additionally, a travel stipend will be provided for those traveling more than 50 miles to the clinical sites in an effort to keep participation from becoming a financial burden. “Cumberland also designed a new method of measuring ifetroban pharmacokinetics for the DMD trial using a finger-stick method that can be done at home. We were informed during the study design review process that traditional methods using multiple blood draws over 24 hours is a challenge for

DMD patients and their families,” said Macias-Perez. “The patient families also told us that having the option of continuing on ifetroban after completing the trial is important to them when considering participation on a clinical trial. We changed our protocol to include an optional, open-label extension for all patients that complete the initial 12 months of treatment. “Incorporating patient feedback into our DMD trial design has added greater value and meaning. We are so grateful to our DMD community for their support of our clinical trial,” she added. “This new program is an excellent strategic fit for our company given our mission to develop new medicines that address unmet medical needs,” said Cumberland Pharmaceuticals CEO A.J.

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Easing the Suffering of Serious Illnesses, continued from page 11

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Kazimi. “As ifetroban may uniquely address the heart failure associated with this deadly disease, we very much appreciate the FDA grant support of our novel treatment for these A.J. Kazimi critically ill patients.” He added, “The FDA’s involvement through the Orphan Drug Grant is the first time they have gotten involved with DMD from a financial support standpoint.” Kazimi said it is exciting the FDA believed this was the right program, the right product and the right clinical sites to move forward.

Opening this

Month

has been in the news. The state recently scored a D on an access report. “Part of this was the math and how the scoring was calculated,” Tucker said. “Alabama has quite a few small hospitals, under 50 beds, that aren’t large enough to offer a palliative care program. But it is true that there is a real problem in access to palliative care, especially in rural counties. In light of this, we’re working with county nurses in health departments using telemedicine to bring palliative care to patients.” Tucker and the center also advocate for legislation to expand education, training and research to make palliative care more widely available. “A bill for creating centers of excellence for training and research in palliative care has passed the House of Representatives and is now in a Senate committee with bipartisan support,” Tucker said. “We hope to see passage of that bill soon.” The center is also gearing up to begin a new training program for physicians to assist them in communicating with patients who are experiencing serious health challenges. “In these conversations, there are three essential questions doctors need to ask,” Tucker said. “What matters most, what gives you strength, and who speaks for you?”

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What You Need to Know About Selling Your Practice to Private Equity By

DeniSe BurKe anD DaViD MarKS

Physicians across specialties are facing mounting legal and operational risks at the same time as health systems and private equity (PE) investors are hungry to buy practices and take that risk off physicians’ hands – at unprecedented valuations. Forwardthinking physicians see the unique opportunity presented by this market, and many are investigating the possibility of selling to private equity firms or health systems. But, while most physicians have a relatively good understanding of what it would be like to work for a hospital, arrangements with PE investors often remain more of a mystery. Those considering the possibility of selling to private equity need to understand its history, the current market and what to do next. What is Private Equity? Private equity firms pool money from high net worth individuals, pension funds, institutional investors and other accredited investors into funds which then invest in privately held businesses. PE firms often field teams of experienced analysts and operators who will advise the companies they own in order to grow and then sell the company

in three to seven years. Because the PE fund must eventually liquidate and return capital to its investors, it is essential to understand each PE fund’s investment horizon, which can affect whether they view a particular transaction as a short-term or long-term partnership with a business. What Might Your Deal Look Like? The structure of a PE deal can take various forms. Most states do not allow PE funds and other nonphysicians to own medical practices. As a result, the most common way a PE fund will invest in a practice is by forming a practice management company which will acquire the non-clinical assets of a seller (e.g., equipment and leases) in exchange for a purchase price and the agreement to lease those non-clinical assets back to the practice in exchange for a management fee. When considering one of these transactions, there are numerous factors you need to consider: • Will the selling physician be required to continue to own the medical practice? If so, what protection will be given to the seller from being named in malpractice or other lawsuits? • How long is the selling physician

required to continue working in the practice? Under what circumstances can he or she be terminated? • Will the seller have to agree to restrictive covenants such as a non-compete? How long will the non-compete last, and how broad will it be? What happens if things do not work out, and the seller is terminated? • How much cash will the physician receive at closing, as opposed to some period after closing? How certain is it that the selling physician will actually receive that cash? Who will keep the accounts receivable from work performed before the deal is finalized? • What are the tax consequences of the transaction to the seller? • Will the seller have an opportunity to invest alongside the PE fund in the management company? If so, what are the terms of the equity investment? • How much autonomy will the physician retain over decisions in their practice? Are there advisory committees to ensure that employed physicians’ voices are heard? How Might This Compare to a Hospital Deal? PE investors typically pay a higher

up-front price for physician practices than hospital systems, in part because PE investors are not subject to some of the laws that restrict hospital payments to referring physicians. In the current market, it is not uncommon to see practice valuations as high as 10 to 12 times EBITDA (Earnings Before Interest, Tax, Depreciation and Amortization) for larger group practices, although single-physician practices will rarely see multiples of EBITDA that high. Post-transaction, physicians should expect to receive compensation based on a percentage of their personal production and, often, a share of practice profits. Although their employment compensation will be less in the shortterm than what it was before the transaction, they will have received attractive up-front payments and, hopefully, an additional upside opportunity in the form of equity or bonuses. Because the goal of these transactions is to bring together PE investors’ business acumen in professionalizing and scaling the nonmedical functions of a platform (e.g., marketing, capital expenditures and buildouts, payor negotiations) with clinically talented physicians, the potential upside for both parties can be signifi(CONTINUED ON PAGE 16)

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The Endocrine Society is a global community of 18,000 researchers, physicians and healthcare professionals focused on advancing hormone science from bench to bedside. The Society supports and shares the work of an international coalition of basic and clinical scientists conducting research across the full spectrum of chemical signals, conditions and disease states tied to the endocrine system. In addition, the organization provides evidence-based practice guidelines, publishes major developments across a series of peerreviewed journals, advocates for public policy beneficial to patients and practitioners, and conducts public education and outreach through the Hormone Health Network. The annual ENDO conference brings together the full complement of members to discuss the latest new news and breakthroughs in the field. Robert W. Lash, MD, chief professional and clinical affairs officer for the Endocrine Society, recently sat down with Medical News to share what’s on tap for ENDO 2020 and other ways the Society supports researchers and works with providers. “The Endocrine Society over the Robert W. Lash, past century has had MD members who have won six Nobel Prizes. We have a strong history of basic science,” Lash noted. A general endocrinologist who spent two decades on faculty at the University of Michigan before accepting the newly created Endocrine Society staff position in 2017, Lash is responsible for leading major initiatives designed to accelerate scientific breakthrough, interacting with strategic partners and policymakers, communicating with the public and serving as a content expert. While diabetes and thyroid conditions tend to be the most recognizable endocrine conditions, he added the Society has expertise in research and practice from adrenal disease and bone health to obesity and transgender medicine. Taking the Message on the Road “One of our goals is for the next generation of basic scientists to feel as connected to the Endocrine Society as previous generations,” said Lash. To help build that relationship, staff and volunteer leadership have reached out to

share scientific insights and information on grant programs and meetings with scientists in the field. “We talk about how we can help them, particularly early in their careers, become successful basic science investigators,” Lash explained. Whether it’s young scientists or physicians, he continued, “We want to make sure our trainee members are prepared to make the transition to becoming independent practitioners.” ENDO 2020 The biggest ‘road show’ each year is the annual ENDO conference. This year, more than 9,500 attendees are expected to attend the March 28-31 meeting in San Francisco. Nearly 40 percent of those registered are international members with the balance coming from across the United States. “What’s always exciting about ENDO is it’s where the world comes to learn about the latest in endocrinology,” said Lash. “If you’re a scientist, it’s your chance to see the latest research being done by your colleagues. If you’re a clinician, you are going to hear about the latest clinical studies on endocrinology and sit down with the experts in the field.” Plenary sessions cover science, clinical application and societal implications of endocrinology. “This year two Nobel Laureates are coming,” Lash said of general sessions featuring Robert J. Lefkowitz, MD, of Duke and Brian K. Kobilka, MD, of Stanford discussing surface receptor signaling. Big data, genome vs. epigenome in cancer battles, bridging the translational divide, how the microbiome modulates metabolism, and new approaches to treating diabetes round out the 2020 plenary sessions. “Meet the Professor” breakout sessions take a deeper dive on 15-20 topics of interest. “We actually publish a book and videos of the Meet the Professor sessions,” Lash said of the recognition that there is broad interest in much more content than can be fit into an individual’s onsite schedule. To help navigate a packed agenda, he added ENDO 2020 also features pathways by topic of interest. “We’re also livestreaming sessions for the first time this year.” Lash added 2020 marks the 25th anniversary of the Society’s formalized commitment to diversity and inclusion and noted there is an exciting slate of pre-conference activities including an early career forum and a hands-on thyroid ultrasound workshop, among other offerings. (CONTINUED ON PAGE 16)


The Literary Examiner BY TERRI SCHLICHENMEYER

Delivered by Midwives: African American Midwifery in the Twentieth-Century South by Jenny M. Luke; c.2018, University Press of Mississippi; $30.00; 193 pages At the turn of the last century, if you were an African American woman who was pregnant, you might have struggled with more than just labor because white doctors didn’t to treat black patients if they didn’t want to. As a result, “many African American women in the Jim Crow South had no expectation of medical care for pregnancy and childbirth.” As Jenny Luke explains in Delivered by Midwives, just as their foremothers did when they were slaves, laboring African American women relied on “granny midwives” to “catch” their babies. Doing so was a natural conclu-

sion, says Luke, since both men and women in early black communities were “authorized to be healers,” which was “a power that the white medical establishment could not undermine.” What the white establishment could do, however, was to point out the high rate of maternal and infant death in black communities. Because of this, laws were enacted in the 1920s to regulate midwives of all races. Classes on hygiene and cleanliness were taught to help improve the health of the most poverty-

stricken mothers and their families, and joining a “midwife club” was mandatory. As World War II began, however, so did the perception that not calling a doctor for a baby’s birth indicated “an indifferent negligence toward” the child. Black mothers still reached out to midwives but it was increasingly becoming “a marker of status” and more “scientific” to have a hospital birth. By 1970, although “hospital care and medical expertise were not expectations of African Americans, nine out of ten Black women delivered their babies in hospitals. The tide is turning back again, says author Luke, but there are issues – specifically, educational requirements for professional midwives have become steeper, which can lead to questions of affordability. Still, in Delivered by Midwives, she shows a continued need for midwives, especially in poorer commu-

nities. Luke moves her history at a good pace before repetition forces everything to slow down, then it speeds up again, so things move quickly inside this book until then they don’t. We’re treated to painful, wincing tales of past midwives and what their patients endured, and those things might make you scream while you wait for relevant-but-scholarly information that slows the process down. It ends in a somewhat-frazzling whoosh. That doesn’t make this a bad book. It makes this informative and interesting, good for students and prospective midwives, but not a curl-up-by-the-fire something to read. Still, if it’s the kind of medical, African American, or feminist history you’re looking for, Delivered by Midwife is the total package. Terri Schlichenmeyer is a professional literary reviewer.

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What You Need to Know About Selling Your Practice, continued from page 13 cant. Over time, physicians in successful platforms may even see their employment compensation approach pretransaction levels – which is on top of their equity upside opportunity. In addition to more up-front money and long-term upside opportunity, in some cases, a private equity option may provide physicians more autonomy over the operation of their practice, with po-

tential opportunities to participate in physician committees or business development roles. With greater flexibility, PE platforms are often more receptive to creative ideas. Where Do You Go From Here? If you want to further explore a PE opportunity, start by building a team. Reach out to reputable investment

bankers and legal, tax and financial advisors with demonstrated experience handling private equity transactions in the healthcare space. Bankers and law firms, in particular, want to help sellers get ready ahead of time because it makes their own lives easier. They will often take calls and meetings offtheclock in exchange for the opportunity to work with those proceeding to a sale. Much like staging a house before a sale, an experienced deal team will help you put your best foot forward before you open the doors to potential bidders.

The opinions expressed in this article are intended for general guidance only. They are not intended as recommendations for specific situations. As always, readers should consult a qualified attorney for specific legal guidance. Denise Burke and David Marks are partners with Waller Lansden Dortch & Davis, LLP who provide legal counsel to the healthcare industry. They can be reached at denise.burke@ wallerlaw.com and david. marks@wallerlaw.com respectively.

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Available for Consult On the practice side, Lash said there are a number of endocrine diseases where other providers routinely refer patients to an endocrinologist, including those with thyroid cancer or pituitary and adrenal gland concerns. “Then there’s the part of endocrinology where other physicians often don’t refer and are probably right not to refer,” he continued of patients with well-managed type 2 diabetes or hypothyroidism. “Where it gets interesting is that gray zone. Who with diabetes really needs to see an endocrinologist? Who with thyroid disease might need to be referred? And that’s where I think endocrinologists and primary care physicians need to be talking to each other more,” he said. While most patients with type 1 diabetes will see an endocrinologist, Lash said those with type 2 who are not as easily controlled are good candidates, as well. When it becomes difficult to hit on the right combination of insulin alongside other medications … or when the diabetes conversation begins to eat up most of the appointment … Lash noted, “It might be time to refer to an endocrinologist, so as a primary care provider, you can focus on the whole patient.”

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Another area where providers might not immediately think to refer to an endocrinologist is with transgender patients. Yet, Lash said the Society has significant expertise in this growing field. “We have some of the best regarded guidelines on transgender medicine,” he stated, adding Society guidelines have already been translated into Spanish and are in the process of being translated into Mandarin and Portuguese. Providers in Vietnam have asked to translate the guidelines for use in their country, as well. Lash noted the Endocrine Society has held briefings with policymakers on Capitol Hill about gender-affirming care for transgender and gender incongruent individuals that is grounded in science and meant to dispel myths that persist in the public arena. “This is an area where we really believe we’ve been leaders. The Society’s resources are state-of-the-art, and our members who practice transgender medicine are really the leaders in the field,” he said. While diabetes plays a big role in the field, Lash pointed out the endocrine system impacts a wide range of conditions from cardiovascular health to fertility. Whether it’s cholesterol that’s unresponsive to medication or a newly diagnosed cancer patient trying to figure out how to achieve parenthood after treatment, Lash said endocrinologists welcome the opportunity to offer their expertise. “We look forward to helping our colleagues help patients live their best possible lives,” he said. “There’s never anything wrong with asking for help,” Lash concluded. “Medicine is practiced best when it’s practiced as a team, and endocrinologists really relish being part of that team.”

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Minimally Invasive Treatments for Varicose Veins By Charles Hunt II, MD, FACS, RVT

Varicose veins appear as bulging, enlarged, bumpy, purple veins. Symptoms can include restless legs, swelling, aches, and cramps. Varicose veins occur more frequently with age but anyone can get them at any time. The American Academy of Dermatology estimates that about 80 million people in the United States have leg vein problems. Several types of vein treatments can improve the health and appearance of damaged veins. These procedures offer minimally invasive alternatives to traditional vein surgery. Vein treatments deliver outcomes comparable to vein removal with less anesthesia, less surgical risk, and less downtime. You’ll get the best results from vein treatment when you work with a provider who has the skill to treat your varicose veins while avoiding damage to nearby healthy veins. The treatment you receive depends on considerations that include the condition of your varicose veins, your overall health, your tolerance of specific procedures, and your treatment goals. Here are some of the vein treatment options that my staff and I work with:

Sclerotherapy Cosmetic sclerotherapy involves the injection of a solution or sclerosant directly into the damaged vein. The solution irritates the lining of the vein, causing it to collapse and seal shut. The remaining dead vein dissolves in your body over time. This procedure treats smaller varicose veins and spider veins effectively. Ultrasound guided foam sclerotherapy works on the same principle as cosmetic sclerotherapy, but uses a thicker liquid that resembles shaving foam. When injected, the foam can be traced using an ultrasound scanner. Ultrasound helps to improve placement accuracy, which maximizes the foam’s effects. Endovenous laser thermal ablation Endovenous laser thermal ablation uses intense heat from a laser to cauterize, or burn, the varicose vein shut. The treatment delivers heat through a catheter to the damaged vein. The heat closes up the varicose vein, but leaves it in place to minimize bleeding and bruising. Microphlebectomy Microphlebectomy works on varicose veins that are too large for sclero-

therapy and too small for laser ablation. The process involves removal of the damaged vein through a tiny incision in your leg. The procedure requires little to no downtime, with no negative effect on your blood flow or circulation. It delivers immediate cosmetic improvement because it involves removal of the damaged vein. Veinwave™ Veinwave treats small veins in the face, ears, and nose. The procedure uses thermocoagulation to seal off the damaged vein with heat from radiofrequency waves. The radio waves are delivered through a pen-like needle placed directly onto the vein without penetrating it. Veinwave produces an instantaneous change, with the veins disappearing immediately. Varithena® Varithena delivers FDA-approved prescription microfoam through a catheter or by direct injection into the damaged vein. This option treats varicose veins caused by problems with the great saphenous vein (GSV), the longest vein in your body. Microfoam fills and expands in the targeted section of the vein causing

it to collapse. After treatment, the damaged vein shuts down and deactivates the microfoam. VenaSeal™ VenaSeal involves administering an adhesive to the varicose vein through a catheter. The treatment uses ultrasound guidance to place adhesive at specific points along the damaged vein. The adhesive closes off the damaged vein, which is left in place. You are mildly sedated during the procedure, without the need for anesthesia injections at the treatment site. Compression hose therapy Compression hose therapy uses a specially fitted hose to reduce the pooling of blood that causes varicose veins. This inexpensive, first-level therapy allows you to continue normal activities while receiving treatment. While compression hose can alleviate symptoms, they don’t improve the appearance of varicose veins. Charles Hunt II, MD, FACS, RVT practices with Alabama Vein & Restoration Medspa, located in Hoover with satellite offices in Oxford, Cullman, Prattville, and Tuscaloosa.

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FEBRUARY 2020 • 17


Treatment Options for a Meniscus Tear By DeWey JoneS, MD

I first want to understand the patient’s symptoms, and I look to see if the knee is locking, catching, or if it feels unstable. Meniscus tears that are unstable create these problems, which may indicate that more damage is being done to the articular cartilage in the rest of the knee. An additional concern here is that the knee could give way at a bad time, causing a fall or buckle leading to another injury. Be careful.

I have a meniscus tear, now what? Many patients who come to my clinic with an MRI that shows a meniscus tear are looking for advice on what to do next. Another physician may have told them that they need surgery because the MRI is abnormal. Some people just want another opinion. Not all meniscus tears need surgery.

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Should I have meniscus surgery? That depends. How much trouble are you having? How long has it been bothering you? What are your expectations? All of these are important questions to consider when deciding if a meniscus surgery is for you. Many tears are more subtle degenerative meniscus tears. These may not cause many symptoms other than a vague ache deep in the knee. There

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Helping patients focus on what really matters

may be a catching episode infrequently, but these patients are often functioning pretty well if they don’t have to bend or twist a lot. A lot of the ache in the knee may be from underlying arthritis in the knee too. This will not necessarily get better with arthroscopic meniscus surgery and you may need to consider other treatments such as visco-supplementation injections. While intra articular steroid injections have been the mainstay of pain-relieving treatments, our current research shows that steroids are not good for your cartilage and should be used sparingly. We now have multiple biologic injection therapies with promising results. However, many patients have so much arthritic loss of cartilage in addition to their meniscus tear that knee replacement may be the best definitive option. I like to review how long the symptoms have been present. While an acute sports injury may tear the meniscus and cause pain and swelling, if it is a small stable tear a trial of rest, ice, compression, and elevation may be the first thing to do. I think most patients should give these injuries a little time and possibly some rehabilitation or physical therapy to see how much trouble they will have. Certainly, if there are continued symptoms after a few weeks it may be necessary to proceed with surgery to get them back to their activities. Other patients may have had knee pain for months or years, but it doesn’t limit them other than once or twice a year. They probably have a degenerative meniscus tear and can be patient on deciding when to have surgery, waiting until the pain interferes with their activities on a more consistent basis. Lastly, I think having the right expectations about what surgery will do is most important. A well informed patient working with a surgeon who is willing to communicate goes a long way to getting a good result. Many patients want to have meniscus surgery and go back to their activities the day after surgery. Unfortunately, you can’t rush mother nature. It will usually take a couple of days of rest immediately after surgery, followed by a couple of weeks of soreness before everyday activities feel comfortable. Good rehabilitation with a therapist after surgery will also help to get them back faster. It may take several weeks to return to their sports or job if a lot of walking and activity are required. It may take longer if the meniscus is repaired. Dewey Jones, MD is an orthopaedic surgeon who practices at Southlake Orthopaedics Sports Medicine & Spine Center.


Microsoft Products End of Life – Just Around the Corner By Curtis Woods

By now you have probably heard this and read it a thousand times. But one last time, we will cover it with some background on the whys and how’s. What is this and what does end of life really mean? Microsoft Windows 7, Server 2008 R2, Exchange (email) 2010 and SQL (database) 2008 R2 will no longer be supported by Microsoft after January 14, 2020. Security patches and feature updates, as well as patches for flaws and bug fixes will no longer be available for these products. Why are they doing this? Like any other company that manufactures a product, processes, materials and better methods are introduced over time and then at some point, when it does not make financial sense to the company continue as-is, upgraded products are introduced. It is no different with Microsoft. It has become so expensive and time-consuming for them to maintain greater than 10 year old versions of their software, that it no longer

makes financial sense to support these, especially since Windows 10 has been out for over four years and the various server-based software upgrades have been upgraded several times since their original introduction. What can happen if I don’t get my computers and servers updated before January 15th? While it’s impossible to know what will happen, the last time Microsoft had a major end of life (Windows XP in 2014) it did not take long for hackers to exploit a vulnerability in Windows XP and released the WannaCry ransomware virus – one of the largest computer virus infections in the history of computing (It infected over 300,000 computers in over 150 countries). While this was a worst-case scenario it’s fair to state that every month that goes by after January, will be at higher risk. If your company has to maintain a regulatory protocol such as HIPAA for medical, PCI for anyone taking credit card payments, you will likely not be compliant once the products are past the end of life. Also, if you maintain Cyber insurance for your company, not having

your computers systems maintained will pose issues with coverage should something happen. What are my options? For Windows 7 there are a few – you can upgrade your existing computers to Windows 10 as long as they have sufficient memory and processor speed (most computers that are less than five years old do have the processor speed and memory upgrades are typically less than $75 each). If the computer does not meet these criteria it will be less expensive over a five year life to just replace them with Windows 10 computers. You can also sign up for Microsoft extended support (ESU) which will cost $50 per computer for the first year, $75 for the second year and $200 per computer for a third year, and all computers on the network must be signed up for the service. There will also be the additional cost of several hundred dollars of labor by an IT professional to set up the service. ESU will provide security updates, but only for those vulnerabilities marked as “very critical� by Microsoft. You may also need to provide a valid business reason to use this service such as an applica-

tion critical to the business that will not work with Windows 10. The options for the other products noted are very limited and for most of them upgrading is the only option. Summary Microsoft will continue to end life on products, typically within 10 years of the release date. As an example, Windows 10 will be end of life on October 14, 2025. A life cycle plan built into your budget every year will keep surprises for IT related expenses to a minimum. Work with your IT provider to develop this and keep your equipment and software applications as up to date as financially feasible, it may very well save you money long term. Curtis Woods is the President of Integrated Solutions.



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FEBRUARY 2020 • 19


Osteoporosis Prevention and Treatment By Holly Scott, CRNP

Breaking a bone is often the first sign of osteoporosis. Approximately one in two women, and up to one in four men age 50 and older will break a bone due to osteoporosis. Osteoporosis causes bone to become brittle and weak, which allows them to fracture with relatively low impact. We typically refer to an osteoporotic fracture as a fragility fracture. There are no clear physical signs of osteoporosis and you won’t feel your bones weakening. This is why it is referred to as a silent disease. Since Osteoporosis is a disease that can be prevented and treated, an early diagnosis can make

a difference. How is osteoporosis diagnosed? In the absence of a fragility fracture, a DEXA scan is the only test to diagnose osteoporosis. Guidelines for ordering DEXA scans vary from organization to organization, but in general postmenopausal women with risk factors for osteoporosis, and any woman over age 65 should obtain a DEXA scan. Recommendations for men rely on risk factors from age 50 to 69, or any man over age 70. Talking with your healthcare provider can help determine your risk factors for osteoporosis, as well as your risk for falls and fractures. Osteoporotic treatment doesn’t

have to wait until you break a bone. Even one fracture is too many. Fracture prevention is a large reason why we treat low bone density (osteopenia and osteoporosis). So, don’t wait until you break a bone to get treated. Be proactive with your bone health. It is never too late to take steps to protect your bones and prevent fractures. Holly Scott is a Nurse Practitioner with Alabama Bone and Joint Clinic. She is certified by the National Osteoporosis Foundation as a Fracture Liaison Service Coordinator. For more information on osteoporosis, fracture prevention and how our office can help, visit our website at www. alabamaboneandjoint.com or

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Two Procedures for Weight Loss By John L. Mathews II, DMD, MD, FACS

As 2020 approaches and people begin to contemplate their New Year’s resolutions, weight loss is often at the top of the list. There are two excellent options available for dramatic weight loss: the gastric bypass procedure and gastric sleeve procedure. Both procedures have been performed thousands of times, and their outcomes have been studied and their risk and benefits evaluated. While the American Diabetes Association has accepted the gastric bypass as the recommended treatment for the obese patient with type 2 diabetes, both procedures are extremely safe when compared to other commonly performed operations. The overall 30-day mortality rate is less than the laparoscopic gallbladder removal. Studies have shown weight loss at 18 months to be 60 to 70 percent with resolution of comorbidities to include hypertension, type 2 diabetes and sleep apnea approximately 60 to 80 percent of the time. Robotic gastric bypass and robotic sleeve gastrectomy are replacing laparoscopy and open procedures. The robot provides a stable platform with improved illumination and visualization. Improved instrumentation also facilitates the procedure, making it shorter with less movement of tissues. Sleeve gastrectomy typically can be performed in less than an hour and the gastric bypass in just over an hour, using the robotic approach, with typically an overnight stay in the hospital. Both procedures are usually covered by insurance, to include Medicare. John L. Mathews II, DMD, MD, FACS is a general surgeon who is Director of Bariatrics and Medical Staff President at Princeton Baptist Medical Center.

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GRAND ROUNDS

CON Approves Cullman Regional Expansion The Health Care Authority of Cullman County/ Cullman Regional Board of Directors announced today that the Alabama State Health Planning & Development Agency has approved the Certificate of Need (CON) for the $30 million expansion project announced by Cullman Regional in June of 2019. The expansion will increase the capacity of the Critical Care Unit (ICU) by 50 percent; increase the capacity of the Emergency Department by 50 percent; and reduce the usage of semi-private rooms throughout the facility. “We appreciate the Alabama Certificate of Need Board for their support of this project,” Board Chair Beth Anderson said. “Cullman Regional continues to see a growing number of patients through the Emergency Department. Last year, the ER provided care for nearly 50,000 patients in a facility built to care for 40,000 annually. Many of these patients are sicker and require a higher-level of care which is provided best in our critical care unit (ICU). Therefore, we need a solution that allows more critically-ill patients access to critical care beds more quickly.” The expansion plans include: • Increase the number of Critical Care Beds (CCU) from 12 to 18. • Expand the current Emergency Room Facility from 21 exam rooms and

3 behavioral health treatment rooms to 30 exam rooms and 8 behavioral health treatment rooms. • Create an Outpatient Behavioral Health Program. • Hospital-wide infrastructure upgrades to accommodate the additional capacity. “These upgrades are necessary in order for us to provide effective care for all our patients,” Cullman Regional CEO James Clements said. “Particularly the need for more effective treatment options for our behavioral health patients. We are eager to find a solution that provides long-term, sustainable care to them.” The infrastructure upgrade will include the expansion of the onsite power plant by approximately 1,100 square feet, replacement of the cooling towers, addition of two new chillers, addition of new elevator controls and modification of the remaining two service elevators to allow them to access all levels of the hospital. The board facilities committee anticipates construction will begin in the third quarter of 2020. Phase one of construction will include the expansion of the Emergency Department. Phase two will include infrastructure improvements and Phase three will be the addition of the critical care beds which will be a ground floor to fourth floor expansion of the west units of the current facility.

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Pictured with Dr. Russ Ronson, Chief of Staff (fourth from left), are the 2019 Melissa Cole Award recipients (left to right): Kim Lewis, Rachel Stamps, Rodney Jones, Katie Stewart and Julie Tidwell

Brookwood Baptist Medical Center Staff Honored The Medical Staff of Brookwood Baptist Medical Center recently honored five members of hospital staff with the distinguished Melissa Cole Award. The award, named in memory of beloved team member who personified dedication and compassion in her role as a Cardiac Intensive Care Unit nurse, is presented annually to nurses and staff who demonstrate the same outstanding qualities that defined Melissa’s career. This year’s recipients include: • Julie Tidwell, RN Inpatient Rehabilitation • Katie Stewart, RN Emergency Department • Rachel Stamps, RN Women’s Health • Rodney Jones, Technician Behavioral Health • Kim Lewis, Technician Main Operating Room “The professionalism, service, and compassion these team members exemplified over the past year is outstanding,” said Russ Ronson, MD, medical staff president. “I am very proud of the way they represent Brookwood Baptist Medical Center.”

Let Aspire’s resort-like atmosphere be a part of your rehab experience.

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Birmingham Medical News

FEBRUARY 2020 • 21


GRAND ROUNDS

RESEARCH NOTES

Carnel Joins Andrews Sports Medicine Charles T. Carnel, MD has joined Andrews Sports Medicine & Orthopaedic Center. Carnel is a nonsurgical spine physician who is board-certified in physical medicine and rehabilitation. He is fellowship-trained in interventional spine and Charles T. Carnel, MD musculoskeletal medicine. Carnel helps patients improve their quality of life through minimally-invasive procedures including X-ray guided spinal injections, nerve ablations, treatment of spinal fractures with kyphoplasty, as well as in-office musculoskeletal injections, which aim to increase function and reduce pain. A native of Cookeville, Tennessee, Carnel earned his bachelor’s degree in biology from East Tennessee State University, and then achieved his medical degree from the James H. Quillen College of Medicine in Johnson City, Tennessee. In 2006, Carnel moved to Birmingham for his residency training in physical medicine and rehabilitation at the University of Alabama at Birmingham, after which he completed an interventional spine and musculoskeletal medicine fellowship.

Carnel treats patients at Andrews Sports Medicine’s clinic locations at St. Vincent’s Birmingham and at St. Vincent’s One Nineteen.

Saag Named Editor of Journal of the International AIDS Society Michael Saag, MD, director of the UAB Center for AIDS Research and professor in the School of Medicine Division of Infectious Diseases, has been named an editor of the Journal of the International AIDS Society, also known as AIDS. “It is an honor to Michael Saag, MD serve as an editor of AIDS, as the journal is one of the most prestigious in the field and has been serving investigators and clinicians since 1987,” Saag said. “I look forward to continuing the outstanding service of editors before me.” As editor, Saag will help review advances in the field of HIV and AIDS research and treatment. In the past 30 years, he has published more than 260 articles in peer-reviewed journals and pioneered many trials for antiviral drugs now commonly used for HIV treatment, as well as founded UAB’s 1917 Clinic, among many other accomplishments.

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Mickey Trimm, PhD Joins Kolbe Clinic

J.M. “Mickey” Trimm, PhD has been named Executive Director of Kolbe Clinic. He will lead the clinic’s plan to expand its services from its current five locations in Alabama and Florida to a large footprint that will cover the south and midwest over the next J.M. “Mickey” Trimm, PhD five years. Kolbe Clinic provides a variety of treatment and recovery services for patients suffering from substance use disorder. It is one of Alabama’s premier providers of medication assisted treatments using suboxone and other medications coupled with counseling to address opioid, drug and alcohol problems. The clinic is also one of the few in Alabama that accepts all major insurance products. Trimm recently retired from the University of Alabama at Birmingham School of Health Professions where he served as Associate Professor and Director of the Center for Healthcare Management and Leadership. He has served the Alabama healthcare industry for over forty years, working initially with the Baptist Health System before starting TwoMark Healthcare Associates. TwoMark continues to help many communities plan and develop clinics and hospitals. In 2006 Trimm joined the staff of the UAB Department of Health Services Administration where he taught strategy, information technology, and operations management. He was also coordinator for the undergraduate Healthcare Management internship program and placed student in many of the healthcare facilities in the Birmingham area. In 2013 he took over the continuing education activities of the department, focusing on expanding the UAB Annual Symposium for Healthcare Executives, held in Destin each summer. Trimm is a board member of the Alabama State Health Coordinating Council. He also serves on the boards of the Alabama Healthcare Executive Forum, the Alabama Rural Health Association, the Alabama Performance Excellence Program, the Alabama Area Health Education Centers, and the Friends of the Birmingham Library.

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Dr. Emily Feely Dr. Emily Feely was born in south Alabama and graduated cum laude from The University of Alabama with a degree in biology in 1999. She received her medical degree at UAB before moving to North Carolina to complete both her internal medicine residency and nephrology fellowship at Wake Forest University. After finishing her medical training, Dr. Feely worked in private practice in Georgia for 7 years while also serving as Clinical Assistant Professor of Medicine for the Medical College of Georgia. In 2015, Dr. Feely moved to Birmingham and joined NaphCare as their corporate Nephrologist caring for incarcerated patients, and became their Chief Medical Officer in 2017. Dr. Feely joined Nephrology Associates in 2020. She is Board Certified in Nephrology and Internal Medicine and is certified by the American Society of Hypertension as a hypertension specialist.

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