CVI to Participate in Two New Clinical Studies

The Research Department at the Cardiovascular Institute will participate in two new national studies which will provide valuable information to validate or improve current treatment protocols.

The CHAMP-HF observational study will examine treatment of heart failure and will help physicians and researchers better understand how different medications affect patients with this condition. This study will enroll up to 5,000 patients across the U.S. who have been diagnosed with heart failure and have a reduced ejection fraction (LVEF < 40% within the last 12 months). Ejection fraction is a measurement physicians use to determine how well the heart is pumping out blood. Patients who qualify and agree to participate will be asked to fill out questionnaires during their usual health care provider visits that occur during the study period (up to two years). Participants will receive payment for their study related expenses and can change their mind to opt out of the study at any time.

The Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study (ARTEMIS) will assess the impact of copayment reduction by equalizing copayments for clopidogrel (Plavix) and tricagrelor (Brilinta). With financial factors removed from the equation, the ARTEMIS study will follow prescribing patterns, patient medication adherence and clinical outcomes for up to one year. This study is designed for patients 18 or older who have been hospitalized for heart attack (STEMI or NSTEMI) and treated with antiplatelet medications (P2Y12 receptor inhibitors). To qualify, patients must also carry US-based health coverage with prescription benefit. At enrollment, patients will receive a prescription voucher card to offset copayments for Plavix or Brilinta. The ARTEMIS study is a multicenter cluster-randomized trial, which means that that each participating site will be randomized as a control site or an interventional site. Sites in the interventional arm of the study will have the opportunity to offer enrolled patients the previously described voucher card to cover costs for the medications included in the study for 12 months following their discharge from the hospital for heart attack. Sites in the control arm will provide the usual standard of care.

Cardiologist Dr. Michael Morrow is the principal investigator at CVI for both of these studies however all CVI cardiologists can enroll patients. “We are grateful to have the opportunity to participate in this research,” says Dr. Morrow. “This gives us access to recent data collected from across the nation that can help us refine our treatment protocols and offer our patients the best, proven therapies currently available.”

 

New Technique Opens Hardened Coronary Arteries

The rotating Diamondback 360 device sands a tunnel through the calcified plaque lesion to restore blood flow.

Plaque build-up in the arteries, or atherosclerosis, is the cause of heart attack. This plaque is usually soft and pliable and a cardiologist uses a procedure called balloon angioplasty to push open the plaque build-up in narrowed arteries to restore blood flow. However, in up to 40 percent of patients who need this procedure, this plaque that has been building for a long time can become calcified or hardened where a standard balloon procedure is not effective. Fortunately, the FDA has approved a new technology to remove this hardened plaque called the Diamondback 360.

 

The Diamondback 360 is essentially an orbital sander literally coated with diamonds for an extra-fine grit to open hardened plaque build-up. Interventional cardiologist, Dr. Samir Patel, who was first to use the technology in the coronary arteries in our area says ” This technique has been successful for several years in treating the long, relatively straight blood vessels in the legs when calcified lesions are present, however this is the first device approved for use in the arteries around the heart.”

The tiny round device uses centrifugal force to sand away the calcification while the flexible, healthy tissue flexes away. As with any sanding process, particulates are produced, however these are far smaller than the blood cells and do not create any further blockages. Once the hardened plaque is removed, a stent can be placed to hold open the artery.

“Clinical trials of this device prior to FDA approval have shown it be highly safe and effective in treating patients with these very difficult coronary lesions,” says Dr. Patel. “At medical centers without advanced technology and techniques such as this for blocked and calcified arteries, these patients might not receive treatment other than medications. The blockage would remain and so would the symptoms that come with it such as chest pain and shortness of breath and leave the patient at increased risk of heart attack.”

Dr. Patel used the new coronary device for the first time in April at Bay Medical Sacred Heart, the only facility in our area offering this technology.  For a local news story with WMBB-News13 featuring Dr. Patel and an animated video of how the new technology works – click here.

New Study Compares Treatment Methods Among Patients with Carotid Disease

carotid-anatomy(copy)(copy)The Cardiovascular Institute of Northwest Florida (CVI) and Bay Medical Center have been selected as a site for a major national study comparing three treatment methods for patients with carotid disease. Only 120 medical centers will be participating in the study which is supported by the National Institute of Neurological Disorders and Stroke of the National Institute of Health.

Buildup of plaque occurs at the point where the carotid artery divides into the internal and external arteries. Patients with carotid artery disease may be at risk for stroke if debris from the plaque, or a clot, is dislodged from the carotid artery wall. As this material travels through blood vessels it can interrupt blood flow to the brain resulting in stroke. Stroke is the fifth most common cause of death in the United States and the leading cause of disability in adults.

The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Study (CREST-2) is seeking 2,480 participants in the United States and Canada and will compare intensive medical management to carotid artery stenting and carotid endarterectomy. To date, no research has been conducted to compare the treatment differences between medical management and these two procedures. CREST-2 is intended to compare these treatment options in patients without recent stroke and without stroke warning signs.

Physicians participating in the study include interventional cardiologists Amir Haghighat, M.D. and Samir Patel, M.D.; neurologist Hoda Elzawahry, M.D.; and vascular surgeon Patrick Tamim, M.D.

“Physicians want to identify the best way to prevent strokes in people who have a narrowing in their carotid artery,” says Dr. Haghighat. “CREST-2 is designed to compare three different methods of stroke prevention to find the safest and most effective treatment for patients with carotid artery narrowing.”

To qualify, participants must be at least 35 years old, have a significant narrowing of one carotid artery with at least seventy percent blockage, and have no history of stroke or transient ischemic attack (TIA) within the last 6 months.

The stroke prevention methods include intensive medical management or intensive medical management combined with carotid endarterectomy (en-dar-ter-EK-ta-mee) or carotid stenting. Carotid endarterectomy is an open surgery in which surgeons clean out and repair the carotid artery supplying blood to the brain. Carotid stenting is a procedure performed using a catheter where a metal device called a stent is navigated through your arteries and placed in the narrowed part of the carotid to cover the plaque and hold the vessel open. During this procedure, a small umbrella-like instrument called an embolic protection device is placed above the stent to catch any particles that might break away.

All study participants will receive intensive medical management to include lifestyle modifications and medications to prevent clot formation and to reduce blood pressure and bad (LDL) cholesterol. Of the participants selected for carotid revascularization, approximately half will receive cardiac endarterectomy and half a carotid stent.

“We are excited to be a part of this national research,” says Dr. Haghighat. “All of these methods have shown improvements over the years and a reduction in the risk of stroke. Comparing these options to each other in asymptomatic patients will help the medical community to further understand the best way to prevent stroke.”

 

Now Offering Treatment of Varicose Veins

varicose veinsThe Cardiovascular Institute is pleased to announce a new treatment program available in our main office for select patients with varicose veins. Dr. Amir Haghighat and Dr. Samir Patel are now using endovenous laser therapy, a minimally invasive alternative to traditional vein stripping, to treat these problem veins in our office allowing patients to return to normal activities the same day.

Varicose veins affect 15-25% of adults in the U.S. and about 50% of people over the age of 50. Common symptoms of varicose veins include aching pain, leg fatigue, and swelling. If left untreated, varicose veins can cause ulcerations which can be very difficult to treat. However, endovenous laser therapy, a relatively new treatment technology, can be performed with local anesthesia in less than an hour.

The procedure involves the insertion of an ultrasound-guided laser fiber directly into the problem vein. Laser energy heats the vein from within, causing it to shrink, collapse, and seal shut. Patients experience only minimal discomfort and are able to walk immediately following the procedure.

According to medical research, endovenous laser therapy is well-tolerated by patients with a 94.5% successful clinical outcome rate at five years following the procedure. While our office does not offer cosmetic vein procedures at this time, improved appearance of the leg is an additional positive outcome in patients with varicose veins.

“As a group of cardiologists who treat vascular disease throughout the body, adding endovenous laser therapy was the next logical step,” says Dr. Patel. “Since this condition impacts so many of our patients, we wanted to be able to provide a quick and relatively painless treatment option.”

 

Do You Have Varicose Veins?

If you are experiencing any of the following in your legs or ankles, talk with your cardiologist to see if you might be a candidate:

• Rope-like bulging just beneath the skin

• Swelling, itching or burning

• Pain and leg tiredness

• Throbbing or cramping at night

• A rash or sore

• Skin discoloration

• Restless leg syndrome

 

Is Your Heart Ready for the Holidays?

boston-market-thanksgiving-dinner-345

Study finds increase in Heart Failure hospitalizations immediately following major holidays.

Thanksgiving, Christmas, New Years. These events are filled with family, friends and lots of delicious food and drink. However according to a study published in the Journal of Cardiac Failure, these events are also associated with an increase in heart related hospitalizations – primarily among patients with heart failure. While the exact causes vary from patient to patient, the top two offenders are: 1.) overeating and increased sodium consumption; and 2.) postponing medical care. It’s understandable that no one wants to miss out on the fun, so we have some tips to help keep your heart healthy while you enjoy the holidays.

1.) Be Aware of Hidden Salt. This is especially important for patients with heart failure, however everyone, even those in perfect health, should be mindful of their sodium consumption. For example, many people do not realize how much sodium is in bread. Now think about what goes into America’s favorite holiday side dish – Stuffing (or Dressing). It’s essentially made of bread (2 oz of cornbread has 340 mg of sodium) and chicken broth (1 cup of broth has 860 mg of sodium), and later topped with gravy (1/4 cup of gravy has 290 mg of sodium). Some estimates come up with more than 5,000 mg of sodium in a typical Thanksgiving meal, more than twice the recommended daily allowance. And that doesn’t include breakfast that day or your late night turkey sandwich.

What Can You Do? With homemade dishes at holiday dinners you can’t read the labels, but you can be mindful of the ingredients. Simply substituting low sodium chicken broth which only has 70 mg of sodium per cup can make a big difference and you’ll find that if you use other seasonings, like sage for example, to give your dressing some flavor that no one will notice the difference. Use this strategy with your favorite casseroles as well. Or substitute steamed green beans and baked sweet potatoes with a sprinkle of cinnamon for some of the more caloric and sodium laden side dishes. Skip the dinner rolls, after all there is already bread on your plate in the dressing. The desserts are loaded with salt too. Pumpkin pie is usually the healthiest of the bunch. Make it healthier by skipping the crust.

2.) Portion Control. At holiday dinners there is so much good food to eat most of us tend to over load our plates making an unhealthy choice even worse when it’s supersized. And American dinner plates are larger than ever, averaging 11-12 inches in diameter. Fifty years ago the average plate was only nine inches. It’s no coincidence the average waist line was also a lot smaller then.

What Can You Do? Remember that you don’t have to fill your plate. It’s ok to have some empty space. If you don’t trust yourself to leave some empty space, eat off of a salad plate. Salad plates have also grown in size, many are nearly the size of an old school dinner plate. Speaking of salad, if that is the initial course of the meal or a veggie tray is available prior to the meal, enjoy plenty of veggies to fill your tummy so you are not so hungry when it’s time for the main course. Remember that you don’t have to eat it all now. You don’t even have to have a helping of everything that is served. Plan on left overs so you don’t have to miss out on anything. Continue to enjoy your holiday favorites in moderation for the next few days.

3.) Do Something With All Those Extra Calories. Another holiday tradition is to fall asleep after the big meal. The frenzy of activity leading up to the big meal and that big dose of tryptophan from the turkey might make it seem that a good nap is inevitable. But remember that the food we eat is fuel for our bodies. If we take in more fuel than we need, it has to be stored somewhere. Think belly, thighs, love handles.

What Can You Do? Start a new holiday tradition and take a family walk. We live in Florida after all so there is no snow or ice to keep us indoors. Look for leaves changing colors or Christmas lights. Enjoy a walk on the beach without all the spring and summer crowds. A nice long walk may not burn all those extra calories, but it will definitely help. As a bonus, you’re creating more fond family memories than you would if you were asleep on the couch. And when you eventually take that nap it will be much more gratifying.

4.) Be Mindful of Symptoms & Don’t Skip Medications. If you have a heart condition, the holidays are not the time to forget about it. After all, you’ll enjoy the holidays much more if you know you have many more of them to come. Even if that means taking the time to see your doctor when there are gatherings to attend, gifts to buy or cakes to be baked. Check your blood pressure at the grocery store and don’t just dismiss high blood pressure as holiday stress. If you have heart failure, don’t forget to weigh yourself everyday and don’t ignore any shortness of breath. Your daily schedule may be thrown off a bit by travel or family events, but keep your medications on track.

With these simple tips and using good common sense, you can hopefully avoid the most common heart health pitfalls that occur over the holidays.

The physicians and staff at Cardiovascular Institute wish you a healthy and joyous holiday season.

 

Cardiovascular Institute Offers Heart Failure Clinic

hrtflr-01Heart Failure is a chronic and progressive disease, but for patients who are willing to work closely with healthcare providers and manage their diet and exercise there can be improvement in heart function and quality of life. The Cardiovascular Institute developed a Heart Failure Clinic in the Fall of 2014 with the primary goal of helping our heart failure patients stay healthy and out of the hospital. Nurse Practitioner Karen Williams, who helped develop the program, says that she has seen marked improvement in our patients who participate fully, including increased activity levels and a reduction in hospitalizations.

The three main components of the Heart Failure clinic include Monitoring, Management and Education.

Heart Failure is caused by other conditions that have damaged the heart muscle, making it weak and unable to supply the body with sufficient blood and oxygen. In addition to monitoring the symptoms of heart failure for any changes, contributing conditions such as high blood pressure, coronary artery disease, and sleep apnea are treated in conjunction with each patient’s healthcare team.

Education plays a vital role in our Heart Failure Clinic. Patients are taught how to read food labels and plan meals that keep sodium intake in check and provide enough fluid but not too much. Excess sodium can cause fluid to back up in the lungs and swelling of the feet and ankles. Patients will learn more about their medications, how they work, potential side effects and the importance of following a proper dosage schedule. We also work with our patients to find fitness activities that are best for their condition and offer a cardiac rehab program.

“Our patients who participate in the Clinic definitely feel more empowered to manage their condition,” says Williams. “While there isn’t a cure for heart failure, our patients can regain a sense of well-being knowing that they have the knowledge and the tools to keep their symptoms in control.”

For patients with advanced stage disease, our clinic provides information for patients and their family members to make end of life care decisions and assists in connecting them with any other necessary services for their continued comfort.

Heart Failure clinic appointments are available five days a week. The frequency of visits to the clinic is dependent on each patient’s condition, however, most patients visit weekly or monthly for ongoing monitoring and treatment of their condition. Clinic visits are covered by all insurances. Talk with your primary care provider or cardiologist about your condition and if participating in our Heart Failure Clinic could be beneficial for you.

News on Local Hospital Quality & Pricing Data — Bay Medical Recognized for both Quality & Value

Patients today are fortunate to have an increasing amount of public data available to them about hospitals and healthcare providers in order to make the most informed decision on where and from whom to receive care.  In June 2015, several sources published data regarding outcomes and charges for hospital care.  Here at the Cardiovascular Institute, we see patients from all over Northwest Florida, so we reviewed the data currently posted for all Northwest Florida hospitals from Pensacola to Tallahassee, as well as the hospitals in Dothan, to see where area patients can go to receive the best quality and value care.

The data most accessible to the public comes from Medicare and is used by a variety of websites to report on mortality rates for the most common conditions and procedures.  The data we found for Coronary Interventions showed Bay Medical with an in-hospital mortality rate of 0.80% – the lowest in the region.   Most other area hospitals had rates in the 2 – 5% range.  Heart Failure is another commonly rated condition and several sites noted that Bay Medical’s in-hospital mortality rates were among the best in the nation.  We certainly found them to be the best in the region in our review of the available data, with a 1.6% mortality rate out of 1,315 cases.  Only one other hospital came close, West Florida , located in Pensacola, with a 1.71%.  All others were in the 2-7% range.

Coronary Bypass Surgery (CABG) is another procedure that is commonly rated in public data, however not all hospitals who offer Coronary Interventions provide this next level of service.  Having the back-up of cardiothoracic surgeons who can offer this procedure in the facility where you have a coronary intervention gives you added security and can be life-saving.  In this category, Bay Medical had a 0.0% in-hospital mortality rate.  Once again, this was the lowest rate in the region by far.  Gulf Coast Regional Medical Center and Sacred Heart on the Emerald Coast do not offer this procedure and were not rated. However, most other hospitals in the region had rates in the range of 2-6%.

Heart Attack is also rated.  Bay Medical Center was the second lowest in-hospital mortality in the region, behind West Florida Hospital in Pensacola, at 5.27%.  The other hospitals in our region had rates ranging from 6-11%.

As the only cardiology group practicing at Bay Medical Center, we were excited to see how favorably Bay Medical compared with others in the region as this reflects directly on the care that we provide.  At Bay Medical, we have the support of administration as they continually invest time and resources into a top of the line heart program and the clinical expertise of well-trained nursing staff caring for our patients.  Together, we make a great team and it shows in these publicly reported outcomes.

In addition to quality data, average charges are also available to the public if you know where to look.  In Florida, the easiest place to find this information is a state site called www.floridahealthfinder.gov.   A recent independent analysis of this charge information found Bay Medical Center to be among the Top 10 Best Values in Florida based on price and quality.  In a separate nationwide study recently reported in the Washington Post, three hospitals in our region were listed among the Top 50 for over-charging with an average charge that is 10 times what Medicare will cover.  One is here in Panama City.   For those who have Medicare, or in-network insurance plans, this practice of overcharging may not have a direct impact on what you pay, however, it does impact overall insurance rates .  As a tourist community, we have many out-of-state visitors who unfortunately find themselves in need of medical care out-of-network.  It is in cases such as these, where insurers and consumers are faced with this price gouging.   Insurers pass this cost along in the form of higher rates for everyone the following year.  In addition, with insurance policies having increasing deductible and out-of-pocket expenses, charges matter.

In the past, consumers did not have access to this information and frequently had no idea of the hospital’s reputation for caring for their condition or of what the charges might be until after they’ve received the care.  As a result, pricing and quality in healthcare have varied widely and often do not go hand-in-hand.

We encourage you to do your research and support institutions who are offering a quality service at a value price.  This is how we will make a difference in the American healthcare system.

For those who wish to research hospital quality in our area or look at how our local hospitals fare on other types of conditions, we recommend:

www.HealthGrades.com   –  This website uses star ratings, however we encourage you to look at the detail information provided to see actual mortality rates.  The stars are based on the actual versus a predicted rate.  Some hospitals have a much higher predicted rate and as a result may have a higher star rating than another hospital with a lower actual mortality rate.

www.medicare.gov/HospitalCompare   – This website only monitors mortality rates for several of the most common conditions. It includes other quality data and patient satisfaction data to help you get a broader picture of a hospital’s overall care.

www.floridahealthfinder.gov  – This website allows you to compare hospitals versus state averages to see a clear picture of price, length of stay for a certain conditions and roughly how many cases a hospital treats of that condition.  When a hospital treats far less of a certain condition than another, it’s possible they have less expertise in that area.

www.consumerreports.org (subscription required)

*The rates reported here were posted in June 2015.  These sites are updated and rates change as newer data becomes available.  Before making your healthcare decisions, please check for the most current quality data available.

Cardiac Caths Performed Through the Wrist

TRI Access 3

Each year, more than one million cardiac catheterizations are performed in the United States and more than 90 percent go through the groin to gain access to the arteries that lead to the heart (transfemoral access). However, cardiologists at the Cardiovascular Institute are increasing the number of procedures performed through the wrist (or transradial access). Why? This access approach is improving patient comfort and recovery times.
“Once the artery is engaged,” says Samir Patel, M.D., interventional cardiologist, “whether through the wrist or the groin, the diagnostic and interventional procedures are virtually the same.” One big difference, however, is what happens at the end of each procedure. With transfemoral access, the patient must have pressure applied to the puncture site and lie flat for several hours post procedure under the observation of a nurse or technician. This is necessary to ensure the transfemoral access site reaches hemostasis (no further bleeding). “With transradial access, a wrist band applies pressure to the access site following the procedure, which enables patients to be mobile much faster and have less soreness during recovery,” says Dr. Patel. “Patients are able to get up almost immediately after the procedure, they can use the bathroom, sit up and read a newspaper, eat or have a cup of coffee.”
“While the transfemoral approach is more common,” says Amir Haghighat, M.D., interventional cardiologist, “the entry point is sometimes difficult to access, especially in heavier patients and sometimes in women. In these cases, using transradial access to perform the procedure can reduce the risk of excess bleeding. However, for more complex cases, gaining access through the femoral artery, a larger vessel, remains the standard.”
The increased use of transradial access is not only helping patients to regain mobility faster following the procedure, but in select cases, patients are able go home the same day rather than stay overnight in the hospital. “Our group is excited to work with Bay Medical to gradually increase usage of this access method for cardiac caths,” says Dr. Haghighat. “Working together with the hospital, we are continually improving the quality of heart care available to patients in our community.”