Advances in Healing - Cardiovascular Innovations

Advances in Healing C A R D I OVA S C U L A R I N N OVAT I O N S

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A N E WS L E T T E R F O R R E F E R R I N G P H Y S I C I A N S

2 Implementing Risk Reduction 4 Coronary Intervention through Radial Artery 4 Women & Heart Disease

Transcatheter Aortic Valve Replacement:

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An Innovative Treatment for High-Risk Patients with Aortic Stenosis

ABSTRACT: Aortic stenosis typically is a disease of the elderly, many of whom are poor candidates for open heart surgery with valve replacement. Transcatheter aortic valve replacement (TAVR) is a minimally invasive, catheter-based procedure for implanting a prosthetic tissue valve inside a stenotic native aortic valve. TAVR has been shown to be superior to medical therapy in the treatment of inoperable patients with aortic stenosis, and that it was equivalent to standard surgical valve replacement in high operative risk patients.

Transcatheter aortic valve replacement (TAVR) is a minimally invasive, catheter-based procedure for implanting a prosthetic tissue valve inside a stenotic native aortic valve. For over 40 years, the treatment standard for severe, symptomatic aortic stenosis (AS) has been open heart surgery with valve replacement. While this approach yields excellent results, many older patients are poor candidates for major surgery and have thus been limited to largely palliative measures, including medication or balloon valvuloplasty. TAVR provides another option for selected high-risk elderly patients.

ABOUT AORTIC STENOSIS In AS, a buildup of calcium restricts the normal functioning of the aortic valve. Ultimately, the size of the valve opening can shrink from the size of a quarter down to a size that may be as small as a pencil eraser, severely limiting the flow of blood into the aorta.

AS can have an insidious onset, with patients remaining asymptomatic or experiencing vague, generalized symptoms such as reduced energy, strength, and activity levels. As the valve opening narrows down significantly, the patient may begin to complain of chest pain, shortness of breath, or syncope. More than 50% of patients with medically managed, severe AS will die within 2 to 3 years.

AS typically occurs in the elderly, more commonly in men, with a prevalence of 2% to 9% in individuals older than 75 years. For persons with a congenitally bicuspid valve, about 1% to 2% of patients, symptomatic AS may develop as early as middle age.

HOW TAVR WORKS AS can be treated very effectively with open heart surgery that includes excision of the diseased valve and replacement with a tissue or mechanical valve. However, AS is most common in an elderly

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population where significant comorbidities (e.g., chronic obstructive pulmonary disease, vascular or cerebrovascular disease, or renal disease) may contraindicate major surgery. Nearly a quarter of elderly patients with symptomatic AS fall into this category and, until recently, there was no other good option for them.

In TAVR, a new tissue valve is delivered by a variety of catheter-based approaches and implanted inside the native valve. Most commonly, a catheter is inserted through the femoral artery. (If the artery is diseased or too small, a transapical, transaortic, or subclavian route can also be used.) The prosthetic valve is compressed or “crimped” and delivered by fluoroscopic and echo guidance to the aortic valve, where it is balloon-expanded, pushing the diseased native valve leaflets aside. In this country, the procedure is typically done under general anesthesia on a beating heart, so there is no need for cardiopulmonary bypass.

Currently, there are two FDA approved TAVR devices in the US. The Edwards SAPIEN® valve and the Medtronic CoreValve®. The Edwards SAPIEN® valve was approved by the US Food and Drug Administration in 2011 for patients who are not good candidates for surgical aortic valve replacement. The Medtronic CoreValve® received FDA approval in January 2014 and has the ability to be delivered through smaller delivery systems (14Fr.-18Fr.).

Recent international trials have shown that both the Edwards SAPIEN® valve and the Medtronic CoreValve® are superior to medical therapy in the treatment of inoperable patients with AS, and that it was equivalent to standard surgical valve replacement in high operative risk patients. An ongoing trial is testing whether the procedure will be appropriate for intermediate-risk patients.

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CENTER FOR VALVE DISORDERS TAVR is currently being performed by teams of surgeons and interventional cardiologists on the medical staff at The Heart Hospital Baylor Plano and at Baylor Heart & Vascular Services at Dallas. At each institution, multidisciplinary teams, including the surgeon, cardiologist, valve clinical coordinator and imaging specialist, evaluate each patient to determine the best course of treatment.

According to Robert Stoler, MD, co-medical director of cardiology and medical director of the catheterization laboratory at Baylor Heart & Vascular Services at Dallas, “This represents a fundamental change in how things are done. Until recently, the surgeon and the cardiologist rarely met together. TAVR has revolutionized the way that these medical professionals work together to treat aortic valve disease.”

Michael J. Mack, MD, Medical Director of Cardiovascular Surgery and Chairman of The Heart Hospital – Baylor Plano Research Center, commented, “This is a treatment that is available for patients that previously could not be treated.

These patients were not traditionally referred to specialists by primary care providers because they were felt to be too old, too debilitated, and too frail to undergo surgery. Primary care providers should be aware that TAVR has the potential to allow this population of patients to be treated and to have full, productive lives.”

Referrals To refer a patient to one of our centers for valve disorders, call 1.800.9BAYLOR or visit BaylorHealth.edu.

Implementing Risk Reduction for Cardiac Disease in Your Daily Practice

ABSTRACT: The goal of the primary care physician (PCP) is to identify those patients at highest risk for cardiac disease as early as possible, moving them into more aggressive screening and management strategies. First-tier risk factors include smoking, diabetes, and a positive family history. Second-tier risk factors include hypertension and abnormal cholesterol levels. Most of these risk factors are modifiable through medication or lifestyle changes, and the PCP is in an ideal position to assist patients in making changes that can have a significant effect on long-term health.

Cardiac disease is the leading cause of death for both men and women in the US, accounting for 1 in every 4 deaths. Every year, 525,000 people suffer a first heart attack. According to Kevin Theleman, MD, medical director of vascular services at Baylor Regional Medical Center at Grapevine, these grim numbers can be reduced through primary prevention: “The goal of the primary care physician (PCP) is to identify the patients at highest risk as early as possible, moving them into more aggressive screening and management strategies.”

First-tier risk factors that place patients at the highest risk for cardiac disease are smoking, diabetes, and a positive family history of premature coronary artery disease.

SMOKING Cigarette smoking is the most important modifiable risk factor for coronary artery disease.

Smokers are 2 to 4 times more likely to develop coronary artery disease, and 2 to 3 times more likely to die from it compared with nonsmokers.

The nicotine in smoke increases blood clotting, increases blood pressure and heart rate, decreases the amount of oxygen carried by red blood cells, and damages cells lining the coronary arteries.

Smoking also lowers HDL levels, and can trigger arrhythmias and spasms in the coronary arteries.

Stopping smoking is the most important step in lowering the risk of coronary artery disease.

Primary care physicians should be aggressive in helping their patients who smoke find strategies that will enable them to quit.

DIABETES From 1980 through 2011, the prevalence of diagnosed diabetes increased more than twofold (from 2.5% to 6.9%). Having diabetes doubles the risk of developing coronary heart disease.

High blood glucose levels over time can lead to increased plaque within the arteries. In addition, patients with diabetes frequently have additional risk factors for heart disease, including hypertension, abnormal cholesterol levels, obesity, lack of physical activity, and smoking.

Early identification and treatment of diabetes are critical. For patients age 40 and above, the standard of care in the primary care setting is the HbA1c test to average out a fasting blood sugar over a period of 3 months. A value above 7 indicates elevated blood sugar, while levels of 6.5 to 7 indicate good control.

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Implementing Risk Reduction for Cardiac Disease in Your Daily Practice POSITIVE FAMILY HISTORY Premature coronary artery disease (history of a heart attack, stent placement, or bypass surgery in fathers or brothers under 55 or mothers or sisters under 65) is a strong risk factor for coronary disease, even in a currently healthy and asymptomatic individual. Thus, all patients, regardless of other risk factors, need a thorough assessment of family members who had premature heart blockage, arrhythmias, valve surgeries, or aneurysms. Patients with a positive family history may have a genetic predisposition for deposition of plaque. The PCP needs to be aggressive at controlling this at an early age. Screening should start at age 30 to 35 and, when appropriate, medical treatment should be used rather than a more conservative strategy.

In the growing field of molecular genetics, there is hope for the future that the concept of “genetic heart disease” may be more closely defined. Of the thousands of genes involved in the construction of the heart, researchers anticipate that it will be possible to identify specific genes responsible for cardiac disease in individual patients.

SECOND-TIER RISK FACTORS A second tier of risk factors includes hypertension, abnormal cholesterol levels, and (with stipulations) obesity. These risk factors have a slightly lower level of priority than the top tier factors, but are very important because they can all be readily managed through lifestyle changes or medication.

HYPERTENSION The target for home blood pressure readings is 135/85 mmHg or less (130/80 mmHg or less if there are additional problems with diabetes, kidney disease, or other health problems). Because “white coat hypertension” is a common problem, patients should be urged to acquire a reliable machine for monitoring their blood pressure at home. In the office, measurements should be taken by a trained professional using a cuff, if possible, and rechecked later in the visit if it is initially elevated.

CHOLESTEROL The current standard of care for cholesterol levels is to aim for an LDL level below 100 mg/dL and an HDL level above 50 mg/ dL. Patients with moderately abnormal levels are typically treated conservatively (exercise, diet) as a first pass strategy, and then rechecked in 3 months. If adequate response is not seen, the PCP should initiate a discussion with their patient about starting a medication.

In November 2013, the American College of Cardiology and the American Heart Association released new evidence-based guidelines for the use of statins. In these guidelines, statins are recommended for individuals with (1) atherosclerotic cardiac disease; (2) LDL levels ≥ 190 mg/ dL; (3) diabetes and LDL levels between 70 and 189 mg/dL; or (4) an estimated 10-year cardiac disease risk of 7.5% or higher. These guidelines represent a significant departure from the previous standard of care, and remain the subject of considerable discussion.

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OBESITY There is some question about whether obesity is really a risk factor for cardiac disease. It probably does not specifically cause artery disease, but it does directly contribute to the development of type II diabetes and hypertension. By losing weight, patients may be able to modify these risk factors and, ideally, get off the medications they might be taking to control them.

The PCP is in an ideal position to assist patients in modifying risk factors through lifestyle change and medication, changes that can have a significant effect on long-term health. Jacob Chemmalakuzky, Medical Director of Interventional Cardiology at Baylor Medical Center at Carrollton, commented, “There are so many different clues to help identify a high-risk person. Detailed attention to the physical examination and the patient’s medical history should allow a PCP to screen, identify, and treat people, greatly improving their long-term chances of avoiding heart disease.”

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Women & Heart Disease:

Bridging the Disparity of Care ABSTRACT: Heart disease causes 1 out of 3 deaths in US women each year, making it the number one health problem for women. However, a survey conducted by the American Heart Association in 2012 found that a significant percentage of women were still not aware of this, and that only 21% had ever discussed the risk of heart disease with their doctors. Almost two-thirds of women who die of coronary heart disease had no previous symptoms, and others may have had atypical symptoms that could be mistaken for other conditions. Women need to be very aware of their personal risk factors for cardiac disease, the majority of which are controllable. Reducing or eliminating one or more of these controllable factors can result in a significant reduction in cardiac risk, and physicians need to be talking more to their female patients about lifestyle changes to mitigate their risk.

Coronary Intervention through the Radial Artery

ABSTRACT: Over the last 40 years, most angiograms have been performed using femoral artery access in the groin, but there is a growing interest in using radial artery catheterization. This approach reduces access site complications and increases patient satisfaction. The procedure is more challenging to learn, due in part to the smaller size of the artery, but once learned, success rates are equivalent to those seen with femoral artery catheterization. With the development of new multipurpose catheter shapes, radial artery catheterization can be used for more complex procedures.

For Mohan Sathyamoorthy, MD, FACC, Medical Director of Non-Invasive Cardiology at Baylor All Saints Medical Center, improving the care of women with heart disease begins with accepting the reality that heart disease is the number one health problem for women in the US. Data from the American Heart Association and the NIH National Heart, Lung, and Blood Institute reveal that heart disease causes 1 out of 3 deaths in women each year, more than all cancers combined. And yet, the recognition of this reality has been slow in coming, with the same myths persevering: • Heart disease is primarily a problem for men: Women do tend to develop heart disease later than men, but after menopause the risk is the same. In fact, since 1984, more women than men have died from heart disease each year.

• The major health concern for women is cancer, especially breast cancer: The numbers say otherwise.

Each year, 1 in 31 American women dies from breast cancer, compared with 1 in 3 who die of heart disease.

• Heart disease is only a concern for old people: The risk of heart disease does increase with increasing age, but some risk factors (congenital heart problems, smoking, birth control pills, diabetes) can significantly increase the risk in younger women.

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Coronary Intervention through the Radial Artery

Over 1 million angiograms are performed in the US each year to elucidate buildup of plaque in the arteries of the heart. The procedure is typically performed on patients presenting in the emergency room with acute coronary syndrome, and may also be recommended for patients in the office setting who complain of symptoms concerning for coronary artery disease.

peripheral vascular disease in the legs, there is typically very little plaque buildup in the arms. In very obese patients, the femoral artery can be difficult to find and the risk of complications may be higher. For older people and women in general, the risk of bleeding from the femoral artery is higher, making radial artery catheterization a safer alternative.

Over the last 40 years, the majority of angiograms have been performed using femoral artery access in the groin. Beginning in 1989, however, interest started growing in radial artery catheterization.

The technique became widespread in Europe and Southeast Asia, but has been slower to catch on in the US. In 2007, approximately 1% to 2% of diagnostic catheterizations in the US were performed using the right radial artery, but that number had grown to 10% by 2011.

Even with these benefits, radial artery catheterization has developed slowly in the US for a number of reasons. It is more challenging to learn, but once learned, yields success rates equivalent to those seen with femoral artery catheterization. One of the major concerns is gaining access to the artery. It is smaller than the femoral artery (about 3.1 mm in men and 2.8 mm in women), making it only a little larger than the 2.5 mm sheath that is used. This can lead to painful spasm, so it is now routine to give the patient a cocktail of verapamil and nitroglycerin after insertion of the sheath and as needed afterwards for pain. Heparin is also given to prevent clots that may develop after removal of the sheath.

There are several important benefits to using the radial artery compared with the femoral artery for catheterization: • The biggest benefit is the reduction of access site complications. With femoral artery catheterization, there is a 4% to 6% chance of vascular complications, including bleeding, pseudoaneurysm, and arteriovenous fistula.

Bleeding can be evident at the access site or it may occur retroperitoneally into the pelvic cavity. In this case, it may not be perceptible until there is a significant drop in blood pressure or the patient complains of back pain.

Because the radial artery is superficial, bleeding is immediately apparent and can be treated with compression. Studies have shown a 50% to 60% reduction in bleeding and vascular complications associated with radial artery compared with femoral artery catheterizations.

• Patient satisfaction is increased. With femoral artery catheterization, patients must remain flat in bed for 2 to 6 hours after the procedure. After radial artery catheterization, they can sit up immediately, start eating, and go to the bathroom. This is especially important for patients with chronic low back pain or those who have difficulty breathing when lying flat.

Overall, radial artery catheterization involves less imaging, fewer transfusions, and fewer complications.

Radial artery catheterization may still be possible in cases where femoral artery catheterization is contraindicated. Even when there is severe

Before the procedure is initiated, patency of both the radial and ulnar arteries is checked to ensure blood flow to the hand if thrombosis should develop in the radial artery during the procedure.

This is done with a simple manual compression test using visual examination of the palmar surface or a pulse oximetry device on the finger.

Radial artery catheterization can also be used for more complex procedures. In other countries, it is commonly used for the placement of carotid artery stents, renal artery stents, and common iliac artery stents. In this country, with newer multipurpose catheter shapes, it is increasingly being used for both angiography and angioplasty.

According to Biren Parikh, MD, an interventional cardiologist on the medical staff at Baylor Medical Center at Garland, “Radial artery catheterization requires a steep learning curve, but can result in reduced patient discomfort, lower cost, and reduction in potentially serious complications.”

To refer your patient to an interventional cardiologist on the medical staff at Baylor who utilizes the radial approach, call 1.800.9BAYLOR or visit BaylorHealth.edu.

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Women & Heart Disease Bridging the Disparity of Care

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• I don’t have any typical heart attack symptoms. Almost two-thirds of women who die of coronary heart disease had no previous symptoms. Others may have had atypical symptoms that could be mistaken for other conditions.

The classic presentation in men, with extreme pressure or pain in the chest that may radiate down the arm, can also be seen in women, but it is as likely that the presentation in women might include shortness of breath, nausea/ vomiting, pain in the back or jaw, dizziness, lightheadedness, fainting, pain in the lower chest or upper abdomen, or extreme fatigue.

In 2012, the American Heart Association conducted a survey to assess 15-year trends in awareness of heart disease in women.

They found that, although the number of women who recognized that heart disease is the leading cause of death in women had doubled in the past 15 years, many women were still unaware of this (35% of white women, 65% of minority women, 56% of women aged 25-34 years). Only 21% of respondents overall reported that their doctor had ever discussed their risk of heart disease with them, and this number was substantially lower in Hispanic women (12%) and women aged 24-35 (6%).

Women need to be very aware of their personal risk factors for heart disease. More than 75% of women between the ages of 40 and 60 have one or more risk factors for heart disease, and the risk rises with the number of risk factors and their severity.

According to Dr. Sathyamoorthy, these traditional risk factors, including hypertension, high cholesterol levels, smoking, diabetes, and positive family history, are generally the same as those seen for men, but some may affect women differently. For example, diabetes or certain rheumatologic conditions such as lupus appear to raise the risk of heart disease more in women than in men.

In addition, there are some risk factors (e.g., the use of birth control pills, menopause) that are specific to women. Women who visit their doctor with suggestive symptoms (e.g., unexplained breathing problems, blacking out, significant palpitations, new swelling in the legs, or persistent dizziness) should be carefully evaluated for cardiac risk factors and possible underlying cardiac conditions.

Although some risk factors, such as family history or congenital heart problems, are not controllable, the majority of them are.

Reducing or eliminating one or more of these controllable factors can result in a significant reduction in cardiac risk. Nonetheless, only about half of respondents in the American

Heart Association survey reported making an effort to get regular physical exercise, reduce stress, or lose weight in order to reduce their risk level. Reported barriers to preventive action included lack of confidence in ability to change behavior, not having enough time, and family obligations. In the 35 to 44 age group, additional barriers included depression and lack of knowledge about what to do.

“We need to be talking more to our female patients and to women in general about making lifestyle changes,” said Dr. Sathyamoorthy. “We can’t alter our genes or the physical problems we may be born with, but all of us can change our lifestyles to improve our health. As physicians, we need to encourage women to take control of what they can, and this starts with improving lifestyle as much as possible.”

Referrals To refer your patient to a cardiologist on the medical staff at Baylor who has an interest in women and heart disease, call 1.800.9BAYLOR or visit BaylorHealth.edu.

The material in Advances in Healing is not intended for diagnosing or prescribing. Not all services are available at all locations. Consult your physician before undertaking any form of medical treatment. Physicians are members of the medical staff at one of Baylor Health Care System’s subsidiary, community or affiliated medical centers, and are neither employees nor agents of those medical centers or Baylor Health Care System. Photographs may include models or actors and may not represent actual patients. If you are receiving multiple copies, need to change your mailing address or do not wish to receive this publication, please send your mailing label(s) and the updated information to Robin Vogel, Baylor Health Care System, 2001 Bryan St., Suite 750, Dallas, TX 75201, or email the information to robinv@baylorhealth.edu. ©v 2014 Baylor Health Care System. BHCSCV_98_2014 RT