A Growing Health ThreatAn estimated 17 million people worldwide die of cardiovascular diseases, particularly heart attacks and strokes, every year. In the United States alone, 616,067 deaths were attributed to cardiovascular disease in 2007, the latest year for which figures were available, according to the Centers for Disease Control and Prevention (CDC). As noted by the American Heart Association, Americans incurred more than $177 billion in total medical costs related to heart disease that same year. Of that amount, $82 billion was due to direct costs for clinical care and medications.

Many of the risk factors for heart diseases and stroke are preventable or can be controlled, thereby reducing risk. Medical researchers and device firms are working on important and innovative tools and R&D programs to better understand, prevent, and treat conditions that affect the heart.

Current treatments include nonsurgical procedures such as angioplasty and stenting, along with surgeries that require placement of a heart valve. In heart bypass surgery, a surgeon builds a bypass around a blocked artery. For heart-rhythm problems, ablation therapy seeks to stop abnormal electrical signals. And for those with persistent angina, enhanced external counterpulsation, or EECP, can sometimes help when other treatments fail.

Each of these techniques requires substantial research and development to produce the most safe and effective product. As a major biomedical hub, California is on the cutting edge of new developments in cardiovascular disease.

Conditions Affecting the Heart:Coronary heart disease Disease of the blood vessels supplying the heart muscle. Major risk factors: High blood pressure, high blood cholesterol, tobacco use, unhealthy diet, physical inactivity, diabetes, advancing age, inherited (genetic) disposition. Other risk factors: Poverty, low educational status, poor mental health (depression), inflammation and blood clotting disorders.

Stroke Strokes are caused by disruption of the blood supply to the brain. This may result from either blockage (ischaemic stroke) or rupture of a blood vessel (haemorrhagic stroke). Risk factors: High blood pressure, atrial fibrillation (a heart rhythm disorder), high blood cholesterol, tobacco use, unhealthy diet, physical inactivity, diabetes and advancing age.

Congenital heart disease Malformations of heart structures existing at birth may be caused by genetic factors or by adverse exposures during gestation. Examples are holes in the heart, abnormal valves, and abnormal heart chambers. Risk factors: Maternal alcohol use, medicines (for example thalidomide, warfarin) used by the expectant mother, maternal infections such as rubella, poor maternal nutrition (low intake of folate), close blood relationship between parents (consanguinity).

Deep venous thrombosis (DVT) and pulmonary embolism Blood clots in the leg veins, which can dislodge and move to the heart and lungs. Risk factors: Surgery, obesity, cancer, previous episode of DVT, recent childbirth, use of oral contraceptive and hormone replacement therapy, long periods of immobility, for example while travelling, high homocysteine levels in the blood.

Aortic aneurysm and dissection Dilatation and rupture of the aorta. Risk factors: Advancing age, longstanding high blood pressure, Marfan syndrome, congenital heart disorders, syphilis, and other infectious and inflammatory disorders.

Peripheral arterial disease Disease in which plaque builds in the arteries supplying the arms and legs. Risk factors are smoking, older age, and having certain diseases or conditions.

Other cardiovascular diseases Tumors of the heart; vascular tumors of the brain; disorders of heart muscle (cardiomyopathy); heart valve diseases; disorders of the lining of the heart.

Source: National Heart, Lung and Blood Institute

Cardiovascular Disease in California: As is the case nationally, cardiovascular disease (CVD), including heart disease, heart failure, and stroke, is the leading cause of death in California, accounting for more than 73,000 deaths, or almost one-third of all deaths in 2004. In 2004, the number of deaths from CVD exceeded the number of deaths from malignant neoplasms (cancer), diabetes, chronic liver disease/ cirrhosis, suicide, homicide, and HIV, combined. The burden of CVD is experienced across the California population, although some groups experience the burden disproportionately. Of further concern, given the changing demographics in California, is that the risk of death from heart disease, stroke, and heart failure increases with older age. As the average length of life extends, the numbers of deaths from heart disease, stroke, and heart failure will increase in future years. With an ever-increasing number of heart disease and stroke events, amidst a healthcare system that is struggling against shrinking resources, the felt burden will not be insignificant. In 2004, the state recorded more than 775,000 CVD-related hospital discharges, including nearly 200,000 stroke-related hospital discharges.

Cardiovascular Disease

Aortic Stenosis

Edwards Lifesciences

The leaflets of a healthy aortic heart valve open wide to allow oxygenated blood to flow unobstructed through the valve into the aorta where it flows out to the rest of the body.

Edwards Lifesciences

The leaflets of a stenotic or calcified aortic heart valve are unable to open wide, obstructing blood flow from the left ventricle into the aorta. The narrowed valve allows less oxygenated blood to flow through and as a result, less oxygen-rich blood is pumped out to the body, which may cause symptoms like severe shortness of breath.

Patient Profile: Connie alexanderAs a young woman, Connie Alexander had toured the world entertaining audiences as a professional roller skater. She later married and had two children, and, in her 30s, battled breast cancer – but the commonly accepted treatment at the time, cobalt radiation, left her ribs extraordinarily brittle, necessitating surgery to remove several ribs and transplant skin and muscle to protect her heart and lungs.

When she began experiencing symptoms of severe aortic stenosis in her late 70s, including breathlessness and tiring during her usual daily activities, she learned that her aortic valve needed to be replaced. But the previous reconstructive surgery meant traditional open-heart surgery was not a good option. Connie and her physician found a treatment solution in transcatheter valve replacement with the Edwards SAPIEN valve, a collapsible aortic heart valve that can be introduced into the body via a catheter-based delivery system. The valve is designed to replace a patient’s diseased “native” aortic valve without traditional open-heart surgery and while the heart continues to beat. It was approved by the U.S. Food and Drug Administration in November 2011 for the treatment of patients who have been determined to be inoperable, like Connie.

In reflecting on her experience, Connie said, “Tuesday, I got my hair done, Thursday I had the procedure, Saturday, I went home. And Tuesday, I went and had my hair done again – never missed a hair appointment.

“I feel great today. I have a brand new heart – because all it needed was the aortic valve. And it has it. I wouldn’t be here today if it weren’t for the valve.”

Connie Alexander

Heart disease and stroke are the No. 1 and No. 3 causes of death, and a leading cause of disability, among Californians.

Compared to the nation, California has slightly above average rates for coronary heart disease and stroke mortality.

Edwards SAPIEN Valve

Edwards Lifesciences

Absorb bioresorbable vascular scaffold

Abbott is a global, broad-based healthcare company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. Abbott’s vascular division is a global leader in cardiac and vascular care with market-leading products and an industry-leading pipeline. The company is focused on bringing leading-edge, minimally invasive vascular devices to patients affected by heart disease, stroke, peripheral artery disease, structural heart disease and other serious medical conditions.

Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company

partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives.

advanCes in CardiovasCular diagnosis and treatment:

California companies are developing pipeline products for the full spectrum of indications

Source: BCIQ: BioCentury Online Intelligence

Dis

ease

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0 50 100 150 200 250 300

CancerNeurologyInfectious

Diagnostic

Endocrine / MetabolicAutoimmune

Cardiovascular

OpthalmicInflammation

HematologyDermatology

Musculoskeletal

Pulmonary

OtherGastrointestinal

TransplantGenitourinary

Renal

Hepatic

Dental

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The St. Jude Medical product portfolio includes implantable cardioverter defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, pacemakers, electrophysiology catheters, mapping and visualization systems, vascular closure devices, heart valve replacement and repair products, and neurostimulation devices.

Fractional Flow Reserve (FFR) is a physiological index

that determines the severity of blood flow blockages in

the coronary arteries and is measured using St. Jude

Medical’s PressureWire technology. An FFR

measurement helps physicians to better identify which

specific lesion or lesions are responsible for a patient’s

ischemia, a deficiency of blood supply to the heart

caused by blood restriction.

MitraClip Mitral Valve Repair System

St. Jude Medical Pressure Wire Certus

Ascenda transapial delivery system

Abbott

Abbott

St. Jude

Edwards

Headquarters 888 Prospect Street, Suite 220

La Jolla, California 92037 858-551-6677

858-551-6688 fax

Sacramento 1215 K Street, Suite 940

Sacramento, California 95814 916-233-3497

916-233-3498 fax

Washington, D.C. 1608 Rhode Island Ave. N.W., 2nd Floor

Washington, DC 20036 202-974-6313

202-974-6330 fax

Additional Resources: Abbott www.abbottvascular.com

American Heart Association www.heart.org www.hearthub.org

California Healthcare Institute www.chi.org

California Heart Disease and Stroke Prevention Program www.cdph.ca.gov/programs/cvd

Cedars-Sinai www.cedars-sinai.edu

Centers for Disease Control and Prevention: www.cdc.gov/HeartDisease

Edwards Lifesciences www.edwards.com

Hearth Rhythm Society www.hrsonline.org

LifeScience Alley www.lifesciencealley.org

National Heart, Lung, and Blood Institute www.nhlbi.nih.gov

Stanford Cardiovascular Institute www.cvi.stanford.edu

St. Jude Medical www.sjm.com

WomenHeart www.womenheart.org

Know Your Signs and SymptomsSome heart attacks are sudden and intense; however, most heart attacks start slowly, with mild pain or discomfort. Often people affected are unsure of what is wrong and wait too long before getting help. Here are signs that can mean a heart attack is happening:

• Chest discomfort. Most heart attacks involve discomfort in the center of the chest that lasts more than a few minutes, or that goes away and comes back. It can feel like uncomfortable pressure, squeezing, fullness, or pain.

• Discomfort in other areas of the upper body. Symptoms can include pain or discomfort in one or both arms, the back, neck, jaw, or stomach.

• Shortness of breath. May occur with or without chest discomfort.

• Other signs. These may include breaking out in a cold sweat, nausea, or lightheadedness.

The American Heart Association, the National Heart, Lung, and Blood Institute, the American Red Cross, and the National Council on Aging have launched a new “Act in Time” campaign to increase people’s awareness of heart attack and the importance of calling 9-1-1 immediately at the onset of heart attack symptoms. To find out more, visit: http://www.nhlbi.nih.gov/actintime/index.htm

Source: American Heart Association

About CholesterolCholesterol comes from two sources: your body and food. Your liver and other cells in your body make about 75 percent of blood cholesterol. The other 25 percent comes from the foods you eat. Cholesterol is only found in animal products.

A cholesterol screening measures your level of HDL and LDL. HDL is the “good”

cholesterol, which helps keep the LDL (bad) cholesterol from getting lodged into your artery walls. A healthy level of HDL may also protect against heart attack and stroke, while low levels of HDL (less than 40 mg/dL for men and less than 50 mg/dL for women) have been shown to increase the risk of heart disease.

Answers: 1) False 2) True 3) False

Cholesterol IQ QuIz

1) Only adults need to have their cholesterol checked. True False

2) High cholesterol levels put me at risk for atherosclerosis. True False

3) People who are thin do not have to worry about high cholesterol. True False

Source: American Heart Association

CHI-California Healthcare InstituteCHI-California Healthcare Institute is a non-profit public policy research organization for California’s biomedical R&D industry. CHI represents more than 275 leading medical device, biotechnology, diagnostics and pharmaceutical companies and public and private academic biomedical research organizations. CHI’s mission is to advance responsible public policies that foster medical innovation and promote scientific discovery. CHI’s website is www.chi.org. Follow us on Twitter @calhealthcare, Facebook, LinkedIn and YouTube.