Home Treatment Devices


Statins Play a Strong Role in Primary Prevention

The benefits of cholesterol-lowering statin drugs to patients with heart disease are well-documented, and there is ample evidence that statins are effective when used as preventive therapy for people who have risk factors but no diagnosed cardiovascular disease (CVD). An analysis of results from 10 statin studies published in the June 30 online edition of the British Medical Journal concluded that statins used for primary prevention in patients with risk factors but no established CVD improved survival and reduced the occurrence of heart attack and stroke. "This article provides a reaffirmation of previous findings on the benefits of statins for people who do not have diagnosed heart disease," says Stanley Hazen, MD, PhD, the section head of preventive cardiology & cardiac rehabilitation at Cleveland Clinic. "The bottom line is that statins save lives. The data is so compelling-no other drug has been shown to have such powerful preventive effects as statin drugs, except for vaccines."

Whats the Best Treatment for Pelvic Arterial Blockages?

More than eight million Americans are affected by peripheral arterial disease (PAD). In patients with PAD, obstructing plaques caused by atherosclerosis commonly occur in the aorta and iliac arteries. When these large blood vessels become blocked, the lower extremities can become starved of blood. In serious cases, amputation may be necessary. In the past, bypass surgery has been the solution, but newer, less-invasive procedures are becoming available. A study in the July issue of the Journal of Vascular Surgery found that endovascular interventions using catheter-based devices to re-open peripheral arteries are being used much more commonly now and that their success rates are proving to be especially effective. "Endovascular techniques are vastly different from traditional, open surgery," says Christopher T. Bajzer, MD, FACC, associate director of Vascular Intervention in the Department of Cardiovascular Medicines, Sections of Vascular Medicine and Interventional Cardiology at Cleveland Clinic. According to Dr. Bajzer, traditional surgery for pelvic arterial blockages include aortic-to-iliac bypass surgery and femoral-to-femoral bypass surgery. Bypass surgery is invasive and can cause serious complications.

Statins Reach Extends Beyond Cholesterol Management

Statins may have been initially developed to reduce LDL ("bad") cholesterol in the body, but research continues to show a much broader potential for the medications. Earlier this year, the landmark Justification for Use of Statins in Prevention: Rosuvastatin (JUPITER) study showed that the drugs provided a nearly 50 percent relative risk reduction for stroke and heart attack among people with normal cholesterol but high levels of C-reactive protein (CRP), which appears in the bloodstream in response to inflammation in the body. Results of the study were presented at the American Stroke Association International Stroke Conference in February. Javier Provencio, MD, of the Cleveland Clinic Cerebrovascular Center says one of JUPITERs most important lessons is that CRP levels, which can remain chronically elevated in patients with diabetes, for example, need to be monitored and managed to reduce risk of cardiac events.

Ventricular Assist Devices Give Failing Hearts a Boost

In the mid-1970s, Cleveland Clinic surgeons developed a pump that could assist a failing heart until a donor heart could be found. Today, ventricular assist devices (VADs) are still used as a bridge to transplantation. But more importantly, VADs are giving a greater number of patients with severe heart failure the chance to lead a longer, better life. The latest models are being used as alternatives to transplantation (destination therapy) or to buy time while optimal treatment is determined (bridge to medical decision). "The new pumps are sturdy, longer-lasting and less prone to infection. We have few problems with them," says Cleveland Clinic heart transplant surgeon Gonzalo Gonzalez-Stawinski, MD. With a low overall mortality rate of 9.7 percent for VAD patients, Cleveland Clinic has been approved by the Centers for Medicare and Medicaid Services and Food and Drug Administration (FDA) to offer these life-saving devices as treatment for heart failure.

Mitral Valve Regurgitation Repair Made Easier with New Device

Every year Cleveland Clinic doctors and research scientists assemble a list of the Top 10 Medical Innovations for the coming year. Typically, the main reason a procedure or device makes the list is because of its potential to treat a vast number of patients in safer and more efficient ways. And that is certainly true of a key cardiac development on the 2009 list: percutaneous mitral valve regurgitation repair. At the center of this innovation is a tiny, barbed wishbone-shaped clip that helps hold the leaflets of the mitral valve together, thus restoring healthy blood flow through the leaflets. The clip is delivered to the heart with a catheter that is guided up the femoral vein from the groin. The improved blood flow is almost immediate once the clip is in place. "This will extend therapy to large numbers of patients with heart failure and to those who are not candidates for surgery," says Cleveland Clinic cardiac surgeon Marc Gillinov, MD.

Magnetic Heart Valves May Ease Replacement Surgeries

As heart valve patients continue to live longer, healthier lives after surgery, the need for subsequent valve replacement procedures continues to grow. An artificial valve may last 10 or 12 years, or longer, though in some difficult cases, a valve may need to be replaced in a matter of months. Researchers at Cleveland Clinic are working on a device that would make that follow-up valve replacement surgery easier and faster. And the keys to the new technology are magnets. Kiyotaka Fukamachi, MD, PhD, is developing a new heart valve that uses a magnetic coupling to keep the valve in the proper position. But another big advantage is that when it comes time to replace the valve, only part of it has to be removed and no stitches have to be taken out or sewn back in. "Traditionally, when the valve has to be replaced, they have to remove old sutures and stitch the new valve into place," says Dr. Fukamachi. "Its time consuming because the heart has to be stopped and the patient is on a heart bypass machine, and there is a risk because the procedure can damage the coronary arteries. But with this (magnetic) one, the second surgery can be easier than the first."

Stents and Bypass Each Have a Role In Treating Coronary Artery Disease

Blockage in one of your coronary arteries, the vital pipelines that provide blood to your heart, can lead to chest pain or worse, a heart attack, if the blockage is so severe that blood flow actually fails to supply the organ tissue. For many years, blocked arteries were treated with bypass surgery, in which the chest was opened up and a blood vessel from elsewhere in the body was used to redirect circulation around the obstruction. Then stents were developed and doctors were able to insert flexible tubes into arteries to open them up without surgery. So if one or more of your coronary arteries is becoming blocked, what is the best course of action? First, its important to understand the degree of blockage that would warrant some type of intervention. "Blockages considered severe enough to stent or bypass are defined as narrowings of 70 percent or more in one of the three major coronary vessels: left anterior descending artery (LAD), right coronary artery (RCA), or circumflex artery (CIRC) or 50 percent or more in the left main trunk (LMT)," explains Cleveland Clinic cardiologist Adam Grasso, MD. "This is the threshold at which the narrowing tends to be hemodynamically significant-flow-limiting under conditions of stress, such as physical exertion."

Statin Therapy May Do Much More Than Lower Cholesterol

The cholesterol-lowering drugs known as statins have been in the news again in recent months, following the landmark JUPITER (Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin) trial, in which the medications were found to cut the risk of heart attacks and strokes in half, even among people with low levels of low-density lipoproteins (LDL or "bad" cholesterol). But Leslie Cho, MD, director of Preventive Cardiology and Rehabilitation at Cleveland Clinic, says its important that the study results not be interpreted as evidence that everyone needs to begin statin therapy, regardless of their cholesterol levels. Dr. Cho points out that the study participants were specifically selected because they had some risk factors-particularly elevated levels of C-reactive protein (CRP), a sign of inflammation in the body. She adds that the average age of the study participants was 66 and that 41 percent of the people in the study had metabolic syndrome, a collection of risk factors such as obesity, high blood pressure and elevated CRP.

Age Alone Not a Barrier to ICD Therapy

Elderly heart patients are seldom included in formal clinical trials of devices such as implantable cardioverter defibrillators (ICDs), yet doctors insist that older and younger people can reap similar rewards from the technology that helps hearts beat in normal rhythms. "ICDs can be just as effective in both types of patients," says cardiologist Bruce Wilkoff, MD, director of Cardiac Pacing and Tachyarrhythmia Devices at Cleveland Clinic. "Theres no evidence to suggest that elderly patients shouldnt have the device. You just want to know what are the co-morbidities and what are the risks of therapy." And research from earlier this year suggests that elderly patients with ICDs live longer after heart failure than those who dont receive the devices and that quality of life doesnt suffer if youre on ICD therapy.

Do You Need a Stress Test Before Stenting?

A recent study suggests that many patients may not get the stress test the American Heart Association (AHA) recommends prior to percutaneous coronary interventions (PCI), such as stenting and angioplasty. A stress test can weed out patients with minimal symptoms who may not need risky invasive procedures, but Stephen Ellis, MD, Section Head of Invasive/Interventional Cardiology at Cleveland Clinics Heart and Vascular Institute, says the study findings may reflect the fact that the test isnt always accurate: "I think the main reason stress tests arent more often used is that theyre generally considered quite unreliable."

Blood Pressure-Measuring Device Eliminates White Coat Effect

A new method of taking patients blood pressure and getting more accurate readings is slowly making its way into physicians offices around the world. The BpTRU device, which will become the standard approach at Cleveland Clinic by the end of the year, records three to five blood pressure readings over the course of five minutes-and it can be done without a nurse or doctor present, thus eliminating the "white coat effect." Research has shown that many patients experience this effect, in which their blood pressure and anxiety rise when a nurse or doctor is in the room for an examination. Extensive research has affirmed BpTRUs accuracy, and also its ability to rule out "white coat hypertension" in the office setting.

Heart Beat: 11/08

A Cleveland Clinic study found that drug-eluting stents (DES) were associated with a 38 percent lower risk of all-cause mortality, compared with bare-metal stents. The study, published in the Sept. 23 issue of the Journal of the American College of Cardiology and led by Mehdi Shishehbor, MD, found that among the more than 6,000 patients followed for four-and-a-half years, the threat of stent thrombosis (the formation of a blood clot within a stent) with DES did not translate into higher mortality rates for those patients. Researchers acknowledged that the results may be partially swayed by the likelihood that patients with extensive comorbidities, terminal illness and low socioeconomic status often receive bare-metal stents. Also, patients with a history of noncompliance to their medication regimen often dont have DES implanted because of doctors concerns about their stopping antiplatelet therapy-a necessary part of the treatment plan with DES patients. Patients with DES are put on a regimen of antiplatelet medications after implantation to help prevent stent thrombosis.