Table of Contents
2000
Perimount bovine pericardial valve:
The first biomechanically engineered valve developed specifically for replacement of the human mitral valve was implanted for the first time in America at the Cleveland Clinic.
Infarct Exclusion:
The damage caused by a heart attack includes scar tissue and aneurysm (abnormal bulge or bubble in a blood vessel), either of which can cause heart failure. Infarct exclusion surgery involves removal of scarred heart tissue, repair of the aneurysm, and return of the left ventricle to a more normal shape. The goal is to improve the heart failure symptoms and angina (chest pain), as well as to improve the pumping ability of the heart. For some patients who have severe heart failure, infarct exclusion may be an alternative to a heart transplant.
Off-pump Coronary Artery Bypass Surgery:
One of the challenges of heart surgery is to perform delicate repair procedures on the heart's surface, while the heart is beating. Thus open-heart surgery usually involves stopping the heart and hooking the patient up to a heart/lung bypass machine. New devices, however, allow surgeons to stabilize targeted portions of a beating heart during surgery. The result is being able to perform coronary artery bypass procedures without using the heart-lung bypass machine.
Surgical Treatment for Aortic Endocarditis:
When the inner surfaces of the aortic valve and aortic root are infected (endocarditis), they are surgically removed and reconstructed using an aortic root from a donor heart. The approach has resulted in a dramatic reduction in mortality from aortic endocarditis.
Refinements of Maze Procedure:
Clinic heart surgeons continue to make refinements to the Maze procedure, a technique used to treat atrial fibrillation (an abnormal heart rhythm). The randomly traveling electrical impulses are redirected down a new path or “maze” created by surgical incisions in the heart's right and left atrium. Maze procedures are often performed in combination with mitral valve repairs. The Maze technique is an open heart procedure, requiring a traditional incision and the use of a heart-lung machine. Clinic surgeons are developing approaches that would allow the Maze to be performed in a minimally invasive manner.
Calcium Score Screening:
High-speed computed tomography (CT) scanning is now being used to predict risk of atherosclerosis. The non-invasive imaging process detects points of calcium buildup in the coronary arteries. The degree of calcification (plaque hardening) combined with other risk factor assessments provide a calculated predicted coronary artery disease risk score. This information helps clinicians develop more effective atherosclerosis treatment and prevention plans.
Ensite 3000 mapping:
Patients with heart rhythm disorders are treated with radiofrequency ablation, which involves heating and destroying small segments of the abnormal heart tissue causing the problem. A limited view of the intended target area, however, hampers the procedure. Using the Ensite 3000 mapping system, cardiologists can view larger areas to determine the most effective site for delivering the heat energy. Increasing target accuracy results in a safer procedure for patients.
Discovery of Gender Differences in Lp(a) Levels and Coronary Artery Disease Risk:
Heart and Vascular Institute researchers show that elevated lipoprotein(a) [lp(a)] may significantly increase the risk of coronary artery disease in women, as well as in men (as had been previously known). In addition, they discovered that while elevated lp(a) levels predicted coronary artery disease in men under age 55, elevated levels increase the disease risk significantly in women of all ages.
New diagnostic tools: Color M-Mode and Tissue Doppler Echocardiography:
Heart and Vascular Institute clinicians demonstrate the utility of Color M-Mode and Tissue Doppler Echocardiography, diagnostic tools that can aid the diagnosis of diastolic dysfunction, a problem that affects the heart's lower pumping chambers. Diastolic dysfunction indicates the presence of conditions such as coronary artery disease, hypertension, cardiomyopathy (abnormal enlargement of the heart) and constrictive pericarditis, inflammation of the protective sac that surrounds the heart. Compared with conventional echocardiography, the new technology offers much more detailed information about diastolic function.
Laser Extraction of Pacemaker Leads:
Pacemakers help maintain normal heart function in people with heart rhythm disorders. They work by sending electrical pulses through wires or “leads” that reside inside the heart's chambers. Sometimes these leads need to be replaced, but this procedure can be problematic if too much fibrous scar tissue has accumulated around the leads. To minimize the potential vessel trauma and pain associated with lead removal, Miller Family Heart & Vascular Institute electrophysiologists use a specially designed laser-equipped catheter that “melts” away the fibrous scar tissue.
Link Between Homocysteine and Atherosclerosis:
New Miller Family Heart & Vascular Institute research findings show that coronary artery disease risk is related to increased levels of plasma homocysteine in the elderly and women, as well as in young men. The findings also show that a low level of serum B6 is an independent risk factor for heart disease.
Homograft Mitral Valve Replacement:
Miller Family Heart & Vascular Institute cardiothoracic surgeons show that replacement of diseased heart valves can be improved in younger patients and women of childbearing age with the use of valves taken from donor hearts unsuitable for transplantation.
Cardiovascular Coordinating Center (C5):
The Cleveland Clinic Cardiovascular Coordinating Center (C5) is created to help streamline the process of developing and managing large-scale clinical trials that are necessary to test and validate new approaches for treating disease. The C5 offers comprehensive planning, coordination and documentation of multicenter clinical trials, and helps assess the accuracy of event-reporting through an adjudicated review of study data.
Radiation for Restenosis:
A stent is a flexible, mesh cylinder used along with angioplasty to help maintain adequate blood flow in a diseased coronary artery. Stents are effective but in some patients, they cannot stop the new accumulation and buildup of plaque on diseased vessel walls, a process known as restenosis. As new plaque develops on the inner surfaces of the stent, its ability to maintain blood flow is significantly reduced. To prevent this, Miller Family Heart & Vascular Institute interventional cardiologists can insert a catheter with an irradiated tip and treat (irradiate) the stented portion of the vessel. By doing so, they significantly reduce the likelihood that the newly re-opened blood vessel will restenose, or close up again.
Intractable Cardiac Failure:
The Surgical Heart Failure Program is being consulted by non-transplant cardiac surgery centers from multiple regions across the United States as an option in the treatment of intractable cardiac failure. The hospital-to-hospital transport of these patients on life support has become common. Transportation is facilitated through our relationship with the regional life flight agency who train with CCF in this effort.
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2001
Genequest:
In one of the largest genetic studies of its kind, “GeneQuest” investigators and collaborators at 15 institutions used a technology called “high throughput” microarray genotyping to sift through 62 genes of 352 families with coronary artery disease and 418 families without. Three previously unidentified genetic variants were discovered that may explain why some families are prone to premature heart disease. The culprit genes belong to a family of genes that regulate thrombospondin, a protein that fosters blood clotting.
Off-pump bypass surgery:
In patients who may benefit from avoiding the heart-lung machine, off-pump coronary artery bypass surgery offers another option. Rather than stopping the heart, technological advances and new kinds of operating equipment now allow the surgeon to stabilize portions of the heart during surgery. With a particular area of the heart stabilized, the surgeon can go ahead and bypass the blocked artery in a highly controlled operative environment. This technique allows the heart to keep pumping and circulating blood to the body.
Jarvik Heart Pump:
Surgeons at the Cleveland Clinic successfully implanted a Jarvik 2000 ventricular assist device into a 60-year-old Cleveland man. The Jarvik 2000 is a valveless, axial flow pump about the size of a “C” battery. Pumps such as these are used to keep failing hearts functioning as a bridge to recovery or until transplant surgery can be performed.
Vascular Intervention Program:
A team of physicians, specifically trained in vascular intervention, including peripheral and carotid interventions, join together to form the Vascular Intervention Program. These physicians employ angioplasty and stenting techniques to prevent stroke in cardiac surgery patients with peripheral or carotid occlusions, and to treat intracranial occlusions in patients with acute stroke or who fail antiplatelet and anticoagulation therapy. Outcomes of percutaneous interventions are monitored through patient registries.
New heart valves:
Currently, an FDA study is underway for a new St. Jude Medical® valve, the Regent aortic valve. This study will substantiate improved hemodynamics and flow characteristics for the redesigned valve. The St. Jude Medical® valve is one of our most frequently used mechanical valves.
ACUTE results decreases cardioversion time for atrial fibrillation:
The ACUTE trial shows high-resolution ultrasound, called transesophageal echocardiography (TEE), a non-invasive imaging technique, cuts the time between diagnosis of atrial fibrillation and electrical cardioversion treatment by quickly revealing whether patients with atrial fibrillation have blood clots that put them at risk for stroke during treatment.
The Maze procedure:
The Maze procedure is performed on patients who have chronic atrial fibrillation or symptomatic drug refractory paroxysmal atrial fibrillation. This technique is frequently combined with mitral valve repair. Return to sinus rhythm is over 90% at 3-year follow-up. In addition, since the left atrial appendage is removed and the left atrial diameter reduced, atrial contraction usually returns (>70%). This has virtually eliminated late thromboembolic events and the need for anticoagulation. Under investigation is the use of radio frequency ablation to reduce the number of incisions and simplify the procedure. Also under investigation are ways to perform the operation using minimally invasive techniques so that the operation can be used more often as an adjunct to other heart operations.
Heart Assist Devices:
All FDA approved heart assist devices are available for use in the surgical treatment of acute heart failure, either as a bridge-to-heart transplantation or as an adjunct to recovery of the native heart function. This is unique to United States cardiac surgery practices and allows adjustment of the technology, not the patient, to suit individual needs.
Cerebral Vascular Protection:
In patients who undergo aneurysm surgery with the use of cardiopulmonary bypass (CPB), retrograde cerebral perfusion is used to protect the brain from stroke. CPB is temporarily suspended during the most critical part of the operation and blood is perfused backward through the brain.
Embolx arterial filter:
Begun mid-2000, CCF was selected as a center for the evaluation of Embolx, an intraaortic filtration system. This system is a filter device deployed via the arterial cannula to capture debris that may occur from the aortic cross clamp or manipulation of the heart during surgery. This technology should help to eliminate or reduce neurologic injury that may occur during heart surgery.
New Risk Factor for CAD:
Researchers from the Cleveland Clinic Center for Cardiovascular Diagnostics and Prevention and The Cleveland Clinic Lerner Research Institute demonstrated that people with increased levels of the enzyme myeloperoxidase (MPO) in white blood cells have increased prevalence of coronary artery disease. Significantly, the research showed that increased levels of MPO were observed in people with coronary artery disease even if they did not have traditional risk factors.
New Technology for Wounds:
The Arglaes Dressing study was begun at the Cleveland Clinic late 1999 and completed in December, 2000. Over 900 patients were randomized to receive Arglaes dressing or conventional dressing therapy. Results are being analyzed and will be reported at the national meetings during the next several months. The Arglaes dressing contains a polymer which releases ionic silver to create an environment hostile to bacteria; the controlled release is achieved by use of special slow-release polymers. The dressing remains intact for up to five days and creates a barrier for wound infection.
Chimeric Therapy:
Heart transplantation is followed by transplantation of donor bone marrow to decrease the need for chronic immunosuppression. This technique stimulates the body's immune system to accept the new heart, and may eventually reduce the need for the long-term use of drugs to prevent rejection.
Space-based Digital Echocardiography:
Working with NASA, the Miller Family Heart & Vascular Institute developed a digital echocardiography laboratory for use in the International Space Station. The project calls for improving methods of compressing digital data for satellite downlinks and new real-time 3-D echocardiogram technology.
Raising a Cautionary Flag About COX-2 Use in High-Risk Heart Patients:
Eric J. Topol, MD, and Steven E. Nissen, MD, Chairman and Vice-Chairman of cardiovascular medicine at the Cleveland Clinic, performed a retrospective review of the original data submitted to the FDA in the randomized multicenter safety trials of rofecoxib (Vioxx) and Celecoxib (Celebrex). They found physicians should use caution when prescribing COX-2 inhibitors to patients with known coronary disease since these anti-inflammatory agents may lead to an increase in risk of heart attack and stroke.
Stenting Renal Arteries Improves Heart-Failure Symptoms:
Peripheral vascular disease interventionalists find percutaneous transluminal angioplasty with stenting of atherosclerotic renal arteries can dramatically improve symptoms of heart failure. A clear advantage of using angioplasty and stenting in patients with bilateral renal artery stenosis or renal artery stenosis to one functioning kidney is that it makes possible the use of angiotensin-converting enzyme (ACE) inhibitors, with numerous cardiac and renal benefits. The use of ACE inhibitors in the presence of untreated renal artery stenosis can lead to azotemia.
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2002
Microchip to monitor heart failure:
The micro-electro mechanical systems (MEMS) device is a small microchip, made of flexible plastic and designed to signal imminent cardiac problems in patients who have heart failure. It’s smaller than a dime, as thick as a sheet of paper, wireless and requires no battery. Power is supplied by a hand-held transmitter/receiver. The device can give doctors daily reports on pressure in the heart chambers. A change in pressure is one of the first events that occur when patients with congestive heart failure are beginning to decompensate, or worsen. This device may have other applications, in vascular and orthopedic patients.
Carotid emboli protection device:
A new filtering device, used in combination with antiplatelet medications, increases the safety of carotid artery angioplasty and stenting. The AngioGuard Emboli Capture Filter device captures particles (emboli) that may break away from the artery walls during the stenting procedure. If these particles travel up the artery and into the brain, they can cause a brain attack, or stroke. Studies show that stenting used in combination with the AngioGaurd filter is as safe and effective as carotid artery surgery, which involves surgically opening the neck and vessel. Learn more.
Myeloperoxidase (MPO), a marker for cardiovascular risk:
The molecule myeloperoxidase, or MPO, has a clear and well-known role in immune-system defense, and is associated with inflammation,a key suspect in atherosclerosis, myocardial infarction (heart attack), stroke and need for bypass surgery. “MPO is one of the most potent chemical weapons used by monocytes, neutrophils and other cells against microbial invasion,” says Stanley L. Hazen, MD, PhD, a cardiovascular researcher and coordinator of the Clinic’s latest study of MPO. “When released, it creates a variety of free radicals and chlorine-based oxidants.” For patients with chest pain, MPO testing increases the ability to predict future (60month) cardiac risks from 50 to 95 percent. Before MPO can be used as a screening tool, a commercially available test needs to be developed.
More options for atrial fibrillation treatments:
Pulmonary vein ablation is an important treatment for managing the heart rhythm disorder, atrial fibrillation. The Tomsich Family Department of Cardiovascular Medicine, section of Electrophysiology and Pacing, employs a new circumferential mapping technique. The new approach boosts ablation success rates to 80% for first attempts and 95% for subsequent attempts. The Maze procedure, another intervention for managing atrial fibrillation, involves heart surgery, during which small incisions in the tissue of the upper heart chambers are used to redirect erratic electrical activity. At the Clinic, as an alternative to creating the Maze incisions surgically, Heart and Vascular Institute surgeons begin testing the effectiveness of different energy sources to create “ablation lines” that help control the rhythm disorder. These new approaches reduce the complexity of the traditional Maze procedure and decrease surgery durations, all of which benefits patients. Learn more.
Pacemaker for heart failure:
In approximately one-third of heart failure patients, the heart's lower chambers no longer pump in synchronized fashion. But, implanting a special device — a transvenous biventricular pacemaker — can help resolve this problem. Two wires, or leads, run from the pacemaker and into the heart — one each in the left and right ventricles. This system allows the heart to pump blood more efficiently, thereby reducing the risk of serious cardiovascular events, and improving quality of life. Some patients with heart failure are also at high risk for sudden death, caused by abrupt, unpredictable life-threatening arrhythmia. These patients can be outfitted with a combination defibrillator/biventricular pacemaker, should a life-threatening heart rhythm occur. Learn more.
Robotic Heart Surgery:
Coronary artery bypass surgery, or CABG, involves using healthy blood vessels (“harvested” from key locations in the body) to reroute blood flow around blocked coronary arteries. This is a significant, complex surgical intervention that involves opening the chest with a large incision to expose the heart and that requires several days of hospitalization. But Cleveland Clinic cardiothoracic surgeon José L. Navia, MD, demonstrates a less invasive option with a robotic device—the da Vinci Surgical System. Robot-assisted surgery is used to assist the surgeon to harvest the mammary artery (in the chest wall) through a very small incision. The mammary artery is then used to bypass a blocked LAD (left anterior descending) artery through a small incision.The da Vinci surgery reduces surgical trauma, causes less pain, and requires lower amounts of pain medication. The da Vinci system also results in less bleeding, a lower risk of infection, shorter hospital stays, and faster return to normal activities. Learn more.
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2003
First Gene Linked to Heart Attack, Coronary Artery Disease:
Scientists at the Cleveland Clinic have identified the first gene confirmed as a cause of coronary heart disease in humans. Results of this groundbreaking research appears in the Nov. 28 issue of Science*. The gene, MEF2A, was discovered by methodically studying the genetic makeup of 21 members of an Iowa family plagued for generations by incidents of coronary artery disease and heart attack. Every patient in the Iowa family who experienced a heart attack had at least one coronary risk factor. As Cleveland Clinic scientists looked for the genetic link, researchers in the laboratory of Qing Wang, Ph.D., scanned the complete genomes of all participating members of the family.
The area of interest proved to be located on chromosome 15, long arm 26. This region contains about 93 genes. Dr. Wang and his colleagues noticed a big difference in the MEF2A gene between family members who had developed coronary heart disease and those who had not. The MEF2A gene makes a regulatory protein that controls the expression of hundreds or even thousands of other genes in the endothelium, the barrier between blood vessels and blood elements. Cleveland Clinic scientists suspect the resulting genetic changes weaken the endothelium, making it more susceptible to invasions and attacks by monocytes and macrophages, which allow the formation of atherosclerotic plaques. Once the arterial wall integrity is lost and thrombosis has occurred, unstable angina, heart attack or sudden cardiac death can result. “Finding the gene opens a new avenue through which scientists can track the pathway that leads to coronary heart disease and heart attack,” Dr. Wang said. “Genes in that pathway then can be used as targets to design new drugs intended to prevent or treat heart disease. Finding the gene also will make it easier to definitively diagnose patients with highly significant family histories of heart disease.”
Replacement of Entire Aorta:
The aorta is the largest and most important artery and the vessel that sends oxygenated blood from the heart out to the rest of the body. Artery disease, connective tissue disorders (such as Marfan Syndrome) smoking, high blood pressure, aging or injury, however, can weaken portions of the aorta, causing the walls of the vessel to bulge, a condition called aneurysm. This is a very serious condition because an aneurysm can rupture and cause swift death. Some patients have aneurysms involving the entire aorta. Cleveland Clinic surgeons now treat the entire aorta in a single operation. The aorta is replaced from the aortic valve down to the aortic bifurcation. If needed, the aortic valve itself can also be replaced. Learn more.
Heart Splint:
As heart failure advances, it changes the shape and integrity of the heart's lower left chamber, or left ventricle. The result is inefficient pumping that leads to a host of serious problems involving the heart, lungs and other organs. The Myocor Myosplint is an innovative therapy developed for patients with heart failure. By surgically implanting the Myosplint into the left ventricle, Cleveland Clinic heart failure specialists hope to reshape and strengthen the left ventricle and reduce ventricle wall stress. This should improve the pumping ability and effectiveness of the heart. A clinical study has been approved by the FDA and is currently underway at the Cleveland Clinic. Learn more.
Mesh “jacket“ for the heart:
Heart failure is the left ventricle’s enemy, causing a change cardiologists call “remodeling.” The left ventricle tissue stretches, the size of the chamber enlarges and the walls grow thinner. All of this weakens pumping ability. As the condition progresses, so does remodeling. To increase left ventricle strength and to help reverse remodeling, Cleveland Clinic heart surgeons enwrap both ventricles with a biocompatible, mesh-like jacket called the Acorn Cardiac Support Device. By supporting the heart and thereby reducing stress-mediated myocardial stretch, the Acorn CSD is intended to stabilize or reduce heart size and improve cardiac function. To date, more than 50 CSD implants have been performed, and a worldwide randomized trial is currently under way. Learn more.
Coated Stents to Decrease Restenosis:
Stents are slender mesh cylinders, used to keep open arteries narrowed because of atherosclerosis. Although stents are effective in reducing restenosis (re-narrowing), 20 percent of stented patients still have this problem. In April 2003, the FDA approved the use of drug-eluting stents, designed specifically to counteract restenosis. It was clinical trail research conducted by Miller Family Heart & Vascular Institute interventional cardiologists that helped demonstrate the effectiveness of the new drug-coated, or drug-eluting stents. The development is important, not only because of restenosis, but because use of drug eluting stents could significantly reduce the need for bypass surgery, a costly involved intervention.
Off-pump bypass surgery:
The heart-lung machine, takes on the job of oxygenating blood and pumping it through the body during heart surgery. Thus blood is diverted from the heart so that surgeons can work on a blood-free, still surface. A new coronary artery bypass grafting (CABG) approach, however, involves foregoing use of the heart lung machine, a procedure called “off pump” bypass surgery. This technique allows the heart to keep pumping and circulating blood to the body during surgery, but it also allows surgeons to stabilize (make still) portions of it as well. Both the traditional and new CABG approaches are safe and effective, but as Cleveland Clinic heart surgeons show, off-pump bypass surgery may be a more effective option for some patients—particularly older patients who have a history of stroke or who have renal disease, lung and breathing problems, and narrowing of the carotid (neck) artery, or small and calcified (hardened) coronary arteries. Learn more.
New Tricuspid Annuloplasty Ring:
The heart’s tricuspid valve separates the right ventricle (lower heart chamber) from the right atrium (upper heart chamber). As oxygen poor blood fills the right atrium, the tricuspid valve promotes its flow into the right ventricle, so it can be sent to the lungs for oxygenation before returning to the left side of the heart. When the tricuspid valve becomes ineffective, blood is allowed to flow back up into the right atrium (called tricuspid valve regurgitation). Resolving the problem surgically with traditional approaches is problematic for many reasons. So Cleveland Clinic heart researchers, working with Edwards Lifesciences Corp., developed a special ring called the Edwards MC3 Tricuspid Annuloplasty System. The ring fits precisely on the contours of the tricuspid opening and reduces amount of regurgitation in persons with valve disease. Learn more.
New Mitral Valve Ring:
The mitral valve is the blood flow manager for the heart’s left side, promoting smooth flow of oxygenated blood from the left atrium (upper chamber) into the left ventricle (lower chamber), where it begins its journey throughout the body’s vessels. The valve cusps—the floodgates here for blood flow—can be damaged, resulting in backflow of blood into the right atrium, a condition called mitral regurgitation. A Cleveland Clinic research collaboration, however, results in the development of a special ring (Carpentier-McCarthy-Adams IMR ETlogix Annuloplasty Ring) that can be fitted strategically to the mitral valve to improve function and reduce the amount of regurgitation in persons with valve disease. Learn more.
1,000th Transplant:
The MIller Family Heart & Vascular Institute at Cleveland Clinic Transplant Program completes its 1,000th heart transplant. Only two other hospitals across the nation achieve this milestone, according to the United Network for Organ Sharing. Although the Clinic performed its first heart transplant in 1968, it officially began a heart transplantation program in 1984. In 1998, the Miller Family Heart & Vascular Institute at Cleveland Clinic performed 113 heart transplants, marking a new world record for the number of heart transplants performed in a single year. The one-year survival rate for these patients was 95 percent, well above the national one-year survival rate average of 83 percent. In 2002, The Cleveland Clinic was only one of 168 U.S. heart transplant programs to achieve better-than-expected patient survival rates at three different time periods after transplant, according to data released by the U.S. Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients. The Clinic's actual survival rate was 96.2 percent vs. an expected rate of 91.7 percent.
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2004
Ascending and descending aortic aneurysm repair: For patients with aneurysms, the aorta can be replaced from the aortic valve down to the aortic bifurcation in a single operation at the Cleveland Clinic. This is done through combined incisions in the chest and mid abdomen.
The axillary artery is used to provide ongoing blood perfusion to organs during aortic aneurysm repair and when atherosclerosis (plaque) is present in the ascending aorta. Learn more.
New statistical method:
What is the prevalence of atrial fibrillation during follow-up after surgical treatment? Patients are not monitored continuously, so the only data available is obtained from sporadic electrocardiograms (EKGs). Researchers anticipated that the prevalence of afib would vary with time in a complex way—high prevalence early after operation, lower prevalence later. Until now, there have been no statistical tools to analyze such data effectively. A method has been developed to “decompose” this temporal data into simple components (see graph), much as a prism breaks white light into a rainbow of colors. Each component, like a color, can have a different intensity that depends on patient and disease factors.
ACORN:
The ACORN CorCap® is a mesh-like polyester “jacket” that is surgically wrapped around a dilated left ventricle to help restore an enlarged heart to a more normal size and shape. Placement of the ACORN CorCap® can be performed during other cardiac procedures. The Cleveland Clinic was integrally involved in a worldwide randomized trial utilizing this device. Nicholas Smedira, MD, and Randall Starling, MD, MPH, were the Cleveland Clinic co-principal investigators. In Fall 2004, clinical trial results presented at the American Heart Association Scientific Sessions indicated that patients treated with this device demonstrated sustained improvements in heart size and shape; showed significant improvements in quality of life using standardized evaluation methods; and were 50 percent less likely to require additional cardiac procedures for worsening heart failure, such as transplants and implants of ventricular assist or electrical stimulation devices. The trial sponsor has submitted these results to the FDA for approval so that this viable treatment option can be made available to appropriate heart failure patients in the United States. The ACORN CorCap® is currently approved in Europe.
Treatment of atrial flutter:
The Cleveland Clinic Heart and Vascular Institute began to use a new cardiac ablation system to treat atrial flutter. The device uses radiofrequency energy to help block the errant electrical impulses that cause the heart to “flutter.” Atrial flutter is a rhythm disturbance that originates in the right atrium of the heart and results in a rapid heartbeat of 240 to 400 beats per minutes. An estimated 200,000 new patients are diagnosed with atrial flutter each year in the United States. The new cardiac ablation system uses a larger tip electrode to deliver up to 100 watts of radiofrequency energy to the heart to create scar tissue. The scar tissue then blocks the electrical impulses that are causing the flutter.
Five Lipo-oxygenase Activation Peptide (FLAP):
Scientists at the Cleveland Clinic were involved in an international study identifying the first complex genetic basis of heart attack. The study identified a set of genes, or haplotype, associated with a 1.8-fold increased risk of heart attack and a 1.6-fold increased risk of stroke. Complete research results appeared in the March, 2004 issue of Nature Genetics. “This discovery is an important step in helping us to identify at-risk patients based on their genetics,” said Eric J. Topol, MD “This early identification will allow us to intervene with measures designed to prevent these heart attacks and strokes from occurring.” Dr. Topol served as a co-author of the landmark study.
A drug that specifically blocks FLAP currently is being tested in a Phase II clinical trial involving patients with this “at risk” haplotype. The trial will seek to determine whether the drug DG031 helps to prevent death, heart attack and stroke in the affected patients. Future research with FLAP also will seek to determine how common the set of genes is in American patients. Currently, no commercial test is available to screen for the haplotype.
Stentless bioprosthetic mitral valves:
The ultimate goal of valve replacement is to mimic the structure and performance of a normal native valve.
Stentless Mitral Bileaflet Valve
Inflow Orifice
Outflow Orifice
Stentless Mitral Bileaflet Valve with Chordae
Inflow Orifice
Posterior Leaflet: side view
Jose L. Navia, MD, Department of Thoracic and Cardiovascular Surgery, has developed a stentless mitral valve, made of one piece of bovine pericardium. This design preserves the structural integrity of the mitral annulus and provides papillary muscle continuity. This is essential for normal left ventricular function and hemodynamic efficiency. Two valve concepts have been created: the Classic Bileaflet Valve and the Classic Bileaflet Valve with Chordae.
The SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy) study
was the first study to compare carotid stenting with embolic protection to traditional open surgery to clear clogged neck arteries and restore blood flow to the brain in high-risk surgical patients. According to the study led by Jay Yadav, MD, Director of Vascular Intervention at the Cleveland Clinic, a minimally invasive procedure to clear plaque-filled neck arteries is as effective as traditional surgery in patients at high risk for open heart surgery. The minimally invasive treatment uses a stent in combination with a special filter to catch any emboli, or bits of plaque, that break free during the procedure. Click here to learn more about carotid stenting.
CRUSADE quality improvement initiative:
Cleveland Clinic cardiologist Deepak L. Bhatt, led research that shows earlier and more aggressive treatment for patients at high risk of heart attack can reduce their chances of dying during hospitalization, but such treatment often is underutilized. According to the research, performing cardiac catheterizations on high-risk patients seeking treatment for acute coronary syndromes — conditions ranging from heart-disease-related chest pain to heart attack — within 48 hours of their seeking help can significantly reduce their risk of in-hospital mortality. Cardiac catheterization is a minimally invasive procedure used to diagnose or treat heart problems, and often serves as a prelude to angioplasty/stenting or bypass surgery.
Exercise stress test combined with health risk assessment helps predict mortality in patients without cardiovascular disease: Research conducted by the Cleveland Clinic showed that combining a simple treadmill test with a global health risk assessment can help to determine a person’s mortality risk even when that person does not have signs or symptoms of cardiovascular disease. Complete results of the 12-year study appear in the Sept. 22 issue of the Journal of the American Medical Association. “Previous Cleveland Clinic research has found exercise stress tests to be valuable in monitoring the health of people with known or strongly suspected cardiovascular disease,” said Michael S. Lauer, MD, study investigator and staff cardiologist at the Cleveland Clinic. “This study shows how to make the tests relevant for people without obvious cardiovascular disease or symptoms. The way we’ve found to do this is to combine a global risk score with the exercise stress test.
REVERSAL trial shows intensive cholesterol lowering with atorvastatin halts progression of heart disease:
The REVERSAL trial, directed by Cleveland Clinic cardiologist Steven Nissen, MD, compared the highest doses available at the time of two popular statin drugs, pravastatin and atorvastatin. Both medications work to block the liver’s ability to produce harmful cholesterol, which can clog coronary arteries. Complete trial results were published March 3 in the Journal of the American Medical Association. The more intensively-treated atorvastatin patients reached an LDL-C level (the bad cholesterol) of 79 milligrams per deciliter (mg/dL), while the more moderately treated pravastatin patients achieved an LDL-C of 110 mg/dL. Current guidelines set by the National Cholesterol Education Program* suggest treating patients to an LDL-C target level of 100 mg/dL. “The REVERSAL trial demonstrates that if we want to prevent the progression of coronary disease, we need to treat patients to much lower levels,” Dr. Nissen said.
Blood pressure control:
Administration of blood pressure-lowering medication to heart disease patients with “normal” blood pressure dramatically reduced the risk of adverse cardiac events and slowed disease progression, according to the CAMELOT trial, published in the November 10, 2004 issue of the Journal of the American Medical Association (JAMA). After two years of treatment with the anti-hypertensive drug amlodipine, which is in a class known as calcium channel blockers, patients experienced a 31-percent reduction in major adverse cardiovascular events, including heart attack, stroke, death, hospitalization for chest pain and need for angioplasty or bypass surgery. “This is the first study to demonstrate that blood pressure reduction can slow or halt the buildup of plaque in the coronary arteries,” said Dr. Nissen, the CAMELOT principal investigator. Previously, only cholesterol-lowering drugs have been shown to slow disease progression. The current study demonstrates that blood pressure-lowering drugs produce similar benefits.
Left ventricular assist device milestones:
In 2004, 19 patients were supported with four different left ventricular assist devices, two Heartmate® II continuous flow pumps and three Abiomed AB5000™ ventricles were inserted, and The Miller Family Heart & Vascular Institute at Cleveland Clinic participated in two randomized ventricular assist device trials (Reliant and Delta) for destination therapy.
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2005
New investigational procedures are being tested to treat leaky mitral valves without surgery:
The first procedure, performed in the cardiac catheterization laboratory on consenting patients, uses a special catheter with a very small, clip-like prosthesis device (called the Cardiovascular Valve Repair System), to hold the mitral valve leaflets together. Ultrasound and fluoroscopy guide the placement of the clip, which connects the leaflet edges. This trial is called EVEREST (Endovascular Valve Edge-to-Edge Repair Study).
A second procedure, called the percutaneous mitral annuloplasty, is currently being tested in the operating room by a cardiologist and a cardiothoracic surgeon on consenting patients. This technology focuses on reshaping the valve annulus and posterior mitral valve leaflet with a special device. Placement of the device pushes the support structures of the mitral valve and its leaflets back into more normal alignment, mimicking a surgical annuloplasty. approach allows the mitral valve to be repaired in the catheterization lab, without the need for surgery. This annuloplasty technique, developed in conjunction with A. Marc Gillinov, MD, may extend mitral valve repair to patients with heart failure and those who have a high surgical risk.
Valve Hemodynamics:
The Cleveland Clinic was one of the earliest adopters of this new tissue based aortic valve. The Magna valve by Edwards Lifesciences represents new valve technology that has helped improve the hemodynamics and durability of bioprostheses. Cleveland Clinic research and experience have demonstrated that for most patients, tissue valves provide the best option when valve replacement is required.
Self-Supported Annuloplasty:
This is a complete, self-supported and semi-flexible mitral and tricuspid annuloplasty stent-ring, introduced percutaneously and deployed into the supra-annular valvular position using balloon expandable technology. The purposes of this prosthetic ring are to restrict and support the native annulus, to correct and prevent valvular regurgitation, and to reestablish the normal shape and contour of the native annulus, allowing effective functioning of the valve. This system is being developed by staff surgeon José L. Navia, MD
Valve Chordae measuring tool, view one
Valve Chordae measuring tool, view two
Valve Chordae:
Placing new chordae is sometimes necessary for mitral valve repair. Cleveland Clinic surgeons have simplified the creation of artificial mitral valve chordae by using an innovative measuring tool or caliper. The tool enables greater precision and accuracy when replacing diseased chordae.
New multi-detector CT scans:
New multi-detector CT scans of the heart (also called coronary computed tomography angiogram or coronary CTA), hold the prospect of largely replacing invasive diagnostic angiograms. These scans, being investigated at the Cleveland Clinic, could be used to determine if a coronary artery is narrowed or blocked by atherosclerosis. These scans take seconds to conduct and require no recuperation.They would be most useful in an emergency room setting when patients are admitted for chest pain, according to Mario Garcia, MD, director of the Echocardiography Lab. The Cleveland Clinic is comparing the outcomes of both 40-detector and 64-detector scanners.The best uses of these scanners – and others – continue to be refined by only a few leading cardiovascular centers. Learn more.
Virtual Histology:
D. Geoffrey Vince, PhD, Department of Biomedical Engineering, D. Geoffrey Vince, PhD, Department of Biomedical Engineering, has developed virtual histology with intravascular ultrasound, which provides an accurate picture of the concentration and composition of vascular plaque in a format that is fast, inexpensive and portable. Learn more.
Innovative Arch Aneurysm Repair:
The image at left, provided by Cleveland Clinic vascular surgeon Roy Greenberg, MD, demonstrates an arch aneurysm repair with an aortic stent graft branching into the left common carotid artery and a carotid-subclavian artery bypass. Our cardiac surgeons frequently work in tandem with vascular surgeons, offering a team- based approach to treating complex aortic disease. Learn more about our Aorta Center.
Retrograde Perfusion System:
Developed by Cleveland Clinic surgeon José L. Navia, MD, this system facilitates auto-retroperfusion of the patient's oxygenated blood through the coronary sinus without total occlusion of the sinus and without a complex gating mechanism for the obstructive balloon. The cannula also allows for percutaneous drug delivery.
Mechanical Assist Devices:
In collaboration with the Department of Thoracic and Cardiovascular Surgery, the Department of Biomedical Engineering has been working on the development of three cardiac mechanical assist devices covering a wide range of uses — from bridge-to-transplant to permanent support; pediatric to adult support; and continuous flow to pulsatile flow. Learn more about these assist devices.
New gene linked to blood vessel formation:
Cleveland Clinic-led researchers identified a new gene that regulates blood vessel formation, or angiogenesis, within the human body. Their discovery may have potential in devising new treatments for cancer, ischemic heart disease, stroke and other conditions. The research, led by Qing Wang, Ph.D., director of The Cleveland Clinic’s Center for Cardiovascular Genetics and associate staff member in the Department of Molecular Cardiology within the Clinic’s Lerner Research Institute, provides additional insight into the rare illness we studied to help isolate the angiogenesis gene. It also has shown how certain processes work within the body to increase or decrease blood vessel growth — either by starting or stopping it — to help control disease. Learn more.
Implantable Hemodynamic Monitor in Patients with Heart Failure:
The HeartSensor® is similar in size to a pacemaker and measures critical clinical factors such as intra-cardiac pressure. Daily pressure readings are conducted via home monitoring devices and the data is transferred over a phone line to the physician.The HeartSensor® may help physicians to better manage patients with heart failure. Medications can be adjusted as necessary, and the device serves as an early warning before physical symptoms are manifested.
Nanotechnology: BioMems
Over the past three decades, the semiconductor and microelectronics industries have introduced technological innovations that have led to economic growth. Many of the techniques developed in these industries have been harnessed to develop MEMS (micro- electromechanical systems). MEMS is technology on the micron and nanometer scale, that integrates mechanical structures, such as sensors and mirrors, with electronics. MEMS is an established technology in airbag sensors, DLP projectors and scanners, but generally has not been applied to medical devices. Shuvo Roy, Ph.D. and Aaron Fleischman, Ph.D., from The Cleveland Clinic BioMEMS Laboratory, apply microelectro-mechanical systems (MEMS) to biomedical applications.
The medical device company CardioMEMS, Inc., is using MEMS technology to create breakthrough devices for the diagnosis, treatment and management of serious diseases. CardioMEMS, Inc., is a Cleveland Clinic and Georgia Institute of Technology company based in Atlanta that was incorporated in 2000. The first devices introduced by CardioMEMS Inc. are wired and wireless sensors for measuring pressure in the heart and aorta. These sensors allow better management of patients with aortic aneurysms as well as patients with congestive heart failure, and have been tested in patients at the Cleveland Clinic.
Minimally Invasive Approach for Biventricular Lead Placement:
Cardiac surgeons are now able to insert biventricular leads using robotics and a thorascopic approach to treat patients with heart failure.
Thorascopic lead placement
Robotic technology for placing pacing leads on the ventricle
Stem Cell and Gene Therapy for Heart Failure: Stem cells are naturally recruited to the site of a myocardial infarction (heart attack) for up to 5 days following the event, but are not recruited days or weeks later, even when stem cells are mobilized in the blood stream.
Marc S. Penn, MD, PhD has been involved in the development of Stromal Cell-Derived Factor 1 (SDF-1). SDF-1 promotes angiogenesis.
Autologous skeletal myoblasts are modified to over-express SDF-1 and then transplanted in the infarct zone 8 weeks after a heart attack. Mobilized stem cells are then “homed” to the area of the infarct and form new blood vessel tissue.
Medication for stem cell mobilization:
The Cleveland Clinic study is evaluating the safety and effectiveness of the use of Neupogen, a medication similar to a naturally-occurring protein that stimulates the production of specific cells in the bone marrow.This drug is being evaluated to potentially bring new life to a damaged heart and improve heart function after a heart attack.
AlloMap:
The Miller Family Heart & Vascular Institute at Cleveland Clinic was one of eight leading transplant centers involved in the Cardiac Allograft Rejection Gene Expression Observational (CARGO) study to evaluate peripheral blood gene expression for cardiac transplantation acute rejection management. AlloMap is a new blood sample based diagnostic test developed to manage the complex immunologic questions posed by cardiac transplant patients.
Traditionally, a heart transplant patient has multiple biopsies on his/her transplanted heart (called an allograft), to detect evidence of rejection.The AlloMap molecular expression test offers a technologically- advanced, less- invasive alternative and is designed to reduce the need for endomyocardial biopsy.
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