A CDU

ORLANDO, Florida A wide variety of companies rolled out an even wider variety of new products and services on the Orange County Convention Center exhibit floor during the American College of Cardiology's (ACC; Bethesda, Maryland) annual scientific sessions last month. In addition to the product introductions in companies' booths, many technologies were the subject of clinical studies reported on either during sessions of the ACC meeting or in poster presentations on the exhibit floor.

Evalve (Redwood City, California) reported that when leaky mitral valves in patients' hearts were re-paired non-surgically with a tiny, catheter-fed clip developed by the company, nearly all more than 90% of the patients whose mitral regurgitation (MR) was significantly reduced one month after receiving the clip maintained the reduction at six months. In addition, 75% of the patients who received the clip as part of a Phase I clinical trial are still surgery-free. Mitral regurgitation is a debilitating condition that occurs when the mitral valve, which allows blood to move through the heart, fails to close properly.

"As we get more experience with this procedure, we're seeing that our ability to control the MR is increasing and the time it takes to accomplish the repair is decreasing. With this device, we can provide a minimally invasive option for decreasing valve leakage without taking away the patient's ability to have surgical valve repair in the future, if it's needed," said principal investigator Ted Feldman, MD, director of the cardiac catheterization lab at Evanston Hospital (Evanston, Illinois), flagship of the Evanston Northwestern Healthcare system.

Results of the study, known as the Endovascular Valve Edge-to-Edge Repair Study (EVEREST I) trial, which used the company's MitraClip, were part of the Oral Contributions: Percutaneous Valve Procedures Session.

To date, a total of 27 patients with severe mitral regurgitation have been enrolled in the trial. Feldman performed the first U.S. procedure in Evanston Hospital's cardiac cath lab. "As a group, we have seen minimal rates of complications occur during the procedures," said Feldman "We've also seen that for the majority of patients who achieve good initial results, favorable results are sustained. The patients who did not receive optimal MR control with the clip were able to have routine, conventional mitral valve surgery," he added.

Nationwide, study centers will soon begin enrolling eligible patients in EVEREST II, a prospective, randomized, multi-center study that will compare the clip approach with open-heart valve surgery.

Newly analyzed research on Orqis Medical's (Lake Forest, California) Cancion CRS cardiac recovery system for treating congestive heart failure was presented at the meeting. The data suggest that patients with acutely decompensated chronic heart failure may benefit from Cancion therapy. Based on Orqis Medical's discoveries in hemodynamic principles, the therapy is designed to create a unique "rest to recovery" environment that enable the failing heart to rest as it continues to function.

The company said it represents a "significant departure" from conventional drug therapy and more invasive blood pumps, which either force the failing heart to work harder, or rest it to the point where it begins to atrophy.

"The patients we analyzed clearly benefited from the Cancion CRS therapy," said Michael Zile, MD, a professor of medicine at Medical University of South Carolina (Charleston, South Carolina), who analyzed the research data. "By providing continuous aortic flow augmentation, the therapy enabled patients to experience progressive improvement in key measures such as cardiac index and pulmonary capillary wedge pressure."

The presentation included data from 24 patients with congestive heart failure who participated in Orqis Medical's feasibility trials in the U.S. and Europe. The Cancion cardiac recovery system (CRS) is the first therapy for congestive heart failure that supplements blood flow specifically in the descending aorta with the aim of initiating progressive hemodynamic improvement. Ongoing research is focused on the therapy's ability to induce vasodilation and improve renal blood flow while reversing the body's compensatory effects caused by abnormal aortic flow.

Vasomedical (Westbury, New York), a leader in the non-invasive treatment and management of cardiovascular diseases, reported the positive results of its PEECH (Prospective Evaluation of EECP in Congestive Heart Failure) trial. Arthur Feldman, MD, professor and chairman of the department of medicine at the Jefferson Medical College of Thomas Jefferson University (Philadelphia, Pennsylvania), presented the results of the PEECH trial at a Late-Breaking Clinical Trials session.

The PEECH trial evaluated the efficacy of external counterpulsation (EECP) therapy for the treatment of congestive heart failure (CHF). The results demonstrated that EECP therapy was significantly more effective in improving exercise duration than optimal pharmacologic therapy alone. After six months, exercise time increased by 25 seconds in the EECP group and decreased by 10 seconds in the control group. Additional endpoints of symptom status, assessed by New York Heart Association (NYHA) functional class, improved 31% in the EECP group compared to 16% in the control group. Overall quality of life, as reported on the Minnesota Living with Heart Failure scale, also improved significantly among patients treated with EECP therapy. Peak oxygen consumption was not significantly different between the two groups.

"The results showed that six months after treatment with EECP therapy, significantly more patients increased their exercise time compared with those receiving optimal drug therapy alone," said Feldman, principal investigator for the study. "That improvement together with improvements seen in symptom status and quality of life support the use of EECP therapy as an adjunctive treatment for chronic stable heart failure patients."

The study included 187 patients with mild to moderate heart failure (NYHA Class II/III) in 29 centers, randomized to receive EECP therapy and optimal pharmacologic therapy or optimal pharmacologic therapy alone. All patients received optimal drug therapy including a beta blocker and an ACE inhibitor or an angiotensin receptor blocker. Patients were followed for six months after completing treatment. EECP therapy is typically given in 35 one-hour-sessions over seven weeks. Patients lie down on a padded table and their calves, lower thighs and upper thighs are wrapped in a cuff set. The system, which is synchronized to the individual patient's cardiac cycle, inflates the cuffs with air to create external pressure when the heart is resting (diastole) and deflates the cuffs just before the heart beats (systole). The system's action, which pulses counter to the heart's beating, increases blood flow to the heart muscle and decreases the heart's workload, creating a greater oxygen supply for the heart muscle while lowering the heart's need for oxygen.

In other ACC news:

Assessment of patients in the various stages of moderate-to-severe heart disease was showcased by Cholestech (Hayward, California) on the exhibit floor and making its introduction on the LDX System to the U.S. market. The hs-CRP (for C-reactive protein) test in whole blood or serum on the LDX System will be available this summer, the company said. CRP is a systemic marker of inflammation, with its measurement useful as an aid in detecting and evaluating "infection, tissue injury, inflammatory disorders and associated disease," according to the company.

On the LDX system, the hs-CRP assay, a physicians' office test, produces results in six minutes. It provides comprehensive results on the LDX to provide cholesterol and liver enzyme assessment. Using a single drop of blood, the test measures a patient's lipid profile to determine overall cholesterol levels and the patient's risk of heart disease. The test, which has received clearance from the FDA, will be available this summer, Cholestech said.

Another simple test to measure the amount of cholesterol in the skin was described in a study presentation concerning the ability to identify those who appear healthy but have early-stage cardiovascular disease. The study, conducted by researchers at the University of Wisconsin Medical School (Madison, Wisconsin), compared the results of a skin cholesterol test done without requiring needle prick or other collection of blood against ultrasound testing in-tended to identify changes in the arteries in the neck. Researchers reported that the results of the two test methods were closely related, with a high skin cholesterol level aiding in predicting the risk of cardiovascular disease, even when other, more common risk factors were considered.

GenVec (Gaithersburg, Maryland) reported that three-year follow-up data from a Phase I study of its myoblast cell transplantation therapy for congestive heart failure was presented at the meeting. The purpose of the multi-center study was to demonstrate the safety and feasibility of using autologous myoblast transplantation to repair damaged heart tissue in patients who have suffered a heart attack.

In the study, myoblasts were harvested from the leg muscles of 30 patients and then cultured using GenVec's technique. Twenty-four patients received escalating doses of each patient's own purified myoblasts, which were injected into the area of the heart scarred by previous myocardial infarction during a previously scheduled coronary artery bypass surgery. Additionally, six patients scheduled to have left ventricular assist device (LVAD) implantation as a bridge to heart transplant received cells at the time of LVAD surgery.

The findings, presented by Nabil Dib, MD, director of cardiovascular research at the Arizona Heart Institute (Phoenix), included evidence of safety with no increased risk of arrhythmia. Encouraging evidence of myocardial remodeling, as shown by MRI, and of tissue viability, as shown by PET scan and MRI, also was seen.

The results indicate that myoblast transplantation is feasible and safe in patients who have suffered myocardial infarction and are scheduled to undergo coronary artery bypass surgery or receive a LVAD, and that this approach to repairing damaged heart muscle warrants further study.

Microlife (Tampa, Florida) introduced on the exhibit floor its new blood pressure (BP) monitor that also provides an indicator to users of potential arrhythmia problems, the company calling the device the first with this additional capability in a home use device. Teresa Barnes, director of communications for the company, told CDU that the key to the arrhythmia feature is its ability to differentiate between irregular heartbeats and motion artifacts. Beginning with the use of a traditional type of BP cuff, the device takes the basic systolic and diastolic measurements but also displays an icon that indicates an arrhythmia. With the display of this icon two or three times in 10 measurements, the user is encouraged to see his or her doctor for additional assessment of potential heart disease.

The system, featuring a highly readable tilted display screen, provides automatic storage of 99 readings with time and date. The line of blood pressure monitors use the company's Microlife Average Mode technology enabling patients "to make up to three consecutive blood pressure measurements automatically, to insure the most accurate measurement," Barnes said.

Scott Dube, president of MicroLife, told CDU that the algorithm for determining irregular rhythms was developed at the company's research facility in Germany. He said that the monitor received FDA clearance last year, and, with the completion of labeling and packaging, will be sold on the company's web site, and in Long's drug stores beginning this month. Microlife specializes in home monitoring equipment, with its core business being the manufacturing of digital thermometers and peak flow meters.

PDSHeart (Conyers, Georgia) a leader in cardiac monitoring and arrhythmia management services, introduced a new auto detection atrial fibrillation (AF) monitor The new Dual Alert monitor uses proprietary algorithms to detect and record asymptomatic arrhythmias. "The advanced algorithms in our monitor makes it the most sensitive and accurate AF event recorder in the industry," said Sean Heyniger, president and CEO of PDSHeart. "The new Dual Alert AF Monitor identifies more asymptomatic patients than was ever possible. Early detection coupled with anticoagulation therapy will greatly reduce the increased risks for AF patients."

ProVation Medical (Minneapolis) reported the official release of its ProVation MD Cardiology software for clinical documentation and coding compliance. ProVation MD for Cardiology is a multi-caregiver documentation and coding system that produces complete, billing-ready, diagram-enhanced procedure notes and coding reports. The software is available for Cath Lab, Echocardiography and Nuc-lear Medicine modalities.

Already in use by more than 4,000 clinicians at 250 medical facilities in specialties including gastroenterology, pulmonology, orthopedics, pain management and urology, ProVation MD software allows clinicians to create and finalize procedure notes in minutes complete with the appropriate ICD and CPT codes with CCI edits for proper reimbursement, compliance and faster payment.