A Medical Device Daily

ORLANDO, Florida – As the American College of Cardiology's (ACC; Bethesda, Maryland) annual meeting wound down at the Orange County Convention Center at midweek, the volume of important new studies and product introductions continued to pour in.

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 at the meeting.

Arthur Feldman, MD, professor and chairman of the Department of Medicine at the Jefferson Medical College of Thomas Jefferson University (Philadelphia) 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.

"The economic burden to treat heart failure is tremendous and there is a dire need for new and effective treatment options given that there are few consensus therapies beyond medical management. The results of the PEECH trial provide clinical evidence demonstrating the benefits of EECP therapy for the management of CHF," said Thomas Glover, president and CEO of Vasomedical. "The positive PEECH results announced today are a critical step toward [our] goal to include EECP therapy in the standard of care in treating CHF."

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.

Mallinckrodt (Hazelwood, Missouri), a business unit of Tyco Healthcare (Mansfield, Massachusetts), reported the successful completion of two Phase II studies using its OptiMark imaging agent to determine safety and effectiveness in identifying the presence, location and extent of myocardial infarctions.

The results of these first, large, multi-center, international trials were presented in abstract form. The data from these dose-ranging studies identified the optimal dose to use in patients with a suspected heart attack and also demonstrated the safety of OptiMark in this patient population.

"Mallinckrodt has made a considerable investment in new indications for OptiMark imaging agent, which demonstrates our commitment to the product and the continued growth potential of magnetic resonance imaging," said Steve Hanley, president of the Mallinckrodt Imaging Division. "As we approach the Phase III trials of OptiMark, we are hopeful that this will lead to a paradigm shift in the diagnosis of myocardial infarction."

The Phase II studies involved more than 600 patients and 26 investigators at 23 sites.

Following a myocardial infarction, the identification of damaged myocardium plays an important role in the management of patients with coronary artery disease. Noninvasive techniques used to identify viable myocardium include echocardiography, thallium nuclear imaging and FDG PET imaging. Although used clinically, these imaging methods possess several limitations such as poor imaging windows, attenuation artifacts causing blurred images, lack of sufficient resolution and lack of ready access.

MRI is able to detect the difference between living heart tissue and tissue that has died or become scarred as a result of a heart attack. The use of gadolinium-based contrast agents enhances areas of non-viable or scarred tissue according to published literature.

Currently, the FDA has approved the OptiMark imaging agent for use in diagnosing abnormally functioning blood vessels and tissues in the brain, spine and liver.

In another of a lengthy list of product announcements it made at ACC, GE Healthcare (Waukesha, Wisconsin) reported that its new Vivid i compact cardiovascular ultrasound system is benefiting pediatric patients in neonatal intensive care units (NICU), as well as infants receiving care in outreach clinics.

GE said the Vivid i is the world's first miniaturized cardiovascular ultrasound system, enhancing the efficiency and reach of physicians by offering the functionality and high performance of full-featured, larger-scale systems – but in a portable and wireless design that weighs up to 40 times less.

Achi Ludomirsky, MD, director of pediatric cardiology at St. Louis Children's Hospital and the Louis Larrick Ward professor of pediatrics and biomedical engineering at Washington University School of Medicine (both St. Louis), said the portability and miniaturization of Vivid i helps address the space constraints around newborns in the NICU and the pediatric cardiac intensive care unit who typically weigh only ounces and require mechanical and respiratory support. "This environment makes image quality, portability and connectivity all key requirements for our echocardiography systems in the intensive care and operating room areas," she said. "In addition, the Vivid i's wireless connectivity features enable our sonographers to instantly transmit studies to our PACS system, resulting in a quicker management response by our cardiologists and surgeons."

Omar Ishrak, president and CEO of GE Healthcare's Ultrasound unit, said, "The mobility of Vivid i is untethering physicians and enabling them to deliver care to the patient wherever it's needed."

In other ACC news:

• GenVec (Gaithersburg, Maryland) said that three year follow-up data from a Phase I study of its myoblast cell trans- plantation therapy for congestive heart failure were presented at the meeting Tuesday.

The purpose of this multicenter 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.

GenVec is a biopharmaceutical company developing treatments for cancer, heart disease, and vision loss, along with vaccines for infectious diseases.

• 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 Nuclear Medicine modalities.

Already in use by more than 4,000 clinicians at 250 medical facilities across the country 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.

"As with our other specialty products, ProVation MD Cardiology was designed by our in-house team of physicians and coders," said Arvind Subramanian, chief operating officer of ProVation. "Features and functionality were based on research and feedback from cardiology experts across the country. The result is software that mimics the natural preferences and workflows of cardiologists, nurses and technologists."

Patients with coronary heart disease who took Pfizer's (New York) cholesterol-lowering medicine Lipitor (atorvastatin calcium) and lowered their cholesterol to well below recommended levels experienced significantly fewer heart attacks and strokes than those who only lowered their cholesterol to recommended levels, according to data presented at the ACC meeting.

The five-year Treating to New Targets (TNT) trial involved 10,000 patients with established coronary heart disease and elevated LDL, or "bad" cholesterol levels. The study assessed whether high-dose Lipitor patients who aggressively lowered their LDL-cholesterol levels to well below the current guidelines (100 mg/dL) would experience additional cardiovascular benefits compared to Lipitor patients who maintained their LDL-cholesterol at recommended levels.

Patients who received 80 mg doses of Lipitor had 22% fewer cardiovascular events, including CHD death, non-fatal heart attacks, resuscitated cardiac arrest, and fatal or non-fatal strokes compared to patients who took 10 mg of Lipitor. In addition, patients treated with high-dose Lipitor had 25% fewer fatal or non-fatal strokes compared to those treated with just 10 mg of Lipitor.

The TNT study demonstrated that the musculoskeletal safety profile of Lipitor at 80 mg dosing was comparable to Lipitor 10 mg doses. The incidence of liver enzyme elevations in both groups was within existing product labeling. TNT is the longest and largest study to date of Lipitor 80 mg efficacy and safety.

"Previous clinical trials including ASCOT and CARDS, have shown the outstanding ability of Lipitor 10 mg to safely get patients to their goal levels and reduce their risk of cardiovascular events," said Joseph Feczko, MD, Pfizer's chief medical officer. "TNT is the very first study to demonstrate even greater cardiovascular benefits of lowering LDL beyond recommended guidelines with Lipitor 80 mg. Patients achieved these results safely, and Lipitor 80 mg was well tolerated."

TNT is an investigator-led trial coordinated by an independent steering committee and was funded by Pfizer. The study enrolled men and women between 35 and 75 years of age in 14 countries.

New ARIES (African American Rosuvastatin Investigation of Efficacy and Safety) data presented at the meeting showed that AstraZeneca's (London) Crestor (rosuvastatin calcium) at 10 mg and 20 mg reduced levels of C-reactive protein (CRP) by 14% and 19%, respectively, while atorvastatin 10 and 20 mg reduced CRP levels by 8% and 15%, respectively.

In a subgroup analysis performed in patients with elevated CRP, Crestor reduced this biomarker of inflammation by 20% and 21% at the 10 and 20 mg doses, respectively, while atorvastatin reduced CRP by 12% and 20%, respectively. CRP is a protein in the body whose level increases when there is inflammation of blood vessels.

"An increasing number of cardiologists believe that CRP may be an important, yet often ignored, diagnostic tool," said Keith Ferdinand, clinical cardiologist and medical director of Heartbeats Life Center and the lead investigator for ARIES. "Through the ARIES trial, we have important new information about the changes caused by Crestor on this potentially critical biomarker in African-Americans."

The ARIES study was the first-ever large-scale, prospective trial exclusively designed to compare the effects of statins in African-American patients. ARIES was a six-week, randomized, controlled, open-label, multi-center trial designed to evaluate the efficacy of Crestor and atorvastatin in African Americans with elevated cholesterol.