ORLANDO, Florida The beauty of a conference with the breadth and depth of the annual scientific sessions of the American College of Cardiology (ACC; Bethesda, Maryland) is the opportunity to see, in specific sectors, the broad range of device applications and their development, from early clinical potential to home use.
This year's ACC gathering has showcased this range in various ways, with the monitoring and diagnostics sector showcased from clinical trial reports to the massive exhibition center, from early intervention to late-stage assessment.
Medtronic (Minneapolis) unveiled an important development with positive data from the Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure (COMPASS-HF) trial, demonstrating the value of its Chronicle implantable hemodynamic monitoring system.
The Chronicle is a pacemaker-size device that records and collects data concerning the patient's intracardiac pressures that can aid in avoiding the frequent hospitalizations seen among serious heart failure patients.
In COMPASS-HF, the Chronicle was implanted in the chests of 274 New York Heart Association Class III/IV patients in 28 clinical sites to provide continuous ambulatory monitoring of intracardiac pressure, with the data transmitted once a week to participating physicians via a home-based remote monitor. A control group of physicians was blinded to the data and so used their traditional methods of assessment and treatment.
Presenting the study at a late-breaking trials session Tuesday was Robert Bourg, MD, director of the Division of Cardiovascular Disease at the University of Alabama at Birmingham.
Bourg reported "a whopping 41%" less in the costs of treating the patients implanted with the Chronicle, as compared to the blinded group. Chronicle, he said, had enabled the physicians to see critical changes in hemodynamics and then "act pre-emptively" with treatment to avoid many patient hospitalizations.
Improved patient outcomes were demonstrated by a 33% reduction in the proportion of patients that experienced worsening heart failure.
Stating the case, Bourg said that use of the Chronicle "has the potential to save a lot of money and [a lot] of morbidity." On the money side, he noted U.S. healthcare industry costs of $3 billion annually for treatment and hospitalization of the severe heart failure group.
In COMPASS-HF, the Chronicle had been used as a "stand-alone device," Bourg said, predicting that in the future and in future studies the device would be combined with defibrillators and resynchronization devices to provide even more detailed information.
Bourg emphasized that, importantly, the device was able to gather the hemodynamic information during a patient's usual daily activities walking, playing, "having intercourse, you name it" and so provided much more useful data than simple physician-room exams.
"We know patients who have higher pressures do worse with heart failure, but it's often difficult to measure those pressures, especially with physical examination," Bourg said. Thus, he said, medications and other therapeutic methods can be adjusted "by knowing this information prospectively and continuously, with the patient at home, and uploading their parameters to us."
Better 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 intended 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.
In the home monitoring sector, 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 Diagnostics & Imaging Week 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 D&IW 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 in April.
Microlife's core business is the manufacturing of digital thermometers and peak flow meters.