A Medical Device Daily

Medtronic (Minneapolis) reported results from the CONNECT trial showing the median time to clinical decision was significantly reduced for cardiac resynchronization therapy-defibrillator (CRT-D) and implantable cardioverter-defibrillator (ICD) patients monitored remotely with the Medtronic CareLink Network, compared to standard in-office follow-up. The trial showed the time from a patient's clinical event (arrhythmias, cardiovascular disease progression and device issues) to the physician's clinical decision was 22 days for those monitored in-office, vs. 4.6 days for patients in the remote monitoring group.

The CareLink Network provides a flexible alert system that offers customizable and color-coded alert notifications for devices with Conexus Wireless Telemetry. Through this network, patient data are transmitted from their implantable device using a portable monitor that is connected to a standard telephone line. Within minutes, the patient's physician and nurses can view the data on a secure Internet website. Available information includes arrhythmia episode reports and stored electrograms along with device integrity information, which is comparable to the information provided during an in-clinic device follow-up visit, and provides the physician with a view of how the device and patient's heart are operating.

In other news from the ACC meeting:

• Lantheus Medical Imaging (North Billerica, Massachusetts), a diagnostic imaging company, reported preliminary data on flurpiridaz F 18, its compound in development as a positron emission tomography (PET) myocardial perfusion imaging (MPI) agent. The study of nine patients compared rest-stress flurpiridaz F 18 PET MPI, with rest-stress technetium-99m (Tc-99m) labeled single photon emission computed tomography (SPECT) for the detection and evaluation of coronary artery disease (CAD). Preliminary results from the single-center study suggest that compared to SPECT MPI, flurpiridaz F 18 PET MPI has a higher diagnostic specificity for detecting right coronary artery disease and a higher accuracy for evaluating the extent of stress-induced myocardial perfusion abnormalities with coronary angiography as the gold standard.

“These initial results, in a very small patient population, are encouraging, as they already show significant improvements in diagnostic accuracy using PET imaging with flurpiridaz F 18 as compared to SPECT imaging with Tc-99m for the detection and evaluation of coronary artery disease,“ said Jamshid Maddahi, MD, the lead investigator. “A product that could demonstrate increased diagnostic specificity would provide physicians with a useful tool to reduce the number of false positive results often associated with SPECT imaging, and, therefore reduce the number of unnecessary cardiac catheterizations.“

Flurpiridaz F 18, a fluorine 18-labeled agent that binds to mitochondrial complex 1 (MC-1), was designed to be a novel myocardial perfusion PET imaging agent for the diagnosis of CAD. The agent is currently in phase II clinical trials.

MPI is a non-invasive test that uses a small amount of radioactive material (radiopharmaceutical) injected into the body to depict the distribution of blood flow to the heart. MPI is used to identify areas of reduced blood flow (perfusion) to the heart muscle.

• Medtronic (Minneapolis) introduced Every Patient First, a health equity initiative that, in partnership with healthcare providers, professional societies and patient advocacy groups, aims to reduce disparities in access to healthcare in the U.S.

“Medtronic's vision is to improve overall access to life-saving therapies for everyone, regardless of age, gender, race, or ethnicity,“ said James Dallas, senior VP of quality and operations at Medtronic. “Every Patient First is more than an awareness program; our goal with this initiative is to provide health care professionals with targeted, actionable strategies and partnership programs to help them overcome barriers to getting patients treatment for their cardiovascular disease.“

Significant differences in medical care, particularly for women and the elderly, were identified in the baseline data from the largest study of U.S.-based heart failure (HF) patients in the outpatient setting from the Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF). Specifically, women were less likely than men to receive an implantable cardioverter defibrillator (ICD) when indicated, education about their condition, or anticoagulation treatment for atrial fibrillation, and older patients were less likely than younger patients to receive certain types of guideline-indicated interventions.