As reported in The Reading Room, the Advisory Board's imaging blog, a study published in the Canadian Medical Association Journal found that patients who underwent radiation-emitting procedures after a heart attack may have a heightened risk of developing cancer down the line. Researchers examined 83,000 Canadian patients who suffered a heart attack and received imaging tests and procedures five years after the initial cardiac event. The results showed that the risk of cancer increased at a rate of 3% risk increase for every 10 millisieverts (mSv) of exposure. To place these data in context, nuclear stress tests, heart catheterization, and CT scans of the heart, typically deliver a radiation dose between 5 and 15 mSv.
Study Finds Heart Attack Patients May Have Increased Risk for Cancer
The Department of Justice (DOJ) is conducting an ongoing multi-state, multi-provider investigation into hospitals billing Medicare for implantable cardioverter defibrillators (ICDs) for patients whose conditions did not satisfy the criteria outlined in a CMS National Coverage Determination. The primary area of interest is the timing of ICD procedures as CMS clearly states that it will not reimburse for procedures outside specific time periods. Specifically, Medicare does not cover implantation of ICDs within 40 days of an acute myocardial infarction (AMI) or within three months of a coronary artery bypass graft (CABG). This investigation could present a major challenge to hospitals as data shows many devices are implanted too soon after an AMI or CABG. More specifically, a recent retrospective analysis of the NCDR-ICD registry, which was published in the Journal of American Medical Association (JAMA), suggests that 22.5 percent of ICDs implanted did not meet evidence-based criteria for implantation. The cases deemed ineligible were largely due to timing issues around recent or late-stage heart failure diagnoses.
Understanding the ICD Utilization Paradox
As reported in The Pipeline, the Advisory Board's technology blog, Medtronic has announced the approval of its Revo MRI SureScan magnetic resonance imaging (MRI)-compatible pacemaker, the first pacemaker in the U.S. that is designed specifically for use in an MRI environment. This approval is expected to significantly boost the device market in the coming year due to the roughly 200,000 U.S. pacemaker patients who currently must forego an MRI. The Revo MRI SureScan—which is priced at a comparable level as other pacemakers (ranging from $5,000 to $10,000)—contains two CapSureFix MRI leads and comes with a function that can be turned on before patients receive an MRI to prepare them for the scan. The device, however, is classified as "MR-conditional," meaning that it can be used in an MRI environment only under certain conditions, such as if a patient has never received a lead or pacemaker previously and if an MRI system has a static magnetic field of 1.5 Tesla.
First U.S. MRI-Compatible Pacemaker Approved, Though Reimbursement a Challenge