Study results released this week point to the advantages of implementing screening tools to determine which patients seeing general cardiologists would benefit from a referral to an electrophysiologist and possible therapy using an implantable cardioverter defibrillator (ICD). Screening tools of this nature are not commonly utilized across the country and have the potential to increase the number of patients accessing these life-saving devices.
The study--conducted by Gravelin et al.--looked at patients from two outpatient cardiology offices and their associated medical records. Cardiologists at these offices were given a screening tool, which first asked whether patients' ejection fraction (EF) was 35 percent or lower; if it was, physicians were then asked whether the patient could be referred to an EP physician for an ICD based on other factors such as presence of comorbidities. When appropriate referrals from the screening group were compared to referrals before the implementation of the screening process, researchers found that significantly more eligible patients were referred to an EP during the screening period compared to the time period before the tool at both clinics. One cardiology office demonstrated an 80 percent referral rate compared to its previous 33 percent rate, whereas the other site referred 100 percent of eligible patients compared to 60 percent before the tool. Overall, 41 percent of patients referred for an ICD ended up receiving the therapy.
Currently, studies suggest that the under-implantation of ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds) in eligible patients is a problem across the country: estimates indicate that as few as 27 percent of patients who could benefit from an ICD receive the device. Lack of understanding from some physicians of the appropriate patient population to receive this therapy for primary prevention as well as communication barriers when eligible patients are admitted to the hospital for other reasons (such as complications due to heart failure) can be roadblocks to patients receiving this treatment option. However, other factors must be considered such as patients' willingness to undergo evaluation for an ICD and the complications and risks involved with these devices. The rate of inappropriate, non-life-saving shocks from EP devices can be as high as 5.1 percent, and numerous complications can arise from the implanted ICDs and their leads, some necessitating removal of the implant. As such, patients must be carefully selected once referred for an EP consult based on factors outside of EF.
Despite the debate surrounding appropriate device implantation, screening tools and similar guidelines integrated into clinical practice have the potential to open the door to new treatment options for many patients, particularly if tools are integrated into electronic medical record (EMR) systems. This practice could streamline the referral process for physicians by generating automated alerts when patients could be eligible for device therapy. Technology Insights will continue to follow developments in screening processes for patients receiving ICDs and CRT-Ds.
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.
Despite this development, the MRI-compatible pacemaker is expected to face challenges since MRIs for Medicare patients with pacemakers are not currently reimbursable. In 2009, CMS stated that--upon the device's approval--it would be willing to review its data to determine whether it is safe for those with pacemakers to receive MRIs, and whether they would then grant reimbursement for these procedures. As such, experts predict that these pacemakers could receive reimbursement approval as early as March of this year.
Though reimbursement may initially hamper procedures with MRI-compatible pacemakers, this technology advancement will greatly aid patients with pacemakers who require MRIs. This device approval could also boost Medtronic's dominant share of the pacemaker market from 51 percent to up to 61 percent. Boston Scientific and St. Jude are developing MRI-compatible pacemakers as well with the Accent MRI-Compatible Pacer and the Tendtril MRI, signaling an interest from physicians and patients in devices with these capabilities. Moreover, Medtronic is currently implementing a FDA-required post-market study that includes 1,800 patients to further test the device and associated patient outcomes. Technology Insights will continue to track development in this and other MRI-compatible pacemakers.
Awareness of chronic disease technologies and remote monitoring among not only the medical community but the general population has continued to increase dramatically, as evidenced by the recent New York Times article about implantable defibrillators ability to remotely track heart failure patients. News coverage of these devices, which are poised to significantly improve quality of life for the 6 million people in the U.S. who suffer from HF, emphasizes the shift toward patient- and consumer-focused care and highlight's the public's increasing involvement in self-managing their health to a greater extent. In the Pipeline, we've covered numerous different developments in remote monitoring, which can all be found here.
For more information about remote monitoring, continue reading after the jump, or contact me at WynnP@advisory.com to discuss how Tech Insights is tracking these devices and their effect on EP and HF strategy.
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