The future of electrophysiology is extremely exciting and always evolving. The results of primary prevention implantable defibrillator trials led to tremendous growth in the field. However, more recently there has been an increase in regulatory oversight related to appropriate device implantation. With this increased attention to compliance with the CMS National Coverage Determinations, the growth in this area has been tempered. In order to keep compliant, hospitals have utilized the wearable cardioverter-defibrillator (LifeVest®, ZOLL Medical Corporation) especially during intervals in which the patient is at high risk for sudden death, but may not qualify for an implantable defibrillator. One example is a patient following a large myocardial infarction with a very low ejection fraction (e.g. 20 percent).
The National Coverage Determination would not permit a primary prevention defibrillator implant within 40 days of the infarction; however, the wearable defibrillator would provide protection during that period. There is only one company with an approved wearable defibrillator product, but that product may be difficult to assemble and uncomfortable for the patient to wear. More recently, a team of biomedical engineering students from Johns Hopkins University, sponsored and mentored by this book’s author, developed a better design called CARDIOGUARD™, in which no assembly is required and improved comfort is achieved. Their system won the NAPEC Innovation Challenge in 2014, and the rights have been acquired by Nexus Control Systems LLC.