This week’s Heart Rhythm Society (HRS) 33rd Annual Scientific Sessions, held in Boston, highlight new innovations in cardiac rhythm management (CRM). Noteworthy research abstracts and late-breaking clinical trials include presentations on sleep disorders and the subcutaneous implantable cardioverter-defibrillator (S-ICD), recently reviewed by an FDA panel. Of particular note was the featured abstract “Remote Monitoring Reduces Healthcare Utilization and Improves Quality of Care in Heart Failure Patients with Implantable Defibrillators: the EVOLVO study.”
HRS 2012: EVOLVO Study Sheds More Light on Remote Monitoring Benefits in EP Device Patients
On April 10, the U.S. Food and Drug Administration (FDA) approved expanded indications for Medtronic’s portfolio of cardiac resynchronization therapy with implantable cardioverter-defibrillator (CRT-D) devices, including the Concerto, Consulta, Maximo II, Concerto II, Protecta XT, and Protecta models.
These devices, previously approved for New York Heart Association (NYHA) Class III and IV heart failure (HF) only, are now approved for treatment of mildly symptomatic HF in NYHA Class II HF patients with a left ventricular ejection fraction (LVEF) of < 30%, left bundle branch block (LBBB), and a QRS duration > 130 ms. Certain NYHA Class II patients are already indicated for an implantables cardioverter defibrillator (ICD), though CRT-D offers advanced bi-ventricular pacing capabilities in addition to defibrillation protection against sudden cardiac death (SCD).
FDA announces expanded HF indications for Medtronic CRT-D devices
As new AF ablation technologies, such as Medtronic's Arctic Front cryo balloon, are reaching the market and peaking physician interest, hospital administrators are more closely examining the finances associated with these procedures. With AF ablation predicted to grow in the coming years and more hospitals entering this market, maintaining profitable procedures will become increasingly important.
Roughly 2.2 million patients suffer from atrial fibrillation in the U.S. While there is not conclusive data available on how many of these patients are referred to an EP, it is estimated that at least 10% do not have underlying heart disease despite an episode of AF, making them unlikely candidates for an electrophysiologist consult. Despite the growing number of AF ablations being conducted in the U.S—driven by improved technology and outcomes as well as growing physician experience—these procedures are not appropriate for every patient with AF. Ablations are largely reserved for those with symptomatic AF (roughly 2/3 of patients) who have not been able to tolerate or see improvements from at least one antiarrhythmic drug. These two-thirds may either receive surgical or catheter ablation.
With hospitals' increasingly limited finances, growing focus on enhancing AF ablation profitability