2006: That Was The Year That Was

Todd J. Cohen, MD, Editor in Chief

Todd J. Cohen, MD, Editor in Chief

2006 also witnessed the acquisition of Guidant Corporation (originally Cardiac Pacemaker Incorporated, the company that invented the implantable defibrillator) by Boston Scientific Corporation (a leader in interventional cardiology and catheter ablation). Finally, T-wave alternans was approved by CMS for reimbursement as another screening modality to identify patients at risk for sudden death. As has been the recent trend, there have been advances in device development as well as methods for catheter ablation. Implantable device platforms continue to grow in both pacing and defibrillation fields. Pacemakers continue to become more automatic and have incorporated atrial fibrillation suppression algorithms. Additionally, algorithms have been developed to promote intrinsic conduction in order to minimize ventricular pacing. The implantation of these devices has become more commonplace. Defibrillators (including biventricular devices) are also routinely incorporating hemodynamic parameters in order to help identify congestive heart failure. One device from Medtronic Inc. utilizes transthoracic impedance and can determine lung wetness before the development of congestive heart failure symptoms. Another system from Boston Scientific can be used to track a patient's weight remotely. Overall, wireless systems have been developed and employed, and are commercially available for tracking and trending device interrogations in both pacemakers and implantable defibrillators. The use of such systems is just beginning to take off, and will be expanding in the foreseeable future. In addition to the above advances and devices and technology, the usual politics of reimbursement came into play in 2006. The electrophysiology community at large was confronted with the possibility of a dramatic cut in the reimbursement to hospitals, which was proposed by CMS. The lobbying of the cardiology societies (including the Heart Rhythm Society) were successful in abating these cuts, at least for the current year. Such potential cuts in reimbursement may have made it prohibitive for hospitals to avoid delivering appropriate arrhythmias services (including implantable defibrillators and biventricular devices). Electrophysiologists must work together with the local, national, and international societies to achieve the necessary goals in order to provide the appropriate care to patients at large. The year 2006 also saw a leveling off of the number of implantable cardioverter-defibrillator devices implanted. This was most likely a reaction to the large number of United States Food and Drug Administration (FDA) recalls that took place in 2005. Less device recalls were issued in 2006 this is perhaps a positive sign that the huge volume of critical device problems were behind us. Still, many patients were scared and skeptical about device procedures and decided not to proceed. Patient education is necessary to overcome their fears and provide appropriate analysis of the risks, benefits, and alternatives to device-based therapy. Further education of general practitioners, internists, cardiologists, as well as the lay public are necessary to break this trend and permit patients to receive appropriate device therapy in order to prevent arrhythmic events before they have a fatal outcome (primary prevention). Catheter ablation procedures continue to expand, with specific targets towards atrial fibrillation. Two approaches have become evident: 1. An anatomic approach creates ablative lesions outside the pulmonary veins in order to electrically isolate pulmonary vein potentials. This method often does not test for pulmonary vein isolation. 2. A second, more rigorous method of pulmonary vein isolation includes testing and proof of the ability of the pulmonary vein potentials to conduct out of the pulmonary vein to the left atrium. A number of trials will be investigating the utility of both of these approaches for the treatment of paroxysmal and persistent atrial fibrillation. Cryoablation has also been used in the surgical arena, in which minimally invasive ablative techniques can be performed. These techniques, however, still require a mini-thoracotomy and introduces additional risks beyond the percutaneous methods utilized by electrophysiologists. Finally, the utility of robotic systems for performing catheter ablation is also undergoing investigation. One system, the Stereotaxis Inc. system, is currently approved and utilizes a magnetic platform together with non-fluoroscopic three-dimensional mapping. The second system, from Hansen Medical, Inc., which is currently seeking approval by the FDA, uses large, steerable robotic sheaths in order to deliver a passive ablation catheter. Additional ablation systems may utilize other technologies in order to achieve the optimal result and make robotic catheter manipulation and ablation more available in the routine electrophysiology laboratory. As Tom Lehrer once said, We only want the world to know, that we support the status quo. They love us everywhere we go, so when in doubt, Send the Marines!...I think he meant the Electrophysiologists.