What prompted the need to create these recommendations? The Heart Rhythm Society is the international leader for cardiac arrhythmia professionals and patients. As part of our mission to improve the care of patients by promoting optimal healthcare policies and standards, we believed it was necessary to develop a set of recommendations and guidelines to address concerns that have been raised about the safety, effectiveness and post-market surveillance of cardiac devices. Change to the current system is needed to ensure continued access to life-saving treatments and to enhance public knowledge, confidence and trust in these therapies. These draft recommendations involve the participation of the FDA, Congress, CMS, physicians, industry, etc. Once the public comment period ends on May 30th, what will be the next step?

Background Lancaster General Hospital (LGH) in Lancaster, Pennsylvania, is a busy 588-bed community hospital located in south-central Pennsylvania. LGH is a non-profit, Level II trauma center. The cardiology program at LGH is extremely robust with a very assertive team of cardiologists, electrophysiologists and staff. This program did well in spite of minimal organization and structure. LGH is experiencing unprecedented growth and is strategically planning for the future of health care in this county. Current plans address the issues not only from the bricks and mortar perspective, but also focus on reviewing and revising the process of care and patient flow to improve efficiency and through-put. The census on any given day can be 104%, meaning we have reached maximum bed capacity and surpassed our ability to place patients (both direct and EMD admissions) into inpatient beds.

What is the size of your EP lab facility and number of staff members?

Case Report The patient is a 58-year-old woman who was plagued by severe palpitations for many years. She was initially diagnosed with supraventricular tachycardia related to a Mahaim fiber in 2000. An ablation was attempted in 2001, but was unsuccessful. At that time, the patient was started on Sotalol, which was ineffective for controlling the patient's frequent symptomatic palpitations. Therapy was changed to Flecainide. This strategy was initially effective, but the patient continued to have palpitations and more recently developed several episodes of syncope and near-syncope. In light of the above, the patient was taken to the electrophysiologic lab after discontinuing Flecainide. The patient was sedated with Midazolam and Fentanyl, and an electrophysiologic study was performed. The study confirmed the presence of a right lateral decrementally conducting accessory pathway with no retrograde conduction. Antidromic atrioventricular reentrant tachycardia could be induced.

John Muir/Mt. Diablo Health System, September 2005: At John Muir/Mt. Diablo Health System in Concord and Walnut Creek, California, quality control checks on the equipment in the procedure rooms are performed on a daily basis by the staff, while the Biomed department tracks and performs the preventative maintenance. Daily checks include the imaging equipment, defibrillators, emergency equipment and the ACT machines. Rockford Memorial Hospital, August 2005: Rockford Memorial Hospital in Rockford, Illinois, recently received the 2005 Health Grades Distinguished Hospital Clinical Excellence Award in eight areas, including Cardiology. Their hospital is ranked among the top 5% of hospitals in the nation. In order to determine how well they care for their patients, Press Ganey scores are used to identify their strengths and weaknesses, ranking regularly in the 90th percentile. This is a national program that reflects customer satisfaction.

New Questions: Catheter Selection We are a newly established EP lab and are finding it extremely frustrating not to understand some of the basics about catheter selection (i.e., what catheter for what region of the heart and why). I know that there are some excellent spiral bound books for heart catheterizations and interventions; is there something out there for the EP lab?

Describe the High Intensity Focused Ultrasound procedure. How does it differ from radiofrequency (RF) ablation?