Topics 1. EVA-3S & Space-Bumps in the road presentation that you gave at TCT 2. CAPTURE 3500-Lesion morphology & Predictors for Stroke 3. CAPTURE II vs. EXACT 1500-Does open or Closed Cell Stent design really matter?
This activity has been developed for Interventional Cardiologists, Vascular Surgeons, Interventional Radiologists, Neurologists, Interventional Nurses and Technologists with an interest in the diagnosis and treatment of peripheral artery disease.
by Kevin O’Sullivan, Charlton Memorial Hospital, Fall River, Massachusetts
I have been involved with cardiac catheterization and electrophysiology for almost 30 years. I started out as a biomedical technician and then gravitated into the cath lab. My first day in the lab was in January of 1979. Over the following decades, I moved from the clinical environment to industry and back again...several times.
by Todd J. Cohen, MD, Alexandru Mitrache, PA, Ilyssa Scheinbach Winthrop-University Hospital Mineola, New York
Case Report - The patient is a 34-year-old man with symptomatic palpitations and nonsustained ventricular tachycardia. He had a traumatic ventricular septal defect that had been clinically stable via two-dimensional echocardiogram and cardiac catheterization, with QP:QS ratio of 1:2, and a left ventricular ejection fraction of 40 percent.
HUYA Bioscience International announced the outcome of its pre-investigational new drug (IND) consultation meeting with the U.S. Food and Drug Administration (FDA) for HBI-3000 (Sulcardine sulphate), a promising anti-arrhythmic compound sourced from China. The Agency reviewed and agreed with HUYA's IND-enabling CMC and toxicology plans and high-level Phase I plans pending review of non-clinical and clinical data to be submitted as part of the complete IND package. The FDA also agreed to accept data generated in China as 'supportive information' that will support the submission of a U.S. IND and the initiation of a U.S. Phase I trial. HUYA anticipates filing an IND application for HBI-3000 in Q1 2009.
Hansen Medical, Inc., a developer of robotic technology for accurate 3D control of catheter movement during cardiac procedures, has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the CoHesion™ 3D Visualization Module for use in complex electrophysiology (EP) mapping procedures. This integrated EP solution offers a software interface between the Hansen Medical Sensei™ Robotic Catheter system and the EnSite™ System advanced mapping software from St. Jude Medical, Inc. Hansen Medical’s platform solution offers physicians the ability to instinctively navigate a catheter during the diagnostic phase of a complex cardiac arrhythmia procedure. The new CoHesion module imports the EnSite System’s 3D cardiac chamber model with anatomic labeling into the Sensei system’s main navigation window, allowing physicians to see the location of Hansen Medical’s Artisan™ Control Catheters within the heart in 3D.
The U.S. Food and Drug Administration (FDA) approved the Xience™ V everolimus-eluting coronary stent system for the treatment of coronary artery disease. Xience V is the only drug-eluting stent to have demonstrated superiority over Boston Scientific’s Taxus® paclitaxel-eluting coronary stent system in two randomized head-to-head clinical trials. Xience V will be launched in the United States immediately. Abbott also supplies a private-label version of Xience V to Boston Scientific called the Promus™ everolimus-eluting coronary stent system. Promus is designed and manufactured by Abbott and supplied to Boston Scientific as part of a distribution agreement between the two companies.
Medtronic, Inc. announced U.S. Food and Drug Administration (FDA) approval of the Medtronic Attain StarFix® OTW (over-the-wire) lead (Model 4195). As the first active fixation left-heart lead for cardiac resynchronization therapy (CRT), the Attain StarFix lead has demonstrated a zero percent chronic dislodgement rate*.
Overall, including the acute dislodgements at one day post-implant, the lead has a low 0.7 percent dislodgement rate. These dislodgement rates are supported by one of the industry’s largest and longest-running left-heart lead clinical studies involving 385 implants followed for up to four years. Traditional passive fixation left-heart leads, where there is no active mechanism to fix the lead in place, show average dislodgement rates of 2-8 percent based on several published clinical studies.
The use of radio frequency identification devices appears to have the potential to cause critical care medical equipment to malfunction, according to a study in JAMA.
“Applications of autoidentification technologies such as radio frequency identification (RFID) in everyday life include security access cards, electronic toll collection, and antitheft clips in retail clothing. RFID applications in health care have received increasing attention because of the potentially positive effect on patient safety and also on tracking and tracing of medical equipment and devices. The current expenditure levels on RFID systems within health care in the United States are estimated to be approximately $90 million per year with 10-year growth projections to $2 billion,” the authors write.
Protocol for Tilt Table Study
I recently encountered a superior manager who halted all tilt studies unless the physician was at the bedside. Prior to this we were performing these exams while the MD was in the lab, within close proximity, and not directly watching the patient. We are only tilting the patient on a table and if they do not respond to an 80-degree tilt in 15 minutes, we spray nitro under the tongue. The worst that has happened is they have gone asystole [during which time] we place them at zero degrees, give fluids, or at the worst-case scenario, give atropine. They immediately respond. Are there any rules which state that the physician must be directly at the patient’s bedside? Are the nurses not qualified to do this if the physician is not within arm’s length?
—name withheld by request
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Attention Readers: Practical EP addendum
The editors of Practical Electrophysiology would like to point out a correction made in Table 27.1 on page 210. Please note that this table heading should read "Table 27.1: Isoproterenol Infusion Rate (µg/min) for Single-Stage HUT”. Please make a note of it in your records that it should read micrograms, not milligrams. We sincerely regret the error.
by Heather Connelly, RN, BSN, EP Lab Manager, Riverside Methodist Hospital, Columbus, Ohio
In my time as the manager of a dynamic and lively EP lab at Riverside Hospital in Columbus, Ohio, I have learned many things. In my opinion, these are the five things that have contributed to our department’s success.
