DRUG-ELUTING STENT SOLUTIONS: DEVICE SELECTION IN THE CATH LAB A Manager`s Perspective

Stephen has been the catheterization laboratory manager at St. Anthony’s Central and North Hospitals in Denver, Colorado, for the past three years. In his twenty years in the lab, he has been responsible for scrub, circulator and monitor positions for cardiac catheterization and endovascular invasive procedures, surgical permanent pacemaker insertion and electrophysiology studies. The combined labs at Central and North Hospitals handle approximately 2,400 procedures each year, and treat approximately 1,600 patients. Stephen is a member of the Society of Invasive Cardiovascular Professionals (SICP) and has designed several continuing education courses for St. Anthony’s Hospital. As cath lab manager, what challenges do you face in an average day? Our cath lab has five rooms located in two different facilities. Volumes range from five to fifteen cases a day, which often presents some unique challenges. The physicians at our center perform numerous direct intervention procedures for acute myocardial infarction and for ST-elevation myocardial infarction. Also, our center offers pre-hospital notification, or what you might call a cardiac alert program, which is utilized an average of five to seven times a week. Quite frankly, the call hours are brutal in our lab, just as they are in many labs across the country. My biggest challenge involves ensuring that acute intervention procedures are performed in a timely fashion both day and night. We try to meet the national average of 90 minutes or less for each interventional procedure performed at our lab. Although we are meeting and exceeding this goal, it requires constant effort and attention to do so. Are drug-eluting stents allowing you to treat patients with more complex disease in your lab? If so, has this changed your product usage? Absolutely. Our cath lab sees a lot more complicated cases today. Our ability to treat patients who have more comorbidities has increased by approximately 40 percent. Although our lab has always performed multivessel interventions, our patient volume has increased significantly. We are able to treat patients who are closer to renal compromise or failure because we are able to use less contrast agent and get right in there. In addition, our lab offers other effective adjunctive therapies such as sodium bicarbonate drips, saline drips and acetylcysteine (Mucomyst®). Our lab can now stage a patient’s therapy over the course of a week, treating two vessels initially, and then bringing the patient back for a third intervention later on in a routine set-up; or, we can treat the culprit lesion in an acute setting and bring the patient back in a week or two to treat the remaining vessels. Drug-eluting stents (DES) have definitely allowed us to treat more complicated patients in the cath lab than in the past. As a cath lab manager, what is your role in the device selection process? I am responsible for bringing new products into the lab and reviewing them. Once I thoroughly understand how and where we can use a device, I set up a trial involving staff and physician input regarding the product’s performance, when it should be used, and whether it should replace an existing technology or product. Training and education on any device is the key to safety and success. Product training and in-services are part of any trial. What factors are important to consider when selecting a device? The three things I look at are safety, availability and performance. My biggest concern is patient safety. I look at how the product will be used and the reputation of the company that makes and sells it. I also review the initial trial data or any other data I can obtain on where and how a product was used. Availability is next in importance. Many companies want to introduce products to our lab, but can’t provide the volume we require. If our lab is going to adopt a new product, we need a guarantee that we will be able to utilize it as we need it. There must be equal access to the product for all patients; we cannot offer it to some patients and not to others. Finally, I look at the performance of the product. For example, with DES, our operators must be able to safely and appropriately deliver the stent to the lesion. A product must meet or beat existing technologies in order to be considered. Our lab will not take a step backwards in terms of deliverability or safety just to bring in something new. If I am evaluating an improvement to an existing product, not a major change, I will ask how this makes the product better or more deliverable, or how it expands on its performance. If I determine that an improvement offers an advantage by increasing the types or number of patients we can treat, then I will probably adopt it. How much do you rely on trial data when evaluating a new device? If a product is brand-new, I extensively review the trial data in order to understand the concept behind the product, how the data support its use, and any issues that came up during the trial. Sometimes I will speak with the sales representatives to find out about things that were not addressed in the trial, where the device is not working very well, and other areas where we may need to exercise more caution. When evaluating a device, do you accept feedback from your physicians and staff equally? Yes. Probably one of the best, most underutilized sources for this information is your staff. They are the people who see the product used more often in one time frame than will any single physician. The staff will have more practical, observational experience with the product. Our physicians definitely look to our staff for suggestions and recommendations. Sponsored by Boston Scientific

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