“We assure full and therapeutic anticoagulation during the procedure, with ACT maintained more than 250 seconds, and we aspirate and de-air the guide catheter after removal of the extension catheter.” “We generally advance the extension catheter over a balloon shaft and avoid direct injection using a powered injector through the extension catheter because the concentrated jet can result in coronary artery perforation or, more commonly, dissection,” Chen said. The take-home message from these data is that the devices are helpful when used properly, he stressed, suggesting several strategies for their use. It is impossible to know the overall incidence of adverse events associated, much less the total use of, guide extension catheters, since this information would only be known by the manufacturers, Chen said. While 77% of GuideLiner reports and 43.6% of Guidezilla reports did not specify the target vessel in which the event occurred, the most commonly affected vessels, regardless of device type, were the left anterior descending (20%) and right circumflex arteries (20%). Unable to Advance or Pass Catheter to Target Lesion Of the 473 reports filed in total, more were filed for the Guidezilla (n = 408) than the GuideLiner (n = 65), with the most frequent type of adverse events being catheter fracture, being unable to pass or damaged PCI devices, and coronary artery dissection. To get a better picture of the kind of adverse events associated with guide extension catheter use during PCI, Chen and colleagues queried the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database for reports associated with both the GuideLiner (2010-2018) and the newer Guidezilla (2016-2018). Chen presented the study results here yesterday at CRT 2019. These devices allow for greater flexibility in delivering stents and balloons by adding 20-25 cm of extra depth beyond that of traditional guide wires, but evidence regarding real-world use of them is lacking, Yuefeng Chen, MD, PhD (MedStar Washington Hospital Center, Washington, DC), told TCTMD. With the increased prevalence of complex PCI today, interventionalists are turning to guide extension catheters like the GuideLiner (Teleflex) and Guidezilla (Boston Scientific) to help them navigate tortuous or calcified coronary arteries.
WASHINGTON, DC-An analysis looking at adverse events related to use of two different guide extension catheters reported to the US Food and Drug Administration should spur operators to use these devices with caution, experts say.
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