TCT: Radial PCI approach should be adopted for clinical, financial reasons

SAN FRANCISCO—Jeffrey J. Popma, MD, stated that it is clinically and fiscally beneficial for U.S. interventionalists to use the radial approach for PCI procedures at the 2009 meeting of the Transcatheter Cardiovascular Therapeutics this week.<br /><br /> When examining the brachial approach, there is a number of indications for which patients should have this approach administered, including severe peripheral vascular disease, abdominal aortic aneurysms, if the patient cannot remain prone or is morbidly obese.<br /><br /> Researchers from Beth Israel Deaconess Medical Center in Boston compared the outcomes of the higher volume radialists and the femorialists in patients who had exclusion with the femoral approach. They found that peripheral vascular disease is the most common reason why the femoral approach is not indicated, but musculoskeletal disorders and bleeding risks also were reasons.<br /><br /> In an analysis of 500 cases, in which two operators primarily performed the radial approach and the others took the femoral approach, the procedural success rates were different. Popma, an interventionalist at Beth Israel, said that the rates were different because there is “a learning curve both with respect to the institution…and for the individual operators themselves.” He suggested that the learning curves is between 20 and 100 cases.<br /><br /> As the operators in this study gained more experience with the radial approach, it was associated with a reduction in procedure time. “The more you do, the more you become familiar with the technique, the better that you become at it,” he explained.<br /><br /> Also, Popma spoke to the extended procedure times associated with the radial approach. First, he said that adopting this approach will require new catheters for the cath lab, which “are not cheap sometimes. It will require an ideological shift to a more radial-friendly lab.”<br /><br /> He suggested that one solution to these learning curve-associated problems is to encourage younger fellows to undergo research and adopt these methods, adding that they need to be involved in writing some of the new outcomes data on the approach.<br /><br /> Importantly, Popma stressed the reduction in bleeding complications associated with the radial access, compared with the femoral access. <br /><br />“It’s pretty hard to ignore the clinical data,” he said. In particular, he mentioned a study which found that patients on warfarin therapy at the time of their catheterization with an INR of 2.2 safely experienced no access-related bleeding complications.<br /><br /> As a result, Popma said that these findings provide evidence that with patients on either glycoprotein IIb/IIIa inhibitors or warfarin anticoagulant therapy, the radial access is “extremely beneficial with a very, very low safety risk."<br /><br /> H added, “While there is no difference in major adverse cardiac events, there are significant reductions in access-site complications."<br /><br /> However, Popma acknowledged that this procedural change will require some “logistical changes” in the cath lab. <br /><br />“You have to be mindful of your gantry to ensure that you can administer fluoroscopy on the arm through very simple maneuvers, such as keeping the arms down by the side,” he noted.<br /><br /> Also, he spoke to the needs of a recovery lab providing reclining chairs because the patients sit upright after a procedure with the radial approach.<br /><br /> Finally, Popma spoke to the financial or cost-savings considerations, particularly highlighting the change in regulatory reimbursement strategies. Based on a 2006 clinical trial, CMS decided that same-day hospital discharge after PCI was “doable,” Popma said.<br /><br /> “While in the U.S., we do not view outpatient coronary intervention as a 24-hour procedure, in fact it’s less than a 24-hour to 48-hour admission,” he said.<br /><br /> Because of these extended stays, one editorial suggested that there would be a savings of $1 billion per year in the U.S. healthcare system if cath labs switched to a radial approach.<br /><br /> Also, in 2007, the criteria for assessing an inpatient DRG for an overnight admission, or several nights of admission, have been changed from all PCIs to only those PCI procedures that were urgent. <br /><br />“This means that all elective PCIs in the U.S. are now classified as outpatient procedures,” Popma explained.<br /><br /> However, PCIs are classified as outpatient procedures in under 10 percent of U.S. facilities, “which could be an area of substantial savings for CMS based on a RAC audit,” he said. “In fact, of the $289 million dollars of overpayment that U.S. hospitals receive, about 78 percent were for inpatient designation, or elective PCIs that come in for DRG codes.”<br /><br /> This savings to the healthcare system would also mean a 30 percent drop in revenue, Popma explained. For instance, in Massachusetts, using DRG classification rather than the APC diagnosis (an outpatient procedure), balloon angioplasty drops from a reimbursement of $13,000 to $3,000. Drug-eluting stent drops from $15,000 to $7,500, and a bare-metal stent drops from $13,000 to $5,600.<br /><br /> “This is a reality that will not change anytime soon, and the SCAI [Society of Cardiovascular Angiography and Interventions] published a guideline on the issue,” Popma said.<br /><br /> As a result, he said that there will be a concerted effort to move many patients to a “quicker, easier and safer way of performing the procedure ...  that is associated with less bleeding, lower mortality and facilitates earlier hospital discharge.”<br /><br />