Heartfelt with Dr Melissa Walton-ShirleyView all posts »
Discussing science, anecdote, and opinion: Up in arms after RIVAL?Apr 5, 2011 01:14 EDT
Cardiovascular healthcare providers tattooed a bull's eye today squarely onto the forearms of coronary artery disease patients around the world. Although the RIVAL trial demonstrated similar mortality and procedural success rates with femoral and radial access, there were reduced vascular complications with the radial approach. There was also the RAPS trial, where radial arteries outperformed saphenous veins for CABG. Soon there won't be enough radial arteries to go around. Surgeons and interventionalists will be lining up for it on a first come, first served basis. The old joke about the need for growing more drumsticks on turkeys at Thanksgiving came to mind, as one might think it a shame that we only have two arms to accommodate all the applications we have found for our radials.
Radialists should be congratulated for finding another way around groin bleeds and retroperitoneal hematomas. They can accommodate patients with the ability to ambulate early. An example is a true story, although told tongue-in-cheek that in a Kentucky lab recently, a patient was able to ambulate to the smoking hut just minutes after his cath, with his TR-band in place. Femoralists are left wondering, "Why bother with learning a new access technique when I have such low complication rates to begin with?" They can always use the brachial approach as a backup and a closure device for early ambulation. They know if they would just switch to bivalirudin, the bottom would virtually fall out of their access-site and non–access-site bleeding rates. But the greater question is this: Why should one enthusiast care what the other one does, anyway?
The answers lie within the issue of appropriate training. With their enthusiasm for a new vascular access technique, high-volume radialists are anxious to market their approach to the public and other operators. The science demonstrates that high-volume programs have a lower complication rate than physicians working in low-volume labs. Some low-volume operators are itching to utilize the radial approach, although there aren't a lot of programs that offer adequate hands-on training that can guarantee early safety. As a result, there are anecdotal reports of patients being subjected to the wrong end of a very steep learning curve.
A patient several weeks ago that has suffered severe complications from a radial approach contacted me. It's not that the same issues don't arise with the occasional femoral patient, but I relate this story to emphasize the need for proper training no matter the access site. The patient suffered severe hand ischemia and has had two percutaneous attempts to restore flow to his hand and two open surgical procedures. He is right-handed and does a job that demands manual dexterity. He contends that not everyone knows how to do a proper Allen's test. He is angry and frustrated, has had several femoral procedures without incident, and claimed he was not given informed consent. It was suggested to him that he might have to consider hand amputation. He is suing. In another state, a cath lab within the first few months of utilizing a radial artery approach experienced a radial artery dissection, a normal coronary artery dissection, dissections that resulted in CABG during PCI attempts, high contrast utilization, long flouro times, and long door-to-balloon times. An ER doctor related an instance where a patient nearly died of cardiogenic shock while a cardiologist struggled to gain radial artery access. "We went through every set of gloves in the ER and all of the radial access kits we had. I thought the gentleman was going to die before we could get him in the lab."
Dr Nick Xenopolous, a high-volume femoralist known for his expertise with complex cases at Jewish Hospital in Louisville, KY, switched back to femoral access after having performed about 50 radial cases. "A proctor was brought in for me for the first five cases. Overall, the procedures were longer and, since patients had to stay overnight anyway, I didn't perceive any other benefit other than faster mobilization. Removing the sheath from the radial appeared to be more painful. The transfemoral approach appeared to be suited for the majority of cases, including complicated bifurcation cases, atherectomies, etc." He then states that several years later, he "can see how catheters have improved, stents have a lower profile, and more cardiologists are trained in formal radial training programs. Significantly lower bleeding complications provide the framework for the rapid expansion of this technique." Then he said, "If I knew then what I know now, I would have been more persistent. A transradial program should be approached with caution, and any problems encountered should be recorded and addressed. Having an experienced partner or proctor to address these concerns may be valuable."
Dr Sunil Rao of Duke University stated, when I expressed concerns at anecdotal reports of complications, "Radial is not for everyone. I have never heard anyone say that one should do radial at all costs, and no one says that radial is without risk. There are definite downsides to radial. Asking me to 'defend' radial is as silly as asking me to defend the use of the JL4 catheter over the multipurpose to inject the left coronary artery. One uses the best tools to get the job done safely."
Dr Gregg Stone of New York Columbia University, a femoral enthusiast, stated prior to the RIVAL trial publication that "radial intervention reduces local access bleeding and in general is preferred by patients; however, radial intervention inherently provides less guide catheter support than the femoral approach, is more difficult to achieve a coaxial position in the left main, and has a distinct learning curve. A nontrivial proportion of cases that begin radial must transition to femoral. There are numerous anatomic variants that the radial operator must be familiar with. And of course, while radial access decreases local access-site bleeding, major non–access-site bleeds—for example, intracranial and GI—would be expected to be the same with radial and femoral access. These are the bleeds that are most often associated with mortality."
Dr Rao forwarded my email to Dr Mitchell Krucoff, who takes a very balanced approach. "The issues here are not transradial or transfemoral but vascular-access safety training (VAST) per se. Current standards for training in cath labs have very little in the way of structured approaches to VAST, and yet most bleeding, bruising, pain and discomfort, dissections, occlusions, fistulae, and other procedural problems largely relate to vascular-access issues. How we train, who we train, and what devices and imaging and concomitant medications make the safest vascular access. Catheter manipulation and vascular closure are essentially overlooked in guidelines for training and certification, despite the fact that it is the major source of patient morbidity and even mortality. The need for radial and femoral access safety is different, but patient safety needs are VAST."
As an angiographer, I have performed over 5000 femoral-access cases. By the grace of God, my bleeding complication rate is less than 1%, including all of those I've referred for PCI. I utilize brachial as a default procedure when necessary, which fortunately isn't all that often. I loathed the arm approach when I was forced to perform the first arm cases utilizing a 4F system for a Cordis trial in my training, but I've utilized it without significant complications when necessary and have been grateful I was trained in that approach. I performed the first arm case in my cath lab in 1991 and taught one of my partners how to do it. I resent the insinuation that the radial approach is better than my femoral or my brachial approach. I also resent it being utilized as a marketing tool around the country while operators are deep into a steep learning curve. I don't like being made to feel that a procedure I worked very hard to administer safely to the public with great success is outdated or archaic while often my flouro times are shorter and my contrast utilization lower. I do applaud the radialists in high-volume centers, both in the US and in the rest of the world, who have done a superb job of perfecting this technique. Only when we can replicate their success by undergoing proper training, monitoring, and reporting should it be introduced into small community cath labs. Only then will I consider radial access a safe adjunct for every operator, and only then, despite any amount of anecdote or opinion, it will no longer be considered a RIVAL.