Discussing science, anecdote, and opinion: Up in arms after RIVAL?

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.

See also:
Five-year data favor radial artery over saphenous vein grafts for CABG
Radial RIVALs femoral access for invasive ACS treatment, but doesn't beat it

Your comments

	Discussing science, anecdote, and opinion: Up in arms after RIVAL?
	# 1 of 5	April 5, 2011 04:50 (EDT)
	Confusing data	Melissa,      Before switching to the "radial first" approach I fervently searched the literature for a single hand complication even coming upon this comment by Dr. Ian Gilchrist of Penn State (a radial operator and enthusiast) in an article written about the approach.      "Likewise, the transradial literature also lacks any clear-cut cases of hand ischemia, despite the fact that many operators no longer use the Allen’s test as an indication to deny transradial access.13 This is not to say that hand ischemia will never occur, but rather the risk is exceedingly small. The risk of morality and morbidity is clear and present from transfemoral puncture. This real risk from femoral puncture must be considered against a potential ischemic risk, not yet reported, when using a hand with an abnormal Allen’s test result, before the transradial approach is lightly rejected."        I think the thing that divides the anectdotalism cited in your comments is that a life threatening retroperitoneal hemorrhage may occur with perfect technique whereas failure to do an Allen's test correctly (notwithstanding the comments by Dr. Gilchrist above) would seem to be a deviation in the standard of care.  I know that for most cases either approach is fine with careful technique but in this age of increasingly obese patients often referred on full dose anticoagulation it is an elegant way around what remains the most common complication of PCI.  Finally for those trained in the brachial approach and skilled in catheter manipulation and willing to exercise appropriate humility when the anatomy dictates I think the learning curve is overstated.
	# 2 of 5	April 5, 2011 11:49 (EDT)
	Melissa Walton-Shirley	CD, Thanks for posting and your points are well taken. Melissa
	# 3 of 5	April 5, 2011 02:01 (EDT)
	Andrey Espinoza	Melissa,   Citing 5,000 cases of diagnostic procedures done transfemorally with a <1% complication rate is rather commendable. Having performed the same number and more of interventional cases including carotid and peripheral I can assure you the complication rates from the access are far more than anyone ever admits. RP bleeds are rare but do occur and at times are life threatening and other times do result in death. Hematoms, PSA's, AV fistulas are also far more common than reported resulting in prolonged hospital stays, blood transfusions and disruption of anti-plt tx which all have a well defined negative impact on short and longterm outcomes.  I am an advocate of skilled operators doing whatever they feel most comfortable doing understanding the end game is the care and outcome of the patient. I still use trans-femoral approach for appropriately selected patients and for all other non-coronary procedures. It still works as well as it did prior to going to a predominant TR strategy. I can tell you though when I have to "stick" the groin now I get feelings of post traumatic stress disorder from my fellowship days holding/compressing expanding hematomas or paging the vascular surgeons stat for assistance and exploration of a hypotensive crashing patient. Anecdotally, we have been performing universal TR approach for STEMI for over almost two years now and have had a 0% bleeding complication rate (reportable to the State of NJ), 0% "ischemic" hand, 0% radial artery thrombosis, no impact on D2B and a very thankful group of patients and CCU staff that cares for these people post procedure. And as RIVAL clearly demonstrated the TR approach should be strongly considered as first line for STEMI patients.  We have had two patients with radial artery thrombosis that resolved with short term anti-coagulant therapy (this is including all elective PCI, diagnostics etc.) and two with sterile seromas that resolved on their own. All we had to do was change out from the cook sheaths to correct those issues and knock on wood things have been quiet since.  No one is insinuating TR is better than TF. But if consider your patients preference and comfort (as you have on many editorials in theheart.org in the past) then you should consider changing your approach just based on that. When you look at the data, all of it, then there is evidence new and old that there is clearly a benefit with regards to access site issues. How about reducing cost to the healthcare system? Does that resonate? I have been sending uncomplicated patients home s/p elective PCI TR approach with a 24 hour office follow up for two years now without any issues at all...the things it has done are decreased hospital costs, patient costs, and avoid all the medication screw ups when my patients get admitted and get all their drugs changed because they aren't on the hospital formulary....the list of benefits are endless...I can only speak to my exerience which has been a positive one in everyway....I feel as a doctor first and Interventionalist second I have finally impacted patients care and outcomes by adapting and changing my practice. This is not a marketing ploy it is a reality supported by facts. And I think it an opportunity for all of us to reconsider what we do and how we can make it better for some if not most. Thanks for listening as always.   Andrey Espinoza, MD FACC FSCAI
	# 4 of 5	April 5, 2011 11:15 (EDT)
	Melissa	Andrey, I appreciate hearing your thoughts. I know you are sincere and wish you the best in your endeavors. I appreciate your posting as well as your compliments. We appreciate your participation here on theheart.org! Melissa
	# 5 of 5	April 11, 2011 04:36 (EDT)
	David	Hi,   RIVAL is interesting that it shows that all cases, bifurcations, ACS, STEMI etc. can be performed as successfully via radial as via femoral.   The bleeding definition was extremely conservative. The presentation gave a cut-off of 5g (like TIMI major) but it is not mentioned in the Lancet paper. 0.5% TIMI major bleeding (both groups) is the lowest rate ever reported in a ACS trial.   Summary - radial access removes local complications. Non-access site remains an issue.   Having worked at a large (European) centre that performs almost exclusively radial procedures, I have never seen a case of hand ischemia. From my previous femoral experience, I have seen multiple cases of bleeds, pseudoaneurysms etc. I also agree with the comment that it now seems bizarre to be blindly "sticking" the groin, in comparison to the ease of radial access.   The other reasons for radial access, patient preference, early mobilization, nurse preference (ask any radial nurse to change back to femoral and see what they say!!), costs, same-day discharge are also very important.   I’m not sure how enlightening your anecdotes are, apart from stating that sometimes the unexpected happens, or sometimes interventional cardiologists can be stubborn (surprised?).

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