The M Word: Is Routine Transfemoral PCI Defensible in 2018?

Last year, on the Mediterranean island of Cyprus, a course dedicated to transradial coronary interventions included one session posing a provocative question: Given current knowledge, should routinely performing PCI with transfemoral access be considered malpractice?

It’s an inflammatory notion—and one that a wide range of interventional cardiologists, speaking with TCTMD, roundly rejected. But it may shine a light on other issues that continue to dog this debate. What are the medicolegal implications of sticking with a transfemoral-dominated practice? What is needed for the evidence base favoring transradial to be considered indisputable? And why does the United States continue to lag behind other countries in its adoption of a “radial-first” approach?

Mamas Mamas, BMBCh (Keele University, Stoke-on-Trent, England), one of the Cyprus program’s course directors, said he believes the malpractice question should be on the table when considering evidence from randomized trials and registries showing mortality, MACE, and major bleeding complications can be reduced by using the radial artery. The most recent European Society of Cardiology (ESC) guidelines, he pointed out, give a class IA recommendation favoring transradial access in patients with NSTE ACS and STEMI.

“If one were to go before a court of law with a transfemoral complication, I think it would be very difficult to justify going transfemorally regularly as a standard practice,” Mamas said, “and I would say that as a community we should consider it equal to, I don’t know, maybe doing PCIs without using antiplatelets, for example.”

If interventional cardiologists want to put their patients’ needs first, and not their own, radial is the way to go, he argued.

“If we’re serving ourselves because we don’t feel comfortable with a particular access site or we don’t feel trained in using a particular access site, then I think it’s the responsibility of the operator to receive this training to optimize their patients’ outcomes. So my view: I do personally feel that it is malpractice to routinely undertake these procedures femorally,” Mamas said.

An important caveat is that there are certainly individual cases that still need to be done using transfemoral access, he said, adding, however, “I think your default approach should be radial unless there’s a very good reason to go femorally.”

Some interventional cardiologists interviewed by TCTMD also supported a radial-first approach for PCI. Others maintained that radial, if not “first,” should play a prominent role in an operator’s practice.

Almost universally, however, experts agreed that talk of malpractice for routine transfemoral access is a step too far. Particularly in the United States, many argued, most PCIs are still performed using transfemoral access, so it would be impossible to claim that anybody doing a majority of cases femorally is committing malpractice, which strongly hinges on standard community practices. Some also questioned whether radial-versus-femoral data really favor radial as heavily as some radial-first proponents have claimed, especially when taking operator proficiency into account.

“I strongly do not believe that it should be considered malpractice,” said Gregg Stone, MD (NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY), who told TCTMD that he still does most of his cases femorally but is increasingly using radial access. “I think there are advantages and disadvantages to radial and femoral access. Most skilled or expert interventionalists should know how to do both and consider the risks and benefits of each in each individual case and also include the patients in the discussions as to which vascular access is optimal for each individual condition.”

A prominent radial-first proponent, Sunil Rao, MD (Duke University Medical Center, Durham, NC), also disagreed with the position that routinely performing transfemoral procedures should be considered malpractice, citing the need to “preserve physicians’ independence to tailor their treatment to the patient in front of them without the threat of adverse legal consequences.”

Moreover, he said, there is no direct correlation between what is deemed medical malpractice and the use of best, evidence-based practices.

There are debates to be had about access site, “but I certainly would not advocate for making this a malpractice issue,” Rao said.

The Legal Perspective

Stone and others pointed out that malpractice implies that a physician is not meeting local standards of care, and that at most US hospitals, both femoral and radial access are considered to be acceptable approaches.

In fact, Shing-Chiu Wong, MD (Weill Cornell Medical Center, New York, NY), said the latest data from the American College of Cardiology’s National Cardiovascular Data Registry (NCDR) show that most procedures are still done with transfemoral access: 57.2% of all cardiac catheterizations and 61.7% of PCIs.

Thus, the argument goes, routinely opting to go through the femoral artery cannot be malpractice.

According to New York-based attorney Jay Rappaport, a founding partner of Aaronson Rappaport Feinstein & Deutsch who specializes in medical malpractice cases, choosing one access site over another would not—on its own—be considered malpractice because both transradial and transfemoral are considered accepted approaches in the field.

It is more of an informed consent issue, he said, in that operators need to discuss the risks, benefits, and alternatives to any approach. “If the doctor who proposes a procedure doesn’t discuss anything to do with the risks, benefits, or alternatives . . . then that would be potentially opening them up to a malpractice claim for lack of informed consent, not for negligence,” he explained.

Asked whether lawsuits related to choice of access site in PCI are common, Rappaport said, “We’ve certainly not had any cases, and I’ve probably seen more cases than anybody.”

Debating ‘Soft’ Outcomes

If the legal criteria for malpractice would not be met by regularly performing transfemoral procedures, then the argument comes down to what the data accumulated from randomized trials, meta-analyses, and registries show and what they mean for how operators should be practicing.

The most established benefits of using radial access are reductions in access-site complications and bleeding. In addition, in the elective setting, transradial procedures have been associated with a shorter length of stay and in some cases same-day discharge, which lower costs. Moreover, several interventional cardiologists pointed out, patients tend to prefer getting punctured in the wrist as opposed to their groin.

Jeffrey Moses, MD (NewYork-Presbyterian/Columbia University Irving Medical Center), believes that the comparison between radial and femoral is not so cut and dried.

The RIVAL trial, for example, was “dead-bang negative,” Moses said, referring to the lack of a difference between radial and femoral in the primary composite endpoint of death, MI, stroke, or major bleeding. And in MATRIX, where only one of the two co-primary endpoints met criteria for statistical significance, there are questions about what drove the differences in outcomes, he said, because the higher MACE rates in the femoral arm were mostly due to higher event rates among operators who performed the fewest transfemoral procedures.

Also raising some questions about the strength of the advantage for radial is a recent Cochrane review that suggests there could be some publication bias at play, Moses said.

“Femoral people don’t sit around studying radial. You never know what other studies have been out there that have not been published, that haven’t been favorable,” he said.

Wolfgang Schöls, MD (Herzzentrum Duisburg, Germany), also argued that “the data in favor of the transradial approach are not as sound as suggested.”

Use of transradial access does not reduce hard endpoints like death, MI, and stroke in elective and stable patients, he said, though there are fewer major bleeds. After taking into consideration longer procedure time, more radiation exposure, and use of more contrast dye, there is only a minor advantage for the radial approach in this population, Schöls said.

When it comes to ACS, there are three studies that formed the basis for ESC recommendations to preferentially use radial access: RIVAL, MATRIX, and SAFE-PCI. Of the four primary endpoints in the trials (including the two co-primary endpoints in MATRIX), Schöls pointed out, only the net adverse clinical event endpoint in MATRIX significantly favored radial. The RIFLE STEACS trial demonstrated a benefit for radial, but Schöls said there are some questions about the unusually high numbers of deaths, strokes, and MIs in the trial.

Moreover, all of those studies involved experienced operators, and in less experienced hands, radial might not look as good, Schöls added.

“Personally I also use the radial approach and I like it, but I do think that it’s not that you have to do each and every procedure by the radial approach just to demonstrate that you can do it,” he said. “It’s always a balancing of the pros and cons, and I think there is some advantage to radial with respect to reduced bleedings, but it’s not a crime if you decide to go for the femoral if you think you have good reasons. The data are not that strong that you could make the point that you have to do radial whatever patient there is.”

It’s always a balancing of the pros and cons, and I think there is some advantage to radial with respect to reduced bleedings, but it’s not a crime if you decide to go for the femoral if you think you have good reasons. Wolfgang Schöls

Zoltan Turi, MD (Hackensack University Medical Center, NJ), pointed out that the malpractice question “presumes that outcomes with radial are superior to femoral.” But he proposed that many of the differences observed between access techniques could be attributed to less-than-optimal approaches to femoral access and closure.

“So the femoral approach gets punished, if you will, by people who use large needles instead of micropuncture needles, by people who don’t do imaging when they get access, a number of things that would make the femoral safer,” Turi said, noting that even though he has spent the last 20 years publishing on and teaching femoral access, he primarily performs PCI using radial access and believes it to be best practice.

For Rao, however, the evidence base is indisputable. “We’ve got over 19,000 patients in randomized trials showing the exact same thing, which is that radial access reduces mortality in ACS, reduces bleeding,” Rao said. He singled out one particular meta-analysis incorporating four randomized trials to make his case. It showed that in patients with ACS, radial access was associated with reductions in death, MACE, and major bleeding; procedural length and access-site crossover were higher with radial.

Nor can poor femoral technique explain the benefits observed for radial, he continued.

“To people who are evaluating the data skeptically, I think that there may be a perception that these data are somehow suggesting that if they’re a femoral operator, they’re just not very good at it, that it’s a technique issue. And obviously, all of us who do procedures take pride in our technique, so I certainly understand why there may be some reluctance to wholeheartedly embrace the radial data if you are largely a femoral operator and in your own mind haven’t made a commitment to convert,” he said. “However, it’s just not accurate to say that the data are not definitive. That’s just factually incorrect.

“The data are the data. You either choose to believe them and move forward, or you choose not to believe them and sort of stay where you are,” Rao continued. “All I think that we in the interventional community who are trying to promote radial access can do is to say, ‘This is the evidence. No one is forcing you to practice by the evidence, but if you want to be an evidence-based physician, this is the evidence and this is what you should do.’”

Much Ado About Mortality

The strongest argument in favor of using a radial-first approach comes from data showing a mortality benefit in the setting of ACS. The meta-analysis cited by Rao, for example, showed that radial access reduced mortality by a relative 27%. Mamas cited this advantage to help back his malpractice argument. Stone, on the other hand, is not convinced.

“To me, that data is not as strong as some people would state it is,” he told TCTMD. There are questions about femoral expertise among operators in the trials, as well as about the inclusion of data from negative trials—like RIVAL—in meta-analyses. And, specifically in STEMI, the magnitude of the mortality reduction with radial “is beyond what’s considered reasonable” when looking at the lack of differences in stroke or reinfarction and the modest differences in access-site bleeding, Stone added.

The data are the data. You either choose to believe them and move forward, or you choose not to believe them and sort of stay where you are. Sunil Rao

“Without a strong mechanism, I’m suspicious that there are underlying confounders that have not been completely explored yet,” Stone said.

Mamas acknowledged that discussions about potential mechanisms are justified, but insisted the survival benefit is clear.

“If the same sort of achievement in mortality could be achieved in interventional cardiology by giving a pill to somebody, we would not be having this debate. Every single patient would have that pill. If several randomized controlled trials had shown that pill X reduced mortality by 20% to 30%, people would not be fixating on what the mechanism is. It would be in every guideline, it would be given. I find it’s astonishing that despite all this evidence, we’re still having this debate in 2018.”

To Ian Gilchrist, MD (Penn State Hershey Heart and Vascular Institute, Hershey, PA), a potential survival advantage is not the primary impetus for switching to a predominantly radial approach. His center was one of the first in the United States to start doing radial procedures in the 1990s, and the main motivation for making the switch was a reduction in access-site problems and bleeding. Then, after a while, it became clear that patients preferred it.

“I felt like I was getting the same results as far as being a cardiologist, but I was also getting patients that were very happy with what happened and certainly much happier with the way they felt, especially if they had previously had a femoral catheterization and knew what that procedure was,” Gilchrist said.

In a Proficiency Pickle

Mamas has made up his mind: “I think personally there’s no place for routine femoral practice in 2018 given the body of evidence, given patient preference, patient comfort, and cost savings [with radial].”

However, Ajay Kirtane, MD (NewYork-Presbyterian/Columbia University Irving Medical Center), another self-proclaimed radial-first operator, pointed out that operator skills remain a factor.

“In the United States, we don’t have full proficiency yet, and so to go forward and indiscriminately say that every case should be done radially probably would result in more complications, because not everybody is fully trained to do it,” he said. “And this is coming from a transradialist. I go radial-first in the majority of my patients that can tolerate it. Even cases where other people wouldn’t, I feel comfortable being able to do it and have learned the skills to be able to do it.”

Sanjit Jolly, MD (Population Health Research Institute, McMaster University, Hamilton, Canada), echoed those sentiments about proficiency. “I think the evidence supports transradial PCI in physicians with the appropriate expertise and radial volume. Physicians who do not have expertise cannot offer transradial,” he said.

So what should be done about the operators still predominantly using transfemoral access? “I think every effort should be made to retrain those individuals, because obviously there are many very skilled transfemoral operators who have a lot of experience, that have a lot to offer,” Jolly said. “If somebody’s close to retirement and isn’t willing to learn, that’s a different scenario.”

Having operators who are not fully skilled in transradial access suddenly shifting to that approach could put patients in harm’s way, according to Lorenzo Azzalini, MD, PhD (San Raffaele Scientific Institute, Milan, Italy), who said he believes transradial access should be the standard of care. Thus, any effort to switch predominantly femoral operators to a radial-first approach would have to allow for a transition period to work through the learning curve.

Moses, who noted that a high percentage of his PCIs are still done transfemorally because he does a lot of “heavy-duty” work involving grafts, calcification, and poor aortic anatomy that requires large guide catheters, said operators who are not proficient in radial access should learn it. He added, however, that there remains a place for femoral procedures.

“I don’t think you should be doing 90% femoral, but I think if you have a high percentage of femoral because you’re comfortable with it and your outcomes are good because of your access-site management and your groin management, then I think it’s fine and I think it ought to be looked at on an operator-by-operator basis,” Moses concluded.

Nobody Is Arguing for 100% Radial

All of the interventional cardiologists interviewed by TCTMD acknowledged that some procedures would need to be performed through the femoral artery, even in a radial-first environment.

Mamas gave the example of patients with cardiogenic shock whose radial pulse can’t be detected, patients who require PCI for a complex chronic total occlusion that would require large guide catheters, or people with small radial arteries.

“In those sorts of cases, I think it’s entirely appropriate to go femorally. What I feel is malpractice are operators who base their whole practice on the transfemoral approach,” he said.

Wong had further additions to the list of patients better suited to transfemoral, namely those with radial arteries that are tortuous or have had spasms and those with Raynaud’s disease. Stone, likewise, pointed to patients with bypass grafts in whom it might be simpler to go through the femoral artery.

All of these examples support the need for some level of femoral training to avoid the so-called Campeau Paradox, a phenomenon first described by a group that included Azzalini. They warned of what might happen if femoral skills disappear in the radial-first era.

Recounting his personal experience, Azzalini described being nervous when he had to stick a femoral artery during his early training in Europe, which involved about 20 femoral cases and 230 radial cases. He said he believes trainees should be sure to also hone their femoral skills, possibly by using simulators and by studying the anatomy of the femoral artery and surrounding structures.

“In my opinion, the perfect balance between the benefit of radial and not forgetting totally your femoral access is about 80% radial and 20% femoral,” he said.

Schöls, on the other hand, was skeptical about a degradation of femoral skills as the field moves more toward radial procedures. An operator who can manage to puncture and navigate the smaller radial artery should not have problems with the larger femoral artery, he said: “I don’t think that there’s a strong argument that you lose your femoral skills if you go mostly through radial.”

Still, Kirtane said, “it’s very important to get experience in both, because not all patients are able to be done transradially, and if you lose your femoral access skills—and more importantly, the groin management skills—then those outcomes will potentially get even worse.”

Making the Switch

Europe, Canada, and other parts of the world have already shifted to performing the majority of PCIs radially; however, in the United States, most PCIs are still done transfemorally.

It’s time for that to change, said Mamas. The reluctance of US operators to adopt radial was understandable perhaps a decade ago, when opportunities for mentorship and training were not as easy to come by, but now there are ample opportunities for radial training, he said.

“I think the support mechanisms are there for operators to switch from femoral to radial, and I started myself as a femoral operator, and I switched,” Mamas said. “And so I think it’s very difficult these days to justify why one wouldn’t switch.”

One potential obstacle, at least in the United States, is the fact that there are many low-volume operators, making it more difficult to get enough cases under one’s belt to work through the radial learning curve—which some data have suggested is 30 to 50 cases but Mamas estimated to be 100 to 200 cases in order to encounter the common problems.

Turi, for his part, predicted that low-volume operators might have a hard time getting past the learning curve. On the other hand, he said, “higher-volume operators should make the effort, but with adequate training and supervision because during your learning curve you’re exposing the patient to a procedure with which you’re inexperienced. I’m not so enthusiastic about low-volume operators suddenly switching to radials.”

Gilchrist said another potential barrier to making the switch is a belief among some predominantly femoral operators that they don’t get complications. However, Gilchrist pointed out, data from the NCDR indicate that the complication rate is higher with transfemoral versus transradial across the country. “It’s awful hard to imagine that everyone that’s sticking with transfemoral actually has no complications,” he said.

Wong noted that the perception that there are no complications with femoral may be exacerbated among low-volume operators, because if they’re only 20 or 30 cases a year, they may go months without having a problem.

As Rao put it: “I think it’s an issue of human nature. We tend to practice today based on what happened to us yesterday. And so if you are doing lower-risk cases, you’re not doing that many cases, you may go 6 months to a year without ever seeing a groin bleed. In which case you think to yourself, ‘Geez, my practice is okay, why should I switch?’ And maybe you shouldn’t switch, maybe you’re not going to be able to overcome that learning curve.”

And yet another reason interventional cardiologists may be reluctant to incorporate more radial into their practices could involve procedure times, Stone suggested.

The strongest data in favor of radial over femoral comes from ACS, particularly STEMI, Stone pointed out. “In that latter scenario time matters. And radial access in the best of hands often entails some delay compared to femoral access. If you’re not a truly expert operator then you can substantially prolong the procedure—in other words, prolong door-to-balloon time—which could lead to worse patient outcomes.”

The same discussions and debates took place in the United Kingdom 10 or 15 years ago, Mamas noted, but now 85% of PCIs being performed there are done via the radial artery. “I think that’s something for the United States to aspire to,” he said.

Taking it a step further, Mamas stated: “We cannot have a situation where we say, ‘Well, okay, we should use best practice as defined by evidence, but it only applies to operators that can achieve those standards because they do enough PCIs.’ That’s not appropriate. Best practice should be applicable to every operator irrespective of their volume, and if their volume does not allow them to achieve best practice then perhaps they shouldn’t be undertaking procedures.”

That’s going too far for Kirtane, who said that telling somebody they should or should not be practicing based on their choice of access site is “too ardent an argument.”

“I think the bottom line is that radial as a whole across populations, across several operators, will reduce bleeding complications, but that doesn’t mean that there aren’t individual operators who can be very, very proficient at femoral access,” Kirtane said.

Past the Tipping Point

Even those who provided skeptical views of the radial superiority data indicated that their radial volumes are increasing, and in some cases, already make up the majority of their procedures. This will only continue to increase.

“Saying that it’s not malpractice [to routinely perform transfemoral PCI] is not the same as my thinking that radial is a critically important part of anyone’s armamentarium in contemporary PCI. It’s just a matter of degree,” Moses said.

Gilchrist said the adoption of radial access follows a logarithmic curve, as seen in other countries that have jumped on board, and the United States is on the steep side of that curve as the proportion of radial cases approaches 50%. But it is past the tipping point, he said, because the vast majority of young interventional cardiologists want to use transradial access. “So basically it’s a matter of time,” Gilchrist said.

Turi said the transition is important to make because radial access is best practice and there remain large numbers of purely femoral operators and inexperienced radial operators. But the process can’t be rushed, he indicated.

“I would be reluctant to force on the community a switch to radial in every case or even in a large majority of cases when they have operators who are primarily femorally trained and experienced,” Turi said. “I think it’s harsh and probably unwise as policy, and I think what will happen is that in the next 10, 15 years we will have a large cadre of radial-trained interventional cardiologists.”

Everyone interviewed stateside seemed to agree: this transition should happen because operators are keeping pace with evidence and practice and not because lawyers or legislators are getting involved.