Transradial approach to PCI, diagnostic angiography brings favorable costs, improved quality of life

For years, the United States has lagged behind the rest of the developed world in using the transradial approach for PCI or diagnostic angiography. However, with mounting evidence that the transradial approach is more cost effective and produces better quality-of-life outcomes compared with the transfemoral approach, that gap is beginning to narrow.

Studies to date have not demonstrated any difference in mortality or other major CV outcomes between the two methods. But, in an era where there is extreme pressure to reduce health care costs and hasten patient recovery, the US interventional cardiology community is in the midst of a shift toward the transradial approach.

A report from the National Cardiovascular Data Registry’s CathPCI Registry released in 2013 revealed that use of the transradial approach for PCI in the United States increased from 2.9% in 2009 to 10.9% in 2011. Experts estimate that the figure is now approximately 20%, and much higher at certain centers.

Referral patterns are also changing, experts said. Although cardiologists need not feel obligated to refer every patient requiring PCI or diagnostic angiography to an interventional cardiologist who uses the transradial approach, patient requests are prompting many to go in that direction, they said.

“Ultimately, patients really advocate for transradial access,” Douglas E. Drachman, MD, director of the cardiology and interventional cardiology fellowship programs at the Massachusetts General Hospital Institute for Heart, Vascular and Stroke Care, told Cardiology Today. “It’s not at all uncommon for patients who have had multiple procedures from different access points to say, ‘I vastly prefer transradial access.’”

Economic appeal

Research has documented the economic appeal of the transradial approach.

“Not only is transradial cost-effective, it is cost-saving,” Sunil V. Rao, MD, FSCAI, FACC, associate professor of medicine at Duke University Medical Center and section chief of cardiology at the Durham, N.C., Veterans Affairs Medical Center, said in an interview. “A lot of new therapies are cost-effective; they actually cost more, but we are getting some value in return. It is unusual for new therapies or strategies to be cost-saving, but the transradial approach actually meets those criteria.”

A study by Amit P. Amin, MD, MSc, and colleagues published in 2013 indicated that transradial access for PCI was associated with a total cost savings of $830 (P<.001) compared with transfemoral access, of which $130 (P=.112) were related to the procedure and $705 (P<.001) were incurred after the procedure. The study covered 7,121 procedures at five US centers.

“Few treatments or procedures exist that cost less and reduce complications. Transradial PCI is one of those rare procedures. The cost savings come from many sources,” Amin, assistant professor in the division of cardiology of the department of internal medicine at Barnes Jewish Hospital and Washington University School of Medicine, St. Louis, told Cardiology Today. “A small, nonsignificant proportion [of cost savings] are from reduced bleeding complications. However, tied to that is earlier patient ambulation and earlier discharge. Since hospital stays are so expensive, an earlier discharge is the major driver of cost savings.”

Another notable finding was that the higher a patient’s risk for bleeding, the greater the savings were with the transradial approach. The savings for patients considered to be at low risk for bleeding were $642 (P=.035); moderate risk, $706 (P=.029); and high risk, $1,621 (P=.039).

Similarly, a study by Robert Applegate, MD, of Wake Forest University School of Medicine, Winston-Salem, N.C., and colleagues published in 2013 demonstrated that transradial access was “economically dominant” over transfemoral access, “with lower costs and fewer complications compared to [femoral access] for PCI and all procedures.”

A major factor in the savings associated with the transradial approach is length of stay, Jordan Safirstein, MD, FACC, FSCAI, director of transradial intervention at Morristown Medical Center, Morristown, N.J., said in an interview.

“Radial PCI in those studies that look at cost-effectiveness tend to show a decreased length of stay for patients, especially in those studies showing the benefit of same-day PCI, where it is possible that select subgroups of patients can be stented and discharged the same day, and therefore cut an overnight stay, which costs quite a bit to the hospital,” Safirstein said.

Length of stay is also shorter for patients undergoing transradial procedures because doctors perceive that they will be at lower risk for complications and quicker to recover, according to Samir B. Pancholy, MD, FACC, FSCAI, program director for fellowship in cardiovascular diseases and associate professor at the Wright Center for Graduate Medical Education at Commonwealth Medical College, Scranton, Pa.

“Although you can send a patient with femoral-access PCI to go home on the same day — and there is nothing to say they should not go — the operators will feel much more comfortable sending a patient done via the radial artery home on the same afternoon, as opposed to somebody who had a 6F or larger groin sheath earlier that morning,” Pancholy said.

Another factor is decreased peripheral vascular complications associated with transradial access, Safirstein said.

“We know that radial PCI is associated with much lower incidence of access-site complications than femoral PCI,” he said. “Along with those access-site complications can come vascular complications and additional imaging studies. For example, if a doctor is worried about a retroperitoneal bleed, they have to do a CT scan, and if they’re worried about a pseudo-aneurysm, they have to do a vascular ultrasound.”

In the current reimbursement environment, this could represent substantial savings to a hospital, said Rao, a member of the Cardiology Today’s Intervention Editorial Board.

“If you can have a strategy that reduces complications, you may actually end up making more money because we are moving toward a more bundled payment scheme,” he said. “In other words, you get one lump sum payment, so if you reduce complications, length of stay, the number of tests that need to be ordered, etc, you actually get a premium.”

The main difference in procedural cost is that a vascular closure device, used in many transfemoral procedures, is approximately $200, whereas the only equipment required for a transradial procedure but not a transfemoral procedure is a radial compression band, which costs $40 or less, Pancholy said.

Enhanced quality of life

Research has also shown that patients who undergo transradial procedures perform better on QOL measures than those undergoing transfemoral procedures.

The landmark study in this area was published by Christopher J. Cooper, MD, chairman of medicine at the University of Toledo Medical Center, Ohio, and colleagues in 1999, who measured the QOL of patients who underwent PCI using the Short Form 36 and visual analog scales at baseline, 1 day and 1 week.

The research team reported that the transradial group had better measures than the transfemoral group at 1 day in bodily pain, back pain and walking ability (P<.05 for all). At 1 week, changes in role limitations caused by physical health, bodily pain and back pain favored the transradial group (P<.05 for all). The majority of patients at 1 day and 1 week said they preferred the transradial method (P<.0001), and among 44 patients who underwent both strategies, 80% indicated a strong preference for transradial and 7% indicated a moderate preference (P<.0001).

Patients also demonstrated a preference for transradial access in the SAFE-PCI for Women study, the results of which were presented by Rao at the TCT conference in 2013. When asked whether they would prefer the assigned access site for a subsequent procedure, 71.9% of SAFE-PCI participants assigned transradial access said they would vs. 23.5% of those assigned transfemoral access.

A study published online in the American Journal of Cardiology in June found that the transradial approach led to better outcomes in health care-related QOL for patients who underwent PCI after STEMI.

Lukasz Koltowski, MD, from the department of cardiology at Medical University of Warsaw, Poland, and colleagues conducted a substudy of the OCEAN RACE trial. Compared with the transfemoral group, the transradial group at 2 hours reported fewer problems with mobility (71.7% vs. 94.4%; P<.01) and self-care (62.5% vs. 97.2%; P<.001). At 4 days, fewer patients in the transradial group reported problems with anxiety or depression compared with the transfemoral group (42.9% vs. 75%; P<.001).

“Anecdotally, my patients who have undergone both types of procedures tell me that their pain and discomfort is much lower” with transradial access, Amin said. “They love that they are able to walk and sit up almost immediately after the procedure. I think it truly is a less-invasive procedure than the transfemoral procedure, so it is not surprising that patients prefer to undergo the radial procedure.”

Another factor, Drachman said, is that “patients are inherently more familiar with handling cuts and minor injuries to the hand, so recovery and care following a transradial procedure may be a straightforward concept for them. In comparison, since femoral access involves a part of the body that is not frequently cut or injured, and vascular structures that may lie deeply obscured from the surface of the skin, patients’ sense of how to manage post-procedural care may be quite unfamiliar or ambiguous.”

Catching up to the rest of the world

The rationale behind why the transradial approach has not caught on as quickly in the United States as in other developed countries is a complicated one, experts said.

“My guess is that there is some inertia on the part of operators who have trained in femoral, in terms of switching to radial,” Rao said. “That is compounded by the fact that we have a lot of low-volume operators in the United States. [Their patients] are probably low-risk patients. Those operators are going to have to go several years before seeing any kind of femoral complication.”

There is also a learning curve associated with the transradial procedure, which could be an impediment for some, Drachman noted.

“People often say that it takes 100 to 200 procedures before you feel very comfortable with this approach. But, I think that at a lower number, people start to feel confident that they can see some of the benefit, both in terms of their skill set and outcomes for the patients. One barrier I’ve observed is that you really need to embrace radial access as a primary strategy, rather than reserving it for an occasional patient,” he said.

In a study published in Circulation in April, researchers concluded that the threshold for overcoming the learning curve of transradial PCI in current US practice is 30 to 50 cases and that adoption rate is related to issues concerning operator proficiency and the need to overcome the assumed learning curve.

However, progress is being made. One reason is that training opportunities were few and far between a decade ago, but that is no longer the case. Professional societies offer courses regularly; an example is the Society for Cardiovascular Angiography and Interventions’ Transradial Interventional Program (TRIP). Medical device companies that make equipment used in radial procedures offer proctorship programs. Some hospitals that have transradial programs in place can help institutions that do not have programs get started.

Moreover, new interventional cardiologists are being trained in the transradial procedure during their fellowship. “Fellows are growing up with the experience and won’t have to seek out additional training in the radial path at another institution,” Safirstein said. “The more fellowship training that is populated with radial instruction, the better off we will be and the more radial we will see in the cath lab every day.”

In some places, the transradial approach has become widespread.

“For some of the trials that we are currently enrolling, we are seeing almost a 50% radial penetration,” Roxana Mehran, MD, FACC, FACP, FCCP, FESC, FAHA, FSCAI, professor of medicine at Icahn School of Medicine at Mount Sinai and Associate Medical Editor of Cardiology Today’s Intervention, said in an interview. “I think that what’s happening is that newer-trained interventionalists are training in the radial technique. Also, there are now much-improved catheters for the radial approach, which makes the job a lot easier. As a result, we are seeing a higher penetration of radial PCI in the United States, and I predict that it will continue to increase.”

Amin noted that some hospitals now perform 80% to 90% of cases via the transradial approach, “and this uptake has been quite impressive in the Northeast particularly.”

Referral considerations

Experts interviewed by Cardiology Today do not recommend using transradial ability as the primary consideration for referral to an interventional cardiologist for PCI or diagnostic angiography. That may be in part due to the lack of difference between the two approaches in major outcomes.

For example, the landmark RIVAL study revealed no difference between the transradial group and the transfemoral group in the primary outcome of death, MI, stroke or non-CABG major bleeding (HR=0.92; 95% CI, 0.72-1.17), secondary outcomes of death, MI or stroke (HR=0.98; 95% CI, 0.76-1.28) or non-CABG major bleeding (HR=0.73; 95% CI, 0.43-1.23). The differences occurred in local vascular complications; for example, the transradial group was less likely than the transfemoral group to have large hematoma (HR=0.4; 95% CI, 0.28-0.57) or pseudoaneurysm needing closure (HR=0.3; 95% CI, 0.13-0.71).

“When it comes to referral patterns, you want to refer to an interventional cardiologist who you can trust is going to do the right thing and is going to communicate with you,” Rao said. “Hopefully that is someone who does radial procedures, but I don’t think we are at the point where we need to be asking for radial procedures from a referral standpoint.”

The reason, Mehran said, is that “if and when there is a radial artery complication, it could be quite fierce. Your hands are important. Your referral patterns should be based on the expertise of the operator in specific techniques.”

This means it is important to understand which patients are not good candidates for either type of access. Experts interviewed said poor candidates for radial access include patients with radial artery spasm, poor upper extremity pulses, conditions that lead to end-arterial spasm or occlusion such as Raynaud’s phenomenon or Berger’s disease, those without ulnar competitive flow and dialysis patients with fistulas in both arms. There are differences of opinion on some patient populations, such as those who have had a radial artery harvested for a bypass graft and those who are considered at high risk for future dialysis.

Case is less clear in women

Debate also surrounds appropriateness of the transradial approach in some women. Elderly women are more likely than other populations to have small vessels that make successful completion of a transradial procedure more difficult, Drachman said. Also, radial artery spasm is more common in women than in men, Mehran noted.

The SAFE-PCI for Women study revealed mixed results. In the total randomized cohort, which included women who had PCI or cardiac catheterization, the transradial approach was associated with lower odds of bleeding or vascular complications compared with the transfemoral approach (OR=0.3; 95% CI, 0.1-0.9). However, among just the women who had PCI, there was no difference between the groups (OR=0.4; 95% CI, 0.1-1.3). Further, women randomly assigned to the transradial approach were more likely to need to be crossed over to transfemoral access compared with the reverse (total cohort, OR=3.7; 95% CI, 2.1-6.4; PCI cohort, OR=3.6; 95% CI, 1.5-9.2).

“The conundrum is that women should probably get more access with their radial artery, but unfortunately the SAFE-PCI study was a negative study in the female patient population,” Mehran said.

An individualized approach

Although the transradial approach appears no different from the transfemoral approach in terms of mortality or major CV outcomes, it is associated with lower costs, fewer bleeding complications and better QOL for patients. In today’s health care climate, that matters.

“As our health care is changing dynamically and our patient population is becoming more complex, performing these radial procedures not only greatly benefits patients, reduces complications and ensures an uneventful quick recovery, but also really benefits hospitals that use the radial approach in their more complex patients,” Amin said. “Transradial PCI truly represents a win-win situation for patients, physicians and hospitals alike.”

For Kreton Mavromatis, MD, while the transradial approach is an important technique with many benefits to patients and the health care system, an individualized approach to each case is still key.

“It is important to note that there are some advantages to transfemoral access, such as decreased fluoroscopy time, capacity for larger catheter size, a lower chance of access failure and no risk for radial artery occlusion. While the significance and magnitude of these advantages generally do not dominate the increased patient comfort and decreased bleeding seen with transradial access, in certain individual situations they may.

“This, coupled with the fact that there has been improvement in the transfemoral technique in the last decade, make the transfemoral approach still hold value in some patients some of the time,” Mavromatis, director of the Atlanta VA Cardiac Catheterization Laboratory and associate professor of medicine at Emory University, told Cardiology Today.

“An individualized approach, taking into account patient characteristics, procedural needs, and the advantages and disadvantages of both techniques, will probably result in the best outcomes,” he said. – by Erik Swain, with additional reporting by Katie Kalvaitis

Disclosures: Amin reports serving on advisory boards for AstraZeneca, Terumo and The Medicines Co. Mehran reports financial ties with AstraZeneca, Boston Scientific, Bristol-Myers Squibb, CSL Behring, Covidien, Janssen Pharmaceuticals, Maya Medical, Merck, Sanofi Aventis and The Medicines Co. Pancholy reports speaking for Terumo. Rao reports consulting for Terumo. Drachman, Mavromatis and Safirstein report no relevant financial disclosures.