In his practice, Sunil V. Rao, MD, uses the transradial approach for interventional cath procedures for about 85 percent of his patients—which is everyone who can safely undergo the technique. But Rao is an anomaly in the U.S., and even within his own institution.

Rao is an assistant professor of medicine at Duke University Medical Center and the director of the cardiac cath lab at Durham VA Medical Center, Durham, N.C. The rates of radial access utilization vary among Rao’s 15 interventionalist colleagues, ranging from zero to 30 to 85 percent.

“The reasons for the variability are unclear,” he said, “but essentially it depends on a physician’s comfort level. In the U.S., we tend to train our fellows to do the procedure from the groin, and they get comfortable with that and develop an inertia for change.”

Change is in the wind

Sunil V. Rao, MD

Within the U.S., there has been a dramatic uptick in interest in the transradial approach within the last 18 months, Rao said. The reason is a combination of factors. “There are more targeted anticoagulation drugs to reduce bleeding complications and pharmaceutical companies have been proactive to spread the message that bleeding complications after cath procedures are not good. People have become more aware of the safety issue,” he said.

The focus until recently has been on using safe drugs to control bleeding complications. But the transradial approach offers interventionalists the option to reduce complications regardless of the drugs employed. “Combined with new equipment designed for the transradial approach, we’ve had the perfect storm to generate a tremendous buzz about this technique,” he said.

Data show clinical benefit

Rao and colleagues conducted a study, using the American College of Cardiology’s National Cardiovascular Data Registry, examining the use of transradial access in the U.S. from 2005-2007 (J Am Coll Cardiol Intv 2008; 1[4]:379-386). They found the average use to be 1.3 percent, with a gradual uptick in the final quarter of 2007 (3 percent).

After analyzing the data from more than 600,000 patients, Rao and colleagues found that the radial approach, procedurally, was as good as the femoral approach. But the radial approach resulted in a 60 percent reduction in bleeding complications compared with femoral access. “What makes it especially interesting is that the reduction in complications also was associated with patients who are at a higher risk of bleeding, such as smaller women and patients with an acute MI who are treated aggressively with blood thinners,” Rao said.

The study confirmed previous data, he said. Even in small studies and randomized trials, “the data have consistently shown that the transradial approach dramatically reduces bleeding complications, regardless of whether or not vascular closure devices are used in the femoral approach,” he said.

Data show economic benefit

Aaron D. Kugelmass, MD, from Henry Ford Hospital in Detroit, and colleagues from various institutions studied Medicare data of nearly 350,000 patients who underwent PCI in 2002 (Am J Cardiol 2006;97:322–327). They found 9.5 percent of those studied developed more than one of seven complications.

The average cost of a PCI hospitalization without complications was nearly $14,000, with an average length of stay of three days. With complications, the average cost rises to nearly $27,000, with an average of nine days spent in the hospital.

A total of 5.4 percent of the patients with multiple complications had vascular complications, while 4.1 percent of those with only one complication had vascular complications. The average incremental length of stay for those with vascular complications was 1.8 days.

“If you can save the healthcare system $7,000 per patient by eliminating vascular complications by employing the transradial approach, that is a huge savings,” Rao said.

But does the radial approach improve survival? That is the big unanswered question. “We know bleeding is associated with increased mortality and we know that the radial approach reduces bleeding. But we don’t know whether the radial approach improves survival.

Rao is hoping that the RIVAL Trial (An International Randomized Trial of Trans-radial Versus Trans-femoral PCI Access Site Approach in Patients With Unstable Angina or MI Managed With an Invasive Strategy) sheds some light on the survival question. RIVAL intends to recruit 7,000 patients and is the largest study comparing the two arterial access approaches.

“The challenge, even with 7,000 patients, is that we may not be able to show a difference in survival, because patients in general tend to do well after angioplasty, in terms of living longer,” he said. Nevertheless, he expects there to be an answer in the next five years.

Formal training

Rao’s early research revolved around safety and bleeding complications, so the move to the transradial approach was a natural one for him. He had only performed one or two cases in his fellowship training, so when he decided to adopt the approach as standard in his practice, he had to learn on his own—trial and error.

Today, that is changing. The Society for Cardiovascular Angiography and Interventions (SCAI) will introduce this spring a formal transradial training module to be offered at the time of its national meeting. Rao has been involved in developing the course. Depending on the interest of the course, it could spread out to major cities and be offered several times a year.

Talks also are underway within SCAI about ways to formalize certification for physicians and accreditation for facilities regarding their proficiency with the transradial approach.

Default approach

For too long, transradial access has been the bailout approach for patients on whom the femoral approach was problematic. Rao wants that to change. He wants the radial approach to become the default technique.

“We need to move from the radial approach being a niche procedure to it becoming standard,” he said. “Our approach to our trainees is to tell them not to make the radial approach a hobby. If you’re going to be good at this, you’ve got to commit to it.”

He elucidated the benefit of the radial approach with the example of a man who arrived at the hospital on a Friday morning suffering from a heart attack. The man was on Coumadin. Normally, the interventional team would have to wait the weekend unto the blood-thinning medication wore off. Instead, Rao used the radial approach, stented the offending artery and the man went home on Saturday.

“We saved four days of hospitalization,” he said.

"It can’t be denied that there is an increased focus to improve the safety of PCI. And I have no doubt that the interest in the transradial approach will reach a fever pitch in 2010," Rao concluded.