Feature | July 20, 2010| Dave Fornell

Crusading to Expand Radial Access

While evidence shows reduced complications, U.S. physicians have been slow to adopt the technique

Use of the radial instead of the femoral artery as a vascular access site can significantly reduce bleeding complications. Above, devices such as the Terumo TR Band allow visual control from start to finish of procedures.

Outside the United States, transradial artery access is used in 50-90 percent of percutaneous interventions over femoral access, while U.S. usage rates are less than 5 percent. However, a patient safety advocacy organization is attempting to accelerate radial access adoption through education and speaking with lawmakers in Washington.

Advocates say radial access via the wrist offers a major reduction in bleeding complications, allows for earlier patient ambulation, reduces the amount of pain and cuts access site infection rates. In the United States radial access has been slow to catch on. This is mainly due to the procedure not having been taught in medical schools until recently. Physicians also stick to procedures they are comfortable with, and femoral access has been the standard of care.

“Why is it 90 percent of the rest of the world goes through the wrist, and 90 percent of the procedures in the United States are done through the femoral artery?” asks Paul Zimnik, D.O., founder and executive director of the Patient Medical Association (PAMEAS).

Femoral access bleeding complication rates are between 5-10 percent, Zimnik said. “That disappears with use of the radial artery – there are no bleeding complications,” he said.

PAMEAS has been pushing for wider adoption of transradial access in cath labs as a health care reform to help reduce costs and increase patient safety. The goal of expanded use is to lower costs associated with admissions and treating bleeding complications and increasing patient safety, Zimnik said. The organization would like to see U.S. transradial access rates go from their current 1-5 percent of procedures, up to 20-30 percent in the next five years.

“If we increased radial access in this country, we would spend less money, patients would be happier and we would have better outcomes,” Zimnik said.

Making a Case in Washington

PAMEAS has been active in speaking with federal lawmakers to make them aware of what radial access is and how it may help reduce health care costs.

“We don’t represent anyone or any company. We just want to inform policy-makers about our views on health care reform and increase patient safety. We have reached out to anyone who will talk to us,” Zimnik said.

This has included the staff of Congressional leaders and the Centers for Medicare and Medicaid Services (CMS).

Asking for Reimbursement Changes

PAMEAS is asking CMS to offer incentive payments when transradial access is utilized. It is also advocating decreased reimbursements for treatment of bleeding complications arising from transfemoral access and fairer compensation for outpatient catheter-based procedures to balance the loss of reimbursements for an overnight hospital stay.

While the initial cost might seem higher for Medicare, Zimnik said much more money would be saved over the long term with fewer complications, readmissions, reduced nursing time and the elimination of most overnight hospital stays. Zimnik said radial access could make most cath lab interventions into outpatient procedures.

“This would encourage hospitals to be more cost-effective,” Zimnik said. “It allows the patients to get out of the hospital more quickly.”

However, asking CMS for reimbursement changes is not a simple task, especially since it has legal limitations of what can influence reimbursements.

“As required by the Medicare statute, payment rates are based on the resources, including physician work and allocations of practice expenses and malpractice expenses that are needed to furnish the service,” said CMS spokeswoman Ellen Griffith. “We do not have authority under the Medicare law to take into account considerations of the alleged clinical value of a particular procedure in setting the payment rate for that procedure.”

However, CMS said it recognizes well-documented deficiencies in the quality and safety of health care, as well as the unsustainable growth in health care spending in the United States. This has caused CMS to consider alternatives to its current payment system, which rewards quantity of services rather than quality of care. CMS is reviewing new payment methods through public reporting programs and demonstration projects. Griffith said some demonstration projects are testing whether a different payment methodology could create incentives to improve outcomes, reduce costs, or both.

“If a case costs less, there may be new reimbursements under some demonstration projects,” Griffith said.

Training Physicians
“Radial is really a no-brainer with training,” Zimnik said. “Most people can learn the technique in a day, but it may take months and numerous procedures before a physician becomes comfortable with it and establishes ‘muscle memory.’”

PAMEAS is developing transradial educational programs for practitioners to help spread its use. The group is creating dinners, seminars and hands-on preceptorship and mentorship programs, Zimnik said. The group is also planning a larger transradial summit in Orlando in August. The hope is to train 1,000 cardiologists in the technique each year.

“It takes one to six months for an interventionalist to really get comfortable with the radial technique,” Zimnik said.

PAMEAS is also hoping to secure federal money for transradial training programs. Currently much of the funding for PAMEAS’ training program comes from industry partnerships, including Terumo, which is making radial access a key theme in its sales strategy. Zimnik has also approached Medical Simulation Corp. to create a transradial training module for its cath lab simulator system.

Creation of a Transradial Industry

Zimnik said the primary interventions using radial access right now are for the coronaries, because most catheters are not long enough to reach lower peripheral vessels. However, Zimnik believes the industry will start offering longer catheters for radial peripheral procedures as demand rises.
“Five years from now I think we will be looking at an industry that will be serving a transradial market,” Zimnik said.

Terumo is the leader in the transradial access market, with most of its business overseas. The company is a big supporter of transradial education programs in the United States to expand radial access use.
In early 2010, St. Jude Medical launched a transradial introducer portfolio and said it plans to introduce other transradial products in both the United States and abroad. The company said it sees transradial as a growing trend in the interventional market. Teleflex also offers radial access introducer kits and plans to expand its transradial portfolio in the coming year as the U.S. market expands.

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