Monday, March 31, 2008

Late-breaking clinical trial at ACC: Angioplasty at medical centers without on-site cardiac surgery
By Kelly Winget

According to a new study, medical centers that do not have on-site cardiac surgery can perform angioplasty safely and effectively, as long as the programs are well-organized, have highly skilled teams and are committed to quality. The study is the largest ever to compare angioplasty programs that have on-site cardiac surgery to programs that need to transfer patients to a surgical hospital in case of emergency.

The study findings were presented as a late-breaking clinical trial at the American College of Cardiology 2008 Scientific Sessions on March 29. The DCRI's Eric Peterson, MD, and Fang-Shu Ou were two of the authors of the study -- Percutaneous Coronary Interventions at Facilities Without On-site Cardiac Surgery: A report from the National Cardiovascular Data Registry (NCDR).

Angioplasty, or percutaneous coronary intervention (PCI), is a procedure to open a blocked coronary artery using a catheter-guided balloon and is often performed on patients who are having heart attacks. Although the risk of needing emergency bypass surgery is very low (approximately 0.3 percent of patients) following PCI, it has a high mortality rate of approximately 13 percent.

There is some discussion in the medical community about performing PCI at medical centers that do not have on-site cardiac surgery. While clinical guidelines support performing this procedure when a patient is having a heart attack (primary PCI), they advise these medical centers against performing elective PCI, where the need is less urgent. The medical centers counter that offering elective PCI is necessary to economical survival and it helps keep staff skills in peak form.

Although the study findings are reassuring, researchers stress that it is not endorsing “boutique” angioplasty but accomplished medical centers can improve outcomes for heart attack patients and better serve patients in remote geographic areas.

The research team, which included interventional cardiologists, statisticians and NCDR officers, gathered data from the NCDR CathPCI Registry, and the Duke Cardiovascular Research Institute performed the analysis. The team reviewed data on more than 9,000 patients treated at 61 medical centers with off-site cardiac surgery and almost 300,000 patients treated at 404 medical centers with on-site cardiac surgery.

The centers that relied on off-site hospitals for emergency cardiac surgery support typically performed fewer PCIs annually but treated more patients who were experiencing a heart attack at the time they had PCI. The study found that approximately 41 percent of patients at centers with off-site support were having a heart attack at the time of the PCI, compared to 29 percent of patients having heart attacks who were treated at centers with on-site cardiac surgery.

Despite this, the two types of medical centers both had approximately 93 percent PCI success rates. Further comparison between off-site centers and on-site centers showed similar overall complication rates (6.4 percent to 6.3 percent, respectively), emergency surgery rates (0.31 percent to 0.37 percent) and mortality rates from emergency surgery (13.6 percent to 12.6 percent).

All of the medical centers that were reviewed in the study voluntarily chose to submit data to the NCDR – an indication of a commitment to quality, according to the researchers. Among the centers with off-site cardiac surgery support, 92 percent were ready to perform PCI 24 hours per day, seven days a week. And when performing PCI on patients with heart attacks, the centers with off-site surgery were able to restore blood flow to the coronary artery within 1.4 hours of the patient's arrival, slightly better than the 1.5 hours for centers with on-site surgery.

The NCDR database study provided the research team with a view of contemporary PCI patterns in the U.S. Researchers said they hoped the study results would not suggest that there should be a rapid expansion of medical centers offering PCI with off-site surgery support, but it confirms that it is appropriate in centers that have a strong commitment to organization and quality assurance.