Significant per-patient savings and better outcomes may be possible with an atherectomy device presented as a late-breaking clinical trial May 30 at the Society for Cardiovascular Angiography and Interventions (SCAI) scientific session in Las Vegas. Compared with Medicare patients, ORBIT II patients saw a cost reduction of over $2,500 per patient and a shorter hospital stay by up to three days.
One-year results from ORBIT II, a pilot study focusing on high-risk, severely calcified lesions, were presented by lead investigator Jeffrey Chambers, MD, director of the cardiac catheterization laboratory at Mercy Hospital in Minnesota. The study looked at 443 patients who were in a patient population typically excluded from clinical trials.
Not only was this one-year pilot successful in lowering major adverse cardiovascular event (MACE) incidents in the target patients, but mortality and target vessel/lesion revascularizations (TVR/TLR) also were reduced, contributing to the overall savings of this program.
Stents were delivered successfully in almost 98 percent of cases. Almost 99 percent of patients experienced less than 50 percent residual stenosis. Out of 443 patients from 49 U.S. sites, 94.1 percent of patients avoided TVR/TLR and 97 percent did not experience cardiac death at one year.
“It shows that it has durable long-term results and cost-saving benefits,” said Chambers during a SCAI press session.
The technology used in the study was the Diamondback 360 Orbital Atherectomy System (Cardiovascular Systems), a catheter-based device that sands calcified arterial plaque with both an orbiting and rotating motion. Using continuous flood of blood and saline, the crown is designed to reduce thermal injury and ensure the small plaque particles are washed downstream. The FDA approved the device in October 2013.
“We see a cost savings primarily in decrease of length of stay and procedural cost of about $3,000,” Chambers stated. The ORBIT II stent procedure was reported as averaging about $14,381 compared with Medicare average costs of about $17,579, based on claims filed for September 2011 to December 2012. After adjusting for age, gender and comorbidities, the estimated cost savings averaged 17 percent.
Cardiovascular Systems sponsored the trial. Chambers reported being a consultant for the company. Further clinical trials are planned with a device incorporating enhancements and with patients with less severe disease.