Published CONFIRM Data Evaluate Orbital Atherectomy Technique Optimization in Calcified Lower Extremity Lesions
December 30, 2013—Tony Das, MD, et al have published findings from the CONFIRM registry in Catheterization & Cardiovascular Interventions (2014;83:115–122). According to the investigators, the purpose of the CONFIRM registry series was to evaluate the use of orbital atherectomy (OA) in peripheral lesions of the lower extremities, as well as optimize the technique of OA. The background of the study is that methods of treating calcified arteries (historically a strong predictor of treatment failure) have improved significantly over the past decade and now include minimally invasive endovascular treatments, such as OA with unique versatility in modifying calcific lesions above and below the knee.
As summarized in Catheterization & Cardiovascular Interventions, the CONFIRM registry was composed of 3,135 patients undergoing OA by more than 350 physicians at more than 200 institutions in the United States. The patients were enrolled on an “all-comers” basis, resulting in registries that provided site-reported patient demographics, ankle-brachial index, Rutherford classification, comorbidities, lesion characteristics, plaque morphology, device usage parameters, and procedural outcomes.
The investigators reported that treatment with OA reduced preprocedural stenosis from an average of 88% to 35%. Final residual stenosis after adjunctive treatments, typically low-pressure percutaneous transluminal angioplasty (PTA), averaged 10%. Plaque removal was most effective for severely calcified lesions and least effective for soft plaque. Shorter spin times and smaller crown sizes significantly lowered procedural complications—including slow flow (4.4%), embolism (2.2%), and spasm (6.3%). This emphasized the importance of treatment regimens that focus on plaque modification over maximizing luminal gain.
The OA technique optimization, which resulted in a change of device usage across the CONFIRM registry series, corresponded to a lower incidence of adverse events irrespective of calcium burden or comorbidities, concluded the investigators in Catheterization & Cardiovascular Interventions.
In October 2012, Dr. Das presented data from CONFIRM at the Vascular InterVentional Advances (VIVA) meeting in Las Vegas, Nevada. At VIVA, Dr. Das noted that CONFIRM was conducted to better understand the potential advantages of the use of the Diamondback OA system (Cardiovascular Systems Inc. [CSI], St. Paul, MN) in real-world patients with calcified infrainguinal disease.