PEARL Registry Supports Boston Scientific’s AngioJet Rheolytic Thrombectomy System for DVT
June 24, 2015—In the Journal of Vascular and Interventional Radiology (JVIR), Mark J. Garcia, MD, et al published the procedural and patient outcomes from the prospective, multicenter PEARL registry, which evaluated peripheral use of the AngioJet rheolytic thrombectomy (RT) system (Boston Scientific Corporation) with a variety of catheter lengths in the endovascular management of deep vein thrombosis (DVT) of the lower extremity (2015;26:777–785).
The investigators concluded in JVIR that the PEARL registry data demonstrate that rheolytic pharmacomechanical catheter-directed thrombolysis (PCDT) treatment of DVT is safe and effective and can potentially reduce the need for concomitant catheter-directed thrombolysis (CDT) and intensive care. The investigators will publish the PEARL Registry results of PCDT for the management of acute limb ischemia in the July issue of the Journal of Endovascular Therapy.
As summarized in JVIR, the registry was conducted at 32 sites in the United States and Europe that enrolled patients with DVT. Patient characteristics and outcomes data were collected from consenting patients who underwent rheolytic AngioJet thrombectomy at the investigative sites from January 2007 through June 2013. Of the 329 patients who were enrolled, 67% of patients received an AngioJet procedure within 14 days of the onset of symptoms.
The investigators identified four treatment approaches using AngioJet thrombectomy: RT without lytic agent in 4% of patients (13 of 329); PCDT in 35% (115 of 329); PCDT and CDT in 52% (172 of 329); and RT in combination with CDT in 9% (29 of 329).
Median procedure times for RT alone, PCDT, PCDT/CDT, and RT/CDT were 1.4, 2, 22, and 41 hours, respectively. Procedures were completed in < 24 hours for 73% of patients, with 36% of procedures completed within 6 hours; 86% of procedures required no more than two catheter laboratory sessions. The 3-, 6-, and 12-month freedom from rethrombosis rates were 94%, 87%, and 83%, respectively. Major bleeding events occurred in 12 patients (3.6%), but none were related to the AngioJet procedure, stated the investigators in JVIR.