Endovascular Management of Deep Vein Thrombosis with Rheolytic Thrombectomy: Final Report of the Prospective Multicenter PEARL (Peripheral Use of AngioJet Rheolytic Thrombectomy with a Variety of Catheter Lengths) Registry

J Vasc Interv Radiol. 2015 Jun;26(6):777-85; quiz 786. doi: 10.1016/j.jvir.2015.01.036. Epub 2015 Mar 29.

Abstract

Purpose: To report procedural and patient outcomes of endovascular treatment for lower-extremity deep vein thrombosis (DVT) with rheolytic thrombectomy (RT).

Materials and methods: A total of 32 sites in the United States and Europe enrolled patients with DVT in the Peripheral Use of AngioJet Rheolytic Thrombectomy with a Variety of Catheter Lengths (PEARL) registry. Patient characteristics and outcomes data were collected from consenting patients who underwent rheolytic AngioJet thrombectomy at investigative sites from January 2007 through June 2013. Three hundred twenty-nine patients were enrolled, with 67% of patients undergoing an AngioJet procedure within 14 days of the onset of symptoms.

Results: Four treatment approaches using AngioJet thrombectomy were identified: RT without lytic agent in 4% of patients (13 of 329), pharmacomechanical catheter-directed thrombolysis (PCDT) in 35% (115 of 329), PCDT and catheter-directed thrombolysis (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 (P < .05, Kruskal-Wallis test). Procedures were completed in less than 24 hours for 73% of patients, with 36% of procedures completed within 6 hours; 86% of procedures required no more than 2 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.

Conclusions: PEARL registry data demonstrate that rheolytic PCDT treatment of DVT is safe and effective, and can potentially reduce the need for concomitant CDT and intensive care.

Trial registration: ClinicalTrials.gov NCT01086215.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Disease-Free Survival
  • Endovascular Procedures / adverse effects
  • Endovascular Procedures / instrumentation*
  • Equipment Design
  • Europe
  • Female
  • Fibrinolytic Agents / administration & dosage*
  • Fibrinolytic Agents / adverse effects
  • Hemorrhage / etiology
  • Humans
  • Lower Extremity / blood supply*
  • Male
  • Middle Aged
  • Prospective Studies
  • Recurrence
  • Registries
  • Risk Factors
  • Thrombectomy / adverse effects
  • Thrombectomy / instrumentation*
  • Thrombolytic Therapy / adverse effects
  • Thrombolytic Therapy / instrumentation*
  • Time Factors
  • Treatment Outcome
  • United States
  • Vascular Access Devices*
  • Venous Thrombosis / diagnosis
  • Venous Thrombosis / therapy*
  • Young Adult

Substances

  • Fibrinolytic Agents

Associated data

  • ClinicalTrials.gov/NCT01086215