AngioJet™

Peripheral Thrombectomy System

Clinical Outcomes

PEARL Registry Overview

Study Design

PEARL I Followed patients for 3 months with documentation of symptomatic improvement after AngioJet™ thrombectomy (with mid-length catheters).

PEARL II Followed patient outcomes through 12 months after AngioJet thrombectomy with any AngioJet catheter.

  • All patients were treated with AngioJet Thrombectomy
  • Patient history, procedural information, adjunctive treatments, outcomes and adverse events were collected
  • Patients were analyzed in arterial, venous & dialysis access indications
AngioJet PEARL Registry Enrollment

Key Resources

Indications, Safety, and Warnings

Objectives

  • Determine efficacy of thrombus removal from baseline to final angiogram/venogram
  • Evaluate clinical outcomes of treated patients at defined intervals of 3, 6 & 12 months
  • Characterize clinical events
  • Characterize treatment options used with the AngioJet System
  • Estimate rate of AngioJet Thrombectomy-related adverse events

PEARL DVT      N=371 patients

Summary

  • 34% of patients treated in single session; 87% of patients had 2 or less lab sessions
  • 38% of procedures treated in ≤ 6 hours; 75% completed in ≤ 24 hours
  • Less total lytic use when delivered utilizing AngioJet™ (Power Pulse™ and/or Rapid Lysis) than if CDT were included in treatment with final venographic results comparable across all technique subgroups
  • 1295 venous vessels treated with 97% showing improvement, 3% unchanged, <1% worse

Venographic Results

by Technique Subgroups (p<0.0001) N=1295 vessels treated

Venographic

CDT, catheter-directed thrombolysis

PMT, pharmacomechanical thrombolysis

Presented by Dr Mark Garcia at CIRSE 2013; Final PEARL Data

  • Amongst the 4 treatment groups there wasn’t any statistical difference in baseline occlusion, final occlusion or in the change of occlusion.
  • The difference seems to be in the treating physician’s preference to treatment.

PEARL Limb Ischemia      N=410 patients

Summary

  • 947 arterial vessels treated with 93% showing improvement, 6% unchanged, <1% worse
  • 89% limb salvage rate (185/207). 207 ALI patients had a baseline Rutherford Classification of lla, llb and lll
  • 56% of patients treated in single session; 86% of patients had 2 or less lab sessions
  • 58% of procedures treated in < 6 hours; 80% completed in < 24 hours

Angiographic Results

by Location (p<0.0001)

PEARL Limb Ischemia - Angiographic Results

CDT, catheter-directed thrombolysis
PMT, pharmacomechanical thrombolysis

Presented by Dr. Ali Amin at Charing Cross 2014; Final PEARL Data

  • Higher % of Substantial lysis were achieved in the groups with PMT.
  • There was a difference (p=0.0003) In the mean baseline thrombus between the 4 groups. With the PMT + CDT group having a greater occlusion initial score than the other groups.

PEARL AV Access      N=145 patients

Summary

  • Hemodialysis Access Overall Patency: 78% patency at 3 months; KDOQI minimum goal is 40% at 3 months
  • 76% graft/fistula survival at 1 year

Treatments Utilized & Subgroups

  • Total 145 patients (65% grafts / 35% fistulas); 186 treated vessels
  • 86% (125/145) of patients treated with AngioJet Thrombectomy without thrombolytics

Hemodialysis Access

Overall Patency

PEARL AV Access - Hemodialysis Access - Overall Patency

*Kakkos SK, Haddad GK, Haddad J, Scully MM. J Endovasc Ther. 2008;15(1):91-102.
Simoni. PEARL Registry Hemodialysis Access. VEITH 2013.

National Kidney Foundation Clinical Practice Guidelines and Recommendations; 2006.

KDOQI, Kidney Disease Outcomes Quality Initiative

Presented by Dr. Eugene Simoni at VEITH 2013; Final PEARL Data

  • KDOQI: minimum goal for percutaneous thrombectomy is 40% unassisted patency and functionality at 3 months
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