title: A Multicenter, Retrospective Study of the Effectiveness of the Trellis-8 System in the Treatment of Proximal Lower-Extremity Deep Vein Thrombosis.
abstract: BACKGROUND
  Deep vein thrombosis (DVT) occurs in up to 600,000 patients in the United States annually and can lead to long-term morbidity because of the post-thrombotic syndrome. The multicenter isolated-pharmacomechanical thrombolysis device (ISOL-8) study was designed to determine the safety and efficacy of the Trellis™-8 peripheral infusion system when used as the primary intervention to achieve DVT thrombolysis in patients with proximal lower-extremity occlusive DVT, and track the incidence and severity of the post-thrombotic syndrome (PTS) symptoms in patients 2 years after treatment.
  
  
  METHODS
  Data were collected retrospectively from 6 centers on patients treated with the Trellis-8 system, an isolated-pharmacomechanical thrombolysis device (IPMTD). Patients with occlusive lower-extremity DVT involving at least the iliac and/or common femoral vein were included. Patient demographics, medical history, procedure outcomes, complications, and follow-up venous duplex and Venous Clinical Severity Score (VCSS) were collected through 24 months. Data analysis of outcomes were performed at 1 and 12 months. A 24-month analysis was not performed because of the small number of patients for whom 24-month data could be collected.
  
  
  RESULTS
  A total of 151 limbs in 139 patients were treated with IPMTD. The mean ± standard deviation (SD) procedure time was 122.6 ± 63.4 min. Single session treatment was delivered in 69.9% (93 of 133) of cases. Occlusive DVT extended from the femoral into the external and/or common iliac vessel segments in most of the cases (113 of 151 limbs; 74.8%). Before treatment, 23.2% (35 of 151) of the treated limbs, based on a history of prior ipsilateral DVT or preoperative imaging revealing chronic venous scar, were expected to have some chronic venous disease despite presenting with acute symptoms. After treatment, 43.7% (66 of 151) of the limbs showed evidence of chronic thrombus. The average amount (mean ± SD) of thrombolysis, as determined by venogram, was highest in patients who had acute thrombus (81 ± 19.7%), compared with subacute thrombus (61 ± 22.5%) and complex cases involving acute and/or subacute thrombus on chronic scar (56 ± 26.5%). VCSS scoring showed the number of patients with none and/or mild pain, varicose veins, and skin changes at 1-month remained stable at 12 months whereas the percent of patients with none and/or mild venous edema improved from 71.7% at 1 month (38 of 53) to 86.8% (46 of 53) at 12 months. Twenty-four-month follow-up data were available for only 15% (23 of 151) of patients. No clinically significant pulmonary emboli or major periprocedural bleeding events were reported.
  
  
  CONCLUSIONS
  Patients with acute lower-extremity DVT involving the proximal veins can be safely and successfully treated with IPMTD. Major procedural bleeding was absent. The occurrence of severe PTS after primary treatment with Trellis-8 system IPMTD is low. Further long-term follow-up data are needed to confirm the benefit of intervention for thrombus removal compared with standard medical management.
authors.affiliation: Southern Connecticut Vascular Center, LLC, Darien, CT. Electronic address: paul.gagne@optonline.net.
authors.forename: Paul
authors.initials: P
authors.lastname: Gagne
authors.affiliation: Southern Ohio Surgical Associates, Portsmouth, OH.
authors.forename: Thomas
authors.initials: T
authors.lastname: Khoury
authors.affiliation: Norwalk Cardiac, Thoracic and Endovascular Therapies, Norwalk, OH.
authors.forename: Barry J
authors.initials: BJ
authors.lastname: Zadeh
authors.affiliation: The Vascular Group of Naples, PLC, Naples, FL.
authors.forename: Hiranya A
authors.initials: HA
authors.lastname: Rajasinghe
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004867:Equipment Design; D005260:Female; D006801:Humans; D035002:Lower Extremity; D008297:Male; D061185:Mechanical Thrombolysis / Q000295:instrumentation*; D008875:Middle Aged; D012189:Retrospective Studies; D015912:Thrombolytic Therapy / Q000295:instrumentation*; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D055815:Young Adult