title: Isolated pharmacomechanical thrombolysis of deep venous thrombosis utilizing a peripheral infusion system: Manuf.
abstract: OBJECTIVE
  The aim of this paper was to prospectively monitor the performance of an isolated pharmacomechanical thrombolysis (IPMT) device, the Trellis(R) Peripheral Infusion System, through a company-sponsored registry.
  
  
  METHODS
  Demographic, thrombus characterization, and procedural data were collected on the treatment of 2203 extremity deep venous thrombosis (DVTs) in 2024 patients via case-report forms submitted by the treating physicians. Data were analyzed using simple accrual and percentages.
  
  
  RESULTS
  Patients averaged 53 (+/-18) years of age and were 49% female. Thrombi were located in the iliofemoral (25.1%); iliofemoral to popliteal (19.3%); inferior vena cava (IVC) only or IVC and infrainguinal lower extremity (18.7%); femoral to popliteal (12.2%); isolated femoral (6%), iliac (6%) or popliteal (0.6%); and upper extremity (12.1%). Thrombus chronicity was reported as acute in 34.5% (N=760), acute-on-chronic in 41.5% (N=914), subacute in 10.4% (N=230), subacute-on-chronic in 9.8% (N=216), and chronic in 3.8% (N=83). The thrombolytic agent chosen by the physician most often was tissue plasminogen activator (tPA; 95.8%) at an average total dose per patient of 14.9 +/-8.3 mg. Combined Grade III and II venous patency following treatment across all thrombus chronicities was 95.5% and was achieved in a single setting in 83.3% (N=1753) of patients. Average IPMT run time per procedure was 22.3 +/-9.4 minutes. Sixteen percent of patients' limbs required additional catheter-directed thrombolysis (CDT); 75% required angioplasty and/or stent. No major bleeding complications, symptomatic pulmonary embolism (PE), or other significant adverse events occurred during the procedures.
  
  
  CONCLUSIONS
  IPMT is an effective therapeutic option for the acute management of extremity DVT. Low lytic doses and short infusion times are associated with a lower risk of bleeding than with CDT. Rapid restoration of patency may be associated with sustained valve function and a decreased incidence of post-thrombotic syndrome.
authors.affiliation: Section of Vascular and Endovascular Surgery, Noninvasive Vascular Laboratory, New York Medical College Director, Danbury Hospital, Danbury, CT, USA.
authors.forename: A M
authors.initials: AM
authors.lastname: Dietzek
mesh_terms: D000328:Adult; D000368:Aged; D002406:Catheterization, Peripheral / Q000009:adverse effects / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007262:Infusions, Intravenous; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D054070:Postthrombotic Syndrome / Q000209:etiology / Q000517:prevention & control; D011446:Prospective Studies; D012042:Registries; D015912:Thrombolytic Therapy / Q000009:adverse effects / Q000295:instrumentation*; D013997:Time Factors; D016896:Treatment Outcome; D034941:Upper Extremity / Q000098:blood supply*; D014654:Vascular Patency; D020246:Venous Thrombosis / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology
chemical_list: D005343:Fibrinolytic Agents