International angiology : a journal of the International Union of Angiology · 2010
Isolated pharmacomechanical thrombolysis of deep venous thrombosis utilizing a peripheral infusion system: Manuf.
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Dietzek A M
Аннотация
AIM: 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.
CONCLUSION: 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.
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.
CONCLUSION: 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.