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Abstract No. 5: Once Daily, Low Dose Alteplase Intraclot Injection Thrombolytic Therapy for Acute Venous Thrombosis
term VTE recurrence rates were 35.7% for CDT vs. 32.5% for CDT ⫹ PMT (p⫽0.8259). CONCLUSION: Percutaneous CDT with PMT is as effective as CDT alone for acute iliofemoral DVT in patients with cancer but requires significantly shorter treatment duration. 10:36 AM
Abstract No. 4
An Endovascular Approach to Deep Venous Thrombosis Utilizing Isolated Thrombolysis and Adjunctive Measures. G.J. O’Sullivan,1 M.K. Rahzavi;2 1University College Hospital, Galway, Ireland; 2St. Joseph Hospital, Orange County, CA PURPOSE: To describe a clinical series derived from registry data in which thrombotic occlusion in lower and upper extremity DVT is removed. Using Isolated Thrombolysis, Venous angioplasty and venous stenting resulted in vessel patency, inline flow, identification of underlying lesions and their repair. These data demonstrate procedural efficacy and safety in the acute followup period. MATERIALS AND METHODS: A voluntary, manufacturer’s sponsored registry of the Trellis-8 Peripheral Infusion System used in the treatment of 532 patients with upper and lower extremity DVT was examined. A two page form filled out by physician and staff tabulated patient DVT history, procedural information, post-case device performance assessment and acute adverse events. There was no formal patient follow-up or verification of patient history. Cases were performed between February 2005 and August 2007 at U.S. and international sites. Data presentation conforms to the guidelines published in JVIR (J Vasc Interv Radiol 2006; 17:417-434). RESULTS: A total of 565 limbs were treated in 532 patients. The average age of the patients was 53 years old ; M:F 1:1. Thrombus chronicity was 28% acute, 44% acute on chronic, 11% sub-acute, 12% sub-acute on chronic and 6% chronic. In 68% percent of the patients, thrombus was located in the iliac vein, 19% in the femoropopliteal veins and 13% in the subclavian vein. Combined Grade II and Grade III lysis were established in 96.8% of acute onset of symptoms, 93.6% in acute on chronic, 96.7% in sub-acute, 89.2% in sub-acute on chronic and 90.9% with chronic onset of symptoms. Venous patency was established in all cases. tPA was the lytic delivered in 92% of the cases. Average tPA dose was 5.9 ⫾ 2.4 mg. Adjunctive measures were carried out in 88% of the cases to remedy underlying chronic obstruction and/or culprit lesions. No adverse events were reported in the acute followup period. CONCLUSION: Isolated Thrombolysis combined with adjunctive measures form an effective and safe strategy for comprehensive vascular treatment of lower and upper extremity DVT. This report merits consideration of a prospective, randomized trial to confirm these results with longer term followup. 10:48 AM
Abstract No. 5
Once Daily, Low Dose Alteplase Intraclot Injection Thrombolytic Therapy for Acute Venous Thrombosis. R. Chang, A.W. Kam, E.A. Chen, T.H. Shawker, R.A. Wesley, E.A. Mao, D.A. Wyrick, M.K. Horne III; National Institutes of Health, Bethesda, MD S4
PURPOSE: Although once daily infiltration of venous thrombi with alteplase (recombinant tissue plasminogen activator or r-tPA) without continuous infusion of additional alteplase has been shown to be effective for large doses of alteplase (20 -50 mg/day), pharmacokinetic data suggest that effective thrombolysis can be achieved with lower doses. To test this hypothesis, we report treatment of subclavian, jugular, and/or central vein thrombosis (SJ-CVT) and treatment of acute deep vein thrombosis of the lower extremity (DVT-LE) using substantially lower doses of alteplase. MATERIALS AND METHODS: Patients: Twenty six patients with SJ-CVT less than 4 weeks old, and 16 patients with DVT-LE less than 2 weeks old were treated. One patient had bilateral DVT-LE due to IVC filter and IVC thrombosis. Technique: Alteplase was diluted with normal saline to a concentration of 0.1 mg/ml. The entire thrombus is “laced” with alteplase by an interventional radiologist using forceful hand injection through pulse spray catheters. For SJ-CVT, the maximum daily dose was 4 mg/day, and for DVT-LE, a maximum of 10 mg/leg/day. A venogram is obtained the day after each treatment. The treatment is repeated once daily until antegrade flow is restored or until a maximum of 4 doses have been given. Balloon angioplasty was used to treat strictures. Uncovered stents were placed only in iliac veins. Pharmacokinetic data was obtained in about a third of patients. Full systemic anticoagulation was used in almost all cases. Patients with SJ-CVT who opted for outpatient thrombolytic therapy received anticoagulation with enoxaparin. RESULTS: For the 26 SJ-CVT patients, average dose of alteplase was 3.6 mg/day for an average of 2 treatments (days), restoring patency in 19 (73%) patients. The average daily dose of alteplase for the 16 patients (17 limbs) with DVT-LE was 7.5 mg/day for an average of 2.5 days of treatment, restoring full venous patency in 15 (94%) patients and partial patency in the remaining patient. There were no significant bleeding complications, and no need for blood transfusions. CONCLUSION: Our study indicates safe and effective thrombolysis can be effected using much smaller doses of alteplase than previously reported. 11:00 AM
Abstract No. 6
Long-Term Efficacy of Catheter-Directed Thrombolysis for Deep Venous Thrombosis in Patients with Cancer. S.R. Preece, J.H. Black, M.B. Streiff, L.D. Pham, H.S. Kim; Johns Hopkins University School of Medicine, Baltimore, MD PURPOSE: The purpose of this study is to assess the long-term clinical benefits of Catheter Directed Thrombolysis (CDT) for upper and lower extremity deep venous thrombosis (DVT) in patients with cancer and study factors that may favor long-term success. MATERIALS AND METHODS: Consecutive patients with acute ilio-femoral or brachio-subclavian DVT treated with CDT between 1995 and 2007 were identified. Demographics and clinical outcomes were compared between patients with cancer and without cancer. RESULTS: 202 limbs in 178 patients (75 limbs in 61 cancer patients and 127 limbs in 117 noncancer patients) were treated with CDT. CDT achieved grade III clot lysis in a similar proportion of patients with (50/75 limbs, 66.7%) and without cancer (82/127 limbs, 64.6%) (p⫽0.7619). Grade II
Abstract No. 4
An Endovascular Approach to Deep Venous Thrombosis Utilizing Isolated Thrombolysis and Adjunctive Measures. G.J. O’Sullivan,1 M.K. Rahzavi;2 1University College Hospital, Galway, Ireland; 2St. Joseph Hospital, Orange County, CA PURPOSE: To describe a clinical series derived from registry data in which thrombotic occlusion in lower and upper extremity DVT is removed. Using Isolated Thrombolysis, Venous angioplasty and venous stenting resulted in vessel patency, inline flow, identification of underlying lesions and their repair. These data demonstrate procedural efficacy and safety in the acute followup period. MATERIALS AND METHODS: A voluntary, manufacturer’s sponsored registry of the Trellis-8 Peripheral Infusion System used in the treatment of 532 patients with upper and lower extremity DVT was examined. A two page form filled out by physician and staff tabulated patient DVT history, procedural information, post-case device performance assessment and acute adverse events. There was no formal patient follow-up or verification of patient history. Cases were performed between February 2005 and August 2007 at U.S. and international sites. Data presentation conforms to the guidelines published in JVIR (J Vasc Interv Radiol 2006; 17:417-434). RESULTS: A total of 565 limbs were treated in 532 patients. The average age of the patients was 53 years old ; M:F 1:1. Thrombus chronicity was 28% acute, 44% acute on chronic, 11% sub-acute, 12% sub-acute on chronic and 6% chronic. In 68% percent of the patients, thrombus was located in the iliac vein, 19% in the femoropopliteal veins and 13% in the subclavian vein. Combined Grade II and Grade III lysis were established in 96.8% of acute onset of symptoms, 93.6% in acute on chronic, 96.7% in sub-acute, 89.2% in sub-acute on chronic and 90.9% with chronic onset of symptoms. Venous patency was established in all cases. tPA was the lytic delivered in 92% of the cases. Average tPA dose was 5.9 ⫾ 2.4 mg. Adjunctive measures were carried out in 88% of the cases to remedy underlying chronic obstruction and/or culprit lesions. No adverse events were reported in the acute followup period. CONCLUSION: Isolated Thrombolysis combined with adjunctive measures form an effective and safe strategy for comprehensive vascular treatment of lower and upper extremity DVT. This report merits consideration of a prospective, randomized trial to confirm these results with longer term followup. 10:48 AM
Abstract No. 5
Once Daily, Low Dose Alteplase Intraclot Injection Thrombolytic Therapy for Acute Venous Thrombosis. R. Chang, A.W. Kam, E.A. Chen, T.H. Shawker, R.A. Wesley, E.A. Mao, D.A. Wyrick, M.K. Horne III; National Institutes of Health, Bethesda, MD S4
PURPOSE: Although once daily infiltration of venous thrombi with alteplase (recombinant tissue plasminogen activator or r-tPA) without continuous infusion of additional alteplase has been shown to be effective for large doses of alteplase (20 -50 mg/day), pharmacokinetic data suggest that effective thrombolysis can be achieved with lower doses. To test this hypothesis, we report treatment of subclavian, jugular, and/or central vein thrombosis (SJ-CVT) and treatment of acute deep vein thrombosis of the lower extremity (DVT-LE) using substantially lower doses of alteplase. MATERIALS AND METHODS: Patients: Twenty six patients with SJ-CVT less than 4 weeks old, and 16 patients with DVT-LE less than 2 weeks old were treated. One patient had bilateral DVT-LE due to IVC filter and IVC thrombosis. Technique: Alteplase was diluted with normal saline to a concentration of 0.1 mg/ml. The entire thrombus is “laced” with alteplase by an interventional radiologist using forceful hand injection through pulse spray catheters. For SJ-CVT, the maximum daily dose was 4 mg/day, and for DVT-LE, a maximum of 10 mg/leg/day. A venogram is obtained the day after each treatment. The treatment is repeated once daily until antegrade flow is restored or until a maximum of 4 doses have been given. Balloon angioplasty was used to treat strictures. Uncovered stents were placed only in iliac veins. Pharmacokinetic data was obtained in about a third of patients. Full systemic anticoagulation was used in almost all cases. Patients with SJ-CVT who opted for outpatient thrombolytic therapy received anticoagulation with enoxaparin. RESULTS: For the 26 SJ-CVT patients, average dose of alteplase was 3.6 mg/day for an average of 2 treatments (days), restoring patency in 19 (73%) patients. The average daily dose of alteplase for the 16 patients (17 limbs) with DVT-LE was 7.5 mg/day for an average of 2.5 days of treatment, restoring full venous patency in 15 (94%) patients and partial patency in the remaining patient. There were no significant bleeding complications, and no need for blood transfusions. CONCLUSION: Our study indicates safe and effective thrombolysis can be effected using much smaller doses of alteplase than previously reported. 11:00 AM
Abstract No. 6
Long-Term Efficacy of Catheter-Directed Thrombolysis for Deep Venous Thrombosis in Patients with Cancer. S.R. Preece, J.H. Black, M.B. Streiff, L.D. Pham, H.S. Kim; Johns Hopkins University School of Medicine, Baltimore, MD PURPOSE: The purpose of this study is to assess the long-term clinical benefits of Catheter Directed Thrombolysis (CDT) for upper and lower extremity deep venous thrombosis (DVT) in patients with cancer and study factors that may favor long-term success. MATERIALS AND METHODS: Consecutive patients with acute ilio-femoral or brachio-subclavian DVT treated with CDT between 1995 and 2007 were identified. Demographics and clinical outcomes were compared between patients with cancer and without cancer. RESULTS: 202 limbs in 178 patients (75 limbs in 61 cancer patients and 127 limbs in 117 noncancer patients) were treated with CDT. CDT achieved grade III clot lysis in a similar proportion of patients with (50/75 limbs, 66.7%) and without cancer (82/127 limbs, 64.6%) (p⫽0.7619). Grade II