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Clinical and Economic Evaluation of the Trellis-8 Infusion Catheter for Deep Vein Thrombosis

2008; Elsevier BV; Volume: 19; Issue: 3 Linguagem: Inglês

10.1016/j.jvir.2007.10.027

1535-7732

Daniel E. Hilleman, Mahmood K. Razavi,

Atrial Fibrillation Management and Outcomes

Purpose To summarize the preliminary experience with the Trellis-8 infusion catheter (TIC) in the treatment of deep venous thrombosis (DVT) and compare the outcome to that with catheter-directed thrombolysis (CDT) by using a meta-analysis of published reports. Materials and Methods Technical success, bleeding complications, and costs for patients treated with the TIC for DVT were reported through a voluntary, company-sponsored registry. Technical success was classified by using the National Venous Registry grading scale for DVT lysis (<50% lysis = grade I, 50%–99% lysis = grade II, and 100% lysis = grade III). The cost of treatment with the TIC was based on equipment (catheters) needed to perform the intervention, thrombolytic agents used, bleeding episodes, procedure time in the angiography and/or interventional suite, and monitoring time in a critical care unit. Outcomes with the TIC were compared against outcomes with CDT by using literature-derived outcomes derived from a meta-analysis. Results Thrombolytic doses and infusion durations were less with TIC than with conventional CDT. Grade II and III lysis was achieved in 93% of patients treated with the TIC and 79% of patients treated with CDT (P = .03). Major hemorrhage was reported in none of the TIC patients and in 8.5% of patients treated with CDT (P < .001). The per-patient cost of therapy was $3,697 for TIC and $5,473 for CDT (P = .03). Conclusions Thrombolysis in DVT with the TIC is associated with a greater technical success rate, a lower rate of bleeding, and a lower cost than that reported for CDT. These preliminary results indicate that further evaluation of the TIC in the treatment of DVT is warranted. To summarize the preliminary experience with the Trellis-8 infusion catheter (TIC) in the treatment of deep venous thrombosis (DVT) and compare the outcome to that with catheter-directed thrombolysis (CDT) by using a meta-analysis of published reports. Technical success, bleeding complications, and costs for patients treated with the TIC for DVT were reported through a voluntary, company-sponsored registry. Technical success was classified by using the National Venous Registry grading scale for DVT lysis (<50% lysis = grade I, 50%–99% lysis = grade II, and 100% lysis = grade III). The cost of treatment with the TIC was based on equipment (catheters) needed to perform the intervention, thrombolytic agents used, bleeding episodes, procedure time in the angiography and/or interventional suite, and monitoring time in a critical care unit. Outcomes with the TIC were compared against outcomes with CDT by using literature-derived outcomes derived from a meta-analysis. Thrombolytic doses and infusion durations were less with TIC than with conventional CDT. Grade II and III lysis was achieved in 93% of patients treated with the TIC and 79% of patients treated with CDT (P = .03). Major hemorrhage was reported in none of the TIC patients and in 8.5% of patients treated with CDT (P < .001). The per-patient cost of therapy was $3,697 for TIC and $5,473 for CDT (P = .03). Thrombolysis in DVT with the TIC is associated with a greater technical success rate, a lower rate of bleeding, and a lower cost than that reported for CDT. These preliminary results indicate that further evaluation of the TIC in the treatment of DVT is warranted.