Clinical and economic evaluation of the Trellis-8 infusion catheter for deep vein thrombosis.
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.