Trellis® System
(How it Works)
Rationale for DVT Interventions Using the Trellis® Peripheral Infusion System
Isolated Pharmacomechanical Thrombolysis using the Trellis® Peripheral Infusion System
- Rapidly, effectively and safely removes peripheral vascular thrombotic occlusions
- Reduces treatment duration and patient exposure to lytic
- Frees up valuable scarce resources in hospitals
- Decreases patient burden
- Significantly improves patient quality of life
Pharmacomechanical Thrombectomy of Acute Deep Vein Thrombosis with the Trellis®-8 Isolated Thrombolysis Catheter
Deep Vein Thrombosis (DVT) has been associated with pulmonary embolism, chronic venous insufficiency and post-thrombotic syndrome (PTS).
Catheter directed thrombolysis (CDT) has been extensively studied with good effectiveness of clearing thrombus. The typical duration of CDT is approximately 40 hours. Up to 11% major bleeding complications have been reported in the literature. The prolonged therapy typically requires access to a monitored bed, multiple trips to the suite to assess progress, prolonged bed rest, patient discomfort and multiple lab evaluations.
This study evaluated the performance of the Trellis®-8 peripheral infusion system in a single-session treatment of patients with acute DVT and other co-morbid conditions.
A retrospective analysis of 19 consecutive patients was conducted. All patients had acute above the knee DVT and were treated using the Trellis®-8 catheter in conjunction with low dose tissue plasminogen activator (t-PA). All patients were treated using the Trellis®-8 followed by venous angioplasty and stent placement.
Restoration of rapid inline flow occurred in all patients. Grade II and Grade III lysis (as defined by the National Venous Registry) was achieved in 96% of all cases. The median t-PA dose was 13.4 mg per patient with mean treatment time of 91 minutes per limb. The first six patients were tested to determine whether any systemic thrombolysis was occurring. There were no changes in serum fibrinogen levels or fibrin degradation products. Mean Trellis® run-time was 21 minutes per thrombosed segment. Primary assisted patency was 100% at 30 days. There were no major complications. All cases were performed in a single setting.
Reference: O’Sullivan, Gerald, Lohan, Derek, Gough, Niall, Cronin, Carmel, Kee, Stephen. Pharmacomechanical Thrombectomy of Acute Deep Vein Thrombosis with the Trellis®-8 Isolated Thrombolysis Catheter. J Vasc Interv Radiol 2007; 18:715-724.
Iliofemoral Venous Thrombosis
Iliofemoral deep vein thrombosis (DVT) is associated with significant short and long-term sequelae. Most patients with acute iliofemoral DVT are treated with anticoagulation therapy alone.
This article reviews published evidence promoting a treatment strategy that involves removal of the thrombus followed by anticoagulation to significantly improve outcomes.
Anticoagulation alone does not result in thrombus resolution. Post-thrombotic chronic venous insufficiency, leg ulceration and claudication are common in these patients.
Ninety-five percent of patients treated with anticoagulation alone had ambulatory venous hypertension at 5 years, 90% had signs of chronic venous insufficiency and 15% developed venous ulcers.
The Trellis®-8 peripheral infusion system provides advantages over traditional catheter directed therapy (CDT) due to its direct ability to deliver mechanical and thrombolytic treatment to the thrombus. The occluding balloons which serve to isolate the clot minimize the systemic release of lytic and reduce the potential for distal embolization.
The authors conclude that patients with acute iliofemoral DVT should be offered a strategy of thrombus removal as a first-line treatment to improve long-term outcomes and reduce post-thrombotic morbidity.
Reference: Comerota, Anthony, Gravett, Marilyn. Iliofemoral Venous Thrombosis. J Vasc Surv 2007;46:1065-76.
Aggressive Percutaneous Mechanical Thrombectomy of Deep Vein Thrombosis
Deep Vein Thrombosis (DVT) is the third most common cardiovascular disease in the United States. The incidence is greater than 600,000 per year, accounting for approximately 100,000 annual deaths.
The primary treatment modality is anticoagulation therapy alone which minimizes clot propagation and reduces the risk of pulmonary embolism. However, anticoagulation does not lyse the clot and, in fact, depends on the vein’s intrinsic fibrinolytic functions. Large clot burdens often overwhelm these mechanisms leaving residual thrombus which can lead to reduced patency, venous hypertension and ultimately post-thrombotic syndrome.
The authors evaluated percutaneous mechanical thrombectomy (PMT) for DVT of both upper and lower extremities for safety and efficacy in restoring venous patency, for recurrent DVT and for clinical symptomatic improvement. Valvular competence was evaluated for the lower legs.
The primary endpoints of the study were thrombus removal, patency and valvular function. Duplex ultrasonography was used to assess patency and valvular function pre and post-procedure. Venography and intravascular ultrasonography assessed periprocedural lysis.
Fourteen patients either underwent Isolated Pharmacomechanical Thrombolysis with the Trellis®-8 peripheral infusion system or rheolytic thrombectomy with the Possis AngioJet.
Venous patency and lower extremity valvular function were maintained in 90% and 88% of the patients respectively with a mean follow-up of 6.2 months.
The authors concluded that PMT is safe and effective in the treatment of both upper and lower extremity DVT.
Reference: Arko, Frank, Davis, Charles, Murphy, Erin, Smith, Stephen, Timaran, Carlos, Modrall, Gregory, Valentine, R. James. Aggressive Percutaneous Mechanical Thrombectomy of Deep Vein Thrombosis. Arch Surg. 2007; 142:513-519.
Iliofemoral Deep Vein Thrombosis: Conventional Therapy Versus Lysis and Percutaneous Transluminal Angioplasty and Stenting
Conventional therapy for iliofemoral DVT is systemic heparinization followed by oral anticoagulants. This therapy has not been associated with rapid resolution of symptoms or removal of thrombus. Secondary complications such as venous inefficiency and PTS are common to this treatment modality.
In this study 51 patients with extensive iliofemoral DVT were treated and followed over a 10 year period. Patients were able to choose whether they wanted anticoagulation therapy alone or a multimodal therapy option including catheter directed thrombolysis (CDT), percutaneous transluminal balloon angioplasty (PTA) and stenting if needed.
The mean follow-up was approximately five years. Long-term symptom resolution was shown in only 30% of the anticoagulation group versus 78% of the multi-modality cohort.
The authors concluded that immediate lysis when combined with PTA or stenting (as indicated) is more effective than conventional anticoagulation treatment in patients with iliofemoral DVT.
Reference: AbuRahma, Ali, Perkins, Samuel, Wulu, John, Ng, Hong. Iliofemoral Deep Vein Thrombosis: Conventional Therapy Versus Lysis and Percutaneous Transluminal Angioplasty and Stenting. Ann Surg 2001; 233:752-760.