Use of the Trellis Device in the Management of Deep Vein Thrombosis: A Retrospective Single-Center Experience

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Abstract: Objectives. The Trellis thrombectomy system (Covidien) is one of the newer devices that incorporates isolated pharmacomechanical thrombectomy and thrombolysis (PMT) for treatment of deep venous thrombosis (DVT). We conducted a retrospective review of patients with upper- and lower-extremity DVT managed with the Trellis thrombectomy system at our center. Methods. All patients with symptomatic DVT who presented to our center between April 2010 and April 2011 who underwent PMT by the Trellis device were included in this retrospective review. Results. Twenty-eight patients (mean age, 46.4 ± 21.2 years) presented with symptoms with a mean duration of 1.3 ± 1.8 months. Eighty-six percent had 100% occlusion on admission, while 14.3% had 70%-90% stenosis. The mean lytic dose used was tPA 20.7 ± 12 mg. The mean Trellis treatment time was 25.1 ± 11.5 minutes. Grade 3 lysis was achieved in 23 of 28 patients (85.8%), while grade 2 lysis was achieved in 14.2%. Mean total hospital stay was 2.6 ± 2.7 days. Postprocedure symptom resolution was 100%, and there was no reocclusion in 78.6% of patients at 1 year. At 12 months, the patency rate (primary or secondary) was 80% as determined by Doppler ultrasound. Conclusions. In patients with DVT involving the ilio-femoral and the upper-extremity vessels, the use of the Trellis device was associated with a high technical success rate as well as a satisfactory 12-month patency rate. Moreover, this strategy was associated with reduced lytic dose, shorter treatment time and hospital stay, and no bleeding complications.

J INVASIVE CARDIOL 2013;25(6):296-299

Key words: deep vein thrombosis

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Deep venous thrombosis (DVT) is a disease entity with the potential for catastrophic complications, such as acute pulmonary embolism (PE) and postthrombotic syndrome (PTS). Historically, the treatment emphasis has been on anticoagulation alone to prevent PE and allow natural local recanalization. Despite this, many patients develop PTS and recurrent DVTs. Catheter-directed thrombolysis (CDT) has been used to treat symptomatic DVT as one of the major strategies in the past, but a number of factors have recently made it less favorable as compared to pharmacomechanical thrombectomy (PMT). These include increased likelihood of major bleeding episodes, risk of embolism, prolonged duration of treatment with high thrombolytic doses and as a result longer inpatient and Intensive Care Unit (ICU) stays. The Trellis device utilizes PMT and isolates the thrombolytic process, thereby making it potentially safer, effective, and more predictable.

Methods

Patients who were admitted to the hospital with DVT and who underwent Trellis thrombectomy at our institution from April 2010 to April 2011 were included in this study. The study sought to include all patients regardless of gender or race. Patients were excluded if they were younger than 10 years of age and older than 90 years. Patients were identified by reviewing medical records. Data regarding demographics, comorbidities, characteristics at presentation, risk factors, procedure details, technical success rates, complications, and follow-up at 6 and 12 months were collected. Grade 1 lysis was defined as <50%, grade 2 as 50%-99%, and grade 3 as >99%.

Results

The major comorbidities and risk factors were hypertension (32%), smoking (32%), immobility (21.4%), hypercoagulable state (32%), and body mass index of >30 kg/m² (32%). Among malignancies, ovarian cancer, large B-cell lymphoma, and non-small cell lung cancer were seen. Of the hypercoagulable states, antiphospholipid syndrome (33.33%) was the most common, while protein S deficiency (16.66%), factor V Leiden (16.66%), antithrombin III deficiency (16.66%), and prothrombin 20210 mutations (16.66%) were seen as well. At the occurrence of the event, 50% of the patients were on warfarin, 32% on aspirin, and 17.8% on clopidogrel, while 7% were on both aspirin and warfarin. Inferior vena cava (IVC) filter placement was not routinely performed before or during the procedure. However, in 6 patients (21.4%), preexisting IVC filters were in place. Postprocedure, anticoagulation therapy was continued. Demographics, risk factors, comorbidities, significant characteristics of DVT, procedural success rate, details of the procedure and follow-up features at 6 months and 1 year are outlined in Table I. There were no complications, ie, major bleeding, access-site pseudoaneurysms, distal embolism, or arteriovenous fistula formation. There was 1 death, which was unrelated to the procedure and was due to extensive traumatic injuries as the result of an automobile accident. It was not associated with any intracranial or extracranial bleeding complications as an early or late consequence of the procedure. 

Discussion

Untreated DVT is an important cause of morbidity and mortality, particularly in hospitalized patients. It is associated with development of PE, which contributes to about 16% of inpatient deaths.²

The most common symptoms are pain and swelling. Prompt diagnosis and institution of treatment are crucial, as this reduces the dreaded possibilities of PE and PTS. The most common treatment is anticoagulation therapy with the duration of the treatment depending on the underlying etiology. Ilio-femoral DVT, a common prerequisite for PTS, is frequent, with rates reported up to 49.3% in acute and 36.3% in cases of chronic DVT.³ One of the feared late complications of DVT is development of PTS, which causes valvular incompetence due to thrombus deposition, resulting in venous reflux and venous hypertension. 

As compared to thrombolytic therapy, CDT is a safer and more efficient alternative, with fewer bleeding complications, higher degree of target clot lysis, improved patency, and reduction in incidence of PTS. However, as shown by Ouriel et al from a registry data of 653 patients treated with CDT over a 9-year period, major bleeding complications occurred in 15% of patients.⁴ Another drawback is the prolonged treatment times, ranging from 36-72 hours as shown in most studies, along with incomplete lysis, which causes chronic venous insufficiency due to residual clot.^5,6

On the other hand, PMT can be safely and effectively used for acute, subacute, and chronic DVT, especially in patients with contraindications for lytic therapy, resulting in improved functional outcomes relative to their debilitated state before the procedure.⁷ Lesser intraprocedural lytic doses allow effective results in a single setting without surgical or prolonged thrombolytic exposure risk. This was shown by O’Sullivan et al in a retrospective study of 19 patients with acute DVT treated by Trellis thrombectomy with angioplasty/stenting. The restoration of rapid inline venous flow was 100%, 50%-82% lysis was achieved in 82% of cases, mean tPA dose was 13.4 mg, mean treatment time was 91 minutes, and primary patency rate was 100% at 1-month follow-up.⁸ In our study, even superior results were seen in terms of greater technical success (grade 3 lysis in 85.7% of patients, shorter treatment times (mean duration of 21.5 minutes), and greater patency at longer follow-up (92% at 6 months and 80% at 12 months).

As compared to CDT, PMT is associated with reduced ICU time as well as decreased total hospital stay and cost.⁹ In our study, these facts were further validated by the short inpatient and ICU stays, (2.6 days and 0.6 days, respectively).

PMT offers the most reasonable solution in patients with moderate to high risk of venous thromboembolism and is associated with lower bleeding risk.¹⁰ In a retrospective study by Rao et al, it was shown that the thrombolytic doses and infusion durations were less with PMT (either Trellis device or Angiojet device) than with conventional CDT. Grade 2 or 3 lysis was achieved in 93% of patients treated with PMT as compared to 79% with CDT. No major bleeding complications occurred in patients treated with PMT, while major hemorrhage was seen in 8.5% of patients treated with CDT.¹¹ No major bleeding complications were reported in any patient managed with PMT, even in patients who received PMT because of a contraindication to thrombolysis.¹¹ Our study identified no bleeding complications either. We recently reported no major bleeding complications in a systematic literature review of 2528 patients with DVT treated by PMT.¹² Figure 1 illustrates the sequence of events in the Trellis thrombectomy procedure in a 22-year-old woman admitted with acute ilio-femoral DVT.

Achievement of grade 3 lysis is considered to be an optimal result and is usually associated with a 1-year patency rate of 79%. In the setting of chronic DVT, grade 2 lysis is acceptable and is associated with a 58% patency rate at 1 year.¹³ In our study, 67.1% of patients had chronic DVT (>2 weeks), with the oldest DVT treated being 9 months. The patency rates in spite of predominance of chronic DVT in our study group were 93% at 6 months and 80% at 1 year.

It was previously thought that PMT alone was less successful than catheter-directed thrombolysis and was associated with unacceptably high complications of pulmonary embolism, but we have shown in our study that the rate of clinical pulmonary embolism was negligible.¹⁴ This was also previously documented in a registry data of 2024 patients with DVT treated by the Trellis thrombectomy system.¹⁵

Adjunctive therapy utilizing venoplasty with or without stenting can be achieved when stricture of the veins is present and is frequently used in up to 93% of the cases.¹⁶ We used venoplasty in 100% and stenting in 78.4% of cases. 

Prophylactic IVC filter placement before thrombectomy/thrombolysis is still debatable. In one series, 45% of patients undergoing CDT with placement of retrievable IVC filter had visible thrombus embolization into the IVC filter, suggesting that filter placement during CDT can prevent silent and symptomatic PE.¹⁷ In a retrospective case series of 69 patients in 2007 by Protack et al, only 14% had IVC placement prior to or during CDT and the rate of development of pulmonary embolism during CDT was 0%.¹⁸ Selective rather than routine IVC filter placement in acute DVT treatment would appear to be a safe and appropriate approach. In our study, none of the patients had IVC filter placement prior to thrombectomy and the incidence of clinical pulmonary embolism was 0%. However, 6 out of 28 patients (21.4%) had previous IVC filter placement unrelated to the current procedure.

Study limitations. Limitations of our study include the retrospective nature of the study, the small number of patients (28), and follow-up duration of 1 year. This study adds to the current clinical experience database while prospective trials are ongoing.

Conclusions

The current literature primarily describes the use of the Trellis device for the management of DVT by vascular surgeons and interventional radiologists. This retrospective study is unique in that we describe the largest experience performed by interventional cardiologists. We conclude that use of the Trellis device for DVT management is a reasonable strategy as it is associated with the administration of a lower thrombolytic dose delivered in an isolated fashion with the achievement of a high initial technical success rate, short hospital stay, reduced bleeding complications, and satisfactory early and late patency rates.  

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