Thrombus Obliteration by Rapid Percutaneous Endovenous Intervention in Deep Venous Occlusion (TORPEDO) trial: midterm results.

PURPOSE: To present midterm results from a randomized study comparing the safety and efficacy of percutaneous endovenous intervention (PEVI) + anticoagulation vs. anticoagulation alone in the reduction of venous thromboembolism (VTE) and post-thrombotic syndrome (PTS) in acute symptomatic proximal deep venous thrombosis (DVT). METHODS: The TORPEDO trial was a randomized study to demonstrate superiority of PEVI in the reduction of the VTE and PTS at 6 months; in that trial, 183 patients (103 men; mean age 61 ± 11 years) with symptomatic proximal DVT were randomized to receive PEVI + anticoagulation (n = 91) or anticoagulation alone (n = 92). PEVI consisted of one or more of a combination of thrombectomy, balloon venoplasty, stenting, and/or local low-dose thrombolytic therapy. RESULTS: At 6 months, recurrent VTE developed in 2.3% of the PEVI + anticoagulation group vs. 14.8% in the anticoagulation only group (p = 0.003); PTS developed in 3.4% vs. 27.2% (p<0.001), respectively. At a mean follow-up of 30 ± 5 months (range 12-41), 88 patients in the PEVI + anticoagulation group and 81 patients in the anticoagulation only group reached target follow-up. Recurrent VTE developed in 4 (4.5%) of the 88 PEVI + anticoagulation patients vs. 13 (16%) of the 81 patients receiving anticoagulation only (p = 0.02). PTS developed in 6 (6.8%) of the PEVI + anticoagulation group vs. 24 (29.6%) of the anticoagulation only group (p<0.001). CONCLUSION: In patients with proximal DVT, PEVI is superior to anticoagulation alone in the reduction of VTE and PTS. This benefit, which appears early in the course of treatment, extends to >2.5 years.

Effect of anticoagulation on endothermal ablation of the great saphenous vein.

BACKGROUND: A growing number of patients who are on systemic anticoagulation with warfarin require endovenous thermal ablation for reflux disease in the great saphenous vein (GSV). Little is known about the effects of anticoagulation on periprocedural bleeding and long-term closure rates of the treated veins. This study evaluated the effects of uninterrupted anticoagulation in patients undergoing endovenous thermal ablation. METHODS: In this prospective observational study, 88 limbs of patients on warfarin (anticoagulation group [AG]) who underwent endovenous thermal ablation for GSV reflux disease were compared with 92 limbs in patients receiving no anticoagulation or antiplatelet agents (control group [CG]). Forty percent of AG patients were also receiving antiplatelet therapy. Periprocedural bleeding and closure rate at 1 year were evaluated. RESULTS: No major bleeding occurred in either group. Minor bleeding was noted in 8 of 88 procedures in the AG vs 4 of 92 in the CG (P = 0.24); all in patients receiving radiofrequency ablation. Four of the eight minor bleeds in the AG were noted in patients receiving "triple therapy" with warfarin, aspirin, and clopidogrel or ticlopidine. Triple therapy in the AG was associated with a higher risk of minor bleeding compared with the CG (relative risk, 13.0; 95% confidence interval, 4.10-41.19, P < .001). All treated venous segments remained closed at the 1-year follow-up in both groups. CONCLUSIONS: In this relatively small, nonrandomized study comparing endovenous thermal ablation in patients with and without warfarin, no differences were found in periprocedural risk of major bleeding or closure rate of the treated venous segments. Minor bleeding was increased in patients receiving triple therapy with warfarin, aspirin, and a thienopyridine who underwent radiofrequency ablation.

Percutaneous therapy of acute on chronic lower extremity venous occlusive disease.

Venous thromboembolic disease is an underdiagnosed disease spectrum with a high mortality and morbidity. Despite significant advances in cardiovascular interventions, venous occlusive disease has not received the attention it deserves from the interventional cardiology community. We describe an 82-year-old man with massive left lower extremity DVT who underwent successful percutaneous endovenous intervention (PEVI) with rapid resolution of symptoms. We like to use this case as a call to action and raise awareness of the importance of PEVI in the treatment of extensive venous occlusive disease.

Endovenous therapy for deep venous thrombosis: the TORPEDO trial.

OBJECTIVES: We compared the efficacy and safety of percutaneous endovenous intervention (PEVI) plus anticoagulation with anticoagulation alone in the reduction of venous thromboembolism (VTE) and post-thrombotic syndrome (PTS) in acute proximal deep venous thrombosis (DVT). BACKGROUND: Recurrent VTE and PTS are common complications of DVT. There are no randomized trials investigating the efficacy of PEVI in the reduction of the above complications. METHODS: Patients with symptomatic proximal DVT were randomized to receive PEVI plus anticoagulation or anticoagulation alone. Anticoagulation consisted of intravenous unfractionated heparin or subcutaneous low-molecular weight heparin plus warfarin. PEVI consisted of one or more of a combination of thrombectomy, balloon venoplasty, stenting, or local low-dose thrombolytic therapy. RESULTS: At 6 months follow-up, recurrent VTE developed in 2 of 88 patients of the PEVI plus anticoagulation group versus 12 of 81of the anticoagulation-alone group (2.3% vs. 14.8%, P = 0.003). PTS developed in 3 of 88 patients of the PEVI plus anticoagulation Group and 22 of 81 of the anticoagulation-alone group (3.4% vs. 27.2%, P < 0.001). CONCLUSIONS: In patients with symptomatic proximal DVT, PEVI plus anticoagulation may be superior to anticoagulation-alone in the reduction of VTE and PTS at 6 months.

Percutaneous balloon aortic valvuloplasty: a new look at an old procedure: a case report.

There has been little change in the technical approach to balloon aortic valvuloplasty (BAV) over the last two decades. Large-caliber sheaths and extra-stiff wires have been used routinely to accommodate the large balloons used for this purpose. Consequently the morbidity (and possibly mortality) rates have been high. With the recent advances in the interventional hardware, a new look at the current approach to BAV is justified. In this report we describe an 89-year-old woman with critical aortic stenosis who underwent rapid and successful BAV by the use of a single 8-French arterial sheath, a regular (and not stiff) wire, and one peripheral balloon. We conclude that BAV can be done easily and safely with the technique and equipment described in this case report.

Moderate pulmonary embolism treated with thrombolysis (from the "MOPETT" Trial).

The role of low-dose thrombolysis in the reduction of pulmonary artery pressure in moderate pulmonary embolism (PE) has not been investigated. Because the lungs are very sensitive to thrombolysis, we postulated that effective and safe thrombolysis might be achieved by a lower dose of tissue plasminogen activator. The purpose of the present study was to evaluate the role of this "safe dose" thrombolysis in the reduction of pulmonary artery pressure in moderate PE. During a 22-month period, 121 patients with moderate PE were randomized to receive a "safe dose" of tissue plasminogen activator plus anticoagulation (thrombolysis group [TG], n = 61 patients) or anticoagulation alone (control group [CG], n = 60). The primary end points consisted of pulmonary hypertension and the composite end point of pulmonary hypertension and recurrent PE at 28 months. Pulmonary hypertension and the composite end point developed in 9 of 58 patients (16%) in the TG and 32 of 56 patients (57%) in the CG (p <0.001) and 9 of 58 patients (16%) in the TG and 35 of 56 patients (63%) in the CG (p <0.001), respectively. The secondary end points were total mortality, the duration of hospital stay, bleeding at the index hospitalization, recurrent PE, and the combination of mortality and recurrent PE. The duration of hospitalization was 2.2 ± 0.5 days in the TG and 4.9 ± 0.8 days in the CG (p <0.001). The combination of death plus recurrent PE was 1 (1.6%) in TG and 6 (10%) in the CG (p = 0.0489). No bleeding occurred in any group, and despite a positive trend in favor of a "safe dose" thrombolysis, no significant difference was noted in the rate of individual outcomes of death and recurrent PE when assessed independently. In conclusion, the results from the present prospective randomized trial suggests that "safe dose" thrombolysis is safe and effective in the treatment of moderate PE, with a significant immediate reduction in the pulmonary artery pressure that was maintained at 28 months.

Is transesophageal echocardiography necessary before D.C. cardioversion in patients with a normal transthoracic echocardiogram?

PURPOSE: Transesophageal echocardiography has emerged as an accepted approach before D.C. cardioversion for atrial fibrillation. The frequency of atrial thrombi detected on transesophageal echocardiography has varied from 7% to 23%. Many patients undergoing transesophageal echocardiography have had a previous transthoracic echocardiogram. Though transthoracic echocardiography has a low yield for the detection of intracardiac thrombi, it is highly accurate in diagnosing a structurally abnormal heart. The purpose of this study was to assess the frequency of thrombi detected by transesophageal echocardiography in patients with an entirely normal transthoracic echocardiogram and hence the advocacy of a selective approach in performing transesophageal echocardiography in patients undergoing D.C. cardioversion for atrial fibrillation. METHODS: 112 consecutive patients with atrial fibrillation who had undergone transesophageal echocardiography before D.C. cardioversion were evaluated. They all had a transthoracic echocardiogram within the 2 months preceding their transesophageal echocardiogram. Based on their transthoracic echocardiographic study, they were divided into two groups: Group 1 consisted of patients with a normal transthoracic echocardiogram and Group 2, those with an abnormal study. RESULTS: Thrombi or spontaneous echo contrast were found in 14 of 112 patients (16%). All however were detected in Group 2 patients. There was no patient with a normal transthoracic echocardiogram who had thrombus on his/her transesophageal echocardiogram. CONCLUSIONS: Our results suggest that a selective approach may be exercised in the use of transesophageal echocardiography prior to D.C. cardioversion for atrial fibrillation. Patients with an entirely "normal" transthoracic echocardiogram may proceed directly to cardioversion without a precardioversion transesophageal echocardiogram.

Intense migraines secondary to percutaneous closure of atrial septal defects.

In this study we evaluated the development of migraine after percutaneous closure of atrial septal defect. An abrupt and excruciating form of migraine developed shortly after shunt closure in 5 of 13 consecutive patients undergoing this procedure. A dramatic relief of pain was achieved almost instantaneously after administration of 300 mg of clopidogrel.