Surgical intervention is not required for all patients with subclavian vein thrombosis

AbstractPurpose: The role of thoracic outlet decompression in the treatment of primary axillary-subclavian vein thrombosis remains controversial. The timing and indications for surgery are not well defined, and thoracic outlet procedures may be associated with infrequent, but significant, morbidity. We examined the outcomes of patients treated with or without surgery after the results of initial thrombolytic therapy and a short period of outpatient anticoagulation. Methods: Patients suspected of having a primary deep venous thrombosis underwent an urgent color-flow venous duplex ultrasound scan, followed by a venogram and catheter-directed thrombolysis. They were then converted from heparin to outpatient warfarin. Patients who remained asymptomatic received anticoagulants for 3 months. Patients who, at 4 weeks, had persistent symptoms of venous hypertension and positional obstruction of the subclavian vein, venous collaterals, or both demonstrated by means of venogram underwent thoracic outlet decompression and postoperative anticoagulation for 1 month. Results: Twenty-two patients were treated between June 1996 and June 1999. Of the 18 patients who received catheter-directed thrombolysis, complete patency was achieved in eight patients (44%), and partial patency was achieved in the remaining 10 patients (56%). Nine of 22 patients (41%) did not require surgery, and the remaining 13 patients underwent thoracic outlet decompression through a supraclavicular approach with scalenectomy, first-rib resection, and venolysis. Recurrent thrombosis developed in only one patient during the immediate period of anticoagulation. Eleven of 13 patients (85%) treated with surgery and eight of nine patients (89%) treated without surgery sustained durable relief of their symptoms and a return to their baseline level of physical activity. All patients who underwent surgery maintained their venous patency on follow-up duplex scanning imaging. Conclusion: Not all patients with primary axillary-subclavian vein thrombosis require surgical intervention. A period of observation while patients are receiving oral anticoagulation for at least 1 month allows the selection of patients who will do well with nonoperative therapy. Patients with persistent symptoms and venous obstruction should be offered thoracic outlet decompression. Chronic anticoagulation is not required in these patients. (J Vasc Surg 2000;32:57-67.

Aortic dissection: Percutaneous management of ischemic complications with endovascular stents and balloon fenestration

AbstractPurpose: The purpose of this study was to evaluate endovascular stenting (EVS) and balloon fenestration (BF) of intimal flaps for the management of lower extremity, renal, and visceral ischemia in acute or chronic aortic dissection.Methods: Twenty-two patients (16 male, 6 female) with a median age of 53 years (range 35 to 77 years) underwent percutaneous treatment for peripheral ischemic complications of 12 type A (five acute, seven chronic) and 10 type B (nine acute, one chronic) aortic dissections.Results: Ten patients had leg ischemia, 13 had renal ischemia, and 6 had visceral ischemia. Sixteen patients were treated with EVS including 11 with renal, 6 with lower extremity, 2 with superior mesenteric artery, and 2 with aortic stents. Three patients had BF of the intimal flap, and three had BF in combination with EVS. Revascularization with clinical success was achieved in all 22 patients. Two patients died 3 days and 13.4 months after the procedure was performed, respectively. Of the remaining 20 patients, 1 is lost to follow-up, and 19 have persistent relief of clinical symptoms. Mean follow-up time is 13.7 months (range 1.1 to 46.5 months). One case was complicated by guidewire-induced perinephric hematoma.Conclusion: EVS and BF provide a safe and effective percutaneous method for managing peripheral ischemic complications of aortic dissection. (J VASC SURG 1996;23:241-53.

Endovascular stent–graft repair of thoracic aortic aneurysms

AbstractConventional repair of aneurysms of the descending thoracic aorta entails thoracotomy and graft interposition. For elderly patients and those with previous operations, obesity, respiratory insufficiency, or other comorbidities, such a procedure entails significant mortality and morbidity. Transluminal stent-graft placement offers an alternative approach with potentially less morbidity and quicker recovery; however, the effectiveness and durability of stent-grafts remain uncertain. Methods: Since July 1992, thoracic aortic stent-grafts have been placed in 44 patients with a variety of pathologic conditions. Each graft was individually constructed from self-expanding, stainless-steel Z stents covered with a woven Dacron polyester fabric graft. Graft dimensions were determined from spiral computed tomographic scans. All implants were performed in the operating theater under fluoroscopic and transesophageal echocardiographic guidance. Follow-up was by computed tomography and contrast angiography in all cases. Patient data: There were 36 men and 8 women. Mean age was 66 years (range 35 to 88 years). Mean aneurysmal diameter was 6.3 cm (range 4.0 to 9.4 cm). Etiologies included 23 degenerative aneurysms, four posttraumatic aneurysms, four pseudoaneurysms, and one chronic aortic dissection. Results: There were three early deaths (<30 days) and two late deaths. One early death resulted from graft failure. There were two instances of paraparesis or paraplegia, with one associated early death. A single stent was deployed in 27 patients, two stents were required in 14 patients, and three stents were required in three patients. In 23 patients, vascular access was attained through the femoral artery; abdominal aortic access, either native or graft, was necessary in the remaining 21 patients. Twelve grafts were placed in conjunction with open abdominal aortic surgical procedures. Mean follow-up (98% complete) was 12.6 months (range 1 to 34 months). One late death occurred from aneurysmal expansion and rupture in a patient with a persistent midgraft leak. The second late death may have resulted from aneurysmal rupture. Immediate thrombosis was achieved in 36 patients, and late thrombosis was achieved in three others. Failure to achieve complete aneurysmal thrombosis occurred in five patients, however, and one individual (previously noted) died of aneurysmal expansion and rupture; the remaining four are being carefully monitored. Only one patient has required conversion of the stent to an open procedure; a contained rupture of the false lumen of a chronic dissection eventually necessitated total descending thoracic aortic exclusion. Conclusions: These early results support the hypothesis that endovascular stent-graft placement may be a safe and durable treatment for selected patients with aneurysmal disease of the descending thoracic aorta. Large introducer size (26F outer diameter) and relatively limited angulation capability, as well as imprecise deployment techniques, currently limit its applicability. Distal embolization and stent migration have not been observed. Failure to achieve complete aneurysmal thrombosis may allow continued aneurysmal expansion and rupture. Further follow-up is clearly necessary to evaluate the true long-term effectiveness of this procedure. (J THORAC CARDIOVASC SURG 1996;111:1054-62

Six-Month Intraocular Pressure Reduction with a Topical Bimatoprost Ocular Insert: Results of a Phase II Randomized Controlled Study.

PurposeImproving adherence to manage elevated intraocular pressure (IOP) remains an unmet need. A topical bimatoprost ocular insert was compared with twice-daily timolol eye drops in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) treated for 6 months.DesignParallel-arm, multicenter, double-masked, randomized, controlled trial.ParticipantsOne hundred thirty adult OAG or OHT patients.MethodsEligible patients were randomized 1:1 to receive a bimatoprost insert plus artificial tears twice daily or a placebo insert plus timolol (0.5% solution) twice daily for 6 months after a screening washout period. Diurnal IOP measurements (at 0, 2, and 8 hours) were obtained at baseline; weeks 2, 6, and 12; and months 4, 5, and 6. Key eligibility included washout IOP of 23 mmHg or more at time 0, IOP of 20 mmHg or more at 2 and 8 hours, and IOP of 34 mmHg or less at all time points; no prior incisional surgery for OAG or OHT; and no known nonresponders to prostaglandins.Main outcome measuresThe primary efficacy end point examined the difference in mean change from baseline in diurnal IOPs (point estimate, 95% confidence interval) across 9 coprimary end points at weeks 2, 6, and 12 comparing the bimatoprost arm with the timolol arm using a noninferiority margin of 1.5 mmHg. Secondary end points were diurnal IOP measurements at months 4, 5, and 6 and adverse events (AEs).ResultsA mean reduction from baseline IOP of -3.2 to -6.4 mmHg was observed for the bimatoprost group compared with -4.2 to -6.4 mmHg for the timolol group over 6 months. The study met the noninferiority definition at 2 of 9 time points but was underpowered for the observed treatment effect. Adverse events were consistent with bimatoprost or timolol exposure; no unexpected ocular AEs were observed. Primary retention rate of the insert was 88.5% of patients at 6 months.ConclusionsClinically relevant reduction in mean IOP was observed over 6 months with a bimatoprost ocular insert and seems to be safe and well tolerated. The topically applied bimatoprost insert may provide an alternative to daily eye drops to improve adherence, consistency of delivery, and reduction of elevated IOP

The safety, efficacy, and pharmacoeconomics of low-dose alteplase compared with urokinase for catheter-directed thrombolysis of arterial and venous occlusions

AbstractPurpose: The purpose of this study was to compare the efficacy, complications, and costs associated with low-dose (<2 mg/h) alteplase (tissue plasminogen activator [t-PA]) versus urokinase for the catheter-directed treatment of acute peripheral arterial occlusive disease (PAO) and deep vein thrombosis (DVT). Materials and Methods: A retrospective review was performed during sequential time periods on two groups with involved extremities treated with either t-PA with subtherapeutic heparin (TPA group) or urokinase with full heparin (UK group) at a single center. Treatment group characteristics, success rates, complications, dosages, infusion time, and costs were compared. Results: Eighty-nine patients with 93 involved limbs underwent treatment (54 with DVT, 39 with PAO). The treatment groups were statistically identical (TPA: 45 limbs; 24 with DVT, 53.3%; 21 with PAO, 46.7%; UK: 48 limbs; 30 with DVT, 62.5%; 18 with PAO, 37.5%). The overall average hourly infused dose, total dose, infusion time, success rates, and cost of thrombolytic agent were as follows (± standard deviation): TPA, 0.86 ± 0.50 mg/h, 21.2 ± 15.1 mg, 24.6 ± 11.2 hours, 89.4%, $466 ±$331; and UK, 13.5 ± 5.6 (104) U/h, 4.485 ± 2.394 million U, 33.3 ± 13.3 hours, 85.7%, $6871 ±$3667, respectively. Major and minor complication rates were: TPA, 2.2% and 8.9%; and UK, 2.1% and 10.4%, respectively. No statistical differences in success rates or complications were observed; however, t-PA was significantly (P <.05) less expensive and faster than urokinase. Conclusion: Low-dose t-PA combined with subtherapeutic heparin is equally efficacious and safe compared with urokinase. Infusions with t-PA were significantly shorter and less expensive than those with urokinase. (J Vasc Surg 2003;37:512-7.