Prospective randomized trial of ACUSEAL (Gore-Tex) versus Hemashield-Finesse patching during carotid endarterectomy: Early results

Background/PurposeSeveral studies have reported that carotid endarterectomy (CEA) with patch angioplasty produces superior results compared with primary closure. Conventional polytetrafluoroethylene (PTFE) patching has been shown to have results comparable to autogenous vein patching; however, it requires a prolonged hemostasis time. Therefore, many surgeons use collagen-impregnated Dacron patching (Hemashield [HP]). Recently, we reported a satisfactory hemostasis time using the new hemostatic PTFE patch (ACUSEAL by Gore). This study is the first prospective randomized trial comparing the ACUSEAL patch with the HP Finesse patch.Methods200 CEAs were 1:1 randomized into two patch closure groups (ACUSEAL or Finesse). All patients underwent immediate and 1 month postoperative duplex ultrasound studies. Demographic and clinical characteristics were similar in both groups, including the mean operative diameter of the internal carotid artery and length of arteriotomy.ResultsThe overall perioperative ipsilateral stroke rate was 2% (2% ACUSEAL, 2% Finesse; P = 1.0). The perioperative ipsilateral TIA rates were 0% for the ACUSEAL and 2% for the Finesse patch (P = .5). The combined perioperative neurological event (TIA + stroke) rates were 2% for ACUSEAL and 4% for the Finesse (P = .68). The early ≥50% restenosis rate was 0% for ACUSEAL vs 4% for Finesse patching. Two perioperative carotid thromboses were noted with Finesse patching vs none with ACUSEAL patching (P = .50). The combined early morbidity rate (TIA, stroke, and ≥50% restenosis or thrombosis) was 2% for the ACUSEAL patch vs 8% for the Finesse patch (P = .10). The mean hemostasis time for the ACUSEAL and Finesse patches was 5.1 vs 3.7 minutes (P = .01), however, the mean operative times were similar for both groups (P = .61).ConclusionThe perioperative neurological events and overall short-term morbidity associated with CEA when using ACUSEAL or Finesse patches were similar. Both patches have short hemostasis times

Prospective controlled study of the natural history of asymptomatic 60% to 69% carotid stenosis according to ultrasonic plaque morphology

AbstractBackground/Purpose: In spite of the conclusions of the Asymptomatic Carotid Atherosclerosis Study, some clinicians are still reluctant to recommend carotid endarterectomy (CEA) for patients with asymptomatic ≥60% carotid stenosis (ACS). This study analyzes the natural history of 60% to 69% ACS according to ultrasonic plaque morphology and its implication on treatment. Patient Population and Methods: During a 2-year period, patients with 60% to 69% ACS entered into a protocol of carotid duplex scan surveillance/clinical examination every 6 months. The ultrasonic plaque morphology was classified as heterogeneous (group A, n = 162) or homogeneous (group B, n = 229) with HDI 3000/HDI 5000 systems (Advanced Technology Laboratories, Bothwell, Wash). CEA was done if lesion progressed to ≥70% stenosis or became symptomatic. Results: Three hundred eighty-two patients (391 arteries) were followed for a mean interval of 37 months. The clinical/demographic characteristics were similar for both groups. The incidence rate of future ipsilateral strokes was significantly higher in group A than in group B: 13.6% versus 3.1% (P = .0001; odds ratio [OR], 5). Similarly, the incidence rate of all neurologic events (stroke or transient ischemic attack [TIA]) was higher in group A than in group B: 27.8% versus 6.6% (P = .0001; OR, 5.5). Progression to ≥70% stenosis was also higher in group A than in group B: 25.3% versus 6.1% (P = .0001; OR, 5.2). Forty-four late CEAs (27.2%) were done in group A (16 for stroke, 21 for TIA, and seven for ≥70% ACS) versus 13 (5.7%) in group B (five for stroke, seven for TIA, and one for ≥70% ACS; P = .0001; OR, 6.2). Conclusion: Patients with 60% to 69% ACS with heterogeneous plaque had a higher incidence rate of late stroke, TIA, and progression to ≥70% stenosis than patients with homogeneous plaque. Prophylactic CEA for 60% to 69% ACS may be justified if associated with heterogeneous plaque. (J Vasc Surg 2002;36-437-42.

Management of Immediate Post- Endovascular Aortic Aneurysm Repair Type Ia Endoleaks and Late Outcomes

BACKGROUND—Post-endovascular aortic aneurysm repair (EVAR) endoleaks and the need for reintervention are challenging. Additional endovascular treatment is advised for type Ia endoleaks detected on post-EVAR completion angiogram. This study analyzed management and late outcomes of these endoleaks. STUDY DESIGN—This was a retrospective review of prospectively collected data from EVAR patients during a 10-year period. All post-EVAR type Ia endoleaks on completion angiogram were identified (group A) and their early (30-day) and late outcomes were compared with outcomes of patients without endoleaks (group B). Kaplan-Meier analysis was used for survival analysis, sac expansion, late type Ia endoleak, and reintervention. RESULTS—Seventy-one of 565 (12.6%) patients had immediate post-EVAR type Ia endoleak. Early intervention (proximal aortic cuffs and/or stenting) was used in 56 of 71 (79%) in group A vs 31 of 494 (6%) in group B (p \u3c 0.0001). Late type Ia endoleak was noted in 9 patients (13%) in group A at a mean follow-up of 28 months vs 10 patients (2%) in group B at a mean follow-up of 32 months (p \u3c 0.0001). Late sac expansion and reintervention rates were 9% and 10% for group A vs 5% and 3% for group B (p = 0.2698 and p = 0.0198), respectively. Freedom rates from late type Ia endoleaks at 1, 3, and 5 years for group A were 88%, 85%, and 80% vs 98%, 98%, and 96% for group B (p \u3c 0.001); and for late intervention, were 94%, 92%, and 77% for group A, and 99%, 97%, and 95% for group B (p = 0.007), respectively. Survival rates were similar. CONCLUSIONS—Immediate post-EVAR type Ia endoleaks are associated with higher rates of early interventions, late endoleaks and reintervention, which will necessitate strict post-EVAR surveillance

Femoral pseudoaneurysms after percutaneous access

The femoral artery has been the primary percutaneous-based arterial access site for coronary artery catheterizations for more than three decades. Noncardiac percutaneous-based procedures have also been performed primarily with femoral access and have increased in number exponentially by vascular specialists in past decades. Groin complications are infrequent in incidence after femoral arterial access for cardiac and peripheral diagnostic and interventional cases, with groin hematomas and pseudoaneurysms being the most common. Until ultrasound-based treatment modalities became the mainstay of treatment, vascular surgeons were the primary specialty managing pseudoaneurysms, but now other specialties also manage these cases. This review outlines the clinical implications and current issues relevant to understanding the ideal treatment strategy for this common complication

A prospective controlled study of the efficacy of short-term anticoagulation therapy in patients with deep vein thrombosis of the lower extremity

AbstractPurpose: The long-term risk for recurrent deep venous thrombosis (DVT) and the incidence of post-thrombotic syndrome (PTS) after long-term anticoagulation (LTA) therapy have been widely debated. In this study, we compare the results of short-term anticoagulation therapy versus conventional LTA therapy in patients with DVT of the lower extremity. Methods: Baseline assessments of DVT symptoms and risk factors were recorded in 105 patients. Diagnosis was made using duplex ultrasound/venography. Patients were sequentially assigned to 1 of the following treatment protocols: (A) conventional LTA therapy, which included initial intravenous standard heparin followed by warfarin on days 3 to 5 and was continued for 3 months for patients without pulmonary embolism (PE); or (B) short-term therapy, which included the same heparin therapy followed by warfarin on days 2 to 3 and was continued for 6 weeks only. Clinical and duplex ultrasound follow-up was done at 6 weeks, 3 and 6 months, and every 6 months thereafter. Results: Risk factors, location of DVT, and mean age of the 2 groups were comparable. Mean follow-up was 59 months. There were 4 immediate major complications in patients of group A (4 of 54 [7%]; 2 PEs and 2 significant bleeds) and 3 in patients of group B (3 of 51 [6%]; 1 PE and 2 bleeds). On long-term follow-up, 18 of 43 (42%) patients in group A and 20 of 44 (46%) patients in group B had PTS. Similarly, 10 of 43 (23%) patients in group A and 9 of 44 (20%) patients in group B had 1 or more recurrent thromboembolic events (not statistically significant). A significant difference was demonstrated only in patients with cancer; LTA was favored in reducing recurrent DVT and PTS. Two other patients in group A had late significant complications secondary to warfarin (hemorrhage in 1 and coumadin necrosis in the other), with no complications in group B. The mean number of days of hospitalization were fewer for patients in group B (5 versus 8 days), which is mainly due to earlier initiation of warfarin therapy for group B. Conclusion: In this study of our local population, we observed that short-term anticoagulation therapy was as effective as LTA therapy and less costly for use in most patients. It may also carry less risk of long-term warfarin complications, such as bleeding or skin necrosis. (J Vasc Surg 1998;28:630-7.

Preparation and In Vitro/In Vivo Characterization of Porous Sublingual Tablets Containing Ternary Kneaded Solid System of Vinpocetine with β-Cyclodextrin and Hydroxy Acid

The demand for sublingual tablets has been growing during the previous decades especially for drugs with extensive hepatic first-pass metabolism. Vinpocetine, a widely used neurotropic agent, has low oral bioavailability due to its poor aqueous solubility and marked first-pass metabolism. Accordingly, the aim of this work was to develop tablets for the sublingual delivery of vinpocetine. Initially, the feasibility of improving vinpocetine’s poor aqueous solubility by preparing kneaded solid systems of the drug with β-Cyclodextrin and hydroxy acids (citric acid and tartaric acid) was assessed. The solid system with improved solubility and dissolution properties was incorporated into porous tablets that rapidly disintegrate permitting fast release of vinpocetine into the sublingual cavity. The pores were induced into these tablets by directly compressing the tablets’ excipients with a sublimable material, either camphor or menthol, which was eventually sublimated leaving pores. The obtained results demonstrated that the tablets prepared using camphor attained sufficient mechanical strength for practical use together with rapid disintegration and dissolution. In vivo absorption study performed in rabbits indicated that the sublingual administration of the proposed porous tablets containing vinpocetine solid system with β-Cyclodextrin and tartaric acid could be useful for therapeutic application