BACKGROUND: To study the long-term patency of thrombosed prosthetic vascular access grafts treated with percutaneous mechanical thrombectomy (PMT) followed by aggressive surveillance and monitoring and repeated endovascular interventions. STUDY DESIGN: Two hundred seven vascular access grafts presented with first-time thrombosis were treated with PMT using the AngioJet device (n=185) or the Arrow-Trerotola percutaneous thrombolytic device (n=22) followed by angioplasty (+/- stenting) of the anatomical lesion responsible for the thrombotic event. Clinical success was considered at least one successful subsequent hemodialysis session. Graft surveillance/monitoring included clinical and hemodialysis parameters to detect a failing or thrombosed graft. RESULTS: PMT was technically successful in 202 cases (97.6%) and clinically successful in 193 cases (93.2%). During follow-up, 149 got thrombosed and either abandoned (n=33) or underwent at least once repeat thrombectomy (n=116); finally 100 grafts were abandoned (n=90), ligated (n=5) or removed (n=5). Endovascular management (0.54 procedures per 100 graft-days, thrombectomy, n=307 sessions and angioplasty, n=162 sessions) increased significantly functional assisted-primary patency rates from 29% and 14% at 1 and 2 years to a secondary patency of 62% and 47%, respectively. Secondary patency was worse in loop grafts (P=.02) and intermediate graft thrombosis (occurred between 31-182 days after graft placement, P<.001) and better when renal failure was due to hypertension or diabetes (compared to other or cryptogenic causes, P=.048) or isolated angioplasty for graft dysfunction during follow-up had been performed (P<.001). Multivariate analysis identified intermediate graft thrombosis and isolated angioplasty as independent predictors of secondary patency (P<.001, relative risk 2.77 and P<.001, relative risk 0.28, respectively). CONCLUSIONS: PMT is a highly successful procedure with acceptable long-term secondary patency results, provided that aggressive endovascular management of subsequent thrombotic or dysfunction episode is performed. Further research to identify the causes of intermediate graft thrombosis is justified.

Until recently, acute arterial or venous thromboses were routinely managed with surgical intervention. With the development of effective thrombolytic pharmacologic agents and improved modes of delivery of these agents to the target site, surgery is no longer the only option. Greater understanding and knowledge about the finely orchestrated, counterbalanced processes of coagulation and fibrinolysis/thrombolysis have enabled development of agents and strategies for pharmacologic restoration of vascular patency while reducing or eliminating the need for surgery. An evidence-based rationale now exists for the use of thrombolysis in acute limb ischemia, deep venous thrombosis, stroke, and arteriovenous vascular access thromboses. Thrombolytic agents are valuable ancillary agents that allow a less invasive solution to a variety of thrombotic vascular conditions. Strategies that combine thrombolytic agents with endovascular techniques provide precise delivery of these drugs to the target thrombus. A more widespread adoption of this strategy has been limited primarily owing to problems with the currently available pharmacologic agents. The future of thrombolysis therapy is discussed in terms of data obtained from ongoing and recently completed clinical trials. Efforts to develop and study new thrombolytic agents that act directly on the thrombus without activation of intermediary biochemical steps will provide the next major step forward, as well as the rational basis for expansion of currently accepted indications for the treatment of acute arterial and venous thromboses.

Purpose: To study the outcome of rheolytic thrombectomy for hemodialysis access occlusion. Methods: A prospective study was conducted of 187 patients (88 men; median age 63 years, range 21-89) with end-stage renal disease treated with the AngioJet rheolytic thrombectomy catheter followed by angioplasty (+/- stenting) of the culprit lesions in 285 episodes of arteriovenous graft (n = 261) or fistula (n = 24) thrombosis. Clinical success was defined as at least one successful subsequent hemodialysis session. Graft monitoring and surveillance included clinical and hemodialysis parameters, respectively, to detect a failing/failed access. Results: Rheolytic thrombectomy had a technical (immediate) success rate of 98.2% and a clinical success rate of 95.1%. Technical and clinical success for patients presenting within 2 days of the thrombosis was 99.6% and 96.6%, respectively, compared to 91.8%(p = 0.003, odds ratio 20.8) and 87.8%(p = 0.019, odds ratio 4) for later presentation. The number of stenoses that was managed (median, interquartile range) was significantly higher in grafts (4, 3-4) compared to fistulae (2, 2-3; p<0.001) and in accesses that had been treated for dysfunction or thrombosis in the past (4, 3-4) compared to accesses that had not (3, 3-4; p = 0.07). During follow-up, 95 (36.6%) accesses had no further thrombotic events, 23 (9%) accesses became dysfunctional and were treated with endovascular techniques, 137 (52.3%) developed recurrent thrombosis for which rheolytic thrombectomy was attempted, and 30 (11.5%) were abandoned or removed for infection. Functional assisted primary patency at 1, 6, 12, and 18 months was 72.4%, 45.1%, 30.3%, and 22.4%, respectively. Reintervention and venous outflow stenosis were associated with better and worse outcomes, respectively; multivariate analysis identified patient age, central vein stenosis, and stenting as additional independent predictors of improved patency. Conclusion: Rheolytic thrombectomy is a highly successful procedure, with acceptable long-term assisted primary patency. Early referral for thrombectomy should be encouraged.

Purpose: To retrospectively review the complications reported during percutaneous thrombectomy procedures performed on polytetrafluoroethylene hemodialysis grafts. Materials and Methods: A retrospective review revealed that 935 percutaneous thrombectomy procedures were performed at our institution between January 1993 and June 2001. The type and number of procedures include: Arrow PTD (527), pulse-spray with urokinase (240), Amplatz Thrombectomy Device (96), AngioJet (17), Oasis (15), Hydrolyser (10), Endovac (7), Lyse and Wait (7), Thrombex (6), Cragg brush (6), Castaneda brush (4). Complications were reported to have occurred in 31 patients. The radiology reports and medical records of these patients were reviewed. Results: The overall complication rate was 3.3%. The type and number of complications included: rupture of a vein during angioplasty (13), severe cardiopulmonary distress (4), arterial emboli (4), rigors related to urokinase (3), minor bleeding (2), hypoxia with chest pain (2), other assorted complications (3). There was one death resulting from a fall from the angiography table immediately following the procedure. There were 12 minor complications, requiring minimal treatment, and 19 major complications that altered the course of the procedure or treatment of the patient. Conclusion: The most common complication was angioplasty-induced rupture of the vein or graft. The most severe complications occurred immediately following dislodgement of the arterial plug and were likely due to acute pulmonary embolization.

PURPOSE: Endovascular removal of intravascular thrombus using the AngioJet rheolytic thrombectomy (RT) system has been shown to be clinically effective. This system also permits the concomitant infusion of thrombolytic agent followed by thrombectomy, thus creating a novel strategy known as pharmacomechanical thrombectomy (PMT). Although these interventions have gained wide clinical application, little is known regarding the vessel wall response following thrombectomy therapy. The aims of this study were to assess the effect of thrombectomy interventions on endothelial function in a porcine model of deep venous thrombosis (DVT) and to evaluate the effect of nitric oxide (NO) precursor L-arginine on endothelial function following thrombectomy therapy. METHODS: Deep vein thrombosis was created in bilateral iliac veins by deploying a self-expanding stent-graft incorporating an intraluminal stenosis from a groin approach. Five pigs underwent sham operation. Following 14 days of DVT, animals were randomized to three groups: the first group received RT treatment (RT group, n = 5); the second group received pharmacomechanical thrombectomy (PMT) with tissue plasminogen activator (alteplase 10 mg; PMT group, n = 5); and the third group received PMT with tPA plus intravenous L-arginine (20 mmol/l)(arginine group, n = 5). Iliac vein patency was evaluated by venography and intravascular ultrasound at 1 week. Nitric oxide level was determined by a chemiluminescent assay of the nitrite/nitrate metabolites (NO(x)). Thrombogenicity was evaluated by radiolabeled platelet and fibrin deposition. Veins were harvested and evaluated with light microscopy and scanning electron microscopy (SEM). Endothelial function was evaluated using organ chamber analysis. RESULTS: The luminal areas in the sham, RT, PMT, and arginine groups were 34 +/- 10 mm(2), 21 +/- 13 mm(2), 35 +/- 18 mm(2), and 37 +/- 16 mm(2), respectively. All iliac veins remained patent at 2 weeks. No difference in endothelial cell structure was observed between the three treatment groups by means of light microscopic or SEM examination. A decrease in platelet deposition occurred in the arginine group compared to the RT and PMT groups (P < 0.05). The arginine group also showed a greater endothelium-dependent relaxation compared to the RT or PMT groups in response to A23187, bradykinin, and ADP (P < 0.05). Local NO(x) level was higher in the arginine group than in the RT or PMT group (2.6 +/- 0.6 mumol/l versus 0.3 +/- 0.1 mumol/l and 0.3 +/- 0.2 mumol/l; P < 0.01). CONCLUSIONS: AngioJet RT and PMT interventions resulted in similar attenuated endothelium-dependent vasoreactivity and morphologic effect. L-Arginine supplementation preserves endothelial vasoreactivity and reduces platelet deposition following PMT in iliac DVT. Additionally, L-arginine enhances NO production at sites of venous thrombosis. The NO precursor L-arginine may have a therapeutic potential in preserving endothelial function following mechanical thrombectomy.

PURPOSE: The present study sought to evaluate the performance of the Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) in the treatment of native fistula thrombosis in a U. S. hemodialysis population. Specifically, the technical success, clinical success, complication rate and type, primary and secondary patency rates, effect of adjunctive thrombolytic therapy, and any variables that affected outcomes of procedures in which this device was used were analyzed. MATERIALS AND METHODS: Forty-two patients with 44 thrombosed native fistulas (17 radiocephalic, 10 brachiocephalic, 10 transposed or superficialized, five graft/fistula hybrids, and two leg fistulas) were treated with 62 mechanical thrombolysis procedures with use of the PTD. All patients had large clot burden. The device type was recorded in 43 procedures: standard (n = 21), over-the-wire (OTW; n = 19), or both (n = 3). No device was used in two cases because of inability to cross the anastomosis. Adjunctive therapies (n = 18) included the use of tissue plasminogen activator (tPA; n = 16) and deployment of the AngioJet device with (n = 1) or without tPA (n = 1). Stents were inserted in four procedures. Outcome variables included technical and clinical success, complications, and primary and secondary patency. Cox proportional-hazards regression and Kaplan-Meier analyses were performed. RESULTS: The technical success rate was 87%(54 of 62) and the clinical success rate was 79%(49 of 62). Percutaneous transluminal angioplasty was performed in all but two procedures. Complications occurred in 13% of procedures (n = 8); three resulted in technical failure. The primary patency rates were 38% at 6 months and 18% at 12 months; secondary patency rates were 74% and 69%, respectively. Outcomes were not affected by adjunctive techniques, fistula type, age of fistula, device type (ie, OTW vs standard), or patient sex. Secondary patency was superior when no residual clot or stenosis was present (P =.003). CONCLUSIONS: The PTD is effective for percutaneous treatment of thrombosed hemodialysis fistulas, with good short- and long-term outcomes in a U.S. population. Within the limitations of a retrospective study with a small sample size, use of an adjunctive thrombolytic agent did not appear to improve results compared with the use of the device alone.

The purpose of this study was to evaluate the efficacy and safety of a new hydrodynamic percutaneous thrombectomy catheter in the treatment of thrombosed hemodialysis fistulas and grafts. Twenty-two patients (median age: 47 years; range: 31-79 years) underwent mechanical thrombectomy for thrombosed hemodialysis fistulas or polytetrafluoroethylene (PTFE) grafts. In all cases, an Oasis hydrodynamic catheter was used. Five patients had native fistulas and 17 had PTFE grafts. Six patients required repeat procedures. All patients with native fistulas and 15 of the 17 with PTFE grafts also underwent angioplasty of the venous limb following the thrombectomy. Major outcome measures included technical success, clinical success, primary and secondary patency, and complication rates. Twenty-eight procedures were performed in total. The technical success rate was 100% and 90% and clinical success was 86% and 76% for native fistulas and grafts, respectively. The primary patency at 6 months was 50% and 59% for fistulas and grafts, respectively, and the secondary patency at 6 months was 75% and 70% for fistulas and grafts, respectively. Two patients died of unrelated causes during the follow-up period. The Oasis catheter is an effective mechanical device for the percutaneous treatment of thrombosed hemodialysis access. Our initial success rate showed that the technique is safe in the treatment of both native fistulas and grafts.

We report the final results of the trial comparing the Amplatz thrombectomy device (ATD) with surgical thromboembolectomy (ST) to declot thrombosed dialysis access grafts (DAG). The study population consisted of 174 DAG, 109 of which were randomized to mechanical thrombectomy using the ATD and 65 of which were randomized to conventional surgical thromboembolectomy. Forty grafts were re-enrolled in the trial when they failed beyond the 90 days follow-up after the initial treatment. Thirty-one were re-enrolled for mechanical thrombectomy and nine were re-enrolled for surgical thrombectomy, resulting in a total of 140 ATD procedures and 74 surgical thromboembolectomy. Immediate thrombectomy success was defined as greater than 90% thrombus removal followed by the ability to dialyze after treatment, and analysis of long term success based on graft patency at 30 and 90 days, with successful dialysis. Immediate thrombectomy success with the ATD procedure was achieved in 79.2% and with ST in 73.4%. Patency of the graft, with successful dialysis, at 30 days with the ATD procedure was 79.2% and with ST was 73.4%. Patency of the graft, with successful dialysis, at 90 days with the ATD procedure was 75.2% and with ST was 67.8%. The data collected in this study provided a prospective comparison of mechanical thrombectomy with the ATD and ST performance in thrombosed DAG. The results of the performance of both methods were comparable. No statistically significant differences were seen.

BACKGROUND: The purpose of this report was to analyze the results obtained from a group of interventional nephrologists working in multiple centers performing basic procedures that are used routinely in the management of vascular access problems, with an effort toward establishing standards for evaluating success, complication rates, and acceptable times for procedure duration and fluoroscopy. METHODS: Data on six basic procedures were analyzed-angioplasty of arteriovenous fistulas (AVF-PTA), angioplasty of synthetic grafts (graft-PTA), thrombectomy of arteriovenous fistulas (AVF declot), thrombectomy of synthetic grafts (graft declot), placement of tunneled dialysis catheters (TDC placement), and tunneled dialysis catheter exchange (TDC exchange). These data were examined both as a group and by individual physician operator. RESULTS. A total of 14,067 cases were performed under the six categories of procedure that were the subject of this report; 13,503 cases (96.18%) were successful. The overall complication rate for the combined group of procedures was 3.54%, with 3.26% falling within the minor category and 0.28% within the major. The number of cases performed in each individual category with success rates for each were as follows: TDC placement-1765 cases, 98.24% successful; TDC exchange-2262 cases, 98.36% successful, AVF-PTA-1561 cases, 96.58% successful; graft-PTA-3560 cases, 98.06% successful; AVF declot-228 cases, 78.10% successful; graft declot-4671 cases, 93.08% successful. CONCLUSION: This study demonstrates that appropriately trained interventional nephrologists can perform these basic procedures in both a safe and effective manner.

BACKGROUND: Access failure in hemodialysis patients is commonly encountered by vascular surgeons. Researchers have reported various solutions for dealing with clotted grafts, including thrombectomy, thrombolysis, interposition grafting, angioplasty, or a combination of these methods. Surgical thrombectomy has been the standard procedure for dealing with thrombosed hemodialysis grafts in the cardiovascular department of Chang Gung Memorial Hospital. However, to correct associated stenotic lesions and improve the results of surgery, intraoperative balloon angioplasty has been applied in consecutive cases of dialysis graft failure since July 2001. METHODS: Initial experience with 13 consecutive intraoperative balloon angioplasties performed during a 2-month period was reviewed. Noncompliant high-pressure balloons were used for the procedures. Age, gender, graft age, and initial outcome were reviewed and analyzed. RESULTS: A success rate of 100% was achieved in the group that underwent thrombectomy plus intraoperative balloon angioplasty. Furthermore, the primary potency rates were 77% at 1 month, 62% at 3 months, and 38% at 6 months. CONCLUSIONS: We recommend intraoperative balloon angioplasty plus surgical thrombectomy as an effective method of salvaging thrombosed hemodialysis grafts. However, since these are the initial results for this kind of hybrid procedure from a single hospital, large-scale studies with long-term follow up are required.

Using a quarterly (3-mo) monitoring and bait-replenishment interval, 122 subterranean termite colonies throughout the United States were baited with a refined cellulose bait matrix containing 0.5% noviflumuron. All colonies were eliminated in less than 1 yr after initiation of baiting as determined by long-term monitoring and genetic markers. Sixty-three percent of the colonies were eliminated during the first quarter after the initiation of baiting and 77% of colonies were eliminated after consuming two bait tubes or less. This suggests that a single baiting cycle and bait installed in response to a single active monitoring device were sufficient to eliminate the majority of colonies. Although termites temporarily abandoned stations after depleting bait, workers resumed feeding when baits were replenished. Colonies that consumed large amounts of bait before elimination foraged into multiple stations, thus allowing adequate amounts of bait to sustain feeding. The time to eliminate termite colonies with bait replenished quarterly was similar to that previously reported for laminated cellulose bait replenished monthly. Our data support the conclusion that extending the bait replenishment interval from monthly to quarterly for bait tubes with refined cellulose containing 0.5% noviflumuron did not adversely impact colony elimination.

AIM: The aim of this paper was to present the interim results of the the Safety and Efficacy of NeuroFlo(TM) Technology in Ischemic Stroke (SENTIS) trial. METHODS: The SENTIS study is a phase III, multi-center randomized prospective study to evaluate cerebral perfusion augmentation with partial aortic occlusion in acute ischemic stroke. The trial was designed to compare conventional management of stroke patients with stroke patients treated by partial occlusion of the abdominal aorta by the NeuroFlo(TM) device. Follow up was at 24 hours and 90 days. RESULTS: Of the 100 patients enrolled, 53 were randomized to treatment and 47 to control. Six patients enrolled to treatment were found to have specific exclusion criteria and were excluded. Therefore, 97 validated patients, 47 treated patients and 47 control patients were included in the analysis. Adverse events were evenly distributed, among the two cohorts of patients with 16 patients or 34% in each group, including fatal and non-fatal adverse events. However, the mortality was significantly lower for the treated population (6.4%) versus the control population (14.9%), with more stroke progression (8.5%) and hemorrhagic transformation of the stroke area (4.3%) in the control population. CONCLUSION: The SENTIS trial was designed to test the hypothesis that the NeuroFlo(TM) system is safe to be used in humans and able to produce cerebral perfusion augmentation, based on imaging and neurological assessment at 24 hours and at 90 days. The preliminary data yielded by the interim analysis showed that the population enrolled in the trial was rather homogeneous regarding age, baseline NIHSS scores, and other risk factors, suggesting that the treated and control cohorts were similar. The analysis also showed that the adverse events were rather comparable between the two groups, suggesting the treatment procedure to be safe enough for continuation of the trial. The NeuroFlo(TM) system so far proved to be safe enough for clinical use and seems to be promising in improving survival in the acute stroke population.

Although rare, misplacement of central venous catheters in supra-aortic arteries is potentially fatal. Five patients had safe catheters removal using percutaneous closure devices. Three patients were coagulopathic, 3 under intensive care and 1 in immediate postoperative limb amputation. Patients were treated successfully, with immediate hemostasis and without complications in a mean follow-up of 12.5 months. Although the number of patients is small, the closure devices proved to be safe. This is a minimally invasive alternative technique in the management of large bore catheters removed from non-compressible puncture sites such as subclavian and brachiocephalic arteries.

Background: Hemodialysis (HD) grafts often fail due to stenosis at the venous anastomosis and thrombotic occlusion. Percutaneous management relies on thrombolysis with plasminogen activators, mechanical removal of thrombus and angioplasty of the stenotic lesion. Objectives: This report describes a phase I trial using Plasmin (Human) TAL 05-00018, a direct-acting fibrinolytic agent, to evaluate safety and, secondarily, to establish effective thrombolytic dosing. Patients/methods: Six cohorts of 5 patients with acute HD graft occlusion documented by angiography were treated with escalating dosages of plasmin (1, 2, 4, 8, 12, and 24 mg) infused over 30 minutes via criss-crossed pulse-spray catheters within the graft. The primary efficacy endpoint was >/=50% thrombolysis, as determined by comparison of pre- and 30-minute post-plasmin fistulograms. Results: Of 31 subjects who received study drug (safety population), 1 withdrew and 30 completed the trial (evaluable for efficacy). There was no significant change in plasma alpha-2 antiplasmin or fibrinogen concentration, major bleeding did not occur and there were no deaths. Serious adverse events in 4 patients were not related to study drug. There was a dose-response relationship for the primary efficacy endpoint, all 5 subjects receiving 24 mg achieving >75% lysis. Conclusions: This first phase I study of Plasmin (Human) TAL 05-00018, infused into thrombosed HD grafts, documents safety at dosages of 1 to 24 mg and an effective thrombolytic dosage of 24 mg. The results establish a foundation for further clinical study of catheter-based plasmin administration in thrombotic disorders.

Venous thromboembolism and pulmonary embolism (PE) is the third most common cardiovascular disease and a leading cause of death in the US. There are many risk factors related to PE. Traditional treatments are anticoagulation, systemic thrombolysis, and surgical thrombectomy. More recently, several minimally invasive procedures were introduced, which includes catheter-directed thrombolysis, percutaneous embolectomy, embolus fragmentation techniques, pulmonary artery stent placement or association of two or more of those techniques. In the present study the Authors review the role of the different techniques for the treatment of PE, and provide some guidelines and indications for treatment. The most popular devices and techniques are described in detail, and the efficacy of the techniques is discussed.

Trauma to the carotid, subclavian, vertebral, or innominate arteries may be blunt or penetrating. Some injuries, such as those caused by central venous catheterization, are iatrogenic. Trauma-induced fistulas and pseudoaneurysms of the supra-aortic arteries are relatively rare, but may result in disabling neurologic symptoms or death. Traditional surgical approaches to supra-aortic artery trauma have high morbidity and mortality rates, especially in patients with multiple injuries and patients with a serious concomitant illness. The minimally invasive endovascular approach may offer an alternative that avoids the tissue damage, bleeding, infectious complications, pain and disability, long recovery time, and high financial cost associated with surgery. In the past 15 years, stent-grafts have evolved from bare-metal stents to which the operator attached autologous vein or a prosthetic material to manufactured balloon-expandable or self-expanding endoprosthetic systems. No devices designed specifically for use in the supra-aortic arteries are yet available. Nevertheless, the reported experience with stent-graft treatment of supra-aortic artery trauma is growing rapidly, although it remains limited to case reports and small series with relatively short follow-up times. Results have been very promising: complete lesion exclusion from the circulation and resolution of symptoms has been achieved in almost all cases, and few procedural complications and stent-graft stenoses and thromboses have been reported. The stent-graft approach warrants additional research on its long-term outcomes, as well as continued development of enhancements for the devices used.

Carotid angioplasty and stenting is now an alternative to surgical endarterectomy to treat carotid occlusive disease and is becoming mainstream in medical practice. However, the information available, the procedure techniques and the technologies are still evolving and several issues are still being discussed. Mandatory training, familiarity with the indications and contraindications, knowledge of the technology and devices are paramount for the success, however, the devices for carotid stenting are still under development. The impact of stent design seems to be greater than previously appreciated. Carotid plaque morphology may be important for the indication of the procedure. The pre, trans, and postprocedure patient management of the patient is essential for reducing morbidity and mortality. Due to the devastating potential complications, compared with other endovascular and minimally invasive procedures, carotid stenting requires a much more strict scrutiny of the operators training and outcomes, since the improvement in the learning curve is accompanied by a comparative reduction in the complication rates. This article presents a review of the information available on how to optimize carotid stenting.

AIM: The aim of this study was to present the preliminary results of a technique of abdominal aortic aneurysm (AAA) sac filling in an attempt to obliterate the sac in a swine AAA model, using deacetylated-poly-N-acetyl glucosamine (DEAC-poly-N-acetyl glucosamine). METHODS: Eleven Yucatan pigs, 6 months of age, 40 kg -60 kg, were used to create an AAA with a Dacron pouch implanted surgically and left to mature for 2 weeks. One animal was used to establish the AAA creation procedures. Eight animals were used for AAA sac filling; of the 8 subjects 2 were used for acute studies, and 6 for longer-term studies. Two additional animals were used as controls without polymer sac filling. Two weeks after the AAA creation, a 13 mmx5.5 cm straight tube AneuRx stent-graft was placed to exclude the aneurysm. The aneurysmal sac was filled with a polymer, DEAC-poly-N-acetyl glucosamine at 1.5%, 70% deacetylated, mixed with iohexol. There was filling of a lumbar artery by the polymer in 2 animals. Endpoints were at 1, 2, 4, 6, 12 and 24 weeks, in the chronic study animals and 6 and 12 weeks in the control subjects, procedures consisting of aortography followed by necropsy and pathologic examination. RESULTS: The AAA creation and aneurysm sac filling was successful in all animals. An organized thrombus layer of about 2 mm in thickness was observed in all subjects along the Dacron aneurysm wall. All aneurysms were angiographically patent at the time of treatment, but fresher thrombus within the sac was seen in 4 subjects before the polymer injection. The stent-graft placement excluded the AAA sac and the polymer injection filled all AAA sacs. The AAA sac had acquired a firm rubberish consistency at the time of necropsy. There was mild inflammatory reaction to the Dacron material in the surrounding tissues and within the sac, to a lesser extent. Two animals developed paralysis of the hind limbs following treatment, most likely related to spinal ischemia, and were used as acute subjects. There was no recanalization of the aneurysm sac, during the follow-up time, ranging from 1 to 24 weeks in the treatment or control subjects. There was a 25% shrinkage of the AAA sac at 6th, 40% at 12th week and 75% by the 24th week. The 2 control subjects showed shrinkage of less than 25% at 6 and 12 weeks. There was replacement of the polymer/thrombus complex by connective tissue, fat tissue with capillary neovascularization in the treated subjects. Fibrosis and calcifications were also detected within the sac, mostly around the stent-graft and in contact with the aortic wall starting at 4 weeks. Control subjects did not show replacement of the thrombus by connective tissue or neovascularization. CONCLUSIONS: The results of this preliminary study support the aneurysm sac filling as a potential tool to exclude the aneurismal sac, promoting shrinkage of the AAA. DEAC -poly-N-acetyl glucosamine promotes clotting within the AAA sac with progressive replacement by connective tissue and neovascularization and may have a potential to prevent endoleaks. The polymer is easy to use, and it seems to have adequate gradual long-term replacement properties, preventing aneu-rysm sac recanalization.

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OBJECTIVES: To compare surgical morbidity and time, as well as anatomical outcomes between vaginal histerectomy and uterine preservation in the treatment of uterine prolapse using a mesh kit (Nazca). METHODS: Randomized controled trial with 31 women with uterine prolapse POP-Q stage 3 or 4 pelvic organ prolapse who underwent vaginal surgery using tipe I polypropilene mesh (Nazca). They were randomized in two groups: group HV: hysterectomy and pelvic reconstruction floor with mesh (n=15); group HP: hysteropexy and pelvic reconstruction floor with mesh (n=16). Race, miccional urgency, intestinal constipation, sacral pain were assessed as well as the amount of bleeding and time of operation. RESULTS: Median follow-up was nine months on both groups. No difference was observed on complication rates and functional outcomes. Operation time was 120 minutes on group HV, versus 58.9 minutes on group HP (X(2)= 17.613*, p < 0.001 ) and intraoperative blood loss was 120 mL on group HV versus 20 mL on group HP (X(2)= 19.425*; p < 0.001). There was no differences in relationship to anatomical cure rates. Objective success rate was 86.67% to group HV and 75% to group HP (p=0,667) at nine months of follow-up. The anatomical results were similar between the two groups. CONCLUSION: The anatomic results between histeropexy and hysterectomy were similar. However, surgical time and blood loss were greater in group with histerectomies. The erosion rate were also similar. Vaginal surgery using mesh is an effective procedure for pelvic organ prolapse.

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Acute massive pulmonary embolism (PE) is a life-threatening condition that requires prompt and aggressive interventions, including anticoagulation, catheter-directed thrombolysis (CDT), mechanical thrombectomy, or surgical thromboembolectomy. The aim of this study was to evaluate the treatment outcome in patients with massive PE who were treated with either ultrasound-accelerated thrombolysis using the EkoSonic Endovascular System (EKOS) or CDT intervention. During a recent 10-year period, the clinical records of all patients with massive PE undergoing catheter-directed interventions were evaluated. Patients were divided into two treatment groups: EKOS versus CDT interventions. Comparisons were made with regard to the treatment outcome between the two groups. Twenty-five patients underwent 33 catheter-directed interventions for massive PE during the study period. Among them, EKOS or CDT was performed in 15 (45%) and 18 (55%) procedures, respectively. In the EKOS group, complete thrombus removal was achieved in 100% cases. In the CDT cohort, complete or partial thrombus removal was accomplished in 7 (50%) and 2 (14%) cases, respectively. Comparing treatment success based on thrombus removal, EKOS treatment resulted in an improved treatment outcome compared with the CDT group (p <.02). The mean time of thrombolysis in EKOS and CDT group was 17.4 +/- 5.23 and 25.3 +/- 7.35 hours, respectively (p =.03). The mortality rate in the EKOS and CDT group was 9.1% and 14.2%, respectively (not significant). Treatment-related hemorrhagic complication rates in the EKOS and CDT group were 0% and 21.4%, respectively (p =.02). A significant reduction in Miller scores was noted in both groups following catheter-based interventions. No significant difference in relative Miller score improvement was observed between groups. Ultrasound-accelerated thrombolysis using the EkoSonic system is an effective treatment modality in patients with acute massive PE. When compared with CDT, this treatment modality provides similar treatment efficacy with reduced thrombolytic infusion time and treatment-related complications.

This prospective, randomized study compared the functional outcome and complications associated with a proximal femoral nail antirotation (PFNA) device with those of a traditional extramedullary device, the dynamic hip screw (DHS), in patients with trochanteric fracture. A total of 121 patients were randomized to the PFNA group (n = 58) or the DHS group (n = 63). Perioperative information and complications were recorded, and assessments of functional outcome were made. The DHS group required a longer operative time and was associated with greater blood loss than the PFNA group. The re-operation rate was lower in the PFNA group compared with the DHS group, especially in patients with unstable fractures, although there was no statistically significant difference in the overall complication rate between the two groups. There were no significant differences in functional outcome between the PFNA and the DHS groups. In conclusion, the PFNA device is useful in the treatment of trochanteric fractures.

BACKGROUND/AIMS: To evaluate whether continuous hemihepatic inflow occlusion (HHO) during hepatectomy can be safer than and be as effective as intermittent total hepatic inflow occlusion (THO) in reducing blood loss. METHODOLOGY: Eighty patients undergoing liver resections were included in a prospective randomized study comparing the intra- and postoperative course under THO (n=40) or HHO (n=40). THO was performed with periods of 20 minutes of occlusion and 5 minutes of releasing, while HHO was performed with continuous occlusion. The surface area of liver transection, amount of blood loss, measurements of alanine aminotransferase (ALT) and aspartate aminotransferase (AST), and postoperative evolution were recorded. RESULTS: The two groups were similar at entry in terms of preoperative liver function and in the proportion of patients experiencing major hepatectomy. The total ischemic time of the two groups was similar (p=0.37), but the operative time in the THO group was longer than in the HHO group (p=0.02). No significant difference was found between the HHO and THO group in blood loss during liver parenchyma transection (p=0.14), the elevations of ALT and AST on the first postoperative day (ALT: p=0.12; AST: p=0.66) and postoperative morbidity (p=0.35). CONCLUSIONS: On the basis of our findings, if it is feasible, continuous HHO is recommended for complex liver resection.

BACKGROUND: Whether laparoscopy offers a benefit over open surgery in the management of acute appendicitis or not remains a subject of controversy despite the publication of numerous randomized studies. This study aimed to compare laparoscopic appendectomy (LA) with open appendectomy (OA) and to ascertain its therapeutic benefit. METHODS: Adult patients older than 14 years presenting with signs and symptoms suggestive of acute appendicitis were randomized to undergo either LA or OA from January 2006 to December 2007. Comparisons were based on operating time, time until return to a general diet, time until return to normal activity and work, length of hospital stay, billed charges, and postoperative complications. RESULTS: The study enrolled 220 patients: 108 to undergo OA and 112 to undergo LA. The groups were similar in terms of clinicopathologic characteristics. The operating time seemed to be shorter for the OA patients than for the LA patients, but the difference was not significant (LA, 30 +/- 15.2 min vs. OA, 28.7 +/- 16.3 min; p > 0.05). The hospital stay of 4.1 +/- 1.5 days for the LA group and 7.2 +/- 1.7 days for the OA group, and the difference was statistically significant (p < 0.05). Laparoscopic appendectomy remained associated with a shorter time until return to a general diet (LA, 20.2 +/- 12.4 h vs. OA, 36.5 +/- 10 h; p < 0.05), to normal activity (LA, 9.1 +/- 4.2 days vs. OA, 13.7 +/- 5.8 days; p < 0.05), and to work (LA, 21.2 +/- 3.5 days vs. OA, 27.7 +/- 4.9 days; p < 0.05). The billed charges appeared to be higher for LA (LA, 5,720.3 +/- 115.7 yuan vs. OA, 5,310 +/- 575.4 yuan), but this difference failed to be clinically important or statistically significant (p > 0.05). Wound infections were more common after OA (n = 14) than after LA (n = 0)(p < 0.05). Intraabdominal abscesses occurred for two patients in the LA group and nine patients in the OA group (p < 0.05). Postoperative ileus occurred with frequencies of 0% in the LA group and 7.4% in the OA group (p < 0.05). The rate for overall complications was significantly lower in the LA group. CONCLUSION: Laparoscopic appendectomy is a useful tool in the treatment of acute appendicitis. Its advantages lie in its minimal invasiveness, its better cosmetic outcome, its lower rate of complications based on surgical expertise and state-of-the-art equipment. It can be recommended as an adoptable method for the routine patient with appendicitis.

OBJECTIVE: Compare the postoperative outcome of the hand-sewn method and the staple method of primary esophagogastric anastomosis after esophagectomy in patients with esophageal carcinoma. The study focused on leakage, stricture rates, operative time, blood loss, and complication. MATERIAL AND METHOD: A prospective randomized trial was undertaken in 117 patients with squamous cell carcinoma of the thoracic esophagus who underwent Ivor-Lewis esophagectomy. Patients were classified according to esophageal size, based on the diameter of the divided esophagus (< or > 30 mm) and then were randomized to have primary anastomosis using either hand-sewn or stapled method. RESULTS: The mean total operating time of esophagectomy when using hand-sewn technique and staple technique were 218.1 +/- 47.8 minutes and 203.7 +/- 23.4 minutes, respectively (p =< 0.001). The mean blood loss in the handsewn group and in the staple group was 864 +/- 346.6 mls and 803 +/- 301.2 mls, respectively (p = 0.02). Anastomotic leakage was 6.7% in the hand-sewn group and 3.4% in the staple group (p = 0.69). Pulmonary and cardiac complications were 13.5% and 16.9% in the hand-sewn group compared with 17.2% and 18.9% in the staple group (p = 0.77, p = 0.96). Anastomotic stricture was found in 10 of 52 patients (19.2%) in the handsewn group and 19 of 52 patients (36.5%) in the staple group (p = 0.08). In the patients with a small esophagus, the stricture rate was significantly lower in the hand-sewn group compared with the staple group (15.2% vs. 38.8%)(p = 0.03). Mortality rate in both groups were not significantly different (11.8% vs. 10.3%)(p = 0.97). CONCLUSION: From the present study, it can be concluded that both hand-sewn method and the staple method in primary esophagogastric anastomosis after esophagectomy in the patients with esophageal carcinoma were safe. The stapled method had a higher incidence of anastomotic stricture especially small esophagus, whereas it consumed less operative time and less blood loss.

OBJECTIVES: To compare the efficacy and safety of BiClamp forceps tonsillectomy (BT) with standard electrocautery tonsillectomy (ET) in terms of postoperative pain and complication rates. STUDY DESIGN: Prospective randomized study. SUBJECTS AND METHODS: The following variables were examined: postoperative complications, intraoperative blood loss, operating time, postoperative pain and diet scores using visual analog scales, and time until return to normal activity. RESULTS: The mean operating time and the grade of intraoperative blood loss were significantly lower in the BT group than in the ET group for both pediatric and adult patients. For adult patients, the overall complication rates were significantly lower in the BT group. In addition, a significant early decrease in the pain score and significant improvement in dietary intake until postoperative day 14 were observed in the BT group for both pediatric and adult patients. CONCLUSIONS: The use of BiClamp forceps in tonsillectomy reduces the intraoperative blood loss and postoperative pain score, and facilitates an early return to normal diet and activity.