Hydrodynamic thrombectomy system versus pulse-spray thrombolysis for thrombosed hemodialysis grafts: a multicenter prospective randomized comparison

P:URPOSE: To evaluate the safety and efficacy of a hydrodynamic thrombectomy system in a prospective, multicenter randomized comparison with pulse-spray thrombolysis in hemodialysis grafts. MATERIALS AND METHODS: Nine centers enrolled 120 adult patients with recently (相似文献   

Pulmonary embolism from pulse-spray pharmacomechanical thrombolysis of clotted hemodialysis grafts: urokinase versus heparinized saline

PURPOSE: To compare the frequency and extent of pulmonary embolism (PE) occurring during pulse-spray pharmacomechanical thrombolysis (PSPMT) of clotted hemodialysis grafts with use of either urokinase (UK) or heparinized saline (HS). Postintervention primary patency and complication rates were compared for each method of thrombolysis. METHODS AND MATERIALS: Twenty-seven patients were enrolled in this prospective, randomized, double-blind study evaluating PE with two PSPMT agents. The doses of heparin were similar between groups. The only variable was that one group of patients received UK and the other received HS. In two cases, the venous anastomosis could not be crossed. Eleven patients were treated with UK and 14 with HS. Nuclear medicine perfusion lung scans were performed before treatment and after graft declotting procedures. Lung perfusion was quantified to 10% of a pulmonary segment (0 = normal perfusion, 1 = segmental perfusion defect), with nine segments counted for each lung. RESULTS: Baseline nuclear medicine perfusion lung scan results were abnormal (> or = 20% segmental perfusion defect) in 19 patients (70.4%). New PE (one or more pulmonary segments) occurred in two patients treated with UK (18.2%) and nine patients treated with HS (64.3%; P = .04). All cases of PE were asymptomatic. Quantitative global pulmonary perfusion analyses revealed that treatment with UK improved flow to 0.2 +/- 2.0 pulmonary segments, whereas treatment with HS decreased perfusion to 1.0 +/- 1.7 segments (P = .16, NS). Although postintervention primary patency rates were similar according to life-table analysis (P = .76, NS), complication rates were higher with use of HS (n = 4, 28.6%) than with use of UK (n = 2, 18.2%) (P = .6, NS). CONCLUSIONS: All PE were asymptomatic during PSPMT, but treatment with UK reduced the rate of PE and tended to result in smaller defects in lung scan results. Most patients undergoing hemodialysis have abnormal baseline perfusion scan results, but PSPMT with UK improved many of them. The postintervention primary patency rates were similar between groups, but complications were more frequent after treatment with HS.     

Thrombosed dialysis access grafts: randomized comparison of the Amplatz thrombectomy device and surgical thromboembolectomy

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.List of Investigators: Carol C. Steenson (Department of Radiology, VA Medical Center, Minneapolis, MN), Renan Uflacker (Interventional Radiology, Medical University of South Carolina, Charleston, SC), Richard J. Gray (Interventional Radiology, Washington Hospital Center, Washington, DC), George A. Fueredi (St Marys Hospital, Milwaukee, WI), Michael P. Hickman (Vascular and Interventional Radiology, St Josephs Regional Health Center, Hot Springs, AR), Robert Smith (Interventional Radiology, Tulane University Medical Center, New Orleans, LA), Paul Kamin (Department of Radiology, Los Alamitos Medical Center, Los Alamitos, CA), Mac Dryjski (Department of Surgery, Millard Filmore Hospital, Buffalo, NY), Michael Bettman (Vascular and Interventional Radiology, Dartmouth-Hitchcock Medical Center, Lebanon, NH).     

Modified use of the arrow-trerotola percutaneous thrombolytic device for the treatment of thrombosed hemodialysis access grafts.

PURPOSE: To assess the safety and efficacy of using the Arrow-Trerotola percutaneous thrombolytic device (PTD) as the sole means of mechanical thrombolysis in hemodialysis access grafts, including in situ treatment of the arterial plug. PATIENTS AND METHODS: Fifty consecutive patients (22 women, 28 men; mean age, 58 years; mean graft age, 29 months), in whom mechanical thrombolysis of a thrombosed hemodialysis access graft using the PTD was planned, were included in the study. In all patients, the PTD was used to treat the arterial plug in situ at the arterial anastomosis, instead of using a Fogarty catheter to reposition the plug, as indicated in the PTD product labeling. Prospective data collection included demographic information, technical details of the procedure, immediate outcomes, and complications. Patients were followed for 3 months using definitions and data forms that were identical to those used in the original clinical trial of the PTD. A sample of procedures drawn from the PTD clinical trial database (n = 54) served as control. RESULTS: Immediate technical patency was 100%. Complications included arterial embolization (6% versus 2% control; P = NS; all successfully treated with backbleeding); venous rupture (6% versus 2% control; P = NS); and sepsis (n = 1), probably due to occult graft infection. Adjunctive therapy with an Adherent Clot catheter was needed in two procedures (4%). Three month patency using life-table analysis was 42% (versus 39% control; P = NS). The number of subsequent interventions (surgical/percutaneous) to the arterial limb of the graft did not differ from the PTD trial, and no native arterial stenoses were detected during the follow-up period. CONCLUSIONS: The PTD is safe and effective when used as the sole means of mechanical thrombolysis of hemodialysis grafts. Treating the arterial plug in situ with the PTD eliminates the need for a Fogarty or Adherent Clot catheter in 96% of procedures. A slight increase in arterial embolic complications was observed but these were easily treated with backbleeding.     

Angioscopic observations after percutaneous thrombectomy of thrombosed hemodialysis grafts

PURPOSE: To use angioscopy to evaluate and compare the amount of residual thrombus and endoluminal wall damage in hemodialysis grafts after percutaneous thrombectomy procedures. MATERIALS AND METHODS: Thirty-nine thrombectomy and angioscopy procedures were performed in 35 patients. Percutaneous thrombectomy methods included eight different mechanical thrombectomy devices and the "lyse and wait" technique. Videotaped images of 33 angioscopic examinations were independently reviewed by three radiologists. Two parameters-the amount of residual thrombus and degree of endoluminal wall damage-were scored on a scale of 1 to 5. Data were initially analyzed to validate the grading system and then further studied to compare the different thrombectomy techniques. RESULTS: The Spearman rank order analysis validated the data pertaining to the amount of residual thrombus (r = 0.71, P < .0001), but there was poor correlation between reviewers regarding the degree of endoluminal wall damage. Combined scores from three reviewers revealed that the Cragg brush and Percutaneous Thrombectomy Device (PTD) left the smallest amounts of residual thrombus. The other methods tested, listed by increasing amount of residual thrombus, were the Endovac, Hydrolyser, Amplatz Thrombectomy Device, AngioJet, Oasis, and the lyse and wait technique. There were two complications related to angioscopy procedures. CONCLUSION: Subjective observations reveal that wall-contact thrombectomy devices leave less residual thrombus than hydrodynamic devices, aspiration devices, or the lyse and wait technique.     

Reteplase in the treatment of thrombosed hemodialysis grafts.

PURPOSE: To prospectively evaluate the efficacy and safety of reteplase with percutaneous transluminal angioplasty (PTA) in the treatment of thrombosed polytetrafluoroethylene hemodialysis arteriovenous grafts (AVGs). MATERIALS AND METHODS: Forty-two patients were entered into the study. Sixty-two procedures in 43 grafts were performed. One unit of reteplase and 4,000 units of heparin were administered into the AVGs. Routine venography and percutaneous transluminal angioplasty (PTA) was then performed. Patients were transferred for hemodialysis immediately after the procedure. RESULTS: Technical success was achieved in 92% of the cases. Four cases involved intentional repeat thrombosis because of poor outflow and/or need for a new graft site. Minor complications occurred in 6.5% of the cases. No major complications occurred. The mean procedure time for experienced versus less-experienced interventionalists was significantly shorter (P <.001). Primary patency rates were 50%, 34%, and 34% at 30, 90, and 180 days, respectively. CONCLUSION: Reteplase in conjunction with heparin and PTA is a safe and effective means of thrombolysis of AVGs. Its efficacy is comparable to that of other available thrombolytic drugs.     

Original report. Pulse-spray thrombolysis of thrombosed hemodialysis grafts with tissue plasminogen activator

OBJECTIVE: The purpose of this study was to evaluate pulse-spray pharmacomechanical thrombolysis with the use of tissue plasminogen activator in the recanalization of thrombosed hemodialysis access grafts. CONCLUSION: Pulse-spray pharmacomechanical thrombolysis with tissue plasminogen activator is an effective method for percutaneous recanalization of thrombosed hemodialysis access grafts with results similar to other percutaneous techniques.     

Contemporary treatment of thrombosed hemodialysis grafts

Maintaining hemodialysis grafts remains a difficult problem. Before the early 1990s, graft declotting was usually performed in the surgical suite. Percutaneous declotting has been evolving since the mid-1980s. Initially, a low-dose thrombolytic infusion of streptokinase through a single catheter was used. Crossing catheters with a higher-dose infusion of urokinase was then introduced. This technique was modified with the adjunctive use of pharmacomechanical techniques with the use of compliant balloons and the adjunctive use of heparin. The advent of the "lyse-and-wait" technique provided a simpler and quicker way to declot thrombosed grafts by using urokinase, with similar outcomes. Since the removal of urokinase from the market, multiple mechanical devices have been used with similar success. Recent reports concerning the use of newer-generation thrombolytic agents report similar outcomes, with a reduction in total cost.     

Mechanical thrombectomy of major and massive pulmonary embolism with use of the Amplatz thrombectomy device.

RATIONALE AND OBJECTIVES: To evaluate the feasibility of mechanical thrombectomy with the Amplatz thrombectomy device (ATD) in restoring patency of acutely thrombosed pulmonary arteries resulting from pulmonary embolism for the improvement of patient outcome. METHODS: Mechanical thrombectomy with the ATD (8F) was performed in nine consecutive patients with angiographically documented thrombus in the left or right pulmonary artery resulting from deep vein thrombosis (n = 4) or unknown cause (n = 5). RESULTS: The Miller index decreased from 18 to 11. In all patients, the majority of the thrombus in the pulmonary artery was cleared after a mean activation time of the ATD of 367 seconds. Thrombectomy was performed with the ATD alone (n = 4) or with additional long-term fibrinolysis therapy (n = 5) with infusion of recombinant tissue-type plasminogen activator. Pulmonary arterial pressure decreased from a mean of 57 mm Hg before mechanical thrombectomy to 55 mm Hg directly after the procedure and to 39 mm Hg after termination of the recombinant tissue-type plasminogen activator infusion. CONCLUSIONS: Mechanical thrombectomy with the ATD in patients with minor and major pulmonary embolism is technically feasible and safe. It is a potential alternative to drug-mediated thrombolysis and surgery. However, the incremental benefit of the ATD over conventional treatments could be shown only in a randomized controlled study.     

Percutaneous ilio-caval thrombectomy with the Amplatz device: preliminary results

The Amplatz Thrombectomy Device (ATD) is a percutaneous, rotational thrombectomy catheter, capable of recirculating and homogenizing the thrombus in order to obtain mechanical clot dissolution. The authors present their experience with mechanical thrombectomy with the ATD in eight cases of ilio-caval thrombosis. Under temporary caval filter protection, the ATD was introduced through the right transjugular approach (in one patient this was used in combination with the right femoral approach) and activated for a time ranging from 90 to 180 s. Complete clearing of thrombotic material in the treated venous segments was achieved in six cases (75 %), partial success was obtained in one case (12.5 %) and failure occurred in one patient (12.5 %). One patient developed a recurrence of venous iliac thrombosis 1 week after the procedure and postphlebitic syndrome 6 months after the first episode of deep venous thrombosis, and one patient died from acute myocardial infarction, unrelated to thrombectomy session, after 3 days. A negative clinical and radiological follow-up at 3, 6, 12 and 24 months was obtained in the remaining six patients. If a fresh free-floating ilio-caval clot must be removed immediately, the ATD can be effective under temporary filter protection. Received: 5 May 1998; Revision received: 8 June 1998; Accepted: 16 September 1998     

Comparison of the angiojet rheolytic catheter to surgical thrombectomy for the treatment of thrombosed hemodialysis grafts. Peripheral AngioJet Clinical Trial.

PURPOSE: To compare the clinical effectiveness of the AngioJet F105 rheolytic catheter to that of surgical thrombectomy for the treatment of thrombosed hemodialysis grafts. MATERIALS AND METHODS: This was a multicenter, prospective, randomized trial comparing technical success, primary patency, and complication rates. A total of 153 patients were enrolled: 82 patients in the AngioJet group and 71 patients in the surgical thrombectomy group. Patient follow-up was performed 24-48 hours, 1 month, and 6 months after the procedures. RESULTS: Technical success, as defined by the patient's ability to undergo hemodialysis treatment, was 73.2% for the AngioJet group and 78.8% for the surgical thrombectomy group (P = .41). The primary patency rates of the AngioJet group were 32%, 21%, and 15% at 1, 2, and 3 months, respectively. The primary patency rates for the surgical group were 41%, 32%, and 26% at 1, 2, and 3 months, respectively. This difference approached statistical significance (P = .053). The groups had similar complication rates-14.6% in the AngioJet group and 14.1% in the surgery group-although the surgery group had more major complications (11.3%). In the AngioJet group, there was a transient increase in plasma-free hemoglobin, which normalized within 24-48 hours. CONCLUSIONS: The AngioJet F105 catheter provides similar clinical results when compared to surgical thrombectomy for the treatment of thrombosed hemodialysis grafts. The difference in patency rates between these two techniques approached statistical significance. In addition, results of both thrombectomy methods were inferior to those suggested by the Dialysis Outcomes Quality Initiative guidelines.     

Amplatz血栓消融器在急性肺动脉栓塞中的临床应用

急性肺动脉栓塞（pulmonary embolism,PE）起病急,病情进展快,未经治疗病死率可高达20％～30％。我院自2001年6月始,采用Amplatz Thrombectomy Device（ATD）成功抢救了5例危重的大面积PE病例。现报道如下。     

Local thrombolysis and thromboaspiration in the treatment of acutely thrombosed arteriovenous hemodialysis fistulas

Sixty-four thrombosed hemodialysis fistulas in 55 patients were treated by local low-dose infusion of urokinase, percutaneous angioplasty, and thromboaspiration. Lysis was initially successful in 38 cases (59%) without any negative side effects. At 1 year, 59% of these fistulas were still functional. When the procedures failed, surgery saved the vascular access in 17 cases. Local fibrinolysis combined with thromboaspiration and angioplasty provides a clinically useful means of access preservation.     

Streptokinase and transluminal angioplasty in the treatment of acutely thrombosed hemodialysis access fistulas

Streptokinase was selectively infused into nine thrombosed hemodialysis access fistulas in eight patients. Lysis occurred in all but one case. Of the eight infusions producing lysis, seven resulted in some clinical benefit. Three grafts functioned adequately for 2 to 6 months after streptokinase infusion alone. A fourth patient had good function for over 11 months after streptokinase treatment and transluminal angioplasty. In a fifth patient, graft function was partially restored, but a persistent arterial defect led to elective graft replacement. Moderate fibrinolysis in the sixth case was of no clinical benefit; rethrombosis developed promptly after SK was discontinued because of bleeding from a recent puncture site. In cases 7 and 8, fibrinolysis restored arterial inflow to the graft, but surgery was needed to revise partially obstructed venous outflow. It is concluded that selective streptokinase infusion, with or without transluminal angioplasty and operation, is often effective in the treatment of acutely thrombosed vascular access fistulas.     

Comparison of the mechanical thrombectomy efficacy of the Amplatz thrombectomy device and the Cragg thrombolytic brush in vitro

RATIONALE AND OBJECTIVES: To determine the efficacy of thrombectomy (without thrombolytic agents) for the Amplatz thrombectomy device (ATD) and the Cragg thrombolytic brush catheter (CBC) in vitro. METHODS: Thrombectomy was performed with the ATD or CBC (6F) in a flow model. Embolus sizes, weight, remaining thrombus, and activation time were evaluated. RESULTS: No significant difference in the activation time was found. The CBC produced significantly less embolism (3.3% vs. 0.03% in the 5-mm and 89% vs. 0.5% in the 7-mm model), but also much more thrombus remained in the system than with the ATD (1% vs. 41% in the 5-mm and 0.1% vs. 62% in the 7-mm model). CONCLUSIONS: The ATD can remove almost all thrombus (99%), whereas the CBC removes only up to 60%, producing fewer emboli than the ATD. This might be due to the lower rotational speed of the CBC compared with the ATD, which is 20 times greater. The soft nylon brush offers less resistance and shear force toward the thrombus than the stainless-steel impeller of the ATD. Because of the large amount of remaining thrombus, the CBC should not be used without lytic agents.