Mechanical thrombolysis of thrombosed hemodialysis native fistulas with use of the Arrow-Trerotola percutaneous thrombolytic device: our preliminary experience

PURPOSE: To evaluate the feasibility of use of the Arrow-Trerotola percutaneous thrombolytic device (PTD) in the treatment of thrombosed hemodialysis native fistula occlusions. MATERIALS AND METHODS: Ten patients with native fistula occlusion underwent mechanical thrombolysis with use of the PTD. The standard PTD was used in seven patients and the over-the-wire device was used in three patients. Major outcomes of our study included procedure time, clinical success, complication rate, and 3- and 6-month patency rates. RESULTS: The technical success rate was 100% and the clinical success rate was 90% (9 of 10). In all 10 cases, the procedure was associated with angioplasty. There were no major complications. The mean time of successful procedures was 126.1 minutes. The 3- and 6-month primary patency rates were 70% and 60%, respectively; the assisted primary patency rate at 6 months was 80%. CONCLUSION: The PTD is an effective mechanical device for percutaneous treatment of thrombosed hemodialysis access. Our clinically successful initial experience with the PTD shows that the technique is rapid and safe for treatment of native fistula occlusions.     

Retrospective comparison of the Amplatz thrombectomy device with modified pulse-spray pharmacomechanical thrombolysis in the treatment of thrombosed hemodialysis access grafts.

PURPOSE: To retrospectively evaluate the Amplatz thrombectomy device (ATD) in the treatment of thrombosed hemodialysis grafts and compare it with modified pulse-spray pharmacomechanical thrombolysis (PPT). MATERIALS AND METHODS: During a 4-month period, 79 patients presented with 126 episodes of graft occlusion. Percutaneous recanalization was performed by using the ATD (n = 57) or the modified PPT technique (n = 69). Evaluation included the technical success, complications, and primary patency rates. RESULTS: Technical success was achieved in 93% (53 to 57) of the cases treated with the ATD and in 96% (66 of 69) of the cases treated with modified PPT (P = .70). Complications occurred in 6% (four of 69) of modified PPT procedures and 16% (nine of 57) of ATD procedures. This difference was not statistically significant (P = .08); however, there were significantly more local complications in the ATD group (P = .04). The primary patency rates at 30, 90, and 180 days were 65% and 65%, 36% and 50%, and 26% and 33% for modified PPT and ATD, respectively. Survival curves were found not to differ significantly (P = .49). CONCLUSION: The ATD and modified PPT were similarly successful in the recanalization of thrombosed hemodialysis access grafts and achieved comparable primary patency rates. The higher rate of local complications and technical difficulties encountered with use of the 8-F ATD limit its usefulness for this indication.     

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.     

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   

Thrombosed hemodialysis grafts: lyse and wait with tissue plasminogen activator or urokinase compared to mechanical thrombolysis with the Arrow-Trerotola Percutaneous Thrombolytic Device

PURPOSE: To determine if the lyse and wait (L&W) technique with a 4-mg dose of alteplase (tissue plasminogen activator; tPA) is a safe and effective method of declotting dialysis grafts as compared to use of the Arrow-Trerotola Percutaneous Thrombectomy Device (PTD) or the L&W technique with use of urokinase (UK). MATERIALS AND METHODS: Forty patients were randomized prospectively to undergo L&W declotting with use of 4 mg of tPA or mechanical thrombolysis with the PTD. The time interval to restored graft flow, total procedure time, hemostasis time, and anatomic success, clinical success, complications, and patency rates were analyzed. These were compared with historic results in 20 patients treated with the L&W technique with use of 250,000 U UK. RESULTS: The immediate anatomic success rate was 95% in the tPA L&W and PTD groups. The mean in-room lysis time with restored flow was 10 minutes for L&W with tPA and 19 minutes for PTD (P = .002). The mean in-room procedure time was 39 minutes for L&W and 45 minutes for PTD (P = NS). Mean hemostasis time with use of manual compression was 44 minutes for L&W with tPA and 23 minutes for PTD (P = .057). The historic group of 20 patients who underwent L&W with UK had a 95% anatomic success rate, a mean of 14 minutes of lysis time, a mean of 34 minutes of procedure time, and a mean of 26 minutes of time to hemostasis. No bleeding complications occurred in the PTD group. Seven episodes of bleeding occurred in six patients given tPA; four were delayed 60-90 minutes after the procedure, one necessitated hospitalization, and two required additional therapies. Four of the 20 patients undergoing L&W with UK had minor puncture site bleeding during the procedure. The 3-month primary patency rates were 65%, 65%, and 60% for L&W with tPA, PTD, and L&W with UK, respectively (P = NS). CONCLUSION: The 4-mg dose of tPA is effective but results in more bleeding complications and longer hemostasis times than mechanical thrombolysis with use of the PTD. Unlike in our experience with UK, bleeding complications with tPA were both major and delayed.     

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.     

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.     

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.     

Pharmacomechanical thrombolysis and angioplasty in the management of clotted hemodialysis grafts: early and late clinical results.

The results of pharmacomechanical thrombolysis and angioplasty of 121 thrombosed hemodialysis grafts were reviewed. The initial pharmacomechanical method (used in 65 cases) employed clot maceration with hook-shaped catheters and clot lacing with highly concentrated urokinase. The current technique (used in 56 cases) consisted of pulsed-spray injection of urokinase into the clot. All fully treated grafts (117 cases) underwent complete or near-complete thrombolysis, and 93% remained patent after 1 day. Mean time for pulsed-spray lysis was 46 minutes +/- 21. One patient (less than 1%) had gastrointestinal bleeding and received a transfusion; minor complications occurred in 3% of patients. Primary and secondary graft patency rates for both methods at 1 year were 26% and 51%, respectively. While graft age and results of angioplasty did not influence future graft patency, shorter intervals between graft thromboses was predictive of earlier subsequent graft failure. Results suggest that pharmacomechanical thrombolysis and angioplasty provide rapid, consistent, and safe recanalization of clotted hemodialysis grafts and represent a promising additional therapeutic approach to long-term graft management.     

Percutaneous transluminal angioplasty and enclosed thrombolysis versus percutaneous transluminal angioplasty in the treatment of femoropopliteal occlusions: Results of a prospective randomized trial

Purpose: To determine whether percutaneous transluminal angioplasty (PTA) and enclosed thrombolysis (ET) is superior to PTA alone in the treatment of femoropopliteal occlusions. Methods: Twenty-five patients with 5–15-cm-long occlusions in the femoropopliteal segments, with otherwise normal run-in arteries and at least one normal tibioperoneal artery to the foot, were randomized to ET/PTA or PTA alone. Ankle brachial systolic index (ABI) was measured before the procedure and at 24 hr and 12 months after the procedure, when a duplex scan was also carried out. End points in the study were patency at, or repeat intervention before, 12 months. Results: Procedures were successful in 23 of 25 patients. There was one immediate occlusion of tibioperoneal arteries, and one early reocclusion of a reopened segment in the ET/PTA group. There was one early reocclusion in the PTA group. At 12 months patency was 70% and 69.2% in the ET/PTA and PTA groups respectively. Covariant analysis showed no significant difference in ABI between the two groups at any of the three measurement times. Conclusion: This trial demonstrated no difference between ET/PTA and PTA alone in femoropopliteal occlusions associated with normal proximal arteries and at least one normal tibioperoneal artery.     

A Randomized Trial of Endovascular Embolization Treatment in Pelvic Congestion Syndrome: Fibered Platinum Coils versus Vascular Plugs with 1-Year Clinical Outcomes

Purpose

To compare safety and efficacy of vascular plugs (VPs) and fibered platinum coils (FPCs) for embolization in pelvic congestion syndrome (PCS).

Embolization of the Superior Rectal Arteries versus Closed Hemorrhoidectomy (Ferguson Technique) in the Treatment of Hemorrhoidal Disease: A Randomized Clinical Trial

PurposeTo compare short-term and medium-term results of superior rectal artery embolization versus surgical hemorrhoidectomy in the treatment of patients with hemorrhoidal disease.Material and MethodsThis study was a prospective randomized clinical trial following 33 patients with symptomatic hemorrhoidal disease Grades 2 and 3 who were randomly assigned to 2 different groups: the superior rectal artery embolization group (n = 15) and Ferguson closed hemorrhoidectomy surgical group (n = 14). Four patients were excluded from the analysis. Pain using the visual analog scale and the use of analgesics were evaluated 3 times daily during the first 7 days of the postoperative period. Recurrent symptoms and satisfaction with treatment were also evaluated in the subsequent first, third, sixth, and twelfth months.ResultsThe mean pain during the first bowel movement after the procedure was 6.08 ± 4.41 in the surgery group and 0 in the embolization group (P = .001). The mean use of pain medication was higher in the surgery group (28.92 doses ± 15.78 vs 2.4 doses ± 5.21; P < .001). In the embolization group, the most prevalent preprocedural symptom was bleeding in 14 patients, with complete improvement in 12 (83.3%) patients. Mucus, skin tag, and pruritus were symptoms that showed little improvement in both groups. The frequency of symptoms (bleeding, pain, prolapse, and pruritus) was similar between the groups at 12 months (P = .691). No severe adverse events were observed in both groups.ConclusionsDespite no difference in outcomes, embolization of the superior rectal arteries for the treatment of hemorrhoidal disease showed pain levels lower than those observed after surgical treatment.     

IN.PACT AV Access Randomized Trial: 12-Month Clinical Results Demonstrating the Sustained Treatment Effect of Drug-Coated Balloons

PurposeTo present the 12-month outcomes of the IN.PACT AV Access Study, a prospective, single-blind trial enrolling participants with obstructive de novo or restenotic native upper extremity arteriovenous dialysis fistula lesions treated with a drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA).Materials and MethodsAfter successful high-pressure PTA, participants at 29 international sites were randomized 1:1 to treatment with an IN.PACT AV DCB (n = 170) or standard uncoated PTA (n = 160). Outcomes at 12 months include target lesion primary patency (TLPP), defined as freedom from clinically driven target lesion revascularization or access circuit thrombosis; access circuit primary patency; number of reinterventions; and adverse events involving the access circuit.ResultsAt 12 months, TLPP was 63.8% (90/141) in the DCB group compared with 43.6% (61/140) in the PTA group (P < .001). The total number of reinterventions required to maintain TLPP through 360 days was 93 in the DCB group and 144 in the PTA group, with a 35.4% reduction in reinterventions when DCB was used. Access circuit thrombosis occurred in 2.9% (4/138) of the participants in the DCB group and in 6.2% (8/129) of those in the PTA group (P = .19). Time to TLPP was assessed using a multivariable analysis to identify the factors associated with loss of patency. The treatment device was the independent predictor with the largest effect, with a hazard ratio of 0.42 (95% confidence interval, 0.29–0.60; P < .001).ConclusionsTLPP was statistically significantly higher with DCBs than with standard PTA at 12 months, demonstrating the sustained and superior effectiveness of this device for the treatment of dysfunctional arteriovenous dialysis fistulae.     

Use of Percutaneous Aspiration Thrombectomy vs. Anticoagulation Therapy to Treat Acute Iliofemoral Venous Thrombosis: 1-year Follow-up Results of a Randomised,Clinical Trial

Purpose

The purpose of this study was to compare the efficacy of percutaneous aspiration thrombectomy (PAT) followed by standard anticoagulant therapy, with anticoagulation therapy alone, for the treatment of acute proximal lower extremity deep vein thrombosis.

Methods

In this randomised, prospective study, 42 patients with acute proximal iliofemoral deep vein thrombosis documented via Doppler ultrasound examination, were separated into an interventional treatment group (16 males, 5 females, average age 51 years) and a medical treatment group (13 males, 8 females, average age 59 years). In the interventional group, PAT with large-lumen 9-F diameter catheterisation was applied, after initiation of standard anticoagulant therapy. Balloon angioplasty (n 19) and stent implementation (n: 14) were used to treat patients with residual stenosis (>50 %) after PAT. Prophylactic IVC filters were placed in two patients. The thrombus clearance status of the venous system was evaluated by venography. In both the medical and interventional groups, venous patency rates and clinical symptom scores were evaluated at months 1, 3, and 12 after treatment.

Results

Deep venous systems became totally cleared of thrombi in 12 patients treated with PAT. The venous patency rates in month 12 were 57.1 and 4.76 % in the interventional and medical treatment groups, respectively. A statistically significant improvement was observed in clinical symptom scores of the interventional group (PAT) with or without stenting (4.23 ± 0.51 before treatment; 0.81 ± 0.92 at month 12) compared with the medical treatment group (4.00 ± 0.63 before treatment; 2.43 ± 0.67 at month 12). During follow-up, four patients in the medical treatment and one in the interventional group developed pulmonary embolisms.

Conclusions

For treatment of acute deep vein thrombosis, PAT with or without stenting is superior to anticoagulant therapy alone in terms of both ensuring venous patency and improving clinical symptoms. PAT is a safe, inexpensive, and easily performed method of endovascular treatment with a low rate of major complications. Our present findings and literature data suggest that PAT can be used as first-line treatment in proximal deep vein thrombosis patients, especially when thrombolytic treatment is contraindicated.     

IN.PACT AV Access Trial: Economic Evaluation of Drug-Coated Balloon Treatment for Dysfunctional Arteriovenous Fistulae Based on 12-Month Clinical Outcomes

PurposeTo study, from a U.S. payer’s perspective, the economic consequences of drug-coated balloon (DCB) versus standard percutaneous transluminal angioplasty (PTA) use for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulae.Materials and MethodsCost differences between DCBs and PTA at year 1 and beyond were calculated via 2 methods. The first approach used the mean absolute number of trial-observed access circuit reinterventions through 12 months (0.65 ± 1.05 vs 1.05 ± 1.18 events per patient for DCBs and PTA, respectively) and projected treatment outcomes to 3 years. The second approach was based on the trial-observed access circuit primary patency rates at 12 months (53.8% vs 32.4%) and calculated the cost difference on the basis of previously published Medicare cost for patients who maintained or did not maintain primary patency. Assumptions regarding DCB device prices were tested in sensitivity analyses, and the numbers needed to treat were calculated.ResultsUsing the absolute number of access circuit reinterventions approach, the DCB strategy resulted in an estimated per-patient savings of $1,632 at 1 year and $4,263 at 3 years before considering the DCB device cost. The access circuit primary patency approach was associated with a per-patient cost savings of $2,152 at 1 year and $3,894 at 2.5 years of follow-up. At the theoretical DCB device reimbursement of $1,800, savings were $1,680 and $2,049 at 2.5 and 3 years, respectively. The one-year NNT of DCB compared to PTA was 2.48.ConclusionsEndovascular therapy for arteriovenous access stenosis with the IN.PACT AV DCB can be expected to be cost-saving if longer follow-up data confirm its clinical effectiveness.