[Thrombectomy in ileofemoral venous thrombosis. Thrombectomy alone and in combination with fibrinolysis].
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PURPOSE: To describe efficacy of hydrodynamic thrombectomy for occluded dialysis native and graft fistulae in 51 instances. MATERIALS AND METHODS: Fifty-one hydrodynamic thrombectomies of 34 native and graft a-v fistulae were performed. There were 32 thrombectomies in PTFE grafts and 19 procedures in native Brescia-Cimino fistulae. Multiple thrombectomies were performed in 11 of 34 fistulae. The estimated occlusion time was 36.4+/-22 h. The length of the occluded segment ranged from 2 to 50 cm (mean 28.8 cm). In all cases, a 7 F hydrodynamic thrombectomy catheter was used. Double-cannulation technique was used for graft fistulae, single-cannulation for native fistulae. Additionally, balloon dilatation was performed in all 51 cases, stenting in six, and aspiration thrombectomy in two cases. RESULTS: Arterialized flow was re-established by hydrodynamic thrombectomy and PTA in 43 of 51 cases (84%). By additional use of other techniques, technical success improved to 46 of 51 procedures (90%). Early re-thrombosis occurred in six cases within 24 h of thrombectomy (11%). Clinical success was achieved in 39 of 46 technically successful cases (85%). Cumulative patency was calculated at 63% after 1 week, 57% after 1 month, 48% after 3 months, 37% after 6 months, and 32% after 12 months. Patency of native fistulae after thrombectomy was better than patency of grafts. CONCLUSIONS: Hydrodynamic thrombectomy is an effective percutaneous technique for declotting haemodialysis fistulae and grafts recently thrombosed.
BACKGROUND: Percutaneous coronary interventions (PCI) in acute myocardial infarction with ST segment elevation (STEMI) are associated with distal coronary embolisation. It may be speculated that percutaneous thrombectomy preceding stent implantation may prevent coronary microcirculation from embolisation. AIM: To assess safety and efficacy of percutaneous thrombectomy in patients with STEMI. METHODS: Seventy two patients with STEMI were randomised to PCI with stent implantation alone (n=32) or percutaneous thrombectomy with the RESCUE system, followed by stent implantation (n=40). Coronary flow in infarct related artery before and after the procedure was assessed using TIMI scale and corrected TIMI frame count - cTFC. Myocardial blood flow was measured using TIMI myocardial perfusion grade - tMPG. The degree of ST segment resolution 60 min after PCI was also assessed. Left ventricular ejection fraction (LVEF) was measured in hospital and three months later. RESULTS: The two groups did not differ with respect to the time from the onset of symptoms to the procedure (236+/-162 min vs 258+/-198 min, NS) or the baseline TIMI, cTFC and tMPG values. An effective thrombectomy procedure was performed in 35 (87%) patients from group B. After the procedure, the number of patients with TIMI 3 grade as well as cTFC values and the proportion of patients with tMPG 3 were similar in both groups (86% vs 85%, NS; 19 vs 21, NS; and 38% vs 54%, NS). The sum of ST segment elevations after the procedure was significantly greater in patients who underwent PCI only compared with patients who had thrombectomy and PCI (6.8+/-5.2 mm vs 3.6+/-2.9 mm, p=0.004). Complete normalisation of ST segment was achieved in 68% of patients treated with thrombectomy and PCI compared with 25% of patients who had PCI only (p=0.005). CK-MB peak values occurred significantly earlier in patients treated with thrombectomy (92.1% vs 66.7% up to 360 min, p=0.01). After 3 months of follow-up, LVEF tended to be greater in patients treated with thrombectomy and PCI than in those who underwent PCI only (55.3+/-14.7% vs 60.3+/-9.2%, NS). CONCLUSIONS: Thrombectomy with the RESCUE system in patients with STEMI is safe and effectively restores patency of infarct related artery. Thrombectomy better improves myocardial perfusion than standard PCI.
BACKGROUND AND OBJECTIVES: The impact of ischemic extent on the efficacy and safety of intravenous thrombolysis before thrombectomy remains uncertain. The aim of this study was to evaluate whether the baseline ischemic extent, measured by the Alberta Stroke Program Early Computed Tomography Score (ASPECTS), modifies outcomes of intravenous tenecteplase administered before endovascular thrombectomy. METHODS: This was a post hoc analysis of the BRIDGE-TNK (thrombectomy with vs without rhTNK-tPA in stroke) trial, conducted across China from May 2022 to September 2024. We compared the efficacy and safety of intravenous tenecteplase plus thrombectomy vs thrombectomy alone in acute large-vessel occlusion stroke patients within 4.5 hours of last known well, stratified by baseline ASPECTS (<8 vs 8-10). The outcomes included 90-day functional independence (modified Rankin Scale score of 0-2), 48-hour symptomatic intracranial hemorrhage (sICH), and 90-day mortality. Regression models incorporating a treatment-by-ASPECTS interaction term were used for analysis. RESULTS: Among 550 patients, 241 (43.8%) had ASPECTS <8 (median [interquartile range, IQR] age, 69 [61-77] years; 56.4% male) and 309 had ASPECTS 8-10 (median [IQR] age, 70 [61-77] years; 59.5% male). The rate of functional independence was significantly higher in the tenecteplase plus thrombectomy group than in the thrombectomy-alone group in the ASPECTS <8 subgroup (adjusted risk ratio [aRR], 1.67; 95% CI 1.18-2.35), but not in the ASPECTS 8-10 subgroup (aRR, 0.99; 95% CI 0.84-1.17; pinteraction = 0.007). Rates of sICH did not differ significantly between treatment groups in either ASPECTS subgroups (ASPECTS <8: 10.0% vs 11.2%; ASPECTS 8-10: 7.5% vs 2.8%; pinteraction = 0.11). Ninety-day mortality was comparable between treatment groups in the ASPECTS <8 subgroup, but numerically higher with tenecteplase plus thrombectomy in the ASPECTS 8-10 subgroup (aRR = 1.89, 95% CI 0.99-3.61, pinteraction = 0.04). DISCUSSION: In this exploratory post hoc analysis, a signal of benefit was observed in patients with ASPECTS <8 who received intravenous tenecteplase before thrombectomy, whereas no functional improvement and possible safety concerns were seen in those with ASPECTS 8-10. Prospective confirmation in randomized trials is required before practice change. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov; Unique identifier: NCT04733742.
The benefit of primary angioplasty for acute myocardial infarction (AMI) is limited by the no-reflow phenomenon, resulting in chronic left ventricular (LV) remodeling. The aim of this study was to evaluate the impact of thrombectomy with the Rescue percutaneous thrombectomy catheter on LV function after AMI. We performed a retrospective study comparing conventional angioplasty with the combination of angioplasty and thrombectomy using the Rescue catheter. The study population was comprised of 109 consecutive patients with AMI who underwent angioplasty and thrombectomy and 86 controls treated with conventional angioplasty. Baseline clinical and lesion characteristics were similar in the 2 groups. Postprocedural restoration of normal flow (Thrombolysis In Myocardial Infarction grade 3) was more frequent in the thrombectomy group (82% vs 69%, p = 0.03). No differences were observed in cardiac events, including death, reinfarction, and target vessel revascularization (thrombectomy vs controls, 27% vs 33%; p = 0.44) or changes in ejection fraction (p = 0.22) during 6-month follow-up. The incidence of LV remodeling, defined as an increase in LV end-diastolic volume index of >20%, was significantly lower in the thrombectomy group (22% vs 44%; p = 0.01). Multiple logistic regression analysis revealed that thrombectomy with the Rescue catheter contributed significantly to reduction of both no-reflow and LV remodeling. In the setting of primary angioplasty, adjunctive pretreatment with a rescue catheter reduces the no-reflow phenomenon and protects against LV remodeling.
OBJECTIVES: We sought to evaluate the effects of mechanical thrombectomy on myocardial reperfusion during direct angioplasty for acute myocardial infarction (AMI). BACKGROUND: Embolization of thrombus and plaque debris may occur during direct angioplasty for AMI. This may lead to distal vessel or side branch occlusion and to obstructions in the microvascular system, resulting in impaired myocardial reperfusion. Mechanical thrombectomy is used to reduce distal embolization. METHODS: Ninety-two patients with AMI and angiographic evidence of intraluminal thrombus were randomized to either intracoronary thrombectomy followed by stenting or to a conventional strategy of stenting. Thrombectomy was performed using the X-Sizer catheter (EndiCOR Inc., San Clemente, California). Myocardial reperfusion was assessed by myocardial blush and ST resolution. RESULTS: Postprocedure Thrombolysis in Myocardial Infarction-3 flow was not different between groups (93.5% vs. 95.7%, p = 0.39). Myocardial blush-3 was observed in 71.7% of patients undergoing thrombectomy and in 36.9% of patients undergoing conventional strategy (p = 0.006). ST-segment resolution >or=50% occurred more often in patients undergoing thrombectomy (82.6% vs. 52.2%, p = 0.001). By multivariate analysis, adjunctive thrombectomy was an independent predictor of blush-3 (odds ratio, 3.27; 95% confidence interval, 1.06 to 10.05; p = 0.039). CONCLUSIONS: Intracoronary thrombectomy as adjunct to stenting during direct angioplasty for AMI improves myocardial reperfusion as assessed by myocardial blush and ST resolution.
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.
RATIONALE AND OBJECTIVES: To evaluate the feasibility of mechanical thrombectomy with the use of the Amplatz thrombectomy device (ATD) in restoring patency to acutely thrombosed stent-shunts after transjugular intrahepatic portosystemic shunt (TIPS) placement. METHODS: Mechanical thrombectomy with the ATD was performed in 10 consecutive patients with angiographically documented complete thrombosis of the stent-shunt (mean +/- SD, 6.6 +/- 3.4 cm), which occurred an average of 2.8 months (range, 0-11 months) after the TIPS procedure. RESULTS: In all patients, immediate restoration of patency of the stent-shunt was achieved after thrombectomy alone (n = 1), thrombectomy plus percutaneous transluminal angioplasty (PTA; n = 4), and thrombectomy, PTA, and stenting (n = 5). The mean activation time of the ATD was 253 +/- 43 seconds. The pressure gradient for portal decompression decreased from 23 +/- 6 mmHg before to 11 +/- 3 mmHg after the procedure. The primary patency rate was 80% at 3 months and 60% at 11 months. CONCLUSIONS: Mechanical thrombectomy with the ATD in acutely thrombosed TIPS is technically feasible. Mechanical thrombectomy is a potential alternative to thrombolysis.
RATIONALE AND OBJECTIVES: Numerous experimental models are used to investigate the effectiveness of thrombectomy devices. We aimed to study the systematic effects of different in vitro thrombus models on the results of experimental thrombectomy and examined how thrombi formed in vitro and ex vivo differ. METHODS: Three variables involved in human in vitro thrombogenesis were investigated: spontaneous or thrombin-induced clotting, age (1 or 5 days old), and storage temperature (4 degrees C or 21 degrees C). The fibrin content of in vitro and fresh or old ex vivo thrombi was measured by histologic studies. Ten experiments were performed with each of 8 different in vitro thrombus types using (1) ultrasound thrombolysis, (2) Oasis thrombectomy, (3) Amplatz thrombectomy, and (4) Straub-Rotarex catheters. Thrombus weight was measured after standardized treatment. RESULTS: The fibrin content was markedly lower in all in vitro than in fresh and old ex vivo thrombi. In vitro thrombus type had no impact on the effectiveness of ultrasound thrombolysis and Amplatz thrombectomy. Thrombogenesis type affected Oasis and Straub-Rotarex catheter use. Storage temperature had a systematic impact on the outcome of Oasis thrombectomies. CONCLUSION: The fibrin content of in vitro thrombi differs substantially from that of fresh and old ex vivo human thrombi. Experimental conditions may systematically impact experimental evaluation of thrombectomy procedures. In vitro thrombi with thrombin-induced thrombogenesis should be favored for use in thrombectomy experiments.
BACKGROUND: Distal embolization during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction may result in reduced myocardial perfusion, infarct extension, and impaired prognosis. METHODS AND RESULTS: In a prospective randomized trial, we studied the effect of routine thrombectomy in 215 patients with ST-segment-elevation myocardial infarction lasting <12 hours undergoing primary PCI. Patients were randomized to thrombectomy pretreatment or standard PCI. The primary end point was myocardial salvage measured by sestamibi SPECT, calculated as the difference between area at risk and final infarct size determined after 30 days (percent). Secondary end points included final infarct size, ST-segment resolution, and troponin T release. Baseline variables, including ST-segment elevation and area at risk, were similar. Salvage was not statistically different in the thrombectomy and control groups (median, 13% [interquartile range, 9% to 21%] and 18% [interquartile range, 7% to 25%]; P=0.12), but 24 patients in the thrombectomy group and 12 patients in the control group did not have an early SPECT scan, mainly because of poor general or cardiac condition (P=0.04). In the thrombectomy group, final infarct size was increased (median, 15%; [interquartile range, 4% to 25%] versus 8% [interquartile range, 2% to 18%]; P=0.004). CONCLUSIONS: Thrombectomy performed as routine therapy in primary PCI for ST-elevation myocardial infarction does not increase myocardial salvage. The study suggests a possible deleterious effect of thrombectomy, resulting in an increased final infarct size, and does not support the use of thrombectomy in unselected primary PCI patients.
PURPOSE: To evaluate hydraulic thrombectomy using a saline-jet aspiration thrombectomy catheter in the treatment of venous thrombosis. MATERIAL AND METHODS: Ten patients underwent 12 hydraulic thrombectomy procedures using 2.7 or 4.0 mm catheters. The site of the thrombus was either central, peripheral or in portal veins. The age of the thrombi was between 2 and 60 days (mean 19.7 days). The efficacy of hydraulic thrombectomy was evaluated based on the aspirated thrombus ratio (ATR), i.e. the volume of the thrombus aspirated divided by the volume of the thrombus before thrombectomy. ATR was estimated by comparing the angiograms of the lesion before and after thrombectomy. RESULTS: Soft thrombi were usually rapidly removed. ATR was >2/3 in 3, 2/3-1/3 in 2, 1/3-0 in 4, and 0 in 1 patient. The activation time of the injector was 23-224 s (mean 102 s) and the volume of aspirated blood was 30-680 ml (mean 250 ml). Compensatory infusion of saline was performed for blood loss, and 400 ml of packed red blood cells was transfused in 1 patient. No complications of the hydraulic thrombectomy were observed. Thrombolysis or additional treatment were performed in 9 patients. CONCLUSION: Hydraulic thrombectomy using this catheter can contribute to the treatment of venous thrombosis.
PURPOSE: To assess the efficacy and safety of the Rotarex rotational thrombectomy catheter in treating occlusions of the femoropopliteal arteries. METHODS: The Rotarex catheter (Straub Medical, Switzerland) is a rotational thrombectomy device which is supposed to be able to remove fresh and partially organized clot material from an acutely or subacutely occluded vessel. Nineteen limbs of 18 patients (10 women, 8 men; mean age 72.9 +/- 7.3 years) with acute or subacute (23 +/- 16 days) occlusions of the middle or distal third of the superficial femoral artery or the popliteal artery were treated. The occlusions were 3-20 cm long. RESULTS: Thrombectomy was technically successful in 15 of 19 vessels (79%). The primary procedural success including additional procedures such as angioplasty and/or stent-graft placement in 17 limbs was 94%. The mean ankle-brachial index improved from 0.36 +/- 0.26 (before thrombectomy) to 0.81 +/- 0.21 (2 days after the procedure) (p = 0.012). Clinical symptoms shifted to at least one Fontaine stage lower in 13 limbs. As complications we observed two perforations (arteries showing heavily calcified plaques), one arteriovenous fistula and three distal embolizations. One perforation, the fistula and one intimal tear after percutaneous transluminal angioplasty were treated with covered stents; the three distal embolizations were treated successfully with aspiration or Rotarex thrombectomy. In the other perforation the intervention was terminated. None of the complications needed surgical treatment. The complication rate was 31.5%. Follow-up studies showed three early (4-11 days) and six late (1-6 months) reocclusions. The cumulative primary patency rate was 68 +/- 12% at 3 months, and 39 +/- 13% at 6, 12 and 19 months; the secondary patency rate was 68 +/- 12% at 3 months and 53 +/- 13% at 6, 12 and 20 months. CONCLUSION: The Rotarex thrombectomy catheter is effective and quick in treating acute and subacute occlusions of the superficial femoral and popliteal arteries. It should not be used in arteries with heavily calcified plaques because of the risk of perforation. Limited long-term patency is mainly due to the complexity of the underlying lesion. Our results suggest that the Rotarex mechanical thrombectomy catheter is effective and might serve as an alternative treatment modality to intra-arterial lysis.
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.
OBJECTIVES: To evaluate the limb salvage rate in patients undergoing thrombectomy for HIV related peripheral arterial thrombosis. METHODS: A prospective review of patients with HIV related peripheral arterial thrombosis managed at the Durban Metropolitan Vascular Service in Kwazulu-Natal South Africa over a 5-year (1998-2003) period. All patients underwent thrombectomy. RESULTS: Twenty-two patients (20 males) with HIV related peripheral arterial thrombosis (two upper limbs, 20 lower limbs) were included in the study. The median age was 36 years (24-46 years). All patients had rest pain and seven patients had gangrene (digital five, forefoot two). Seven patients had a short history of claudication before development of rest pain. Mean duration of symptoms was 30 days (1-120 days) with 10 patients presenting within 24 h. Most patients had a good general state of health and only three had clinical evidence of HIV infection. Ten patients who presented with threatened limbs from acute arterial occlusion were subjected to thrombectomy without any diagnostic investigations. Twelve patients who did not present with critical limb ischaemia had duplex ultrasonography, which showed arterial occlusion by a thrombus with normal proximal arteries. The striking features were the normal proximal vessels and absence of distal run-off. The search for an underlying cause, echocardiography in seven patients and coagulation screening in 10 patients, was always negative. All patients were subjected to thrombectomy with an on-table angiogram and received systemic heparin intra-operatively and deltaparin post-operatively. In 20 patients, duplex ultrasonography confirmed re-thrombosis within 48 h. Two patients remained with patent arteries. Most (16/20) patients who re-thrombosed required a major amputation and thrombectomy did not alter the level of amputation. The other four patients with re-thrombosis had symptomatic relief. Three patients died within 30 days of thrombectomy, all of HIV related complications. Overall the limb salvage rate was 6/22 (27%). CONCLUSION: Limb salvage rate following thrombectomy in HIV related peripheral arterial thrombosis is very low. Duplex ultrasonography appears to be an adequate radiological diagnostic investigation for these patients.
PURPOSE: To assess the efficacy of clot removal with use of the Hydrolyser thrombectomy catheter in acute massive pulmonary embolism (PE). MATERIALS AND METHODS: Eleven patients (eight women, three men) with a mean age of 61 (range, 37-79) years with acute massive PE underwent percutaneous mechanical thrombectomy (PMT) with use of the Hydrolyser. In four patients with no contraindication, fibrinolysis was performed with use of urokinase at low doses after thrombectomy. RESULTS: Ten patients (90.91%) recovered from massive PE and were discharged within 11 days. The Urokinase Pulmonary Embolism Trial angiographic severity indexes (mean +/- SD) were 14.7 +/- 2.6 and 7.5 +/- 2.7, respectively, before and after thrombectomy (P < .001). Partial arterial pressures of O2 increased from 72.8 mm Hg +/- 16.4 to 93.5 mm Hg +/- 5.6 (P < .005). Pulmonary artery pressure decreased from 45.5 mm Hg +/- 14.2 to 29.5 mm Hg +/- 13.6 after thrombectomy (P < .0001). Calculated by semiquantitative computed analysis, PMT with use of the Hydrolyser removed 74.06% of thrombus +/- 13.46%. One patient developed self-limited hemoptysis immediately after thrombectomy. One patient died during the procedure secondary to PE. CONCLUSION: PMT with use of the Hydrolyser is effective and safe in massive PE, resulting in improved hemodynamics and blood oxygenation and decreased pulmonary artery pressure. It offers an alternative to fibrinolysis and surgical thrombectomy.
PURPOSE: To determine in vitro the efficacy of clot removal of the AngioJet (AJ; new 6-F generation), Hydrolyser (HL; 6-F), and Oasis (OS; 6-F) hydrodynamic thrombectomy devices and the Amplatz Thrombectomy Device fragmentation catheter (ATD; 8-F and new-generation 7-F) in large-diameter vessels and low-pressure fluid dynamic applications (ie, pulmonary embolism). MATERIALS AND METHODS: Thrombectomy of clots (N = 60; n = 12 for each tested device) created from 5-day-old porcine blood (16 g) was performed with the AJ (with coaxial 0.035-inch guide wire), HL, OS, and ATD in a bench-top model simulating low-pressure fluid dynamics (pulsed flow, 1,250 L/min). Tubes made of silicone (20-mm inner diameter) containing thrombus simulated a large-diameter vessel. The effluent was passed through a three-step filter system (10-1,000 micro m; pressure drop, 15 mm Hg). RESULTS: Mean thrombectomy time ranged from 83 seconds (7-F ATD) to 185 seconds (OS; P <.0001 compared to all). Remaining thrombus ranged from 5.4 g/32.7% (AJ) to 11.1 g/68.1% (HL; P <.001 compared to all). The AJ's fluid balance was 0.92, whereas the mean ratio of applied saline solution to aspirated fluid for the other devices were significantly different than isovolumetric conditions (HL, 0.64; OS, 0.59; P <.0001 compared to AJ). The AJ (0.36%), HL (0.43%), and OS (0.38%) caused the least overall emboli larger than 10 micro m; the ATD (7-F, 0.82%; 8-F, 0.74%) caused the most (P <.001 for both). CONCLUSIONS: The tested mechanical thrombectomy devices showed performance differences in thrombectomy time, efficacy of thrombus removal, and peripheral embolization rates. Based on low embolization rates for all devices tested, the experimental data indicate that the 7-F ATD and the 0.035-inch guide-wire-compatible AJ showed feasibility advantages for thrombectomy in large vessel diameter and low-pressure fluid dynamic applications.
OBJECTIVE: To evaluate prospectively the impact on left ventricular (LV) remodelling of an intracoronary aspiration thrombectomy device as adjunctive therapy in primary percutaneous coronary intervention (PCI) in patients with anterior ST elevation myocardial infarction (STEMI). METHODS: 76 consecutive patients with anterior STEMI (65.3 (11.2) years, 48 men) were randomly assigned to intracoronary thrombectomy and stent placement (n = 38) or to conventional stenting (n = 38) of the infarct related artery. Each patient underwent transthoracic echocardiography immediately after PCI and at six months. At the time of echocardiographic control, major adverse cardiovascular events (MACE) in terms of death, new onset of myocardial infarction, and hospitalisation for heart failure were also evaluated. RESULTS: After a successful primary PCI, patients in the thrombectomy group achieved a higher rate of post-procedure myocardial blush grade 3 (36.8% v 13.1%, p = 0.03) and effective ST segment resolution at 90 minutes (81.6% v 55.3%, p = 0.02). Six months after the index intervention, 19 patients (26.8%) developed LV dilatation, defined as an increase in end diastolic volume (EDV) >or= 20%: 15 in the conventional group and four in the thrombectomy group (p = 0.006). Accordingly, at six months patients treated conventionally had significantly higher end systolic volumes (82 (7.7) ml v 75.3 (4.9) ml, p < 0.0001) and EDV (152.5 (18.1) ml v 138.1 (10.7) ml, p < 0.0001) than patients treated with thrombectomy. No differences in cumulative MACE were observed (10.5% in the conventional group v 8.6% in the thrombectomy group, not significant). CONCLUSION: Compared with conventional stenting, adjunctive aspiration thrombectomy in successful primary PCI seems to be associated with a significantly lower incidence of LV remodelling at six months in patients with anterior STEMI.
PURPOSE: To determine the in vitro efficacy of three hydrodynamic thrombectomy devices. MATERIALS AND METHODS: Thrombectomy of clots was performed with three thrombectomy devices (Angiojet [AJ], Possis Medical, Minneapolis, Minn; Hydrolyser [HL] Cordis Europe, Roden, the Netherlands; and the Shredding Embolectomy Thrombectomy [SET] catheter, HP-Medica, Augsburg, Germany) in a flow model. RESULTS: Mean thrombectomy time ranged from 10.22 seconds (HL) to 37.73 seconds (AJ with guide wire). For the AJ and HL, the use of guide wires prolonged thrombectomy time (P < .01). The AJ with and without a guide wire and the HL with a 0.018-inch guide wire worked isovolumetrically, whereas the mean ratio of applied saline and aspirated fluid for the other devices was different from 1, ranging from 0.54 to 0.72. Mean embolus weight with the AJ alone (56.44 mg) was significantly higher than that with the SET catheter alone (3.15 mg) and with a guide wire (1.31 mg, P < .01 for both) and the HL alone (3.9 mg, P < .05), as was the embolus weight with the HL with a 0.018-inch guide wire (66.5 mg) compared with the SET catheter with and without a guide wire (P < .01), AJ with a guide wire (22.33 mg, P < .05), the HL alone (P < .01), and the HL with a 0.025-inch guide wire (24.86 mg, P < .05). CONCLUSION: The devices showed performance differences. The SET catheter alone and with a guide wire and the HL may bear an increased risk of procedure-related anemia. In clinical applications, hydrodynamic thrombectomy might substantially reduce the need for thrombolytic therapy.