Export Aspiration Catheter Research Articles

Thrombus aspiration in people living with HIV- a night mare for interventionist

Abstract Background Cardiovascular disease, particularly atherosclerosis, and its complications are a growing cause of morbidity and mortality among individuals living with human immunodeficiency virus (HIV) in the post-antiretroviral therapy era. The role of thrombus aspiration combined with primary percutaneous coronary intervention (PCI) in ST-segment elevation myocardial infarction (STEMI) within this population remains contentious. While PCI is the preferred strategy for immediate revascularization in acute STEMI, challenges persist, with about 30% of patients experiencing persistent chest pain and ST-segment elevation despite achieving TIMI III flow in the culprit vessel. Methods We conducted a prospective observational study spanning from January 2015 to September 2023, involving ten consecutive HIV-infected patients presenting with STEMI to our acute coronary care unit. The study encompassed an analysis of baseline clinical characteristics, response to fibrinolytic therapy, angiographic findings, thrombus aspiration using the Export Aspiration Catheter, and the outcomes of percutaneous coronary intervention (PCI). Patients were closely monitored for in-hospital outcomes and followed up for five years, during which they received adjuvant highly active antiretroviral therapy (HAART). Results The mean age of the patients was 46 years, lower than their uninfected counterparts. Most patients presented with a lower Killip class, indicating favorable outcomes. CD4 count distribution showed variability, with ten patients undergoing rescue angioplasty with thrombus aspiration using the Export Catheter. The cohort was followed for five years, receiving consistent HAART therapy. Conclusion HIV-associated atherosclerosis presents a considerable health burden, characterized by distinctive non-calcified and inflammatory plaques vulnerable to rupture. Thrombus aspiration during PCI emerged as a valuable strategy, reducing thrombotic burden and contributing to improved clinical outcomes in people living with HIV.

The effect of intracoronary versus intralesional injection of eptifibatide on myocardial perfusion outcomes during primary percutaneous coronary intervention in acute ST-segment elevation myocardial infarction; A randomized clinical trial study.

BACKGROUNDPrevious studies have proved that intracoronary injection of eptifibatide is safe and more effective in infarct size reduction and clinical outcomes than intravenously injection in the patients with acute myocardial infarction (AMI). This study aimed to compare the effect of localized and intracoronary injection of eptifibatide on myocardial perfusion improvement and its outcomes.METHODSWe conducted a randomized clinical trial study of 60 patients presented with thrombotic AMI. The patients underwent percutaneous coronary intervention (PCI), and were randomly divided into two equal number groups. The first group received two bolus doses of 180 μg/kg eptifibatide through guiding catheter. The second group received the same bolus doses through export aspiration catheter into the coronary lesion directly. Thrombolysis in myocardial infarction (TIMI) flow, myocardial blush grade (MBG), and no-reflow phenomenon were primary end points. Secondary end points were pre- and postprocedure cardiac arrhythmia, in-hospital mortality, adverse effects, reinfection, pre-discharge ventricular systolic function, and re-hospitalization and mortality after 6 month of follow up.RESULTSThe mean ages of group I and group II were 58.3 ± 1.8 and 57.0 ±2.0 years, respectively, and most of patient were men (90% in group I and 80% in group II). Postprocedural TIMI flow grade 3 was achieved in 60.0% and 76.7% of the intracoronary and intralesional groups, respectively (P = 0.307). Postprocedural MBG grade 3 was achieved in 53.3% and 70.0% in intracoronary and intralesional groups, respectively (P = 0.479). There was no significant difference between the groups in no-reflow assessment. Moreover, no significant difference was seen between the two groups in secondary end-point analysis.CONCLUSIONBoth methods of intracoronary and intralesional eptifibatide administration during primary PCI in patients with acute ST-elevation myocardial infarction (STEMI) were safe and similar in myocardial perfusion outcomes.

Efficacy of thrombosuction using export aspiration catheter during primary percutaneous coronary interventions

Efficacy of thrombosuction using export aspiration catheter during primary percutaneous coronary interventions

Aspiracija tromba tokom primarne perkutane koronarne intervencije - gde smo sada?

Introduction. thrombus aspiration is not recommended as a routine procedure considering the results of large randomised trials. It is necessary to define new indications for thrombus aspiration in myocardial infarction and to conduct appropriate trials. The aim of this paper was to report a patient with successful aspiration of large thrombus mass from right coronary artery made after primary balloon angioplasty, and to consider which patients could benefit with this procedure. Case report. a male, 80 years old, has been admitted to a catheterisation laboratory with clinical, biochemical and electrocardiographic signs of acute myocardial infarction with ST segment elevation (STEMI) of inferoposterolateral localisation along with sinus bradycardia and profound arterial hypotension, which all are characteristic for inferior myocardial wall infarction with right ventricular involvement. Two hours after pain onset the patient was admitted to hospital in Bijeljina and sent to catheterisation laboratory straight after. All branches of left coronary artery were well visualized and without significant stenosis. Right coronary artery was occluded in proximal segment. Predilatation was performed with SC Sprinter legend 2,0x20mm balloon. After predilatation thrombus burden is still large, blood flow was slow with significant residual stenosis. Than, BMS Pro-kinetic energy 3,5x20mm stent was implanted. After stent implantation thrombus burden existed and there was no flow in PLV branch. Thrombus mass was 2 cm long and successfully aspirated with Export aspiration catheter. Control coronarography showed no residual stenosis and normal blood flow was restored through branches of right coronary artery. Conclusion. Procedure must be gradual, carefully planned and aspiration of thrombus should be taken only after initial balloon angioplasty with flow evaluation. Large thrombus burden or several smaller thrombi with clear flow obstruction and poor peripheral flow could be the reason for aspiration of thrombus along with possible intracoronary administration of GP IIbIIIa inhibitors. If conducted cautiously, aspiration of thrombus may still be considered as a valuable technique in selected patients with a large angiographic thrombus burden.

The impact of successful manual thrombus aspiration on in-stent restenosis after primary PCI

This study sought to investigate the impact of successful manual thrombus aspiration on angiographic in-stent restenosis and clinical outcome in patients treated by bare metal stent implantation for ST-segment elevation acute myocardial infarction. There are very limited data on the impact of manual thrombus aspiration on the occurrence of in-stent restenosis after bare metal stent implantation. This was a prospective, randomized, single-center study. Patients (N=60) presenting within 12 h of ST-segment elevation acute myocardial infarction symptom onset were randomized to primary percutaneous coronary intervention (PCI) with (N=30) or without (N=30) upfront manual thrombus aspiration using the Export aspiration catheter. All patients underwent control coronary angiography after 6 months. Baseline, clinical, and angiographic preprocedural findings did not differ between the two groups. Patients who underwent successful manual thrombus aspiration had significantly higher minimal lumen diameter after 6 months (2.25±0.90 vs. 1.63±0.76, P=0.005), significantly lower percentage diameter stenosis (28.81 vs. 45.03%, P=0.017), and significantly lower late lumen loss (0.73±0.84 vs. 1.18±0.79, P=0.035). There was a trend for lower rate of major adverse cardiocerebrovascular events such as death, myocardial reinfarction, stroke, and target lesion revascularization in the same group of patients (16.67 vs. 26.67%, P=0.347). Successful upfront manual thrombus aspiration during primary PCI showed beneficial effects on the reduction of in-stent restenosis after bare metal stent implantation compared with standard PCI.

Effects of aspiration thrombectomy on necrosis size and ejection fraction after transradial percutaneous coronary intervention in acute ST‐elevation myocardial infarction

The use of routine aspiration thrombectomy in primary percutaneous coronary intervention (PCI) remains controversial. Patients in the EArly Discharge after Transradial Stenting of CoronarY Arteries in Acute Myocardial Infarction (n = 105) study were treated with aspirin, clopidogrel, and abciximab within 6 hr of symptoms onset. Operators were allowed to use 6 Fr Export aspiration catheter at their discretion. In this observational analysis, we compared acute and late results in patients treated with and without thrombectomy using cardiac biomarkers, angiographic, cardiovascular magnetic resonance (CMR), and clinical parameters. Patients in the thrombectomy group (n = 44) had longer symptoms to balloon time (196 ± 86 min vs. 164 ± 62, P = 0.039) and higher incidence of preprocedural TIMI flow grade 0 or 1 (84% vs. 64%, P = 0.028). Following PCI, both groups had similar incidence of TIMI flow grade 3 (93 vs. 92%, P = 0.73) and myocardial blush grade 2 or 3 (80 vs. 77%, P = 0.86), respectively. Patients in thrombectomy group had significantly higher post-PCI maximum values of creatine kinase-MB (P = 0.0007) and troponin T (P = 0.0010). Accordingly, post-PCI myocardial necrosis by CMR was higher (P = 0.0030) in patients in the thrombectomy group. At 6-month follow-up, necrosis size remained higher (20.7% ± 13.3% vs. 13.5% ± 11.1%, P = 0.012) in the thrombectomy group. Ejection fraction at 6 months was 65% ± 9% in patients in thrombectomy group compared to 70% ± 11% in patients without (P = 0.070). Results were not affected by initial TIMI flow or symptoms to balloon time. Clinical events remained comparable in both groups at 12 months follow-up. In patients with ST-segment elevation myocardial infarction presenting within 6 hr of symptoms and undergoing primary angioplasty with maximal antiplatelet therapy, acute and late results did not suggest significant benefit for additional aspiration thrombectomy, irrespective of initial TIMI flow or total ischemic time.

Rationale and design of the INFUSE-AMI study: A 2 × 2 factorial, randomized, multicenter, single-blind evaluation of intracoronary abciximab infusion and aspiration thrombectomy in patients undergoing percutaneous coronary intervention for anterior ST-segment elevation myocardial infarction

Whether thrombus aspiration and local glycoprotein IIb/IIIa administration reduce infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) has not been established in multicenter studies. INFUSE-AMI is a multicenter, open-label, controlled, single-blind randomized study enrolling 452 subjects with anterior STEMI and an occluded proximal or mid-left anterior descending artery with thrombosis in myocardial infarction 0, 1, or 2 grade flow undergoing primary PCI with bivalirudin anticoagulation. Subjects are randomized in a 2 × 2 factorial to one of the following 4 arms: (1) local infusion of abciximab using the ClearWay RX Local Therapeutic Infusion Catheter (ClearWay, Atrium Medical Corp, Hudson, NH) after aspiration with a 6F Export Aspiration Catheter (Medtronic, Inc, Minneapolis, MN), (2) local infusion of abciximab using the ClearWay RX Infusion Catheter and no aspiration, (3) no local infusion of abciximab and aspiration with a 6F Export Aspiration Catheter, or (4) no local infusion of abciximab and no aspiration. The primary end point is infarct size (percentage of total left ventricular mass) at 30 days measured by cardiac magnetic resonance imaging. Other secondary end points include microvascular obstruction by cardiac magnetic resonance imaging at 5 days, ST-segment resolution, angiographic myocardial perfusion, thrombus burden, angiographic complications, and clinical events through 1-year follow-up. Safety end points include major and minor bleeding. INFUSE-AMI is testing the hypothesis that the intracoronary administration of an abciximab bolus with or without thrombus aspiration before stent implantation compared to no infusion with or without thrombus aspiration reduces infarct size among patients undergoing primary PCI for anterior STEMI who are treated with bivalirudin.

Coronary thrombectomy, technical comparison of two systems on a laboratory bench: the impact of bends, angles and thrombus age

Despite the results of recent randomised studies, the systematic use of aspiration techniques in ST-elevation myocardial infarction has not been included in the new guidelines. To date, there have been very few bench tests of the different systems and the aim of our study was to test two catheters on different models of arteries with thrombi at six and 12 hours. The test apparatus consisted of 3 mm diameter glass tubes of 150 mm in length. The thrombi were left for either six or 12 hours and ten models of tubes were used: straight, with a single bend and with two bends. Two types of catheters were tested: the Export® aspiration catheter (EAC) and the Proxis® embolic protection system (PES). The main assessment criterion was total thrombectomy. Total thrombectomy was achieved in only 55.3% of the tests and no difference appeared between the two systems. Total thrombectomy was achieved more frequently with 6-hour thrombi than with 12-hour thrombi for the two techniques, 62.5% vs. 42.5% (p = 0.018) and 67.5% vs. 48.7% (p = 0.025) for EAC and PES catheter, respectively. In contrast, total thrombectomy was more frequent in straight tubes and in tubes with a single bend than in tubes with double bends, respectively for EAC (64% vs. 44.8%, p = 0.028) and for PES (85.9% vs. 35.4%, p < 0.001). The use of thrombectomy in the invasive management of acute coronary syndromes is growing. Our work on a "laboratory bench" reveals important technical differences. In consequence, in clinical practice, we speculate that the catheter system must be chosen according to both the artery anatomy and the delay between chest pain and PCI.

045 Coronary thrombectomy: technical comparison of two systems on a laboratory bench. Impact of bends, angles and thrombus age

Despite the results of recent randomized studies, the systematic use of aspiration techniques in ST-elevation myocardial infarction has not been included in the new guidelines. To date, there have been very few bench tests of the different systems and the aim of our study was to test two catheters on different models of arteries with 6 and 12-hour-old thrombi. The test apparatus consisted of 3-mm diameter glass tubes of 150 mm in length. The thrombi were left for either 6 or 12 hours and ten models of tubes were used: straight, with a single bend and with two bends. Two types of catheter were tested: the Export® aspiration catheter (EAC) and the Proxis® embolic protection system (PES). The main assessment criterion was total thrombectomy. Total thrombectomy was achieved in only 55.3% of the tests and no difference appeared between the two systems. Total thrombectomy was achieved more frequently with 6-h thrombi than with 12-h thrombi for the two techniques, 62.5% vs. 42.5% (p = 0.018) and 67.5% vs. 48.7% (p = 0.025) for EAC and PES catheter, respectively. In contrast, total thrombectomy was more frequent in straight tubes and in tubes with a single bend than in tubes with double bends, respectively for EAC (64% vs. 44.8%, p = 0.028) and for PES (85.9% vs. 35.4%, p<0.001). The use of thrombectomy in the invasive management of acute coronary syndromes is growing. Our work on a “laboratory bench” reveals important technical differences. In consequence, in clinical practice, we speculate that the catheter system must be chosen according to both the artery anatomy and the delay between chest pain and PCI.

Impact of thrombus aspiration on angiographic and clinical outcomes in patients with ST-elevation myocardial infarction

Primary percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI) may be limited by thrombus embolization. Export aspiration catheter (EAC) is a thrombectomy device which may enhance angiographic results, but its impact on clinical outcomes is unclear. This trial objective was to assess the impact of EAC on angiographic and clinical outcomes in patients with STEMI. All STEMI patients undergoing primary or rescue PCI in a tertiary care center were included. Patients were divided in two groups according to the use of the EAC. Patients were followed up prospectively for death, reinfarction, revascularization, or stroke. Thrombolysis In Myocardial Infarction (TIMI) flow in the culprit vessel was assessed before and after PCI. Included in the analysis were 535 patients. EAC was used in 165 patients before angioplasty (Group 1) and 370 patients underwent PCI without thrombus aspiration (Group 2). More patients in Group 1 had initial TIMI flow 0-1 compared to Group 2 (88% vs. 62%, P<.001). Proportion of patients with a final TIMI flow 3 was the same in both groups (89.1% vs. 87.6% for Groups 1 and 2, respectively; P=.67). An analysis restricted to patients with initial TIMI flow 0-1 yielded similar results. No difference in clinical outcomes was observed between the two groups (P=.70). Selective use of the EAC based on the judgment of operators results in excellent angiographic and clinical results. Further clinical investigation is needed to definitely answer whether thromboaspiration needs to be performed in all STEMI patients undergoing primary PCI.

Distal protection beneficial?

The pathogenesis of acute coronary syndromes (ACS) includes the rupture or erosion of a coronary atherosclerotic plaque with variable degrees of superimposed platelet aggregation inducing a thrombus [1]. ST-elevation myocardial infarction (STEMI) is often caused by a total coronary occlusion of the atherothrombotic plaque, whereas in non-ST-elevation myocardial infarction (NSTEMI) the thrombus is mainly nonocclusive or transient occlusive causing less myocardial damage [2]. Conventional percutaneous coronary intervention (PCI) focuses on compressing the atherothrombotic plaque with the aim to normalize flow in the coronary artery and therefore restore perfusion of the ischemic myocardium [3]. However, embolization of atherothrombotic material may occur spontaneously after plaque rupture or due to mechanical crushing of the culprit lesion during PCI [4]. This results in obstruction of distal vessels or the microcirculation in the down-stream bed of the ischemia-related artery. Although normal epicardial flow may be achieved, this will lead to diminished myocardial perfusion, which is associated with larger infarct size, diminished left ventricular ejection fraction and increased mortality [5]. Microvascular obstruction is frequently implicated as the underlying cause through the mechanism of embolization [6–8]. Distal protection devices (DPDs) can be used for transient distal balloon occlusion during PCI, and allow recovery of any liberated plaque by aspiration before restoration of the antegrade flow [9]. Whether myocardial function can be improved with DPDs compared with conventional PCI in patients with acute myocardial infarction (AMI) has still to be proven. Over the years, echocardiography [10–13] and CMR [14–37] have found a fixed niche in the setting of AMI. In particular CMR allows the visualization of infarct site and size whereby the identification of microvascular obstruction has become unique to CMR [38–40]. For echocardiography, there are limited data describing changes in cardiac function in DPDs studies, and no data describing changes in regional myocardial function. Tissue Doppler imaging (TDI) is a useful echocardiographic tool that permits quantitative and objective assessment of both global and regional function [41–43]. In the current issue of the International Journal of Cardiovascular Imaging, Duan et al. [44] assessed the effects of DPDs on global and regional LV systolic and diastolic function were assessed by TDI in 69 patients with anterior AMI, who were randomly assigned to either PCI with DPDs (DPD group, n = 46) or conventional PCI (control group, n = 50). At 3- and 6-month follow-up, the DPD group showed a higher LV ejection fraction than the control group. Moreover, peak systolic and early diastolic mitral annular velocities obtained by TDI were significantly higher in the DPD group than in the control group. Lastly, the systolic and diastolic regional myocardial velocities were significantly improved in the DPD group compared to the control group. The authors concluded that patients with DPDs showed significant improvement of LV function. Especially patients with anterior AMI may benefit from DPDs during PCI. In recent years various distal protection devices and thrombectomy devices have been developed to protect the microcirculation against embolization of atherothrombotic material and to improve myocardial reperfusion and LV function after PCI [45]. As the use of distal protection devices is still under debate, several trials in patients with STEMI have recently focused on thrombus aspiration [46–49]. These trials have clearly shown that thrombus aspiration improves myocardial reperfusion compared to conventional PCI. The largest study to date, the TAPAS-trial, showed that manual thrombus aspiration using the Export Aspiration Catheter (EAC) in patients with STEMI improves myocardial perfusion and one-year clinical outcome compared to conventional PCI [47]. As a consequence, thrombus aspiration has been included in the new European guidelines for patients with STEMI as a therapy to improve myocardial perfusion [50]. To conclude, the study of Duan et al. [44] lends support to the notion that distal protection may be beneficial in patients with STEMI.

Prophylactic use of manual thrombectomy in ST-segment elevation myocardial infarction

We sought to evaluate the effects of manual thrombectomy on myocardial reperfusion performed during percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). Complete reperfusion after primary PCI is compromised by the presence of intraluminal thrombus. Thus effective and safe extraction of thrombus in a timely fashion is important for successful reperfusion. Thirty-two patients (age 51+/-12 years, males 78%) with STEMI and angiographic evidence of intraluminal thrombus underwent thrombectomy during an 18-month period. Thrombectomy was performed after the presence of thrombus was confirmed angiographically by the operator either before or after primary angioplasty. Thrombectomy was performed using the 6F Export Aspiration Catheter (Medtronic Corporation, Santa Rosa, CA, USA). Myocardial reperfusion using Thrombolysis in Myocardial Infarction (TIMI) flow and myocardial blush grade was assessed by two independent observers. The infarct-related artery was left anterior descending (59%), right coronary artery (19%), saphenous venous graft (19%), or left circumflex artery (3%). The coronary lesion was Type B in 62% and Type C in 37% patients, with an average length of 18.2+4.6 mm and reference vessel diameter of 3.2+/-0.4 mm. The preprocedural TIMI flow was 0 in 62%, 1 in 12%, 2 in 22%, and 3 in 3% of patients. The postprocedural TIMI flow was 0 in 3%, 1 in 6%, 2 in 25%, and 3 in 56% of patients. The postprocedural myocardial blush grade was 0 in 6%, 1 in 9%, 2 in 35%, and 3 in 48% of patients. The in-hospital mortality was 0 and the 30-day mortality was 3%. Manual thrombectomy using an Export catheter is safe and effective in establishing myocardial reperfusion after STEMI.

Effect of High-Dose Intracoronary Adenosine Administration During Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction: A Randomized Controlled Trial

Effect of High-Dose Intracoronary Adenosine Administration During Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction: A Randomized Controlled Trial

A rare case of paradoxical embolism causing myocardial infarction: Successfully aborted by aspiration alone

A 58-year-old male presented with severe substernal chest pain along with bilateral lower extremity pain. He was tachycardic, tachypneic, and hypoxic with tender right calf. Electrocardiogram showed ST elevation in anterior-lateral leads. Emergency coronary angiography revealed widely patent proximal left anterior descending (LAD) artery and total distal occlusion with an abrupt cut-off. The remaining coronary arteries did not have significant disease. An Export aspiration catheter was used and thrombus was aspirated from the LAD with return of TIMI flow grade 3 and normalization of the ST elevations. Doppler ultrasound revealed deep vein thrombosis; transthoracic echocardiogram using agitated saline echocontrast showed a patent foramen ovale. Nearly 5% of patients with ST elevation myocardial infarction do not have demonstrable atherosclerosis by coronary angiography; paradoxical coronary embolism is among the leading causes in such cases. Paradoxical embolism to the coronary tree is under diagnosed and its antemortem diagnosis is difficult. Information regarding appropriate management of myocardial infarction due to coronary embolism is scant. Aspiration of intracoronary thrombus provides good clinical results, avoiding clot fragmentation and balloon injury associated with angioplasty. We present a rare case of antemortem diagnosis of paradoxical embolism to the coronary artery successfully treated with aspiration alone.

Pseudo-no-Reflow Phenomenon in Carotid Artery Stenting using FilterWire EX: Successful Recovery by Aspiration Thrombectomy

Distal protection devices such as FilterWire EX have been widely used in carotid artery stenting, however, the large amount of atherothrombotic debris entrapped in the filter could reduce or stop antegrade flow. We present a case of pseudo-no-reflow phenomenon after postdilatation of the stent in a patient with asymptomatic carotid artery stenosis. After several passes using an Export Aspiration catheter, normal flow in the internal carotid artery was restored. Aspiration thrombectomy can successfully recover pseudo-no-reflow phenomenon.

The feasibility and safety of routine thrombus aspiration in patients with non‐ST‐elevation myocardial infarction

To investigate the feasibility and safety of manual thrombus aspiration in patients undergoing percutaneous coronary intervention (PCI) for non-ST-elevation myocardial infarction (NSTEMI). Myocardial necrosis in patients with acute coronary syndromes may be a sign of microvascular obstruction, owing to spontaneous or PCI-induced embolization of atherothrombotic material. Manual thrombus aspiration results in improved myocardial reperfusion in patients undergoing PCI for ST-elevation myocardial infarction. Currently, no published data on thrombus aspiration in patients with NSTEMI are available. As part of a prospective cohort study, 70 patients undergoing PCI for NSTEMI were treated with thrombus aspiration (Export Aspiration Catheter, Medtronic, Minneapolis, MN). Histopathological analysis was performed on aspirated material. Thrombus aspiration was effective in 58 patients (83%) and resulted in a marked reduction of TIMI-thrombus score 4/5 (40% pre- versus 7% postthrombus aspiration) and increase of the rate of TIMI-flow 3 (36% pre- versus 66% postthrombus aspiration). The incidence of myocardial blush grade 2 and 3 were 39 and 45%, respectively. Distal embolization was visible in three patients (4%) on the final angiogram. This study demonstrates that thrombus aspiration in most NSTEMI patients is feasible and safe and is associated with a high rate of retrieval of thrombotic material.

Systematic primary aspiration in acute myocardial percutaneous intervention: a multicentre randomised controlled trial of the export aspiration catheter

It is unclear whether primary aspiration can prevent distal embolisation and thereby improve myocardial perfusion in patients presenting with acute myocardial infarction (AMI) within 12 hours after onset. At 24 centres in Europe and India, 249 AMI patients were randomised to primary aspiration with the Export aspiration catheter (Medtronic Vascular, Santa Rosa, CA, U.S.A.) followed by stenting (N=120) or to conventional stenting without primary aspiration (N=129). There were no significant differences between the 2 groups in baseline characteristics or target lesion TIMI scores. Procedure time was 36.7 +/- 18.0 minutes for primary aspiration followed by stenting versus 34.5 +/- 21.5 minutes for conventional stenting (P=0.08). Debris was obtained by primary aspiration from 85.3% of the arteries. The use of a bailout technique was significantly lower for primary aspiration than for conventional stenting (5.8% vs. 14.7%, P=0.02). For the primary endpoint of the combined rate of myocardial blush grade 3 and/or ST-segment resolution >50% to assess myocardial perfusion, primary aspiration followed by stenting was superior to conventional stenting (85.0% vs. 71.9%, P=0.025). Immediately postprocedure, the rate of myocardial blush grade 3 was 35.8% for primary aspiration followed by stenting versus 25.4% for conventional stenting (P=0.094). At 60 minutes post procedure, the rate of ST-segment resolution >50% was 73.5% for primary aspiration followed by stenting versus 64.8% for conventional stenting (P=0.218). Primary aspiration was also associated with a significantly higher postprocedure corrected TIMI frame count than conventional stenting (20 +/- 14.9 vs. 22.8 +/- 14, P=0.02). At 30 days, there were no differences between the treatments in the rate of major adverse cardiac and cerebral events. Compared with conventional stenting, primary aspiration with the Export aspiration catheter followed by stenting improved myocardial reperfusion in AMI patients presenting with TIMI flow grade 0 to 1. Further study of primary aspiration involving larger numbers of patients is warranted to assess its effect on longer-term clinical outcome.

A Comparison of 2 Thrombus Aspiration Devices With Histopathological Analysis of Retrieved Material in Patients Presenting With ST-Segment Elevation Myocardial Infarction

The objective of this study was to compare 2 manual thrombus aspiration catheters in unselected patients with ST-segment elevation myocardial infarction. Distal embolization is common during percutaneous coronary intervention in ST-segment elevation myocardial infarction and can induce impaired myocardial perfusion. Several aspiration thrombectomy devices have been introduced to prevent distal embolization, however, with conflicting clinical results. Currently, it is unclear to what extent this variance in outcome can be explained by device-related factors, such as internal lumen size. We performed a prospective cohort study in which patients undergoing primary percutaneous coronary intervention were treated with a large-internal-lumen catheter (Diver, Invatec, Roncadelle, Italy). Outcomes were compared with a matched population of the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS) trial, in which patients were treated with a medium-sized catheter (Export, Medtronic, Minneapolis, Minnesota). A histopathological analysis was performed of retrieved material. A total of 160 patients, treated with the Diver (n = 80) or Export (n = 80) aspiration catheter, were enrolled. Effective thrombus aspiration was seen in 70.3% of the patients treated with the Diver catheter versus 81.8% with the Export catheter (p = 0.10) No significant difference was found in myocardial blush grade or electrocardiographic outcome between the 2 devices. Size distribution of retrieved thrombotic particles was similar per device. Erythrocyte-rich thrombi were found in 34.8% of the cases and were predominately seen in patients with low initial Thrombolysis In Myocardial Infarction flow grade (p = 0.008). A larger internal lumen diameter does not result in retrieval of larger thrombotic particles, nor in improved angiographic or electrocardiographic outcomes.

Impact of export aspiration catheter device on patients with acute myocardial infarction: a large single-center experience

Impact of export aspiration catheter device on patients with acute myocardial infarction: a large single-center experience

Intracoronary Thrombectomy with the Export Aspiration Catheter Before Angioplasty in Patients with ST‐Segment Elevation Myocardial Infarction

We aimed to assess the safety and feasibility of thrombectomy with the Export Aspiration Catheter (EAC) before angioplasty, and its ability to improve angiographic results in patients with ST-segment elevation myocardial infarction (STEMI). Distal embolization of atherothrombotic material often occurs during angioplasty in STEMI, compromising optimal myocardial reperfusion. We performed a thrombus-aspiration with EAC prior to angioplasty in 64 consecutive patients with STEMI. Successful thrombectomy was defined as an improvement of TIMI flow grade >or=1. Successful thrombectomy (increase of TIMI flow >or=1) was achieved in 40 patients (62.5%). Mean TIMI flow grade increased from 0.7 +/- 1 to 1.9 +/- 1.2 (p < 0.0001) after thrombectomy. TIMI flow grade 3 was observed more frequently after EAC compared with guidewire alone (51.5% vs. 9%, p = 0.0062). Direct stenting was performed in most of the patients (n = 41, 64%). Distal embolization and no reflow/slow flow phenomenon occurred in 8 patients (12.5%). No vessel injury after EAC thrombectomy was reported. After treatment with balloon angioplasty and/or stenting, final TIMI flow grade 3 was achieved in 54 patients (84.5%). By multivariate analysis, ischemic time < 6 hours was a significant independent predictor of successful thrombectomy (p = 0.0437). Our series suggests that EAC thrombectomy prior to angioplasty in the setting of STEMI is safe and feasible. It might reduce the culprit coronary lesion's thrombus burden, leading to improved flow restoration and myocardial reperfusion. Further large randomized studies are warranted to confirm these preliminary results and to assess the impact of thrombus-aspiration on infarct size as well as on clinical outcomes.