Adjunctive Thrombectomy Research Articles

A risk score for iliofemoral patients with deep vein thrombosis

ObjectiveDeep vein thrombosis (DVT) is a common condition with a high risk of post-thrombotic morbidity, especially in patients with a proximal thrombus. Successful iliofemoral clot removal has been shown to decrease the severity of post-thrombotic syndrome. It is assumed that earlier thrombus lysis is associated with a better outcome. Generally, the earlier IFDVT is confirmed, the earlier thrombus lysis could be performed. d-Dimer levels and Wells score are currently used to assess the preduplex probability for DVT; however, some studies indicate that the d-dimer value varies depending on the thrombus extent and localization. Using d-dimer and other risk factors might facilitate development of a model selecting those with an increased risk of IFDVT that might benefit from early referral for additional analysis and adjunctive iliofemoral thrombectomy. MethodsAll consecutive adult patients from a retrospective cohort of STAR diagnostic center (primary care) in Rotterdam suspected of having DVT between September 2004 and August 2016 were assessed for this retrospective study. The diagnostic workup for DVT including Wells score and d-dimer were performed as well as complete duplex ultrasound examination. Patients with objective evidence of DVT were categorized according to thrombus localization using the Lower Extremity Thrombolysis classification. Logistic regression analysis was done for a model predicting IFDVT. The cut-off value of the model was determined using a receiver operating characteristic curve. ResultsA total of 3381 patients were eligible for study recruitment, of whom 489 (14.5%) had confirmed DVT. We developed a multivariate model (sensitivity of 77% and specificity of 82%; area under the curve, 0.90; 0.86-0.93) based on d-dimer, Wells score, age, and anticoagulation use, which is able to distinguish IFDVT patients from all patients suspected of DVT. ConclusionsThis multivariate model adequately distinguishes IFDVT among all suspected DVT patients. Practically, this model could give each patient a preduplex risk score, which could be used to prioritize suspected IFDVT patients for an immediate imaging test to confirm or exclude IFDVT. Further validation studies are needed to confirm potential of this prediction model for IFDVT.

Chronic Femoropopliteal Occlusions: Comparison of Drug-Eluting Balloon Angioplasty with or without Prior Rotational Thrombectomy.

The aim of this study was to compare drug eluting balloon (DEB) angioplasty with and without mechanical thrombectomy system in patients with chronic (> 6 months) femoropopliteal occlusions. We retrospectively identified patients from May 2012 to September 2014 at our clinic with severely diseased femoropopliteal arteries treated by endovascular approach with or without adjunctive thrombectomy system. All patients had ankle-brachial index (ABI) measured before and after the intervention, and regular clinical follow-up with Doppler ultrasonography performed at 1 month, 6 months and 1 year. Patients underwent peripheral angiography if needed. Mechanical thrombectomy system (MTS + DEB) was used in 33 patients (31 enrolled 2 patients were lost to follow-up, mean lesion length 149.7mm ± 82.69). The remaining 33 patients were treated without MTS (31 enrolled 2 patients were lost to follow-up DEB N = 31 mean lesion length 157.3 mm ± 92.90). There were 5 restenosis in the MTS + DEB group (83.3% patency rate) and 5 restenosis in the DEB group (82.8% patency rate) at 1 year. The technical success rate was 93.5% in both groups. A statistically significant increase in the ABI (MTS + DEB before 0.47 ± 0.11 vs. after 0.92 ± 0.11 p < 0.01 DEB before 0.47 ± 0.11 vs. after 0.90 ± 0.14 p < 0.01) and improvement in Rutherford staging (p < 0.01) was noted in both groups following intervention. DEB angioplasty is effective in the treatment of chronic total femoropopliteal occlusions. Combining DEB angioplasty and thrombectomy system does not appear to improve outcomes for treatment of chronic femoropopliteal occlusions.

Single-session inferior vena cava filter removal, recanalization, and endovenous reconstruction for chronic iliocaval thrombosis

ObjectiveThe objective of this study was to demonstrate the safety and efficacy of treatment of inferior vena cava filter (IVCF)-related chronic iliocaval thrombosis with single-session IVCF retrieval and iliocaval recanalization, thereby optimizing stent deployment and avoiding adverse events (AEs) related to stent placement across an obstructed filter. MethodsFrom January 2015 to April 2018, a cohort of 25 consecutive patients presented for treatment of IVCF-related chronic iliocaval thrombosis with filter retrieval, followed by recanalization with stent placement and adjunctive iliofemoral thrombectomy as needed. Inclusion criteria included computed tomography (CT) imaging and clinical presentations consistent with chronic (>30 days) IVCF-related chronic thrombosis. A retrospective analysis of technical success, clinical success as measured with the Venous Clinical Severity Score, use of advanced filter retrieval techniques, and AEs was performed. Primary patency was evaluated with CT at 1 to 3 months and 1 year. Data analysis was performed using a paired t-test. ResultsThere were 25 patients (median age, 58.0 years; standard deviation, 15.6 years) with eight types of IVCF encountered; all were treated in a single session. Technical success was achieved in all patients. Mean improvement in the Venous Clinical Severity Score was 1.4 (95% confidence interval, 1.0-1.7; P < .01) in the venous edema subscore and 0.6 (95% confidence interval, 0.2-1.0; P < .01) in the pain subscore. At 1 to 3 months, iliocaval stent patency was maintained in 96% of patients; unilateral iliac vein stent thrombus was seen in one patient. One-year follow-up was available in eight patients, with CT imaging demonstrating maintained patency. Median filter implantation time was 12.3 months (mean, 41.9 months; range, 0.8-245.1 months; standard deviation, 63.3 months). Advanced IVCF retrieval techniques were required for 17 procedures. One major AE and minor AE occurred; no patients died in the study period. ConclusionsSingle-session iliocaval recanalization with IVCF retrieval has high rates of technical and clinical success in patients with IVCF-related chronic iliocaval thrombosis.

Efficacy of ProLumen in percutaneous thrombectomy of clotted dialysis access: a single-center prospective study.

To prospectively evaluate the efficacy of the ProLumen thrombectomy device for declot of dialysis access. 16 women and 4 men suffering from end-stage renal disease (ESRD) dependent on hemodialysis (mean age, 66.4 years) and presenting with thrombosed dialysis access were enrolled form October 2005 through February 2006. Sixteen patients had synthetic grafts and 4 had native fistulas. Mean age of access was 24.65 months (range, 2 to 96 months). A history of previous intervention was noted for seven patients (6 percutaneous, 1 surgical). A mean of 2.7 passes of the ProLumen device were required for the venous limb (range, 1 to 6) and 2.35 passes for the arterial limb (range, 0 to 5). Average procedure time was 48 minutes (range 32-81 minutes). Adjunctive thrombectomy devices were utilized in 5 cases. Good angiographic and clinical results were reported in 19 patients; one patient had a poor result. Dialysis flow rate prior to thrombosis was 425 mL/min (range, 300 to 550). The mean post-thrombectomy flow rate was 380 mL/min (range, 200 to 480; n=19). "Ease of use" of Pro Lumen thrombectomy device was rated good in 17 patients. Maneuverability was good in 14 patients and clot removal around the opposite sheath was rated as good in 18 patients. ProLumen is effective in thrombectomy of dialysis access. The device is easy to use, and effectively removes clot around the opposite sheath.

Percutaneous Mechanical Thrombectomy Using Rotarex® S Device in Acute Limb Ischemia in Infrainguinal Occlusions.

Purpose To evaluate the effectiveness of percutaneous mechanical thrombectomy using Rotarex S in the treatment of acute limb ischemia (ALI) in infrainguinal occlusions in a retrospective study of patients treated in our institution. Methods In this study, we identified a total of 147 ALI patients that underwent mechanical thrombectomy using Rotarex S at our institution. In 82% of the cases, percutaneous thrombectomy was used as first-line treatment, and for the remainder of the cases, it was used as bailout after ineffective aspiration or thrombolysis. Additional fibrinolysis and adjunctive aspirational thrombectomy were utilized for outflow occlusion when required. Procedural outcomes, amputation rate, and mortality at 30 days were evaluated. Results Of the 147 patients treated with mechanical thrombectomy, Rotarex S was used as first-line treatment in 120 cases and as second-line treatment in 27 cases. Overall, we achieved 90.5% procedural revascularization success rate when combining mechanical thrombectomy with limited thrombolysis for severe outflow obstruction, and 1 death and 3 amputations were observed. We achieved primary success in 68.7% of the patients with the mechanical thrombectomy only, and in 21.8% of the patients, we successfully used additional limited thrombolysis in the outflow. The overall mortality was 0.7% and amputation rate was 2% at 30 days. Conclusion Percutaneous mechanical thrombectomy as first-line mini-invasive treatment in infrainguinal ALI is safe, quick, and effective, and the performance outcomes can be superior to that of traditional surgical embolectomy.

Effect of Aspiration Thrombectomy on Microvascular Obstruction in NSTEMI Patients: The TATORT-NSTEMI Trial

BackgroundAspiration thrombectomy in ST-segment elevation myocardial infarction is recommended by current guidelines based on several randomized trials. There are no trials assessing thrombectomy in non–ST-segment elevation myocardial infarction (NSTEMI) patients. ObjectivesThe TATORT-NSTEMI (Thrombus Aspiration in Thrombus Containing Culprit Lesions in Non–ST-Elevation Myocardial Infarction) trial sought to assess the effect of aspiration thrombectomy on microvascular injury in patients with NSTEMI compared with standard percutaneous coronary intervention (PCI). MethodsThis prospective, controlled, multicenter study randomized 440 patients to adjunctive thrombectomy (n = 221) compared with conventional PCI (n = 219) in NSTEMI patients with thrombus-containing lesions. The primary endpoint of the extent of microvascular obstruction (MO) in the percentage of left ventricular mass (%LV) was assessed by cardiac magnetic resonance imaging within 4 days. Secondary endpoints included infarct size, myocardial salvage index, and angiographic parameters including myocardial blush grade and Thrombolysis In Myocardial Infarction flow grade. The combined clinical endpoint consisted of death, reinfarction, target vessel revascularization, and new congestive heart failure within 6 months. ResultsThe primary endpoint of MO was not different between the thrombectomy and the standard PCI group with 2.0%LV (interquartile range [IQR]: 0.8 to 4.1) versus 1.4%LV (IQR: 0.7 to 2.6) (p = 0.17). Similarly, no significant differences were observed for infarct size (8.6%LV; IQR: 4.0 to 14.7 vs. 7.4%LV; IQR: 4.1 to 13.1; p = 0.46), myocardial salvage index (63.3; IQR: 35.4 to 87.2 vs. 65.6; IQR: 46.9 to 82.6; p = 0.45), or angiographic parameters such as blush grade (p = 0.63) and Thrombolysis In Myocardial Infarction flow grade (p = 0.66). Clinical follow-up at 6 months revealed no differences in the combined clinical endpoints (p = 0.22). ConclusionsAspiration thrombectomy in conjunction with PCI in NSTEMI with a thrombus-containing lesion does not lead to a reduction in MO. (Thrombus Aspiration in Thrombus Containing Culprit Lesions in Non-ST-Elevation Myocardial Infarction [TATORT-NSTEMI]; NCT01612312).

Aspiration thrombectomy in patients undergoing primary angioplasty: totality of data to 2013.

We sought to update our meta-analysis on clinical outcomes with aspiration thrombectomy prior to primary percutaneous coronary intervention (PPCI) compared with conventional PPCI alone due to the availability of additional trial data. The clinical efficacy of adjunctive aspiration thrombectomy in ST-elevation myocardial infarction (STEMI) patients undergoing PPCI remains controversial. A recent large-scale randomized trial showed no benefit in terms of mortality at 30 days. Clinical trials that randomized STEMI patients to aspiration thrombectomy prior to PPCI compared with conventional PPCI alone were included. A total of 11,321 patients from 20 randomized controlled trials were included. The composite major adverse cardiac event (MACE) endpoint was lower in the aspiration thrombectomy arm compared with conventional PPCI alone (risk ratio [RR] = 0.81, 95% CI 0.70-0.94; P = 0.006). Although all-cause mortality was similar between the adjunctive aspiration thrombectomy arm and PPCI arms (RR = 0.83, 95% CI 0.67-1.01; P = 0.06), late mortality (6-12 months) was significantly reduced (RR = 0.64; 95% CI 0.44-0.92; P = 0.016). Reinfarction (RR = 0.64, 95% CI 0.44-0.92; P = 0.017) and stent thrombosis (RR = 0.54; 95% CI 0.32-0.91; P = 0.021) were similarly lower. Differences in target vessel revascularization were of borderline significance (RR = 0.83, 95% CI 0.68-1.01; P = 0.06). Our meta-analysis including all randomized controlled trials on aspiration thrombectomy to date demonstrates a significant reduction in adverse clinical outcomes including stent thrombosis compared with conventional PCI alone.

The Smoking Paradox: Impact of Smoking on Recanalization in the Setting of Intra-Arterial Thrombolysis

Background: The smoking paradox refers to a better outcome in smokers eligible for thrombolytic treatment in myocardial infarction or ischemic stroke. Recent findings suggest that current smokers may present higher recanalization rates after intravenous (IV) thrombolysis with recombinant tissue plasminogen activator (rt-PA). We evaluated the impact of smoking in a consecutive series of patients treated with intra-arterial (IA) rt-PA. Methods: We analyzed data collected between April 2007 and December 2012 in our prospective registry. All acute ischemic stroke patients with an arterial occlusion treated by IA rt-PA (± IV, ± thrombectomy) were included. Arterial status was monitored with conventional angiography during the IA procedure. The primary study outcome was a complete recanalization achieved immediately after termination of IA rt-PA infusion. Secondary outcomes included complete recanalization after the end of the endovascular therapy (including complete recanalization achieved after adjunctive thrombectomy), favorable outcome (90-day modified Rankin Score ≤2), 90-day all-cause mortality, and any intracerebral hemorrhage. Results: Among the 227 included patients, 18.5% (n = 42) were current smokers and 16.7% (n = 38) former smokers. Compared with nonsmokers, current smokers were younger, more often men, had less frequently hypertension, and cardioembolic etiology, whereas former smokers were more often men and had more frequently hypercholesterolemia. The rate of complete recanalization was 30% (n = 68) after IA rt-PA infusion and 49% after adjunctive thrombectomy. A higher complete recanalization rate was found both in current smokers (45.2%) and former smokers (42.1%) compared to nonsmokers (22.5%). After adjustment for potential confounders, the adjusted odds ratio (OR) for complete recanalization associated with ever-smokers was 2.51 [95% confidence interval (CI) 1.26-4.99; p = 0.009]. A similar adjusted OR was found when the complete recanalization achieved after thrombectomy was included (OR 2.18, 95% CI 1.13-4.19; p = 0.019). However, smoking status was not independently associated with favorable outcome (adjusted OR 1.41, 95% CI 0.62-3.22 for former smokers, and adjusted OR 1.35, 95% CI 0.59-3.05 for current smokers), 90-day all-cause mortality (adjusted OR 0.68, 95% CI 0.25-1.81 for former smokers, and adjusted OR 1.55, 95% CI 0.54-4.48 for current smokers) or intracerebral hemorrhage (adjusted OR 0.72, 95% CI 0.29-1.76 for former smokers, and adjusted OR 0.80, 95% CI 0.32-1.96 for current smokers). Conclusions: IA rt-PA administration was more effective to achieve complete arterial recanalization in current as well as former smokers. The characterization of the smoking paradox pathophysiology may lead to the identification of a patient-target population with a favorable response to rt-PA therapy. However, the smoking paradox should not be misinterpreted and not be used to promote smoking.

PT186 Different efficacy of thrombectomy aspiration catheters on epicardial blood flow – stratified metaanalysis of randomized controlled trials of adjunctive manual thrombectomy in treatment of ST elevation myocardial infarction

PT186 Different efficacy of thrombectomy aspiration catheters on epicardial blood flow – stratified metaanalysis of randomized controlled trials of adjunctive manual thrombectomy in treatment of ST elevation myocardial infarction

Procedural success and long‐term outcomes of aspiration thrombectomy for the treatment of stent thrombosis

Stent thrombosis (ST) is associated with a significant burden of coronary thrombus and potential microvascular obstruction. Aspiration thrombectomy may decrease the extent of microvascular obstruction in patients with acute myocardial infarction but its role in the treatment of ST is uncertain. The present study sought to evaluate the association between aspiration thrombectomy, procedural success and long-term outcomes among patients presenting with ST. In a multicenter cohort of patients with definite ST, procedural success, long-term mortality, and major adverse cardiovascular events (death, stroke, re-infarction, revascularization) were ascertained. Propensity weighting was used to determine the association between aspiration thrombectomy and long-term outcomes. A total of 205 patients with ST were identified. Among these, 115 (56%) patients underwent adjunctive aspiration thrombectomy during percutaneous coronary intervention. Patients undergoing aspiration thrombectomy were more likely to present with ST-elevation myocardial infarction (75% vs. 52%, P < 0.003) and require hemodynamic support (19% vs. 10%, P = 0.07). Aspiration thrombectomy was associated with improved procedural outcomes including postprocedural TIMI 3 flow, resulting in higher angiographic and procedural success (each 96% vs. 83%, P < 0.001). Despite improved angiographic outcomes, the use of aspiration thrombectomy was not associated with a difference in long-term mortality (adjusted HR 0.99, 95% CI 0.44-2.24) or major adverse cardiovascular events (adjusted HR 1.06, 95% CI 0.45-2.48). Aspiration thrombectomy is associated with improved coronary flow and procedural success but is not associated with improved long-term outcomes among patients undergoing percutaneous intervention for definite ST. NCT00931502 (http://www.clinicaltrials.gov/ct2/show/NCT00931502)

Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI): study protocol for a randomized controlled trial

BackgroundCurrent guidelines recommend thrombus aspiration in patients with ST-elevation myocardial infarction (STEMI); however, there are insufficient data to unequivocally support thrombectomy in patients with non-STEMI (NSTEMI).Methods/DesignThe TATORT-NSTEMI (Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction) trial is a prospective, controlled, multicenter, randomized, open-label trial enrolling 460 patients. The hypothesis is that, against a background of early revascularization, adjunctive thrombectomy leads to less microvascular obstruction (MO) compared with conventional percutaneous coronary intervention (PCI) alone, as assessed by cardiac magnetic resonance imaging (CMR) in patients with NSTEMI. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary endpoint is the extent of late MO assessed by CMR. Secondary endpoints include early MO, infarct size, and myocardial salvage assessed by CMR as well as enzymatic infarct size and angiographic parameters, such as thrombolysis in myocardial infarction flow post-PCI and myocardial blush grade. Furthermore, clinical endpoints including death, myocardial re-infarction, target vessel revascularization, and new congestive heart failure will be recorded at 6 and 12 months. Safety will be assessed by the incidence of bleeding and stroke.SummaryThe TATORT-NSTEMI trial has been designed to test the hypothesis that thrombectomy will improve myocardial perfusion in patients with NSTEMI and relevant thrombus burden in the culprit vessel reperfused by early PCI.Trial registrationThe trial is registered under http://www.clinicaltrials.gov: NCT01612312.

A contemporary re-evaluation of culprit lesion severity in patients presenting with STEMI

Historical data report fatal myocardial infarction occurring when mildly-stenotic coronary plaques rupture; however, recent data suggest haemodynamically-significant coronary stenoses with fractional flow reserve (FFR) ≤ 0.8 and vessels with high plaque burden and minimum luminal area (MLA) < 4 mm(2) by intravascular ultrasound (IVUS) may be prognostically important. Therefore, we sought to re-evaluate culprit stenosis severity in patients presenting with ST-segment elevation myocardial infarction (STEMI). Patients undergoing primary percutaneous coronary intervention (PPCI) for STEMI with adjunctive thrombectomy between October 2008 and February 2010 (n = 336/572; 59%) underwent quantitative coronary angiography (QCA) after thrombus aspiration to determine vessel reference area (RA), MLA and percentage area stenosis (AS). To validate findings, QCA and FFR were measured in 50 patients with stable angina and an angiographically-intermediate lesion. STEMI patients had anatomically-severe underlying culprit disease similar to that of the stable cohort (AS: 91.6 ± 9.5% versus 90.1 ± 8.1%; P = 0.11). Additionally, anatomically-severe lesions defined by QCA were more likely to be functionally-significant by FFR and vice-versa (P = 0.02 and 0.002 respectively). These contemporary data suggest that STEMI culprit lesions, defined by luminal stenosis after thrombus aspiration, are angiographically significant, with similar stenosis severity to stable, ischaemia-inducing lesions.

TCT-501 Impact of Adjunctive Thrombectomy on Myocardial Perfusion in Patients undergoing Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction: An Updated Meta-analysis

TCT-501 Impact of Adjunctive Thrombectomy on Myocardial Perfusion in Patients undergoing Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction: An Updated Meta-analysis

Contemporary use of adjunctive thrombectomy during primary percutaneous coronary intervention for ST‐elevation myocardial infarction in the united states

We sought to examine the contemporary use of thrombectomy during primary percutaneous coronary intervention (PCI) in the United States. Adjunctive thrombectomy during primary PCI for patients with ST-segment elevation myocardial infarction (STEMI) has demonstrated mixed results. While earlier studies showed either unfavorable or neutral effects with rheolytic thrombectomy, recent clinical trials have shown benefits with manual or rheolytic thrombectomy when compared to PCI alone. We analyzed data from 122,449 patients undergoing primary PCI for STEMI from 1,181 centers reported to the CathPCI Registry® between July 2009 and December 2010. We used logistic regression analysis to examine factors associated with the use of manual and rheolytic thrombectomy. Thrombectomy was performed in 23,195 patients (18.9%): 22,404 (18.3%) had manual thrombectomy and 791 (0.6%) had rheolytic thrombectomy. The use of manual thrombectomy increased over time (P < 0.05). The use of rheolytic thrombectomy did not change. There was significant variation in the use of thrombectomy across hospitals. The strongest predictors of manual versus no thrombectomy included TIMI 0/1 flow (odds ratio 1.69), younger age (OR 0.90 per 10 year increase), saphenous vein graft (OR 2.22), glycoprotein IIb/IIIa inhibitor (OR 1.34), single-vessel disease (OR 1.13), and year of admission (OR 1.20 per year; all P < 0.001). The strongest predictor of manual versus rheolytic thrombectomy was year of admission (OR 1.23, P < 0.001). Our data show that thrombectomy is performed infrequently in the US during primary PCI for STEMI. There is significant variation in the use of thrombectomy across US hospitals.

Use of Advanced Endovascular Techniques for Management of an Iatrogenic Iliac-Vein Injury

Background: Iatrogenic vascular injury during gynecologic surgery can be a serious complication. In addition to the risks of hemorrhage and death, this type of injury places patients at risk for postoperative thrombosis. Case: A patient sustained an iatrogenic vascular injury and underwent primary repair. Subsequently, the patient developed postoperative thrombosis at the site of repair. Results: The patient was then managed successfully with catheter-directed thrombolysis (CDT). Conclusions: According to current guidelines, recent surgery is considered to be a contraindication to CDT. However, the safe use of limited CDT with adjunctive mechanical thrombectomy in this case after recent surgery, suggests consideration of this option in similar cases. (J GYNECOL SURG 28:134)

Trombectomia adjunta em intervenção percutânea primária para infarto agudo do miocárdio

Primary percutaneous coronary intervention (PCI) has become the favored reperfusion strategy in acute ST-segment elevation myocardial infarction. Lower post-PCI myocardial perfusion grade, no-reflow and even drug-eluting stent thrombosis have been related to the presence of intracoronary thrombus. Adjunctive thrombectomy refers to procedures and devices that remove thrombotic material from the infarction-related artery, in theory, before distal embolization can occur. There is substantial variability between randomized controlled trials of thrombectomy in primary PCI with regards to tested devices, procedural characteristics, adjuvant medical regimen and examined outcomes. As a general statement, improvements in myocardial perfusion endpoints do not translate into reductions in clinical outcomes. Yet, an increasing number of trials with a longer follow-up reported benefits arising late after the index myocardial infarction. Simple aspiration catheters may also produce better outcomes than devices that fragment the thrombus before aspirating debris. Clinical or angiographic variables which best predict benefits from the use of thrombectomy remain to be defined. The aim of this review is to provide perspective on the conclusions of available trials and meta-analysis of adjunctive thrombectomy in acute myocardial infarction. Targets for future studies are discussed.

A randomized comparison of manual versus mechanical thrombus removal in primary percutaneous coronary intervention in the treatment of ST‐segment elevation myocardial infarction (TREAT‐MI)

The objective of this study was to compare the efficacy and long-term clinical outcome of manual thrombus aspiration with the Export catheter (Medtronic, Minneapolis, MN) versus mechanical thrombus cutting/aspiration with the X-sizer system (eV3, White Bear Lake, MN) in primary percutaneous coronary intervention (PPCI). In PPCI for acute ST-segment elevation myocardial infarction (STEMI), markers of myocardial reperfusion are improved with adjunctive thrombectomy. Previous studies of different devices showed a variability in performance, suitability, and short-term clinical outcome. In current literature, no direct comparison is available. We prospectively randomized 201 patients admitted for PPCI for STEMI to either the Export catheter or the X-sizer prior to stent deployment. Technical success in advancing to and across the lesion, improvement of flow, reduction of thrombus, and the effect on ST-segment resolution were examined. The primary endpoint of the follow-up study was the combined endpoint of cardiac death, recurrent myocardial infarction (MI), or target-vessel revascularization (TVR) at 3 years. Although the Export catheter was more successfully deployed, other procedural parameters were similar with a trend toward better ST-segment resolution (56.6% vs. 44%; P = 0.06) as compared to the X-sizer system. The occurrence of the primary clinical endpoint at 3 years was 22.2% and 18.6%, respectively (HR 1.20; 95% CI 0.65-2.22; P = 0.35). Despite shorter procedural times, better lesion crossing, and fewer complications, both surrogate endpoints as well as 3-year clinical follow-up were similar with the use of the Export catheter as compared to the X-sizer system.

Thrombectomy During Primary Angioplasty: Methods, Devices, and Clinical Trial Data

Distal embolization is a relatively common complication in primary angioplasty and is associated with poor perfusion and higher mortality. The aim of this article is to critically review literature on thrombectomy devices to prevent distal embolization in patients undergoing primary angioplasty. Several manual and mechanical devices have been proposed. Although negative data have been observed with mechanical devices, significant impact on mortality has been observed with routine use of manual thrombectomy devices, due to an improvement in myocardial perfusion and reduction in distal embolization. Therefore, routine adjunctive manual thrombectomy devices should be recommended in the setting of ST-segment elevation myocardial infarction, whereas the use of larger manual thrombectomy devices (7F) or mechanical devices may be considered in patients with large thrombotic burden to provide more guarantees for complete thrombus removal.

Letter by Lozano et al Regarding Article, “Adjunctive Thrombectomy for Acute Myocardial Infarction: A Bayesian Meta-Analysis”

To the Editor: We have read with interest the article by Mongeon et al1 related to thrombectomy in acute myocardial infarction. Since the introduction of the first device in the interventional arena a decade ago, we have used a long list of different designs with varying clinical results, frequently disappointing in comparison with the expectations. Although the hypothesis of thrombus elimination may look attractive, …

Response to Letter Regarding Article, “Adjunctive Thrombectomy for Acute Myocardial Infarction: A Bayesian Meta-Analysis”

Response: Angiographically visible thrombus was required in only 5 of the 21 trials1,–,5; therefore, a subanalysis limited …