Mechanical thrombectomy with a novel device: initial clinical experience with the ANA thrombectomy device.

INTRODUCTION: The ANA™ (Anaconda Biomed) thrombectomy system is a novel stroke thrombectomy device comprising a self-expanding funnel designed to reduce clot fragmentation by locally restricting flow while becoming as wide as the lodging artery. Once deployed, ANA allows distal aspiration in combination with a stentretriever (SR) to mobilize the clot into the funnel where it remains copped during extraction. We investigate safety and efficacy of ANA™ in a first-in-man study. METHODS: Prospective data was collected on 35 consecutive patients treated as first line with ANA™ at a single centre. Outcome measures included per-pass reperfusion scores, symptomatic intracerebral hemorrhage (sICH), NIHSS at day 5, and mRS at 90 days. RESULTS: Median NIHSS was 12(9-18). Sites of primary occlusion were: 5 ICA, 15 M1-MCA, 15 M2-MCA. Primary performance endpoint, mTICI 2b-3 within 3 passes without rescue therapy was achieved in 91.4% (n = 32) of patients; rate of complete recanalization (mTICI 2c-3) was 65.7%. First pass complete recanalization rate was 42.9%, and median number of ANA passes 1(IQR: 1-2). In 17.1% (n = 6) rescue treatment was used; median number of rescue passes was 2(1-7), leading to a final mTICI2b-3rate of 94.3% (n = 33). There were no device related serious adverse events, and rate of sICH was 5.7% (n = 2). At 5 days median NIHSS was 1 (IQR 1-6) and 90 days mRS 0-2 was achieved in 60% of patients. CONCLUSIONS: In this initial clinical experience, the ANA™ device achieved a high rate of complete recanalization with a good safety profile and favourable 90 days clinical outcomes.

Increased intracranial hemorrhage of mechanical thrombectomy in acute ischemic stroke patients with atrial fibrillation.

The impact of atrial fibrillation (AF) on outcomes of mechanical thrombectomy (MT) for acute ischemic stroke (AIS) is controversial, and with a paucity of evidence base. This study aimed to investigate the potential association between AF and outcomes after MT in AIS patients. A post-hoc analysis of a multi-center prospective clinical trial was conducted. Before and after propensity score matching (PSM), the clinical features were compared between patients with and without AF. Multivariable logistic regression and mediation analyses were performed to assess the relationship between AF and ICH. Of the total 245 patients, 123 patients were included in the AF group. After PSM, the AF group showed more retrieval attempts (P = 0.004), comparable favorable outcome (P = 0.493), and mortality (P = 0.362) at 90 days. Multivariate analysis revealed that AF was significantly associated with increased risk for ICH (OR 2.198; 95%CI 1.099-4.395; P = 0.026). INR and retrieval attempts were found to act as partial mediations. In the subgroup with lower INR, AF still had a significant association with ICH (OR 2.496; 95%CI 1.331-4.679; P = 0.004). In AIS patients undergoing MT, AF was associated with more retrieval attempts and higher risk of any ICH. Of note, the effect of AF on the increased risk of ICH was partly attributable to the adjusted anticoagulation status and more retrieval attempts. It is crucial to elaborately prevent ICH after thrombectomy for stroke patients with AF.

Rescue catheter-based therapies for the treatment of acute massive pulmonary embolism after unsuccessful systemic thrombolysis.

The management of acute massive pulmonary embolism (PE) patients who did not respond to systemic thrombolysis (ST) has not been well established. The present study aimed to investigate the safety and effectiveness of catheter-based therapies (CDT) in this condition. We conducted a retrospective study of PE patients after unsuccessful ST (UST) between January 2012 and January 2018. Massive PE was identified in 408 patients and treated with full-dose ST therapy. Thrombolysis at 36 h was judged to be unsuccessful in 52 patients. Four ineligible patients were excluded, and the remaining 48 patients underwent rescue CDT: 30 patients underwent thrombus fragmentation with a rotating pigtail catheter; 8 patients underwent Straub rotational thrombectomy; and 10 patients underwent AngioJet rheolytic thrombectomy. In total, 42 patients subsequently underwent CDT relative to reduced-dose thrombolysis. Pooled clinical success was achieved in 45 patients, and the time-to-clinical instability relief for CDT was short (i.e., 48 h). Clinical findings significantly improved with oxygen saturation and the shock index (p < 0.01). CDT resulted in a significant decrease in the right ventricular (RV)/left ventricular end-diastolic diameter ratio and the average number of patients with pulmonary hypertension (p < 0.01). None of the patients suffered major complications or procedure-related adverse events, and two patients experienced minor complications. During follow-up, RV function symptoms were uneventful. The present study found that CDT is a safe and effective modality for rescue management of massive PE in patients with clinical instability and RV dysfunction after UST, leading to improved clinical outcomes and RV function with a low complication rate.

The perplexity of catheter-directed thrombolysis for deep venous thrombosis: the approaches play an important role.

The recent adjunctive catheter-directed thrombolysis (ATTRACT) trial rose a controversy about the treatment effect of catheter-directed thrombolysis (CDT) in deep venous thrombosis (DVT). In fact, most studies including the ATTRACT trial did not perform subgroup analysis of catheterization approaches. Different approaches would confound the conclusions. Therefore, a single-center retrospective analysis was performed to compare the differences between the antegrade (AGA) and retrograde (RGA) approaches. Total 217 DVT patients treated with CDT were enrolled from January 2010 to December 2017, with mean age of 55.3 years (67 received antegrade approach, 150 received retrograde approach). The clot burden reduction by segment was evaluated. The mean access establishment time and thrombolytic time were compared. The patency of the iliofemoral vein at 6 months was evaluated. The rate of PTS, quality of life and venous insufficiency were assessed at 1 year. AGA group showed better thrombolytic effect in popliteal and femoral vein than RGA group. The rate of iliofemoral clot burden reduction in RGA group was mostly at Grade II, while most were at Grade III in AGA group. The retrograde approach showed better thrombolysis effect in iliofemoral DVT than popliteal to iliac DVT. The RGA group reported longer mean access establishment time (5.4 ± 1.8 vs 27.0 ± 7.5 min, p < 0.001) and thrombolytic time (6.9 ± 1.5 days vs 6.8 ± 1.5 days, p = 0.586). At 6 months, RGA group had a lower rate of femoral vein patency (52.0% vs 89.6%, p < 0.001) and a higher rate of venous insufficiency (52.0% vs 29.9%, p < 0.001), compared with AGA group. Although there was no difference in the rate of PTS, the RGA group showed higher Villalta scores in the free and mild PTS. The antegrade approach was preferably recommended over the retrograde approach for CDT treatment.

Mechanical thrombectomy with a novel stent retriever with multifunctional zones: Initial clinical experience with the NeVa™ thrombectomy device.

BACKGROUND AND PURPOSE: The NeVa™ (Vesalio, Nashville, Tennessee) thrombectomy device is a CE-approved novel hybrid-cell stent retriever with offset enlarged openings coupled with functional zones and a closed distal end. The device was designed to incorporate and trap resistant emboli. The purpose was to determine the safety and efficacy of the NeVa™ stent. METHODS: Prospective data was collected on the first thirty consecutive patients treated at four stroke centers with NeVa™ as first line treatment between December 2017 and May 2018. Clinical outcome measures included re-perfusion scores after each pass, complications (per-procedural complications, device related adverse events, all intracerebral hemorrhage (ICH) and symptomatic ICH (sICH) on follow up imaging), 24 hour NIHSS, mRS at discharge and 90 days. Baseline data as well as treatment parameters were documented. RESULTS: Mean presenting NIHSS was 16. Sites of primary occlusion were 10 ICA, 16 M1-MCA, 3 M2-MCA and one basilar. There were five tandem occlusions. Reperfusion outcomes after each NeVa pass; TICI ≥ 2b after first pass 63%, after 1 or 2 passes 83%, after 1 to 3 passes 90%. TICI 2c-3 after first pass 47%, after 1-2 passes 57%, after 1-3 passes 60%. TICI ≥ 2b after final pass 93%; TICI 2c-3, 63%. There were no device related serious averse events and no sICH. Clot material was partially or completely incorporated into the device after 70% passes. The mean 24 hour NIHSS was 7 and the 90 day mRS was 0-2 in 53%. CONCLUSIONS: The NeVa™ device demonstrated a high rate of first pass complete reperfusion effect, a good safety profile and favorable 90 day clinical outcomes in this initial clinical experience.

Single-session catheter-directed lysis using adjunctive power-pulse spray with AngioJet for the treatment of acute massive and submassive pulmonary embolism.

OBJECTIVE: An alternative single-session catheter-directed thrombolysis (CDT) method using adjunctive power-pulse spray (PPS) technique (with the AngioJet system; Boston Scientific, Fremont, Calif) was investigated to evaluate its safety and effectiveness in the treatment of acute massive and submassive high-risk pulmonary embolism (PE). METHODS: Between May 2016 and July 2018, patients diagnosed with extensive massive or submassive PE who triggered intensive care unit involvement and were considered for escalation of treatment were offered CDT with adjunctive PPS technique, provided they met the clinical inclusion criteria. Clinical success was defined as stabilization of hemodynamic parameters, resolution of hypoxia, and survival to discharge. In addition, reversal of right ventricular (RV) failure and pulmonary artery hypertension was evaluated after 24 to 48 hours using echocardiography. After 4 weeks, echocardiography was repeated to check for reversal of RV failure and pulmonary artery hypertension. In addition, computed tomography pulmonary angiography was performed to check for residual thrombus. Functional capacity was also re-evaluated at the follow-up consultation. RESULTS: During the study period, 575 inpatients were diagnosed with PE at The Wollongong Hospital. Of these patients, 32 (5.6%) were referred for escalation of treatment, met the inclusion criteria, and received treatment with the CDT and PPS technique. These patients were classified as having massive (23 [71.9%]) or submassive (9 [28.1%]) PE. Technical success was achieved in all 32 patients, and 31 patients survived to discharge (96.9%). There were no major or minor adverse events and no procedure-related complications. Improvement of RV strain and pulmonary hypertension was achieved in all survivors within 48 hours of the intervention. Furthermore, all echocardiograms completed at 4 weeks after discharge were reported normal. Results from computed tomography pulmonary angiography 4 weeks after discharge demonstrated complete resolution of thrombus in 79.3% of patients, and the remaining 20.7% had only minor residual thrombus reported. In addition, 82.8% of patients reported a return to premorbid exercise tolerance by the time of postoperative consultation with the treating physician (mean follow-up, 6.7 weeks). CONCLUSIONS: This initial series indicates that single-session CDT with adjunctive PPS technique using the AngioJet system is safe and effective in treating massive and submassive acute PE. It appears to offer several potential advantages compared with current options, allowing safer and faster thrombus resolution. Multicenter prospective trials are required to validate these findings.

Catheter Directed Thrombolysis Protocols for Peripheral Arterial Occlusions: a Systematic Review.

OBJECTIVE: Catheter directed thrombolysis (CDT) for peripheral arterial occlusions is a well established alternative to thrombo-embolectomy in patients with (sub)acute limb ischaemia. However, protocols are heterogeneous and need optimisation to improve results and lower bleeding risks. The objective was to review the results and outcomes of different CDT protocols for patients with peripheral arterial occlusions. DATA SOURCES: Electronic information sources (MEDLINE, Embase, Cochrane) and reference lists were searched to identify studies reporting results of CDT of peripheral arterial occlusions. METHODS: Two independent observers performed study selection, quality assessment and data extraction. Primary outcomes were treatment duration, success rates, and bleeding complications. Secondary outcomes were mortality and amputation rates. RESULTS: One hundred and six studies were included: 19 randomised controlled trials (RCTs), 38 prospective studies, 48 retrospective studies, and one mixed cohort study. The studies comprised a total number of 10,643 cases of which 9877 received CDT for lower extremity arterial occlusion, with a mean treatment duration of 21.4 h (95% confidence interval [CI] 21.0-21.8), an angiographic patency of 75% (95% CI 74.6-75.1), and freedom from amputation rate of 91% (95% CI 90.3-90.7). Pooled results showed a thrombolysis duration with high dose protocols of 21.9 h (95% CI 21.4-22.5) and 32.7 h with low dose protocols, with bleeding rates of 16.7% (95% CI 16.3-17.1) and 13.4% (95% CI 12.8-14.0), respectively. Weighted mean results for all RCTs and prospective cohorts of >100 cases analysed separately, showed comparable results to all observational cohorts pooled. Bleeding complications occurred in 18% (95% CI 17.8-18.3) of patients and remain an important risk of CDT. CONCLUSION: CDT is an effective treatment for peripheral arterial occlusions, the main concern is bleeding complications. Although no formal meta-analysis could be performed, the pooled results suggest that lower doses of fibrinolytics lead to similar success rates at a cost of longer treatment duration but with less bleeding. There is large variation in treatment protocols and the available literature suffers from absence of reporting standards and high heterogeneity.

Economic challenges of using innovative medical devices in major public health pathologies: Example of acute ischemic stroke management by mechanical thrombectomy.

BACKGROUND: Activity-based Funding can induce financial imbalances for health institutions if innovative medical devices (MD) used to perform acts are included in Diagnosis Related Groups (DRG) tariff. To be reimbursed in addition to the DRG tariff, innovative MD must have received a favorable evaluation by the French National Authority for Health (Haute Autorité de Santé) and be registered on the positive list. The aim of this study was to evaluate the expenses and incomes generated by each scenario (before and after the reimbursement of MD), and the financial reports. This study concerned the management of ischemic stroke by mechanical thrombectomy devices, in high-volume French hospital. METHODS: All patients who have had an acute ischemic stroke and admitted to the interventional neuroradiology unit between January 2016 and December 2017 were included retrospectively in this monocentric study. They were divided into four subgroups based on the severity of the DRG. The cost study was carried out using the French National Cost Study Methodology adjusted for the duration of the stays and by micro-costing on MD. RESULTS: A total of 267 patients were included. Over the study period, the average cost of the hospital stay was €10,492±6364 for a refund of €9838±6749 per patient. The acts performed became profitable once the MD were registered on the positive list (€-1017±3551 vs. €560±2671; P<0.05). Despite this reimbursement, this activity remained in deficit for DRG lowest severity (level 1) patients (€-492±1244). Specific MD used for mechanical thrombectomy represented 37% of the total cost of stay. CONCLUSION: The time required to evaluate MD reimbursement files is too long compared to their development. As a result, practitioners are in difficulty to be able to carry out acts according to the consensual practices of their learned societies, without causing any financial deficit of their institutions.

Mechanical thrombectomy of M2 occlusions with distal access catheters using ADAPT.

BACKGROUND AND PURPOSE: The direct aspiration first pass technique (ADAPT) using distal access catheters (DAC) has proven to be an effective and safe endovascular treatment strategy of acute ischemic stroke with large vessel occlusions (LVO). However, data about direct aspiration using DAC in M2 segment occlusions is limited. We assess the safety and efficacy of DACs in acute M2 occlusions using ADAPT with large bore (5 French /6 French) aspiration catheters as the primary method for endovascular recanalization. MATERIALS AND METHODS: From January 2017 to July 2018, 52 patients with an acute ischemic stroke due to M2 occlusions underwent mechanical thrombectomy using ADAPT with DACs (SOFIA 5 French/Catalyst 6) as frontline therapy. Patient demographics, technical parameters and outcome data were recorded. RESULTS: Median National Institutes of Health Strokes Scale (NIHSS) Score was 12 at admission. Successful revascularization to mTICI 2b-3 with ADAPT alone was achieved in 45 of 52 patients (86.5%) with mTICI 3 achieved in 32 patients (61.5%). Additional stent retrievers were used in 6 patients and led to an overall successful revascularisation of 92.3% (48/52). Median NIHSS at discharge was 4. 29 of 52 (55.8%) patients had a modified Rankin Scale (mRS) Score 0-2 at three months. Symptomatic intracranial hemorrhage did not occur. CONCLUSION: DACs can safely be used for mechanical thrombectomy of acute M2 occlusions by the ADAPT approach. Their use alone can be a high efficacious treatment of distal intracranial thromboembolic occlusions.

A direct aspiration first pass technique for acute stroke therapy: a systematic review and meta-analysis.

BACKGROUND AND PURPOSE: A direct aspiration first pass technique (ADAPT), involving the first-line use of a large-bore distal aspiration catheter, is a new strategy in the mechanical thrombectomy of acute ischemic stroke caused by large-vessel occlusion. However, its impact on reperfusion rates, clinical outcomes and complication rates has not been fully examined. METHODS: We conducted a systematic review of the literature searching multiple databases for reports on thrombectomy of acute stroke with ADAPT and performed meta-analyses of clinical and radiographic outcomes. RESULTS: We selected 16 articles that included a total of 1378 patients treated with ADAPT. The mean admission National Institutes of Health Stroke Scale score was 17 and pre-treatment intravenous thrombolysis was used in 51% of cases. The successful recanalization (thrombolysis in cerebral ischemia 2b-3) rate was 66% [95% confidence interval (CI), 59-72%] with ADAPT and a rescue stent retriever was used in 31% of cases (95% CI, 24-37%) yielding an overall thrombolysis in cerebral ischemia 2b-3 rate of 89% (95% CI, 85-92%). We found a pooled estimate of 50% (95% CI, 45-54%) for functional independence (modified Rankin Scale score 0-2) at 90 days, 15% (95% CI, 10-21%) for mortality within 90 days and 5% (95% CI, 3-7%) for symptomatic intracranial hemorrhage. CONCLUSIONS: ADAPT therapy is associated with similar reperfusion rates, clinical outcomes and complication rates compared with thrombectomy with stent retrievers. However, the major limitations of current evidence (i.e. retrospective studies and selection bias) indicate a need for adequately powered, multicenter randomized controlled trials to determine the best strategy.

Multicenter initial experience with the EmboTrap device in acute anterior ischemic stroke.

BACKGROUND AND PURPOSE: Mechanical thrombectomy predominantly using stent retrievers effectively restores cerebral blood flow and improves functional outcomes in patients with acute ischemic stroke. We sought to determine the safety and efficacy of mechanical thrombectomy using the EmboTrap device. MATERIALS AND METHODS: We identified 80 consecutive patients from 4 centers with acute ischemic stroke treated with EmboTrap from June 2015 to December 2016. All patients had confirmed large vessel occlusions in the anterior circulation using CT or MR angiography with salvageable tissue. We assessed baseline characteristics and treatment related parameters including onset-to-treatment time, recanalization success (mTICI 2b or greater), complications, and good clinical outcome (mRS 0 to 2). RESULTS: Successful recanalization was achieved in 72 patients (90%). When considering the use of a second thrombectomy device as failure, the EmboTrap successfully recanalized 65 patients (81%), with complete (mTICI 3) recanalization in 40 patients (50%) within 1 or 2 passes. Median procedure time (groin to recanalization) was 35 minutes (8-161 minutes). During the procedure, distal emboli in previously unaffected territories were found in 5 (6%) patients. There were 3 vasospasms (4%) and no vessel perforations. Intracranial hemorrhage on CT at day 1 was found in 18 17 (2321%) patients, none with subarachnoid hemorrhages, and 5 were symptomatic (6%). Good clinical outcome occurred in 4749/68 78 patients (6963%). CONCLUSIONS: In this multicenter retrospective study, the EmboTrap device achieved high recanalization rates, good clinical outcomes and was safe in treating acute stroke patients with large vessel occlusions.

Guided longer pulses from a diagnostic ultrasound and intraclot microbubble enhanced catheter-directed thrombolysis in vivo.

The mechanism of ultrasound thrombolysis (UT) is generally attributed to cavitation. The insufficiency of microbubbles (MB) to serve as cavitation nuclei in the vessel-obstructing thrombi significantly reduces the effectiveness of UT. Taking advantage of the widely performed catheter-directed therapy (CDT), in a thrombo-embolized rabbit IVC model with a simultaneous catheter directed rt-PA thrombolysis procedure, guided moderate mechanical index longer pulses from a modified diagnostic ultrasound transducer, combined with an intraclot infusion of MB, significantly accelerated the thrombolysis process. The higher thrombolysis efficacy score and consistent elevated post-treatment plasma concentration level of D-Dimer, a product of fibrinolysis, both indicated the superiority of CDT + UT over CDT/UT alone. Pathologic examination of the treated occluded IVC segments revealed an almost complete dissolution of the thrombi treated with CDT + UT. There was no evidences of thrombo-embolism or local thrombus formation in the cardiac-pulmonary vessels. Combined with intraclot infusion of MB, guided longer pulse ultrasound from a diagnostic transducer is able to safely and significantly improve a catheter-directed thrombolysis procedure. It thus has the potential to achieve earlier clot removal, administration of a lower dosage of thrombolytic agent and, consequently, a lower incidence of thrombolysis-related side effects.

Comparison of ASPIRE Mechanical Thrombectomy Versus AngioJet Thrombectomy System in a Porcine Iliac Vein Thrombosis Model.

BACKGROUND: Percutaneous mechanical thrombectomy device has become an important therapeutic armamentarium in the management of venous thromboembolism. In this study, we compare the efficacy and safety profile of the AngioJet thrombectomy device and ASPIRE thrombectomy system in a porcine venous thrombosis model. METHODS: Twelve adult pigs underwent bilateral iliac venous thrombosis created by using a stent graft thrombosis model and subsequently underwent either AngioJet (n = 6) or ASPIRE mechanical thrombectomy (n = 6) 1 week later. Intravascular ultrasound (IVUS) was used to assess thrombectomy efficacy, and computed tomography was used to evaluate pulmonary embolism (PE). Hemolytic effect was measured by plasma-free hemoglobin (PfHgb). Iliac vein thrombogenicity was evaluated with radiolabeled platelet and fibrin deposition. Veins were harvested and evaluated with light microscopy and scanning electron microscopy (SEM). RESULTS: Similar thrombectomy efficacy by IVUS evaluation was noted in both groups. Significant greater PE and hemolysis were identified in the AngioJet group compared to the ASPIRE group. The AngioJet group had greater reduction in WBC and platelet compared to the ASPIRE group. No difference was found in thrombogenicity, light microscopic evaluation, or SEM. CONCLUSIONS: Both devices had similar thrombectomy efficacy and thrombogenicity response. The ASPIRE catheter incurred less PE and hemolysis compared to the AngioJet device. Vessel wall response by histological analysis and SEM was similar in both groups.

Risk of Acute Kidney Injury after Percutaneous Pharmacomechanical Thrombectomy Using AngioJet in Venous and Arterial Thrombosis.

BACKGROUND: Percutaneous mechanical thrombectomy is commonly used to treat acute thrombotic syndromes. AngioJet (AJ) forcibly sprays fibrinolytics to fragment and aspirate thrombus. It is known to cause hemolysis and gross hematuria, yet potential consequences to renal function after AJ remain unstudied. We sought to determine the risk of acute kidney injury (AKI) after AJ when compared with other lysis techniques. METHODS AND RESULTS: We retrospectively reviewed patients treated with thrombolysis over 5 years. We identified those treated with AJ or catheter-directed thrombolysis (CDT). Demographics, indications, procedures, and laboratory values within 3 days were recorded. AKI was defined as an increase >25% above the baseline creatinine within 72 hr of the procedure. IN total, 102 patients (52 AJ, 50 CDT) had no statistical difference in mean age (50 and 51), indication (arterial thrombosis 65% and 88%), or baseline creatinine (0.9 and 1.0 mg/dL), respectively. AKI occurred in 15 (29%) patients treated with AJ versus 4 (8%) of CDT (P = 0.007). Similar numbers of AJ and CDT patients underwent additional open surgical procedures (21% and 30%, respectively, P = not significant). Multivariable analysis demonstrated that the odds of AKI were only increased by AJ (odds ratio [OR] 8.2, 95% confidence interval [CI] 1.98-34.17, P = 0.004), open surgery (OR 5.4, 95% CI 1.43-20.17, P = 0.013), or a >10% drop in hematocrit (OR 4.0, 95% CI 1.15-14.25, P = 0.03). CONCLUSIONS: In our observational study, AJ is an independent risk factor for AKI. Concomitant open surgery and drop in hematocrit also raise the odds of AKI. Renal injury after AJ is under-reported in the literature, and may be related to hemolysis from the device.

Evaluation of recanalisation treatment on posterior circulation ischemic stroke by Solitaire device-A multicenter retrospective study.

OBJECTIVES: Posterior circulation ischemic stroke (PCIS), accounting for approximately 20% of total ischemic stroke, is a sever disease that associated with high rate of morbidity and mortality. Though the effectiveness of endovascular mechanical thrombectomy has been well demonstrated in many types of ischemic stroke, it is still unclear what the outcome is in posterior circulation ischemic stroke. METHODS AND MATERIALS: In current study, data was collected from 139 Chinese patients who received endovascular mechanical thrombectomy treatment with Solitaire device after acute posterior circulation ischemic stroke. We measured the mortality, symptomatic intracranial hemorrhage (SICH) and National Institutes of Health Stroke Scale (NIHSS) to evaluate the safety of endovascular mechanical thrombectomy. Meanwhile, the clinical outcome of endovascular mechanical thrombectomy was also evaluated based on recanalisation rate, HIHSS, and the modified Rankin Scale (mRS). RESULTS: Recanalisation was successful in 124 (89.3%) patients after surgery. Herniation was the second fatal stroke complication, out of the 6 patients suffered from herniation, 3 patients (50%) died during surgery and 2 (33%) died after surgery. As for other stroke complications such as pulmonary infection, 1 patient (4.3%) died during surgery and 1 patient (4.3%) died 3 days after surgery. CONCLUSION: Our findings indicate that endovascular mechanical treatment is a safe treatment which brings clear benefit to patients suffered from posterior circulation ischemic stroke, in both the recanalisation rate and functional outcomes.

An efficacy and safety comparison between different stentriever designs in acute ischaemic stroke: a systematic review and meta-analysis.

AIM: To assess the recanalisation rates and long-term functional outcomes of the Solitaire and Trevo devices; to compare these results to those from the Solitaire With the Intention For Thrombectomy (SWIFT) trial and TREVO 2 studies; and to assess for statistical differences in the outcomes between the two devices. MATERIALS AND METHODS: A systematic review and meta-analysis of studies that utilised stentrievers in the treatment of acute ischaemic stroke was conducted. The results were compared to those of the SWIFT and TREVO 2 trials and outcome differences between Trevo (Stryker, Kalamazoo, Michigan, USA) and Solitaire (ev3/Covidien, Irvine, California, USA) were analysed statistically. RESULTS: Solitaire had a lower mortality rate compared to Trevo (16.2% [95% confidence interval {CI}: 13.1%, 19.8%] versus 22.2% [95% CI: 10.8%, 40.2%]) and achieved a higher rate of functional independence (52.1% [95% CI: 46.3%, 57.8%] versus 47.6% [95% CI: 36.7%, 58.8%]). Statistical tests, however, failed to demonstrate significant differences in either functional outcomes or 3-month mortality rates. No significant differences were noted in weighted mean recanalisation rates between the Solitaire and Trevo groups. CONCLUSION: Stentrievers achieve a high rate of recanalisation and functional independence in acute ischaemic stroke and have a relatively good safety profile. No significant differences in functional outcomes, mortality, and symptomatic intra-cranial haemorrhage could be demonstrated between two popular stentrievers designs, namely Trevo and Solitaire.

[Mechanical thrombectomy - technique]. / Mechanische Thrombektomie - Technik.

Mechanical thrombectomy with stent retrievers in acute stroke has emerged as the technique with the highest recanalization rate of therapeutic procedures available so far. Recently it was demonstrated that compared to intravenous rTPA alone, mechanical thrombectomy improves outcomes of patients with acute occlusions of intracranial arteries of the anterior circulation in several randomized clinical trials. In this article we will give an overview of the steps required for the thrombectomy procedure.

Novel use of the AngioVac® system to remove thrombus during simultaneous extracorporeal membrane oxygenation life support.

Extracorporeal membrane oxygenation (ECMO) was introduced to clinical medicine over 40 years ago. While initially used as a treatment for acute respiratory failure in infants, the use of ECMO has grown to include respiratory and circulatory failure in both children and adults, cardiogenic shock, pulmonary embolism, sepsis, trauma, malignancy, pulmonary hemorrhage and as a treatment for hypothermic drowning.(1) Recent technological improvements in ECMO circuitry make it possible to minimize anticoagulation of the ECMO patient, decreasing the incidence of bleeding. Thrombus deposition within the ECMO circuit can be a life-threating complication. ECMO circuit thrombus can be contained in the circuit, adherent to cannula and deposited within the patient. The ability to remove thrombus while the patient remains on ECMO support could be a life-saving measure for some patients. The present case report outlines use of the AngioVac(®) thrombus removal system in concert with ECMO to remove a large thrombus adherent to an ECMO cannula.

The Enhancing Effect of Focused Ultrasound on TNK-Tissue Plasminogen Activator-Induced Thrombolysis Using an In Vitro Circulating Flow Model.

BACKGROUND: The limited efficacy of thrombolytic therapy in patients with ischemic stroke has created the need to use focused ultrasound (FUS) energy as a way to enhance thrombolysis efficacy (sonothrombolysis). Using an in vitro circulating flow model, we evaluated the role of physical parameters on tenecteplase (TNK-tPA)-mediated thrombolysis. MATERIALS AND METHODS: Fully retracted porcine blood clots were used for the proposed experimental study. To provide a more realistic clinical environment of stroke, the study was conducted under realistic flow conditions and TNK-tPA concentrations. Two spherically FUS transducers (4-cm diameter), focusing at 10 cm and operating at .6 and 1.05 MHz, respectively, were used. Pulsed ultrasound protocols that maintained a localized temperature elevation at the focus of 1°C were applied. Thrombolysis efficacy was measured in milligram of mass clot removed. RESULTS: The effect of physical parameters such as temperature, FUS frequency, acoustic power (AP), FUS energy, and microbubble (MB) administration on thrombolysis efficacy was examined. CONCLUSIONS: Study findings established that higher FUS frequencies (1 MHz) are associated with enhanced thrombolysis compared to lower FUS frequencies (.6 MHz). Furthermore, an increase in the linear relationship between AP and thrombolysis efficacy was exhibited. Also, the outcome of the study showed that the combination of 1-MHz FUS pulses with MBs strongly enhanced the enzymatic thrombolytic efficacy of TNK-tPA, because with 30 minutes of treatment, 1050 mg of clot was removed through nonthermal mechanisms. Taking into consideration that stroke is time dependent, this thrombolytic rate should be sufficient for timely recanalization of the occluded cerebral artery.

[Endovascular stroke treatment following recent positive clinical trials]. / Endovaskuläre Schlaganfallbehandlung vor dem Hintergrund der aktuellen positiven klinischen Studien.

Recently, five independent randomized controlled clinical trials demonstrated the efficacy and safety of endovascular stroke treatment in stroke patients with occlusion of proximal intracranial arteries. The five trials MR CLEAN, ESCAPE, EXTEND-IA, SWIFT-PRIME and REVASCAT randomized a total of 1287 stroke patients to either standard treatment, which in the majority of patients consisted of intravenous thrombolysis within 4.5 h of symptom onset or additional endovascular stroke treatment. In all the studies endovascular treatment resulted in a better clinical outcome with an odds ratio for a better clinical outcome 90 days after stroke ranging between 1.7 and 3.1 and an absolute increase in the proportion of patients with functionally independent outcome between 14% and 31%. The overwhelming benefit of endovascular treatment mainly results from mechanical thrombectomy using stent retriever devices and starting endovascular treatment within 6 h of symptom onset in stroke patients.