A novel technique for preventing distal embolism during endovascular therapy for femoropopliteal lesions: The flow-controlled anti-embolic technique.

The clinical benefit of endovascular stroke therapy has been demonstrated in several prospective randomized trials. However, in a relevant percentage of patients, mechanical thrombectomy bears the risk of causing new infarction in initially unaffected vascular territories through thrombus fragmentation and migration of clot debris. The goal of this study was to evaluate the use of the balloon guide catheter (BGC) to effectively achieve flow arrest and thrombus aspiration during the intervention to avoid distal embolization. A retrospective study was performed in 139 patients between October 2010 and May 2016 to analyze occlusions in the middle cerebral artery (MCA) or internal carotid artery (ICA) by using a stent retriever with a BGC (n=73) or a non-BGC (n=66). The following data were collected: patient age and gender, along with history of diabetes mellitus, hypertension, atrial fibrillation, smoking, obesity, dyslipidemia, and previous ischemic stroke. Data on procedure time, number of passes, and angiographic findings were also collected. The final reperfusion score was rated based on the Thrombolysis in Cerebral Infarction (TICI) grading scale. Successful recanalization was defined as TICI 3 or 2b. A total of 139 patients underwent mechanical thrombectomy with the stent retriever. Of the 139 patients, 73 (52.5%) underwent placement of a BGC. The mean age was 65.8±13.5years, and the median National Institutes of Health Stroke Scale (NIHSS) score was 11. The average initial NIHSS score was lower in the BGC group compared with the non-BGC group (mean, 11.2±5.6 vs. 13.2±5.6; P=0.03). Patients with BGC had fewer incidences of previous ischemic stroke (12.3% vs. 28.8%; P=0.01). The numbers of passes were similar between the two groups. The procedure time (99±49.4min vs. 124±72.2min; P=0.02) and the time from onset of symptoms to procedure end (302±102min vs. 357.2±136.1min; P=0.009) were shorter in the BGC group. TICI 3 or 2b recanalization scores were higher in the BGC group compared to the non-BGC group [63/73, 86.3% vs. 48/66, 72.7%; odds ratio (OR), 0.6; 95% confidence interval (CI), 0.2-1.4; P=0.04]. Importantly, distal embolization was less frequent in the BGC group (5/73, 6.8% vs. 21/66, 31.8%; OR, 6.3; 95% CI, 2.2-18.0; P < 0.001). The risk of distal embolization was significantly decreased with the use of a BGC.

ObjectiveTo evaluate the efficacy of balloon guiding catheter (BGC) during thrombectomy in anterior circulation ischemic stroke.MethodsSixty-two patients with acute anterior circulation ischemic stroke were treated with thrombectomy using a Solitaire stent from 2011 to 2016. Patients were divided into the BGC group (n=24, 39%) and the non-BGC group (n=38, 61%). The number of retrievals, procedure time, thrombolysis in cerebral infarction (TICI) grade, presence of distal emboli, and clinical outcomes at 3 months were evaluated.ResultsSuccessful recanalization was more frequent in BGC than in non-BGC (83% vs. 66%, p=0.13). Distal emboli occurred less in BGC than in non-BGC (23.1% vs. 57.1%, p=0.02). Good clinical outcome was more frequent in BGC than in non-BGC (50% vs. 16%, p=0.03). The multivariate analysis showed that use of BGC was the only independent predictor of good clinical outcome (odds ratio, 5.19: 95% confidence interval, 1.07–25.11). More patients in BGC were successfully recanalized in internal carotid artery (ICA) occlusion with small retrieval numbers (<3) than those in non-BGC (70% vs. 24%, p=0.005). In successfully recanalized ICA occlusion, distal emboli did not occur in BGC, whereas nine patients had distal emboli in non-BGC (0% vs. 75%, p=0.001) and good clinical outcome was superior in BGC than in non-BGC (55.6% vs. 8.3%, p=0.01).ConclusionA BGC significantly reduces the number of retrievals and the occurrence of distal emboli, thereby resulting in better clinical outcomes in patients with anterior circulation ischemic stroke, particularly with ICA occlusion.

Drug-eluting stents (DESs) play an important role in endovascular therapy (EVT) for femoropopliteal (FP) lesions. Cilostazol improves patency after bare-metal nitinol stent (BNS) implantation for femoropopliteal lesions. This study aimed to establish whether cilostazol is effective in improving the patency of DESs and determine whether BNS or DESs with or without cilostazol are more effective in improving the 12-month patency after EVT for FP lesions. In this prospective, open-label, multicenter study, 85 patients with symptomatic peripheral artery disease due to de novo FP lesions were enrolled and treated with DESs with cilostazol from eight cardiovascular centers between April 2018 and May 2019. They were compared with 255 patients from the DEBATE SFA study, in which patients were randomly assigned to the BNS, BNS with cilostazol, or DES groups. The primary endpoint was the 12-month patency rate using duplex ultrasound (peak systolic velocity ratio < 2.5). This study was approved by the ethics committee of each hospital. The 12-month patency rates for the BNS, BNS with cilostazol, DES, and DES with cilostazol groups were 77.6%, 93.1%, 82.8%, and 94.2%, respectively (p = 0.007). The 12-month patency rate was higher in the DES with cilostazol group than in the DES group (p = 0.044). In small vessels, the DES with cilostazol group had a higher patency rate than the DES group (100.0% vs. 83.4%, p = 0.023). DES with cilostazol showed better patency than DES alone. Cilostazol improved patency after EVT with DES in FP lesions and small vessels. University Hospital Medical Information Network Clinical Trials Registry (no. UMIN 000032473).

Efficacy of a proximal occlusion catheter with reversal of flow in the prevention of embolic events during carotid artery stenting: An experimental analysis

PurposeThe hypothesis is that proximal flow control with a balloon guide catheter (BGC) in the cervical internal carotid artery (ICA) during mechanical thrombectomy will reduce the amount of distal emboli.Materials...

Efficient and timely recanalization is an important goal in acute stroke endovascular therapy. Several studies demonstrated improved recanalization and clinical outcomes with the stent retriever devices compared with the Merci device. The goal of this study was to evaluate the role of the balloon guide catheter (BGC) and recanalization success in a substudy of the North American Solitaire Acute Stroke (NASA) registry. The investigator-initiated NASA registry recruited 24 clinical sites within North America to submit demographic, clinical, site-adjudicated angiographic, and clinical outcome data on consecutive patients treated with the Solitaire Flow Restoration device. BGC use was at the discretion of the treating physicians. There were 354 patients included in the NASA registry. BGC data were reported in 338 of 354 patients in this subanalysis, of which 149 (44%) had placement of a BGC. Mean age was 67.3±15.2 years, and median National Institutes of Health Stroke Scale score was 18. Patients with BGC had more hypertension (82.4% versus 72.5%; P=0.05), atrial fibrillation (50.3% versus 32.8%; P=0.001), and were more commonly administered tissue plasminogen activator (51.6% versus 38.8%; P=0.02) compared with patients without BGC. Time from symptom onset to groin puncture and number of passes were similar between the 2 groups. Procedure time was shorter in patients with BGC (120±28.5 versus 161±35.6 minutes; P=0.02), and less adjunctive therapy was used in patients with BGC (20% versus 28.6%; P=0.05). Thrombolysis in cerebral infarction 3 reperfusion scores were higher in patients with BGC (53.7% versus 32.5%; P<0.001). Distal emboli and emboli in new territory were similar between the 2 groups. Discharge National Institutes of Health Stroke Scale score (mean, 12±14.5 versus 17.5±16; P=0.002) and good clinical outcome at 3 months were superior in patients with BGC compared with patients without (51.6% versus 35.8%; P=0.02). Multivariate analysis demonstrated that the use of BGC was an independent predictor of good clinical outcome (odds ratio, 2.5; 95% confidence interval, 1.2-4.9). Use of a BGC with the Solitaire Flow Restoration device resulted in superior revascularization results, faster procedure times, decreased need for adjunctive therapy, and improved clinical outcome.

Severe calcification in femoropopliteal lesions remains a clinical challenge to achieve both the technical and long-term success in endovascular therapy. Although atherectomy is an effective treatment for calcified lesions, it is associated with the risk of distal embolization, even with the use of embolic protection devices (EPDs), and currently, no definitive strategy has been established to prevent this complication. We present a case successfully treated with atherectomy under EPDs and Parodi Anti-Embolism System (PAES). We report the case of a 77-year-old man with intermittent claudication in the left leg due to a severely calcified lesion in the superficial femoral artery. To mitigate the risk of distal embolization during atherectomy, proximal protection was achieved using Optimo catheter and distal protection was provided by Filtrap device. Additionally, arteriovenous circulation was established via a venous sheath and an external filter chamber, facilitating continuous flow reversal from the artery to the vein and effectively capturing debris within the external chamber. Atherectomy was performed under this double protection system, followed by drug-coated balloon angioplasty. Completion angiography confirmed the absence of distal embolization. Multiple calcified embolic debris were successfully captured by the aspiration system, filter, and filter chamber. This case demonstrates that combining double protection with arteriovenous circulation can establish a reliable flow reversal circuit during atherectomy, effectively preventing distal embolization. This strategy may offer an enhanced protection method for the atherectomy treatment of severely calcified femoropopliteal lesions.

Clinical outcome of endovascular therapy for femoropopliteal artery lesions in patients with intermittent claudication: Twenty-four-month outcomes from the TALENT registry.

ObjectivesCarotid artery stenting (CAS) by proximal occlusion of the common carotid artery (CCA) using a balloon guide catheter (BGC) is a simple proximal protection method to prevent distal embolism, however, it requires at least an 8 French (F) system. A 7 F Optimo BGC is the smallest BGC with an inner lumen diameter of 0.071 inches, and which permits the passage of a 5 F carotid stent. We retrospectively investigated the clinical results and the safety of CAS by using a 7 F Optimo BGC combined with a distal filter.Materials and MethodsOne-hundred carotid arterial stenosis patients were treated with CAS using combined protection of a 7 F Optimo BGC and a distal filter. The BGC was navigated from the femoral and radial arteries in 85 and 15 patients, respectively.ResultsThe 7 F Optimo BGC was successfully navigated into the CCA in all patients, and the technical success rate of CAS was 100%. Major adverse events of any death, stroke, or myocardial infarction within 30-day after the procedure were observed in one (1%). Post-procedural diffusion-weighted magnetic resonance imaging revealed high signals in 21% of the patients, all of whom were asymptomatic.ConclusionsThe 7 F Optimo is the smallest BGC to achieve CAS using a proximal protection system. The combined use of a 7 F Optimo BGC and a distal filter is effective for navigating the BGC and distal embolic protection.

IntroductionRecent studies have demonstrated that a direct aspiration first pass technique (ADAPT) for the treatment of acute ischemic stroke may be effective and safe. In this study, we sought to...

A direct aspiration first pass technique (ADAPT) is an effective thrombectomy option in patients with acute ischemic stroke. Balloon guide catheters (BGC) seem to improve the efficacy of stent retrievers and ADAPT. The last generation 6F aspiration catheters require 9F BGCs, which are rigid devices that are challenging to position in a tortuous anatomy. In this experimental study the efficacy of 6F ADAPT alone and 5F ADAPT combined with 8F BGC was evaluated. Either a fibrin rich (white) clot or an RBC rich (red) clot was placed in the M1 segment of a transparent silicon phantom. Physiological hemodynamic conditions were maintained. The clots were retrieved by 6F aspiration catheter via 8F long sheath or 5F aspiration catheter via a flexible 8F BGC. Thrombectomy was performed under direct visual control. The primary endpoints were the number of passes and the number of distal emboli. Ten experiments were made with each clot model and thrombectomy technique (n = 40). Full recanalization could be achieved in every experiment. First pass mTICI 3 could be achieved by 6F ADAPT in 80 % of red clots and 90 % of white clots. Distal emboli were caused in 10 % and 20 %, respectively. When using 5F ADAPT combined with BGC, a first pass mTICI 3 rate of 90 % in red clots and 100 % in white clots could be achieved. A 10 % rate of distal emboli occurred in both groups. In almost all experiments (both techniques), the thrombi clogged the aspiration catheter. No statistically significant differences could be found between the techniques and clot models. 6F ADAPT without BGC was as effective as 5FADAPT combined with a flexible 8F BGC, with both techniques showing high first-pass recanalization rates and low distal emboli rates. Especially in the case of a tortuous anatomy, these setups should be considered as alternatives to a rigid 9F BGC. The thrombus compositions seemed to be irrelevant in this setting. · 6F ADAPT with no BGC and 5F ADAPT with BGC were very effective and performed equally.. · Both techniques should be considered in tortuous anatomy.. · In this setting the clot composition showed no effect on the recanalization rate.. · Madjidyar J, Nerkada L, Larsen N et al. Choosing an Effective and Safe Direct Aspiration Setup for Tortuous Anatomy in Acute Ischemic Stroke: In vitro Study in a Physiological Flow Model. Fortschr Röntgenstr 2021; 193: 544 - 550.

PurposeDrug-eluting stents (DESs) play an important role in endovascular therapy (EVT) for femoropopliteal (FP) lesions. Cilostazol improves patency after bare-metal nitinol stent (BNS) implantation for femoropopliteal lesions. This study aimed to establish whether cilostazol is effective in improving the patency of DESs and determine whether BNS or DESs with or without cilostazol are more effective in improving the 12-month patency after EVT for FP lesions.Materials and methodsIn this prospective, open-label, multicenter study, 85 patients with symptomatic peripheral artery disease due to de novo FP lesions were enrolled and treated with DESs with cilostazol from eight cardiovascular centers between April 2018 and May 2019. They were compared with 255 patients from the DEBATE SFA study, in which patients were randomly assigned to the BNS, BNS with cilostazol, or DES groups. The primary endpoint was the 12-month patency rate using duplex ultrasound (peak systolic velocity ratio < 2.5). This study was approved by the ethics committee of each hospital.ResultsThe 12-month patency rates for the BNS, BNS with cilostazol, DES, and DES with cilostazol groups were 77.6%, 93.1%, 82.8%, and 94.2%, respectively (p = 0.007). The 12-month patency rate was higher in the DES with cilostazol group than in the DES group (p = 0.044). In small vessels, the DES with cilostazol group had a higher patency rate than the DES group (100.0% vs. 83.4%, p = 0.023).ConclusionsDES with cilostazol showed better patency than DES alone. Cilostazol improved patency after EVT with DES in FP lesions and small vessels.Clinical trial registrationUniversity Hospital Medical Information Network Clinical Trials Registry (no. UMIN 000032473).

Feasibility and Safety of Distal and Proximal Combined Endovascular Approach with a Balloon-Guiding Catheter for Subclavian Artery Total Occlusion.

PurposeSpecific decisions made by neurointerventionists are often lost behind the data of large-scale trials, and many of these studies have taken place before the development of new techniques and devices. This study compares the stent-retriever assisted vacuum-locked extraction (SAVE) technique with a direct aspiration first pass (ADAPT), as well as the use of a balloon guide catheter (BGC), in intracranial internal carotid artery (IC-ICA) occlusions.MethodsObservational and retrospective study from an Italian hospital, including patients who underwent thrombectomy for IC-ICA occlusion between 1 January 2019 and 31 March 2021.ResultsOut of 91 IC-ICA occlusions, the ADAPT was the first choice in 20 (22%) and the SAVE in 71 (78%). A BGC was used in 32 (35%) cases, always in conjunction with the SAVE technique. The use of SAVE technique without BGC was associated with the least risk of distal embolization (DE) in the territory occluded (44% vs. 75% when ADAPT technique was used; p = 0.03) and achieved first pass effect (FPE) more frequently (51% vs. 25%, p = 0.09). When the SAVE technique was used, BGC (BGC-SAVE) compared to no BGC (NoBGC-SAVE) was associated with a tendency for less DE (31% vs. 44%, p = 0.3), more FPE (63% vs. 51%, p = 0.5), the same median number of passes (1, p = 0.8) and similar groin-to-recanalization times (36.5 vs. 35.5 min, p = 0.5), none of which reached statistical significance.ConclusionOur findings support the use of SAVE technique for IC-ICA occlusions; the added benefit of BGC compared to long sheaths was not remarkable in this sample.

ObjectiveMechanical thrombectomies with balloon-guide catheters (BGC) are thought to improve successful recanalization rates and to decrease the incidence of distal emboli compared to thrombectomies without BGC. We aimed to assess the effects of BGC on the outcomes of mechanical thrombectomy in acute ischemic strokes.MethodsStudies from PubMed, EMBASE, and the Cochrane library database from January 2010 to February 2018 were reviewed. Random effect model for meta-analysis was used. Analyses such as meta-regression and the “trim-and-fill” method were additionally carried out.ResultsA total of seven articles involving 2223 patients were analyzed. Mechanical thrombectomy with BGC was associated with higher rates of successful recanalization (odds ratio [OR], 1.632; 95% confidence interval [CI], 1.293–2.059). BGC did not significantly decrease distal emboli, both before (OR, 0.404; 95% CI, 0.108–1.505) and after correcting for bias (adjusted OR, 1.165; 95% CI, 0.310–4.382). Good outcomes were observed more frequently in the BGC group (OR, 1.886; 95% CI, 1.564–2.273). Symptomatic intracranial hemorrhage and mortality did not differ significantly with BGC use.ConclusionOur meta-analysis demonstrates that BGC enhance recanalization rates. However, BGC use did not decrease distal emboli after mechanical thrombectomies. This should be interpreted with caution due to possible publication bias and heterogeneity. Additional meta-analyses based on individual patient data are needed to clarify the role of BGC in mechanical thrombectomies.