Cyclic Aspiration in Mechanical Thrombectomy: Influencing Factors and Experimental Validation.

BACKGROUND AND PURPOSE: Mechanical thrombectomy is a fundamental intervention for acute ischemic stroke treatment. While conventional techniques are effective, cyclic aspiration (CyA) shows potential for better recanalization rates. We aim to investigate factors affecting CyA and compare them with static aspiration (StA). MATERIALS AND METHODS: StA setup consisted of an aspiration pump connected to pressure transducer. CyA was tested with five subsequent iterations: single solenoid valve with air+saline (1) or saline alone (2) as aspiration medium; two solenoid valves with air+saline (3) as aspiration medium; complete air removal and saline feeding (4); pressurized saline feeding (5). To assess the efficacy of clot ingestion, the pressure transducer was replaced with a distal aspiration catheter. Moderately stiff clot analogs (15 mm) were used to investigate the ingestion quantified as clot relative weight loss. Additionally, the aspiration flow rate was assessed for each setup. RESULTS: With CyA setup 1, the amplitude of the achieved negative pressure waves declined with increasing frequencies but progressively increased with each subsequent iteration, achieving a maximum amplitude of 81 kPa for setup 5 at 1Hz. Relative clot weight loss was significantly higher with setup 5 at 5Hz than with StA (100% vs. 37,8%; p=0.05). Aspiration flow rate was lower with CyA than with StA (setup 5 at 5Hz: 199,8ml/min vs. StA: 311ml/min; p<0.01). CONCLUSIONS: Cyclic aspiration with the appropriate setup may represent an encouraging innovation in mechanical thrombectomy, offering a promising pathway for improving efficacy in clot ingestion and recanalization. The observed benefits warrant confirmation in a clinical setting. ABBREVIATIONS: CyA -cyclic aspiration, StA - static aspiration, FPR -first pass reperfusion, MT -mechanical thrombectomy, DAC -distal aspiration catheter, LVO -large vessel occlusion.

Modeling Robotic-Assisted Mechanical Thrombectomy Procedures with the CorPath GRX Robot: The Core-Flow Study.

BACKGROUND AND PURPOSE: Endovascular robotic devices may enable experienced neurointerventionalists to remotely perform endovascular thrombectomy. This study aimed to assess the feasibility, safety, and efficacy of robot-assisted endovascular thrombectomy compared with manual procedures by operators with varying levels of experience, using a 3D printed neurovascular model. MATERIALS AND METHODS: M1 MCA occlusions were simulated in a 3D printed neurovascular model, linked to a CorPath GRX robot in a biplane angiography suite. Four interventionalists performed manual endovascular thrombectomy (n = 45) and robot-assisted endovascular thrombectomy (n = 37) procedures. The outcomes included first-pass recanalization (TICI 2c-3), the number and size of generated distal emboli, and procedural length. RESULTS: A total of 82 experimental endovascular thrombectomies were conducted. A nonsignificant trend favoring the robot-assisted endovascular thrombectomy was observed in terms of final recanalization (89.2% versus manual endovascular thrombectomy, 71.1%; P = .083). There were no differences in total mean emboli count (16.54 [SD, 15.15] versus 15.16 [SD, 16.43]; P = .303). However, a higher mean count of emboli of > 1 mm was observed in the robot-assisted endovascular thrombectomy group (1.08 [SD, 1.00] versus 0.49 [SD, 0.84]; P = .001) compared with manual endovascular thrombectomy. The mean procedural length was longer in robot-assisted endovascular thrombectomy (6.43 [SD, 1.71] minutes versus 3.98 [SD, 1.84] minutes; P < .001). Among established neurointerventionalists, previous experience with robotic procedures did not influence recanalization (95.8% were considered experienced; 76.9% were considered novices; P = .225). CONCLUSIONS: In a 3D printed neurovascular model, robot-assisted endovascular thrombectomy has the potential to achieve recanalization rates comparable with those of manual endovascular thrombectomy within competitive procedural times. Optimization of the procedural setup is still required before implementation in clinical practice.

Impact of stent-retriever tip design on distal embolization during mechanical thrombectomy: a randomized in vitro evaluation.

BACKGROUND: Repeated number of passes, clot fragmentation, and distal embolization during mechanical thrombectomy (MT) lead to worse clinical outcomes in acute ischemic stroke. This study aimed to assess the recanalization and embolic outcomes of different stent-retrievers (SRs): open-tip SR (Solitaire X 6×40 mm), closed-tip SR (EmboTrap II 5×33 mm), and filter-tip SR (NeVa NET 5.5×37 mm). METHODS: Stiff-friable clot analogs were used to create middle cerebral artery (M1-MCA) occlusions in a benchtop model. After occlusion, experiments were randomized into one of the three treatment arms. The thrombectomy technique consisted of retrieving the SR into a balloon guide catheter under proximal flow arrest and continuous aspiration. A total of 150 single-attempt cases were performed (50 cases/treatment arm). Distal emboli (>100 µm) were collected and analyzed after each experiment. RESULTS: Filter-tip SR achieved a non-significantly higher first-pass recanalization rate than open-tip SR and closed-tip SR (66% vs 48% vs 44%; P=0.064). Filter-tip SR prevented clot fragments>1 mm from embolizing distal territories in 44% of cases, compared with 16% in open-tip SR and 20% in closed-tip (P=0.003). There were no significant differences between treatment arms in terms of total emboli count (open-tip=19.2±13.1, closed-tip=19.1±10.7, filter-tip=17.2±13.0; P=0.660). Nonetheless, the number of large emboli (>1 mm) and total area of emboli were significantly lower in the filter-tip arm (n=0.88±1.2, A=2.06±1.85 mm2) than in the closed-tip arm (n=2.34±3.38, A=4.06±4.80 mm2; P<0.05). CONCLUSIONS: When facing fragment-prone clots, the filter-tip SR significantly reduces the number of large clots (>1 mm) that embolize distally during an MT procedure, which in turn may increase the chances of first-pass complete recanalization.

Partial (SAVE) versus Complete (Solumbra) Stent Retriever Retraction Technique for Mechanical Thrombectomy: A Randomized In Vitro Study.

BACKGROUND AND PURPOSE: Mechanical thrombectomy has become a first-line treatment for acute ischemic stroke. Several techniques combining stent retrievers and distal aspiration catheters have been described. We aimed to characterize the efficacy of 2 commonly used techniques according to clot characteristics. MATERIALS AND METHODS: Soft (mean stiffness = 95.77 [SD, 5.80] kPa) or stiff (mean stiffness = 205.63 [SD, 6.70] kPa) clots (3 × 10 mm and 2 × 10 mm, respectively) were embolized to the distal M1 segment of the MCA in an in vitro model. The technique was randomly allocated (1:1): stent retriever assisted vacuum-locked extraction (SAVE) versus complete retraction (Solumbra). The primary end point was the percentage of first-pass recanalization. Secondary end points were periprocedural distal embolization measures. RESULTS: A total of 130 mechanical thrombectomies were performed (50 for soft clots and 15 for stiff clots per arm). Overall, the rate of first-pass recanalizaton was 35% with Solumbra and 15% with SAVE (P < .01). For stiff clots, the first-pass recanalizaton was equal for both methods (27%; P = 1.00). With soft clots, the first-pass recanalizaton was higher with Solumbra (38%) than with SAVE (12%; P < .01). When we used soft clots, the maximum embolus size (mean, 1.19 [SD, 0.9] mm versus 2.16 [SD, 1.48] mm; P < .01) and total area of emboli (mean, 1.82 [SD, 2.73] versus 3.34 [SD, 3.2]; P = .01) were also lower with Solumbra than with SAVE. CONCLUSIONS: Clot characteristics may influence the efficacy of the thrombectomy technique. In occlusions caused by soft clots, complete retrieval into the distal aspiration catheters achieved higher rates of first-pass recanalizaton and lower embolization.

Impact on collateral flow of devices used for endovascular treatment of stroke: an in-vitro flow model.

BACKGROUND: Collateral blood supply of distal vessels has been linked to clinical outcome, infarct volume and recanalization rates in patients with large vessel occlusion. Our study aimed to explore the effects of catheterization during mechanical thrombectomy in collaterals. METHODS: We quantified the flow diversion effect secondary to arterial occlusions in an in vitro model which was connected in a flow-loop setup with a saline reservoir and a pump supplying pulsatile flow. Clot analogs were embolized to the middle cerebral artery (MCA) M1 or M2 segments. We used the same model with a clamped anterior communicating artery (AComA) to simulate its absence. An ultrasound flow sensor was placed at the vessel of interest. Flow rates and pressures were evaluated according to the following catheter locations: baseline (1) before and (2) after the occlusion; (3) 8F guiding catheter at the internal carotid artery (ICA) bulb; (4) at the cavernous segment; (5) at the cavernous segment a 0.071" distal access catheter at proximal M1; (6) 8F balloon guide catheter inflated. RESULTS: Collateral blood flow measured at distal anterior cerebral artery (ACA) (M1-MCA occlusion) and M2-MCA (M2-MCA occlusion) was progressively reduced as catheters were advanced through the ICA and MCA. In the lacking AComA model, the flow was further diminished as compared with the model with a patent AComA. CONCLUSION: Our in vitro study showed a progressive reduction of collateral blood flow due to the advance of catheters during mechanical thrombectomy.

Granulocytes-Rich Thrombi in Cerebral Large Vessel Occlusion Are Associated with Increased Stiffness and Poorer Revascularization Outcomes.

We aim to identify a profile of intracranial thrombus resistant to recanalization by mechanical thrombectomy (MT) in acute stroke treatment. The first extracted clot of each MT was analyzed by flow cytometry obtaining the composition of the main leukocyte populations: granulocytes, monocytes, and lymphocytes. Demographics, reperfusion treatment, and grade of recanalization were registered. MT failure (MTF) was defined as final thrombolysis in cerebral infarction score IIa or lower and/or need of permanent intracranial stenting as a rescue therapy. To explore the relationship between stiffness of intracranial clots and cellular composition, unconfined compression tests were performed in other cohorts of cases. Thrombi obtained in 225 patients were analyzed. MTF were observed in 30 cases (13%). MTF was associated with atherosclerosis etiology (33.3% vs. 15.9%; p = 0.021) and higher number of passes (3 vs. 2; p < 0.001). Clot analysis of MTF showed higher percentage of granulocytes [82.46 vs. 68.90% p < 0.001] and lower percentage of monocytes [9.18% vs.17.34%, p < 0.001] in comparison to successful MT cases. The proportion of clot granulocytes (aOR 1.07; 95% CI 1.01-1.14) remained an independent marker of MTF. Among thirty-eight clots mechanically tested, there was a positive correlation between granulocyte proportion and thrombi stiffness (Pearson's r = 0.35, p = 0.032), with a median clot stiffness of 30.2 (IQR, 18.9-42.7) kPa. Granulocytes-rich thrombi are harder to capture by mechanical thrombectomy due to increased stiffness, so a proportion of intracranial granulocytes might be useful to guide personalized endovascular procedures in acute stroke treatment.

Double stent-retriever as the first-line approach in mechanical thrombectomy: a randomized in vitro evaluation.

BACKGROUND: A repeated number of passes during mechanical thrombectomy leads to worse clinical outcomes in acute ischemic stroke. Initial experiences with the simultaneous double stent-retriever (double-SR) technique as the first-line treatment showed promising safety and efficacy results. OBJECTIVE: To characterize the potential benefits of using the double-SR as first-line technique as compared with the traditional single-SR approach. METHODS: Three types of clot analogs (soft, moderately stiff, and stiff) were used to create terminal internal carotid artery (T-ICA=44) and middle cerebral artery (MCA=88) occlusions in an in vitro neurovascular model. Sixty-six cases were randomized into each treatment arm: single-SR or double-SR, in combination with a 0.071" distal aspiration catheter. A total of 132 in vitro thrombectomies were performed. Primary endpoints were the rate of first-pass recanalization (%FPR) and procedural-related distal emboli. RESULTS: FPR was achieved in 42% of the cases. Overall, double-SR achieved a significantly higher %FPR than single-SR (52% vs 33%, P=0.035). Both techniques showed similar %FPR in T-ICA occlusions (single vs double: 23% vs 27%, P=0.728). Double-SR significantly outperformed single-SR in MCA occlusions (63% vs 38%, P=0.019), most notably in saddle occlusions (64% vs 14%, P=0.011), although no significant differences were found in single-branch occlusions (64% vs 50%, P=0.275). Double-SR reduced the maximal size of the clot fragments migrating distally (Feret diameter=1.08±0.65 mm vs 2.05±1.14 mm, P=0.038). CONCLUSIONS: This randomized in vitro evaluation demonstrates that the front-line double-SR technique is more effective than single-SR in achieving FPR when treating MCA bifurcation occlusions that present saddle thrombus.

Trackability of distal access catheters: an in vitro quantitative evaluation of navigation strategies.

BACKGROUND: In mechanical thrombectomy (MT), distal access catheters (DACs) are tracked through the vascular anatomy to reach the occlusion site. The inability of DACs to reach the occlusion site has been reported as a predictor of unsuccessful recanalization. This study aims to provide insight into how to navigate devices through the vascular anatomy with minimal track forces, since higher forces may imply more risk of vascular injuries. METHODS: We designed an experimental setup to monitor DAC track forces when navigating through an in vitro anatomical model. Experiments were recorded to study mechanical behaviors such as tension buildup against vessel walls, DAC buckling, and abrupt advancements. A multiple regression analysis was performed to predict track forces from the catheters' design specifications. RESULTS: DACs were successfully delivered to the target M1 in 60 of 63 in vitro experiments (95.2%). Compared to navigation with unsupported DAC, the concomitant coaxial use of a microcatheter/microguidewire and microcatheter/stent retriever anchoring significantly reduced the track forces by about 63% and 77%, respectively (p<0.01). The presence of the braid pattern in the reinforcement significantly reduced the track forces regardless of the technique used (p<0.05). Combined coil and braid reinforcement configuration, as compared with coil alone, and a thinner distal wall were predictors of lower track force when navigating with unsupported DAC. CONCLUSIONS: The use of microcatheter and stent retriever facilitate smooth navigation of DACs through the vascular tortuosity to reach the occlusion site, which in turn improves the reliability of tracking when positioning the DAC closer to the thrombus interface.