Article Figures & Data
Figures
- Fig 1.
Illustration of the L5 thrombectomy device removing thrombus. The L5 device is a helix of flexible nitinol wire with an arcade of filaments secured to the loops of the helix. This differs from the X5 and X6 Merci Retrievers by having filaments and no taper to the coils. Within 8 hours of acute ischemic stroke, the balloon guide catheter is placed via femoral artery into the proximal internal carotid or vertebral artery. The blue microcatheter is advanced through the balloon guide catheter and placed through the occlusion using a microguidewire. The guidewire is then exchanged for the Retriever, which is advanced distal to the clot and several loops are deployed (A). The device is further deployed so as to fully ensnare the clot (B). Then, the proximal balloon of the guide is inflated to prevent distal embolization, some torquing maneuvers are applied, and the microcatheter and Retriever are withdrawn together to retrieve the clot (C).
- Fig 2.
Multi MERCI patient flow and primary outcomes. Recanalization is from device alone; final recanalization is after Retriever and any adjuvant therapy. Patients with symptomatic intracranial hemorrhage (ICH), and procedural complications may overlap.
Tables
Variable Overall (N = 111) IV tPA (N = 30) No IV tPA (N = 81) P Value Age, y (mean ± SD) 66.2 ± 17.0 65.4 ± 13.5 66.5 ± 18.2 .772† Female, % 56.8% 56.7% 56.8% >.99‡ Baseline NIHSSS* (mean ± SD) 19.0 ± 6.3 19.6 ± 4.3 18.8 ± 6.9 .565† Hours to device treatment, median (range) 4.2 (1.3–17.3) 3.6 (2.1–7.0) 4.4 (1.3–17.3) .072§ Procedure length (h), median (range) 1.6 (0.5–5.8) 1.6 (0.6–3.3) 1.7 (0.5–5.8) .353§ No. of passes (mean ± SD) 2.8 ± 1.6 2.7 ± 1.7 2.8 ± 1.6 .460§ IV tPA, N (%) 30 (27.0) 30 (100) 0 (0) – IA tPA postretriever, N (%) 43 (38.7) 13 (43.3) 30 (37.0) .661‡ Vascular occlusion location, N (%) .296¶ ICA 1 (0.9) 1 (3.3) 0 (0) ICA-T 32 (28.8) 10 (33.3) 22 (27.2) MCA 68 (61.3) 18 (60.0) 50 (62.0) Vertebral alone 0 0 0 Vertebral + basilar, basilar 9 (8.1) 1 (3.3) 8 (9.9) P1 1 (0.9) 0 (0) 1 (1.2) Note:—IV tPA indicates intravenous tissue-type plasminogen activator; NIHSSS, National Institutes of Health Stroke Scale score; IA, intraarterial; ICA, intracranial carotid artery; ICA-T, ICA terminal bifurcation; MCA, middle cerebral artery.
* One posterior circulation (distal basilar artery occlusion) patient was enrolled against protocol with a baseline NIHSS score of 4. No other patients had a baseline NIHSS score below the required protocol score of 8. Procedure length was the time from groin puncture to final angiogram.
† t Test.
‡ Fisher exact test.
§ Wilcoxon rank-sum test.
¶ Likelihood ratio χ2 test.
No. IV tPA dose (mg/kg) IA tPA dose (mg) Total tPA Dose (mg) Total tPA dose (mg/kg) IV tPA only 17 0.68 ± 0.14 52.6 ± 17.3 0.68 ± 0.14 Lower dose 12 0.60 ± 0.04 45.0 ± 8.97 0.60 ± 0.04 Regular dose 5 0.88 ± 0.03 70.9 ± 19.5 0.88 ± 0.03 IA tPA only 27 14.0 ± 9.65 14.0 ± 9.65 0.19 ± 0.14 IA + IV tPA 13 0.67 ± 0.17 7.54 ± 3.91 69.3 ± 12.5 0.76 ± 0.17 Lower dose 7 0.53 ± 0.05 8.87 ± 4.67 64.4 ± 8.74 0.61 ± 0.04 Regular dose 6 0.85 ± 0.06 6.00 ± 2.28 74.9 ± 14.5 0.93 ± 0.08 Note:—IV indicates intravenous; IA, intraarterial; tPA, tissue plasminogen activator.
Doses are shown as means ± SD; 3 patients each received 250,000 U of urokinase IA and IV tPA (not shown).
Result Overall (N = 111) IV tPA (N = 30) No IV tPA (N = 81) P Value* Revascularization postretriever, N (%) 60 (54.1) 16 (53.3) 44 (54.3) >.99 Revascularization postadjuvant, N (%) 77 (69.4) 22 (73.3) 55 (67.9) .649 mRS ≤2 at 90 d, N (%)† 37 (34.3) 10 (33.3) 27 (34.6) >.99 Mortality at 90 d, N (%)† 33 (30.6) 8 (26.7) 25 (32.1) .647 Intracranial hemorrhage Symptomatic ICH,‡ N (%) 10 (9.0) 2 (6.7) 8 (9.9) .726 Asymptomatic ICH,§ N (%) 33 (29.7) 12 (40) 21 (25.9) .166 Procedure-related serious adverse events, N (%) 11 (9.9) 0 (0) 11 (13.6) .034 Dissection 3 (2.7) 0 3 (3.7) .562 Perforation¶ 3 (2.7) 0 3 (3.7) .562 Embolization of a previously uninvolved vessel 1 (0.9) 0 1 (1.2) >.99 Groin complications 0 0 0 Symptomatic ICH not associated with perforation‖ 3 (2.7) 0 3 (3.7) .562 Asymptomatic SAH associated with death 1 (0.9) 0 1 (1.2) >.99 Clinically significant procedure complications, N (%) 5 (4.5) 0 (0) 5 (6.2) .321 Note:—IV tPA indicates intravenous tissue plasminogen activator; mRS, modified Rankin score; ICH, intracranial hemorrhage; SAH, subarachnoid hemorrhage.
* Fisher exact test.
† N = 108 (data not available at 90 days in 3 patients in the no IV tPA group).
‡ Includes 3 patients with symptomatic SAH, all within the no IV tPA group. Symptomatic hemorrhage includes 6 hemorrhages adjudicated as evolution of the primary stroke and 4 that were adjudicated as procedure-related as detailed below.
§ Includes 8 patients with asymptomatic SAH; 4 were in the IV tPA group and 4 were in the IV tPA group.
¶ One perforation lead to symptomatic hemorrhage.
‖ Patients in whom the symptomatic ICH was either caused by the procedure or the procedure could not be ruled out as the cause of the hemorrhage.
Result No Major Protocol Violations (N = 73) Major Protocol Violation(s) (N = 38)* P Value† Procedure-related serious adverse events, N (%) 4 (5.5) 7 (18.4) .044 Intracranial hemorrhage Symptomatic ICH†, N (%) 7 (9.6) 3 (7.9) >.99 Symptomatic SAH, N (%) 2 (2.7) 1 (2.6) >.99 Asymptomatic ICH, N (%) 20 (27.4) 13 (34.2) .514 Asymptomatic SAH, N (%) 3 (4.1) 5 (13.1) .120 mRS ≤2 at 90 d, N (%)† 24 (33.3) 13 (36.1) >.99 Mortality at 90 d, N (%)† 20 (27.8) 13 (36.1) .514 Note:—ICH indicates intracranial hemorrhage; SAH, subarachnoid hemorrhage; mRS, modified Rankin score.
* Protocol violations are tabulated per patient.
† Fisher exact test.
‡ N = 72 in no protocol violations group and 36 in the protocol violation group at 90 days.
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