Y Kayan

Comparison of clinical outcomes in patients with acute ischemic strokes treated with mechanical thrombectomy using either Solumbra or ADAPT techniques

Purpose To compare rates of symptomatic intracranial hemorrhage (SICH) and good clinical outcome at 90 days in patients with ischemic strokes from anterior circulation emergent large vessel occlusions (ELVO) treated with mechanical thrombectomy using either Solumbra or A Direct Aspiration first-Pass Thrombectomy (ADAPT) techniques. Methods We compared clinical characteristics, procedural variables, and clinical outcomes in patients with anterior circulation ELVOs treated with mechanical thrombectomy using either a Solumbra or ADAPT technique at our institution over a 38-month period. SICH was defined using the SITS-MOST criteria. A good clinical outcome was defined as a modified Rankin Scale score of 0–2 at 90 days. Results One hundred patients were included, 55 in the Solumbra group and 45 in the ADAPT group. Patients in the ADAPT group had higher National Institutes of Health Stroke Scale (NIHSS) (19.2 vs 16.8, p=0.02) and a higher proportion of internal carotid artery terminus thrombi (42.2% vs 20%, p=0.03) than patients in the Solumbra group. Patients in the ADAPT group had a trend toward a lower rate of SICH than patients in the Solumbra group (2.2% vs 12.7%, p=0.07). Patients in the ADAPT group had a significantly higher rate of good clinical outcome at 90 days than patients in the Solumbra group (55.6% vs 30.9%, p=0.015). Use of the ADAPT technique (OR 6 (95% CI 1.0 to 31.2), p=0.049) was an independent predictor of a good clinical outcome at 90 days in our cohort. Conclusions In our cohort, the ADAPT technique was associated with significantly higher good clinical outcomes at 90 days in patients with acute ischemic stroke due to anterior circulation ELVOs treated with mechanical thrombectomy.

Efficacy of a two-test protocol for achieving a therapeutic response to clopidogrel prior to elective endovascular intracranial aneurysm treatment and an ‘induced’ postoperative hyper-response

Introduction Variable response to clopidogrel can impact perioperative risk in elective endovascular intracranial aneurysm treatment. The present study aims to determine the efficacy of a two-test protocol in reaching in-range preoperative P2Y12 reaction units (PRU) of 60–240 and the rate of postoperative conversion to hyper-response. Methods A 17-day two-test protocol (with tests on days 10 and 17) for patients starting clopidogrel in anticipation of elective endovascular intracranial aneurysm treatment was introduced in February 2013 at our institution. Records for patients started on this protocol through December 2014 were reviewed for preoperative and postoperative PRUs, patient and procedural data, and thromboembolic and hemorrhagic events within 30 days. Logistic regression analyses were performed to identify predictors of postoperative hyper-response (p<0.05 considered significant). Results 103 patients (80 women) of mean age 57 years were included. 74 patients (71.8%) were in range at the first test and 92 patients (89.3%) were in range at the second test. A postoperative test was performed in 82 patients (79.6%) at a median of 9 days. 51 patients (62.2%) converted into hyper-responders. There were five non-disabling strokes and one intracranial hemorrhage within 30 days. There were no major strokes (modified Rankin Scale score >2) or deaths. There was no association between out-of-range PRU and thromboembolic or hemorrhagic neurological complications. Conclusions The protocol achieves in-range preoperative PRU by the second test in almost nine of 10 patients. Nearly two-thirds of patients exhibited postoperative hyper-response to clopidogrel. Out-of-range PRU was not associated with thromboembolic or hemorrhagic neurological complications in this cohort of patients with actively managed P2Y12 inhibition.

Pipeline Embolization of Posterior Communicating Artery Aneurysms Associated with a Fetal Origin Posterior Cerebral Artery

BACKGROUND AND PURPOSE Flow diversion may have advantages in the treatment of posterior communicating artery (PComA) aneurysms associated with a fetal origin posterior cerebral artery (PCA), which can be challenging to treat with conventional techniques. However, a PComA incorporated into the aneurysm may prevent or delay aneurysm occlusion. Also, coverage of a fetal origin PCA risks infarction of a large vascular territory. The purpose of this study was to examine the safety and effectiveness of using the Pipeline Embolization Device (PED) to treat PComA aneurysms associated with a fetal origin PCA. PATIENTS AND METHODS Retrospective review of PComA aneurysms associated with a fetal origin PCA treated with the PED at two neurovascular centers was performed. Periprocedural complications and clinical and angiographic outcomes were reviewed. RESULTS Seven female patients underwent a total of seven PED procedures to treat seven PcomA aneurysms associated with a fetal origin PCA. The symptomatic complication rate was 14% (1/7) per patient and 13% (1/8) per procedure. Angiographic follow up was obtained for 6 of 7 aneurysms. Follow-up DSA at 5-7 months after treatment demonstrated complete occlusion of 17% (1/6) of aneurysms. One aneurysm was retreated with a second PED and occlusion was demonstrated 36 months after the second treatment, yielding an overall complete occlusion rate of 33% (2/6). CONCLUSIONS PED treatment was largely ineffective at treating PComA aneurysms associated with a fetal origin PCA, and should only be considered when conventional treatment options, including microsurgical clipping, are not feasible.

A case of right middle cerebral artery ‘tendonectomy’ following mitral valve replacement surgery

Following mechanical mitral valve replacement surgery, a 69-year-old woman had an ischemic stroke in the right middle cerebral artery territory. Mechanical thrombectomy showed the embolus to be a piece of chordae tendineae excised during the valve replacement surgery.

E-057 Process Improvement in Door-to-Groin Puncture Times at a Comprehensive Stroke Center Shows a Trend Towards Reduced Mortality at 90 Days

Introduction Safe and effective endovascular treatment of acute ischemic stroke is dependent on prompt intervention. In light of the positive trials published last year, we intensified our efforts to improve the process of taking patients from the emergency department to the angiography suite for mechanical thrombectomy. Methods At the beginning of 2015, a process improvement project to improve door-to-groin puncture times for mechanical thrombectomy for emergent large vessel occlusions was undertaken at our institution. After a systematic analysis of the process, the following key changes were standardized: early consultation with the neurointerventionalist for patients presenting with a high National Institutes of Health Stroke Scale (NIHSS ≥6), the stroke neurologist and the neurointerventionalist meet the patient in the emergency department for transfers or meet in the CT department for non-transfers, elimination of emergency physician triage for medically stable patients, elimination of lab tests such as creatinine, establishment of a minimum level of clinical information required for the sedation nurse to care for stroke patients safely, institution of a “stroke bag” containing all necessary devices to perform efficient thrombectomy, standardized setup of the procedure table and devices for all operators, calling for patients when the sedation nurse is ready without waiting for the entire team, elimination of unnecessary preoperative steps (e.g. Foley catheter placement, groin shaving, checking of distal pulses), and institution of an abbreviated time-out procedure. All attempted thrombectomies performed in 2013 and 2014 were compared to those performed in 2015 visà-vis the following variables: door-to-groin puncture time, symptomatic intracranial hemorrhage (SICH) rate as defined by SITS-MOST criteria, 90 day mortality rate, and 90 day rate of good clinical outcome defined by a modified Rankin Scale (mRS) of 0–2. A one-tailed Student’s t-test and Fisher’s exact tests were performed. A p-value <0.05 was considered statistically significant. Results From January 2013 to December 2015, we attempted 108 mechanical thrombectomies. Of these, 43 were in 2015 (40%). Both the mean and median door-to-groin puncture times were significantly reduced from the previous two years (35 minutes versus 89 minutes and 22 minutes versus 73 minutes, respectively, p < 0.001). There was a trend towards reduced mortality at 90 days (16% versus 26%, p = 0.166). The rates of SICH and mRS 0–2 at 90 days were not significantly different (see Table 1).Abstract E-057 Table 1 2013 and 2014 2015 p-value Thrombectomies 65 43 Door-to-groin punctureMean time (minutes)Median time (minutes) 8973 3522 <0.001 SICH 3 (5%) 3 (7%) 0.452 90 day mortality 17 (26%) 7 (16%) 0.166 90 day mRS 0–2 24 (37%) 18 (42%) 0.376 Conclusion Our systematic process improvement initiative significantly reduced door-to-groin puncture times and showed a trend towards reduced mortality at 90 days. A multidisciplinary approach and ensuring hospital system investment are key to an effective process. Disclosures Y. Kayan: 2; C; Medtronic, Penumbra. J. Delgado Almandoz: 2; C; Medtronic, Penumbra. M. Young: None. J. Fease: None. J. Scholz: None. A. Milner: None. T. Hehr: None. M. Mulder: None. P. Roohani: None. R. Tarrel: None.

Endovascular Treatment of Posterior Inferior Cerebellar Artery Aneurysms with Flow Diversion

BACKGROUND Flow diversion is a viable alternative for treatment of wide-neck and fusiform aneurysms originating from the posterior inferior cerebellar artery (PICA), but coverage of the PICA and vertebral perforating arteries may be a concern. The aim of this study was to examine procedural, clinical, and angiographic outcomes of patients with PICA aneurysms treated with the Pipeline Embolization Device. METHODS Retrospective review was performed of PICA aneurysms treated with the Pipeline device at 3 neurovascular centers, including periprocedural complications and clinical and angiographic outcomes. RESULTS In 16 procedures, 14 PICA aneurysms were treated with the Pipeline device. These included 11 saccular aneurysms with a mean size of 7.4 mm (range, 2.0-11.1 mm) and 3 fusiform aneurysms with a mean diameter of 6.1 mm (range, 5.0-8.0 mm) and mean length of 10.3 mm (range, 6.0-15.0 mm). One patient developed a PICA territory infarct with mild leg weakness that resolved in <7 days. Overall complication rate was 7% (1/14) per patient and 6% (1/16) per procedure. Mean duration of clinical follow-up was 13.5 months (range, 3 weeks to 61.7 months), with all patients returning to baseline functional status. Complete or near-complete aneurysm occlusion was achieved in 58% (7/12) of cases with angiographic follow-up (mean, 15 months; range, 4-61 months). All covered PICAs remained patent. CONCLUSIONS Flow diversion of PICA aneurysms is a safe and viable treatment option when traditional endovascular options are unlikely to preserve parent vessel patency.

Endovascular Treatment of Posterior Cerebral Artery Aneurysms With Flow Diversion: Case Series and Systematic Review

BACKGROUND Flow diversion of posterior cerebral artery (PCA) aneurysms has not been widely reported, possibly owing to concerns regarding parent vessel size and branch vessel coverage. OBJECTIVE To examine the safety and effectiveness of PCA aneurysm flow diverter treatment. METHODS Retrospective review of PCA aneurysms treated with the Pipeline Embolization Device (PED; Medtronic Inc, Dublin, Ireland) at 3 neurovascular centers, including periprocedural complications and clinical and angiographic outcomes. Systematic review of the literature identified published reports of PCA aneurysms treated with flow diversion. Rates of aneurysm occlusion and complications were calculated, and outcomes of saccular and fusiform aneurysm treatments were compared. RESULTS Ten PCA aneurysms in 9 patients were treated with the PED. There were 2 intraprocedural thromboembolic events (20%), including 1 symptomatic infarction and 1 delayed PED thrombosis. Eight of 10 patients returned to or improved from their baseline functional status. Complete aneurysm occlusion with parent vessel preservation was achieved in 75% (6/8) of cases at mean follow-up of 16.7 mo. Eleven of 12 (92%) major branch vessels covered by a PED remained patent. Including the present study, systematic review of 15 studies found a complete aneurysm occlusion rate of 88% (30/34) and complication rate of 26% (10/38), including 5 symptomatic ischemic strokes (13%; 5/38). Fusiform aneurysms more frequently completely occluded compared with saccular aneurysms (100% vs 70%; P = .03) but were associated with a higher complication rate (43% vs 9%; P = .06). CONCLUSION The safety and effectiveness profile of flow diverter treatment of PCA aneurysms may be acceptable in select cases.

Larger ACE 68 aspiration catheter increases first-pass efficacy of ADAPT technique

Purpose To report the efficacy of A Direct Aspiration first-Pass Thrombectomy (ADAPT) technique with larger-bore ACE aspiration catheters as first-line treatment for anterior circulation emergent large vessel occlusions (ELVOs), and assess for the presence of a first-pass effect with ADAPT. Methods We retrospectively reviewed 152 consecutive patients with anterior circulation ELVOs treated with the ADAPT technique as first-line treatment using ACE60, 64, or 68 at our institution. Baseline characteristics, procedural variables, and modified Rankin Scale (mRS) at 90 days were recorded. Results Fifty-seven patients were treated with ACE60 (37.5%), 35 with ACE64 (23%), and 60 with ACE68 (39.5%). Median groin puncture to reperfusion time was 30 min with ACE60, 26 min with ACE64, and 19.5 min with ACE68. Successful reperfusion after the first ADAPT pass was 33% with ACE60 and 53% with ACE68 (P=0.04). The stent-retriever rescue rate was 26% with ACE60, 3% with ACE64, and 10% with ACE68 (P=0.004). In multivariate logistic regression analysis, use of the ACE68 aspiration catheter was an independent predictor of successful reperfusion after the first ADAPT pass (P=0.016, OR1.67, 95% CI 1.1 to 2.54), and successful reperfusion after the first ADAPT pass was an independent predictor of good clinical outcome at 90 days (P=0.0004, OR6.2, 95% CI 2.27 to 16.8). Conclusion Use of the larger-bore ACE 68 aspiration catheter was associated with shorter groin puncture to reperfusion time, higher rate of successful reperfusion after the first ADAPT pass, and lower rate of stent-retriever rescue. Further, a first-pass effect was demonstrated in our ADAPT patient cohort.

E-041 Safety and effectiveness of the pipeline embolization device in patients with nickel skin allergy

Introduction The Pipeline Embolization Device (PED; Medtronic Neurovascular, Irvine, CA) has expanded the spectrum of aneurysms amenable to endovascular treatment. The device is a braided mesh cylinder composed of 48 strands of 25% platinum and 75% cobalt-nickel alloy. An estimated 17% of women and 3% of men are allergic to nickel, and the safety PED implantation in these patients is a concern. The purpose of this study was to assess the clinical and angiographic outcomes of PED treatment in patients with nickel allergy. Methods A single institution neurointerventional database was retrospectively reviewed for patients treated with the PED who had a documented nickel allergy. In some patients patch testing was performed preoperatively, consisting of taping a PED to the patient’s skin for 1 week. Patient demographics, aneurysm characteristics, and procedural details were recorded. All patients received dual antiplatelet therapy for approximately 17 days before treatment, and response was assessed with VerifyNow (Accriva Diagnostics; San Diego, CA). Follow-up digital subtraction angiography was performed 6 months post procedure. Longer-term follow up was performed with CT angiography when PED alone was used or MRA with and without contrast when adjunctive coiling was performed. Follow-up functional status was graded using the modified Rankin Scale (mRS). Good clinical outcome was defined as mRS ≤2 at last clinical follow up. Results During the study period, 22 patients with documented nickel contact dermatitis underwent 23 PED treatments for 29 aneurysms. Patch testing was performed in 55% (12/22) of patients, none of whom experienced a skin reaction. The cohort included 21 women and 1 man with a mean age of 53.6±14 years. Patient medical comorbidities were as follows: hypertension, 40.9%; hyperlipidemia, 9.1%; type 2 diabetes mellitus, 0%. 36% (8/22) of patients actively smoked at the time of treatment. Mean aneurysm size was 8.8±8.1 mm (range, 2.0–32.0 mm), with 93% (27/29) located in the anterior circulation and 7% (2/29) in the posterior circulation. No aneurysms were treated in the setting of subarachnoid hemorrhage. Most patients were treated with a single PED (79.3%, 23/29). Five patients were treated with two PEDs and one was treated with three PEDs. 28% (8/29) of aneurysms were treated with adjunctive coiling. 18% (4/22) of patients experienced a symptomatic complication, all of which were thromboembolic, but all patients (100%, 22/22) had a good clinical outcome. During a mean angiographic follow-up of 16.2±13.0 months (range, 3–64 months), complete and near-complete (>90%) occlusion rates were 77% (20/26) and 4% (1/26), respectively. Endothelial hyperplasia occurred in one case (3%), which resulted in approximately 65% asymptomatic parent artery stenosis. Conclusion All patients with nickel allergy treated with the PED had a good clinical outcome, but the thromboembolic complication rate was higher than typically reported for PED series. Further research is needed to determine if nickel allergy is an independent risk factor for procedural complications. Disclosures A. Wallace: None. J. Delagado Almandoz: 2; C; Medtronic, Penumbra, Accriva, Microvention. Y. Kayan: 2; C; Medtronic, Penumbra, Microvention. J. Fease: None. M. Thomas: None. J. Scholz: None. A. Milner: None.

O-029 Ace aspiration is a safe and effective first-line treatment for acute ischemic strokes in the anterior circulation

Purpose To evaluate the effectiveness of the Penumbra system with ACE reperfusion catheters only (ACE only) versus ACE followed by Solitaire stent-retriever rescue (Solumbra rescue) for the treatment of anterior circulation emergent large vessel occlusions (ELVOs). Methods We performed a single center, retrospective review of 100 consecutive patients with anterior circulation ELVOs treated with ACE as first-line therapy. If successful revascularization (TICI 2b-3) was not achieved with ACE only, then Solumbra rescue was utilized. Baseline characteristics, procedural variables, and modified Rankin Scale (mRS) at 90 days were recorded. Results 84 patients were treated with ACE only and 16 patients required Solumbra rescue. 53 patients received iv-tPA prior to mechanical thrombectomy. Overall successful revascularization for all 100 consecutive patients was 90%, with puncture to reperfusion time of 38.7 min, embolization to new territory rate of 5%, and post-procedure symptomatic intracranial hemorrhage rate of 3% (2 subarachnoid, 1 intraparenchymal). Successful revascularization using ACE only was achieved in 78 patients (38 after a single pass), while 12 of the 16 patients requiring Solumbra rescue were successfully revascularized (75%). Puncture to reperfusion time for ACE only versus Solumbra rescue were 30.5 and 81.8 min, respectively (p<0.0001). A good clinical outcome, mRS 0–2 at 90 days, was achieved in 46% (46/100) of patients, including 49% (41/84) of patients treated with ACE only and 31% (5/16) of patients requiring Solumbra rescue. There was a statistically-significant difference in the rate of successful revascularization with ACE only as well as Solumbra rescue rate between the first 20 and subsequent 80 cases (Table 1). Successful revascularization with ACE only was achieved in 64% of patients treated with ACE 60, 88% with ACE 64, and 100% with ACE 68 (p<0.001, Table 2). One-pass successful revascularization rate was 31% with ACE 60, 38% with ACE 64, and 50% with ACE 68 (p=0.09). Mean puncture to reperfusion time was 49 min with ACE 60 and 30 min with ACE 64/68 (p=0.002). The Solumbra rescue rate was 29% in patients treated with ACE 60, 3% with ACE 64 and 0 with ACE 68 (p=<0.001). Abstract O-029 Table 1 Learning curve for ADAPT technique Mean time puncture to reperfusion (min): TICI 2b/3 after 1 ADAPT pass: TICI 2b/3 with ADAPT only: Mean total number of ADAPT passes: Solumbra rescue rate: All 100 cases: 38.7 38 78 2.4 16% First 20 cases: 48.7 30 50 2.1 45% Next 80 cases: 36.2 40 85 2.5 8.8% p-value: 0.09 0.45 0.002 0.27 <0.001 Abstract O-029 Table 2 Efficacy of ADAPT Technique with Evolving Aspiration Catheter Technology First aspiration catheter used: Mean time puncture to reperfusion (min): TICI 2b/3 after 1 ADAPT pass: TICI 2b/3 with ADAPT only: Mean total number of ADAPT passes: Solumbra rescue rate: 3 Max: (n=2) 55.5 0 0 2.5 100 ACE 60: (n=45) 48.8 31% 64% 2.4 29% ACE 64: (n=34) 30.2 38% 88% 2.5 3% ACE 68: (n=16) 29.3 50% 100% 2.6 0 NeuronMax: (n=3) 22.7 100% 100% 1 0 p-value: 0.002 (ACE 60 vs ACE 64/68) 0.09 <0.001 0.78 (ACE 60 vs ACE 64/68) <0.001 Conclusion Aspiration thrombectomy using the Penumbra system with ACE reperfusion catheters is an effective first-line treatment for anterior circulation ELVOs, with the option to use adjunctive stent-retriever devices if aspiration alone is not sufficient. Advancements in reperfusion catheter technology from ACE 60 to ACE 68 have resulted in shorter procedural times and reduced need for adjunctive stent-retriever device use. Disclosures J. Delgado Almandoz: 2; C; Penumbra, Inc, Medtronic Neurovacular. Y. Kayan: 2; C; Penumbra, Inc, Medtronic Neurovacular. M. Young: None. J. Scholz: None. A. Milner: None. J. Fease: None. P. Roohani: None. A. Wallace: None. M. Mulder: None. R. Tarrel: None.