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1.
J Neurointerv Surg ; 2024 Jan 09.
Article in English | MEDLINE | ID: mdl-38195248

ABSTRACT

BACKGROUND: Patients treated with mechanical thrombectomy (MT) for acute ischemic strokes from large vessel occlusion (LVO) have better outcomes with effective reperfusion. However, it is unknown which technique leads to better technical and clinical success. We aimed to determine which technique yields the most effective first pass reperfusion during MT. METHODS: In a prospective, multicenter global registry we enrolled patients treated with operator preferred MT technique at 71 hospitals from January 2019 to January 2022. Three techniques were assessed: SR Classic with stent retriever (SR) and balloon guide catheter (BGC); SR Combination which employed SR with contact aspiration with or without BGC; and direct aspiration (DA) with or without BGC. The primary outcome was achieving an expanded Thrombolysis In Cerebral Infarction (eTICI) score of 2c or 3 on the first pass, with the primary technique as adjudicated by core lab. The primary clinical outcome measure was a 90-day modified Rankin Scale (mRS) score of 0-2. RESULTS: A total of 1492 patients were enrolled. Patients treated with SR Classic or SR Combination were more likely to achieve first pass eTICI 2c or 3 reperfusion (P=0.01). There was no significant difference in mRS 0-2 (P=0.46) or safety endpoints. CONCLUSIONS: The use of SR Classic or SR Combination was more likely to achieve first pass eTICI 2c or 3 reperfusion. There were no significant differences in clinical outcomes and safety endpoints.

2.
J Neurointerv Surg ; 2023 Nov 08.
Article in English | MEDLINE | ID: mdl-37940387

ABSTRACT

BACKGROUND: The Neuroform Atlas Stent System is an established treatment modality for unruptured anterior and posterior circulation intracranial aneurysms. Location-specific results are needed to guide treatment decision-making. However, it is unclear whether there are differences in safety and efficacy outcomes between carotid and more distal anterior circulation aneurysms. METHODS: The ATLAS IDE trial was a prospective, multicenter, single-arm, open-label interventional study that evaluated the safety and efficacy of the Neuroform Atlas Stent System. We compared differences in efficacy and safety outcomes of proximal internal carotid artery (ICA) versus distal and bifurcation anterior circulation aneurysms. RESULTS: Of 182 cases, there were 70 aneurysms in the ICA and 112 in the distal anterior circulation (including ICA terminus/bifurcation). There were no significant differences in the primary efficacy endpoint (85.5% vs 83.9%, p=0.78) and complete aneurysm occlusion rates (88.7% vs 87.9%, p=0.78) between proximal ICA aneurysms and distal aneurysms, respectively. Complications were more often encountered in distal and bifurcation aneurysms, but the overall rate of major safety events was low and comparable between the two groups (1.4% vs 6.3%, p=0.14). Recanalization and retreatment rates were also similar between the groups. CONCLUSION: The results of this study suggest that the Neuroform Atlas Stent System is a safe and efficacious treatment modality for unruptured anterior circulation intracranial aneurysms, regardless of aneurysm location. TRIAL REGISTRATION NUMBER: NCT02340585.

3.
J Neurointerv Surg ; 2023 Sep 12.
Article in English | MEDLINE | ID: mdl-37699704

ABSTRACT

BACKGROUNDS: Recent trials have shown improved outcomes after mechanical thrombectomy (MT) for vertebrobasilar occlusion (VBO) stroke. However, there is a paucity of data regarding safety and outcomes of rescue intracranial stenting (RS) after failed MT (FRRS+) for posterior circulation stroke. We sought to compare RS to failed reperfusion without RS (FRRS-). METHODS: This is a retrospective analysis of the Stenting and Angioplasty in NeuroThrombectomy (SAINT) study, a multicenter collaboration involving prospectively collected databases. Patients were included if they had posterior circulation stroke and failed MT. The cohort was divided into two groups: FRRS+ and FRRS- (defined as modified Thrombolysis In Cerebral Infarction (mTICI) score 0-2a). The primary outcome was a shift in the degree of disability as measured by the modified Rankin Scale (mRS) at 90 days. Secondary outcomes included mRS 0-2 and mRS 0-3 at 90 days. Safety measures included rates of symptomatic intracranial hemorrhage (sICH), procedural complications, and 90-day mortality. Sensitivity and subgroup analyses were performed to identify outcomes in a matched cohort and in those with VBO, respectively. RESULTS: A total of 152 failed thrombectomies were included in the analysis. FRRS+ (n=84) was associated with increased likelihood of lower disability (acOR 2.24, 95% CI 1.04 to 4.95, P=0.04), higher rates of mRS 0-2 (26.8% vs 12.5%, aOR 4.43, 95% CI 1.22 to 16.05, P=0.02) and mRS 0-3 (35.4% vs 18.8%, aOR 3.13, 95% CI 1.08 to 9.10, P=0.036), and lower mortality (42.7% vs 59.4%, aOR 0.40, 95% CI 0.17 to 0.97, P=0.04) at 90 days compared with FRRS- (n=68). The rates of sICH and procedural complications were comparable between the groups. Sensitivity and subgroup analyses showed similar results. CONCLUSION: In patients with posterior circulation stroke who had failed MT, RS resulted in better functional outcomes with comparable safety profile to procedure termination.

4.
J Neurointerv Surg ; 15(e2): e240-e247, 2023 Nov.
Article in English | MEDLINE | ID: mdl-36597943

ABSTRACT

BACKGROUND: There is little data available to guide optimal anesthesia management during rescue intracranial angioplasty and stenting (ICAS) for failed mechanical thrombectomy (MT). We sought to compare the procedural safety and functional outcomes of patients undergoing rescue ICAS for failed MT under general anesthesia (GA) vs non-general anesthesia (non-GA). METHODS: We searched the data from the Stenting and Angioplasty In Neuro Thrombectomy (SAINT) study. In our review we included patients if they had anterior circulation large vessel occlusion strokes due to intracranial internal carotid artery (ICA) or middle cerebral artery (MCA-M1/M2) segments, failed MT, and underwent rescue ICAS. The cohort was divided into two groups: GA and non-GA. We used propensity score matching to balance the two groups. The primary outcome was the shift in the degree of disability as measured by the modified Rankin Scale (mRS) at 90 days. Secondary outcomes included functional independence (90-day mRS0-2) and successful reperfusion defined as mTICI2B-3. Safety measures included symptomatic intracranial hemorrhage (sICH) and 90-day mortality. RESULTS: Among 253 patients who underwent rescue ICAS, 156 qualified for the matching analysis at a 1:1 ratio. Baseline demographic and clinical characteristics were balanced between both groups. Non-GA patients had comparable outcomes to GA patients both in terms of the overall degree of disability (mRS ordinal shift; adjusted common odds ratio 1.29, 95% CI [0.69 to 2.43], P=0.43) and rates of functional independence (33.3% vs 28.6%, adjusted odds ratio 1.32, 95% CI [0.51 to 3.41], P=0.56) at 90 days. Likewise, there were no significant differences in rates of successful reperfusion, sICH, procedural complications or 90-day mortality among both groups. CONCLUSIONS: Non-GA seems to be a safe and effective anesthesia strategy for patients undergoing rescue ICAS after failed MT. Larger prospective studies are warranted for more concrete evidence.


Subject(s)
Brain Ischemia , Stroke , Humans , Intention to Treat Analysis , Treatment Outcome , Stroke/surgery , Intracranial Hemorrhages/etiology , Anesthesia, General/adverse effects , Thrombectomy/adverse effects , Brain Ischemia/surgery
5.
Stroke ; 53(9): 2779-2788, 2022 09.
Article in English | MEDLINE | ID: mdl-35770672

ABSTRACT

BACKGROUND: Successful reperfusion is one of the strongest predictors of functional outcomes after mechanical thrombectomy (MT). Despite continuous advancements in MT technology and techniques, reperfusion failure still occurs in ≈15% to 30% of patients with large vessel occlusion strokes undergoing MT. We aim to evaluate the safety and efficacy of rescue intracranial stenting for large vessel occlusion stroke after failed MT. METHODS: The SAINT (Stenting and Angioplasty in Neurothrombectomy) Study is a retrospective analysis of prospectively collected data from 14 comprehensive stroke centers through January 2015 to December 2020. Patients were included if they had anterior circulation large vessel occlusion stroke due to intracranial internal carotid artery and middle cerebral artery-M1/M2 segments and failed MT. The cohort was divided into 2 groups: rescue intracranial stenting and failed recanalization (modified Thrombolysis in Cerebral Ischemia score 0-1). Propensity score matching was used to balance the 2 groups. The primary outcome was the shift in the degree of disability as measured by the modified Rankin Scale at 90 days. Secondary outcomes included functional independence (90-day modified Rankin Scale score 0-2). Safety measures included symptomatic intracranial hemorrhage and 90-day mortality. RESULTS: A total of 499 patients were included in the analysis. Compared with the failed reperfusion group, rescue intracranial stenting had a favorable shift in the overall modified Rankin Scale score distribution (acOR, 2.31 [95% CI, 1.61-3.32]; P<0.001), higher rates of functional independence (35.1% versus 7%; adjusted odds ratio [aOR], 6.33 [95% CI, 3.14-12.76]; P<0.001), and lower mortality (28% versus 46.5%; aOR, 0.55 [95% CI, 0.31-0.96]; P=0.04) at 90 days. Rates of symptomatic intracerebral hemorrhage were comparable across both groups (7.1% versus 10.2%; aOR, 0.99 [95% CI, 0.42-2.34]; P=0.98). The matched cohort analysis demonstrated similar results. Specifically, rescue intracranial stenting (n=107) had a favorable shift in the overall modified Rankin Scale score distribution (acOR, 3.74 [95% CI, 2.16-6.57]; P<0.001), higher rates of functional independence (34.6% versus 6.5%; aOR, 10.91 [95% CI, 4.11-28.92]; P<0.001), and lower mortality (29.9% versus 43%; aOR, 0.49 [95% CI, 0.25-0.94]; P=0.03) at 90 days with similar rates of symptomatic intracerebral hemorrhage (7.5% versus 11.2%; aOR, 0.87 [95% CI, 0.31-2.42]; P=0.79) compared with patients who failed to reperfuse (n=107). There was no heterogeneity of treatment effect across the prespecified subgroups for improvement in functional outcomes. CONCLUSIONS: Acute intracranial stenting appears to be a safe and effective rescue strategy in patients with large vessel occlusion stroke who failed MT. Randomized multicenter trials are warranted.


Subject(s)
Arterial Occlusive Diseases , Brain Ischemia , Stroke , Angioplasty , Brain Ischemia/etiology , Brain Ischemia/surgery , Cerebral Hemorrhage/etiology , Humans , Retrospective Studies , Stents , Stroke/therapy , Thrombectomy/methods , Treatment Outcome
6.
J Neurointerv Surg ; 14(2): 143-148, 2022 Feb.
Article in English | MEDLINE | ID: mdl-33722961

ABSTRACT

BACKGROUND: Stent-assisted coiling of wide-necked intracranial aneurysms (IAs) using the Neuroform Atlas Stent System (Atlas) has shown promising results. OBJECTIVE: To present the primary efficacy and safety results of the ATLAS Investigational Device Exemption (IDE) trial in a cohort of patients with posterior circulation IAs. METHODS: The ATLAS trial is a prospective, multicenter, single-arm, open-label study of unruptured, wide-necked, IAs treated with the Atlas stent and adjunctive coiling. This study reports the results of patients with posterior circulation IAs. The primary efficacy endpoint was complete aneurysm occlusion (Raymond-Roy (RR) class I) on 12-month angiography, in the absence of re-treatment or parent artery stenosis >50%. The primary safety endpoint was any major ipsilateral stroke or neurological death within 12 months. Adjudication of the primary endpoints was performed by an imaging core laboratory and a Clinical Events Committee. RESULTS: The ATLAS trial enrolled and treated 116 patients at 25 medical centers with unruptured, wide-necked, posterior circulation IAs (mean age 60.2±10.5 years, 81.0% (94/116) female). Stents were placed in all patients with 100% technical success rate. A total of 95/116 (81.9%) patients had complete angiographic follow-up at 12 months, of whom 81 (85.3%) had complete aneurysm occlusion (RR class I). The primary effectiveness outcome was achieved in 76.7% (95% CI 67.0% to 86.5%) of patients. Overall, major ipsilateral stroke and secondary persistent neurological deficit occurred in 4.3% (5/116) and 1.7% (2/116) of patients, respectively. CONCLUSIONS: In the ATLAS IDE posterior circulation cohort, the Neuroform Atlas Stent System with adjunctive coiling demonstrated high rates of technical and safety performance. Trial registration number https://clinicaltrials.gov/ct2/show/NCT02340585.


Subject(s)
Embolization, Therapeutic , Intracranial Aneurysm , Aged , Cerebral Angiography , Female , Humans , Intracranial Aneurysm/diagnostic imaging , Intracranial Aneurysm/surgery , Middle Aged , Prospective Studies , Retrospective Studies , Stents , Treatment Outcome
7.
Neurosurgery ; 89(1): 102-108, 2021 06 15.
Article in English | MEDLINE | ID: mdl-33826707

ABSTRACT

BACKGROUND: Heterogeneous effect of endovascular aneurysm therapy has been observed across different anatomic locations. There is a paucity of data for stent-assisted coiling of middle cerebral artery (MCA) aneurysms. OBJECTIVE: To present the results of the MCA aneurysm group from the Neuroform Atlas (Stryker Neurovascular) investigational device exemption (IDE) trial. METHODS: The Atlas IDE trial is a prospective, multicenter, single-arm, open-label study of wide-neck aneurysms (neck ≥ 4 mm or dome-to-neck ratio < 2) in the anterior circulation treated with the Neuroform Atlas Stent and approved coils. Follow-up was obtained immediately postprocedure and 2, 6, and 12 mo postoperatively. We herein describe safety and efficacy outcomes, and functional independence of the subjects with aneurysms from all segments of MCA. RESULTS: A total of 35 patients were included (27 MCA bifurcation, 5 M1, 3 M2). The mean aneurysm size was 6.0 ± 1.8 mm, and the mean neck was 4.4 ± 1.2 mm. Technical procedural success was achieved in all patients. A total of 26 patients had follow-up digital subtraction angiography available at 12 mo, with 80.8% (21/26) having complete aneurysm occlusion. Twelve-month safety data were collected for 91.4% (32/35), 8.5% (3/35) had primary safety endpoint, all 3 major ischemic strokes. Mortality occurred in 2 patients beyond 30 d unrelated to procedure (1 gallbladder cancer and 1 fentanyl intoxication). At 1 yr, modified Rankin Score was 0 to 2 in 84.4% (27/32), 3 in 9.4%, and 3 patients were missing. Approximately 5.7% (2/35) of patients were retreated at 12 mo. CONCLUSION: Stent-assisted coiling with the Neuroform Atlas Stent is a viable alternative to clipping for selected MCA aneurysms. Complete aneurysm occlusion rates have improved compared to historical data. Proper case selection can lead to acceptable endovascular results.


Subject(s)
Aortic Aneurysm, Abdominal , Embolization, Therapeutic , Intracranial Aneurysm , Stents , Blood Vessel Prosthesis Implantation , Cerebral Angiography , Endovascular Procedures , Humans , Intracranial Aneurysm/diagnostic imaging , Intracranial Aneurysm/surgery , Prospective Studies , Retrospective Studies , Treatment Outcome
9.
Stroke ; 51(7): 2087-2094, 2020 07.
Article in English | MEDLINE | ID: mdl-32568654

ABSTRACT

BACKGROUND AND PURPOSE: Stent-assisted coil embolization using the new generation Neuroform Atlas Stent System has shown promising safety and efficacy. The primary study results of the anterior circulation aneurysm cohort of the treatment of wide-neck, saccular, intracranial, aneurysms with the Neuroform Atlas Stent System (ATLAS trial [Safety and Effectiveness of the Treatment of Wide Neck, Saccular Intracranial Aneurysms With the Neuroform Atlas Stent System]) are presented. METHODS: ATLAS IDE trial (Investigational Device Exemption) is a prospective, multicenter, single-arm, open-label study of wide-neck (neck ≥4 mm or dome-to-neck ratio <2) intracranial aneurysms in the anterior circulation treated with the Neuroform Atlas Stent and approved coils. The primary efficacy end point was complete aneurysm occlusion (Raymond-Roy class 1) on 12-month angiography, in the absence of retreatment or parent artery stenosis (>50%) at the target location. The primary safety end point was any major stroke or ipsilateral stroke or neurological death within 12 months. Adjudication of the primary end points was performed by an independent Imaging Core Laboratory and the Clinical Events Committee. RESULTS: A total of 182 patients with wide-neck anterior circulation aneurysms at 25 US centers were enrolled. The mean age was 60.3±11.4 years, 73.1% (133/182) women, and 80.8% (147/182) white. Mean aneurysm size was 6.1±2.2 mm, mean neck width was 4.1±1.2 mm, and mean dome-to-neck ratio was 1.2±0.3. The most frequent aneurysm locations were the anterior communicating artery (64/182, 35.2%), internal carotid artery ophthalmic artery segment (29/182, 15.9%), and middle cerebral artery bifurcation (27/182, 14.8%). Stents were placed in the anticipated anatomic location in all patients. The study met both primary safety and efficacy end points. The composite primary efficacy end point of complete aneurysm occlusion (Raymond-Roy 1) without parent artery stenosis or aneurysm retreatment was achieved in 84.7% (95% CI, 78.6%-90.9%) of patients. Overall, 4.4% (8/182, 95% CI, 1.9%-8.5%) of patients experienced a primary safety end point of major ipsilateral stroke or neurological death. CONCLUSIONS: In the ATLAS IDE anterior circulation aneurysm cohort premarket approval study, the Neuroform Atlas stent with adjunctive coiling met the primary end points and demonstrated high rates of long-term complete aneurysm occlusion at 12 months, with 100% technical success and <5% morbidity. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02340585.


Subject(s)
Embolization, Therapeutic/instrumentation , Endovascular Procedures/instrumentation , Intracranial Aneurysm/therapy , Stents , Adult , Aged , Female , Humans , Male , Middle Aged , Treatment Outcome
10.
J Neurointerv Surg ; 11(8): 801-806, 2019 Aug.
Article in English | MEDLINE | ID: mdl-30670625

ABSTRACT

BACKGROUND AND OBJECTIVE: Stent-assisted coil embolization is a well-established treatment of intracranial wide-necked aneurysms. The Neuroform Atlas Stent System is a new generation microstent designed to enhance coil support, conformability, deliverability, and improve deployment accuracy. We present the 1-year efficacy and angiographic results of the Humanitarian Device Exemption (HDE) cohort from the Atlas Investigational Device Exemption (IDE) clinical trial. METHOD: The Atlas IDE trial is a prospective, multicenter, single-arm, open-label study of unruptured wide-necked intracranial aneurysms treated with the Neuroform Atlas stent and approved coils. The primary efficacy endpoint was the rate of 12-month complete aneurysm angiographic occlusion (Raymond class I) without target aneurysm retreatment or significant parent artery stenosis (>50%) at the target location. The primary safety endpoint was the rate of major ipsilateral stroke or neurological death within 12 months. Imaging core laboratory and Clinical EventsCommittee adjudicated the primary endpoints. RESULTS: 30 patients were enrolled at eight US centers, with 27 patients completing the 12-month angiographic follow-up. The mean age was 59.4±11.8 years and 24/30 patients (80%) were women. The mean aneurysm size was 5.3±1.7 mm and the dome:neck ratio was 1.1±0.2. Procedural technical success of Neuroform Atlas Stent deployment was 100%. 27 patients completed 12-month angiographic follow-up and 30 patients completed their 6-month follow-up. When applying the last observation carried forward method, the primary efficacy endpoint was observed in 26/30 patients (86.7%, 95% CI 69.3% to 96.2%) compared with 25/27 patients (92.6%, 95% CI 75.7% to 99.1%) who completed the 12-month angiographic follow-up. The primary safety endpoint of stroke occurred in one patient (3.3%), who made a complete clinical recovery at discharge. There were no neurological deaths. CONCLUSION: The Neuroform Atlas stent in conjunction with coils demonstrated a high rate of complete aneurysm occlusion at 12-month angiographic follow-up, with an improved safety profile in the HDE cohort. CLINICAL TRIALGOV REGISTRATION NUMBER: NCT0234058;Results.


Subject(s)
Compassionate Use Trials/instrumentation , Compassionate Use Trials/trends , Intracranial Aneurysm/diagnostic imaging , Intracranial Aneurysm/surgery , Self Expandable Metallic Stents , Adult , Aged , Blood Vessel Prosthesis/trends , Cerebral Angiography/methods , Cerebral Angiography/trends , Cohort Studies , Compassionate Use Trials/methods , Embolization, Therapeutic/instrumentation , Embolization, Therapeutic/methods , Embolization, Therapeutic/trends , Female , Humans , Intracranial Aneurysm/therapy , Male , Middle Aged , Patient Discharge/trends , Prospective Studies , Retreatment/trends , Treatment Outcome
11.
J Neurointerv Surg ; 9(7): 641-643, 2017 Jul.
Article in English | MEDLINE | ID: mdl-27358282

ABSTRACT

BACKGROUND: Mechanical thrombectomy has become the accepted treatment for large vessel occlusion in acute ischemic stroke. Unfortunately, a large cohort of patients do not achieve functional independence with treatment, even though the results are more robust than with medical management. The hyperintense acute reperfusion marker (HARM) on MRI is an indication of the breakdown of the blood-brain barrier and reperfusion injury. OBJECTIVE: To examine the hypothesis that the presence of HARM on MRI correlates with worse neurological recovery after reperfusion therapy. METHODS: We retrospectively reviewed 35 consecutive patients who between February 24, 2016 and April 23, 2016 underwent MRI to determine the presence of HARM after thrombectomy for anterior circulation large vessel occlusion. Demographic, radiographic imaging, and outcome data were collected. Univariate and binary logistic regression models were performed to assess predictors for improvement of the National Institutes of Health Stroke Scale (NIHSS) score by ≥8 points at 24 hours. RESULTS: The 35 patients studied had an average age of 64±14 years of age with a median NIHSS score of 15 (IQR 9-20). Eighteen patients (51%) were found to have a HARM-positive MRI. In univariate analysis, patients with HARM were older, had lower reperfusion rates and more postprocedural hemorrhages. In binary logistic regression modeling, the absence of HARM was independently associated with a ≥8-point NIHSS score improvement at 24 hours (OR=7.14, 95% CI 1.22 to 41.67). CONCLUSIONS: This preliminary analysis shows that the presence of HARM may be linked to worse neurological recovery 24 hours after thrombectomy. Reperfusion injury may affect the number of patients achieving functional independence after treatment.


Subject(s)
Cerebral Revascularization/adverse effects , Magnetic Resonance Imaging , Recovery of Function , Stroke/surgery , Thrombectomy/adverse effects , Aged , Blood-Brain Barrier/diagnostic imaging , Cerebral Revascularization/trends , Female , Humans , Magnetic Resonance Imaging/trends , Male , Middle Aged , Recovery of Function/physiology , Reperfusion/adverse effects , Reperfusion/trends , Retrospective Studies , Stroke/diagnostic imaging , Thrombectomy/trends , Treatment Outcome
12.
J Neurointerv Surg ; 8(8): 775-7, 2016 Aug.
Article in English | MEDLINE | ID: mdl-26276076

ABSTRACT

INTRODUCTION: With the publication of the recent trials showing the tremendous benefits of mechanical thrombectomy, opportunities exist to refine prehospital processes to identify patients with larger stroke syndromes. MATERIALS AND METHODS: We retrospectively reviewed consecutive patients who were brought via scene flight from rural parts of the region to our institution, from December 1, 2014 to June 5, 2015, with severe hemiparesis or hemiplegia. We assessed the accuracy of the diagnosis of stroke and the number of patients requiring endovascular therapy. Moreover, we reviewed the times along the pathway of patients who were treated with endovascular therapy. RESULTS: 45 patients were brought via helicopter from the field to our institution. 27 (60%) patients were diagnosed with an ischemic stroke. Of these, 12 (26.7%) were treated with mechanical thrombectomy and 6 (13.3%) with intravenous tissue plasminogen activator alone. An additional three patients required embolization procedures for either a dural arteriovenous fistula or cerebral aneurysm. Thus a total of 15 (33%) patients received an endovascular procedure and 21/45 (46.7%) received an acute treatment. For patients treated with thrombectomy, the median time from first medical contact to groin puncture was 101 min, with 8 of the 12 patients (66.7%) being discharged to home. CONCLUSIONS: We have presented a pilot study showing that severe hemiparesis or hemiplegia may be a reasonable prehospital tool in recognizing patients requiring endovascular treatment. Patients being identified earlier may be treated faster and potentially improve outcomes. Further prospective controlled studies are required to assess the impact on outcomes and cost effectiveness using this methodology.


Subject(s)
Paresis/diagnosis , Stroke/diagnosis , Triage/methods , Adult , Aged , Aged, 80 and over , Air Ambulances , Brain Ischemia/complications , Central Nervous System Vascular Malformations/surgery , Central Nervous System Vascular Malformations/therapy , Embolization, Therapeutic , Endovascular Procedures/methods , Female , Humans , Intracranial Aneurysm/complications , Intracranial Aneurysm/surgery , Male , Middle Aged , Pilot Projects , Reproducibility of Results , Retrospective Studies , Thrombectomy , Time-to-Treatment , Tissue Plasminogen Activator/therapeutic use , Treatment Outcome
13.
J Neurointerv Surg ; 8(7): 661-4, 2016 Jul.
Article in English | MEDLINE | ID: mdl-26089402

ABSTRACT

BACKGROUND: Rapid delivery of IV tissue plasminogen activator (tPA) in qualifying patients leads to better clinical outcomes. The American Heart Association has reduced target door-to-needle (DTN) times from 60 to 45 min in the hopes of continued process improvements across institutions. OBJECTIVE: To start a quality improvement project called CODE FAST in order to reduce DTN times at our institution. MATERIALS AND METHODS: We retrospectively reviewed data from our internally maintained database of patients treated with intravenous tPA before and after implementation of the CODE FAST protocol. We assessed demographic information, time of day and times of arrival to first image and delivery of tPA in patients from February 2014 to February 2015. Outcomes were assessed based on discharge to home. Univariate analysis was performed to assess for improvement in DTN times before and after implementation of the protocol. RESULTS: A total of 93 patients (41 pre-CODE FAST and 52 post-CODE FAST) received IV tPA during the study period. Patients were equally matched between the two groups except that in the pre-CODE FAST era patients receiving tPA were younger and more likely to be men. There was a substantial reduction in door-to-imaging time from a median of 16 to 8 min (p<0.0001) and DTN time with a reduction in the median from 62 to 25 min (p<0.0001). In logistic regression modeling, there was a trend towards more discharges to home in patients treated during the CODE FAST era. CONCLUSIONS: We present a quality improvement project that has been overwhelmingly successful in reducing DTN time to <30 min. The template we present may be helpful to other institutions looking to reduce their DTN times and may also reduce costs as we note a trend towards more discharges to home.


Subject(s)
Fibrinolytic Agents/therapeutic use , Quality Improvement/organization & administration , Stroke/therapy , Thrombolytic Therapy/methods , Time-to-Treatment/statistics & numerical data , Tissue Plasminogen Activator/therapeutic use , Age Factors , Aged , Aged, 80 and over , Databases, Factual , Emergency Medical Services , Female , Fibrinolytic Agents/administration & dosage , Humans , Male , Middle Aged , Neuroimaging , Patient Discharge/statistics & numerical data , Retrospective Studies , Sex Factors , Stroke/diagnostic imaging , Stroke/epidemiology , Thrombolytic Therapy/statistics & numerical data , Tissue Plasminogen Activator/administration & dosage
14.
J Vasc Interv Neurol ; 5(1): 17-21, 2012 Jun.
Article in English | MEDLINE | ID: mdl-22737261

ABSTRACT

Increase packing density with the use of softer three-dimensional (3D) coils has been indicated in reducing aneurysm recurrence. We are reporting a multicenter initial experience of using the Orbit Galaxy XTRASOFT which is a stretch-resistant, softer 3D coil in both ruptured and unruptured aneurysms. A total of 57 consecutive patients from five high-volume neurointerventional centers were reported where at least one Galaxy XTRASOFT coil was used during a procedure. There were 25 patients with ruptured aneurysm and 32 with elective coiling. The overall complication rate was 3.5%, one patient with nonoperative retroperitoneal hematoma and one patient with intraoperative rupture but with no neurological deficit. The occlusion rate of 90% or greater was achieved in 86% of the cases. The discharge modified Rankin score of 0 or 1 was achieved in 100% of the elective coiling and 65% in the ruptured cases. Early experience with Galaxy XTRASOFT coils for both ruptured and unruptured aneurysms appears to be safe with good aneurysm obliteration and low complication rate.

15.
J Neurointerv Surg ; 4(5): 375-8, 2012 Sep.
Article in English | MEDLINE | ID: mdl-21990538

ABSTRACT

OBJECTIVE: Hydrosoft coils were developed to serve as finishing coils to prevent aneurysmal recurrence at the neck. Initial animal studies were encouraging since some studies showed endothelial healing across the neck without recurrence over time. However, theoretical concerns exist regarding the potential threat to parent vessels as the Hydrosoft coils at the neck expand, as well as whether such coils can be adequately supple to safely serve as a true finishing coil. A retrospective review of the initial clinical experience utilizing Hydrosoft coils from three high-volume centers was performed. METHODS: Each center was asked to report angiographic (aneurysmal location, aneurysmal maximal size, neck size, incidence of intraprocedural parent vessel thrombosis, coil herniation, aneurysmal rupture as well as Raymond scale and percent occlusion after coiling) and clinical (rupture status, Hunt and Hess grade, incidence of stroke, hemorrhage, vasospasm and hydrocephalus) data on consecutive patients who underwent placement of Hydrosoft coils. RESULTS: A total of 141 patients were enrolled. Embolization achieved a Raymond scale score of I (complete obliteration) in 79 aneurysms (56%), II (residual neck) in 40 aneurysms (28%) and III (residual dome) in 21 aneurysms (15%); in one case the Hydrosoft coil could not be placed. Procedural morbidity and mortality were 2.1% and 1.4%, respectively. No complications were definitively attributed to the use of Hydrosoft coils. There were three cases (2.1%) of parent vessel thrombosis, two of which resolved after intraprocedural administration of thrombolytic agents and did not lead to neurological sequelae. The incidences of intraprocedural or periprocedural aneurysmal rupture (2.1%), cerebral hemorrhage (3.5%), stroke (4.9%), vasospasm (26.2%) or hydrocephalus (31.1%) were comparable to contemporary literature. CONCLUSION: The use of Hydrosoft coils appears to be safe and does not lead to higher complication rates than are currently accepted in the literature. Further prospective studies are required to determine whether the use of Hydrosoft coils results in a lower incidence of aneurysmal recurrence.


Subject(s)
Embolization, Therapeutic/methods , Intracranial Aneurysm/therapy , Patient Safety , Perioperative Care/methods , Embolization, Therapeutic/adverse effects , Embolization, Therapeutic/mortality , Humans , Intracranial Aneurysm/mortality , Perioperative Care/adverse effects , Perioperative Care/mortality , Retrospective Studies , Treatment Outcome
16.
Spine J ; 11(7): e9-e14, 2011 Jul.
Article in English | MEDLINE | ID: mdl-21641873

ABSTRACT

BACKGROUND CONTEXT: Hemangiopericytoma (HPC) occurs infrequently in the central nervous system. Spinal involvement is particularly uncommon; and intradural localization is rare. Here, we describe an intradural extramedullary thoracic HPC that went undiagnosed initially on computed tomography scan of the abdomen. PURPOSE: To describe the clinical presentation and operative management of a patient diagnosed with an intradural extramedullary thoracic HPC that was missed on initial workup. We also describe the pathologic features of HPC. STUDY DESIGN: Case report. METHODS: Chart review and literature search. CASE: A 58-year-old man presented with acute weakness of the lower extremities and bladder and bowel incontinence. Magnetic resonance imaging of his spine revealed a T10 intradural extramedullary lesion that displaced the cord to the right. RESULTS: The patient was taken emergently to surgery for T9-T11 laminectomy and en bloc resection of the tumor. The lesion was identified and resected. Histology revealed randomly oriented tumor cells with irregular capillaries consistent with HPC. Postoperatively, the patient had an improved neurological examination, and he continued to do so with intense physical therapy. CONCLUSION: The standard treatment for HPC is surgery when the lesion is resectable. Despite gross total resection, there is still a high risk of recurrence and metastasis; therefore, patients should be followed up closely by their physicians with serial postoperative clinical examinations and radiographic imaging.


Subject(s)
Hemangiopericytoma/pathology , Spinal Neoplasms/pathology , Thoracic Vertebrae/pathology , Hemangiopericytoma/surgery , Humans , Male , Middle Aged , Spinal Neoplasms/surgery , Thoracic Vertebrae/surgery
17.
J Neurosurg ; 114(1): 40-6, 2011 Jan.
Article in English | MEDLINE | ID: mdl-20815694

ABSTRACT

OBJECT: Venous thromboembolism (VTE), a combination of deep venous thrombosis (DVT) and pulmonary embolism (PE), is a major cause of morbidity and death in neurosurgical patients. This study evaluates 1) the risk of developing lower-extremity DVT following a neurosurgical procedure; 2) the timing of initiation of pharmacological DVT prophylaxis upon the occurrence of VTE; and 3) the relationship between DVT and PE as related to VTE prophylaxis in neurosurgical patients. METHODS: The records of all neurosurgical patients between January 2006 and December 2008 (2638 total) were reviewed for clinical documentation of VTE. As part of a quality improvement initiative, a subgroup of 1638 patients was studied during the implementation of pharmacological prophylaxis. A high-risk group of 555 neurosurgical patients in the intensive care unit underwent surveillance venous lower-extremity duplex ultrasonography studies twice weekly. All patients throughout the review received mechanical DVT prophylaxis. Pharmacological DVT prophylaxis, consisting of 5000 U of subcutaneous heparin twice daily (initially started within 48 hours of a neurosurgical procedure and subsequently within 24 hours of a procedure) was implemented in combination with mechanical prophylaxis. The DVT and PE rates were calculated for each group. RESULTS: In the surveillance group (555 patients), 84% of the DVTs occurred within 1 week and 92% within 2 weeks of a neurosurgical procedure. There was a linear correlation between the duration of surgery and DVT development. The use of subcutaneous heparin reduced the rate of DVT from 16% to 9% when medication was given at either 24 or 48 hours postoperatively, without any increase in hemorrhagic complications. In the overall group (2638 patients), there were 94 patients who exhibited clinical signs of a possible PE and therefore underwent spiral CT; 22 of these patients (0.8%) had radiological confirmation of PE. There was no correlation between the use of pharmacological prophylaxis at either time point and the occurrence of PE, despite a 43% reduction in the lower-extremity DVT rate with pharmacological intervention. CONCLUSIONS: The majority of DVTs occurred within the first week after a neurosurgical procedure. There was a linear correlation between the duration of surgery and DVT occurrence. Use of early subcutaneous heparin (at either 24 or 48 hours) was associated with a 43% reduction of developing a lower-extremity DVT, without an increase in surgical site hemorrhage. There was no association of pharmacological prophylaxis with overall PE occurrence.


Subject(s)
Neurosurgical Procedures/adverse effects , Pulmonary Embolism/etiology , Venous Thromboembolism/etiology , Venous Thrombosis/etiology , Adolescent , Adult , Aged , Aged, 80 and over , Anticoagulants/adverse effects , Anticoagulants/therapeutic use , Child , Child, Preschool , Female , Hemorrhage/epidemiology , Heparin/adverse effects , Heparin/therapeutic use , Humans , Incidence , Infant , Infant, Newborn , Male , Middle Aged , Pulmonary Embolism/epidemiology , Pulmonary Embolism/prevention & control , Retrospective Studies , Risk Factors , Time Factors , Venous Thromboembolism/epidemiology , Venous Thromboembolism/prevention & control , Venous Thrombosis/epidemiology , Venous Thrombosis/prevention & control , Young Adult
18.
Skull Base Rep ; 1(1): 7-12, 2011 May.
Article in English | MEDLINE | ID: mdl-23984195

ABSTRACT

Lesions of the lower clivus represent a technically challenging subset of skull base disease that requires careful treatment. A 75-year-old woman with tongue atrophy was referred for resection of a presumed clival chordoma. The lesion was resected via an endoscopic transnasal transclival approach with no complications. Pathology revealed only chronic inflammatory tissue consistent with a degenerative pannus. Degenerative pannus should be included in the differential diagnosis of lower clival extradural lesions. The endoscopic transnasal transclival corridor should be considered for resection of such lesions as an alternative to larger, more morbid, traditional skull base approaches.

19.
Neurol Clin ; 28(4): 1037-59, 2010 Nov.
Article in English | MEDLINE | ID: mdl-20816276

ABSTRACT

World Health Organization grade II gliomas (GIIG) are diffuse, slow-growing, primary neuroectodermal tumors that occur in the central nervous system. They are generally seen in young individuals and are slightly more common in Whites and males. Most patients present with seizures but neurologic deficits are rare. Magnetic resonance imaging best detects GIIG and they are most frequently located in the frontal and temporal lobes. An accurate pathologic diagnosis is essential because the natural history of a GIIG may be unpredictable. In recent years, the emphasis has been on surgically removing as much tumor as safely possible to obtain an accurate diagnosis, improve symptoms, reduce tumor burden, and determine the need for adjuvant therapies. Radiation and chemotherapy are integral to the management of GIIG but their efficacy varies by tumor histology and is balanced against complications associated with them. Genetic, histopathologic, clinical, and radiographic changes are noted as GIIG progress to malignant gliomas. The risk of malignant transformation and subsequent survival may be predicted by pretreatment and treatment-related factors.


Subject(s)
Brain Neoplasms/therapy , Brain/pathology , Glioma/therapy , Brain Neoplasms/pathology , Glioma/pathology , Humans
20.
J Neurosurg ; 113(5): 1021-5, 2010 Nov.
Article in English | MEDLINE | ID: mdl-20020840

ABSTRACT

OBJECT: This study was conducted to evaluate the value of postoperative CT scans in determining the probability of return to the operating room (OR) and the optimal time to obtain such scans to determine the effects of surgery. METHODS: Between January and December 2006 (12 months), all postoperative head CT scans obtained for 3 individual surgeons were reviewed. Scans were divided into 3 groups, which were determined by the preference of each surgeon: Group A (early scans-scheduled between 0 and 7 hours); Group B (delayed scans-scheduled between 8 and 24 hours); and Group C (urgent scans-ordered because of a new neurological deficit). The initial scans were reviewed and analyzed in 2 different fashions. The first was to analyze the efficacy of the scans in predicting return to the OR. The second was to determine the optimal time for obtaining a scan. The second analysis was a review of serial postoperative scans for expected versus unexpected findings and changes in the acuity of these findings over time. RESULTS: In 251 (74%) of 338 cases, the patients had postoperative head CT scans within 24 hours of surgery. Analysis 1 determined the percent of patients returning to the OR for emergency treatment based on postoperative scans: Group A (early)-133 patients, with 0% returning to the OR; Group B (delayed)-108 patients, with 0% returning to the OR; and Group C (urgent)-10 patients, with 30% returning to the OR (p < 0.05). Analysis 2 determined the optimal timing of postoperative scans and changes in scan acuity: Group A (early scan) had an 11% incidence of change in acuity on subsequent scans. Group B (delayed scan) had a 3% incidence of change in acuity on follow-up scans (p < 0.05). CONCLUSIONS: Routine postoperative scans at 0-7 hours or at 8-24 hours are not predictive of return to the OR, whereas patients with a new neurological deficit in the postoperative period have a 30% chance of emergency reoperation based on CT scans. In addition, early postoperative scans (0-7 hours) fail to predict CT changes, which might evolve over time and may influence postoperative medical management.


Subject(s)
Brain/diagnostic imaging , Neurosurgical Procedures/methods , Tomography, X-Ray Computed , Brain/surgery , Humans , Postoperative Period , Time Factors
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