Original Paper Cerebrovasc Dis 2013;36:394–400 DOI: 10.1159/000356185
Received: May 23, 2013 Accepted: September 30, 2013 Published online: November 15, 2013
Improved Clinical Outcome after Acute Basilar Artery Occlusion since the Introduction of Endovascular Thrombectomy Devices S. Nagel a L. Kellert a M. Möhlenbruch b J. Bösel a S. Rohde b P. Ringleb a
Departments of a Neurology and b Neuroradiology, University Hospital Heidelberg, Heidelberg, Germany
Key Words Basilar artery occlusion · Thrombolysis · Bridging therapy · Mechanical thrombectomy
Abstract Background: Thrombectomy devices are increasingly used for intra-arterial recanalization therapy in stroke. We analyzed whether the use of these devices modified the outcome of patients with acute basilar occlusion (BAO) at our institution. Methods: Between 1998 and 2012, one hundred forty-seven consecutive patients with acute BAO received recanalization therapy. In July 2009, for the first time, a thrombectomy device was used and hence the cohort was split into two chronological groups: BAO-1 (before July 2009) and BAO-2 (after July 2009). All patients were treated at a dedicated neurological ICU following institutional standard operating procedures. A good clinical outcome was defined as a modified Rankin scale score of 0–2 after 3 months. Univariate and multivariate analyses were applied using outcome parameters as dependent variables and baseline variables with a significant p value in univariate tests as independent variables. Results: One hundred eleven patients (BAO-1) were treated before and 36 were treated after July 2009 (BAO-2). Patients in the BAO-1 and BAO-2 groups had similar neurological deficits on admission as expressed by the Glasgow Coma Scale (BAO-1: median 4, IQR 5, vs. BAO-2: median 4.5, IQR 8, p = 0.41) and the
© 2013 S. Karger AG, Basel 0000–0000/13/0366–0394$38.00/0 E-Mail [email protected] www.karger.com/ced
proportion of patients who were presented intubated and ventilated was similar in both groups as well (49.5 vs. 47.7%, p = 0.85). Bridging concepts with intravenous recombinant tissue plasminogen activator (rtPA) were applied in 18.9% (BAO-1) versus 63.9% (BAO-2, p < 0.001) of cases, whereas glycoprotein IIb/IIIa antagonists were used significantly more frequently in the BAO-1 cohort (57.7 vs. 33.3%, p = 0.034). Thrombectomies were performed in 20 patients (55.5%) of the BAO-2 group but in none of the BAO-1 cohort. Complete recanalization (TICI 3) was achieved in 45.1% (BAO-1) versus 66.7% (BAO-2, p = 0.062) of patients. A good clinical outcome was observed in 13.5% of the BAO-1 group and 30.6% of the BAO-2 cohort (p = 0.026); mortality was 57.7% in the earlier group and 36.1% in the later group (p = 0.034). The frequency of symptomatic intracranial hemorrhage was similar in both groups (8.1% BAO-1 vs. 2.8% BAO-2, p = 0.45). Treatment in the BAO-2 cohort was an independent predictor of good clinical outcome (OR 2.56; 95% CI 1.01–6.78) and mortality (OR 0.36; 95% CI 0.15–0.86) in an adjusted logistic regression model. Conclusion: Our results show improved outcomes in patients in the BAO-2 cohort. The treatment approach in this group was an independent predictor of both good outcome and mortality. Especially in patients with BAO – where endovascular treatment strategies are common clinical practice – bridging protocols with rtPA and modern thrombectomy devices should be used more frequently. © 2013 S. Karger AG, Basel
Dr. S. Nagel, MD Department of Neurology, University of Heidelberg Im Neuenheimer Feld 400 DE–69120 Heidelberg (Germany) E-Mail simon.nagel @ med.uni-heidelberg.de
Downloaded by: Kainan University 203.64.11.45 - 3/7/2015 10:42:19 PM
The survival and functional outcome of patients with acute basilar artery occlusion (BAO) are highly dependent on vessel recanalization [1]. Therefore, intra-arterial (i.a.) thrombolysis is recommended in international guidelines and practiced in many comprehensive stroke centers. Bridging approaches combining the use of intravenous (i.v.) and i.a. interventions have been shown to increase recanalization rates and improve clinical outcomes [2, 3]. For several years, thrombectomy devices have been increasingly used for i.a. therapy. The new generation of these devices comprises innovative stent technology-based clot retrievers [4]. We analyzed whether the employment of treatment approaches using i.v. bridging therapy with recombinant tissue plasminogen activator (rtPA) together with these modern i.a. thrombectomy devices modified the outcome of patients with BAO at our institution.
Methods Since March 1998, all patients treated with thrombolysis have been entered into a prospective database. Data from patients up to September 2012 with confirmed [by either computed tomography angiography (CTA) or magnetic resonance angiography (MRA)] acute BAO who were diagnosed and primarily treated at our institution were retrospectively analyzed. Collected data included age, gender, time of symptom onset, time to treatment, treatment specifications, baseline clinical severity of the stroke syndrome as measured using the Glasgow Coma Scale (GCS), vascular risk factors, imaging data, and outcome measures. Patients were excluded if they did not receive acute revascularization therapy within 24 h after symptom onset, i.e. elective endovascular treatment of BAO after secondary deterioration or of critical basilar artery stenosis, and if they did not receive the full treatment protocol at our institution. The decision for acute therapy was made by the treating physicians based on medical history, clinical presentation, and imaging information. Generally, no acute recanalization treatment was performed if the following criteria were fulfilled: coma >3 h, tetraplegia >6 h, bilateral mydriasis and extinct brainstem reflexes >1 h, and extensive multilevel infarctions on baseline imaging. Patients eligible for treatment received either i.a. thrombolysis with rt-PA alone, i.v. treatment with abciximab (initial bolus of 0.25 mg/kg of body weight followed by infusion of 0.125 µg/kg of body weight/ min over 12 h), and i.a. thrombolysis with rtPA or bridging with i.v. rtPA (0.9 mg/kg of body weight for 40 min) and subsequent i.a. thrombolysis with the remaining dose. For the first time, in July 2009 a stent retriever-based thrombectomy device was used in a patient with BAO. Since that time, two different systems (SolitaireTM FR; ev3 Endovascular, Inc., USA, and Revive SE; Codman & Shurtleff, Inc., USA) have been used in the clinical routine. In selected cases, tirofiban was administered i.v. (initial bolus of 0.4 μg/kg/min over 30 min, then infusion of 0.1 μg/kg/min over 24–
Mechanical Thrombectomy for Acute BAO
48 h). At any time, whenever endovascular therapy was not feasible, i.v. thrombolysis with rtPA was performed with the standard dose. All patients included in this study were treated at a dedicated neurological ICU following institutional standard operating procedures. Symptomatic intracranial hemorrhage (sICH) was defined as intracranial blood on follow-up imaging up to 36 h after treatment associated with clinical worsening of at least 4 points of the NIHSS or leading to death (ECASS 2 definition). Recanalization status was classified according to the Thrombolysis in Cerebral Infarction (TICI) classification (grade 0, no perfusion; grade 1, penetration with minimal perfusion; grade 2a, partial filling – two thirds of the entire vascular territory; grade 2b, complete filling, but the filling is slower than normal, and grade 3, complete perfusion) [5]. Functional outcome was assessed using the modified Rankin scale (mRS) 3 months after treatment during an outpatient visit or using a semistandardized telephone interview (the rater was not blinded to the treatment). A good clinical outcome was defined as an mRS score of 0–2. The entire cohort was split into two chronological groups: BAO-1 before July 2009 and BAO-2 after July 2009 and the introduction of stent retrievers. Our aim was to analyze whether the increasing use of these thrombectomy devices since that time influenced our patients’ outcomes. However, both cohorts also included patients in whom no endovascular treatment was possible. Univariate (Fisher’s exact test, t-test or Mann-Whitney U test) and multivariate (logistic regression) analyses were applied using good clinical outcome and mortality as dependent variables and baseline variables with a significant p value
Received: May 23, 2013 Accepted: September 30, 2013 Published online: November 15, 2013
Improved Clinical Outcome after Acute Basilar Artery Occlusion since the Introduction of Endovascular Thrombectomy Devices S. Nagel a L. Kellert a M. Möhlenbruch b J. Bösel a S. Rohde b P. Ringleb a
Departments of a Neurology and b Neuroradiology, University Hospital Heidelberg, Heidelberg, Germany
Key Words Basilar artery occlusion · Thrombolysis · Bridging therapy · Mechanical thrombectomy
Abstract Background: Thrombectomy devices are increasingly used for intra-arterial recanalization therapy in stroke. We analyzed whether the use of these devices modified the outcome of patients with acute basilar occlusion (BAO) at our institution. Methods: Between 1998 and 2012, one hundred forty-seven consecutive patients with acute BAO received recanalization therapy. In July 2009, for the first time, a thrombectomy device was used and hence the cohort was split into two chronological groups: BAO-1 (before July 2009) and BAO-2 (after July 2009). All patients were treated at a dedicated neurological ICU following institutional standard operating procedures. A good clinical outcome was defined as a modified Rankin scale score of 0–2 after 3 months. Univariate and multivariate analyses were applied using outcome parameters as dependent variables and baseline variables with a significant p value in univariate tests as independent variables. Results: One hundred eleven patients (BAO-1) were treated before and 36 were treated after July 2009 (BAO-2). Patients in the BAO-1 and BAO-2 groups had similar neurological deficits on admission as expressed by the Glasgow Coma Scale (BAO-1: median 4, IQR 5, vs. BAO-2: median 4.5, IQR 8, p = 0.41) and the
© 2013 S. Karger AG, Basel 0000–0000/13/0366–0394$38.00/0 E-Mail [email protected] www.karger.com/ced
proportion of patients who were presented intubated and ventilated was similar in both groups as well (49.5 vs. 47.7%, p = 0.85). Bridging concepts with intravenous recombinant tissue plasminogen activator (rtPA) were applied in 18.9% (BAO-1) versus 63.9% (BAO-2, p < 0.001) of cases, whereas glycoprotein IIb/IIIa antagonists were used significantly more frequently in the BAO-1 cohort (57.7 vs. 33.3%, p = 0.034). Thrombectomies were performed in 20 patients (55.5%) of the BAO-2 group but in none of the BAO-1 cohort. Complete recanalization (TICI 3) was achieved in 45.1% (BAO-1) versus 66.7% (BAO-2, p = 0.062) of patients. A good clinical outcome was observed in 13.5% of the BAO-1 group and 30.6% of the BAO-2 cohort (p = 0.026); mortality was 57.7% in the earlier group and 36.1% in the later group (p = 0.034). The frequency of symptomatic intracranial hemorrhage was similar in both groups (8.1% BAO-1 vs. 2.8% BAO-2, p = 0.45). Treatment in the BAO-2 cohort was an independent predictor of good clinical outcome (OR 2.56; 95% CI 1.01–6.78) and mortality (OR 0.36; 95% CI 0.15–0.86) in an adjusted logistic regression model. Conclusion: Our results show improved outcomes in patients in the BAO-2 cohort. The treatment approach in this group was an independent predictor of both good outcome and mortality. Especially in patients with BAO – where endovascular treatment strategies are common clinical practice – bridging protocols with rtPA and modern thrombectomy devices should be used more frequently. © 2013 S. Karger AG, Basel
Dr. S. Nagel, MD Department of Neurology, University of Heidelberg Im Neuenheimer Feld 400 DE–69120 Heidelberg (Germany) E-Mail simon.nagel @ med.uni-heidelberg.de
Downloaded by: Kainan University 203.64.11.45 - 3/7/2015 10:42:19 PM
The survival and functional outcome of patients with acute basilar artery occlusion (BAO) are highly dependent on vessel recanalization [1]. Therefore, intra-arterial (i.a.) thrombolysis is recommended in international guidelines and practiced in many comprehensive stroke centers. Bridging approaches combining the use of intravenous (i.v.) and i.a. interventions have been shown to increase recanalization rates and improve clinical outcomes [2, 3]. For several years, thrombectomy devices have been increasingly used for i.a. therapy. The new generation of these devices comprises innovative stent technology-based clot retrievers [4]. We analyzed whether the employment of treatment approaches using i.v. bridging therapy with recombinant tissue plasminogen activator (rtPA) together with these modern i.a. thrombectomy devices modified the outcome of patients with BAO at our institution.
Methods Since March 1998, all patients treated with thrombolysis have been entered into a prospective database. Data from patients up to September 2012 with confirmed [by either computed tomography angiography (CTA) or magnetic resonance angiography (MRA)] acute BAO who were diagnosed and primarily treated at our institution were retrospectively analyzed. Collected data included age, gender, time of symptom onset, time to treatment, treatment specifications, baseline clinical severity of the stroke syndrome as measured using the Glasgow Coma Scale (GCS), vascular risk factors, imaging data, and outcome measures. Patients were excluded if they did not receive acute revascularization therapy within 24 h after symptom onset, i.e. elective endovascular treatment of BAO after secondary deterioration or of critical basilar artery stenosis, and if they did not receive the full treatment protocol at our institution. The decision for acute therapy was made by the treating physicians based on medical history, clinical presentation, and imaging information. Generally, no acute recanalization treatment was performed if the following criteria were fulfilled: coma >3 h, tetraplegia >6 h, bilateral mydriasis and extinct brainstem reflexes >1 h, and extensive multilevel infarctions on baseline imaging. Patients eligible for treatment received either i.a. thrombolysis with rt-PA alone, i.v. treatment with abciximab (initial bolus of 0.25 mg/kg of body weight followed by infusion of 0.125 µg/kg of body weight/ min over 12 h), and i.a. thrombolysis with rtPA or bridging with i.v. rtPA (0.9 mg/kg of body weight for 40 min) and subsequent i.a. thrombolysis with the remaining dose. For the first time, in July 2009 a stent retriever-based thrombectomy device was used in a patient with BAO. Since that time, two different systems (SolitaireTM FR; ev3 Endovascular, Inc., USA, and Revive SE; Codman & Shurtleff, Inc., USA) have been used in the clinical routine. In selected cases, tirofiban was administered i.v. (initial bolus of 0.4 μg/kg/min over 30 min, then infusion of 0.1 μg/kg/min over 24–
Mechanical Thrombectomy for Acute BAO
48 h). At any time, whenever endovascular therapy was not feasible, i.v. thrombolysis with rtPA was performed with the standard dose. All patients included in this study were treated at a dedicated neurological ICU following institutional standard operating procedures. Symptomatic intracranial hemorrhage (sICH) was defined as intracranial blood on follow-up imaging up to 36 h after treatment associated with clinical worsening of at least 4 points of the NIHSS or leading to death (ECASS 2 definition). Recanalization status was classified according to the Thrombolysis in Cerebral Infarction (TICI) classification (grade 0, no perfusion; grade 1, penetration with minimal perfusion; grade 2a, partial filling – two thirds of the entire vascular territory; grade 2b, complete filling, but the filling is slower than normal, and grade 3, complete perfusion) [5]. Functional outcome was assessed using the modified Rankin scale (mRS) 3 months after treatment during an outpatient visit or using a semistandardized telephone interview (the rater was not blinded to the treatment). A good clinical outcome was defined as an mRS score of 0–2. The entire cohort was split into two chronological groups: BAO-1 before July 2009 and BAO-2 after July 2009 and the introduction of stent retrievers. Our aim was to analyze whether the increasing use of these thrombectomy devices since that time influenced our patients’ outcomes. However, both cohorts also included patients in whom no endovascular treatment was possible. Univariate (Fisher’s exact test, t-test or Mann-Whitney U test) and multivariate (logistic regression) analyses were applied using good clinical outcome and mortality as dependent variables and baseline variables with a significant p value
