Safety and efficacy of the sofia (6F) PLUS distal access reperfusion catheter in the endovascular treatment of acute ischemic stroke

Hussain Shallwani, Hakeem J. Shakir, Leonardo Rangel-Castilla, Jason M. Davies, Ashish Sonig, Mithun G. Sattur, Bernard Bendok, Kenneth V. Snyder, Adnan H. Siddiqui, Elad I. Levy

Research output: Contribution to journalReview article

9 Citations (Scopus)

Abstract

BACKGROUND: Neuroendovascular intervention has become a key treatment option for acute ischemic stroke. The Sofia (6F) PLUS catheter was designed for neurovascular access for diagnostic or therapeutic interventions. OBJECTIVE: To report the first series describing use of the Sofia PLUS intermediate/distal access reperfusion catheter in the treatment of acute ischemic stroke. METHODS: In this retrospective study, 41 stroke cases were identified in which the catheter was utilized for thrombolysis/thrombectomy. Mean preprocedure National Institutes of Health Stroke Scale score was 16.5 ± 5.2 (range 4-29). Occluded vessels included the M1 segment, M2 segment, internal carotid artery terminus, cervical internal carotid artery, and basilar artery. RESULTS: Successful positioning of the Sofia PLUS catheter near the occlusion site was achieved in 38 (92.7%) of 41 cases in which thrombectomy or thrombolysis was attempted using intraarterial tissue plasminogen activator, a direct aspiration first-pass technique, and/or stent retrieval. A postprocedure thrombolysis in cerebral infarction (TICI) score of 2b/3 was achieved in 37 of 41 cases. Of 15 cases where the Sofia PLUS was used for a direct aspiration first-pass technique, TICI 2b/3 was achieved in 11 (73.3%). In one case where intraarterial tissue plasminogen activator was used as the only treatment modality, TICI 2a was achieved. No device-related or catheter-related complications were observed. The mean 7-d-postprocedure National Institutes of Health Stroke Scale score among the 39 survivors was 8.5 ± 7.3 (range 0-23). CONCLUSION: Initial results with use of the Sofia (6F) PLUS for endovascular treatment of acute ischemic stroke have been encouraging. Experience with a larger series is warranted to further evaluate the safety and efficacy of this device and compare it with other reperfusion catheters.

Original languageEnglish (US)
Pages (from-to)312-321
Number of pages10
JournalClinical Neurosurgery
Volume82
Issue number3
StatePublished - Mar 1 2018

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Reperfusion
Catheters
Stroke
Safety
Cerebral Infarction
Thrombectomy
National Institutes of Health (U.S.)
Internal Carotid Artery
Tissue Plasminogen Activator
Protective Devices
Therapeutics
Basilar Artery
Stents
Survivors
Retrospective Studies
Equipment and Supplies

Keywords

  • Distal access catheter
  • Neuroendovascular
  • Sofia PLUS
  • Stroke

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology

Cite this

Shallwani, H., Shakir, H. J., Rangel-Castilla, L., Davies, J. M., Sonig, A., Sattur, M. G., ... Levy, E. I. (2018). Safety and efficacy of the sofia (6F) PLUS distal access reperfusion catheter in the endovascular treatment of acute ischemic stroke. Clinical Neurosurgery, 82(3), 312-321.

Safety and efficacy of the sofia (6F) PLUS distal access reperfusion catheter in the endovascular treatment of acute ischemic stroke. / Shallwani, Hussain; Shakir, Hakeem J.; Rangel-Castilla, Leonardo; Davies, Jason M.; Sonig, Ashish; Sattur, Mithun G.; Bendok, Bernard; Snyder, Kenneth V.; Siddiqui, Adnan H.; Levy, Elad I.

In: Clinical Neurosurgery, Vol. 82, No. 3, 01.03.2018, p. 312-321.

Research output: Contribution to journalReview article

Shallwani, H, Shakir, HJ, Rangel-Castilla, L, Davies, JM, Sonig, A, Sattur, MG, Bendok, B, Snyder, KV, Siddiqui, AH & Levy, EI 2018, 'Safety and efficacy of the sofia (6F) PLUS distal access reperfusion catheter in the endovascular treatment of acute ischemic stroke', Clinical Neurosurgery, vol. 82, no. 3, pp. 312-321.
Shallwani H, Shakir HJ, Rangel-Castilla L, Davies JM, Sonig A, Sattur MG et al. Safety and efficacy of the sofia (6F) PLUS distal access reperfusion catheter in the endovascular treatment of acute ischemic stroke. Clinical Neurosurgery. 2018 Mar 1;82(3):312-321.
Shallwani, Hussain ; Shakir, Hakeem J. ; Rangel-Castilla, Leonardo ; Davies, Jason M. ; Sonig, Ashish ; Sattur, Mithun G. ; Bendok, Bernard ; Snyder, Kenneth V. ; Siddiqui, Adnan H. ; Levy, Elad I. / Safety and efficacy of the sofia (6F) PLUS distal access reperfusion catheter in the endovascular treatment of acute ischemic stroke. In: Clinical Neurosurgery. 2018 ; Vol. 82, No. 3. pp. 312-321.
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abstract = "BACKGROUND: Neuroendovascular intervention has become a key treatment option for acute ischemic stroke. The Sofia (6F) PLUS catheter was designed for neurovascular access for diagnostic or therapeutic interventions. OBJECTIVE: To report the first series describing use of the Sofia PLUS intermediate/distal access reperfusion catheter in the treatment of acute ischemic stroke. METHODS: In this retrospective study, 41 stroke cases were identified in which the catheter was utilized for thrombolysis/thrombectomy. Mean preprocedure National Institutes of Health Stroke Scale score was 16.5 ± 5.2 (range 4-29). Occluded vessels included the M1 segment, M2 segment, internal carotid artery terminus, cervical internal carotid artery, and basilar artery. RESULTS: Successful positioning of the Sofia PLUS catheter near the occlusion site was achieved in 38 (92.7{\%}) of 41 cases in which thrombectomy or thrombolysis was attempted using intraarterial tissue plasminogen activator, a direct aspiration first-pass technique, and/or stent retrieval. A postprocedure thrombolysis in cerebral infarction (TICI) score of 2b/3 was achieved in 37 of 41 cases. Of 15 cases where the Sofia PLUS was used for a direct aspiration first-pass technique, TICI 2b/3 was achieved in 11 (73.3{\%}). In one case where intraarterial tissue plasminogen activator was used as the only treatment modality, TICI 2a was achieved. No device-related or catheter-related complications were observed. The mean 7-d-postprocedure National Institutes of Health Stroke Scale score among the 39 survivors was 8.5 ± 7.3 (range 0-23). CONCLUSION: Initial results with use of the Sofia (6F) PLUS for endovascular treatment of acute ischemic stroke have been encouraging. Experience with a larger series is warranted to further evaluate the safety and efficacy of this device and compare it with other reperfusion catheters.",
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T1 - Safety and efficacy of the sofia (6F) PLUS distal access reperfusion catheter in the endovascular treatment of acute ischemic stroke

AU - Shallwani, Hussain

AU - Shakir, Hakeem J.

AU - Rangel-Castilla, Leonardo

AU - Davies, Jason M.

AU - Sonig, Ashish

AU - Sattur, Mithun G.

AU - Bendok, Bernard

AU - Snyder, Kenneth V.

AU - Siddiqui, Adnan H.

AU - Levy, Elad I.

PY - 2018/3/1

Y1 - 2018/3/1

N2 - BACKGROUND: Neuroendovascular intervention has become a key treatment option for acute ischemic stroke. The Sofia (6F) PLUS catheter was designed for neurovascular access for diagnostic or therapeutic interventions. OBJECTIVE: To report the first series describing use of the Sofia PLUS intermediate/distal access reperfusion catheter in the treatment of acute ischemic stroke. METHODS: In this retrospective study, 41 stroke cases were identified in which the catheter was utilized for thrombolysis/thrombectomy. Mean preprocedure National Institutes of Health Stroke Scale score was 16.5 ± 5.2 (range 4-29). Occluded vessels included the M1 segment, M2 segment, internal carotid artery terminus, cervical internal carotid artery, and basilar artery. RESULTS: Successful positioning of the Sofia PLUS catheter near the occlusion site was achieved in 38 (92.7%) of 41 cases in which thrombectomy or thrombolysis was attempted using intraarterial tissue plasminogen activator, a direct aspiration first-pass technique, and/or stent retrieval. A postprocedure thrombolysis in cerebral infarction (TICI) score of 2b/3 was achieved in 37 of 41 cases. Of 15 cases where the Sofia PLUS was used for a direct aspiration first-pass technique, TICI 2b/3 was achieved in 11 (73.3%). In one case where intraarterial tissue plasminogen activator was used as the only treatment modality, TICI 2a was achieved. No device-related or catheter-related complications were observed. The mean 7-d-postprocedure National Institutes of Health Stroke Scale score among the 39 survivors was 8.5 ± 7.3 (range 0-23). CONCLUSION: Initial results with use of the Sofia (6F) PLUS for endovascular treatment of acute ischemic stroke have been encouraging. Experience with a larger series is warranted to further evaluate the safety and efficacy of this device and compare it with other reperfusion catheters.

AB - BACKGROUND: Neuroendovascular intervention has become a key treatment option for acute ischemic stroke. The Sofia (6F) PLUS catheter was designed for neurovascular access for diagnostic or therapeutic interventions. OBJECTIVE: To report the first series describing use of the Sofia PLUS intermediate/distal access reperfusion catheter in the treatment of acute ischemic stroke. METHODS: In this retrospective study, 41 stroke cases were identified in which the catheter was utilized for thrombolysis/thrombectomy. Mean preprocedure National Institutes of Health Stroke Scale score was 16.5 ± 5.2 (range 4-29). Occluded vessels included the M1 segment, M2 segment, internal carotid artery terminus, cervical internal carotid artery, and basilar artery. RESULTS: Successful positioning of the Sofia PLUS catheter near the occlusion site was achieved in 38 (92.7%) of 41 cases in which thrombectomy or thrombolysis was attempted using intraarterial tissue plasminogen activator, a direct aspiration first-pass technique, and/or stent retrieval. A postprocedure thrombolysis in cerebral infarction (TICI) score of 2b/3 was achieved in 37 of 41 cases. Of 15 cases where the Sofia PLUS was used for a direct aspiration first-pass technique, TICI 2b/3 was achieved in 11 (73.3%). In one case where intraarterial tissue plasminogen activator was used as the only treatment modality, TICI 2a was achieved. No device-related or catheter-related complications were observed. The mean 7-d-postprocedure National Institutes of Health Stroke Scale score among the 39 survivors was 8.5 ± 7.3 (range 0-23). CONCLUSION: Initial results with use of the Sofia (6F) PLUS for endovascular treatment of acute ischemic stroke have been encouraging. Experience with a larger series is warranted to further evaluate the safety and efficacy of this device and compare it with other reperfusion catheters.

KW - Distal access catheter

KW - Neuroendovascular

KW - Sofia PLUS

KW - Stroke

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