Safety and Efficacy of the Sofia (6F) PLUS Distal Access Reperfusion Catheter in the Endovascular Treatment of Acute Ischemic Stroke

Neurosurgery. 2018 Mar 1;82(3):312-321. doi: 10.1093/neuros/nyx169.

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 intra-arterial 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.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Brain Ischemia / diagnostic imaging
  • Brain Ischemia / therapy*
  • Catheters / adverse effects
  • Endovascular Procedures / adverse effects
  • Endovascular Procedures / instrumentation*
  • Endovascular Procedures / methods
  • Female
  • Humans
  • Male
  • Middle Aged
  • Postoperative Complications / diagnostic imaging
  • Postoperative Complications / prevention & control
  • Reperfusion / adverse effects
  • Reperfusion / instrumentation
  • Reperfusion / methods
  • Retrospective Studies
  • Stroke / diagnostic imaging
  • Stroke / therapy*
  • Thrombectomy / adverse effects
  • Thrombectomy / instrumentation*
  • Thrombectomy / methods
  • Tissue Plasminogen Activator / administration & dosage
  • Treatment Outcome

Substances

  • PLAT protein, human
  • Tissue Plasminogen Activator