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  • Characterization of Pipeline Flex Delivery Wire Recapture in 85 Consecutive Deployments

    Final Number:

    Jessica K. Campos MD; Matthew T Bender MD; Bowen Jiang MD; Erick M Westbroek MD; David A. Zarrin BS; Chau D. Vo BA; Justin M. Caplan MD; Judy Huang MD; Rafael Jesus Tamargo MD; Li-Mei Lin BA; Geoffrey P. Colby MD, PhD; Alexander L. Coon MD

    Study Design:

    Subject Category:
    Aneurysm/Subarachnoid Hemorrhage

    Meeting: AANS/CNS Cerebrovascular Section 2018 Annual Meeting

    Introduction: The second-generation Pipeline Embolization Device (PED-Flex; Medtronic Neurovascular) has a re-engineered delivery system for simplified device deployment during treatment of cerebral aneurysms. The distal-device constraining mechanism (leaflets) have been purported to complicate PED-Flex delivery wire (PDW) recapture. In this report, we characterize the technical complexity of PDW recapture by analyzing a contemporary series of PED-Flex deployments.

    Methods: PDW recapture details were analyzed from 65 consecutive aneurysm cases for number of recapture attempts and recapture technique employed. Patient and aneurysm characteristics, vessel tortuosity, procedural details, and technical outcomes were collected.

    Results: Eighty-five PED-Flexes were deployed to treat 67 aneurysms in 65 patients. The mean aneurysm size was 5.5 +/- 4.5 mm (1-26 mm), with 97% (n=63) of cases located within the anterior circulation, and 12 aneurysms (19%) distal to the ICA termination. Significant cervical carotid tortuosity and moderate to severe cavernous tortuosity (cavernous grade =2) was present in 23% and 55% of cases, respectively. Technical success of PDW recapture and PED-Flex implantation was achieved in 100% of cases. The overall major complication rate was 3% (n=2), with one minor stroke and one mortality (both procedure-related hemorrhages). A unique grading scale was utilized to characterize the recapture of the PDW with the delivery microcatheter after all PED deployments. Grade 1 recapture (on first attempt) was achieved in 96.5% (n=82) and Grade 2 recapture (multiple attempts) in 2% (n=2), Grade 3 recapture, requiring a mated, single-unit withdrawal of the PDW and microcatheter, occurred in 1% (n=1). There were no failures of PDW retrieval (Grade 4, n=0).

    Conclusions: Recapture of the PED-Flex delivery wire can be performed both reliably and safely. Loss of endoluminal delivery catheter access during recapture is a rare occurrence that does not affect procedural success.

    Patient Care: Characterizing the technical complexity of the Pipeline embolization device delivery wire recapture will improve the neurointerventional surgeon’s understanding of PED wire recapture and offer insight into procedural salvage techniques for recapture difficulties.

    Learning Objectives: By the conclusion of this session, participants should be able to: 1) Describe the reengineered deployment mechanism of the second-generation Pipeline embolization device (PED), 2) Discuss, in small groups, the incidence of delivery wire recapture failure with the Pipeline Flex device, 3) Identify an effective neurointerventional maneuvers for managing technical difficulties in PED delivery wire recapture.

    References: 1. Mooney MA, Moon K, Gross BA, Ducruet AF, Albuquerque FC. Incidence of delivery wire recapture failure with the Pipeline Flex device. J Neurointerv Surg 2017;9:571-573.

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