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  • Submaximal Angioplasty Prospective Registry: Preliminary Report

    Final Number:

    Travis Michael Dumont MD; Maxim Mokin; Jorge Luis Eller MD; Grant C. Sorkin MD; Kenneth V. Snyder MD, PhD; L. Nelson Hopkins MD; Adnan Hussain Siddiqui MD, PhD; Elad I. Levy MD, FACS, FAHA, FAANS

    Study Design:
    Clinical Trial

    Subject Category:

    Meeting: Congress of Neurological Surgeons 2013 Annual Meeting

    Introduction: Intracranial atherosclerotic disease (ICAD) accounts for approximately 10% of ischemic strokes. A recent study displayed high perioperative complications (15%) for treatment of ICAD with stenting. Recurrent stroke was found in 12% of patients treated with aggressive medical management, suggesting intervention may remain a viable option if perioperative risk is minimized. Angioplasty without stenting represents an alternative and understudied revascularization treatment for ICAD. A submaximal angioplasty limits the risk of thromboembolism, vessel perforation, and reperfusion hemorrhage frequently reported with stenting in the SAMMPRIS trial. Preliminary results of an ongoing registry are reported.

    Methods: A phase 1 prospective registry for treatment of symptomatic ICAD with submaximal angioplasty was designed and approved by the local institutional review board. Demographic, and clinical data were prospectively collected. Angioplasty was performed with a balloon undersized to approximately 50-70% of the nondiseased vessel diameter. Neurological status measured by NIHSS and modified Rankin score were collected on days 0, 4, 30, 90, and at one year. The primary outcome measure is incidence of perioperative complications (combined endpoint includes death, stroke, and hemorrhage). Secondary outcome measure is stroke free survival at 90 days and one year.

    Results: To date, 16 patients have been enrolled in this registry (81% men; mean age 63 years), with no intraoperative or perioperative complications. In follow-up (median 155 days) 15 patients remain stroke-free in follow-up, with a single mild delayed stroke the only event in follow-up.

    Conclusions: We report interim analysis of a phase 1 prospective registry to assess the safety of submaximal angioplasty for ICAD. No perioperative complications have occurred to date in 16 patients. Long-term follow-up data at this point are limited to a single mild stroke in 2,588 person-days of follow-up. Updated material will be presented for the October conference.

    Patient Care: We believe submaximal angioplasty is a more safe alternative to intracranial stenting for symptomatic intracranial atherosclerotic disease, and may provide stroke reduction risk compared with medical therapy alone.

    Learning Objectives: By the end of this session, participants should be able to 1) understand the importance of surgical treatment of intracranial atherosclerotic disease 2) understand the difference between submaximal angioplasty and intracranial stenting and the inherent benefits of the latter over the former


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