Original Article| Volume 23, ISSUE 6, P1457-1461, July 2014

Efficacy of NeuroFlo Device in Treatment of Patients with Atrial Fibrillation

      Atrial fibrillation (AF) is a well-established independent risk factor for stroke. We examined cerebral blood flow augmentation in the treatment of acute ischemic stroke (AIS) in patients with AF by performing secondary analysis of data from the Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS) trial, a randomized controlled trial evaluating NeuroFlo treatment in stroke patients within 14 hours of symptom onset. We report subgroup analyses of outcomes in SENTIS patients with a history or new diagnosis of AF. Among patients with AF, those treated with NeuroFlo demonstrated significant improvement over those not treated for multiple end points: global efficacy end point (P = .030), modified Rankin Scale (mRS) score 0-2 versus 3-6 (P = .029), and stroke-related mortality (P = .015). There was a significant improvement in global end point for those aged 60 years or older (P = .042) and 80 years or older (P = .017), with a trend toward improvement for age 70 years or older (P = .055), and significant improvement in those who achieved good outcomes (mRS score 0-2 versus 3-6) at age 60 years or older (P = .038), 70 years or older (P = .022), and 80 years or older (P = .008). NeuroFlo treatment in stroke patients with AF resulted in significantly better outcomes compared with nontreated patients with AF. Collateral flow recruitment, maintenance of cerebral blood flow around stroke core, and improvement of penumbral blood flow are potential mechanisms for these improved outcomes. NeuroFlo may represent a valid therapeutic option for patients with AF and AIS, and therefore, future trials of the device are warranted.

      Key Words

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Journal of Stroke and Cerebrovascular Diseases
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Go A.S.
        • Hylek E.M.
        • Phillips K.A.
        • et al.
        Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) study.
        JAMA. 2001; 285: 2370-2375
        • Steger C.
        • Pratter A.
        • Martinek-Bregel M.
        • et al.
        Stroke patients with atrial fibrillation have a worse prognosis than patients without: data from the Austrian Stroke registry.
        Eur Heart J. 2004; 25: 1734-1740
        • Tu H.T.
        • Campbell B.C.
        • Churilov L.
        • et al.
        Frequent early cardiac complications contribute to worse stroke outcomes in atrial fibrillation.
        Cerebrovasc Dis. 2011; 32: 454-460
        • Seet R.C.
        • Zhang Y.
        • Wijdicks E.F.
        • et al.
        Relationship between chronic atrial fibrillation and worse outcomes in stroke patients after intravenous thrombolysis.
        Arch Neurol. 2011; 68: 1454-1458
        • Shuaib A.
        • Bornstein N.M.
        • Hans-Christoph D.
        • et al.
        • for the SENTIS Trial Investigators
        Partial aortic occlusion for cerebral perfusion augmentation. Safety and Efficacy of NeuroFlo in Acute Ischemic Stroke Trial.
        Stroke. 2011; 42: 1680-1690
        • Thijs V.
        More bad news about atrial fibrillation.
        Eur Heart J. 2004; 25: 1670-1671
        • Gatterllari M.
        • Goumas C.
        • Aitken R.
        • et al.
        Outcomes for patients with ischaemic stroke and atrial fibrillation: the PRISM study (A Program of Research Informing Stroke Management).
        Cerebrovasc Dis. 2011; 32: 370-382
        • Hacke W.
        • Kaste M.
        • Bluhmki E.
        • et al.
        • for ECASS Investigators
        Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke.
        N Engl J Med. 2008; 359: 1317-1329
        • Leker R.R.
        • Molina C.
        • Cockroft K.
        • et al.
        Effects of age on outcome in the SENTIS trial: better outcomes in elderly patients.
        Cerebrovasc Dis. 2012; 34: 263-271
        • Lima F.O.
        • Furie K.L.
        • Silva G.S.
        • et al.
        The pattern of leptomeningeal collaterals on CT angiography is a strong predictor of long-term functional outcome in stroke patients with large vessel intracranial occlusion.
        Stroke. 2010; 41: 2316-2322
        • Ringelstein E.B.
        • Biniek R.
        • Weiller C.
        • et al.
        Type and extent of hemispheric brain infarctions and clinical outcome in early and delayed middle cerebral artery recanalization.
        Neurology. 1992; 42: 289-298
        • Hammer M.
        • Jovin T.
        • Wahr J.A.
        • et al.
        Partial occlusion of the descending aorta increases cerebral blood flow in a non-stroke porcine model.
        Cerebrovasc Dis. 2009; 28: 406-410
        • Nussbaum E.S.
        • Sebring L.A.
        • Ganz W.F.
        • et al.
        Intra-aortic balloon counterpulsation augments cerebral blood flow in the patient with cerebral vasospasm: a xenon-enhanced computerized tomographic study.
        Neurosurgery. 1998; 42: 206-214
        • Liebeskind D.S.
        Reperfusion for acute ischemic stroke: arterial revascularization and collateral therapeutics.
        Curr Opin Neurol. 2010; 23: 36-45