Original Article
Efficacy of NeuroFlo Device in Treatment of Patients with Atrial Fibrillation

https://doi.org/10.1016/j.jstrokecerebrovasdis.2013.12.006Get rights and content

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.

Introduction

Atrial fibrillation (AF) affects over 2.3 million people in the United States and is an independent risk factor for ischemic stroke.1 Furthermore, it is associated with hypertension, older age, and more severe strokes.2, 3 Patients with acute ischemic stroke (AIS) because of AF have poorer prognosis, increased in-hospital medical and neurologic complications, and higher rates of mortality (particularly in those older than 75 years) than patients without AF.2 Unfortunately, acute stroke treatment is limited in AF patients on anticoagulation therapy because of contraindication for thrombolytic therapy; even in those who receive intravenous thrombolytic therapy, outcomes are worse.4 The recently published Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS) trial5 evaluated cerebral blood flow augmentation using the NeuroFlo catheter (CoAxia, Maple Grove, MN) in the treatment of AIS. We performed post hoc analysis on acute treatment effects of NeuroFlo in a subset of SENTIS patients with AF to determine whether outcomes were significantly improved compared with nontreated patients with AF.

Section snippets

Materials and Methods

The SENTIS trial5 was an international, prospective, randomized controlled trial. The objective of the trial was to determine the safety and efficacy of NeuroFlo treatment in improving neurologic outcome in AIS. The trial was approved by the Institutional Review Board or Ethics Committee at each participating center. Written informed consent was obtained for all patients. See the previously published report on SENTIS study design and enrollment.5

The primary efficacy end point in SENTIS was the

Results

In this analysis from SENTIS trial, 56 treated and 87 nontreated patients had AF. Demographics, baseline characteristics, and medical history are listed in Table 1. There were no significant differences in demographic or baseline characteristics nor serious adverse events between groups.

NeuroFlo-treated patients with AF had significant improvement in global efficacy end point (odds ratio [OR], 2.48; confidence interval [CI], 1.09-5.62; P = .030), good functional outcome with mRS dichotomized

Discussion

The SENTIS trial is the first randomized trial evaluating an interventional device to treat ischemic stroke with long-term neurologic end points.5 Patients with a history or new diagnosis of AF treated with NeuroFlo in SENTIS had significant improvement in the primary end point of global outcome and in the secondary end points of good outcome of mRS (score 0-2 versus 3-6) and stroke-related mortality compared with nontreated patients with AF. There was significant improvement in stroke-related

Conclusions

The current analysis of data from the SENTIS trial shows that therapy with the NeuroFlo device may lower stroke burden in patients with AF who are otherwise more likely to have poorer outcomes and higher mortality rates. For many anticoagulated patients with AF and AIS, NeuroFlo may represent a valid therapeutic option. These observations should be confirmed in future trials with the device.

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    Although partial aortic occlusion improved cerebral hemodynamics (Liebeskind, 2008), it failed to improved long-term disability (Shuaib et al., 2011). Subgroup analysis, however, revealed application of NeuroFlo in patients older than 70, patients with underlying atrial fibrillation, those presented very early (< 6 h), or patients with mild to moderate neurological disability (NIHSS < 14) improved functional outcome (Shuaib et al., 2011; Bernardini et al., 2014). In addition, a complete circle of Willis determined if hemodynamics augmentation in SENTIS trial was translated into clinical benefits (Schellinger et al., 2013), indicating increased CPP acts in synergy with collateral circulation.

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    As summarized in Table 1, the primary efficacy outcome of the randomized trial that evaluated this therapy − SENTIS − was neutral (Shuaib et al., 2011a). However, in a post-hoc subgroup analysis, patients with strokes of moderate severity randomized within 6 h had an improved outcome when treated with the NeuroFlo device (Shuaib et al., 2013), as did patients with atrial fibrillation (Bernardini et al., 2014). A further post-hoc analysis of the SENTIS dataset included subjects having a so-called “favorable vascular profile” (FVP), which was defined as an intact circle of Willis on MRA, CTA, or conventional angiography, and mean arterial pressure >65 mmHg in the first 12 h (Schellinger et al., 2013a).

  • The role of leptomeningeal collateral flow in acute ischemic stroke

    2014, Romanian Journal of Neurology/ Revista Romana de Neurologie

Disclosures: The SENTIS trial was sponsored by CoAxia, Inc., Maple Grove, MN. All participating sites received clinical study payments based on the number of patients enrolled in the SENTIS trial. G.L.B., R.R.L., A.A.-C, K.C., A.S., R.S., and H.-C.D. have no disclosures. S.S. received consulting fees from CoAxia, Inc. P.D.S. received consulting fees/honorarium from CoAxia, Inc. N.M.B. received consultation fees from CoAxia, Inc.

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