title: Systematic Review and Patient-Level Meta-analysis of the Streamliner Multilayer Flow Modulator in the Management of Complex Thoracoabdominal Aortic Pathology.
abstract: OBJECTIVE
  To examine the safety and short-term efficacy of the Streamliner Multilayer Flow Modulator (SMFM) in the management of patients with complex thoracoabdominal aortic pathology who are unfit for alternative interventions.
  
  
  METHODS
  Biomedical databases were systematically searched for articles published between 2008 and 2015 on the SMFM. A patient-level meta-analysis was used to evaluate aneurysm-related survival. Secondary outcomes were all-cause survival, stroke, spinal cord ischemia, renal impairment, and branch vessel patency. Other considerations were the impact of compliance with the instructions for use (IFU) on clinical outcome. Mean values and Kaplan-Meier estimates are presented with the 95% confidence interval (CI).
  
  
  RESULTS
  Fifteen articles (3 multicenter cohort studies, 3 observational cohort studies, and 9 case reports) were included, presenting 171 patients (mean age 68.8±12.3 years; 139 men). The mean aneurysm diameter was 6.7±1.6 cm (95% CI 6.4 to 6.9 cm). Technical success reported in 15 studies was 77.2%. Aneurysm-related survival at 1 year was 78.7% (95% CI 71.7% to 84.4%). One-year all-cause survival was 53.7% (95% CI 46.0% to 61.3%). There were no reported cases of spinal cord ischemia, renal insult, or stroke.
  
  
  CONCLUSIONS
  The SMFM can be safely utilized in some patients with complex thoracoabdominal pathologies provided operators adhere to the IFU. The SMFM is a novel technology with no long-term published data on its sustained effectiveness and a lack of comparative studies. Randomized clinical trials, registries, and continued assessment are essential before this flow-modulating technology can be widely disseminated.
authors.affiliation: Western Vascular Institute, Department of Vascular and Endovascular Surgery, University Hospital Galway, National University of Ireland, Galway, Ireland Galway Clinic, Royal College of Surgeons of Ireland Affiliated Hospital, Doughiska, Galway, Ireland.
authors.forename: Niamh
authors.initials: N
authors.lastname: Hynes
authors.affiliation: Western Vascular Institute, Department of Vascular and Endovascular Surgery, University Hospital Galway, National University of Ireland, Galway, Ireland Galway Clinic, Royal College of Surgeons of Ireland Affiliated Hospital, Doughiska, Galway, Ireland sherif.sultan@hse.ie.
authors.forename: Sherif
authors.initials: S
authors.lastname: Sultan
authors.affiliation: Western Vascular Institute, Department of Vascular and Endovascular Surgery, University Hospital Galway, National University of Ireland, Galway, Ireland GMedTech, Department of Biomedical Engineering, Galway Mayo Institute of Technology, Galway, Ireland.
authors.forename: Ala
authors.initials: A
authors.lastname: Elhelali
authors.affiliation: Arizona Heart Foundation, Phoenix, AZ, USA.
authors.forename: Edward B
authors.initials: EB
authors.lastname: Diethrich
authors.affiliation: Western Vascular Institute, Department of Vascular and Endovascular Surgery, University Hospital Galway, National University of Ireland, Galway, Ireland.
authors.forename: Edel P
authors.initials: EP
authors.lastname: Kavanagh
authors.affiliation: Western Vascular Institute, Department of Vascular and Endovascular Surgery, University Hospital Galway, National University of Ireland, Galway, Ireland.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Sultan
authors.affiliation: Western Vascular Institute, Department of Vascular and Endovascular Surgery, University Hospital Galway, National University of Ireland, Galway, Ireland GMedTech, Department of Biomedical Engineering, Galway Mayo Institute of Technology, Galway, Ireland.
authors.forename: Florian
authors.initials: F
authors.lastname: Stefanov
authors.affiliation: GMedTech, Department of Biomedical Engineering, Galway Mayo Institute of Technology, Galway, Ireland.
authors.forename: Patrick
authors.initials: P
authors.lastname: Delassus
authors.affiliation: GMedTech, Department of Biomedical Engineering, Galway Mayo Institute of Technology, Galway, Ireland.
authors.forename: Liam
authors.initials: L
authors.lastname: Morris
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D017545:Aortic Aneurysm, Thoracic / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D001783:Blood Flow Velocity; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology / Q000628:therapy; D011474:Prosthesis Design; D012039:Regional Blood Flow; D019233:Retreatment; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
keywords: aneurysm; complications; flow modulation; meta-analysis; mortality; multilayer flow modulator; systematic review; thoracoabdominal aortic aneurysm