Niamh Hynes, MRCS, MMSc, MD1,2, Sherif Sultan, MCh, MD, FRCS, PhD12, Ala Elhelali, MSc 1,3 Edward B. Dietrich, MD 4, Edel Kavanagh, PhD 1, Mohamed Sultan, MSc 1, Florian Stefanov, PhD 1,3 Patrick Delassus, PhD 3, Liam Morris, PhD 3.
Purpose: 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.
Conclusion: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.
The author(s) disclosed receipt of the following financial sup- port for the research, authorship, and/or publication of this article: This paper/research is supported by the Competitiveness Operational Programme 2014–2020, financed from European Regional Development Fund and by the Romanian Government under the project “ Next generation computer aided research in cardiovascular disease management –NextCARDIO”, project code: COP P_37_701.