Systematic Review and Patient-Level Meta-analysis of the Streamliner Multilayer Flow Modulator in the Management of Complex Thoracoabdominal Aortic Pathology

Abstract

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.

Evidence of use of multilayer flow modulator stents in treatment of thoracoabdominal aortic aneurysms and dissections

“…Hynes and colleagues reported a systematic review of 15 publications including 171 patients treated for TAAAs with mean age of 69 years. 35 Technical success was 77%, and there were no cases of spinal cord injury. Aneurysm-related survival at 1 year was 78%, and allcause survival was only 50%.…”

“…In the study of Sultan and colleagues, important limitations were the retrospective design, short follow-up interval (w1 year), and the large number of patients (38%) who were lost to follow-up in the initial Global Registry cohort. 35 Although MFM stents promote aneurysm and false lumen thrombosis, several reports and one meta-analysis have shown continued aortic enlargement in treated segments. 27,28,33,34 Overall, there is lack of evidence that MFM stents effectively prevent aneurysm rupture and aortic-related deaths beyond 1 year of follow-up.…”

“…Reinterventions in prior reports consisted of realignment of the MFM stent by stent grafts or by placement of additional MFM stents, with little evidence that these were effective. [24][25][26][27][28][29][30][31][32][33][34][35] Other endovascular alternatives (eg, F-BEVAR or parallel grafts) are not feasible to address rupture or branch-related problems, and therefore open surgical repair is the only definitive option. Until a welldesigned, prospective randomized trial with independent core laboratory monitoring is conducted, these questions and skepticism are likely to remain.…”

Endovascular management of chronic symptomatic aortic dissection with the Streamliner Multilayer Flow Modulator: Twelve-month outcomes from the global registry

“…These include device foreshortening resulting in inadequate overlap of devices or device dislocation, poor SMFM sizing often undersizing, and inadequate overlap between devices or device foreshortening, which can result in failure mode I or between two overlapping stents, resulting in failure mode II. 39 The authors postulate that treatment of CSAD with the SMFM equalize arterial pressure between the true and false lumen. This thereby stabilizes the injured aortic wall, and reduces aneurysm formation as it covers normal-to-normal aorta without compromising the side branches.…”

Is endovascular treatment with multilayer flow modulator stent insertion a safe alternative to open surgery for high-risk patients with thoracoabdominal aortic aneurysm?

“…In 2016, Hynes et al. [2] published a meta-analysis of MFMS reviewing data on 171 patients with complex aortic pathology (59.1% had TAAA). They found that the aneurysm-related survival rate was 78.7% at 1 year and 66.6% at 18 months.…”