A Systematic Review and Meta-analysis of the use of Streamliner Multilayer Flow Modulator Stents for the treatment of complex aortic lesions

Abstract Objectives To evaluate the safety and efficacy of Multilayer Flow Modulator (MFM) stents (Cardiatis, Isnes, Belgium) for the treatment of complex aortic lesions Methods A systematic electronic research was conducted for articles published from December 2008 up to May 2020. Data extracted from 15 eligible case series (CS) were thereafter appropriately pooled and meta-analyzed. Patients' baseline characteristics were recorded and 16 outcomes of interest were studied. Primary end points include, 30-day all-cause and aneurysm related mortality, aneurysm related mortality at one year, vessel patency, any endoleaks, ruptures, re-interventions and aneurysm exclusion at the end of follow-up. Results Thirty-nine studies (15 CS and 24 case reports; CR) involving 429 patients fulfilled the inclusion criteria. Overall 436 lesions were treated and 1,521 aortic branches were covered by the multilayer stent. The mean follow-up of 15 CS with 404 patients was 14.6 months. Compliance to instructions for use (IFU) was reported by 8 CS with 75% of the procedures being performed inside IFU, while a total of 41% of the patients reported by 12 CS, had a previous aortic intervention. Pooled rates for 30-day all-cause and 30-day aneurysm related mortality were 0.56% (95% Cl:0.00-2.54) and 0.00% (95% Cl:0.00-0.80) respectively. Pooled aneurysm related mortality at 1-year follow-up was 5.25% (95% Cl:0.07-14.91). Pooled vessel patency at the end of follow-up was 99.12% (95% Cl:97.73-99.93). Pooled re-intervention and endoleak rates at the end of follow-up were 10.94% (95% Cl:3.64-20.67) and 10.70% (95% Cl:4.45-18.66), respectively. Crude spinal cord ischemia and renal failure rates were 0.69% and 1.8% respectively. Conclusion This review and meta-analysis indicated the safety and efficacy of MFM stents for treating challenging aortic pathologies when the device was used as the first line of treatment and inside the IFU. The almost zero pooled 30-day all-cause and aneurysm related mortality rates in combination with low crude spinal cord ischemia and renal failure rates, indicated a good treatment option for complex aortic lesions in the short-term and mid-term periods. The lack of long-term follow-up might warrant further research concerning the efficacy of the device in the long term.