A systematic review and meta-analysis of the streamliner multilayer flow modulator stent for treatment of complex aortic lesions.

OBJECTIVE

We evaluated 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 studies reported from December 2008 to May 2020. Data extracted from 15 eligible case series (CS) were appropriately pooled and analyzed in a meta-analysis. The patient baseline characteristics were recorded, and 16 outcomes of interest were studied. The primary end points included 30-day all-cause and aneurysm-related mortality, aneurysm-related mortality at 1 year, vessel patency, and any endoleaks, ruptures, reinterventions, and aneurysm exclusion at the end of follow-up.

RESULTS

A total of 39 studies (15 CS and 24 case reports), involving 429 patients, met the inclusion criteria. Overall, 436 lesions were treated, and 1521 aortic branches were covered by the multilayer stent. The mean follow-up for the 15 CS with 404 patients was 14.6 months. Compliance with the instructions for use was reported by eight CS, with 75% of the procedures performed within the instructions for use. However, 41% of the patients reported by 12 CS had undergone a previous aortic intervention. The pooled 30-day all-cause and 30-day aneurysm-related mortality rates were 0.56% (95% confidence interval [CI], 0.00%-2.54%) and 0.00% (95% CI, 0.00%-0.80%), respectively. The pooled aneurysm-related mortality at 1 year of follow-up was 5.25% (95% CI, 0.07%-14.91%). The pooled vessel patency at the end of follow-up was 99.12% (95% CI, 97.73%-99.93%). The pooled reintervention and endoleak rates at the end of follow-up were 10.94% (95% CI, 3.64%-20.67%) and 10.70% (95% CI, 4.45%-18.66%), respectively. The crude spinal cord ischemia and renal failure rates were 0.69% and 1.8%, respectively.

CONCLUSIONS

The results from the present review and meta-analysis have indicated the safety and efficacy of MFM stents for treating challenging aortic pathologic lesions when used as first-line treatment and within the instructions for use. The almost zero pooled 30-day all-cause and aneurysm-related mortality rates combined with the low crude spinal cord ischemia and renal failure rates indicate the use of MFM stents is a good treatment option for complex aortic lesions in the short- and mid-term periods. The lack of long-term follow-up warrants further research concerning the efficacy of the device in the long term.