Sherif1, N.Hynes2, E.P. Kavanagh3, V.S. Costache4, F. Stefanov3, A. Elhelali5,
1Galway University Hospitals, Ireland, 2Western Vascular Institut, 3Galway, Ireland, 2Galway Clinic, Ireland, 4University, Sibiu, Romania, 5GMedTech, Galway, Ireland
Regulatory disclosure: This presetation will describe the use of the Multilayer Flow Modulator by Cardiatis, which has an FDA status of investigational.
Purpose: This study reports the initual 12-month oucomes of patiens treated for chronic symptomatic aortic dissection (CSAD) by yhe Streamliner Multilayer flow modulator (SMFM). Primary endpoints were freedom from rupture and aortic related death, as well as reduction in false lumen index. Secondary endpoints were patency of great vessels and visceral branches, and freedom from stroke, paraplegia, and renal failure.
Methods: Out of 876 SMFM implanted globally, we have knowledge of 542. To date, 312 patients are maintained in the global registry, of which 38 patiens were identified as having an aortic dissection (12,2%). Indications included 35 Stanford type B dissections, two Stanford type A and B dissections, and one mycotic Stanford type B dissection.
Results: Morphological analysis exhibited dissection remodelling by the reduction in longitudinal lenght of the dissected aorta and false lumen volume. A statistically significant reduction in false lumen index (P=.016) at 12 months and increase in true lumen volume (P=.053) confirmed dissection remodellng. All-cause survival was 85.3%. Twelve-month freedom from neurological events was 100%, and there were no incidences of end-organ ischemia, paraplegia, or renal insults.
Conclusions: The SMFM offers immense promise in the treatment of complex pan-aortic dissection. Results highlight that placement of the SMFM leads to dissection stabilization with no further aneurism progression and no retrograde type A dissection. Treatment using the SMFM resulted in freedom from aortic rupture, neurological stroke, paraplegia, and renal failure.