Endovascular management of chronic symptomatic aortic dissection with the Streamliner Multilayer Flow Modulator: Twelve-month outcomes from the global registry.
OBJECTIVE
Reported are initial 12-month outcomes of patients with chronic symptomatic aortic dissection managed by the Streamliner Multilayer Flow Modulator (SMFM; Cardiatis, Isnes, Belgium). Primary end points were freedom from rupture- and aortic-related death, and reduction in false lumen index. Secondary end points were patency of great vessels and visceral branches, and freedom of 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 patients 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
There were no reported ruptures or aortic-related deaths. All cause survival was 85.3% Twelve-month freedom from neurologic events was 100%, and there were no incidences of end-organ ischemia, paraplegia or renal insult. Morphologic analysis exhibited dissection remodeling by a reduction in longitudinal length of the dissected aorta, and false lumen volume. A statistically significant reduction in false lumen index (P = .016) at 12 months, and a borderline significant increase in true lumen volume (P = .053) confirmed dissection remodeling.


CONCLUSIONS
The SMFM is an option in management of complex pan-aortic dissection. Results highlight SMFM implantation leads to dissection stabilization with no further aneurysm progression, and no retrograde type A dissection. Thoracic endovascular aneurysm repair by SMFM ensued in freedom from aortic rupture, neurologic stroke, paraplegia and renal failure. Further analysis of the global registry data will inform long-term outcomes.
Department of Vascular and Endovascular Surgery, Western Vascular Institute, Galway University Hospital, National University of Ireland, Galway, Ireland; Department of Vascular and Endovascular Surgery, Galway Clinic, Doughiska, Galway, Ireland. Electronic address: sherif.sultan@hse.ie.
Sherif
S
Sultan
Department of Vascular and Endovascular Surgery, Galway Clinic, Doughiska, Galway, Ireland.
Edel P
EP
Kavanagh
Department of Mechanical and Industrial Engineering, Galway Medical Technologies Center (GMedTech), Galway Mayo Institute of Technology, Galway, Ireland.
Florian
F
Stefanov
Department of Vascular and Endovascular Surgery, Western Vascular Institute, Galway University Hospital, National University of Ireland, Galway, Ireland.
Mohamed
M
Sultan
Department of Vascular and Endovascular Surgery, Western Vascular Institute, Galway University Hospital, National University of Ireland, Galway, Ireland; Department of Mechanical and Industrial Engineering, Galway Medical Technologies Center (GMedTech), Galway Mayo Institute of Technology, Galway, Ireland.
Ala
A
Elhelali
Department of Cardio-Vascular Surgery, European Clinic Polisano Hospital, Sibiu, Romania.
Victor
V
Costache
Arizona Heart Institute, Phoenix, Ariz.
Edward
E
Diethrich
Department of Vascular and Endovascular Surgery, Western Vascular Institute, Galway University Hospital, National University of Ireland, Galway, Ireland; Department of Vascular and Endovascular Surgery, Galway Clinic, Doughiska, Galway, Ireland.
Niamh
N
Hynes
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000784:Aortic Dissection / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D000785:Aneurysm, Infected / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D001014:Aortic Aneurysm / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D001027:Aortography / Q000379:methods; D001783:Blood Flow Velocity; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D002908:Chronic Disease; D000072226:Computed Tomography Angiography; D018572:Disease-Free Survival; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D005060:Europe; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011474:Prosthesis Design; D012039:Regional Blood Flow; D012042:Registries; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014654:Vascular Patency