TY - JOUR
T1 - Endovascular management of chronic symptomatic aortic dissection with the Streamliner Multilayer Flow Modulator
T2 - Twelve-month outcomes from the global registry
AU - Sultan, Sherif
AU - Kavanagh, Edel P.
AU - Stefanov, Florian
AU - Sultan, Mohamed
AU - Elhelali, Ala
AU - Costache, Victor
AU - Diethrich, Edward
AU - Hynes, Niamh
AU - Petrov, Ivo
AU - Grozdinski, Lachezar
AU - Moosdorf, Rainer
AU - Remsey-Semmelweis, Ernö
AU - Mathias, Klaus
AU - Chocron, Sidney
AU - Bouayad, Mohamed Nadjib
N1 - Publisher Copyright:
© 2017 Society for Vascular Surgery
PY - 2017/4/1
Y1 - 2017/4/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85016014897&partnerID=8YFLogxK
U2 - 10.1016/j.jvs.2016.09.059
DO - 10.1016/j.jvs.2016.09.059
M3 - Article
C2 - 28342521
AN - SCOPUS:85016014897
SN - 0741-5214
VL - 65
SP - 940
EP - 950
JO - Journal of Vascular Surgery
JF - Journal of Vascular Surgery
IS - 4
ER -