Three year experience with multilayer stent in the treatment of thoracoabdominal aneurysms no evidence for aneurysm stabilization
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1 Three year experience with multilayer stent in the treatment of thoracoabdominal aneurysms no evidence for aneurysm stabilization Thomas Larzon, MD, PhD Head of Vascular Surgery Dept of Cardiothoracic and Vascular Surgery Örebro University Hospital, Sweden LINC, 2015
2 Disclosures I have the following potential conflicts of interest to report: Educational Program Consultant Stockholder W.L Gore & Associates Covidien Covidien LeMaitre
3 Ruffino MA, Rabbia C; Italian Cardiatis Registry Investigators Group Endovascular repair of peripheral and visceral aneurysms with the Cardiatis multilayer flow modulator: one-year results from the Italian Multicenter Registry J Endovasc Ther Oct;19(5): patients Complete aneurysm thrombosis 93% Diameter 12 months = 63% No ruptures
4 Sherif Sultan et al Early mid-term results of the first 103 cases of multilayer flow modulator stent done under indication for use in the management of thoracoabdominal aortic pathology from the independent global MFM registry J Cardiovasc Surg 2014;55:21-32 Outcome effect on aortic sac year Percetage change Max diameter Total volume 333 cm cm
5 Sherif Sultan et al Early mid-term results of the first 103 cases of multilayer flow modulator stent done under indication for use in the management of thoracoabdominal aortic pathology from the independent global MFM registry J Cardiovasc Surg 2014;55:21-32 Outcome effect on aortic sac year Percetage change Max diameter Total volume 333 cm cm
6 Sherif Sultan et al Early mid-term results of the first 103 cases of multilayer flow modulator stent done under indication for use in the management of thoracoabdominal aortic pathology from the independent global MFM registry J Cardiovasc Surg 2014;55: year 13.2% all-cause mortality No aneurysm-related mortality
7 Sherif Sultan et al Early mid-term results of the first 103 cases of multilayer flow modulator stent done under indication for use in the management of thoracoabdominal aortic pathology from the independent global MFM registry J Cardiovasc Surg 2014;55: year 10.7% reintervention rate due to stent shortening with retraction into the aneurysm
8 Vaislic CD et al One-year outcomes following repair of thoracoabdominal aneurysms with the multilayer flow modulator: report from the STRATO trial. J Endovasc Ther Feb;21(1): % technical success Stable aneurysm in 18/20 patients No aneurysm rupture
9 .but they also reported 3 patients with type I endoleaks during follow-up Conclusion was device misplacement which contributed to incomplete MFM opening in each case Aneurysm expansion was defined, per protocol, as a >10 mm increase in the maximum diameter compared to discharge imaging
10 Örebro experience 13 pts Nov 2010 Dec 2011 Thoraco-abdominal 11 Crawford I 1 Crawford II 2 Crawford III 5 Crawford IV 3 Juxtarenal 1 EVAR type I endoleak 1 Previous repair (6 pts) Mean age 75 yrs (55-89)
11 Process Considered as compassionate cases by our team Graft planning together with Cardiatis company who rewieved the initial patients
12 Survival 3 years follow-up Total number 13 pts Elective 9 pts Ø 71 mm (58-94) Emergency 4 pts Ø 70 mm (56-84) Alive 5 pts Death 4 pts Rupture 2 pts Symptomatic 2 pts Death 2 pts Death 2 pts
13 Survival 3 years follow-up Total number 13 pts Elective 9 pts Ø 71 mm (58-94) Emergency 4 pts Ø 70 mm (56-84) Alive 5 pts Death 4 pts Rupture 2 pts Symptomatic 2 pts Death 2 pts Death 2 pts
14 Survival 3 years follow-up Total number 13 pts Elective 9 pts Ø 71 mm (58-94) Emergency 4 pts Ø 70 mm (56-84) Alive 5 pts Death 4 pts Rupture 2 pts Symptomatic 2 pts 2 were AAA-related Death 2 pts Death 2 pts
15 Survival 3 years follow-up Total number 13 pts Elective 9 pts Ø 71 mm (58-94) Emergency 4 pts Ø 70 mm (56-84) Alive 5 pts Death 4 pts Rupture 2 pts Symptomatic 2 pts Death 2 pts Death 2 pts
16 Thrombosed and 3m Preop 1 week 1 month 3 months 58 mm 60 mm 60 mm 60 mm
17 >6 months increased size 6 months 12 months 18 months 24 months 6 months = 62mm 12 months = 64mm 18 months = 66mm 62 mm 64 mm 66 mm 69 mm
18 Complete thrombos formation in 1 pt
19 Branch vessel occlusion (3/29) SMA and right renal patent SMA and right renal occluded
20 SAE (elective group) 1pt spinal infarction with m 1 pt cerebral infarction postop 1 pt died after open 33 m 1 pt died due to multi-organ failure (occluded SMA and renal 39 m Reintervention rate 67% (6 out of 9 elective)
21 mm Change of aneurysm size
22 Change of aneurysm size mm + 6mm
23 Change of aneurysm size mm + 6mm + 4mm
24 Change of aneurysm size mm + 6mm + 4mm + 7mm
25 Summary MFM Registry, STRATO and Örebro trial all report an increase of aneurysm size
26 MFM Registry Summary STRATO Örebro trial
27 MFM Registry Summary STRATO Örebro trial
28 Conclusion MFM stents have not proven efficacy or safety
29 Conclusion MLFM stents have not proven efficacy or safety Aneurysm growth cannot be prevented
30 Conclusion MLFM stents have not proven efficacy or safety Aneurysm growth cannot be prevented Branch vessel patency is not obligate
31 Conclusion MLFM stents have not proven efficacy or safety Aneurysm growth cannot be prevented Branch vessel patency is not obligate Aortic aneurysms are contraindicated
32 Conclusion MLFM stents have not proven efficacy or safety Aneurysm growth cannot be prevented Branch vessel patency is not obligate Aortic aneurysms are contraindicated We urge the company to withdraw the product
33 Three year experience with multilayer stent in the treatment of thoracoabdominal aneurysms no evidence for aneurysm stabilization Thomas Larzon, MD, PhD Head of Vascular Surgery Dept of Cardiothoracic and Vascular Surgery Örebro University Hospital, Sweden LINC, 2015
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