Three year experience with multilayer stent in the treatment of thoracoabdominal aneurysms no evidence for aneurysm stabilization

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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

Disclosures I have the following potential conflicts of interest to report: Educational Program Consultant Stockholder W.L Gore & Associates Covidien Covidien LeMaitre

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. 2012 Oct;19(5):599-610 54 patients Complete aneurysm thrombosis 93% Diameter reduction @ 12 months = 63% No ruptures

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 Baseline @1 year Percetage change Max diameter 63 71 +12.6 Total volume 333 cm 3 355 cm 3 +6.8

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 Baseline @1 year Percetage change Max diameter 63 71 +12.6 Total volume 333 cm 3 355 cm 3 +6.8

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 @ 1 year 13.2% all-cause mortality No aneurysm-related mortality

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 @ 1 year 10.7% reintervention rate due to stent shortening with retraction into the aneurysm

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. 2014 Feb;21(1):85-95 100% technical success Stable aneurysm in 18/20 patients No aneurysm rupture

.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

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)

Process Considered as compassionate cases by our team Graft planning together with Cardiatis company who rewieved the initial patients

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

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

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

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

Thrombosed and stable @ 3m Preop 1 week 1 month 3 months 58 mm 60 mm 60 mm 60 mm

>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

Complete thrombos formation in 1 pt

Branch vessel occlusion (3/29) SMA and right renal patent SMA and right renal occluded

SAE (elective group) 1pt spinal infarction with paraplegia @15 m 1 pt cerebral infarction postop 1 pt died after open debranching @ 33 m 1 pt died due to multi-organ failure (occluded SMA and renal artery @ 39 m Reintervention rate 67% (6 out of 9 elective)

mm Change of aneurysm size

Change of aneurysm size mm + 6mm

Change of aneurysm size mm + 6mm + 4mm

Change of aneurysm size mm + 6mm + 4mm + 7mm

Summary MFM Registry, STRATO and Örebro trial all report an increase of aneurysm size

MFM Registry Summary STRATO Örebro trial

MFM Registry Summary STRATO Örebro trial

Conclusion MFM stents have not proven efficacy or safety

Conclusion MLFM stents have not proven efficacy or safety Aneurysm growth cannot be prevented

Conclusion MLFM stents have not proven efficacy or safety Aneurysm growth cannot be prevented Branch vessel patency is not obligate

Conclusion MLFM stents have not proven efficacy or safety Aneurysm growth cannot be prevented Branch vessel patency is not obligate Aortic aneurysms are contraindicated

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

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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