Multilayer stents for thoracoabdominal aortic aneurysam Ivo Petrov,MD,PhD,FESC,FACC Zoran Stankov MD City Clinic Sofia Bulgaria

Crawford classification

Historical perspective The first successful repairs of a TAAA in the United States was reported in 1955 by Etheredge (1) Cooley and DeBakey’s subsequent report in 1965 included 42 patients in whom knitted Dacron grafts were utilized as the initial shunt and then converted to the formal conduit by stepwise side branch anastomoses of the visceral arteries (2) Crawford is credited with pioneering the technique of an intra-aortic anastomosis after longitudinal division of the sac. In addition, he also described the technique of a single pedicled visceral segment anastomosis including the celiac, superior mesenteric, and right renal arteries, followed by a left renal anastomosis with sequential reperfusion after the completion of each. His results were superb with only one death in 23 consecutive cases(3) 1.Etheredge SN, Yee J, Smith JV, et al. Successful resection of a large aneurysm of the upper abdominal aorta and replacement with homograft. Surgery 1955;38:1071-81. 2DeBakey ME, Crawford ES, Garrett HE, et al. Surgical considerations in the treatment of aneurysms of the thoraco-abdominal aorta. Ann Surg 1965;162:650-62. 3Crawford ES. Thoraco-abdominal and abdominal aortic aneurysms involving renal, superior mesenteric, celiac arteries. Ann Surg 1974;179:763-72.

Hybrid Open Visceral Revascularization and Endograft Aneurysm Exclusion Schema of TAA treated with initial left iliac artery–to–left renal artery–to–superior mesenteric artery bypass graft and subsequent placement of a thoracoabdominal endograft. Proximal superior mesenteric artery and left renal arteries were ligated. SMA indicates superior mesenteric artery; and TAA, thoracoabdominal aneurysm. SOURCE: Adapted from Flye, et al. J Vasc Surg. 2004;39:454–8.

Cost EVAR repair, Abularrage CJ, et al. 2005 Open AAA (30pt) “fast-track” EVAR (28pt) Length of surgery (min) 216 ± 7.4 158 ± 6.8 Volume of blood transfusion (un.) 1.8 ± .29 0.32 ± .24 Colloid transfusion (cc) 565 ± 89 32 ± 22 Crystalloid (cc) 4625 ± 252 2627 ± 170 Resume regular diet 1.8 ± .11 0.21 ± .08

Cost EVAR repair, Abularrage CJ, et al. 2005 ICU stay (day) 0.87 ± .01 0.50 ± .10 Floor stay ( day) 2.6 ± .21 2.1 ± .23 Total length of stay (day) 3.4 ± .18 2.8 ± .32 Hospital cost ( $$ ) 10.205 ± 736 20,640 ± 1206 Hospital earning ( $$ ) 6,141 ± 1280 107 ± 1940

2 year Outcomes after Conventional EVAR of AAA DREAM Trial Group, 2005 Randomized trial, multicenter comparing open repair with EVAR in 26 centers in Netherlands and 4 centers in Belgium. Open repair EVAR 178 pt 173 pt 2 y survival rate 89.6 89.7 Aneurysm related death 5.7 2.1 Survival free of complications 65.9 65.6 The perioperative survival advantage with EVAR repair as compare with open repair is not sustained after the 1-st postoperative year.

The 30-day survival rate was 94.3% (1,672 patients). Thoracoabdominal aortic aneurysm repair: review and update of current strategies Presented at the Aortic Surgery Symposium VIII, May 2–3, 2002, New York, NY. Joseph S Coselli, Mda,Lori D Conklin, MDa, Scott A LeMaire, MDa a The Michael E. DeBakey Department of Surgery, Division of Cardiothoracic Surgery, Baylor College of Medicine, and The Methodist DeBakey Heart Center, Houston, Texas, USA The 30-day survival rate was 94.3% (1,672 patients). Postoperative complications included : Renal failure requiring hemodialysis in 105 patients (5.9%) Paraplegia or paraparesis in 79 patients (4.5%). Actuarial 5-year survival was 73.5% ± 1.6%.

Recommendations (open and endovascular )for Descending Thoracic Aorta and Thoracoabdominal Aortic Aneurysms For patients with chronic dissection, particularly if associated with a connective tissue disorder, but without significant comorbid disease, and a descending thoracic aortic diameter exceeding 5.5 cm, open repair is recommended. For patients with degenerative or traumatic aneurysms of the descending thoracic aorta exceeding 5.5 cm, saccular aneurysms, or postoperative pseudoaneurysms, endovascular stent grafting should be strongly considered when feasible. I IIa IIb III B I IIa IIb III B

Endovascular options for TAAA repair Chimney/snorkel Surgeon-modified In-situ fenestration Custom fenestrations MFM

Outcomes Ch-EVAR

Outcomes FEVAR

Primary endpoints were: 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 103 cases 12 countries Primary endpoints were: -one-year freedom from rupture and aneurysm-related death - one year all cause mortality, patency of visceral branches at one year, - one year incidence of stroke and paraplegia. Primary technical endpoints were aneurysm sac volume modulation at one year. Secondary technical endpoints were technical success and one-year freedom from reintervention J Cardiovasc Surg (Torino). 2014 Feb;55(1):21-32.

Mean age of 69.2 years (16-93 years), 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 Mean age of 69.2 years (16-93 years), Mean aneurysm diameter was 6.4±1.66 cm Mean length was 12.96 cm. 75 Crawford thoracoabdominal aortic aneurysms (TAAA) :(11 Type I, 14 Type II, 26 Type III, and 24 Type IV), 7 arch aneurysms, 15 suprarenal aortic aneurysms 6 type B dissections. The mean number of side branches covered for a total number of 378 branches is 3.7 side branches per case. Total numbers of stents used was 176 with a mean of 1.71 MFM stents per case; 77.77 were ASA IV E, 72.7% had previous thoracic endovascular aortic repair or open TAAA repair. J Cardiovasc Surg (Torino). 2014 Feb;55(1):21-32.

Results Thirty-day morbidity was 5.4% with zero mortality. Aneurysm related survival was 91.7% at one year. No rupture occurred. Four cases of consumptive coagulopathy were observed, two of which resulted in death from hemorrhagic cerebrovascular stroke and one of which resulted in death from a gastrointestinal bleed. Technical success was 97.3%. One-year all-cause survival was 86.8%. At 12 months 95.1% of all visceral branches were patent. There were no stent fractures. One-year intervention free survival was 89.4%. J Cardiovasc Surg (Torino). 2014 Feb;55(1):21-32.

Cardiatis multilayer stent

Streamlines inside an aneurysm without stent(left) and with porous wired stent (right, stent in blue). Steady computation.

Our experience. Procedural data: A/D TAA/AAA N. STENT F.TIME T.TIME 1 A TAA 2 12 40 AAA 6 30 3 D 4 22 150* 5 8 50 Average 10,4 min 62 min.

Case report 1 White male 71 yo Admitted in hospital with persistent severe abdominal and peripheral ischemia with abdominal angina. History of pervious surgical treatment for Type A Ao dissection

Diagnostic angiogram

Stent implantation

Postdilatation

Final

CT- angio after 2- months

CT- angio after 6- months. Centralized blood flow CT- angio after 6- months. Centralized blood flow. Complete distal healing, patent visceral vessels:

CT- angio after 12 months

Color codded Doppler of the abdominal aorta Color codded Doppler of the abdominal aorta. Normal flow into the abdominal aorta and visceral arteries arteries. Thrombosis of the false lumen:

Celiac trunk

Left common iliac artery

Right Common Iliac Artery

ABI A.tib. Ant. Dex.- 145 mmHg ABI (right leg)= 1.20 A.tib post. Dex.-155 mmHg A.tib. Ant sin.-140 mmHg ABI (left leg)=1.15 A.tib post. Sin- 150 mmHg A.brachialis-140 mmHg

Case presentation 2 73 y, male Comorbidities- CoAD-1VD. PCI +stents/DES/x2 in LAD. Arterial hypertension, hypercholesterolemia, aortic insufficiency II gr., episodes of paroxismal atrial fibrillation Diagnosed with an asymptomatic abdominal aortic aneurysm, proven by echo doppler, CT and aortograpgy.

CT-angio. Distal abdominal aorta aneurysm involving both iliacs CT-angio. Distal abdominal aorta aneurysm involving both iliacs. Extreme tortuosity.

CT-angio. Distal abdominal aorta aneurysm involving both iliacs CT-angio. Distal abdominal aorta aneurysm involving both iliacs. Extreme tortuosity.

Angiography

Aorto-uniiliac Cardiatis multilayer stent implantation fully covering the contralateral Common iliac artery:

Final

CT- angio after 1- months

CT-angio after 6 months

Abdominal Aorta and both iliac arteries

Abdominal aorta and superior mesenteric artery

ABI A.tib. Ant. Dex.- 130 mmHg ABIdex= 1.16 A.tib post. Dex.-140 mmHg A.tib. Ant sin.-140 mmHg ABIsin=1.16 A.tib post. Sin- 130 mmHg A.brachialis-120 mmHg

Case presentation 3 74 y, male Comorbidities- CoAD-2VD. PCI +stents/ICS/ in RD1. /2004/ Arterial hypertension , Operation due to Ca recti Diagnosed with an asymptomatic thoracic aortic aneurysm / descending aorta/ , which was treated successfully in 2004 with a stent graft.

Angiography In february 2012 due to chest pain coronaro- and aortography was done and it was found an aneurysm below the stent graft, above the renal arteries. Angiography of coronary artery- patent stent in RD1, LCx with occlusion in OM2; RCA-degenerative changes.

CT- angio

Aortography

Implantation

Final

Control CT after 3 monts

12 months f-up

Case presentation H.T.H.; 75 year old male; with a history of an asymptomatic abdominal aortic aneurysm Comorbidities: Coronary Artery Disease-2vessel disease. PCI + stent x3 in the RCA. And PCI and stent in RIM. Periphery Artery Disease II st. Arterial Hypertension III gr. Operation due to Ca recti.

Aortography

CT- angio SMA

CT- angio SMA RR

1 mont CT angio f-up:

Conclusion: The implantation of Cardiatis multilayer stent in the treatment of complicated aneurysms of the thoracic and abdominal aorta is effective and safe. This treatment allows preservation of blood flow in the branches arising from the stented area. The early and mid-term follow-up results are promising We need more systematic procedural and clinical data in order to establish the exact indications of this novel technology

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