THE EVOLUTION OF FET-TECHNIQUE
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1 4 th Aortic Live Symposium THE EVOLUTION OF FET-TECHNIQUE Heinz Jakob, MD PhD West German Heart andvascular Center, University Duisburg-Essen, Germany
2 Disclosure Speaker name: Heinz Jakob JOTEC GmbH, Hechingen, Germany q I have the following potential conflicts of interest to report: q Receipt of grants/research support q Receipt of honoraria and travel support q Participation in a company sponsored speakers bureau q Employment in industry q Shareholder in a healthcare company q Owner of a healthcare company q I do not have any potential conflict of interest
3 FET Devices Blood tight polyester vascular graft E-vita Open Plus Collar for distal anastomosis Endovascular Z-shaped nitinol skeleton High SG and introducer flexibility Inflatable tip-balloon for atraumatic delivery mm diameters Jotec GmbH Thoraflex Individual choice of LZ for sufficient sealing (tube configuration) Blood tight polyester vascular graft Jakob et al., EJCTS 2012 Collar for distal anastomosis Ring stent configuration Vascutec Ltd Branched configuration Shrestha et al., EJCTS 2013
4 FET Classic Indications Acute Type I Chronic Type I Chronic Type III Distal Arch Aneurysm
5 FET Extended Indications Megaaorta Complicated Acute Type III No proximal landing zone No proximal sealing zone Gothic arch FET as docking graft for 2nd stage repair
6 FET Concept E-vita open Plus
7 Angioscopy Pathology and Landing Zone Visualization Angioscopy Demonstration Location of re-entry sites Distance (cm) LSA to lesion
8 Zone 2 Surgery current Status
9 FET Essen Results / /2017 (%) Overall N = 245 Acute AD N = 131 Chronic AD N = 62 Aneurysm N = 52 Mortality 30 days Stroke Paraplegia Survival 10 Years Results Freedom from re-intervention downstream 55% 69% Periprosthetic healing almost 100% overtime
10 Acute Type I AD Survival and Freedom of secondary Aortic Intervention Cumulative survival + freedom from ao. re-intervention Acute Type I AD With FET vs. Without - FET (FU mean 1.9 ± 1.7 yrs.) Survival Freedom from re-intervention 3 years 5 years Cumulative survival + Freedom from ao. reintervention With FET Without FET p With FET Without FET 74% 44% % 18% p Tsagakis et al, AHA 2015
11 Multisegmental Thoracic Aortic Aneurysm Survival and Freedom from Reintervention Survival Freedom from Reintervention
12 Aortic Remodeling after FET in Acute Type I AD Descending Aorta mm Type II Type I Proximal repair Type I FET Aortic Levels Remodeling based on volume changes SG SG-TC TC-distal Tsagakis et al Eur J Cardiothorac Surg 2012 Dohle et al Eur J Cardiothorac Surg 2016
13 Frozen Elephant Trunk The Surgical Option to Deal with Multisegmental Thoracic Aortic Disease 12 yrs after E-vita open for acute type I AD
14 New Concepts E-novia E-vita open NEO
15 Preoperative variables west german heart and vascular center essen Overall Acute AD Chronic AD Aneurysm N =178 p N = 96 p N = 43 p N = 39 p Age 59± ± ± ± Emergency 97 (55) (95) (5) (10) Male 125 (70) (68) (84) (62) Univariate analysis Previous proximal ao. surg. 39 (22) (5) (63) (18) Coronary artery disease AV regurgitation EF <40% 51 (29) 73 (41) 16 (9) p 25 (26) value (13) 59 (62) (21) 9 (9) (7) (49) 5 (13) 4 (10) Peripheral artery disease 30 (17) (6) (16) (44) Preoperative variables Creatinine >1.5mg/dl 37 (21) (22) (12) (28) COPD 41 (23) (15) (26) (41) Diabetes mellitus 16 (9) (6) (9) (15) Previous stroke 22 (12) (7) (16) (21) Tamponade 19 (11) (20) Compromised hemodynamic 33 (19) (32) (2) (3) Malperfusion 58 (33) (60) (2) Intraoperative variables Axillary cannulation 96 (54) (34) (74%) (80) Ascending ao. cannulation 72 (40) (59) (23%) (13) Selective LSA perfusion 73 (41) (33) (47) (54) Distal perfusion 51 (29) Compromised 25 (26) (28) (36) Separate head 83 (47) (49) (49) (39) vessels implantation hemodynamics Zone 3 anastomosis 95 (53) (60) (47) (44) Root replacement 18 (10) (12) (16) Additional cardiac surg. 54 (30) (30) (21) (41) Operative times,mean±sd Intraoperative variables CPB, min 249± ± ± ± Cardioplegic arrest, min 135± ± ± ± SACP, min 63± ± ± ± Visceral ischemia, min 60± ± ± ± HCA, min 5± ± ± ± Postoperative variables Stroke Permanent Transient Spinal injury Paraplegia Paraparesis No residuals 17 (10) 12 (7) 5 (3) 11 (6) 5 (3) 4 (2) 2 (1) (7) 5 (5) 2 (2) (5) 2 (2) 2 (2) 1 (1) (12) 3 (7) 2 (5) (12) 2 (5) 2 (5) 1 (2) (13) 4 (10) 1 (3) (3) Temporary hemodiafiltration 56 (32) (41) (26) (15) Reexploration 21 (12) (13) (14) (8) Distal ischemia 22 (12) < (19) (7) (3) Ventilation >72hours 77 (43) (50) (37) (33) (3) FET - Essen Results Risk Factors for Mortality Overall AAD CAD TAA EF<40% Periph. Art. disease COPD CPB duration Multivariate analysis Compromised hemodynamics p CPB duration Jakob et al, EJCTS 2017
16 E-novia Concept One hemostatic suture line for Arch + Descending Ao.
17 E-novia in Acute Type I AD 68y, male, Visceral ischemia since 8 hours with hematemesis, free rupture Asc.
18 Lessons learned Design E- novia 2nd Generation Technical modifications: Ø Uncovered stent remains crimped within the longer covered stent during release Ø Uncovered Stent mobile within the covered stent Ø Additional 5 10mm tissue bridge at the concavity Ø Modified nitinol mesh angle and better memory characteristics for better expansion and significant reduction of thrombogenicity Successful mechanical durability testing patent pending
19 E-novia 2 nd Generation CT Case 2 (Zone 2-Concept) 2D-MPR Branciocephalic trunk Left Carotid Artery
20 Unknown Perspectives / Suspected Shortcomings Radial + longitudinal aortic movement
21 Prevention of Type I Endoleak
22 New Concepts E-novia E-vita open NEO
23 The E-Vita Open NEO Concept Ascending + Arch Aortic Repair with 2 anastomoses Combining debranching with E-vita open principle v Suture line in Zone 0, no touch arch principle v Stentgraft length cm v Trifurcation graft (Spielvogel type) v Separate Perfusion port lower body v Short introducer v Maximum flexibility, easyness of surgery v Short ischemic times
24 STENT GRAFT DESIGN Ø8 Ø10 Ø26, 28, 30 Ø22 bis 40 Ø
25 E-vita open NEO
26 90 Rotation of the Trifurcation I II
27 FET - Gold Standard in Complex Aortic Arch Surgery? v durable repair v at low risk in experienced centers v shortened period of hypothermic arrest v shortened CPB time v applicable in elective and emergency cases v perfect docking for open and endo reintervention
28 Conclusion The E-Vita Open Plus, E-Novia and E-Vita Open NEO will represent a family of graft variations to enable us to deal with all kinds of pathologies of the arch, but remains open surgery
29 Total aortic endovascular repair versus open surgery Currently in early phase of application in selected centers with great interventional experience for a highly selected patient population Today: Open Gold Standard But
30 The Future The Future: Open Surgery embraces Endovascular
31 European E-vita Open Registry WEST-GERMAN HEART AND VASCULAR CENTER ESSEN Thoracic and Cardiovascular Surgery UNIVERSITY CLINIC OF ESSEN
32 Chronic Type A Aortic Dissection (AD) St.p. prox. ao. repair for acute Type I AD Patent false lumen distally ~ 70-89% Ø Aortic growth Ø Aortic rupture Ø Malperfusion Redo Surgery at 5-12 yrs: 16 39% Glauber, Murzi 2010 Park 2009, Ishihara 2009 Zierer 2007 Geirsson, Bavaria 2007 Kirsch 2002
33 Perfusion Management in Essen Whole body selective perfusion during arch replacement SACP 22 C (blood), mmhg [steroids] LCCA Tsagakis, Jakob et al, MITAT, 2015 Vent / Field / Sump Right axillary artery Left axillary artery venous reservoir centrifugal pump Venous line Add. reservoir Cooling 28 C (bladder) extra pump desc. Aorta Selective whole body perfusion 28 C Separate circuit for selective perfusion of Ø Left subclavian/axillary artery Ø Downstream aorta
34 Angioscopy to Secure Guide Wire Position and SG Deployment Guide wire repositioning Guide wire retrieval
35 Real World Experience Retro-Type A after TEVAR for Complicated Type B
36 Real World Experience
37 Hamburg, October 21-22, st EACTS/ESVS Endovascular Skills Course Educational and Training Program for Endovascular Skills
38 Heading 28pt Calibri
39 E-vita open NEO Facilitation of Surgery - Zone 0 Anastomosis Shortening of ischemic times Spielvogel type trifurcated head branches Maximum Flexibility, easiness
40 Zone 2 Arch Repair + Selective Distal Perfusion Times Reduction CPB, min Cardiac arrest, min SACP, min Visceral ischemia, min P = P = <0.001 P = <0.001 P = <0.001 Current perfusion management - Results Median, min SACP + LSA + SDP N = 78 CPB 225 Cardiac arrest 120 SACP 54 Visceral ischemia 31 SDP = Selective Distal Perfusion
41 E-vita open Neo (Prototype)
42 E-novia 2 nd Generation CT Examinations Case 1 Case 2
43 New hybrid graft (3-Zone Graft = E-novia) for fast asc. / arch and desc. aortic repair Aim Transfer of E-vita open zone 2 hemostatic sutureline to zone zero Reduction of distal ischemic/sacp Time < 20 min Downstream splinting of TL LZ for add. TEVAR/SURGERY Ascending Ao Components Arch *Patent pending Descending Ao Vascular graft Uncovered Stent Stentgraft (5cm)
44
45 E-vita Open Sufficient Sealing for One Stage Repair CAD, Marfan, 44y male, 204cm/115KG St.p. prox. ao. replacement for AAD New Entry in the arch (A) Dissection in desc. ao. (B) A B One stage treatment E-vita open (28x130mm) Anastomosis No stented part 22cm to LZ SG part 20cm Distance to distal LZ
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