TOTAL AORTIC ARCH REPLACEMENT WITH THORAFLEX HYBRID FROZEN ELEPHANT TRUNK PROSTHESIS: RESULTS OF FIRST 100 PATIENTS Malakh Shrestha, Heike Krueger, Tim.

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TOTAL AORTIC ARCH REPLACEMENT WITH THORAFLEX HYBRID FROZEN ELEPHANT TRUNK PROSTHESIS: RESULTS OF FIRST 100 PATIENTS Malakh Shrestha, Heike Krueger, Tim Kaufeld, Erik Beckmann, Nurbol Koigeldiyev, Felix Fleissner, Julia Umminger, Axel Haverich and Andreas Martens. Hannover Medical School

Disclosures Consultant Vascutek Terumo

“Elephant Trunk Technique“ Stage 1 1. Aneurysm:15th March 1982 2. CADA: 28th October 1983 3. AADA: 22nd May 1989 Modifications of the Classical Elephant Trunk Borst HG et al. Extensive aortic replacement using the ‚elephant trunk prosthesis‘ Thorac Cardiovasc Surg 1983; 31 (1): 37-40

The second stage completion is inevitable! METHODS: March 1982 to March 2012, 179 patients (112 males, age 56 ± 13years) (91 aneurysms, 88 dissections (47 acute)). The second stage completion is inevitable!

Is branched graft technique better for total aortic arch replacement? Ann Thorac Surg. 2004 Jun;77(6):2021-8. Separate grafts or en bloc anastomosis for arch vessels reimplantation to the aortic arch. Di Eusanio M, Schepens MA, Morshuis WJ, Dossche KM, Kazui T, Ohkura K, Washiyama N, Di Bartolomeo R, Pacini D, Pierangeli A. Spielvogel 2005

Thoraflex Hybrid FET graft Unstented proximal part & stented distal part 4 ‘fingers’, three for supra-aortic vessels, one for ECC Stent length: 100 & 150 mm Unstented & stented part available in different sizes sewing collar Radio-opaque markers Fully Sealed Device, gelatine

Delivery System Release Clip Tip Splitter Splittable Sheath with side guide wire access Splitter Splittable Sheath Completely removed from system after deployment Malleable Shaft Handle Strap Release Clip

Thoraflex Hybrid FET Graft Plexus 4 Branched graft Sewing Collar for distal anastmosis Fully Sealed Device Radio opaque markers

Hannover Concept Core temperature 25°C Bilateral SACP (22-24°C) ‘Beating Heart‘ arch surgery Minimize lower body ischaemia CSF drainage CO2 Sufflation FET

Pre-operative Data All Acute Dissection Chronic Dissection Aneurysm P   All Acute Dissection Chronic Dissection Aneurysm P Patients (n) n = 100 n = 37 n = 21 n = 42 Sex (Male (n,%)) n = 65 (65%) n = 28 (76%) n = 12 (57%) n = 25 (60%) 0.226 Age (Years) 59 ± 14 56 ± 13 54 ± 16 64 ± 11 0.004 Marfan Syndrome (n,%) n = 11 (11%) n = 4 (11%) n = 5 (24%) n = 2 (5%) 0.075 Previous surgery (n,%) n = 28 (28%) n = 1 (3%) n = 15 (71%) n = 12 (29%) <0.0001

Intra-operative Data All Acute Dissection Chronic Dissection Aneurysm   All Acute Dissection Chronic Dissection Aneurysm P Patients (n) n =100 n = 37 n = 21 n = 42 Operation time (min) 367 ± 80 391 ± 62 393 ± 64 334 ± 90 0.001 CPB time (min) 241 ± 61 267 ± 46 244 ± 52 217 ± 68 0.0007 Cardiac ischemia time (min) 123 ± 62 146 ± 56 117 ± 61 105 ± 63 0.011 Distal CA time (min 57 ± 55 60 ± 39 64 ± 34 51 ± 32 0.354 SACP time (min) 98 ± 36 110 ± 35 104 ± 36 84 ± 31 0.003 “Beating Heart” arch repair n = 47 (47%) n=14 (38%) n = 9 (43%) n = 24 (57%) 0.210 Concomitant procedures: - Bentall - Valve sparing root - CABG - MVR - AVR n = 52 (52%) n = 10 n = 30 n = 12 n = 3 n = 2 n = 26 (70%) n = 5 n = 4 n = 1 n = 0 n = 17 (40%) n = 8 n = 6 n =1 0.019

Post-operative Data *1 pt. has permanent Paraplegia   All Acute Dissection Chronic Dissection Aneurysm P Patients (n) n = 100 n = 37 n = 21 n = 42 Ventilation (days) 1.0 (0.6-3.7) 2.8 (0.8-6.0) 0.9 (0.4-7.2) 0.7 (0.5-1.7) 0.0019 Rethoracotomy for bleeding (n,%) n = 16 (16%) n = 8 (22%) n = 3 (14%) n = 5 (12%) 0.487 Stroke (n,%) n = 10 (10%) n = 5 (14%) n = 2 (5%) 0.330 Paraparesis * (n/%) n = 7 (7%) n = 3 (8%) n = 2 (10%) 0.741 Recurrent nerve palsy (n,%) n = 25 (25%) n = 9 (24%) n = 8 (38%) n = 8 (19%) 0.256 Renal failure; dialysis ** (n,%) n = 14 (14%) n = 4 (11%) n = 4 (19%) n = 6 (14%) 0.684 30 day mortality (n,%) n = 1 (5%) n = 3 (7%) 0.890 *1 pt. has permanent Paraplegia ** 1 pt. needs permanent Dialysis

Distal aortic reinterventions   All Acute Dissection Chronic Dissection Aneurysm P Patients (n) n = 100 n = 37 n = 21 n = 42 Second procedure downstream aorta (n,%) n = 20 (20%) n = 2 (3%) n = 7 (33%) n = 11 (26%) 0.016 Time to reoperation (months) 7.0 (1.8-9.7) 6.8 (1.9-8.1) 9.2 (6.9-11) 5.3 (0.7-9.9) 0.295 - open surgical - thoraco-abdominal - descending aorta - abdominal/iliac - endo-vascular n = 7 (7%) n = 2 n = 3 n = 13 (13%) n = 0 (0%) n = 0 n = 2 (5%) n = 3 (14%) n = 1 n = 4 (19%) n = 4 (10%) n = 7 (17%) 0.086 0.216

Aortic imaging Segment A Segment B Segment C

Aortic remodeling: False lumen thrombosis in AADA   Pre-OP Post-OP Last Follow Up Patent Partial Thromb. P vs. Pre Segment A 22 (85%) 1 (4%) 3 (12%) 4 (16%) 20 (80%) <0.001 1 (6%) 2 (11%) 15 (83%) Segment B 21 (84%) 10 (41%) 8 (33%) 6 (25%) 0.006 5 (31%) 16 (38%) Segment C 0 (0%) 14 (58%) 4 (17%) 0.056 11 (69%) 4 (25%) 0.3233

Aortic remodeling in AADA Aortic diameters   Post-OP vs. Pre-OP Last Follow Up vs. Pre-OP Aortic diameter difference (%, P) Aortic diameter difference (%,P) AL TL FL Segment A +0.0% (0.506) +66% (0.001) -32% (0.0001) -3.0% (0.179) +92 (<0.0001) -68% Segment B +0.5% (0.854) +53% (0.015) -23% (0.020) +31% (0.704) +60% (0.005) -13% (0.023) Segment C +3.3% (0.267) +43% (0.104) -26% (0.066) +8.5% (0.331) +44% (0.051) -8.2% (0.330)

Aortic remodeling: False lumen thrombosis in CAD   Pre-OP Post-OP Last Follow Up Patent Partial Thromb. P vs. Pre Segment A 15 (71%) 1 (5%) 5 (24%) 4 (20%) 6 (30%) 10 (50%) 0.003 3 (18%) 5 (29%) 9 (53%) Segment B 15 (75%) 2 (10%) 3 (15%) 14 (74%) 3 (16%) 2 (11%) 0.815 15 (94%) 1 (6%) 0 (0%) 0.232 Segment C 16 (89%) 14 (82%) 2 (12%) 0.295 12 (92%) 1 (8%) 0.242

Aortic remodeling in CAD Aortic diameters   Post-OP vs. Pre-OP Last Follow Up vs. Pre-OP Aortic diameter difference (%, P) Aortic diameter difference (%,P) AL TL FL Segment A -4.7 % (0.454) +45 % (0.100) -19 % (0.049) -14 % (0.133) +77 % (0.003) -31 % (0.001) Segment B -3.3 % (0.560) +15 % (0.500) -11 % (0.227) -0.6 % (0.967) +25 % (0.668) -2.6 % (0.528) Segment C -2.4 % (0.673) +9.4 % (0.718) -10 % (0.452) -0.8 % (0.725) +1.2 % +2 % (0.676)

Kaplan Meier Curve: Freedom from Re-intervention

Kaplan Meier Curve: Survival

Conclusion The Thoraflex Hybrid FET: 1. Combines advantages of FET and Plexus arch graft 2. Ease of FET delivery 3. Unique features , e.g. “Sewing Collar“ 4. Aortic “remodelling“ in Aortic dissections 5. Potentially „single stage“ therapy in Aneurysms 6. Excellent peri-operative and mid-term results. ‘Beating Heart’ in Aortic Arch Surgery 1983 1988 1991/93 1997/2003 2004 2006 2013 Borst Svensson Kazui Usui, Karck Neri ‘Siena graft‘ Shrestha, Haverich

Thank You! “The Aortic Team“ Hannover Medical School!