No Disclosure. Aortic Dissection in Japan. This. The Challenge of Acute and Chronic Type B Aortic Dissections with Endovascular Aortic Repair

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No Disclosure The Challenge of Acute and Chronic Type B Aortic Dissections with Endovascular Aortic Repair Toru Kuratani Department of Cardiovascular Surgery Osaka University Graduate School of Medicine, Japan Aortic Dissection in Japan T F Population 57 / million cases/year in Japan M : F = 6 : 4 Treatment Strategy for Acute Aortic Dissection Type A Dissection Emergency Operation This over three times the incidence rate 4319 surgical cases/year Type B Dissection Medical Hypotensive Therapy serious complications Emergency Operation in Japan Stanford type A Stanford type B (9)

Surgical Mortality Rate for Acute type B Aortic Dissection Complicated cases : 8 9 Uncomplicated cases : 13 Treatment Strategy for Acute type B Aortic Dissection before TEVAR Complication specific treatment Uncomplicated Medical Management T F Comparison of medical and surgical therapy for uncomplicated descending aortic dissection. Glower DD, Fann JI, Speier RH, Morrison L, White WD, Smith LR, Rankin JS, Miller DC, Wolfe WG. Circulation 199;8(5 Suppl):IV39-46. Complicated Rupture Ischemia Expansion Surgical Management Graft replacement Fenestration Graft replacement (rarely, Thromboexclusion) Management of descending aortic dissection. Elefteriades JA, Lovoulos CJ, Coady MA, Tellides G, Kopf GS, Rizzo JA. Ann Thorac Surg 1999;67(6):-5; discussion 14-9. Morphological change in chronic type B Dissection Acute Chronic The Long-term Results of Uncomplicated Acute Type B Aortic Dissection with Best Medical Treatment Freedom from aortic enlargement (Rupture, >1mm/ year, >6mm) Narrowing of true lumen Involved visceral arteries Marui Circulation 199 Kato M, Kuratani T Circulation 1995 1 year 3years 5 years 1 years 75% 6% 88% 68% 6% Winnerkivist EJVES 6 75% 67% 8

Our Team Target Goal 1 To prevent enlargement for uncomplicated type B dissection in chronic phase Prediction of Aortic Enlargement at the onset 1. Prediction of Aortic Enlargement Study Design # Retrospective study with 41 uncomplicated type B pts. Entry Closure with minimal risk # Multivariate analysis Predictive factor Freedom from Aortic Enlargement Comparison between <4mm and >4mm of aortic diameter at onset 1 % aortic diameter < 4 mm Goal 8 6 76% aortic diameter 4 mm Entry Closure with Minimal Risk 4 44% 35% We need THE SURGERY of entry closure with less invasiveness. 1.. 3. 4. 5. Years 6. Kato M, Kuratani T, et. al. Circulation 1995;9( Suppl):II17-1. CONCLUSIONS: These data suggest that patients with acute type B dissection who have a large aortic diameter (> or = 4 mm) and a patent primary entry site in the thorax should be treated surgically during the acute phase on the condition that the surgical risk in this phase is limited. Study Design # Animal study with experimental aortic dissection # Clinical trial for patients with type B aortic dissection

TEVAR for Acute type B aortic dissection IA graft (intra aortic graft) = Stent Graft Entry close Thrombosed false lumen Experimental assessment of newly devised transcatheter stent-graft for aortic dissection. Kato M, Kuratani T, Kaneko M, et.al. Ann Thorac Surg 1995;59(4):98-14; discussion 914-5. Tapered graft: 8-5:GZV(3) 5-5 Device TEVAR for type B dissection Giantuco Z-stent + Thin wall woven polyester graft Cases Jan. 1993 -Mar. 11 Aortic Aneurysm (Included Aortic Dissection): 517 cases Flares Open area to fit the curve for aortic arch Treatment with Stent-graft: 1883 (74.8%) Aortic Dissection : 76 Acute 54 Chronic 67 Aortic Arch Aneurysm: 531 Open Stent Grafting: 16 Branched Open Stent Grafting: 13 Debranched TEVAR: 19 Descending Aortic Aneurysm: 79 Thoraco-Abdominal Aortic Aneurysm: 18 Abdominal Aortic Aneurysm: 515

Patients 1999-1 TEVAR TEVAR and Device data for acute type B aortic dissection 34 cases DISTAL 5-1% PROXIMAL 1-% Device Age 6.4(4-8) Gender M/F=3/11 UNCOMPLICATED TYPE B 1 COMPLICATED TYPE B 4 1 minimal coverage of the entry all entry closure in descending aorta 3 Early results 4 Home made 3 Home made + TAG 1 Home made + cuff TAG cuff TAG+cuff Device size (mm) proximal diameter 9.5 distal diameter 5.4 Device length (mm) 1 Long-term results Primary success: 37/39 (94.8%) (minor type I endoleak:) Hospital mortality: /39 (5.%) (complicated type B: ) Follow up: 3.3 month (-19), 95.3% completion freedom from dissection related death: 94.8%/5year Complications: Stroke 1/39 spinal cord ischemia /39 renal failure 1/39 retrograde type A /39 re-dissection /39 new intimal injury 1/39 iliac injury /39 ALL CAUSE SURVIVAL: 9.9%/1YEAR 7.7%/3YEAR 7.7%/5YEAR

Status of Thoracic false lumen (FL) with CT image Aortic event proximal event 3 At discharge 1 year later Disappear Clotted(size no change) shrinkage patent clotted enlarge (size no change) FREEDOM FROM AORTIC EVENT: 9.%/1YEAR 79.%/3YEAR 73.1%/5YEAR event No. post op month intervention erosion 4, 16 TAR 1, TEVAR 1 ULP 1 5 TAR 1 distal event 4 event No. post op month intervention floating 5, 16 TEVAR erosion 1, 14 TEVAR middle descending aorta (LA level) re-entry event Approval of the next generation device is absolutely essentialential Chronic Type B Aortic Dissection

Impact of treatment timing on aortic event free survival in patients with aortic dissection I.Akin, Nienaber etc Eur J Vasc Endovasc Surg 9(38),89-96 Demographics Chronic B Dissections with follow-up by MDCT 6 cases Periods from onset to TEVAR: 9.7 months (1-49) M/F 5 / 1 Age 66. Preoperative complications 5-1 CVD 9 (14.5%) CAD 1 (16.1%) COPD 5 (8.1%) CRF(C( r>1.5mg/dl 6 (9.7%) Cancer 5 (8.1%) Marfan 1 (1.6%) Past AAA 6 (9.7%) Early Results Primary success 58 / 6 (93.5%) (Endoleak I, 4) 3 days mortality / 6 In hospital mortality Postoperative complications Stroke Spinal cord ischemia Prolonged intubation Acute renal failure Retrograde Type A dissection Iliac injury Emboli Thrombosis of False lumen at discharge (Distal side of devices) 3 / 6 (4.8%) (Sepsis / Rupture / ABF) 1 (1.6%) 1 (1.6%) 1 (1.6%) 54 / 6 (87.1%) ABF: aorto bronchial fistula 1 (%) 75 5 5 Freedom from aortic event Patients at risk Follow-up: 3.±17.6 months 89.1%/1y 77.1%/3y 6 38 8 8 (months) 1 4 36 48

Freedom from Aortic event excluded hospital death and Type I endoleak) Patients at risk 9months 95.8% / 1y 85.% / y 75.7% / 3y 9months 1% / 1y 9.3% / y 9.3% / 3y P=.1143 *: Period from on-set to TEVAR 4 16 11 3 1 1 4 Conclusions TEVAR for acute type B aortic dissection had provided satisfactory early and mid-term results, even if TEVAR for uncomplicated cases. By using TEVAR, we have also achieved outstanding early and long-term results for chronic dissection. The period between TEVAR and onset may be critical and should be considered in order to avoid postoperative aortic events. TEVAR for type B aortic dissection may serve as an alternative to conventional open surgery, but this requires devises from the next generation.