Antegrade Thoracic Stent Grafting during Repair of Acute Debakey I Dissection: Promotes Distal Aortic Remodeling and Reduces Late Open Re-operation

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Antegrade Thoracic Stent Grafting during Repair of Acute Debakey I Dissection: Promotes Distal Aortic Remodeling and Reduces Late Open Re-operation Vallabhajosyula, P: Szeto, W; Desai, N; Pulsipher, A; Moeller, P; Musthaq, S; Pochettino, A; Bavaria, JE Thoracic Aortic Surgery Program University of Pennsylvania, Philadelphia, PA

Medtronic: Consultant; Co-Primary Investigator Talent Trial; Primary Investigator Valiant Valor II Trial, National CV PI Acute Type B Dissection trial W.L. Gore: Consultant; Primary Investigator TAG Trial; FDA PMA submission; Primary Investigator High Risk Trial, Dissection trial and Large Diameter 45 trial Cook Medical: Co-Primary Investigator TX2 Thoracic Aorta Trial, PI Post market TX2 trial Bolton Relay: PI TEVAR trial Jotec: Consultant; FDA E-Vita submission Vascutek: Aortic Symposium Director

Cause of death Acute CHF due to AI Coronary malperfusion Cerebral malperfusion Free Ascending rupture Treatment Aortic valve resuspension Aortic root repair Arch replacement Asc aortic replacement

Note: Finished Product, Efficient Conduct of operation, good results

This is Consecutive All Comers with Immediate transfer to OR protocol 30 day Mortality 12.1% Intra-op mortality 2.3% NEW Stroke rate 4.5% Prior to 1992 Death/CVA 30-40%

Cause of death Acute CHF due to AI Coronary malperfusion Cerebral malperfusion Free Ascending rupture Treatment Aortic valve resuspension Aortic root repair Arch replacement Asc aortic replacement

Cause of death Acute CHF due to AI Coronary malperfusion Cerebral malperfusion Free Ascending rupture Treatment Aortic valve resuspension Aortic root repair Arch replacement Asc aortic replacement Fate of Distal Descending Aorta!

CT scans after Successful Type A Dissection surgery: No Reasonable distal Aortic Remodelling Mal-Perfusion Chronic Distal Dissecting aneurysm Chronic Complex Arch Dissecting aneurysm Residual 6.8 cm Dissecting Aneurysm after Type A Repair with Arch involvement

Senior Surgeon Series Bavaria et al, 2007 (USA), 26% Reoperation at 12 years Included Debakey II Ishihara et al, 2009 (Japan), 27% Aortic Events at 5 years Di Bartolomeo et al, 2001 (Italy), 27% Reoperation at 7 years Griepp et al, (USA), 16% reoperation at 8 years Included Debakey II Glauber and Murzi, 2010 (UK), 39% reoperation at 10 years (proximal and distal)

False lumen remains patent distal to the end of the stent grafts Courtesy: M. Grabenwoger, Vienna Courtesy: R. DiBartolomeo, Bologna Italy Note: H. Jakob, Essen Germany, ATS 2008 89% Re-modeled Aorta in Type A Dissection with E-Vita

Type A (Debakey Type I) Dissection: Pre and Post Proximal Repair with E-Vita (type) Distal Graft Beijing, China

Aortic Event rate

77% of Stented Descending Aorta cases with Obliterated False Lumen vs only 25% for Standard hemi-arch Repair

Methods Analysis of 242 DeBakey I dissection repairs performed at the University of Pennsylvania from 2005 to 2012 Antegrade stent grafting of the Distal Arch/Proximal DTA performed during circulatory arrest starting in 2005 Comparison of a concurrent series of DeBakey I dissection repairs : open repair + antegrade stent grafting (Stented group) versus open repair (Standard group) Aortic Dissection Repair 1995 to 2012 (n=556) DeBakey I Repair 1995 to 2012 (n=398) DeBakey II Repair 1995 to 2012 (n=158) DeBakey I Repair 2005 to 2012 (n=242) Stented Group (n = 62) Standard Group (n=180)

All parameters Non significant: No differences Stented Non-Stented P N 62 180 Age 58.2 11.9 59.4 13.9 N Male 40 65% 125 69% 0.52 Prior sternotomy 6 10% 19 11% 0.8 Prior AAA repair (open or EVAR) 1 2% 7 4% 0.7 Hypertension 51 82% 147 82% 1 Renal failure 3 5% 17 9% 0.42 Diabetic 8 13% 21 12% 0.82 Chronic Lung Disease 6 10% 18 10% 1 Preop Malperfusion 30 48% 70 39% 0.23

Stented (n=62) Standard (n=180) P Root Replacement 10 (16%) 36 (20%) 0.57 Root Reimplantation 0 (0%) 3 (2%) 0.57 Aortic Valve Replacement 8 (13%) 37 (21%) 0.22 Cardiopulmonary Bypass Time (minutes) 232 + 37 218 + 59 0.07 Aortic Cross Clamp Time (minutes) 171 + 40 143 + 50 0.001 Retrograde + Antegrade Cerebral Perfusion 8 (13%) 19 (11%) 0.64 Retrograde Perfusion 11 (18%) 117 (65%) <0.001 Antegrade Perfusion 43 (69%) 44 (24%) <0.001 Circulatory Arrest Time (minutes) 55 + 18 37 + 18 0.001

Stented (n=62) Standard (n=180) P In-hospital Mortality 6 (10%) 25 (14%) 0.51 Stroke 3 (5%) 15 (8%) 0.57 Permanent Paraplegia 0 (0%) 1 (1%) 1 Transient Spinal cord Ischemia 4 (6%) 3 (2%) 0.07 Ischemic Bowel 3 (5%) 7 (4%) 0.71 Prolonged Ventilation (>24 hours) 14 (23%) 69 (38%) 0.02 Renal Insufficiency/ Failure 13 (21%) 42 (23%) 0.86 w/ Hemodialysis 4 (6%) 21 (12%) 0.33 Reoperation for bleeding 7 (11%) 15 (8%) 0.45 Length of Stay (Days) 16 + 12 14 + 12 0.35

CTA follow-up Stent: 56/62 discharged, CTA follow-up on 55/56 (98%) Standard: 155/180 discharge, CTA follow-up on 120/155 (77%)

13/55 (23%) Stented mail.uphs.upenn.edu- 1.webloc 28/120 (23%) Controls

27/55 (49%) Stented 19/120 (16%) Controls

15/55 (28%) Stented 73/120 (61%) Controls

Combined Total Aortic and Thoracic Aortic Remodeling = 72% in Stented group and 39% in Standard Repair group (p=.001)

Stented Standard p = 0.58 N at risk Stented Standard 40 114 28 50 15 27

Stented Group (n=55) Standard Group (n=120) Stented Group (n=55) Total Distal Reinterventions (TEVAR + Open) Open Distal Reinterventions 11 1 16 11 p = 0.26 p = 0.1 Standard Group (n=120) Reinterventions (11 patients) n = 11 Reinterventions (11 patients) n = 16 TEVAR n = 10 Open Distal Operation n = 1 TEVAR n = 5 Open Distal Operation n = 11 Redo Total Arch n = 1 Thoracoabdominal Repair n = 0 Redo Total Arch n = 3 Thoracoabdominal Repair n = 8

Stented Standard p= 0.1 N at risk Stented Standard 28 45 18 23 6 6

2009-2012 p = 0.1 2005-2008 Trend showing improved application of the Stent Procedure N at risk 2009-2012 2005-2008 14 26 4 24 15

Stent 2009-2012 Standard 2009-2012 p = 0.2 Trend towards improved survival in later cohort N at risk Stent Standard 20 100 8 42 1 2

Conclusions Antegrade stent grafting of the DTA during DeBakey I aortic dissection repair can be safely performed, without increasing morbidity and mortality over postoperative and midterm follow-up Antegrade stent grafting promotes aortic remodeling of the remnant dissected thoracoabdominal aorta by promoting false lumen thrombosis/ obliteration It also provides a platform that enables endovascular solutions for late aortic reinterventions This technique decreases morbidity over midterm follow-up, without increasing mortality Open distal reoperation rate was lower in the antegrade stent graft patients (1 open reintervention versus 11) There is a learning curve to the antegrade stent graft technique Outcomes were superior in patients who underwent this procedure during the late period (2009 to 2012) compared to the early period (2005 to 2008) Further follow-up may attest to the validity of this technique for potential long-term mortality and morbidity benefit

Thank You

Stented Early 2005-2008 (n=35) Stented Late 2009-2012 (n=27) In-hospital death 5 (14%) 1 (4%) 0.21 Stroke 2 (6%) 1 (4%) 1 Paraplegia 0 (0%) 0 (0%) 1 Transient Spinal Cord Ischemia 3 (9%) 1 (4%) 0.62 Ischemic bowel 3 (9%) 0 (0%) 0.25 Prolonged Ventilation (>24 hours) 5 (14%) 9 (33%) 0.12 Renal Insufficiency 7 (20%) 6 (22%) 1 w/dialysis 2 (6%) 2 (7%) 1 Reoperation for bleeding 4 (11%) 3 (11%) 1 Length of Stay (Days) 17 + 14 15 + 13 0.6 P