Outcomes of 3309 Thoracoabdominal Aortic Aneurysm Repairs

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Outcomes of 3309 Thoracoabdominal Aortic Aneurysm Repairs Joseph S. Coselli, M.D. ? Scott A. LeMaire, MD Ourania Preventza, MD Kim I de la Cruz, MD Denton A. Cooley, MD Matt D. Price, MS Alan Stolz, Med Susan Y. Green, MPH Courtney N. Arredondo, MSPH Todd K. Rosengart, MD 95th Annual Meeting, American Association of Thoracic Surgery (AATS) Plenary Scientific Session: Abstract 1 Seattle, Washington • Monday, April 27, 2015 1

Disclosure GlaxoSmithKline PI Clinical Trial Vascutek, a Terumo company Royalties Consultant Educational Grant Medtronic, Inc WL Gore & Associates

Thoracoabdominal Aortic Aneurysm E. Stanley Crawford refined and standardized repair Improved technique Categorized by extent of repair Greatest aortic surgeon of era E. Stanley Crawford 1922-1992

Thoracoabdominal Aortic Aneurysm E. Stanley Crawford refined and standardized repair Improved technique Categorized by extent of repair Greatest aortic surgeon of era Our practice built on his legacy E. Stanley Crawford 1922-1992

3309 TAAA Repairs October 1986 to December 2014 Study Enrollment Clinical research protocol approved by Baylor College of Medicine in 2006 Prospective from 2006 Retrospective before 2006 Single-practice series Baylor College of Medicine’s institutional review board approved our clinical research protocol in 2006. For patients who underwent surgery after protocol approval, data were collected prospectively, and informed consent was obtained whenever possible; waiver of consent was approved for patients who could not provide consent because of illness and whose family members were not available. For patients who underwent surgery before protocol approval, data were collected retrospectively from medical records, and consent was waived. From October 1986 to December 2014, 3320 consecutive open TAAA repairs  were performed on our service; of these, 3309 repairs met criteria for inclusion in our clinical database and form the basis of this report. Repairs included 914 Crawford extent I TAAA  For our records, how many refused consent?   Per MP, From October 1986 to December 2014, 4 TAAA patients “refused consent.” We were unable to consent 7 others who remain “not approved” because they could not be consented during hospitalization or could not be contacted thereafter.

914 1066 660 669

Patient Characteristics (n = 3309) n (%) Thoracoabdominal Aortic Aneurysm Repair Patient Characteristics (n = 3309) n (%) Median age, y [IQR]; range 12 y to 92 67 [59-73] Age ≤ 50 y 439 (13.3) Age > 79 y 193 (5.8)

Patient Characteristics (n = 3309) n (%) Thoracoabdominal Aortic Aneurysm Repair Patient Characteristics (n = 3309) n (%) Median age, y [IQR]; range 12 y to 92 67 [59-73] Age ≤ 50 y 439 (13.3) Age > 79 y 193 (5.8) Aortic dissection involving distal aorta 1185 (35.1) Acute or subacute dissection 165 (5.0) Chronic dissection 1020 (30.8)

Patient Characteristics (n = 3309) n (%) Thoracoabdominal Aortic Aneurysm Repair Patient Characteristics (n = 3309) n (%) Median age, y [IQR]; range 12 y to 92 67 [59-73] Age ≤ 50 y 439 (13.3) Age > 79 y 193 (5.8) Aortic dissection involving distal aorta 1185 (35.1) Acute or subacute dissection 165 (5.0) Chronic dissection 1020 (30.8) Connective tissue disorder 330 (10.0) Marfan syndrome 288 (8.7)

3309 TAAA Repairs Preoperative Characteristics by Extent of Repair Age y [IQR] Chronic Dissection n (%) Connective Tissue Disorder I (n=914) 67 [57-73] 352 (38.5) 67 (7.3) II (n=1066) 66 [56-72] 469 (44.0) 177 (16.6) III (n=660) 69 [61-74] 124 (18.8) 56 (8.5) IV (n=669) 70 [64-75] 75 (11.2) 30 (4.5) Total 67 [59-73] 1020 (30.8) 330 (10.0) P=0.0001 P<0.001

Aortic Dissection by Type (%)

Aortic Aneurysm Repair Patient Characteristics (n = 3309) n (%) Thoracoabdominal Aortic Aneurysm Repair Patient Characteristics (n = 3309) n (%) Hypertension 2805 (84.8) Hyperlipidemia 967 (29.2) Diabetes 261 (7.9) Coronary artery disease 1232 (37.2) Previous coronary artery bypass graft 496 (15.0) Prior myocardial infarction 652 (19.7)

3309 TAAA Repairs Coronary Artery Disease by Extent of Repair Disease, n (%) Previous CABG n (%) Previous MI I (n=914) 259 (28.3) 98 (10.7) 131 (14.3) II (n=1066) 351 (32.9) 136 (12.8) 181 (17.0) III (n=660) 291 (44.1) 121 (18.3) 162 (24.6) IV (n=669) 331 (49.5) 141 (21.1) 178 (26.6) Total 1232 (37.2) 496 (15.0) 652 (19.7) P<0.001

3309 TAAA Repairs Preoperative Characteristics by Extent of Repair Chronic renal insufficiency n (%) Chronic renal failure I (n=914) 15 (1.6) 11 (1.2) II (n=1066) 28 (2.6) 17 (1.6) III (n=660) 30 (4.6) 18 (2.7) IV (n=669) 26 (3.9) 14 (2.1) Total 99 (3.0) 60 (1.8) P=0.004 P=0.1

3309 TAAA Repairs Preoperative Characteristics by Extent of Repair Pulmonary disease n (%) COPD Past /Current Tobacco I (n=914) 314 (34.4) 288 (31.5) 669 (73.2) II (n=1066) 363 (34.1) 334 (31.3) 835 (78.3) III (n=660) 322 (48.8) 303 (45.91) 546 (82.7) IV (n=669) 299 (44.7) 289 (43.2) 566 (84.6) Total 1298 (39.2) 1214 (36.7) 2616 (79.1) P<0.001

3309 TAAA Repairs Preoperative Symptoms by Extent of Repair Asymptomatic no. (%) Symptomatic Acute symptoms I (n=914) 311 (34.0) 603 (66.0) 169 (18.5) II (n=1066) 400 (37.5) 666 (62.5) 161 (15.1) III (n=660) 239 (36.2) 421 (63.8) 109 (16.5) IV (n=669) 242 (36.2) 427 (63.8) 110 (16.4) Total 1192 (36.0) 2117 (64.0) 549 (16.6) P=0.5 P=0.3

3309 TAAA Repairs Rupture and PVD by Extent of Repair Peripheral Vascular Disease I (n=914) 48 (5.3) 148 (16.2) II (n=1066) 32 (3.0) 252 (23.6) III (n=660) 43 (6.5) 191 (28.9) IV (n=669) 47 (7.0) 264 (39.5) Total 170 (5.1) 855 (25.8) P<0.001

3309 TAAA Repairs Prior Aortic Repair by Extent of Repair Failure of Prior Aortic Repair  I (n=914) 145 (15.9) 9 (1.0) II (n=1066) 198 (18.6) 23 (2.2) III (n=660) 276 (41.8) 47 (7.1) IV (n=669) 244 (36.5) 57 (8.5) Total 863 (26.1) 136 (4.1) P<0.001

Intraoperative Strategies All extents Moderate heparinization Permissive mild hypothermia Aggressive reattachment of segmental arteries Cold renal perfusion whenever renal ostia can be accessed Expeditious repair Extent I and II repairs Cerebrospinal fluid drainage Left heart bypass Selective celiac/SMA perfusion

3309 TAAA Repairs Urgency of Repair by Extent of Repair Elective n (%) Urgent Emergent I (n=914) 700 (76.6) 131 (14.3) 83 (9.1) II (n=1066) 866 (81.2) 127 (11.9) 73 (6.8) III (n=660) 504 (76.4) 86 (13.0) 70 (10.6) IV (n=669) 516 (77.1) 84 (12.6) 69 (10.3) Total 2586 (78.2) 428 (12.9) 295 (8.9) P=0.03 P=0.4 P=0.02

Aortic Aneurysm Repair Operative Details (n = 3309) n (%) Thoracoabdominal Aortic Aneurysm Repair Operative Details (n = 3309) n (%) Redo thoracotomy 563 (17.0) Extraction of endograft 48 (1.5) Extraction of TEVAR 29 (0.7) Reverse elephant trunk 80 (2.4) Completion of elephant trunk 133 (4.0) Clamping proximal to the left subclavian artery (LSCA) 517 (15.6)

3309 TAAA Repairs Aortic Clamp and Ischemic Times by Extent of Repair Aortic Clamp Time min, med [IQR] Intercostal Total Time min, med [IQR] Intercostal Unprotected Time min, med [IQR] I (n=914) 40.5 [32-52] 40.0 [31-50] 26.0 [20-32] II (n=1066) 63.0 [53-75] 52.0 [41-63.5] 35.0 [27-42] III (n=660) 43.0 [34-53] 35.0 [27-44] 33.5 [26-42] IV (n=669) 41.0 [31-50.8] 31.0 [24-40] Total 48.0 [36-62] 40.0 [30-52] 31.0 [24-39] P<.001

3309 TAAA Repairs Operative Details by Extent of Repair Intercostal/Lumbar Artery Reattachment n (%) I (n=914) 498 (54.5) II (n=1066) 941 (88.3) III (n=660) 221 (33.5) IV (n=669) 15 (2.2) Total 1675 (50.6) P<.001

3309 TAAA Repairs Management of Visceral Arteries by Extent of Repair Visceral/Renal Endarterectomy n (%) Visceral/Renal Stent or Stent Visceral/Renal Endarterectomy or Stent or Bypass I (n=914) 51 (5.6) 15 (1.6) 58 (6.3) 88 (9.6) II (n=1066) 275 (25.8) 86 (8.1) 303 (28.4) 510 (47.8) III (n=660) 250 (37.9) 73 (11.1) 270 (40.9) 357 (54.1) IV (n=669) 281 (42.0) 90 (13.5) 405 (60.5) Total 857 (25.9) 264 (8.0) 940 (28.4) 1360 (41.1) P<0.001

3309 TAAA Repairs Perfusion by Extent of Repair Left Heart Bypass n (%) Selective Celiac/Superior Mesenteric I (n=914) 557 (60.9) 60 (6.6) II (n=1066) 874 (82.0) 675 (63.3) III (n=660) 43 (6.5) 36 (5.5) IV (n=669) 6 (0.9) 8 (1.2) Total 1480 (44.7) 779 (23.5) P<.001

3309 TAAA Repairs Operative Details by Extent of Repair Cold Renal Perfusion n (%) I (n=914) 158 (17.3) II (n=1066) 701 (65.8) III (n=660) 511 (77.4) IV (n=669) 564 (84.3) Total 1934 (58.4) P<.001

Operative Mortality The most inclusive category of early death: In-hospital death regardless of the length of hospital stay In-hospital death includes any death after transfer to another hospital or long term acute care facility 30-day death, including those rare deaths after discharge to home

Adverse Event A composite endpoint Comprised of: Operative mortality Permanent stroke Permanent paraplegia Permanent paraparesis Permanent renal failure 30-day or in-hospital death, including death after transfer Permanent = present at time of hospital discharge or early death

Life-Altering Complication Discharge of early survivors with a complication that negatively impacts quality of life and longevity Discharge with unresolved: Paraplegia Paraparesis Stroke Renal failure necessitating dialysis

3309 TAAA Repairs Early Outcomes by Extent of Repair Adverse Event n (%) Operative Death 30-Day I (n=914) 98 (10.7) 54 (5.9) 34 (3.7) II (n=1066) 203 (19.0) 101 (9.5) 68 (6.4) III (n=660) 110 (16.7) 58 (8.8) 34 (5.2) IV (n=669) 67 (10.0) 36 (5.4) 23 (3.4) Total 478 (14.4) 249 (7.5) 159 (4.8) P<.001 P=.002 P=.01

3309 TAAA Repairs Select Rates of Operative Mortality Subgroups of interest n Early Death n (%) P Patients ≤ 50 y 439 14 (3.2%) <.001 Patients > 79 y 193 37 (19.2%) Connective tissue disorder 330 10 (3.0%) .001 Chronic aortic dissection 1020 58 (5.7%) .007 Rupture 170 37 (21.8%) Prior aortic repair 858 70 (8.2%) .4 Elective repair 2586 161 (6.2%) Urgent or emergent repair 723 88 (12.2%)

3309 TAAA Repairs Early Outcomes by Extent of Repair All Stroke n (%) Stroke, Permanent Stroke, Temporary I (n=914) 33 (3.6) 22 (2.4) 11 (1.2) II (n=1066) 46 (4.3) 36 (3.4) 10 (0.9) III (n=660) 9 (1.4) 7 (1.1) 2 (0.3) IV (n=669) 10 (1.5) 9 (1.3) 1 (0.1) Total 98 (3.0) 74 (2.2) 24 (0.7) P<.001 P=.004 P=.04

3309 TAAA Repairs Early Outcomes by Extent of Repair Spinal Cord Deficits n (%) Permanent Paraplegia Permanent Paraparesis I (n=914) 71 (7.8) 12 (1.3) 19 (2.1) II (n=1066) 147 (13.9) 50 (4.7) 35 (3.3) III (n=660) 71 (10.8) 29 (4.4) 17 (2.6) IV (n=669) 27 (4.0) 6 (0.9) 10 (1.5) Total 317 (9.6) 97 (2.9) 81 (2.4) P<.001 P=.1

Periods Without Permanent Paraplegia October 1986 to December 2014 Gap of ≥ 50 Date 1 Date 2 Sequential cases without paraplegia 1 Oct 1991 May 1992 69 2 Nov 1992 51 3 July 1993 Apr 1995 261 4 Oct 1995 92 5 Sep 1996 May 1997 117 6 Apr 1998 Feb 1999 113 7 May 1999 8 May 2000 Aug 2000 60 9 Dec 2000 Apr 2001 53 10 Feb 2002 July 2002 84 11 Feb 2003 102 12 Nov 2003 Apr 2004 65 13 June 2004 Dec 2004 62 14 Jan 2007 Dec 2007 90 15 Dec 2010 May 2011 50 16 Mar 2014 Dec 2014 67

3309 TAAA Repairs Early Outcomes by Extent of Repair Acute Renal Dysfunction n (%) Permanent Renal Failure Temporary Renal Failure I (n=914) 73 (8.0) 29 (3.2) 16 (1.8) II (n=1066) 170 (15.9) 78 (7.3) 24 (2.3) III (n=660) 81 (12.3) 43 (6.5) 9 (1.4) IV (n=669) 82 (12.3) 39 (5.8) 12 (1.8) Total 406 (12.3) 189 (5.7) 61 (1.8) P<.001 P=.001 P=.6

3309 TAAA Repairs Survivors: Life-Altering Complications by Extent of Repair Survival with Renal Failure n (%) Survival with Permanent Stroke Survival with Permanent Paraplegia I (n=914) 12 (1.3) 9 (1.0) 7 (0.8) II (n=1066) 36 (3.4) 18 (1.7) 25 (2.3) III (n=660) 17 (2.6) 4 (0.6) IV (n=669) 17 (2.5) 3 (0.4) Total 82 (2.5) 35 (1.1) 52 (1.6) P=.03 P=.08 P=.001

Thoracoabdominal Aortic Aneurysms: Predictors: Multivariate Analysis Operative Mortality RRR p value Age (by increasing year) 1.05 <.001 Clamp time (by increasing min) 1.01 Rupture 2.38 Renal insufficiency 1.98 .02 Symptomatic aneurysm 1.62 .004 Endarterectomy, stent, or bypass 1.46 Extent IV repair 0.50 0.001 n= 249 cases of operative mortality

Paraplegia in Extent II Thoracoabdominal Aortic Aneurysms Independent Predictors: Multivariate Analysis Paraplegia in Extent II RRR p value Coronary artery disease 1.92 .03 Chronic aortic symptoms 3.00 .001 Past or current tobacco use 2.75 .1 (NS) n= 50 cases of permanent paraplegia in extent II TAAA repair

Paraplegia in Extent II Thoracoabdominal Aortic Aneurysms Independent Predictors: Multivariate Analysis Paraplegia in Extent II RRR p value Coronary artery disease 1.92 .03 Chronic aortic symptoms 3.00 .001 Past or current tobacco use 2.75 .1 (NS) Genetically triggered disorder 0.23 .05 n= 50 cases of permanent paraplegia in extent II TAAA repair

Paraplegia in Extent II Thoracoabdominal Aortic Aneurysms Independent Predictors: Multivariate Analysis Paraplegia in Extent II RRR p value Coronary artery disease 1.92 .03 Chronic aortic symptoms 3.00 .001 Past or current tobacco use 2.75 .1 (NS) Genetically triggered disorder 0.23 .05 Reduces risk by 77% n= 50 cases of permanent paraplegia in extent II TAAA repair

Paraplegia in Extent II Thoracoabdominal Aortic Aneurysms Independent Predictors: Multivariate Analysis Paraplegia in Extent II RRR p value Coronary artery disease 1.92 .03 Chronic aortic symptoms 3.00 .001 Past or current tobacco use 2.75 .1 (NS) Genetically triggered disorder 0.23 .05 Reduces risk by 77% Reattachment of intercostal or lumbar arteries 0.46 .03 n= 50 cases of permanent paraplegia in extent II TAAA repair

Paraplegia in Extent II Thoracoabdominal Aortic Aneurysms Independent Predictors: Multivariate Analysis Paraplegia in Extent II RRR p value Coronary artery disease 1.92 .03 Chronic aortic symptoms 3.00 .001 Past or current tobacco use 2.75 .1 (NS) Genetically triggered disorder 0.23 .05 Reduces risk by 77% Reattachment of intercostal or lumbar arteries 0.46 .03 Reduces risk by 54% n= 50 cases of permanent paraplegia in extent II TAAA repair

Long-term Survival Survival (%) Follow up (Years) Number at Risk 3309 63.6 ± 0.9 Survival (%) 36.8 ± 1.0 18.3 ± 0.9 All Follow up (Years) Number at Risk 3309 1684 724 194

Long-term Survival by Age Cohorts All lines are P < 0.001 (from each other)

Long-term Survival by Extent I/II P < 0.001 I/III P < 0.001 I/IV P < 0.001 II/III P = 0.003 II/IV P = 0.085 III/IV P = 0.270 Survival (%) Extent I Extent II Extent III Extent IV Follow up (Years) Number at Risk 914 525 274 78 1066 539 237 58 660 314 112 28 669 306 101 30

Long-term Survival by Rupture 64.9 ± 0.9 Survival (%) 37.6 ± 1.0 18.7 ± 1.0 39.3 ± 4.1 No Rupture Rupture 20.4 ± 3.6 9.6 ± 3.1 Follow up (Years) Number at Risk 3139 1634 704 187 170 50 22 7

Long-term Survival by Genetic Disorder 82.3 ± 4.1 65.8 ± 2.6 47.4 ± 3.3 Survival (%) 60.3 ± 1.0 32.1 ± 1.0 Genetic Disorder No Genetic Disorder 14.0 ± 0.9 Follow up (Years) Number at Risk 523 308 164 60 2786 1376 560 134

Long-term Survival by Aortic Dissection 73.7 ± 1.4 52.1 ± 1.7 Survival (%) 58.3 ± 1.1 31.4 ± 2.0 Dissection No Dissection 29.2 ± 1.1 12.2 ± 0.9 Follow up (Years) Number at Risk 1196 647 324 97 2113 1037 400

Long-term Survival in Those Discharged With a Life-Altering Complication P = 0.004 70.5 ± 0.9 Survival (%) 41.2 ± 1.1 48.5 ± 3.6 20.5 ± 1.0 22.0 ± 3.3 No Life Altering Life Altering 9.9 ± 2.8 Follow up (Years) Number at Risk 2831 1600 694 186 229 84 30 8

Early Survivors by Genetic Disorder 98.1 ± 0.3 96.0 ± 0.6 95.5 ± 0.7 97.1 ± 0.8 92.6 ± 1.6 90.2 ± 2.1 Freedom from Repair Failure (%) No Genetic Disorder Genetic Disorder Follow up (Years) Number at Risk 2555 1360 545 133 505 301 156 56

Freedom from Repair Failure

Conclusions Contemporary TAAA repair yields good-to-excellent outcomes in experienced centers Results are generally better in younger patients Patients with Marfan syndrome Survivors of DeBakey I dissection Extent I and II Long-term survival reasonable Patients are usually > 65 years and generally achieve near life expectancy Repairs are reliable Few late events or secondary reinterventions

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