Does Moderate Hypothermia Really Carry Less Bleeding Risk than Deep Hypothermia For Circulatory Arrest? A Propensity-Matched Comparison in Hemiarch Replacement.

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Does Moderate Hypothermia Really Carry Less Bleeding Risk than Deep Hypothermia For Circulatory Arrest? A Propensity-Matched Comparison in Hemiarch Replacement Jeffrey E. Keenan, MD; Hanghang Wang, MD; Brian C. Gulack, MD; Asvin M. Ganapathi, MD; Nicholas D. Andersen MD; Brian R. Englum, MD; Yamini Krishnamurthy, MSIV; Jerrold H. Levy, MD; Ian J. Welsby, MD; G. Chad Hughes, MD 1 American Association for Thoracic Surgery Annual Meeting April 28, 2015 Seattle, WA

Disclosures The authors have no conflicts of interest to report 2

Background Controversy exists over the optimal degree of hypothermia during surgery of aortic arch with circulatory arrest 3

Background Controversy exists over the optimal degree of hypothermia during surgery of aortic arch with circulatory arrest 4 Greater suppression of metabolic activity May offer better organ protection, particularly for the brain and spinal cord which are highly susceptible to hypoxic injury May provide adequate visceral and cerebral protection in conjunction with regional perfusion to the brain during systemic arrest Potentially mitigates hypothermia-related complications Deep Hypothermia Moderate Hypothermia Vs.

Background 5 Coagulopathic bleeding during aortic arch surgery –Multifactorial Hypothermia-related platelet dysfunction Coagulation factor consumption during prolonged CPB Theoretically, milder degrees of hypothermia may reduce coagulopathy and bleeding-related complications –Lack of empirical data to support this claim

Objective 6 To determine whether moderate hypothermic circulatory arrest (MHCA) compared to deep hypothermic circulatory arrest (DHCA) reduced the risk of bleeding and the blood product transfusion in patients undergoing aortic hemiarch replacement

Methods Duke University Medical Center Aortic Surgery Database –Prospectively maintained –Contains >1500 procedures from 2005-present Study population –Patients who underwent replacement of aortic root or supracoronary ascending aorta (+/- valve) with concomitant hemiarch replacement from 7/2005 to 8/2014 7

Aortic Hemiarch Replacement Deep HCA Minimum Systemic Temperature ≤ 20°C Moderate HCA Minimum Systemic Temperature > 20°C Methods

Aortic Hemiarch Replacement Deep HCA Minimum Systemic Temperature ≤ 20°C Moderate HCA Minimum Systemic Temperature > 20°C Methods Recent expert consensus guidelines on deep vs. moderate degrees of hypothermia in aortic arch surgery: Yan et. al Annals of Cardiothoracic Surgery 2013

10 Aortic Hemiarch Replacement Deep HCA Minimum Systemic Temperature ≤ 20°C Moderate HCA Minimum Systemic Temperature > 20°C Methods 1:1 Propensity Match age, gender, race, BMI, hypertension, tobacco use, diabetes, coronary artery disease, congestive heart failure, history of stroke, chronic renal insufficiency (baseline creatinine >1.5), connective tissue disease, ASA class, bicuspid aortic valve, acute type A aortic dissection, chronic type A aortic dissection, preoperative malperfusion or shock, aortic rupture, procedural status, concomitant root replacement, redo sternotomy, and preoperative hematologic labs

11 Aortic Hemiarch Replacement Deep HCA Minimum Systemic Temperature ≤ 20°C Moderate HCA Minimum Systemic Temperature > 20°C Methods Study Outcomes Primary (bleeding-related): operative day transfusion, reoperation for bleeding, cell saver transfusion, rFVIIa utilization, 12 hour postoperative chest tube output, post-op labs Secondary: mortality, organ-specific morbidity, intraoperative outcomes Propensity Match

12 Aortic Hemiarch Replacement N=571 Deep HCA N=401 (70.2%) Min. Sys. Temp.= 17.1°C Moderate HCA N=170 (29.8%) Min. Sys. Temp.= 24.0°C Results

13 Results: Frequency of DHCA and MHCA Through 8/2014

14 Aortic Hemiarch Replacement Deep HCA N=401 Min. Sys. Temp.= 17.1°C Moderate HCA N=170 Min. Sys. Temp.= 24.0°C Methods Deep HCA N=155 Min. Sys. Temp.= 17.0°C Moderate HCA N=155 Min. Sys. Temp.= 24.0°C Propensity Matching

Results: Matched Baseline Characteristics 15 Variable Deep HCA (N=155) Moderate HCA (N=155) P-value Age60 (47, 69)58 (51.5, 68)0.82 Female50 (32.3%)49 (31.6%)0.99 White Race108 (69.7%)114 (73.5%)0.53 Body Mass Index28.4 (25.0, 31.8)28.4 (25.3, 32.3)0.66 Hypertension124 (80.0%)123 (79.4%)0.99 Hyperlipidemia78 (50.3%)86 (55.5%)0.43 Smoker62 (40.0%)55 (35.5%)0.48 Diabetes12 (7.7%)13 (8.4%)0.99 Coronary Artery Disease38 (24.5%) 0.99 History of MI10 (6.5%)16 (10.3%)0.31 CHF (NYHA ≥2)52 (33.5%)43 (27.7%)0.32 History of Stroke/TIA11 (7.1%)12 (7.7%)0.99 COPD13 (8.4%)17 (11.0%)0.57 Chronic Kidney Disease24 (15.5%)23 (14.8%)0.99 Peripheral Artery Disease6 (3.9%)11 (7.1%)0.32

Results: Matched Aortic Characteristics 16 Variable Deep HCA (N=155) Moderate HCA (N=155) P-value Connective Tissue Disease4 (2.6%)5 (3.2%)0.99 Bicuspid Aortic Valve58 (37.4%)56 (36.1%)0.91 Ascending Aortic Dissection45 (29.0%)48 (31.0%)0.80 Acute35 (77.8%)42 (87.5%)0.28 Chronic10 (22.2%)7 (14.6%)0.42 Acute Dissection with Malperfusion or Shock 10 (6.5%)12 (7.7%)0.83 Max Aortic Diameter5.4 (5.0, 5.8)5.3 (5.0, 5.8)0.53 Aortic Rupture8 (5.2%)9 (5.8%)0.99

Results: Matched Procedural Characteristics 17 Variable Deep HCA (N=155) Moderate HCA (N=155) P-value ASA class (11.6%)27 (17.4%) 394 (60.6%)83 (53.5%) 443 (27.7%)45 (29.0%) Procedural Status 0.45 Elective111 (71.6%)104 (67.1%) Urgent16 (10.3%)14 (9.0%) Emergent28 (18.1%)37 (23.9%) Previous Aortic Surgery25 (16.1%)22 (14.2%)0.75 Redo Sternotomy28 (18.1%)25 (16.1%)0.76 Root Replacement49 (31.6%) 0.99

Results: Preoperative Hematologic Labs 18 Variable Deep HCA (N=155) Moderate HCA (N=155) P-value Hemoglobin (g/dL)13.3 (11.9, 14.7)13.5 (12.1, 14.7)0.28 INR1.0 (1.0, 1.1) 0.47 Platelets (10 9 /L)204 (170.5, 249)197 (165, 242)0.26 PTT30.1 (27.8, 32.7)30.5 (28.0, 32.7)0.70 Creatinine1.0 (0.9, 1.2) 0.58

Results: Bleeding-Related Outcomes 19 Outcome Deep HCA (N=155) Moderate HCA (N=155) P-value Operative Day Transfusion PRBC (units)2 (0, 4) 0.86 Plasma (units)6 (4, 8)4 (4, 8)0.1 Platelets (units)2 (1, 3)2 (1.5, 3)0.45 Cryoprecipitate (units)0 (0, 1) 0.02 ≥1 unit Cryoprecipitate 60 (36.1%)70 (44.5%)0.003 Cell Saver (mL)500 (250, 744)472 (250, 700)< Intraoperative rFVIIa35 (22.6%)52 (33.5%)0.04 Postoperative rFVIIa8 (5.2%)5 (3.2%) hr Chest Tube Output (mL) 405 (262, 740)360 (230, 633)< Reoperation for Bleeding5 (3.2%) 1

Results: Bleeding-Related Outcomes 20 Outcome Deep HCA (N=155) Moderate HCA (N=155) P-value Operative Day Transfusion PRBC (units)2 (0, 4) 0.86 Plasma (units)6 (4, 8)4 (4, 8)0.1 Platelets (units)2 (1, 3)2 (1.5, 3)0.45 Cryoprecipitate (units)0 (0, 1) 0.02 ≥1 unit Cryoprecipitate 60 (36.1%)70 (44.5%)0.003 Cell Saver (mL)500 (250, 744)472 (250, 700)< Intraoperative rFVIIa35 (22.6%)52 (33.5%)0.04 Postoperative rFVIIa8 (5.2%)5 (3.2%) hr Chest Tube Output (mL) 405 (262, 740)360 (230, 633)< Reoperation for Bleeding5 (3.2%) 1

Results: Bleeding-Related Outcomes 21 Outcome Deep HCA (N=155) Moderate HCA (N=155) P-value Operative Day Transfusion PRBC (units)2 (0, 4) 0.86 Plasma (units)6 (4, 8)4 (4, 8)0.10 Platelets (units)2 (1, 3)2 (1.5, 3)0.45 Cryoprecipitate (units)0 (0, 1) 0.02 ≥1 unit Cryoprecipitate 60 (36.1%)70 (44.5%)0.003 Cell Saver (mL)500 (250, 744)472 (250, 700)< Intraoperative rFVIIa35 (22.6%)52 (33.5%)0.04 Postoperative rFVIIa8 (5.2%)5 (3.2%) hr Chest Tube Output (mL) 405 (262, 740)360 (230, 633)< Reoperation for Bleeding5 (3.2%) 1

Results: Bleeding-Related Outcomes 22 Outcome Deep HCA (N=155) Moderate HCA (N=155) P-value Operative Day Transfusion PRBC (units)2 (0, 4) 0.86 Plasma (units)6 (4, 8)4 (4, 8)0.1 Platelets (units)2 (1, 3)2 (1.5, 3)0.45 Cryoprecipitate (units)0 (0, 1) 0.02 ≥1 unit Cryoprecipitate 60 (36.1%)70 (44.5%)0.003 Cell Saver (mL)500 (250, 744)472 (250, 700)< Intraoperative rFVIIa35 (22.6%)52 (33.5%)0.04 Postoperative rFVIIa8 (5.2%)5 (3.2%) hr Chest Tube Output (mL) 405 (262, 740)360 (230, 633)< Reoperation for Bleeding5 (3.2%) 1

Results: Bleeding-Related Outcomes 23 Outcome Deep HCA (N=155) Moderate HCA (N=155) P-value Operative Day Transfusion PRBC (units)2 (0, 4) 0.86 Plasma (units)6 (4, 8)4 (4, 8)0.1 Platelets (units)2 (1, 3)2 (1.5, 3)0.45 Cryoprecipitate (units)0 (0, 1) 0.02 ≥1 unit Cryoprecipitate 60 (36.1%)70 (44.5%)0.003 Cell Saver (mL)500 (250, 744)472 (250, 700)< Intraoperative rFVIIa35 (22.6%)52 (33.5%)0.04 Postoperative rFVIIa8 (5.2%)5 (3.2%) hr Chest Tube Output (mL) 405 (262, 740)360 (230, 633)< Reoperation for Bleeding5 (3.2%) 1

Results: Bleeding-Related Outcomes 24 Outcome Deep HCA (N=155) Moderate HCA (N=155) P-value Operative Day Transfusion PRBC (units)2 (0, 4) 0.86 Plasma (units)6 (4, 8)4 (4, 8)0.1 Platelets (units)2 (1, 3)2 (1.5, 3)0.45 Cryoprecipitate (units)0 (0, 1) 0.02 ≥1 unit Cryoprecipitate 60 (36.1%)70 (44.5%)0.003 Cell Saver (mL)500 (250, 744)472 (250, 700)< Intraoperative rFVIIa35 (22.6%)52 (33.5%)0.04 Postoperative rFVIIa8 (5.2%)5 (3.2%) hr Chest Tube Output (mL) 405 (262, 740)360 (230, 633)< Reoperation for Bleeding5 (3.2%) 1

Results: Bleeding-Related Outcomes 25 Outcome Deep HCA (N=155) Moderate HCA (N=155) P-value Hemoglobin (g/dL) 9.9 (9.25, 10.5)10.0 (9.4, 10.55)0.23 Platelets (10 9 /L) 140 (115, 176.5)147 (127, 173)0.08 INR 1.1 (1.0, 1.2)1.1 (0.9, 1.2)0.03 INR ≥ (46.8%)53 (35.6%)0.048 PTT (sec)28.7 (25.95, 37.0)28.6 (21.3, 31.4)0.26

Results: Secondary Outcomes - Intraoperative 26 Variable Deep HCA (N=155) Moderate HCA (N=155) P-value Cardiopulmonary Bypass Time204 (182, 232)182 (150, 215)< Crossclamp Time127 (107, 154)117 (95, 147)0.07 Circulatory Arrest Time17 (15, 22)16.5 (13, 20)0.04 Operative Time329 (297, 378)320 (281, 367)0.27

Results: Secondary Outcomes - Intraoperative 27 Variable Deep HCA (N=155) Moderate HCA (N=155) P-value Cardiopulmonary Bypass Time204 (182, 232)182 (150, 215)< Crossclamp Time127 (107, 154)117 (95, 147)0.07 Circulatory Arrest Time17 (15, 22)16.5 (13, 20)0.04 Operative Time329 (297, 378)320 (281, 367)0.27

Results: Secondary Outcomes - Intraoperative 28 Variable Deep HCA (N=155) Moderate HCA (N=155) P-value Cardiopulmonary Bypass Time204 (182, 232)182 (150, 215)< Crossclamp Time127 (107, 154)117 (95, 147)0.07 Circulatory Arrest Time17 (15, 22)16.5 (13, 20)0.04 Operative Time329 (297, 378)320 (281, 367)0.27

Results: Secondary Outcomes - Clinical 29 Outcome Deep HCA (N=155) Moderate HCA (N=155) P-value 30-Day/Inpatient Mortality3 (1.9%)5 (3.2%)0.72 AKI ( Creatinine > 2.0 & 2x baseline)11 (7.1%)16 (10.3%)0.42 New Onset Dialysis1 (0.6%)7 (4.5%)0.07 Stroke2 (1.3%)1 (0.6%)0.99 Transient Ischemic Attack1 (0.6%)00.99 Prolonged Ventilation (>24 hours)19 (12.3%)13 (8.4%) Day Readmission20 (12.9%)16 (10.3%)0.60 Discharge to location other than home3 (1.9%) 0.99

Results: Secondary Outcomes - Clinical 30 Outcome Deep HCA (N=155) Moderate HCA (N=155) P-value 30-Day/Inpatient Mortality3 (1.9%)5 (3.2%)0.72 AKI ( Creatinine > 2.0 & 2x baseline)11 (7.1%)16 (10.3%)0.42 New Onset Dialysis1 (0.6%)7 (4.5%)0.07 Stroke2 (1.3%)1 (0.6%)0.99 Transient Ischemic Attack1 (0.6%)00.99 Prolonged Ventilation (>24 hours)19 (12.3%)13 (8.4%) Day Readmission20 (12.9%)16 (10.3%)0.60 Discharge to location other than home3 (1.9%) 0.99

Results: Secondary Outcomes - Clinical 31 Outcome Deep HCA (N=155) Moderate HCA (N=155) P-value 30-Day/Inpatient Mortality3 (1.9%)5 (3.2%)0.72 AKI ( Creatinine > 2.0 & 2x baseline)11 (7.1%)16 (10.3%)0.42 New Onset Dialysis1 (0.6%)7 (4.5%)0.07 Stroke2 (1.3%)1 (0.6%)0.99 Transient Ischemic Attack1 (0.6%)00.99 Prolonged Ventilation (>24 hours)19 (12.3%)13 (8.4%) Day Readmission20 (12.9%)16 (10.3%)0.60 Discharge to location other than home3 (1.9%) 0.99

Summary MHCA compared to DHCA may have led to a slight statistical decrease in perioperative bleeding (decreased cell saver transfusion, post-operative output) However, this did not translate to clinically apparent benefit such as reduced rate of transfusion or reoperation for bleeding Mortality and morbidity did not appear to differ between patients managed with MHCA vs. DHCA 32

Limitations Potential for unobserved confounding Non-standardization of transfusion and surgical practice over the entire course of the study –Institution of transfusion (~2010) algorithm may account for increased cryoprecipitate and rFVIIa use in MHCA patients Lack of functional coagulation assessments 33

Conclusions MHCA compared to DHCA did not appear to lead to a clinically significant reduction in bleeding or blood product transfusion –This draws into question whether reduced severity of bleeding should be used to justify use of MHCA over DHCA Comparable mortality and morbidity between the DHCA and MHCA confirms clinical equipoise and supports the need for prospective study to better elucidate the optimal degree of hypothermia during aortic reconstruction with circulatory arrest 34