Which Cyanotic Patient Needs Anticoagulation?

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1 Which Cyanotic Patient Needs Anticoagulation? Erwin Oechslin, MD, FRCPC, FESC Director, Adult Congenital Heart Disease Program The Bitove Family Professor of ACHD Professor of Medicine, U of T Peter Munk Cardiac Centre / Toronto General Hospital Toronto, ON, Canada

2 Conflicts of Interest None

3 Objectives To appreciate the risks of thrombotic and bleeding complications To understand the complex mechanisms of ischemic / thrombotic complications To determine the risks / benefit of anticoagulation in pts

4 Outline Which Cyanotic Pts Needs Anticoagulation? Prevalence of thrombotic / bleeding complications? Survival benefit on anticoagulants? Which patients benefit from anticoagulation? Summary

5 Who Routinely Anticoagulates Patients with CCHD?

6 35 y/o Man: CCHD, Eisenmenger Physiology Aneurysmal PA Laminated Thrombus * Calcium *

7 Prevalence of Thrombus Formation in PAs Eisenmenger Syndrome Year Institution N Thrombus Percent 1998 (Daliento, EHJ 1998) 1999 (Niwa, JACC 1999) 2003 (Perloff, AJC 2003) 2003 (Silversides, JACC 2003) 2007 (Broberg, JACC 2007) London Torino Padua % UCLA % UCLA 31 (none on anticoagulants) Toronto 34 (15% on anticoagulants) London, Brompton 55 (55% on Warfarin) (15% on ASA) 31 (mild in 22 mod massive in 9 100% (71% 29%) 7 21% 24% combined 11 20%

8 Risk Factors for Thrombus Formation Brompton (n = 55) Toronto (n = 34) Variable Thrombus (n=11) No Thrombus Age (yrs) NYHA 3/4 64% 32% ns Female Gender 55% 70% ns Hemoptysis 73% 43% 0.08 Oxygen Saturation (%) ns Hemoglobin (g/dl) ns Platelet count (1,000/L) ns Broberg C et al, JACC 2007 P Variable Thrombus (n=7) No Thrombus Age (yrs) ns NYHA 3/4 43% 26% ns Female Gender 86% 37% 0.04 History of bleeding 57% 30% ns Oxygen Saturation (%) Hemoglobin (g/dl) ns Platelet count (1,000/L) ns Silversides C et al, JACC 2003 P

9 Risk Factors for Thrombus Formation Variable Brompton (n = 55) Thrombus (n=11) No Thrombus MPA diameter (cm) Calcified PA 73% 23% RV ejection fraction (%) LV ejection fraction (%) BNP (pmol/l) 24 [43] 10 [15] P Variable Toronto (n = 34) Thrombus (n=7) No Thrombus MPA diameter (cm) ns Calcified PA 71% 19% 0.01 RV dysfunction 71% 56% ns LV ejection fraction N/A N/A BNP (pmol/l) N/A N/A P Broberg C et al, JACC 2007 Silversides C et al, JACC 2003

10 Mechanism of Thrombus Formation Embolic???? Hypercoagulability? Related to MPA diameter and flow Atherosclerosis (vascular injury, Ca 2+) Ca ++

11 Prevalence of Pulmonary Thrombosis in Pts with CCHD Cross-sectional, descriptive, multicentre study Patient population: n=98 Eisenmenger syndrome: 69 pts (70%) Jensen AS, et al. Heart 2015; 101:1540-6

12 Prevalence of Pulmonary Thrombosis MDCT 20% (n= 15/76) Location: proximal and peripheral PAs Mural / occlusive thrombi; mural calcification of the PAs 34% Aneurysmal dilatation of the PAs 21% V/Q SPECT / CT of the lungs 29% (n=19/66) OVERALL PREVALENCE: Either MDCT or V/Q SPECT/CT 31% (24/78) Both imaging modality 33% (21/64) Jensen AS, et al. Heart 2015; 101:1540-6

13 Risk Factor for Thromboembolic Complication Jensen AS, et al. Heart 2015; 101:1540-6

14 Cerebral Infarction Are Common Prevalence of Cerebral Thrombosis Cerebral infarction: 47% 53% (18/34) had more than one infarction Under-reporting: 22% stroke by clinical history Open Questions: Embolic? Ischemic? Jensen AS, et al. Heart 2015; 101:1540-6

15 Risk Factor for Thromboembolic Complication Cerebral Infarction / PA Thrombosis NO Association: Secondary Erythrocytosis / Iron Status Hemostatic Abnormalities (Plt count, TEG) Jensen AS, et al. Heart 2015; 101:1540-6

16 Coagulation Abnormalities are Common and Complex in CCHD Platelets Low Platelet Count Dysfunction Coagulation Pathway Intrinsic / Extrinsic Pathway Vascular Factors Endothelium dysfunction!

17 FBF (ml/min/100ml FAV) Forearm Blood Flow Response to Acetylcholine Controls 50 CCHD * Interaction 40 Controls vs CCHD p< Severe * 30 Controls * Endothelial 20 Dysfunction! p< * 10 CCHD p=0.01 * * * 0 BL Ach1 Ach2 Ach3 Ach4 Ach5 * p<0.05 vs baseline, p<0.05 between groups Oechslin E, et al. Circulation 2005; 112:

18 Should We Routinely Anticoagulate Patients With CCHD? Hard End-points Improved survival Decreased prevalence of thromboembolic complications without increased risk of bleeding Risk - Benefit Assessment Bleeding Prevention of Thrombus Formation Prevention of Thrombus Formation Bleeding

19 Landmark Paper on ES: Paul Wood Courtesy of Prof. Jane Somerville, London

20 Prevalence of Hemoptysis Year Institution N Hemoptysis Percent 1958 (Wood, BMJ 5099) 1998 (Daliento, EHJ 1998) 1999 (Niwa, JACC 1999) 1999 (Cantor, AJC 1999) 2007 (Broberg, JACC 2007) London, Brompton Torino Padua London % % UCLA % Toronto % London, Brompton 28% combined %

21 Hemoptysis: Most Common Mode of Death Courtesy of Prof. Jane Somerville, London

22 Eisenmenger Syndrome: Cause of the Death in the Modern Era 8% 7% From: Past and current cause-specific mortality in Eisenmenger syndrome Eur Heart J. Published online April 18, doi: /eurheartj/ehx201 Hjortshoj CMS et al. Eur Heart J 2017; in press

23 Platelet Abnormalities Low Platelet Count Platelet Dysfunction Coagulation Pathway Ischemia / Thrombosis Bleeding Vascular Factors Arteriolar Dilatation Increased Tissue Vascularity Endothelial Dysfunction

24 THROMBUS Intrapulmonary Hemorrhage BLEEDING / HEMOPTYSIS

25 Thrombosis of subclavian vein Therapeutic anticoagulation Mechanical Fall: Hematoma 48 y/o man: CCHD: Non-Eisenmenger Physiology D/C Warfarin

26 Thrombosis of subclavian vein: Therapeutic anticoagulation Mechanical Fall: Hematoma D/C Warfarin Ischemic stroke

27 Anticoagulation? PRO Thrombus formation Laminated thrombus Cons No clinical trial Retrospective data Intrinsic coagulopathy to support the benefit of Eisenmenger syndrome IPAHT Monitoring of INR!! routine anticoagulation Target INR? Dismal hemoptysis in cyanotic CHD Warfarin related deaths (Somerville 1998)

28

29 Sandoval J, et al. Congenit Heart Dis 2012; 7:268-76

30 p=0.22 Univariate Predictors of Death: Functional Class III/IV Clinical evidence of heart failure MCV < 80fL Higher mean PAP Sandoval J, et al. Congenit Heart Dis 2012; 7:268-76

31 Hemorrhagic Complications Anticoagulated Patients: Severe bleeding: 4 Two fatal bleedings (hematothorax -1 cardiac tamponade -1) Minor bleeding: 3 Epistaxis, gingival bleeding, bruising Non-anticoagulated Patients: NO serious bleeding Minor bleeding: 3 Epistaxis (2) Mild hemoptysis (1) Sandoval J, et al. Congenit Heart Dis 2012; 7:268-76

32

33 No Survival Benefit for Pts on OAK / ASA HR 1.07 ( ) HR 0.93 ( ) Study population: n = 153 Mean age yrs Oral anticoagulation: 17.6% ASA: 23.5% Diller GP, et al. Eur Heart J 2016;371:

34 Key Questions Is there a survival benefit? Probably not Increased morbidity? Probably yes Is monitoring of INR simple? NO!!!! Strong Indication for Anticoagulation

35 Which Cyanotic Patients Should Be Anticoagulated? Prophylaxis Therapy No risk factors No anticoagulation Risk factors AFli / AFla Anticoagulation Vein thrombosis Thromboembolic events

36 Optimal INR? No prospective study Therapeutic aptt: 1 x control Target INR: Narrow therapeutic range because of increased risk of bleeding!

37 Laboratory Precautions Hematocrit Plasma Volume 60% 70% 40% Cyanotic Congenital Heart Disease

38 Laboratory Precautions 70% Clinical and Laboratory Standards Institute To adjust the amount of sodium citrate

39 Summary High prevalence of silent thromboembolic events Underreported prevalence of CVA and pulmonary thrombosis Prevalence of both cerebral and pulmonary thrombosis of around 30% - 40% (Jensen et al, Heart 2015) Fragile balance of hemostasis: Bleeding vs thrombus formation

40 Summary Anecdotal experiences No prospective data Small case series / limited follow-up Routine anticoagulation remains controversial without proven benefit / strong indication Meticulous monitoring remains a challenge

41 RISK REDUCTION Strategy for Thrombosis and Bleeding Assessment of integrity of hemostasis Assessment of thromboembolic risk Risk reduction strategy for: Bleeding complications Thromboembolic events Multidisciplinary team approach!

42 INDIVIDUAL RISK ASSESSMENT AND STRATIFICATION ANTICOAGULATION: YES or NO

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