On-Pump vs. Off-Pump CABG: The Controversy Continues. Miguel Sousa Uva Immediate Past President European Association for Cardiothoracic Surgery

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1 On-Pump vs. Off-Pump CABG: The Controversy Continues Miguel Sousa Uva Immediate Past President European Association for Cardiothoracic Surgery

2 On-pump vs. Off-Pump CABG: The Controversy Continues Conflict of Interest: Nothing to Disclose Except I used to perform 95% CABG Off Pump

3 On-pump vs. Off-Pump CABG: The Controversy Continues Summary 1. Introduction 2. Randomized trials 3. Meta-Analysis 4. Stroke 5. Patency 6. High Risk Subgroups 7. Volume Outcome 8. Take Home Messages

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6 Trade offs On-pump vs. Off-Pump CABG: The Controversy Continues On-Pump Less early morbidity Reduced long-term graft patency? Increased repeat revascularization Long-term survival? Myocardial ischemic injury, Neurocognitive deficits, Stroke Inflammatory pathways Pulmonary, renal, and hematologic complications? Off-Pump

7 Randomized Trials On-pump vs. Off-Pump CABG: The Controversy Continues

8 Number Needed to Cause 1 Harmful event = 71 ROOBY N = 2203 Off pump On Pump day Death 1.6% 1.2% 0.47 Death/complication 7% 5.6% yr All death 4.1% 2.9% 0.15 Cardiac death 2.7% 1.3% 0.03 Composite 9.9% 7.4% 0.04 MI 2.0% 2.2% 0.76 Revasc 4.6% 3.4% 0.18

9 On-pump vs. Off-Pump CABG: The Controversy Continues The Problems with ROOBY Surgeons: At least 20 off-pump including some in which complete revascularization was performed for all vascular territories of the heart OPCAB experience of the surgeons median= 50. Average 3.3 OPCAB/year Conversion: ONCAB 3.6 % vs OPCAB 12.4 % Low Risk patients (estimated 30d risk of death 1.9%) ROOBY shows that OPCAB performed by occasional off-pump teams is inferior to on-pump surgery.

10 N= d OFF % ON % p Primary Death MI Stroke New dialysis o4752 patients osurgeon >100 OPCABG o(82% of patients Euroscore <5) omean number of grafts 3.0 vs 3.2 (p<0.001) 1 YEAR: HR 0.91 ( ) Repeat Revasc Resp Failure Re-hospital Renal Injury AF N=4752: 1 yr OFF % ON % p Primary Death MI Stroke New dialysis REVASC Courtesy D Taggart

11 CORONARY Subgroups (1) 11

12 Courtesy D Taggart N=2539: 30 d OFF % ON % p 2539 patients > 75 years Experience: 322 OPCAB vs 578 ON (median) Predicted mortality 3.8% Mean number of grafts 2.7 vs 2.8 Primary Death MI Stroke New dialysis REVASC Year Event Free Survival HR=0.93 ( :p=0.48) N=2539: 1 yr OFF % ON % p Primary Death MI Stroke New dialysis REVASC

13 ROOBY at 5 Years N = 2203 Off pump On Pump Death: Absolute Difference 3.3% Relative Risk 28% Number Patients Primary at 5 y Death 15.2% 11.9% 0.02 MACE with Death 31.0% 27.1% ary at 5 y Cardiac Death 6.3% 5.3% 0.29 Acute MI 12.1% 9.6% 0.05 Repeat Revascularization 13.1% 11.9% 0.39 Repeat CABG 1.4% 0.5% 0.02 N Engl J Med 2017;377:623-32

14 N Engl J Med 2017;377: ROOBY 5 Years

15 Circulation. 2010;122[suppl 1]:S48 S52.

16 Meta-Analysis On-pump vs. Off-Pump CABG: The Controversy Continues

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18 J Thorac Cardiovasc Surg 2017 in press 42 randomized controlled trials 31 adjusted observational studies >1.1 million patients Results: RCT-only data showed no significant differences at any time point Observational data and the combined analysis showed short-term mortality favored off-pump At 10 years, only observational data were available off- pump showed significantly greater mortality

19 Stroke On-pump vs. Off-Pump CABG: The Controversy Continues

20 Significantly lower frequencies of stroke (0.7% vs 2.3%) N Technique Stroke 56 Partial Clamping (PC) 2.3% 1368 `No touch` with Heartstring (HS) 0.7% 268 No touch all arterial grafting 0.7% 211 On-pump Control Group 2.4%

21 J Am Heart Assoc. 2016;5: 18 studies (3 randomized controlled trials) N= Aortic no-touch technique was associated with an ~ 60% statistically significant lower risk of postoperative CVA vs conventional partial clamp OPCAB (0.36% vs 1.28%)

22 J Am Coll Cardiol 2017;69: Bayesian network meta-analysis. 13 studies / 37,720 patients

23 Patency On-pump vs. Off-Pump CABG: The Controversy Continues

24 N = 150 No difference in MACCE Overall Graft Patency 89.9% vs 95.0% p=0.03 After Heparin Dose Adjustment p=0.83

25 12 RCTs Significantly increased rates (35%) of occlusion of all graft types with OPCAB compared with ONCAB LIMA and Radial NOT affected

26 Conclusion: Off-pump CABG resulted in significantly lower FitzGibbonA patency for arterial and saphenous vein graft conduits and less effective revascularization than on-pump CABG. At 1 year, patients with less effective revascularization had higher adverse event rates. Circulation. 2012;125:

27 High Risk Subgroups On-pump vs. Off-Pump CABG: The Controversy Continues

28 J Thorac Cardiovasc Surg 2013;146: N = (retrospective + multivariate analysis) BMI<25 OPCAB associated with lower risk (despite STS higher predicted risk of mortality) In-hospital mortality (AOR, 0.48; 95% CI ) Stroke (AOR, 0.31; 95% CI ) New Renal failure (AOR, 0.59; 95%CI ) Prolonged ventilation (AOR 0.50; 95% ) Same long term survival

29 876,081 patients 689,943,On-pump 186,138 Off-pump intent-to-treat analysis OPCAB was associated with a significant reduction in risk of death, stroke, acute renal failure, mortality or morbidity, LOS after adjustment for 30 patient risk factors

30 Off-Pump vs On-Pump CABG Outcomes Stratified by Preoperative Renal Function N=742,909 STS Database Propensity Weighted Analysis OPCAB associated with a Reduction in the Composite Hospital Death or Dialysis Conversion Rate 2.9%) J Am Soc Nephrol 2012; 23: Patients having lower preoperative renal function exhibiting greater benefit

31 Volume Outcome Relationship On-pump vs. Off-Pump CABG: The Controversy Continues

32 J Thorac Cardiovasc Surg 2012;143: Nationwide Inpatient Sample (NIS) databases N= OPCAB = (38.1%) Median surgeon volume for OPCAB=105 (56 156) operation/year 5% decrease in the absolute probability of death occurred after OPCAB performed by the surgeons with the highest volume Threshold for the greatest change in unadjusted mortality risk appeared to occur after more than 50 OPCAB operations per year, and the lowest probability of death was associated with surgeon volumes of 150 OPCAB operations or more per year

33 O/E Planned Conversion 1.4 Unplanned for Visualization 1.6 Unplaned for Instability ,576 patients STS Database Rate of conversion 5.5% (50% planned) Independent predictors for conversion to ONCAB Advanced age EF <35% Preoperative IABP Increasing number of diseased coronary arteries Preoperative heart failure Urgent procedural status Ann Thorac Surg 2017;104: )

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35 On-pump vs. Off-Pump CABG: The Controversy Continues Gaps in Knowledge OPCAB for All or High Risk? What is the Training and Surgeon Experience Threshold in OPCAB? How do we Define Proficiency? Graft Patency Control Role of Completeness of Revascularization? Adapted Antithrombotic Protocols Role of Minimal Extra Corporeal Circuits, NoClamp, Eco- Guided Cannulation?

36 On-pump vs. Off-Pump CABG: The Controversy Continues Take Home Messages 1. There Is NO Perfect Technique but for low risk On Pump Preferable 2. Evidence Shows Off-Pump No Touch Aorta Reduces Stroke Rate 3. On-Pump: Probably Less Graft Failure & Repeat Revascularization 4. OPCAB is a specialized technique requiring dedication, strict rules, and regular practice to achieve proficiency and good results 5. For higher risk patients, the evidence from registry data consistently reports significant clinical benefits with OPCAB in terms of reductions in mortality and all major complications 6. Monitoring of Results + Graft Patency Assessment is Recommended 7. OPCAB Should NOT be Performed if it Means: Incomplete Revascularization Inadequate Proficiency

37 On-pump vs. Off-Pump CABG: The Controversy Continues It s time to focus on identifying which patients benefit from which procedure! Muito OBRIGADO

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