on-pump vs. off-pump cabg: the controversy continues · summary. 1. introduction 2. randomized...

On-Pump vs. Off-Pump CABG: The Controversy Continues

Miguel Sousa UvaImmediate Past President

European Association for Cardiothoracic Surgery

Conflict of Interest:Nothing to Disclose

Except I used to perform 95% CABG Off Pump

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

Summary1. Introduction2. Randomized trials3. Meta-Analysis4. Stroke5. Patency 6. High Risk Subgroups7. Volume Outcome 8. Take Home Messages


Trade offsLess 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

On-Pump

Off-Pump

?


Randomized Trials


N = 2203 Off pump On Pump

1104 1099

30 day Death 1.6% 1.2% 0.47

Death/complication 7% 5.6% 0.19

1 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

Number Needed to Cause 1 Harmful event = 71

ROOBY

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.


N=4752: 1 yr OFF % ON % p

Primary 12.1 13.3 .24

Death 5.1 5.0 1.03

MI 6.8 7.5 .90

Stroke 1.5 1.7 .90

New dialysis 1.3 1.3 .97

REVASC 1.4 0.8 .07

1 YEAR: HR 0.91 (0.77-1.07)

o4752 patients oSurgeon >100 OPCABGo(82% of patients Euroscore <5)oMean number of grafts 3.0 vs 3.2 (p<0.001)

N=4752 30d OFF % ON % p

Primary 9.8 10.3 .59Death 2.5 2.5 1.02MI 6.7 7.2 .93Stroke 1.0 1.1 .89New dialysis 1.2 1.1 1.04

Repeat Revasc 0.7 0.2 .01

Resp Failure 5.9 7.5 .03

Re-hospital 5.2 5.0 .84

Renal Injury 28 32 .01

AF 18.3 17.9 .72

Courtesy D Taggart

11

CORONARY Subgroups (1)

1 –Year Event Free SurvivalHR=0.93 (0.76-1.16:p=0.48)

2539 patients > 75 yearsExperience: 322 OPCAB vs 578 ON (median)Predicted mortality 3.8%Mean number of grafts 2.7 vs 2.8

N=2539: 1 yr OFF % ON % p

Primary 13.1 14.0 .48Death 7.0 8.0 .38MI 2.1 2.4 .7Stroke 3.5 4.4 .26New dialysis 2.9 3.5 .37REVASC 3.1 2.0 .11

N=2539: 30 d OFF % ON % p

Primary 7.8 8.2 .74Death 2.6 2.8 .55MI 1.5 1.7 .79Stroke 2.2 2.7 .47New dialysis 2.4 3.1 .80REVASC 1.3 0.4 .04

Courtesy D Taggart

N Engl J Med 2017;377:623-32

N = 2203 Off pump On Pump

NumberPatients

1104 1099

Primary at 5 y Death 15.2% 11.9% 0.02

MACE with Death 31.0% 27.1% 0.046

2ary 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

ROOBY at 5 Years

Death:Absolute Difference 3.3%Relative Risk 28%

ROOBY 5 Years

N Engl J Med 2017;377:623-32

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

Meta-Analysis


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 pointObservational data and the combined analysis showed short-term mortality favored off-pumpAt 10 years, only observational data were availableoff- pump showed significantly greater mortality

Stroke


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%

• 18 studies (3 randomized controlled trials) N= 25 163

• 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%)

J Am Heart Assoc. 2016;5:

• Bayesian network meta-analysis. • 13 studies / 37,720 patients J Am Coll Cardiol 2017;69:924–36

Patency


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

Significantly increased rates (35%) of occlusion of all graft types with OPCAB compared with ONCABLIMA and Radial NOT affected

12 RCTs

Circulation. 2012;125:2827-2835

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.

High Risk Subgroups


• N = 6.801 (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 0.28-0.82)• Stroke (AOR, 0.31; 95% CI 0.18-0.56)• New Renal failure (AOR, 0.59; 95%CI 0.36-0.96)• Prolonged ventilation (AOR 0.50; 95% 0.38-0.64)

• Same long term survival

J Thorac Cardiovasc Surg 2013;146:1442-8

876,081 patients689,943,On-pump186,138 Off-pump

OPCAB was associated with a significant reduction in risk of death, stroke, acute renal failure, mortality or morbidity, LOSafter adjustment for 30 patient risk factors

intent-to-treat analysis

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%)

• Patients having lower preoperative renal function exhibiting greater benefit

J Am Soc Nephrol 2012; 23: 1389–1397

Volume Outcome Relationship


• Nationwide Inpatient Sample (NIS) databases • N= 709 483 • OPCAB = 270 230 (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

J Thorac Cardiovasc Surg 2012;143:854–63.

• 196,576 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

O/EPlanned Conversion 1.4

Unplanned for Visualization 1.6

Unplaned for Instability 2.7

Ann Thorac Surg 2017;104:1267–74)

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 ?


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


It’s time to focus on identifying which patients benefit from which procedure !

Muito OBRIGADO


on-pump vs. off-pump cabg: the controversy continues · summary. 1. introduction 2. randomized...

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