Off-Pump Cardiac Surgery is not Dead

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1 Off-Pump Cardiac Surgery is not Dead Gonzalo J. Carrizo, M.D. Fellow Cardiothoracic Surgery Division Cardiothoracic Surgery Department of Surgery University of Colorado Hopeman Lectureship September 10,2007

2 3 rd Annual Alan Hopeman Lectureship in Cardiothoracic Surgery

3 a surgeon who tries to suture a heart wound deserves to loose the esteem of his colleagues

4 Introduction Surgical revascularization of the coronary arterial system remains the foundation of cardiothoracic surgical practice While many procedures in other specialties have undergone change and redefinition due to introduction of facilitating technology Standard coronary bypass grafting has resisted change to a large degree

5 The success of catheter-based techniques for treating ischemic coronary syndromes, combined with the shift towards less invasive approaches, has renewed interest in minimally invasive techniques, including beating heart surgery

6 Recognition of improved outcomes in selected patients with the elimination of CPB serves as the impetus to develop off-pump coronary artery bypass (OPCAB) as a treatment option for multivessel coronary artery disease

7 Patient Selection Few absolute contraindications Surgeon s s experience and comfort level Initial or limited experience: - hemodynamically stable - limited number of bypasses (1-3) - located in easily accessible areas Large target

8 Avoid Emergency Hemodynamically or electrically unstable Small, heavily calcified targets

9 Anesthesia Close collaboration with familiar and involved anesthesia team Avoid high-dose narcotics, use short and intermediate-acting acting anesthetic agents Maintain body heat Early extubation Preload sensitive: volume loading/trendelenburg Pacing wires, intracardiac shunts Heparin: mg/kg Cardiopulmonary bypass circuit available

10 Surgical technique Incision Patient positioning Target exposure and stabilization Grafting strategy Proximal anastomosis

11 Surgical technique

12 OPCAB Offers Significant Clinical Benefits Off-pump coronary artery bypass surgery may be superior to conventional CABG in many patients, especially those who are considered high-risk 1 - Reduced transfusions and bleeding 2,4 - Reduced inotropes2,4 - Reduced arrhythmias2-4 - Reduced sternal wound infection2-4 - Reduced cerebral emboli and cognitive dysfunction3 - Reduced postoperative hospital length of stay2 1. Puskas J, Cheng D, Knight J, et al. Off-pump versus conventional coronary artery bypass grafting: a meta-analysis analysis and consensus statement from the 2004 ISMICS Consensus Conference. Innovations ;1: Ascione R, Angelini GD. OPCAB surgery: a voyage of discovery back to the e future. Eur Heart J. 2003;24: Puskas JD, Williams WH, Duke PG, et al. Off-pump coronary artery bypass grafting provides complete revascularization rization with reduced myocardial injury, transfusion requirements, and length of stay: a prospective randomized comparison of two hundred unselected patients p undergoing off-pump versus conventional coronary artery bypass grafting. J Thorac Cardiovasc Surg ;125: Angelini GD, Taylor FC, Reeves BC, Ascione R. Early and midterm outcome after off-pump and on-pump surgery in Beating Heart Against Cardioplegic Arrest Studies (BHACAS 1 and 2): a pooled analysis of two randomized controlled trials. Lancet. 2002;359:

13 OPCAB: Additional Clinical Benefits OPCAB surgery has been associated with reduced stroke, atrial fibrillation, and procedure- related infection - OPCAB was associated with 50% relative risk reduction of stroke. 1,2 - Postoperative atrial fibrillation events were reduced by 80 per 1000 CABGs performed off-pump. 1,2 - OPCAB surgery was associated with a 48% reduction in the risk of wound infection as compared with on-pump surgery. 1,2 1. Sedrakyan A, Wu A, et al. Off-pump is associated with reduced occurrence of stroke and other morbidity m as compared with traditional coronary artery bypass grafting. A meta-analysis analysis of systematically reviewed trials. Stroke. Sept Off-pump bypass surgery associated with reduced occurrence of stroke and other complications. Press release, October 25, Agency for Healthcare Research and Quality, Rockville, MD.

14 Who Is a High-Risk Patient? Today s s Surgical Candidates 1 : Experience abnormal ventricular function Have extensive coronary disease Present with multiple co- morbidities Are elderly (>65 years) Percentage Relative Increase in Risk Factors ( ) 1 NY Heart Assoc. Class IV Left Main Stenosis >50% COPD Diabetes Renal Failure Hypertension Triple Vessel Disease Female Gender Ferguson TB Jr, Hammill BG, Peterson ED, DeLong ER, Grover FL. A decade of change risk profiles and outcomes for isolated coronary artery bypass grafting procedures, : a report from the STS National Database Committee and the Duke Clinical Research Institute. Ann Thorac Surg. 2002;73:

15 What Risks Do High-Risk High-risk patients of all types have higher incidence of postoperative complications after traditional CABG procedures1: Atrial fibrillation Need for transfusion Respiratory infections Inpatient inotropes Cognitive dysfunction (2 to 6 months) Mortality (30 days) Patients Face? 1. Puskas J, Cheng D, Knight J, et al. Off-pump versus conventional coronary artery bypass grafting: a meta-analysis analysis and consensus statement from the 2004 ISMICS Consensus Conference. Innovations. 2005;1:

16 OPCAB Offers Better Outcomes for High-Risk Patients This procedure offers hope for better outcomes in high-risk patients whose prognosis may have been poor with conventional bypass surgery Puskas J, Cheng D, Knight J, et al. Off-pump versus conventional coronary artery bypass grafting: a meta-analysis analysis and consensus statement from the 2004 ISMICS Consensus Conference. Innovations. 2005;1:

17 Women: A Specific High-Risk Group Coronary artery disease is the leading cause of mortality in women: 234,000 deaths annually in the US1 Women have higher morbidity and mortality rates than men after conventional CABG2 Female gender is an independent risk factor for mortality in conventional CABG3 1. American Heart Association Web site. Available at: Accessed May 25, Mack MJ, Brown P, Houser F, et al. On-pump versus off-pump coronary artery bypass surgery in a matched sample of women. Circulation. 2004;110(suppl II):II-1-II II Athanasiou T, Al-Ruzzeh S, Del Stanbridge R, Casula RP, Glenville BE, Amrani M. Is the female gender an independent predictor of adverse outcome after off-pump coronary artery bypass grafting? Ann Thorac Surg. 2003;75:

18 Women: Potential Factors in High-Risk Female patients are recognized as being at increasingly high risk: Later clinical presentation More acute presentation Older age at presentation Higher incidence of diabetes mellitus

19 Female patients are recognized as being at increasingly high risk: Higher incidence of left ventricular hypertrophy and hypertensive heart disease Smaller coronary arteries Less benefit of LITA graft Less complete revascularization

20 OPCAB Offers Better Outcomes for Women In a large study of 7,376 women, OPCAB procedures resulted not only in a lower mortality rate, but also in significant reductions in neurological, respiratory, and bleeding complications compared with on-pump procedures.1

21 OPCAB Offers Better Outcomes for Women In a large study of 7,376 women, OPCAB procedures resulted not only o in a lower mortality rate, but also in significant reductions in neurological, respiratory, and bleeding complications compared with on-pump procedures Mack M, Brown P, Kugelmass A, et al. Outcomes differences in women undergoing off-pump and on-pump CABG surgery: a matched sample of 7,376 women from the HCA database. Paper presented at: American Heart Association Scientific Sessions; November 9-12, ; Orlando, Fla.

22 Renal Dysfunction: A High-Risk Subgroup Among patients about to undergo CABG surgery, as many as 78% have at least some form of renal dysfunction preoperatively1. 1. Cooper WA, O Brien O SM, Thourani VH, et al. Impact of renal dysfunction on outcomes from coronary artery bypass grafting. Circulation ; 113:

23 Renal Dysfunction: A High-Risk Subgroup In a study of patients with renal dysfunction, acute renal failure was >2.5-fold more common among patients receiving conventional CABG compared with OPCAB patients2. 2. Ascione R, Nason G, Al-Ruzzeh S, et al. Coronary revascularization with or without cardiopulmonary bypass in patients with preoperative nondialysis dependent renal insufficiency. Ann Thorac Surg. 2001;72:

24 Renal Dysfunction: A High-Risk Subgroup Off-pump coronary bypass surgery was shown to: - Reduce postoperative morbidity and risk of acute renal failure2. - Significantly lower serum creatanine and urea at 12 hours post-op op (P<.5) 2 1. Cooper WA, O Brien O SM, Thourani VH, et al. Impact of renal dysfunction on outcomes from coronary artery bypass grafting. Circulation ; 113: Ascione R, Nason G, Al-Ruzzeh S, et al. Coronary revascularization with or without cardiopulmonary bypass in patients with preoperative nondialysis dependent renal insufficiency. Ann Thorac Surg. 2001;72:

25 Renal Dysfunction: Postoperative Benefits In patients with preoperative renal dysfunction, OPCAB surgery resulted in significantly lower incidence of postoperative inotropic requirement, arrhythmias, stroke, and acute renal failure Ascione R, Nason G, Al-Ruzzeh S, et al. Coronary revascularization with or without cardiopulmonary bypass in patients with preoperative nondialysis dependent renal insufficiency. Ann Thorac Surg. 2001;72:

26 Clampless Beating Heart Surgery: The Key To Better Outcomes Emboli have been linked to adverse clinical outcomes, both immediate and delayed Elimination of CPB and cross- clamp has led to decreased emboli and improved clinical outcomes Side-biting clamp has been shown to liberate a large percentage of emboli Reducing aortic manipulation has the potential to further improve patient outcomes Fraction of Total Embolic Signals 1 35% 30% 25% 20% 15% 10% 5% 0% 5% 2% 3% CPB On CPB Off X Clamp On 34% X Clamp Off 5% 24% Side Side Clamp On Clamp Off 1. Barbut, D. Cerebral emboli detected during bypass surgery are associated with clamp removal. Stroke. 1994:25;

27 Atherosclerotic Embolization Linked to Adverse Outcomes % 40% 30% 20% % 100 0% < > Stroke Cardiac Number of Embolic Signals Any Complications No Complications 1. Pugsley W et al. The impact of microemboli during cardiopulmonary bypass s on neuropsychological functioning. Stroke. 1994;25: Barbut,, D. Impact of embolization during coronary artery bypass grafting on outcome and length of stay. AnnThorac Surg. 1997;63:

28 Additional OPCAB Benefits: Reductions In The Cost Of Care Studies have documented the significant reductions in cost of care made possible with off- pump coronary artery bypass (OPCAB), compared with traditional CABG:

29 Additional OPCAB Benefits: Reductions In The Cost Of Care In one study, OPCAB reduced postoperative hospital stay from 5.5 days in the CABG group to 3.3 days (P( =.02), with a decrease in hospital cost of 24% 1 1. Puskas JD, Wright CE, Ronson RS, Brown WM, Gott JP, Guyton RA. Clinical outcomes and angiographic patency in 125 consecutive off-pump coronary artery bypass patients. Heart Surg Forum ;2: In another study, mean total hospitalization cost per patient at discharge was $2,272 less for OPCAB patients (P =.002) 2 2. Puskas JD, Williams WH, Mahoney EM, et al. Off-pump vs conventional coronary artery bypass grafting: Early and 1-year 1 graft patency,, cost, and quality-of of-life outcomes. JAMA. 2004;291:

30 Additional OPCAB Benefits: Reductions In The Cost Of Care Stroke alone is a major cause of increased cost of care; a third study reported that patients with adverse neurologic outcomes 3 Stayed an additional 4 to 8 days in the ICU Stayed an additional 7 days in the ward Required long-term out-of of-hospital medical and rehabilitation services 1. Puskas JD, Wright CE, Ronson RS, Brown WM, Gott JP, Guyton RA. Clinical l outcomes and angiographic patency in 125 consecutive off-pump coronary artery bypass patients. Heart Surg Forum ;2: Puskas JD, Williams WH, Mahoney EM, et al. Off-pump vs conventional coronary artery bypass grafting: Early and 1- year graft patency, cost, and quality-of of-life outcomes. JAMA. 2004;291: Roach GW, Kanchuger M, Mangano CM, et al. Adverse cerebral outcomes o after coronary bypass surgery. N Engl J Med ;335:

31 Graft Patency 1. Berger et al. Circulation 1999; 100: Puskas JD, et al. The Heart Surgery Forum, 1999, 2(3): Puskas JD, et al. Paper presented at Annual Meeting of the International Society for Minimally Invasive Cardiac Surgery, June 19-21, 2003, San Francisco CA

32 Demonstrated Clinical Benefit to In a large retrospective analysis (STS Adult Cardiac Surgery Database), OPCAB decreased risk-adjusted mortality and major complications. Avoiding CPB 1. Cleveland JC, Grover FL, et al. Annals of Thoracic Surgery, 2001;72:1282-9

33 Demonstrated Clinical Benefit to Avoiding CPB Three randomized studies documented the following benefits: OPCAB reduced chest infection by 12%, inotrope requirement by 18%, RBC transfusion by 31% and intubation time by 16%. 2. Angelini GD et al. Lancet, 2002 Apr 6;359(9313):1194-9

34 Demonstrated Clinical Benefit to Avoiding CPB Three randomized studies documented the following benefits: OPCAB patients had a 41% reduction in CK-MB release, 75% reduction in transfusions and 1-day 1 reduction in length of stay. 3. van Dijk D et al. Circulation, 2001 Oct 9;104(15):1761-6

35 Demonstrated Clinical Benefit to Avoiding CPB Three randomized studies documented the following benefits: OPCAB resulted in shorter length of stay, less myocardial injury, and reduced transfusion requirements with similar completeness of revascularization and in-hospital and 30-day outcomes. 4. Puskas JD et al. Journal of Thoracic and Cardiovascular Surgery, 2003;125:

36 STS database 100% 80% 86% 84% 91% 80% 60% 40% 29% 28% 27% 28% 20% 0% USER ADOPTION (% of surgeons performing OPCAB) PENETRATION (% of CABG off pump) Although 80% of surgeons perform OPCAB, <30% of the cases are performed with the OPCAB approach Source: STS Floor Surveys ( )

37 Conclusion Learning curve Technically demanding The impetus to change established patterns of practice rests upon the scientific validation of the clinical benefits of off-pump surgery

38 Conclusion Large multicenter studies are needed to produce confirmation of the clinical benefits seen in smaller studies Performance of these studies can be problematic given the inherent prejudice either for or against the technique by participating surgeons OPCB is not for everybody Off-pump cardiac surgery is not dead

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