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Eur J Cardiothorac Surg 2002;22:255-260
© 2002 Elsevier Science NL

The effect off-pump coronary artery bypass surgery on in-hospital mortality and morbidity

^a Department of Cardiothoracic Surgery, The Cardiothoracic Centre – Liverpool, Thomas Drive, Liverpool L14 3PE, UK
^b Department of Clinical Audit, The Cardiothoracic Centre – Liverpool, Thomas Drive, Liverpool L14 3PE, UK
^c Department of Cardiothoracic Surgery, Blackpool Victoria Hospital, Blackpool, UK
^d Department of Cardiothoracic Surgery, Wythenshawe Hospital, Manchester, UK
^e Department of Cardiothoracic Surgery, Manchester Royal Infirmary, Manchester, UK

Received 3 January 2002; received in revised form 14 May 2002; accepted 17 May 2002.

* Corresponding author. Tel.: +44-151-293-2397; fax: +44-151-220-8573
e-mail: bfabr{at}ccl-tr.nwest.nhs.uk

	Abstract

Top Abstract 1. Introduction 2. Methods 3. Results 4. Discussion References

 
Objective: Off-pump coronary artery bypass (OPCAB) surgery is being increasingly reported to show better outcomes compared to conventional on bypass grafting. We examined the effect of OPCAB on in-hospital mortality and morbidity, while adjusting for patient and disease characteristics, in four institutions in the North West of England. Methods: Between April 1997 and March 2001, 10 941 consecutive patients underwent isolated coronary artery bypass surgery at these four institutions. Of these, 7.7% were performed off-pump. We used logistic regression to examine the effect of OPCAB on in-hospital mortality and morbidity after adjusting for potentially confounding variables. Results: The crude odds ratio (OR) for death (off-pump versus on-pump coronary bypass grafting) was 0.48 (95% confidence interval, CI 0.26–0.92; P=0.023). After adjustment for all major risk factors, the OR for death was 0.59 (95% CI 0.31–1.12; P=0.105). Off-pump patients had a substantially reduced risk of post-operative stroke (0.6 versus 2.3%, respectively; adjusted OR 0.26 (95% CI 0.09–0.70; P=0.008) and a significant reduction in post-operative hospital stay. Other morbidity outcomes were similar in both groups. Conclusions: Off-pump coronary artery bypass incurs no increased risk of in-hospital mortality. In contrast, there is a significant reduction in morbidity in patients undergoing off-pump coronary bypass grafting when compared to that performed on cardiopulmonary bypass.

Key Words: Off-pump • Coronary artery bypass • Mortality • Morbidity • Risk adjustment

	1. Introduction

Top Abstract 1. Introduction 2. Methods 3. Results 4. Discussion References

 
After initial pioneering work by Benetti and Buffolo [1,2] less invasive techniques in coronary artery revascularisation have been increasingly used. Advances in instrumentation for stabilisation of the heart have made access to lateral and posterior wall vessels possible. Consequently, the use of beating-heart or off-pump coronary bypass grafting (OPCAB) has become more popular.

OPCAB is being increasingly reported to show better outcomes compared to conventional on bypass grafting (ONCAB) by various institutions [3–5]. Theoretically, by avoiding cardiopulmonary bypass, many adverse effects of extracorporeal circulation may be eliminated. This should hasten recovery and reduce morbidity. However, beating heart surgery is technically more demanding and concerns have been raised about imperfect anastomoses and incomplete revascularisation.

We report on the effect of introducing OPCAB techniques in the North West of England and its impact on outcomes following coronary artery bypass grafting. The primary purpose of this study was to examine the effect of OPCAB surgery on in-hospital mortality and morbidity while adjusting for patient and disease characteristics.

	2. Methods

Top Abstract 1. Introduction 2. Methods 3. Results 4. Discussion References

 
2.1. Patient population and data
The North West Quality Improvement Programme in Cardiac Interventions is a regional consortium involving all four centres (Blackpool Victoria Hospital, Blackpool; The Cardiothoracic Centre, Liverpool; Manchester Royal Infirmary, Manchester, Wythenshawe Hospital, Manchester) performing adult cardiac surgery in the North West of England. The aim of the group is to continuously improve the quality of care for patients receiving cardiac interventions using a regionally based systems approach.

Data was prospectively collected on a total of 10 941 consecutive patients undergoing coronary artery bypass graft (CABG) surgery between 1st April 1997 and 30th September 2000 in the North West of England. Patients undergoing CABG that was incidental to heart valve repair or replacement, resection of a ventricular aneurysm or other surgical procedure were not included. Data collection methods and definitions have been described in detail previously [6].

Data was collected on the following variables: age, sex, body mass index, urgency of operation, prior cardiac surgery, New York Heart Association (NYHA) functional class, Canadian Cardiovascular Society angina class, history of myocardial infarction, smoking, diabetes, hypercholesterolaemia, hypertension, peripheral vascular disease, cerebrovascular disease, respiratory disease, renal dysfunction, previous cardiological intervention, intravenous nitroglycerin therapy, cardiogenic shock, intra-aortic balloon pump and ventilation support as well as the extent of coronary disease, and left ventricular ejection fraction.

The main outcome measures for our study were in-hospital mortality, length of post-operative hospital stay, neurological deficit, peri-operative myocardial infarction and re-operation for bleeding. Outcome variables of in-hospital mortality and length of post-operative hospital stay were available for all patients in our study. Data on post-operative complications (neurological deficit, peri-operative myocardial infarction, and re-operation for bleeding) were only available for all patients in two of our centres, which equates to 6117 consecutive patients.

In-hospital mortality was defined as death within the same hospital admission regardless of cause. All patients transferred from the base hospital to another hospital were followed up to confirm their status at discharge. Post-operative neurological deficit was defined as a new focal neurological deficit and comatose states occurring post-operatively that persisted for >24 h after its onset and was noted before discharge. We excluded confused states, transient events and intellectual impairment from our study to avoid any subjective bias. Post-operative myocardial infarction was defined as a new Q-wave post-operatively in two or more contiguous leads on an electrocardiogram or significant rise in post-operative cardiac enzymes combined with hemodynamic and echocardiographic signs of myocardial infaction. Post-operative bleeding was defined as bleeding that required surgical re-exploration after initial departure from the operating theatre.

2.2. Statistical methods
Continuous variables are shown as median with 25th and 75th centiles and categorical variables are shown as a percentage with 95% confidence intervals (CI). Comparisons were made with Wilcoxon rank sum tests and Chi-square tests as appropriate. Standard statistical tests were used to calculate odds ratios (OR) and 95% CI. A modified Parsonnet score was derived to assess differences in patient case mix between OPCAB and ONCAB techniques [6]. Logistic regression was used to examine the effect of OPCAB on in-hospital mortality and morbidity after adjusting for potentially confounding variables (risk adjustment) [7]. These variables were the variables (age, sex, previous cardiac surgery, left ventricular ejection fraction, left main stem stenosis, number of major coronary arteries with stenosis >70%, priority of surgery, body mass index, peripheral vascular disease, diabetes, renal dysfunction, and respiratory disease) suggested for risk adjustment of in-hospital CABG outcomes by Jones et al. [8] and the American College of Cardiology/American Heart Association practice guidelines [9]. This method was preferred over identification of those variables driving the outcome of interest and using these so called risk factors for adjustment as a consequence of the low event rate and concerns regarding model over specification. Treatment selection bias was controlled for in each model by obtaining a propensity score, which was the probability that a patient would undergo CABG without cardiopulmonary bypass [10]. This propensity score was included as a co-variate in the risk adjusted analysis. The C statistic and the Lemeshow–Hosmer goodness of fit statistic were calculated to assess the performance and calibration of these models, respectively [7]. In all cases a P value <0.05 was considered significant. All statistical analysis was performed with SAS for Windows Version 8.

	3. Results

Top Abstract 1. Introduction 2. Methods 3. Results 4. Discussion References

 
Overall, 843 of the 10 941 patients (7.7%) were performed off-pump. The increase in OPCAB procedures since April 1997 in the North West Region is shown in Fig. 1 .

View larger version (22K): [in this window] [in a new window]   Fig. 1. Increase in percentage of OPCAB in all centres through duration of the study.

The post-operative lengths of stay were significantly shorter for OPCAB patients compared to ONCAB patients (6 days (25th and 75th centiles: 5–7) versus 7 days (25th and 75th centiles: 6–9); P<0.001).

Of the 6117 patients with post-operative complication data, 745 (12.2%) were performed without the use of cardiopulmonary bypass. Stroke was observed in 0.5% (95% CI 0.2–1.5) of the OPCAB group and 2.3% (95% CI 1.9–2.8) of the ONCAB patients (P=0.001). OPCAB patients had a lower incidence of peri-operative myocardial infarction, but this difference was not statistically significant (1.6% (95% CI 0.9–2.9) versus 2.4% (95% CI 2.0–2.9); P=0.178). Higher rates of return to the operating theatre for bleeding were observed in OPCAB patients compared to the ONCAB group but this failed to reach statistical significance (3.2% (95% CI 2.1–4.8) versus 2.3% (95% CI 1.9–2.7); P=0.119).

After adjusting for confounding variables, OPCAB patients were still less likely to have a stroke post-operatively than ONCAB patients. The adjusted stroke rate was 0.6% (95% CI 0.2–1.7) for OPCAB patients versus 2.3% (95% CI 1.9–2.7) for ONCAB patients (P=0.008). With regard to peri-operative myocardial infarction, OPCAB patients had an adjusted rate of 1.9% (95% CI 1.1–3.5) compared with 2.3% (95% CI 2.0–2.8) for ONCAB patients (P=0.512). Adjusted rates for bleeding were still higher in OPCAB patients compared to ONCAB patients, but this was not statistically significant (3.2% (95% CI 2.1–4.7) versus 2.3% (95% CI 1.9–2.7); P=0.125).

The crude and adjusted OR for in-hospital mortality, stroke, peri-operative myocardial infarction, and bleeding are shown in Table 2.

	4. Discussion

Top Abstract 1. Introduction 2. Methods 3. Results 4. Discussion References

In the last 3 years there has been an increase in OPCAB cases performed across all the four Centres. There is no comparable data available from United Kingdom. The wider acceptance of OPCAB is attributed to improved stabilisation techniques and the widespread use of intracoronary shunts. The introduction of the Octopus II tissue stabilisation system (Medtronic, Inc., Minneapolis, MN) has enabled access to target vessels on any aspect of the heart, in particular the inferior and the posterior surfaces.

As shown in Table 1 the preoperative disease characteristics were unevenly distributed in both groups of patients. The finding that OPCAB patients are of a lower age, have better ventricular function and a lower number of diseased coronary arteries can be explained on the basis of patient selection. This was taken account of in the analysis by calculation of a propensity score, expressed as the predicted probability of receiving OPCAB compared to ONCAB. Inclusion of this variable as a co-variate provides better adjustment for those factors driving operation selection [10]. The overall effect is more complete risk adjustment.

Initially OPCAB procedures were performed in patients with single and double vessel disease with good ventricular function. As surgeons got more experienced with the techniques, OPCAB was applied to a wider patient population. This has led to the profile of predicted operative risk (modified Parsonnet) being similar in both groups.

OPCAB patients received, on an average, one distal anastomosis less than the ONCAB patients (median number of grafts 3 versus 4; P<0.001). This experience is shared by most large series reporting on beating heart coronary artery surgery [3–5,11,12]. This difference could be more pronounced as our study included patients with minimally invasive direct coronary surgery in the OPCAB group. However, as the surgeons gained more experience with OPCAB the difference in the number of distal anastomoses between the two groups has diminished (2.9 versus 3.2) over the study period. This suggests that more and more surgeons are applying OPCAB almost universally to their entire revascularisation practice.

The incidence of crude in-hospital mortality was significantly lower in the OPCAB group. This trend in decreasing mortality has been shared by other centres with a large experience of off-pump coronary artery surgery [3–5,11]. Logistic regression analysis was used to isolate the effect of OPCAB on in-hospital mortality by using the core variables and the propensity score. This showed that OPCAB incurs no increased risk of mortality in our population and if anything it exhibits a tendency towards decreased mortality compared to ONCAB.

Our experience shares the lower trend in peri-operative myocardial infarction in OPCAB group with other reports [13–15]. This could be explained on the basis of avoidance of global ischaemia secondary to cross clamping of aorta during ONCAB.

The avoidance of cardiopulmonary bypass leads to a reduction in inflammatory response, which promotes quicker patient recovery. In our experience OPCAB patients had a significantly reduced hospital stay. This has been reported by other groups who showed reduced resource utilisation, which in turn improves the cost effectiveness of the procedure [3–5,11,13].

The rate of return to the operating theatre for bleeding was higher in patients receiving their operation off-pump, which is contrary to other reports [11,13]. As this variable just avoided statistical significance when adjusted for confounders, it will remain an outcome of interest as our experience grows.

One of the most devastating complications of the use of cardiopulmonary bypass relates to the potential for adverse neurological and neurocognitive outcomes. In a large multicentre report Newman showed that the risk of stroke in coronary artery bypass patients is 3–4% [16]. Advanced age and prolonged cardiopulmonary bypass were the strongest predictors of stroke. Our experience has shown a significant reduction in focal neurological deficits in the OPCAB group, as reported by other groups [17–19]. This significance is confirmed even after adjusting for the effect of core variables on both groups. The role of micro and macro embolism in the development of neurological impairment has been well documented [20–22]. We believe that avoiding cardiopulmonary bypass reduces micro and macro embolism leading to a reduction in the incidence of adverse neurological outcomes.

This report represents a relatively recent population undergoing coronary artery bypass grafting, with a large sample size and multiple institutions. However, there are some limitations, which may effect the conclusions drawn from our observational study. These include variables not measured in this study such as the quality of the coronary vessels, which is important in selecting the type of surgery and in determining the outcome, and selection bias resulting from the operating surgeon's decision to perform the procedure off-pump or on-pump. For this to effect our conclusions by a significant amount, the variables used in the risk adjustment (diabetes, age, sex, peripheral vascular disease) would have to be uncorrelated with the variables not measured (quality of coronary vessels or distal coronary disease), but we do not believe that this is likely.

Multivariable analysis with propensity score adjustment is no substitute for a properly designed, ethically approved, randomised clinical trial. The retrospective nature of the study cannot account for the unknown variables affecting the outcome that are not correlated strongly with measured variables. On the other hand retrospective comparisons with multivariable adjustment and propensity scoring are more versatile and may be more widely acceptable than randomised controlled trials. This study also does not take into account long-term outcomes for these patients; such outcomes will be of great interest as our experience grows. Realistically, the only way to have conclusive evidence of the superiority of either technique is to conduct a well designed, randomised controlled trial, with large number of patients, without many exclusion criteria and including a long-term observational outcome study. We believe that this is unlikely to happen and that the methodologies we applied will allow for legitimate inferences to be made from unrandomised, clinical experiences.

In summary, off-pump coronary artery bypass grafting is increasingly being performed in the North West of England. Off-pump coronary artery bypass incurs no increased risk in in-hospital mortality. In contrast, there is a significant reduction in morbidity in the off-pump patients compared to bypass grafts performed on cardiopulmonary bypass. This is especially reflected in the length of post-operative hospital stay and the incidence of neurological injury.

	Acknowledgments

 
We would like to acknowledge the co-operation given to us by all the Consultant Cardiac Surgeons in the region. Blackpool Victoria Hospital: Mr Au, Mr Duncan, Mr Fagan, Mr Millner, Mr Nkere, Mr Sharpe. The Cardiothoracic Centre-Liverpool: Mr Chalmers, Mr Dihmis, Mr Drakeley, Mr Fabri, Miss Griffiths, Mr Mediratta, Mr Page, Mr Pullan, Mr Rashid, Mr Weir. Manchester Royal Infirmary: Mr Grotte, Mr Hasan, Mr Keenan, Mr Odom, Mr Pendergast. Wythenshawe Hospital: Mr Bridgewater, Mr Campbell, Mr Carey, Mr Deiraniya, Mr Hooper, Mr Jones, Mr Lawson, Mr Rahman, Mr Waterworth, Mr Yonan. We would also like to thank for their considerable efforts Suzanne Chaisty, Paula Clark, Janet Deane and Valerie McLannahan, who maintain the quality and ensure completeness of data collected in our Cardiac Surgery Registry.

	References

Top Abstract 1. Introduction 2. Methods 3. Results 4. Discussion References

 

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