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Eur J Cardiothorac Surg 2005;27:296-301
© 2005 Elsevier Science NL
Division of Cardiovascular Surgery, Dalhousie University, 1796 Summer Str. Rm 2006, New Halifax Infirmary, Halifax, NS, Canada B3H 3A7
Received 10 September 2004; received in revised form 4 November 2004; accepted 17 November 2004.
* Corresponding author. Tel.: +1 902 473 3808; fax: +1 902 473 4448. (E-mail: jean.legare{at}cdha.nshealth.ca).
| Abstract |
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Key Words: CABG Coronary Off pump Cardiopulmonary bypass
| 1. Introduction |
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One of the limitations of beating heart surgery is that in some instances the procedure cannot be completed safely without resorting to cardiopulmonary bypass (CPB). The most common reasons for conversions to CPB include: ischemia, inability to visualize a target vessel, and hemodynamic instability. The reported incidence of conversion has varied from 0 to 25% [811].
The fate of converted patients when compared to non-converted or to surgery using CPB remains to be clearly determined. Several groups have reported that converted patients have a higher mortality, higher morbidity, prolonged length of hospitalization and higher cost than patients not requiring conversion [8,10,12,13]. However, there are important limitations to these reports including the retrospective nature of these studies and the possibility of under-reporting of conversions. This may explain in part the marked variation in published rates of conversion and their clinical implications.
The objective of the present study was to evaluate all conversions occurring in the setting of one of the largest randomized controlled trial published to date comparing CABG surgery performed with or without CPB and evaluating the clinical impact of conversion [14].
| 2. Methods |
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The present study focuses specifically on the patients that crossed over from the OPCAB group to the CPB group and will be defined as the converted group. Converted patients will be compared in terms of risk factors and outcomes to the remaining OPCAB patients and will be referred to as the not-converted group.
2.2. Surgical technique
A median sternotomy was performed in all patients. OPCAB surgery was performed in standardized fashion as previously described [16]. Briefly three traction sutures were placed in the posterior pericardium for retraction followed by placement of a commercially available tissue stabilizer (Medtronic Octopus and Coronéo Corvasc). With the advent of the Octopus III (Medtronic), posterior pericardial traction sutures were no longer necessary. A non-traumatic small bulldog clamp was then applied to the target vessel proximal to the anastomotic site in order to achieve hemostasis after arteriotomy. All anastamoses were constructed with continuous suture technique using 7-0 or 8-0 monofilament sutures.
The decision to convert was made by the treating surgeon and the reason for conversion recorded. A primed ready-to-use CPB circuit was ready in all cases to minimize delay in instituting CPB. In all cases CPB was initiated using ascending aortic cannulation and two-stage venous cannulation of the right atrium. During CPB, mean arterial pressure target was set at 60mmHg and body temperature allowed to drift to a minimum of approximately 32°C. Intermittent cold blood cardioplegia (1:4 blood to crystalloid with maximal K+ concentration 22meq/L) was delivered antegrade via the aortic root unless otherwise indicated.
The choice of conduits and/or construction of composite grafts was based on surgeon preferences rather than fixed criteria. Heparin was given at a dose of 100IU/kg in all beating heart patients and an additional dose was given of 200IU/Kg was given to achieve target activated clotting time (ACT) >450s in any patient requiring conversion to CPB. On completion of anastomoses both groups received protamine sulfate to reverse the effects of heparin and return the ACT to pre-operative levels. No special blood conservation techniques were utilized other than: non-hemic prime, retransfusion of all contents of the oxygenator at the end of CPB, and acceptance of normovolemic anemia. Post-operatively non-hemic volume expanders were utilized routinely.
2.3. Post-operative management
All post-operative cardiac surgery patients were taken to a dedicated cardiovascular intensive care unit (CVICU). Each patient was required to meet standard criteria prior to extubation and prior to transfer to the intermediate care unit. Discharged patients were transferred to an intermediate care or general care ward under the care of the same team. All patients were monitored continuously for a minimum of 24h.
All patients received intravenous nitroglycerin (0.18ug/kg/min) infusions for the first 24h unless hypotensive (systolic blood pressure <90mmHg). Oral nifedipine (Adalat 10mg po QID or Adalat XL 30mg daily) was prescribed for all patients receiving a radial artery graft beginning on day 1 post-operatively for a period of 36 months. Other routine medications included daily aspirin and resumption of cholesterol lowering agents, ß-blockers and angiotensin converting enzyme inhibitors as appropriate.
2.4. Data collection
Peri-operative patient variables were collected prospectively by three full time research assistants. An elective case was defined as a patient waiting at home prior to the procedure, in-house cases were defined as hospitalized patients requiring surgery, urgent cases were defined as cases where surgery was deemed necessary within 24h to prevent further clinical deterioration, and emergent/emergent salvage cases were those patients who required an immediate operation. A 12-lead electrocardiogram was recorded before the operation, at 2h after surgery and then when clinically indicated. Electrocardiographic criteria for peri-operative myocardial infarction were new Q wave (0.04ms) in at least two leads, or electrocardiographic ST changes in association with significant CKMB enzyme release.
2.5. Data analysis
All analyses were performed with the Statistical Analysis Systems software package (SAS, Release 8.2, Cary, North Carolina). Groups were analyzed on an intention to treat basis. Descriptive statistics included continuous and discrete variables, which were analyzed accordingly with an unpaired t-test, Wilcoxon rank sum test, chi-square test, and Fisher exact test. Statistical significance was defined as a p value of less than 0.05.
| 3. Results |
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Pre-operative patient characteristics were similar in both groups and are illustrated in Table 1. For the entire cohort the average age of patients was 62 (3887) years with 22% aged more than 70. Twenty nine percent of patients were diabetic, 13% had moderate left ventricular dysfunction, 48% had a history of previous myocardial infarction, and 67% had three-vessel coronary artery disease. The urgency of the procedure was: elective in 81%, in-house or hospitalized in 17% and urgent in 2% of the randomized patients. A mean of 3.0±1.0 grafts were performed in the converted group as compared to 2.8±0.9 grafts in the not-converted group (P=0.39) (Table 2). There were no significant differences between the converted and not-converted groups with regards to complete arterial revascularization (60 vs. 69%; P=0.41), and avoidance of aortic proximal anastomoses (45 vs. 57%; P=0.32).
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| 4. Discussion |
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Taken together, OPCAB surgery appears to be safe when performed in selected patients. It remains to be determined, however, what the risk is to the patient who requires conversion from OPCAB to CPB. We have attempted in the present study to address this question by evaluating the rate of conversion and the patient outcomes from a group of patients randomized to have their CABG performed with or without CPB. In the setting of a randomized controlled trial, all conversion would be captured, as would all clinical outcomes. The patients enrolled in this study reflect a typical referral practice for a tertiary Canadian center with a large proportion of patients having advanced coronary artery disease manifested by previous history of myocardial infraction (45%) and the majority having three-vessel coronary artery disease [23].
We reported a total of 20 patients requiring conversion resulting in a conversion rate of 13% (20/150) in the OPCAB group. The incidence of conversion reported in the context of exclusively randomized studies has ranged from 0 to 15% [11,18,20,21]. In fact two of the largest trials to date have reported a conversion rate of 8% (n=281) and 10% (n=388) respectively [18,21]. In addition Straka et al. [21] reported that 85% of the patients assigned to the OPCAB group completed the procedure as such resulting in an overall cross over rate of 15%. Our conversion rate of 13% appears somewhat higher than is normally perceived and reported by the largest retrospective studies with conversion rates of less than 5% often quoted [8]. Higher rates of conversion may be explained by multiple factors including: variable surgeon experience, high percentage of three vessel coronary artery disease in our population and the possibly underreporting of beating heart CABG attempts in retrospective studies. Surgeon experience is a difficult variable to quantify, however, all surgeons involved in this study have had prior experience (minimum of 1 year) with OPCAB surgery but have differed between them as to what proportion of cases are routinely performed as OPCAB.
We have shown that surgical conversion from OPCAB to CABG performed with CPB was associated with a significantly higher mortality, utilization of inotropes leaving the operating room, and blood product transfusions. We report that the only 2 patients (2/150) that died in the OPCAB group had been converted resulting in a mortality rate of 10% (2/20) in converted patients. None of the published trials have attempted to separately evaluate the outcomes of patients requiring conversion. However, in support of our findings was the report from Straka et al. [21] that two of the cross-over (2/31) patients in their OPCAB group died. Our findings are also in agreement with several retrospective studies that have suggested that intra-operative conversion is associated with a significant mortality and morbidity risk [8,10,12,13].
Despite the strength of the present study drawn from a randomized controlled trial we are limited in the conclusions we can make. Primarily the present study was limited by a small number of patients requiring conversion such that we were unable to identify trends or independent risk factors that would help predict which patient undergoing OPCAB may require conversion. An elevated BMI (mean of 32) was the only variable significantly higher in the converted patients as compared to the remaining beating heart patients. It is conceivable that an elevated BMI could add additional technical difficulty to performing OPCAB resulting in a higher rate of conversion something not shown by others. Elevated body mass index and its effect on patient outcome following CABG surgery remains controversial but has been suggested by some to result in worse outcome [24]. We were unable to confirm previously suggested predictors of conversion which have included: previous CABG, congestive heart failure, surgeon with early experience, low ejection fraction, and recent myocardial infarction [8,10,25,26]. Similarly, we believe that any conclusion as to why converted patients may have a higher morbidity and mortality would be speculative.
In conclusion, we have shown that in a setting of a randomized controlled trial the overall conversion rate from OPCAB to using CPB was 13% and was associated with a significant morbidity and mortality risk.
| Appendix A. Conference discussion |
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Dr Legare: The percentage of patients that are done on beating heart has really not changed over time for us. Overall, it is on a surgeon-practice basis.
Out of the 10 surgeons in our institution, only five participated in this particular study. Overall, 1015% of all cases are done off-pump, and for some of these surgeons participating in this, their practice is more than 50%. However, again, it is very surgeon-dependent.
Dr P. Sergeant (Leuven, Belgium): At the K.U. Leuven we have applied the OPCAB approach to 99% of all primary and redo CABGs since four years. The conversion rate over the complete experience, including the initial one, was 0.4%, versus the 13% that you mentioned, over a consecutive series of 2191 patients. That is a total n of 10 patients. One of these 10 patients died. A logistic regression, not correcting for the specific variability of that particular patient, did not identify any relationship between mortality and conversion in the presence of this extremely low conversion rate. My question is, how do you plan to reduce the conversion rate in this institution?
Dr Legare: I will make two points. First you are illustrating a very good and large experience. The point of the comparison we are trying to make is that this was in the setting of a randomized trial, which is a little different, unless you have consecutive cases. Most of the randomized trials did show conversion rates of 10 up to 15%, and these are the largest trials. The problem with a retrospective study tends to be perhaps many of the times there is some under-reporting, where all events are captured in a randomized study.
In terms of reducing the event rate for conversion, it is, again, one of those things that are difficult, because we did not identify a particular risk factor for conversion. The classically described risk factors are always low ejection fraction, congestive heart failure, emergency surgery or redo surgery. These are in the large retrospective study. No one has looked at this in a randomized type setting, and now there is probably enough experience with the current randomized trials to look at a meta analysis to look at this particular question. However, right now I don't have any other answer to try to help or to reduce this conversion rate.
Dr T. Aberg (Umea, Sweden): I would like to ask you whether you had any signs of a learning curve during the trial?
Dr Legare: None of these conversions were grouped in the beginning or middle or end. The conversions were also not surgeon-dependent. So we did look at surgeon as a factor, because there was, as I said, five surgeons involved, and some obviously did a larger part of the study than others. In addition we were doing off-pump CABG before the onset of the study for over a year to a year and a half so that most of these surgeons had had at least a year of experience prior to entering the study or the beginning of the study.
In summary we did not notice a learning effect, but learning effect has been described before as a risk factor for conversion, and it probably is, but we haven't seen it in this study.
| Footnotes |
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Presented at the joint 18th Annual Meeting of the European Association for Cardio-thoracic Surgery and the 12th Annual Meeting of the European Society of Thoracic Surgeons, Leizpig, Germany, September 1215, 2004. | References |
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