Abstract
A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was: In patients undergoing off-pump coronary artery bypass (OPCAB) surgery, does the off-pump to on-pump conversion rate have an impact on post-operative results? Altogether more than 420 papers were found using the reported search, of which 14 randomized controlled trials (RCTs) represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated and ordered according to the sample size. In the 14 RCTs reviewed, the off-pump to on-pump conversion rate incidence ranged from 0 to 13.3%. The most frequent causes of conversion were haemodynamic instability and intramyocardial-coronary target. A low conversion rate (<2%) was reported by five studies. Three of them did not show any difference in terms of mortality between the OPCAB and on-pump groups, one showed better survival of the OPCAB group at 5 years, and one reported better early survival of the OPCAB group. Three of these trials describe a high OPCAB experience and reported that patients undergoing OPCAB had a shorter post-operative stay and lower morbidity compared with patients undergoing on-pump coronary artery bypass grafting. Five RCTs showed a high conversion rate (>9%), and among them, one reported lower morbidity of the OPCAB patients, three were not able to show any benefit in terms of morbidity of the OPCAB, and one reported worse survival and patency graft rate of the OPCAB group. Four RCTs reported conversion rates ranging from 3.7 to 7.0%, describing a wide spectrum of results. We conclude that RCTs with a high off-pump to on-pump conversion rate were often associated with a lower experience in OPCAB of the surgeons participating in the trials. These studies were also mostly unable to show any benefit in terms of mortality or morbidity of OPCAB over the on-pump strategy. On the contrary, a low conversion rate is mostly reported by RCTs with a high structured experience in OPCAB. These trials were mostly able to show a benefit, in terms of morbidity and survival, of the OPCAB over the on-pump strategy.
Keywords: Off-pump, OPCAB, CABG, Coronary surgery, Myocardial revascularization
INTRODUCTION
A best evidence topic was constructed according to a structured protocol. This is fully described in the ICVTS [1].
THREE-PART QUESTION
In [patients undergoing off-pump CABG] does [the off-pump to on-pump conversion rate] have an impact [on post-operative results]?
CLINICAL SCENARIO
After starting your OPCAB programme, one of the referring cardiologists at your hospital suggests you abort your project because of the bad results reported by the ROOBY trial in terms of survival. You want to check the literature for evidence on this issue.
SEARCH STRATEGY
The MEDLINE database was searched from January 1966 to May 2011. The medical subject headings keywords included OPCAB, off-pump, off-pump, beating heart. Only randomized clinical trials with a sample population of 100 or more patients were included in this review.
SEARCH OUTCOME
More than 420 papers were found using the reported search. From these, 14 papers were identified. That provided the best evidence to answer the question. These are presented in Table 1.
Table 1:
Best evidence papers
| Author, date and country, study type (level of evidence) | Patient group | Outcomes | Key results | Comments |
|---|---|---|---|---|
| ROOBY trial: Shroyer et al., N Engl J Med 2009 [5], USA Multicentre controlled, single-blind, randomized trial (level 1b) |
|
30-day survival | Overall mortality: off-pump 1.6%; on-pump mortality 1.2% (P = 0.47) |
|
| 1-year survival |
|
|||
| Off-pump to on-pump conversion rate | 12.4% Causes not specified | |||
| Experience in OPCAB | ‘Participating surgeons were required to document that they had performed at least 20 off-pump including some in which complete revascularization was performed for all vascular territories of the heart’ | |||
| BACHAS 1 and BACHAS 2 trials: Angelini et al., Lancet 2002 [2], J Thorac Cardiovasc Surg 2009 [18], UK Single centre, observer-blinded randomized, clinical trials (level 1b) |
|
30-day survival |
|
|
| 75-month survival | BACHAS 1 and 2 were pooled together: no difference in survival between the 2 groups (hazard ratio, 1.24; 95% CI, 0.72–2.15; P = 0.44) | |||
| Off-pump to on-pump conversion rate |
|
|||
| Experience in OPCAB | ‘BHACAS trials were carried out in a single centre by a single academic surgical team. This surgical team has documented innovations in OPCAB technique, their performance and that of residents learning OPCAB, and other aspects of their experience with OPCAB over more than a decade’ | |||
| Prague-4 Trial: Straka, Widimsky et al., Ann Thorac Surg 2004 [11], Circulation 2004 [19], Czech Republic Single centre, observer-blinded randomized (level 1b) |
|
30-day survival | Overall mortality: off-pump 2.0%; on-pump 1.1% (P = 0.39) |
|
| Off-pump to on-pump conversion rate | 9.8% Causes: small or intramuscular arteries (n = 14), haemodynamic instability (n = 6) | |||
| Experience in OPCAB | ‘All surgeons had experience with the off-pump technique, which was adopted in this centre in 1996’ | |||
| Best Bypass Surgery trial: Møller et al., Circulation 2010 [14], Denmark Single centre, randomized, observer-blinded, clinical trial (level 1b) | 341 patients with 3-vessel disease, >54 years old and EuroSCORE ≥ 5 Exclusion criteria: previous heart surgery, left ventricular ejection fraction (EF) ≤30%, unstable preoperative condition | 30-day survival | Overall mortality: off-pump 3.4%, on-pump 6.7% (P = 0.21) |
|
| Off-pump to on-pump conversion rate | 4.5% Causes: unstable haemodynamic (n = 3), intraoperative transoesophageal echocardiography showing aortic valve disease requiring repair (n = 1), intraoperative recognition of left ventricular aneurysm requiring surgical repair (n = 1), not operated on by a trial surgeon because of logistics (n = 2), and anaesthesiologist unwilling to participate in off-pump surgery (n = 1) | |||
| Experience in OPCAB | ‘Each of the 3 participating surgeons performed at least 50%of their CABG procedures as off-pump procedures in their normal activity’ | |||
| MASS III trial: Hueb et al., Circulation 2010 [4], Brazil Single centre, observer-blinded randomized, clinical trials (level 1b) |
|
30-day survival | Overall mortality: off-pump 0.6%; on-pump 0% | No difference was found between groups in the primary composite end point at 5-year follow-up. Although OPCAB surgery was related to a lower number of grafts and higher episodes of atrial fibrillation, it had no significant implications related to long-term outcomes |
| 60-month survival | Overall mortality: off-pump 8.4%; on-pump 5.2% (P = 0.18) | |||
| Off-pump to on-pump conversion rate | 1.9% Causes: haemodynamic instability (n = 3) | |||
| Experience in OPCAB | ‘The procedure was performed by surgeons experienced in both on-pump and off-pump bypass surgery’ | |||
| Légaré, et al., Circulation. 2004 [12] and Karolak et al., Am Heart J 2007 [20], Canada Single centre, randomized, clinical trial (level 1b) |
|
In hospital survival | Overall mortality: off-pump 1.3%; on-pump 0.7% (P = 1) | No differences in short-term mortality or morbidity outcomes between on-pump and off-pump groups |
| 45.6 months survival | Overall mortality: off-pump 6.7%; on-pump 3.3% (P = 0.18) | |||
| Off-pump to on-pump conversion rate | 13.3% Causes: of haemodynamic instability (n = 14), inadequate visualization of target vessel (n = 5), or inability to place the stabilizer because of obesity (n = 1) | |||
| Experience in OPCAB | No data | |||
| Octopus trial: Nathoe et al., N Engl J Med 2003 [15], The Netherlands Multicentre controlled, single-blind, randomized trial (level 1b) |
|
In hospital survival | Overall mortality: off-pump 0%; on-pump 0% | No statistically significant difference in cardiac outcome, symptoms or quality of life at 1 year between patients who underwent on-pump surgery and those who underwent off-pump surgery |
| 12-month survival | Overall mortality: off-pump 1.4%; on-pump 0% | |||
| Off-pump to on-pump conversion rate | 7.0% Causes not specified | |||
| Experience | ‘Surgery was performed by surgeons experienced in both on-pump and off-pump bypass surgery’ | |||
| Hernandez et al., Ann Thorac Surg 2007 [6], USA Single centre, randomized, clinical trial (level 1b) |
|
In hospital survival | Overall mortality: off-pump 0%; on-pump 1% |
|
| Off-pump to on-pump conversion rate | 1% Causes not specified | |||
| Experience in OPCAB | No data | |||
| Smart trial: Puskas et al., J Thorac Cardiovasc Surg 2003 [3], J Am Med Assoc 2004 [7], Ann Thorac Surg 2011 [8], USA Single centre, observer-blinded randomized, clinical trial (level 1b) |
|
In hospital survival | Overall mortality: off-pump 3.1%; on-pump 2.0% (P = 0.64) |
|
| 60-month survival | On-pump 81.8%, off-pump 92.9% (P = 0.02) | |||
| 84-month survival | On-pump 73.7%, off-pump 83.7% (P = 0.09) | |||
| Off-pump to on-pump conversion rate | 1% Causes: intramyocardial coronary artery (n = 1) | |||
| Experience in OPCAB | Surgical procedures were performed by a single experienced OPCAB practitioner, who routinely performs more than 90% of his isolated coronary cases using OPCAB | |||
| Muneretto et al., Ann Thorac Surg 2003 [9], Italy Single centre, randomized, clinical trial (level 1b) |
|
In hospital survival | Overall mortality: off-pump 3.4%; on-pump 2.3% (P = NS) | Off-pump patients had a considerable reduction of ventilation time, ICU stay, post-operative stay and atrial fibrillation rate |
| 15 months survival | Overall mortality: off-pump 1.2%; on-pump 2.3% (P = NS) | |||
| Off-pump to on-pump conversion rate | 9.1% Causes: intramyocardial or calcified vessels (n = 8) | |||
| Experience in OPCAB | No data | |||
| Fattouch et al., J Thorac Cardiovasc Surg 2009 [10], Italy Single centre, observer-blinded randomized, clinical trial (level 1b) |
|
In hospital survival | Overall mortality: off-pump 1.6%; on-pump 7.7% (P ≤ 0.04) | Off-pump surgery reduced early mortality and morbidity in patients with ST-segment elevation myocardial infarction in respect to the on-pump |
| 36-month survival | No cardiac-related late deaths occurred | |||
| Off-pump to on-pump conversion rate | 1.6% Causes: haemodynamic instability (n = 1) | |||
| Experience in OPCAB | No data | |||
| Masoumi et al., Asian Cardiovasc Thorac Ann 2008 [16], Iran Single centre, randomized, clinical trial (level 1b) | 124 patients with an EF of 35% or less who were referred for isolated first-time CABG. Exclusion criteria: single-graft CABG | In hospital survival | Overall mortality: off-pump 0%; on-pump 6.45% (P ≤ 0.045) | There were significantly fewer incidences of mortality, low cardiac output events, arrhythmias, renal failure and gastrointestinal haemorrhage in the off-pump group compared with on-pump group |
| Off-pump to on-pump conversion rate | 4.8% Causes not specified | |||
| Experience in OPCAB | No data | |||
| Lingaas et al., Ann Thorac Surg 2006 [13], Norway Single centre, observer-blinded randomized, clinical trial (level 1b) |
|
30-day survival | Overall mortality: off-pump 1.6%; on-pump 1.6% (P = NS) | No differences between off-pump and on-pump groups in terms of survival, cardiac function expressed as functional class, exercise ECG, MRI of the heart and graft patency |
| 12-month survival | No mortality events | |||
| Off-pump to on-pump conversion rate | 9.1% Causes: haemodynamic instability or inaccessible target (n = 5), to facilitate revision of grafts after intra-operative coronary angiography (n = 2) | |||
| Experience in OPCAB | ‘Four participating surgeons with varying experience in on-pump and off-pump coronary surgery, including one surgeon in training, performed the operations’ | |||
| Khan et al., N Engl J Med 2004 [17], UK Single centre, observer-blinded randomized, clinical trial (level 1b) |
|
30-day survival | Overall mortality: off-pump 0%; on-pump 0% | Graft-patency rate was lower at 3 months in the off-pump group than in the on-pump group |
| Off-pump to on-pump conversion rate | 3.7% Causes: electrical instability (n = 1) and intramyocardial LAD (n = 1) | |||
| Experience in OPCAB | ‘In the two years preceding the study, the surgeons performed 13% of their coronary work off-pump’ |
RESULTS
In the 14 randomized controlled trials (RCTs) reviewed, the off-pump to on-pump conversion rate ranged from 0 to 13.3%. The most frequent causes of conversion were haemodynamic instability and intramyocardial-coronary target.
A low conversion rate (<2%) was reported by five studies: the BACHAS trials [2], the Smart trial [3], the Mass III [4], the study published by Fattouch et al. [5] and the study published by Hernandez et al. [6]. The first three of them (BACHAS trials [2], Smart trial [3] and Mass III [4]) describe a high structured experience in OPCAB. In the remaining studies [3, 6–10], no data about experience in off-pump are available.
Among these five RCTs, three [2, 4, 6] did not show any difference in terms of early, mid- or long-term mortality between the OPCAB and on-pump groups, one showed better survival of the OPCAB group at 5 years [3], and one [10] reported a lower early mortality in patients with ST-segment elevation myocardial infarction undergoing OPCAB in comparison to the on-pump group. Three RCTs described lower post-operative morbidity (rate of atrial fibrillation, chest infection, transfusion of red blood, inotropic requirement [2], stroke [6]) and lower hospital stay [2, 3] in patients undergoing OPCAB).
Both studies analysing the bypasses functionality (BACHAS trials [2], Smart trial [3]) reported no differences in long-term graft patency.
Five RCTs presented a high conversion rate (>9%): the ROOBY Trial [5], the Prague-4 Trial [11], and the studies published by Legare et al. [12], Muneretto et al. [9], and Lingass et al. [13]. Among them, the ROOBY Trial [5] is the largest RCT (2203 patients), the one documenting the poorest experience in OPCAB by the surgeons participating in the trial, and the one associated with the second highest conversion rate (12.4%).
Among this group of RCTs only the ROOBY Trial [5] documented a worse early survival of the OPCAB group. None, except one [5], documented a benefit in term of reduction of the morbidity in the OPCAB group.
Among the 3 trials exploring graft patency [5, 11, 13] only the ROOBY trial [5] showed a lower overall rate of graft patency of the OPCAB group.
Four RCTs showed an intermediate conversion rate, ranging from 3.7 to 7.0%: the Best Bypass Surgery Trial [14], Octopus trial [15] and the studies published by Masoumi et al. [16] and Khan et al. [17].
In this group, only the Best Bypass Surgery Trial [14] reported a high experience in OPCAB of the surgeons participating in the trial.
The Best Bypass Surgery Trial, which is also the largest study of this group (341 patients), showed that the on-pump early overall mortality and incidence of myocardial infarction nearly doubled those of the off-pump group (no statistical significant in both cases). It also showed no differences in terms of graft numbers between the two groups.
The Octopus trial [15] reported no difference with regards to cardiac outcomes and early survival and quality of life between the OPCAB and on pump groups.
Masoumi et al. [16] have analysed only patients with severe left ventricle dysfunction. This trial was able to show lower mortality, low cardiac output events, arrhythmias, renal failure and gastrointestinal haemorrhage in the off-pump group compared with the on-pump group.
Khan et al. [17] showed a lower graft-patency rate at 3 months in the off-pump group than in the on-pump group.
CLINICAL BOTTOM LINE
We conclude that RCTs with a high off-pump to on-pump conversion rate (>9%) were often associated with a low experience in OPCAB of the surgeons participating in the trials. These studies were also mostly not able to show any benefit in terms of mortality or morbidity of OPCAB over the on-pump strategy.
On the contrary, a low conversion rate (<2%) is mostly reported by RCTs with a high structured experience in OPCAB. These trials were mostly able to show a benefit in terms of morbidity, and in two cases of survival, of the OPCAB over the on-pump strategy. No trials with a low conversion rate were able to document a significant difference in terms of graft patency between the on-pump and the OPCAB groups.
RCTs with an intermediate conversion rate reported a wide spectrum of results.
The results of this review may be jeopardized by the fact that the outcomes of the trials included were strongly influenced by their statistical power.
Conflict of interest: none declared.
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