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Ann Thorac Surg 2009;88:796-801. doi:10.1016/j.athoracsur.2009.04.104
© 2009 The Society of Thoracic Surgeons
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Original Articles: Adult Cardiac

Four-Year Outcome of OPCAB No-Touch With Total Arterial Y-Graft: Making the Best Treatment a Daily Practice

Wouter Bas Halbersma, MDa, Sara Camilla Arrigoni, MDa, Gianclaudio Mecozzi, MDa, Jan Gerard Grandjean, MD, PhDa, Arie Pieter Kappetein, MD, PhDb, Job van der Palen, MD, PhDc, Felix Zijlstra, MD, PhDd, Massimo Alessandro Mariani, MD, PhDa,*

a Thoraxcenter Twente, Enschede, the Netherlands
b Thoraxcenter Erasmus Medical Center, Rotterdam, the Netherlands
c Department of Epidemiology, Medisch Spectrum Twente, Enschede, the Netherlands
d Thoraxcenter, University Medical Center Groningen, Groningen, the Netherlands

Accepted for publication April 27, 2009.

* Address correspondence to Dr Mariani, Department of Cardiothoracic Surgery, Thoraxcentrum, T4.232, HPC AB32, University Medical Center Groningen, Postbus 30.001, 9700 RB, Groningen, the Netherlands (Email: m.mariani{at}thorax.umcgonl).


   Abstract
Top
 Abstract
Introduction
 Material and Methods
 Results
 Comment
 References
 
Background: A retrospective, single-center 4-year clinical study of the off-pump coronary artery bypass grafting no-touch technique with arterial conduits (Y-graft) was compared with the Syntax trial.

Methods: Four hundred consecutive patients ("all-comers") who underwent coronary surgery between 2004 and 2008 at the Thorax Center Twente (TCT) formed the study group. The primary end point was in-hospital and 12-month major cardiovascular or cerebrovascular event (MACCE). Event rates of MACCE were based on life tables, and overall MACCE was determined by Kaplan-Meier analysis.

Results: In-hospital mortality was 0.2%. Cumulative 1-year survival was 98.2%, and freedom from MACCE was 94.7% ± 1.1%. Cumulative 4-year survival and freedom from MACCE were 91.2% ± 2.4% and 82.1% ± 3.0%, respectively. There were no significant differences in the baseline characteristics between the patients of the TCT group and the surgical arm of the Syntax trial. Repeat revascularization, MACCE, and symptomatic graft occlusion in the TCT group were significantly lower than in the Syntax trial. The event rate of myocardial infarction and all-cause death in the TCT group were significantly lower than those of the percutaneous coronary intervention arm of the Syntax trial. There was a clear trend toward a reduction of the event rate of stroke in the TCT group (0.8%) compared with the surgical arm of the Syntax trial (2.2%). There was no significant difference of stroke rate between the TCT group and the percutaneous coronary intervention arm of the Syntax trial.

Conclusions: A state-of-the-art surgical technique such as off-pump coronary artery bypass grafting no-touch can further improve the advantage of surgical treatment with respect to percutaneous coronary intervention. Off-pump coronary artery bypass grafting no-touch surgery can be the treatment of choice for patients with three-vessel disease and left main stenosis.


   Introduction
Top
 Abstract
 Introduction
Material and Methods
 Results
 Comment
 References
 
Coronary artery bypass grafting (CABG) is the most widespread cardiac procedure and represents the gold standard for the treatment for three-vessel and left main coronary artery disease. The development of the off-pump coronary artery bypass grafting (OPCAB) technique [1] aimed to avoid some of the adverse effects associated with the use of cardiopulmonary bypass: cardioplegic arrest of the heart, manipulation of the aorta, stimulation of the inflammatory cascade related to the blood-air and blood-circuit contact, and clotting disorders. In several studies OPCAB surgery was superior to conventional CABG owing to a decreased incidence of cerebrovascular accidents, blood loss and transfusion, reoperation for bleeding, ventilation time, and resource utilization [2–4].

The "no-touch technique" is a surgical strategy aiming to avoid aortic manipulation by using either pedicled or composite arterial grafts combined with OPCAB. Some recent studies demonstrated that the aortic no-touch technique is safe and effective [5–9]. Even in high-risk patients this technique results in fewer neurologic events [10–14].

The long-term safety and efficacy of percutaneous coronary intervention (PCI) with bare metal stenting and CABG for multivessel coronary artery disease have been compared in several randomized controlled trials [15]. In a pooled analysis of data from 3,051 individual patients enrolled in four trials with 5-year follow up, the cumulative incidence of death, myocardial infarction (MI), and stroke was similar in patients randomized to undergo PCI versus CABG, (16.7% versus 16.9%, respectively). However, repeat revascularization occurred significantly more often after PCI with bare metal stenting compared with CABG (29.0% versus 7.9%; p < 0.001). Data from the ARTS II trial, a nonrandomized comparison of a cohort of patients treated with a drug-eluting stent with the PCI and CABG patients enrolled in ARTS I, suggested that the systematic application of drug-eluting stents might bridge the gap between PCI and CABG, and this hypothesis formed the basis to perform the Syntax trial [16–18].

Regardless of this expectation, the Syntax data demonstrated a still markedly lower rate of repeat revascularization in the CABG arm. However, in the CABG arm of the Syntax trial there was also a significantly higher rate of stroke. This fact of course sheds a different light on the benefits of the surgical approach. Despite the evidence of the advantages of OPCAB and the use of arterial conduits, these techniques were applied in only 15% and 19% of the cases, respectively [18]. This approach may have led to a relatively higher rate of repeat revascularization and stroke in the surgical arm, although the rate of repeat revascularization remains lower than in the PCI arm of the study.

To investigate whether the results of the Syntax study can be considered as state-of-the-art and the best surgical strategy for myocardial revascularization, this study reviewed the results of 400 patients who underwent OPCAB using total arterial grafting and aortic no-touch technique and compared these with the results of the Syntax trial. The present study therefore performs an analysis that is similar to the comparison of ARTS II and I [16, 17], in recognition of the fact that both modes of reperfusion therapy evolve continuously with the application of new concepts as well as technology.


   Material and Methods
Top
 Abstract
 Introduction
 Material and Methods
Results
 Comment
 References
 
Study Design
Patient selection
The Institutional Review Board of the Thorax Center Twente (TCT) has decided that formal approval was not needed because data were collected as part of routine medical care and patients were not individually identified. Therefore, informed consent was not deemed necessary.

We selected from our institutional custom-made database (Medical Computer Support, version 5.10.0, Wilp, The Netherlands) patients with OPCAB no-touch technique operated on at the TCT between September 2004 and May 2008. The operations were performed by 4 surgeons. Inclusion criteria were off-pump coronary surgery using the aortic no-touch technique and composite arterial conduits with the left internal mammary artery, right internal mammary artery, radial artery, or gastroepiploic artery.

The study cohort consisted of 407 consecutive patients enrolled as "all-comers," irrespective of emergent or urgent status. Seven patients were excluded from the study because of intraoperative conversion to on-pump surgery owing to hemodynamic instability (n = 5) and because total arterial revascularization was not possible as a result of the unsuitability of the radial artery (n = 2).

Primary end point
The primary end point was defined as in-hospital and 12-month major adverse cardiovascular or cerebrovascular event rate (MACCE), defined as all-cause death, stroke, MI, and any repeat revascularization [19]. Myocardial infarction was defined according to the definition by the Academic Research Consortium [19].

Secondary end points
Secondary end points were defined as 12-month MACCE compared with the randomized arms of the Syntax trial, MACCE at cumulative follow-up, and feasibility of the technique in a daily clinical practice.

Data Collection
Preoperative, operative, and postoperative data from 400 patients were retrospectively collected. Preoperative patients' demographics are listed in Table 1. In-hospital mortality was defined as 30-day and or in-hospital mortality (whatever condition occurred). In 94 patients there was a left main stenosis of more than 50%.


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  		Table 1 Preoperative Patient Characteristics
 
Surgical Technique
All procedures were performed through a median sternotomy [1]. The internal mammary arteries were harvested as pedicles, both for free and in situ grafting. All arterial conduits were distally divided after heparinization of the patient and were irrigated with 1% saline solution of papaverine. Heparinization was achieved by giving heparin 150 IU/kg to obtain a target activated clotting time longer than 400 seconds [20]. Protamine sulfate was used to reverse the heparin dose at the completion of the procedure. To obtain a better visualization of the target coronary arteries a suction stabilizer (Axius Vacuum 2 Stabilizer System; Guidant, Santa Clara, CA, or Octopus 3; Medtronic, Minneapolis, MN) was used to stabilize the target coronary artery. Intracoronary shunt occluders were used in all grafted vessels, unless the coronary anatomy made the insertion impossible. All patients received postoperative low-molecular-weight heparin 3,000 IU twice daily until discharge. Acetylsalicylic acid was given intravenously (500 mg) once, 6 hours after admission on the intensive care unit, and continued lifelong at a dose of 100 mg daily orally, starting from postoperative day 1.

Follow-Up
Telephone follow-up was successful in all patients. When additional clinical data were required or for data on cause of death, the patient's primary physician or cardiologist was contacted. The mean follow-up time for the 400 patients was 25.3 ± 13.9 months and ranged from 2 days to 50 months. The median length of follow-up was 22.4 months.

Data Management and Statistical Analysis
All data were entered in an Excel spreadsheet (Microsoft Corp, Redmond, WA). Statistical analysis was performed using SPSS 15.0 (SPSS Inc, Chicago, IL). Values are reported as mean ± standard deviation or as percentages. A probability value less than 0.05 was considered significant. For statistical analysis Kaplan-Meier plots were constructed and Fisher's exact test was used to compare differences in complication rates between the Syntax trial and the TCT data. Estimates of the cumulative event rates of MI, stroke, repeat revascularization, symptomatic graft occlusion, and death were calculated by the Kaplan–Meier method. The baseline characteristics (age, sex, EuroScore) of the TCT data were compared with the data of the surgical arm of the Syntax trial. A comparison (Fisher's exact test) was also made between the cumulative event rates of TCT data and both the randomized PCI and CABG data from the Syntax trial for MI, stroke, repeat revascularization, death, symptomatic graft occlusion, and MACCE.


   Results
Top
 Abstract
 Introduction
 Material and Methods
 Results
Comment
 References
 
Intraoperative data are listed in Table 2. Mean operating time was 187 ± 33 minutes. The number of distal anastomoses per patient was 3.5 ± 0.8 (range, 2 to 6). The composite graft was made with the left internal mammary artery and the radial artery in 94.3% of patients. In other cases the right internal mammary artery was used as a free graft to construct a composite Y-graft with the left internal mammary artery.


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  		Table 2 Intraoperative Data
 
In-Hospital Complications
In-hospital results are listed in Table 3. The mean hospital stay was 7.5 ± 5.5 days. One patient died in the hospital. This patient died of multiorgan failure on the second postoperative day. Reoperation for bleeding was required in 17 patients (4.2%).


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  		Table 3 In-Hospital Data
 
One-Year Follow-Up
The 1-year results are listed in Table 4. The observed 1-year mortality was 1.8% (7 patients); 4 of these were cardiac deaths. The cumulative 1-year survival rate was 98.2% ± 0.7%. The cumulative 1-year freedom from MACCE was 94.7% ± 1.1%. Five patients needed a repeat revascularization: 1 reoperation and 4 PCI.


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  		Table 4 One-Year Follow-Up Data, Based on Life Tables
 
Overall Follow-Up
Overall results are listed in Table 5. During the follow-up 18 patients died; 7 were cardiac deaths. The cumulative 4-year survival was 91.2% ± 2.4% (Fig 1). The cumulative 4-year freedom from MACCE was 82.1% ± 3.0% (Fig 1). Thirteen patients (5.8%) needed a repeat revascularization: 1 reoperation and 12 PCI.


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  		Table 5 Overall Follow-Up, Based on Life Tables
 

Figure 1
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  		Fig 1. Kaplan-Meier curves for survival. (CVA = cerebrovascular accident; MACCE = major adverse cardiovascular or cerebrovascular event.)

 
Comparison With the Syntax Trial
Repeat revascularization in the TCT group was significantly lower compared with PCI and CABG in Syntax trial. Similarly, symptomatic graft occlusion in the TCT group was significantly lower than that in both arms of the Syntax trial (Table 6). The percentage of MACCE was significantly lower in the TCT group compared with CABG and PCI in the Syntax trial. All-cause death and MI were significantly lower compared with the PCI arm of the Syntax trial.


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  		Table 6 Comparison With the Syntax Trial
 
There was a clear trend toward a reduction of the event rate of stroke in the TCT group (0.8%) with respect to the surgical arm of the Syntax (2.2%; p = 0.07). There was no significant difference of stroke rate between the TCT group and the PCI arm of the Syntax trial.


   Comment
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
References
 
The aim of this study was to analyze the clinical midterm follow-up of 400 patients who underwent OPCAB using total arterial grafting and no-touch technique at the Thorax Center Twente, the Netherlands (TCT group). In addition, the outcomes were compared with the results of the randomized arms of the Syntax trial, in a comparison similar to the ARTS I and II trials [16–18].

The cumulative 4-year survival (91.2%) and freedom from MACCE (82.1%) confirmed the safety and efficacy of OPCAB no-touch technique at midterm follow-up. As reported in the comparison analysis (Table 6), the results of the TCT group for MI and all-cause death were similar to the results of the surgical arm of the Syntax trial, but significantly better than those of the PCI arm. The results of the TCT group are significantly better than those of the Syntax study (both arms) for repeat revascularization and symptomatic graft occlusion. The results of the TCT group are significantly better than those of the Syntax study (both arms) for the rate of MACCE.

The results of the Syntax trial have been recently published [18] and represent the contemporary results of revascularization treatment in patients with three-vessel disease or left main stenosis. Even though the results in the surgical arm of the Syntax trial were superior to those of the PCI arm, the high incidence of stroke and repeat revascularization needs to be addressed. Aortic manipulation and derangements related to cardiopulmonary bypass are the most significant determinants of stroke after CABG [21]. The release of emboli in the case of atherosclerotic walls of the ascending aorta [22] and macro and micro cerebral embolization related to cardiopulmonary bypass [23] are the mechanisms responsible for the cerebral injuries. Strokes are potentially fatal and invalidating complications that negatively influence the outcome of patients who undergo surgical revascularization.

In the TCT group we aimed to improve the neurologic outcome of coronary surgery by avoiding manipulation of the ascending aorta. At the same time, we intended to improve the surgical results in term of MI, repeat revascularization, and death, by using only arterial grafts. The results of the TCT group showed a clear trend toward a reduction in stroke although this did not reach statistical significance (p = 0.07) with respect to the surgical arm of the Syntax study (0.8% versus 2.2%). In addition, the rates of stroke in the TCT group were not different from those of the PCI arm of the Syntax study (0.8% versus 0.6%). The low percentage of stroke of the TCT group (2.3%) observed at 4 years' follow-up proves the additional value of the neurologic protection offered by this procedure.

Some authors have questioned the patency of multiple anastomoses with composite grafts, because of competitive flow especially in cases of moderate stenosis of the native vessels [24–26]. Other concerns were whether the interactions between coronary branches and the graft arrangement can influence flow distribution [27]. However, other studies demonstrated that the flow reserve of the internal mammary artery was adequate for multiple coronary anastomoses, irrespective of the choice of the second arterial graft [28, 29], and the results of graft flow in sequential internal mammary artery grafting were comparable with those in single grafting [30]. Finally, recent studies on the adaptability of the internal mammary artery to flow dynamics concluded that Y-grafts were able to regulate flow capacity to myocardial demand, probably through the release of endothelial vasoactive mediators [31, 32]. The observed low percentage of graft occlusion in the TCT group (2.1%) at follow-up showed a satisfactory patency of composite grafts using total arterial conduits.

Another secondary end point of this study was to establish the feasibility of OPCAB no-touch. The low percentage of cases (1.7%; 7 patients) in whom this surgical technique could not be performed owing to intraoperative circumstances, such as unsuitable anatomy or hemodynamic instability, clearly showed its high feasibility. In addition, since we did not record MACCE at follow-up in these 7 patients, we can conclude that we did not overestimate the outcome in the TCT group by removing these patients from the analysis. We can therefore state that this technique can be used as part of a daily practice, irrespective either of the emergency status or the anatomic variability of the patients.

The main limitation of this study is that it is a single-center retrospective study. On the other hand, the operations were carried out in a high-volume center with uniformity in the technique used, across 4 independent surgeons. There were no exclusion criteria, so that we consider this study as an intended all-comers study.

In summary, this study shows that use of a state-of-the-art surgical technique such as the OPCAB no-touch procedure can further improve the advantage of surgical treatment with respect to PCI, as shown by the Syntax trial. In addition, this study shows that neurologic complications by using OPCAB no-touch methods are not different from the PCI arm of the Syntax trial. Therefore, we can conclude that the OPCAB no-touch technique can be reasonably seen as the treatment of choice for patients with three-vessel disease and left main stenosis. Finally, owing to the continuous changes and improvements of both surgical technique and PCI, a randomized study between the state of the art OPCAB no-touch technique and PCI using the latest generation drug-eluting stents is recommended.


   References
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 

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