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Eur J Cardiothorac Surg 2001;20:127-132
© 2001 Elsevier Science NL

Single-clamp technique does not protect against cerebrovascular accident in coronary artery bypass grafting

Richard W. Kima, Dominick C. Maricondaa, George Tellidesa, Gary S. Kopfa, Michael L. Dewara, Zhenqui Linb, John A. Elefteriadesa

a Department of Surgery, Section of Cardiothoracic Surgery, Yale University School of Medicine, New Haven, CT 06510, USA
b Center for Outcomes Research, Yale–New Haven Hospital, New Haven, CT 06510, USA

Received 11 December 2000; received in revised form 10 April 2001; accepted 23 April 2001.

Corresponding author. Tel.: +1-203-785-2705; fax: +1-203-785-3346
e-mail: john.elefteriades{at}yale.edu


   Abstract
Top
 Abstract
1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 References
 
Objectives: By potentially avoiding the embolic consequences of a side-biting aortic clamp, the single-clamp technique may decrease cerebrovascular accidents in coronary artery bypass grafting. However, this theoretical superiority in stroke prevention has not been conclusively demonstrated and use of this technique may lead to adverse myocardial effects due to longer cross-clamp times. In this study, we sought to determine if the single-clamp technique prevents postoperative stroke in clinical practice. Methods: Of 607 consecutive isolated coronary bypass operations completed over a 3 year period, 301 (50%) were performed by one surgeon using exclusively the single-clamp technique and 306 (50%) were performed by a second surgeon using exclusively the two-clamp technique. Postoperative adverse events were retrospectively compared between these two groups. Results: There were no differences between groups in terms of postoperative stroke (1.7% single-clamp vs. 2.0% two-clamp, P=0.78), hospital mortality (2.7% single-clamp vs. 1.6% two-clamp, P=0.38), or perioperative myocardial infarction (2.6% single-clamp vs. 0.7% two-clamp, P=0.052). The two-clamp technique was not a significant predictor of stroke by logistic regression analysis (P=0.72). Conclusions: We conclude that there are no statistically significant differences between clamp techniques with regard to stroke prevention or myocardial protection. We find no compelling evidence for surgeons successfully utilizing one technique to change to the other.

Key Words: Coronary disease • Surgery • Stroke • Complications


   1. Introduction
Top
 Abstract
 1. Introduction
2. Materials and methods
 3. Results
 4. Discussion
 References
 
Proposed by Buckberg [1] and developed and popularized by Salerno [2] and Aranki et al. [3,4], the single aortic cross-clamp technique for coronary artery bypass grafting (CABG) is based on sound theoretical grounds. By eliminating the second, partially occluding aortic clamp, this technique may potentially decrease the incidence of embolic stroke in CABG. Accordingly, the single-clamp technique has been gaining popularity among cardiac surgeons. However, the clinical superiority of this technique for stroke prevention has not been conclusively demonstrated. In fact, the few studies in the literature that have looked directly at this issue have, for the most part, failed to demonstrate cardiac or cerebral benefit directly attributable to this technique [3,5–9]. Although avoiding the application of the conventional second clamp may decrease the number of aortic emboli [10], this method necessarily results in longer cross-clamp times and converts the otherwise closed bypass operation to an open procedure, with increased risk of cardiac and cerebral air embolization. The open aorta may also complicate venting of the left ventricle by gravity or suction.

Surgeons currently using the conventional two-clamp technique also question the potential adverse myocardial effects attendant to the extended period of aortic cross-clamping inherent in the single-clamp technique. Supporters of the single-clamp technique argue that using a single clamp allows for more uniform cardioplegia delivery as the grafts are constructed and better prepares the myocardium for reperfusion following clamp release [3,4]. Conversely, proponents of the two-clamp technique maintain that no preservation technique is better than early removal of the cross-clamp and point to the beneficial immediate release of the internal mammary artery graft possible with the two-clamp technique. The balance of these various factors is not clear.

We recognized an opportunity to study this issue as two surgeons in our group exclusively use one technique in all their patients. We performed a retrospective comparison of clinical outcome following isolated coronary bypass surgery to determine if the single-clamp technique prevents postoperative stroke in clinical practice.


   2. Materials and methods
Top
 Abstract
 1. Introduction
 2. Materials and methods
3. Results
 4. Discussion
 References
 
2.1. Patients
Six hundred and seven consecutive patients who underwent isolated CABG surgery by two equally experienced cardiac surgeons at Yale–New Haven Hospital constituted the study group. All patients having associated valvular, aortic, or left ventricular aneurysm repairs were eliminated, as were all patients having off-pump CABG and all patients having concomitant carotid endarterectomy. These patients were operated upon during a 3-year period extending from October 1996 to September 1999. Three hundred and one (50%) patients underwent surgery via the single-clamp technique (by one surgeon) while 306 (50%) patients underwent CABG using the two-clamp technique (by the other surgeon). Segregation into each treatment group was based upon the routine practice of the individual surgeon and not on patient characteristics.

2.2. Clinical assessment
Clinical details were collected from patient charts and a Society of Thoracic Surgeons-based computer database. Recorded preoperative variables included age, gender, a history of diabetes, hypertension, congestive heart failure, peripheral vascular disease, atrial fibrillation, triple vessel disease, past cerebrovascular accident (CVA), preoperative shock, renal failure, urgency of operation and intraaortic balloon pump (IABP) placement. As potential bypass patients do not undergo routine imaging for carotid disease, only a subset of patients had additional data available on preexisting carotid stenosis (157 patients) and/or aortic calcification (276 patients). Intraoperative variables included the number of vessels bypassed, the number of internal mammary artery grafts, aortic cross-clamp time, cardiopulmonary bypass time, and need for cardioversion, external pacing, inotropic support or use of the IABP upon discontinuation of cardiopulmonary bypass. Postoperative variables included the onset of atrial fibrillation, stroke, perioperative myocardial infarction and hospital mortality. Stroke was defined as the onset of a permanent focal, central neurologic injury following CABG surgery. Perioperative myocardial infarction was defined as the new onset of Q waves in two or more leads by electrocardiogram. Mortality was defined as in-hospital death within 30 days of and within the same hospital admission as CABG surgery.

Patient records for all patient deaths or complications were reviewed individually, and the temporal onset of neurologic symptoms was recorded for all patients with a confirmed postoperative diagnosis of stroke. All available cerebral radiographic imaging was obtained on these patients and reviewed with a neuroradiologist to characterize the stroke, where possible, as embolic, non-embolic ischemic, or hemorrhagic.

2.3. Operative technique
All patients underwent isolated CABG surgery using cardiopulmonary bypass and moderate systemic hypothermia (28–32°C). Myocardial preservation was achieved with topical hypothermia using iced saline, and antegrade cold blood or crystalloid cardioplegia. The two-clamp surgeon utilized cold crystalloid cardioplegia given antegrade. The single-clamp surgeon utilized blood cardioplegia also given antegrade. In the single-clamp method, distal and proximal anastomoses were constructed during a single period of aortic occlusion. Grafting of the internal mammary artery was performed following the sequential completion of saphenous vein anastomoses. Additional cardioplegia was delivered upon completion of each proximal anastomosis. In the two-clamp method, proximal anastomoses were constructed following release of the initial aortic clamp and after applying a second partially occluding aortic clamp. This method allowed for early reperfusion of the heart and early release of the internal mammary artery graft. Although almost all patients in both groups underwent pedicled left internal mammary artery grafting, sequential arterial or ‘Y’ grafting was not utilized by either surgeon.

2.4. Statistical analysis
Determination of statistical significance was performed using the {chi}2-test, Fisher's exact test, the unpaired t-test, or the Mann–Whitney U-test for continuous variables where appropriate. A P value of <0.05 was considered statistically significant. All values are reported as the mean±standard deviation. Multivariate logistic regression analysis was also performed to determine the significance of treatment technique or preoperative characteristics in predicting postoperative stroke.


   3. Results
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
4. Discussion
 References
 
3.1. Preoperative and operative details
Preoperatively, there were no significant differences between the two groups of patients with regard to age, gender, history of diabetes, hypertension, congestive heart failure, peripheral vascular disease, triple vessel disease, preoperative shock, renal failure, urgency of operation or IABP use. There were also no significant differences in preoperative risk factors for stroke including prior CVA or incidence of atrial fibrillation. In the subset of patients with recorded data regarding aortic calcification or carotid stenosis, there were also no significant differences between the single-clamp and the two-clamp groups (Table 1).


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  		Table 1. Preoperative patient characteristics

 
The cross-clamp time in the single-clamp group (94.9±28 min) was twice that in the two-clamp group (46.7±15 min, P<0.01). The cardiopulmonary bypass time was also significantly longer in the single-clamp group (118±82 vs. 88±49 min, P<0.01). Although patients in the single-clamp group had a slightly higher number of vessels grafted (3.1±0.9 vs. 2.8±0.8, P<0.01), there was no difference in the use of a pedicled left internal mammary artery graft (P=0.26). There were also no differences between patient groups with regard to inotropic support, the need for pacing, or IABP use in weaning from cardiopulmonary bypass. Patients in the two-clamp group were more likely to require cardioversion (P<0.01) (Table 2).


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  		Table 2. Operative variables

 
3.2. Postoperative outcome
There were no differences between groups in the incidence of perioperative myocardial infarction, hospital mortality, or permanent stroke. There was also no difference in total adverse outcome defined by combining myocardial infarction, death and stroke (Fig. 1) . Myocardial infarction occurred in 2.6% of the single-clamp and 0.7% of the two-clamp patients (P=0.052). Mortality occurred in 2.7% of the single-clamp and 1.6% of the two-clamp patients (P=0.38). Stroke occurred in five single-clamp patients (1.7%) and six two-clamp patients (2.0%, P=0.78). There was also no difference in the incidence of stroke for higher risk patients over the age of 65 years (0.3% single-clamp, 1.2% two-clamp, P=0.24). Total adverse outcome occurred in 6% of single-clamp patients and 4% of two-clamp patients (P=0.19). Multivariate logistic regression analysis failed to identify a significant relationship between preoperative characteristics as segregated by clamp technique and postoperative CVA (Table 3). Univariate analysis of the subset of patients with data on preexisting carotid disease also failed to identify a significant relationship between carotid disease and postoperative CVA (P=1.0).



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  		Fig. 1. Incidence of postoperative complications following CABG. There are no significant differences between the single-clamp and the two-clamp groups. MI, myocardial infarction; CVA, cerebrovascular accident.

 

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  		Table 3. Multivariate analysis of relevant preoperative characteristics to determine significant predictors of postoperative stroke

 
Of the 11 patients determined to have suffered a postoperative stroke, eight of these patients (72.7%) had radiographic evidence on computed tomography (CT scan) of an embolic stroke, two had evidence of an ischemic stroke and one could not be classified (no CT scan). No stroke was hemorrhagic. Fig. 2 presents a histogram of the temporal onset of neurologic symptoms in these patients. Only five out of the 11 strokes occurred on postoperative day 1 or 2.



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  		Fig. 2. Distribution of stroke patients according to day of symptomatic onset. More than half of the patients became symptomatic on or after postoperative day 4.

 

   4. Discussion
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
References
 
In this report, we present a large series of patients who were specifically analyzed to determine the relationship between the aortic clamping technique and postoperative outcome in isolated CABG surgery. Advocates of a single aortic clamp suggest that completion of both distal and proximal anastomoses in a single extended period of aortic cross-clamping may decrease cerebrovascular complications and improve myocardial protection during CABG surgery [3,4,8,11]. This method challenges the traditional wisdom of releasing the aortic cross-clamp early, after completing the distal anastomoses, and using a second partially occluding clamp to construct the proximal anastomoses. Our data indicate that despite theoretical benefits of each method, there are no significant clinical differences between the two techniques in terms of cerebral and cardiac morbidity. Specifically, the anticipated benefit in stroke prevention from the single-clamp technique is not confirmed.

Experimental evidence for the superiority of the single-clamp technique includes pathologic evidence of aortic damage following clamp application [12] and echo Doppler documentation of cerebral artery emboli following the application and removal of aortic clamps [10,12–15]. Several previous clinical studies have also correlated the single-clamp technique to a reduction in postoperative morbidity. Aranki et al. [3] demonstrated that in 310 patients operated upon by a single surgeon using both techniques, use of a single clamp correlated with a decrease in postoperative adverse outcome, although not with stroke alone or mortality alone. It is of note that with the exception of these data none of the other studies looking directly at this issue in the current decade could attribute cerebral benefit to the use of this technique (Table 4). A large study by Loop et al. [11] did find an ancillary stroke benefit from the single-clamp technique, but also included patients who underwent additional procedures such as carotid endarterectomy, valve replacement, and ascending aortic aneurysm resection. In our study examining 607 consecutive patients, no advantages of the single-clamp technique were realized. Our rate of postoperative stroke was virtually identical between the two groups (1.7% in the single-clamp group, 2.0% in the two-clamp group). We submit that in isolated CABG surgery the theoretical increase in cerebral vascular accidents due to additional aortic clamping is so low that it is not borne out in clinical practice.


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  		Table 4. Previous studies evaluating the single-clamp technique

 
Although the number of patients in this study exceeds that of prior reports, offering almost as many patients for analysis as the sum of patients in prior studies shown in Table 4, the following weaknesses deserve mention. Statistical power calculations indicate that even larger patient numbers are required for attainment of formal data sufficiency and although multivariate analysis failed to identify significant differences between single and double clamp techniques, this may merely reflect a sample size too small to show possible benefit. This study is also retrospective, and although the clinical characteristics of the two groups appear quite similar, the groups were not assigned randomly. The two techniques were applied by different surgeons, leaving open the possibility that surgeon-to-surgeon variability may influence stroke rate. This cannot be resolved by data analysis in our study, as the variables of clamp technique and surgeon segregate together. Finally, this was a study looking for purely clinical, major, focal stroke events. Detailed psychometric studies could conceivably uncover subtle advantages of the single-clamp technique.

We suggest that the failure of the single-clamp technique to tangibly manifest its theoretical potential for stroke prevention reinforces the need for a multifactorial approach to stroke prevention after CABG. The single-clamp technique addresses only one potential factor and is overshadowed by the effects of multiple other potential causes of stroke in this setting. Embolic material may be liberated not only by the side-biting clamp, but also by the main cross-clamp itself, by aortic cannulation, by the perfusion jet, and by the aortic punch. Manual manipulation of the aorta may liberate debris. In patients with preexisting atrial fibrillation, emboli may be liberated from the left atrium. None of these other potential sources of emboli would be influenced by application of a side-biting clamp. Ischemic post-CABG strokes due to carotid or intracranial stenoses or thrombosis are also not influenced by the clamping technique.

This analysis is supported experimentally by a recent report from Grocott et al. [15], who investigated serum levels of S100B, a protein marker of cerebral injury, in coronary bypass operations. They demonstrated that serum levels of S100B are highest at initial aortic cannulation rather than at cross-clamp application or removal. These observations suggest that although the use of an additional partially occluding aortic clamp may increase the number of cerebral transcranial Doppler signals, it does not result in increased brain injury.

The data in the present study on the nature and timing of stroke after CABG are also pertinent. Although eight of 11 (72.7%) strokes appeared embolic on CT scan, less than half of our stroke patients manifested neurologic symptoms on postoperative day 1 or 2. The majority displayed symptoms only on or after postoperative day 4. It is difficult to attribute these relatively delayed neurologic events to the use of an additional partially occluding clamp.

Although the single-clamp technique was not protective for stroke in this or other overall series of patients, we do believe that it is an important and appropriate technique, especially for individual high-risk patients with severe ascending aortic arteriosclerosis detected clinically or by transesophageal echocardiography. We suspect that other techniques directed at preventing embolic stoke may be more effective than the single-clamp technique in preventing embolic complications. These include, for example, the ‘no touch’ method of revascularization [16,17] and off-pump CABG. Originally described in 1981 by Mills and Everson, the ‘no touch’ method involves no ascending aortic cannulation or clamping, low-flow hypothermic cardiac fibrillatory arrest with or without circulatory arrest, and placement of all proximal vein graft anastomoses end-to-side to the internal mammary artery. Sixteen patients preoperatively assessed to be at high risk for postoperative stroke were operated upon by those authors using this technique with no cerebral complications. The cerebral benefits of off-pump CABG are beginning to be documented [18]. Other alternate strategies that deserve consideration include the direct aortic replacement recommended by Kouchoukos and Wareing [19], and the use of intraaortic mechanical filters [20].

Surgeons trained using the partially occluding second clamp have been hesitant to change to the single-clamp method because of concerns that the prolonged ischemia time inherent to this technique may increase cardiac morbidity. We have found no evidence to suggest that use of the single-clamp technique results in increased cardiac morbidity. Although the difference in perioperative myocardial infarction between the two treatment groups was nearly significant (P=0.052), the actual incidence of infarction was still a low 2.3% even in the single-clamp group. Our data demonstrate that the clamp technique makes no difference in the need for inotropic support, pacing, or IABP use, although there is a difference in the need for cardioversion. We contend that both techniques provide excellent myocardial protection in CABG surgery.

We conclude that while both techniques have their own theoretical advantages, there are no significant differences in clinical outcome attributable to using either technique. Although the two-clamp technique required placement of an additional partial cross-clamp, patients treated in this fashion did not realize any penalty in terms of postoperative stroke. Similarly, although patients treated with the single-clamp technique required a significantly longer period of aortic cross-clamping, there was no significant cardiac or mortality penalty. On the basis of this study, we find no compelling evidence for surgeons successfully utilizing either method of constructing their proximal anastomoses to yield to pressure to change clamp technique.


   Footnotes
 
Presented at the 36th Annual Meeting of the Society for Thoracic Surgeons, Fort Lauderdale, FL, USA, January 31–February 2, 2000.


   References
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 References
 

  1. Buckberg G.D. A proposed solution to the cardioplegia controversy. J Thorac Cardiovasc Surg 1979;77:803-815.[Medline]
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  3. Aranki S.F., Rizzo R.J., Adams D.H., Couper G.S., Kinchla N.M., Gildea J.S., Cohn L.H. Single-clamp technique: an important adjunct to myocardial and cerebral protection in coronary operations. Ann Thorac Surg 1994;58:296-303.[Abstract]
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  6. Rajalin A., Kuttila K., Niinikoski J., Sarunen T., Vanttinen E., Heikkila H., Jalonen J., Perttila J., Valtonen M., Engblom E. Myocardial reperfusion after coronary bypass surgery. Suture of only distal or all anastomoses with the aorta cross-clamped?. Scand J Thorac Cardiovasc Surg 1995;29(4):175-180.[Medline]
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  8. Hammon J.W., Jr, Stump D.A., Kon N.D., Cordell A.R., Hudspeth A.S., Oaks T.E., Brooker R.F., Rogers A.T., Hilbawi R., Coker L.H., Troost B.T. Risk factors and solutions for the development of neurobehavioral changes after coronary artery bypass grafting. Ann Thorac Surg 1997;63:1613-1618.[Abstract/Free Full Text]
  9. Musumeci F., Feccia M., MacCarthy P.A., Ellis G.R., Mammana L., Brinn F., Penny W.J. Prospective randomized trial of single clamp technique versus intermittent ischaemic arrest: myocardial and neurological outcome. Eur J Cardio-thorac Surg 1998;13(6):702-709.[Abstract/Free Full Text]
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  12. Stefaniszyn H.J., Novick R.J., Sheldon H., Sniderman A.D., Salerno T.A. Anatomical observations in cadavers during the application of a partial exclusion clamp to the ascending aorta. Curr Surg 1984;41:184-187.[Medline]
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  14. Barbut D., Yao F.S.F., Lo Y.W., Silverman R., Hager D.N., Trifiletti R.R., Gold J.P. Determination of size of aortic emboli and embolic load during coronary artery bypass grafting. Ann Thorac Surg 1997;63:1262-1267.[Abstract/Free Full Text]
  15. Grocott H.P., Croughwell N.D., Amory D.W., White W.D., Kirchner J.L., Newman M.F. Cerebral emboli and serum S100B during cardiac operations. Ann Thorac Surg 1998;65:1645-1650.[Abstract/Free Full Text]
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