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Eur J Cardiothorac Surg 2004;25:993-1000
© 2004 Elsevier Science NL

Automatic connector devices for proximal anastomoses do not decrease embolic debris compared with conventional anastomoses in CABG

Sven Martensa*, Markus Dietricha, Christopher Herzogb, Mirko Dossa, Gunnar Schneidera, Anton Moritza, Gerhard Wimmer-Greineckera

a Department for Thoracic and Cardiovascular Surgery, University Hospital J.W. Goethe, Frankfurt 60590, Germany
b Department of Radiology, University Hospital J.W. Goethe, Frankfurt 60590, Germany

Received 15 December 2003; received in revised form 9 February 2004; accepted 27 February 2004.

* Corresponding author. Tel.: +4969-6301-5850; fax: +4969-6301-5849
e-mail: martens.herz{at}gmx.de


   Abstract
Top
 Abstract
1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 5. Conclusion
 Appendix A. Conference...
 References
 
Objective: Emboli generated during cardiac surgery have been associated with aortic clamping and manipulation. Proximal anastomotic devices are thought to be less traumatic by eliminating partial clamping, potentially resulting in fewer adverse outcomes. Intra-aortic filtration has been shown to effectively capture particulate debris. We compared the amount of debris released using intra-aortic filtration and the clinical outcomes between conventionally handsewn and automated proximal anastomoses. Methods: Seventy-seven patients undergoing primary coronary artery bypass grafting with cardiopulmonary bypass were enrolled in a prospective randomized study. Patients were assigned to the anastomotic device Group I (SymmetryTM Aortic Connector, n=39) or the conventional handsewn anastomosis control Group II (n=38). Proximal anastomoses were performed before cardiopulmonary bypass in both groups. Intra-aortic Filter 1 (EMBOL-XTM) was deployed prior to partial clamping or puncturing the aorta for device application and removed after the proximal anastomosis was completed. Prior to cross-clamp removal, a second filter was inserted (Filter 2). A core laboratory performed quantitative and histologic analyses of the debris captured. Clinical outcomes included adverse events, neurocognitive test scores, graft patency, and mortality. Results: Preoperative variables and risk factors were not significantly different between Groups I and II (EuroSCORE 3.9±2.6 vs. 4.2±2.5). Filter analyses showed no significant difference between Groups I and II in Filter 1 or 2 for either surface area of particles or total number of particles (P>0.05). There was a significant decrease between Filters 1 and 2 in both Groups for surface area of particles (Group I: 18.5±23.8 mm2 vs. 10.7±16.3 mm2, P=0.017; Group II: 15.0±15.4 mm2 vs. 6.9±.6.5 mm2, P=0.004), and for total number of particles in Group II (8.6±3.7 vs. 7.1±2.4, P=0.023). No significant differences were observed between Group I (device) and Group II (control) outcomes for myocardial infarction, neurocognitive deficit, stroke, length of stay, graft occlusion, or mortality. Conclusions: The application of proximal aortic connectors without partial clamping does not reduce particulate emboli or affect clinical outcomes compared with conventional anastomoses. Cross-clamping during cardiopulmonary bypass produces less particulate debris than conventional or automated proximal anastomoses performed off-pump, suggesting a major source of emboli is the anastomotic process.

Key Words: Proximal anastomosis device • Coronary artery bypass grafting • Aortic trauma • Atheromatous debris • Intra-aortic filtration


   1. Introduction
Top
 Abstract
 1. Introduction
2. Materials and methods
 3. Results
 4. Discussion
 5. Conclusion
 Appendix A. Conference...
 References
 
Anastomotic devices were first introduced in vascular surgery to achieve reproducible anastomotic quality and to facilitate surgical procedures. As the next step, these devices would allow anastomoses to be performed via limited incisions or, in cardiac surgery, on the beating heart. The development of alternative ways to construct proximal or distal anastomoses is characterized by reducing the technical demand with respect to the total number of manual maneuvers [1,2]. Guyton and colleagues [3] presented a mechanical device for sutureless aorta–saphenous vein anastomoses in 1979. The device adapted the principle of venous eversion, which required the anastomosis to be smaller than the vein utilized. Results regarding short- and long-term patency were encouraging. Calafiore and coworkers [4] presented early clinical experiences with a sutureless anastomotic device for proximal anastomoses for coronary artery bypass grafting (CABG) in 2001. The same year, Eckstein and colleagues published clinical results with the SymmetryTM aortic connector, postulating a clinical as well as technical benefit through reduced aortic manipulation with connector devices [5].

Currently, proximal anastomoses for CABG procedures are almost exclusively performed with conventional running sutures. Anastomotic devices such as the SymmetryTM aortic connector may reduce dependency on surgical skills as a prognostic factor for long-term patency. Avoiding aortic side-clamping may also be useful to avoid particulate embolization and related compliations [3–8]. However, the demonstration that reducing aortic trauma causes less neurocognitive impairment still requires confirmation in randomized clinical trials. Because the construction of proximal anastomoses on the beating heart is associated with the potential for increased aortic wall trauma due to pulsatile flow and higher arterial pressure when compared to conditions on pump, the differences regarding neurologic injury and release of atheromatous debris may be more pronounced in a beating heart setting.

The amount of particulate and atheromatous debris released through manipulation of the ascending aorta during cardiac operations has been demonstrated by intra-aortic filter capture [9]. The present study compared automated or conventionally handsewn proximal anastomoses for the amount of debris released using intra-aortic filtration and subsequent clinical outcomes.


   2. Materials and methods
Top
 Abstract
 1. Introduction
 2. Materials and methods
3. Results
 4. Discussion
 5. Conclusion
 Appendix A. Conference...
 References
 
Eighty consecutive elective CABG patients were randomly assigned to the automated proximal anastomotic device group (device Group I, n=40) or the conventionally handsewn proximal anastomoses with partial clamping group (control Group II, n=40). One patient in Group I and two patients in Group II were excluded intra-operatively because of severe aortic calcification revealed by palpation of the ascending aorta and lack of vein graft material, respectively. These patients received bilateral internal thoracic artery grafts (ITA), two of which had T-graft revascularization using a radial artery. The remaining 77 patients met all inclusion criteria of the protocol. All procedures were performed by the same surgeon between August 2001 and April 2002. The study was approved by the local ethics committee at J.W. Goethe University Hospital, and written informed consent was obtained from all patients.

One day prior to surgery, neurocognitive tests were administered and scores were assessed according to the ‘Statement of consensus on assessment of neurobehavioral outcomes after cardiac surgery’ [10] by a trained member of our group who was blinded to the treatment arm. The results were analyzed by comparing changes in individual test scores according to the ‘Statement of Consensus’ of 1997 and the guidelines of Stump [11]. A decline in performance from the initial test interval that exceeded 20% in two or more tests was considered a deficit. The neurocognitive test battery included the Block Design Test (problem solving strategies, recognition and analysis of forms), Benton Revised Retention Test (describing constructive abilities), Trail-Making Test (cognitive achievement at speed), Digit Span Test (short term memory and memory of figures), d2 Test of Attention (for concentration performance), and a questionnaire focusing on the mood state of the patient. The tests were repeated five days after surgery by the same researcher.

All patients received at least one arterial graft, with preference to the left anterior descending artery. Vein harvesting was performed in a standardized fashion, avoiding the use of clips on side branches. After inspection of the ascending aorta, patients received full dose heparin (LiqueminTM Roche, 300 IU/kg). Arterial cannulation was performed using an EMBOL-X aortic cannula (EMBOL-XTM System, Edwards Lifesciences, Irvine, CA, USA). After measuring the ascending aorta, an appropriately sized filter was chosen and inserted into the aorta. For patients randomized to the aortic connector group (SymmetryTM Bypass Connector, St Jude Medical, Inc., Minneapolis, MN, USA), the connector size was chosen after measurement of the vein diameter. Three sizes were available: 4.5–5 mm (A), 5–5.5 mm (B), and 5.5–6 mm (C). The loading process, as previously described [5], and the deployment in the ascending aorta were performed by the surgeon. In the control group (Group II), standard proximal anastomoses were performed with 6/0 Prolene running sutures. After the proximal anastomoses were in place, a standard two-stage cannula was inserted into the right atrium and cardiopulmonary bypass (CPB) was started after extraction of the first intra-aortic filter. The distal anastomoses were performed under cardioplegic arrest (warm blood cardioplegia, Calafiore protocol) using 7/0 Prolene for vein graft and 8/0 Prolene for ITA graft anastomoses, respectively. A second intra-aortic filter was inserted before release of the aortic cross-clamp and remained until CPB was discontinued and the heparin antagonist protamine was administered.

For patency control, non-invasive ultrafast CT (MDCT) was performed on postoperative day 5. A total of 53 grafts (87%) from Group I and 25 grafts (40%) from Group II were evaluated by MDCT for evidence of stenosis or occlusion. Fig. 1 shows the randomization and device placement scheme for Groups I and II and Filters 1 and 2.



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  		Fig. 1. Diagram showing the study protocol and intra-aortic Filters 1 and 2 deployment.

 
Filters were collected in specimen tubes and fixed in formalin for analysis. Upon receipt, gross examination was performed on each filter and its contents; this included the quantitative measurements of the number of captured particles and the total surface area. The particulate content of filters were sent to a core pathology laboratory (Stanford University, Stanford, CA, USA) for histologic analysis. Three stains were performed—hemotoxylin and eosin, trichome, and elastin van geisson—to identify the composition of the particles, and in particular, to look for evidence of fibrous atheroma. All examiners were blinded as to the group and filter number.

Demographic, Perioperative, and outcome data were collected and submitted to an independent data management group. A stroke was defined as a new neurologic deficit resulting in a permanent disabling neurologic deficit, with confirmation of an ischemic lesion on CT. Both Q wave and non-Q wave perioperative myocardial infarction (MI) were recorded. An MI was confirmed with new pathological Q waves in two or more contiguous leads or creatine kinase (CK) greater than five times normal and creatine kinase myocardial b fraction (CK-MB) greater than five times above the upper limit of normal for our institution, in the absence of new Q wave findings. Follow-up of clinical status was obtained by phone interview.

Continuous data are presented as mean±SD and categorical data are presented as percentages. Chi-square or Fisher exact test for small cell frequencies were used to compare categorical data. For statistical comparison between groups and filters, t test was applied. Mann-Whitney U test or Wilcoxon signed-rank test was utilized if the absence of a normal distribution was confirmed.


   3. Results
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
4. Discussion
 5. Conclusion
 Appendix A. Conference...
 References
 
3.1. Patients and procedures
Patients in Groups I and II were comparable as to key baseline and perioperative variables (Table 1). In Group I, 61 proximal anastomoses were created in 39 patients using the aortic connector. One proximal anastomosis was redone by conventional hand sewing due to bleeding. After removal of the nitinol implant, it was realized that the hooks were not completely covered by the vessel wall of the vein graft, which caused leakage (Fig. 2) . Automated anastomoses were successfully completed for all other patients in Group I. The size of proximal connectors used were 11 of the smallest size (A), 27 of the medium size (B), and 23 of the large size (C). In Group II, 62 conventional anastomoses were handsewn in 38 patients. The caliber of the vein grafts was not significantly different (5.6±0.5 mm for Group I and 5.4±0.7 mm for Group II). The number of distal anastomoses also was not significantly different (3.3±0.7 for Group I vs. 3.2±0.7 for Group II). Perioperative and baseline variables are summarized in Table 1.


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  		Table 1. Perioperative data

 


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  		Fig. 2. Failed connector application after extraction of the leaking anastomosis. Two hooks were not covered by all layers of the vein graft wall, probably a result of improper loading of the device.

 
3.2. Clinical outcomes
Clinical outcomes are summarized in Table 2. One patient in Group I showed clinical signs of a perioperative myocardial infarction with a relevant creatine kinase elevation on postoperative day one. An angiography was performed immediately and the vein graft to the circumflex artery was found to be occluded, but distal vessels appeared to be supplied by collaterals. Because contractile function was not impaired, it was decided not to perform a reintervention on this patient. Unfortunately, the patient died three days later of left ventricular rupture. In another patient, the connector graft was found occluded on postoperative MDCT, without clinical or biochemical signs of a myocardial infarction. In Group II, myocardial infarctions occurred in two patients with patent grafts on MDCT, one after an intra-operative revision of a conventional anastomosis. Both patients completely recovered after a prolonged ICU stay.


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  		Table 2. Selected clinical outcomes

 
The neurocognitive test batteries did not reveal significant differences between groups. (Table 2). In Group I, eight patients showed a decline of 20% or more on at least two tests (20.5%), compared to six patients in Group II (15.8%). One patient in Group II suffered a perioperative stroke with hemiparesis and subsequently died in the hospital from pneumonia three months postoperatively. Total in-hospital mortality was 2.6% (1/39) for Group I and 2.6% (1/38) for Group II. Follow up was 92% complete (71/77 patients) at a mean follow-up of 8.3±2.1 months. One late death (within one year of surgery) was identified in a patient in Group II with a history of preoperative stroke and pulmonary fibrosis. Freedom from angina or congestive heart failure was 94.1% for Group I and 96.9% for Group II, and freedom from coronary reinterventions was 100% in both groups.

3.3. Filter analysis
Quantitative and histologic evaluations of captured intra-aortic debris were completed in 153 of 154 filters in 77 patients operated according to the protocol (99%) (Table 3). Analyses of the filter content showed no significant differences between Group I (device) and Group II (control) in Filter 1 (which was applied during the anastomotic procedure under beating heart conditions) for either the surface area of particles (P>0.45) or the total number of particles (P>0.75). Similarly, there were no significant differences between Groups I and II in terms of particulate capture in Filter 2, which was deployed before cross-clamp release during CPB. However, Group II had significantly fewer particles (P=0.023) and less surface area of debris (P=0.004) in Filter 2 compared with Filter 1. In Group I, the surface area was significantly less in Filter 2 than in Filter 1 (P=0.017) with a trend toward a decreased number of particles in Filter 2 (P=0.096). (Table 3) Particulate debris was captured in 100% of filters and fibrous atheroma was present in 47% (Group I) to 63% of filters (Group II). There was no significant difference between groups or between Filters 1 and 2 for the presence of fibrous atheroma. Fig. 3 shows a typical representation of the particulate debris captured.


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  		Table 3. Intra-aortic filter analysis

 


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  		Fig. 3. Typical representation of the particulate debris captured by the intra-aortic filter in a patient from Group I (anastomotic device) shown on a 3 mm grid.

 

   4. Discussion
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
5. Conclusion
 Appendix A. Conference...
 References
 
Mechanical devices for aorta–saphenous vein graft anastomoses have already been described in 1979 [3]. The first clinical application and possible advantages, such as minimizing aortic manipulation, were reported recently [4,5]. However, even if partial clamping seems more traumatic compared to anastomotic coupling of vein grafts mounted on a nitinol implant, reduced dislodgement of atheromatous debris and clinical benefit such as less neurocognitive impairment still needs confirmation in clinical trials. Hypertension and pulsatile flow may exacerbate trauma to the aortic wall during proximal anastomoses on the beating heart [12]. Thus, differences regarding neurologic injury may be more pronounced in a beating heart setting than during traditional ‘on-pump’ CABG. In patients with severe aortic calcification, any manipulation on the aorta should be avoided. Consequently, this study excluded two patients intra-operatively who presented with severe aortic calcification revealed by palpation of the ascending aorta. Another patient was excluded during surgery because of inadequate vein graft material. Automated anastomoses were successfully completed for all but one of the other patients in Group I. One SymmetryTM connector had to be removed for bleeding, probably caused by an improper loading procedure. The other automated anastomoses were hemostatic, and no procedure-related problems occurred.

This study attempted to isolate the traumatic effects of partial clamping or automated anastomotic device application for proximal anastomoses, from those due to the effects of the cross-clamp during CPB surgery. For the amount of particulate debris released, there were no differences between the techniques during the proximal anastomoses, but there was significantly more debris captured when compared to the cross-clamp release. Ultrasonographic studies have revealed significant atheromatous disease in the ascending aorta with increased risk of embolization in 13.6% of CABG patients [13]. In these patients, clamp manipulation of the aorta may lead to release of aortic atheromatous debris. In off-pump CABG cases the use of side-clamping provides the same neurologic risk as for patients in which CPB, aortic cannulation, and cross-clamping were used [14]. A small study using intra-aortic filtration by van Boven also suggests that there is no difference between the amount of particulate debris generated in off-pump cases compared with CPB cases. In off-pump cases where an anastomosis device was used without a partial clamp, particulate debris was reduced but not eliminated [15]. Removal of the aortic cross-clamp is associated with 34% of embolic signals during CABG, and another 24% of signals were detected after removal of the partial clamp for proximal anastomoses in a study by Barbut and colleagues [16,17]. Other studies by Aranki and colleagues and Bertolini and colleagues [7,8] also implicated the partial occlusion clamp as a source of atheroemboli release and associated complications. This study corroborates the embolic potential of proximal anastomoses regardless of technique and suggests a previously under-recognized source of adverse embolic events. However, it should be noted that with the small number of patients in this study, the possibility of Type II statistical error cannot be ruled out.

The reasons for the graft occlusions in our study group remain unclear. Early graft failure may be caused by problems of the proximal or distal anastomosis, twisting of the vein graft, or poor graft function. An early occlusion rate of 3.8% does not exceed occlusion rates reported in the literature on large series of vein grafts [18]. Traverse and colleagues reported that 11/74 patients (14.9%) in which aortic connectors were used during CABG developed symptomatic graft stenosis or occlusion requiring multiple interventions [19]. We did not observe graft occlusion in the control group, but only 16 patients received postoperative patency control with MDCT to validate our method compared with 34 patients in Group I. Long-term patency after application of graft connector devices using metal implants needs to be evaluated. Despite one failed application causing leakage, the SymmetryTM aortic connector created proximal anastomoses of reproducible quality, and a low conversion rate to conventionally handsewn anastomoses was demonstrated.

Because neurocognitive test scores did not reveal differences between Groups I and II, a clinical benefit regarding neurocognitive outcome could not be demonstrated in our study. Even if test scores represent a sensitive method for detection of minor neurologic dysfunctions [8], this study is limited by a small group size. Recent studies have associated the use of intra-aortic filters with reduced embolic load and reduced risk of adverse outcomes [20,21]. Schmitz and colleagues [22] recently reported in a controlled trial that a patient who does not receive an intra-aortic filter was 2.7 times more likely to experience an adverse neurologic event. Thus, the use of intra-aortic filters in both the device and conventional anastomoses groups in the present study could possibly mask the impact of particulate emboli released to the cerebral circulation through partial clamping or insertion of the aortic connector.


   5. Conclusion
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 5. Conclusion
Appendix A. Conference...
 References
 
In our randomized study, proximal anastomotic procedures have been identified as a major source of atheroemboli release. The amount of particulate debris captured in the intra-aortic filters was the same regardless of which of the two proximal anastomotic construction techniques was used. The amount of fibrous atheroma captured by intra-aortic filtration was also the same. There was a significantly greater amount of debris captured during the anastomotic procedure (whether by aortic connector or partial clamp and conventional anastomoses) than after release of the aortic cross-clamp. It is important to note that the first filter, which evaluated the aortic trauma of the proximal anastomoses, was applied in a beating heart setting for both groups. The second filter was applied during CPB. Cross-clamp manipulations on the ascending aorta were thought to be more traumatic, but the cross-clamp procedure produced less particulate debris than either conventional or automated proximal anastomoses performed off-pump. In this study, we were unable to demonstrate a reduction in aortic injury when using a proximal aortic connector device.


   Acknowledgments
 
This study received financial support from St. Jude Medical, Inc.


   Footnotes
 
Presented at the joint 17th Annual Meeting of the European Association for Cardio-thoracic Surgery and the 11th Annual Meeting of the European Society of Thoracic Surgeons, Vienna, Austria, October 12–15, 2003.


   Appendix A. Conference discussion
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 5. Conclusion
 Appendix A. Conference...
References
 
Dr P. Tozzi (Lausanne, Switzerland): I had a question concerning the study design. Don't you think that the number of patients you enrolled in your study is too small to come to any conclusions concerning the incidence of cerebrovascular accidents?

Dr Martens: I agree that regarding the end point cerebrovascular events it is clear that the study group size is too small. But regarding the end point "debris captured", it is a completely different question, and we do not even see a trend towards less particulate debris in the connector group.

Mr. von Oppell (Cardiff, UK): Did you do epiaortic scanning to grade the degree of atheromatous disease in the ascending aorta, to ensure that both groups were equal. If not, how did you exclude the three patients who you said had calcific aortic disease?

Dr Martens: Definitely, we did not perform epiaortic scanning in our patients. I palpated the aorta, and if I found severe aortic calcification by palpation, I excluded these two patients from the study. But we did not perform epiaortic scanning.

Dr D. Birnbaum (Regensburg, Germany): How will you go on after these observations?

Dr Martens: Well, I do believe that the aortic connector has good indications in certain patients, and that is what we are doing at our institution. We apply it in patients where we do not have a space for placing a clamp on the ascending aorta but we absolutely need a proximal vein graft anastomosis, perhaps because there is no arterial in situ graft available, or other problems.

I think I have shown with my data that in general, there is no advantage of using the connector in all patients, but I am absolutely sure that there are certain groups which might profit from the use of these connectors, as they avoid partial clamping and they enable to perform a proximal anastomosis if there is absolutely no space for placing a clamp.

Dr Birnbaum: There remains the question, who is paying for it?

Dr Martens: Yes, that is true.

Dr T. Carrel (Berne, Switzerland): These data are in contradiction with previous studies that have shown that HITS are particularly frequent when we remove either the tangential or the cross clamp. Do you have an idea now how to reconcile data, because your data clearly show microemboli that you capture within the net, but I would still suspect that the rate of HITS is much higher using a cross-clamp or a tangential one than the few manipulations required to create this really nice ostium?

Dr Martens: I think you refer to the study of Barbut and co-workers who showed that 34% of emboli are released by cross-clamp release, but they have a completely on-pump process. The first part of my procedure when I applied the anastomotic connector or the partial clamp was off-pump, and I think that the aortic trauma is higher in any off-pump manipulation on the ascending aorta because of pulsatile flow and higher blood pressure. And so I think these data are not really comparable to the results obtained by Barbut and co-workers.

Dr Carrel: Do you think that the quantity of emboli is dependent on the arterial pressure when you deploy the connector?

Dr Martens: Well, we deployed the connector at an arterial pressure between 80 and 100 mmHg, and I think it may be more problematic to connect the graft at a blood pressure above 100 mmHg, but we compared blood pressures in both groups and they were not significantly different.

Mr V. Zamvar (Edinburgh, UK): I have one comment regarding the conclusion that you have reached, that cross-clamping produces less debris than proximal anastomosis construction. Is it possible that you had less debris during cross clamping because you did that after constructing the proximal anastomosis? I mean, there could be some debris which is very loose and has a tendency to embolize anyway, and because you did the proximal anastomosis first, they embolized, and therefore your debris capture rate was higher initially than during de-clamping, which was done later on. In conventional surgery, you de-clamp first and then construct the proximal anastomosis.

Dr Martens: Yes, for sure, the sequence of filter application in this study is particular, but I really wanted to compare the two anastomotic processes in an off-pump setting, and that was mandatory for me. The fact that the amount of debris captured by the second filter is not completely comparable, as I refer to the question of Professor Carrel, is clear because they are completely different processes; the first one was off-pump, the second one was on-pump. However, I think I showed that the off-pump application is more traumatic than any on-pump applications of a cross clamp.

Mr R. Ascione (Bristol, UK): I think the efficacy of these connectors has to be assessed not only in view of their potential for neurological embolization but also evaluating their impact on the mid-term or long-term patency rate of those vein grafts whom proximal anastomosis has been performed with connectors. Do you have any data in that respect?

Dr Martens: Yes, we have data. As I have shown in one slide, the immediately post-op patency was very good in both groups. We had two occlusions in the connector group, we saw no occlusion in the hand-sewn anastomosis group, and there are other data available on a 12-months follow-up which will be presented by my colleague, Markus Dietrich, this afternoon, and I don't want to present his data now this morning.


   References
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 5. Conclusion
 Appendix A. Conference...
 References
 

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