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Ann Thorac Surg 2004;77:563-568
© 2004 The Society of Thoracic Surgeons

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Original article: cardiovascular

Initial experience with sutureless proximal anastomoses performed with a mechanical connector leading to clampless off-pump coronary artery bypass surgery

^a Division of Cardiothoracic Surgery, University of Miami/Jackson Memorial Hospital, Miami, Florida, USA

^* Address reprint requests to Dr Katariya, Cardiothoracic Surgery, University of Miami, 1611 NW 12th Ave, ET 3072, Miami, FL 33133, USA.
e-mail: kkatariya{at}med.miami.edu

Presented at the Thirty-ninth Annual Meeting of The Society of Thoracic Surgeons, San Diego, CA, Jan 31–Feb 2, 2003.

	Abstract

Top Abstract Introduction Patients and methods Results Comment Discussion References

 
BACKGROUND: We report our early experience with the Symmetry Aortic Connector (St. Jude Medical, St. Paul, MN) used for sutureless proximal aortosaphenous vein graft anastomoses without any cross clamp during coronary bypass procedures.

METHODS: Between November 2001 and August 2002, 206 saphenous vein to aorta proximal anastomoses were created in 132 patients using the Symmetry device. All procedures were performed as part of off-pump coronary artery bypass surgery without any aortic clamping. Intraoperative variables and postoperative data were collected and analyzed retrospectively.

RESULTS: All 206 anastomoses (100%) were successfully completed with the connector. Severe atherosclerotic disease of the aorta was documented in 16 patients (12%). Four anastomoses (2%) required additional suture placement. Predeployment problems occurred with 3 grafts (2.5%) during loading of the connector. Average number of distal bypasses was 3.2 per patient. One patient (0.7%) required reoperation for bleeding from a proximal anastomosis. Six patients (4.5%) had perioperative myocardial infarction documented by electrocardiographic changes. Thirty-day operative mortality was 3% (4 patients). Intraoperative transit time flow measurement was performed in all cases (100%). Postoperative angiography in 43 patients at a median 3 months postoperatively revealed occlusion of 9 of the 81 saphenous vein grafts (11%).

CONCLUSIONS: The initial experience with a proximal saphenous vein graft to aorta anastomosis using the Symmetry connector demonstrates safety and ease of use. There is however some concern with early graft closure. A prospective randomized study is needed to clarify these concerns.

	Introduction

Top Abstract Introduction Patients and methods Results Comment Discussion References

 
The introduction of off-pump coronary artery bypass surgery (OPCAB) in the mid 1990s was seen as a major advance in the field of cardiac surgery [1]. Since then increasing interest in OPCAB has been accompanied by the development of epicardial stabilizers and blowers to facilitate creation of the distal anastomosis. Until recently however creation of the proximal aortosaphenous vein graft anastomosis remained unchanged from the conventional technique practiced during the on-pump coronary artery bypass grafting (CABG) procedure, requiring partial aortic cross clamping and hand suturing. Manipulation of the ascending aorta due to cannulation, decannulation, and full or partial aortic cross clamping is the primary cause of neurologic morbidity related to coronary artery bypass surgery [2, 3]. Off-pump coronary artery bypass surgery eliminated the former three but until recently there was no way to avoid partial aortic cross clamping.

The St. Jude Symmetry (St. Paul, MN) aortic connector system (ACS) was developed to allow creation of saphenous vein graft (SVG) to aorta anastomosis without the use of sutures or partial or total aortic cross clamping. This device received European certification in May 2000 and Food and Drug Administration approval in May 2001. We report our experience to date with 206 deployments in 132 patients.

	Patients and methods

Top Abstract Introduction Patients and methods Results Comment Discussion References

 
Between November 2001 and August 2002, 206 aortosaphenous vein anastomoses were created using the Symmetry ACS in 132 patients undergoing OPCAB through median sternotomy. All procedures were done after informed consent by two surgeons at two centers (Jackson Memorial Hospital and Miami Veterans Administration Hospital, Florida). Total number of isolated coronary bypass operations done by the same surgeons during the same time period was 267 OPCAB and 26 on-pump CABG. The Symmetry ACS was not used in the rest of the patients because of unavailability of the device, use of arterial conduit, inappropriate vein size, or surgeon or patient preference.

The Symmetry ACS uses a self-expanding nitinol stent that creates an anastomosis by anchoring the vein graft to the aorta without any sutures. The Symmetry ACS is designed to create the proximal anastomosis between the SVG and the aorta before the distal is constructed. Insertion is a simple process performed without aortic cross clamping. Before loading the vein on to the ACS, the external diameter of the SVG is assessed using a color-coded sizer to allow selection of the appropriate sized Symmetry ACS. The next step creates the aortotomy with the specially designed cutter that corresponds to the size of the connector being used. The aortic cutter is then removed from the aortotomy and is replaced with the connector that has the vein loaded onto it. The final step involves firing the connector, which deploys the nitinol stent that anchors the SVG to the aorta. A detailed description of the Symmetry ACS is reported elsewhere by Eckstein and colleagues [4].

Preoperative patient characteristics are shown in Table 1. All proximal SVG to aorta anastomoses were created with the ACS. A total of 249 distal SVG anastomoses were created with 43 (17%) being sequential anastomoses. Of these, 107 distals were to the obtuse marginal branches of the circumflex coronary artery, 93 to the right coronary artery territory, 39 to diagonal branches of the left anterior descending (LAD) artery, and 10 to left anterior descending artery (Table 2). Of the 206 connectors deployed, 69 were color-coded gray (4.5 to 5.0 mm), 88 green (5.0 to 5.5 mm), 35 blue (5.5 to 6.0 mm), and 14 purple (6.0 to 7.0 mm). The left internal thoracic artery (LITA) was used in 124 patients (94%).

	Results

Top Abstract Introduction Patients and methods Results Comment Discussion References

 
The time taken to assemble the ACS and load the vein graft ranged from 2 to 6 minutes with consistent decrease in the time required to perform the anastomosis compared with the conventional hand sewn technique. Three (1.5%) connectors were discarded owing to incorrect assembly or loading. After deployment four (2%) of the ACS proximals needed additional suture placement for leak. There was one (0.5%) complete ACS anastomotic disruption when the device was pulled out inadvertently before the construction of the distal anastomosis; this happened early in our experience and the vein was reloaded on another device and redeployed with no consequences. Eleven distal anastomosis were revised owing to inadequate flow (low or no diastolic flow pattern or high pulsatility index). The mean flow in these grafts before revision was 4 mL/min with a pulsatility index (systolic flow minus diastolic flow divided by mean flow) of 12.2. Flow in the nonrevised grafts ranged from 12 to 130 mL/min, with a mean flow of 37 cmL/min and pulsatility index of 0.3 to 4.5 with a mean of 2.7. One patient (0.7%) returned to the operating room for mediastinal bleeding from the proximal anastomotic site. Six patients (4.5%) had a postoperative myocardial infarction (by electrocardiographic changes), 3 of whom were studied angiographically. One of these 3 patients had a lateral wall myocardial infarction and the study showed occlusion of the obtuse marginal vein graft; the other 2 patients were found to have occlusion of all their grafts including the mammary artery graft. One of these 2 patients (who had all their grafts closed) was found to have a hypercoagulable state, with protein C deficiency and positive lupus anticoagulant. Thirty-day mortality was 3% (4 patients). Permission for autopsy was asked for in all four cases and was obtained for 2 patients. In 1 patient all the grafts were closed and the death was due to massive myocardial infarction on the sixth postoperative day, and the second patient died after motor vehicle accident and the autopsy showed traumatic aortic rupture and patent vein graft. In the other 2 patients we were unable to get consent for the autopsy and the cause of death was thought to be myocardial infarction in 1 patient and respiratory failure leading to multiorgan failure in the other. There was 1 patient (0.7%) with postoperative neurologic deficit: a transient ischemic attack in a patient whose preoperative carotid duplex showed nonsignificant disease but which after the event revealed a complete occlusion of the left internal carotid artery by duplex and magnetic resonance angiogram imaging. There was no reoperation in this series of patients during the follow-up period. Complications are summarized in Table 3.

All patients were called back for postoperative coronary angiography. Forty-three patients (32.6%) underwent a postoperative cardiac catheterization, which was performed at a median of 3 months after surgery. Of these, 8 patients (18.6%) had symptoms of cardiac origin and 35 patients (81.4%) were asymptomatic. This enabled follow-up of 135 grafts including SVG to 81 distal targets. A total of nine grafts (11%) in 6 patients were occluded with no sign of retrograde filling (Table 4). In this group of 6 patients, 2 had closure of all their grafts including the LITA. The other 4 patients had closure of each of their ACS vein grafts but the LITA grafts were patent.

View larger version (163K): [in this window] [in a new window]   Fig 1. Angiogram of proximal anastomosis of saphenous vein graft to aorta facilitated with Symmetry aortic connector showing more than 50% stenosis just distal to anastomotic site (using gray connector size 4.5 to 5 mm external diameter of vein, 2 months postoperative).

View larger version (139K): [in this window] [in a new window]   Fig 2. Angiogram of proximal anastomosis of saphenous vein graft to aorta facilitated with Symmetry aortic connector without any stenosis (using gray connector size 4.5 to 5 mm external diameter of vein, 2 months postoperative).

	Comment

Top Abstract Introduction Patients and methods Results Comment Discussion References

The first description of a mechanically facilitated vascular anastomosis was by Androsov [7] from Russia who used a stapler to create an end-end vascular anastomosis in 71 patients. Subsequently modified designs of this stapler were used in the United States by Mallina, in Japan by Inokuchi, and in Canada by Vogelfanger [8]. Owing to the cumbersome loading process and the necessity of having essentially normal blood vessels, these designs fell into disfavor. More recently Calafiore and associates [9] reported the use of a proximal anastomotic device in 17 patients undergoing coronary bypass surgery. With the advent and increasing popularity of OPCAB there has been renewed interest in the use of vascular anastomotic devices.

The incidence of severe neurologic complication after coronary artery bypass surgery is 1% to 6% [10–11]; manipulation of the aorta is a significant cause of microembolization of particulate matter to the brain leading to the neurologic morbidity seen during coronary revascularization procedures. Landolfo in as yet unpublished data studies has shown that the number of microemboli detected by transcranial doppler ultrasonography was reduced significantly (mean 29.5, 99% confidence interval, 15.2 to 43.8) when the Symmetry ACS was used to create SVG-aorta proximal anastomosis as compared with the conventional hand sewn anastomosis with a partial occlusion aortic clamp (mean 304.6, 99% confidence interval, 161.5 to 447.7) [3]. He suggested that the majority of microemboli are the result of clamping or unclamping the aorta, whether it is a partial or total. Palpation is an inaccurate technique to judge the presence of atheromatous plaque inside the ascending aorta and may be the source of these atheroemboli released by clamping. The ability to perform OPCAB without aortic clamping is therefore clearly desirable in order to lower neurologic morbidity. Therein lays the advantage of the Symmetry ACS. Furthermore, creation of proximal anastomoses with the Symmetry ACS is quick and reproducible and has a low complication rate in our small retrospective series. There is a learning curve in loading the vein on the device which is neither steep nor long.

Disadvantages of using the Symmetry connector include the need to complete the proximal anastomosis before creating the distal anastomosis. With current technologic limitations the connector is not available for use with arterial conduits. The other major disadvantage of the Symmetry connector is the inability to bevel the end of the SVG at the proximal anastomotic site. This leads to a 90-degree take-off angle of the SVG from the ascending aorta that may predispose to kinking of the conduit. Appropriate positioning of the anastomosis on the ascending aorta is essential to avoid this problem. We recommend selection of the antero-lateral aspect of the aorta as proximal anastomotic site when using the Symmetry ACS with special attention to the measurement of the graft length to avoid kinking of the vein graft.

Our ACS vein graft occlusion rate is 11% at a median interval of 3 months after surgery. Two of the 6 patients in this group had closure of all grafts including the LITA. One of these 2 patients in whom all grafts were occluded was later found to have a hypercoagulable state with positive lupus anticoagulant and protein S deficiency. In view of the fact that intraoperative flowmetry of the grafts was performed and found to be satisfactory in these patients, the chance of technical error in all of these grafts appears to be small. A possible explanation is a hypercoagulable state either related to OPCAB surgery as has been proposed by Kim and colleagues [12] or to a preexisting and inherent hypercoagulable in the patient. We did note a trend in the occlusion rate with the use of smaller size connectors (4.5 to 5 mm) although this was not statistically significant. The use of a smaller size ACS owing to small vein diameter could be associated with poorer quality conduit, which could contribute to graft closure. The design of the Symmetry ACS is such that the anchoring nitinol stent is exposed to the blood elements on the inside of the anastomosis. As is seen with intracoronary stents this may elicit two responses that may lead to graft closure. The first is acute in-stent thrombosis, which typically occurs in smaller size stents particularly within the first 2 weeks of insertion. The second is in-stent restenosis due to intimal hyperplasia occurring within months of insertion.

Other proximal assist devices such as heartstring (Guidant), Enclose (Novare), IPAD (Coalescent), and Corlink (Ethicon) that facilitate the performance of proximal anastomoses without aortic clamp are available.

In summary more work is needed to define the optimal conduit and the optimal patients for whom this technique using the Symmetry ACS should be used. Meanwhile hand suturing with partial aortic clamping remains the gold standard for creation of the proximal aortosaphenous anastomosis to which all new techniques and technologies must be compared. The ACS is an important addition to the armamentarium of the surgeon performing OPCAB by virtue of avoiding partial aortic cross-clamping. Early patency is comparable with that of historical controls using conventional hand-sewn techniques. A prospective randomized controlled trial using the ACS is under way at our institution to further investigate these issues and evaluate this interesting new technology.

	Discussion

Top Abstract Introduction Patients and methods Results Comment Discussion References

 
DR KEVIN A. HORVATH (Chicago, IL): I have a question regarding the 11% failure rate that you reported. To what do you attribute that? Are these failures due to the methodology of use or to the device? And related to that, were any of these patients treated with Plavix, or clopidogrel, postoperatively?

DR KATARIYA: To answer the question initially, I don't think I can be exact about what the nature of the problem was that caused these occlusions. Obviously as we all know occlusions and flows in these grafts are related to a number of other factors, not just the proximal anastomosis, the technique with which it is performed. The conduit itself may be to blame, the distal anastomosis may be to blame, as may be a whole host of other factors.

The device itself does have certain disadvantages. The proximal anastomosis must be done first. The vein comes off at an awkward angle, to say the least, from the aorta itself. And how this lies in the closed chest may also have a relation to the problem.

As far as recommendations on how to use this, again I would wait for a prospective randomized study to be completed before one can really look at how this compares with the conventional hands-on anastomosis.

DR HORVATH: And the use of Plavix in any cases?

DR KATARIYA: Most of these patients actually went back to the cardiologist and went home on aspirin. They did not all receive Plavix postoperatively.

DR VALAVANUR A. SUBRAMANIAN (New York, NY): It's somewhat concerning with the pattern of occlusion you get with this device. It is most commonly a flush occlusion at the aortic anastomotic opening, which is rare in the hand-sewn anastomosis still. This is probably due to an inherent problem with the concept of telescoping the vein through the aortic wall with these connectors. When you inject the aorta, you do not see any hood of the aortic end of the vein graft. Although the patency may be the same frequency but the nature of occlusion is an important concern.

DR KATARIYA: Thank you for your comments, Dr Subramanian. I totally agree with you. I think much more needs to be studied as far as the nature of the occlusion is concerned and the pattern of the occlusion in the grafts. Unfortunately in the connector devices or the connected anastomoses that were occluded, the cardiologist couldn't tell us anything more than that the graft was totally occluded.

DR HUMBERTO R. RAVELO (Long Beach, CA): I would like to congratulate the authors on a very timely presentation. I also wish to make some comments concerning the use of this sutureless proximal mechanical connector. We have had some experience with this devise which I believe is called Symmetry and is made by the St. Jude company.

First of all the use of this device is to be considered only in those selected cases in which you cannot not or should not manipulate the ascending aorta with a partial aortic occlusion clamp.

Secondly there is a degree of complexity in the loading and deployment of the device in its present design and thus the surgeon has to go through a learning curve before being able to use it effectively. The learning curve also involves strictly following the recommended criteria for vein selection and harvesting. Because the device's deployment on the ascending aorta always occurs at a 90-degree angle, we avoid placing it at the 11, 12 or 1 o'clock positions to minimize the possibility graft kinking, once the chest is closed. A more lateral deployment to either side avoids this problem by allowing for the graft to make a smooth curvature.

Finally in order to minimize failures with the intermittent selective use of the Symmetry device it is advantageous to have the Symmetry's technical representative present in the operating room whenever you elect to utilize it.

DR JOEL MORGAN (Winston-Salem, NC): Eighty-three patients were done in the first 6 months by one surgeon at my hospital using this device. They were a combination of on-pump and off-pump. Many patients had two, three, and even four connectors put on. Ten patients of 83 have come back. Three patients have had to be reoperated on. And in many of them the cardiologists will restudy them and you can see dye go down the native coronary, out the anastomosis, back up the vein graft to the aorta, and stop at the connector. Many of them have stenosis right at the connector. We have abandoned use of this device. I never used it but one surgeon used it. And I watched him use it, he's very careful, and I believe there's some inherent problems with this device.

DR KATARIYA: Thank you for your comments.

DR VARICK R. BERNSTEIN (Scranton, PA): Having had the unfortunate circumstance of a Symmetry device completely dislodging itself from the aorta 24 hours postoperating leading to a patient death, I was interested in that you had several deaths in your paper, which was an excellent paper, and my question is whether or not these patients had autopsies and what was the mechanism of death for these patients?

DR KATARIYA: We had autopsies in 2 of these 4 patients. One patient had an acute myocardial infarction postoperative day 1, actually less than postoperative day 1. He eventually was proven to have a hypercoagulable state. He died 6 days after surgery after having all his graft occluded, which we saw on an angiogram that was done 2 days after surgery.

The second patient who had an autopsy was actually a noncardiac death. The patient was discharged from the hospital at 6 days and actually had a blunt injury after a motor vehicle accident. He was brought into the trauma center and actually had an autopsy on the table. He was taken to the operating room for massive bleeding that probably had nothing to do with the coronary bypass operation. Unfortunately the other 2 patients who died did not have an autopsy.

	References

Top Abstract Introduction Patients and methods Results Comment Discussion References

 

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2. Barbut D., Gold J.P. Aortic atheromatosis and risks of cerebral embolization. J Cardiothorac Vasc Anesth 1996;10:24-29.[Medline]
3. Landolfo KP. Sutureless proximal anastomotic devices reduce intraoperative cerebral microemboli during off-pump CABG. Presented at the St. Jude Medical Symmetry Symposium, San Diego, California, April 5–7, 2002
4. Eckstein FS, Bonilla LF, Englberger L, et al. Minimizing aortic manipulation during OPCAB using the Symmetry aortic connector system for proximal vein graft anastomoses. Ann Thorac Surg 2001;72(Suppl):s995–8
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6. Fitzgibbon G.M., Kafka H.P., Leach A.J., et al. Coronary bypass graft fate and patient outcome: angiographic follow-up of 5,065 grafts related to survival and reoperation in 1,388 patients during 25 years. J Am Coll Cardiol 1996;28:616-626.[Abstract]
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9. Calafiore A.M., Bar-El Y., Vitolla G., et al. Early clinical experience with a new sutureless anastomotic device for proximal anastomosis of the saphenous vein to the aorta. J Thorac Card Surg 2001;121:854-858.[Abstract/Free Full Text]
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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Kushagra Katariya Said Yassin Hassan Y. Tehrani Pierluca Lombardi Saqib Masroor Tomas A. Salerno Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Katariya, K. Articles by Salerno, T. A. Search for Related Content PubMed PubMed Citation Articles by Katariya, K. Articles by Salerno, T. A. Related Collections Coronary disease