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Ann Thorac Surg 2002;74:2101-2105
© 2002 The Society of Thoracic Surgeons


Original article: cardiovascular

Assessment of an aortosaphenous vein graft anastomotic device in coronary surgery

Clinical experience and early angiographic results

Carlo Antona, MDa, Roberto Scrofani, MDaa*, Massimo Lemma, MDa, Paolo Vanelli, MDa, Andrea Mangini, MDa, Paolo Danna, MDb, Guido Gelpi, MDa

a Division of Cardiovascular Surgery, "L. Sacco" Hospital, Milan, Italy
b Department of Cardiology, "L. Sacco" Hospital, Milan, Italy

Accepted for publication June 28, 2002.

* Address reprint requests to Dr Scrofani, Divisione di Cardiochirurgia, Ospedale "L. Sacco", Via G. B. Grassi n. 74, 20157 Milan, Italy.
e-mail: scrofani{at}robertomail.it


    Abstract
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 
BACKGROUND: Until now technologic evolution in coronary bypass surgery has focused on extracorporeal circulation, on operation without extracorporeal circulation, and on the exposure of the operative site. Recently a one-shot anastomotic device for the proximal anastomosis in coronary surgery was developed. We investigated whether the use of the aortic connector system (ACS) could facilitate the creation of aortosaphenous vein graft anastomoses in myocardial revascularization.

METHODS: From November 2000, 40 ACS devices were used in 36 consecutive patients (mean age 70.7 ± 8.9 years); 12 patients (33.3%) underwent surgery on pump and 24 patients (66.6%) off pump; 50 distal anastomoses were performed. In all cases the connection with the ascending aorta was created before the distal anastomoses because of the necessity to slide the saphenous vein graft (SVG) over the vein transfer sheath. Intraoperative graft function was tested measuring blood flow by Doppler analysis. Postoperative evaluation of the anastomotic patency was carried out by early angiography in 34 patients (94.7%) but was excluded in 5 patients (5.3%) with extensive extracardiac vascular occlusive disease.

RESULTS: Of 38 AC (95%) evaluated, 36 (94.7%) functioned properly. The end-to-side proximal anastomosis without aortic clamping is instantaneous, the quality of anastomoses was highly rated, no additional stitches were required, and all coronary arteries could be reached. Intraoperative quantity flow was measured by Doppler analysis and all but one showed good flow. Early postoperative angiography demonstrated good patency of the grafts in all cases but 2 (5.3%). At 1-year follow-up, 1 patient died of stroke; all other patients remained free of symptoms and no reoperation was required.

CONCLUSIONS: The use of ACS makes end-to-side anastomosis rapid, effective, and reproducible while eliminating aortic cross clamping; it opens a new era in beating or nonbeating coronary surgery. Long-term results are mandatory to confirm our favorable preliminary results.


    Introduction
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 
During the last 2 decades surgical techniques have evolved in coronary surgery. Recently off-pump techniques [14], endoscopic procedures [5], and robot-assisted instruments [6] have aroused great interest among cardiac surgeons.

Until now coronary artery revascularization has been performed using conventionally hand-sutured anastomoses. New technology to perform precise and reproducible proximal and distal vascular connection in less time than sutured anastomoses is evolving [711]. A new aortic connector system (ACS) device has been introduced in coronary surgery; it allows quick sutureless anastomoses between the ascending aorta and a saphenous vein graft (SVG). Evaluating the feasibility, safety, and clinical outcome of this new device is the objective of this study.


    Material and methods
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 
The ACS (St. Jude Medical, Fullerton, CA) is a nitinol implant designed to create the proximal anastomoses between the aorta and the SVG. A detailed description of the ACS and its technical feasibility have been previously reported by Eckstein and colleagues [12].

From November 2000, 40 ACS devices were evaluated in 36 consecutive patients (26 male [72.2%]) with a mean age of 70.7 ± 8.9 years. Preoperative clinical characteristics are shown in Table 1. All proximal anastomoses in this group of patients were done using the new automated anastomotic device. Exclusion criteria were a history of preoperative neurologic events, significantly calcified ascending aorta, and preoperative chronic coagulation disorders. Twelve patients (33.3%) received on-pump surgery and 24 (66.6%) received off-pump surgery; of these, 2 (5.5%) were redo operations. Four patients (11%) received two ACS anastomoses.


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Table 1. Preoperative Characteristics of the Study Population

 
The connection of the SVG requires no cross clamping or side biting during deployment. It is done before the distal anastomoses because of the necessity to slide the vein over the transfer sheath.

The veins connected to the aorta by means of an ACS device were successfully used to graft all coronary branches (Table 2). In 10 cases (27.7%) sequential anastomoses were performed; of these, in 9 cases (25%) two distal anastomoses were made and in 1 patient (2.7%) three distal anastomoses were made. As graft conduit the left internal thoracic artery (LITA) was used in 33 patients (91.6%), the radial artery anastomosed as a Y graft with the LITA was used in 1 patient (2.7%), and a SVG was used in 36 patients (100%). The mean number of ACS anastomoses per patient was 1.3 ± 0.59.


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Table 2. Operative Data

 
Routine intraoperative measurements of blood flow in the proximal portion of the vein, to allow prompt revision of technical problems, were performed in all patients using an 8 MHz Doppler flowprobe (Transonic Flow-QC System [Transonic Systems, Inc, Ithaca, NY]). An optimal Doppler signal was obtained by moving the guide probe across the vein and adjusting the velocity range. Systolic and diastolic peak velocities were determined.

All patients but 2 underwent angiographic control at discharge to assess the ACS patency.


    Results
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 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 
All results are expressed as mean ± standard deviation. Time for assembly of all ACS components and for vein loading ranged from 4 to 6 minutes (4 ± 2.1); the end-to side proximal anastomosis was instantaneous and was performed in all patients without complications. No intraoperative device failure was observed, no anastomoses leaked, and no additional stiches were required (Table 3). Quantitative Doppler analysis measurements in the vein graft revealed high blood flow volume (32 ± 3.4 mL/min).


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Table 3. Postoperative Complications

 
One patient (2.7%) died 2 months after surgery as a result of a stroke that had occurred 2 weeks after surgery. In this patient an autopsy revealed a completely patent SV aortic connection.

To evaluate the early patency rate postoperative angiography was performed in 34 patients (94.7%); 2 patients were excluded because of diffuse vascular occlusive disease. All veins grafts were evaluated for occlusion, development of string sign, and presence of a significant stenosis. In 1 patient (2.9%) a subcritical stenosis (40%) of the vein graft due to kinking was present approximately 1.5 cm from its connection to the aorta (Fig 1). Two grafts (4.1%) were occluded, one because of kinking and one owing to poor distal outflow (Fig 2). Both vein grafts were anastomosed on the right coronary artery. All the other conduits were widely patent (Table 4; Fig 3). There were no surgical complications in the postoperative period; reexploration for bleeding not related to the ACS was necessary for 2 patients (5.5%). Inferior acute myocardial infarction occurred in 1 patient (2.7%) and a percutaneous coronary angioplasty (PTCA) procedure on the right coronary artery was successfully done.



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Fig 1. Left anterior oblique projection 45°: the saphenous vein graft, approximately 1.5 cm from its connection with the aortic wall, is kinked and a subcritical stenosis (40%) is evident (black arrow). The nitinol deployed connector (white arrow) is well positioned and completely patent.

 


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Fig 2. Right anterior oblique projection 40°: the saphenous vein graft anastomosed on the right coronary artery is completely occluded (arrow).

 

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Table 4. Angiographic Controls After ACS Implant

 


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Fig 3. (A) Left anterior oblique projection 45°: a completely patent vein graft proximal anastomoses. The proximal end of the vein has been connected with the ascending aorta with the aortic connector system (arrow). (B) Right anterior oblique projection 30°: the deployed connector on the aorta (arrow). Back flow opacification of the vein graft.

 
Neurologic events occurred in 2 patients (5.5%); in the one it was a permanent deficit and in the other it was a transient ischemic attack. At 6-month follow-up (range 1 to 8) all patients were free of symptoms and no reoperations were required.


    Comment
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 
Many systems for intraluminal or extraluminal stenting have been designed to facilitate the creation of vascular anastomoses; the clinical application of these devices has been limited and the results of their application have been poor [8]. Recently Calafiore and associates [11] presented the clinical results of the first human approach with a sutureless system for end-to-side anastomoses between the aorta and the SVG; this device is different from the ACS and in that series there is no evidence of postoperative angiographic control.

We investigated whether a new and innovative automated vascular suturing system could facilitate the approach to aortosaphenous vein anastomoses in coronary surgery. The ACS is designed for performing nonsutured anastomoses not only in conventional coronary surgery but also, and mainly, in off-pump procedures and in redo operations.

During our experience we observed two main potential limitations: (1) the inability to access the distal anastomoses before; and (2) a 90° take-off of the graft from the aorta. We believe the first issue may be a relative limitation of the device especially in off-pump multivessel procedures when, despite preoperative angiography, some vessels are difficult to reach and graft; that could require the surgeon to change the conventional surgical procedures. As for the second limitation, we believe that the implantation of the vein at a 90° angle, necessary to make the proximal anastomoses, is the main reason for the kinking of two bypass grafts to the right coronary artery in our first 5 patients. We have postoperative angiographic documentation that one of these grafts was still patent, but showed after take-off a residual nonsignificant (40%) stenosis (Fig 1).

To avoid this problem, also seen in the experience of Ekstein and coworkers [12], we suggest changing the usual proximal anastomotic aortic site toward a more lateral position on the aortic wall, more adjacent to the pulmonary artery for grafts to the left coronary artery and more adjacent to the right atrium for grafts to the right coronary artery. Doing so should make possible a routing of the vein to avoid possible kinking that may occur from pleural compression after chest closure. In the other 8 patients in whom the right coronary artery was grafted, the ACS was used following this criteria and any problems were detected at postoperative angiography. We observed that all the veins used to graft the left coronary branches positioned on the left lateral aortic wall were widely patent at postoperative angiography.

What potential benefits to patients will this technology offer? As already mentioned by other authors [13], this technique is attractive because the anastomoses can be performed without a side clamp on the aorta and that may result in a potential decreased incidence of adverse neurologic or embolic events. The adverse thromboembolic events in 2 of our patients seemed not to be related to the ACS (as confirmed by autopsy in 1 patient). The ACS offers also the possibility to choose the best target site in the ascending aorta for proximal anastomoses, avoiding the place where atherosclerotic disease has modified the quality of the aortic wall. Moreover for patients with multivessel disease, more than one ACS per patient can be used.

The anastomotic procedure is easy to perform and can be completed more rapidly than with conventional suturing techniques even in beating heart surgery and that is an obvious advantage of the system. The ACS device also can be extremely useful in off-pump redo operations. In these patients some vein grafts previously sutured to the aorta could be patent: the potentially harmful temporary interruption of blood flow produced by a sideclamp on the aorta is not required.

The reproducibility of the quality of the anastomoses is, in our experience, high. We believe that with a short mandatory training course results will be generally excellent with little variation among different surgeons.

Some questions remain. We believe that the role of nitinol in the progression of anastomotic neointimal hyperplasia needs to be further investigated even though this material has a successful history of use in cardiovascular applications [14, 15]. More detailed information is absolutely required about the possible damage of sliding the vein onto and off the transfer sheath to the endothelial cells because this could affect long-term patency; some investigations are under way to test for histologic damage [12].

Our initial clinical experience proves that proximal anastomoses in coronary artery bypass surgery using the ACS may offer an attractive alternative to conventional hand-sutured techniques. The integrated approach—particularly the combination of ACS, off-pump surgery, and reoperative procedures—provides the greatest benefit.

We look forward to a second generation of devices, even more convenient, and applicable also to arterial grafts and distal anastomoses. These modifications will increase the potential benefit of the device, which will become applicable to a wide variety of patients with coronary artery disease.


    Acknowledgments
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 
The authors thank Dr Robert Frater for the language editing of this manuscript.


    References
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 

  1. Buffolo E., Andrade J.C.S., Branco J.N.R., Teles C.A., Aguiar L.F., Gomes W.J. Coronary artery bypass grafting without cardiopulmonary bypass. Ann Thorac Surg 1996;61:63-66.[Abstract/Free Full Text]
  2. Bergsland J., Hasnan S., Lewin A.N., Bhayana J., Lajos T.Z., Salerno T.A. Coronary artery bypass grafting without cardiopulmonary bypass: an attractive alternative in high risk patients. Eur J Cardio-thorac Surg 1997;11:876-880.[Abstract/Free Full Text]
  3. Buffolo E., Gerola L.R. Coronary artery bypass grafting without cardiopulmonary bypass through sternotomy and minimally invasive procedure. Int J Cardiol 1997;62:89-93.
  4. Yokoyama T., Baumgartner F.J., Gheissari A., Capouya E.R., Panagiotides G.P., Declusin R.J. Off-pump versus on-pump coronary bypass in high-risk subgroups. Ann Thorac Surg 2000;70:1546-1550.[Abstract/Free Full Text]
  5. Loulmet D., Carpentier A., Attellis N. Endoscopic coronary artery bypass grafting with the aid of robotic assisted instruments. J Thorac Cardiovasc Surg 1999;118:4-10.[Abstract/Free Full Text]
  6. Stephenson E.R., Sankholkar S., Ducko C.T., Damiano R.J. Robotically assisted microsurgery for endoscopic coronary artery bypass grafting. Ann Thorac Surg 1998;66:1064-1067.[Abstract/Free Full Text]
  7. Scheltes J.S., Heikens M., Pistecky P.V., Andel C.J., Borst C. Assessment of patented coronary end-to-side anastomotic devices using micromechanical bonding. Ann Thorac Surg 2000;70:218-221.[Abstract/Free Full Text]
  8. Werker P.M.N., Kon M. Review of facilitated approaches to vascular anastomoses surgery. Ann Thorac Surg 1997;63:S122-127.[Medline]
  9. Shennib H., Korkola S.J., Bousette N., Giaid A. An automated interrupted suturing device for coronary artery bypass grafting: automated coronary anastomoses. Ann Thorac Surg 2000;70:1046-1048.[Abstract/Free Full Text]
  10. Solem J.O., Boumzera D., Al-Buraiki J., Nakeeb S., Rafeh W., Al-Halees Z. Evaluation of a new device for quick sutureless coronary artery anastomoses in surviving sheep. Eur J Cardio-thorac Surg 2000;17:312-318.[Abstract/Free Full Text]
  11. Calafiore A.M., Bar-El Y., Vitolla G. Early clinical experience with a new sutureless anastomotic device for proximal anastomoses of the saphenous vein to the aorta. J Thorac Cardiovasc Surg 2001;121:854-858.[Abstract/Free Full Text]
  12. Ekstein F.S., Bonilla L.F., Englberger L. Minimising aortic manipulation during OPCAB using the symmetry aortic connector system for proximal vein graft anastomoses. Ann Thorac Surg 2001;72:S995-998.[Abstract/Free Full Text]
  13. Heijmen R.H., Hinchliffe P., Borst C.A. A novel one-shot anastomotic stapler prototype for coronary bypass grafting on the beating heart: feasibility in the pig. J Thorac Cardiovasc Surg 1999;117:117-125.[Abstract/Free Full Text]
  14. Hill A.C., Maroney T.P., Virmani R. Facilitated anastomosis using a nitinol U-clip device: bovine model. J Thorac Cardiovasc Surg 2001;121:859-870.[Abstract/Free Full Text]
  15. Mukherjee D., Kalahasty V., Roffi M. : Self expanding stents for carotid interventions: comparison of nitinol versus stainless-steel stents. J Invasive Cardiol 2001;13:732-735.[Medline]



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