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Ann Thorac Surg 2001;72:S999-S1003
© 2001 The Society of Thoracic Surgeons

Supplement: Cardiothoracic techniques and technologies

Is the GraftConnector a valid alternative to running suture in end-to-side coronary arteries anastomoses?

Piergiorgio Tozzi, MDa, Jan Otto Solem, MDc, D. Boumzebra, MDc, Antonio Muccioloa, Claude Y. Genton, MDb, Pascal Chaubert, MDb, Ludwig Karl von Segesser, MDa

a Department of Cardiovascular Surgery, University of Lausanne, Lausanne, Switzerland
b Department of Pathology, University of Lausanne, Lausanne, Switzerland
c Department of Cardiac Surgery, Lund University Hospital, Lund, Sweden

Address reprint requests to Dr Tozzi, Service de Chirurgie CardioVasculaire—BH10, Centre Hospitalier Universitaire Vaudois, Rue du Bugnon, 46 1011 Lausanne, Switzerland
e-mail: tozzig{at}hotmail.com

Presented at the Seventh Annual Cardiothoracic Techniques and Technologies Meeting 2001, New Orleans, LA, Jan 24–27, 2001.


   Abstract
Top
 Footnotes
 Abstract
Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 
Background. An animal study was carried out to compare long-term patency rates of coronary anastomoses performed with the GraftConnector versus running suture technique.

Methods. 10 sheep, 45 to 55 kg, underwent off-pump coronary artery bypass grafting (right internal mammary artery to left anterior descending artery). In 5 animals, the anastomosis was performed with a GraftConnector and in 5 animals with 7-0 running suture. Intraoperative fluoroscopy and a fluoroscopic control at 6 months were performed. After 6 months, the animals were sacrificed and the anastomoses were examined histologically.

Results. All animals survived at 6 months with 100% anastomosis patency rates in both groups. In the GraftConnector group, the anastomosis diameter at 6 months fluoroscopy was 118% of native left anterior descending artery versus 97% of the control group. Luminal anastomotic width at histology was 1.7 ± 0.2 mm in the device group versus 1.6 ± 0.1 mm in the control group. Mean intimal hyperplasia thickness was 0.21 ± 0.1 mm in the device group versus 0.01 mm in the control group.

Conclusions. The GraftConnector provides a consistent and reproducible coronary artery anastomosis and reduces technical demand and manual dexterity in coronary operations. Long-term results demonstrate that off-pump coronary artery bypass grafting performed with the GraftConnector had the same patency rate and luminal width as those performed with running suture.


   Introduction
Top
 Footnotes
 Abstract
 Introduction
Material and methods
 Results
 Comment
 Acknowledgments
 References
 
Minimal invasive coronary artery bypass (MIDCAB) and off-pump coronary artery bypass grafting (OPCABG) have been developed recently to reduce the morbidity of coronary surgical procedures. It is likely that if MIDCAB and OPCABG are carried out with conventional means, the risk of constructing a distal anastomosis of inferior quality increases. To achieve a high-quality distal anastomosis with closed chest CABG on the beating heart, two main strategies are followed: the development of master-slave robotic surgery systems [1] that allow conventional suturing in thoracoscopic approach, and the development of alternative ways to construct the coronary anastomosis, characterized by reduced technical demand with respect to the total number of manual maneuvers and the required manual dexterity.

Through modern stent technology, Jomed International AB (Helsingborg, Sweden) has recently developed the GraftConnector (GC), which allows sutureless anastomoses between blood vessels. The GC reduces the time to perform an end-to-side anastomosis and facilitates a consistent and reproducible sutureless coronary artery anastomosis for minimally invasive and beating heart operations as already demonstrated in an animal model [2]. The aim of the present study was to evaluate histology and luminal width of end-to-side coronary arteries anastomoses performed in a sheep model with GC compared with standard running suture technique. These animals are part of a feasibility study and the present results concern sheep that were kept alive for 6 months after device implantation.


   Material and methods
Top
 Footnotes
 Abstract
 Introduction
 Material and methods
Results
 Comment
 Acknowledgments
 References
 
GraftConnector design
A dedicated coronary artery Nitinol stent is covered by a 10-µm thick layer of polytetrafluoroethylene (PTFE) and has a side branch, called a tower, of 4 mm PTFE vascular graft as shown in Figure 1. The tower is where the internal mammary artery (IMA) is inserted and fixated by means of a ligature after it is first inserted through and then everted over the outside of a Nitinol ring. The covered stent is then inserted in the receiving coronary artery through a 4- to 6-mm arteriotomy. To facilitate the device insertion in the coronary artery, the device is kept in a crimped loaded configuration (1-mm outer diameter) by means of a plastic handle (Fig 1). Once in the correct position, the release mechanism is activated and the covered stented graft self-expands in the receiving vessel and fixates the conduit (IMA) to the coronary artery. The GC can be used in a coronary size of 1.5 to 3.5 mm.



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  		Fig 1. 1. The conduit (internal mammary artery) is connected inside the sidearm of the GraftConnector (GC) before conducting the anastomosis. The sleeve being inserted into the artery is in the crimped position. 2. An arteriotomy is made and the tip of the GC is inserted into the coronary artery. 3. The main body of the GC is positioned in the coronary artery. 4. By pulling the cap 3-mm out, the expansion of the main body is activated. The anastomosis is now completed and the handle is retrieved.

 
Surgical procedure
Ten sheep (8 to 12 months old, 45 to 55 kg) of the Najdi and Naimi breeds were selected for the experiment after a physical examination and routine laboratory workup. General anesthesia was induced with propofol 4 mg/kg and maintained with 1.5% Fluothane (halothane). Electrocardiograms, SatO2, and pCO2 were continuously monitored while arterial blood gases were checked every 30 minutes. A pressure probe was inserted in the right carotid artery. With the animal positioned in supine position, a left anterior thoracotomy was performed under the fourth rib. Right IMA (RIMA) was isolated and 100 IU/kg of heparin was injected; then 1 mg/kg lidocaine was given as a bolus followed by continuous IV injection of 0.1 mg · kg-1 · min-1 lidocaine to reduce the risk of ventricular fibrillation during ischemia. Propranolol 1 to 6 mg was given to maintain the heart rate below 80 bpm.

The left anterior descending artery (LAD) was then explored and a 4-0 polypropylene suture was placed around the proximal LAD for snaring it. In 5 animals, the end-to-side anastomosis between RIMA and LAD was performed with the device (GC group), whereas in another 5 animals the procedure was performed using the running suture (7-0 polypropylene) technique (control group). No stabilizer was used in both groups. The proximal LAD was ligated and the blood flow in the RIMA was measured by a transit time flow meter. The RIMA was cannulated and injected with contrast medium (Omnipaque, Nycomed) to acquire fluoroscopic images of the anastomosis.

Animals received ticlopidine 250 mg/day for 1 month and aspirin 100 mg/day for 6 months. At 1 and 6 months, under general anesthesia, the animals underwent fluoroscopy control through a direct cannulation of the RIMA at its origin from the subclavian artery behind the sternocleido muscle. All animals received human care in compliance with the European Convention on Animal Care, and our ethics committee approved the study. After 6 months all animals were sacrificed and anastomoses were carefully harvested.

Specimen preparation
Anastomoses carried out with the device were fixed in formaldehyde 10%, preserved in a special acrylic resin, and cut with a diamond-coated wire saw developed for cutting tissue samples with metallic implants in situ. Slice thickness varied between 60 and 150 µm. Anastomoses with the running suture technique were fixed in formaldehyde 10%, preserved in paraffin, and cut with a standard microtome. All specimens were stained with hematoxylin-eosin and elastine or toluidine blue. Specimens were cut according to the section plans showed in Figure 2. We prepared up to 15 slices for each specimen.



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  		Fig 2. Representation of fluoroscopic images of end-to-side anastomosis done with the GraftConnector between right internal mammalian artery (RIMA) and left anterior descending artery (LAD). a = RIMA’s maximal diameter; b = smallest GraftConnector’s diameter; c = distal LAD’s maximal diameter (usually 1 cm distal to the end of GraftConnector). The large arrow shows the junction between the device and the native vessel (transition area). Dashed lines represent histologic section plans.

 
Acquisition of fluoroscopic images
Fluoroscopic images were recorded on videotapes. For each fluoroscopy we chose the best-quality photograph and saved it in a .jpg file format using Matrox PC-VCR software. Image-Pro Plus 4 was used for image analysis. We measured the maximal diameter of RIMA and of the distal LAD, and the smallest diameter of GC (Fig 3) and expressed the anastomotic diameter (/) as percentage of the distal LAD diameter using the after formula:



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  		Fig 3. Postoperative fluoroscopy control of the coronary artery bypass grafting performed with the GraftConnector. RIMA = right internal mammary artery; LAD = left anterior descending coronary artery; a, b, and c represent the sites where measurements were taken with Image-Pro Plus 4 in order to calculate anastomotic diameter compared with distal LAD.

 
Analysis of histologic images
images were acquired with a 3CCD video camera connected to Nikon E-800 light microscopy. Image-Pro Plus 4 was used for image analysis. Surfaces were delimited manually tracking the device/intima line for native artery and the intima/blood line for residual lumen (Fig 4). For each image we calculated the reduction of artery cross-sectional area resulting from intimal hyperplasia as follows:

where St is the reduction of artery cross-sectional area expressed in percentage of device cross-sectional area; Ad is the device cross-sectional area and is considered the reference area assuming that at the time of device implantation this was the native artery cross-sectional area—this is true only if the GC diameter perfectly matches the native LAD diameter; and Al is the effective lumen area. We calculated the luminal width and the thickness of intima layer using the device thickness as reference.



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  		Fig 4. Cross-section of left anterior descending coronary artery (LAD) at the anastomotic site. The anastomosis was carried out with the GraftConnector. The yellow outline shows the device cross-sectional area, which is considered as the reference area, assuming that this was the native artery cross-sectional area at the implantation (hypothetical native LAD cross-sectional area that corresponds to real native LAD cross-sectional area only if the GraftConnector is correctly sized). The green outline shows the luminal width after 6 months.

 
Special care was taken to study the junction between GC and native vessel at the proximal and the distal ends (transition area) as indicated in Figures 2 and 5.



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  		Fig 5. Specimen has been cut axially to better identify the transition area (Fig 2). The GraftConnector is oversized compared with the left anterior descending coronary artery and the difference between the two diameters has been filled out with intima (green arrow).

 

   Results
Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
Comment
 Acknowledgments
 References
 
Blood flow in RIMA after closure of proximal LAD was 33 ± 3.8 mL/min in the GC group versus 23.2 ± 3.6 mL/min in the control group. All animals survived at 6 months with a 100% anastomosis patency rate in both groups. In the GC group there was one minor wound infection. Fluoroscopy performed soon after the anastomosis showed that the mean anastomotic diameter in the GC group was 136% of distal LAD versus 99% of the control group. At a 6-month fluoroscopy examination, anastomoses done with the device had mean diameter of 118% of native LAD versus 97% of the control group (Table 1). At histology, mean luminal anastomotic width was 1.7 ± 0.2 mm in the device group versus 1.6 ± 0.1 mm in the control group; the cross-sectionalanastomotic area was 64.4% of distal LAD in the device group versus 95% in the control group (Table 2). Mean myointimal hyperplasia thickness was 0.21 ± 0.1 mm in the device group versus 0.01 mm in the control group. In only 2 specimens from the device group were giant cells found, mostly in the proximity of the PTFE layer as sign of mild chronic inflammatory reaction.


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  		Table 1. Minimal Anastomotic Diameter (mm) as Percentage of Distal LAD at Fluoroscopy

 

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  		Table 2. Long-Term Results of OPCABGs Done With GraftConnector versus Running Suture Technique in a Sheep Model

 

   Comment
Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
 Comment
Acknowledgments
 References
 
Solem and coworkers [2] already demonstrated that coronary artery anastomoses can be carried out with GC in less than 3 minutes on a beating heart, without using any stabilizer. Moreover, they demonstrated that GC is a less technically demanding procedure than running suture, requiring low manual dexterity [2]. This new surgical tool seems to meet the basic requirements to achieve a high-quality distal anastomosis with closed-chest CABG on the beating heart. Only long-term results will reveal if GC can be considered a valid alternative to running suture technique on end-to-side anastomoses. We have considered 6 months as long-term follow-up because the US Food and Drug Administration accepts 6 months as adequate long-term follow-up in an animal model; for such devices, the FDA is of the opinion that the most interesting reactions occur in the 1- to 3-month period.

Fluoroscopic and histologic data showed that all anastomoses examined were patent after 6 months. As fluoroscopic images demonstrated, the GC diameter was larger than native coronary diameter at the implantation (Table 1): anastomoses had a mean diameter of 136% of the distal LAD. After 6 months, fluoroscopic control demonstrated that mean minimal anastomotic diameter was 118% of the distal LAD. Blood flow in the RIMA after closure of the proximal LAD was 33 ± 3.8 mL/min in the GC group and 23.2 ± 3.6 mL/min in the control group (p value = NS). We can speculate that after 6 months, anastomotic flow is as good as the time of the device implantation because anastomotic diameter remained larger than distal LAD. Therefore, fluoroscopic evaluation of the anastomosis demonstrated that flow in the distal LAD was excellent in both groups after 6 months.

A review of the histologic results showed that the thickness of myointimal hyperplasia differed between groups: 0.21 ± 0.1 mm in the device group versus 0.01 mm in the control group (p < 0.001). Because myointimal hyperplasia is the first cause of anastomotic stenosis, we would presume it would cause a reduction of anastomotic diameter, but this was not the case. Mean anastomotic diameter was 1.7 mm in the GC group versus 1.6 mm in the control group (p value = NS). Mean anastomotic diameter in the GC group corresponded to mean LAD diameter of adult sheep. In other words, there was no angiographic or histopathological sign of stenosis in any groups even if myointimal hyperplasia was more important in the GC group, because anastomotic luminal width corresponds to the normal adult sheep LAD diameter.

Myointimal hyperplasia was less predominant in the tower but no statistical difference was noted in the different parts of the GC (tower and stent). Myointimal hyperplasia, although it did not affect anastomosis patency, was significantly higher in the GC group. Vessel injury, stent material, and stent geometry are factors known to correlate closely with late neointimal thickening in experimental models [3, 4]. The degree of hyperplasia has been related linearly to the degree of stent-induced vessel wall injury [3], but the specimens of the GC group had intact internal elastic lamina and we can reasonably assume that the GC did not provoke any significant vessel injury during deployment.

Animal studies [4] have demonstrated that stent design could cause late neointimal thickening because of the optimization of fluid flow at the blood–metal interface, without affecting vessel patency. At deployment, the stent stretches the vessel, imposing a cross-sectional polygonal luminal shape that depends on the stent design. The lumen therefore initially assumes the geometric shape of a polygon, with the struts marking each vertex. Altered stent-imposed fluid dynamics may cause regions of turbulence or stagnation in the immediate vicinity of stent struts and provide a basis for the observation that restoring the lumen to a circular shape will optimize fluid flow characteristics at the blood–metal interface. Figure 4 shows that stent struts alter vessel geometry; the restoration of luminal circularity by neointimal growth seems to be the physiologic response to optimize flow at the blood–metal interface. The oversizing of the device at the implantation has also played a role in the degree of intimal proliferation. As fluoroscopy images demonstrated, all GC had a diameter larger than native LAD (Table 1) at the preoperative fluoroscopy and we can imagine that the difference between GC and native vessel diameter has been filled up with myointimal proliferation in order to optimize blood flow. Figure 5 illustrates the histologic reaction at the GC edges (transitional area) and elucidates this phenomenon: neointimal growth optimizes blood flow characteristics, reducing turbulence in the proximity of the GC edges.

The oversizing phenomenon may also explain the reduction of cross-sectional anastomotic area 35.6% of distal LAD in the device group versus 5% in the control group (Table 2). These values were calculated assuming that native vessel cross-sectional area corresponds to GC cross-sectional area as reported in Figure 4. This assumption, however, is valid only if the GC is oversized with respect to the native LAD diameter. The consequence of the GC oversizing is an overestimation of cross-sectional anastomotic area reduction. Therefore, the mean anastomotic cross-sectional area reduction of 35.6%, corresponding to a 15% reduction of anastomotic diameter, is overestimated.

No sign of artery wall degeneration has been found. Signs of mild chronic inflammatory reaction have been found in some specimens mostly in the proximity of PTFE layer. This tissue reaction, already described by other authors, seems to be related to the PTFE itself [5, 6]. There is no evidence in current literature that this tissue reaction has ever affected the anastomosis patency.

The segment of the IMA having been everted and tied onto a rigid structure (tower) was still viable even if it is not possible to recognize an intimal layer and the media has signs of chronic inflammatory reaction. Carrying out the histologic analysis, we also focused our attention on the rim of PTFE, which is between the end of the IMA and the endothelium of the coronary: this PTFE was covered with myointimal cells as were the other parts of the GC.

In conclusion, the GC provides a consistent and reproducible coronary artery anastomosis and reduces technical demand and manual dexterity in coronary operations. Long-term results demonstrate that OPCABG performed with GC had the same patency rate and luminal width as those performed with running suture. Myointimal hyperplasia was more important in GC group as consequence of vessel remodeling to optimize anastomotic blood flow. We think that the device oversizing at the implantation has played a major role in determining myointimal hyperplasia. More precise GC sizing could reduce myointimal hyperplasia even if, in our experience, size is not associated with stenosis. However, it remains to be determined whether this favorable outcome will also be present in humans.


   Acknowledgments
Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
References
 
This study was supported by Jomed International AB, Helsingborg, Sweden.


   Footnotes
Top
 Footnotes
Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 
Dr Solem discloses that he has a financial relationship with Jomed International AB.


   References
Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 

  1. Shennib H., Bastwisy A., McLoughlin J., Moll F. Robotic computer-assisted telemanipulation enhances coronary artery bypass. J Thorac Cardiovasc Surg 1999;117:310-313.[Abstract/Free Full Text]
  2. Solem J.O., Boumzebra D., Al-Buraiki J., Nakeeb S., Rafeh W., Al-Halees Z. Evaluation of a new device for quick sutureless coronary artery anastomosis in surviving sheep. Eur J Cardiothorac Surg 2000;17:312-318.[Abstract/Free Full Text]
  3. Bar F.W., van der Veen F.H., Benzina A., Habets J., Koole L.H. New biocompatible polymer surface coating for stents results in a low neointimal response. J Biomed Mater Res 2000;52:193-198.[Medline]
  4. Garasic J.M., Edelman E.R., Squire J.C., et al. Stent, and artery geometry determine intimal thickening independent of arterial injury. Circulation 2000;101:812.[Abstract/Free Full Text]
  5. Marty B., Dirsch O., von Segesser L.K., Schneider J., Turina M. Reaction of the blood vessel wall to microporous endovascular prostheses. Vasa 1997;26(1):33-38.[Medline]
  6. Galgut P., Pitrola R., Waite I., Doyle C., Smith R. Histological evaluation of biodegradable and nondegradable membranes placed transcutaneously in rats. J Clin Periodontol 1991;18:581-586.[Medline]



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