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Ann Thorac Surg 2000;70:1046-1048
© 2000 The Society of Thoracic Surgeons

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Supplement: cardiothoracic techniques & technologies

An automated interrupted suturing device for coronary artery bypass grafting: automated coronary anastomosis

^a Center for Innovative Cardiovascular Therapy, Roosevelt and Beth Israel Hospital, New York, New York, USA
^b McGill University Health Center, Montreal, Quebec, Canada

Address reprint requests to Dr Shennib, Heart Institute, 1^st Ave at 16th St, New York, NY 10003
e-mail: mchs{at}musica.mcgill.ca

Presented at the Sixth Annual Cardiothoracic Techniques and Technologies Meeting 2000, Ft Lauderdale, FL, Jan 27–29, 2000.

	Abstract

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 
Background. The purpose of this study was to have a preliminary assessment of the safety and efficacy of an automated vascular suturing device.

Methods. The device (Heartflo, Perclose/Abbott Labs, Redwood City, CA), which delivers 10 interrupted 7-0 polypropylene sutures between side-to-side arteriotomies, was evaluated in animals (8 Yorkshire pigs).

Results. Tissue edge capture and quality of anastomosis were highly rated. Time of anastomoses averaged 22 minutes. This time was prolonged primarily due to suture management, tying of interrupted sutures, and learning curve effects. Six of the anastomoses were hemostatic and two required an additional stitch each. Angiography and histology of the anastomosis confirmed patency and quality of the anastomosis.

Conclusions. Our preliminary results indicate that the Heartflo automated anastomotic device is safe and effective. Preclinical and clinical studies to validate its acute and long-term effectiveness will commence shortly.

	Introduction

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 
The ultimate objective of minimally invasive coronary artery bypass grafting (CABG) is to achieve surgical revascularization through the smallest incisions possible and on the beating heart [1–3]. Over the last 4 years, we have observed an important impact of coronary artery stabilization technology on the adaptation of beating heart CABG through sternotomy and thoracotomy. Adaptation of port access techniques requiring cardiopulmonary bypass was much slower [4]. However to achieve beating heart CABG through smaller incisions, the emerging technology, including visualization, endoscopic stabilization, and anastomotic technology [5], must permit facile and precise anastomoses. Any anastomotic device must be simple to use and provide precise and effective outcomes. Coronary anastomoses are currently carried out primarily through the use of running sutures and to a lesser extent interrupted techniques. The key element in performing a precise anastomosis is the placement of sutures between target and graft vessels. Any imprecision may lead to occlusion or compromised flow.

Several anastomotic devices have been proposed for potential use in coronary operations, including staples, needles, hooks, harpoons, coupling, and stenting devices [6, 7]. However, the success of any is yet to be proved. The utility of an automated suturing device using the same suturing material currently used in handsewn anastomoses (eg, polypropylene), holds great attraction as such a device does not leave endovascular material behind, and hence, is not likely to induce intimal proliferation as in stents. Furthermore, suturing devices that achieve eversion of vascular anastomotic edges offer additional advantages over clipping and other devices that may lead to edge inversion.

In this study we report preliminary observations on the use of an innovative automated vascular suturing device, Heartflo, developed by Perclose/Abbott Labs (Redwood City, CA). We describe early experience with this side-to-side and end-to-side anastomotic device in animals.

	Material and methods

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 
Device description
The Heartflo automated anastomotic device (Fig 1) contains 10 interrupted 7-0 polypropylene sutures that can be deployed simultaneously to perform a side-to-side or end-to-side anastomosis. Each foot on opposite ends of the device is inserted into the arteriotomy (approximately 4 to 5 mm). Once triggered the device releases the sutures through the wall of the vessels at an approximate distance from the edge of 1 to 2 mm. The ends of the 10 sutures are then sorted and pulled to approximate the edges of the graft and coronary artery. Each pair is tied conventionally to complete the anastomosis.

View larger version (83K): [in this window] [in a new window]   Fig 1. The Heartflo automated anastomotic device.

The animals were acutely sacrificed and examined for graft patency, anastomotic quality, and gross or histologic evidence of tissue damage. Subsequently the graft and native coronary arteries were cut and examined grossly and histologically for evidence of injury. Both hematoxylin and eosin stains and endothelin receptor markers were used.

	Results

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 
Data from this animal study indicate that the anastomoses were uneventful with no complications and with good tissue capture, spacing, and coaptation (Figs 2, 3). The tissue capture for both the LAD and the left internal mammary artery (LIMA) were rated as either good, moderate, or poor for each of the eight anastomoses. On evaluation of the tissue capture on both sides of the anastomosis, the tissue capture was good in seven, and moderate in one of the eight LIMA tissue sides. On the LAD anastomotic side, the tissue capture was good in five, moderate in two, and poor in one. Suture spacing was also designated good, moderate, or poor for all anastomoses. Specifically it was found that seven of the eight LIMA sutures had good spacing and only one had moderate quality (ie, wide) spacing. Five of the LAD vessels showed good spacing, two showed moderate spacing, and one showed poor spacing. Tissue handling and tying was tedious (Fig 4) and consumed most of the anastomotic time (mean 22 ± 5.3 minutes). Additional suturing was required in only two anastomoses, each necessitating one suture. Angiographic examination revealed grade A Fitzgerald quality anastomosis in all (Fig 5).

View larger version (74K): [in this window] [in a new window]   Fig 2. External view of anastomosis.

View larger version (96K): [in this window] [in a new window]   Fig 3. Internal view of anastomosis.

View larger version (13K): [in this window] [in a new window]   Fig 4. Suture management (identifying, sorting, and tying sutures).

View larger version (95K): [in this window] [in a new window]   Fig 5. Angiogram of patent anastomosis.

	Comment

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

Endoscopic coronary artery anastomosis using conventional endoscopic instruments is cumbersome and technically challenging with poor quality and prolonged anastomotic time. Attempts to perform endoscopic anastomosis with robotic assistance remains experimental and has not yet permitted multivessel revascularization of posterior and other vessels, which are not accessible through lateral thoracic ports [5]. A principal conceptual limitation of endoscopic robotic anastomosis is its insistence on having the anastomosis carried out using "conventional running suturing techniques." Naturally, a true evolution in endoscopic coronary anastomosis would require an "out of the box" nonsuturing or automated suturing technique for performing the anastomosis.

Despite wide applicability of mechanical anastomotic devices in gastrointestinal and other surgical procedures, vascular anastomosis has not been successful. This problem may be attributed in part to the delicacy of vascular tissue, risk of bleeding due to endoluminal tension, and concern with stenosis and limited long-term patency when foreign material is used.

In this article we reported on our initial animal experience in using an innovative automated anastomotic suturing device for CABG. Our initial and preliminary results indicate the potential for using this current prototype device for the safe and effective performance of coronary anastomosis. Although application of the device for such purpose appears simple and effective from the point of view of deployment, tissue spacing, and capture, it will require, in our opinion, additional or alternative measures to improve the process of handling, sorting, and tying of sutures. Since this study was completed, we have experimented with different glues as an adjunct to this device after its deployment and precise approximation of the graft and native vessels, and we were able to reduce complete anastomotic time in 2 animals (pigs) to less than 2 minutes.

In conclusion, we believe that the Heartflo vascular anastomotic device may offer an attractive alternative to "conventional" handsewn or robotically assisted CABG anastomosis. Further preclinical and clinical validation of its efficacy and safety is required in the open sternotomy setting, on or off bypass. The next generation Heartflo device has already been developed and is currently being evaluated in animals and humans. This next device addresses some of the limitations of the first generation, which included ability to access and maneuver in deep vessels, tissue capture, and deployment consistency. The next generation device also takes another step toward applicability in a totally endoscopic setting.

	Acknowledgments

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 
We greatly appreciate the assistance given to us during conduction of this study by Carla Maupin, John Barrett (Perclose), and Dianne Murray.

	References

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 

1. Shennib H., Lee A.G., Akin J. Safe and effective method of stabilization for coronary artery bypass grafting on the beating heart. Ann Thorac Surg 1997;63:988-992.[Abstract/Free Full Text]
2. Shennib H., Bastawisy A. Coronary artery bypass grafting on the beating heart. Ann Thorac Surg 1999;67:870-871.[Abstract/Free Full Text]
3. Soulez G., Gagner M., Therasse E., et al. Catheter-assisted totally thoracoscopic coronary artery bypass grafting. Ann Thorac Surg 1997;64:1036-1040.[Abstract/Free Full Text]
4. Schwartz D.S., Ribakove G.H., Grossi E.A., et al. Single and multivessel port-access coronary artery bypass grafting with cardioplegic arrest. J Thorac Cardiovasc Surg 1997;114:46-52.[Abstract/Free Full Text]
5. Falk V., Gummert J.F., Walther T., Hayase M., Berr G.H., Mohr F.W. Quality of computer enhanced totally endoscopic coronary bypass graft anastomosis—comparison to conventional technique. Eur J Cardiothorac Surg 1999;15:260-264.[Abstract/Free Full Text]
6. Heijmen R.H., Hinchliffe P., Borst C., et al. A novel one-shot anastomotic stapler prototype for coronary bypass grafting on the beating heart. J Thorac Cardiovasc Surg 1999;117:117-125.[Abstract/Free Full Text]
7. Pikoulis E., Burris D., Rhee P., et al. Rapid arterial anastomosis with titanium clips. Am J Surg 1998;175:494-496.[Medline]

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