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New device for saphenous vein-to-aorta proximal anastomosis without side-clamping
© Tappainer; licensee BioMed Central Ltd. 2007
Received: 19 April 2007
Accepted: 04 May 2007
Published: 04 May 2007
Side clamping to perform saphenous vein-to-aorta proximal anastomosis is a well known cause of cerebral embolization during coronary bypass surgery. Automatic and manual devices have been introduced to avoid aortic clamping and facilitate proximal anastomosis but the manual ones only allow the traditional hand-sewing running suture. Nevertheless, they are not easy to use and very expensive to buy.
We developed a simple object that helps to perform a manual proximal anastomosis without the need to clamp the side of the aorta. This device is a steel bar which blocks the aortic hole and simultaneously it provides a slit to receive the needle. Through the slit comes out a thin, sharp, straight, but also well directed and predictable jet of blood which could be easily controlled during the suture.
The function of the object is quite different from other devices. Nothing is deployed in the aorta. The object is only placed on the aorta with the small appendage slipped into the hole. The main advantage of the device is that while manipulation of the aorta is avoided no foreign bodies are incorporated in the suture and – most importantly – the aortic intima is not touched at all. The main drawback of the device is the blood jet coming from the slit so that the blood pressure has to be lowered by vasodilators during the anastomosis. Moreover, the suture has to change direction and the needle has to enter the aortic wall first to slip out through the slit.
The object was named "Slit Device" and is not a routine instrument. It would be only an alternative to other anastomotic devices with the same surgical indications. In the case of ascending aortic disease and saphenous vein grafting, the Slit Device avoids aortic clamping thereby preventing atheroembolism and also avoiding the need for hypothermic circulatory arrest in patients with unclampable aorta.
Automatic proximal anastomotic devices:
Symmetry Aortic Connector System (St. Jude Medical, Minneapolis, MN, USA)
Cardica Pas-Port II anastomosis system (Cardica, Redwood City, CA, USA)
CorLink device (Bypass Ltd, Herzelia, Israel)
One-Shot Vascular Anastomotic Dev (Horologe Factory, Jinan City, Shandong, China)
Spyder Proximal Anastomotic Device (Medtronic, Minneapolis, MN, USA)
Manual proximal anastomotic devices:
Novare Enclose II (Novare Surgical Systems, Cupertino, CA, USA)
Heartstring Proximal Seal System (Guidant Corporation, Santa Clara, CA, USA)
History of the new object
Many years ago an unclampable aorta forced me to stop extracorporeal circulation for every aortic bite during the proximal anastomosis. At the same time, I had to cover the hole with a finger while the pump was resumed repeatedly during every bite to the vein. Immediately I looked for something to block or curtail the loss of blood.
When I used some of the devices introduced by the manufacturers to facilitate proximal anastomosis, I realized that the cost was very high and they were not easy to use. It seemed to me they were not easier to handle than an object with a sharp jet of blood. Therefore, I returned to my original idea. I thought that if I scooped out the ball I could probably grasp the tip of the needle.
The Slit Device
no complex mechanisms
no breakable parts
it can be used for many anastomoses in the same patient if made of plastic
it can be used for many patients if it is made of stainless steel
it allows the possibility of deciding whether to perform distal or proximal anastomoses first
it allows giving the right inclination to the graft.
nothing is deployed in the aorta
no manipulation of the aorta
no foreign bodies are incorporated in the suture
no touching of the aortic intima
Need for manual dexterity
Need for rapid blind manoeuvre
scalpel, finger, punch, finger, device (but it is the same thing with the other devices)
Inversion of the suture
could be not acceptable to everyone
Need for a bigger needle
large enough to pass through the aorta and the device itself
Not a completely bloodless field
blood pressure has to be lowered by vasodilators
Thus, Slit Device belongs to manual anastomotic devices, such as Enclose II and Heartstring, but its function is completely different. It is not a sophisticated device like them. Nevertheless, like the others it could be safer than the partial occluding clamp in off-pump patients, too . Slit Device can be useful in patients with severe atherosclerotic disease of the ascending aorta where a clamp cannot be applied.
Complete arterial revascularization and hand-sewing suture are the most effective procedures in coronary artery bypass surgery. Nevertheless, vein grafting is still used in many patients and devices to aid vein anastomosis have been introduced by manufacturers. Slit Device belongs to these devices but is not designed to replace the traditional procedures. It is intended only for preventing atheroembolism in a heavily diseased ascending aorta, thus avoiding the need for hypothermic circulatory arrest in patients with unclampable aortas.
The author thanks his colleagues Vinicio Fiorani, Jacopo Manfredi, Andrea Nocchi, Nicola Pederzolli e Mario Zogno of the Cardiac Surgery Unit of the Azienda Ospedaliera "Carlo Poma", Mantova. All are members of the surgical team. They supported the project and and helped to test the device with constructive criticism and suggestions.
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