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Ann Thorac Surg 1998;66:1041-1044
© 1998 The Society of Thoracic Surgeons

Supplement

Facilitated vascular anastomoses: the one-shot device1

Patrick Nataf, MDa, Peter Hinchliffeb, Scott Manzo, BSMEb, James Simpson, MDb, Wolff M. Kirsch, MDb, Yong Hua Zhu, MDb, Toomas Anton, MDb

a Department of Thoracic and Cardiovascular Surgery, Centre Cardiologique du Nord, St. Denis, France
b Section of Neurosurgery, Loma Linda University Medical Center, Loma Linda, California, USA

Address reprint requests to Dr Kirsch, Section of Neurosurgery, Loma Linda University Medical Center, 11234 Anderson St, Loma Linda, CA 92354

Presented at "Facts and Myths of Minimally Invasive Cardiac Surgery: Current Trends in Thoracic Surgery IV," New Orleans, LA, Jan 24, 1998.

Abstract

Background. A mechanical system for facilitating vascular anastomosis (end-to-side, end-to-end) is described that enables the rapid construction of nonpenetrated, compliant junctions. The instrument (United States Surgical One-Shot system) simultaneously applies either 10 or 12 nonpenetrating, arcuate-legged titanium clips to everted vessel or prosthetic conduit edges.

Methods and Results. The instrument has been tested in animals (jugular and femoral vein jump grafts in carotid and femoral arteries, interpositional grafts, 20 pigs) and human cadaveric constructs (saphenous veins to left anterior descending coronary arteries, 20 cases, 5 brachiocephalic access fistulas) as end-to-side constructs. Clipped constructs have equivalent or superior physical properties to control sutured constructs (6-0 polypropylene) as gauged by burst and tensile strength. All studies were performed under Food and Drug Administration Good Laboratory Practice standards, and the device has been approved for marketing by the Food and Drug Administration.

Conclusions. The device enables rapid and reproducible vascular anastomotic constructs with vessels as small as 1.8 mm outer diameter. The constructs are flanged, interrupted, and nonpenetrated.

A mechanical system for facilitating vascular anastomoses (end-to-side, end-to-end) is described that enables the rapid and reproducible production of a nonpenetrated, compliant vascular reconstruction. The instrument (One-Shot System; United States Surgical Corporation, Norwalk, CT) simultaneously applies either 10 or 12 arcuate-legged titanium clips (VCS) to symmetrically everted and approximated vessel edges. The interrupted, nonpenetrated, flanged anastomotic line formed by clips has proven in both experimental and prospectively randomized clinical trials to be both biological and technically superior to junctions attainable by conventional, hand-sewn vascular anastomoses [1, 2]. Previously reported studies and ongoing clinical work with the VCS clip technology is based on reconstructions with appliers capable of serial clip closure. This report deals with the One-Shot system and its experimental and clinical use.

Methods and results

Description of the "one-shot" instrument
The anastomotic device consists of a circumferentially preloaded, disposable cartridge (10 to 12 clips) activated by one squeeze of the instrument handle. The donor vascular conduit is pulled through a disposable cartridge housing the 12 medium or large VCS clips, and then everted over the distal clip tips (Fig 1). Eversion of the vessel over the clip tips maintains positioning. The VCS clip is an arcuate-legged, nonpenetrating titanium clip that autoregulates its final closing pressure on the basis of the width of interposed tissue between the clip tips [2]. The effectiveness of his paradigm for vascular reconstruction has been extensively described [1, 2]. Currently marketed VCS clips of four different sizes are applied individually and serially with commercially available appliers containing 25 to 30 clips.



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  		Fig 1. Construction of a porcine femoral artery (3 mm outer diameter) to common carotid artery (2.5 mm outer diameter) end-to-side anastomoses with the One-Shot device: Eversion of the femoral artery over the exposed clip tips (medium VCS) to load the cartridge after tunneling.

 
The One-Shot device represents a technical advance over the serial clip applier because the entire anastomotic circumference is formed simultaneously, thus facilitating the reconstruction. Because symmetric vessel wall eversion and approximation is critical to successful clip application, an optimized everted intima-to-intima configuration is attained by the contour of the disposable clip-containing cartridge within the recipient vessel. The loading unit everts the opening in the recipient vessel and maintains approximation to the already everted donor vessel held in place by the exposed clip tips (Figs 2, 3). Cartridges contain 10 to 12 large or medium VCS clips. After the clips are fired simultaneously, the cartridges separate to allow easy withdrawal of the device from the anastomotic construct (Fig. 4). The disposable cartridge is angulated at 45 degrees to accomplish an oblique end-to-side anastomosis and filled with either 10 or 12 large or medium VCS clips, depending on vessel diameter and on thickness (Figs 5, 6). Dimensions of disposable loading units vary in size to enable anastomosis of vessels as small as 1.8 mm in outer diameter. A special configuration is being tested for synthetic polytetrafluoroethylene graft conduits, but is not yet commercially available. The device works well with expanded polytetrafluoroethylene prosthetic conduits (Fig 7). The technique of performing an end-to-side anastomosis is summarized in Figs 1–6.



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  		Fig 2. Proceeding to insert the everted vessel on the 45-degree contoured cartridge into the common carotid arteriotomy.

 


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  		Fig 3. The cartridge has snapped into place within the carotid artery and everts the arteriotomy edges. The exposed tip clips that will secure the arteriotomy edges are visible.

 


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  		Fig 4. The clips have been fixed and closed by a squeeze on the handle and the instrument separates to allow an easy withdrawal.

 


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  		Fig 5. Clipped anastomoses are "blood-tight" at the outset and, because of their interrupted configuration, tend to enlarge with time.

 


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  		Fig 6. The nonpenetrated, blood-tight, anastomotic line viewed from the interior.

 


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  		Fig 7. Insertion of a 3-mm thin-walled polytetrafluorethylene prosthetic conduit into a 3-mm dog common carotid artery with the One-Shot device.

 
Animal experiments
Extensive laboratory testing of the One-Shot device has been conducted at Division of Cardiothoracic Surgery, Duke University, Durham, North Carolina; University of Utrecht, the Netherlands; and the Minimal Invasive Surgical Laboratories, Loma Linda University Medical Center, Loma Linda, California. All animals received humane care in compliance with the "Guide for the Care and Use of Laboratory Animals" published by the National Institutes of Health (NIH publication 85-23, revised 1985). The device has successfully created jugular vein interpositional jump grafts in the pig common carotid artery and femoral vein jump grafts in both dog and pig femoral artery (20 animals). Fourteen consecutive porcine internal mammary (2 mm outer diameter) to left anterior descending (2 to 3 mm outer diameter) end-to-side coronary anastomoses have been performed and are currently in long term follow-up. Clipped anastomotic constructs are at least physically and functionally equivalent to control suture constructs and demonstrate augmented blood flow. These studies will form the subject of separate reports. Cadaveric human studies have been performed, with successful anastomosis of the saphenous vein to the left anterior descending coronary arteries in 20 cases and creation of brachiocephalic access fistulas in 5 cases. Clipped anastomotic constructs are "blood-tight" in contrast to those created with sutures, and have physical properties (burst, tensile, strength) equivalent or superior to those attainable by suture (Figs 8, 9).



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  		Fig 8. Scanning electron microscopic view of human cadaveric vascular access (brachiocephalic) anastomotic line viewed from the adventitial side. The clips are VCS medium with a thickness of 0.3 mm. (x4,000 before 51% reduction.)

 


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  		Fig 9. Scanning electron microscopic view of intimal-to-intimal approximation of human cadaveric brachiocephalic access viewed from the intimal side. Clipped anastomoses are blood-tight at the outset. (x4,000 before 51% reduction.)

 
Clinical application
Although FDA approval to market the One-Shot device was achieved in the fall of 1997, clinical application has so far been confined to selected surgeons and the performance of arteriovenous fistulas for vascular access. A multicenter clinical study of the device for construction of hemodialysis vascular access sites has been inaugurated under the direction of Dr A. Frederick Schild of the University of Miami Medical Center. Doctor James Simpson of the Riverside Kaiser-Permanente Hospital performed the first arteriovenous One-Shot vascular access construction in fall 1997. The cephalic vein to brachial artery anastomosis was created instantaneously, was blood-tight at the outset, and remains functional.

Comment

The challenge to mechanize and thus facilitate and improve the quality of vascular reconstructions to exceed those attainable by manual skill has been reactivated by advancing surgical interventions, particularly at the microvascular level. Previous attempts to achieve automated blood vessel anastomosis depended on stapling techniques that were either too cumbersome or impractical for use clinically [3–6]. Furthermore, penetrating staples form a cuff—not a flange—and may damage endothelium. Although automated stapling was readily accepted for intestinal reconstructions, stapling and other mechanical anastomotic systems have met resistance from the vascular surgical community. As vascular surgical reconstructions progressed to include smaller vessels, prosthetic conduits, transplantation operations, and microvascular and venous reconstructions, the impetus and need for the development of facilitated vascular anastomotic devices has become evident. The need for a reliable microvascular reconstruction device is particularly warranted in the field of minimally invasive cardiothoracic surgery, in which the capability of performing an end-to-side anastomosis in a restricted field in a critical necessity [7]. This article describes a different system for vascular reconstruction, based on a nonpenetrating clip rather than a staple, and offers advantages for the performance of a high-quality compliant vascular reconstruction.

Footnotes

1 Doctors Kirsch, Simpson, Nataf, and Zhu are consultants to the United States Surgical Corporation, and Mr Hinchliffe and Mr Manzo are research engineers employed by the United States Surgical Corporation. Doctor Anton has no financial or consultant relationship with the United States Surgical Corporation. This research was supported by funding from the United States Surgical Corporation. Back

References

  1. Kirsch W.M., Zhu Y.H., Hardesty R.A., et al. A new method for microvascular anastomosis: report of experimental and clinical research. Am Surg 1992;58:722-727.[Medline]
  2. Kirsch W.M., Zhu Y.H., Wahlstrom E., Wang Z.G., Hardesty R., Oberg K. Vascular reconstructions with nonpenetrating arcuate-legged clips. In: Yao J.S.T., Pearce W.H., eds. Techniques in vascular and endovascular surgery. Stamford, CT: Appleton & Lange, 1998:67-89.
  3. Bikfalvi A., Dubecz S. Observations in animal experiments with mechanized vessel suture. J Intern Chir 1953;13:481-497.
  4. Andrusov P.I. New method of surgical treatment of blood vessel lesions. AMA Arch Surg 1956;73:902-906.
  5. Nakayama K., Yamamoto K., Tamiya T. A new simple apparatus for anastomosis of small vessels, preliminary report. J Int Coll Surg 1962;38:12-26.[Medline]
  6. Inokuchi K. Stapling device for end-to-side anastomosis of blood vessels. Arch Surg 1961;82:337-341.
  7. Nataf P., Kirsch W.M., Hill A., et al. Nonpenetrating clips for coronary anastomoses: initial clinical experience. Ann Thorac Surg 1997;63:S135-S137.



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