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Sutureless vascular anastomosis: the VCS® clip
PII: S0967-2109(01)00087-4
Cardiovascular Surgery, Vol. 9, No. 6, pp. 523–525, 2001 2001 The International Society for Cardiovascular Surgery Published by Elsevier Science Ltd. All rights reserved 0967-2109/01 $20.00
www.elsevier.com/locate/cardiosur
SYMPOSIUM: SUTURELESS VASCULAR ANASTOMOSIS Introduction Sutureless vascular anastomosis: the VCS clip W. M. Kirsch*, S. Gupta* and Y. H. Zhu† *Division of Neurosurgery, Loma Linda University, Loma Linda, CA 92350, USA and †Department of Surgery, Guthrie Clinic, Sayre, PA 18840, USA Non-penetrating, arcuate-legged clips facilitate vascular reconstructions and significantly reduce the incidence of anastomotic neointimal hyperplasia. Though originally developed as a microvascular-approximating instrument, by far the largest application has been for hemodialysis vascular access. Long-term studies comparing suture to clip for access creation have demonstrated the clear technical and biological superiority of the clip for this procedure. This “sutureless” vascular anastomotic technique is more demanding than conventional suturing, requiring precise vessel preparation and supervised training. 2001 The International Society for Cardiovascular Surgery. Published by Elsevier Science Ltd. All rights reserved Keywords: VCS clips, anastomotic intimal hyperplasia, surgical stapling, needle-and-suture, microvascular, vascular prosthesis
Technical and biological problems have long been recognized as associated with conventionally sutured vascular reconstructions, especially when applied to veins, small arteries and vascular prostheses. The permissive and traumatic nature of suturing sets the stage for either early thrombosis or stricture secondary to anastomotic neointimal hyperplasia. Needleand-suture related trauma is magnified at the small vessel level (O.D. ⬍2.0 mm) because of the diameter limitations of needles with respect to suture size and the limits of human proprioception. Standard vascular reconstructions with a penetrating needle and a continuous suture provide all the elements required for the development of anastomotic neointimal hyperplasia: platelet and clot deposition, anastomotic shear stress, zones of hyper and hypocompliance and bleeding from the anastomotic line. Anastomotic bleeding occurs most frequently with prosthetic
Correspondence to: Wolff M. Kirsch, M.D. Neurosurgery Center for Research, Training and Education, Loma Linda University, Coleman Pavilion, Suite 11113, 11175 Campus St., Loma Linda, CA 92350, USA. Tel.: +1-909-558-7070; Fax: +1-909-558-047; e-mail: [email protected]
CARDIOVASCULAR SURGERY
DECEMBER 2001 VOL 9 NO 6
graft insertions, particularly PTFE insertions. These problems at the sutured anastomotic line generate platelet and fibrin emboli that result in distal vascular occlusion, a significant hazard of cerebral revascularization procedures. It is likely that many of the untoward neurologic events associated with the extracranial–intracranial (EC–IC) bypass procedures, a microvascular operation, were related to suture-induced, embolic phenomena [1]. A patent, hand sewn, high flow rate microvascular anastomosis is an excellent generator of platelet emboli [2]. The technical difficulties associated with creating the superficial temporal middle cerebral artery (‘EC– IC’) bypass, a procedure that requires micro suturing of 1–2.5 mm O.D. vessels with both mismatched wall thickness and diameter stimulated the search for a non-suture, alternative microvascular anastomosing system. This work resulted in the development of the non-penetrating arcuate-legged clip that has been approved by the FDA for vascular reconstruction [3]. The VCS clip produces a focal and interrupted compression of the everted tissue walls without penetration of the vessel lumen or compromise in lumen diameter. The arcuate legs and back span confer the 523
The VCS clip: W. M. Kirsch et al.
novel property of auto-regulating the final pressure between the clip tips. This ‘sutureless’ vascular anastomotic technique demands precise vessel preparation as well as supervised training in a CMEsponsored sutureless anastomosis preceptorship [4]. Usage of the clip provides the surgeon with a high quality sutureless anastomosis that with practice can be performed more rapidly than with continuous suture. It is now becoming apparent with long-term studies of these anastomoses that the incidence of neointimal hyperplasia is reduced and that certain commonly performed procedures such as a vascular access perform better when constructed with clips rather than suture [5]. From a historical perspective, it is of interest to note that even though Carrel and Guthrie outlined suturing procedures for preserving the patency of anastomosed vessels between 1902 and 1907, there were still disputes as late as 1920 as to whether vessel suturing and reconstruction was warranted or would indeed work [6,7]. Thus a full 20 years passed before the surgical community accepted suturing for vascular reconstruction, even though Carrel had demonstrated success in the surgical laboratory. Mechanized staple suturing originated in Hungary with the work of Professor Hu¨ ltl and his brother, who together developed the first successful device for gastric reconstruction in 1909 [8]. Stapling for vascular reconstruction was promoted in the USSR as a result of a shortage of surgeons and the exigencies of war. Staples theoretically provided greater speed, safety, and accuracy. In 1941, B.F. Gudov, a Soviet engineer designed and constructed a vessel anastomotic stapler that was utilized successfully both in the surgical laboratory and operating room [9]. Because of encouraging results the Soviet Ministry of Health in 1952 established a scientific research institute in Moscow for the development of surgical stapling instruments. Stapling is a fundamentally different process than clipping. A stapler consists of a ‘pusher’ that forces the two ends of a U-shaped length of wire through the objects to be joined, coupled with an anvil that bends the ends of the staple to grip the objects. The stapler is thus a penetrating device, whereas clips are usually non-penetrating. Previously described vascular clips have been toothed and penetrating [10]. The introduction of the Soviet vessel stapler stimulated efforts through the 1950s and 60s in Canada, Japan, Hungary and the United States to develop vascular stapling devices that could be used clinically [11–13]. Staplers though successfully applied for occasional human vascular constructs in the United States, never gained wide acceptance because of the complexity and cumbersome nature of the devices. In addition to stapling, alternative vascular approximating techniques such as tantalum rings, ring and pin devices, adhesives, lasers and glue have all been tested and compared to suturing. 524
There are a number of reports of successful blood vessel reconstructions with metal clips both experimentally and clinically [7,10]. Clips were singly applied, V shaped with penetrating teeth. These penetrating clips never gained general acceptance, and the concept of mechanized vascular reconstruction never really caught on because of the cumbersome nature of the devices and the technical demands of loading either clips or staples. The demands of quality anastomosis in microvascular, prosthetic and transplant surgery have warranted a re-examination of mechanical systems because of perceived limitations of needle-and-suture. The multiple firing VCS clip and applier represents new technology that fulfills a number of needs for a speedier highquality anastomoses. The anastomotic line is nonpenetrated, interrupted, and the titanium is markedly unreactive in tissue. Evidence is now available from both prospective, randomized controlled studies that the clip is superior to conventional suturing [5,14,15]. The VCS clip gives the surgeons new options, particularly with regard to dealing with some of the more problematic vascular reconstructions particularly at the micro level involving veins and vascular prosthesis. As experience with the device has grown and the results of controlled clinical trials has emerged, it is apparent that the VCS clip offers biological and technical advantages over conventional needle and stitch in certain clinical circumstances. These circumstances are rapidly being defined and are described in the papers that form the basis of this special report.
References 1. EC–IC Bypass Study Group, Failure of extracranial–intracranial arterial bypass to reduce the risk of ischemic stroke. New England Journal of Medicine, 1985, 313, 1191. 2. O’Shaughnessay, M., Gu, J. M., Wyllie, F. et al., Microcirculatory consequences of microvascular surgery. Microsurgery, 1994, 15, 405–412. 3. Kirsch, W. M., Zhu, Y. H., Hardesty, R. A. et al., A new method for microvascular anastomoses: report of experimental and clinical research. The American Surgeon, 1992, 58, 722–727. 4. Kirsch, W.M., Zhu, Y.H., Anton, T., et al., Sutureless vascular anastomosis: the VCS clip, Current Critical Problems, New Horizons and Techniques in Vascular and Endovascular Surgery, 25th Annual Symposium, sponsored by Montefiore Medical Center, New York City, November 19–22, 1998, IX 10.1. 5. Schild, A. F. and Raines, J., Preliminary prospective randomized experience with vascular clips in the creation of arteriovenous fistulae for hemodialysis. American Journal of Surgery, 1999, 178, 33–37. 6. Carrel, A., The surgery of blood vessels, etc. Johns Hopkins Hospital Bulletin, 1907, 18, 18–28. 7. Bikfalvi, A. and Dubecz, S., Observations in animal experiments with mechanized vessel suture. Journal International de Chirurgie, 1953, 5, 481–495. 8. Hu¨ ltl, H., II Kongress der Ungarisdhen Gesellschaft fu¨ r Chirur-
CARDIOVASCULAR SURGERY
DECEMBER 2001 VOL 9 NO 6
The VCS clip: W. M. Kirsch et al.
9. 10. 11. 12.
gie, Budapest May 1908. Pester Med.-Chir. Presse, 1909, 45(108– 110), 121–122. Androsov, P. I., New method of surgical treatment of blood vessel lesions. A.M.A. Archives of Surgery, 1956, 73, 902–910. Samuels, P. B., Method of blood vessel anastomoses by means of metal clips: an experimental study. A.M.A. Archives of Surgery, 1955, 70, 29–38. Mallina, R. F., Miller, T. R., Cooper, P. et al., Surgical stapling. Scientific American, 1962, 207, 48–56. Vogelfanger, I. J. and Beattie, W. G., A concept of automation in vascular surgery: a preliminary report on a mechanical instru-
CARDIOVASCULAR SURGERY
DECEMBER 2001 VOL 9 NO 6
ment for arterial anastomoses. Canadian Journal of Surgery, 1958, 1, 262–265. 13. Takaro, T. and Oteen, N. C., A simple stapling device for anastomoses of blood vessels. Journal of Thoracic and Cardiovascular Surgery, 1960, 40, 673–684. 14. Zeebregts, C. J., van den Dungen, J. J., Kalicharan, D. et al., Nonpenetrating vascular clips for small-caliber anastomosis. Microsurgery, 2000, 20, 131–138. 15. Leppa¨ niemi, A., Wherry, D., Pikoulis, E. et al., Arterial and venous repair with vascular clips: comparison with suture closure. Journal of Vascular Surgery, 1997, 26, 24–28.
525
Cardiovascular Surgery, Vol. 9, No. 6, pp. 523–525, 2001 2001 The International Society for Cardiovascular Surgery Published by Elsevier Science Ltd. All rights reserved 0967-2109/01 $20.00
www.elsevier.com/locate/cardiosur
SYMPOSIUM: SUTURELESS VASCULAR ANASTOMOSIS Introduction Sutureless vascular anastomosis: the VCS clip W. M. Kirsch*, S. Gupta* and Y. H. Zhu† *Division of Neurosurgery, Loma Linda University, Loma Linda, CA 92350, USA and †Department of Surgery, Guthrie Clinic, Sayre, PA 18840, USA Non-penetrating, arcuate-legged clips facilitate vascular reconstructions and significantly reduce the incidence of anastomotic neointimal hyperplasia. Though originally developed as a microvascular-approximating instrument, by far the largest application has been for hemodialysis vascular access. Long-term studies comparing suture to clip for access creation have demonstrated the clear technical and biological superiority of the clip for this procedure. This “sutureless” vascular anastomotic technique is more demanding than conventional suturing, requiring precise vessel preparation and supervised training. 2001 The International Society for Cardiovascular Surgery. Published by Elsevier Science Ltd. All rights reserved Keywords: VCS clips, anastomotic intimal hyperplasia, surgical stapling, needle-and-suture, microvascular, vascular prosthesis
Technical and biological problems have long been recognized as associated with conventionally sutured vascular reconstructions, especially when applied to veins, small arteries and vascular prostheses. The permissive and traumatic nature of suturing sets the stage for either early thrombosis or stricture secondary to anastomotic neointimal hyperplasia. Needleand-suture related trauma is magnified at the small vessel level (O.D. ⬍2.0 mm) because of the diameter limitations of needles with respect to suture size and the limits of human proprioception. Standard vascular reconstructions with a penetrating needle and a continuous suture provide all the elements required for the development of anastomotic neointimal hyperplasia: platelet and clot deposition, anastomotic shear stress, zones of hyper and hypocompliance and bleeding from the anastomotic line. Anastomotic bleeding occurs most frequently with prosthetic
Correspondence to: Wolff M. Kirsch, M.D. Neurosurgery Center for Research, Training and Education, Loma Linda University, Coleman Pavilion, Suite 11113, 11175 Campus St., Loma Linda, CA 92350, USA. Tel.: +1-909-558-7070; Fax: +1-909-558-047; e-mail: [email protected]
CARDIOVASCULAR SURGERY
DECEMBER 2001 VOL 9 NO 6
graft insertions, particularly PTFE insertions. These problems at the sutured anastomotic line generate platelet and fibrin emboli that result in distal vascular occlusion, a significant hazard of cerebral revascularization procedures. It is likely that many of the untoward neurologic events associated with the extracranial–intracranial (EC–IC) bypass procedures, a microvascular operation, were related to suture-induced, embolic phenomena [1]. A patent, hand sewn, high flow rate microvascular anastomosis is an excellent generator of platelet emboli [2]. The technical difficulties associated with creating the superficial temporal middle cerebral artery (‘EC– IC’) bypass, a procedure that requires micro suturing of 1–2.5 mm O.D. vessels with both mismatched wall thickness and diameter stimulated the search for a non-suture, alternative microvascular anastomosing system. This work resulted in the development of the non-penetrating arcuate-legged clip that has been approved by the FDA for vascular reconstruction [3]. The VCS clip produces a focal and interrupted compression of the everted tissue walls without penetration of the vessel lumen or compromise in lumen diameter. The arcuate legs and back span confer the 523
The VCS clip: W. M. Kirsch et al.
novel property of auto-regulating the final pressure between the clip tips. This ‘sutureless’ vascular anastomotic technique demands precise vessel preparation as well as supervised training in a CMEsponsored sutureless anastomosis preceptorship [4]. Usage of the clip provides the surgeon with a high quality sutureless anastomosis that with practice can be performed more rapidly than with continuous suture. It is now becoming apparent with long-term studies of these anastomoses that the incidence of neointimal hyperplasia is reduced and that certain commonly performed procedures such as a vascular access perform better when constructed with clips rather than suture [5]. From a historical perspective, it is of interest to note that even though Carrel and Guthrie outlined suturing procedures for preserving the patency of anastomosed vessels between 1902 and 1907, there were still disputes as late as 1920 as to whether vessel suturing and reconstruction was warranted or would indeed work [6,7]. Thus a full 20 years passed before the surgical community accepted suturing for vascular reconstruction, even though Carrel had demonstrated success in the surgical laboratory. Mechanized staple suturing originated in Hungary with the work of Professor Hu¨ ltl and his brother, who together developed the first successful device for gastric reconstruction in 1909 [8]. Stapling for vascular reconstruction was promoted in the USSR as a result of a shortage of surgeons and the exigencies of war. Staples theoretically provided greater speed, safety, and accuracy. In 1941, B.F. Gudov, a Soviet engineer designed and constructed a vessel anastomotic stapler that was utilized successfully both in the surgical laboratory and operating room [9]. Because of encouraging results the Soviet Ministry of Health in 1952 established a scientific research institute in Moscow for the development of surgical stapling instruments. Stapling is a fundamentally different process than clipping. A stapler consists of a ‘pusher’ that forces the two ends of a U-shaped length of wire through the objects to be joined, coupled with an anvil that bends the ends of the staple to grip the objects. The stapler is thus a penetrating device, whereas clips are usually non-penetrating. Previously described vascular clips have been toothed and penetrating [10]. The introduction of the Soviet vessel stapler stimulated efforts through the 1950s and 60s in Canada, Japan, Hungary and the United States to develop vascular stapling devices that could be used clinically [11–13]. Staplers though successfully applied for occasional human vascular constructs in the United States, never gained wide acceptance because of the complexity and cumbersome nature of the devices. In addition to stapling, alternative vascular approximating techniques such as tantalum rings, ring and pin devices, adhesives, lasers and glue have all been tested and compared to suturing. 524
There are a number of reports of successful blood vessel reconstructions with metal clips both experimentally and clinically [7,10]. Clips were singly applied, V shaped with penetrating teeth. These penetrating clips never gained general acceptance, and the concept of mechanized vascular reconstruction never really caught on because of the cumbersome nature of the devices and the technical demands of loading either clips or staples. The demands of quality anastomosis in microvascular, prosthetic and transplant surgery have warranted a re-examination of mechanical systems because of perceived limitations of needle-and-suture. The multiple firing VCS clip and applier represents new technology that fulfills a number of needs for a speedier highquality anastomoses. The anastomotic line is nonpenetrated, interrupted, and the titanium is markedly unreactive in tissue. Evidence is now available from both prospective, randomized controlled studies that the clip is superior to conventional suturing [5,14,15]. The VCS clip gives the surgeons new options, particularly with regard to dealing with some of the more problematic vascular reconstructions particularly at the micro level involving veins and vascular prosthesis. As experience with the device has grown and the results of controlled clinical trials has emerged, it is apparent that the VCS clip offers biological and technical advantages over conventional needle and stitch in certain clinical circumstances. These circumstances are rapidly being defined and are described in the papers that form the basis of this special report.
References 1. EC–IC Bypass Study Group, Failure of extracranial–intracranial arterial bypass to reduce the risk of ischemic stroke. New England Journal of Medicine, 1985, 313, 1191. 2. O’Shaughnessay, M., Gu, J. M., Wyllie, F. et al., Microcirculatory consequences of microvascular surgery. Microsurgery, 1994, 15, 405–412. 3. Kirsch, W. M., Zhu, Y. H., Hardesty, R. A. et al., A new method for microvascular anastomoses: report of experimental and clinical research. The American Surgeon, 1992, 58, 722–727. 4. Kirsch, W.M., Zhu, Y.H., Anton, T., et al., Sutureless vascular anastomosis: the VCS clip, Current Critical Problems, New Horizons and Techniques in Vascular and Endovascular Surgery, 25th Annual Symposium, sponsored by Montefiore Medical Center, New York City, November 19–22, 1998, IX 10.1. 5. Schild, A. F. and Raines, J., Preliminary prospective randomized experience with vascular clips in the creation of arteriovenous fistulae for hemodialysis. American Journal of Surgery, 1999, 178, 33–37. 6. Carrel, A., The surgery of blood vessels, etc. Johns Hopkins Hospital Bulletin, 1907, 18, 18–28. 7. Bikfalvi, A. and Dubecz, S., Observations in animal experiments with mechanized vessel suture. Journal International de Chirurgie, 1953, 5, 481–495. 8. Hu¨ ltl, H., II Kongress der Ungarisdhen Gesellschaft fu¨ r Chirur-
CARDIOVASCULAR SURGERY
DECEMBER 2001 VOL 9 NO 6
The VCS clip: W. M. Kirsch et al.
9. 10. 11. 12.
gie, Budapest May 1908. Pester Med.-Chir. Presse, 1909, 45(108– 110), 121–122. Androsov, P. I., New method of surgical treatment of blood vessel lesions. A.M.A. Archives of Surgery, 1956, 73, 902–910. Samuels, P. B., Method of blood vessel anastomoses by means of metal clips: an experimental study. A.M.A. Archives of Surgery, 1955, 70, 29–38. Mallina, R. F., Miller, T. R., Cooper, P. et al., Surgical stapling. Scientific American, 1962, 207, 48–56. Vogelfanger, I. J. and Beattie, W. G., A concept of automation in vascular surgery: a preliminary report on a mechanical instru-
CARDIOVASCULAR SURGERY
DECEMBER 2001 VOL 9 NO 6
ment for arterial anastomoses. Canadian Journal of Surgery, 1958, 1, 262–265. 13. Takaro, T. and Oteen, N. C., A simple stapling device for anastomoses of blood vessels. Journal of Thoracic and Cardiovascular Surgery, 1960, 40, 673–684. 14. Zeebregts, C. J., van den Dungen, J. J., Kalicharan, D. et al., Nonpenetrating vascular clips for small-caliber anastomosis. Microsurgery, 2000, 20, 131–138. 15. Leppa¨ niemi, A., Wherry, D., Pikoulis, E. et al., Arterial and venous repair with vascular clips: comparison with suture closure. Journal of Vascular Surgery, 1997, 26, 24–28.
525