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The TachoSil-Pledget Stitch: Towards Eradication of Suture Hole Bleeding

2008; Elsevier BV; Volume: 86; Issue: 6 Linguagem: Inglês

10.1016/j.athoracsur.2008.08.073

1552-6259

Takeshi Shimamoto, Akira Marui, Takeshi Nishina, Yoshiaki Saji, Masashi Komeda,

Reconstructive Surgery and Microvascular Techniques

We describe a novel suture consisting of a small piece of TachoSil (Nycomed, Copenhagen, Denmark) and a felt pledget—the TachoSil-pledget stitch—which was used to facilitate mechanical and biologic hemostasis in 5 patients undergoing aortic arch aneurysm repair. The TachoSil-pledget stitch achieved good or very good hemostasis at all 56 bleeding points to which it was applied, while 5 of 12 points to which a conventional felt-pledget stitch was applied required additional stitching or an additional hemostatic method. We describe a novel suture consisting of a small piece of TachoSil (Nycomed, Copenhagen, Denmark) and a felt pledget—the TachoSil-pledget stitch—which was used to facilitate mechanical and biologic hemostasis in 5 patients undergoing aortic arch aneurysm repair. The TachoSil-pledget stitch achieved good or very good hemostasis at all 56 bleeding points to which it was applied, while 5 of 12 points to which a conventional felt-pledget stitch was applied required additional stitching or an additional hemostatic method. Intraoperative suture hole bleeding—particularly when exacerbated by coagulopathy caused by deep hypothermia for brain protection or preoperative use of antiplatelet medication (eg, in patients with drug-eluting stents)—can be a serious problem in aortic operations. Felt-pledget stitches provide firm but gentle external mechanical support for wound sealing, making this a popular technique for achieving hemostasis after a surgical intervention. However, residual bleeding through or underneath pledgets, or exacerbation of bleeding by the addition of more stitches, is frequently observed and can be challenging to control. TachoSil (Nycomed, Copenhagen, Denmark) consists of a collagen matrix coated with lyophilized human fibrinogen and bovine thrombin and has been reported to be effective in achieving hemostasis [1Carbon R.T. Baar S. Kriegelstein S. Huemmer H.P. Baar K. Simon S.I. Evaluating the in vitro adhesive strength of biomaterials Biosimulator for selective leak closure.Biomaterials. 2003; 24: 1469-1475Crossref PubMed Scopus (31) Google Scholar]. However, its utility can be limited in arterial bleeding if arterial pressure exceeds the tamponade effect of TachoSil's adhesive strength [1Carbon R.T. Baar S. Kriegelstein S. Huemmer H.P. Baar K. Simon S.I. Evaluating the in vitro adhesive strength of biomaterials Biosimulator for selective leak closure.Biomaterials. 2003; 24: 1469-1475Crossref PubMed Scopus (31) Google Scholar]. We combined TachoSil with a conventional felt-pledget stitch to offset the disadvantages of each method and have used this combined product in patients undergoing aortic arch aneurysm repair. A piece of TachoSil measuring approximately 5 × 10 mm was placed inside a polypropylene felt pledget measuring approximately 4 × 8 mm, with the yellow surface of TachoSil—containing the active components—facing outwards for application to the surface of the aorta (Fig 1). These “sandwich” sutures are designed to be used in the same way as a conventional felt-pledget stitch. This TachoSil-pledget stitch can be used de novo or to replace a failing conventional felt-pledget stitch. It can be used to control bleeding at any point on the native aorta, on the body of the graft prosthesis, or anastomotic bleeding between the native aorta and the graft. Between April and September 2005, our surgeons used TachoSil-pledget stitches (Nycomed) and conventional pledget stitches in 5 consecutive patients undergoing aortic arch aneurysm repair with hypothermic circulatory arrest. The requirement for hemostatic stitches was indicated by persistent suture hole bleeding from either the graft prosthesis or native aorta lasting more than 20 minutes after protamine infusion while systemic blood pressure was being maintained between 90 to 110 mm Hg and activated coagulation time was maintained at less than 120 seconds. The efficacy of hemostasis was graded from 1 to 4:1—Unsatisfactory: another method was required to achieve hemostasis.2—Suboptimal hemostasis: an additional stitch was required to stop residual bleeding.3—Good hemostasis: small amounts of residual bleeding persisted after the hemostatic stitch was applied, which consequently stopped spontaneously.4—Very good hemostasis; bleeding stopped immediately after the hemostatic stitch was applied. These hemostatic efficiency scores were analyzed by the Mann-Whitney U test with SPSS 10 software (SPSS Inc, Chicago, IL). Results with p < 0.05 were considered statistically significant. The TachoSil-pledget stitch was used at 56 bleeding points. After the procedure, hemostasis at these sites was graded as 4 in 54 sites (96.4%) or 3 in 2 sites (3.6%). The conventional pledget stitch was used at 12 sites. Among these, hemostasis in 5 sites (41.7%) was graded as 1 or 2. Three sites needed an additional figure-of-eight stitch, and 2 sites required the conventional pledget stitch to be replaced by a TachoSil-pledget stitch to achieve hemostasis. The mean hemostatic efficacy score for the TachoSil-pledget and conventional pledget stitches (± standard deviation) were 3.96 ± 0.19 and 2.83 ± 1.19, respectively (p < 0.01), which showed the TachoSil-pledget stitch significantly improved control of suture hole bleeding in aortic operations. In aortic procedures, especially with deep hypothermia or where the patients are receiving modern antiplatelet medications, surgeons frequently encounter suture hole bleeding, especially when the aortic tissue is friable [2Dunst K.M. Antretter H. Bonatti J. Control of suture hole bleeding after aortic valve replacement by application of BioGlue during circulatory arrest.Int Heart J. 2005; 46: 175-179Crossref PubMed Scopus (9) Google Scholar, 3Czerny M. Verrel F. Weber H. et al.Collagen patch coated with fibrin glue components Treatment of suture hole bleedings in vascular reconstruction.J Cardiovasc Surg (Torino). 2000; 41: 553-557PubMed Google Scholar]. The options available to control this kind of bleeding are currently to simply oversew the initial suture, to apply surgical glue [2Dunst K.M. Antretter H. Bonatti J. Control of suture hole bleeding after aortic valve replacement by application of BioGlue during circulatory arrest.Int Heart J. 2005; 46: 175-179Crossref PubMed Scopus (9) Google Scholar], or to use TachoSil [3Czerny M. Verrel F. Weber H. et al.Collagen patch coated with fibrin glue components Treatment of suture hole bleedings in vascular reconstruction.J Cardiovasc Surg (Torino). 2000; 41: 553-557PubMed Google Scholar]. All three techniques have their limitations, however. Additional stitches can themselves create new leaks, especially when the aortic tissue is friable [2Dunst K.M. Antretter H. Bonatti J. Control of suture hole bleeding after aortic valve replacement by application of BioGlue during circulatory arrest.Int Heart J. 2005; 46: 175-179Crossref PubMed Scopus (9) Google Scholar]. Surgical glue is useless if it comes away from the wound surface [2Dunst K.M. Antretter H. Bonatti J. Control of suture hole bleeding after aortic valve replacement by application of BioGlue during circulatory arrest.Int Heart J. 2005; 46: 175-179Crossref PubMed Scopus (9) Google Scholar, 3Czerny M. Verrel F. Weber H. et al.Collagen patch coated with fibrin glue components Treatment of suture hole bleedings in vascular reconstruction.J Cardiovasc Surg (Torino). 2000; 41: 553-557PubMed Google Scholar]. TachoSil has the advantage that the collagen matrix glues itself to the wound surface and provides high a concentration of fibrinogen and thrombin locally at the site of bleeding, thus enhancing biologic hemostasis [1Carbon R.T. Baar S. Kriegelstein S. Huemmer H.P. Baar K. Simon S.I. Evaluating the in vitro adhesive strength of biomaterials Biosimulator for selective leak closure.Biomaterials. 2003; 24: 1469-1475Crossref PubMed Scopus (31) Google Scholar, 3Czerny M. Verrel F. Weber H. et al.Collagen patch coated with fibrin glue components Treatment of suture hole bleedings in vascular reconstruction.J Cardiovasc Surg (Torino). 2000; 41: 553-557PubMed Google Scholar]. The adhesive strength of TachoSil is reported as 50.2 ± 6.9 mm Hg, however, which is insufficient to overcome arterial pressure and makes TachoSil less effective for arterial bleeding than for venous bleeding [1Carbon R.T. Baar S. Kriegelstein S. Huemmer H.P. Baar K. Simon S.I. Evaluating the in vitro adhesive strength of biomaterials Biosimulator for selective leak closure.Biomaterials. 2003; 24: 1469-1475Crossref PubMed Scopus (31) Google Scholar]. In addition, TachoSil is less likely to adhere to a prosthetic surface than to native tissue. The application of the outer felt pledget provides sufficient additional pressure to overcome the stripping force of arterial bleeding and to seat the TachoSil patch at the site at which it was applied. It also protects fragile, diseased aortic tissue from the shear force of the narrow, sharp polypropylene stitch. This combined mechanical and biologic hemostatic effect appears the same regardless of whether bleeding occurred at the prosthesis, the native tissue, or the junction between the two because the combination of TachoSil with external supporting pledget stitch can create sufficient strength to plug the bleeding gaps both mechanically and biologically. Although the effectiveness and utility of this technique has been well received by our cardiovascular surgical team, we have received feedback from our nursing colleagues that preparation of the TachoSil pledget is quite labor intensive. Further, when handled in its dry state, TachoSil is crisp, like a thin cracker, and can easily become damaged during manipulation with standard surgical instruments. To overcome these practical difficulties, we have developed a custom-built holder for the TachoSil-pledget stitch. This holder has two distinctive features: First, the tips of each arm are trifurcated, with one arm having long side fingers and a short middle finger, and the other has short side fingers and a long middle finger (Fig 2a). Second, a space several millimeters wide is created between the 2 tips when the ratchet is closed. This holds the TachoSil and pledget in place without applying excessive pressure (Figs 2b and 2c). The holder thus allows the TachoSil patch to be held firmly enough to allow a needle to pass through it, but minimizes unwanted damage to the patch surface. Although the number of bleeding points that have fixed with the TachoSil-pledget stitch is as yet limited, and the use of the combination product is associated with an additional cost of about US $10 per stitch by comparison with the conventional pledget stitch, this technique seems more effective in achieving hemostasis in aortic procedures with friable aortic tissues and considerable coagulopathy associated with deep hypothermia. A ready-to-use combination product would be more surgeon-friendly and might be cheaper.