Current applications of fibrin sealant in urologic surgery

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Biosurgical preparations designed to promote surgical hemostasis and tissue adhesion are being increasingly employed across all surgical disciplines. Fibrin sealant is the most widely studied and utilized biosurgical adjunct in urology. Complex
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  131 Fibrin Sealant in Urology Review Article International Braz J UrolVol. 32 (2): 131-141, March - April, 2006 Current Applications of Fibrin Sealant in Urologic Surgery L. Andrew Evans, Allen F. Morey Urology Service, Brooke Army Medical Center, Fort Sam Houston, Texas, USA ABSTRACT Biosurgical preparations designed to promote surgical hemostasis and tissue adhesion are being increasingly employedacross all surgical disciplines. Fibrin sealant is the most widely studied and utilized biosurgical adjunct in urology. Com-plex reconstructive, oncologic, and laparoscopic genitourinary procedures are those most appropriate for sealant use. Thisarticle details the diverse urologic applications of fibrin sealant in the management of genitourinary injuries, surgery, andcomplications.  Key words : fibrin sealant; urology; hemostasis; complications; surgery; biologics  Int Braz J Urol. 2006; 32: 131-41 INTRODUCTION Although most applications are off-label, tis-sue sealants and hemostatic agents are being increas-ingly employed across all surgical disciplines.Biosurgical compounds can serve as adjuncts to pri-mary surgical therapy or may assist in managing orpreventing surgical complications. In urology, hemo-static agents and tissue sealants are finding increas-ing roles in managing traumatic and iatrogenic uro-logic injuries and promoting optimal wound healing.Among the variety of hemostatic productsnow available in the United States (Table-1), fibrinsealant is the most widely utilized biosurgical agentin urologic surgery. This article details the diverseurologic applications of fibrin sealant for hemosta-sis, tissue adhesion, and urinary tract sealing. FIBRIN SEALANTDevelopment Mixtures of coagulation factors have beenused in surgery for almost a century, dating back tothe use of a fibrin emulsion by Bergel in 1909 to pro-mote wound healing (1). Purified thrombin becameavailable in 1938, and was first combined with fi-brinogen in 1944 to enhance adhesion of skin graftsto burned soldiers (2). Although commercial fibrinsealant has been widely used in Europe since the1970’s, concerns about possible viral transmissionlimited sealant use in the United States until recently.In 1998, Tisseel® (Baxter Healthcare, Deerfield, Il-linois) became the first fibrin sealant approved by theFood and Drug Administration (FDA) for use in theUnited States.Although the three FDA approved indicationsfor fibrin sealant are reoperative cardiac surgery, co-lon anastomosis, and treatment of splenic injury, fi-brin sealants have been successfully employed incountless numbers of non-urologic surgical applica-tions, including liver laceration, hepatic resection,bowel and vascular anastomoses, enterocutaneous andanorectal fistulae closure, cardiothoracic surgery, andneurosurgery. A review in 2002 by Shekarriz & Stoller(3) was the first major contemporary urological pub-lication addressing the use of fibrin sealant in uro-  132 Fibrin Sealant in Urology Table 1 –  Hemostatic agents and tissue adhesive available in the United States. Component Brand Name Manufacturer Fibrin sealantTisseel VH ® Crosseal®Baxter Healthcare OmrixGelatin matrix thrombinFloSeal®Baxter HealthcareThrombinThrombin-JMI®Jones PharmaGelatin spongeGelfoam®Pharmacia UpjohnOxidized celluloseSurgicel®EthiconCollagen spongeActifoam®CR BardCollagen fleeceAvitene®CR BardRecombinant factor VIIaNovoSeven®Novo Nordisk A/S  Tissue Adhesives Fibrin sealantTisseel VH ® Crosseal®Baxter Healthcare OmrixPolyethylene glycolCoSeal®Baxter HealthcareCyanoacrylateDermabond®Ethicon Hemostatic Agents  Figure 1 –  Mechanism of action of liquid fibrin sealant in recapitulating the terminal portion of the coagulation cascade. logic surgery, and an increasing number of urologi-cal sealant applications have followed. Composition Fibrin sealant contains 2 major components(thrombin and highly concentrated fibrinogen) whichreplicate and augment the final stage of the coagula-tion cascade—the cleavage of fibrinogen into fibrinby the action of thrombin—when mixed together. Itis important to note that the fibrinogen concentrationof sealant is supraphysiologic, 15 to 25 times higherthan that of circulating plasma. The resultant clot tendsto form more rapidly and more reliably than normal.Other key components of fibrin sealant are FactorXIII, which covalently crosslinks the fibrin polymerto produce an insoluble fibrin coagulum, and anantifibrinolytic agent which inhibits fibrinolysis thuspreserving the stable fibrin clot (Figure-1).  133 Fibrin Sealant in Urology Table 2 –  Urological applications of fibrin sealant. I. Hemostasis Partial nephrectomyOpenLaparoscopic (13-16)Percutaneous nephrolithotomy (22)Management of splenic injury (23)Hemophilia and other coagulopathy (24)Circumcision (25)Hemorrhagic cystitis (27) II. Urinary Tract Sealant Laparoscopic and open pyeloplasty (31-34)Ureteral anastomoses (31-34)Urethral reconstruction (37)Simple retropubic prostatectomy (35)Radical retropubic prostatectomy (36)Bladder injury (24)Lymphadenectomy (38,39)Percutaneous nephrolithotomy tract closure (22) III. Tissue Adhesion Fournier’s gangrene reconstruction (41,42)Fistula closure (24,45,46)Skin grafting (42)Complex urethroplasty (37) Tisseel® (Baxter Healthcare, Deerfield, Illi-nois) and Crosseal® (Omrix Biopharmaceuticals, Ltd,Israel) are the two fibrin sealants currently marketedin the United States. Tisseel® contains bovine aprotininas its antifibrinolytic agent. Aprotinin is a serine pro-tease inhibitor derived from bovine lung that works tolimit fibrinolysis by inhibiting plasmin, kallikrein, andtrypsin. Crosseal utilizes only human-derived proteinsby including tranexamic acid as its antifibrinolyticagent instead of bovine aprotinin. Tranexamic acid isa synthetic analogue of the amino acid lysine and com-petes for lysine binding sites on plasminogen and plas-min, preventing binding to fibrin and inhibiting fi-brinolysis (4). Safety All approved fibrin sealant preparations uti-lize a combination of donor screening, serum testingand retesting after 90 days storage, and a two-stepvapor heating process to ensure viral safety (5,6).These steps are highly effective in ensuring viralsafety and, to our knowledge, there are in 2005 stillno reported transmissions of blood-borne viral patho-gens associated with the use of FDA approved fibrinsealants (5). One parvovirus B19 transmission involv-ing a non-FDA approved fibrin sealant was reportedfrom Japan, but most adults have preexisting anti-bodies to this virus and the infection is usually a self-limited diarrhea (7). Delivery Methods Fibrin sealants are administered using a dual-chamber delivery system in which one chamber con-taining fibrinogen and factor XIII is admixed withthe other chamber containing thrombin directly at thesite of application using a “Y” adaptor, allowing animmediate conversion of fibrinogen to fibrin as thesolutions exit the syringe. Dual lumen catheters en-sure smooth, rapid sealant delivery, and a variety of specialized catheters and cannulae are available forendoscopic, laparoscopic, and open surgical applica-tion. We have also successfully used a dual lumenperipherally inserted central catheter (PICC) line forpercutaneous transrenal application (8). Polymeriza-tion into the biocompatible fibrin clot is completedwithin 3 minutes (9), and the clot is gradually brokendown and removed from the site by macrophageswithin 2-4 weeks, eventually becoming histopatho-logically invisible, without fibrosis or foreign-bodyreaction (10). UROLOGICAL APPLICATIONS Commercial fibrin sealant is employed forthree major reasons in urologic surgery - as a hemo-static agent, a urinary tract sealant, and/or a tissueadhesive. A list of the most common urological ap-plications is presented in Table-2. Fibrin sealant’sunique properties as a hemostatic agent, urinary tractsealant, and tissue adhesive make it an effective ad- junct for managing complex urologic injury and pro-moting wound healing in the genitourinary tract.  134 Fibrin Sealant in Urology Hemostasis  Partial Nephrectomy Fibrin sealant has been used since 1979 inopen partial nephrectomy (11). The recent adventof minimally invasive techniques for nephron spar-ing surgery has resulted in widespread fibrin seal-ant use during laparoscopic partial nephrectomy to-day (12-15). A recent survey of 193 members of the World Congress of Endourology discovered68% of surgeons routinely utilized fibrin sealantto assist with hemostasis during laparoscopic par-tial nephrectomy (16). Application of fibrin sealantto the cut surface of the renal parenchymal woundafter segmental vascular and collecting system su-ture ligation during partial nephrectomy enhanceshemostasis. The fibrin sealant layer can then be sup-ported by a gelatin or collagen bolster, which is ef-fectively glued into the renal defect by holdingmanual pressure on the bolster “sandwich”. In vivotesting of fibrin sealant in a porcine model of openpartial nephrectomy demonstrated supra-physiologi-cal sealing pressures of the renal parenchymal vas-culature (mean 378 mm Hg) and collecting system(mean 166 mm Hg) compared to unsealedcontrols(17).  Renal Trauma In 1989, Kram and colleagues first reportedfibrin sealant use in 14 patients with traumatic renalinjuries: renal salvage was achieved in all cases withno postoperative infection, delayed hemorrhage, orurinoma formation (18). In 2004, our laboratory re-ported the effective use of FDA-approved fibrin seal-ant in central porcine renal stab wounds when usedin conjunction with a bolster of absorbable gelatinsponge or microfibrillar collagen (19). Though notyet commercially available, the absorbable fibrin ad-hesive bandage (AFAB), a similar product consistingof dry fibrin sealant on a polyglactin mesh backingdeveloped in conjunction with the American RedCross, significantly reduced bleeding in addition tooperative and ischemic times in repair of porcinemodels of lower renal pole amputation (20) and gradeIV renal stab wounds (21).  Miscellaneous Hemostatic Applications Noller et al. reported no hemorrhagic com-plications in 10 consecutive renal units treated withfibrin sealant-assisted tubeless percutaneous nephroli-thotomy (PCNL) (22). The instillation of 2 to 3 mLof fibrin sealant into the parenchymal defect is per-formed as the sheath is removed at the conclusion of PCNL in lieu of nephrostomy drainage. Postopera-tive computed tomography has confirmed the absenceof perirenal hematomas in these “tubeless” proce-dures.We have found that intraoperative splenicinjury during left nephrectomy is easily managed withdirect application of fibrin sealant to the bleedingparenchyma, thereby promoting prompt hemostasisand avoiding the need for splenectomy (23). Fibrinsealant has also been successfully used to control“medical” bleeding caused by warfarin use or othercoagulopathies during urologic surgical procedures(24,25). Other urologic hemostatic applications in-clude sealing the oral mucosal donor site during buc-cal graft urethroplasty (26) and cystoscopic applica-tion of fibrin sealant after fulguration to provide he-mostasis in refractory radiation-induced hemorrhagiccystitis after supravesical urinary diversion (27). Urinary Tract Sealant A variety of non-urological studies has sug-gested the increased strength of sealed anastomoses.Skin sutures supported by a layer of fibrin sealantprovided watertight anastomoses immediately aftersurgery and withstood significantly higher hydrostaticpressures than non-sealed anastomoses (28). Han etal. noted that microvascular sutured anastomoses sup-ported by fibrin sealant had enhanced re-endotheliazation (29), and Park et al. reported signifi-cantly increased tensile strength in sealed skin clo-sure versus controls (30). Ureteral Anastomosis Kram and colleagues first reported the suc-cessful use of fibrin sealant as a bolster over the su-ture line for ureteral anastomosis in 1989 (18). Wehave found fibrin sealant to be a useful adjunct inmanaging a variety of ureteral injuries, both iatro-genic and traumatic, and have frequently performed  135 Fibrin Sealant in Urology  Figure 2 –  A) Stab wound to right flank with medial perirenalcontrast material extravasation on preoperative trauma computed tomography (CT). A 4 cm laceration to the right renal pelvis wassuccessfully repaired using 5-0 PDS suture with the applicationof a bolster of 5 cc of fibrin sealant over the suture line to rein- force urinary tract seal. No drain was placed. B) PostoperativeCT image obtained 72 hours later demonstrates drain-free intact repair over ureteral stent without evidence of extravasation or urinoma. AB “drain-free” sealed repairs. Between 2001 and 2003,10 patients underwent definitive management of ure-teral injury at our institution. Our experience hasshown that sealant effectively prevents ureteral uri-nary extravasation and has not been associated withpostoperative infection, leak, or scar formation (Fig-ure-2). We believe that a sealed, stented ureteral re-pair is prudent in cases where a transabdominal ap-proach has been performed because transabdominaldrains are avoided. We also feel it is important to ap-ply the sealant as a means of “suture support” by re-inforcing standard suture lines, not in lieu of carefulsuture repair.The increasing performance of laparoscopicrenal reconstruction surgery may lead to increasedsealant use. Fibrin sealant has been shown to suc-cessfully support approximating sutures in a porcinemodel of laparoscopic ureteral anastomoses (31) andhas improved radiographic outcomes compared to freeneedle suturing and laser weld closure (32). A vari-ety of studies have shown fibrin sealant to be effec-tive as a bolster for laparoscopic pyeloplasty or col-lecting system repair (33), and satisfactory drainagehas been confirmed by radiologic imaging at one totwo years (34).  Prostatectomy Drain-free simple retropubic prostatectomyhas been successfully performed in over 25 cases inour institution, and we have demonstrated a fasterreturn to regular diet and shortened hospital stay whencompared with conventional simple prostatectomy(35). Again, we believe it is important to apply thesealant outside the urinary tract, over the sutured pro-static capsular closure, to ensure that the fibrin clotdoes not occlude urinary catheter drainage. Similarly,Diner et al. reported in 2004 that a significant de-crease in postoperative drain output was noted in 16patients following radical retropubic prostatectomywhen 5 cc of fibrin sealant was applied to the sutureline of the urethrovesical anastomosis (36). Earlierdrain removal should facilitate a more expedient re-covery and earlier discharge from the hospital lead-ing to cost savings. Urethroplasty Fibrin sealant appears to allow earlier cath-eter removal, improved patient satisfaction, and en-hanced wound healing after pendulous urethroplasty(37). In our experience of applying fibrin sealantdirectly over a suture line of 5-zero polydiaxanoneduring pendulous urethroplasty in 18 patients, a com-pletely healed anastomosis was confirmed by void-ing cystourethrography (VCUG) performed 1 week postoperatively in 83% of patients; all 18 patientsdemonstrated complete healing within 14 days, com-
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