Case Report Cyanacrylate Glue Caused Extrinsic Compression of an Infrapopliteal Vein Graft Maria Vittoria Carati,1 Raffaele Grande,1 Antonio V. Sterpetti,1 Ciro Ferrer,1 Giuseppe D’Ermo,1 Raffaele Serra,2 Francesco Pugliese,3 Andrea Mingoli,3 and Paolo Sapienza,1 Rome and Catanzaro, Italy
Several surgical sealant devices are commercially available after their rigorous clinical testing with no apparent complications reported so far in the current literature. Cyanoacrylate glue can be used to stabilize the anastomoses and permit a better tensile strength in cardiovascular surgery. We first report the case of a 71-year-old male patient presenting with symptoms of progressive limitation of walking distance, 13 months after a successful femoroinfrapopliteal bypass surgery, because of a calcified tissue extrinsically stenosizing the first segment of the previous bypass graft, caused by the use of cyanoacrylate glue.
The risk of bleeding from the anastomosis in vascular surgery can lead to postoperative complications including blood loss and the need of transfusion, perianastomotic hematoma, pseudoaneurysm formation and often failure of vascular reconstruction.1,2 A potentially ready and easy-to-use vascular sealant with elevated efficacy is needed to prevent anastomotic bleeding. In the recent years, a continuous progress toward the development of novel surgical sealant devices has been registered, with no apparent complications so far reported.3 Several surgical sealants such as fibrin sealant, cyanoacrylate
1 Department of Surgery ‘‘Pietro Valdoni’’, ‘‘Sapienza’’ University of Rome, Rome, Italy. 2
Department of Medical and Surgical Sciences, University ‘‘Magna Graecia’’, Catanzaro, Italy. 3 Department of Emergency, ‘‘Sapienza’’ University of Rome, Rome, Italy.
Correspondence to: Paolo Sapienza, MD, PhD, Associate Professor of Surgery Department of Surgery ‘‘Pietro Valdoni’’, ‘‘Sapienza’’ University of Rome, Policlinico Umberto I Viale del Policlinico, 151 00161 Rome, Italy; E-mail:
[email protected] Ann Vasc Surg 2019; -: 1.e1–1.e4 https://doi.org/10.1016/j.avsg.2019.09.020 Ó 2019 Elsevier Inc. All rights reserved. Manuscript received: July 22, 2019; manuscript accepted: September 1, 2019; published online: - - -
glue, bovine collagen and thrombin, polyethylene glycol polymer and albumin crosslinked with glutaraldehyde are in fact clinically used as adjuvant or alternative to classical methods of hemostasis in vascular surgery.4 A case of a patient, after 13 months of a successful femoroinfrapopliteal bypass surgery, with an extrinsic stenosis at level of the proximal anastomosis and extending caudally for 3 cm caused by the use of cyanoacrylate glue is first reported.
CASE REPORT A 71-year-old Caucasian man was readmitted to our institution because of a progressive disabling claudication limiting his walking distance to 150 meters and a decrease of the ankle brachial index from 0.9 to 0.6 in six months. A control B-mode ultrasonography and color imaging showed the presence of a stenotic segment (3 cm in length) extending caudally from the proximal anastomosis (Fig. 1A). A computed tomography angiography scan demonstrated a calcific, annular-shaped concretion determining an extrinsic compression of the vein bypass starting from the proximal anastomotic site (Fig. 1B). The certainty and nature of the extrinsic compression were doubtful. Thirteen months earlier, the patient was emergently admitted at our institution for acute critical right lower limb ischemia with sudden onset of pain, pallor and hypothermia. Medical history was remarkable for systemic 1.e1
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Annals of Vascular Surgery
Fig. 1. (A) B-mode ultrasonography and color imaging showing the proximal anastomosis (yellow arrow), the superficial femoral artery (SFA) and the stenosis of the lumen of the vein graft (red stars) (B) 3D computed
tomography angiography reconstruction. The arrow indicates the calcified tissue extrinsically compressing the first 3 cm of the vein graft (red stars). (C) Control 3D reconstructions showing patency of the revised vein graft.
hypertension controlled with oral agents, dyslipidemia, smoking habits (20 cigarettes per day), previous cholecystectomy and a history of prostate cancer treated with surgery and radiotherapy. Attempts to treat the limb ischemia with percutaneous thrombus aspiration and percutaneous transluminal angioplasty failed, and the patient underwent a femoropopliteal reversed vein graft.5e7 To obtain a better tensile strength at the level of the proximal anastomosis because the vein was of suboptimal quality and extremely fragile, few drops of cyanoacrylate glue (GEM-GluBran2Ò) were used to increase the resistance and stabilize the anastomosis according to the manufacturer’s instructions for use. Endovascular attempts were felt at risk of anastomotic disruption and surgical revision of the proximal portion of the vein graft was planned. The superficial femoral artery 5 cm above the previous incision and the proximal segment of the bypass were completely dissected free from the surrounding structures. A heavily calcified and tenaciously adherent tissue involving the first 3 cm of the previous reconstruction was present. Even after the removal of the graft from the calcified tissue the bypass had a suboptimal digital pulsation. Therefore, a segment of the proximal ipsilateral greater saphenous vein was used to redo a more proximal anastomosis and to restore adequate blood flow. A control computed tomography angiography showed the patency of the reconstruction (Fig. 1C). The patient was discharged after five days and a control outpatient B-mode ultrasonography and color imaging showed the functionality of the vein graft with resolution of the preoperative symptoms at four months.
DISCUSSION Bleeding might be a consequence of vascular surgery, and postoperative hemorrhage is one of the most common major complications of femoropopliteal bypass graft. Present data from a systematic review including 38 articles for a total of 6,374 femoropopliteal bypasses in 6,007 patients, which studied the 30-days adverse events after above and below the knee bypass showed postoperative hemorrhage in 7.4% (range, 0e26%), of which 2.5% required return to surgery.8Furthermore, a significant percentage of patients add to the surgical risk of bleeding due to the concomitant use of anticoagulants and antiplatelet agents or the presence of coagulative diseases, increasing even more the operative risk of hemorrhage. Careful monitoring of hemostasis is necessary to avoid reintervention and potentially lifethreatening events. Our center usually performs an anatomical dissection to avoid unnecessary bleeding and permit a perfect hemostasis before closure of the skin and, therefore, sealant agents are very rarely used and generally avoided.9,10 Our center’s current policy is to recommend the judicious use of the hemostatic agents, only when coagulation factors are imbalanced or depleted.
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We only treat patients affected with rest pain or necrosis, who are at high risk of prosthetic graft infection. Therefore, we strongly support the use of vein graft even if it is suboptimal in quality. Furthermore, vein patency is always significantly better when compared to synthetic or composite graft. In our opinion, any kind of vein harvested from the upper limb to the deep superficial femoral vein should be used. In our center, synthetic grafts are the last chance, i.e., when all venous heritage is completely depleted. In the last decade many types of sealants and hemostatic agents have been developed and widely used in various branches of surgery.4 Recently, Rogers et al.3 showed that surgical sealants are effective and rapid in reducing suture-line bleeding in vascular anastomoses, with a small reduction in both duration of surgery and blood loss. The cyanoacrylate glue surgical sealant has some properties that make it particularly useful for the vascular surgeon: it can be easily and quickly prepared in the applicator device and easily applied; furthermore, its action is independent from coagulation factors. During our first operation, a thin film of this sealant was used to strengthen the proximal anastomosis because of the extremely poor quality and fragility of the vein. Currently used to strengthening coronary artery bypass graft, the cyanoacrylate glue seems to be more efficacious when compared to the other commercially available sealants in reinforcing the vascular anastomosis. Because of the poor vein quality in our patient, Teflon felt pledgets were judged not useful because of the theoretical risk of creating an anastomotic stenosis. Lumsden et al.11 showed that cyanoacrylate is effective at reducing time of hemostasis in femoral bypass procedures: for patients treated with cyanoacrylate surgical sealant, the mean time to hemostasis was 302 seconds faster than control; and no patient required further adjunctive hemostatic measures. Furthermore, an immediate hemostasis was obtained in 55% of the patients in whom the cyanoacrylate surgical sealant was used as compared with 10% of the control group. Our center followed up on patients, who underwent femoroinfrapopliteal vein graft, every one, four, six months and thereafter once a year, consisting of an outpatient visit using control B-mode ultrasonography and color imaging with ankle brachial index measurements. However, our controls showed no specific alteration during the first six months, but after one year an extrinsic compression by a calcified tissue involving proximal anastomosis
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was found. We assumed that this slowly calcifying tissue was the result of a chronic reaction to the cyanoacrylate glue during the follow-up. Various studies have analyzed the toxicity and possible carcinogenicity of cyanoacrylates. Leggat et al.12 highlighted that cyanoacrylates have been shown to cause inflammation and tissue necrosis in vivo and cytotoxic in vitro; in other studies these concerns have been downgraded.13,14 Montanaro et al.15 demonstrated that cytotoxicity was severe with the undiluted cyanoacrylate glue, whereas it was acceptable when the glue was diluted. At present the safety of absorbable type of cyanoacrylate for internal use has been clearly assessed from a pilot16 and, thereafter, from a large multicenter study. 11 The concerns about carcinogenicity have also been resolved17,18; though isobutyl and n-butyl-cyanoacrylate have a mutagenic capacity at the standard Ames test, they are considered noncarcinogenic. In conclusion, cyanoacrylate glue is certainly an effective, easy and fast way to obtain hemostasis. However, it seems necessary to conduct more studies about its use in peripheral vascular surgery. Anastomotic reinforcement at least in peripheral reconstructive vascular surgery should be discouraged. The event of perianastomotic calcification first described herein might also be due to concurrent events, which are unknown. REFERENCES 1. McCready RA, Siderys H, Pittman JN, et al. Delayed postoperative bleeding from polytetrafluoroethylene carotid artery patches. J Vasc Surg 1992;15:661e3. 2. Gasbarro V, Traina L, Mascoli F, et al. Absorbable suture material in carotid surgery. Vasa 2015;44:451e7. 3. Rogers AC, Turley LP, Cross KS, et al. Meta-analysis of the use of surgical sealants for suture-hole bleeding in arterial anastomoses. Br J Surg 2016;103:1758e67. 4. Heher P, Ferguson J, Redl H, et al. An overview of surgical sealant devices: current approaches and future trends. Expert Rev Med Devices 2018;15:747e55. 5. Sapienza P, Venturini L, Grande R, et al. Is the endovascular treatment of mild iliac stenoses worthwhile to improve found healing in patients undergoing femorotibial bypass? Ann Vasc Surg 2018;47:162e9. 6. Sapienza P, Mingoli A, Sterpetti AV, et al. External iliac artery to tibial arteries vein graft for inaccessibile femoral artery. Ann Vasc Surg 2019;60:293e300. 7. Cavallaro A, Sterpetti AV, DiMarzo L, et al. Worsening of preoperative foot ischemia after occlusion of polytetrafluoroethylene femorotibial grafts: a comparison with saphenous vein grafts. Ann Vasc Surg 2013;27:634e7. 8. van de Weijer MAJ, Kruse RR, Schamp K, et al. Morbidity of femoropopliteal bypass surgery. Semin Vasc Surg 2015;28:112e21. 9. Sapienza P, Mingoli A, Borrelli V, et al. Inflammatory biomarkers, vascular procedures of lower limbs, and wound healing. Int Wound J 2019;16:716e23.
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10. Sapienza P, Mingoli A, Borrelli V, et al. Different inflammatory cytokines release after open and endovascular reconstructions influence wound healing. Int Wound J 2019;16: 1034e44. 11. Lumsden AB, Heyman ER. Closure Medical Surgical Sealant Study Group. Prospective randomized study evaluating an absorbable cyanoacrylate for use in vascular reconstructions. J Vasc Surg 2006;44:1002e9. 12. Leggat PA, Smith DR, Kedjarune U. Surgical applications of cyanoacrylate adhesives: a review of toxicity. ANZ J Surg 2007;77:209e13. 13. Thumwanit V, Kedjarune U. Cytotoxicity of polymerized commercial cyanoacrylate adhesive on cultured human oral fibroblasts. Aust Dent J 1999;44:248e52.
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14. Lim JI, Kim JH. Enhanced biocompatibility and adhesive properties of modified allyl 2-cyanoacrylate-based elastic bio-glues. Colloids Surf B Biointerfaces 2015;133:19e23. 15. Montanaro L, Arciola CR, Cenni E, et al. Cytotoxicity, blood compatibility and antimicrobial activity of two cyanoacrylate glues for surgical use. Biomaterials 2001;22:59e66. 16. Schenk WG III, Spotnitz WD, Burks SG, et al. Absorbable cyanoacrylate as a vascular hemostatic sealant: a preliminary trial. Am Surg 2005;71:658e61. 17. Sampson D, Marshall D. Carcinogenic potential of isobutyl2-cyanoacrylate. J Neurosurg 1986;65:571e2. 18. Vinters HV, Galil KA, Lundie MJ, et al. The histotoxicity of cyanoacrylates. A selective review. Neuroradiology 1985;27:279e91.