Contrast-Free Endovascular Aneurysm Repair Combined With Fibrin Sealant Filling for Treating Abdominal Aortic Aneurysm: Technical Note.

INTRODUCTION: Endovascular aneurysm repair using iodinated contrast agents risks contrast-induced nephropathy, especially in high-risk patients. This technical note describes a contrast-free endovascular aneurysm repair (EVAR) protocol using preoperative imaging measurement and fibrin sealant (FS) filling. TECHNIQUE: Preoperative imaging measurement and intraoperative guidewire manipulation facilitated anatomical identification without contrast. After endograft deployment, the aneurysm sac was filled with FS if endoleak was indicated by pressure fluctuations. RESULT: Between 2017 and 2020, 6 high-risk patients underwent contrast-free EVAR with FS filling. Complete exclusion was achieved in all cases. Over follow-up, no endoleaks, deterioration in renal function, or other complications were observed. CONCLUSION: Contrast-free EVAR with FS filling shows early feasibility as an alternative technique for contrast-induced nephropathy (CIN) high-risk patients, while larger studies with long-term monitoring are imperative to validate outcomes. CLINICAL IMPACT: This study showcases a contrast-free EVAR technique with fibrin sealant filling for high-risk CIN patients. It offers a safer approach for those with renal challenges, reducing CIN risk. The technique's feasibility in a small cohort suggests its utility in treating AAA without iodinated contrast, crucial for patients with specific health risks. For clinicians, it introduces a method that decreases nephrotoxic risks, potentially changing practice for vulnerable patients.

Management of Tarlov cysts: an uncommon but potentially serious spinal column disease-review of the literature and experience with over 1000 referrals.

Tarlov cysts were thought to be anatomic variants of uncertain etiology and clinical significance when initially described over 80 years ago. They are often detected in routine lumbosacral imaging and generally not reported in a differential diagnosis. There is increasing evidence that at least some Tarlov cysts are symptomatic and can have a significant adverse impact on patients' health and well-being. Women are disproportionately affected with this condition, often presenting with long-standing pain and neurological dysfunctions. Significant gender bias has been a concern in the management of these patients. Unfortunately, there is no consensus on patient selection or management approaches for symptomatic Tarlov cysts. This review article updates information on the prevalence, diagnosis, clinical significance, and treatments of these cysts. Based on these findings and experience with over 1000 patient referrals, a treatment decision algorithm for symptomatic Tarlov cysts was constructed to provide guidance for appropriate management of patients with these complex cysts.

Fibrin sealant for closure of mucosal penetration at the oesophagus or cardia during submucosal tunnelling endoscopic resection for gastrointestinal submucosal tumours.

BACKGROUND AND STUDY AIM: To assess the efficacy and safety of a fibrin sealant for the prevention of leak resulting from mucosal penetration at the esophagus or cardia during a STER procedure to remove gastrointestinal submucosal tumors (SMTs). PATIENTS AND METHODS: Between April 2014 and October 2022, a total of 290 patients with oesophageal or cardiac SMTs underwent STER at our centre. We retrospectively identified patients with oesophageal or cardia SMTs who underwent STER and experienced mucosal penetration of the cardia or oesophagus during the procedure. A total of 31 mucosal penetrations in 30 procedures were included. Of the 31 mucosal penetrations, 12 occurred in the cardia, and the other 19 occurred in the oesophagus. All 31 sites received the fibrin sealant to close the mucosal penetration. Clinical characteristics, procedure-related parameters, detailed data of the mucosal penetrations, and treatment outcomes using the fibrin sealant were reviewed for all 30 patients to assess the efficacy and safety of the fibrin sealant for closure of mucosal penetration at the cardia or oesophagus. RESULTS: For the 31 mucosal penetrations, the mean size was 0.08 ± 0.06 cm2 (range 0.01-0.25 cm2). Mucosal closure using the fibrin sealant was performed successfully in all 31 mucosal penetrations. Of the 31 mucosal penetrations, clips were used in 13 cases. All 30 patients were discharged after a median of 7 days (range 4-20 day) postoperatively. During a mean 62 months (range 6-107 months) follow-up, all 31 mucosal penetrations successfully healed without the occurrence of infection, ulcer, oesophagitis, chest infection or abdominal infection. CONCLUSION: For the closure of mucosal penetration during STER at the cardia or oesophagus, a fibrin sealant is both safe and efficacious. It is necessary to conduct more research on the viability, effectiveness, and safety of using a fibrin sealant to close wider mucosal penetrations.

Safety and effectiveness of Evicel® fibrin sealant as an adjunct to sutured dural repair in children undergoing cranial neurosurgery.

PURPOSE: Cerebrospinal fluid (CSF) leakage is a challenging complication of intradural cranial surgery, and children are particularly at risk. The use of dural sealants confers protection in adults, but pediatric studies are scarce. We evaluated the safety and efficacy of Evicel® fibrin sealant as an adjunct to primary dural suturing in children undergoing cranial surgery. METHODS: A multicenter trial prospectively enrolled pediatric subjects (< 18 years) undergoing cranial neurosurgery who, upon completion of primary sutured dural repair, experienced CSF leakage. As agreed by the EMA Evicel® Pediatric Investigation Plan, 40 subjects were intra-operatively randomized 2:1 to Evicel® or additional sutures ('Sutures'). Data analysis was descriptive. The efficacy endpoint was treatment success rate, with success defined as intra-operative watertight closure after provocative Valsalva maneuver (primary endpoint). Safety endpoints were postoperative CSF leakage (incisional CSF leakage, pseudomeningocele or both) and surgical site complications (secondary endpoints). RESULTS: Forty subjects (0.6-17 years) were randomized to Evicel® (N = 25) or Sutures (N = 15) (intention-to-treat). Intracranial tumor was the most common indication and procedures were mostly supratentorial craniotomies. Success rates were 92.0% for Evicel® and 33.3% for Sutures, with a 2.76 estimated ratio of success rates (Farrington-Manning 95% CI [1.53, 6.16]). Sensitivity analyses in per-protocol and safety sets showed similar results. Despite a higher rescue treatment rate, the frequencies of postoperative CSF leakage and wound complications were higher for Sutures than for Evicel®. CONCLUSION: This small-scale prospective study shows Evicel® treatment to be safe and effective as an adjunct to primary sutured dura mater closure in a pediatric population. Compared to additional sutures, Evicel® was associated with reduced postoperative CSF leakage and surgical site complications. (Trial registration: The trial was registered as NCT02309645 and EudraCT 2013-003558-26).

A Systematic Review: Fibrin Glue in Drainless Rhytidoplasty.

The following questions guided the study: Can the use of fibrin glue in drainless rhytidoplasty reduce hematoma prevalence, seroma prevalence increase patient satisfaction or decrease the length of hospital in the adult population compared with standard treatment? The following inclusion and exclusion criteria apply: The procedure performed was rhytidoplasty for both groups. Participants were limited to adults who did not have any other procedure performed during the study. The intervention consisted of the use of fibrin glue without drains compared to the control group, in which drains and/or pressure dressing were applied. Databases: clinicaltrials.gov, MEDLINE, COCHRANE, mRCT, PubMed, Google Scholar, Scopus, Embase, VHL, GHL were searched on 03/25/2023 by 2 different investigators. The Cochrane Risk of Bias Tool 2.0 was used. Five studies were included with a total number of 1277 participants (2554 face sides). The cumulative hematoma rate was OR 0.47 (95% CI 0.26-0.84) in favor of using fibrin glue. Insufficient data were available to assess seroma rate, patient satisfaction, and length of hospital stay. The risk of study bias was judged to be low and moderate. The certainty for the use of fibrin sealant versus drainage is high and the importance of outcomes is rated as important in the GRADEpro GDT tool. Fibrin glue use is more beneficial comparing to drainage in patients undergoing rhytidectomy in terms of hematoma prevalence. This study was registered in PROSPERO (CRD42023421475).Level of Evidence I This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Thoracoscopic Management of Chylothorax by Application of a Fibrin Sealant Patch.

Thoracic duct ligation is a demanding procedure when the chyle leak and/or the duct itself are not identified. This report describes a new procedure using thoracoscopic closure of the chyle leak by application of a fibrin sealant patch. This strategy was successfully applied for closing (i) a small fistula due to a postoperative lesion of the lymphatic tributary vessels in one case, and (ii) a large fistula due to idiopathic rupture of the thoracic duct in another case.

An Outcome Analysis of Fibrin Sealant versus Staples for Fixation of Split-Thickness Skin Grafts.

Background Skin grafting plays a vital role in post-burn and post-traumatic wound management. Split-thickness skin grafts (STSG) are traditionally fixed using staples or sutures, which have tedious application and their removal necessitates painkillers, medical equipment, and human intervention. As an alternative, fibrin sealant is a biological tissue adhesive, composed of thrombin, calcium, and fibrinogen. Fibrin sealant promotes hemostasis and acts as a biological adherent. Objective The aim of this study was to evaluate the outcomes (graft take, wound healing and complications) of fibrin sealant and staples for STSG fixation. Methods It is a randomized controlled trial on 40 patients with wounds of minimum 400 cm 2 . Wound area was divided into equal halves and randomly allocated to the study group or control group. In the study group, 4 mL per 200 cm 2 of fibrin sealant was sprayed followed by STSG application. In the control group, STSG was fixed with only skin staples. Evaluation was done on postoperative days 3, 5, 15, and 30 for graft take, hematoma/seroma, infection, and complete wound healing. Results The mean graft take was significantly higher ( p -value < 0.05) in the study group than in the control group (91 vs. 89%). No seroma or hematoma formation was seen in either group. Complete wound healing was seen in more patients in the study group, but the difference was statistically insignificant. Conclusion Fibrin sealant is an excellent alternative to staples for skin grafting, with the advantage of better graft take and being free of pain that is incurred during staple removal.

Volumetric analysis of effectiveness of embolization for preventing type II endoleaks following endovascular aortic aneurysm repair.

OBJECTIVE: The presence of endoleak was associated with the failure of endovascular aortic aneurysm repair (EVAR) treatment. The key to eliminating type II endoleak has shifted from reintervention to prevention. This study aimed to evaluate the effectiveness and safety of applying fibrin sealant to prevent type II endoleak in conjunction with EVAR. METHODS: All patients with abdominal aortic aneurysm who underwent EVAR from June 2019 to July 2021 were reviewed. Patients were grouped as Group A: standard EVAR with preemptive embolization and Group B: standard EVAR alone. The primary endpoint was the incidence of type II endoleak. The secondary endpoints were aneurysm sac regression, the inferior mesenteric artery patency, the numbers of patent lumbar arteries, and all-cause mortality. RESULTS: A total of 104 patients were included in Group A, and 116 were included in Group B. Technical success rate was 100%. The overall incidence of type II endoleak in Group A was significantly lower than that in Group B (4.8% vs 19.0%). The mean time of freedom from type II endoleak was 22.71 months for Group A (95% confidence interval, 21.59-23.83 months) and 19.89 months for Group B (95% confidence interval, 18.08-21.70 months). The Kaplan-Meier estimate of freedom from type II endoleak showed a significantly longer duration of freedom from type II endoleak in Group A (81.0% vs 95.2%). Group A showed a continuous sac regression tendency. In Group B, the sac volume decreased within 12 months but increased by 3.07 cm3 at 24 months. No complications were noted in both groups. CONCLUSIONS: Nonselective preemptive embolization with porcine fibrin sealant during EVAR was safe and effective in preventing type II endoleak in the short and mid-term. Preemptive embolization can lead to a significantly higher sac regression rate. Larger patient populations and longer follow-ups with randomized control designed trials are expected to verify the long-term effectiveness and safety of preemptive embolization in preventing type II endoleak.

Neuroregeneration and immune response after neurorrhaphy are improved with the use of heterologous fibrin biopolymer in addition to suture repair alone.

INTRODUCTION/AIMS: Peripheral nerve injuries result in impaired neuromuscular interactions, leading to morphological and functional alterations. Adjuvant suture repair methods have been used to improve nerve regeneration and modulate the immune response. Heterologous fibrin biopolymer (HFB), a scaffold with adhesive properties, plays a critical role in tissue repair. The aim of this study is to evaluate neuroregeneration and immune response focusing on neuromuscular recovery, using suture-associated HFB for sciatic nerve repair. METHODS: Forty adult male Wistar rats were distributed into four groups (n = 10): C (control), only sciatic nerve location; D (denervated), neurotmesis and 6-mm gap removal and fixation stumps in subcutaneous tissue; S (suture), neurotmesis followed by suture; and SB (suture + HFB), neurotmesis followed by suture and HFB. Analysis of M2 macrophages (CD206+ ), as well as the morphology and morphometry of nerves, soleus muscle, and neuromuscular junctions (NMJs), were performed at 7 and 30 days after surgery. RESULTS: The SB group had the highest M2 macrophage area in both periods. After 7 days, SB was the only group similar to the C group regarding the number of axons; furthermore, after 30 days, the SB group was closer to the C group concerning blood vessel and central myonuclear numbers, NMJ angle, and connective tissue volume. After 7 days, increases in nerve area, as well as the number and area of blood vessels, were also observed in SB. DISCUSSION: HFB potentiates the immune response, increases axonal regeneration, induces angiogenesis, prevents severe muscle degeneration, and assists in NMJ recovery. In conclusion, suture-associated HFB has major implications for improved peripheral nerve repair.

Impact of drainless neck dissection on surgical outcome: a matched case-control study.

PURPOSE: The safety of drainless lateral neck dissection (ND) remains to be proven. Hereby, we describe outcomes of drainless ND using fibrin sealant (FS). METHODS: A retrospective, single academic institute, matched cased control. The study group included patients who underwent drainless ND (drainless group), matched to control patients by age, sex, body mass index, laterality and median number of levels dissected. Additional comparison of patients who underwent at least II-IV lateral ND for a thyroid cancer indication was also conducted. Outcomes were post-operative seroma\infections. RESULTS: A total of 118 patients (42 cases and 76 controls) were included in the study. Groups did not differ in pre-operative characteristics, percentage of bilateral ND, and extension of ND. No significant difference was found in terms of post-operative infections, seroma, aspirations, and post-operative antibiotic use. The additional analysis included 23 drainless lateral ND and matched controls, of which 91% underwent concomitant level V dissection. No significant difference was found in terms of post-operative seroma or infection. These findings were confirmed with a multivariate analysis. CONCLUSIONS: Drainless ND using FS in non-violating mucosa surgeries appears to be feasible and safe, without significantly increasing post-operative seroma and its associated complications.

NHS-POx-loaded patch versus fibrin sealant patch in a porcine robotic liver bleeding model.

BACKGROUND: The management of bleeding is paramount to any surgical procedure. With the increased use of less invasive laparoscopic and robotic methods, achieving hemostasis can be challenging since the surgeons cannot manually apply hemostatic agents directly onto bleeding tissue. In this study, we assessed the use of a pliable hemostatic sealant patch comprising fibrous gelatin carrier impregnated with poly(2-oxazoline) (NHS-POx) for hemostasis in robotic liver resection in a porcine bleeding model. METHODS: The NHS-POx-loaded patch (GATT-Patch), was first evaluated in a Feasibility Study to treat surgical bleeding in 10 lesions, followed by a Comparative Study in which the NHS-POx patch was compared to a standard-of-care fibrin sealant patch (TachoSil), in 36 lesions (superficial, resection, or deep injuries mimicking metastasectomies). For each lesion type, the NHS-POx and fibrin sealant patches were used in an alternating fashion with 18 lesions treated with NHS-POx and 18 with the fibrin patch. Animal preparation and surgical procedures were consistent across studies. The primary outcome was time to hemostasis (TTH) within 3 min for the Feasibility Study and within 5 min for the Comparative Study. RESULTS: In the Feasibility Study, 8 of the 10 NHS-POx-treated lesions achieved hemostasis at 30 s and 3 min. In the Comparative Study, all 18 NHS-POx patch-treated lesions and 9 of the 18 fibrin sealant patch-treated lesions achieved hemostasis at 5 min. Median TTH with NHS-POx vs fibrin sealant patch was 30 vs 300 s (P < 0.001). CONCLUSIONS: In this animal study, hemostasis during robotic liver surgery was achieved faster and more often with the NHS-POx loaded vs fibrin sealant patch.

Tissue Bioengineering with Fibrin Scaffolds and Deproteinized Bone Matrix Associated or Not with the Transoperative Laser Photobiomodulation Protocol.

Extending the range of use of the heterologous fibrin biopolymer, this pre-clinical study showed a new proportionality of its components directed to the formation of scaffold with a lower density of the resulting mesh to facilitate the infiltration of bone cells, and combined with therapy by laser photobiomodulation, in order to accelerate the repair process and decrease the morphofunctional recovery time. Thus, a transoperative protocol of laser photobiomodulation (L) was evaluated in critical bone defects filled with deproteinized bovine bone particles (P) associated with heterologous fibrin biopolymer (HF). The groups were: BCL (blood clot + laser); HF; HFL; PHF (P+HF); PHFL (P+HF+L). Microtomographically, bone volume (BV) at 14 days, was higher in the PHF and PHFL groups (10.45 ± 3.31 mm3 and 9.94 ± 1.51 mm3), significantly increasing in the BCL, HFL and PHFL groups. Histologically, in all experimental groups, the defects were not reestablished either in the external cortical bone or in the epidural, occurring only in partial bone repair. At 42 days, the bone area (BA) increased in all groups, being significantly higher in the laser-treated groups. The quantification of bone collagen fibers showed that the percentage of collagen fibers in the bone tissue was similar between the groups for each experimental period, but significantly higher at 42 days (35.71 ± 6.89%) compared to 14 days (18.94 ± 6.86%). It can be concluded that the results of the present study denote potential effects of laser radiation capable of inducing functional bone regeneration, through the synergistic combination of biomaterials and the new ratio of heterologous fibrin biopolymer components (1:1:1) was able to make the resulting fibrin mesh less dense and susceptible to cellular permeability. Thus, the best fibrinogen concentration should be evaluated to find the ideal heterologous fibrin scaffold.

A comparative study of conventional intermarginal split lamella with labial mucous membrane graft versus sutureless procedure using fibrin sealant to manage major trichiasis.

OBJECTIVE: In the intermarginal split lamella with labial mucous membrane graft procedure to manage major trichiasis, the graft is usually sutured in the receptor bed using 6-0 polyglactin sutures. We aimed to compare the use of fibrin sealant to seal the graft to the receptor bed versus the conventional technique using sutures. METHODS: This is a retrospective comparative study of patients who underwent conventional intermarginal split lamella with labial mucous membrane graft or sutureless procedure using fibrin sealant (Tisseel, Baxter Healthcare Corp) between 2016 and 2021. Etiology of the trichiasis, procedure duration, postoperative discomfort and edema, complications, and follow-up period were extracted from these patients' charts. RESULTS: Twenty-seven eyelids from 19 patients underwent the procedure: twelve patients underwent the sutureless procedure, while seven underwent the conventional procedure. Mean follow-up was 8.4 ± 2.9 months and 13.7 ± 6.5 months for the sutureless and conventional groups, respectively. Patients who underwent the sutureless procedure reported no postoperative foreign body sensation, while 71.4% of patients who underwent the conventional procedure reported some degree of ocular discomfort. In the sutureless group, operating time and postoperative edema were significantly reduced. Labial mucous membrane graft dehiscence was observed in one eyelid (8.3%) on the first postoperative day in the sutureless group. No dehiscence was observed in the conventional technique group. CONCLUSION: The use of fibrin sealant showed to be a good alternative to conventional absorbable sutures. Advantages include expedited operating time, decreased postoperative discomfort, and expedite postoperative recovery.

Tissue sealant versus surgical drain following parotidectomy.

PURPOSE: Sialocele and salivary fistula are recognised complications of parotid surgery and have been reported to be more common with less extensive parotidectomy. We investigated the efficacy of tissue sealant(Cunniffe et al., 2019) 1 as an alternative to surgical drainage in terms of length of hospital stay (LOS), cost, and incidence of wound complications. METHODS: The study comprised a retrospective review of a prospectively maintained parotidectomy database at a single tertiary Head and Neck referral centre between 2009 and 2020. Cases undergoing concomitant neck dissection or major skin resection were excluded. Patients were divided into Group 1 (without tissue sealant), and Group 2 (with tissue sealant). Patients were also divided based on extent of surgery 1) Extracapsular dissection/Partial superficial parotidectomy 2) Superficial/total parotidectomy. RESULTS: Of 202 included patients, there were 146 in Group 1 (143 with drain), and 56 in Group 2 (7 with drain). Compared to Group 1, Group 2 had a significantly shorter LOS (mean 1.4 ± 0.98 versus 3.1 ± 1.29 days, p < 0.05) and estimated cost (€1386 versus €2736). There was no significant difference in the complication rates (15.8% Group 1 versus 10.7% Group 2, p = 0.50). Group 1 showed a higher incidence of complications in patients undergoing less extensive parotidectomy (19/70 versus 4/76, p = 0.02), whereas in Group 2, the difference was not significant (5/30 versus 1/26, p = 0.20). CONCLUSION: The use of tissue sealant as an alternative to surgical drains after parotidectomy facilitates reduced LOS and cost savings without increase in morbidity.

Evaluation of Fibrin Sealant in Prevention of Cervical Anastomotic Leakage After McKeown Esophagectomy: A Single-Center, Retrospective Study.

BACKGROUND: Anastomotic leakage remains an issue after esophagectomy for patients with esophageal or esophagogastric junction cancer. Previous studies have indicated that the intraoperative application of fibrin sealant may reduce the incidence of postoperative anastomotic leakage. This retrospective study was aimed to evaluate the efficacy and safety of fibrin sealant in the prevention of anastomotic leakage in patients undergoing McKeown esophagectomy. METHODS: We designed a single-center, retrospective study. Between January 2018 and December 2019, 227 patients with esophageal or esophagogastric junction cancer undergoing McKeown esophagectomy performed by our team were retrospectively identified, of whom 86 patients were included in the FS group and 141 patients were included in the control group. Intraoperatively, 2.5 ml of porcine fibrin sealant was applied circumferentially to the cervical anastomosis after the anastomosis was created in the FS group. The primary outcome was the incidence of cervical anastomotic leakage within the first three months after surgery. RESULTS: The differences in baseline clinical characteristics between the two groups were not significant except for a history of drinking. In the FS group, the postoperative cervical anastomotic leakage rate was lower (FS group: 4.7% [4 of 82] vs. control group: 19.9% [28 of 141], p < 0.01). Multivariate logistic regression showed that the intraoperative application of fibrin sealant was an independent protective factor for anastomotic leakage (OR 0.169, 95% CI 0.055-0.515, p = 0.002). CONCLUSIONS: The intraoperative application of fibrin sealant could possibly prevent cervical anastomotic leakage after McKeown esophagectomy with satisfactory safety. Further prospective clinical trials are warranted.

A Fibrin Coating Method of Polypropylene Meshes Enables the Adhesion of Menstrual Blood-Derived Mesenchymal Stromal Cells: A New Delivery Strategy for Stem Cell-Based Therapies.

Polypropylene (PP) mesh is well-known as a gold standard of all prosthetic materials of choice for the reinforcement of soft tissues in case of hernia, organ prolapse, and urinary incontinence. The adverse effects that follow surgical mesh implantation remain an unmet medical challenge. Herein, it is outlined a new approach to allow viability and adhesion of human menstrual blood-derived mesenchymal stromal cells (MenSCs) on PP surgical meshes. A multilayered fibrin coating, based on fibrinogen and thrombin from a commercial fibrin sealant, was optimized to guarantee a homogeneous and stratified film on PP mesh. MenSCs were seeded on the optimized fibrin-coated meshes and their adhesion, viability, phenotype, gene expression, and immunomodulatory capacity were fully evaluated. This coating guaranteed MenSC viability, adhesion and did not trigger any change in their stemness and inflammatory profile. Additionally, MenSCs seeded on fibrin-coated meshes significantly decreased CD4+ and CD8+ T cell proliferation, compared to in vitro stimulated lymphocytes (p < 0.0001). Hence, the proposed fibrin coating for PP surgical meshes may allow the local administration of stromal cells and the reduction of the exacerbated inflammatory response following mesh implantation surgery. Reproducible and easy to adapt to other cell types, this method undoubtedly requires a multidisciplinary and translational approach to be improved for future clinical uses.

Does autologous fibrin sealant (vivostat©) reduce the incidence of postoperative pancreatic fistula after distal pancreatectomy? - a matched pairs analysis.

BACKGROUND: Postoperative pancreatic fistula (POPF) is the most common complication following distal pancreatectomy. This retrospective study investigated the effects of autologous fibrin sealant (Vivostat©) in reducing the incidence of POPF after distal pancreatectomy. METHODS: A matched pairs analysis was performed to compare the incidence of clinically relevant POPF of 41 patients who underwent a distal pancreatectomy with application of autologous fibrin sealant (Vivostat©) with a historical control group. RESULTS: Clinically relevant POPF were present in 11 patients in the study group (27%) and in 13 patients in the control group (32%, p = .639). No patient of the study group required emergency angiographic treatment for postoperative hemorrhage due to POPF, whereas three patients were identified in the control group (7%, p = .079). CONCLUSIONS: POPF cannot be prevented under treatment with autologous fibrin sealant (Vivostat©). We observed the tendency of a lower rate of postoperative pancreatic hemorrhage due to POPF. However, prospective randomized controlled studies are required.

Fibrin and Thrombin Sealants in Vascular and Cardiac Surgery: A Systematic Review and Meta-analysis.

OBJECTIVE: In vascular and cardiac surgery, the ability to maintain haemostasis and seal haemorrhagic tissues is key. Fibrin and thrombin based sealants were introduced as a means to prevent or halt bleeding during surgery. Whether fibrin and thrombin sealants affect surgical outcomes is poorly established. A systematic review and meta-analysis was performed to examine the impact of fibrin or thrombin sealants on patient outcomes in vascular and cardiac surgery. DATA SOURCES: Cochrane CENTRAL, Embase, and MEDLINE, as well as trial registries, conference abstracts, and reference lists of included articles were searched from inception to December 2019. REVIEW METHODS: Studies comparing the use of fibrin or thrombin sealant with either an active (other haemostatic methods) or standard surgical haemostatic control in vascular and cardiac surgery were searched for. The Cochrane risk of bias tool and the ROBINS-I tool (Risk Of Bias In Non-randomised Studies - of Interventions) were used to assess the risk of bias of the included randomised and non-randomised studies; quality of evidence was assessed by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. Two reviewers screened studies, assessed risk of bias, and extracted data independently and in duplicate. Data from included trials were pooled using a random effects model. RESULTS: Twenty-one studies (n = 7 622 patients) were included: 13 randomised controlled trials (RCTs), five retrospective, and three prospective cohort studies. Meta-analysis of the RCTs showed a statistically significant decrease in the volume of blood lost (mean difference 120.7 mL, in favour of sealant use [95% confidence interval {CI} -150.6 - -90.7; p < .001], moderate quality). Time to haemostasis was also shown to be reduced in patients receiving sealant (mean difference -2.5 minutes [95% CI -4.0 - -1.1; p < .001], low quality). Post-operative blood transfusions, re-operation due to bleeding, and 30 day mortality were not significantly different for either RCTs or observational data. CONCLUSION: The use of fibrin and thrombin sealants confers a statistically significant but clinically small reduction in blood loss and time to haemostasis; it does not reduce blood transfusion. These Results may support selective rather than routine use of fibrin and thrombin sealants in vascular and cardiac surgery.

Effectiveness of fibrin sealant as hemostatic technique in accelerating ESD-induced ulcer healing: a retrospective study.

OBJECTIVES: Healing of gastric endoscopic submucosal dissection (ESD)-induced ulcer is critical for patient recovery. During ESD treatment, submucosal incisions are made with an electrosurgical knife to accomplish en bloc resections of superficial lesions. Nevertheless, excess electrocoagulation may decrease the blood supply of ESD-induced ulcer and delay the ulcer healing. The aim of this retrospective study was to evaluate the effectiveness of conservative electrocoagulation followed by porcine fibrin sealant (FS) as a wound microvessels-protective hemostatic technique in promoting the healing of ESD-induced ulcer. METHODS: A total of 332 patients with early gastric cancer (EGCs), or gastric precancerous lesion and gastric adenoma were retrospectively analyzed. Propensity score matching was used to compensate for the differences in age, gender, tumor location, resected specimen area, and pathology. One-month ulcer healing rates and delayed bleeding were compared between two matched groups (combined hemostats group and electrocautery group). RESULTS: A total of 115 matched pairs were created after propensity score matching. There was no difference in tumor location, specimen surface area, tumor differentiation and invasion depth between groups. The completed healing rate 1 month after ESD was 44.3% in combined hemostats group and 30.4% in electrocautery group (P = 0.004). There was no difference in delayed massive bleeding rate between two groups (P = 0.300). In addition, based on the multivariate regression analysis for ulcer healing rate, the use of FS (OR, 0.348, 95% CI 0.196 - 0.617, P = 0.000) and larger specimen size (OR, 2.640, 95% CI 2.015-3.458, P = 0.000) were associated with nonhealing ulcer 1 month after ESD. CONCLUSION: Applying conservative electrocoagulation followed by porcine FS as a wound microvessels-protective hemostatic technique can promote ESD-induced ulcer healing without increasing delayed bleeding.

Long-term outcome and chronic pain in atraumatic fibrin glue versus staple fixation of extra light titanized meshes in laparoscopic inguinal hernia repair (TAPP): a single-center experience.

BACKGROUND: Inguinal hernia repair belongs to the most frequently performed surgical procedures. Endoscopic techniques like TAPP and TEP have become standard of care together with the conventional open techniques. Especially in endoscopic techniques, there is a confusing amount of different meshes and fixation techniques with impact on perioperative and long-term outcome. We present the first single-center data on the use of titanized extra lightweight meshes and fibrin glue fixation compared to staple fixation regarding long-term outcome, especially chronic pain. MATERIALS AND METHODS: A clinical trial with retrospective analysis of patient- and procedure-related data and questionnaire-based follow-up of TAPP procedures performed in 2012-2014 was conducted in a specialized hernia center. Standard TAPP technique was used with placement of TiMesh extra light (16 g/m2) and either fibrin glue or staple fixation. Procedure- and patient-related data are compared after propensity score matching regarding perioperative complications and long-term outcome. RESULTS: Of 612 TAPP procedures 372 procedures were included in analysis after propensity score matching. Fibrin glue was used in n = 279 and staple fixation in n = 93 cases. There were significant differences regarding duration of the surgical procedures (p = 0.001) and distribution of mesh size. No differences were noted regarding perioperative complications such as seroma or hematoma formation and need for re-laparoscopy. During a mean follow-up of 32.1 ± 20.6 month with a follow-up rate of 79%, there was no difference in long-term outcome, especially for rate of recurrence (p = 0.112) and development of chronic pain (p = 0.846). The overall rate of recurrence was 3.0% (n = 11), and in 2.4% (n = 9) patients complained of chronic pain. CONCLUSION: Inguinal hernia repair using extra lightweight titanized meshes and fibrin glue fixation is safe and feasible compared to staple fixation even in large and combined hernia defects, if mesh size is adjusted to size of hernia defect. The rate of chronic pain was extremely low at 2.4%.