Use Of Biosynthetic Mesh Research Articles

Comparative anatomic and symptomatic recurrence outcomes of diaphragmatic suture cruroplasty versus biosynthetic mesh reinforcement in robotic hiatal and paraesophageal hernia repair.

Hiatal and paraesophageal hernia (HH/PEH) recurrence is the most common cause of failure after gastroesophageal anti-reflux surgery. Crural reinforcement with mesh has been suggested to address this issue, but its efficacy remains debated. In this study, we aimed to determine the impact of biosynthetic mesh reinforcement compared to suture cruroplasty on anatomic and symptomatic hernia recurrence. Data of patients who underwent robotic HH/PEH repair with suture cruroplasty with or without biosynthetic mesh reinforcement between January 2012 and April 2024 were retrospectively reviewed. Gastroesophageal reflux disease symptoms and anatomic hernia recurrence were assessed at short-term (3months to 1year) and longer-term (≥ 1year) follow-up. Symptomatic hernia recurrence was defined as having both anatomic recurrence and symptoms. Out of the 503 patients in the study, 308 had undergone biosynthetic mesh repair, while 195 had suture-only repair. After the surgery, both groups demonstrated comparable improvements in symptoms. Short-term anatomic hernia recurrence rates were 11.8% and 15.6% for mesh and suture groups, respectively (p = 0.609), while longer-term rates were 24.7% and 44.9% (p = 0.015). The rates of symptomatic hernia recurrence in the same group were 8.8% and 14.6% in the short-term (p = 0.256), and 17.2% and 42.2% in longer-term follow-ups (p = 0.003). In the repair of medium and large-size hernias, mesh reinforcement resulted in a 50.0% relative risk reduction in anatomic hernia recurrences and a 59.2% reduction in symptomatic hernia recurrences at ≥ 1-year follow-up. After more than a year of follow-up, it has been found that using biosynthetic mesh for medium and large hiatal or paraesophageal hernia repair significantly reduces the likelihood of both anatomic and symptomatic recurrence compared to using only suture cruroplasty. These findings strongly support the use of biosynthetic mesh to manage larger hernias. However, further long-term multicenter randomized studies are needed to provide more conclusive evidence.

Does crural repair with biosynthetic mesh improve outcomes of revisional surgery for recurrent hiatal hernia?

BackgroundLaparoscopic revisional surgery for recurrent hiatal hernia (HH) is technically demanding. Re-recurrences are common and esophageal hiatus mesh reinforcement might improve durability of the repair, thus minimizing the risk of re-herniation.PurposeAssess safety and effectiveness of simple suture repair (no mesh group) vs. crural augmentation with a biosynthetic absorbable mesh (mesh group) in patients with recurrent HH.MethodsObservational retrospective study from September 2012 to December 2022. Only patients undergoing redo surgery for previous failures of hiatal hernia repair were enrolled. Surgical failure was defined as symptomatic recurrent HH with > 2 cm of gastric tissue above the diaphragmatic impression at upper gastrointestinal endoscopy and/or swallow study. Gastro-Esophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) and Short Form-36 (SF-36) questionnaires were used to assess and preoperative and postoperative symptoms and quality of life.ResultsOne hundred four patients were included. Overall, 60 patients (57.7%) underwent mesh-reinforced cruroplasty, whereas 44 (42.3%) underwent simple suture cruroplasty. Mesh and no mesh groups had similar baseline demographics, symptoms, prevalence of esophagitis and Barrett’s esophagus, and HH size. A composite crural repair was most commonly performed in the mesh group (38.3% vs. 20.5%; p = 0.07). In addition to cruroplasty, most patients (91%) underwent a Toupet fundoplication. The 90-day postoperative complication rate was 8.6%, and there was no mortality. Recurrent HH was diagnosed in 21 patients (20.2%) with a clinical trend toward reduced incidence in the mesh group (16.7% vs. 25%; p = 0.06). Compared to baseline, there was a statistically significant improvement of median GERD-HRQL score (p < 0.01) and all SF-36 items (p < 0.01).ConclusionsLaparoscopic revisional surgery for recurrent HH is safe and effective. Selective use of biosynthetic mesh may protect from early recurrence and has the potential to reduce re-herniation in the long-term.

Long-term outcomes of PGA-TMC absorbable synthetic scaffold in both clean and contaminated ventral hernia repairs.

Biosynthetic meshes afford the cost advantages of being made from fully synthetic material, but are also biodegradable, making them a versatile option that can be used in both clean and contaminated cases. The aim of this study is to evaluate the safety profile and long-term outcomes of using GORE BIO-A (BIO-A) as an adjunct to abdominal wall reconstruction in all wound classes. A retrospective review identified patients undergoing abdominal hernia repair using BIO-A from October 2008 to June 2018. The primary outcome was hernia recurrence rate. Only patients with at least 6-month follow-up were included when looking at recurrence rates. Secondary outcomes included 30-day morbidity categorized according to CDC Surgical Site Infection Criteria, return to operating/procedure room (RTOR), 30-day readmission, length of stay (LOS), and mortality. A total of 207 patients were identified, CDC Wound Classification breakdown was 127 (61.4%), 41 (19.8%), 14 (6.8%), and 25 (12.1%) for wound classes I, II, III, and IV, respectively. Median follow-up was 55.4months (range 0.2-162.4). Overall recurrence rate was 17.4%. Contaminated cases experienced higher recurrence rates (28.8% versus 10.4%, p = 0.002) at a mean follow up of 46.9 and 60.8months for contaminated and clean patients, respectively. Recurrent patients had higher BMI (32.4 versus 28.4kg/m2, p = 0.0011), larger hernias (162.2 versus 106.7 cm2, p = 0.10), higher LOS (11.1 versus 5.6days, p = 0.0051), and higher RTOR rates (16.7% versus 5.6%, p = 0.053). 51 (24.5%) patients experienced some morbidity, including 19 (9.2%) surgical site occurences, 7 (3.4%) superficial surgical site infections, 16 (7.7%) deep surgical site infections, and 1 (0.5%) organ space infection. This study affirms the use of biosynthetic mesh as a cost-effective alternative in all wound classifications, yielding good outcomes, limited long-term complications, and low recurrence. rates.

635 ROBOTIC REDO FUNDUPLICATION FOR A TWO TIME RECURRENT HIATAL HERNIA. HOW WE DO?

Abstract In the video we perform the crural robotic reinforcement with de use of biosynthetic mesh (Gore Bio-A) without any funduplication in a 37 years-old woman with a two time hernia hiatal recurrence. Although laparoscopic surgery to treat primary hiatal hernias (HHs) is the gold standard approach, the use of robotic platforms seems to gain weight. This video aims to show the step-by-step in a redo hiatal surgery and the benefits of robotic surgery. Methods Here in the video we present a 37-year old woman patient who underwent previously two laparoscopic Nissen fundoplication because of hiatal hernia and gastroesophageal reflux disease. The first surgery was done in 2015 and the patient needed a laparoscopic redo due to hiatal relapse, done in 2019 with nonabsorbable mesh reinforcement. Posteriorly, the patient visited our clinic for epigastric pain and vomits. The proper study with gastroscopy, CT scan and barium swallow was ruled out, pointing a new relapse. With this results, the patient was purposed a redo cruroplasty with robotic approach. Results In the video we perform the crural robotic reinforcement with de use of biosynthetic absorbable mesh (Gore Bio-A) without any funduplication. This video aims to show the step-by-step in a redo hiatal surgery and the benefits of robotic surgery. In our short experience and according to the related publications we believe the robotic platform is feasible, safe and effective. Conclusion Although laparoscopic surgery to treat primary hiatal hernias (HHs) is the gold standard approach, the use of robotic platforms in complicated procedures such as relapsed hiatal hernias or gastroesophageal reflux disease (GERD) recurrence seems to gain weight. This is because of robotic approach may help in demanding surgeries with fibrosis and modified anatomy so it provides more precision with the articulating arms and better visualisation due to a 3D view and stable camera. Video https://drive.google.com/file/d/1BjwLWiEaNZWv6ULO9p-rec1LgSopfb1f/view?usp=sharing

Abdominal wall reconstruction using biosynthetic absorbable mesh in high-risk complex ventral hernia.

Biosynthetic mesh may represent an improvement on biological and large pore synthetic meshes for high-risk complex ventral hernia repair. This study aimed to evaluate the performance of polyglycolic acid (PGA):trimethylene carbonate (TMC) biosynthetic mesh for reinforcement of the midline fascial closure in a single-stage repair of complex ventral hernias in high-risk patients. A retrospective review was undertaken for patients who underwent a planned open single-stage complex ventral hernia repair with a single unit of PGA:TMC biosynthetic mesh between May 2013 and August 2017. Data on outcome variables were recorded and quality of life assessed using the Short Form-12 (SF-12) instrument. Overall, 56 patients underwent abdominal wall reconstruction for complex ventral hernias. All meshes were placed in the retrorectus position. Some 39% underwent component separation. The majority of patients (86%, n = 48) had high risk (grade 2 or 3) hernias according to the Ventral Hernia Working Group classification. Overall hernia recurrence rate was 3.6% (n = 2). Postoperative surgical site infection occurred in 26.8% (n = 15). Median follow-up by clinical examination was 6 months (range 4&ndash;17). Median telephone follow-up was 21 months (range 4&ndash;54). Pre- and post-treatment SF-12 quality of life assessments demonstrated significant improvements in both the physical and mental components. This study reports a large series of abdominal wall reconstructions using biosynthetic mesh in complex ventral hernia. The findings indicate promising early outcome data associated with use of biosynthetic mesh. Larger well-controlled studies with longer follow-up are needed for confirmation of these findings.

The use of biosynthetic mesh in giant hiatal hernia repair: is there a rationale? A 3-year single-center experience.

Reinforced prosthetic crural repair is particularly indicated for giant hiatal hernias. The rationale is to reduce the recurrence rate in the long term. The aim of our study is to evaluate the outcomes of laparoscopic giant hiatal hernia repair using a biosynthetic mesh. We retrospectively analyzed 44 patients who underwent laparoscopic mesh-reinforced hiatal closure and fundoplication using a biosynthetic material. Inclusion criterion was large hiatal defects (> 5cm). Follow-up was scheduled at 6, 12 and 36months after surgery. 44 patients (29F) with a mean age of 62years (range 14-85) and mean of BMI 24.5kg/m2 (range 21-29) underwent successful laparoscopic repair. Twenty-six (59.1%) patients had Nissen-Rossetti fundoplication, whereas 18 (40.9%) had Toupet fundoplication. Six-month questionnaire for the evaluation of symptoms was available for 43 patients (97.7%) and for 40 (90.9%) patients at 12 and 36months. Mean preoperative symptoms score analysis was 1.68 ± 0.73. Mean scores at each follow-up time were significantly improved compared to baseline (p > 0.05). Barium swallow was available in 37 patients (84.1%) at 1year after surgery. Radiologic recurrence was observed in two patients (4.5%). No patient had symptoms attributable to recurrence or required revisional surgery. There were no mesh-related complications at 3years follow-up. The use of biosynthetic mesh for crural reinforcement is associated with a low incidence of mesh-related complications and with a reasonably low recurrence rate (4.5%) at 36months. However, additional data with longer follow-up are needed to determine long-term safety and efficacy.

When the Mesh Goes Away: An Analysis of Poly-4-Hydroxybutyrate Mesh for Complex Hernia Repair.

Background:Mesh reinforcement is a cornerstone of modern ventral hernia repair (VHR); yet, complications with synthetic mesh and cost of biologic have created a need for alternative options. Biosynthetic mesh is a resorbable scaffold that theoretically leverages the benefits and minimizes deficiencies of existing mesh types. This study evaluates 2-year outcomes following poly-4-hydroxybutyrate (P4HB) mesh reinforcement for complex VHR.Methods:A retrospective review of all consecutive VHR with P4HB (n = 70) was conducted from 2015 to 2018 by a single surgeon. Clinical outcomes, quality of life (QoL; and cost were assessed.Results:Seventy patients were included with an average age and body mass index of 58.6 years and 33 kg/m2, respectively. High-risk comorbidities included hypertension (59%), and smoking history (50%). Cases were primarily modified Ventral Hernia Working Group class 2 (50%), or 3 (36%), with average defect size of 323 cm2 (25–972 cm2). P4HB was placed in the retromuscular (80%) or onlay (20%) plane. Mean follow-up was 24 months (12.2–41 months). Hernia recurrence rate was 5.7% (n = 4) and occurred an average of 285 days (209–368 days) post-repair. Of the 21 surgical site occurrences (SSO), 5 (7%) required surgical intervention. A significant improvement in overall QoL (P = 0.001) was noted following repair. Defect size and SSOPI were independently associated with increased direct cost.Conclusions:P4HB mesh for complex VHR is associated with favorable 2-year clinical outcomes, acceptable hernia recurrence rate, and a significant improvement in QoL. This study supports the use of biosynthetic mesh as an effective biomaterial for complex VHR.

Early Wound Morbidity after Open Ventral Hernia Repair with Biosynthetic or Polypropylene Mesh

Recently introduced slow-resorbing biosynthetic and non-resorbing macroporous polypropylene meshes are being used in hernias with clean-contaminated and contaminated wounds. However, information about the use of biosynthetic meshes and their outcomes compared with polypropylene meshes in clean-contaminated and contaminated cases is lacking. Here we evaluate the use of biosynthetic mesh and polypropylene mesh in elective open ventral hernia repair (OVHR) and investigate differences in early wound morbidity after OVHR within clean-contaminated and contaminated cases. All elective, OVHR with biosynthetic mesh or uncoated polypropylene mesh from January 2013 through October 2016 were identified within the Americas Hernia Society Quality Collaborative. Association of mesh type with 30-day wound events in clean-contaminated or contaminated wounds was investigated using a 1:3 propensity-matched analysis. Biosynthetic meshes were used in 8.5% (175 of 2,051) of elective OVHR, with the majority (57.1%) used in low-risk or comorbid clean cases. Propensity-matched analysis in clean-contaminated and contaminated cases showed no significant difference between biosynthetic mesh and polypropylene mesh groups for 30-day surgical site occurrences (20.7% vs 16.7%; p= 0.49) or unplanned readmission (13.8% vs 9.8%; p= 0.4). However, surgical site infections (22.4% vs 10.9%; p= 0.03), surgical site occurrences requiring procedural intervention (24.1% vs 13.2%; p= 0.049), and reoperation rates (13.8% vs 4.0%; p=0.009) were significantly higher in the biosynthetic group. Biosynthetic mesh appears to have higher rates of 30-day wound morbidity compared with polypropylene mesh in elective OVHR with clean-contaminated or contaminated wounds. Additional post-market analysis is needed to provide evidence defining best mesh choices, location, and surgical technique for repairing contaminated ventral hernias.

PWE-258 Outcomes of mesh reconstruction of perineal wounds following extralevator abdominoperineal excision of the rectum (aper)

Introduction Extralevator APER for low rectal cancer is used to avoid the adverse oncological outcomes of inadvertent perforation and a positive circumferential resection margin associated with the conventional APER technique. Removal of the levators leaves a large defect requiring pelvic floor reconstruction. Controversy still exists on the best method of closure. The aim of this study is to present the outcomes of biosynthetic mesh for pelvic floor reconstruction. Method Perineal reconstruction was done using biosynthetic mesh. We evaluated the short term outcomes with regards to perineal wound complications and perineal hernias. Results 25 patients had biosynthetic mesh repairs. 23 of the patients had surgery for rectal cancer and 2 for anal cancer. Median operative time was 3.5 h. At a median follow up period of 26 months, there were 4 perineal complications (2 wound infections, 1 haematoma and 1 wound dehiscence) but no meshes were removed. 1 patient required vacuum assisted dressing for wound dehiscence. There were no perineal hernias. There was no mortality. Conclusion The low complication rate, good outcomes in perineal wound healing and absence of perineal hernia demonstrates that use of biosynthetic mesh for pelvic floor reconstruction is safe and feasible. Disclosure of interest None Declared.

The treatment of recurrent tracheo-oesophageal fistula with biosynthetic mesh

1,2 the incidence of which is reported as 5 - 15%. Secondary recurrences following fistula re-closure are also not uncommon. 3 Traditional therapy for a recurrent tracheo-oesophageal fistula (RTF) involves a repeat thoracotomy, with its associated risks and significant morbidity. An endoscopic procedure provides an attractive alternative. Use of a bronchoscopic technique was first reported in 1975 by Gdanietz and Krause, 4 who used histo-acryl adhesive to close an RTF. Since then, a variety of other endoscopic techniques have been reported. The strategies employed in these techniques include plugging the fistula with fibrin glue or tissue adhesives, 3 plugging it after de-epithelisation of the fistula, 5,6 or obliteration of the fistula using cauterisation or laser therapy. 7 More than one treatment session was needed in most of the cases reported in which these techniques were used. Recently Keckler et al. 8 reported successful obliteration of an RTF with two successive applications of Surgisis biological mesh (Cooke Inc., Bloomington, Ind.). Encouraged by their results, we used Permacol (TissueScience, Hampshire, UK), a porcine dermal biological mesh, on a 6-month-old baby with an RTF. Only a single application of Permacol was necessary. In this patient, rigid bronchoscopy revealed a recurrent fistula a few millimetres proximal to the carina. To create a raw surface, de-epithelisation of the fistula tract was performed with an endoscopic brush. Using an endoscopic grasper, a 3 mm × 3 mm piece of Permacol was introduced and pushed into the fistula until it was seen through a gastroscope to be close to the opening in the oesophagus. Four more similar pieces of Permacol were introduced. DuraSeal (Confluent Surgical Inc., Waltham, Mass.) was then injected into the fistula tract with an extended tip applicator. The DuraSeal was used to seal off the Permacol and keep it in position. The patient was extubated and kept on nasogastric feeds for 48 hours, after which oral feeds were started. Postoperative recovery was uneventful. A postoperative oesophagram on day 4 was normal. The patient continued to recover and remained asymptomatic 24 months after this procedure. Permacol provides a long-lasting and stable collagen lattice that allows the incorporation of fibroblasts and capillaries to form a growing scar. Experimental evidence suggests that the biosynthetic scaffold degrades over time, but that the tissue remodelling that replaces it is stronger than the native tissue. The use of biosynthetic mesh has gained wide acceptance. It has been used with encouraging results in the repair of diaphragmatic hernias, abdominal and thoracic wall defects and para-oesophageal hernias. 9-11 The bronchoscopic placement of biosynthetic mesh is an added modality in the treatment of the difficult problem of RTF, and holds great promise. This bronchoscopic procedure is easy to perform and is repeatable if necessary. It is a much less invasive and less risky procedure than the alternative, repeat thoracotomy, and should be considered as a good treatment option for patients with an RTF.

The use of biosynthetic mesh to enhance hiatal repair at the time of redo Nissen fundoplication

Objective There are a number of reports in the literature describing the need for a redo fundoplication in patients who have previously undergone open fundoplication. However, these data are not well characterized in our current era of laparoscopic surgery. The purpose of this report is to document the management of patients requiring a redo fundoplication who originally underwent a laparoscopic Nissen fundoplication. Methods After internal review board approval, the senior surgeon performed a retrospective chart review on all patients undergoing laparoscopic fundoplication between January 2000 and April 2006. Data collected included the patient's age, sex, neurologic impairment, need for gastrostomy, time interval between the initial and redo fundoplication, operative approach for the redo fundoplication, use of a biologic patch for the redo procedure, and length of follow-up. Results Two hundred seventy-three patients underwent laparoscopic Nissen fundoplication by the senior author during this time interval. Twenty-one patients have required a redo fundoplication and repair of the enlarged hiatus after laparoscopic fundoplication. No patient has undergone a redo procedure without the development of transmigration of the fundoplication wrap. A redo operation was performed without mesh in 13 patients, of which there were 4 recurrences (31%). The other 8 cases were repaired with Surgisis (Cook, Inc, Bloomington, Ind), and none of these have recurred, with a minimum of 11 months' follow-up and a mean follow-up of 26 months. In the 4 patients requiring a second redo procedure, the enlarged esophageal hiatus was reinforced with Surgisis, and none of these cases have recurred, with a minimum of 3 years' follow-up. Conclusions Our data support the use of a biosynthetic mesh to reinforce the crural closure during the repair of iatrogenic hiatal hernias in children.

The Use of Biosynthetic Mesh to Separate the Anastomoses During the Thoracoscopic Repair of Esophageal Atresia and Tracheoesophageal Fistula

Recurrent tracheoesophageal fistula following the repair of esophageal atresia and tracheoesophageal fistula (EA/TEF) is a difficult complication to manage, which makes prevention the dominant concern of surgeons performing the primary repair. To this end, the surrounding pleural tissues are usually brought over the tracheal closure to prevent the development of a recurrence during the open repair. This maneuver is not usually feasible when using the thoracoscopic approach. Therefore, in this paper, we describe a case in which we interposed a biosynthetic mesh between the esophageal and tracheal suture lines during the thoracoscopic repair of EA/TEF on a 2.9-kg newborn girl.