Tissue Reinforcement Research Articles

Conception d’un treillis anti-infectieux et visible en IRM pour la prise en charge chirurgicale des prolapsus génitaux et des hernies abdominales

Surgical operations for soft tissue reinforcement (i.e. pelvic organs prolapse or abdominal hernias) are common procedures and require annually at least 1,200,000 of prostheses. Unfortunately, postoperatory complications and reinterventions are still important, mainly due to infection, inflammation, erosion, exposition or meshes migration. We present here several strategies to bring to meshes anti-infective resistance and clinical follow-up capability through an MRI visible material. A coating of the mesh by degradable polymers (polyesters) trapping antibiotics was created using an airbrushing technique, without modifying dramatically the morphology and the mechanical properties of the meshes. This temporary drug reservoir-coating allows a sustained release of the drugs and hamper in vitro bacterial contamination and biofilm formation on the meshes, associated to a large periprosthetic microorganism growth inhibition for a minimum of three days. Simultaneously, magnetic resonance contrast agent was grafted onto the backbone of polymers and used as coating material in order to bring MRI visibility property to meshes. In vitro, polymers-contrast agent coating induce a significant signal in an experimental MRI (7 Tesla) and no contrast agent release was observed during the stability studies, whatever the sterilization procedures used.

Laparoscopic Sleeve Gastrectomy with Staple Line Buttress Reinforcement in 116 Consecutive Morbidly Obese Patients

Obesity rates have reached epidemic levels with over 300 million obese individuals worldwide. Laparoscopic sleeve gastrectomy (LSG) as a primarily restrictive bariatric surgical procedure has been shown to be effective in producing marked weight loss. However, LSG-associated gastric leakage and hemorrhages remain the most important challenges postoperatively. Staple line buttress reinforcement has been suggested to reduce these postoperative complications. Our objective was to assess staple line buttress reinforcement via the Duet™ tissue reinforcement stapler system in morbidly obese patients undergoing LSG as part of a comprehensive weight management strategy, focusing on postoperative complications. Between January 2008 and April 2011, we retrospectively reviewed the medical records of 116 consecutive patients that underwent LSG with staple line buttress reinforcement at an academic teaching hospital with advanced bariatric fellowship. The mean age of patients was 44.3 ± 9.5 years, with mean preoperative BMI of 44 ± 7 kg/m2. The mean operative time to perform LSG was 96 ± 25 min. Postoperative weight was significantly lower following LSG at 1-year follow-up compared to baseline (104 ± 25 vs. 125 ± 27 kg, P < 0.05). There were no postoperative gastric leaks observed. Postoperative bleeding from the gastric staple line occurred in one patient (0.9%) and was treated with conservative management. In LSG, staple line buttress reinforcement limits postoperative gastric leakage and bleeding in morbidly obese patients.

Iatrogenic tracheal rupture: bovine pericardial patch repair without flap reinforcement

We describe a case of an extensive post-intubation membranous tracheal rupture in a 67-year old patient after emergency intubation. This was managed surgically by bovine pericardial patch repair. Other cases of autologous and bovine patch repair of tracheal lacerations exist in the literature, and we believe this is the first report of successful bovine patch repair without accessory autologous tissue reinforcement. This technique may be used in surgically managed cases of membranous tracheal rupture where primary repair is unsuitable, thereby reducing procedural complexity.

Preliminary Study of Hiatal Hernia Repair Using Polyglycolic Acid: Trimethylene Carbonate Mesh

Repairing large hiatal hernias using mesh has been shown to reduce recurrence. Drawbacks to mesh include added time to place and secure the prosthesis as well as complications such as esophageal erosion. We used a laparoscopic technique for repair of hiatal hernias (HH) >5cm, incorporating primary crural repair with onlay fixation of a synthetic polyglycolicacid:trimethylene carbonate (PGA:TMC) absorbable tissue reinforcement. The purpose of this report is to present short-term follow-up data. Patients with hiatal hernia types I-III and defects >5cm were included. Primary closure of the hernia defect was performed using interrupted nonpledgeted sutures, followed by PGA:TMC mesh onlay fixed with absorbable tacks. A fundoplication was then performed. Evaluation of patients was carried out at routine follow-up visits. Outcomes measured were symptoms of gastroesophageal reflux disease (GERD), or other symptoms suspicious for recurrence. Patients exhibiting these complaints underwent further evaluation including radiographic imaging and endoscopy. Follow-up data were analyzed on 11 patients. Two patients were male; 9 were female. The mean age was 60 years. The mean length of follow-up was 13 months. There were no complications related to the mesh. One patient suffered from respiratory failure, one from gas bloat syndrome, and another had a superficial port-site infection. One patient developed a recurrent hiatal hernia. In this small series, laparoscopic repair of hiatal hernias >5cm with onlay fixation of PGA:TMC tissue reinforcement has short-term outcomes with a reasonably low recurrence rate. However, due to the preliminary and nonrandomized nature of the data, no strong comparison can be made with other types of mesh repairs. Additional data collection is warranted.

Instability after total hip arthroplasty

Instability following total hip arthroplasty (THA) is an unfortunately frequent and serious problem that requires thorough evaluation and preoperative planning before surgical intervention. Prevention through optimal index surgery is of great importance, as the management of an unstable THA is challenging even for an experienced joints surgeon. However, even after well-planned surgery, a significant incidence of recurrent instability still exists. Non-operative management is often successful if the components are well-fixed and correctly positioned in the absence of neurocognitive disorders. If conservative management fails, surgical options include revision of malpositioned components; exchange of modular components such as the femoral head and acetabular liner; bipolar arthroplasty; tripolar arthroplasty; use of a larger femoral head; use of a constrained liner; soft tissue reinforcement and advancement of the greater trochanter.

自動縫合器の補強材が原因と思われた術後出血

自動縫合器の補強材が原因と思われた術後出血

Massive haemothorax after pulmonary endostapling preloaded with bioabsorbable tissue reinforcement material

Reinforced endostapling can prevent postoperative air leakage from surgical stumps. We herein present a 58-year old woman with idiopathic interstitial pneumonia who developed lethal haemothorax after a thoracoscopic lung biopsy with the use of an endostapler preloaded with bioabsorbable tissue reinforcement material. This lethal haemothorax, which occurred on the day after the lung biopsy, required an emergency operation. The bleeding point was an intercostal artery of the inferior chest wall adjacent to the surgical stump. The operative findings suggested that the reinforced material on the surgical stump scratched the chest wall through respiratory movement.

New magnetic-resonance-imaging-visible poly(ε-caprolactone)-based polyester for biomedical applications

A great deal of effort has been made since the 1990s to enlarge the field of magnetic resonance imaging. Better tissue contrast, more biocompatible contrast agents and the absence of any radiation for the patient are some of the many advantages of using magnetic resonance imaging (MRI) rather than X-ray technology. But implantable medical devices cannot be visualized by conventional MRI and a tool therefore needs to be developed to rectify this. The synthesis of a new MRI-visible degradable polymer is described by grafting an MR contrast agent (DTPA-Gd) to a non-water-soluble, biocompatible and degradable poly(ε-caprolactone) (PCL). The substitution degree, calculated by 1H nuclear magnetic resonance and inductively coupled plasma-mass spectrometry, is close to 0.5% and proves to be sufficient to provide a strong and clear T1 contrast enhancement. This new MRI-visible polymer was coated onto a commercial mesh for tissue reinforcement using an airbrush system and enabled in vitro MR visualization of the mesh for at least 1year. A stability study of the DTPA-Gd-PCL chelate in phosphate-buffered saline showed that a very low amount of gadolinium was released into the medium over 52weeks, guaranteeing the safety of the device. This study shows that this new MRI-visible polymer has great potential for the MR visualization of implantable medical devices and therefore the post-operative management of patients.

Bioabsorbable Gore BIO-A plug and patch hernia repair in young adults

We read with great interest the report by Efthimiou et al. [1] on plug and patch hernia repair using a polyglycolic acid-trimethylene carbonate mesh. The purpose of this pilot study (ten patients with direct and indirect inguinal hernia with a mean age of 65.6 years) was to evaluate the efficacy of using a totally absorbable device (Gore BIO-A Tissue Reinforcement patch and Gore BIO-A plug), looking primarily at recurrence and chronic pain assessed 1 year after the operation. The authors stress, and we agree with, that an ideal mesh for inguinal hernia repair should cause the minimum foreign body reaction. Moreover, the excessive local inflammatory reaction that occurs when a polypropylene (PP) mesh, especially heavyweight PP, is implanted, may cause prosthetic shrinkage and chronic pain. For these reasons, surgeons would consider the use of PP with different characteristics (low-weight large porous PP, PP/polyglactine composite, PP with polytetrafluorethylene surface) or other materials as polyvinyliden fluoride (PVDF). Gore BIO-A mesh is made of a biocompatible synthetic polymer. Its design structure (with open highly interconnected pores) creates a scaffold that facilitates tissue generation, mimicking native collagen fibres. This material is fully absorbed in approximately 6 months. At 1 year follow-up, none of the patients from Efthimiou’s study had clinical signs of recurrence. Only one patient experienced intermittent pain without the need for any medication. On the other hand, the authors do not highlight any protective role on the vas deferens that could possibly be played by Gore BIO-A plug and patch repair, probably because all patients in their study were elderly. Many experimental studies in animals have shown that PP mesh can adversely affect spermatic cord structure and/ or function [2–5]. On the contrary, little clinical information is available regarding the long-term effects of PP mesh on the vas deferens. One possible reason is that most men undergoing hernia repair tend to be elderly, and thus not so concerned about maintaining their reproductive potential. However, a multiinstitutional experiment and some casereports [6–8] have confirmed the potential risk of injury when a PP mesh is placed in contact with the bare vas deferens, as in the case of plug and patch repair. PP herniorraphy is being offered to young adults whose fertility status will be an issue in the future. At present, we are unable to determine whether PP mesh will result in an higher incidence of inguinal vasal obstruction and infertility. In 2009, we began a prospective multicentre study on the use of BIO-A prosthesis in young adults (maximum age 45 years) to try to answer these questions, and to offer a safer repair to patients. Only primary indirect (L, lateral, according to EHS’s classification) hernias were included in the study. All patients underwent open plug and patch repair. C-reactive protein (CRP) samples were collected to estimate the inflammatory response. Pain was evaluated using VAS score, and quality of life status by the SF-36 system. Mid-term results (at 2 years) will be published soon. In the meantime, we wish to point out that, at 18-month follow-up, none of the 15 patients enrolled by our Centre had any complications and all patients were totally satisfied. We can also assume that no adverse events affected the cord structure. P. Negro (&) F. Gossetti M. R. Dassatti J. Andreuccetti L. D’Amore Department of General Surgery ‘‘P. Stefanini’’, Sapienza University of Rome, Viale del Policlinico 155, 00161 Rome, Italy e-mail: pal.negro@libero.it

Artelon® Tissue Reinforcement in the Repair of a Ruptured, Degenerative Rotator Cuff in an Elderly Man

Background Massive degenerative rotator cuff tears are a considerable problem in the elderly. It is known that about one third of surgical repairs of damaged rotator cuffs result in re-tear. The most common reason for this failure is poor quality of the cuff due to degenerative changes. The aim of our study was to see if Artelon Tissue Reinforcement® (ATR) in the repair of a degenerative rotator cuff tear could improve the postoperative outcome. Methods An 81-year old man was treated surgically with repair of a massive degenerative rotator cuff tear, reinforced by an ATR-patch. The patient was followed postoperatively with clinical examinations and MRI at 6- and 15-months postoperatively. Objective outcome measures using Constant Score, WORC and Oxford Shoulder Score were analyzed 2.5 years postoperatively. Results The MRI showed maintained integrity of the rotator cuff at both 6- and 15-months postoperatively. The results from WORC and Oxford Shoulder Score indicate a return to normal shoulder function. Discussion The experience from this case and two other similar cases with excellent patient satisfaction and no signs of adverse effects has encouraged us to commence a prospective, randomized study to further analyze the effect of ATR in treating degenerative rotator cuff tears.

Use of Artelon(®) Cosmetic in soft tissue augmentation in dentistry.

BackgroundSoft tissue augmentation is a widely used procedure in partially and fully edentulous patients to increase soft tissue volume. Polyurethanes have been used for scaffolds in a variety of implantable devices. Artelon® is a degradable polyurethane that has been manufactured as fibers, films, and porous scaffolds to be used for various purposes. In this review, the characteristics of Artelon are described, and its clinical applications in orthopedics, dermatology, cardiovascular medicine, and dentistry are also discussed.MethodsA Medline (PubMed) search was conducted, and articles published in English were included. Keywords, including “Artelon”, “polyurethanes”, “soft tissue augmentation”, “biocompatibility”, “resorption”, “mechanical stability”, and “complications” were used in different combinations. Titles and abstracts were screened, and full text article analyses were performed.ResultsMost of the studies reported orthopedic, dermal, and myocardial applications. There were only a few reports related to dental and implant applications. Artelon has been successfully used for reinforcement of soft tissues, including the rotator cuff, Achilles, patellar, biceps, and quadriceps tendons in orthopedic surgery, and is used clinically for the treatment of osteoarthritis in the hand, wrist, and foot. One type of Artelon material, Artelon Cosmetic, has been used in the dental field to increase soft tissue volume, and stable results are achieved for up to 6 months. This material is reported to be easily handled when cut to the desired shape, with little additional time needed for manipulation during surgery, eliminates the need for connective tissue autografts, and thereby decreases patient morbidity and postoperative discomfort, with increased likelihood of a positive subjective outcome.ConclusionArtelon may be applied in the dental field to increase soft tissue volume. Further studies of various applications in dentistry with long-term results are needed to confirm the safety and efficacy of this material before it can be used on a routine basis in dentistry.

Use of Artelon&lt;sup&gt;&amp;reg;&lt;/sup&gt; Cosmetic in soft tissue augmentation in dentistry

Use of Artelon&reg; Cosmetic in soft tissue augmentation in dentistry Youngkyung Ko, NamRyang Kim, Seojin Park, Jun-Beom ParkDepartment of Periodontics, Seoul St Mary&#39;s Hospital, The Catholic University of Korea, Seoul, KoreaBackground: Soft tissue augmentation is a widely used procedure in partially and fully edentulous patients to increase soft tissue volume. Polyurethanes have been used for scaffolds in a variety of implantable devices. Artelon&reg; is a degradable polyurethane that has been manufactured as fibers, films, and porous scaffolds to be used for various purposes. In this review, the characteristics of Artelon are described, and its clinical applications in orthopedics, dermatology, cardiovascular medicine, and dentistry are also discussed.Methods: A Medline (PubMed) search was conducted, and articles published in English were included. Keywords, including &ldquo;Artelon&rdquo;, &ldquo;polyurethanes&rdquo;, &ldquo;soft tissue augmentation&rdquo;, &ldquo;biocompatibility&rdquo;, &ldquo;resorption&rdquo;, &ldquo;mechanical stability&rdquo;, and &ldquo;complications&rdquo; were used in different combinations. Titles and abstracts were screened, and full text article analyses were performed.Results: Most of the studies reported orthopedic, dermal, and myocardial applications. There were only a few reports related to dental and implant applications. Artelon has been successfully used for reinforcement of soft tissues, including the rotator cuff, Achilles, patellar, biceps, and quadriceps tendons in orthopedic surgery, and is used clinically for the treatment of osteoarthritis in the hand, wrist, and foot. One type of Artelon material, Artelon Cosmetic, has been used in the dental field to increase soft tissue volume, and stable results are achieved for up to 6 months. This material is reported to be easily handled when cut to the desired shape, with little additional time needed for manipulation during surgery, eliminates the need for connective tissue autografts, and thereby decreases patient morbidity and postoperative discomfort, with increased likelihood of a positive subjective outcome.Conclusion: Artelon may be applied in the dental field to increase soft tissue volume. Further studies of various applications in dentistry with long-term results are needed to confirm the safety and efficacy of this material before it can be used on a routine basis in dentistry.Keywords: Artelon&reg; Cosmetic, dentistry, soft tissue augmentation, polyurethanes

New antibiotic-eluting mesh used for soft tissue reinforcement

The surgical implantation of prostheses for soft tissue repair may be followed by post-operative mesh-related infection, a significant and dramatic complication, that is treated by mesh removal. A new antibiotic-eluting mesh has been manufactured on pre-existing polypropylene prostheses using an airbrush spraying technology. Among the degradable polymers tested as coating agents and drug reservoirs, poly(ε-caprolactone) (PCL), which is deposited after heating, provides a homogeneous, regular and smooth shell around the polypropylene filaments of the mesh without dramatically altering the biomechanical properties of the new modified mesh. An anti-infective drug (e.g. ofloxacin) is incorporated into this polymeric coating giving a limited burst effect followed by sustained drug diffusion for several days. An ofloxacin-eluting mesh has demonstrated excellent antibacterial activity in vitro on Escherichia coli adherence, biofilm formation and inhibitory diameter, even with low drug loads. Although further in vivo investigations are required to draw conclusions on the anti-infective effectiveness of the coated mesh, the airbrush coating of ofloxacin–PCL on existing prostheses is already potentially appealing in an effort to decrease post-operative infection.

Mechanical properties and tissue reinforcement of polypropylene grafts used for pelvic floor repair—an experimental study

Although grafts can be made from the same materials, the final weave of the product may play a role in the ultimate outcomes or complications. The aim of this experimental study is to evaluate and compare the mechanical properties of the meshes and their influence on biological characteristics as well. Full-thickness abdominal wall defect with respect to the peritoneum was primary repaired in 144 male Wister rats using the overlay technique. Monofilament, multifilament and coated polypropylene grafts were used for the repairs. Graft shrinkage, thickness and tensile strength of the explants were analysed after 3 and 6weeks. Monofilament grafts showed the highest shrinkage level of 11.97-18% during the investigated period. The thickness of monofilament explants increased gradually, with a maximum of 25.35% after 6weeks. Multifilament and collagen explants did swell more rapidly in the third week, decreasing thereafter to 19.63-23.04% above the pre-implantation values after 6weeks. The tensile strength showed a gradual increase over the course of the experiment in all groups. After graft stabilisation, all samples had similar strength, regardless of the significant differences in the pre-implantation values of graft strength.

Augmented Tendon Achilles Repair Using a Tissue Reinforcement Scaffold: A Biomechanical Study

Missed or chronic Achilles tendon ruptures may have muscle atrophy and tendon retraction resulting in a defect that must be augmented with endogenous or exogenous materials. The Artelon® Tissue Reinforcement (ATR) scaffold is a readily available synthetic degradable poly(urethane urea) material used to augment tendon repair. The objective of this study was to compare human cadaveric Achilles tendon repairs with and without ATR. Eighteen fresh frozen human cadaver limbs were dissected and the tendon transected 2 cm proximal to the calcaneal insertion. The control group of nine specimens was repaired with sutures, while the experimental group was repaired with sutures and reinforced with a tubularized patch of ATR. Specimens were tested for ultimate load to failure in an Instron machine after preloading to 10 N followed by cyclic loading for 20 cycles from 2 to 30 N. The ultimate load to failure in the control group was a mean of 248.1 N ± 19.6 (202 to 293 at 95% CI) versus 370.4 N ± 25.2 (312 to 428 at 95% CI) in the ATR group. The ultimate load to failure was 370.4 ± 25.2 N (312 to 428 at 95% CI) and 248.1 ± 19.6 N (202 to 293 at 95% CI) in the experimental and control groups, respectively (p = 0.0015). Creep of the ATR augmented group was 2.0 ± 0.5 mm, compared to 3.1 ± 1.1 mm for the control group (p = 0.026). ATR provided a statistically significant improvement in load to failure when compared to control specimens in a cadaver model. This finding may allow for development of more aggressive rehabilitation techniques following chronic Achilles tendon repairs.

Synthetic, biological and composite scaffolds for abdominal wall reconstruction

The reconstruction of abdominal wall defects remains a huge surgical challenge. Tension-free repair is proven to be superior to suture repair in abdominal wall reconstruction. Scaffolds are essential for tension-free repair. They are used to bridge a defect or reinforce the abdominal wall. A huge variety of scaffolds are now commercially available. Most of the synthetic scaffolds are composed of polypropylene. They provide strong tissue reinforcement, but cause a foreign body reaction, which can result in serious complications. Absorbable synthetic scaffolds, such as Dexon™ (polyglycolic acid) and Vicryl™ (polyglactin 910), are not suitable for abdominal wall reconstruction as they usually require subsequent surgeries to repair recurrent hernias. Composite scaffolds combine the strength of nonabsorbable synthetic scaffolds with the antiadhesive properties of the absorbable scaffold, but require long-term follow-up. Biological scaffolds, such as Permacol™, Surgisis® and Alloderm®, are derived from acellular mammalian tissues. Non-cross-linked biological scaffolds show excellent biocompatibility and degrade slowly over time. However, remnant DNA has been found in several products and the degradation leads to recurrence. Randomized controlled trials with long-term follow-up studies are lacking for all of the available scaffolds, particularly those derived from animal tissue. This article provides an overview of the different types of scaffolds available, and presents the key clinical studies of the commercially available synthetic, composite and biological scaffolds for abdominal wall reconstruction.

Engineering bioartificial tracheal tissue using hybrid fibroblast-mesenchymal stem cell cultures in collagen hydrogels☆

We aimed at providing the first in vitro and in vivo proof-of-concept for a novel tracheal tissue engineering technology. We hypothesized that bioartificial trachea (BT) could be generated from fibroblast and collagen hydrogels, mechanically supported by osteogenically-induced mesenchymal stem cells (MSC) in ring-shaped 3D-hydrogel cultures, and applied in an experimental model of rat trachea injury. Tube-shaped tissue was constructed from mixtures of rat fibroblasts and collagen in custom-made casting molds. The tissue was characterized histologically and mechanically. Ring-shaped tissue was constructed from mixtures of rat MSCs and collagen and fused to the tissue-engineered tubes to function as reinforcement. Stiffness of the biological reinforcement was enhanced by induction of osteogeneic differentiation in MSCs. Osteogenic differentiation was evaluated by assessment of osteocalcin (OC) secretion, quantification of calcium (Ca) deposit, and mechanical testing. Finally, BT was implanted to bridge a surgically-induced tracheal defect. A three-layer tubular tissue structure composed of an interconnected network of fibroblasts was constructed. Tissue collapse was prevented by the placement of MSC-containing ring-shaped tissue reinforcement around the tubular constructs. Osteogenic induction resulted in high OC secretion, high Ca deposit, and enhanced construct stiffness. Ultimately, when BT was implanted, recipient rats were able to breathe spontaneously.

New antibiotic-eluting mesh used for soft tissue reinforcement

New antibiotic-eluting mesh used for soft tissue reinforcement

Amyand Hernia Repaired with Bio-A: A Case Report and Review

A 53-year-old man with an Amyand hernia with indirect and direct components was repaired with a Bio-A (Gore, Newark, Delaware) plug and a patch made of Bio-A tissue reinforcement material. The repair of an Amyand hernia addresses the pathology of the appendix as well as the hernia. We report a case in which a plug and patch repair was undertaken using Bio-A implants in a clean-contaminated field with no signs of infection or recurrence in the follow-up period, and we review the literature regarding the diagnosis and repair of an Amyand hernia.

Integrated Bioabsorbable Tissue Reinforcement in Laparoscopic Sleeve Gastrectomy

Division of the stomach in laparoscopic sleeve gastrectomy may be performed using bare stapler cartridges or cartridges fitted with tissue reinforcement strips, with or without oversewing. Many tissue reinforcement strips are after-market add-on products that must be fitted onto a stapler during surgery. A retrospective review was conducted of 85 consecutive patients undergoing laparoscopic sleeve gastrectomy using a novel integrated bioabsorbable polymer buttress pre-mounted on a single-use loading unit stapler. Mean preoperative body mass index (BMI) was 41.7 ± 5.2 kg/m(2). Morbidity and short-term outcomes were documented. Mean follow-up was 8.1 ± 3.6 months (range, 1.0-16.2 months). There were no mortalities or staple line leaks noted in this series with short-term follow up. The major complication rate (grade III and above) was 7.1% and included: reoperation for staple line bleeding (2.4%, n = 2), gastric sleeve stenosis requiring balloon dilation (2.4%, n = 2), choledocholithiasis 2 weeks after surgery (1.2%, n = 1), and reoperation without abnormality for suspected perioperative obstruction (1.2%, n = 1). Mean percent excess BMI loss at 3 (44.6 ± 11.3), 6 (57.9 ± 17.2), and 12 months (72.4 ± 27.5) was comparable to other published series. The use of an integrated absorbable synthetic polymer for stapled tissue reinforcement in laparoscopic sleeve gastrectomy appears to be feasible and safe, and yields results consistent with other published techniques.