Synthetic Patch Research Articles

Durability of Carotid Endarterectomy with Bovine Pericardial Patch

Multiple studies have shown that patch angioplasty after carotid endarterectomy (CEA) reduces the risk of stroke and restenosis when compared with primary closure. Biological, synthetic, or vein patches have been traditionally used in CEA. This article reports the early and long-term outcomes of bovine pericardium (BP) for patch angioplasty in CEA. A retrospective, consecutive analysis of 874 patients who underwent CEA during the past 17years at Mayo Clinic, Florida, was performed. BP patch (BPP) was used in 680 patients. Other CEA techniques were used in 194 patients (standard without patch, 78; standard with Dacron, 74; standard with vein patch, 16; and other techniques: bypasses, 26). We defined group 1 as those who underwent BPP angioplasty and group 2 as those who underwent all other techniques. Early and late clinical outcomes and patch-related complications (restenosis, infection, and hematoma) were recorded and analyzed. Median follow-up for the entire series was 39.6months. There were no statistically significant differences in 30-day mortality and morbidity between the 2 groups, except that BP group has less 30-day stroke (0.1%, 1 of 680) versus other techniques (1.5%, 3 of 194, P=0.03). Thirty-day postoperative mortality rate was 0.1% (1 of 680) in BPP group and 1.0% (2 of 194) in other technique group (P=0.13). No statistically significant difference was noted in 30-day postoperative major complications (transient ischemic attack [TIA], wound infection, hematoma requiring surgical evacuation, and nerve injury) between the 2 groups. Ten-year freedom from stroke/TIA were 97.8% in the BP group compared with 98.5% in the other group (P=0.86). Ten-year freedom from restenosis was also similar between groups (89.0% BP vs. 90.4% others, P=0.69). Ten-year survival rate was 38.4% in BP group and 45.0% in other technique group, and this was statistically significant on univariate analysis only. CEA with BP angioplasty has excellent early and late outcomes with minor morbidity and mortality.

Invited commentary

Computational studies of carotid artery hemodynamics have been performed for almost three decades. We now know that the localized arterial dilation found exclusively in the carotid bulb produces disturbed flow patterns with low and oscillatory shear stress that can alter endothelial function and activate atherogenic cellular phenotypes. Intensified by the deleterious effects of systemic risk factors and high intramural stresses and strains, these hemodynamic conditions can stimulate arterial wall stiffening and thickening that can further perturb normal physiology. This vicious circle of abnormal hemodynamics and pathologic remodeling may produce plaques that can become unstable, presenting vascular surgeons with opportunities to intervene. Two of the most commonly used variations on the technique of carotid endarterectomy are primary closure and patch angioplasty. Whereas clinical evidence has historically advocated for patch use,1Brott T.G. Halperin J.L. Abbara S. Bacharach J.M. Barr J.D. Bush R.L. et al.2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS Guideline on the Management of Patients With Extracranial Carotid and Vertebral Artery Disease: a report of the American College of Cardiology Foundation/American Heart Association Task F.Circulation. 2011; 124: e54-e130Crossref PubMed Scopus (453) Google Scholar recent data suggest that benefits are only of borderline significance2Rerkasem K. Rothwell P.M. Systematic review of randomized controlled trials of patch angioplasty versus primary closure and different types of patch materials during carotid endarterectomy.Asian J Surg. 2011; 34: 32-40Crossref PubMed Scopus (68) Google Scholar or may not even be significant at all.3Avgerinos E.D. Chaer R.A. Naddaf A. El-Shazly O.M. Marone L. Makaroun M.S. Primary closure after carotid endarterectomy is not inferior to other closure techniques.J Vasc Surg. 2016; 64: 678-683.e1Abstract Full Text Full Text PDF PubMed Scopus (21) Google Scholar This poses a question of whether increased clamp time, higher risk of cerebral ischemia, potential infectious issues, and patch-associated aneurysmal dilation are justified for every patient. In this study by Domanin et al, this argument is explored from a hemodynamic perspective whereby the authors compare flow characteristics in carotid arteries virtually repaired with primary closure and patch angioplasty. Because addition of the patch widened the carotid bifurcation, patch angioplasty was found to be associated with less favorable hemodynamics compared with primary closure. The authors conclude that patch use should be elective and performed with the purpose of re-creating the original shape of the carotid bifurcation rather than enlarging it. We arrived at similar conclusions in our computational analysis of carotid artery reconstruction, demonstrating more favorable flow patterns and lower intramural mechanical stresses for the artery repaired without a patch.4Kamenskiy A.V. Pipinos I.I. Dzenis Y.A. Gupta P.K. Jaffar Kazmi S.A. MacTaggart J.N. A mathematical evaluation of hemodynamic parameters after carotid eversion and conventional patch angioplasty.Am J Physiol Heart Circ Physiol. 2013; 305: H716-H724Crossref PubMed Scopus (19) Google Scholar To produce favorable hemodynamics with patching, our analysis demonstrated that the patch should be tailored to ensure smooth transition in arterial diameter, be placed anteriorly (as opposed to laterally), and be made of material that most closely matches the compliance of the recipient artery.5Kamenskiy A.V. MacTaggart J.N. Pipinos I.I. Gupta P.K. Dzenis Y.A. Hemodynamically motivated choice of patch angioplasty for the performance of carotid endarterectomy.Ann Biomed Eng. 2012; 41: 263-278Crossref PubMed Scopus (17) Google Scholar Patch compliance was particularly important as the mismatch in stiffness between synthetic patches and the host wall resulted in high stress and strain concentrations at the suture-artery interface, causing the posterior aspect of the artery to bulge out and to perturb flow and intramural stresses. Whereas these findings are merely suggestions offered by computational modeling, they have the potential to help clinicians choose the optimal type of repair material and geometry based on patient-specific arterial characteristics. Computational modeling of vascular physiology is frequently met by clinicians with skepticism as it is still in its infancy in describing complex mechanobiologic phenomena. There is much to be learned to improve fidelity of these models, and prospective validation in patients is a difficult next step to make these techniques clinically relevant. This cannot be achieved without synergistic collaborations between engineers and vascular surgeons. Sparking and nurturing these collaborations is the best way to make meaningful progress in making computational models useful to clinicians, as even the best of tools are only as good as the hands that use them. The opinions or views expressed in this commentary are those of the authors and do not necessarily reflect the opinions or recommendations of the Journal of Vascular Surgery or the Society for Vascular Surgery. Computational fluid dynamic comparison between patch-based and primary closure techniques after carotid endarterectomyJournal of Vascular SurgeryVol. 67Issue 3PreviewThe aim of the study was to provide, by means of computational fluid dynamics, a comparative analysis after carotid endarterectomy (CEA) between patch graft (PG) and primary closure (PC) techniques performed in real carotid geometries to identify disturbed flow conditions potentially involved in the development of restenosis. Full-Text PDF Open Archive

The Role of Biologic Therapy in Rotator Cuff Tears and Repairs.

The purpose of this review was to establish the foundation of the major biologic adjuvants to rotator cuff repairs and review recent scientific findings. Platelet-rich plasma (PRP) overall has no significant impact on functional outcomes and repair integrity, but may be more advantageous in small to medium tears. Further studies should focus on leukocyte-rich versus poor preparations and the use of PRP in patients that are high risk for repair failure. Biologic and synthetic patches or augments provide mechanical stability for large and massive rotator cuff tears and decrease re-tear rates. Mesenchymal stem cells have demonstrated improved healing rates without an impact on outcomes. Cytokines and growth factors show promise in animal models, but require human trials to further evaluate. In massive or revision repairs, allograft or synthetic patch augmentation should be considered. Platelet-rich plasma may have benefit in smaller tears. Further studies are needed to evaluate the value of mesenchymal stem cells and various cytologic chemical signals.

An efficacy of carotid arteries repair for tortuosity combined with stenosis

To assess an efficacy of carotid arteries reconstruction in patients with internal carotid artery stenosis combined with tortuosity. 86 patients with ICA tortuosity and stenosis were enrolled. All patients were divided into groups depending on type of surgery: group I - open carotid endarterectomy (CEA) followed by obligatory repair with synthetic patch (31 (36%) patients); group II - eversion CEA with ICA resection, redressation and reimplantation into own ostium (35 (40.7%) patients); group III - ICA replacement (20 (23.3%) patients). Synthetic prosthesis and autovein were used in 13 (65%) and 7 (35%) patients respectively. The study included patients with ICA stenosis ≥60% (any type of plaque) and any degree of cerebrovascular insufficiency or ICA stenosis <60% (plaque type I-III) with CVI grade II-IV combined with S- or C-tortuosity, bend or loop with blood flow velocity over 110 cm/s and its turbulence. Only 6 (7.0%) out of 86 patients had no clinical signs of CVI/previous stroke. Asymptomatic/symptomatic patients ratio was following in all groups: group I - 12 (38.7%)/19 (61.3%); group II - 29 (82.9%)/6 (17.1%); group III - 10 (50%)/10 (50%). Within 6-month follow-up 22 (70.9%) out of 31 patients were asymptomatic in group I, 30 (85.7%) (p=0.9475) out of 35 - in group II, 9 (45%) (p=0.9511) out of 20 patients - in group III and 1 (5%) patient developed thrombosis of the reconstruction zone followed by ischemic stroke. After 12 months following patients were asymptomatic: 22 (70.9%) in group I, 30 (85.7%) (p=0.9475) in group II and 9 (45%) patients (p=0.9511) in group III. After 1 year 4 (33.3%) out of 12 patients with CVI grade IV had partial regression of focal neurological symptoms. Surgery for ICA tortuosity combined with stenosis confirmed its efficacy and safety for both asymptomatic and symptomatic patients. Significantly better results were observed in eversion CEA compared with conventional procedure and ICA replacement.

Carotid Endarterectomy: Which Technique Prevails?

For decades, carotid endarterectomy has been the golden standard for the management of severe carotid artery stenosis. However, several techniques have been proposed till date, and there has been a long-lasting debate concerning the proper method. Several research studies have been conducted not only evaluating the role of patch suturing versus that of primary carotid closure, but also comparing the advantages and disadvantages of different patch materials. Both synthetic and venous patches have been utilized, each with specific features and effects on postoperative outcomes. This editorial aims to summarize basic characteristics of each technique, current guidelines recommendations and pooled research data on this subject, and produce conclusions for everyday clinical practice.

Excision of giant desmoid in the abdominal wall, method of abdominal wall reconstruction, and follow-up of long-termed effect

Objective: To explore the ideal procedure of excision and repair for giant desmoid in the abdominal wall and long-termed follow-up results. Methods: Clinical and follow-up data of 24 patients with giant desmoid in the abdominal wall underwent radical removal and immediate abdominal wall reconstruction in Diagnostic and Therapeutic Center of Hernia and Abdominal Wall Diseases, First Affiliated Hospital of People's Liberation Army General Hospital from October 2006 to October 2016 were analyzed retrospectively. Twenty-one female patients with the mean age of 34.6 years and 3 male patients with the mean age of 42.6 years were recruited. The minimal diameter of these tumors was 15 cm, and the maximal diameter was from xiphoid bone to pubic symphysis. Results: All of desmoids were removed radically and proved by the rapid pathologic examination. The size of abdominal wall defect after desmoids removal were 483 (21 cm×23 cm) to 2 100 cm(2) (35 cm×60 cm), averaged 945 cm(2) (27 cm×35 cm). All of defects were repaired with compound synthetic prosthesis using bridging procedure. Twenty-one patients were recovered smoothly and got primary wound healing. Three patients had prosthesis infected during 1 month postoperatively and 1 patient recovered with conservative therapy, the other 2 patients underwent infected prosthesis removal at 2 weeks and 3 months postoperatively, respectively. Twenty-two patients were followed up with the period of 12 to 121 months and the median period was 63 months. No marginal neoplasm recurrence, incisional hernia, and abdominal wall bulge happened. Eight patients developped fresh desmoids in the abdominal cavity or in the back. Two patients died because of intestinal obstruction due to desmoid infiltration, and the other 6 patients still survived along with stable desmoids. Conclusions: Radical removal for patients with giant desmoid in the abdominal wall is an ideal therapeutic method, and compound synthetic patch can be used to repair huge abdominal wall defect, even the defect compromised all of abdominal wall. The long-termed follow-up results showed these procedures had not put bad influence on the quality of patients' life.

Thoracoscopic approach to congenital diaphragmatic hernias in adults: Southampton approach and review of the literature.

Congenital diaphragmatic hernias (CDH) are likely to present in early postnatal or infancy and are associated with significant morbidity and mortality due to associated pulmonary hypoplasia, pulmonary hypertension and heart failure. Symptomatic adult congenital Bochdalek hernia, on the other hand, is extremely rare with a prevalence of 0.17-6% of all diaphragmatic hernias. They present with recurrent abdominal pain and shortness of breath. Acute presentations could be life threatening especially if there is incarcerated or threatened bowel in the chest. Repair of symptomatic Bochdalek hernia is recommended in the adult population. We present two cases of right and left symptomatic Bochdalek hernias in adults, encountered over 15 years of practice in a tertiary referral centre in the UK. We discuss their presentation and surgical management and review the literature of similar cases treated by video-assisted thoracoscopic surgery (VATS). Thoracic surgeons are increasingly becoming involved in these cases, which used to be the domain of upper gastrointestinal surgeons. A synthetic patch may be required to close the defect, therefore; the thoracic surgeon must be familiar with such techniques. The recent expansion in video format publishing in the internet and social media has revolutionized the way knowledge and how-to-do-it expertise is distributed around the world. It has the advantage of reaching far more viewer than subscription paper-printed format journals and has a rising significance in encouraging thoracic surgeons to do things they were not used to do. Finally; Symptomatic Bochdalek hernia, and possibly Morgagni hernia in the adult population could be safely repaired by VATS with good and lasting results.

Follow up of meningomyelocele and associated hydrocephalus, bladder and/or bowel incontinence and foot deformity in a developing country

Background: Meningomyelocele (MMC) and meningocele (MC) are the two most common types of neural tube defects (NTD) seen. Some of the problems associated with care of these patients are psychological stress is parents, average financial condition of caretakers, ignorance on the part of parents, local physicians for management of this condition, very few dedicated Spina bifida clinics and social stigma associated with this condition. The aim of treatment of meningomyelocele is to the patients with maximum mobility and social continence which is possible through multidisciplinary care involving paediatric surgeon, paediatrician, nursing staff, occupational therapist, physiotherapist, social worker, parents and patients themselves. The aim of this study is to discuss our experience in initial management of meningomyelocele (MMC) and hydrocephalus and long-term management of bladder/bowel incontinence and foot deformity in a tertiary care hospital of a developing country.Methods: A retrospective nonrandomized observational study was conducted in the department of pediatric surgery at a tertiary hospital, from August 2008 to October 2015. Overall 145 patients of meningomyelocele were included in the study. Patients were managed according to our institution protocol.Results: 68.2% MMC patients were repaired primarily. 24.1% of total patients needed Y-V plasty skin advancement flap. 7.5% patients needed synthetic patch for dural closure. 24.1% patients were incontinent since birth. 19.3% patients had decreased lower limb power since birth. 5.5% patients were incontinent after MMC repair. 8.2% patients had decreased lower limb power after MMC repair. 28.9% patients needed VP shunt for gross hydrocephalus before MMC repair. 51.03% patients needed VP shunt after MMC repair. 20% patients did not require VP shunt in the present series. 13.1% patients in the present series had urinary incontinence. 11.03% patients had fecal incontinence. 73.6% patients with urinary incontinence were successfully managed with conservative treatment. 87.5% patients with fecal incontinence responded to conservative treatment. Bladder augmentation was done in 26.3% of neurogenic bladder dysfunction patients. 60% of these patients had dry interval of more than 4 hours. MACE was done in 12.5% of neurogenic bowel dysfunction patients. 2 patients required simultaneous bladder augmentation, Mitrofanoff’s and MACE procedure. One of these patients achieved a dry interval of &gt;4 hour.Conclusions: Successful rehabilitation of children with MMC can be achieved with parental education and support, dedicated clinicians, trained nursing staff, regular follow-up and low threshold for diagnosing clinical deterioration and proactive management to prevent further clinical deterioration.

Polyester vascular patches acquire arterial or venous identity depending on their environment.

Polyester is commonly used in vascular surgery for patch angioplasty and grafts. We hypothesized that polyester patches heal by infiltration of arterial or venous progenitor cells depending on the site of implantation. Polyester patches were implanted into the Wistar rat aorta or inferior vena cava and explanted on day 7 or 30. Neointima that formed on polyester patches was thicker in the venous environment compared to the amount that formed on patches in the arterial environment. Venous patches had more cell proliferation and greater numbers of VCAM-positive and CD68-positive cells, whereas arterial patches had greater numbers of vimentin-positive and alpha-actin-positive cells. Although there were similar numbers of endothelial progenitor cells in the neointimal endothelium, cells in the arterial patch were Ephrin-B2- and notch-4-positive while those in the venous patch were Eph-B4- and COUP-TFII-positive. Venous patches treated with an arteriovenous fistula had decreased neointimal thickness; neointimal endothelial cells expressed Ephrin-B2 and notch-4 in addition to Eph-B4 and COUP-TFII. Polyester patches in the venous environment acquire venous identity, whereas patches in the arterial environment acquire arterial identity; patches in the fistula environment acquire dual arterial-venous identity. These data suggest that synthetic patches heal by acquisition of identity of their environment. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 105A: 3422-3431, 2017.

Microwave Heating of Crystals with Gold Nanoparticles and Synovial Fluid under Synthetic Skin Patches.

Gout is a disease with elusive treatment options. Reduction of the size of l-alanine crystals as a model crystal for gouty tophi with the use of a monomode solid-state microwave was examined as a possible therapeutic aid. The effect of microwave heating on l-alanine crystals in the presence of gold nanoparticles (Au NPs) in solution and synovial fluid (SF) in a plastic pouch through a synthetic skin patch was investigated. In this regard, three experimental paradigms were employed: Paradigm 1 includes the effect of variable microwave power (5–10 W) and variable heating time (5–60 s) and Au NPs in water (20 nm size, volume of 10 μL) in a plastic pouch (1 × 2 cm2 in size). Paradigm 2 includes the effect of a variable volume of 20 nm Au NPs in a variable volume of SF up to 100 μL in a plastic pouch at a constant microwave power (10 W) for 30 s. Paradigm 3 includes the effect of constant microwave power (10 W) and microwave heating time (30 s), constant volume of Au NPs (100 μL), and variable size of Au NPs (20–200 nm) placed in a plastic pouch through a synthetic skin patch. In these experiments, an average of 60–100% reduction in the size of an l-alanine crystal (initial size = 450 μm) without damage to the synthetic skin or increasing the temperature of the samples beyond the physiological range was reported.

Surgery for T4 lung cancer invading the thoracic aorta: Do we push the limits?

Few investigators have described en bloc resection of non-small cell lung cancer (NSCLC) invading the aorta. Analysis of outcome and prognostic factors for en bloc resections of NSCLC invading the aorta. Thirty-five patients (27 males, 8 females; mean age 63 ± 8.6 years) were operated between 1994 and 2015 in four European Centers. 12 (34.3%) squamous cell carcinoma, and 6 (17.1%) undifferentiated/large cell carcinoma. The site of aortic infiltration was the descending thoracic aorta in 24 (68.6%) patients, the aortic arch in 9 (25.7%), and the aortic arch and supraortic trunks in 2 (5.7%). Lung resection consisted of pneumonectomy in 19 (54.3%) patients and lobectomy in 16 (45.7%). Aortic resection management was undertaken by endograft positioning (37.1%), subadventitial dissection (37.1%), cardiopulmonary/aorto-aortic bypass (17.2%), and direct clamping (8.6%). A tubular graft replacement was carried out in five cases, a synthetic patch repair in 6. Mortality was 2.9%, morbidity 37.1%. Patients undergoing pneumonectomy had a significantly higher morbidity rate compared with lobectomy (52% vs 18.7%; P = 0.003), although patients managed with aortic endografting had a lower complication rate. Median overall and disease-free survival rates were 31.3 and 22.2 months, respectively. Gender and site of aortic infiltration were independent prognostic factors. Resection of NSCLC combined with an infiltrated aorta is a challenging procedure that can be performed with reasonable morbidity and mortality in highly selected patients.

A PC–PU nanoparticle/PU/decellularized scaffold composite vascular patch: Synergistically optimized overall performance promotes endothelialization

Composite vascular patches have gained increasingly attention due to the limited availability of autologous patches (vascular graft materials made from the blood vessels of the same recipient), the lack of growth capability of nonautologous patches (vascular graft materials made from the blood vessels of a different donor) and the disadvantages of synthetic patches. In this study, we report a highly biocompatible phosphatidylcholine–polyurethane nanoparticle/polyurethane/decellularized scaffold composite vascular patch (PCVP). It was fabricated by a facile method − cosedimentation. Its in vitro blood and cell compatibility including hemolysis, plasma recalcification time, coagulation time, platelet adhesion and cytotoxicity was evaluated. The surface modified with phosphatidylcholine–polyurethane (PC–PU) nanoparticles exhibited the improved anticoagulation activity. The in vivo performance of the PCVP was investigated in a mouse model. The nanopatterned surface that resembled the concave-convex structure of the luminal surface of native blood vessels enhanced cell attachment, proliferation, migration and differentiation. The decellularized scaffold had the mechanical property similar to that of the targeted blood vessels, which could withstand in vivo dynamic blood pressure. The overall performance of the PCVP was synergistically optimized by each layer of the multilayer design. The patched artery remained patent and the formation of endothelial tissue − endothelialization was achieved 30days after the in vivo implantation in a mouse model.

Transseptal puncture using surgical electrocautery in children and adults with and without complex congenital heart disease.

Atrial transseptal puncture (TSP) for cardiac catheterization procedures remain challenging in children and adults with complex congenital heart disease (CHD). We sought to evaluate our experience using radiofrequency (RF) current via surgical electrocautery needle for TSP to facilitate diagnostic and interventional procedures. Retrospective chart review of all patients (pts) who underwent TSP using RF energy (10-25 W) via surgical electrocautery from three centers from January 2011 to January 2017 were evaluated. Echocardiograms were reviewed to define the atrial septum as normal and complex (thin aneurysmal, thick/fibrotic, synthetic patch material, and extra cardiac conduit). A total of 54 pts underwent 55 successful TSP. Median age was 12.5 years (1 day-54 years) and weight was 52.7 kg (2-162). Indications for TSP included; EP study and ablation procedures in structurally normal hearts (n = 24) and in complex atrial septum/CHD and structural heart disease pts (n = 30): Electrophysiology study and ablation in 4, diagnostic catheterization in 9, and interventional procedures in 17 pts were performed. Atrial TSP was successful in 54/55 (98%). Atrial perforation with tiny-small pericardial effusion not requiring intervention was noted in 2 pts. TSP was unsuccessful in one critically ill neonate with unobstructed TAPVR and restricted atrial septum who experienced cardiac arrest requiring CPR, ECMO, and emergent surgery. RF current delivery using surgical electrocautery for TSP is a feasible and an effective option in patients with complex CHD for diagnostic, interventional, and electrophysiology procedures.

REOPERATIONS IN HIGH RISK GROUP CHILDREN WITH CONGENITAL DIAPHRAGMATIC HERNIA

Background. Nowadays the survival of newborns with congenital diaphragmatic hernia (CDH) is increasing. That’s why high frequency of chronic diseases and surgical complications is predictable.Purpose: determination of the structure and frequency of CDH reoperation in children with high risk, retrospective evaluation of perinatal clinical and intraoperative risk factors for repeat surgery.Materials and methods. Prospectively established group of 68 high-risk children with CDH, which were operated and survived during the period from 2000 to 2014. Left-sided hernias were dominated (82%) and right-sided CDH were diagnosed in 18% of newborns. Correction of left-sided CDH were performed by laparotomy in 51 patients (88%), including upper midline laparotomy in 43 cases and in 8 patients upper transverse laparotomy was performed. Thoracotomy was performed in 19 patients. Also thoracotomy was preferred in right-sided CDH (66.7%). Plastic of the diaphragm in case of left-sided CDH was performed by own tissues in 50 patients (73.5%). Plastic with using synthetic materials was made in 17 patients (26.5%): Medical Teflon ePTFE (n = 8), patch in the form of "sandwich" ("Tutoplast-pericardium" and mash) was used in four patients, Gor-Tex (n = 3) and with "Tutoplast-pericardium" was performed in two patients.Results. 23 operations in 20 of 68 patients were performed (29.4%). The reason of performing reoperations were such disease: adhesive bowel obstruction - 8 (40%), including strangulation obstruction with necrosis - 2 (10%), recurrent hernia - 6 (30%), gastroesophageal reflux - 5 (25%), obstruction caused by malrotation- 1 (5%), spleen torsion - 1 (5%), funnel chest deformation - 1 (5%). In patient with left diaphragmatic dome agenesis and primary plastics using synthetic ePTFE patch surgical treatment for recurrence was performed twice - at the age of 6 months and 1 year. Antireflux procedure was performed in the early postoperative period in two children, and in three children in the age of 5 years. In all children antireflux operation was performed by Nissen method. Correction of the funnel chest deformation by Nuss method was performed in patient after plastic CDH by own tissues, combined with recurrent hernia. The cause of postoperative intestinal obstruction in most patients were adhesions (n=8) and in one case was malrotation. Adhesive intestinal obstruction was occurred in 6 patients after using laparotomic access, including two of them with necrosis and intestinal resection. In two patients adhesive intestinal obstruction was occurred after using thoracotomic access and obstruction was caused by solitary threadlike adhesion.Conclusions. There is a high probability of surgical complications and reoperations in patients with high risk who survived after the CDH correction. The main factors that determine the risk of recurrence of CDH are the size of the hernia defect and the way of surgical plastic of the diaphragm. Laparotomic access increases the risk of postoperative adhesive intestinal obstruction. It is essential to long-term observation of these children to find out the risk factors of specific surgical complications.

A Prospective, Randomized, Multicenter Clinical Trial on the Safety and Efficacy of a Ready-to-Use Fibrin Sealant as an Adjunct to Hemostasis during Vascular Surgery

Anastomotic or "stitch hole" bleeding is common during vascular surgery with synthetic material such as Dacron or polytetrafluoroethylene. Hemostatic adjuncts such as fibrin sealant (FS) may reduce blood loss and operating time in such circumstances. We evaluated the safety and the hemostatic effectiveness of a ready-to-use human plasma-derived FS in vascular surgery. Patients with mild/moderate suture line bleeding during elective, open, vascular surgery using synthetic grafts or patches were studied. In an initial Exploratory Study, all patients were treated with FS Grifols, and in a subsequent Primary Study were randomized in a 2:1 ratio to FS Grifols or manual compression (MC). The primary efficacy end point was time to hemostasis (TTH), assessed at defined intervals from the start of treatment application, during a 10-min observational period. Safety end points (in Exploratory+Primary Studies) included adverse events (AEs), vital signs, physical assessments, common clinical laboratory tests (coagulation, complete blood count, serum clinical chemistry parameters, microscopic urinalysis), viral markers, and immunogenicity. In the Primary Study, the proportion of patients who achieved hemostasis at the 3-min time point was higher in the FS Grifols group (46.4%, n=51/110) than in the MC group (26.3%, n=15/57) (P<0.05). The benefit was maintained at successive time intervals: 69 FS Grifols patients (62.7%) and 18MC patients (31.6%) at 4min; 82 FS Grifols patients (74.5%) and 28MC patients (49.1%) at 5min. The differences between the groups persisted for TTH ≤ 7min and TTH ≤ 10min. Treatment failure was reported for 13 FS Grifols patients (11.8%) and 16MC patients (28.1%). TTH was shorter after FS Grifols application than after MC application. Differences were statistically significant in favor of FS Grifols for each TTH category and for the overall comparison (P<0.001) as well as for each TTH category (cumulative) and for treatment failure (P=0.016). Overall, AE experience and types of AEs reported were those expected in this patient population and were similar between the 2 treatment groups. The most frequently reported AEs were procedural pain (59.9% and 69.2% of patients in the FS Grifols [n=72+111] and MC [n=57] groups, respectively) and nausea (23.5% and 19.2% of patients, respectively). FS Grifols was efficacious and safe as an adjunct to anastomotic hemostasis in patients undergoing arterial surgery using prosthetic material with mild to moderate bleeding.

Biocompatibility of polypropylene mesh scaffold with adipose-derived stem cells.

In this study, we investigated the rejection of the synthetic patch and human tissues in the host. We observed the growth of adipose-derived stem cells (ADSCs) cultured with polypropylene mesh in vitro. The results of flow cytometry showed that the expression of CD44, CD73, CD90, CD45, CD14 and CD34 was 98.54, 95.32, 98.49, 1.21, 3.01 and 2.14%, respectively. ADSCs were isolated from rabbit subcutaneous adipose tissue after collagenase digestion, filtration and centrifugation. The ADSCs of passage 3 were seeded onto the polypropylene mesh scaffolds. New Zealand White female breeder rabbits were implanted with polypropylene mesh, ADSC-fixed polypropylene mesh in the abdomen. After 4 weeks, adhesion was performed and the erosion of the mesh was evaluated. It was found that polypropylene mesh, ADSC-fixed polypropylene mesh all had different degrees of corrosion, and adhesion, but polypropylene mesh was more corroded. ADSC-fixed polypropylene mesh induced a milder chronic inflammation response compared with polypropylene, had significantly lower scores for inflammation (t=11.083), and had significantly higher scores for neovascularization (t=14.362) and fibroblastic proliferation (t=15.979). The relative amount of VEGF mRNA was significantly lower for ADSC-fixed polypropylene compared with the other polypropylene meshes (t=94.6). In conclusion, polypropylene mesh scaffold with ADSCs exhibit excellent cellular compatibility and are promising in clinical practice.

Arthroscopic Partial Repair of Irreparable, Massive Rotator Cuff Tears

Several treatment options for chronic, massive rotator cuff tears exist, and they include debridement with possible biceps tenotomy or tenodesis, open or arthroscopic partial repair, muscle or tendon transfer, superior capsule reconstruction, synthetic patch augmentation, and reverse total shoulder arthroplasty. The aim of this technique article is to describe our preferred surgical option for irreparable, massive rotator cuff tears with an irreparable supraspinatus, a reparable infraspinatus, and an intact or reparable subscapularis tendon.

Preliminary Results of a Consecutive Series of Large & Massive Rotator Cuff Tears Treated with Arthroscopic Rotator Cuff Repairs Augmented with Extracellular Matrix.

Recurrence rate of rotator cuff tears is still high despite the improvements of surgical techniques, materials used and a better knowledge of the healing process of the rotator cuff tendons. Large to massive rotator cuff tears are particularly associated with a high failure rate, especially in elderly. Augmentation of rotator cuff repairs with extracellular matrix or synthetic patches has gained popularity in recent years with the aim of reducing failure. The aim of this study was to investigate the outcome of rotator cuff repairs augmented with denatured extracellular matrix in a series of patients who underwent arthroscopic rotator cuff repair for large to massive tears. Ten consecutive patients, undergoing arthroscopic rotator cuff repair with extracellular matrix augment for large and massive tears, were prospectively enrolled into this single surgeon study. All repairs were performed arthroscopically with a double row technique augmented with extracellular matrix. Oxford Shoulder Score, Constant Score and pain visual analogue scale (VAS) were used to monitor the shoulder function and outcome pre-operatively and at three, six and 12-month follow-up. Minimum follow up was three months. Mean follow up was 7 months. Mean Constant score improved from 53 (SD=4) pre-operatively to 75 (SD=11) at final follow up. Mean Oxford score also increased from 30 (SD=8) pre-operatively to 47 (SD=10) at the final follow up. The visual analogue scale (VAS) improved from seven out of 10 (SD=2) preoperatively to 0.6 (SD=0.8) at final follow up. Additionally, there was significant improvement at three months mark in Constant score. Arthroscopic repair and augmentation of large and massive rotator cuff tears with extracellular matrix patch has good early outcome.

P1.08-051 VATS Lobectomy Combined with Limited Thoracotomy for Treatment of Superior Sulcus Tumors

Despite the increasing of VATS procedures even for locally advanced NSCLC, Pancoast tumors have been rarely approached with VATS combined with chest wall resection. This report describes a hybrid surgical technique to approach “en block” chest resection and pulmonary lobectomy for superior sulcus tumors. We present two cases of patients referred to our Institution. A female patient affected by right anterior Pancoast tumor surgically staged as cT4N0M0 for suspected anonymous vein invasion, underwent induction therapy with four cycles of cisplatin and Pemetrexed plus 60 Gy irradiation, with satisfactory tumor reduction. The surgical operation comprised an initial VATS approach to the hilar structures followed by a limited C-shaped anterior contra-incision; finally, the right upper lobe “en block” with the anterior part of the first and second rib was removed. The second case is a 57-year-old man, affected by a cT3N0M0 posterior Pancoast tumor, treated with induction chemoradiotherapy prior to the hybrid surgical approach. After thoracoscopic pleural cavity inspection, an upper right VATS lobectomy by a 3-port standard approach was performed. The chest wall was resected through a limited paravertebral incision, allowing the extraction of the lobe together with the rib segments. The posterior chest wall defect was repaired with a synthetic patch. The postoperative period was uneventful in both cases, and the pain never exceed a score of 4 on a visual analogue scale. The patients were discharged respectively 9 and 11 days after surgery. Pathological results revealed in both cases nonvital tumor cells in the specimen (ypT0N0M0). The patients are free from disease and post-thoracotomy syndrome at 14 and 18 months' follow-up. VATS combined with thoracotomy approach leads to asses with precision the thoracic wall resection and reduce surgical trauma with very good results in term of postoperative morbidity. We strongly support the “VATS observation first” philosophy, to exclude previously undetected pleural dissemination and to precisely define the tumor location. Further experiences are needed to validate the role of VATS lobectomy in the multidisciplinary management of Pancoast tumor.

Postoperative pulmonary artery stenosis: current options and future directions.

This study by Kim et al . (1) addresses an important and frequent issue in pediatric cardiac surgery, which is the management of postoperative pulmonary artery (PA) branches stenoses. Different options are currently available to treat a PA branch stenosis, including a conventional surgical plasty using (or not) a biological patch (autologous pericardium, human cryopreserved pericardium, bovine or equine pericardium, or decellularized porcine intestinal submucosa extracellular matrix) or a synthetic patch (polytetrafluoroethylene, terephtalate, ...), percutaneous procedures (balloon dilation, stent placement, cutting balloon dilation, ...) and hybrid procedures.