Porcine Small Intestinal Submucosa Research Articles

EARLY HYDRODYNAMIC ASSESSMENT OF INTESTINAL SUB-MUCOSA BIOSCAFFOLD FOR MITRAL VALVE REPLACEMENT

Background: Infants and children with severe valve lesions have limited surgical options. It has been shown that acellular porcine small intestinal submucosa (PSIS) scaffolds support cell infiltration and tissue remodeling after implantation. Our group has implanted custom-made PSIS valves in 4

Perivascular extracellular matrix hydrogels mimic native matrix microarchitecture and promote angiogenesis via basic fibroblast growth factor.

Extracellular matrix (ECM)-derived bioscaffolds have been shown to elicit tissue repair through retention of bioactive signals. Given that the adventitia of large blood vessels is a richly vascularized microenvironment, we hypothesized that perivascular ECM contains bioactive signals that influence cells of blood vessel lineages. ECM bioscaffolds were derived from decellularized human and porcine aortic adventitia (hAdv and pAdv, respectively) and then shown have minimal DNA content and retain elastin and collagen proteins. Hydrogel formulations of hAdv and pAdv ECM bioscaffolds exhibited gelation kinetics similar to ECM hydrogels derived from porcine small intestinal submucosa (pSIS). hAdv and pAdv ECM hydrogels displayed thinner, less undulated, and fibrous microarchitecture reminiscent of native adventitia, with slight differences in ultrastructure visible in comparison to pSIS ECM hydrogels. Pepsin-digested pAdv and pSIS ECM bioscaffolds increased proliferation of human adventitia-derived endothelial cells and this effect was mediated in part by basic fibroblast growth factor (FGF2). Human endothelial cells cultured on Matrigel substrates formed more numerous and longer tube-like structures when supplemented with pAdv ECM bioscaffolds, and FGF2 mediated this matrix signaling. ECM bioscaffolds derived from pAdv promoted FGF2-dependent invivo angiogenesis in the chick chorioallantoic membrane model. Using an angiogenesis-focused protein array, we detected 55 angiogenesis-related proteins, including FGF2 in hAdv, pAdv and pSIS ECMs. Interestingly, 19 of these factors were less abundant in ECMs bioscaffolds derived from aneurysmal specimens of human aorta when compared with non-aneurysmal (normal) specimens. This study reveals that Adv ECM hydrogels recapitulate matrix fiber microarchitecture of native adventitia, and retain angiogenesis-related actors and bioactive properties such as FGF2 signaling capable of influencing processes important for angiogenesis. This work supports the use of Adv ECM bioscaffolds for both discovery biology and potential translation towards microvascular regeneration in clinical applications.

Cost-effectiveness of using adjunctive porcine small intestine submucosa tri-layer matrix compared with standard care in managing diabetic foot ulcers in the US

To estimate the cost-effectiveness of using tri-layer porcine small intestine submucosa (SIS; Oasis Ultra) as an adjunct to standard care compared with standard care alone in managing diabetic foot ulcers (DFUs) in the US, from the perspective of Medicare. A Markov model was constructed to simulate the management of diabetic neuropathic lower extremity ulcers over a period of one year in the US. The model was used to estimate the cost-effectiveness of initially using adjunctive SIS compared with standard care alone to treat a DFU in the US at 2016 prices. At 12 months after the start of treatment, the use of adjunctive SIS instead of standard care alone is expected to lead to a 42 % increase in the number of ulcer-free months, 32 % increase in the probability of healing, a 3 % decrease in the probability of developing complicated ulcers and a 1 % decrease in the probability of undergoing an amputation. Health-care resource use is expected to be reduced by 11-14 % among patients who are initially managed with adjunctive SIS compared with those initially managed with standard care alone, with the exception of debridement, which is expected to be reduced by 35 %. Hence, the total health-care cost of starting treatment with adjunctive SIS instead of standard care alone was estimated to reduce payer costs by 1% (i.e. $105 per patient) over 12 months following the start of treatment. Within the study's limitations, the use of adjunctive SIS instead of standard care alone improves outcome for less cost and thereby affords a cost-effective use of Medicare-funded resources in the management of neuropathic foot ulcers among adult patients with type 1 or 2 diabetes mellitus in the US.

不同组织来源的胶原蛋白生物材料物理性能对比研究

本文对比考察了四种不同来源的胶原蛋白植入材料的物理性能，主要包括形貌、粗糙度、孔隙率、亲水性、力学强度以及变性温度等性质。实验结果表明，脱细胞猪小肠粘膜下层生物材料(VIDASIS)的物理性能与进口同类产品无显著差异。 In this paper, physical properties of different tissue-derived collagen biomaterials were studied, including morphology, roughness, porosity, hydrophilicity, mechanical strength and denaturation temperature. Results demonstrated that physical property of porcine small intestinal submucosa extracellular matrix (VIDASIS) was almost the same with other domestic and foreign products.

脱细胞猪小肠粘膜下层材料体内外降解过程对比研究

通过对脱细胞猪小肠粘膜下层基质材料进行体内外降解实验，考察了SIS材料在不同降解环境下的降解行为，为其在临床应用中的有效性提供依据。体外降解实验采用I型胶原酶，蛋白酶K酶解来模拟体内降解环境；体内降解实验采用大鼠和新西兰兔分别进行皮下以及腹壁植入。结果显示SIS材料在体内修复组织需要8~12周，相当于体外I型胶原酶降解12 h (降解40.24%)，蛋白酶K降解60 min (56.33%)；材料在体内完全降解的时间为24周，而体外胶原酶和蛋白酶K完全降解分别需要96 h和120 min，同时SIS材料组织相容性好，无黏连，血肿等症状发生。结果表明SIS降解与组织修复过程相匹配，排异反应弱，可以为组织修复提供力学强度与生物学模板，表明SIS材料是一种可用于临床修复的生物材料。 Degradation behaviors of acellular porcine small intestinal submucosa (SIS) matrix under different circumstances were investigated by taking the degradation experiments in vivo and in vitro respectively. In vitro, solutions of collagenase type I and Proteinase K were used to mimic the de-gradation environment. Wistar mice and New Zealand Rabbits were used as subcutaneous and abdominal degradation model in vivo. Results showed that it took 8-12 weeks for the tissue to re-pair in vivo, while the time intervals needed to get the same degradation percentage for collagenase I and Proteinase K in vitro were 12 h and 60 min respectively. SIS was totally degraded in 24 weeks in vivo and the corresponding time for collagenase I and Proteinase K in vitro were 96 h and 120 min. Besides, SIS showed good histocompatibility and did not have symptoms of adhesion and hematomas. Results demonstrated the processes of degradation and tissue repair were matched well with each other without immunological rejection and SIS could supply the mechanical strength and biological template during tissue repair, suggesting SIS is a potential surgical biomaterial for clinical applications.

Development and clinical application of decellularized porcine SIS and cornea for the repair of corneal defects in animals

Porcine small intestine sub-mucosa (SIS) and cornea were decellularized using ionic biological detergent (1% SDS) and stored at –20°C in sterile phosphate buffer saline (PBS) solution containing mixture of antibiotics. The prepared biomaterials were subjected to histological and scanning electron microscopic observations to ascertain the decellularization status before their clinical application. Both the biomaterials were evaluated for the repair of corneal defects in 11 animals. Five animals having corneal defects repaired with SIS and 4 repaired with cornea demonstrated successful healing without clinical signs of infections or reoccurrence during the 8 months follow up period. Results of study support the use of decellularized porcine SIS and cornea as an alternative to traditional implantation materials to treat different corneal defects in animals.

Hydrodynamic Assessment of Aortic Valves Prepared from Porcine Small Intestinal Submucosa.

Infants and children born with severe cardiac valve lesions have no effective long term treatment options since currently available tissue or mechanical prosthetic valves have sizing limitations and no avenue to accommodate the growth of the pediatric patient. Tissue engineered heart valves (TEHVs) which could provide for growth, self-repair, infection resistance, and long-term replacement could be an ideal solution. Porcine small intestinal submucosa (PSIS) has recently emerged as a potentially attractive bioscaffold for TEHVs. PSIS may possess the ability to recruit endogenous cardiovascular cells, leading to phenotypically-matched replacement tissue when the scaffold has completely degraded. Our group has successfully implanted custom-made PSIS valves in 4 infants with critical valve defects in whom standard bioprosthetic or mechanical valves were not an option. Short term clinical follow-up has been promising. However, no hydrodynamic data has been reported to date on these valves. The purpose of this study was to assess the functional effectiveness of tri-leaflet PSIS bioscaffolds in the aortic position compared to standard tri-leaflet porcine bioprosthetic valves. Hydrodynamic evaluation of acute PSIS function was conducted using a left heart simulator in our laboratory. Our results demonstrated similar flow and pressure profiles (p>0.05) between the PSIS valves and the control valves. However, forward flow energy losses were found to be significantly greater (p<0.05) in the PSIS valves compared to the controls possibly as a result of stiffer material properties of PSIS relative to glutaraldehyde-fixed porcine valve tissue. Our findings suggest that optimization of valve dimensions and shape may be important in accelerating de novo valve tissue growth and avoidance of long-term complications associated with higher energy losses (e.g. left ventricular hypertrophy). Furthermore, long term animal and clinical studies will be needed in order to conclusively address somatic growth potential of PSIS valves.

A Gingiva-Derived Mesenchymal Stem Cell-Laden Porcine Small Intestinal Submucosa Extracellular Matrix Construct Promotes Myomucosal Regeneration of the Tongue.

In the oral cavity, the tongue is the anatomic subsite most commonly involved by invasive squamous cell carcinoma. Current treatment protocols often require significant tissue resection to achieve adequate negative margins and optimal local tumor control. Reconstruction of the tongue while preserving and/or restoring its critical vocal, chewing, and swallowing functions remains one of the major challenges in head and neck oncologic surgery. We investigated the in vitro feasibility of fabricating a novel combinatorial construct using porcine small intestinal submucosa extracellular matrix (SIS-ECM) and human gingiva-derived mesenchymal stem cells (GMSCs) as a GMSC/SIS-ECM tissue graft for the tongue reconstruction. We developed a rat model of critical-sized myomucosal defect of the tongue that allowed the testing of therapeutic effects of an acellular SIS-ECM construct versus a GMSC/SIS-ECM construct on repair and regeneration of the tongue defect. We showed that the GMSC/SIS-ECM construct engrafted at the host recipient site, promoted soft tissue healing, and regenerated the muscular layer, compared to the SIS-ECM alone or nontreated defect controls. Furthermore, our results revealed that transplantation of the GMSC/SIS-ECM construct significantly increased the expression of several myogenic transcriptional factors and simultaneously suppressed the expression of type I collagen at the wounded area of the tongue. These compelling findings suggest that, unlike the tongue contracture and fibrosis of the nontreated defect group, transplantation of the combinatorial GMSC/SIS-ECM constructs accelerates wound healing and muscle regeneration and maintains the overall tongue shape, possibly by both enhancing the function of endogenous skeletal progenitor cells and suppressing fibrosis. Together, our findings indicate that GMSC/SIS-ECM potentially served as a myomucosal graft for tongue reconstruction postsurgery of head and neck cancer.

Can Grafts Provide Superior Tendon Healing and Clinical Outcomes After Rotator Cuff Repairs?: A Meta-analysis.

Background:Arthroscopic repair of large to massive rotator cuff tears commonly retear. To improve healing rates, a number of different approaches have been utilized, including the use of grafts, which may enhance the biomechanical and biologic aspects of the repair construct. However, the outcomes after the use of grafts are diverse.Purpose:To systematically review the literature for large to massive rotator cuff tears to determine whether the use of grafts generally provides superior tendon healing and clinical outcomes to the repairs without grafts.Study Design:Systematic review; Level of evidence, 3.Methods:A systematic review of the literature was performed. Clinical studies comparing the repairs with (graft group) and without grafts (control group) were included and analyzed. The primary outcome was tendon healing on either magnetic resonance imaging or ultrasound. The secondary outcome measures included visual analog scale for pain, University of California at Los Angles (UCLA) score, and forward elevation range. Differences between groups in all outcome measures were statistically analyzed.Results:Six comparative studies (level of evidence 2 or 3) with 13 study groups were included. A total of 242 repairs in the graft group (mean age, 62.5 ± 4.6 years) and 185 repairs in the control group (mean age, 62.5 ± 5.0 years) were analyzed. The graft types utilized included autograft (fascia lata) in 1 study, allograft (human dermis) in 2 studies, xenograft (bovine pericardium, porcine small intestine submucosa) in 2 studies, synthetic graft (polypropylene) in 1 study, and a combination of autograft (the long head of biceps) and synthetic graft (polypropylene) in 1 study. The overall mean follow-up time was 28.4 ± 9.0 months. When 1 or 2 studies/study groups were excluded due to practical or statistical reasons, the graft group demonstrated significantly improved healing (odds ratio, 2.48; 95% CI, 1.58-3.90; P < .0001) and all clinical outcome measures at final follow-up (P ≤ .02).Conclusion:The use of grafts generally provides superior tendon healing and clinical outcomes compared to repairs without grafts, except for some specific graft types (eg, porcine small intestine submucosa, bovine pericardium). Further investigations are required to determine the benefits of the use of grafts.

Bicentric prospective evaluation of corporoplasty with porcine small intestinal submucosa (SIS) in patients with severe Peyronie's disease.

Advanced Peyronie's disease (PD) with severe penile deviation demands grafting procedures following plaque incision or partial plaque excision in order to avoid penile shortening and to improve quality of life of affected patients. Small intestinal submucosa (SIS) is an established xenograft. The objective of the present study was to validate external results in a bicentric prospective manner. Patient selection criteria, surgical technique and standards for pre- and postoperative care were defined. Consecutively, patients with severe penile deviation in stable disease and sufficient erectile function were included between 2007 and 2015. After plaque incision, grafting was performed using SIS in a standardized manner. The postoperative evaluation using a non-validated questionnaire included complications, correction of curvature, pre- and postoperative erectile function, change in penile length and general satisfaction with the procedure. Forty-three patients underwent surgery between 2007 and 2015. The mean degree of preoperative curvature was 73.8° (range 60-90°). No intraoperative or major postoperative complications were reported. After a mean follow-up of 33.0months (range 10-59), complete straightening of the penis was achieved in 74.4%. 88.4% of all patients were able to achieve satisfying sexual intercourse (67.4% unaided, 21.0% with assistance). The IIEF-5 score was improved in 69.8% (mean improvement 4.0 points). Overall 86.0% were satisfied with the surgical treatment. Corporoplasty with SIS in patients with PD and severe penile curvature is a safe approach and shows good long-term results. A thorough patient selection and a standardized pre-, intra- and postoperative procedure are decisive for a satisfying outcome.

Porcine Small Intestinal Submucosa Mesh for Treatment of Pelvic Organ Prolapsed.

Background:Pelvic organ prolapse (POP) is a major health concern that affects women. Surgeons have increasingly used prosthetic meshes to correct POP. However, the most common used is synthetic mesh, and absorbable mesh is less reported. This research aimed to evaluate the clinical effectiveness of porcine small intestinal submucosa (SIS).Methods:Consecutive forty POP patients who met the inclusion criteria underwent pelvic reconstruction surgery with SIS between March 2012 and December 2013. The patients’ clinical characteristics were recorded preoperatively. Surgical outcomes, measured by objective and subjective success rates, were investigated. We evaluated the quality of life (QOL) using the Pelvic Floor Distress Inventory-20 (PFDI-20) and the Pelvic Floor Impact Questionnaire-7 (PFIQ-7). Sexual QOL was assessed by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12 (PISQ-12).Results:At postoperative 12 months, the subjective recurrence rate (7.5%) was much lower than the objective recurrence rate (40.0%). Postoperatively, no erosion was identified. One underwent a graft release procedure because of urinary retention, and one had anus sphincter reconstruction surgery due to defecation urgency. Another experienced posterior vaginal wall infection where the mesh was implanted, accompanied by severe vaginal pain. Estrogen cream relieved the pain. One patient with recurrence underwent a secondary surgery with Bard Mesh because of stage 3 anterior vaginal wall prolapse. Scoring system of PFDI-20 was from 59.150 ± 13.143 preoperatively to 8.400 ± 4.749 postoperatively and PFIQ-7 was from 73.350 ± 32.281 to 7.150 ± 3.110, while PISQ-12 was from 15.825 ± 4.050 to 12.725 ± 3.471.Conclusions:QOL and the degree of subjective satisfaction were significantly improved postoperatively. Anterior repair deserves more attention because of the higher recurrence rate. The long-term follow-up of the patient is warranted to draw firm conclusion.

Treatment of total pelvic organ prolapse using a whole biological patch: A pilot study of 17 patients.

A complete and non-splice porcine small-intestine submucosa (SIS) patch was used for total pelvic anatomical repair of organ prolapse. This study included a total of 17 patients with severe total pelvic organ prolapse, including five patients with combined stress urinary incontinence (SUI). Panhysterectomy was performed, and then a porcine SIS patch was placed on the anterior (posterior) vaginal wall. The top of the vaginal wall was moved to the corresponding side of the vaginal wall, and the patch was sutured to bilateral uterosacral ligaments, the sacrospinous ligament, and arcus tendineus fasciae pelvis. SUI was addressed at the same time. 'Failure' was defined as anterior or posterior wall prolapse beyond the hymen. The mean follow-up duration was 11.6 ± 7.45 months (2-24 months). No symptom recurrence was observed in the five patients with combined SUI. One patient who underwent porcine SIS patch placement on the posterior wall experienced stage II anterior vaginal wall prolapse after surgery. The vaginal wall and fornix of the remaining patients with patches were restored to stable anatomical positions (92.85%). No organ damage, infection, erosion, or rejection was observed, and no blood transfusion was necessary. This study is the first to implement total pelvic anatomical repair using a complete and non-splice SIS. Our results suggest that this new surgical method is safe and can achieve satisfactory therapeutic effects, especially for patients with combined SUI.

Magnetic Resonance Imaging Appearance and Mechanism of Action of Five Hemostatic Agents Used in Neurosurgery.

To describe the magnetic resonance (MR) image appearance of 5 hemostatic agents placed in the brain, and to review their clinical application. Descriptive ex vivo and in vivo study. Canine cadavers (n=4), client-owned dogs (n=4). Heads from 4 canine cadavers were used, each with 5 hemostatic agents placed in specific locations in the brain. Hemostatic agents were used in their native form in 2 cadaveric brains, and in 2 others the materials were saturated with fresh whole blood prior to placement to mimic application in a field of active hemorrhage. The heads underwent MR imaging and the images were reviewed. Postoperative MRI images from 4 dogs undergoing brain tumor resection were retrospectively reviewed and compared to the images from the cadavers. All clinical cases and cadaveric specimens underwent surgical closure prior to MR imaging including placement of titanium mesh over the craniotomy defect with a dural graft of porcine small intestinal submucosa (SIS) sealed with Tisseel (fibrin sealant). The SIS and Tisseel used in the dural graft were consistently indistinguishable from the surrounding tissues on MR images. The MR imaging appearance of the remaining 4 hemostatic agents (Gelfoam, Avitene, Surgicel, and Floseal) placed on the surface or in the parenchyma of canine brain, varied with MR sequence weighting and blood saturation. Accurate evaluation of the degree of brain tumor resection on postoperative MR images requires careful differentiation between hemorrhage, residual tumor, and hemostatic agents implanted.

CorMatrix valved conduit in a porcine model: long-term remodelling and biomechanical characterization.

Porcine small intestinal submucosa extracellular matrix (CorMatrix; CorMatrix Cardiovascular, Rosewell, GA) is a relatively novel tissue substitute used in cardiovascular applications. We investigated the biological reaction and remodelling of CorMatrix as a tri-leaflet valved conduit in a pig model. We hypothesized that CorMatrix maintains a durable architecture as a valved conduit and remodels to resemble surrounding tissues. We fashioned the valved conduit using a 7 × 10 cm 4-ply CorMatrix sheet and placed it in the thoracic aorta of seven landrace pigs for 3, 4, 5 and 6 months. Biodegradation, replacement by native tissue, strength and durability were examined by histology, immunohistochemistry and mechanical testing. Four pigs, one per time frame, completed the study. The conduit lost its original architecture as a tri-leaflet valve due to cusp immobility, subsequent attachment to the wall segment and consequent maintenance of a thick arterial wall-like structure. Scaffold resorption was incomplete, with disorganized inconsistent spatial and temporal degradation even at 6 months. Fibrosis, scarring and calcification started at 4 months and chronic inflammation persisted. The partially remodelled scaffold did not resemble the aortic wall, suggesting impaired remodelling. Mechanical testing showed progressive weakening of the tissues over time, which were liable to breakage. CorMatrix is biodegradable; however, it failed to remodel in a structured and anatomical fashion in an arterial environment. Progressive mechanical and remodelling failure in this scenario might be explained by the complexity of the conduit design and the host's chronic inflammatory response, leading to early fibrosis and calcification.

Lingual Nerve Microsurgery Outcomes Using 2 Different Conduits: A Retrospective Cohort Study

This study compared a type 1 collagen conduit (NeuraGen) with a porcine small intestinal submucosa conduit (AxoGuard) when used in lingual nerve microsurgery and any differences in achieving functional sensory recovery (FSR). All patients who underwent lingual nerve microsurgery performed by 1 surgeon (V.B.Z.) from 2007 to 2014 had their surgical information obtained by a retrospective review of hospital records and office charts after institutional review board approval. Those patients whose surgery included the use of a nerve conduit were included in the study. Subjective neurosensory recovery was determined by neurosensory testing, including responses to hot, cold, wisp, brush, and pinprick. Objective recovery was determined by testing 2-point discrimination and fine touch threshold with von Frey fibers. The objective findings were correlated to a Medical Research Council System score, with grades S3, S3+, and S4 indicating FSR. The conduits were compared using a Student t test with a 2-tailed hypothesis. The von Frey fiber test had a preoperative mean of 6.29 (standard deviation [SD], 0.95), which improved to 3.97 (SD, 0.67) for the NeuraGen and 4.17 (SD, 0.56) for the AxoGuard. Two-point discrimination improved from a mean higher than 19.42 to 9.32mm (SD, 2.96mm) for the NeuraGen and 9.67mm (SD, 2.13mm) for the AxoGuard. The mean FSR was S3+. There were no meaningful differences in outcomes between the 2 conduits studied, and all patients achieved FSR according to the Medical Research Council Scale.

Erratum: Experimental Aortic Valve Cusp Extension with CorMatrix in a Porcine Model.

Background We tested the feasibility of using porcine small intestinal submucosal extracellular matrix (CorMatrix) for aortic valve (AV) repair in porcine model examining its resorption and remodeling potential. Methods The non-coronary cusp was replaced with CorMatrix in four animals for 120 days. Valve function was assessed by echocardiography. Explants were examined by histology, immunohistochemistry, and collagen assessment. Results CorMatrix was almost totally replaced with tissue resembling the native cusp with a partial two-layer architecture. However, function was lost due to thickening and calcification. Conclusions Tested in high-pressure AV position in a pig model, CorMatrix degrades and remodels, but also loses function.

Experimental Aortic Valve Cusp Extension with CorMatrix in a Porcine Model.

Background We tested the feasibility of using porcine small intestinal submucosal extracellular matrix (CorMatrix) for aortic valve (AV) repair in porcine model examining its resorption and remodeling potential. Methods The non-coronary cusp was replaced with CorMatrix in four animals for 120 days. Valve function was assessed by echocardiography. Explants were examined by histology, immunohistochemistry, and collagen assessment. Results CorMatrix was almost totally replaced with tissue resembling the native cusp with a partial two-layer architecture. However, function was lost due to thickening and calcification. Conclusions Tested in high-pressure AV position in a pig model, CorMatrix degrades and remodels, but also loses function.

A randomized clinical trial to compare the effectiveness of rotator cuff repair with or without augmentation using porcine small intestine submucosa for patients with moderate to large rotator cuff tears: a pilot study

The rate of rotator cuff repair failure is between 13% and 67%. Porcine small intestine submucosa (SIS) may be suitable to augment the repair. There were 62 patients with moderate and large cuff tears randomized to repair alone (control) or augmentation with SIS (Restore Orthobiologic Implant; DePuy, Warsaw, IN, USA). Primary outcome was repair failure using magnetic resonance arthrography. Randomization occurred on completion of the repair. Patients and assessors were blind to group. Assessments occurred preoperatively and postoperatively at 2 and 6 weeks and 3, 6, 12, and 24 months. There were 62 patients randomized (34 SIS, 28 control). Patient demographics, rotator cuff tear characteristics, and repair details were similar between groups. At 1 year, risk of failure was 52.9% (18/34) in the SIS group and 65.4% (17/26) in the control group for a risk difference of 12% (80% confidence interval, -7% to 32%) or relative risk of 0.81 (95% confidence interval, 0.53-1.24, P = .33) in favor of SIS. At 1 and 2 years, the mean difference between groups for patient-reported outcomes was small and consistent with chance but did not exclude the possibility of a clinically important difference. There was no statistically significant difference (P = .50) between the SIS group (59.6 ± 38.9; range, 3-112) and the control group (52.7 ± 38.6; range, 5-112) in number of days to being narcotic and pain free (<20 mm on a 100-mm visual analog scale). We found no evidence that SIS-augmented rotator cuff repair provides superior outcomes in patients with moderate rotator cuff tears.

Biologic mesh for repair of ventral hernias in contaminated fields: long-term clinical and patient-reported outcomes.

Guidelines recommend biologic prosthetics for ventral hernia repair (VHR) in contaminated fields, yet long-term and patient-reported data are limited. We aimed to determine the long-term rate of hernia recurrence, and other clinical and patient-reported outcomes following the use of porcine small intestine submucosa (PSIS) for VHR in a contaminated field. Consecutive patients undergoing open VHR with PSIS mesh in a contaminated field from 2004 to 2014 were prospectively evaluated for hernia recurrence and other post-operative complications. Multivariate logistic and Cox regression analyses identified predictors of hernia recurrence and surgical site infection. Patient-reported outcomes were evaluated using SF-36, Hernia-Related Quality-of-Life Survey (HerQLes) and Body Image Questionnaire instruments. Forty-six hernias were repaired in clean-contaminated [16 (35%)], contaminated [11 (24%)] and dirty [19 (41%)] fields. Median follow-up was 47months [interquartile range: 31-79] and all patients had greater than 12-month follow-up. Sixteen patients (35%) were not re-examined. Incidence of surgical site events and surgical site infection were 43% (n=20) and 56% (n=25), respectively. American Society of Anesthesiologists score 3 or greater was an independent predictor of surgical site infection (odds ratio 5.34 [95% confidence interval 1.01-41.80], p=0.04). Hernia recurrence occurred in 61% (n=28) with a median time to diagnosis of 16months [interquartile range 8-26]. After bridged repair, 16 of 18 patients (89%) recurred, compared to 12 of 28 (43%) when fascia was approximated (p<0.01). Bridged repair was an independent predictor of recurrence (odds ratio 10.67 [95% confidence interval 2.42-76.08], p<0.01). Patients with recurrences had significantly worse scores on the SF-36 mental health component and self-perceived body image, whereas HerQLes scores were similar. Hernia recurrences and wound infections are high with the use of biologic PSIS mesh in contaminated surgical fields. Careful consideration is warranted using this approach.

Evaluation of Explanted CorMatrix Intracardiac Patches in Children With Congenital Heart Disease

Animal data demonstrate that intracardiac patches of decellularized porcine small intestine submucosa (CorMatrix; CorMatrix Cardiovascular, Inc, Atlanta, GA) become repopulated with native cells, suggesting the possibility of a substrate for regenerative tissue in humans. We report the only prospective series to date of explanted CorMatrix patches placed in infants with congenital heart disease. CorMatrix patches were implanted as the hemi-Fontan baffle in patients during their second stage of palliation. The patch material was explanted as part of the standard Fontan operation. Specimens were analyzed with the use of hematoxylin and eosin, Movat pentachrome, and trichrome stains. Of the 12 implantations, 10 specimens were explanted. Two patients did not undergo Fontan because of unfavorable hemodynamics. Acellular material,chronic inflammation, fibrosis, and foreign body giant cell reaction was seen in all explanted patches. Also noted in explanted specimens was calcification(n= 2), elastic fibers (n= 2), and eosinophils(n=2).No explanted CorMatrix material showed evidence of ingrowth of native cells or transformation into cardiac tissue at a median of 21 months after implantation. Although the CorMatrix remained pliable and most did not exhibit calcification, these intracardiac patches did not show evidence of native heart tissue ingrowth at a median of 21 months invivo.