Rehabilitation of an existing device implant pocket using a biologic extracellular matrix envelope.
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ABSTRACT:
SUBMITTER: Srivastava A
PROVIDER: S-EPMC10667117 | biostudies-literature | 2023 Nov
REPOSITORIES: biostudies-literature
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Rehabilitation of an existing device implant pocket using a biologic extracellular matrix envelope.
Srivastava Ankur A Nayak Hemal M HM
HeartRhythm case reports 20230822 11
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Project description:Biologic scaffolds prepared from the extracellular matrix (ECM) of decellularized mammalian tissues have been shown to facilitate constructive remodeling in injured tissues such as skeletal muscle, the esophagus, and lower urinary tract, among others. The ECM of every tissue has a unique composition and structure that likely has direct effects on the host response and it is plausible that ECM harvested from a given tissue would provide distinct advantages over ECM harvested from nonhomologous tissues. For example, a tissue specific muscle ECM scaffold may be more suitable for constructive remodeling of skeletal muscle than non-homologous ECM tissue sources. The present study describes an enzymatic and chemical decellularization process for isolating skeletal muscle ECM scaffolds using established decellularization criteria and characterized the structure and chemical composition of the resulting ECM. The results were compared to those from a non-muscle ECM derived from small intestine (SIS). Muscle ECM was shown to contain growth factors, glycosaminoglycans, and basement membrane structural proteins which differed from those present in SIS. Myogenic cells survived and proliferated on muscle ECM scaffolds in vitro, and when implanted in a rat abdominal wall injury model in vivo was shown to induce a constructive remodeling response associated with scaffold degradation and myogenesis in the implant area; however, the remodeling outcome did not differ from that induced by SIS by 35 days post surgery. These results suggest that superior tissue remodeling outcomes are not universally dependent upon homologous tissue derived ECM scaffold materials.
| S-EPMC5942557 | biostudies-literature
Project description:BackgroundSkin-sparing mastectomy followed by immediate implant-based breast reconstruction is a commonly used treatment for breast cancer. However, when placing the implant in a subpectoral pocket, a high incidence of breast animation deformity (BAD) has been reported. Besides the nuisance that BAD can cause, lifting of the pectoralis major muscle (PMM) can result in a more extended postoperative recovery period. When placing the implant solely prepectorally leaving the PMM undisturbed, the incidence and severity of BAD might be mitigated. However, new challenges may occur because of thinner skin cover.Methods/designA prospective, multi-centre, randomised controlled trial will be carried out with the primary aim of assessing and comparing the incidence and degree of BAD in women having a direct-to-implant breast reconstruction with either a prepectorally or a subpectorally placed implant. The secondary outcomes are shoulder and arm function, quality of life, aesthetic evaluation, length of stay, complications, need for surgical corrections, and development of capsular contracture. A total of 70 included patients will be followed under admittance and at clinical check-ups 3 months and 1 year after surgery.DiscussionTo our knowledge, this trial is the first randomised controlled trial evaluating and comparing subpectoral and prepectoral implant placement when performing direct-to-implant breast reconstruction following skin-sparing mastectomy. The results will hopefully provide us with a broader knowledge of the outcomes of immediate breast reconstruction, making better preoperative planning possible in the future by providing our patients with a more objective information.Trial registrationClinicalTrials.gov, ID: NCT03143335. Prospectively registered on 8 May 2017.
| S-EPMC7011213 | biostudies-literature
Project description:BackgroundUsing synthetic antibiotic-eluting envelope (ABE) is an effective intervention for prevention of cardiovascular implantable electronic device (CIED) infection. The biologic extracellular-matrix envelope (ECME), may offer potential advantages over the synthetic ABE. To further minimize the risk of infection, the ECME can be hydrated in gentamicin prior to CIED implantation. We aimed to evaluate the efficacy and pharmacokinetics (PK) of gentamicin containing ECME in an animal model.MethodsFor all experiments, the ECME was hydrated in gentamicin (40 mg/Ml) (treatment) for 2 min. In vitro antimicrobial efficacy against six different bacterial species was assessed. In vivo experiments were conducted using a rabbit model of CIED pocket infection. Serum and ECM gentamicin concentrations were measured. Five different organisms were inoculated into the device pocket of control (ECME hydrated in 0.9% saline) and treatment groups. Macroscopic appearance and colony forming units from CIED, ECME, and tissue were determined.ResultsNo bacteria were recovered from any culture after 12 h of exposure to the gentamicin containing ECME. Serum gentamicin levels dropped below the limit of quantification at 15 h after implant. Gentamicin concentration in the ECME remained relatively stable for up to 7 days. Signs of clinical infection were observed in the control but not in the treatment group. In the presence of gentamicin, statistically significant reduction was demonstrated across all tested bacterial species.ConclusionsIn this preclinical animal infection model, gentamicin containing ECME was highly effective in reducing bacterial burden in the implant pocket, while systemic exposure after implantation remained low.
| S-EPMC7155100 | biostudies-literature
Project description:Applications of meniscus scaffolds are crucial for preserving articular cartilage tissue, restoring normal joint mechanics, and stabilizing joints with partial meniscus deficits. Studies are still being conducted to determine how meniscus scaffold applications can create viable and durable tissue. The surgical procedure described in this study uses the meniscus scaffold and minced meniscus tissue. Technique Video Video 1 Technical depiction of a minced meniscus procedure.
| S-EPMC10265602 | biostudies-literature
Project description:The major challenge for dentistry is to provide the patient an oral rehabilitation to maintain healthy bone conditions in order to reduce the time for loading protocols. Advancement in implant surface design is necessary to favour and promote the osseointegration process. The surface features of titanium dental implant can promote a relevant influence on the morphology and differentiation ability of mesenchymal stem cells, induction of the osteoblastic genes expression and the release of extracellular matrix (ECM) components. The present study aimed at evaluating the in vitro effects of two different dental implants with titanium surfaces, TEST and CTRL, to culture the human periodontal ligament stem cells (hPDLSCs). Expression of ECM components such as Vimentin, Fibronectin, N-cadherin, Laminin, Focal Adhesion Kinase (FAK) and Integrin beta-1 (ITGB1), and the osteogenic related markers, as runt related transcription factor 2 (RUNX2) and alkaline phosphatase (ALP), were investigated. Human PDLSCs cultured on the TEST implant surface demonstrated a better cell adhesion capability as observed by Scanning Electron Microscopy (SEM) and immunofluorescence analysis. Moreover, immunofluorescence and Western blot experiments showed an over expression of Fibronectin, Laminin, N-cadherin and RUNX2 in hPDLSCs seeded on TEST implant surface. The gene expression study by RT-PCR validated the results obtained in protein assays and exhibited the expression of RUNX2, ALP, Vimentin (VIM), Fibronectin (FN1), N-cadherin (CDH2), Laminin (LAMB1), FAK and ITGB1 in hPDLSCs seeded on TEST surface compared to the CTRL dental implant surface. Understanding the mechanisms of ECM components release and its regulation are essential for developing novel strategies in tissue engineering and regenerative medicine. Our results demonstrated that the impact of treated surfaces of titanium dental implants might increase and accelerate the ECM apposition and provide the starting point to initiate the osseointegration process.
| S-EPMC8470763 | biostudies-literature
Project description:We established a platform for the brain organoid culture by using human decellularized brain extracellular matrix (BEM) and a microfluidic device. This engineering concept of reconstituting brain-mimetic microenvironments facilitates development of a reliable culture platform for brain organoids, enabling effective modeling and drug development.
2021-06-01 | GSE145386 | GEO
Project description:Introduction While many authors have reported their experience in immediate prepectoral breast reconstruction (BR), implant pocket conversion from a submuscular to a prepectoral plane is less well described. The aim of this study is to provide a comprehensive review on plane conversion in implant-based BR, including the indications, surgical techniques, functional, and esthetic results. Materials and Methods A literature search via PubMed, Medline, Google Scholar, and Cochrane databases was performed using the following MeSH terms: “prepectoral pocket conversion”, “subcutaneous pocket conversion”, “prepectoral plane conversion”, “subcutaneous plane conversion”, and “prepectoral breast reconstruction”. Results Ten articles in which 504 breasts were studied were deemed eligible for inclusion. The indications to perform plane conversion were animation deformity (AD), chronic pain, and implant malposition. Seven studies described complete or partial capsulectomy. The use of acellular dermal matrices (ADM) was reported in all cases except for three studies. The mean follow-up was 10.64 months. There was resolution of AD in 100% of cases. Three studies reported complete resolution of chronic pain. The overall complication rate was 12.102% and capsular contracture (CC) was the most frequent complication. Cosmetic revisions were reported in six studies (9.52%). The use of ADMs and fat grafting appeared to decrease the rate of subsequent CC formation and cosmetic revisions. Conclusions The current article represents the first review about implant pocket conversion from a submuscular to a prepectoral plane, delineating its indications, surgical technique, postoperative complications, and functional and esthetic outcomes.
| S-EPMC7502407 | biostudies-literature
Project description:Biologic materials from various species and tissues are commonly used as surgical meshes or scaffolds for tissue reconstruction. Extracellular matrix (ECM) represents the secreted product of the cells comprising each tissue and organ, and therefore provides a unique biologic material for selected regenerative medicine applications. Minimal disruption of ECM ultrastructure and content during tissue processing is typically desirable. The objective of this study was to systematically evaluate effects of commonly used tissue processing steps upon porcine dermal ECM scaffold composition, mechanical properties, and cytocompatibility. Processing steps evaluated included liming and hot water sanitation, trypsin/SDS/TritonX-100 decellularization, and trypsin/TritonX-100 decellularization. Liming decreased the growth factor and glycosaminoglycan content, the mechanical strength, and the ability of the ECM to support in vitro cell growth (p ? 0.05 for all). Hot water sanitation treatment decreased only the growth factor content of the ECM (p ? 0.05). Trypsin/SDS/TritonX-100 decellularization decreased the growth factor content and the ability of the ECM to support in vitro cell growth (p ? 0.05 for both). Trypsin/Triton X-100 decellularization also decreased the growth factor content of the ECM but increased the ability of the ECM to support in vitro cell growth (p ? 0.05 for both). We conclude that processing steps evaluated in the present study affect content, mechanical strength, and/or cytocompatibility of the resultant porcine dermal ECM, and therefore care must be taken in choosing appropriate processing steps to maintain the beneficial effects of ECM in biologic scaffolds.
| S-EPMC2956268 | biostudies-literature
Project description:PurposeInvasive surgical management of cryptoglandular perianal fistulas (PF) is challenging because of high recurrence rates and the potential for injury to the sphincter complex. In the present technical note, we introduce a minimally invasive treatment for PF using a perianal fistula implant (PAFI) comprising ovine forestomach matrix (OFM).MethodsThis retrospective observational case series highlights 14 patients who had undergone a PAFI procedure at a single center between 2020 and 2023. During the procedure, previously deployed setons were removed and tracts were de-epithelialized with curettage. OFM was rehydrated, rolled, passed through the debrided tract, and secured in place at both openings with absorbable suture. Primary outcome was fistula healing at 8 weeks, and secondary outcomes included recurrence or postoperative adverse events.ResultsFourteen patients underwent PAFI using OFM with a mean follow-up period of 37.6 ± 20.1 weeks. In follow-up, 64% (n = 9/14) had complete healing at 8 weeks and all remained healed, except one at last follow-up visit. Two patients underwent a second PAFI procedure and were healed with no recurrence at the last follow-up visit. Of all patients that healed during the study period (n = 11), the median time to healing was 3.6 (IQR 2.9-6.0) weeks. No postprocedural infections nor adverse events were noted.ConclusionsThe minimally invasive OFM-based PAFI technique for PF treatment was demonstrated to be a safe and feasible option for patients with trans-sphincteric PF of cryptoglandular origin.
| S-EPMC10404168 | biostudies-literature
Project description:ImportanceBiologic drugs account for a growing share of US pharmaceutical spending. Competition from follow-on biosimilar products (subsequent versions that have no clinically meaningful differences from the original biologic) has led to modest reductions in US health care spending, but these savings may not translate to lower out-of-pocket (OOP) costs for patients.ObjectiveTo investigate whether biosimilar competition is associated with lower OOP spending for patients using biologics.Design, setting, and participantsThis cohort study used a national commercial claims database (Optum Clinformatics Data Mart) to identify outpatient claims for 1 of 7 clinician-administered biologics (filgrastim, infliximab, pegfilgrastim, epoetin alfa, bevacizumab, rituximab, and trastuzumab) from January 2009 through March 2022. Claims by commercially insured patients younger than 65 years were included.ExposureYear relative to first biosimilar availability and use of original or biosimilar version.Main outcomes and measuresPatients' annual OOP spending on biologics for each calendar year was determined, and OOP spending per claim between reference biologic and biosimilar versions was compared. Two-part regression models assessed for differences in OOP spending, adjusting for patient and clinical characteristics (age, sex, US Census region, health plan type, diagnosis, and place of service) and year relative to initial biosimilar entry.ResultsOver 1.7 million claims from 190 364 individuals (median [IQR] age, 53 [42-59] years; 58.3% females) who used at least 1 of the 7 biologics between 2009 and 2022 were included in the analysis. Over 251 566 patient-years of observation, annual OOP costs increased before and after biosimilar availability. Two years after the start of biosimilar competition, the adjusted odds ratio of nonzero annual OOP spending was 1.08 (95% CI, 1.04-1.12; P < .001) and average nonzero annual spending was 12% higher (95% CI, 10%-14%; P < .001) compared with the year before biosimilar competition. After biosimilars became available, claims for biosimilars were more likely than reference biologics to have nonzero OOP costs (adjusted odds ratio, 1.13 [95% CI, 1.11-1.16]; P < .001) but had 8% lower mean nonzero OOP costs (adjusted mean ratio, 0.92 [95% CI, 0.90-0.93; P < .001). Findings varied by drug.Conclusions and relevanceFindings of this cohort study suggest that biosimilar competition was not consistently associated with lower OOP costs for commercially insured outpatients, highlighting the need for targeted policy interventions to ensure that the savings generated from biosimilar competition translate into increased affordability for patients who need biologics.
| S-EPMC10980968 | biostudies-literature