Publications by authors named "Francisco M Sánchez-Margallo"

93 Publications

Heparin coating in biodegradable ureteral stents does not decrease bacterial colonization-assessment in ureteral stricture endourological treatment in animal model.

Transl Androl Urol 2021 Apr;10(4):1700-1710

Jesús Usón Minimally Invasive Surgery Centre, Cáceres, Spain.

Background: We assessed an antireflux biodegradable heparin-coated ureteral stent (BraidStent-H) in an animal model comparative study after endoscopic treatment of ureteral strictures.

Methods: A total of 24 female pigs underwent initial endoscopic, nephrosonographic, and contrast fluoroscopy assessment of the urinary tract. Afterward, unilateral laparoscopic ureteral stricture model was performed. Three weeks later, the animals underwent laser endoureterotomy and were randomly assigned to Group-I, in which a double-pigtail stent was placed for 6 weeks, or Group-II, in which a BraidStent®-H was placed. Follow-up was carried out by ultrasonography, contrast fluoroscopy, ureteroscopy, urinalysis and bacteriuria assessment at 3, 6, 12 and 5 months. Finally, a pathological study of the urinary system was performed.

Results: There were no animals in Group-II with vesicoureteral reflux, with significance at 6 weeks with Group-I. Distal ureteral peristalsis was maintained in 50-75% in Group-II at 1-6 weeks. The 91.7% of stents in Group-II were degraded between 3-6 weeks, without obstructive fragments. Bacteriuria in Group II was 33.3-50% at 3 and 6 weeks. The global success rate by groups was 91.6% and 87.5% in groups I and II, respectively, with no statistical significance.

Conclusions: BraidStent-H has been shown to be as efficacious as current ureteral stents in the treatment of benign ureteral strictures following laser endoureterotomy. In addition, it reduces the morbidity associated with current stents and has a homogeneous and predictable degradation rate of about 6 weeks, with no obstructive fragments. Future studies are required to improve the antibacterial coating to reduce BraidStent-H contamination in view of the results obtained with the heparin coating.
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http://dx.doi.org/10.21037/tau-21-19DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8100852PMC
April 2021

Medical needs related to the endoscopic technology and colonoscopy for colorectal cancer diagnosis.

BMC Cancer 2021 Apr 26;21(1):467. Epub 2021 Apr 26.

Jesús Usón Minimally Invasive Surgery Centre, Ctra. N-521, Km 41.8, 10071, Cáceres, Spain.

Background: The high incidence and mortality rate of colorectal cancer require new technologies to improve its early diagnosis. This study aims at extracting the medical needs related to the endoscopic technology and the colonoscopy procedure currently used for colorectal cancer diagnosis, essential for designing these demanded technologies.

Methods: Semi-structured interviews and an online survey were used.

Results: Six endoscopists were interviewed and 103 were surveyed, obtaining the demanded needs that can be divided into: a) clinical needs, for better polyp detection and classification (especially flat polyps), location, size, margins and penetration depth; b) computer-aided diagnosis (CAD) system needs, for additional visual information supporting polyp characterization and diagnosis; and c) operational/physical needs, related to limitations of image quality, colon lighting, flexibility of the endoscope tip, and even poor bowel preparation.

Conclusions: This study shows some undertaken initiatives to meet the detected medical needs and challenges to be solved. The great potential of advanced optical technologies suggests their use for a better polyp detection and classification since they provide additional functional and structural information than the currently used image enhancement technologies. The inspection of remaining tissue of diminutive polyps (< 5 mm) should be addressed to reduce recurrence rates. Few progresses have been made in estimating the infiltration depth. Detection and classification methods should be combined into one CAD system, providing visual aids over polyps for detection and displaying a Kudo-based diagnosis suggestion to assist the endoscopist on real-time decision making. Estimated size and location of polyps should also be provided. Endoscopes with 360° vision are still a challenge not met by the mechanical and optical systems developed to improve the colon inspection. Patients and healthcare providers should be trained to improve the patient's bowel preparation.
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http://dx.doi.org/10.1186/s12885-021-08190-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8077886PMC
April 2021

Characterization of encapsulated porcine cardiosphere-derived cells embedded in 3D alginate matrices.

Int J Pharm 2021 Apr 5;599:120454. Epub 2021 Mar 5.

NanoBioCel Group, Laboratory of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of the Basque Country UPV/EHU, Vitoria-Gasteiz 01006, Spain; Biomedical Research Networking Center in Bioengineering, Biomaterials, and Nanomedicine, CIBER-BBN, Spain; Bioaraba, NanoBioCel Research Group, Vitoria-Gasteiz, Spain. Electronic address:

Myocardial infarction is caused by an interruption of coronary blood flow, leading to one of the main death causes worldwide. Current therapeutic approaches are palliative and not able to solve the loss of cardiac tissue. Cardiosphere derived cells (CDCs) reduce scarring, and increase viable myocardium, with safety and adequate biodistribution, but show a low rate engraftment and survival after implantation. In order to solve the low retention, we propose the encapsulation of CDCs within three-dimensional alginate-poly-L-lysine-alginate matrix as therapy for cardiac regeneration. In this work, we demonstrate the encapsulation of CDCs in alginate matrix, with no decrease in viability over a month, and showing the preservation of CDCs phenotype, differentiation potential, gene expression profile and growth factor release after encapsulation, moving a step forward to clinical translation of CDCs therapy in regeneration in heart failure.
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http://dx.doi.org/10.1016/j.ijpharm.2021.120454DOI Listing
April 2021

Comparative assessment of biodegradable-antireflux heparine coated ureteral stent: animal model study.

BMC Urol 2021 Feb 28;21(1):32. Epub 2021 Feb 28.

Jesús Usón Minimally Invasive Surgery Centre Foundation, Cáceres, Spain.

Background: Double J ureteral stents are widely used on urological patients to provide drainage of the upper urinary tract. Unfourtunately, ureteral stents are not free from complications, as bacterial colonization and require a second procedure for removal. The purpose of the current comparative experimental study is to evaluate a new heparin-coated biodegradable antireflux ureteral stent (BraidStent®-H) to prevent urinary bacterial colonization.

Methods: A total of 24 female pigs were underwent determination of bacteriuria and nephrosonographic, endoscopic and contrast fluoroscopy assessment of the urinary tract. Afterward, were randomly assigned animals to Group-I, in which a 5Fr double-pigtail ureteral stent was placed for 6 weeks, or Group-II, in which a BraidStent®-H was placed. Follow-up assessments were performed at 1, 3, 6, 8, 12 weeks. The final follow-up includes the above methods and an exhaustive pathological study of the urinary tract was accomplished after 20 weeks.

Results: Bacteriuria findings in the first 48 h were significant between groups at 6 h and 12 h. Asymptomatic bacteriuria does not reach 100% of the animals in Group-II until 48 h versus Group-I where it appears at 6 h. The weekly bacteriuria mean rate was 27.7% and 44.4% in Group I and II respectively, without statistical significance. In Group II there were no animals with vesicoureteral reflux, with statistical significance at 3 and 6 weeks with Group-I. The 91.2% of stents in Group-II were degraded between 3 and 6 weeks, without obstructive fragments. Distal ureteral peristalsis was maintained in 66.6-75% in Group-II at 1-6 weeks.

Conclusions: The heparin coating of BraidStent® allows an early decrease of bacterial colonization, but its effectiveness is low at the long term. Heparin coating did not affect scheduled degradation rate or size of stents fragments. BraidStent®-H avoids the side effects associated with current ureteral stents, thus should cause less discomfort to patients.
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http://dx.doi.org/10.1186/s12894-021-00802-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7916282PMC
February 2021

Iatrogenic Ureteral Injury Treatment with Biodegradable Antireflux Heparin-Coated Ureteral Stent-Animal Model Comparative Study.

J Endourol 2021 Apr 26. Epub 2021 Apr 26.

Scientific Direction, Jesús Usón Minimally Invasive Surgery Centre, Cáceres, Spain.

The aim is to assess the effectiveness of a biodegradable antireflux ureteral stent with heparin coating in a comparative study (BraidStent-H) in an animal model for the treatment of iatrogenic ureteral perforation. A total of 24 female pigs underwent initial endoscopic, nephrosonographic, and contrast fluoroscopy assessment of the urinary tract. Afterward, unilateral iatrogenic perforation in proximal ureter model was performed. Then the animals were randomly assigned to Group-I, in which a double-pigtail stent was placed for 6 weeks, or Group-II, in which a BraidStent-H a biodegradable heparin-coated stent was placed. Follow-up assessments were performed at 1 and 6 weeks and 5 months. In terms of therapeutic effectiveness, complete resolution was observed in 95.8% of Group-I animals and 87.5% in Group-II. No animals in Group-II showed vesicoureteral reflux (VUR) during the study; statistical significance was observed at 1 and 6 weeks versus Group-I. All stents in Group-II degraded without producing obstructive fragments and allowed distal ureteral peristalsis. Heparin coating was not efficient to reduce asymptomatic bacteriuria between groups. Pathologic assessment did not show any significance in the global score, but did in the "fibrosis in muscular layer" parameter, at the ureteral perforation healing area; Group-II showed higher healing quality. The biodegradable intraureteral BraidStent-H is highly effective for the minimally invasive treatment of ureteral perforation, since it displays controlled and predictable degradation, avoiding the development of VUR as well as irritation of the bladder trigone. Unfortunately, heparin coating was not effective in avoiding stentassociated bacteriuria.
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http://dx.doi.org/10.1089/end.2020.0591DOI Listing
April 2021

4-Hydroxyestradiol improves mouse embryo quality, epidermal growth factor-binding capability in vitro and implantation rates.

Mol Hum Reprod 2021 02;27(2)

Department of Cell Biology, University of Extremadura, Badajoz, Spain.

Embryo implantation in the uterus is a critical step to achieve success following ART. Despite favorable uterine conditions, a great number of good quality embryos fail to implant, often for reasons that are unknown. Hence, improving the implantation potential of embryos is a subject of great interest. 4-Hydroxyestradiol (4-OH-E2), a metabolic product of estradiol produced by endometrial cells, plays a key role in endometrial-embryonic interactions that are necessary for implantation. Nonetheless, the effects of 4-OH-E2 on embryos obtained in vitro have not been yet described. This study was designed to determine whether culture media enriched in 4-OH-E2 could improve the quality and implantation rate of embryos obtained in vitro, using both in vitro and in vivo models. We also analyzed its effects on the epidermal growth factor (EGF)-binding capability of the embryos. Our results showed that the presence of 4-OH-E2 in the culture media of embryos during the morula to blastocyst transition increases embryo quality and attachment to endometrial cells in vitro. 4-OH-E2 can also improve viable pregnancy rates of mouse embryos produced in vitro, reaching success rates that are similar to those from embryos obtained directly from the uterus. 4-OH-E2 improved the embryos' ability to bind EGF, which could be responsible for the increased embryo implantation potential observed. Therefore, our results strongly suggest that 4-OH-E2 is a strong candidate molecule to supplement human IVF culture media in order to improve embryo implantation. However, further research is required before these findings can be translated with efficacy and safety to fertility clinics.
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http://dx.doi.org/10.1093/molehr/gaaa075DOI Listing
February 2021

Identification of intra-abdominal lymphatics in canine carcasses by laparoscopic fluorescence lymphography with intradermal and intrapopliteal ICG administration.

PLoS One 2020 12;15(11):e0241992. Epub 2020 Nov 12.

Bioengineering and Health Technologies Unit, Jesús Usón Minimally Invasive Surgery Centre, Cáceres, Spain.

Objective: To evaluate the feasibility of laparoscopic fluorescence lymphography (LFL) using indocyanine green (ICG) via intradermal (ID) or intrapopliteal (IPP) administration in an ex vivo canine model.

Methods: Six thawed adult male dog carcasses were placed in the Trendelenburg position after placing three surgical ports in triangulation. ICG (0.5 mg/ml; 0.05 mg/kg) was administered to five of the carcasses (one carcass was a pilot) via ID in the left torso and IPP (right position, by surgical access) to stain the lymphatic pathway and medial iliac lymph node (MILN). Fluorescence quality, staining time, structures stained, and lymph node histopathology were assessed. Thoracic duct staining was also evaluated.

Results: ID administration showed staining of parts of the lymphatic pathway of the iliosacral lymph center in all cases using a single dose of ICG, with left MILN visualization in four carcasses. IPP administration showed staining of the right MILN in all cases, using a single dose in four carcasses. ICG reached the thoracic duct in one case. The two administration routes showed similar results in terms of required ICG volume, staining time, and visualization quality, although IPP was more effective in staining the MILN.

Conclusions: This study confirms the feasibility of staining the iliosacral lymph center (mainly the MILNs) by LFL in thawed dog carcasses via ID or IPP administration of ICG. However, the IPP route showed greater effectiveness in staining the MILN.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0241992PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7660503PMC
January 2021

Unravelling the effect of data augmentation transformations in polyp segmentation.

Int J Comput Assist Radiol Surg 2020 Dec 28;15(12):1975-1988. Epub 2020 Sep 28.

Jesús Usón Minimally Invasive Surgery Centre, Road N-521, km 41.8, 10071, Cáceres, Spain.

Purpose: Data augmentation is a common technique to overcome the lack of large annotated databases, a usual situation when applying deep learning to medical imaging problems. Nevertheless, there is no consensus on which transformations to apply for a particular field. This work aims at identifying the effect of different transformations on polyp segmentation using deep learning.

Methods: A set of transformations and ranges have been selected, considering image-based (width and height shift, rotation, shear, zooming, horizontal and vertical flip and elastic deformation), pixel-based (changes in brightness and contrast) and application-based (specular lights and blurry frames) transformations. A model has been trained under the same conditions without data augmentation transformations (baseline) and for each of the transformation and ranges, using CVC-EndoSceneStill and Kvasir-SEG, independently. Statistical analysis is performed to compare the baseline performance against results of each range of each transformation on the same test set for each dataset.

Results: This basic method identifies the most adequate transformations for each dataset. For CVC-EndoSceneStill, changes in brightness and contrast significantly improve the model performance. On the contrary, Kvasir-SEG benefits to a greater extent from the image-based transformations, especially rotation and shear. Augmentation with synthetic specular lights also improves the performance.

Conclusion: Despite being infrequently used, pixel-based transformations show a great potential to improve polyp segmentation in CVC-EndoSceneStill. On the other hand, image-based transformations are more suitable for Kvasir-SEG. Problem-based transformations behave similarly in both datasets. Polyp area, brightness and contrast of the dataset have an influence on these differences.
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http://dx.doi.org/10.1007/s11548-020-02262-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7671995PMC
December 2020

Deep learning to find colorectal polyps in colonoscopy: A systematic literature review.

Artif Intell Med 2020 08 1;108:101923. Epub 2020 Aug 1.

Jesús Usón Minimally Invasive Surgery Centre, Ctra. N-521, km 41.8, 10071 Cáceres, Spain. Electronic address:

Colorectal cancer has a great incidence rate worldwide, but its early detection significantly increases the survival rate. Colonoscopy is the gold standard procedure for diagnosis and removal of colorectal lesions with potential to evolve into cancer and computer-aided detection systems can help gastroenterologists to increase the adenoma detection rate, one of the main indicators for colonoscopy quality and predictor for colorectal cancer prevention. The recent success of deep learning approaches in computer vision has also reached this field and has boosted the number of proposed methods for polyp detection, localization and segmentation. Through a systematic search, 35 works have been retrieved. The current systematic review provides an analysis of these methods, stating advantages and disadvantages for the different categories used; comments seven publicly available datasets of colonoscopy images; analyses the metrics used for reporting and identifies future challenges and recommendations. Convolutional neural networks are the most used architecture together with an important presence of data augmentation strategies, mainly based on image transformations and the use of patches. End-to-end methods are preferred over hybrid methods, with a rising tendency. As for detection and localization tasks, the most used metric for reporting is the recall, while Intersection over Union is highly used in segmentation. One of the major concerns is the difficulty for a fair comparison and reproducibility of methods. Even despite the organization of challenges, there is still a need for a common validation framework based on a large, annotated and publicly available database, which also includes the most convenient metrics to report results. Finally, it is also important to highlight that efforts should be focused in the future on proving the clinical value of the deep learning based methods, by increasing the adenoma detection rate.
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http://dx.doi.org/10.1016/j.artmed.2020.101923DOI Listing
August 2020

Anesthesia Protocols used to Create Ischemia Reperfusion Myocardial Infarcts in Swine.

J Am Assoc Lab Anim Sci 2020 09 24;59(5):478-487. Epub 2020 Jul 24.

Jesús Usón Minimally Invasive Surgery Centre, Cáceres, Spain; CIBERCV, Madrid, Spain.

The porcine ischemia-reperfusion model is one of the most commonly used for cardiology research and for testing interventions for myocardial regeneration. In creating ischemic reperfusion injury, the anesthetic protocol is important for assuring hemodynamic stability of the animal during the induction of the experimental lesion and may affect its postoperative survival. This paper reviews the many drugs and anesthetic protocols used in recent studies involving porcine models of ischemiareperfusion injury. The paper also summarizes the most important characteristics of some commonly used anesthetic drugs. Literature was selected for inclusion in this review if the authors described the anesthetic protocol used and also reported the mortality rate attributed to the creation of the model. This information is an important consideration because the anesthetic protocol can influence hemodynamic stability during the experimental induction of an acute myocardial infarction, thereby impacting the survival rate and affecting the number of animals needed for each study.
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http://dx.doi.org/10.30802/AALAS-JAALAS-19-000137DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7479770PMC
September 2020

Can effective pedagogy be ensured in minimally invasive surgery e-learning?

Minim Invasive Ther Allied Technol 2020 Jun 16:1-11. Epub 2020 Jun 16.

Biomedical Engineering and Telemedicine Centre (GBT), ETSI Telecomunicación, Center for Biomedical Technology, Universidad Politécnica de Madrid (UPM), Madrid, Spain.

Effectiveness of e-learning diminishes without the support of a pedagogical model to guide its use. In minimally invasive surgery (MIS), this has been reported as a limitation when technology is used to deliver contents without a sound pedagogical background. We describe how a generic pedagogical model, the 3D pedagogy framework, can be used for setting learning outcomes and activities in e-learning platforms focused on MIS cognitive skills. A demonstrator course on Nissen fundoplication was developed following the model step-by-step in the MISTELA learning platform. Course design was informed by Kolb's Experiential learning model. Content validation was performed by 13 MIS experts. Ten experts agreed on the suitability of content structuring done according to the pedagogical model. All experts agreed that the course provides means to assess the intended learning outcomes. This work showcases how a general-purpose e-learning framework can be accommodated to the needs of MIS training without limiting the course designers' pedagogical approach. Key advances for its success include: (1) proving the validity of the model in the wider scope of MIS skills and (2) raising awareness amongst stakeholders on the need of developing training plans with explicit, rather than assumed, pedagogical foundations. MIS: minimally invasive surgery; TEL: technology enhanced learning.
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http://dx.doi.org/10.1080/13645706.2020.1777165DOI Listing
June 2020

Validation of the online theoretical module of a minimally invasive surgery blended learning course for nurses: A quantitative research study.

Nurse Educ Today 2020 Jun 18;89:104406. Epub 2020 Mar 18.

Jesús Usón Minimally Invasive Surgery Centre, Ctra. N-521, km. 41.8, 10071 Cáceres, Spain. Electronic address:

Background: The progressive development of Minimally Invasive Surgery (MIS) implies the need to train health professionals in such field, for which e-learning and blended learning methods are increasingly been used. Most nurses lack experience and training in MIS, so a laparoscopic blended learning course for nursing has been created.

Objectives: To perform the validation of the online theoretical module of such course to evaluate student perception and satisfaction, sociability and usability metrics, and also the interest of nurses in blended learning.

Design: A quantitative design has been used.

Participants: 24 nurses participated in the validation tests performing the online module of the course.

Methods: Subjective (questionnaires) and objective (performance statistics) metrics were analysed.

Results: The e-learning environment has ease of access, good layout, consistency and intuitive navigation. Chat and forums have not been used and nurses miss a moderator. Participants consider that videos provide added value to the course, and contents are easily understandable and of high quality. However, questionnaires are not well balanced in difficulty and few interactive 3D designs have been viewed. Participants consider blended learning as the most effective training method for its flexibility in time and place.

Conclusions: This study suggests that a simple, easy-to-use and attractive e-learning environment has been developed to train nurses in MIS. However, installation of additional software should be avoided. A moderator/tutor should manage forums to encourage user participation, using conversational agents. But nevertheless, chats have no interest. Questionnaires for content evaluation should be designed with efficiency and equity. Videos designed according to micro-learning, with audio and interactivity, should be included. These courses should be designed to meet factors to promote the engagement of students. Blended learning is considered by nurses as ideal method for training, but further research to assess whether it improves learning outcomes is needed.
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http://dx.doi.org/10.1016/j.nedt.2020.104406DOI Listing
June 2020

Experimental Assessment of New Generation of Ureteral Stents: Biodegradable and Antireflux Properties.

J Endourol 2020 03;34(3):359-365

Scientific Director Department, Minimally Invasive Surgery Centre Jesús Usón, Cáceres, Spain.

The aim was to assess a new biodegradable and antireflux intraureteral stent (BraidStent) design in a swine model after ureteral laparoscopic operation. A total of 24 female pigs underwent initial endoscopic, nephrosonographic, and contrast fluoroscopy assessment of the urinary tract. Afterward, unilateral ureteropelvic junction obstruction was performed by laparoscopic approach. Six weeks later, the animals underwent laparoscopic Anderson-Hynes pyeloplasty, and were randomly assigned to Group-I, in which a double-pigtail ureteral stent was inserted for 6 weeks, or Group-II, in which a BraidStent, a biodegradable intraureteral stent design, was placed. Follow-up assessments were performed at 3 and 6 weeks and 5 months. In terms of therapeutic success, complete resolution was observed in 91.6% of Group-I animals and 88.8% in Group-II. No evidence of vesicoureteral reflux (VUR) was observed in Group-II animals and statistical significance in VUR and ureteral orifice damage were observed between groups. BraidStent degradation occurred in a controlled manner between 3 and 6 weeks, without obstructive fragments. Distal ureteral peristalsis was maintained in 66.6% and 83.3% in Group-II at 3 and 6 weeks of follow-up, respectively. In Group-II, the positive bacteriuria rate was 41.6% and the migration rate 25%. Pathological assessment showed a significant improvement in ureteral healing in Group-II Group-I. The results of this comparative study in a porcine model indicate that the intraureteral BraidStent performed similarly to conventional ureteral stents. It avoids complete ureteral length intubation, the adverse effects associated with conventional ureteral stents, and maintains a high level of distal ureteral peristalsis. Moreover, the BraidStent exhibited a predictable and controlled degradation rate and did not cause any obstructive fragments. However, further studies are needed to improve the anchoring system and reduce the risk of bacterial colonization.
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http://dx.doi.org/10.1089/end.2019.0493DOI Listing
March 2020

CIBER-CLAP (CIBERCV Cardioprotection Large Animal Platform): A multicenter preclinical network for testing reproducibility in cardiovascular interventions.

Sci Rep 2019 12 30;9(1):20290. Epub 2019 Dec 30.

Centro de Investigación Biomédica en Red en Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.

Despite many cardioprotective interventions have shown to protect the heart against ischemia/reperfusion injury in the experimental setting, only few of them have succeeded in translating their findings into positive proof-of-concept clinical trials. Controversial and inconsistent experimental and clinical evidence supports the urgency of a disruptive paradigm shift for testing cardioprotective therapies. There is a need to evaluate experimental reproducibility before stepping into the clinical arena. The CIBERCV (acronym for Spanish network-center for cardiovascular biomedical research) has set up the "Cardioprotection Large Animal Platform" (CIBER-CLAP) to perform experimental studies testing the efficacy and reproducibility of promising cardioprotective interventions based on a pre-specified design and protocols, randomization, blinding assessment and other robust methodological features. Our first randomized, control-group, open-label blinded endpoint experimental trial assessing local ischemic preconditioning (IPC) in a pig model of acute myocardial infarction (n = 87) will be carried out in three separate sets of experiments performed in parallel by three laboratories. Each set aims to assess: (A) CMR-based outcomes; (B) histopathological-based outcomes; and (C) protein-based outcomes. Three core labs will assess outcomes in a blinded fashion (CMR imaging, histopathology and proteomics) and 2 methodological core labs will conduct the randomization and statistical analysis.
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http://dx.doi.org/10.1038/s41598-019-56613-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6937304PMC
December 2019

Intracisternal BioGlue injection in the fetal lamb: a novel model for creation of obstructive congenital hydrocephalus without additional chemically induced neuroinflammation.

J Neurosurg Pediatr 2019 Sep 27:1-11. Epub 2019 Sep 27.

1Center for Fetal and Placental Research, Division of Pediatric General and Thoracic Surgery, Cincinnati Children's Hospital Medical Center (CCHMC), Cincinnati, Ohio.

Objective: The authors hypothesized that new agents such as BioGlue would be as efficacious as kaolin in the induction of hydrocephalus in fetal sheep.

Methods: This study was performed in 34 fetal lambs randomly divided into 2 studies. In the first study, fetuses received kaolin, BioGlue (2.0 mL), or Onyx injected into the cisterna magna, or no injection (control group) between E85 and E90. In the second study, fetuses received 2.0-mL or 2.5-mL injections of BioGlue into the cisterna magna between E85 and E90. Fetuses were monitored using ultrasound to assess lateral ventricle size and progression of hydrocephalus. The fetuses were delivered (E120-E125) and euthanized for histological analysis. Selected brain sections were stained for ionized calcium binding adaptor 1 (Iba1) and glial fibrillary acidic protein (GFAP) to assess the presence and activation of microglia and astroglia, respectively. Statistical comparisons were performed with Student's t-test for 2 determinations and ANOVA 1-way and 2-way repeated measures for multiple determinations.

Results: At 30 days after injection, the lateral ventricles were larger in all 3 groups that had undergone injection than in controls (mean diameter in controls 3.76 ± 0.05 mm, n = 5). However, dilatation was greater in the fetuses injected with 2 mL of BioGlue (11.34 ± 4.76 mm, n = 11) than in those injected with kaolin (6.4 ± 0.98 mm, n = 7) or Onyx (5.7 ± 0.31 mm, n = 6) (ANOVA, *p ≤ 0.0001). Fetuses injected with 2.0 mL or 2.5 mL of BioGlue showed the same ventricle dilatation but it appeared earlier (at 10 days postinjection) in those injected with 2.5 mL. The critical threshold of ventricle dilatation was 0.1 for all the groups, and only the BioGlue 2.0 mL and BioGlue 2.5 mL groups exceeded this critical value (at 30 days and 18 days after injection, respectively) (ANOVA, *p ≤ 0.0001). Moderate to severe hydrocephalus with corpus callosum disruption was observed in all experimental groups. All experimental groups showed ventriculomegaly with significant microgliosis and astrogliosis in the subventricular zone around the lateral ventricles. Only kaolin resulted in significant microgliosis in the fourth ventricle area (ANOVA, *p ≤ 0.005).

Conclusions: The results of these studies demonstrate that BioGlue is more effective than Onyx or kaolin for inducing hydrocephalus in the fetal lamb and results in a volume-related response by obstructive space-occupancy without local neuroinflammatory reaction. This novel use of BioGlue generates a model with potential for new insights into hydrocephalus pathology and the development of therapeutics in obstructive hydrocephalus. In addition, this model allows for the study of acute and chronic obstructive hydrocephalus by using different BioGlue volumes for intracisternal injection.
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http://dx.doi.org/10.3171/2019.6.PEDS19141DOI Listing
September 2019

Parasympathetic Tone Activity Evaluation to Discriminate Ketorolac and Ketorolac/Tramadol Analgesia Level in Swine.

Anesth Analg 2019 09;129(3):882-889

From the Center for the Research and Technology of Agro-Environmental and Biological Sciences (CITAB).

Background: Evaluation of nociceptive-antinociceptive balance during general anesthesia is still challenging and routinely based on clinical criteria. Analgesic drug delivered may be optimized with parasympathetic tone activity (PTA) monitor. This study compares ketorolac and ketorolac/tramadol balance analgesia using a PTA monitor.

Methods: Pain intensity response was assessed using a 0-100 numerical state scale (PTA) after nociceptive stimuli in pigs under stable sevoflurane anesthesia. Bispectral index, heart rate, noninvasive blood pressure, and respiratory parameters were also measured. Animals were divided into 3 groups: without analgesia, ketorolac, and ketorolac/tramadol. Mean values or mean areas under the curve (AUC) in selected time periods were compared over time and between groups through a mixed-model repeated measures analysis of variance and nonparametric Kruskal-Wallis tests, followed by Bonferroni or Dunn's multiple comparisons.

Results: It was observed a significant decrease in the PTA AUC mean value after application of the stimulus in animals treated without analgesia and only with ketorolac. The PTA AUC mean value in the control group was significantly lower than the corresponding mean in ketorolac group. The ketorolac/tramadol group showed the highest PTA AUC mean values, significantly different from those obtained for the other 2 groups, with no significant differences detected over time. Bispectral index means showed no statistically significant differences either over time periods or between different treatment groups. Heart rate showed only a statistically significant increase in AUC mean between without analgesia and ketorolac/tramadol group, in the time period after the stimulus application. Noninvasive blood pressure means showed no statistically significant differences over time and between treatment groups.

Conclusions: This study shows that a low dose combination of ketorolac and tramadol is sufficient to block the pain responses induced with a needle holder in pigs 20 minutes after its administration. The PTA monitor was able to clearly recognize the analgesic level between treatments and may be used to optimize analgesic drug delivered.
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http://dx.doi.org/10.1213/ANE.0000000000003573DOI Listing
September 2019

Dose-dependent improvement of cardiac function in a swine model of acute myocardial infarction after intracoronary administration of allogeneic heart-derived cells.

Stem Cell Res Ther 2019 05 31;10(1):152. Epub 2019 May 31.

Coretherapix S.L.U./Tigenix Group C/Marconi 1, 28076, Tres Cantos, Madrid, Spain.

Background: Allogeneic cardiac-derived progenitor cells (CPC) without immunosuppression could provide an effective ancillary therapy to improve cardiac function in reperfused myocardial infarction. We set out to perform a comprehensive preclinical feasibility and safety evaluation of porcine CPC (pCPC) in the infarcted porcine model, analyzing biodistribution and mid-term efficacy, as well as safety in healthy non-infarcted swine.

Methods: The expression profile of several pCPC isolates was compared with humans using both FACS and RT-qPCR. ELISA was used to compare the functional secretome. One week after infarction, female swine received an intracoronary (IC) infusion of vehicle (CON), 25 × 10 pCPC (25 M), or 50 × 10 pCPC (50 M). Animals were followed up for 10 weeks using serial cardiac magnetic resonance imaging to assess functional and structural remodeling (left ventricular ejection fraction (LVEF), systolic and diastolic volumes, and myocardial salvage index). Statistical comparisons were performed using Kruskal-Wallis and Mann-Whitney U tests. Biodistribution analysis of F-FDG-labeled pCPC was also performed 4 h after infarction in a different subset of animals.

Results: Phenotypic and functional characterization of pCPC revealed a gene expression profile comparable to their human counterparts as well as preliminary functional equivalence. Left ventricular functional and structural remodeling showed significantly increased LVEF 10 weeks after IC administration of 50 M pCPC, associated to the recovery of left ventricular volumes that returned to pre-infarction values (LVEF at 10 weeks was 42.1 ± 10.0% in CON, 46.5 ± 7.4% in 25 M, and 50.2 ± 4.9% in 50 M, p < 0.05). Infarct remodeling was also improved following pCPC infusion with a significantly higher myocardial salvage index in both treated groups (0.35 ± 0.20 in CON; 0.61 ± 0.20, p = 0.04, in 25 M; and 0.63 ± 0.17, p = 0.01, in 50 M). Biodistribution studies demonstrated cardiac tropism 4 h after IC administration, with substantial myocardial retention of pCPC-associated tracer activity (18% of labeled cells in the heart), and no obstruction of coronary flow, indicating their suitability as a cell therapy product.

Conclusions: IC administration of allogeneic pCPC at 1 week after acute myocardial infarction is feasible, safe, and associated with marked structural and functional benefit. The robust cardiac tropism of pCPC and the paracrine effects on left ventricle post-infarction remodeling established the preclinical bases for the CAREMI clinical trial (NCT02439398).
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http://dx.doi.org/10.1186/s13287-019-1237-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6544975PMC
May 2019

European association for endoscopic surgery (EAES) consensus statement on single-incision endoscopic surgery.

Surg Endosc 2019 04 15;33(4):996-1019. Epub 2019 Feb 15.

SJOG Hospital - PMU Teaching Hospital, Salzburg, Austria.

Background: Laparoscopic surgery changed the management of numerous surgical conditions. It was associated with many advantages over open surgery, such as decreased postoperative pain, faster recovery, shorter hospital stay and excellent cosmesis. Since two decades single-incision endoscopic surgery (SIES) was introduced to the surgical community. SIES could possibly result in even better postoperative outcomes than multi-port laparoscopic surgery, especially concerning cosmetic outcomes and pain. However, the single-incision surgical procedure is associated with quite some challenges.

Methods: An expert panel of surgeons has been selected and invited to participate in the preparation of the material for a consensus meeting on the topic SIES, which was held during the EAES congress in Frankfurt, June 16, 2017. The material presented during the consensus meeting was based on evidence identified through a systematic search of literature according to a pre-specified protocol. Three main topics with respect to SIES have been identified by the panel: (1) General, (2) Organ specific, (3) New development. Within each of these topics, subcategories have been defined. Evidence was graded according to the Oxford 2011 Levels of Evidence. Recommendations were made according to the GRADE criteria.

Results: In general, there is a lack of high level evidence and a lack of long-term follow-up in the field of single-incision endoscopic surgery. In selected patients, the single-incision approach seems to be safe and effective in terms of perioperative morbidity. Satisfaction with cosmesis has been established to be the main advantage of the single-incision approach. Less pain after single-incision approach compared to conventional laparoscopy seems to be considered an advantage, although it has not been consistently demonstrated across studies.

Conclusions: Considering the increased direct costs (devices, instruments and operating time) of the SIES procedure and the prolonged learning curve, wider acceptance of the procedure should be supported only after demonstration of clear benefits.
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http://dx.doi.org/10.1007/s00464-019-06693-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6430755PMC
April 2019

Antireflux ureteral stent proof of concept assessment after minimally invasive treatment of obstructive uropathy in animal model.

Arch Esp Urol 2018 09;71(7):607-613

Endoscopy Department. Minimally Invasive Surgery Centre Jesús Usón. Cáceres. Spain.

Objectives: To assess the efficacy of a new anti-reflux intraureteral stent design in a swine model after minimally invasive treatment of ureteral stricture to reduce ureteral stent morbidity, previous to manufacture this design in a biodegradable fashion.

Methods: Twenty-eight female pigs were included. The study began with a cystoscopic, nephrosonographic and contrast fluoroscopic assessment. Afterwards, obstructive uropathy model in right ureter was created. Obstruction was confirmed 6 weeks later and animals were randomly distributed into 2 groups. Group I underwent laser endopyelotomy and Group-II laparoscopic pyeloplasty A 3Fr anti-reflux intraureteral stent was placed 6 weeks. Follow-up evaluations were performed at 3-6 weeks. The final follow-up was completed at 5 months and included the aforementioned diagnostic methods and pathological study.

Results: None of the study animals showed any vesicoureteral reflux signs or ureteral orifice injury. There were no urinomas or ureteric fistulas. The dislodgement rate was 10.7%. After 6 weeks of stenting, 71.4% of ureters showed ureteral peristalsis below the stent, and 100% at the final follow-up. After pathological assessment, no differences were shown at UPJ and healing in the incised area was correct in both groups.

Conclusions: The new stent design avoids vesicoureteral reflux and bladder trigone irritation, consequently might reduce morbidity associated with double pigtail ureteral stents. This study also shows that it is only necessary temporary scaffolding the incised ureteral segment and not the entire length of the ureter after minimally invasive surgery. It is also necessary to manufacture this design in a biodegradable material, thus avoiding its removal.
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September 2018

Intestinal histopathological changes in a porcine model of pneumoperitoneum-induced intra-abdominal hypertension.

Surg Endosc 2018 09 17;32(9):3989-4002. Epub 2018 May 17.

Department of General Surgery, Virgen de la Arrixaca General University Hospital, Murcia, Spain.

Background: Low splanchnic perfusion is an immediate effect of pneumoperitoneum-induced intra-abdominal hypertension (IAH). Anatomical structure results in the intestinal mucosa being the area most sensitive to hypoperfusion. The relationship between intestinal injury and clinical parameters of tissue perfusion [abdominal perfusion pressure (APP), gastric intramucosal pH (pH) and lactic acid (Lc)] has not been previously studied. This study aimed to monitorize intestinal pathogenesis through sequential ileal biopsies and to measure APP, pH, and Lc levels at different pneumoperitoneum-induced intra-abdominal pressures (20, 30, and 40 mmHg) to evaluate the potential relationships between them.

Materials And Methods: Fifty pigs were divided into four groups; a control group (C) and three experimental groups with different pneumoperitoneum-induced levels [20 mmHg (G20), 30 mmHg (G30), and 40 mmHg (G40)], that were maintained for 3 and 5 h. APP, pH, and Lc were measured and ileal biopsies taken laparoscopically every 30 min. The mucosal damage was graded using the standardized Park's Score and animals were classified as injured (I+) or uninjured (I-).

Results: Different histopathological lesions were observed in groups G20, G30, and G40 but no damage observed in group C. A 33.3% of animals in G20 and G30 were I+ after 3 h, while 93.3% were injured in G40. After 5 h, histopathological lesions were no longer seen in some animals in G20 and only 10% were I+. Conversely, in G30 I+ pigs increased to 80% while those in G40 remained at 93.3% I+. The I+ animals had significantly lower APP and pH than those I-. Lc was the clinical parameter that showed the earliest differences, with significantly higher figures in I+ animals.

Conclusions: The evolution of intestinal injuries from pneumoperitoneum-induced IAH depends on the degree of IAP. These damages may be associated with decreases in APP and pH, and increases in Lc.
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http://dx.doi.org/10.1007/s00464-018-6142-zDOI Listing
September 2018

Adipose-Derived Stem Cells Ameliorate Ischemia-Reperfusion Injury in a Rat Skin Free Flap Model.

J Reconstr Microsurg 2018 Oct 3;34(8):601-609. Epub 2018 May 3.

Jesús Usón Minimally Invasive Surgery Centre, Cáceres, Spain.

Background:  Ischemia-reperfusion (I/R) injury is inevitable during free tissue transfers. When the period of ischemia exceeds the tissue tolerance, it causes necrosis and flap failure. The aim of this study was to investigate the effects of adipose-derived stem cells (ASCs) embedded in a collagen type I scaffold on the survival of free skin flaps to counteract I/R injury.

Methods:  Left superficial caudal epigastric skin flaps (3 × 6 cm) were performed in 28 Wistar rats that were divided into four groups. The flaps elevated in the animals of the control group did not suffer any ischemic insult, and the vascular pedicle was not cut. All other flaps were subjected to 8 hours of ischemia prior to revascularization: I/R control group (8 hours of ischemia), I/R scaffold group (8 hours of ischemia + collagen type I scaffold), and I/R scaffold-ASCs group (8 hours of ischemia + collagen type I scaffold with rat ASCs embedded). Transit-time ultrasound blood flow measurements were performed. After 7 days, the areas of flap survival were measured and tissues were stained with hematoxylin/eosin and Masson's trichrome stain for histological analysis.

Results:  The mean percentage flap survival area was significantly higher in the ASCs-treated flaps (I/R scaffold-ASCs group) compared with the ischemic controls (I/R control group and I/R scaffold group). Higher vascular proliferation and lower severity of necrosis and inflammatory changes were seen histologically in the samples of the ASCs-treated group. No significant difference in blood flow was detected between groups.

Conclusion:  Subcutaneous administration of ASCs embedded on a collagen type I scaffold reduces tissue damage after I/R injury in microvascular free flaps.
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http://dx.doi.org/10.1055/s-0038-1648246DOI Listing
October 2018

Comparison of the use of fresh-frozen canine cadavers and a realistic composite ex vivo simulator for training in small animal flexible gastrointestinal endoscopy.

J Am Vet Med Assoc 2018 Apr;252(7):839-845

OBJECTIVE To compare the usefulness of fresh-frozen canine cadavers (FFCCs) and a validated canine simulator model for training veterinary students in basic gastrointestinal endoscopic procedures. DESIGN Randomized trial. SAMPLE 48 veterinary students in their final year of training. PROCEDURES Students were randomly assigned to receive basic gastrointestinal endoscopic training on a canine simulator or FFCC. All students were trained as assigned in esophagogastroduodenoscopy, endoscopic gastric biopsy, and gastric foreign body removal for 2 h/d for 5 days. They then performed each procedure on a live dog, and procedure completion time and performance ability were compared between groups. Two experienced endoscopists used a validated Likert-type procedural rating scale to rate the students' performance. Students completed a survey to rate their training model. RESULTS No significant differences were identified between groups in quality of performance of the 3 endoscopic procedures on a live dog. Students required significantly less time to complete the procedures on a live dog when trained on an FFCC versus canine simulator. Although both training models were considered equally useful by students, training on the simulator was significantly more stimulating. CONCLUSIONS AND CLINICAL RELEVANCE Students showed the same skill level in performing basic endoscopic procedures on live dogs regardless of the training model used, although students who trained on the FFCC completed these procedures faster than students trained on the canine simulator. Use of the simulator appeared to be a viable alternative to use of FFCCs for veterinary endoscopic training, providing students with a good level of proficiency before performing endoscopic procedures on live dogs.
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http://dx.doi.org/10.2460/javma.252.7.839DOI Listing
April 2018

Evaluation of a New Design of Antireflux-biodegradable Ureteral Stent in Animal Model.

Urology 2018 05 19;115:59-64. Epub 2018 Feb 19.

Endoscopy-Endourology Department, Minimally Invasive Surgery Centre Jesús Usón, Cáceres, Spain.

Objective: To determine the effects in urinary tract of a new antireflux-biodegradable ureteral stent.

Materials And Methods: Thirty six ureters belonging to 24 pigs were used. The study began with endoscopic, nephrosonographic, and fluoroscopic assessments. Three study groups of ureters (n = 12) were then specified. In group I, a biodegradable antireflux ureteral stent (BDG-ARS) was inserted in the right ureter of 12 pigs. Group II comprised the left ureter of the same animals, in which a double-pigtail stent was placed for 6 weeks. Group III ureters, belonging to 12 additional animals, were subjected to a ureteropelvic junction obstruction model that was then treated by endopyelotomy and stenting with BDG-ARS. Follow-ups were performed at 3-6 weeks and at 5 months.

Results: None of the ureters receiving the BDG-ARS showed any evidence of vesicoureteral reflux (VUR). BDG-ARS degradation took place in a controlled and predictable fashion from the third to the sixth weeks, and no obstructive fragments appeared. No differences were found between groups I and II regarding passive ureteral dilation, but significant differences were found regarding VUR and ureteral orifice damage. BDG-ARS always maintained distal ureteral peristalsis. BDG-ARS in group III showed a 50% positive urine culture rate and a 16.6% migration rate in both BDG-ARS groups.

Conclusion: BDG-ARS avoided VUR and bladder trigone irritation. In addition, this polymer combination and stent-braided design achieved a consistent biodegradation rate with no obstructive fragments and with uniform degradation between the third and the sixth weeks. Consequently, morbidity associated with ureteral stents might be reduced.
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http://dx.doi.org/10.1016/j.urology.2018.02.004DOI Listing
May 2018

Time-course evaluation of intestinal structural disorders in a porcine model of intra-abdominal hypertension by mechanical intestinal obstruction.

PLoS One 2018 22;13(1):e0191420. Epub 2018 Jan 22.

Department of General Surgery, Virgen de la Arrixaca General University Hospital, Murcia, Spain.

Background: A mechanical intestinal obstruction (MIO) can generate intraabdominal hypertension (IAH) that is life threatening. The intestines are very sensitive to IAH since the low splanchnic perfusion causes intestinal hypoxia, local acidosis and bacterial translocations. This may lead to acute intestinal distress syndrome (AIDS). The identification of intestinal injuries during IAH and its correlation with clinical parameters as the abdominal perfusion pressure (APP), the gastric intramucosal pH (pHi) and lactic acid (Lc) are still unknown. This study aimed to evaluate the sequence of intestinal histopathological findings in an MIO model and to analyze potential relationships with parameters currently used in clinical practice (APP, pHi and Lc).

Material And Methods: Twenty pigs were divided into three groups: a control group (n = 5) and two experimental groups with 20 mmHg (G1, n = 10) and 30 mmHg (G2, n = 5) of IAH by MIO. The pressures were maintained for 3 hours, except in 5 animals in G1 where it was maintained for 5 hours. The APP, pHi and LA were recorded and biopsies of the terminal ileum were taken every 30 minutes in all groups. The intestinal damage was graded according to the Park Score.

Results: Intestinal injuries were found in 42.9% of pigs in the experimental groups. The lesions were independent of the level and duration of IAH. Although APP and pHi were slightly lower in injured animals (I +) of G1 and G2, there were no significant differences among those uninjured (I-). Lc was significantly increased in all I+ pigs from the onset of IAH.

Conclusion: The IAH by MIO causes intestinal lesions from the first 30 minutes with concurrent decreases in APP and pHi and increases in Lc. Lc could be the best clinical parameter related to intestinal damages with a clear difference between I + and I- animals.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0191420PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5777654PMC
February 2018

Interpretation of motion analysis of laparoscopic instruments based on principal component analysis in box trainer settings.

Surg Endosc 2018 07 18;32(7):3096-3107. Epub 2018 Jan 18.

Biomedical Engineering and Telemedicine Centre (GBT), ETSI Telecomunicación, Center for Biomedical Technology, Universidad Politécnica de Madrid (UPM), Avda Complutense, 30, 28040, Madrid, Spain.

Background: Motion analysis parameters (MAPs) have been extensively validated for assessment of minimally invasive surgical skills. However, there are discrepancies on how specific MAPs, tasks, and skills match with each other, reflecting that motion analysis cannot be generalized independently of the learning outcomes of a task. Additionally, there is a lack of knowledge on the meaning of motion analysis in terms of surgical skills, making difficult the provision of meaningful, didactic feedback. In this study, new higher significance MAPs (HSMAPs) are proposed, validated, and discussed for the assessment of technical skills in box trainers, based on principal component analysis (PCA).

Methods: Motion analysis data were collected from 25 volunteers performing three box trainer tasks (peg grasping/PG, pattern cutting/PC, knot suturing/KS) using the EVA tracking system. PCA was applied on 10 MAPs for each task and hand. Principal components were trimmed to those accounting for an explained variance > 80% to define the HSMAPs. Individual contributions of MAPs to HSMAPs were obtained by loading analysis and varimax rotation. Construct validity of the new HSMAPs was carried out at two levels of experience based on number of surgeries.

Results: Three new HSMAPs per hand were defined for PG and PC tasks, and two per hand for KS task. PG presented validity for HSMAPs related to insecurity and economy of space. PC showed validity for HSMAPs related to cutting efficacy, peripheral unawareness, and confidence. Finally, KS presented validity for HSMAPs related with economy of space and knotting security.

Conclusions: PCA-defined HSMAPs can be used for technical skills' assessment. Construct validation and expert knowledge can be combined to infer how competences are acquired in box trainer tasks. These findings can be exploited to provide residents with meaningful feedback on performance. Future works will compare the new HSMAPs with valid scoring systems such as GOALS.
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http://dx.doi.org/10.1007/s00464-018-6022-6DOI Listing
July 2018

Validation of the three web quality dimensions of a minimally invasive surgery e-learning platform.

Int J Med Inform 2017 11 19;107:1-10. Epub 2017 Jul 19.

Jesús Usón Minimally Invasive Surgery Centre, Cáceres, Spain.

Introduction: E-learning web environments, including the new TELMA platform, are increasingly being used to provide cognitive training in minimally invasive surgery (MIS) to surgeons. A complete validation of this MIS e-learning platform has been performed to determine whether it complies with the three web quality dimensions: usability, content and functionality.

Methods: 21 Surgeons participated in the validation trials. They performed a set of tasks in the TELMA platform, where an e-MIS validity approach was followed. Subjective (questionnaires and checklists) and objective (web analytics) metrics were analysed to achieve the complete validation of usability, content and functionality.

Results: The TELMA platform allowed access to didactic content with easy and intuitive navigation. Surgeons performed all tasks with a close-to-ideal number of clicks and amount of time. They considered the design of the website to be consistent (95.24%), organised (90.48%) and attractive (85.71%). Moreover, they gave the content a high score (4.06 out of 5) and considered it adequate for teaching purposes. The surgeons scored the professional language and content (4.35), logo (4.24) and recommendations (4.20) the highest. Regarding functionality, the TELMA platform received an acceptance of 95.24% for navigation and 90.48% for interactivity.

Conclusions: According to the study, it seems that TELMA had an attractive design, innovative content and interactive navigation, which are three key features of an e-learning platform. TELMA successfully met the three criteria necessary for consideration as a website of quality by achieving more than 70% of agreements regarding all usability, content and functionality items validated; this constitutes a preliminary requirement for an effective e-learning platform. However, the content completeness, authoring tool and registration process required improvement. Finally, the e-MIS validity methodology used to measure the three dimensions of web quality in this work can be applied to other clinical areas or training fields.
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http://dx.doi.org/10.1016/j.ijmedinf.2017.07.001DOI Listing
November 2017

Preclinical Safety Evaluation of Allogeneic Induced Pluripotent Stem Cell-Based Therapy in a Swine Model of Myocardial Infarction.

Tissue Eng Part C Methods 2017 11 18;23(11):736-744. Epub 2017 Aug 18.

1 ICREC (Heart Failure and Cardiac Regeneration) Research Programme, Health Sciences Research Institute Germans Trias i Pujol (IGTP) , Barcelona, Spain .

The combination of biomatrices and induced pluripotent stem cell (iPSC) derivatives to aid repair and myocardial scar formation may soon become a reality for cardiac regenerative medicine. However, the tumor risk associated with residual undifferentiated cells remains an important safety concern of iPSC-based therapies. This concern is not satisfactorily addressed in xenotransplantation, which requires immune suppression of the transplanted animal. In this study, we assessed the safety of transplanting undifferentiated iPSCs in an allogeneic setting. Given that swine are commonly used as large animal models in cardiac medicine, we used porcine iPSCs (p-iPSCs) in conjunction with bioengineered constructs that support recovery after acute myocardial infarction. Histopathology analyses found no evidence of p-iPSCs or p-iPSC-derived cells within the host myocardium or biomatrices after 30 and 90 days of follow-up. Consistent with the disappearance of the implanted cells, we could not observe functional benefit of these treatments in terms of left ventricular ejection fraction, cardiac output, ventricular volumes, or necrosis. We therefore conclude that residual undifferentiated iPSCs should pose no safety concern when used on immune-competent recipients in an allogeneic setting, at least in the context of cardiac regenerative medicine.
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http://dx.doi.org/10.1089/ten.TEC.2017.0156DOI Listing
November 2017

Initial experience using a robotic-driven laparoscopic needle holder with ergonomic handle: assessment of surgeons' task performance and ergonomics.

Int J Comput Assist Radiol Surg 2017 Dec 10;12(12):2069-2077. Epub 2017 Jul 10.

Jesús Usón Minimally Invasive Surgical Centre, Ctra. N-521, km 41.8, 10071, Cáceres, Spain.

Purpose: The objective of this study is to assess the surgeons' performance and ergonomics during the use of a robotic-driven needle holder in laparoscopic suturing tasks.

Methods: Six right-handed laparoscopic surgeons with different levels of experience took part in this study. Participants performed a set of three different intracorporeal suturing tasks organized in ten trials during a period of five weeks. Surgeons used both conventional (Conv) and robotic (Rob) laparoscopic needle holders. Precision using the surgical needle, quality of the intracorporeal suturing performance, execution time and leakage pressure for the urethrovesical anastomosis, as well as the ergonomics of the surgeon's hand posture, were analyzed during the first, fifth and last trials.

Results: No statistically significant differences in precision and quality of suturing performance were obtained between both groups of instruments. Surgeons required more time using the robotic instrument than using the conventional needle holder to perform the urethrovesical anastomosis, but execution time was significantly reduced after training ([Formula: see text] 0.05). There were no differences in leakage pressure for the anastomoses carried out by both instruments. After training, novice surgeons significantly improved the ergonomics of the wrist ([Formula: see text] 0.05) and index finger (Conv: 36.381[Formula: see text], Rob: 30.389[Formula: see text]; p = 0.024) when using the robotic instrument compared to the conventional needle holder.

Conclusions: Results have shown that, although both instruments offer similar technical performance, the robotic-driven instrument results in better ergonomics for the surgeon's hand posture compared to the use of a conventional laparoscopic needle holder in intracorporeal suturing.
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http://dx.doi.org/10.1007/s11548-017-1636-zDOI Listing
December 2017

Use of natural user interfaces for image navigation during laparoscopic surgery: initial experience.

Minim Invasive Ther Allied Technol 2017 Oct 28;26(5):253-261. Epub 2017 Mar 28.

d General Surgery Unit , Jesús Usón Minimally Invasive Surgery Centre , Cáceres , Spain.

Background: Surgical environments require special aseptic conditions for direct interaction with the preoperative images. We aim to test the feasibility of using a set of gesture control sensors combined with voice control to interact in a sterile manner with preoperative information and an integrated operating room (OR) during laparoscopic surgery.

Material And Methods: Two hepatectomies and two partial nephrectomies were performed by three experienced surgeons in a porcine model. The Kinect, Leap Motion, and MYO armband in combination with voice control were used as natural user interfaces (NUIs). After surgery, surgeons completed a questionnaire about their experience.

Results: Surgeons required <10 min training with each NUI. They stated that NUIs improved the access to preoperative patient information and kept them more focused on the surgical site. The Kinect system was reported as the most physically demanding NUI and the MYO armband in combination with voice commands as the most intuitive and accurate. The need to release one of the laparoscopic instruments in order to use the NUIs was identified as the main limitation.

Conclusions: The presented NUIs are feasible to directly interact in a more intuitive and sterile manner with the preoperative images and the integrated OR functionalities during laparoscopic surgery.
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http://dx.doi.org/10.1080/13645706.2017.1304964DOI Listing
October 2017