SARS-CoV-2 and Atherosclerosis: Should COVID-19 Be Recognized as a New Predisposing Cardiovascular Risk Factor?

At the beginning of the COVID-19 pandemic, the lung was recognized as the main target organ; now, new evidence suggests that SARS-CoV-2 infection leads to vascular disease. In a previous review, we supposed a bidirectional link between endothelial dysfunction and COVID-19, identifying atherosclerosis as having a crucial role in its pathogenesis. Atherosclerosis with an existing endothelial dysfunction may worsen COVID-19 manifestations, leading to adverse outcomes, as largely reported. However, COVID-19 may be the trigger factor in the progression of the atherosclerotic process up to making it clinically manifest. The thrombotic complications can involve not only the atherosclerotic plaque, but also the durability of the surgical device implanted to treat a pre-existing coronary artery disease as recently reported. The burden of the disease makes necessary a long-term stratification of patients, revising drastically targeted therapy among others.

Comparison of Postoperative complications between Conventional Ferguson’s Hemorrhoidectomy and LigaSureTM Hemorrhoidectomy

Background For symptomatic grade III and IV haemorrhoids, some form of hemorrhoidectomy remains the accepted modality of treatment. The traditional methods like the Milligan-Morgan method and the Ferguson‘s method have been in practice for more than half a century. Recently we acquired the LigaSureTM device. It is an electro-surgical device, which is an improved version of bipolar diathermy, now widely used for hemorrhoidectomy. This study will give a comprehensive overview on differences between conventional Ferguson‘s haemorrhoidectomy and LigaSureTM haemorrhoidectomy focusing on post-operative complications mainly postoperative pain, bleeding and peri-anal fistulae occurrence Objective To compere between closed hemorrhoidectomy, Ferguson‘s method, and LigaSureTM hemorrhoidectomy as regards post-operative pain, bleeding and peri-anal fistula occurrence. Patients and Methods It is a prospective study conducted over 40 patients with grade III and IV hemorrhoids, randomly divided into two groups to compare between closed hemorrhoidectomy, Ferguson‘s method, and LigaSure™ hemorrhoidectomy as regards post-operative pain, bleeding and peri-anal fistula occurrence. Results An overall favorable trend exists toward LigaSureTM hemorrhoidectomy in all parameters of the current study, in another word, the postoperative complications mainly pain, bleeding and peri-anal fistula occurrence was much lesser in the LigaSureTM group. Conclusion LigaSureTM hemorrhoidectomy is a sutureless, hemorrhoidectomy technique dependent on a modified electro- surgical unit to achieve vessel and tissue sealing. It is safe and effective, has less blood loss, postoperative pain, bleeding and perianal fistula occurrence compared to conventional Ferguson‘s hemorrhoidectomy.

Limited Scalability of Single Deep Neural Network for Surgical Instrument Segmentation in Different Surgical Environments

Clarifying the scalability of deep-learning-based surgical instrument segmentation networks in diverse surgical environments is important in recognizing the challenges of overfitting in surgical device development. This study comprehensively evaluated deep neural network scalability for surgical instrument segmentation, using 5238 images randomly extracted from 128 intraoperative videos. The video dataset contained 112 laparoscopic colorectal resection, 5 laparoscopic distal gastrectomy, 5 laparoscopic cholecystectomy, and 6 laparoscopic partial hepatectomy cases. Deep-learning-based surgical instrument segmentation was performed for test sets with 1) the same conditions as the training set; 2) the same recognition target surgical instrument and surgery type but different laparoscopic recording systems; 3) the same laparoscopic recording system and surgery type but slightly different recognition target laparoscopic surgical forceps; 4) the same laparoscopic recording system and recognition target surgical instrument but different surgery types. The mean average precision and mean intersection over union for test sets 1, 2, 3, and 4 were 0.941 and 0.887, 0.866 and 0.671, 0.772 and 0.676, and 0.588 and 0.395, respectively. Therefore, the recognition accuracy decreased even under slightly different conditions. To enhance the generalization of deep neural networks in surgery, constructing a training set that considers diverse surgical environments under real-world conditions is crucial. Trial Registration Number: 2020–315, date of registration: October 5, 2020

Developing a Needle-Knife Surgical Device

Introduction: Nowadays, a new era of orthopedic surgery is taking place. Procedures like video surgery, ultrasound-guided interventions, invasive pain interventions, orthopedic procedures, hydro dissection, dry needling, thermography-assisted pain management, and modern acupuncture started to be widely performed1,2. Background: In 2011 and 2012, Ravaglia & Cliquet presented papers on an Arthroscopic Needle-Knife Surgical Prototype Device (ANKSD)2 in Prague, TWC 20112, and in Dubai, OWC 20123. It was a paper presenting a prototype of a needle-knife for orthopedic procedures based on an 18G11/2 needle. Ravaglia and Cliquet wrote the paper “Comparison of two different needles used as knife on knee arthroscopic portal scalpel procedures”4, which was presented at the XXVI SICOT Triennial World Congress, in Guangzhou, China, in 2015. This research compares arthroscopic portal incisions using an 18G11/2 needle or a metal guide intravenous catheter 14Gx2. They concluded that there were no differences in complications such as infections, wound healing, hematoma, and skin healing time. After this, these researchers started a virtual development of a new needle-knife surgical device. Objective: The aim of the project is a virtual development of a needle-knife surgical device to be useful for minimally invasive ultrasound-assisted orthopedic surgical procedures, videos arthroscopic portals augmentation, and other surgical procedures. Method: Three different needle devices were compared. One is a base model 1 and the other two are experimental models (2 and 3). They are based on a metal guide for intravenous catheter 14Gx2''. The base one model 1 is the metal guide for intravenous catheter 14Gx2''; the experimental model 2 is a flat beveled edge, and experimental model 3 is a board bevel edge6,7,8,9,10,11,12,13,14,15,16. They are all graduated, parylene-coated, with a stop handle needle guard. The devices are multifunctional: Infusion, aspiration, and surgical sever.The devices were developed by 3D Design 3D STEP Standard Format, Catia V5 Format, and 2D Format Design and 3D Model. They were performed through simulation (Software Simulia Abaqus). They were biomechanically simulated with Virtual Biomechanical Strength Simulation17,18,19,20. The Strengths were assessed by Needle Strength Analysis (CAE Simulation)21.Results: For the displacement result, stiffness assessment, we have 7.48 mm for the baseline needle, 8.08mm for model 2, an increase of 8%, and for model 3 we have 7.75 mm, an increase of 3.6%. Conclusion: These devices seem suitable for echo-assisted orthopedic surgery interventions and other procedures according to virtual analysis. Further in vivo procedures shall be performed.

A world-first thorascopic surgical instrument for minimally invasive robotically-enabled transplantation of 3D bioprinted heart patches for myocardial regeneration

Patch-based approaches to regenerating damaged myocardium include 3D bioprinting of heart patches for epicardial transplantation. By the time this is ready for widespread clinical use, it will be important that patches can be delivered via minimally invasive and robotic surgical approaches. Here, we aimed to design a minimally invasive patch transplantation surgical device for human operation as well as master-slave and fully automated robotic control. METHOD: Over a 12-month period (2019-20) in our multidisciplinary team we designed a surgical instrument to transplant 3D bioprinted heart patches to the epicardial surface. The device was designed for use via uni-portal or multi-portal Video-Assisted Thorascopic Surgery (VATS). Forpreliminary feasibility and sizing, we used a 3D printer to produce a flexible resin model from a computer-aided design (CAD) software platform in preparation for more robust high-resolution metal manufacturing. RESULTS: The instrument was designed as a sheath containing foldable arms, less than 2 cm in diameter when infolded to fit minimally invasive thoracic ports. The total length was 35 cm. When the arms were projected from the sheath, three moveable mechanical arms at the distal end were designed to hold the 3D bioprinted patch. A rotational head allowing for the arms to be angled in real time, a surface with micro-attachment points for patches and a releasing mechanism to release the patch was included. At the proximal end, right-angled handles corresponding to each distal arm could be used to control the distal arms, either manually, or by robotic hardware attached to the arms. CONCLUSION: This world-first design paves the way for a new approach for epicardial patch transplantation via minimally invasive robotic surgery. Full prototyping, proof-of-concept and efficacy trials will be needed to confirm the utility of this approach for translation from bench to bedside.

Infective endocarditis late after patent foramen ovale percutaneous closure in an addict patient

We report an uncommon case of late infective endocarditis, in a patient with a history of intravenous drug abuse and HIV positivity, 9 years after a percutaneous closure of a patent foramen ovale. Despite a target and prolonged intravenous antibiotic therapy, he was then referred for surgical device and vegetation removal. Given the high risk associated with drug addiction lifestyle, especially in HIV positive cases, it is mandatory to observe this group of patients with lifelong follow-up and support. Furthermore, it may be considered a multidisciplinary-team approach to find the best option for these patients, also evaluating a surgical correction.

Innovators’ views on involving users and patients in surgical device development: a qualitative interview study

ObjectivesInvolving end-users and patients in the development of surgical devices, even when patients are not end-users, is deemed important in policy and in academia since it could improve strategic choices in research and development (R&D). Nonetheless, research into innovators’ views on end-user and patient involvement is rare. This study explores what end-users and patients are being involved by innovators during development, what methods for involvement are being used and what topics are being discussed with these end-users and patients.DesignA qualitative study featuring semi-structured interviews with innovators of surgical devices. Interviews were recorded and a thematic analysis was performed on verbatim transcripts.Participants15 interviews were conducted with 19 innovators of 14 surgical devices.SettingInnovation practices of surgical devices in the Netherlands and Belgium.ResultsEnd-users were engaged in R&D with formal methods and in unsystematic ways. These users all work in the clinical domain, for example, as surgeons or nurses. The innovators engaged users to analyse problems for which a device could be a solution, define functionalities, make design choices, analyse usability, ensure safety and improve aesthetics. Patients were rarely involved. Innovators stated that patients are not considered to be end-users, that physicians can represent patient interests and that involving patients is unethical as false expectations could be raised.ConclusionInnovators involve end-users with methods and unsystematic ways in the development of surgical devices. Despite governmental calls for patient involvement in the development of medical devices and surgical devices, innovators do not generally involve patients.