Safe Implementation of a Next-Generation Surgical Robot: First Analysis of 2,083 Cases in the Versius Surgical Registry.

OBJECTIVE: To present the first report of data from the Versius Surgical Registry, a prospective, multicenter data registry with ongoing collection across numerous surgical indications, developed to accompany the Versius Robotic Surgical System into clinical practice. BACKGROUND: A data registry can be utilized to minimize risk to patients by establishing the safety and effectiveness of innovative medical devices and generating a thorough evidence base of real-world data. METHODS: Surgical outcome data were collected and inputted through a secure online platform. Preoperative data included patient age, sex, body mass index, surgical history, and planned procedures. Intraoperative data included operative time, complications during surgery, conversion from robot-assisted surgery to an alternative surgical technique, and blood loss. Postoperative outcome data included length of hospital stay, complications following surgery, serious adverse events, return to the operating room, readmission to the hospital, and mortality within 90 days of surgery. RESULTS: This registry analysis included 2083 cases spanning general, colorectal, hernia, gynecologic, urological, and thoracic indications. A considerable number of cases were recorded for cholecystectomy (n=539), anterior resection (n=162), and total laparoscopic hysterocolpectomy (n=324) procedures. The rates of conversion to an alternative technique, serious adverse events, and 90-day mortality were low for all procedures across all surgical indications. CONCLUSIONS: We report the large-scale analysis of the first 2083 cases recorded in this surgical registry, with substantial data collected for cholecystectomies, anterior resections, and total laparoscopic hysterectomies. The extensive surgical outcome data reported here provide real-world evidence for the safe implementation of the surgical robot into clinical practice.

Is vacuum-assisted closure therapy the main culprit in right ventricular rupture after deep sternal wound infection?

Right ventricular rupture after deep sternal wound infection (DSWI) is a rare but fatal complication, and can occur with or without vacuum assisted closure (VAC) therapy. There is currently no strong evidence to suggest whether or not VAC therapy is a contributing factor to this complication. In total, 30 articles were retrieved and assessed through a systematic review strategy from 1953 to 2022. The keywords: 'vacuum assisted closure'; 'VAC'; 'negative pressure wound therapy'; 'deep sternal wound infection'; 'DSWI'; 'right ventricular rupture'; and 'cardiac rupture' were used in the search. Overall, 15 of the included articles satisfied the predefined eligibility criteria. Fatal right ventricular ruptures were reported in 18 (36%) out of 50 cases. In this article, the risk factors, mechanisms and management of right ventricular rupture are discussed. A novel view of the mechanism of VAC-associated right ventricular rupture is highlighted, with a focus on both pre- and intraoperative management.

Investigating balance, gait, and physical function in people who have undergone thoracic surgery for a diagnosis of lung cancer: A mixed-methods study.

OBJECTIVES: Symptoms associated with lung cancer and thoracic surgery might increase fall risk. We aimed to investigate: 1) balance, gait and functional status in people post-thoracic surgery compared to healthy controls; 2) perceptions of balance, gait and functional status. METHODS: Recruitment targeted older adults (≥50 years) who had undergone thoracic surgery for a diagnosis of lung cancer in the previous 3 months, and healthy age-matched controls. Dynamic and static balance, gait velocity, knee-extension strength and physical activity levels were assessed using the BESTest, Kistler force plate, GAITRite system, Biodex System 3 and CHAMPS questionnaire, respectively. Two-part semi-structured interviews were conducted post-surgery. RESULTS: Individuals post-surgery (n = 15) had worse dynamic balance and gait, and lower levels of moderate/vigorous physical activity (MVPA) (all p<0.05) versus healthy controls (n = 15). Strength did not differ between groups (p > 0.05). No associations between BESTest and strength or physical activity existed post-surgery (p > 0.05). Three themes were identified: 1) Symptoms affect daily activities; 2) Functional assessments alter perceptions of balance ability and 3) Open to supervised rehabilitation. CONCLUSION: Balance, gait and MVPA are impaired post-thoracic surgery, yet balance was not viewed to be important in enabling activities of daily living. However, supervised rehabilitation was considered acceptable.

Pulmonary nodules precision localization techniques.

The advent of helical high-resolution CT scanners, the application of screening programs and the follow-up of patient with oncological history, led to an increasing number of diagnosis of small pulmonary nodule (less than 10 mm in maximum diameter), partially solid nodule or completely ground glass ones. Their management is controversial. Excisional biopsy by mean of video-assisted thoracic surgery is often a viable choice but to locate these lesions intraoperatively can be impossible without the aid of preoperative or intraoperative localization techniques. In this brief review we will analyze the benefit of adopting localization techniques prior to pulmonary resection for small pulmonary lesions and face the advantages and problems with the main techniques described in the literatures.

Systematic review and meta-analysis found significant risk of brain injury and neurosurgery in alert children after a post-traumatic seizure.

AIM: This study aimed to determine the frequency of traumatic brain injury (TBI) on neuroimaging and the need for emergency neurosurgery in children with normal mental status following a post-traumatic seizure (PTS). METHODS: We searched six electronic databases from inception to October 15, 2018, to identify studies including children under 18 years with head injury and a Glasgow Coma Score of 15 after an immediate PTS. Relevant non-English articles were translated to determine eligibility. RESULTS: We performed random effect meta-analyses and assessed heterogeneity with I2 . The pooled estimate of the frequency of TBI, from seven studies, was 13.0% (95% CI: 4.0-26.1; I2  = 81%). Data on the need of emergency neurosurgery were reported in four studies and the pooled estimate of its frequency was 2.3% (95% CI: 0.0-9.9; I2  = 86%). Two studies reported on children with isolated PTS without any other signs of head injury, representing 0.1% of patients in both studies, for a total of 76 children. Of these, only three had TBI and one underwent neurosurgery. CONCLUSION: Children with immediate PTS and normal mental status frequently have TBI with a substantial need for neurosurgery. Clinicians should strongly consider neuroimaging for these children, although prolonged observation may be considered for those with isolated PTS.

Sternal wound infections following open heart surgery - a review.

Surgical site infections (SSIs) are common complications after open heart surgery. Fortunately, most are superficial and respond to minor wound debridement and antibiotics. However, 1-3% of patients develop deep sternal wound infections that can be fatal. Late infections with sternocutaneous fistulas, are encountered less often, but represent a complex surgical problem. This evidence-based review covers etiology, risk factors, prevention and treatment of sternal SSIs following open heart surgery with special focus on advances in treatment, especially negative-pressure wound therapy.

Lung Biopsies with the Curved Radial Reload™ Stapler.

OBJECTIVE: We describe our experience at the James Cook University Hospital (UK) in using the curved Radial Reload™ (RR) stapler (Medtronic, Dublin, Ireland) for lung wedge resections, which is an endoscopic stapler used mainly in endoscopic general surgery. MATERIALS AND METHODS: A single center experience (James Cook University Hospital) for patients who had superficial or deep video-assisted thoracoscopic surgery (VATS) lung wedge resection, using the curved RR stapler. RESULTS: Seven patients had superficial or deep VATS lung biopsies-their ages ranged from 38 to 75 years, with a median length of hospital stay of two days (one to six days), and a mean length of hospital stay of 2.5 days. No complications were encountered. CONCLUSION: The curved RR stapler is effective in several situations and allows fewer firing of staplers. Our experience would suggest that they are as haemostatic and pneumostatic as the straight staplers and can be used effectively in both superficial and deep lung biopsies.

VATS Diaphragm Plication.

Elevated diaphragm can be due to diaphragmatic eventration or diaphragm paralysis. Diaphragm paralysis is a rare condition that can be congenital or acquired. Acquired diaphragmatic paralysis can result from injury to the phrenic nerve. Subsequently, there is loss of contractility of the diaphragm muscle leading to progressive atrophy and, hence, distension of the dome of the diaphragm leading to elevated right, left, or both copula of the diaphragm. Diaphragm plication aims to return the abdominal contents back to their normal position and allow for greater lung expansion by reducing the abundant diaphragmatic surface. Traditionally, diaphragm plication was performed through thoracotomy, until 1996 when Moroux introduced the widely used thoracoscopic technique of diaphragm plication. With the advancement of minimally-invasive surgery over the years, the approach to diaphragm plication has evolved from four ports to an uniportal approach and robotics.

Novel Techniques in Video-assisted Thoracic Surgery (VATS) Lobectomy.

Twenty years ago, thoracic surgery witnessed the leap from thoracotomy to the first video-assisted thoracic surgery (VATS) lobectomy. Gradually VATS lobectomy has become widely accepted and practiced worldwide. As the idea of less-invasive, fewer, and smaller incisions is taken up by surgeons, thoracic surgery has witnessed the progress of the conventional three-port VATS lung resection to two-port VATS and finally the birth of uniportal VATS lobectomy. Incisions have also become much smaller over the years, such as those seen in total port access lobectomy or microlobectomy. A modified version of the uniportal VATS lobectomy through the subxiphoid incision has also recently been used. The movement toward less-invasive surgery has no doubt driven the innovation of sophisticated instruments and technology to cope with the demanding need of working through a restricted incision. Reported outcomes and results of these new developments are encouraging.

Results of an exploratory survey within ESTS membership in 2022 on current trend of robotic-assisted thoracic surgery and its training perspectives.

OBJECTIVES: Robotic-assisted thoracic surgery (RATS) is increasingly used in our specialty. We surveyed European Society of Thoracic Surgeons membership with the objective to determine current status of robotic thoracic surgery practice including training perspectives. METHODS: A survey of 17 questions was rolled out with 1 surgeon per unit responses considered as acceptable. RESULTS: A total of 174 responses were obtained; 56% (97) were board-certified thoracic surgeons; 28% (49) were unit heads. Most responses came from Italy (20); 22% (38) had no robot in their institutions, 31% (54) had limited access and only 17% (30) had full access including proctoring. Da Vinci Xi was the commonest system in 56% (96) centres, 25% (41) of them had dual console in all systems, whereas RATS simulator was available only in half (51.18% or 87). Video-assisted thoracic surgery (VATS) was the most commonly adopted surgical approach in 81% of centres (139), followed by thoracotomy in 67% (115) and RATS in 36% (62); 39% spent their training time on robotic simulator for training, 51% on robotic wet/dry lab, which being no significantly different to 46-59% who had training on VATS platform. There was indeed huge overlap between simulator models or varieties usage; 52% (90) reported of robotic surgery not a part of training curriculum with no plans to introduce it in future. Overall, 51.5% (89) responded of VATS experience being helpful in robotic training in view of familiarity with minimally invasive surgery anatomical views and dissection; 71% (124) reported that future thoracic surgeons should be proficient in both VATS and RATS. Half of the respondents found no difference in earlier chest drain removal with either approach (90), 35% (60) reported no difference in postoperative pain and 49% (84) found no difference in hospital stay; 52% (90) observed better lymph node harvest by RATS. CONCLUSIONS: Survey concluded on a positive response with at least 71% (123) surgeons recommending to adopt robotics in future.

British societies guideline on the management of emergencies in implantable left ventricular assist device recipients in transplant centres.

An implantable left ventricular assist device (LVAD) is indicated as a bridge to transplantation or recovery in the United Kingdom (UK). The mechanism of action of the LVAD results in a unique state of haemodynamic stability with diminished arterial pulsatility. The clinical assessment of an LVAD recipient can be challenging because non-invasive blood pressure, pulse and oxygen saturation measurements may be hard to obtain. As a result of this unusual situation and complex interplay between the device and the native circulation, resuscitation of LVAD recipients requires bespoke guidelines. Through collaboration with key UK stakeholders, we assessed the current evidence base and developed guidelines for the recognition of clinical deterioration, inadequate circulation and time-critical interventions. Such guidelines, intended for use in transplant centres, are designed to be deployed by those providing immediate care of LVAD patients under conditions of precipitous clinical deterioration. In summary, the Joint British Societies and Transplant Centres LVAD Working Group present the UK guideline on management of emergencies in implantable LVAD recipients for use in advanced heart failure centres. These recommendations have been made with a UK resuscitation focus but are widely applicable to professionals regularly managing patients with implantable LVADs.

Safe implementation of surgical innovation: a prospective registry of the Versius Robotic Surgical System.

Objectives: To describe a new, international, prospective surgical registry developed to accompany the clinical implementation of the Versius Robotic Surgical System by accumulating real-world evidence of its safety and effectiveness. Interventions: This robotic surgical system was introduced in 2019 for its first live-human case. With its introduction, cumulative database enrollment was initiated across several surgical specialties, with systematic data collection via a secure online platform. Main outcome measures: Pre-operative data include diagnosis, planned procedure(s), characteristics (age, sex, body mass index and disease status) and surgical history. Peri-operative data include operative time, intra-operative blood loss and use of blood transfusion products, intra-operative complications, conversion to an alternative technique, return to the operating room prior to discharge and length of hospital stay. Complications and mortality within 90 days of surgery are also recorded. Results: The data collected in the registry are analyzed as comparative performance metrics, by meta-analyses or by individual surgeon performance using control method analysis. Continual monitoring of key performance indicators, using various types of analyses and outputs within the registry, have provided meaningful insights that help institutions, teams and individual surgeons to perform most effectively and ensure optimal patient safety. Conclusions: Harnessing the power of large-scale, real-world registry data for routine surveillance of device performance in live-human surgery from first use will enhance the safety and efficacy outcomes of innovative surgical techniques. Data are crucial to driving the evolution of robot-assisted minimal access surgery while minimizing risk to patients. Trial registration number: CTRI/2019/02/017872.

Video atlas of each uniportal robotic-assisted thoracic surgery lobectomy and lymphadenectomy.

It is important when evaluating new techniques that a surgeon can see and assess all the differences and similarities between their usual technique and the novel technique. Thus, we have collated a comprehensive atlas of videos of uniportal robotic lobectomies for every lobe. Surgeons who are considering embarking on a program of uniportal robotic lobectomies can accordingly see the different views and techniques that will be required for when they perform their first procedure. We have fully narrated the videos, so that you will be taken through each procedure. Whilst these five videos are fifty-five minutes in total, our intention is not necessarily for you to watch them all from start to finish, but rather, come to this video, select the lobe that you will shortly embark on, and watch it prior to your case so that you can visualise, as closely as possible, the procedure that you will be performing. We recommend that you watch the videos with your bedside assistant as the uniportal robotic lobectomy is a joint procedure between two surgeons, rather than a single surgeon's operation with an assistant. Though we have not provided videos on segmentectomies, the uniportal robotic lobectomy is an advanced technique and we are confident that advanced surgeons will be able to gain key insights with what has been included, even if they are proceeding to a segmentectomy for their first cases. We feel for an advanced surgeon, a segmentectomy will be just as suitable an operation as a lobectomy in the initial learning phase.

The transition to uniportal robotic surgery in the second decade of uniportal surgery.

Uniportal robotic surgery was created by Dr. Diego Gonzalez-Rivas as a fusion of his decade of experience with uniportal video-assisted thoracoscopic surgery (VATS) and his recent experience with the Intuitive Robotic System. It represents, in his view, the natural evolution of the uniportal technique in the era of robotic surgery. In this article, we discuss some of the novel issues that this raises, including capacitive coupling, and we describe the technique in detail to help surgeons who may be interested in starting uniportal robotic surgery. We go through case selection, which should start with wedge resections and lymphadenectomy. We look at port placement, which is more posterior and lower than the usual uniportal VATS approach, and we discuss the optimal instruments and ports for the technique. We discuss the role of the assistant in uniportal robotic surgery, which is a key part of the operation as we regard this as a two-surgeon technique. We then discuss the future and other possible robotic platforms that might be suitable for uniportal robotic surgery. It is an exciting new development for robotic surgery, and we recommend that this technique is suitable for advanced surgeons who are experienced in uniportal VATS lobectomy and in multiportal robotic surgery.

Uniportal fully robotic-assisted major pulmonary resections.

Robotic-assisted thoracoscopic surgery (RATS) has proven advantages over that of conventional thoracic surgery, primarily by offering a three-dimensional view and excellent maneuverability, and by providing great ergonomic comfort to the surgeon. The instrumentation specifically offers seven degrees of freedom, allowing for safe, yet complex dissections and radical lymphadenectomies. However, the robotic platform was initially designed with four robotic arms in mind, and therefore four to five incisions were needed for most thoracic approaches. The uniportal video-assisted thoracoscopic surgery (UVATS) approach, the philosophical predecessor to the uniportal robotic-assisted thoracoscopic surgery (URATS) approach, evolved very quickly with the help of the latest technologies during the last decade. Since the first cases of UVATS in 2010, we have improved upon the technique, such that we are now able to do increasingly more complex cases. This is due to the acquired experience, specifically designed instruments, better high-definition cameras and more angulated staplers. In our efforts to improve and adapt robotic surgery to the uniportal approach, we utilized the initial available platforms (Davinci Si and X) to test the feasibility of this approach, in terms of safety and possibilities. The latest platform, the Da Vinci Xi, due to the configuration of its arms, did indeed allow for us to reduce the number of incisions to two initially and finally to one. We hence decided to fully adapt the Da Vinci Xi® to allow for the URATS approach routinely, and performed the first fully robotic anatomic resections in the world in September 2021, in Coruña, Spain. We define pure or fully robotic URATS as robotic thoracic surgery performed by a single intercostal incision, without rib spreading, using the robotic camera, robotic dissecting instruments and robotic staplers.

Comparison of uniportal robotic-assisted thoracic surgery pulmonary anatomic resections with multiport robotic-assisted thoracic surgery: a multicenter study of the European experience.

Background: Robotic-assisted thoracic surgery (RATS) has seen increasing interest in the last few years, with most procedures primarily being performed in the conventional multiport manner. Our team has developed a new approach that has the potential to convert surgeons from uniportal video-assisted thoracic surgery (VATS) or open surgery to robotic-assisted surgery, uniportal-RATS (U-RATS). We aimed to evaluate the outcomes of one single incision, uniportal robotic-assisted thoracic surgery (U-RATS) against standard multiport RATS (M-RATS) with regards to safety, feasibility, surgical technique, immediate oncological result, postoperative recovery, and 30-day follow-up morbidity and mortality. Methods: We performed a large retrospective multi-institutional review of our prospectively curated database, including 101 consecutive U-RATS procedures performed from September 2021 to October 2022, in the European centers that our main surgeon operates in. We compared these cases to 101 consecutive M-RATS cases done by our colleagues in Barcelona between 2019 to 2022. Results: Both patient groups were similar with respect to demographics, smoking status and tumor size, but were significantly younger in the U-RATS group [M-RATS =69 (range, 39-81) years; U-RATS =63 years (range, 19-82) years; P<0.0001]. Most patients in both operative groups underwent resection of a primary non-small cell lung cancer (NSCLC) [M-RATS 96/101 (95%); U-RATS =60/101 (59%); P<0.0001]. The main type of anatomic resection was lobectomy for the multiport group, and segmentectomy for the U-RATS group. In the M-RATS group, only one anatomical segmentectomy was performed, while the U-RATS group had twenty-four (24%) segmentectomies (P=0.0006). All M-RATS and U-RATS surgical specimens had negative resection margins (R0) and contained an equivalent median number of lymph nodes available for pathologic analysis [M-RATS =11 (range, 5-54); U-RATS =15 (range, 0-41); P=0.87]. Conversion rate to thoracotomy was zero in the U-RATS group and low in M-RATS [M-RATS =2/101 (2%); U-RATS =0/101; P=0.19]. Median operative time was also statistically different [M-RATS =150 (range, 60-300) minutes; U-RATS =136 (range, 30-308) minutes; P=0.0001]. Median length of stay was significantly lower in U-RATS group at four days [M-RATS =5 (range, 2-31) days; U-RATS =4 (range, 1-18) days; P<0.0001]. Rate of complications and 30-day mortality was low in both groups. Conclusions: U-RATS is feasible and safe for anatomic lung resections and comparable to the multiport conventional approach regarding surgical outcomes. Given the similarity of the technique to uniportal VATS, it presents the potential to convert minimally invasive thoracic surgeons to a robotic-assisted approach.

Comparing CATCH, CHALICE and PECARN clinical decision rules for paediatric head injuries.

Many children present to emergency departments following head injury (HI), with a small number at risk of avoidable poor outcome. Difficulty identifying such children, coupled with increased availability of cranial CT, has led to variation in practice and increased CT rates. Clinical decision rules (CDRs) have been derived for paediatric HI but there is no published comparison to assist in deciding which to implement. The content of the three of highest quality and accuracy are described and compared. Systematic reviews of paediatric HI CDRs were published in 2009 and 2011. To identify CDRs published since the most recent review, key databases were searched, selecting studies which included CDRs involving children aged 0-18 years with a history of HI. Quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies Tool, and performance evaluated by reported accuracy. Three high quality CDRs were identified: CATCH (Canadian Assessment of Tomography for Childhood Head Injury) CHALICE (Children's Head Injury Algorithm for the Prediction of Important Clinical Events) and PECARN (Paediatric Emergency Care Applied Research Network). All were derived with high methodological standards but differed in key areas, including study population, outcomes and severity of HI. Each stated different predictor variables and only PECARN provided a separate algorithm for young children. CATCH and CHALICE identify children requiring CT and PECARN those who do not. All perform with high sensitivity and low specificity. PECARN is the only validated CDR, and none has undergone impact analysis. These three CDRs should undergo validation and comparison in a single population, with analysis of their impact on practice and financial implications, to aid relevant bodies in deciding which to implement.

Preclinical evaluation of Versius, an innovative device for use in robot-assisted thoracic surgery.

OBJECTIVES: The adoption of robot-assisted thoracic surgery (RATS) has helped to overcome some of the challenges associated with surgeons performing conventional video-assisted thoracic surgery. The Versius Surgical System (CMR Surgical, Cambridge, UK) has been developed iteratively in line with surgical team feedback to improve the surgeon's experience and patient outcomes. The goal of this study was to assess the use of the device in RATS in a preclinical setting and to fulfil Idea, Development, Exploration, Assessment, Long-Term Follow Up-Devices stage 1 (Idea). METHODS: Four cadaveric sessions were conducted between November 2018 and December 2020, during which device performance in a range of thoracic operations was assessed. Procedures were categorized as either completed or not completed, and surgeons evaluated the device's ability to successfully complete necessary surgical steps. Port and bedside unit positions were recorded. RESULTS: In total, 22/24 (91.7%) thoracic procedures were successfully completed, including 17/18 lobectomies, 2/3 thymectomies and 3/3 diaphragm plications, in 9 cadaver specimens. One thymectomy could not be completed due to cadaver anatomy and 1 lobectomy was not completed due a console system fault. Port and bedside unit configurations were successfully validated for all procedures, and lead surgeons deemed the device to be well-suited for thoracic surgery. CONCLUSIONS: This preclinical study demonstrated the successful use of the device in RATS in cadaveric models and supports progression to small-scale clinical studies, as part of Idea, Development, Exploration, Assessment, Long-Term Follow Up-Devices stage 2a (Development).

Joint British Societies' guideline on management of cardiac arrest in the cardiac catheter laboratory.

More than 300 000 procedures are performed in cardiac catheter laboratories in the UK each year. The variety and complexity of percutaneous cardiovascular procedures have both increased substantially since the early days of invasive cardiology, when it was largely focused on elective coronary angiography and single chamber (right ventricular) permanent pacemaker implantation. Modern-day invasive cardiology encompasses primary percutaneous coronary intervention, cardiac resynchronisation therapy, complex arrhythmia ablation and structural heart interventions. These procedures all carry the risk of cardiac arrest.We have developed evidence-based guidelines for the management of cardiac arrest in adult patients in the catheter laboratory. The guidelines include recommendations which were developed by collaboration between nine professional and patient societies that are involved in promoting high-quality care for patients with cardiovascular conditions. We present a set of protocols which use the skills of the whole catheter laboratory team and which are aimed at achieving the best possible outcomes for patients who suffer a cardiac arrest in this setting. We identified six roles and developed a treatment algorithm which should be adopted during cardiac arrest in the catheter laboratory. We recommend that all catheter laboratory staff undergo regular training for these emergency situations which they will inevitably face.