Prospective development study of the Versius Surgical System for use in transoral robotic surgery: an IDEAL stage 1/2a first in human and initial case series experience.

PURPOSE: Transoral robotic surgery is well established in the treatment paradigm of oropharyngeal pathology. The Versius Surgical System (CMR Surgical) is a robotic platform in clinical use in multiple specialities but is currently untested in the head and neck. This study utilises the IDEAL framework of surgical innovation to prospectively evaluate and report a first in human clinical experience and single centre case series of transoral robotic surgery (TORS) with Versius. METHODS: Following IDEAL framework stages 1 and 2a, the study evaluated Versius to perform first in human TORS before transitioning from benign to malignant cases. Iterative adjustments were made to system setup, instrumentation, and technique, recorded in accordance with IDEAL recommendations. Evaluation criteria included successful procedure completion, setup time, operative time, complications, and subjective impressions. Further evaluation of the system to perform four-arm surgery was conducted. RESULTS: 30 TORS procedures were successfully completed (15 benign, 15 malignant) without intraoperative complication or conversion to open surgery. Setup time significantly decreased over the study period. Instrumentation challenges were identified, urging the need for TORS-specific instruments. The study introduced four-arm surgery, showcasing Versius' unique capabilities, although limitations in distal access were observed. CONCLUSIONS: TORS is feasible with the Versius Surgical System. The development of TORS-specific instruments would benefit performance and wider adoption of the system. 4-arm surgery is possible however further evaluation is required. Multicentre evaluation (IDEAL stage 2b) is recommended.

New robotic platform for transoral robotic surgery: an IDEAL stage 0 study.

Objectives: This study aims to assess the feasibility to perform transoral robotic surgery (TORS) with a new robotic platform, the Versius Surgical System (CMR Surgical, UK) in a preclinical cadaveric setting in accordance to stage 0 of the IDEAL-D framework. Design: IDEAL stage 0 preclinical assessment of the Versius Robotic System in TORS in human cadavers. Setting: All procedures were performed in a simulated operating theatre environment at a UK surgical training centre. Participants: 11 consultant head and neck surgeons from the UK, mainland Europe and the USA took part in TORS procedures on six human cadavers. Interventions: 3 key index procedures were assessed that represent the core surgical workload of TORS: lateral oropharyngectomy, tongue base resection and partial supraglottic laryngectomy. Main outcome measures: The primary outcome was the successful completion of each surgical procedure. Secondary outcomes included the optimisation of system setup, instrumentation and surgeon-reported outcomes for feasibility of each component procedural step. Results: 33 cadaveric procedures were performed and 32 were successfully completed. One supraglottic laryngectomy was not fully completed due to issues dividing the epiglottic cartilage with available instrumentation. Surgeon-reported outcomes met the minimal level of feasibility in all procedures and a consensus that it is feasible to perform TORS with Versius was reached. Available instrumentation was not representative of other robotic platforms used in TORS and further instrument optimisation is recommended before wider dissemination. Conclusions: It is feasible to perform TORS with the Versius Surgical System (CMR Surgical) within a pre-clinical cadaveric setting. Clinical evaluation is needed and appropriate with the system. Further instrument development and optimisation is desirable.

Robotic assisted orbital surgery for resection of advanced periocular tumours - a case series report on the feasibility, safety and outcome.

PURPOSE: Orbital surgery benefits from well-designed instrumentation that offers gentle tissue manipulation, high manoeuvrability and control. Nevertheless, in confined spaces, tissue manipulation must be accomplished with exceptionally high accuracy and precision. This is where robotic surgery offers an advantage. We aimed to evaluate a robotic-assisted surgical system's feasibility, safety and outcome in assisting tumour clearance. PATIENTS AND METHODS: A case series of patients with advanced periocular tumours undergoing robotic-assisted globe-sparing resection was performed using the DaVinci XI system (Intuitive Surgical, Inc). Institutional ethics and multidisciplinary approval were sought in all cases. RESULTS: Four patients with advanced periocular tumours underwent robotic-assisted orbital surgery at a mean age of 63 years (range 42-86). Two patients were diagnosed with squamous cell carcinoma, and two had basal cell carcinoma. One patient was found to have positive lymph nodes at the time of surgery and underwent simultaneous parotidectomy and lymph node clearance. Clear resection of the primary tumour was achieved in all patients; three patients underwent further resection due to narrow margins prior to reconstruction. Patients were follow-up for at least one year, and three remained disease-free. One patient with pre-existing extra-orbital disease developed metastatic disease four months post-op. All patients preserved vision peri-operatively, with no complaints of diplopia. Moderate ocular surface disease was noted in two patients. CONCLUSION: Our series highlights the potential advantage of three-dimensional optics, multi-directional instrumentation and motion scaling technology to achieve globe-sparing tumour resection in advanced periocular tumours. However, further robotic instrumentation development is required for orbital surgery.

Soft Tissue Robotic Assisted Orbital Surgery Using da Vinci SP: A Cadaveric Experience.

PURPOSE: Robotic surgical techniques have transformed many surgical specialties however robotic techniques and applications have been much more limited in ophthalmology. This study aims to evaluate the feasibility of robotic assisted orbital surgery using a single-port novel robotic platform, the da Vinci SP. METHODS: A series of orbital procedures were performed in cadaveric specimens utilizing the da Vinci SP robotic system. The procedures performed included lacrimal gland dissection and biopsy, medial and lateral orbital wall dissections, enucleation, and lid-sparing orbital exenteration. Successful completion of each procedure was defined by the operating surgeon and was considered the primary outcome and marker of feasibility. RESULTS: Seven cadaveric procedures were performed in 3 cadaveric specimens. All 7 procedures were completed successfully without complication. Setup optimization occurred throughout the study and setup and operative times were acceptable. Three instrument arms and 1 endoscope were utilized throughout the study allowing 3 arm operating and dynamic retraction. Instrument size was found to limit surgical access and precision particular at the orbital apex. CONCLUSIONS: This preclinical study demonstrates that the da Vinci SP can be utilized within the orbit and is feasible for several applications. Robotic surgical systems offer significant advantages over conventional techniques and should be embraced. However, current commercially available robotic platforms are not optimized for the orbit and have their limitations although they may be suitable for some clinical applications.

Health risk factors in Australian Stroke Survivors: A latent class analysis.

ISSUES ADDRESSED: To (i) determine the prevalence of health risk factors (physical activity, diet, alcohol, smoking, blood pressure medication use and mental health) in community-dwelling stroke survivors; and (ii) examine how these health risk factors cluster, and identify associations with physical functioning, independent living, or sociodemographic factors. METHODS: A secondary analysis of data obtained during a national randomised controlled trial. Participants had experienced stroke and completed a baseline telephone survey on demographic and stroke characteristics, health risk factors, physical functioning and independence in activities of daily living. A latent class analysis was performed to determine health risk profiles. Univariate logistic regressions were performed to identify if participant characteristics were associated with resulting classes. RESULTS: Data analysed from 399 participants. Two classes of health risk factors were identified: Low Mood, Food & Moves Risk (16% of participants) and Alcohol Use Risk (84% of participants). The Low Mood, Food & Moves Risk group had poorer diet quality, lower physical activity levels and higher levels of depression and anxiety. Lower levels of independence and physical functioning were predictor variables for this group. In contrast, the Alcohol Use Risk group had better physical activity and diet scores, significantly lower probability of depression and anxiety, but a higher probability of risky drinking. CONCLUSIONS: We identified two distinct health risk factor groups in our population. SO WHAT?: Future interventions may benefit from targeting the specific needs and requirements of people who have experienced stroke based on their distinct risk group. Alcohol consumption in poststroke populations requires further attention.

Neck Dissection Timing in Transoral Robotic or Laser Microsurgery in Oropharyngeal Cancer: A Systematic Review.

Objective: This review assesses the effect on intra- and postoperative patient outcomes of the timing of neck dissection in relation to transoral surgery. Outcome measures include postoperative bleeding, intra- and postoperative fistula formation, and disease-specific and overall survival. Data Sources: A search was conducted across the MEDLINE, Embase, US National Library of Medicine, and Cochrane databases with search terms in July 2021. Review Methods: Articles that conformed with specified inclusion criteria were included. Included articles were scanned for bias with the ROBINS-I tool. Results: Nineteen articles were selected for qualitative analysis, including 546 patients who had neck dissection in conjunction with transoral robotic surgery/transoral laser microsurgery (TORS/TLM). Seventy-one (18%) patients had neck dissection prior to TORS/TLM, 39 (10%) had neck dissection performed after TORS/TLM, and 281 (72%) had concurrent procedures. In patients with neck dissection before TORS/TLM, 3% experienced major postoperative bleeding, and fistula rates were 0%. In the cohort with neck dissection after TORS/TLM, 3% experienced minor postoperative hemorrhage, and 8% had intraoperative fistulae. In the concurrent cohort of patients, 1% had major postoperative bleeds and 0.3% had minor bleeds, while 4% developed intraoperative fistulas and 0.3% developed postoperative fistulas. Conclusion: Current evidence indicated that there appears to be no correlation between timing of neck dissection and complications. This systematic review found insufficient data to comment on whether the timing of neck dissection in relation to TORS/TLM affects the outcomes of patients.

Clustering of chronic disease risks among people accessing community mental health services.

This study identified clusters of chronic disease risks and explored associations between clusters and demographic characteristics and mental health conditions, among people accessing community mental health services. Data from a cross-sectional telephone survey of Australian mental health consumers (n = 567) were analysed. Clusters were identified based on tobacco smoking (53.5%), harmful chronic alcohol consumption (20.1%), harmful acute alcohol consumption (43.5%), inadequate fruit and vegetable intake (66.0%), inadequate physical activity (75.5%), inadequate strength activity (81.8%), and high body mass index (BMI) (67.9%), using latent class analysis. Multinomial logistic regression examined associations between cluster membership and participant characteristics. Three groups were identified: Cluster 1 (19.05%) had < 0.5 probabilities for most risks; Cluster 2 (34.04%) had high probabilities of all risks, particularly tobacco smoking and both types of harmful alcohol consumption; and Cluster 3 (46.91%) had high probabilities of both inadequate physical and strength activity, inadequate fruit and vegetable intake, and high BMI. Compared to Cluster 1 membership, participants with higher education were less likely to be in either Cluster 2 or 3, females or those over 55 were more likely to be in Cluster 3, those with a substance use disorder were more likely to be in Cluster 2, and those with a personality disorder were less likely to be in Cluster 3. The clustering patterns reinforce the importance of addressing multiple chronic disease risks for people with a mental health condition. Preventive care interventions targeting clusters of risks may help reduce the burden of chronic disease among this high-risk population.

Generation of cardio-protective antibodies after pneumococcal polysaccharide vaccine: Early results from a randomised controlled trial.

BACKGROUND AND AIMS: Observational studies have demonstrated that the pneumococcal polysaccharide vaccine (PPV) is associated with reduced risk of cardiovascular events. This may be mediated through IgM antibodies to OxLDL, which have previously been associated with cardioprotective effects. The Australian Study for the Prevention through Immunisation of Cardiovascular Events (AUSPICE) is a double-blind, randomised controlled trial (RCT) of PPV in preventing ischaemic events. Participants received PPV or placebo once at baseline and are being followed-up for incident fatal and non-fatal myocardial infarction or stroke over 6 years. METHODS: A subgroup of participants at one centre (Canberra; n = 1,001) were evaluated at 1 month and 2 years post immunisation for changes in surrogate markers of atherosclerosis, as pre-specified secondary outcomes: high-sensitive C-reactive protein (CRP), pulse wave velocity (PWV), and carotid intima-media thickness (CIMT). In addition, 100 participants were randomly selected in each of the intervention and control groups for measurement of anti-pneumococcal antibodies (IgG, IgG2, IgM) as well as anti-OxLDL antibodies (IgG and IgM to CuOxLDL, MDA-LDL, and PC-KLH). RESULTS: Concentrations of anti-pneumococcal IgG and IgG2 increased and remained high at 2 years in the PPV group compared to the placebo group, while IgM increased and then declined, but remained detectable, at 2 years. There were statistically significant increases in all anti-OxLDL IgM antibodies at 1 month, which were no longer detectable at 2 years; there was no increase in anti-OxLDL IgG antibodies. There were no significant changes in CRP, PWV or CIMT between the treatment groups at the 2-year follow-up. CONCLUSIONS: PPV engenders a long-lasting increase in anti-pneumococcal IgG, and to a lesser extent, IgM titres, as well as a transient increase in anti-OxLDL IgM antibodies. However, there were no detectable changes in surrogate markers of atherosclerosis at the 2-year follow-up. Long-term, prospective follow-up of clinical outcomes is continuing to assess if PPV reduces CVD events.

Sputum mast cell/basophil gene expression relates to inflammatory and clinical features of severe asthma.

BACKGROUND: Mast cells (MCs) and basophils are important in asthma pathophysiology, however direct measurement is difficult, and clinical and inflammatory associations in severe asthma are poorly understood. Transcriptomic hallmarks of MCs/basophils may allow their measurement in sputum using gene expression. OBJECTIVES: This study sought to develop and validate a sputum MC/basophil gene signature and investigate its relationship to inflammatory and clinical characteristics of severe asthma. METHODS: A total of 134 candidate MC/basophil genes (identified by the Immunological Genome Project Consortium) were screened in sputum microarray for differential expression among control subjects (n = 18), patients with eosinophilic (n = 29), and patients with noneosinophilic asthma (n = 30). Candidate genes were validated by confirming correlation of gene expression with flow cytometry-quantified sputum MCs and basophils in a separate asthma cohort (n = 20). The validated gene signature was measured in a severe asthma cohort (n = 81), and inflammatory and clinical associations were tested. RESULTS: Through microarray screening and subsequent validation, we found quantitative PCR gene expression of 8 targets correlated with sputum MCs/basophils: TPSAB1/TPSB2, CPA3, ENO2, GATA2, KIT, GPR56, HDC, SOCS2. In severe asthma, MC/basophil genes were associated with eosinophilic airway inflammation (GATA2, TPSB2, CPA3, GPR56, HDC, SOCS2), blood eosinophils (TPSB2, CPA3, GATA2, SOCS2, FCER1A, HDC), fractional exhaled NO (GATA2, SOCS2), decreased lung function (KIT, ENO2), and moderate exacerbation history (GATA2, SOCS2). CONCLUSIONS: Quantitative PCR-based measures reflect varying sputum MC/basophil abundance, demonstrating associations of MCs/basophils with eosinophilic inflammation, spirometry and exacerbation history in severe asthma.

A rare case report of an ilio-psoas abscess due to entero-retroperitoneal fistula from gallstones post cholecystectomy.

INTRODUCTION AND IMPORTANCE: This is a novel case of a 50-year-old female presenting with several months of left iliac fossa pain, on a background of a cholecystectomy 5 years prior. The aetiology of her pain was an ilio-psoas abscess secondary to an entero-retroperitoneal gallstone fistula, a condition not previously reported in the literature. CASE PRESENTATION: CT imaging revealed an abscess superior to the left psoas muscle, with a clear fistula to the small bowel and two calcified stones at the site of the fistula. The patient was managed operatively, with the fistula disconnected and a 5 cm section of small bowel disconnected. CLINICAL DISCUSSION: This is a novel case whereby a left sided iliopsoas abscess occurred due to entero-retroperitoneal fistulation of gallstones several years after the patient underwent laparoscopic cholecystectomy. Gallstone fistulation from within the small bowel does not appear to have previously been documented and the exact pathogenesis is unknown. CONCLUSION: Gallstones should remain an important, albeit rare, differential diagnosis of small bowel fistulation and abscess formation following cholecystectomy.

Coblation® intracapsular tonsillectomy in children with recurrent tonsillitis: Initial experience.

OBJECTIVES: The use of Coblation® intracapsular tonsillectomy for the treatment of sleep disordered breathing (SDB)/obstructive sleep apnoea (OSA) has an increasing evidence base. However, the results for tonsillitis as the predominant indication for surgery are not as clear. We present our initial results from 80 paediatric cases undergoing Coblation® intracapsular tonsillectomy for infective indications. METHODS: Prospective case series within the secondary care environment, January 2016-July 2018, all with completed follow-up. We utilised the validated T14 tonsil symptom questionnaire pre- and postoperatively and also collected data regarding postoperative complications. RESULTS: 80 consecutive patients (age range 2-16 years and mean 7.2 years) undergoing Coblation® intracapsular tonsillectomy (with or without adenoidectomy) predominantly for infective reasons although some also had concomitant adenoidectomy for snoring/sleep disordered breathing were included. Mean follow-up was at 13 months postoperatively. 38 children had tonsillitis (with or without snoring) and 42 children had SDB in combination with tonsillitis. The mean over-all total T14 score was 32.7 preoperatively and 2.7 postoperatively (p < 0.0001). The mean infective score was 22.1 preoperatively and 1.5 postoperatively (p < 0.0001). The mean SDB score was 10.6 preoperatively and 1.5 postoperatively (p < 0.0001). There were no cases of haemorrhage, re-admission or regrowth noted. CONCLUSION: Coblation® intracapsular tonsillectomy is a safe and effective technique for treating children with recurrent tonsillitis. Future studies should incorporate longer term follow-up.

Multiple concurrent atypical parathyroid adenomas: a rare occurrence.

We present a case of an 80-year-old patient with three concurrent multiple atypical parathyroid adenomas. The patient was managed with bilateral parathyroid exploration and concurrent parathyroidectomy. Postoperative recovery was uneventful. Atypical parathyroid adenomas are a rare entity that are clinically difficult to distinguish from parathyroid carcinoma. Histological characteristics are similar however atypical adenomas lack complete capsular or vascular invasion and cannot be considered malignant. All reported cases of atypical parathyroid adenoma are solitary lesions. We present the first case of multiple concurrent atypical parathyroid adenomas.

A UK reported case of Graves' disease with thyroid hemiagenesis.

We present a rare case of a 31-year-old patient with Graves' disease with agenesis of the left thyroid lobe. The patient was managed with a right hemithyroidectomy and isthmusectomy as definitively treatment of Graves' disease. The patient had an uneventful postoperative outcome and the histology was benign and consistent with Graves' disease. This is a rare case in the literature of Graves' disease with unilateral thyroid agenesis, and to our knowledge is the first reported case from the UK.

Treatment of dysplastic Barrett's Oesophagus in lower volume centres after structured training.

AIM: To investigate whether dysplastic Barrett's Oesophagus can be safely and effectively treated endoscopically in low volume centres after structured training. METHODS: After attending a structured training program in Amsterdam on the endoscopic treatment of dysplastic Barrett's Oesophagus, treatment of these patients was initiated at St Marys Hospital. This is a retrospective case series conducted at a United Kingdom teaching Hospital, of patients referred for endoscopic treatment of Barrett's oesophagus with high grade dysplasia or early cancer, who were diagnosed between January 2008 and February 2012. Data was collected on treatment provided (radiofrequency ablation and endoscopic resection), and success of treatment both at the end of treatment and at follow up. Rates of immediate and long term complications were assessed. RESULTS: Thirty-two patients were referred to St Marys with high grade dysplasia or intramucosal cancer within a segment of Barrett's Oesophagus. Twenty-seven met the study inclusion criteria, 16 of these had a visible nodule at initial endoscopy. Treatment was given over a median of 5 mo, and patients received a median of 3 treatment sessions over this time. At the end of treatment dysplasia was successfully eradicated in 96% and intestinal metaplasia in 88%, on per protocol analysis. Patients were followed up for a median of 18 mo. At which time complete eradication of dysplasia was maintained in 86%. Complications were rare: 2 patients suffered from post-procedural bleeding, 4 cases were complicated by oesophageal stenosis. Recurrence of cancer was seen in 1 case. CONCLUSION: With structured training good outcomes can be achieved in low volume centres treating dysplastic Barrett's Oesophagus.