Feasibility of using real-world data in the evaluation of cardiac ablation catheters: a test-case of the National Evaluation System for Health Technology Coordinating Center

ObjectivesTo determine the feasibility of using real-world data to assess the safety and effectiveness of two cardiac ablation catheters for the treatment of persistent atrial fibrillation and ischaemic ventricular tachycardia.DesignRetrospective cohort.SettingThree health systems in the USA.ParticipantsPatients receiving ablation with the two ablation catheters of interest at any of the three health systems.Main outcome measuresFeasibility of identifying the medical devices and participant populations of interest as well as the duration of follow-up and positive predictive values (PPVs) for serious safety (ischaemic stroke, acute heart failure and cardiac tamponade) and effectiveness (arrhythmia-related hospitalisation) clinical outcomes of interest compared with manual chart validation by clinicians.ResultsOverall, the catheter of interest for treatment of persistent atrial fibrillation was used for 4280 ablations and the catheter of interest for ischaemic ventricular tachycardia was used 1516 times across the data available within the three health systems. The duration of patient follow-up in the three health systems ranged from 91% to 97% at ≥7 days, 89% to 96% at ≥30 days, 77% to 90% at ≥6 months and 66% to 84% at ≥1 year. PPVs were 63.4% for ischaemic stroke, 96.4% for acute heart failure, 100% at one health system for cardiac tamponade and 55.7% for arrhythmia-related hospitalisation.ConclusionsIt is feasible to use real-world health system data to evaluate the safety and effectiveness of cardiac ablation catheters, though evaluations must consider the implications of variation in follow-up and endpoint ascertainment among health systems.

Surgery versus non-operative treatment for ER-stress unstable Weber-B unimalleolar fractures: a study protocol for a prospective randomized non-inferiority (Super-Fin) trial

Roughly two-thirds of ankle fractures are unimalleolar injuries, the Weber B-type fibula fracture being by far the most common type. Depending on the trauma and the accompanying soft-tissue injury, these fractures are either stable or unstable. Current clinical practice guidelines recommend surgical treatment for unstable Weber B-type fibula fractures. An ongoing randomized, parallel group, non-inferiority trial comparing surgery and non-operative treatment for unstable Weber B-type ankle fractures with allocation ratio 1:1. The rationale for non-inferiority design is as follows: By being able to prove non-inferiority of non-operative treatment, we would be able to avoid complications related to surgery. However, the primary concern related to non-operative treatment is increased risks of ankle mortise incongruency, leading to secondary surgery, early post-traumatic osteoarthritis and poor function. After providing informed consent, 126 patients aged 16 years or older with an unimalleolar Weber B-type unstable fibula fracture were randomly assigned to surgery (open reduction and internal fixation) or non-operative treatment (6-week cast immobilization). We have completed the patient enrolment and are currently in the final stages of the 2-year follow-up. The primary, non-inferiority outcome is the Olerud-Molander Ankle Score (OMAS) at 2 years (primary time point). The predefined non-inferiority margin is set at 8 OMAS points. Secondary outcomes include the Foot and Ankle Score, a 100 mm Visual Analogue Scale for function and pain, the RAND-36-Item Health Survey for health-related quality-of-life, the range-of-motion of the injured ankle, malunion (ankle joint incongruity) and fracture union. Treatment-related complications and harms; symptomatic non-unions, loss of congruity of the ankle joint, reoperations and wound infections will also be recorded. We hypothesize that non-operative treatment yields non-inferior functional outcome to surgery, the current standard treatment, with no increased risk of harms.

1-year cost-utility analysis of prostate artery embolization (PAE) versus transurethral resection of the prostate (TURP) in benign prostatic hyperplasia (BPH)

ObjectiveTo determine whether prostate artery embolization (PAE) is a cost-effective alternative to transurethral resection of the prostate (TURP) in the management of benign prostate hyperplasia (BPH) after 1-year follow-up.Design, setting and main outcome measuresA retrospective cost-utility analysis over a 12-month time period was conducted to compare the two interventions from a National Health Service perspective. Effectiveness was measured as quality-adjusted life years (QALYs) derived from data collected during the observational UK Register of Prostate Embolisation (UK-ROPE) Study. Costs for both PAE and TURP were derived from University Hospital Southampton, a tertiary referral centre for BPH and the largest contributor to the UK-ROPE. An incremental cost-effectiveness ratio (ICER) was derived from cost and QALY values associated with both interventions to assess the cost-effectiveness of PAE versus TURP. Further sensitivity analyses involved a decision tree model to account for the impact of patient-reported complications on the cost-effectiveness of the interventions.ResultsThe mean patient age for TURP (n=31) and PAE (n=133) was 69 and 65.6 years, respectively. In comparison to TURP, PAE was cheaper due to shorter patient stays and the lack of necessity for an operating theatre. Analysis revealed an ICER of £64 798.10 saved per QALY lost when comparing PAE to TURP after 1-year follow-up.ConclusionOur findings suggest that PAE is initially a cost-effective alternative to TURP for the management of BPH after 1-year follow-up. Due to a higher reintervention rate in the PAE group, this benefit may be lost in subsequent years.Trial registration numberNCT02434575.

Assessment of the training program for Versius, a new innovative robotic system for use in minimal access surgery

ObjectivesThe Versius surgical system has been developed for use in robot-assisted minimal access surgery (MAS). This study aimed to evaluate the effectiveness of the Versius training program.DesignA 3.5-day program following 10 hours of online didactic training. Participants were assessed during the technical training using the Global Evaluative Assessment of Robotic Skills (GEARS).SettingDry box exercises were conducted in classrooms, and wet lab sessions simulated an operating room environment using cadaveric specimens.ParticipantsSeventeen surgical teams participated; surgeons represented general, colorectal, obstetrics/gynecology, and urology specialties. All surgeons had previous laparoscopic MAS experience, while experience with robotics varied.Main outcomes measuresParticipants were scored on a five-point Likert Scale for each of six validated GEARS domains (depth perception, bimanual dexterity, efficiency, force sensitivity, autonomy, and robotic control). Additional metrics used to chart surgeon performance included: combined instrument path length; combined instrument angular path; and time taken to complete each task.ResultsParticipants demonstrated an overall improvement in performance during the study, with a mean GEARS Score of 21.0 (SD: 1.9) in Assessment 1 increasing to 23.4 (SD: 2.9) in Validation. Greatest improvements were observed in the depth perception and robotic control domains. Greatest differences were observed when stratifying by robotic experience; those with extensive experience consistently scored higher than those with some or no experience.ConclusionsThe Versius training program is effective; participants were able to successfully operate the system by program completion, and more surgeons achieved intermediate-level and expert-level GEARS scores in Validation compared with Assessment 1.

Cohort study of impact on length of stay of individual enhanced recovery after surgery protocol components

ObjectiveThe goal of this study was to explore which enhanced recovery after surgery (ERAS) bundle items were most associated with decreased length of stay after surgery, most likely associated with decreased length of stay after surgery.DesignA cohort study.SettingLarge tertiary academic medical centre.ParticipantsThe study included 1318 women undergoing hysterectomy as part of our ERAS pathway between 1 February 2018 and 30 January 2020 and a matched historical cohort of all hysterectomies performed at our institution between 3 October 2016 and 30 January 2018 (n=1063).InterventionThe addition of ERAS to perioperative care.This is a cohort study of all patients undergoing hysterectomy at an academic medical centre after ERAS implementation on 1 February 2018. Compliance and outcomes after ERAS roll out were monitored and managed by a centralised team. Descriptive statistics, multivariate regression, interrupted time series analysis were used as indicated.Main outcome measuresImpact of ERAS process measure adherence on length of stay.ResultsAfter initiation of ERAS pathway, 1318 women underwent hysterectomy. There were more open surgeries after ERAS implementation, but cohorts were otherwise balanced. The impact of process measure adherence on length of stay varied based on surgical approach (minimally invasive vs open). For open surgery, compliance with intraoperative antiemetics (−30%, 95% CI −18% to 40%) and decreased postoperative fluid administration (−12%, 95% CI −1% to 21%) were significantly associated with reduced length of stay. For minimally invasive surgery, ambulation within 8 hours of surgery was associated with reduced length of stay (−53%, 95% CI −55% to 52%).ConclusionsWhile adherence to overall ERAS protocols decreases length of stay, the specific components of the bundle most significantly impacting this outcome remain elusive. Our data identify early ambulation, use of antiemetics and decreasing postoperative fluid administration to be associated with decreased length of stay.