Objective: To assess the feasibility of collecting, examining and reporting observational, real-world evidence regarding the novel use of the GORE EXCLUDER Iliac Branch Endoprosthesis (IBE) in conjunction with the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (IBE+VBX stent graft).
Design: Multicentre retrospective cohort study.
Setting: Four real-world data sources were used: a national quality improvement registry, a statewide clinical research network, a regional quaternary health system and two tertiary academic medical centres.
Participants: In total, 30 patients with 37 IBE+VBX stent graft were identified. Of those, the mean age was 72±10.2 years and 90% were male. The cohort was 77% white, 10% black, 3% Hispanic and 10% other.
Main outcome measures: Outcome measures included: proportion of percutaneous vs open surgical access, intensive care admission, intensive care unit (ICU) length-of-stay (LOS), total LOS, postoperative complications, discharge disposition and 30-day mortality.
Results: The majority (89%) of cases were performed percutaneously, 5% required surgical exposure following failed percutaneous access and 6% required open surgical exposure outright. Nearly half (43%) required intensive care admission with a median ICU LOS of 1 day (range: 1-2). Median total LOS was 1 day (IQR: 1-2). There were zero postoperative myocardial infarctions, zero reported leg embolisations and no reported reinterventions. Access site complications were described in 1 of 28 patients, manifesting as a haematoma or pseudoaneurysm. Ultimately, 97% were discharged to home and one patient was discharged to a nursing home or rehabilitation facility. There were no 30-day perioperative deaths.
Conclusions: This project demonstrates the feasibility of identifying and integrating real-world evidence, as it pertains to an unapproved combination of endovascular devices (IBE+VBX stent graft), for short-term outcomes analysis. This new paradigm of evidence has potential to be used for device monitoring, submission to regulatory agencies, or consideration in indication expansions and approvals with further efforts to systematise data collection and transmission mechanisms.
Objectives: To 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.
Design: Retrospective cohort.
Setting: Three health systems in the USA.
Participants: Patients receiving ablation with the two ablation catheters of interest at any of the three health systems.
Main outcome measures: Feasibility 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.
Results: Overall, 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.
Conclusions: It 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.
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.
Objective: To 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 measures: A 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.
Results: The 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.
Conclusion: Our 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 number: NCT02434575.
Objectives: Intraoperative fluorescence imaging is currently used in a variety of surgical fields for four main purposes: assessing tissue perfusion; identifying/localizing cancer; mapping lymphatic systems; and visualizing anatomy. To establish evidence-based guidance for research and practice, understanding the state of research on fluorescence imaging in different surgical fields is needed. We evaluated the evidence on fluorescence imaging for perfusion assessments using the Idea, Development, Exploration, Assessment, Long Term Study (IDEAL) framework, which was designed for describing the stages of innovation in surgery and other interventional procedures.
Design: Narrative literature review with analysis of IDEAL stage of each field of study.
Setting: All publications on intraoperative fluorescence imaging for perfusion assessments reported in PubMed through 2019 were identified for six surgical procedures: coronary artery bypass grafting (CABG), upper gastrointestinal (GI) surgery, colorectal surgery, solid organ transplantation, reconstructive surgery, and cerebral aneurysm surgery.
Main outcome measures: The IDEAL stage of research evidence was determined for each specialty field using a previously described approach.
Results: 196 articles (15 003 cases) were selected for analysis. Current status of research evidence was determined to be IDEAL Stage 2a for upper GI and transplantation surgery, IDEAL 2b for CABG, colorectal and cerebral aneurysm surgery, and IDEAL Stage 3 for reconstructive surgery. Using the technique resulted in a high (up to 50%) rate of revisions among surgical procedures, but its efficacy improving postoperative outcomes has not yet been demonstrated by randomized controlled trials in any discipline. Only one possible adverse reaction to intravenous indocyanine green was reported.
Conclusions: Using fluorescence imaging intraoperatively to assess perfusion is feasible and appears useful for surgical decision making across a range of disciplines. Identifying the IDEAL stage of current research knowledge aids in planning further studies to establish the potential for patient benefit.
Objectives: The 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.
Design: A 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).
Setting: Dry box exercises were conducted in classrooms, and wet lab sessions simulated an operating room environment using cadaveric specimens.
Participants: Seventeen 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 measures: Participants 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.
Results: Participants 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.
Conclusions: The 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.
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：