BMJ Surgery Interventions Health Technologies最新文献

Objectives: Medical device registries in Europe report limited information about their structure and methodological characteristics. This hinders their utility for evaluation of medical device safety and performance under the Medical Device Regulation. This study aimed to define a minimum checklist of items necessary for regulators to assess the quality of evidence produced using registry data for the evaluation of medical device safety and performance.

Design: A three-round Delphi panel.

Setting: A task within the Coordinating Research and Evidence for Medical Devices project.

Participants: 101 experts in the medical device community (healthcare professionals, methodologists, registry experts, regulators, and assessors from notified bodies) were invited.

Interventions: Based on a literature review and expert advice, 27 items relating to the quality of registry data and the analysis of medical device safety and performance were selected. In round 1, participants selected which items were required for a minimum checklist. They could also propose new items. Items selected by ≥70% of participants indicated consensus. Remaining items were discussed in round 2, resulting in a final checklist that was ranked by participants for importance (round 3).

Main outcome measures: Consensus of items to be included in the minimum checklist.

Results: 51 experts participated in round 1, achieving consensus on 18 (67%) items and suggesting 12 items. After discussion in round 2, 5 additional items were selected, resulting in a final set of 15 data quality items and 8 data analysis items. The most important items were 'completeness of procedures' (data quality) and 'definition of outcome analyzed'" (quality of analysis).

Conclusions: Reporting all items from the minimum checklist will facilitate judgment of the utility of registry data to evaluate medical devices during post-market surveillance.

Objectives: Patients with type 2 diabetes mellitus (T2DM) are associated with a higher risk of carotid artery stenosis and adverse postoperative outcomes compared with individuals without T2DM. The comparative effectiveness after carotid endarterectomy (CEA) versus carotid artery stenting (CAS) in this population remains unclear. This study aimed to compare the in-hospital outcomes of CEA versus CAS in patients with carotid artery stenosis and T2DM.

Design: A retrospective cohort study using a doubly robust estimation model which incorporated an inverse probability weighting (IPW) model, followed by logistic regression to balance baseline characteristics.

Setting: Nation-wide administrative hospitalizations in the US National Inpatient Sample, 2016-2021.

Participants: Adults (≥18 years) with T2DM who underwent either CEA or CAS for asymptomatic or symptomatic carotid stenosis.

Main outcome measures: In-hospital mortality, postoperative stroke and myocardial infarction during the same admission.

Results: A total of 31,363 patients with asymptomatic carotid stenosis (CAS, n=6338; CEA, n=25,025) and 3710 patients with symptomatic carotid stenosis (CAS, n=1271; CEA, n=2439) were evaluated. Among asymptomatic patients, the CEA group had a lower risk of mortality (108 (0.4%) vs 58 (0.9%); adjusted OR 0.997, 95% CI 0.995 to 0.999) but a higher incidence of myocardial infarction (500 (2.0%) vs 151 (2.4%); adjusted OR (aOR) 1.005, 95% CI 1.001 to 1.008) compared with the CAS group. No significant difference in the incidence of postoperative stroke was observed. Among symptomatic patients, the CEA group was also associated with a lower risk of mortality (29 (1.2%) vs 56 (4.4%); aOR 0.973, 95% CI 0.961 to 0.985), with no significant differences in postoperative stroke or myocardial infarction.

Conclusions: CEA was associated with lower in-hospital mortality in type 2 diabetic patients with symptomatic or asymptomatic carotid stenosis compared with CAS, but its use in asymptomatic individuals should be carefully considered due to potential cardiovascular risks.

Objectives: Reporting standards for adverse events (AEs) in arthroscopic rotator cuff repair (ARCR) vary. A standardized "core event set" (CES) was developed to enhance AE documentation. This study describes AE risks in a large Swiss-German ARCR cohort, evaluates concordance between patient-reported and clinician-reported events, and investigates AE variability according to tear severity.

Design: Prospective multicenter cohort study.

Setting: Between June 2020 and November 2021, 973 patients were enrolled across 19 orthopedic centers and followed for 24 months.

Participants: Adult patients with a rotator cuff tear.

Interventions: Primary ARCR.

Main outcome measures: AEs were documented using a structured CES and classified into five severity grades. AE reporting was compared between patients and clinical staff. AE cumulative risks (CR) were calculated by occurrence period, severity grade, and tear severity.

Results: A total of 342 AEs were documented in 314 patients within 2 years. Of these, 41% were reported only by clinical staff, 40% only by patients, and 19% by both. The 2-year CR of AEs was 29.1%, with persistent pain (12.2%) and deep soft tissue complications (10.6%) being most common. Severity classification revealed 61.7% grade I, 24.3% grade II, 13.2% grade III, and 0.9% grade IV. Tear severity was inversely associated with overall AE risk, ranging from 41.5% in partial tears to 28% in massive tears.

Conclusions: Standardized AE documentation using CES identified pain, deep soft tissue complications, and rotator cuff issues as the most frequent local AEs. Both clinicians and patients should be involved in AE reporting. Most AEs were mild, and tear severity predicted AE risk, highlighting the need for tailored postoperative strategies and further research on preventive measures.

Objectives: To study the cost-effectiveness of additional intra-arterial thrombolysis (IA lysis) after successful recanalization with endovascular thrombectomy (EVT).

Design: A cost-effectiveness model was used to estimate both direct medical costs and quality-adjusted life years (QALYs) gained in six European countries (Spain, the Netherlands, Italy, the United Kingdom, France, Germany) and the USA.

Setting: The model was based on published data from those countries on health economics.

Participants: Cost of procedure as well as acute, mid-term and long-term care costs were estimated based on expected modified Rankin Scale (mRS) scores as reported in the Chemical Optimization of Cerebral Embolectomy (CHOICE) trial, which reported improved neurological outcomes after adjunctive IA lysis following EVT.

Main outcome measures: QALYs in the model were calculated by mapping mRS outcomes from the CHOICE trial to EQ-5D utility values from a validated poststroke cohort, projecting these over a 20-year lifetime horizon with 3% annual discounting, assuming health state transitions only after recurrent stroke (always to a worse mRS) and no recurrent stroke risk in the first 90 days.

Results: IA lysis was found to be a cost-effective option in seven different countries (Spain, the Netherlands, Italy, the United Kingdom, France, Germany and the USA). We found an incremental cost-effectiveness ratio ranging from US$-2350 per QALY gained in Germany to US$9628 per QALY gained in the USA. A cost-effectiveness acceptability curve showed 90% acceptability of IA lysis at the willingness to pay varying between US$10 000 and US$45 000 depending on the country.

Conclusions: IA lysis after successful EVT was cost-efficient after reperfusion in the seven countries studied. The early termination, small sample and limited power of the CHOICE trial reduce generalizability of our results. Larger trials are needed to confirm cost-effectiveness of IA lysis after successful EVT.

Objective: This study aimed to review the impact of bone conduction hearing implants (BCHIs) surgery on patients' quality of life (QoL) across general, physical, social and overall well-being domains.

Design: A prospective correlational study.

Setting: Single tertiary referral center in the UK.

Participants: All adult patients undergoing their first BCHI over a 10-year and 6-month period (between June 1, 2012, and December 31, 2022). A total of 163 were included out of 195 potentially eligible participants.

Main outcome measure: The Glasgow Health Status Inventory (GHSI) was used to assess patients' QoL pre and post BCHI surgery.

Results: BCHI surgery showed significant improvements across all GHSI QoL domains; total (p<0.0001), general (p<0.0001), social (p<0.0001) and physical (p<0.0001).

Conclusion: The largest of its kind, this study recognizes the wide-reaching impact of BCHIs on patients' QoL, evidencing them as a highly effective and life-improving surgical intervention.

Objectives: To compare the long-term outcomes of initial thoracic endovascular aortic repair (TEVAR) versus initial medical therapy (iMT) in patients with acute uncomplicated type B aortic dissection (uTBAD), using real-world evidence from a nationwide claims database in Japan. This study aligns with stage 4 of the Idea, Development, Exploration, Assessment, and Long-term Study (IDEAL) framework for surgical innovation.

Design: A retrospective cohort study using propensity score matching (PSM) to balance baseline characteristics.

Setting: Japanese nationwide health insurance claims database, between 1 January 2015 and 31 December 2023.

Participants: Among 40 229 cases with tentative codes for aortic dissection (International Classification of Diseases-10: I71.0), 4995 met all eligibility criteria for acute uTBAD. Among these patients, 96 underwent TEVAR in the subacute phase (15-90 days post diagnosis), while 4899 were managed with iMT. After PSM, 96 TEVAR cases were matched to 480 iMT cases in a 1:5 ratio.

Main outcome measures: The primary outcomes were aorta-related events and all-cause mortality. The secondary outcome was the frequency of follow-up CT imaging every year.

Results: After PSM, the baseline characteristics of both groups were balanced. Median age was 56 years (IQR: 50-62 years) in both groups, and follow-up duration was similar (TEVAR: 31 months; iMT: 28 months, p=0.84).At 60 months, Kaplan-Meier estimates showed an aorta-related event rate of 21.9% (95% CI: 12.6% to 36.4%) for TEVAR and 19.9% (95% CI: 15.6% to 25.2%) for iMT (p=0.99).All-cause mortality was 4.4% (95% CI: 1.4% to 13.6%) for TEVAR and 6.6% (95% CI: 4.0% to 10.6%) for iMT (p=0.70). No significant differences were observed.

Conclusions: While aorta-related events accumulated steadily in the crude iMT group, no survival benefit was observed for subacute TEVAR. These findings support ongoing randomized controlled trials and show the utility of claims-based analyses in IDEAL Stage 4.

The Society of Cardiothoracic Surgery (SCTS) in Great Britain and Ireland provides comprehensive guidelines for the management of adult mitral valve disease, addressing both surgical and transcatheter interventions. These guidelines serve as a resource for healthcare professionals, supplementing existing clinical guidelines. They emphasize the evolving complexity of mitral valve disease management, influenced by the development of new technologies, ongoing research, and randomized trials. The guidelines detail a thorough methodology, incorporating an extensive literature review and evidence assessment conducted by a clinical guidelines team. They outline best practices of preinterventional patient assessment and indications of mitral interventions, while considering the management of patient comorbidities and concomitant diseases. Detailed repair techniques for mitral regurgitation and rheumatic valve disease are provided, along with a summary of indications for emerging transcatheter and hybrid procedures, including transcatheter edge-to-edge repair, transapical neo-chordee placement, transcatheter aortic valve mitral implantation, and percutaneous mitral annuloplasty. The guidelines address postoperative mitral complications and prosthesis considerations, including up-to-date recommendations for antithrombotic management. These guidelines aim to improve patient outcomes through detailed, evidence-based recommendations and encourage the development of specialized mitral MDTs within UK practice. They provide an educational resource, clarifying the implementation of recent technologies and supporting clinical decision-making in the management of adult mitral valve disease.

Objectives: This study aimed to assess the surgical quality, safety, and healthcare utilization associated with gastric cancer surgery in China, using international studies for benchmarking.

Design: A prospective registered study was conducted utilizing data from the Prevalence of Abdominal Complications After Gastroenterological Surgery study, comprised of 1859 patients without postoperative complications (non-POC group) and 412 patients with at least one POC group. Baseline characteristics, surgical outcomes, and healthcare utilization were compared between groups, and results were further contextualized through a review of international multicenter studies.

Setting: 20 centers across China, with data collected from December 2018 to December 2020.

Participants: 2271 patients who underwent gastrectomy for gastric cancer, including 1859 in the non-POC group and 412 in the POC group.

Main outcome measures: POC incidence, postoperative hospital stay, healthcare costs, and cross-regional comparisons of surgical quality.

Results: Patients with POCs exhibited distinct baseline and intraoperative profiles compared with those without. The most frequent complications were respiratory infections, anastomotic leakage, and non-leak intra-abdominal infections. Among surgical types, proximal gastrectomy had the highest POC incidence. Costs and postoperative hospital stay were significantly higher in patients with these complications. Compared with international cohorts, China demonstrated comparable surgical quality and complication profiles. However, the cost burden associated with major POCs was substantially lower in China, despite similar hospital stays.

Conclusion: China's gastric cancer surgery outcomes align with international standards in terms of surgical quality and complication rates. Notably, major complications were associated with significantly lower costs than those reported internationally, suggesting greater cost advantages in postoperative management. These findings highlight the value of robust complication reporting systems and evidence-based management protocols in delivering cost-effective, high-quality surgical care.

Trial registration number: NCT03828266.

Objectives: To evaluate the influence of femtosecond laser-assisted cataract surgery (FLACS) on the post-operative capsular bag and visual performance using a novel aspheric hydrophobic intraocular lens (IOL).

Design: Randomized controlled bilateral study.

Setting: Department of Ophthalmology and Optometry, Kepler University Hospital, Linz, Austria.

Participants: Patients scheduled for bilateral cataract surgery.

Interventions: Patients were scheduled either for conventional cataract surgery or femtolaser-assisted cataract surgery.

Main outcome measures: Anterior chamber depth, IOL tilt, IOL decentration, best-corrected distance visual acuity, uncorrected distance visual acuity.

Results: In total, 100 eyes of 50 patients were included in this study. After 6 months, there was no relevant difference between the FLACS and the conventional cataract group regarding anterior chamber depth (4.56±1.68 mm and 4.60±0.26 mm; p=0.903), tilt (4.87°±2.17° and 4.37°±1.62°; p=0.124) or decentration (0.28±0.14 mm and 0.33±0.20 mm; p=0.414), respectively. The postoperative mean spherical equivalent showed a slight hyperopic shift with no relevant difference between both groups (+0.17±0.49 D and +0.19±0.50 D; p=0.996) with a target refraction of emmetropia or myopia (-2.5 D).

Conclusions: FLACS was not superior to manual cataract surgery regarding capsular bag or visual performance, and the investigated IOL was safe and stable.

Trial registration number: NCT06069752.

Abstract:

Background: In France, 25% of healthcare emissions are attributed to the supply of medical devices, underscoring the necessity for the development of more sustainable procurement policies. However, comparing the carbon footprint of different devices, especially single-use devices versus reusable ones, presents challenges.

Objective: To assess the carbon footprint of single-use and reusable electrosurgical scalpels over 1 year of use in our hospital setting.

Design: A cradle-to-grave analysis was conducted from May 1, 2022, to April 30, 2023.

Setting: Nantes University Hospital, France.

Main outcome measures: The study quantifies carbon emissions across all life cycle stages: raw material extraction, manufacturing, transportation, use, maintenance, and disposal. For reusable devices, sterilization emissions were allocated based on the total annual workload of the Central Sterile Services Department. Carbon footprint values were derived from direct measurements, manufacturer and supplier data, and literature, with conversions using a public and national database (Base Empreinte, ADEME).

Results: The carbon footprint of single-use devices was estimated at 4291 kg of carbon dioxide equivalent (CO₂e), with 94% attributed to the production of the device itself. The carbon footprint related to the reusable device was estimated at 494 kg CO₂e, with 86% stemming from handling at our sterilization unit.

Conclusions: These findings are contingent on our hospital's practices and may vary based on several factors. Beyond estimating these carbon footprints, it provides a practical, decision-oriented analysis accessible for hospital leadership and healthcare professionals, supporting institutional change.