Christophe Barea

Effectiveness of the surgical safety checklist in a high standard care environment

Background:Use of surgical safety checklists has been associated with significant reduction in postoperative surgical site infection (SSI), morbidity, and mortality. Objective:To evaluate the effectiveness of an intraoperative checklist in high-risk surgical patients in a high standard care environment with long-standing regular perioperative safety control programs. Research Design:Quasi-experiment pre-post checklist implementation. Subjects:Surgical patients above 16 years with an American Society of Anesthesiologists (ASA) score 3–5 operated upon at a large tertiary hospital. Measures:Unplanned return to operating room for any reason, reoperation for SSI, unplanned admission to intensive care unit, and in-hospital death within 30 days. Results:A total of 609 patients (53% elective, 85% ASA 3, mean age 70 y) were included before and 1818 after implementation (52% elective, 87% ASA 3, mean age 69 y), the latter with 552, 558, and 708 in period I, II, and III, respectively. Comparing preimplementation to postimplementation periods: unplanned return to operating room occurred in 45/609 (7.4%) versus 109/1818 (6.0%) interventions [adjusted risk ratios (RR) 0.82; 95% confidence interval (CI), 0.59–1.14]; reoperation for SSI in 18/609 (3.0%) versus 109/1818 (1.7%) interventions (adjusted RR 0.56; 95% CI, 0.32–1.00); unplanned admission to intensive care unit in 17 (2.8%) versus 48 (2.6%) interventions (adjusted RR 0.90; 95% CI, 0.52–1.55); and in-hospital death occurred in 26 (4.3%) versus 108 (5.9%) patients (adjusted RR 1.44; 95% CI, 0.97–2.14). Checklist use during 77 interventions prevented 1 reoperation for SSI. Conclusions:A trend toward reduced reoperation rates for SSI was observed after checklist implementation in this high standard care environment; no influence on other outcome measures was observed.

Strong association between smoking and the risk of revision in a cohort study of patients with metal-on-metal total hip arthroplasty

Thus far the ability to predict who will develop early failure following the insertion of a metal‐on‐metal (MoM) bearing has been very limited. Our objective was to assess the effect of smoking on failure rates in patients with MoM bearing, compared with patients with ceramic‐on‐polyethylene (CoP) bearing. From a prospective hospital‐based registry we included all primary THAs operated upon between 1/2001 and 12/2011 with MoM or CoP bearings of the same cup design and head size (28 mm). We compared revision rates through 10/2013 classified by smoking status and type of bearing. We included 1,964 patients (median age 71, 57% women), 663 with MoM and 1,301 with CoP bearing. Mean follow‐up was 6.9 years (range 1.8–12.8). Revisions were required for 56 THAs. In patients with MoM bearing the adjusted incidence rate of revision among ever‐smokers was four times greater than among never‐smokers (95% CI 1.4–10.9). Among those with CoP bearing, the rate ratio was only 1.3 (95% CI 0.6–2.5). We found a strong association between smoking and increased failure of MoM THAs. In contrast, the association was weak for patients with CoP bearing. Smoking might be a trigger or an effect amplifier for adverse reactions to metal debris from MoM bearings.

Arthroscopically-assisted Latarjet: an easy and reproducible technique for improving the accuracy of graft and screw placement

Background The effectiveness of the Latarjet largely depends on accurate graft placement, as well as on proper position and direction of the screws. We present our technique for an arthroscopically-assisted Latarjet comparing radiological results with the open technique. Methods We retrospectively reviewed the postoperative computed tomography scans of 38 patients who underwent a Latarjet procedure. For 16 patients, the procedure was performed with the open technique and, for 22 patients, it was performed using an arthroscopically-assisted technique. An independent radiologist evaluated graft and hardware position, as well as graft integration or resorption. Postoperative complications were also documented. Results The graft was correctly placed in only 18.8% of cases in the open group and 72.7% of cases in the arthroscopically-assisted group. There were no postoperative complications in the arthroscopically-assisted group, whereas one patient had a recurrence and two required hardware removal in the open group. Conclusions The Latarjet procedure is a challenging procedure for which a key point is the correct placement of the coracoid graft onto the glenoid neck and correct position of the screws. The present study substantiates a clear benefit for the use of a guide with an arthroscopically-assisted technique in terms of graft and hardware placement. At short-term follow-up, there appears to be a benefit for graft integration and avoidance of resorption.

International variation in shoulder arthroplasty

Background and purpose — The number of shoulder registries increases. We assessed international trends in use of shoulder arthroplasty, and described the current state of procedure selection and outcome presentation as documented in national and regional joint registries. Methods — Published reports from 9 population-based shoulder arthroplasty registries (country/region: Norway, Sweden, New Zealand, Denmark, California, Australia, Emilia-Romagna, Germany, and United Kingdom) were analyzed. Data were extracted on age, sex, disease indication, type of surgical procedure, surgical volume, and outcomes. Results — Shoulder arthroplasty incidence rate in 2012 was 20 procedures/105 population with a 6-fold variation between the highest (Germany) and lowest (United Kingdom) country. The annual incidence rate increased 2.8-fold in the past decade. Within the indications osteoarthritis, fracture, and cuff-tear arthropathy variations in procedure choice between registries were large. Outcomes evaluation focused on revision in all registries, but different measures and strata were used. Only Australia provided revision rates for prosthesis brands stratified by both indication and procedure. Finally, in 2 registries with available data surgeons performed on average 10–11 procedures yearly. Interpretation — Annual incidence rates of shoulder arthroplasty have almost tripled over the past decade. There is wide variation in procedure selection for the major indications, a low average surgeon volume, a substantial number of brands with small annual volume, and large variation in outcome presentation. The internationally increasing registry activity is an excellent basis for improving the so far weak evidence in shoulder arthroplasty.

Mapping existing hip and knee replacement registries in Europe

The general shortage of evidence regarding benefits and harms of medical devices has been highlighted following the serious safety concerns with metal-on-metal hip replacements and silicone breast implants and was again pointed out in a recent survey of European Health Technology Assessment institutions. In this context the new European medical device regulation will enforce post-marketing surveillance of existing and new implants. The usefulness of registry data as a source of information for medical device real-world clinical performance and safety has been demonstrated. However, these data might be under-used by researchers and policy makers. One reason for this is the insufficient awareness of their existence. The aim of this review is to provide information to relevant stakeholders on the extent and breadth of the data currently collected in European joint replacement registries. We identified 24 registries, most of them of national coverage. Total numbers of primary total hip and knee replacements included were over 3.1 and 2.5 million records, respectively. The current focus of these registries is on whole-lifespan implant surveillance via revision rate monitoring, quality assessment of surgical and perioperative care, and hospital performance assessment. More recently, national and international comparison and benchmarking have increasingly become part of their endeavors.

The role of national registries in improving patient safety for hip and knee replacements.

BackgroundThe serious adverse events associated with metal on metal hip replacements have highlighted the importance of improving methods for monitoring surgical implants.The new European Union (EU) device regulation will enforce post-marketing surveillance based on registries among other surveillance tools. Europe has a common regulatory environment, a common market for medical devices, and extensive experience with joint replacement registries. In this context, we elaborate how joint replacement registries, while building on existing structure and data, can better ensure safety and balance risks and benefits.Main textActions to improve registry-based implant surveillance include: enriching baseline and diversifying outcomes data collection; improving methodology to limit bias; speeding-up failure detection by active real-time monitoring; implementing risk-benefit analysis; coordinating collaboration between registries; and translating knowledge gained from the data into clinical decision-making and public health policy.ConclusionsThe changes proposed here will improve patient safety, enforce the application of the new legal EU requirements, augment evidence, improve clinical decision-making, facilitate value-based health-care delivery, and provide up-to-date guidance for public health.