Implementation of Hospital Mortality Reviews: A Systematic Review.

OBJECTIVE: The objective of this study was to give an overview of the published literature on the implementation of mortality reviews in hospital settings. METHODS: We searched MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, and Web of Science databases up to August 2022 for studies describing implementation or results of implementation of hospital mortality reviews published in English or German. Quality appraisal was conducted using the Mixed Methods Appraisal Tool. Two independent reviewers screened the title/abstract and the full text of potentially relevant records and extracted data using a standardized form. We synthesized and integrated quantitative and qualitative findings narratively following a convergent segregated mixed methods review approach. RESULTS: From the 884 studies screened, 18 publications met all inclusion criteria and were included in the review. Observed mortality rates reported in 10 publications ranged from 0.4% to 7.8%. In 10 publications, mortality reviews were implemented as a multistep process. In 7 publications, structured mortality review meetings were implemented. Key aspects of success in developing and implementing mortality reviews in hospitals were involvement of multiple stakeholders, providing enough resources for included staff, and constant monitoring and adaption of the processes. CONCLUSIONS: Although awareness of hospital mortality reviews has increased over the last decades, published research in this area is still rare. Our results may inform hospitals considering development and implementation of mortality reviews by providing key aspects and lessons learned from existing implementation experiences.

Standing the test of time: total aortic remodeling 13 years after TEVAR for acute type B aortic dissection.

Long-term outcome after thoracic endovascular aortic repair (TEVAR) of acute type B aortic dissection (aTBAD) is still underreported in current literature. This case report shows persistence of aortic remodeling without secondary complication or need of reintervention 13 years after TEVAR. A 45-year-old woman was referred to the emergency room with aTBAD. Due to early diameter progression in combination with therapy-refractory pain and uncontrolled hypertension, TEVAR was performed. Hereafter, the patient showed complete remodeling of the descending thoracic aorta without persistent false lumen perfusion in this segment and with stable true and false lumen diameter in the untreated abdominal segment for a 13-year period. No aortic-related reintervention was needed. With contemporary devices and adapted therapy, TEVAR seems able to treat complex thoracic disease. Long-term follow-up (FU) is mandatory to monitor the efficacy and durability of endovascular treatment in aortic disease.

Systematic Review on Abdominal Penetrating Atherosclerotic Aortic Ulcers: Outcomes of Endovascular Repair.

PURPOSE: To systematically review existing evidence on outcomes of endovascular repair of abdominal atherosclerotic penetrating aortic ulcers (PAUs). MATERIAL AND METHODS: Cochrane Central Registry of Registered Trials (CENTRAL), MEDLINE (via PubMed), and Web of Science databases were systematically searched. The systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis protocol (PRISMA-P 2020). The protocol was registered in the international registry of systematic reviews (PROSPERO CRD42022313404). Studies reporting on technical and clinical outcomes of endovascular PAU repair in 3 or more patients were included. Random effects modeling was used to estimate pooled technical success, survival, reinterventions, and type 1 and type 3 endoleaks. Statistical heterogeneity was assessed using the I2 statistic. Pooled results are reported with 95% confidence intervals (CIs). Study quality was assessed using an adapted version of the Modified Coleman Methodology Score. RESULTS: Sixteen studies including 165 patients with a mean/median age ranging from 64 to 78 years receiving endovascular therapy for PAU between 1997 and 2020 were identified. Pooled technical success was 99.0% (CI: 96.0%-100%). In all, 30-day mortality was 1.0% (CI: 0%-6.0%) with an in-hospital mortality of 1.0% (CI: 0.0%-13.0%). There were no reinterventions, type 1, or type 3 endoleaks at 30 days. Median/mean follow-up ranged from 1 to 33 months. Overall, there were 16 deaths (9.7%), 5 reinterventions (3.3%), 3 type 1 (1.8%), and 1 type 3 endoleak (0.6%) during follow-up. The quality of studies was rated low according to the Modified Coleman score at 43.4 (+/- 8.5) of 85 points. CONCLUSION: There is low-level evidence on outcomes of endovascular PAU repair. While in the short-term endovascular repair of abdominal PAU seems safe and effective, mid-term and long-term data are lacking. Recommendations with regard to treatment indications and techniques in asymptomatic PAU should be made cautiously. CLINICAL IMPACT: This systematic review demonstrated that evidence on outcomes of endovascular abdominal PAU repair is limited. While in the short-term endovascular repair of abdominal PAU seems safe and effective, mid-term and long-term data are lacking. In the context of a benign prognosis of asymptomatic PAU and lacking standardization in current reporting, recommendations with regard to treatment indications and techniques in asymptomatic PAUs should be made cautiously.

TEVAR Following FET: Current Outcomes of Rendezvous Procedures in Clinical Practice.

BACKGROUND: The treatment of extensive thoracic/thoracoabdominal aortic pathologies with arch involvement remains a challenging task in aortic surgery. The introduction of the frozen elephant trunk (FET) technique offered a link between open surgery and thoracic endovascular aortic repair (TEVAR). Despite a decade of experience, data on the complementary use of these techniques are scant. The aim of this study was to evaluate TEVAR following FET in clinical reality. METHODS: Between November 2006 and June 2018, 20 patients (9 females; median age of 69 years) underwent endovascular second-stage completion after FET. The clinical outcomes, technical feasibility, and morphological findings were analyzed retrospectively. RESULTS: Eleven of the 20 interventions were intended "rendezvous procedures" in a multistage approach; 4 were elective reinterventions, and 5 were emergency complication repairs. The median interval between FET and TEVAR was 231 days (11 days-7.4 years). The technical success rate was 100%. During a median follow-up (FU) period of 58.3 months, the overall survival rate was 95%, with one in-hospital death. Neurological complications occurred in three cases (spinal cord injury: n = 1; stroke: n = 2). Computed tomography angiography showed overall regression in the median diameter of the proximal descending aorta (from 57 to 48.5 mm). CONCLUSION: TEVAR as a second-stage intervention after FET is a feasible option, with satisfactory results at medium-term FU. In extensive thoracoabdominal aortic disease without proximal landing zones, the complementary use of both techniques in a multistage approach should be considered.

Self-reported health literacy and medication adherence in older adults: a systematic review.

OBJECTIVES: To give an overview over the associations between self-reported health literacy and medication adherence in older adults. DESIGN: A systematic literature review of quantitative studies published in English and German. DATA SOURCES: MEDLINE via PubMed, CINAHL, Cochrane Library, Epistemonikos and LIVIVO were searched. ELIGIBILITY CRITERIA: Included studies had to examine the associations between self-reported health literacy and medication adherence in the elderly (samples including ≥66% of ≥60 years old) and had to use a quantitative methodology and had to be written in English or German. DATA EXTRACTION AND SYNTHESIS: All studies were screened for inclusion criteria by two independent reviewers. A narrative synthesis was applied to analyse all included studies thematically. Quality assessment was conducted using the NIH Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies. RESULTS: We found 2313 studies, of which nine publications from eight studies were included in this review. Five studies reported a majority of participants with limited health literacy, one study reported a majority of participants with adequate health literacy, and three publications from two studies only reported mean levels of health literacy. Eight publications from seven studies used self-reports to measure medication adherence, while one study used the medication possession ratio. Overall, six publications from five studies reported significantly positive associations between health literacy and medication adherence while two studies reported positive but non-significant associations between both constructs and one study reported mixed results. CONCLUSION: In this review, associations between self-reported health literacy and medication adherence are rather consistent, indicating positive associations between both constructs in older adults. However, concepts and measures of health literacy and medication adherence applied in the included studies still show a noteworthy amount of heterogeneity (eg, different use of cutoffs). These results reveal the need for more differentiated research in this area. PROSPERO REGISTRATION NUMBER: CRD42019141028.

Pharmaceutical management of elderly high-risk patients in perioperative settings (PHAROS): protocol of a pilot sequential intervention study.

INTRODUCTION: With increasing age, the risk of complications after surgery rises in elderly patients. Furthermore, the prevalence of multimorbidity and polypharmacy rises with age, making this elderly population especially vulnerable for drug-related problems and posing an additional risk for postoperative complications. Still, only few studies have concentrated on investigating how medication safety can be improved in these patients. The aim of this pilot study is to examine the impact of a comprehensive intervention (interprofessional systematic medication therapy management) on medication appropriateness in elderly polymedicated, multimorbid patients during hospital stay for elective surgery. METHODS AND ANALYSIS: This pilot study will include a total number of 140 patients. Surgical high-risk patients ≥65 years taking more than five chronic systemic drugs will be recruited consecutively for 9 months in the control group capturing usual care regarding medication history and in-hospital medication therapy management without any study intervention. Recruitment of the intervention group will be conducted for another 9 months. The intervention consists of the following components: an additional medication history by a hospital pharmacist before admission, a subsequent medication review, optimisation of the long-term medication and recommendations to the patient's general practitioner. A follow-up will be performed 3 months after surgery. As the primary study outcome, medication appropriateness will be measured using the Medication Appropriateness Index.Secondary outcomes are postoperative complications, incidence and frequency of adverse drug reactions and potentially inappropriate medication in the elderly, satisfaction with inpatient and outpatient care, medication reconciliation and health-related quality of life. Multivariable analyses will be used to analyse all quantitative research questions. ETHICS AND DISSEMINATION: Ethics approval was obtained by the medical ethics committee of the Medical Chamber of Hamburg (study ID: PV5754). Data will be published in peer-reviewed journals and presented at conferences. TRIAL REGISTRATION NUMBER: The study is registered at www.drks.de: DRKS00014621.

Preliminary results of spot-stent grafting in Stanford type B aortic dissection and intramural haematoma.

OBJECTIVES: Optimal treatment for patients with diseased proximal landing zones in acute/subacute Stanford type B dissection and intramural haematoma remains unclear. This study describes the preliminary outcomes of a localized endovascular treatment [spot-stent grafting (SSG)] of main entries/intramural blood pooling located downstream (aortic zones 4 and 5) using one single short device comprising diseased landing zones, looking particularly at the technical and morphological outcomes. METHODS: Patients undergoing thoracic endovascular aortic repair (TEVAR) for acute/subacute aortic dissection Stanford type B/intramural haematoma Stanford type B between 1997 and 2018 were identified from a prospectively maintained institutional database. In a total of 183 cases, 22 patients (7 women; median age 62 years; range 35-79 years) received SSG. The primary study end point was technical success. The primary morphological end point was false lumen thrombosis/aortic remodelling. Secondary end points were TEVAR-related mortality/morbidity and reinterventions. The median follow-up was 28.5 months (5 days-15.6 years). RESULTS: The primary technical success rate was 100% (22/22). During follow-up, false lumen thrombosis was seen in 21 patients (95.5%) at a median of 6 days (0 days to 2.7 years) after the index procedure (limited/extended false lumen thrombosis: n = 9 vs 12). Aortic remodelling was achieved in 15 of 22 patients (68.2%) at a median of 360 days (3 days to 7.2 years). Limited/extended remodelling was observed in 8/15 and 7/15, respectively. Retrograde dissection or stent graft-induced new entry was not observed. No stroke or spinal cord injury occurred. Reinterventions were performed in 4/22 cases. The in-hospital mortality and 30-day mortality were 0%. Overall mortality during the follow-up period was 22.7% (5/22). CONCLUSIONS: This study shows favourable technical and morphological results for SSG in selected patients with acute/subacute aortic dissection Stanford type B/intramural haematoma Stanford type B. Patient allocation to SSG remains individual. Prospective large-scale long-term data may allow refinement of the application.

Laboratory Limitations of Excluding Hereditary Protein C Deficiency by Chromogenic Assay: Discrepancies of Phenotype and Genotype.

Protein C (PC) deficiency is associated with an increased risk for venous thromboembolism (VTE). In daily practice, exclusion of a hereditary PC deficiency is often based on a single determination of PC activity, by either clotting time-based or mostly chromogenic assay. However, diagnosis of hereditary PC deficiency is challenging due to several laboratory and clinical limitations. We compared the potential of PC activity values measured by either chromogenic or clotting time-based assay to predict a variation in the PROC gene. One hundred one (35%) of 287 patients carried variations within the PROC gene, including 2 previously not published variations. In 20 (20%) patients with identified variation, PC activity, determined by chromogenic assay, was within the reference range. For prediction of an underlying genetic defect determined by chromogenic and clotting time-based assay, sensitivity was 80% versus 99%, specificity 75% versus 18%, positive predictive value 64% versus 39%, and negative predictive value (NPV) 88% versus 97%. The lower NPV of chromogenic versus clotting time-based PC assay can be mainly explained by the presence of PC deficiency type IIb. Following our proposed diagnostic algorithm, additional measurement of PC activity by clotting time-based assay in case of a positive VTE history improves detection of this subtype of PC deficiency. Considering potential therapeutic consequences for primary and especially for secondary VTE prophylaxis, genetic analysis is required not only for confirmation but also for clarification of PC deficiency.

Antimicrobial functionalization of bacterial nanocellulose by loading with polihexanide and povidone-iodine.

Bacterial nanocellulose (BNC) is chemically identical with plant cellulose but free of byproducts like lignin, pectin, and hemicelluloses, featuring a unique reticulate network of fine fibers. BNC sheets are mostly obtained by static cultivation. Now, a Horizontal Lift Reactor may provide a cost efficient method for mass production. This is of particular interest as BNC features several properties of an ideal wound dressing although it exhibits no bactericidal activity. Therefore, BNC was functionalized with the antiseptics povidone-iodine (PI) and polihexanide (PHMB). Drug loading and release, mechanical characteristics, biocompatibility, and antimicrobial efficacy were investigated. Antiseptics release was based on diffusion and swelling according to Ritger-Peppas equation. PI-loaded BNC demonstrated a delayed release compared to PHMB due to a high molar drug mass and structural changes induced by PI insertion into BNC that also increased the compressive strength of BNC samples. Biological assays demonstrated high biocompatibility of PI-loaded BNC in human keratinocytes but a distinctly lower antimicrobial activity against Staphylococcus aureus compared to PHMB-loaded BNC. Overall, BNC loaded with PHMB demonstrated a better therapeutic window. Moreover, compressive and tensile strength were not changed by incorporation of PHMB into BNC, and solidity during loading and release could be confirmed.

Active wound dressings based on bacterial nanocellulose as drug delivery system for octenidine.

Although bacterial nanocellulose (BNC) may serve as an ideal wound dressing, it exhibits no antibacterial properties by itself. Therefore, in the present study BNC was functionalized with the antiseptic drug octenidine. Drug loading and release, mechanical characteristics, biocompatibility, and antimicrobial efficacy were investigated. Octenidine release was based on diffusion and swelling according to the Ritger-Peppas equation and characterized by a time dependent biphasic release profile, with a rapid release in the first 8h, followed by a slower release rate up to 96 h. The comparison between lab-scale and up-scale BNC identified thickness, water content, and the surface area to volume ratio as parameters which have an impact on the control of the release characteristics. Compression and tensile strength remained unchanged upon incorporation of octenidine in BNC. In biological assays, drug-loaded BNC demonstrated high biocompatibility in human keratinocytes and antimicrobial activity against Staphylococcus aureus. In a long-term storage test, the octenidine loaded in BNC was found to be stable, releasable, and biologically active over a period of 6 months without changes. In conclusion, octenidine loaded BNC presents a ready-to-use wound dressing for the treatment of infected wounds that can be stored over 6 months without losing its antibacterial activity.

Nanocelluloses: a new family of nature-based materials.

Cellulose fibrils with widths in the nanometer range are nature-based materials with unique and potentially useful features. Most importantly, these novel nanocelluloses open up the strongly expanding fields of sustainable materials and nanocomposites, as well as medical and life-science devices, to the natural polymer cellulose. The nanodimensions of the structural elements result in a high surface area and hence the powerful interaction of these celluloses with surrounding species, such as water, organic and polymeric compounds, nanoparticles, and living cells. This Review assembles the current knowledge on the isolation of microfibrillated cellulose from wood and its application in nanocomposites; the preparation of nanocrystalline cellulose and its use as a reinforcing agent; and the biofabrication of bacterial nanocellulose, as well as its evaluation as a biomaterial for medical implants.