Association between hospital ownership and patient selection, management, and outcomes after carotid endarterectomy or carotid artery stenting : - Secondary data analysis of the Bavarian statutory quality assurance database.

BACKGROUND: This study analyses the association between hospital ownership and patient selection, treatment, and outcome of carotid endarterectomy (CEA) or carotid artery stenting (CAS). METHODS: The analysis is based on the Bavarian subset of the nationwide German statutory quality assurance database. All patients receiving CEA or CAS for carotid artery stenosis between 2014 and 2018 were included. Hospitals were subdivided into four groups: university hospitals, public hospitals, hospitals owned by charitable organizations, and private hospitals. The primary outcome was any stroke or death until discharge from hospital. Research was funded by Germany's Federal Joint Committee Innovation Fund (01VSF19016 ISAR-IQ). RESULTS: In total, 22,446 patients were included. The majority of patients were treated in public hospitals (62%), followed by private hospitals (17%), university hospitals (16%), and hospitals under charitable ownership (6%). Two thirds of patients were male (68%), and the median age was 72 years. CAS was most often applied in university hospitals (25%) and most rarely used in private hospitals (9%). Compared to university hospitals, patients in private hospitals were more likely asymptomatic (65% vs. 49%). In asymptomatic patients, the risk of stroke or death was 1.3% in university hospitals, 1.5% in public hospitals, 1.0% in hospitals of charitable owners, and 1.2% in private hospitals. In symptomatic patients, these figures were 3.0%, 2.5%, 3.4%, and 1.2% respectively. Univariate analysis revealed no statistically significant differences between hospital groups. In the multivariable analysis, compared to university hospitals, the odds ratio of stroke or death in asymptomatic patients treated by CEA was significantly lower in charitable hospitals (OR 0.19 [95%-CI 0.07-0.56, p = 0.002]) and private hospitals (OR 0.47 [95%-CI 0.23-0.98, p = 0.043]). In symptomatic patients (elective treatment, CEA), patients treated in private or public hospitals showed a significantly lower odds ratio compared to university hospitals (0.36 [95%-CI 0.17-0.72, p = 0.004] and 0.65 [95%-CI 0.42-1.00, p = 0.048], respectively). CONCLUSIONS: Hospital ownership was related to patient selection and treatment, but not generally to outcomes. The lower risk of stroke or death in the subgroup of electively treated patients in private hospitals might be due to the right timing, the choice of treatment modality or actually to better structural and process quality.

Intraoperative Completion Studies and their Associations with Carotid Endarterectomy Outcomes.

OBJECTIVE: This study aimed at assessing outcomes after carotid endarterectomy (CEA) in dependence of center policy with respect to imaging intraoperative completion study (ICS i ) usage. SUMMARY BACKGROUND DATA: Although randomized controlled studies are missing, a beneficial effect was shown for ICS i techniques (i.e., angiography and intraoperative duplex ultrasound) after CEA. METHODS: This secondary data analysis is based on the German statutory quality assurance database. Research was funded by Germany's Federal Joint Committee Innovation Fund (G-BA Innovationsfonds, 01VSF19016 ISAR-IQ). According to their ICS i policy, hospitals were categorized as routine ICSi (>90%), selective ICSi (10-90%), or sporadic ICSi (<10%) centers . Primary study outcome was in-hospital stroke or death. Multivariable regression analyses were performed. RESULTS: Between 2012 and 2016, a total of 119,800 patients underwent CEA. In-hospital stroke or death rates were lower in routine ICSicenters (1.7%) compared to selective (2.1%) and sporadic ICSicenters (2.0%). The multivariable regression analysis showed, that in routine ICSicenters , ICS i use was associated with lower rates of stroke or death (aOR 0.64; 95% CI 0.44-0.93). In selective ICSicenters , ICS i was not associated with the occurrence of either of the assessed outcomes. In sporadic ICSicenters , ICS i was associated with higher rates of stroke or death (aOR 1.91; 95% CI 1.26-2.91). CONCLUSIONS: Lowest in-hospital stroke or death rates are achieved in r outine ICSicenters . While ICS i is associated with a lower perioperative risk in r outine ICSicenters , it might act as a surrogate marker for worse outcomes due to intraoperative irregularities in sporadic ICSicenters . Routine use of ICS i is advisable.

Endovascular aortic repair with sac embolization for the prevention of type II endoleaks (the EVAR-SE study): study protocol for a randomized controlled multicentre study in Germany.

BACKGROUND: Beyond a certain threshold diameter, abdominal aortic aneurysms (AAA) are to be treated by open surgical or endovascular aortic aneurysm repair (EVAR). In a quarter of patients who undergo EVAR, inversion of blood flow in the inferior mesenteric artery or lumbar arteries may lead to type II endoleak (T2EL), which is associated with complications (e.g. AAA growth, secondary type I endoleak, rupture). As secondary interventions to treat T2EL often fail and may be highly invasive, prevention of T2EL is desirable. The present study aims to assess the efficacy of sac embolization (SE) with metal coils during EVAR to prevent T2EL in patients at high risk. METHODS: Over a 24-month recruitment period, a total of 100 patients undergoing EVAR in four vascular centres (i.e. Klinikum rechts der Isar of the Technical University of Munich, University Hospital Augsburg, University Hospital Dresden, St. Joseph's Hospital Wiesbaden) are to be included in the present study. Patients at high risk for T2EL (i.e. ≥ 5 efferent vessels covered by endograft or aneurysmal thrombus volume <40%) are randomized to one group receiving standard EVAR and another group receiving EVAR with SE. Follow-up assessments postoperatively, after 30 days, and 6 months involve contrast-enhanced ultrasound scans (CEUS) and after 12 months an additional computed tomography angiography (CTA) scan. The presence of T2EL detected by CEUS or CTA after 12 months is the primary endpoint. Secondary endpoints comprise quality of life (quantified by the SF-36 questionnaire), reintervention rate, occurrence of type I/III endoleak, aortic rupture, death, alteration of aneurysm volume, or diameter. Standardized evaluation of CTA scans happens through a core lab. The study will be terminated after the final follow-up visit of the ultimate patient. DISCUSSION: Although preexisting studies repeatedly indicated a beneficial effect of SE on T2EL rates after EVAR, patient relevant outcomes have not been assessed until now. The present study is the first randomized controlled multicentre study to assess the impact of SE on quality of life. Further unique features include employment of easily assessable high-risk criteria, a contemporary follow-up protocol, and approval to use any commercially available coil material. Overcoming limitations of previous studies might help SE to be implemented in daily practice and to enhance patient safety. TRIAL REGISTRATION: ClinicalTrials.gov NCT05665101. Registered on 23 December 2022.

Editor's Choice - Temporal fluctuations of hospital incidence and mortality of ruptured abdominal aortic aneurysms in Germany: A secondary data analysis of German hospital episode statistics 2009 - 2018.

OBJECTIVE: Abdominal aortic aneurysm rupture (rAAA) is still associated with high mortality. Recent studies have shown higher incidences in autumn and winter, and worse outcomes after rAAA treatment on weekends in some countries. This study aimed to analyse seasonal, weekday, and daytime fluctuations of the hospital incidence, treatment modalities, and outcomes of rAAA, based on the most recent nationwide German real world data. METHODS: A secondary data analysis of diagnosis related group statistics (2009 - 2018), obtained from the German Federal Statistical Office, was conducted. Cases encoded by a diagnosis of rAAA in conjunction with procedural codes for endovascular aortic repair (EVAR) or open aortic repair were included. Patient and procedural characteristics, comorbidities, and outcomes were analysed for seasonal (spring, summer, autumn, and winter), weekday (Monday - Sunday) and daytime (0:00 - 8:00, 8:00 -16:00, 16:00 -20:00, and 20:00 - 24:00) fluctuations by descriptive statistics and multivariable regression analyses. RESULTS: Thirteen thousand and seventy patients (85% male, median age 75 years) were treated for rAAA. Endovascular aortic repair was associated with lower mortality (adjusted OR 0.40, 95% CI 0.37 - 0.44). While no significant seasonal fluctuations were found, on a weekday basis lower hospital incidences were found on Mondays (12%) and Sundays (11%) compared with other weekdays (15 - 16%). Similarly, EVAR rates were lower on Mondays and Sundays (25% and 24%, respectively) compared with other weekdays (30 - 33%). Multivariable analyses revealed higher mortality rates on Mondays and Sundays. On a daytime basis, lower EVAR rates and higher mortality rates were found during the 16:00 - 8:00 period. CONCLUSION: In German hospitals, incidences and EVAR rates to treat rAAA were lowest on Mondays and Sundays. The associated overall mortality rates were highest on the respective days. Further restructuring and centralisation of AAA treatment in Germany could potentially mitigate this weekday effect.

The Incidence of IgG4-Related and Inflammatory Abdominal Aortic Aneurysm Is Rare in a 101 Patient Cohort.

Abdominal aortic aneurysms (AAA) are the most frequent aortic dilation, with considerable morbidity and mortality. Inflammatory (infl) and IgG4-positive AAAs represent specific subtypes of unclear incidence and clinical significance. Here, histologic and serologic analyses with retrospective clinical data acquisition are investigated via detailed histology, including morphologic (HE, EvG: inflammatory subtype, angiogenesis, and fibrosis) and immunhistochemic analyses (IgG and IgG4). In addition, complement factors C3/C4 and immunoglobulins IgG, IgG2, IgG4 and IgE were measured in serum samples and clinical data uses patients' metrics, as well as through semi-automated morphometric analysis (diameter, volume, angulation and vessel tortuosity). A total of 101 eligible patients showed five (5%) IgG4 positive (all scored 1) and seven (7%) inflammatory AAAs. An increased degree of inflammation was seen in IgG4 positive and inflAAA, respectively. However, serologic analysis revealed no increased levels of IgG or IgG4. The operative procedure time was not different for those cases and the short-term clinical outcomes were equal for the entire AAA cohort. Overall, the incidence of inflammatory and IgG4-positive AAA samples seems very low based on histologic and serum analyses. Both entities must be considered distinct disease phenotypes. Short-term operative outcomes were not different for both sub-cohorts.

Locoregional Anaesthesia and Intra-Operative Angiography in Carotid Endarterectomy: 16 Year Results of a Consecutive Single Centre Series.

OBJECTIVE: The benefit of local (LA) over general (GA) anaesthesia and the rationale of intra-operative imaging strategies during carotid endarterectomy (CEA) is debated. This study analysed the associations between patient characteristics, LA, and intra-operative imaging strategies and the in hospital stroke and death rates in elective CEA over a 16 year period. METHODS: All consecutive patients treated by elective CEA between January 2004 and December 2019 (n = 1 872; median age 71 years, 70% male, 37% symptomatic) were included. All patients were assessed neurologically before and within 48 hours after CEA. The primary outcome event was the combined rate of any in hospital stroke or death. Secondary outcome events were the combined rates of any in hospital major stroke (modified Rankin scale [mRS] 3 - 5) or death, stroke, minor stroke (mRS 0 - 2), major stroke, and death alone. To detect changes over time, four quartiles (2004 - 2007, 2008 - 2011, 2012 - 2015, and 2016 - 2019) of this cohort were analysed. Statistical analysis comprised trend tests, and uni- and multivariable logistic regression. RESULTS: Median patient age increased from 68 to 73 years (p < .001). Over time, LA (from 28% to 91%) and intra-operative imaging (angiography 2.8 - 98.1%, duplex ultrasound 0 - 78.2%) was applied more frequently. Surgical techniques did not change. The in hospital stroke or death and major stroke or death rates decreased from 3.7% to 1.5% (p = .041) and from 2.8% to 0.9% (p = .014), respectively, corresponding to a relative risk of decline of 7% and 12% annually. Multivariable analysis revealed that LA (odds ratio [OR] 0.25, 95% confidence interval [CI] 0.1 - 0.62) and intra-operative angiography (OR 0.09, 95% CI 0.10 - 0.81) were associated with lower in hospital major stroke and death rates. CONCLUSION: These data demonstrate a decline in the combined rates of any in hospital major stroke or death after non-emergency CEA over time. Locoregional anaesthesia and intra-operative quality control were associated with these improvements and might be worthwhile in elective CEA.

Variation of synovial fluid leucocyte cell count and polymorphonuclear percentage in patients with aseptic revision total knee arthroplasty.

AIMS: Current guidelines consider analyses of joint aspirates, including leucocyte cell count (LC) and polymorphonuclear percentage (PMN%) as a diagnostic mainstay of periprosthetic joint infection (PJI). It is unclear if these parameters are subject to a certain degree of variability over time. Therefore, the aim of this study was to evaluate the variation of LC and PMN% in patients with aseptic revision total knee arthroplasty (TKA). METHODS: We conducted a prospective, double-centre study of 40 patients with 40 knee joints. Patients underwent joint aspiration at two different time points with a maximum period of 120 days in between these interventions and without any events such as other joint aspirations or surgeries. The main indications for TKA revision surgery were aseptic implant loosening (n = 24) and joint instability (n = 11). RESULTS: Overall, 80 synovial fluid samples of 40 patients were analyzed. The average time period between the joint aspirations was 50 days (SD 32). There was a significantly higher percentage change in LC when compared to PMN% (44.1% (SD 28.6%) vs 27.3% (SD 23.7%); p = 0.003). When applying standard definition criteria, LC counts were found to skip back and forth between the two time points with exceeding the thresholds in up to 20% of cases, which was significantly more compared to PMN% for the European Bone and Joint Infection Society (EBJIS) criteria (p = 0.001), as well as for Musculoskeletal Infection Society (MSIS) (p = 0.029). CONCLUSION: LC and PMN% are subject to considerable variation. According to its higher interindividual variance, LC evaluation might contribute to false-positive or false-negative results in PJI assessment. Single LC testing prior to TKA revision surgery seems to be insufficient to exclude PJI. On the basis of the obtained results, PMN% analyses overrule LC measurements with regard to a conclusive diagnostic algorithm. Cite this article: Bone Jt Open 2021;2(8):566-572.

Train early and with deliberate practice: simple coronary surgery simulation platform results in fast increase in technical surgical skills in residents and students.

OBJECTIVES: The amount of intense and focused training with the specific goal to improve performance (i.e. deliberate practice) is a predictor of expert-level performance in multiple domains of psychomotor skill learning. Simulation training improves surgical skills in cardiac surgery. We established a training programme that enables early surgical exposure and assessment. We investigated the training effects in coronary surgery simulations in trainees with different levels of surgical experience. METHODS: The early surgical exposure and assessment programme comprises a low- and high-fidelity simulation, self-organized training, instructed workshops and a stepwise challenge increase. Performance was assessed with a multidimensional skill matrix using video recordings. Two groups of trainees [students (N = 7), 1-/2-year residents (N = 6)] completed introductory training (pretraining, level 1) and two 3-week training periods (levels 2 and 3). Fellows (N = 6) served as controls. Residents and students underwent deliberate practice training with specific training targets. Fellows performed regularly scheduled coronary surgery cases. Entry and exit assessments were conducted for levels 2 and 3. RESULTS: Fellows did not improve overall performance. Residents and students showed significant improvements in both technical accuracy and completion times. Residents reached an overall performance level comparable to fellows. Students reached similar accuracy of surgical skills with longer completion times [level 3 exit score/time: fellows 27 (24-29)/min; residents 27 (21-30)/min, P = 0.94; students 17 (17-25)/min, P = 0.068]. CONCLUSIONS: Deliberate practice training resulted in a fast and substantial increase in surgical skills in residents and students. Unexperienced residents reach performance levels of fellows. Deliberate practice simulation programmes should be a mandatory component of surgical training.

Wearable Cardioverter-Defibrillators following Cardiac Surgery-A Single-Center Experience.

BACKGROUND: A wearable cardioverter-defibrillator (WCD) can terminate ventricular fibrillation and ventricular tachycardias via electrical shock and thus give transient protection from sudden cardiac death. We investigated its role after cardiac surgery. METHODS: We retrospectively analyzed all patients who were discharged with a WCD from cardiac surgery department. The WCD was prescribed for patients with a left ventricular ejection fraction (LVEF) of ≤35% or an explanted implantable cardioverter-defibrillator (ICD). RESULTS: A total of 100 patients were included in this study, the majority (n = 59) had received coronary artery bypass graft surgery. The median wearing time of a WCD patient was 23.5 hours per day. LVEF was 28.9 ± 8% after surgery and improved in the follow-up to 36.7 ± 11% (p < 0.001). Three patients were successfully defibrillated. Ten patients experienced ventricular tachycardias. No inappropriate shocks were given. An ICD was implanted in 25 patients after the WCD wearing period. CONCLUSION: Ventricular arrhythmias occurred in 13% of the investigated patients. LVEF improved significantly after 3 months, and thus a permanent ICD implantation was avoided in several cases. Sternotomy did not impair wearing time of the WCD. A WCD can effectively protect patients against ventricular tachyarrhythmias after cardiac surgery.

Fibroblast growth factor 23 is induced by an activated renin-angiotensin-aldosterone system in cardiac myocytes and promotes the pro-fibrotic crosstalk between cardiac myocytes and fibroblasts.

Background: Fibroblast growth factor 23 (FGF23) is discussed as a new biomarker of cardiac hypertrophy and mortality in patients with and without chronic kidney disease (CKD). We previously demonstrated that FGF23 is expressed by cardiac myocytes, enhanced in CKD and induces cardiac hypertrophy via activation of FGF receptor 4 independent of its co-receptor klotho. The impact of FGF23 on cardiac fibrosis is largely unknown. Methods: By conducting a retrospective case-control study including myocardial autopsy samples from 24 patients with end-stage CKD and in vitro studies in cardiac fibroblasts and myocytes, we investigated the pro-fibrotic properties of FGF23. Results: The accumulation of fibrillar collagens I and III was increased in myocardial tissue of CKD patients and correlated with dialysis vintage, klotho deficiency and enhanced cardiac angiotensinogen (AGT) expression. Using human fibrosis RT2 Profiler PCR array analysis, transforming growth factor (TGF)-ß and its related TGF-ß receptor/Smad complexes, extracellular matrix remodeling enzymes and pro-fibrotic growth factors were upregulated in myocardial tissue of CKD patients. FGF23 stimulated cell proliferation, migration, pro-fibrotic TGF-ß receptor/Smad complexes and collagen synthesis in cultured cardiac fibroblasts. In isolated cardiac myocytes, FGF23 enhanced collagen remodeling, expression of pro-inflammatory genes and pro-survival pathways and induced pro-hypertrophic genes. FGF23 stimulated AGT expression in cardiac myocytes and angiotensin II and aldosterone, as components of the renin-angiotensin-aldosterone system (RAAS), induced FGF23 in cardiac myocytes. Conclusions: Our data demonstrate that activated RAAS induces FGF23 expression in cardiac myocytes and thereby stimulates a pro-fibrotic crosstalk between cardiac myocytes and fibroblasts, which may contribute to myocardial fibrosis in CKD.

Induction of cardiac FGF23/FGFR4 expression is associated with left ventricular hypertrophy in patients with chronic kidney disease.

BACKGROUND: In chronic kidney disease (CKD), serum concentrations of fibroblast growth factor 23 (FGF23) increase progressively as glomerular filtration rate declines, while renal expression of the FGF23 coreceptor Klotho decreases. Elevated circulating FGF23 levels are strongly associated with mortality and with left ventricular hypertrophy (LVH), which is a major cause of cardiovascular death in CKD patients. The cardiac FGF23/FGF receptor (FGFR) system and its role in the development of LVH in humans have not been addressed previously. METHODS: We conducted a retrospective case-control study in 24 deceased patients with childhood-onset end-stage renal disease (dialysis: n = 17; transplanted: n = 7), and 24 age- and sex-matched control subjects. Myocardial autopsy samples of the left ventricle were evaluated for expression of endogenous FGF23, FGFR isoforms, Klotho, calcineurin and nuclear factor of activated T-cells (NFAT) by immunohistochemistry, immunofluorescence microscopy, qRT-PCR and western blotting. RESULTS: The majority of patients presented with LVH (67%). Human cardiomyocytes express full-length FGF23, and cardiac FGF23 is excessively high in patients with CKD. Enhanced myocardial expression of FGF23 in concert with Klotho deficiency strongly correlates with the presence of LVH. Cardiac FGF23 levels associate with time-averaged serum phosphate levels, up-regulation of FGFR4 and activation of the calcineurin-NFAT signaling pathway, an established mediator of cardiac remodelling and LVH. These changes are detected in patients on dialysis but not in those with a functioning kidney transplant. CONCLUSIONS: Our results indicate a strong association between LVH and enhanced expression levels of FGF23, FGFR4 and calcineurin, activation of NFAT and reduced levels of soluble Klotho in the myocardium of patients with CKD. These alterations are not observed in kidney transplant patients.