Outcome after total ankle replacement or ankle arthrodesis in end-stage ankle osteoarthritis on the basis of german-wide data: a retrospective comparative study over 10 years.

BACKGROUND: In symptomatic end-stage osteoarthritis of the ankle joint, total ankle replacement and ankle arthrodesis are the two primary surgical options for patients for whom conservative treatment fails. Published revision rates are often biased and difficult to compare. In this study, unplanned reoperation rates and revision rates were determined for both surgical interventions based on a large dataset, and risk factors for unplanned reoperations were identified. METHODS: German-wide health data of the largest German health-care insurance carrier between 2001 and 2012 were retrospectively analyzed, and unplanned reoperation rates within 10 years were determined for index surgeries conducted in 2001 and 2002. Unplanned reoperation rates within 5 years for index surgeries conducted in 2001/2002 were compared to index surgeries conducted in 2006/2007. Multivariate logistic regression was used to identify risk factors for unplanned reoperations. RESULTS: After ankle arthrodesis, 19% (95% confidence interval [CI], 16-22%) of 741 patients needed to undergo an unplanned reoperation within ten years. After total ankle replacement, the unplanned reoperation rate was 38% [95% CI, 29-48%] among 172 patients. For initial surgeries conducted at a later date, unplanned reoperation rates within five years were 21% [95% CI, 19-24%] for 1,168 ankle arthrodesis patients and 23% [95% CI, 19-28%] for 561 total ankle replacement patients. Significant risk factors for unplanned reoperations after ankle arthrodesis in the initial cohort were age < 50 years (odds ratio [OR] = 4.65 [95% CI 1.10;19.56]) and osteoporosis (OR = 3.72 [95% CI, 1.06;13.11]); after total ankle replacement, they were osteoporosis (OR = 2.96 [95% CI, 1.65;5.31]), Patient Clinical Complexity Level (PCCL) grade 3 (OR = 2.19 [95% CI, 1.19;4.03]), PCCL grade 4 (OR = 2.51 [95% CI, 1.22;5.17]) and diabetes mellitus (OR = 2.48 [95% CI, 1.33;4.66]). Kaplan-Meier analyses including 1,525 ankle arthrodesis patients and 644 total ankle replacement patients revealed an average unplanned reoperation-free time of approximately 17 years for both procedures. CONCLUSIONS: Similar revision rates and unplanned reoperation rates for both procedures in the later-date cohort can likely be attributed to a learning curve for surgeons as well as advances in implant design. This analysis of billing health insurance data supports an increase in total ankle replacement surgeries.

Are birth outcomes in low risk birth cohorts related to hospital birth volumes? A systematic review.

BACKGROUND: There is convincing evidence that birth in hospitals with high birth volumes increases the chance of healthy survival in high-risk infants. However, it is unclear whether this is true also for low risk infants. The aim of this systematic review was to analyze effects of hospital's birth volume on mortality, mode of delivery, readmissions, complications and subsequent developmental delays in all births or predefined low risk birth cohorts. The search strategy included EMBASE and Medline supplemented by citing and cited literature of included studies and expert panel highlighting additional literature, published between January/2000 and February/2020. We included studies which were published in English or German language reporting effects of birth volumes on mortality in term or all births in countries with neonatal mortality < 5/1000. We undertook a double-independent title-abstract- and full-text screening and extraction of study characteristics, critical appraisal and outcomes in a qualitative evidence synthesis. RESULTS: 13 retrospective studies with mostly acceptable quality were included. Heterogeneous volume-thresholds, risk adjustments, outcomes and populations hindered a meta-analysis. Qualitatively, four of six studies reported significantly higher perinatal mortality in lower birth volume hospitals. Volume-outcome effects on neonatal mortality (n = 7), stillbirths (n = 3), maternal mortality (n = 1), caesarean sections (n = 2), maternal (n = 1) and neonatal complications (n = 1) were inconclusive. CONCLUSION: Analyzed studies indicate higher rates of perinatal mortality for low risk birth in hospitals with low birth volumes. Due to heterogeneity of studies, data synthesis was complicated and a meta-analysis was not possible. Therefore international core outcome sets should be defined and implemented in perinatal registries. SYSTEMATIC REVIEW REGISTRATION: PROSPERO: CRD42018095289.

Low Hospital Volume Increases Re-Revision Rate Following Aseptic Revision Total Knee Arthroplasty: An Analysis of 23,644 Cases.

BACKGROUND: Along with rising numbers of primary total knee arthroplasty (TKA), the number of revision total knee arthroplasties (R-TKAs) has been increasing. R-TKA is a complex procedure requiring special instruments, implants, and surgical skills. Therefore it is likely that hospitals with more R-TKAs have more experience with this type of surgery and therefore fewer complications. The purpose of this study is to evaluate the relationship between hospital volume and re-revision rate following R-TKA. METHODS: Using nationwide healthcare insurance data for inpatient hospital treatment, 23,644 aseptic R-TKAs in 21,573 patients treated between January 2013 and December 2017 were analyzed. Outcomes were 90-day mortality, 1-year re-revision rate, and in-house adverse events. The effect of hospital volumes on outcomes were analyzed by means of multivariate logistic regression. Adjusted odds ratios (OR) and 95% confidence intervals (CI) were calculated. RESULTS: Hospital volume had a significant effect on 1-year re-revision rate (≤12 R-TKA/a: OR 1.44, CI 1.20-1.72; 13-24 R-TKA/a: OR 1.43, CI 1.20-1.71; 25-52 R-TKA/a: OR 1.13, CI 0.94-1.35; ≥53 R-TKA/a: reference). Ninety-day mortality and major in-house adverse events decreased with increasing volume per year, but after risk adjustment this was not statistically significant. CONCLUSION: We found evidence of higher risk for re-revision surgery in hospitals with fewer than 25 R-TKA per year. It might contribute to improved patient care if complex elective procedures like R-TKA which require experience and a specific logistic background were performed in specialized centers.

Low Hospital Volume Increases Revision Rate and Mortality Following Revision Total Hip Arthroplasty: An Analysis of 17,773 Cases.

BACKGROUND: With the number of primary total hip arthroplasty (THA), the amount of revision THA (R-THA) increases. R-THA is a complex procedure requiring special instruments, implants, and surgical skills. Therefore it is likely that hospitals performing a higher number of R-THAs have more experience with this type of surgery and therefore fewer complications. The purpose of this study was to evaluate the relationship between hospital volume and risk of postoperative complications following R-THA. METHODS: Using nationwide healthcare insurance data for inpatient hospital treatment, 17,773 aseptic R-THAs in 16,376 patients treated between January 2014 and December 2016 were included. Outcomes were 90-day mortality, 1-year revision procedures, and in-house adverse events. The effect of hospital volume on outcome was analyzed by means of multivariate logistic regression. Adjusted odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. RESULTS: Hospital volume had a significant effect on 90-day mortality (≤12 cases per year: OR 2.13, CI 1.53-2.96; 13-24: OR 1.79, CI 1.29-2.50; 25-52: OR 1.53, CI 1.11-2.10; ≥53: reference) and 1-year revision procedures (≤12: OR 1.26, CI 1.09-1.47; 13-24: OR 1.18, CI 1.02-1.37; 25-52: OR 1.03, CI 0.90-1.19; ≥53: reference). There was no significant effect on risk-adjusted major in-house adverse events. CONCLUSION: We found evidence of higher risk for revision surgery and mortality in hospitals with fewer than 25 and 53 R-THA per year, respectively. To improve patient care, complex elective procedures like R-THA which require experience and a specific logistic background should be performed in specialized centers.

Obesity Increases the Risk of Postoperative Complications and Revision Rates Following Primary Total Hip Arthroplasty: An Analysis of 131,576 Total Hip Arthroplasty Cases.

BACKGROUND: The aim of our study is to evaluate the association of body mass index (BMI) and the risk of postoperative complications, mortality, and revision rates following primary total hip arthroplasty given other potentially confounding patient characteristics in a large cohort study. METHODS: Using nationwide billing data for inpatient hospital treatment of the biggest German healthcare insurance, 131,576 total hip arthroplasties in 124,368 patients between January 2012 and December 2014 were included. Outcomes were 90-day mortality, 1-year revision procedures (with and without removal or exchange of implants), 90-day surgical complications, 90-day femoral fractures, and overall complications. The effect of BMI on outcome was analyzed using multivariable logistic regression. Risk-adjusted odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. RESULTS: BMI had a significant effect on overall complications (30-34 in kg/m2: OR 1.1, CI 1.0-1.2, P = .014; 35-39: OR 1.5, CI 1.3-1.6, P < .001; ≥40: OR 2.1, CI 1.9-2.3, P < .001; <30: reference). The OR for 1-year revision procedures (30-34: OR 1.2, CI 1.1-1.4, P = .001; 35-39: OR 1.6, CI 1.4-1.8, P < .001; ≥40: OR 2.4, CI 2.1-2.7, P < .001; <30: reference) and 90-day surgical complications increased with every BMI category. For mortality and periprosthetic fractures there was a higher risk only for patients with BMI ≥40. CONCLUSION: BMI increases the risk of revision rates in a liner trend. Therefore, the authors believe that patients with a BMI >40 kg/m2 should be sent to obesity medicine physicians in order to decrease the body weight prior elective surgery.

Are TKAs Performed in High-volume Hospitals Less Likely to Undergo Revision Than TKAs Performed in Low-volume Hospitals?

BACKGROUND: High-volume hospitals have achieved better outcomes for THAs and unicompartmental knee arthroplasties (UKAs). However, few studies have analyzed implant survival after primary TKA in high-volume centers. QUESTIONS/PURPOSES: Is the risk of revision surgery higher when receiving a TKA in a low-volume hospital than in a high-volume hospital? METHODS: Using nationwide billing data of the largest German healthcare insurer for inpatient hospital treatment, we identified 45,165 TKAs in 44,465 patients insured by Allgemeine Ortskrankenkasse who had undergone knee replacement surgery between January 2012 and December 2012. Revision rates were calculated at 1 and 2 years in all knees. The hospital volume was calculated using volume quintiles of the number of all knee arthroplasties performed in each center. We used multiple logistic regression to model the odds of revision surgery as a function of hospital volume. Age, sex, 31 comorbidities, and variables for socioeconomic status were included as independent variables in the model. RESULTS: After controlling for socioeconomic factors, patient age, sex, and comorbidities, we found that having surgery in a high-volume hospital was associated with a decreased risk of having revision TKA within 2 years of the index procedure. The odds ratio for the 2-year revision was 1.6 (95% CI, 1.4-2.0; p < 0.001) for an annual hospital volume of 56 or fewer cases, 1.5 (95% CI, 1.3-1.7; p < 0.001) for 57 to 93 cases, 1.2 (95% CI, 1.0-1.3; p = 0.039) for 94 to 144 cases, and 1.1 (95% CI, 0.9-1.2; p = 0.319) for 145 to 251 cases compared with a hospital volume of 252 or more cases. CONCLUSIONS: We found a clear association of higher risk for revision surgery when undergoing a TKA in a hospital where less than 145 arthroplasties per year were performed. The study results could help practitioners to guide potential patients in hospitals that perform more TKAs to reduce the overall revision and complication rates. Furthermore, this study underscores the importance of a minimum hospital threshold of arthroplasty cases per year to get permission to perform an arthroplasty. LEVEL OF EVIDENCE: Level III, therapeutic study.

Oral anticoagulation in heart failure complicated by atrial fibrillation: A nationwide routine data study.

BACKGROUND: This nationwide routine data analysis evaluates if oral anticoagulant (OAC) use in patients with heart failure (HF) and atrial fibrillation (AF) leads to a lower mortality and reduced readmission rate. Superiority of new oral anticoagulants (NOACs), compared to vitamin K antagonists (VKA), was analyzed for these endpoints. METHODS: Anonymous data of patients with a health insurance at the Allgemeine Ortskrankenkasse and a claims record for hospitalization with the main diagnosis of HF and secondary diagnosis of AF (2017-2019) were included. A hospital stay in the previous year was an exclusion criterion. Mortality and readmission for all-cause and stroke/intracranial bleeding (ICB) were analyzed 91-365 days after the index hospitalization. Kaplan-Meier survival curves and multivariable Cox regression models were used to evaluate the impact of medication on outcome. RESULTS: 180,316 cases were included [81 years (IQR 76-86), 55.6% female, CHA2DS2-VASc score ≥ 2 (96.81%)]. In 80.6%, OACs were prescribed (VKA: 21.7%; direct factor Xa inhibitors (FXaI): 60.0%; direct thrombin inhibitors (DTI): 3.4%; with multiple prescriptions per patient included). Mortality rate was 19.1%, readmission rate was 29.9% and stroke/ICB occurred in 1.9%. Risk of death was lower with any OAC (HR 0.77, 95% CI [0.75-0.79]) but without significant differences in OAC type (VKA: HR 0.73, [0.71-0.76]; FXaI: HR 0.77, [0.75-0.78]; DTI: HR 0.71, [0.66-0.77]). The total readmission rate (HR 0.97, [0.94 to 0.99]) and readmission for stroke/ICB (HR 0.71, [0.65-0.77]) was lower with OAC. CONCLUSIONS: Nationwide data confirm a reduction in mortality and readmission rate in HF-AF patients taking OACs, without NOAC superiority.

[Three-year revision rate of certified centres for joint replacement according to EndoCert : Risk-adjusted analysis of outcome quality and comparison with other quality assurance systems]. / 3-Jahres-Revisionsrate von zertifizierten EndoProthetikZentren nach EndoCert : Risikoadjustierte Analyse der Ergebnisqualität und Vergleich mit anderen Qualitätssicherungssystemen.

BACKGROUND: The EndoCert initiative does not yet allow a long-term assessment of outcome quality. The assessment cannot be achieved without cooperation with the German arthroplasty registry (EPRD) and other quality assurance infrastructure, such as the quality assurance system of the nationwide healthcare insurance data for inpatient hospital treatment (QSR) by the German local healthcare fund (AOK). Therefore, the quality of care of all certified centres for joint replacement (EPZ) after primary hip and knee arthroplasty was to be examined for the first time. These data were subsequently compared to the data of the EPRD. MATERIALS AND METHODS: In EPZ that provided care to at least one AOK-insured patient in 2016, the risk-adjusted 3­year revision rate and the SMR-value (standardised mortality or morbidity ratio), which is the quotient of the observed and expected revision rate, were analysed as markers for the quality of care. Annual hospital volume, type of centre and audit results were examined as possible influencing factors. RESULTS: In the group comparison, significant differences (p = 0.042) for the SMR value of the 3­year revision rate were demonstrated for hip arthroplasty with regard to the EPZ type. The annual number of primary hip arthroplasties, however, did not influence the 3­year revision rate. For knee arthroplasties, no effect of the defined categories on the 3­year revision rate and its SMR value was observed. The comparison of our 3­year revision rates with those of the EPRD showed similar results for the hip but indicated significant differences for the knee. CONCLUSION: We did not observe a correlation between quality of care and annual hospital volume in certified EPZ. However, different quality assurance procedures can lead to different results with respect to the outcome quality. Therefore, a considerably improved interaction of the German quality systems must be achieved. Participation in the EPRD is not sufficient for this. Rather, a complete report of all arthroplasties must be required, at least with the achievement of a minimum reporting rate per participating hospital. Uniform inclusion and exclusion criteria should be defined.

Prevalence and Infant Mortality of Major Congenital Malformations Stratified by Birthweight.

BACKGROUND: Low birthweight and major congenital malformations (MCMs) are key causes of infant mortality. OBJECTIVES: The aim of this study was to explore the prevalence of MCMs in infants with low and very low birthweight and analyze the impact of MCMs and birthweight on infant mortality. METHODS: We determined prevalence and infant mortality of 28 life-threatening MCMs in very-low-birthweight (<1,500 g, VLBW), low-birthweight (1,500-2,499 g, LBW), or normal-birthweight (≥2,500 g, NBW) infants in a cohort of 2,727,002 infants born in Germany in 2006-2017, using de-identified administrative data of the largest statutory public health insurance system in Germany. RESULTS: The rates of VLBW, LBW, and NBW infants studied were 1.3% (34,401), 4.0% (109,558), and 94.7% (2,583,043). MCMs affected 0.5% (13,563) infants, of whom >75% (10,316) had severe congenital heart disease. The prevalence (per 10,000) of any/cardiac MCM was increased in VLBW (286/176) and LBW (244/143), as compared to NBW infants (38/32). Infant mortality rates were significantly higher in infants with an MCM, as opposed to infants without an MCM, in each birthweight group (VLBW 28.5% vs. 11.5%, LBW 16.7% vs. 0.9%, and NBW 8.6% vs. 0.1%). For most MCMs, observed survival rates in VLBW and LBW infants were lower than expected, as calculated from survival rates of VLBW or LBW infants without an MCM, and NBW infants with an MCM. CONCLUSIONS: Infants with an MCM are more often born with LBW or VLBW, as opposed to infants without an MCM. Many MCMs carry significant excess mortality when occurring in VLBW or LBW infants.

Risk-related short-term clinical outcomes after transcatheter aortic valve implantation and their impact on early mortality: an analysis of claims-based data from Germany.

OBJECTIVES: We aimed to define and assess risk-specific adverse outcomes after transcatheter aortic valve implantation (TAVI) in an all-comers patient population based on German administrative claims data. METHODS: Administrative claims data of patients undergoing transvascular TAVI between 2017 and 2019 derived from the largest provider of statutory health-care insurance in Germany were used. Patients' risk profile was assessed using the established Hospital Frailty Risk (HFR) score and 30-day adverse events were evaluated. Multivariable logistic regression models were applied to investigate the relation of patients' risk factors to clinical outcomes and, subsequently, of clinical outcomes to mortality. RESULTS: A total of 21,430 patients were included in the analysis. Of those, 51% were categorized as low-, 37% as intermediate-, and 12% as high-risk TAVI patients according to HFR score. Whereas low-risk TAVI patients showed low rates of periprocedural adverse events, TAVI patients at intermediate or high risk suffered from worse outcomes. An increase in HFR score was associated with an increased risk for all adverse outcome measures. The strongest association of patients' risk profile and outcome was present for cerebrovascular events and acute renal failure after TAVI. Independent of patients' risk, the latter showed the strongest relation with early mortality after TAVI. CONCLUSIONS: Differentiated outcomes after TAVI can be assessed using claims-based data and are highly dependent on patients' risk profile. The present study might be of use to define risk-adjusted outcome margins for TAVI patients in Germany on the basis of health-insurance data.

Blood transfusion and venous thromboembolism trends and risk factors in primary and aseptic revision total hip and knee arthroplasties: A nationwide investigation of 736,061 cases.

BACKGROUND: Over the last years, new transfusion guidelines and pharmaceuticals have been introduced in primary and revision total hip and knee arthroplasty (P-THA, P-TKA, R-THA, R-TKA). In the US, a substantial decrease in transfusions has been observed in recent years. Little data exists on the subject in Europe. In this context we aimed to analyze: (1) Is there also a significant decrease in blood transfusion for these procedures in Germany? (2) Which patient and hospital related factors are associated with the risk of blood transfusion? (3) Is there a trend in complications, especially venous thromboembolism and stroke events that can be linked to tranexamic acid use? HYPOTHESIS: There is a significant trend in decreasing blood transfusions in hip and knee arthroplasty. METHODS: Using nationwide healthcare insurance data for inpatient hospital treatment, 736,061 cases treated between January 2011 and December 2017 were included (318,997 P-THAs, 43,780 R-THAs, 338,641 P-TKAs, 34,643 R-TKAs). Multivariable logistic regression was used to model the odds of transfusion as a function of the year of surgery. Adjusted odds ratios (OR) and 95% confidence intervals (CI) were calculated. RESULTS: In each cohort the odds of transfusion decreased over time (2017 vs. 2011 (reference): P-THA: OR 0.42 (95%CI: 0.39-0.45), P-TKA: OR 0.41 (95%CI: 0.37-0.46), R-THA: OR 0.52 (95%CI: 0.47-0.58), R-TKA: OR 0.53 (95%CI: 0.46-0.61). Patient-related risk factors for blood transfusion included older age, female gender, lower Body Mass Index, comorbidities such as renal failure, cardiac arrhythmia, congestive heart failure, valvular disease, coagulopathy, depression, and antithrombotic medication prior to surgery. Venous thromboembolism or stroke events did not increase over the study period. DISCUSSION: The incidence of blood transfusions in primary and revision TKA and THA decreased over the study period. This may be due to new transfusion guidelines and the introduction of novel pharmaceuticals such as tranexamic acid. A further improved patient blood management and a focus on vulnerable patient groups might lead to a further future reduction of transfusions, especially in R-THA. LEVEL OF EVIDENCE: III; comparative observational study.

Time to Surgery and Outcome in the Treatment of Proximal Femoral Fractures.

BACKGROUND: It has not been conclusively established whether, or to what extent, the time to surgery affects mortality and the risk of complications after the surgical treatment of proximal femoral fractures. METHODS: Data on 106 187 hospitalizations over the period 2015-2017 involving insurees of the German AOK health insurance company aged 20 and above were drawn from pseudonymized billing data and stratified in three subgroups: osteosynthesis for pertrochanteric fracture (PTF-OS: N = 52 358), osteosynthesis for femoral neck fracture (FNF-OS: N = 7970), and endoprosthesis for femoral neck fracture (FNF-EP: N = 45 859). Multivariate regression models were used to analyze the relation between preoperative in-hospital stay (time to surgery, TTS: 0 days [reference category], 1, 2, 3, 4-7 days) and mortality and general complications within 90 days, with risk adjustment for fracture site, operative method, age, sex, accompanying illnesses, and antithrombotic medication in the preceding year. RESULTS: Mortality was significantly elevated only with PTF-OS, and only with a TTS of 2 days (odds ratio: 1.12 [95% confidence interval: (1.02; 1.23)]). General complications in relation to TTS were significantly elevated in the following situations: PTF-OS: 2 days: OR 1.24 [1.13; 1.37], 3 days: OR 1.33 [1.11; 1.60], 4-7 days: OR 1.47 [1.21; 1.78]; FNF-EP: 3 days: OR 1.21 [1.06; 1.37], 4-7 days: OR 1.42 [1.25; 1.62]; FNF-OS: 4-7 days: OR 1.86 [1.26; 2.73]. CONCLUSION: A prolonged time to surgery is associated with an elevated general complication risk depending on the site of the fracture and the type of surgical procedure used.

Impact of regionalisation and case-volume on neonatal and perinatal mortality: an umbrella review.

OBJECTIVE: This umbrella review summarises and critically appraises the evidence on the effects of regulated or high-volume perinatal care on outcome among very low birth weight/very preterm infants born in countries with neonatal mortality <5/1000 births. INTERVENTION/EXPOSITION: Perinatal regionalisation, centralisation, case-volume. PRIMARY OUTCOMES: Death. SECONDARY OUTCOMES: Disability, discomfort, disease, dissatisfaction. METHODS: On 29 November 2019 a systematic search in MEDLINE and Embase was performed and supplemented by hand search. Relevant systematic reviews (SRs) were critically appraised with A MeaSurement Tool to Assess systematic Reviews 2. RESULTS: The literature search revealed 508 hits and three SRs were included. Effects of perinatal regionalisation were assessed in three (34 studies) and case-volume in one SR (6 studies). Centralisation has not been evaluated. The included SRs reported effects on 'death' (eg, neonatal), 'disability' (eg, mental status), 'discomfort' (eg, maternal sensitivity) and 'disease' (eg, intraventricular haemorrhages). 'Dissatisfactions' were not reported. The critical appraisal showed a heterogeneous quality ranging from moderate to critically low. A pooled effect estimate was reported once and showed a significant favour of perinatal regionalisation in terms of neonatal mortality (OR 1.60, 95% CI 1.33-1.92). The qualitative evidence synthesis of the two SRs without pooled estimate suggests superiority of perinatal regionalisation in terms of different mortality and non-mortality outcomes. In one SR, contradictory results of lower neonatal mortality rates were reported in hospitals with higher birth volumes. CONCLUSIONS: Regionalised perinatal care seems to be a crucial care strategy to improve the survival of very low birth weight and preterm births. To overcome the low and critically low methodological quality and to consider additional clinical and patient-reported results that were not addressed by the SRs included, we recommend an updated SR. In the long term, an international, uniformly conceived and defined perinatal database could help to provide evidence-based recommendations on optimal strategies to regionalise perinatal care. PROSPERO REGISTRATION NUMBER: CRD42018094835.

Case characteristics, resource use, and outcomes of 10 021 patients with COVID-19 admitted to 920 German hospitals: an observational study.

Background Nationwide, unbiased, and unselected data of hospitalised patients with COVID-19 are scarce. Our aim was to provide a detailed account of case characteristics, resource use, and outcomes of hospitalised patients with COVID-19 in Germany, where the health-care system has not been overwhelmed by the pandemic. METHODS: In this observational study, adult patients with a confirmed COVID-19 diagnosis, who were admitted to hospital in Germany between Feb 26 and April 19, 2020, and for whom a complete hospital course was available (ie, the patient was discharged or died in hospital) were included in the study cohort. Claims data from the German Local Health Care Funds were analysed. The data set included detailed information on patient characteristics, duration of hospital stay, type and duration of ventilation, and survival status. Patients with adjacent completed hospital stays were grouped into one case. Patients were grouped according to whether or not they had received any form of mechanical ventilation. To account for comorbidities, we used the Charlson comorbidity index. FINDINGS: Of 10 021 hospitalised patients being treated in 920 different hospitals, 1727 (17%) received mechanical ventilation (of whom 422 [24%] were aged 18-59 years, 382 [22%] were aged 60-69 years, 535 [31%] were aged 70-79 years, and 388 [23%] were aged ≥80 years). The median age was 72 years (IQR 57-82). Men and women were equally represented in the non-ventilated group, whereas twice as many men than women were in the ventilated group. The likelihood of being ventilated was 12% for women (580 of 4822) and 22% for men (1147 of 5199). The most common comorbidities were hypertension (5575 [56%] of 10 021), diabetes (2791 [28%]), cardiac arrhythmia (2699 [27%]), renal failure (2287 [23%]), heart failure (1963 [20%]), and chronic pulmonary disease (1358 [14%]). Dialysis was required in 599 (6%) of all patients and in 469 (27%) of 1727 ventilated patients. The Charlson comorbidity index was 0 for 3237 (39%) of 8294 patients without ventilation, but only 374 (22%) of 1727 ventilated patients. The mean duration of ventilation was 13·5 days (SD 12·1). In-hospital mortality was 22% overall (2229 of 10 021), with wide variation between patients without ventilation (1323 [16%] of 8294) and with ventilation (906 [53%] of 1727; 65 [45%] of 145 for non-invasive ventilation only, 70 [50%] of 141 for non-invasive ventilation failure, and 696 [53%] of 1318 for invasive mechanical ventilation). In-hospital mortality in ventilated patients requiring dialysis was 73% (342 of 469). In-hospital mortality for patients with ventilation by age ranged from 28% (117 of 422) in patients aged 18-59 years to 72% (280 of 388) in patients aged 80 years or older. INTERPRETATION: In the German health-care system, in which hospital capacities have not been overwhelmed by the COVID-19 pandemic, mortality has been high for patients receiving mechanical ventilation, particularly for patients aged 80 years or older and those requiring dialysis, and has been considerably lower for patients younger than 60 years. FUNDING: None.

[Impact of Case Numbers on the 5-Year Survival Rate of Unicondylar Knee Replacements in Germany]. / Einfluss der Fallzahl pro Klinik auf die 5-Jahres-Überlebensrate des unikondylären Kniegelenkersatzes in Deutschland.

BACKGROUND: Reported survival rates of unicondylar knee arthroplasty (UKA) vary considerably. The influences of patient characteristics and the type of implant have already been examined. This analysis investigated the influence of hospital volume on 5-year-survival rate, using administrative claims data of Germany's largest health insurance provider. METHODS: We analysed administrative claims data for 20,946 UKAs covered by the German local healthcare funds (Allgemeine Ortskrankenkasse, AOK) between 2006 and 2012. Survival rates were estimated using Kaplan-Meier analysis. The influence of hospital case numbers on 5-year survival was analysed by means of multivariable Cox regression adjusted for patient characteristics. We estimated hazard ratios (HR) with 95% confidence intervals for five hospital volume categories: < 12 cases, 13 - 24 cases, 25 - 52 cases, 53 - 104 cases, > 104 cases (per hospital and year). RESULTS: The overall 5-year Kaplan-Meier survival rate was 87.8% (95%-CI: 87.3 - 88.3%). This increased with hospital volume (< 12 cases: 84.1% vs. > 104 cases: 93.2%). The analysis identified low hospital volume as an independent risk factor for surgical revision (< 12 cases: HR = 2.13 [95%-CI 1.83 - 2.48]; 13 - 24 cases: HR = 1.94 [95%-CI: 1.67 - 2.25]; 25 - 52 cases: HR = 1.66 [95%-CI: 1.41 - 1.96]; 53 - 104 cases: HR = 1.51 [95%-CI: 1.28 - 1.77]; > 104 cases: reference category). DISCUSSION: Our analysis revealed a significant relationship between hospital case numbers and 5-year survival rate, which increases with hospital volume. The risk of surgical revision within 5 years in hospitals with fewer than 25 UKAs per year is approximately twice as high as in hospitals with more than 104 cases.

Drug-eluting stents in clinical routine: a 1-year follow-up analysis based on German health insurance administrative data from 2008 to 2014.

OBJECTIVES: To describe the use of drug-eluting stents (DESs) in the largest population of statutory health insurance members in Germany, including newly developed bio-resorbable vascular scaffolds (BVSs), and to evaluate 1-year complication rates of DES as compared with bare metal stents (BMSs) in this cohort. DESIGN: Routine data analysis of statutory health insurance claims data from the years 2008 to 2014. SETTING: The German healthcare insurance Allgemeine Ortskrankenkasse covers approximately 30% of the German population and is the largest nationwide provider of statutory healthcare insurance in Germany. PARTICIPANTS AND INTERVENTIONS: We included all patients with a claims record for a percutaneous coronary intervention (PCI) with either DES or BMS and additionally, from 2013, BVS. Patients with acute myocardial infarction (AMI) were excluded. MAIN OUTCOME MEASURE: major adverse cerebrovascular and cardiovascular event (MACCE, defined as mortality, AMI, stroke and transient ischaemic attack), bypass surgery, PCI and coronary angiography) at 1 year after the intervention. RESULTS: A total of 243 581 PCI cases were included (DES excluding BVS: 143 765; BVS: 1440; BMS: 98 376). The 1-year MACCE rate was 7.42% in the DES subgroup excluding BVS and 11.29% in the BMS subgroup. The adjusted OR for MACCE was 0.72 (95% CI 0.70 to 0.75) in patients with DES excluding BVS as compared with patients with BMS. In the BVS group, the proportion of 1-year MACCE was 5.0%. CONCLUSION: The analyses demonstrate a lower MACCE rate for PCI with DES. BVSs are used in clinical routine in selected cases and seem to provide a high degree of safety, but data are still sparse.

Indication Criteria for Total Knee Arthroplasty in Patients with Osteoarthritis - A Multi-perspective Consensus Study.

Background and Objectives Knee osteoarthritis (OA) is a significant public health burden. Rates of total knee arthroplasty (TKA) in OA vary substantially between geographical regions, most likely due to the lack of standardised indication criteria. We set out to define indication criteria for the German healthcare system for TKA in patients with knee OA, on the basis of best evidence and transparent multi-stakeholder consensus. Methods We undertook a complex mixed methods study, including an iterative process of systematic appraisal of existing evidence, Delphi consensus methods and stakeholder conferences. We established a consensus panel representing key German national societies of healthcare providers (orthopaedic surgeons, rheumatologists, pain physicians, psychologists, physiotherapists), payers, and patient representatives. A priori defined consensus criteria were at least 70% agreement and less than 20% disagreement among the consensus panel. Agreement was sought for (1) core indication criteria defined as criteria that must be met to consider TKA in a normal patient with knee OA, (2) additional (not obligatory) indication criteria, (3) absolute contraindication criteria that generally prohibit TKA, and (4) risk factors that do not prohibit TKA, but usually do not lead to a recommendation for TKA. Results The following 5 core indication criteria were agreed within the panel: 1. intermittent (several times per week) or constant knee pain for at least 3 - 6 months; 2. radiological confirmation of structural knee damage (osteoarthritis, osteonecrosis); 3. inadequate response to conservative treatment, including pharmacological and non-pharmacological treatment for at least 3 - 6 months; 4. adverse impact of knee disease on patient's quality of life for at least 3 - 6 months; 5. patient-reported suffering/impairment due to knee disease. Additional indication criteria, contraindication criteria, and risk factors for adverse outcome were also agreed by a large majority within the multi-perspective stakeholder panel. Conclusion The defined indication criteria constitute a prerequisite for appropriate provision of TKA in patients with knee OA in Germany. In eligible patients, shared-decision making should eventually determine if TKA is performed or not. The next important steps are the implementation of the defined indication criteria, and the prospective investigation of predictors of success or failure of TKA in the context of routine care provision in Germany.

Revascularisation of patients with end-stage renal disease on chronic haemodialysis: bypass surgery versus PCI-analysis of routine statutory health insurance data.

OBJECTIVES: We aimed to analyse the short-term and long-term outcome of patients with end-stage renal disease (ESRD) undergoing percutaneous intervention (PCI) as compared to coronary artery bypass surgery (CABG) to evaluate the optimal coronary revascularisation strategy. DESIGN: Retrospective analysis of routine statutory health insurance data between 2010 and 2012. MAIN OUTCOME MEASURES: Primary outcome was adjusted all-cause mortality after 30 days and major adverse cardiovascular and cerebrovascular events at 1 year. Secondary outcomes were repeat revascularisation at 30 days and 1 year and bleeding events within 7 days. RESULTS: The total number of cases was n=4123 (PCI; n=3417), median age was 71 (IQR 62-77), 30.4% were women. The adjusted OR for death within 30 days was 0.59 (95% CI 0.43 to 0.81) for patients undergoing PCI versus CABG. At 1 year, the adjusted OR for major adverse cardiac and cerebrovascular events (MACCE) was 1.58 (1.32 to 1.89) for PCI versus CABG and 1.47 (1.23 to 1.75) for all-cause death. In the subgroup of patients with acute myocardial infarction (AMI), adjusted all-cause mortality at 30 days did not differ significantly between both groups (OR 0.75 (0.47 to 1.20)), whereas in patients without AMI the OR for 30-day mortality was 0.44 (0.28 to 0.68) for PCI versus CABG. At 1 year, the adjusted OR for MACCE in patients with AMI was 1.40 (1.06 to 1.85) for PCI versus CABG and 1.47 (1.08 to 1.99) for mortality. CONCLUSIONS: In this cohort of unselected patients with ESRD undergoing revascularisation, the 1-year outcome was better for CABG in patients with and without AMI. The 30-day mortality was higher in non-AMI patients with CABG reflecting an early hazard with surgery. In cases where the patient's characteristics and risk profile make it difficult to decide on a revascularisation strategy, CABG could be the preferred option.