Center Volumes Correlate with Likelihood of Stent Implantation in German Coronary Angiography.

Aims: Literature on percutaneous coronary intervention (PCI) stated an inverse relationship between hospital volume and mortality, but the effects on other characteristics are unclear. Methods: Using German national records, all coronary angiographies with coronary artery disease in 2017 were identified. We applied risk-adjustment to account for differences in population characteristics. Results: Of overall 528,188 patients, 55.22% received at least one stent, with on average 1.01 stents implanted in all patients. Based on those patients who received at least one stent, this corresponds to an average number of 1.82 stents. In-hospital mortality across all patients was 2.93%, length of hospital stay was 6.46 days, and mean reimbursement was €5,531. There were comparatively more emergency admissions in low volume centers and more complex cases (3-vessel disease, left main stenosis, and in-stent stenosis) in high volume centers. In multivariable regression analysis, volume and likelihood of stent implantation (p=0.003) as well as number of stents (p=0.020) were positively correlated. No relationship was seen for in-hospital mortality (p=0.105), length of stay (p=0.201), and reimbursement (p=0.108). Nonlinear influence of volume suggests a ceiling effect: In hospitals with ≤100 interventions, likelihood and number of implanted stents are lowest (∼34% and 0.6). After that, both rise steadily until a volume of 500 interventions. Finally, both remain stable in the categories of over 500 interventions (∼60% and 1.1). Conclusion: In PCI, lower volume centers contribute to emergency care. Higher volume centers treat more complex cases and show a higher likelihood of stent implantations, with a stable safety.

Coronary artery bypass grafting versus stent implantation in patients with chronic coronary syndrome and left main disease: insights from a register throughout Germany.

BACKGROUND: Recent randomized controlled trials have sparked debate about the optimal treatment of patients suffering from left main coronary artery disease. The present study analyzes outcomes of left main stenting versus coronary bypass grafting (CABG) in a nationwide registry in patients with chronic coronary syndrome (CCS). METHODS: All cases suffering from CCS and left main coronary artery disease treated either with CABG or stent, were identified within the database of the German bureau of statistics. Logistic or linear regression models were used with 20 baseline patient characteristics as potential confounders to compare both regimens. RESULTS: In 2018, 1318 cases with left main stenosis were treated with CABG and 8,920 with stent. Patients assigned for stenting were older (72.58 ± 9.87 vs. 68.63 ± 9.40, p < 0.001) and at higher operative risk, as assessed by logistic EuroSCORE (8.77 ± 8.45 vs. 4.85 ± 4.65, p < 0.001). After risk adjustment, no marked differences in outcomes were found for in-hospital mortality and stroke (risk adjusted odds ratio (aOR) for stent instead of CABG: aOR mortality: 1.08 [95% CI 0.66; 1.78], p = 0.748; aOR stroke: 0.59 [0.27; 1.32], p = 0.199). Stent implantation was associated with a reduced risk of relevant bleeding (aOR 0.38 [0.24; 0.61], p < 0.001), reduced prolonged ventilation time (aOR 0.54 [0.37 0.79], p = 0.002), and postoperative delirium (aOR 0.16 [0.11; 0.22], p < 0.001). Furthermore, stent implantation was associated with shorter hospital stay (- 6.78 days [- 5.86; - 7.71], p < 0.001) and lower costs (- €10,035 [- €11,500; - €8570], p < 0.001). CONCLUSION: Left main stenting is a safe and effective treatment option for CCS-patients suffering from left main coronary artery disease at reasonable economic cost. Coronary artery bypass grafting versus stent implantation in patients with chronic coronary syndrome and left main disease: insights from a register throughout Germany. All cases with chronic coronary syndrome and left main stenosis treated in 2018 in Germany either with left main stenting or coronary bypass grafting were extracted from a nation-wide database. In-hospital outcomes were compared after logistic regression analysis.

In-hospital outcomes of self-expanding and balloon-expandable transcatheter heart valves in Germany.

INTRODUCTION: The effect of valve type on outcomes in transfemoral transcatheter aortic valve replacement (TF-TAVR) has recently been subject of debate. We investigate outcomes of patients treated with balloon-expanding (BE) vs. self-expanding (SE) valves in in a cohort of all these procedures performed in Germany in 2018. METHODS: All patients receiving TF-TAVR with either BE (N = 9,882) or SE (N = 7,413) valves in Germany in 2018 were identified. In-hospital outcomes were analyzed for the endpoints in-hospital mortality, major bleeding, stroke, acute kidney injury, postoperative delirium, permanent pacemaker implantation, mechanical ventilation > 48 h, length of hospital stay, and reimbursement. Since patients were not randomized to the two treatment options, logistic or linear regression models were used with 22 baseline patient characteristics and center-specific variables as potential confounders. As a sensitivity analysis, the same confounding factors were taken into account using the propensity score methods (inverse probability of treatment weighting). RESULTS: Baseline characteristics differed substantially, with higher EuroSCORE (p < 0.001), age (p < 0.001) and rate of female sex (p < 0.001) in SE treated patients. After risk adjustment, no marked differences in outcomes were found for in-hospital mortality [risk adjusted odds ratio (aOR) for SE instead of BE 0.94 (96% CI 0.76;1.17), p = 0.617] major bleeding [aOR 0.91 (0.73;1.14), p = 0.400], stroke [aOR 1.13 (0.88;1.46), p = 0.347], acute kidney injury [OR 0.97 (0.85;1.10), p = 0.621], postoperative delirium [aOR 1.09 (0.96;1.24), p = 0.184], mechanical ventilation > 48 h [aOR 0.98 (0.77;1.25), p = 0.893], length of hospital stay (risk adjusted difference in days of hospitalization (SE instead of BE): - 0.05 [- 0.34;0.25], p = 0.762) and reimbursement [risk adjusted difference in reimbursement (SE instead of BE): - €72 (- €291;€147), p = 0.519)] There is, however, an increased risk of PPI for SE valves (aOR 1.27 [1.15;1.41], p < 0.001). Similar results were found after application of propensity score adjustment. CONCLUSIONS: We find broadly equivalent outcomes in contemporary TF-TAVR procedures, regardless of the valve type used. Incidence of major complications is very low for both types of valve.

The complex interplay of climate, TBEV vector dynamics and TBEV infection rates in ticks-Monitoring a natural TBEV focus in Germany, 2009-2018.

BACKGROUND: Tick-borne encephalitis (TBE) is the most important tick-borne viral disease in Eurasia and causes disease in humans and in a number of animals, among them dogs and horses. There is still no good correlation between tick numbers, weather conditions and human cases. There is the hypothesis that co-feeding due to simultaneous occurrence of larvae and nymphs may be a factor for the increased transmission of the virus in nature and for human disease. Based on long-term data from a natural TBEV focus, phylogenetic results and meteorological data we sought to challenge this hypothesis. METHODS: Ticks from an identified TBE natural focus were sampled monthly from 04/2009 to 12/2018. Ticks were identified and pooled. Pools were tested by RT-qPCR. Positive pools were confirmed by virus isolation and/or sequencing of additional genes (E gene, NS2 gene). Temperature data such as the decadal (10-day) mean daily maximum air temperature (DMDMAT) were obtained from a nearby weather station and statistical correlations between tick occurrence and minimal infection rates (MIR) were calculated. RESULTS: In the study period from 04/2009 to 12/2018 a total of 15,530 ticks (2,226 females, 2,268 males, 11,036 nymphs) were collected. The overall MIR in nymphs over the whole period was 77/15,530 (0.49%), ranging from 0.09% (2009) to 1.36% (2015). The overall MIR of female ticks was 0.76% (17/2,226 ticks), range 0.14% (2013) to 3.59% (2016). The overall MIR of males was 0.57% (13/2,268 ticks), range from 0.26% (2009) to 0.97% (2015). The number of nymphs was statistically associated with a later start of spring/vegetation period, indicated by the onset of forsythia flowering. CONCLUSION: There was no particular correlation between DMDMAT dynamics in spring and/or autumn and the MIR of nymphs or adult ticks detected. However, there was a positive correlation between the number of nymphs and the number of reported human TBE cases in the following months, but not in the following year. The hypothesis of the importance of co-feeding of larvae and nymphs for the maintenance of transmission cycle of TBEV in nature is not supported by our findings.

Hospital costs associated with post-traumatic stress disorder in somatic patients: a retrospective study.

BACKGROUND: Post-traumatic stress disorder is likely to affect clinical courses in the somatic hospital ward when appearing as comorbidity. Thus, this study aimed to assess the costs associated with comorbid post-traumatic stress disorder in a somatic hospital and to analyze if reimbursement appropriately compensated additional costs. METHODS: The study used data from a German university hospital between 2011 and 2014, analyzing 198,819 inpatient episodes. Inpatient's episodes were included for analysis if they had a somatic primary diagnosis and a secondary diagnosis of post-traumatic stress disorder. Costs were calculated based on resource use and compared to reimbursement. Analyses were adjusted for sex, age and somatic comorbidities. RESULTS: N = 219 Inpatient's episode were found with primary somatic disorder and a comorbid post-traumatic stress disorder. Inpatients episodes with comorbid post-traumatic stress disorder were compared to 34,229 control episodes, which were hospitalized with the same main diagnosis. Post-traumatic stress disorder was associated with additional hospital costs of €2311 [95%CI €1268 - €3355], while reimbursement rose by €1387 [€563 - €2212]. Results indicate that extra costs associated with post-traumatic stress disorder are not fully reimbursed. Male patients showed higher hospital costs associated with post-traumatic stress disorder. On average, post-traumatic stress disorder was associated with an extra length of stay of 3.4 days [2.1-4.6 days]. CONCLUSION: Costs associated with post-traumatic stress disorder were substantial and exceeded reimbursement, indicating an inadequate reimbursement for somatic patients with comorbid post-traumatic stress disorder.

The impact of hospital-acquired infections on the patient-level reimbursement-cost relationship in a DRG-based hospital payment system.

Hospital-acquired infections (HAIs) are a common complication in inpatient care. We investigate the incentives to prevent HAIs under the German DRG-based reimbursement system. We analyze the relationship between resource use and reimbursements for HAI in 188,731 patient records from the University Medical Center Freiburg (2011-2014), comparing cases to appropriate non-HAI controls. Resource use is approximated using national standardized costing system data. Reimbursements are the actual payments to hospitals under the G-DRG system. Timing of HAI exposure, cost-clustering within main diagnoses and risk-adjustment are considered. The reimbursement-cost difference of HAI patients is negative (approximately - €4000). While controls on average also have a negative reimbursement-cost difference (approximately - €2000), HAI significantly increase this difference after controlling for confounding and timing of infection (- 1500, p < 0.01). HAIs caused by vancomycin-resistant Enterococci have the most unfavorable reimbursement-cost difference (- €10,800), significantly higher (- €9100, p < 0.05) than controls. Among infection types, pneumonia is associated with highest losses (- €8400 and - €5700 compared with controls, p < 0.05), while cost-reimbursement relationship for Clostridium difficile-associated diarrhea is comparatively balanced (- €3200 and - €500 compared to controls, p = 0.198). From the hospital administration's perspective, it is not the additional costs of HAIs, but rather the cost-reimbursement relationship which guides decisions. Costs exceeding reimbursements for HAI may increase infection prevention and control efforts and can be used to show their cost-effectiveness from the hospital perspective.

Impact of mechanical ventilation on the daily costs of ICU care: a systematic review and meta regression.

The impact of mechanical ventilation on the daily costs of intensive care unit (ICU) care is largely unknown. We thus conducted a systematic search for studies measuring the daily costs of ICU stays for general populations of adults (age ≥18 years) and the added costs of mechanical ventilation. The relative increase in the daily costs was estimated using random effects meta regression. The results of the analyses were applied to a recent study calculating the excess length-of-stay associated with ICU-acquired (ventilator-associated) pneumonia, a major complication of mechanical ventilation. The search identified five eligible studies including a total of 54 766 patients and ~238 037 patient days in the ICU. Overall, mechanical ventilation was associated with a 25.8% (95% CI 4.7%-51.2%) increase in the daily costs of ICU care. A combination of these estimates with standardised unit costs results in approximate daily costs of a single ventilated ICU day of €1654 and €1580 in France and Germany, respectively. Mechanical ventilation is a major driver of ICU costs and should be taken into account when measuring the financial burden of adverse events in ICU settings.

Tick-borne encephalitis virus infections in Germany. Seasonality and in-year patterns. A retrospective analysis from 2001-2018.

BACKGROUND: Little is known regarding the changing seasonality of infections with the tick-borne encephalitis virus (TBEV) and the incidence of the resulting disease over the last two decades. Seasonal patterns have to our knowledge not previously been systematically investigated and are poorly understood. We investigate emerging seasonal changes in clinical aspects like potentially increasing hospitalization during the year, variations in clinical symptoms and disease severity during the season and seasonal dynamics of fatal outcomes. MATERIAL AND METHODS: TBEV infection became a notifiable disease in Germany in 2001. We used the national reporting dataset spanning from 2001-2018, provided by the Robert Koch-Institute (RKI). There were general epidemiological variables available, including "symptom onset", "age" and "sex". Furthermore, several variables documented disease severity. These included "CNS symptoms", "myelitis", "fatal outcome" and "hospitalization". Potential factors influencing the occurrence of CNS symptoms, myelitis, hospitalizations and fatal outcome were analyzed using logistic regression models. Linear trends, including the "time point in year" at which TBEV infection related symptoms were detected, were tested using calendar year as a continuous covariate. In addition, seasonal trends and age and sex specific differences were exploratively tested for non-linear effects using restricted cubic splines with knot locations based on Harrell's recommended percentiles. Finally, the dynamic relationship between in-seasonal trends year of detection, sex and age was tested using interaction terms. RESULTS: 6,073 TBEV infection cases from 2001-2018 were included in our analysis. We find that from 2001-2018 TBEV infections are reported 0.69 days earlier each year (p<0.001). There was no detectable seasonal variation regarding the occurrence of fatal outcome, CNS and myelitis. However, there was a significant changing trend regarding hospitalizations over the course of the year: The risk for hospitalization increases until August, decreases again from October on. CONCLUSION: We present epidemiological evidence that the TBE season in Germany has shifted to start earlier over the last years, beginning approximately 12 days earlier in 2018 than it did in 2001. There are seasonal patterns regarding a higher risk of hospitalization during August.

Costs of hospital-acquired Clostridium difficile infections: an analysis on the effect of time-dependent exposures using routine and surveillance data.

BACKGROUND: Hospital-acquired infections have not only gained increasing attention clinically, but also methodologically, as a time-varying exposure. While methods to appropriately estimate extra length of stay (LOS) have been established and are increasingly used in the literature, proper estimation of cost figures has lagged behind. METHODS: Analysing the additional costs and reimbursements of Clostridium difficile-infections (CDI), we use a within-main-diagnosis-time-to-exposure stratification approach to incorporate time-varying exposures in a regression model, while at the same time accounting for cost clustering within diagnosis groups. RESULTS: We find that CDI is associated with €9000 of extra costs, €7800 of higher reimbursements, and 6.4 days extra length of stay. Using a conventional method, which suffers from time-dependent bias, we derive estimates more than three times as high (€23,000, €8000, 21 days respectively). We discuss our method in the context of recent methodological advances in the estimation of the costs of hospital-acquired infections. CONCLUSIONS: CDI is associated with sizeable in-hospital costs. Neglecting the methodological particularities of hospital-acquired infections can however substantially bias results. As the data needed for an appropriate analysis are collected routinely in most hospitals, we recommend our approach as a feasible way for estimating the economic impact of time-varying adverse events during hospital stay.

Estimating the additional costs per life saved due to transcatheter aortic valve replacement: a secondary data analysis of electronic health records in Germany.

Aortic stenosis (AS) is the most common valvular heart disease, with a dismal prognosis when untreated. Recommended therapy is surgical (SAVR) or transcatheter (TAVR) aortic valve replacement. Based on a retrospective cohort of isolated SAVR and TAVR procedures performed in Germany in 2015 (N = 17,826), we examine the impact of treatment selection on in-hospital mortality and total in-hospital costs for a variety of at-risk populations. Since patients were not randomized to the two treatment options, the two endpoints in-hospital mortality and reimbursement are analyzed using logistic and linear regression models with 20 predefined patient characteristics as potential confounders. Incremental cost-effectiveness ratios were calculated as a ratio of the risk-adjusted reimbursement and mortality differences with 95% confidence intervals obtained by Fieller's theorem. Our study shows that TF-TAVR is more costly that SAVR and that cost differences between the procedures vary little between patient groups. Results regarding in-hospital mortality are mixed. SAVR is the predominant procedure among younger patients. For patients older than 85 years or at intermediate and higher pre-operative risk TF-TAVR seems to be the treatment of choice. Incremental cost-effectiveness ratios (ICER) are most favorable for patients older than 85 years (ICER €154,839, 95% CI €89,163-€302,862), followed by patients at higher pre-operative risk (ICER €413,745, 95% CI €258,027-€952,273). A hypothetical shift from SAVR towards TF-TAVR among patients at intermediate pre-operative risk is associated with a less favorable ICER (€1,486,118, 95% CI €764,732-€23,692,323), as the risk-adjusted mortality benefit is relatively small (- 0.97% point), while the additional reimbursement is still eminent (+€14,464). From a German healthcare system payer's perspective, the additional costs per life saved due to TAVR are most favorable for patients older than 85 and/or at higher pre-operative risk.

Volume-outcome relationship in transcatheter aortic valve implantations in Germany 2008-2014: a secondary data analysis of electronic health records.

OBJECTIVES: We examine the volume-outcome relationship in isolated transcatheter aortic valve implantations (TAVI). Our interest was whether the volume-outcome relationship for TAVI exists on the centre level, whether it occurs equally for different outcomes and how it develops over time. DESIGN: Secondary data analysis of electronic health records. The comprehensive German Federal Bureau of Statistics Diagnosis Related Groups database was queried for data on all isolated TAVI procedures performed in Germany between 2008 and 2014. Logistic and linear regression analyses were carried out. Risk adjustment was applied using a predefined set of patient characteristics to account for differences in the risk factor composition of the patient populations between centres and over time. Centres performing TAVI were stratified into groups performing <50, 50-99 and ≥100 procedures per year. SETTING: Germany 2008-2014. PARTICIPANTS: All patients undergoing isolated TAVI in the observation period. INTERVENTIONS: None. PRIMARY AND SECONDARY OUTCOME MEASURES: In-hospital mortality, bleeding, stroke, probability of ventilation >48 hours, length of hospital stay and reimbursement. RESULTS: Between 2008 and 2014, a total of 43 996 TAVI procedures were performed in 113 different centres in Germany with a total of 2532 cases of in-hospital mortality. Risk-adjusted in-hospital mortality decreases over the years and is lower the higher the annual procedure volume at the centre is. The magnitude of the latter effect declines over the observation period. Our results indicate a ceiling effect in the volume-outcome relationship: the volume-outcome relationship is eminent in circumstances of relatively unfavourable outcomes. Alongside improving outcomes, however, the volume-outcome relationship decreases. Also, a volume-outcome relationship seems to be absent in circumstances of constantly low event rates. CONCLUSIONS: The hypothesised volume-outcome relationship for TAVI exists but diminishes and may disappear over time. This should be taken into account when considering mandatory minimum thresholds.

Sex-Specific Differences in Outcome of Transcatheter or Surgical Aortic Valve Replacement.

BACKGROUND: Differences in baseline characteristics and anatomy between female and male patients with aortic valve stenosis may influence outcomes after surgical and transcatheter aortic valve replacement (TAVR). We evaluated the effect of sex on in-hospital outcomes after transfemoral (TF-TAVR), transapical (TA-TAVR), or surgical (SAVR) aortic valve replacement in a nationwide cohort. METHODS: Baseline characteristics and outcomes from all isolated TAVR or SAVR procedures performed between 2011 and 2014 in German hospitals were analyzed (N = 64,794). Primary outcome was in-hospital mortality. Unadjusted and adjusted comparisons between women and men were performed within each treatment group. RESULTS: Females were generally older and had a higher EuroSCORE. Thus, they were preferentially treated with TF-TAVR, whereas the share of TF-TAVR and SAVR was similar in males. Females suffered more relevant bleeding after TF-TAVR and SAVR (TF-TAVR: adjusted odds ratio [aOR] = 1.16, P = 0.018; TA-TAVR: aOR = 0.98, P = 0.799; SAVR: aOR = 1.12, P = 0.005). However, prolonged postoperative ventilation was less frequently necessary in females (aOR TF-TAVR: 0.69, P < 0.001; TA-TAVR: 0.69, P < 0.001; SAVR: 0.76, P < 0.001) and stroke risk was lower (TA-TAVR: aOR = 0.60, P = 0.001; TF-TAVR: aOR = 0.74, P = 0.001; SAVR: aOR = 0.61, P < 0.001). In-hospital mortality was slightly decreased in females undergoing TF-TAVR after adjustment (aOR = 0.87, P = 0.047), and equal in TA-TAVR (aOR = 0.96, P = 0.640) or SAVR (aOR = 1.02, P = 0.807). CONCLUSIONS: This nation-wide analysis of sex-specific outcomes after aortic-valve replacement procedures showed that women are higher-risk for bleeding, but lower-risk for stroke, mechanical ventilation, and TF-TAVR mortality. Understanding these differences and their basis may help improve outcomes.

Risk factors and outcome of postoperative delirium after transcatheter aortic valve replacement.

BACKGROUND: POD is associated with a worse postoperative course in patients after cardiac surgery, but its incidence and effects after TAVR are not well-understood. The aim of the present study was to analyze incidence, risk factors, and in-hospital outcomes of postoperative delirium (POD) after transfemoral (TF-AVR) and transapical (TA-AVR) transcatheter aortic valve replacement (TAVR) in a nationwide cohort. METHODS AND RESULTS: Administrative data on all patients undergoing isolated TAVR in Germany in 2014 were analyzed. 9038 TF-AVR and 2522 TA-AVR procedures were performed. POD incidence was 7% after TF-AVR and 12% after TA-AVR. Atrial fibrillation (TF: OR 1.35, p < 0.001; TA: OR 1.53, p = 0.001) and NYHA III/IV (TF: OR 1.23, p = 0.017, TA: OR 1.51, p = 0.001) were independent risk factors for POD. Dementia was a risk factor only in TF-AVR (OR 3.04, p < 0.001). Female sex was protective (TF: OR 0.56, p < 0.001, TA: OR 0.51, p < 0.001). We found the occurrence of POD to be associated with more postoperative complications such as stroke and bleeding. Consequently, patients with POD were ventilated and hospitalized longer and suffered an increased risk of in-hospital mortality (unadjusted OR TF: 1.83, p = 0.001, TA: 1.82, p = 0.01). After adjusting for postoperative events and comorbidities, POD's effect on in-hospital mortality disappeared. In contrast, stroke and bleeding remained independent predictors for mortality irrespective of POD. CONCLUSIONS: Patients with POD after TAVR are at increased risk for in-hospital mortality. However, after adjusting for postoperative events and comorbidities, stroke and bleeding, but not POD, are independent mortality predictors.

The impact of post-procedural complications on reimbursement, length of stay and mechanical ventilation among patients undergoing transcatheter aortic valve implantation in Germany.

BACKGROUND: The impact of various post-procedural complications after transcatheter aortic valve implantation (TAVI) on resource use and their consequences in the German reimbursement system has still not been properly quantified. METHODS: In a retrospective observational study, we use data from the German DRG statistic on patient characteristics and in-hospital outcomes of all isolated TAVI procedures in 2013 (N = 9147). The impact of post-procedural complications on reimbursement, length of stay and mechanical ventilation was analyzed using both unadjusted and risk-adjusted linear and logistic regression analyses. RESULTS: A total of 235 (2.57%) strokes, 583 (6.37%) bleeding events, 474 (5.18%) cases of acute kidney injury and 1428 (15.61%) pacemaker implantations were documented. The predicted reimbursement of an uncomplicated TAVI procedure was €33,272, and bleeding events were associated with highest additional reimbursement (€12,839, p < 0.001), extra length of stay (14.58 days, p < 0.001), and increased likelihood of mechanical ventilation for more than 48 h (OR 17.91, p < 0.001). A more moderate complication-related impact on resource use and reimbursement was found for acute kidney injury (additional reimbursement: €5963, p < 0.001; extra length of stay: 7.92 days, p < 0.001; ventilation >48 h: OR 6.93, p < 0.001) as well as for stroke (additional reimbursement: €4125, p < 0.001; extra length of stay: 4.68 days, p < 0.001; ventilation >48 h: OR 5.73, p < 0.001). Pacemaker implantations, in contrast, were associated with comparably small increases in reimbursement (€662, p = 0.006) and length of stay (3.54 days, p = 0.006) and no impaired likelihood of mechanical ventilation more than 48 h (OR 1.22, p = 0.156). Interestingly, these complication-related consequences remain mostly unchanged after baseline risk-adjustment. CONCLUSIONS: Post procedural complications such as bleeding events, acute kidney injuries and strokes are associated with increased resource use and substantial amounts of additional reimbursement in Germany, which has important implications for decision making outside of the usual clinical sphere.

Two-year post-discharge costs of care among patients treated with transcatheter or surgical aortic valve replacement in Germany.

BACKGROUND: This study presents data on post-discharge costs of care among patients treated with transcatheter or surgical aortic valve replacement over a two year period. METHODS: Based on a prospective clinical trial, post-discharge utilization of health services and status of assistance were collected for 151 elderly patients via 2250 monthly telephone interviews, valued using standardized unit costs and analysed using two-part regression models. RESULTS: At month 1 post-discharge, total costs of care are substantially elevated (monthly mean: €3506.7) and then remain relatively stable over the following 23 months (monthly mean: €622.3). As expected, the majority of these costs are related to in-hospital care (~98% in month 1 post-discharge and ~72% in months 2-24). Patients that died during follow-up were associated with substantially higher cost estimates of in-hospital care than those surviving the two-year study period, while patients' age and other patient characteristics were of minor relevance. Estimated costs of outpatient care are lower at month 1 than during the rest of the study period, and not affected by the event of death during follow-up. The estimated costs of nursing care are, in contrast, much higher in year 2 than in year 1 and differ substantially by gender and type of procedure as well as by patients' age. Overall, these monthly cost estimates add up to €10,352 for the first and €7467.6 for the second year post-discharge. CONCLUSIONS: Substantial cost increases at month 1 post-discharge and in case of death during follow-up are the main findings of the study, which should be taken into account in future economic evaluations on the topic. Application of standardized unit costs in combination with monthly patient interviews allows for a far more precise estimate of the variability in post-discharge health service utilization in this group of patients than the ones given in previous studies. TRIAL REGISTRATION: German Clinical Trial Register Nr. DRKS00000797 .

Learning Curves Among All Patients Undergoing Transcatheter Aortic Valve Implantation in Germany: A Retrospective Observational Study.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a rapidly evolving technique for therapy of aortic stenosis. Previous studies report learning curves with respect to in-hospital mortality and clinical complications. We aim to determine whether observed improvements of in-hospital outcomes after TAVI are the result of improvements in procedures or due to a change in the patient population, and whether improvements differ between the transfemoral (TF) and the transapical (TA) approach. METHODS: Data was analyzed using risk-adjusted regression analyses in order to track the development of clinical outcomes of all isolated TAVI procedures performed in Germany from 2008 to 2013 (N=32.436) in all German hospitals performing TAVI. Measurements include in-hospital mortality, stroke, bleeding, and mechanical ventilation. RESULTS: Unadjusted mortality rates decrease over time for both TA-TAVI and TF-TAVI. Reductions in mortality were smaller for TA-TAVI than for TF-TAVI. These trends could also be observed for risk-adjusted (standardized) mortality rates, indicating that time trends and differences between TA-TAVI (around 7% in 2013) and TF-TAVI (around 4% in 2013) cannot be explained by changes in the risk factor composition of the patient populations. Bleeding complications decreased for both access routes. Both unadjusted and standardized bleeding rates were substantially higher for TA-TAVI. In addition, TA-TAVI procedures were associated with an increased likelihood of requiring >48h of mechanical ventilation. CONCLUSIONS: Observed improvements in TAVI-related in-hospital mortality are not due to a change in patient population. The results indicate the superiority of a TF-first approach.

Results of a randomized controlled trial analyzing telemedically supported case management in the first year after living donor kidney transplantation - a budget impact analysis from the healthcare perspective.

ᅟ: We analyze one-year costs and savings of a telemedically supported case management program after kidney transplantation from the perspective of the German Healthcare System. Recipients of living donor kidney transplantation (N = 46) were randomly allocated to either (1) standard aftercare or (2) standard aftercare plus additional telemedically supported case management. A range of cost figures of each patient's medical service utilization were calculated at month 3, 6 and 12 and analyzed using two-part regression models. In comparison to standard aftercare, patients receiving telemedically supported case management are associated with substantial lower costs related to unscheduled hospitalizations (mean difference: €3,417.46 per patient for the entire one-year period, p = 0.003). Taking all cost figures into account, patients receiving standard aftercare are associated, on average, with one-year medical service utilization costs of €10,449.28, while patients receiving telemedically supported case management are associated with €5,504.21 of costs (mean difference: € 4,945.07 per patient, p < 0.001). With estimated expenditures of €3,001.5 for telemedically supported case management of a single patient, we determined a mean difference of €1,943.57, but this result is not statistically significant (p = 0.128). Sensitivity analyses show that the program becomes cost-neutral at around ten participating patients, and was beneficial starting at 15 patients. Routine implementation of telemedically supported case management in German medium and high-volume transplant centers would result in annual cost savings of €791,033 for the German healthcare system. Patients with telemedically supported case management showed a lower utilization of medical services as well as better medical outcomes. Therefore, such programs should be implemented in medium and high-volume transplant centers. TRIAL REGISTRATION: DRKS00007634 ( http://www.drks.de/DRKS00007634 ).

Quality of life among elderly patients undergoing transcatheter or surgical aortic valve replacement- a model-based longitudinal data analysis.

BACKGROUND: Quality of life (QoL) measurements reported in observational studies are often biased, since patients who failed to improve are more likely to be unable to respond due to death or impairment. In order to observe the development of QoL in patients close to death, we analyzed a set of monthly QoL measurements for a cohort of elderly patients treated for aortic valve stenosis (AS) with special consideration of the effect of distance to death. METHODS: QoL in 169 elderly patients (age ≥ 75 years), treated either with transcatheter aortic valve replacement (TAVR; n = 92), surgical aortic-valve replacement (n = 70), or drug-based therapy (n = 7), was evaluated using the standardized EQ-5D questionnaire. Over a two-year period, patients were consulted using monthly telephone interviews or outpatient visits, leading to a total of 2463 time points at which QoL values, New York Heart Association (NYHA) Functional Classification and their status of assistance were assessed. Furthermore, post-procedural clinical events and complications were monitored. Linear and ordered logistic regression analyses with random intercept were carried out, taking into account overall trends and distance to death. RESULTS: QoL measures decreased slightly over time, were temporarily impaired at month 1 after the initial episode of hospitalization and decreased substantially at the end of life with a measurable effect starting at the sixth from last follow-up (month) before death. Many clinical complications (bleeding complications, stroke, acute kidney injury) showed an impairment of QoL measurements, but the inclusion of lagged variables demonstrated medium term (three months) QoL impairments for access site bleeding only. All other complications are associated with event-related impairments that decreased dramatically at the second and third follow-up interviews (month) after event. CONCLUSIONS: Distance to death shows clear effects on QoL and should be taken into account when analyzing QoL measures in the elderly patients treated for aortic valve stenosis. TRIAL REGISTRATION: German Clinical Trial Register Nr. DRKS00000797.

Implementing an intensified antibiotic stewardship programme targeting daptomycin use in orthopaedic surgery: a cost-benefit analysis from the hospital perspective.

BACKGROUND: Hospital antibiotic stewardship (ABS) programmes offer several evidence-based tools to control prescription rates of antibiotics in different settings, influence the incidence of nosocomial infections and to contain the development of multi-drug-resistant bacteria. In the context of endoprosthetic surgery, however, knowledge of core antibiotic stewardship strategies, comparisons of costs and benefits of hospital ABS programmes are still lacking. MATERIALS AND METHODS: We identified a high daptomycin use for the treatment of methicillin-sensitive staphylococcal infections as a potential target for our ABS intervention. In addition, we endorsed periprosthetic tissue cultures for the diagnosis of PJI. Monthly antibiotic use data were obtained from the hospital pharmacy and were expressed as WHO-ATC defined daily doses (DDD) and dose definitions adapted to local guidelines (recommended daily doses, RDD), normalized per 1000 patient days. The pre-intervention period was defined from February 2012 through January 2014 (24 months). The post-intervention period included monthly time points from February 2014 to April 2015 (15 months). For a basic cost-benefit analysis from the hospital perspective, three cost drivers were taken into account: (1) the cost savings due to changes in antimicrobial prescribing; (2) costs associated with the increase in the number of cultured tissue samples, and (3) the appointment of an infectious disease consultant. Interrupted time-series analysis (ITS) was applied. RESULTS: Descriptive analysis of the usage data showed a decline in overall use of anti-infective substances in the post-intervention period (334.9 vs. 221.4 RDDs/1000 patient days). The drug use density of daptomycin dropped by -75 % (51.7 vs. 12.9 RDD/1000 patient days), whereas the utilization of narrow-spectrum penicillins, in particular flucloxacillin, increased from 13.8 to 33.6 RDDs/1000 patient days. ITS analysis of the consumption dataset showed significant level changes for overall prescriptions, as well as for daptomycin (p < 0.001) and for narrow-spectrum penicillins (p = 0.001). The total costs of antibiotic consumption decreased by an estimated € 4563 per month (p < 0.001), and around 90 % of these savings were linked to a decrease in daptomycin consumption. Overall, the antibiotic stewardship programme was beneficial, as monthly cost savings of € 2575 (p = 0.005) were achieved. INTERPRETATION: In this example of large endoprosthetic surgery department in a community-based hospital, the applied hospital ABS programme targeting daptomycin use has shown to be feasible, effective and beneficial compared to no intervention.