One-year outcome of robotical vs. manual percutaneous coronary intervention.

BACKGROUND: Robotic-assisted percutaneous coronary intervention (R-PCI) is a promising technology for optimizing the treatment of patients with coronary heart disease. For a better understanding of the potential of R-PCI in clinical routine compared to conventional manual PCI (M-PCI) both initial treatment success of the index procedure and long-term outcome have to be analysed. METHODS: Prospective evaluation from the FRiK (DRKS00023868) registry of all R-PCI cases with the CorPath GRX Cardiology by Siemens Healthineers and Corindus in the Freiburg University Heart Center between 04/2022 and 03/2023. Index procedure success and safety, radiation dose of patients and personnel, and 1-year outcome will be reported. Findings will be compared to a prospective control group of M-PCI patients treated by the same team of interventionalists during the same observation period. RESULTS: Seventy patients received R-PCI and were included in the registry. PCI success rate was 100%, with 19% requiring manual assistance. No complications (MACE-major adverse cardiovascular events) occurred. Compared with 70 matched-pair M-PCI patients, there was a higher median procedural time (103 min vs. 67 min, p < 0.001) and fluoroscopy time (18 min vs. 15 min, p = 0.002), and more contrast volume was used (180 ml vs. 160 ml, p = 0.041) in R-PCI vs. M-PCI patients. However, there was no significant difference of the dose-area product (4062 vs. 3242 cGycm2, p = 0.361). One year after the intervention, there was no difference in mortality, rehospitalisation, unscheduled PCI or target vessel failure. Health-related quality of life evaluation 6 and 12 months after the index procedure (NYHA, CCS, SAQ7 and EQ-5D-5L) was similar in both groups. CONCLUSION: R-PCI is feasible and safe. Compared to M-PCI, index procedure success rate is high, safety profile is favourable, and manual assistance was required in only few cases. At 1-year follow-up results for R-PCI vs. M-PCI considering mortality, rehospitalisation, morbidity and target vessel failure were equal.

Myocarditis incidence and hospital mortality from 2007 to 2022: insights from a nationwide registry.

OBJECTIVES: To investigate the burden of disease of myocarditis in Germany and identify similarities and differences in myocarditis with or without COVID-19. METHODS: All patients hospitalized with myocarditis in Germany were included in this nationwide retrospective analysis. Data were retrieved from the Federal Statistical Office of Germany (DESTATIS) for the years from 2007 to 2022. The primary endpoint was hospital mortality. RESULTS: A total of 88,159 patients hospitalized with myocarditis were analyzed. Annual cases increased from 5100 in 2007 to 6593 in 2022 (p < 0.001 for trend) with higher incidence during winter months. Incidence per 100,000 inhabitants was 6.2 in 2007 rising to 7.8 in 2022 (p < 0.001 for trend). Hospital mortality remained constant at an average of 2.44% (p = 0.164 for trend). From 2020 to 2022, 1547/16,229 (9.53%) patients were hospitalized with both, myocarditis and COVID-19 (incidence 0.62/100,000 inhabitants and 180/100,000 hospitalizations with COVID-19). These patients differed significantly in most patient characteristics and had a higher rate of hospital mortality compared to myocarditis without COVID-19 (12.54% vs. 2.26%, respectively, p < 0.001). CONCLUSIONS: Myocarditis hospitalizations were slowly rising over the past 16 years with hospital mortality remaining unchanged. Incidence of hospitalizations with combined myocarditis and COVID-19 was low, but hospital mortality was high.

Estimated Annual Healthcare Costs After Acute Pulmonary Embolism: Results From a Prospective Multicentre Cohort Study.

OBJECTIVE: Patients surviving acute pulmonary embolism (PE) necessitate long-term treatment and follow-up. However, the chronic economic impact of PE on European healthcare systems remains to be determined. METHODS AND RESULTS: We calculated the direct cost of illness during the first year after discharge for the index PE, analyzing data from a multicentre prospective cohort study in Germany. Main and accompanying readmission diagnoses were used to calculate DRG-based hospital reimbursements; anticoagulation costs were estimated from the exact treatment duration and each drug's unique national identifier; and outpatient post-PE care costs from guidelines-recommended algorithms and national reimbursement catalogues. Of 1017 patients enrolled at 17 centres, 958 (94%) completed ≥ 3-month follow-up; of those, 24% were rehospitalized (0.34 [95% CI 0.30-0.39] readmissions per PE survivor). Age, coronary artery, pulmonary and kidney disease, diabetes, and (in the sensitivity analysis of 837 patients with complete 12-month follow-up) cancer, but not recurrent PE, were independent cost predictors by hurdle gamma regression accounting for zero readmissions. Estimated rehospitalization cost was €1138 (95% CI 896-1420) per patient. Anticoagulation duration was 329 (IQR 142-365) days, with estimated average per-patient costs of €1050 (median 972; IQR 458-1197); costs of scheduled ambulatory follow-up visits amounted to €181. Total estimated direct per-patient costs during the first year after PE ranged from €2369 (primary analysis) to €2542 (sensitivity analysis). CONCLUSIONS: By estimating per-patient costs and identifying cost drivers of post-PE care, our study may inform decisions concerning implementation and reimbursement of follow-up programmes aiming at improved cardiovascular prevention. (Trial registration number: DRKS00005939).

Reweighting and validation of the hospital frailty risk score using electronic health records in Germany: a retrospective observational study.

BACKGROUND: In the hospital setting, frailty is a significant risk factor, but difficult to measure in clinical practice. We propose a reweighting of an existing diagnoses-based frailty score using routine data from a tertiary care teaching hospital in southern Germany. METHODS: The dataset includes patient characteristics such as sex, age, primary and secondary diagnoses and in-hospital mortality. Based on this information, we recalculate the existing Hospital Frailty Risk Score. The cohort includes patients aged ≥ 75 and was divided into a development cohort (admission year 2011 to 2013, N = 30,525) and a validation cohort (2014, N = 11,202). A limited external validation is also conducted in a second validation cohort containing inpatient cases aged ≥ 75 in 2022 throughout Germany (N = 491,251). In the development cohort, LASSO regression analysis was used to select the most relevant variables and to generate a reweighted Frailty Score for the German setting. Discrimination is assessed using the area under the receiver operating characteristic curve (AUC). Visualization of calibration curves and decision curve analysis were carried out. Applicability of the reweighted Frailty Score in a non-elderly population was assessed using logistic regression models. RESULTS: Reweighting of the Frailty Score included only 53 out of the 109 frailty-related diagnoses and resulted in substantially better discrimination than the initial weighting of the score (AUC = 0.89 vs. AUC = 0.80, p < 0.001 in the validation cohort). Calibration curves show a good agreement between score-based predictions and actual observed mortality. Additional external validation using inpatient cases aged ≥ 75 in 2022 throughout Germany (N = 491,251) confirms the results regarding discrimination and calibration and underlines the geographic and temporal validity of the reweighted Frailty Score. Decision curve analysis indicates that the clinical usefulness of the reweighted score as a general decision support tool is superior to the initial version of the score. Assessment of the applicability of the reweighted Frailty Score in a non-elderly population (N = 198,819) shows that discrimination is superior to the initial version of the score (AUC = 0.92 vs. AUC = 0.87, p < 0.001). In addition, we observe a fairly age-stable influence of the reweighted Frailty Score on in-hospital mortality, which does not differ substantially for women and men. CONCLUSIONS: Our data indicate that the reweighted Frailty Score is superior to the original Frailty Score for identification of older, frail patients at risk for in-hospital mortality. Hence, we recommend using the reweighted Frailty Score in the German in-hospital setting.

The impact of the Covid-19 pandemic on the effectiveness of psychosomatic rehabilitation in Germany.

BACKGROUND: The aim of the present study is to investigate the impact of the Covid-19 pandemic on the effectiveness of psychosomatic rehabilitation. METHODS: Between April 2019 and March 2022, a total of 18,388 patients from 7 rehabilitation centres could be included in the study. For each patient, score values from the HEALTH-49 and ICF AT-50 Psych questionnaires were calculated at the beginning and at the end of rehabilitation and the effectiveness of the rehabilitation program was determined by comparing the scores at the beginning and at the end of the rehabilitation programme. Using risk adjusted linear mixed models, three time intervals were compared: a pre-pandemic episode (April 2019 to March 2020), the first year of the pandemic (April 2020 to March 2021) and the second year of the pandemic (April 2021 to March 2022). RESULTS: Overall, it can be stated that the pandemic has substantially impaired the effectiveness of psychosomatic rehabilitation measures. This phenomenon can be observed across a wide range of psychosocial markers and even two years after the start of the pandemic there is no end to the limited effectiveness. With regard to 'psychological and somatoform disorders', for example, there was a relative decrease in the effectiveness of the rehabilitation measure by 11.29% in the first year of the pandemic compared to the pre-pandemic episode, p < 0.001. In the second year of the pandemic, the effectiveness of the rehabilitation measure was still decreased by 8.8% compared to the pre-pandemic episode, p < 0.001. In addition, the evaluations show that a division of the pandemic effect into direct effects (on the individual) and indirect effects (via further complication of the occupational problem environment) can be made and that the pandemic-related complication of the occupational problem environment are still prevalent more than two years after the start of the pandemic. DISCUSSION: The Covid-19 pandemic has had a significant impact on the psychosomatic rehabilitation programs reducing the effectiveness of treatment not only for a short period of time but constantly until March 2022. TRIAL REGISTRATION NUMBER: DRKS00029669; Date of registration: 02/08/2022.

The Impact of COVID-19 on Mortality and Clinical Characteristics in Hospitalized Patients With Peripheral Artery Disease in the Year 2020 in Germany.

BACKGROUND: The COVID-19 pandemic developed its full destructive capacity in 2020. This retrospective study aimed to examine the effects of COVID-19 on the mortality and the clinical characteristics in PAD patients with COVID-19 compared to PAD patients without COVID-19. METHODS AND RESULTS: Data derived from a German nationwide register of the year 2020 which encompassed all hospitalized patients with PAD (n = 173.075); N = 2553 also suffered from a COVID-19 infection and had significantly higher mortality rates of 11.2%. PAD + COVID-19 patients presented more clinical complications like major amputations (11.59%), myocardial infarction (2.08%), cardiogenic shock (2.98%), chronic kidney failure with GFR<= 15 mL/min (5.33%) and prolonged ventilation time >48 h (3.37%). Rates of pulmonary thromboembolism (0.24%), myocardial infarction (2.08%), and stroke (1.02%) were low in patients with PAD + COVID-19. Adjusted regression analyses for risk differences revealed possible causes of higher mortality rates, such as prolonged ventilation time, pneumonia, major amputations, multiple organ system failure, and length of hospital stay in patients with severe PAD (Rutherford 5-6) + COVID-19. CONCLUSION: Pneumonia and major amputations were associated with high mortality rates in PAD + COVID-19 in 2020. However, we could not detect a relevant influence of pulmonary thromboembolism, myocardial infarction or stroke on higher death rates of PAD + COVID-19.

Drivers and recent trends of hospitalisation costs related to acute pulmonary embolism.

BACKGROUND AND AIMS: The socio-economic burden imposed by acute pulmonary embolism (PE) on European healthcare systems is largely unknown. We sought to determine temporal trends and identify cost drivers of hospitalisation for PE in Germany. METHODS AND RESULTS: We analysed the totality of reimbursed hospitalisation costs in Germany (G-DRG system) in the years 2016-2020. Overall, 484 884 PE hospitalisations were coded in this period. Direct hospital costs amounted to a median of 3572 (IQR, 2804 to 5869) euros, resulting in average total reimbursements of 710 million euros annually. Age, PE severity, comorbidities and in-hospital (particularly bleeding) complications were identified by multivariable logistic regression as significant cost drivers. Use of catheter-directed therapy (CDT) constantly increased (annual change in the absolute proportion of hospitalisations with CDT + 0.40% [95% CI + 0.32% to + 0.47%]; P < 0.001), and it more than doubled in the group of patients with severe PE (28% of the entire population) over time. Although CDT use was overall associated with increased hospitalisation costs, this association was no longer present (adjusted OR 1.02 [0.80-1.31]) in patients with severe PE and shock; this was related, at least in part, to a reduction in the median length of hospital stay (for 14.0 to 8.0 days). CONCLUSIONS: We identified current and emerging cost drivers of hospitalisation for PE, focusing on severe disease and intermediate/high risk of an adverse early outcome. The present study may inform reimbursement decisions by policymakers and help to guide future health economic analysis of advanced treatment options for patients with PE.

Accuracy of Event Rate and Effect Size Estimation in Major Cardiovascular Trials: A Systematic Review.

Importance: For the design of a randomized clinical trial (RCT), estimation of the expected event rate and effect size of an intervention is needed to calculate the sample size. Overestimation may lead to an underpowered trial. Objective: To evaluate the accuracy of published estimates of event rate and effect size in contemporary cardiovascular RCTs. Evidence Review: A systematic search was conducted in MEDLINE for multicenter cardiovascular RCTs associated with MeSH (Medical Subject Headings) terms for cardiovascular diseases published in the New England Journal of Medicine, JAMA, or the Lancet between January 1, 2010, and December 31, 2019. Identified trials underwent abstract review; eligible trials then underwent full review, and those with insufficiently reported data were excluded. Data were extracted from the original publication or the study protocol, and a random-effects model was used for data pooling. This review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guideline. The primary outcome was the accuracy of event rate and effect size estimation. Accuracy was determined by comparing the observed event rate in the control group and the effect size with their hypothesized values. Linear regression was used to determine the association between estimation accuracy and trial characteristics. Findings: Of the 873 RCTs identified, 374 underwent full review and 30 were subsequently excluded, resulting in 344 trials for analysis. The median observed event rate was 9.0% (IQR, 4.3% to 21.4%), which was significantly lower than the estimated event rate of 11.0% (IQR, 6.0% to 25.0%) with a median deviation of -12.3% (95% CI, -16.4% to -5.6%; P < .001). More than half of the trials (196 [61.1%]) overestimated the expected event rate. Accuracy of event rate estimation was associated with a higher likelihood of refuting the null hypothesis (0.13 [95% CI, 0.01 to 0.25]; P = .03). The median observed effect size in superiority trials was 0.91 (IQR, 0.74 to 0.99), which was significantly lower than the estimated effect size of 0.72 (IQR, 0.60 to 0.80), indicating a median overestimation of 23.1% (95% CI, 17.9% to 28.3%). A total of 216 trials (82.1%) overestimated the effect size. Conclusions and Relevance: In this systematic review of contemporary cardiovascular RCTs, event rates of the primary end point and effect sizes of an intervention were frequently overestimated. This overestimation may have contributed to the inability to adequately test the trial hypothesis.

Transcatheter aortic valve replacement in Germany with need for a surgical bailout.

BACKGROUND: In transcatheter aortic valve replacement (TAVR), complications may force the need for a surgical bailout, but knowledge is rare about outcomes in Germany. METHODS: Using national health records, we investigated all TAVR in German hospitals between 2007 and 2020, focusing on 2018-2020. We extracted data on those interventions with need for a surgical bailout. RESULTS: A total of 159,643 TAVR were analyzed, with an overall rate of surgical bailout of 2.30 %, an overall in-hospital mortality of 3.85 %, and in-hospital mortality in case of bailout of 16.51 %. The number of all annual TAVR procedures increased substantially (202 to 22,972), with the rate of surgical bailout declining from 27.23 to 0.61 % and overall mortality from 11.39 to 2.29 %. However, in-hospital mortality after bailout was still high (28.37 % in 2020). The standardized rates of overall mortality and surgical bailout between 2018 and 2020 were significantly lower for balloon-expandable and self-expanding transfemoral TAVR than for transapical TAVR after risk adjustment [transapical/transfemoral balloon-expandable/transfemoral self-expanding TAVR: in-hospital mortality: 5.66 % (95 % CI 4.81 %; 6.52 %)/2.30 % (2.03 %; 2.57 %)/2.32 % (2.07 %; 2.57 %); surgical bailout: 2.33 % (1.68 %; 2.97 %)/0.79 % (0.60 %; 0.98 %)/0.42 % (0.31 %; 0.53 %)]. Coronary artery disease [risk-adjusted OR = 1.50 (1.21; 1.85), p < 0.001] and atrial fibrillation [OR = 1.29 (1.07; 1.57), p = 0.009] were found to be the main risk factors for bailout. CONCLUSIONS: Rates of TAVR with need for a surgical bailout and overall in-hospital mortality have declined noticeably over the years in Germany. However, the outcomes are still unfavorable after surgical bailout, as in-hospital mortality is continuously high. We present risk factors for surgical bailout to improve preparation of subsequent measures. It must be a major goal to further reduce the rate of surgical bailouts in the future.

Low on-clopidogrel ADP- and TRAP-6-induced platelet aggregation in patients with atrial fibrillation undergoing percutaneous coronary intervention: an observational pilot study.

High on-clopidogrel platelet reactivity (HPR) associates with ischemic risk in patients after percutaneous intervention (PCI). This study aimed to evaluate the association of HPR as assessed by multiple electrode aggregometry (MEA) with ischemic, thromboembolic, and bleeding risk in patients with atrial fibrillation (AF) undergoing PCI. Patients with AF and an indication for oral anticoagulation (OAC) were included in this prospective cohort study on day 1-3 after PCI. Platelet aggregation [U] was analyzed by MEA. HPR and low platelet reactivity (LPR) were defined as ADP-induced aggregation ≥ 46 U and ≤ 18 U, respectively. TRAP-6-induced aggregation reference was 94-156 U. The primary outcome was time to all-cause death, myocardial infarction, or stroke at 6 months. The secondary outcome was time to non-major clinically relevant bleedings or major bleedings. 159 patients were enrolled between May 2020 and May 2021. The median age was 78 years (interquartile range 72-82) and 111 (70%) were male. Median ADP- and TRAP-induced aggregation were 12 (6-17) and 49 (35-68) U, respectively. 147 (93%) patients had a low overall aggregability. HPR was detected in 2 patients (1%) and 125 (79%) had LPR. ADP-induced aggregation did not significantly associate with the primary outcome (r = 0.081, p = 0.309) but correlated inversely with bleeding risk (r = - 0.201, p = 0.011). HPR status as assessed by MEA among patients with AF after PCI was rare and overall aggregability was low. Conventional cut-off values for HPR might be inappropriate for these patients. ADP-induced aggregation might be helpful to identify patients at risk for bleeding.

Modelling costs of interventional pulmonary embolism treatment: implications of US trends for a European healthcare system.

AIMS: Catheter-directed treatment (CDT) of acute pulmonary embolism (PE) is entering a growth phase in Europe following a steady increase in the USA in the past decade, but the potential economic impact on European healthcare systems remains unknown. METHODS AND RESULTS: We built two statistical models for the monthly trend of proportion of CDT among patients with severe (intermediate- or high-risk) PE in the USA. The conservative model was based on admission data from the National Inpatient Sample (NIS) 2016-20 and the model reflecting increasing access to advanced treatment from the PERT™ national quality assurance database registry 2018-21. By applying these models to the forecast of annual PE-related hospitalizations in Germany, we calculated the annual number of severe PE cases and the expected increase in CDT use for the period 2025-30. The NIS-based model yielded a slow increase, reaching 3.1% (95% confidence interval 3.0-3.2%) among all hospitalizations with PE in 2030; in the PERT-based model, increase would be steeper, reaching 8.7% (8.3-9.2%). Based on current reimbursement rates, we estimated an increase of annual costs for PE-related hospitalizations in Germany ranging from 15.3 to 49.8 million euros by 2030. This calculation does not account for potential cost savings, including those from reduced length of hospital stay. CONCLUSION: Our approach and results, which may be adapted to other European healthcare systems, provide a benchmark for healthcare costs expected to result from CDT. Data from ongoing trials on clinical benefits and cost savings are needed to determine cost-effectiveness and inform reimbursement decisions.

Impact of a complex health services intervention in long-term care nursing homes on 3-year overall survival: results from the CoCare study.

BACKGROUND: The Coordinated medical Care (CoCare) project aimed to improve the quality of medical care in nursing homes by optimizing collaboration between nurses and physicians. We analyze the impact of the CoCare intervention on overall survival. METHODS: The effect of time-varying treatment on 3-year overall survival was analyzed with treatment as time-varying covariate within the entire cohort. To reduce bias due to non-random assignment to treatment groups, regression adjustment was applied. Therefore, age, sex, and level of care were used as potential confounders. RESULTS: The study population consisted of 8,893 nursing home residents (NHRs), of which 1,330 participated in the CoCare intervention. The three-year overall survival was 49.8% in the entire cohort. NHRs receiving the intervention were associated with a higher survival probability compared to NHRs of the control group. In a univariable cox model with time-dependent treatment, the intervention was associated with a hazard ratio of 0.70 [95%CI 0.56-0.87, p = 0.002]. After adjustment for age, sex and level of care, the hazard ratio increased to 0.82 but was still significant [95%CI 0.71-0.96, p = 0.011]. CONCLUSION: The analysis shows that optimizing collaboration between nurses and physicians leads to better survival of NHRs in Germany. This adds to the already published favorable cost-benefit ratio of the CoCare intervention and shows that a routine implementation of optimized collaboration between nurses and physicians is highly recommended.

Longitudinal cardiac dimensions in patients undergoing LVAD implantation.

BACKGROUND: In conventional left ventricular assist devices (LVAD), a separate outflow graft is sutured to the ascending aorta. Novel device designs may include a transventricular outflow cannula crossing the aortic valve (AV). While transversal ventricular dimensions are well investigated in patients with severe heart failure, little is known about the longitudinal dimensions. These dimensions are, however, particularly critical for the design and development of mechanical circulatory support (MCS) devices with transaortic outflow cannula. METHODS: In an explorative retrospective cohort study at the University Medical Center Freiburg, Germany, the longitudinal cardiac dimensions of patients undergoing computed tomography angiography (CTA) before and, if available, after LVAD implantation were analyzed. Among others, the following dimensions were assessed: (a) apex to AV, (b) apex to mitral valve, (c) AV to sinotubular junction (STJ), (d) apex to STJ, (e) apex to brachiocephalic artery (BCA), and (f) AV to BCA. RESULTS: In total, 44 LVAD patients (36 male, age 55.8 years, height 1.75 m) were included. The longitudinal cardiac dimensions were (a) 114.5 ± 12.1 mm, (b) 108.0 ± 12.4 mm, (c) 20.9 ± 2.9, (d) 135.4 ± 13.4 mm, (e) 206.0 ± 18.3, and (f) 91.5 ± 9.8 mm. Postoperatively, (a) and (b) decreased by 31.5% and 39.5%, respectively (N = 14). CONCLUSIONS: Longitudinal cardiac dimensions may be reduced by up to 40% after LVAD implantation. A better knowledge of these dimensions and their postoperative alterations in LVAD patients may improve surgical planning and help to design MCS devices with transventricular outflow cannula.

Non-vitamin-K-antagonist oral anticoagulants (NOACs) after acute myocardial infarction: a network meta-analysis.

BACKGROUND: Balancing the risk of bleeding and thrombosis after acute myocardial infarction (AMI) is challenging, and the optimal antithrombotic therapy remains uncertain. The potential of non-vitamin K antagonist oral anticoagulants (NOACs) to prevent ischaemic cardiovascular events is promising, but the evidence remains limited. OBJECTIVES: To evaluate the efficacy and safety of non-vitamin-K-antagonist oral anticoagulants (NOACs) in addition to background antiplatelet therapy, compared with placebo, antiplatelet therapy, or both, after acute myocardial infarction (AMI) in people without an indication for anticoagulation (i.e. atrial fibrillation or venous thromboembolism). SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, the Conference Proceedings Citation Index - Science, and two clinical trial registers in September 2022 with no language restrictions. We checked the reference lists of included studies for any additional trials. SELECTION CRITERIA: We searched for randomised controlled trials (RCTs) that evaluated NOACs plus antiplatelet therapy versus placebo, antiplatelet therapy, or both, in people without an indication for anticoagulation after an AMI. DATA COLLECTION AND ANALYSIS: Two review authors independently checked the results of searches to identify relevant studies, assessed each included study, and extracted study data. We conducted random-effects pairwise analyses using Review Manager Web, and network meta-analysis using the R package 'netmeta'. We ranked competing treatments by P scores, which are derived from the P values of all pairwise comparisons and allow ranking of treatments on a continuous 0-to-1 scale. MAIN RESULTS: We identified seven eligible RCTs, including an ongoing trial that we could not include in the analysis. Of the six RCTs involving 33,039 participants, three RCTs compared rivaroxaban with placebo, two RCTs compared apixaban with placebo, and one RCT compared dabigatran with placebo. All participants in the six RCTs received concomitant antiplatelet therapy. The available evidence suggests that rivaroxaban compared with placebo reduces the rate of all-cause mortality (risk ratio (RR) 0.82, 95% confidence interval (CI) 0.69 to 0.98; number needed to treat for an additional beneficial outcome (NNTB) 250; 3 studies, 21,870 participants; high certainty) and probably reduces cardiovascular mortality (RR 0.83, 95% CI 0.69 to 1.01; NNTB 250; 3 studies, 21,870 participants; moderate certainty). There is probably little or no difference between apixaban and placebo in all-cause mortality (RR 1.09, 95% CI 0.88 to 1.35; number needed to treat for an additional harmful outcome (NNTH) 334; 2 studies, 8638 participants; moderate certainty) and cardiovascular mortality (RR 0.99, 95% CI 0.77 to 1.27; number needed to treat not applicable; 2 studies, 8638 participants; moderate certainty). Dabigatran may reduce the rate of all-cause mortality compared with placebo (RR 0.57, 95% CI 0.31 to 1.06; NNTB 63; 1 study, 1861 participants; low certainty). Dabigatran compared with placebo may have little or no effect on cardiovascular mortality, although the point estimate suggests benefit (RR 0.72, 95% CI 0.34 to 1.52; NNTB 143; 1 study, 1861 participants; low certainty). Two of the investigated NOACs were associated with an increased risk of major bleeding compared to placebo: apixaban (RR 2.41, 95% CI 1.44 to 4.06; NNTH 143; 2 studies, 8544 participants; high certainty) and rivaroxaban (RR 3.31, 95% CI 1.12 to 9.77; NNTH 125; 3 studies, 21,870 participants; high certainty). There may be little or no difference between dabigatran and placebo in the risk of major bleeding (RR 1.74, 95% CI 0.22 to 14.12; NNTH 500; 1 study, 1861 participants; low certainty). The results of the network meta-analysis were inconclusive between the different NOACs at all individual doses for all primary outcomes. However, low-certainty evidence suggests that apixaban (combined dose) may be less effective than rivaroxaban and dabigatran for preventing all-cause mortality after AMI in people without an indication for anticoagulation. AUTHORS' CONCLUSIONS: Compared with placebo, rivaroxaban reduces all-cause mortality and probably reduces cardiovascular mortality after AMI in people without an indication for anticoagulation. Dabigatran may reduce the rate of all-cause mortality and may have little or no effect on cardiovascular mortality. There is probably no meaningful difference in the rate of all-cause mortality and cardiovascular mortality between apixaban and placebo. Moreover, we found no meaningful benefit in efficacy outcomes for specific therapy doses of any investigated NOACs following AMI in people without an indication for anticoagulation. Evidence from the included studies suggests that rivaroxaban and apixaban increase the risk of major bleeding compared with placebo. There may be little or no difference between dabigatran and placebo in the risk of major bleeding. Network meta-analysis did not show any superiority of one NOAC over another for our prespecified primary outcomes. Although the evidence suggests that NOACs reduce mortality, the effect size or impact is small; moreover, NOACs may increase major bleeding. Head-to-head trials, comparing NOACs against each other, are required to provide more solid evidence.

Healthcare resource utilisation and associated costs after low-risk pulmonary embolism: pre-specified analysis of the Home Treatment of Pulmonary Embolism (HoT-PE) study.

BACKGROUND: Pulmonary embolism (PE) and its sequelae impact healthcare systems globally. Low-risk PE patients can be managed with early discharge strategies leading to cost savings, but post-discharge costs are undetermined. PURPOSE: To define healthcare resource utilisation and overall costs during follow-up of low-risk PE. METHODS: We used an incidence-based, bottom-up approach and calculated direct and indirect costs over 3-month follow-up after low-risk PE, with data from the Home Treatment of Patients with Low-Risk Pulmonary Embolism (HoT-PE) cohort study. RESULTS: Average 3-month costs per patient having suffered low-risk PE were 7029.62 €; of this amount, 4872.93 € were associated with PE, accounting to 69.3% of total costs. Specifically, direct costs totalled 3019.33 €, and of those, 862.64 € (28.6%) were associated with PE. Anticoagulation (279.00 €), rehospitalisations (296.83 €), and ambulatory visits (194.95 €) comprised the majority of the 3-month direct costs. The remaining costs amounting to 4010.29 € were indirect costs due to loss of productivity. CONCLUSION: In a patient cohort with acute low-risk PE followed over 3 months, the majority of costs were indirect costs related to productivity loss, whereas direct, PE-specific post-discharge costs were low. Effective interventions are needed to reduce the burden of PE and associated costs, especially those related to productivity loss.

A Mortality Prediction Score for Patients With Veno-Venous Extracorporeal Membrane Oxygenation (VV-ECMO): The PREDICT VV-ECMO Score.

Mortality prediction for patients with the severe acute respiratory distress syndrome (ARDS) supported with veno-venous extracorporeal membrane oxygenation (VV-ECMO) is challenging. Clinical variables at baseline and on day 3 after initiation of ECMO support of all patients treated from October 2010 through April 2020 were analyzed. Multivariate logistic regression analysis was used to identify score variables. Internal and external (Monza, Italy) validation was used to evaluate the predictive value of the model. Overall, 272 patients could be included for data analysis and creation of the PREDICT VV-ECMO score. The score comprises five parameters (age, lung fibrosis, immunosuppression, cumulative fluid balance, and ECMO sweep gas flow on day 3). Higher score values are associated with a higher probability of hospital death. The score showed favorable results in derivation and external validation cohorts (area under the receiver operating curve, AUC derivation cohort 0.76 [95% confidence interval, CI, 0.71-0.82] and AUC validation cohort 0.74 [95% CI, 0.67-0.82]). Four risk classes were defined: I ≤ 30, II 31-60, III 61-90, and IV ≥ 91 with a predicted mortality of 28.2%, 56.2%, 84.8%, and 96.1%, respectively. The PREDICT VV-ECMO score suggests favorable performance in predicting hospital mortality under ongoing ECMO support providing a sound basis for further evaluation in larger cohorts.

Comparing balloon-expandable and self-expanding transfemoral transcatheter aortic valve replacement based on subgroups in Germany 2019/2020.

BACKGROUND: Previously, overall comparable outcomes were seen for balloon-expandable (BE) or self-expanding (SE) transfemoral transcatheter aortic valve replacement (TAVR). However, subgroup analyses based on large case numbers are still needed. METHODS: German national data of all BE and SE transfemoral TAVR treating aortic valve stenosis in 2019 and 2020 were analysed. We then compared different outcomes and performed a subgroup analysis for the endpoint in-hospital mortality. RESULTS: Overall, 46,243 TAVR were analysed, 19,910 BE, and 26,333 SE. Patients in the SE group had a significantly higher logistic EuroSCORE (13.61 vs 12.66%, p < 0.001), age (81.55 vs 79.99a, p < 0.001), and proportion of women (54.82 vs 40.06%, p < 0.001). Both groups showed a similar in-hospital mortality with 2.37% in BE and 2.35% in SE (p = 0.916). In-hospital mortality also did not differ significantly after risk adjustment (OR = 0.98 [0.86, 1.13], p = 0.799). Patients in the SE group had a significantly lower risk of major bleeding (OR = 0.83 [0.73, 0.95], p = 0.006), but a significantly higher risk of stroke (OR = 1.38 [1.19, 1.59], p < 0.001), delirium (OR = 1.15 [1.06, 1.24], p = 0.001), and permanent pacemaker implantation (OR = 1.29 [1.21, 1.37], p < 0.001). In the subgroup analysis of in-hospital mortality, there were no significant differences in any of the observed subgroups (age < 75/75-79/80-84/ ≥ 85a, logistic EuroSCORE < 4/4- < 9/ ≥ 9, gender, NYHA III/IV, previous CABG, peripheral vascular disease, COPD, pulmonary hypertension, renal disease GFR < 30 ml/min, and diabetes mellitus). CONCLUSION: In the direct comparison of balloon-expandable and self-expanding TAVR, there are no differences for in-hospital mortality in subgroups.

Association between three-year mortality after transcatheter aortic valve implantation and paravalvular regurgitation graded by videodensitometry in comparison with visual grading.

BACKGROUND: Estimation of regurgitant fraction by videodensitometry (VD-AR) of aortic root angiograms is a new tool for objective grading of paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI). Stratification with boundaries at 6% and 17% has been proposed to reflect "none/trace", "mild" and "moderate or higher" PVR. OBJECTIVE: We sought to investigate the association of strata of VD-AR with 3-year mortality and to compare VD-AR with visual grading of angiograms. METHODS: We interrogated our database for patients undergoing transfemoral TAVI from 2008 to 2018. Vital status of the patients was obtained from population registers. To test differences in survival and estimate adjusted hazard ratios (HRs) we fitted Cox models. RESULTS: Our retrospective study included 699 patients with evaluable angiograms at completion of the TAVI procedure. Cumulative 3-year mortality was 35.0% in 261 (37.3%) patients with VD-AR < 6%, 33.9% in 325 (46.5%) patients with VD-AR between 6 and 17% (HR [95% confidence interval] 1.06 [0.80-1.42]; P = 0.684) and 47.2% in 113 (16.2%) patients with VD-AR > 17% (HR 1.57 [1.11-2.22]; P = 0.011). Visually, PVR was graded as "none/trace" in 470 (67.2%) patients, as "mild" in 219 (31.3%) and as "moderate" in 10 (1.4%). Both mild PVR and moderate PVR on visual grading were significantly associated with mortality (HRs 1.31 [1.12-1.54]; P = 0.001 and 1.92 [1.13-3.24]; P = 0.015; respectively). CONCLUSIONS: VD-AR > 17%, but not VD-AR 6-17%, was independently associated with mortality. Compared with subjective visual evaluation, VD-AR resulted in a smaller proportion of patients with PVR classified as prognostically relevant.

Cerebral aneurysms: Germany-wide real-world outcome data of endovascular or neurosurgical treatment from 2007 to 2019.

BACKGROUND: Evidence on clinical outcome after endovascular treatment (EVT) vs neurosurgical clipping of intracranial aneurysms (IAs) is based on one randomized and one pseudo-randomized trial for ruptured aneurysms. Herein, we analyze nationwide real-world hospital outcomes after EVT vs clipping of ruptured and unruptured IAs. METHODS: This cohort study analyzed all EVT and clipping procedures for IAs in Germany between 2007 and 2019. The data basis was the billing-data of all German hospitals from the German Federal Statistical Office. EVT and clipping interventions, comorbidities, and in-hospital outcomes were identified using International Classification of Diseases (ICD) and Operation and Procedure (OPS) codes. Discharge type was used as a surrogate marker for functional independence. Poor clinical outcome at discharge was additionally defined by the dichotomous US National Inpatient Sample-Subarachnoid hemorrhage Outcome Measure score (NIH-SOM). Secondary outcomes included length of hospital stay, prolonged mechanical ventilation (>48 hour), and hospital reimbursement. RESULTS: We analyzed 90 039 procedures (62.6% EVT, 35.52% clipping, 1.8% combined) for the treatment of IAs. After adjustment in-hospital mortality was equal after EVT compared with clipping, in ruptured IAs (adjusted OR (aOR) 0.98, p=0.707) and unruptured IAs (aOR 0.92, p=0.482). Functional independence was more likely after EVT for ruptured (aOR 0.81, p<0.001) and unruptured IAs (aOR 0.4, p<0.001). Poor clinical outcome was more likely after clipping for ruptured (aOR 0.67, p<0.001) and unruptured IAs (aOR 0.56, p<0.001). CONCLUSIONS: In German clinical practice, we observed higher rates of functional independence and lower rates of poor outcomes at discharge with equal mortality for EVT.