Transfemoral aortic valve implantation: procedural hospital volume and mortality in Germany.

AIMS: Studies assessing transfemoral transcatheter aortic valve implantation (TF-TAVI) showed lower rates of in-hospital mortality at high-volume hospitals and minimum caseloads were recommended to assure quality standards. METHODS AND RESULTS: All patients in the German mandatory quality assurance registry with elective or urgent TF-TAVI procedures in 2018 and 2019 at 81 and 82 hospitals, respectively, were analysed. Observed in-hospital mortality was adjusted to expected mortality by the German AKL-KATH score (O/E) as well as by the EuroScore II (O/E2). Hospital volume and O/E were correlated by regression analyses and volume quartiles. 18 763 patients (age: 81.1 ± 1.0 years, mean EuroSCORE II: 6.9 ± 1.8%) and 22 137 patients (mean age: 80.7 ± 3.5 years, mean EuroSCORE II: 6.5 ± 1.6%) were analysed in 2018 and 2019, respectively. The average observed in-hospital mortality was 2.57 ± 1.83% and 2.36 ± 1.60%, respectively. Unadjusted in-hospital mortality was significantly inversely related to hospital volume by linear regression in both years. After risk adjustment, the association between hospital volume and O/E was statistically significant in 2019 (R2 = 0.049; P = 0.046), but not in 2018 (R2 = 0.027; P = 0.14). The variance of O/E explained by the number of cases in 2019 was low (4.9%). Differences in O/E outcome between the first and the fourth quartile were not statistically significant in both years (1.10 ± 1.02 vs. 0.82 ± 0.46; P = 0.26 in 2018; 1.16 0 .97 vs. 0.74 ± 0.39; P = 0.084 in 2019). Any chosen volume cut-off could not precisely differentiate between hospitals with not acceptable quality (>95th percentile O/E of all hospitals) and those with acceptable (O/E ≤95th percentile) or above-average (O/E < 1) quality. For example, in 2019 a cut-off value of 150 would only exclude one of two hospitals with not acceptable quality, while 20 hospitals with acceptable or above-average quality (25% of all hospitals) would be excluded. CONCLUSION: The association between hospital volume and in-hospital mortality in patients undergoing elective TF-TAVI in Germany in 2018 and 2019 was weak and not consistent throughout various analytical approaches, indicating no clinical relevance of hospital volume for the outcome. However, these data were derived from a healthcare system with restricted access to hospitals to perform TAVI and overall high TAVI volumes. Instead of the unprecise surrogate hospital volume, the quality of hospitals performing TF-TAVI should be directly assessed by real achieved risk-adjusted mortality.

Healthcare provision of transcatheter aortic valve implantation in Germany.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) for aortic stenosis in older patients is the standard of care with a well-established supply density in Germany. In the near future, healthcare reform is planned that may affect TAVI capacities. Therefore, it is important to know how political regulations may interfere with access to services and what the need for TAVI will be in the future, based on demographic trends. METHODS: The number of TAVI procedures (DRG F98A +F98) and the in-hospital main diagnoses of aortic stenosis (ICD I35) in 2021 were analyzed at the level of county or federal state based on anonymized data from hospital reports, according to § 21 of the German hospital reimbursement law. The number of TAVI and aortic stenosis cases was projected for 2035 based on data from the German Federal Statistical Office on demographic developments. With quality assurance data from hospitals in 2019 and a route planner, the travel time to the next hospital performing TAVI (OPS 5­35a.0) was calculated, and the consequence of a politically suggested minimum volume cut-off was analyzed. RESULTS: In 2021, a total of 26,506 TAVI procedures were reported with a mean number of TAVI per 100,000 inhabitants of 32 (range between federal states from 25 to 42). Among the 66,045 diagnoses of aortic stenosis, there was a variation per 100,000 inhabitants from 64 to 108 (mean 79) between federal states. Compared to 2021, an additional 8748 (+13%) diagnoses of aortic stenosis and an increase of 4673 (+18%) TAVI procedures is to be expected in 2035. In 2019, 57% of German citizens could reach a TAVI hospital within 30 min and 91% within 60 min of driving time by car (mean time to hospital 31 min). Applying a minimum number of 150 TAVI/hospital per year would increase the driving time to hospital from 33 to 52 min in Saxony-Anhalt and instantly remove six out of eight hospitals from service in Hesse. CONCLUSION: Regulation of TAVI services by minimum volume numbers would arbitrarily interfere with access to services, in contradiction to the medical service assurance tasks of federal state governments. These issues should be considered in the upcoming healthcare system reform.

[Postacute care after transcatheter aortic valve implantation (TAVI)]. / Nachsorge nach kathetergestütztem perkutanen Aortenklappenersatz (TAVI).

With increasing age valvular heart disease is among the most frequent diseases of the heart. Relevant valvular disease impairs not only the long-term prognosis but also physical resilience, activities of daily living and the quality of life. In cases of middle to high-grade symptomatic cardiac defects, valve replacement or valve reconstruction is still the surgical procedure of choice; however, in recent years the transcatheter percutaneous aortic valve replacement (TAVI) procedure has become more prominent for the most frequent defect, aortic valve stenosis. This article provides an overview of the aftercare and rehabilitation of patients following a TAVI intervention.

[Memorandum Registry for Health Services Research: Update 2019]. / Memorandum Register für die Versorgungsforschung: Update 2019.

Health registries could be used to analyze questions concerning routine practice in healthcare. Therefore, registries are a core method in health services research. The German Network for Health Services Research (Deutsches Netzwerk Versorgungsforschung, DNVF) promotes the quality of registries by scientific exchange, organization of advanced training, and recommendations in the form of a memorandum "Registry for Health Services Research". The current recommendations are an update of the memorandum's first version of 2010. The update describes the capabilities and aims of registries in health services research. Furthermore, it illustrates the state-of-the-art in designing and implementing health registries. The memorandum provides developers the methodological basis to ensure high quality health registries. It further provides users of health registries with insights that enable assessing the quality of data and results of health registries. Finally, funding agencies and health policy actors can use the quality criteria to establish a framework for the financing and legislative requirements for health registries. The memorandum provides first a definition of health registries and presents an overview of their utility in health services research and health care improvement. Second, several areas of methodological importance for the development and operation of health registries are presented. This includes the conceptual and preliminary design, implementation, technical organization of a health registry, statistical analysis, reporting of results, and data protection. From these areas, criteria are deduced to allow the assessment of the quality of a health registry. Finally, a checklist is presented.

Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation.

BACKGROUND: Current guidelines recommend pulmonary-vein isolation by means of catheter ablation as treatment for drug-refractory paroxysmal atrial fibrillation. Radiofrequency ablation is the most common method, and cryoballoon ablation is the second most frequently used technology. METHODS: We conducted a multicenter, randomized trial to determine whether cryoballoon ablation was noninferior to radiofrequency ablation in symptomatic patients with drug-refractory paroxysmal atrial fibrillation. The primary efficacy end point in a time-to-event analysis was the first documented clinical failure (recurrence of atrial fibrillation, occurrence of atrial flutter or atrial tachycardia, use of antiarrhythmic drugs, or repeat ablation) following a 90-day period after the index ablation. The noninferiority margin was prespecified as a hazard ratio of 1.43. The primary safety end point was a composite of death, cerebrovascular events, or serious treatment-related adverse events. RESULTS: A total of 762 patients underwent randomization (378 assigned to cryoballoon ablation and 384 assigned to radiofrequency ablation). The mean duration of follow-up was 1.5 years. The primary efficacy end point occurred in 138 patients in the cryoballoon group and in 143 in the radiofrequency group (1-year Kaplan-Meier event rate estimates, 34.6% and 35.9%, respectively; hazard ratio, 0.96; 95% confidence interval [CI], 0.76 to 1.22; P<0.001 for noninferiority). The primary safety end point occurred in 40 patients in the cryoballoon group and in 51 patients in the radiofrequency group (1-year Kaplan-Meier event rate estimates, 10.2% and 12.8%, respectively; hazard ratio, 0.78; 95% CI, 0.52 to 1.18; P=0.24). CONCLUSIONS: In this randomized trial, cryoballoon ablation was noninferior to radiofrequency ablation with respect to efficacy for the treatment of patients with drug-refractory paroxysmal atrial fibrillation, and there was no significant difference between the two methods with regard to overall safety. (Funded by Medtronic; FIRE AND ICE ClinicalTrials.gov number, NCT01490814.).

Outcomes of transfemoral transcatheter aortic valve implantation at hospitals with and without on-site cardiac surgery department: insights from the prospective German aortic valve replacement quality assurance registry (AQUA) in 17 919 patients.

AIMS: Performing transcatheter aortic valve implantation (TAVI) at hospitals with only cardiology department but no cardiac surgery (CS) on-site is at great odds with current Guidelines. METHODS AND RESULTS: We analysed data from the official, prospective German Quality Assurance Registry on Aortic Valve Replacement to compare characteristics and in-hospital outcomes of patients undergoing transfemoral TAVI at hospitals with (n = 75) and without CS departments (n = 22). An interdisciplinary Heart Team was established at all centres (internal staff physicians at hospitals with on-site CS; in-house cardiologists and visiting cardiac surgical teams from collaborating hospitals at non-CS hospitals). In 2013 and 2014, 17 919 patients (81.2 ± 6.1 years, 55% females, German aortic valve (GAV) score 2.0 5.6 ± 5.8%, logistic EuroSCORE I 21.1 ± 15.4%) underwent transfemoral TAVI in Germany: 1332 (7.4%) at hospitals without on-site CS department. Patients in non-CS hospitals were older (82.1 ± 5.8 vs. 81.1 ± 6.1 years, P < 0.001), with more frequent co-morbidities. Predicted mortality risks per GAV-score 2.0 (6.1 + 5.5 vs. 5.5 ± 5.9%, P < 0.001) and logEuroSCORE I (23.2 ± 15.8 vs. 21.0 ± 15.4%, P < 0.001) were higher in patients at non-CS sites. Complications, including strokes (2.6 vs. 2.3%, P = 0.452) and in-hospital mortality (3.8 vs. 4.2%, P = 0.396), were similar in both groups. Matched-pair analysis of 555 patients in each group with identical GAV-score confirmed similar rates of intraprocedural complications (9.2 vs. 10.3%, P = 0.543), strokes (3.2% for both groups, P = 1.00), and in-hospital mortality (1.8 vs. 2.9%, P = 0.234). CONCLUSION: Although patients undergoing TAVI at hospitals without on-site CS department were older and at higher predicted perioperative death risk, major complications, and in-hospital mortality were not statistically different, suggesting the feasibility and safety of Heart Team-based TAVI at non-CS sites. These findings need confirmation in future randomized study.

German Heart Report 2013.

OBJECTIVES: The 25th German Heart Report provides a comprehensive analysis of morbidity and mortality in patients with selected heart diseases as well as services and care in cardiology and cardiac surgery in Germany during the period 2011-2012. It is the result of a multidisciplinary collaboration between the German Heart Foundation, the German Cardiac Society, the German Society for Thoracic and Cardiovascular Surgery, and the German Society of Pediatric Cardiology and is based on data from different sources. In addition, trends of the period from 1995 to 2012 are presented. RESULTS: The trends in morbidity due to cardiac diseases in 2010 and previous years continued in 2011. Compared with data from 1995 to 2010, one can observe: · a slight decrease in ischemic heart disease in every age group.. · a distinct increase in valve diseases, predominantly at age >75 years.. · an increase in arrhythmias from the age of 45 years on.. · an increase in cardiac failure, especially beyond the age of 75 years.. Compared with data from 2009, the mortality rates in 2011 differ somewhat; there is: · a decrease in heart failure and coronary heart disease.. · no change in arrhythmias.. · a distinct increase in valvular heart diseases.. · an additional, small decrease in congenital heart defects.. These data are in agreement with findings from other Western countries. Coronary heart disease, the most frequent cardiac disease, has continuously decreased in frequency and mortality since 2000. The underlying reasons are discussed. CONCLUSION: This report is an important resource for all parties of the healthcare system regarding heart disease conditions and their treatment in Germany.

Rationale and Design of FIRE AND ICE: A multicenter randomized trial comparing efficacy and safety of pulmonary vein isolation using a cryoballoon versus radiofrequency ablation with 3D-reconstruction.

BACKGROUND: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia imposing substantial morbidity and mortality. Catheter-based pulmonary vein isolation (PVI) using radiofrequency current (RFC) has become a standard treatment for drug-resistant and symptomatic paroxysmal AF (PAF). In recent years, the cryoballoon-based technique is increasingly used as a promising alternative with a short learning curve. METHODS: The FIRE AND ICE trial is a prospective, randomized, controlled, open, blinded outcome assessment, noninferiority trial comparing cryoballoon-, and RFC-based PVI. Patients with drug-resistant PAF will be randomized in a 1:1 matrix in multiple European centers. The primary hypothesis is that cryoballoon ablation is not inferior to RFC ablation using 3-dimensional mapping with respect to clinical efficacy. The primary endpoint is defined as the time to first documented clinical failure, including: (1) recurrence of AF; (2) atrial flutter or atrial tachycardia; (3) prescription of class I or III antiarrhythmic drugs; or (4) re-ablation, whichever comes first, following a blanking period of 3 months after the index ablation procedure. The primary safety endpoint is a composite of death, stroke/transient ischemic attack, cardiac arrhythmias (apart from AF recurrence) causally related to the therapeutic intervention, and procedure-related serious adverse events. CONCLUSION: The FIRE AND ICE trial compares 2 different technologies to perform catheter ablation of PAF with respect to efficacy and safety. It aims at providing objective data to guide selection and usage of ablation catheters in the treatment of AF.

Should health insurers target prevention of cardiovascular disease? A cost-effectiveness analysis of an individualised programme in Germany based on routine data.

BACKGROUND: Cardiovascular diseases are the main cause of death worldwide, making their prevention a major health care challenge. In 2006, a German statutory health insurance company presented a novel individualised prevention programme (KardioPro), which focused on coronary heart disease (CHD) screening, risk factor assessment, early detection and secondary prevention. This study evaluates KardioPro in CHD risk subgroups, and analyses the cost-effectiveness of different individualised prevention strategies. METHODS: The CHD risk subgroups were assembled based on routine data from the statutory health insurance company, making use of a quasi-beta regression model for risk prediction. The control group was selected via propensity score matching based on logistic regression and an approximate nearest neighbour approach. The main outcome was cost-effectiveness. Effectiveness was measured as event-free time, and events were defined as myocardial infarction, stroke and death. Incremental cost-effectiveness ratios comparing participants with non-participants were calculated for each subgroup. To assess the uncertainty of results, a bootstrapping approach was applied. RESULTS: The cost-effectiveness of KardioPro in the group at high risk of CHD was € 20,901 per event-free year; in the medium-risk group, € 52,323 per event-free year; in the low-risk group, € 186,074 per event-free year; and in the group with known CHD, € 26,456 per event-free year. KardioPro was associated with a significant health gain but also a significant cost increase. However, statistical significance could not be shown for all subgroups. CONCLUSION: The cost-effectiveness of KardioPro differs substantially according to the group being targeted. Depending on the willingness-to-pay, it may be reasonable to only offer KardioPro to patients at high risk of further cardiovascular events. This high-risk group could be identified from routine statutory health insurance data. However, the long-term consequences of KardioPro still need to be evaluated.

OECD indicator 'AMI 30-day mortality' is neither comparable between countries nor suitable as indicator for quality of acute care.

BACKGROUND: Hospital mortality after acute myocardial infarction (AMI, ICD-10: I21-I22) is used as OECD indicator of the quality of acute care. The reported AMI hospital mortality in Germany is more than twice as high as in the Netherlands or Scandinavia. Yet, in Europe, Germany ranks high in health spending and availability of cardiac procedures. We provide insights into this contradictory situation. METHODS: Information was collected on possible factors causing the reported differences in AMI mortality such as prevalence of risk factors or comorbidities, guideline conform treatment, patient registration, and health system structures of European countries. International experts were interviewed. Data on OECD indicators 'AMI 30-day mortality using unlinked data' and 'average length of stay after AMI' were used to describe the association between these variables graphically and by linear regression. RESULTS: Differences in prevalence of risk factors or comorbidities or in guideline conform acute care account only to a smaller extent for the reported differences in AMI hospital mortality. It is influenced mainly by patient registration rules and organization of health care. Non-reporting of day cases as patients and centralization of AMI care-with more frequent inter-hospital patient transfers-artificially lead to lower calculated hospital mortality. Frequency of patient transfers and national reimbursement policies affect the average length of stay in hospital which is strongly associated with AMI hospital mortality (adj R2 = 0.56). AMI mortality reported from registries is distorted by different underlying populations. CONCLUSION: Most of the variation in AMI hospital mortality is explained by differences in patient registration and organization of care instead of differences in quality of care, which hinders cross-country comparisons of AMI mortality. Europe-wide sentinel regions with comparable registries are necessary to compare (acute) care after myocardial infarction.

[Impact of COVID-19 on cardiac rehabilitation during the first year of the pandemic: A comparison of the performance numbers in Germany from 2019 and 2020]. / Wie stark hat die COVID-19-Pandemie die kardiologische Rehabilitation im ersten Jahr der Pandemie beeinflusst? Ein Vergleich der Leistungszahlen aus 2019 mit 2020 in Deutschland.

INTRODUCTION: In Germany, the COVID-19 pandemic led to substantial changes in outpatient and acute clinical cardiac care and rehabilitation. To estimate the influence of the COVID-19 pandemic on cardiac rehabilitation in 2020, institutional performance was compared to the pre-pandemic year 2019. METHODS: The performance numbers from rehabilitation institutions were compared. These data were provided in 2019 and 2020 as part of an online survey that the German Society for the Prevention and Rehabilitation of Cardiovascular Diseases (DGPR) performs annually. RESULTS: Complete data for 2019 and 2020 were available from 60 institutions. The overall number of patients treated was reduced by 14.3%, with substantial differences between institutions. Women were more affected (-16.4%) than men (-13.4%) and retirees (-14.5%) significantly more than people still in the workforce (-7.5%). In 25 institutions (42.4%) there was a COVID-19 outbreak resulting in a partial or complete shutdown in 15.7%. In total, 34.5% of the institutions treated patients with COVID-19 infection, 30.5% after such an infection. A large majority of these institutions (72.1%) had to bear the costs for testing suspected cases of SARS-CoV-2-infection alone. CONCLUSION: The economic and logistic burden of the COVID-19 pandemic has posed a threat to cardiac rehabilitation in Germany.

[Cardiac rehabilitation during the COVID-19 pandemic in Germany - a quick poll of the German Society of rehabilitation and Prevention of Heart and Circulation Diseases (DGPR)]. / Situation der kardiologischen Rehabilitation im Rahmen der COVID-19-Pandemie in Deutschland ­ eine Blitzumfrage der Deutschen Gesellschaft für Rehabilitation und Prävention von Herz-Kreislauferkrankungen (DGPR) zur aktuellen Situation (August 2020).

BACKGROUND: In Germany, the COVID-19 pandemic has significantly changed cardiological care in both the outpatient and inpatient setting, including the cancellation of elective interventions. The investigation presented here was carried out in order to obtain information on the extent to which this also applies to cardiac rehabilitation facilities. METHODS: In August 2020, all 107 member institutions of the DGPR were contacted and asked to take part in an online survey containing 12 sets of questions on the topic. RESULTS: At the end of August, data were available from 45 institutions. 31.1 % of the institutions provided rehabilitation services for patients with cardiac complications/manifestations of COVID-19 disease, mainly after acute coronary syndrome (29.6 %) and pulmonary artery embolism (25.9 %). More than 40 % of the facilities were required to close down partially or completely, and 14 % feared a partial or complete closure by the end of 2020. The costs for testing, if SARS-CoV-2 infection was suspected (72.1 %), were mainly borne by the rehabilitation facilities. CONCLUSIONS: Despite the limitations of a short-term data collection and a response rate of approx. 45 %, the present study gives indications of the challenging situation of the COVID-19 pandemic for cardiological rehabilitation facilities in Germany.

Cardiac Rehabilitation in German Speaking Countries of Europe-Evidence-Based Guidelines from Germany, Austria and Switzerland LLKardReha-DACH-Part 1.

BACKGROUND: Although cardiovascular rehabilitation (CR) is well accepted in general, CR-attendance and delivery still considerably vary between the European countries. Moreover, clinical and prognostic effects of CR are not well established for a variety of cardiovascular diseases. METHODS: The guidelines address all aspects of CR including indications, contents and delivery. By processing the guidelines, every step was externally supervised and moderated by independent members of the "Association of the Scientific Medical Societies in Germany" (AWMF). Four meta-analyses were performed to evaluate the prognostic effect of CR after acute coronary syndrome (ACS), after coronary bypass grafting (CABG), in patients with severe chronic systolic heart failure (HFrEF), and to define the effect of psychological interventions during CR. All other indications for CR-delivery were based on a predefined semi-structured literature search and recommendations were established by a formal consenting process including all medical societies involved in guideline generation. RESULTS: Multidisciplinary CR is associated with a significant reduction in all-cause mortality in patients after ACS and after CABG, whereas HFrEF-patients (left ventricular ejection fraction <40%) especially benefit in terms of exercise capacity and health-related quality of life. Patients with other cardiovascular diseases also benefit from CR-participation, but the scientific evidence is less clear. There is increasing evidence that the beneficial effect of CR strongly depends on "treatment intensity" including medical supervision, treatment of cardiovascular risk factors, information and education, and a minimum of individually adapted exercise volume. Additional psychologic interventions should be performed on the basis of individual needs. CONCLUSIONS: These guidelines reinforce the substantial benefit of CR in specific clinical indications, but also describe remaining deficits in CR-delivery in clinical practice as well as in CR-science with respect to methodology and presentation.

Improvement of hypertension management by structured physician education and feedback system: cluster randomized trial.

INTRODUCTION: We aimed to assess whether hypertension management with a structured physician information program and a feedback system leads to improved blood pressure (BP) control and cardiovascular outcomes. METHODS: Cluster randomized (3 : 1), open, monitored, multicenter trial in Germany. Primary care-based physicians in the information group (IG) received detailed training on hypertension guidelines, feedback on target-level attainment, and a reminder to intensify treatment after each patient visit, whereas the observation/control group (CG) did not receive any such measures. A three-level mixed model was developed. Time-independent level differences between groups, group-independent changes, and nonparallel group-specific changes over time were tested. RESULTS: A total of 15 041 (78.1%) hypertensive patients were in the IG and 4213 (21.9%) in the CG. By 1-year follow-up, 82.9% of patients in the IG and 81.5% in the CG remained in the study. The guideline-oriented BP target was attained by 56.8% in the IG and 52.5% in the CG (+4.3%, P = 0.03), whereas the individual BP target was attained by 57.0% in the IG and 51% in the CG (P = NS). BP control in the IG was achieved 2 months earlier on average. Clinical inertia, defined as the absence of medication changes, despite noncontrol of BP, occurred significantly less often in the IG group. One-year cardiovascular outcomes did not differ between groups. CONCLUSION: The delivery of systematic information in connection with a feedback system reduces clinical inertia and improves guideline adherence. Although compared with earlier studies, the hypertension control rates obtained are higher, there is still considerable room for improvement.

Guideline-recommended secondary prevention drug therapy after acute myocardial infarction: predictors and outcomes of nonadherence.

BACKGROUND: Guideline-recommended pharmacotherapy after myocardial infarction (MI) has been shown to reduce cardiovascular morbidity and mortality. Our objectives were to determine factors of, and to measure outcomes associated with nonadherence after MI. DESIGN: Multicentre, prospective, observational study (Acute Coronary Syndromes Registry). METHODS: We analyzed data of 11,823 consecutive hospital survivors of acute MI and evaluated their discharge medication with the five following drugs: acetyl salicylic acid, clopidogrel, ß-blocker, angiotensin-converting enzyme inhibitor/sartan and statin. Patients receiving less than four drugs (group 1, n=3439, 29.1%) were compared with those receiving 4-5 drugs (group 2, n=8384, 70.9%). The impact of clinical, demographic and treatment factors on not prescribing each of these five drugs at discharge was investigated by using multiple logistic regression models. RESULTS: Patients of group 1 were older, had more comorbidities, more frequently suffered a nonST elevation MI and less often received reperfusion therapy. In the multivariate analysis, group 1 was associated with an increased risk for death at 1-year follow-up [odds ratio (OR): 1.6, 95% confidence interval (CI): 1.4-1.9]. After adjustment for confounding variables chronic oral anticoagulation was the strongest predictor for not receiving acetyl salicylic acid (OR: 19.6, 95% CI: 15.9-24.0) at discharge, no percutaneous coronary intervention within 48 h for not receiving statin (OR: 2.1, 95% CI: 1.9-2.4) and clopidogrel (OR: 10.4, 95% CI: 9.4-11.5), chronic obstructive lung disease for not receiving ß-blocker (OR: 4.2, 95% CI: 3.6-4.9) and chronic renal insufficiency for not receiving angiotensin-converting enzyme inhibitor/sartan (OR: 2.8, 95% CI: 2.2-3.5). CONCLUSION: In clinical practice guideline-adherent secondary prevention drug therapy is linked with an improved 1-year survival. Comorbidities and no interventional treatment were strong negative predictors for guideline-adherent discharge medication.

Long-term effects of a standardized feedback-driven quality improvement program for timely reperfusion therapy in regional STEMI care networks.

AIMS: Current European Society of Cardiology guidelines state that repetitive monitoring and feedback should be implemented for ST-elevation myocardial infarction (STEMI) treatment, but no evidence is available supporting this recommendation. We aimed to analyze the long-term effects of a formalized data assessment and systematic feedback on performance and mortality within the prospective, multicenter Feedback Intervention and Treatment Times in STEMI (FITT-STEMI) study. METHODS: Regular interactive feedback sessions with local STEMI management teams were performed at six participating German percutaneous coronary intervention (PCI) centers over a 10-year period starting from October 2007. RESULTS: From the first to the 10th year of study participation, all predefined key-quality indicators for performance measurement used for feedback improved significantly in all 4926 consecutive PCI-treated patients - namely, the percentages of patients with pre-hospital electrocardiogram (ECG) recordings (83.3% vs 97.1%, p < 0.0001) and ECG recordings within 10 minutes after first medical contact (41.7% vs 63.8%, p < 0.0001), pre-announcement by telephone (77.0% vs 85.4%, p = 0.0007), direct transfer to the catheterization laboratory bypassing the emergency department (29.4% vs 64.2%, p < 0.0001), and contact-to-balloon times of less than 90 minutes (37.2% vs 53.7%, p < 0.0001). Moreover, this feedback-related continuous improvement of key-quality indicators was linked to a significant reduction in in-hospital mortality from 10.8% to 6.8% (p = 0.0244). Logistic regression models confirmed an independent beneficial effect of duration of study participation on hospital mortality (odds ratio = 0.986, 95% confidence interval = 0.976-0.996, p = 0.0087). In contrast, data from a nationwide PCI registry showed a continuous increase in in-hospital mortality in all PCI-treated STEMI patients in Germany from 2008 to 2015 (n = 398,027; 6.7% to 9.2%, p < 0.0001). CONCLUSIONS: Our results indicate that systematic data assessment and regular feedback is a feasible long-term strategy and may be linked to improved performance and a reduction in mortality in STEMI management.

Long-term effects of a standardized feedback-driven quality improvement program for timely reperfusion therapy in regional STEMI care networks.

AIMS: Current European Society of Cardiology guidelines state that repetitive monitoring and feedback should be implemented for ST-elevation myocardial infarction (STEMI) treatment, but no evidence is available supporting this recommendation. We aimed to analyze the long-term effects of a formalized data assessment and systematic feedback on performance and mortality within the prospective, multicenter Feedback Intervention and Treatment Times in STEMI (FITT-STEMI) study. METHODS: Regular interactive feedback sessions with local STEMI management teams were performed at six participating German percutaneous coronary intervention (PCI) centers over a 10-year period starting from October 2007. RESULTS: From the first to the 10th year of study participation, all predefined key-quality indicators for performance measurement used for feedback improved significantly in all 4926 consecutive PCI-treated patients - namely, the percentages of patients with pre-hospital electrocardiogram (ECG) recordings (83.3% vs 97.1%, p < 0.0001) and ECG recordings within 10 minutes after first medical contact (41.7% vs 63.8%, p < 0.0001), pre-announcement by telephone (77.0% vs 85.4%, p = 0.0007), direct transfer to the catheterization laboratory bypassing the emergency department (29.4% vs 64.2%, p < 0.0001), and contact-to-balloon times of less than 90 minutes (37.2% vs 53.7%, p < 0.0001). Moreover, this feedback-related continuous improvement of key-quality indicators was linked to a significant reduction in in-hospital mortality from 10.8% to 6.8% (p = 0.0244). Logistic regression models confirmed an independent beneficial effect of duration of study participation on hospital mortality (odds ratio = 0.986, 95% confidence interval = 0.976-0.996, p = 0.0087). In contrast, data from a nationwide PCI registry showed a continuous increase in in-hospital mortality in all PCI-treated STEMI patients in Germany from 2008 to 2015 (n = 398,027; 6.7% to 9.2%, p < 0.0001). CONCLUSIONS: Our results indicate that systematic data assessment and regular feedback is a feasible long-term strategy and may be linked to improved performance and a reduction in mortality in STEMI management.

Patterns and predictors of statin prescription in patients with type 2 diabetes.

BACKGROUND: The benefit of statins for prevention of cardiovascular events in type 2 diabetes is established, but a gap exists between guideline recommendations and clinical practice. The aim of the study was to identify patient-related factors predicting statin prescription. METHODS: We assessed the quality of care in 51,640 patients with type 2 diabetes in a German diabetes registry. Patients were stratified according to primary and secondary prevention. Five-year risk for cardiovascular events was calculated in primary prevention patients. A multivariate adjusted logistic regression model was constructed to determine which parameters influenced statin prescription. RESULTS: 34% had established atherosclerotic disease and 25.5% received a statin. Prescription was significantly higher in the secondary compared to the primary prevention group (38.1% [95% CI 37.4-38.9%] vs. 18.5% [95% CI 18.0-19.0%], respectively). In primary prevention the odds for statin prescription increased with estimated cardiovascular risk (OR 1.17 per 5% increase in 5-year risk, 95% CI 1.11-1.22). Positive predictors for statin prescription were secondary prevention, hypertension, former smoking, baseline LDL-cholesterol, and microalbuminuria. The odds of receiving a statin had an inverted U-shaped relation with age (nadir, 66 years), age at first diagnosis of diabetes (nadir, 56 years), and body mass index (nadir, 32 kg/m2). The model predicted prescription in 70% of the patients correctly. CONCLUSION: The majority of patients with type 2 diabetes are not receiving statins. The predominant factors determining statin prescription are the patient's prevention status and, in primary prevention, estimated cardiovascular risk. The results suggest that although physicians are aware of the general concept of cardiovascular risk, they fail to consistently implement guidelines.

Guideline-oriented ambulatory lipid-lowering therapy of patients at high risk for cardiovascular events by cardiologists in clinical practice: the 2L cardio registry.

BACKGROUND: Lipid-lowering treatment has been proven to decrease the rate of cardiovascular events in high-risk patients with manifest coronary artery disease (CAD) or CAD equivalent risk profile. Current treatment guidelines recommend low-density lipoprotein-cholesterol (LDL-C) less than 100 mg/dl (optional <70 mg/dl) as the target level for this high-risk population. Little is known about the ambulatory treatment of high-risk patients in clinical practice and the achievement of guideline recommended target values. METHODS AND RESULTS: In the '2L cardio' registry in Germany, 295 cardiologists enrolled 6711 consecutive patients with known CAD, and/or diabetes mellitus, peripheral arterial disease (summarized as 'coronary risk equivalent', CE), on chronic statin treatment. They recorded actual LDL-C values at entry, probable changes in therapy, and the expected LDL-C values using a lipid calculator based on an earlier observational study in a similar setting. The three groups comprised 2618 patients with CAD plus CE (39.0%; median LDL-C 112 mg/dl), 3436 patients with CAD only (51.2%; median LDL-C 108 mg/dl), and 657 with CE only (9.8%; median LDL-C 124 mg/dl). They had LDL-C levels less than 100 mg/dl in 36.2% [95% confidence intervals (CI): 34.3-38.1], 39.7% (CI: 38.0-41.4), and 27.2% (CI: 23.7-30.7), respectively. Statin doses at entry were usually in the lower to intermediate range (e.g. simvastatin median 25 mg/day). Cardiologists switched to another statin in 10.1% (9.4-10.8), increased the dose of statins (if same drug) in 22.2% (CI: 21.1-23.2) and/or added a cholesterol absorption inhibitor in 23.7% (CI: 22.7-24.7) of the patients. The cardiologists' intervention improved expected LDL-C levels in the total cohort by a mean of 9.0 mg/dl, but the 100 mg/dl LDL-C target was only reached in 51.3% (CI: 50.0-52.5) of the total cohort. CE patients appeared undertreated in terms of antiplatelet drugs. DISCUSSION: Through infrequent increases in statin doses and mainly through add-on of a cholesterol absorption inhibitor, cardiologists improved target level attainment. Compared with earlier studies in the outpatient setting, the treatment to target for LDL-C of high-risk CAD patients has improved, but is not satisfactory.

Effect of chronic statin pretreatment on hospital outcome in patients with acute non-ST-elevation myocardial infarction.

PURPOSE: We sought to investigate the impact of prior statin therapy on in-hospital outcome in patients presenting with acute non-ST-elevation myocardial infarction. METHODS AND RESULTS: We analyzed the data of consecutive patients with non-ST-elevation myocardial infarction who were prospectively enrolled in the German Acute Coronary Syndrome Registry between July 2000 and November 2002. Overall, 6358 patients were included, and we compared the patients who received statins before hospital admission (n = 1247, 19.6%) with those who did not (n = 5111, 80.4%). There was no age difference between the two groups; however, pretreated patients had a higher incidence of prior atherothrombotic events diabetes mellitus and renal insufficiency. The percentage of patients undergoing percutaneous coronary intervention and coronary artery bypass grafting was similar. Infarct size measured by peak creatine kinase level was lower in statin users (238 vs. 283 U/L, P < 0.0001). After adjustment for confounding variables, a significant reduction of in-hospital death could be observed in patients on statins (odds ratio 0.65, 95% confidence interval 0.46-0.90). CONCLUSIONS: In clinical practice, pretreatment with statins was associated with smaller myocardial infarction size (peak creatine kinase level) and a significant reduction of hospital mortality. However, the data were obtained from an observational study, and the results need further prospective confirmation.