Christof Veit

The German Aortic Valve Registry (GARY): in-hospital outcome

Background Aortic stenosis is a frequent valvular disease especially in elderly patients. Catheter-based valve implantation has emerged as a valuable treatment approach for these patients being either at very high risk for conventional surgery or even deemed inoperable. The German Aortic Valve Registry (GARY) provides data on conventional and catheter-based aortic procedures on an all-comers basis. Methods and results A total of 13 860 consecutive patients undergoing repair for aortic valve disease [conventional surgery and transvascular (TV) or transapical (TA) catheter-based techniques] have been enrolled in this registry during 2011 and baseline, procedural, and outcome data have been acquired. The registry summarizes the results of 6523 conventional aortic valve replacements without (AVR) and 3464 with concomitant coronary bypass surgery (AVR + CABG) as well as 2695 TV AVI and 1181 TA interventions (TA AVI). Patients undergoing catheter-based techniques were significantly older and had higher risk profiles. The stroke rate was low in all groups with 1.3% (AVR), 1.9% (AVR + CABG), 1.7% (TV AVI), and 2.3% (TA AVI). The in-hospital mortality was 2.1% (AVR) and 4.5% (AVR + CABG) for patients undergoing conventional surgery, and 5.1% (TV AVI) and AVI 7.7% (TA AVI). Conclusion The in-hospital outcome results of this registry show that conventional surgery yields excellent results in all risk groups and that catheter-based aortic valve replacements is an alternative to conventional surgery in high risk and elderly patients.

The German Aortic Valve Registry: 1-year results from 13 680 patients with aortic valve disease †

OBJECTIVES The German Aortic Valve Registry (GARY) seeks to provide information on a real-world, all-comers basis for patients undergoing aortic valve interventions. This registry comprises patients undergoing the complete spectrum of transcutaneous and conventional surgical aortic valve interventions. The aim of this study was to use the GARY registry to evaluate conventional and catheter-based aortic valve interventions in several risk groups. METHODS A total of 13 860 consecutive patients undergoing intervention for aortic valve disease [conventional aortic valve replacement (AVR) or transvascular/transapical TAVR (TV-/TA-TAVR)] were enrolled in 78 German centres in 2011. Baseline, procedural and outcome data, including quality of life, were acquired up to 1 year post-intervention. Vital status at 1 year was known for 98.1% of patients. RESULTS The 1-year mortality rate was 6.7% for conventional AVR patients (n = 6523) and 11.0% for patients who underwent AVR with coronary artery bypass grafting (n = 3464). The 1-year mortality rate was 20.7 and 28.0% in TV- and TA-TAVR patients, respectively (n = 2695 and 1181). However, if patients were stratified into four risk groups by means of the EuroSCORE and the German AV Score, the highest risk cohorts showed the same mortality at 1 year with either therapy. More than 80% of patients in all groups were in the same or better state of health at 1 year post-intervention and were satisfied with the procedural outcome. CONCLUSIONS Conventional AVR surgery yields excellent results after 1 year in lower-risk patients. Catheter-based AVR is a good alternative in high-risk and elderly patients.

German Aortic Valve Score: a new scoring system for prediction of mortality related to aortic valve procedures in adults

OBJECTIVES The aim of the study was to establish a scoring system to predict mortality in aortic valve procedures in adults [German Aortic Valve Score (German AV Score)] based upon the comprehensive data pool mandatory by law in Germany. METHODS In 2008, 11 794 cases were documented who had either open aortic valve surgery or transcatheter aortic valve implantation (TAVI). In-hospital mortality was chosen as a binary outcome measure. Potential risk factors were identified on the basis of published scoring systems and clinical knowledge. First, each of these risk factors was tested in an univariate manner by Fishers exact test for significant influence on mortality. Then, a multiple logistic regression model with backward and forward selection was used. Calibration was ascertained by the Hosmer-Lemeshow method. In order to define the quality of discrimination, the area under the receiver operating characteristic (ROC) curve was calculated. RESULTS In 11 147 of 11 794 cases (94.5%), a complete data set was available. In-hospital mortality was 3.7% for all patients, 3.4% in the surgical group (95% confidence interval 3.0-3.7%, n = 10 574) and 10.6% in the TAVI group (95% confidence interval 8.2-13.5%, n = 573). Based on multiple logistic regression, 15 risk factors with an influence on mortality were identified. Among them, age, body mass index and left ventricular function were categorized in three (body mass index, left ventricular dysfunction) or 6 subgroups (age). The Hosmer-Lemeshow method corroborated a valid concordance of predicted and observed mortality in 10 different risk groups. The area under the ROC curve with a value of 0.808 affirmed the quality of discrimination of the established scoring model. CONCLUSIONS It is well known that a predictive model works best in the setting where it was developed; therefore, the German AV Score fits well to the patient population in Germany. It was designed for fair and reliable outcome evaluation. It allows comparison of predicted and observed mortality for conventional aortic valve surgery and transcatheter aortic valve implantation in low-, moderate- and high-risk groups. Thus, it enables primarily a risk-adjusted benchmark of outcome and fosters the efforts for continuous improvement of quality in aortic valve procedures.

TAVI for low-flow, low-gradient severe aortic stenosis with preserved or reduced ejection fraction: a subgroup analysis from the German Aortic Valve Registry (GARY).

AIMS The study analyses the outcome of patients undergoing transcatheter aortic valve implantation (TAVI) for different subtypes of severe aortic stenosis (AS) based on data from the GARY registry. METHODS AND RESULTS Low-EF, low-gradient (LEF-LGAS: EF ≤40%, MPG <40 mmHg), paradoxical low-gradient (PLF-LGAS: EF ≥50%, MPG <40 mmHg) and high-gradient AS (HGAS: MPG ≥40 mmHg) were observed in 11.7% (n=359), 20.8% (n=640) and 60.6% (n=1,864) of the study population, respectively. EuroSCORE I (36.7±20.9 vs. 22.6±15.7 vs. 24.3±17.4; p<0.001) differed significantly among subgroups. In-hospital and one-year mortality were higher in patients with LEF-LGAS compared to HGAS (in-hospital: 7.8% vs. 4.9%; p=0.029; one-year: 32.3% vs. 19.8%; p=0.001). In contrast, mortality in patients with PLF-LGAS was comparable to patients with HGAS (in-hospital: PLF-LGAS: 5.3%; p=0.67; one-year: 22.3%; p=0.192). The rate of TAVI-associated complications was not significantly different among groups. However, postoperative low cardiac output occurred significantly more frequently in patients with LEF-LGAS Conclusions: Severe AS with a reduced transaortic flow and gradient is a common finding and is present in >30% of patients undergoing TAVI. Patients with low flow and impaired LV function have a significantly higher mortality within the first year after TAVI. In contrast, the outcome of patients with low flow and preserved EF is comparable to those with a high transvalvular aortic gradient.

Selection of hospital quality indicators for public disclosure in Germany

OBJECTIVES This paper introduces the QUALIFY instrument as an indicator assessment method used to select quality indicators suitable for public disclosure in Germany. METHODS Fifty-five hospital quality indicators previously approved in routine use were systematically tested for suitability in public disclosure. A multi-disciplinary expert team including patient representatives used the QUALIFY instrument to assess the methodological quality of these indicators in detailed respect to their purpose. The team applied 14 of the 20 QUALIFY criteria to each indicator, the minimum acceptance level for public reporting was determined in advance. RESULTS Thirty one indicators from eleven clinical conditions fulfilled all fourteen methodological criteria required for national reporting. They include eleven outcome and twenty process indicators. CONCLUSIONS QUALIFY proved to be a useful tool for selecting quality indicators suitable for public disclosure and thus contributes substantially to proper information on German hospital quality. It ensures high transparency in a very sensitive context to all stakeholders.

German CABG Score: A Specific Risk Model for Patients Undergoing Isolated Coronary Artery Bypass Grafting

BACKGROUND A specific risk model concerning mortality of patients undergoing isolated coronary artery bypass grafting (CABG) is developed based on the national quality benchmarking mandatory by law in Germany. METHODS On the basis of the national data pool from 2004, a risk score model for patients undergoing isolated CABG was developed and finally adjusted with the data of 43,145 patients of the year 2008. Modeling was performed by logistic regression analysis. This risk model was validated with the 2007 data pool which comprised 45,569 patients. RESULTS Observed in-hospital mortality after isolated CABG procedures was 3.0% in 2008. Hosmer-Lemeshow test p value was 0.189 and area under receiver operating characteristic curve was 0.826. Applying the German CABG score for 2007 resulted in an observed-to-expected mortality ratio of 1.01. CONCLUSION The German CABG score for in-hospital mortality is a risk score with proven validity for isolated CABG, developed by means of the patient population in Germany. It can be used for the assessment of patient risk groups and for interhospital benchmarking. We encourage other researchers to apply and validate this score in comparable health care systems.

Decision-to-Delivery Time and Perinatal Complications in Emergency Cesarean Section

BACKGROUND A decision-to-delivery interval (DDI) of no more than 20 minutes has long been considered a requirement for cesarean sections, even though there have hardly been any studies on this topic. We retrospectively investigated data relevant to DDI for emergency cesarean sections performed for the most common indications, namely, suspected and documented fetal asphyxia. METHODS We analyzed data on emergency in-hospital cesarean sections in the period 2008-2015. Low 5- and 10-minute Apgar scores (a scheme with points awarded for breathing, heart rate, muscle tone, skin coloration, and the elicitability of reflexes) were the primary endpoints; acid-base status in arterial cord blood and in-hospital neonatal death were the secondary endpoints. The raw analysis was supplemented by an analysis adjusted for various factors including gestational age, maternal age, and obstetrical presentation. RESULTS Data from 39 291 neonates were included. The DDI was up to 10 minutes in 64.6% of cases, from 11 to 20 minutes in 34.3%, and over 20 minutes in 1.1%. Low Apgar scores were less common in children whose emergency cesarean sections were performed within 10 minutes or within 20 minutes. For example, the adjusted odds ratio for a 10-minute Apgar score below 4 was 0.49 (95% confidence interval [0.25; 0.96] when a DDI of more than 20 minutes was used as the reference criterion. CONCLUSION This is the largest population-based, risk-adjusted analysis to be carried out on this topic to date. It reveals, for the first time, an association between DDI of 20 minutes or less and the avoidance of outcomes that are dangerous to the child. As it is not possible to predict such obstetrical emergencies in advance, it seems reasonable to ensure the availability of caredelivery structures that make it possible for emergency cesarean sections to be performed within 20 minutes of the decision to do so.

Bericht aus der Praxis: Möglichkeiten einrichtungsübergreifender Qualitätsinitiativen. QS-Projekte des BQS-Instituts Januar 2010 bis Juli 2013

Alongside the projects of internal quality management and mandatory quality assurance there is a variety of quality driven projects across institutions initiated and run by various partners to continuously improve the quality of care. The multiplicity and characteristics of these projects are discussed on the basis of projects run by the BQS Institute between 2010 and 2013. In addition, useful interactions and linking with mandatory quality benchmarking and with internal quality management are discussed. (As supplied by publisher).