Quality of Life After Transcatheter Aortic Valve Replacement: Prospective Data From GARY (German Aortic Valve Registry).

OBJECTIVES: This study sought to analyze health-related quality-of-life (HrQoL) outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) based on data from GARY (German Aortic Valve Registry). BACKGROUND: Typically, patients currently referred for and treated by TAVR are elderly with a concomitant variable spectrum of multiple comorbidities, disabilities, and limited life expectancy. Beyond mortality and morbidity, the assessment of HrQoL is of paramount importance not only to guide patient-centered clinical decision-making but also to judge this new treatment modality in this high-risk patient population. METHODS: In 2011, 3,875 patients undergoing TAVR were included in the GARY registry. HrQoL was prospectively measured using the EuroQol 5 dimensions questionnaire self-complete version on paper at baseline and 1 year. RESULTS: Complete follow-up EuroQol 5 dimensions questionnaire evaluation was available for 2,288 patients (transvascular transcatheter aortic valve replacement [TAVR-TV]: n = 1,626 and transapical TAVR [TAVR-TA]: n = 662). In-hospital mortality was 5.9% (n = 229) and the 1-year mortality was 23% (n = 893). The baseline visual analog scale score for general health status was 52.6% for TAVR-TV and 55.8% for TAVR-TA and, in parallel to an improvement in New York Heart Association functional class, improved to 59.6% and 58.5% at 1 year, respectively (p < 0.001). Between baseline and 1 year, the number of patients reporting no complaints increased by 7.8% (TAVR-TV) and by 3.5% within the mobility dimension, and by 14.1% (TAVR-TV) and 9.2% within the usual activity dimension, whereas only moderate changes were found for the self-care, pain or discomfort, and anxiety or depression dimensions. In a multiple linear regression analysis several pre- and post-operative factors were predictive for less pronounced HrQoL benefits. CONCLUSIONS: TAVR treatment led to improvements in HrQoL, especially in terms of mobility and usual activities. The magnitude of improvements was higher in the TAVR-TV group as compared to the TAVR-TA group. However, there was a sizable group of patients who did not derive any HrQoL benefits. Several independent pre- and post-operative factors were identified being predictive for less pronounced HrQoL benefits.

Current Results of Surgical Aortic Valve Replacement: Insights From the German Aortic Valve Registry.

BACKGROUND: Conventional aortic valve replacement (AVR) remains the therapy of choice for many patients with severe aortic valve disease. The unique German Aortic Valve Registry (GARY) allows the comparison of contemporary outcomes of AVR with those of transcatheter AVRs. We report here real-world, all-comers outcomes of AVR, including combined AVR and coronary bypass grafting (AVR+CABG). METHODS: A total of 34,063 patients who received AVR (22,107 patients, 39% female; mean age 68.0 ± 11.3 years, mean logistic European System for Cardiac Operative Risk Evaluation, 8.6%) or AVR+CABG (11,956 patients, 28% female; mean age 72.6 ± 7.8 years, mean logistic European System for Cardiac Operative Risk Evaluation, 10.7%) between 2011 and 2013 were analyzed and followed up to assess the 1-year outcome. RESULTS: In-hospital mortality was 2.3% for AVR and 4.1% for AVR+CABG. Other important outcome variables include stroke (AVR, 1.2%; AVR+CABG, 1.9%) and new pacemaker implantation (AVR, 4.4%; AVR+CABG, 3.6%). Survival at 1 year was 93.2% for AVR and 89.4% for AVR+CABG. Total stroke rates at 1 year were 1.6% for AVR and 2.0% AVR+CABG. Quality of life assessment indicated that most patients were in New York Heart Association Functional Classification I or II (AVR, 86%; AVR+CABG, 84%) and that they were satisfied with the overall postoperative course (AVR, 88%; AVR+CABG, 87%). CONCLUSIONS: Contemporary surgical AVR yields excellent outcomes with low in-hospital mortality, a low overall complication rate, and good 1-year outcome for all risk groups. Accordingly, conventional AVR remains an important therapeutic option for many patients.

Perioperative Results and Complications in 15,964 Transcatheter Aortic Valve Replacements: Prospective Data From the GARY Registry.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has evolved into a routine procedure with good outcomes in high-risk patients. OBJECTIVES: TAVR complication rates were evaluated based on prospective data from the German Aortic Valve Registry (GARY). METHODS: From 2011 to 2013, a total of 15,964 TAVR procedures were registered. We evaluated the total cohort for severe vital complications (SVCs), including the following: death on the day of intervention, conversion to sternotomy, low cardiac output that required mechanical support, aortic dissection, and annular rupture; technical complications of the procedures (TCOs), such as repositioning or retrieval of the valve prosthesis and embolization of the prosthesis; and other complications. RESULTS: Mean patient age was 81 ± 6 years, 54% of the patients were women, the median logistic Euroscore I was 18.3, the German aortic valve score was 5.6, and the Society of Thoracic Surgeons score was 5.0. Overall in-hospital mortality was 5.2%, whereas SVCs occurred in 5.0% of the population. Independent predictors for SVCs were female sex, pre-operative New York Heart Association functional class IV, ejection fraction <30%, pre-operative intravenous inotropes, arterial vascular disease, and higher degree of calcifications. TCOs occurred in 4.7% of patients and decreased significantly from 2011 to 2013. An emergency sternotomy was performed in 1.3% of the patients; however, multivariate analysis did not identify any predictors for conversion to sternotomy. CONCLUSIONS: The all-comers GARY registry revealed good outcomes after TAVR and a regression in complications. Survival of approximately 60% of patients who experienced SVCs or who required sternotomy underlines the need for heart team-led indication, intervention, and follow-up care of TAVR patients.

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.

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.

[Potentials of cooperative quality management initiatives: BQS Institute projects, January 2010 - July 2013]. / 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).

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 Fisher's 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.

The care of preterm infants with birth weight below 1250 g: risk-adjusted quality benchmarking as part of validating a caseload-based management system.

BACKGROUND: In Germany, controversy currently surrounds the contention that the quality of care for preterm infants weighing less than 1250 g is best assured by requiring that centers treat a minimum of 30 such cases per year. METHODS: A risk-adjusted model was developed on the basis of neonatal data from 7405 preterm infants treated in German centers, and the effect of caseload on risk-adjusted mortality was analyzed. In addition, the discriminative ability of the minimal caseload requirement for quality assessment was studied. The authors designate the quality of care in a particular center as above average if the observed mortality is lower than would have been expected from the risk profile of the preterm infants treated there. RESULTS: Risk-adjusted mortality was found to be significantly higher in smaller centers (those with fewer than 30 cases per year) than in larger ones (odds ratio, 1.34). Even among centers whose caseload exceeded the minimum requirement, there was still marked variability in risk-adjusted mortality (range: 3.5% to 28.6%). Of all the preterm infants treated in larger centers, 56% were treated in centers with above-average quality of care. 44% of the centers with above-average quality of care had caseloads in the range of 14 to 29 cases per year. CONCLUSION: Because of the marked variability in risk-adjusted mortality, even among larger centers, a caseload of 30 or more cases per year is not a suitable indicator of the quality of care. The neonatal data of external quality assurance should be used to develop an instrument for quality-based coordination of care that takes not just morbidity and mortality, but also the treating centers' competence profiles into account.

Cardiac surgery in the elderly patient.

BACKGROUND: As life expectancies rise and the number of persons over age 75 in the population increases, the proper treatment of elderly cardiac patients is becoming a matter of ever greater medical and political importance. METHODS: In collaboration with the German Federal Quality Assurance Office (Bundesgeschäftsstelle Qualitätssicherung, BQS), the authors analyzed the risk profiles of elderly patients by means of data sets from all cardiac surgical centers in Germany for the year 2007. The results regarding risk distribution and the morbidity and lethality statistics for isolated coronary surgery were derived from the complete, nationwide BQS data pool, containing information on a total of 47,881 operations. Data on quality of life and long-term survival were obtained from a selective literature search using Medline. RESULTS: Compared to patients under age 65, those over age 75 have significantly more prognosis-determining comorbidities and risk factors. Accordingly, complication rates and lethality are higher in the latter age group (for example, there is a 4.3-fold relative risk elevation for renal dysfunction, a 3.0-fold elevation for neurological complications, and 3.7-fold elevation for in-hospital lethality). The patient's chronological age is a risk factor for lethality and morbidity after coronary surgical procedures. CONCLUSIONS: The lethality risk of a bypass operation can be predicted very accurately with the aid of modern scoring systems. Successful cardiac surgical procedures can return the patient to a normal life expectancy and quality of life for his or her age group.

[QUALIFY--a tool for assessing quality indicators]. / QUALIFY: Ein Instrument zur Bewertung von Qualitätsindikatoren.

Quality indicators are used world-wide to control the quality of health care. To be effective these indicators have to meet quality criteria themselves. But until now there has been no fully operational method for assessing indicators. Using a systematic review of existing criteria and scientific analyses the criteria set QUALIFY was developed. Particular characteristics of QUALIFY include clear definitions of all criteria, consistent information as the basis of assessment and a standardized approach throughout the assessment process. QUALIFY comprises 20 criteria which are assigned to the three categories relevance, scientific soundness and feasibility. It was tested during the assessment of 55 indicators and served as the methodological basis for selecting those quality indicators that German hospitals are required to report publicly.