Andreas Beckmann

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.

Perioperative Results and Complications in 15,964 Transcatheter Aortic Valve Replacements

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.

Cardiac Surgery in Germany during 2010: A Report on Behalf of the German Society for Thoracic and Cardiovascular Surgery

All cardiac surgical procedures performed in 79 German cardiac surgical units throughout the year 2010 are presented in this report, based on a voluntary registry which is organized by the German Society for Thoracic and Cardiovascular Surgery. In 2010 a total of 95,734 cardiac surgical procedures (ICD and pacemaker procedures excluded) have been collected in this registry. More than 12.4% of the patients were older than 80 years compared to 11.8% in 2009. Hospital mortality in 42,804 isolated CABG procedures (14.2% off-pump procedures) was 2.8%. In 25,127 isolated valve procedures (including 3660 transcatheter-valve implantations) a mortality of 4.9% has been observed. This voluntary registry of the German Society for Thoracic and Cardiovascular Surgery will continue to be an important tool enabling quality control and illustrating the development of cardiac surgery in Germany.

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.

Position article for the use of extracorporeal life support in adult patients

Extracorporeal life support (ECLS) is one of the recent fields in cardiac surgery which has improved significantly the quality of patient care in acute or chronic end-stage heart disease. The safe use of this new technology requires many different prerequisites which are summarized in this position article. It includes the necessary personnel and their qualifications, the structural assumptions, the required equipment, and the parameters which have to be monitored for the safe usage of these devices. In addition, indications and contraindications for ECLS, the management and control of a wide range of parameters related to the extracorporeal circulation, as well as the necessary equipment are described. Quality assurance and education are also described in this position article.

Cardiac Surgery in Germany during 2007: A Report on Behalf of the German Society for Thoracic and Cardiovascular Surgery

All cardiac surgical procedures performed in 80 German cardiac surgical units throughout the year 2007 are presented in this report, based on a voluntary registry which is organized by the German Society for Thoracic and Cardiovascular Surgery. In 2007 a total of 99,990 cardiac surgical procedures (ICD and pacemaker procedures excluded) have been collected in this registry. More than 9.8% of the patients were older than 80 years compared to 9.6% in 2006. Hospital mortality in 49,788 isolated CABG procedures (10.1% off-pump) was 2.7%. In 21,312 isolated valve procedures a mortality of 5.1% has been observed. This voluntary registry of the German Society for Thoracic and Cardiovascular Surgery will continue to be an important tool enabling quality control and illustrating the development of cardiac surgery in Germany.

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.

Cardiac Surgery in Germany during 2011: A Report on Behalf of the German Society for Thoracic and Cardiovascular Surgery

All cardiac surgical procedures performed in 78 German cardiac surgical units throughout the year 2011 are presented in this report, based on a voluntary registry which is organized by the German Society for Thoracic and Cardiovascular Surgery. In 2011, a total of 100,291 cardiac surgical procedures (implantable cardioverter defibrillator and pacemakers procedures excluded) have been collected in this registry. More than 13.4% of the patients were older than 80 years compared with 12.4% in 2010. Hospital mortality in 41,976 isolated coronary artery bypass graft procedures (14.7% off-pump) was 2.9%. In 26,972 isolated valve procedures (including 5,210 catheter-based procedures), an in-hospital mortality of 5.2% has been observed.This voluntary registry of the German Society for Thoracic and Cardiovascular Surgery will continue to be an important tool enabling quality control and illustrating current facts and the development of cardiac surgery in Germany.

Cardiac Surgery in Germany during 2014: A Report on Behalf of the German Society for Thoracic and Cardiovascular Surgery

Based on a voluntary registry of the German Society for Thoracic and Cardiovascular Surgery (GSTCVS), data of all heart surgery procedures performed in 78 German cardiac surgical units during the year 2014 are presented. In 2014, a total of 100,398 cardiac surgical procedures (implantable cardioverter-defibrillator and pacemaker procedures excluded) were submitted to the registry. More than 14.2% of the patients were older than 80 years, describing an increase of 0.4% compared with the previous year. The unadjusted in-hospital mortality for 40,006 isolated coronary artery bypass grafting procedures (84.7% on-pump, 15.3% off-pump) was 2.6%. In 31,359 isolated valve procedures (including 9,194 catheter-based procedures), an in-hospital mortality of 4.4% was observed. This annual updated registry of the GSTCVS is published since 1989. It is an important tool for quality assurance and voluntary public reporting by illustrating current standards and actual developments for nearly all cardiac surgical procedures in Germany.

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.