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.

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.

In-hospital outcomes after transcatheter or surgical aortic valve replacement in younger patients less than 75 years old: a propensity-matched comparison.

AIMS: Randomised trials comparing transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (SAVR) have included mainly elderly patients >80 years. The authors investigated comparative in-hospital outcomes of younger patients <75 years undergoing transfemoral (TF) TAVR or isolated SAVR. METHODS AND RESULTS: A total of 6,972 patients aged 65-74 years undergoing TF-TAVR or SAVR between 2013 and 2014 were identified from the observational German Quality Assurance Registry on Aortic Valve Replacement (AQUA), which comprises all TAVR and SAVR procedures performed in Germany. Analyses were performed for the overall unmatched cohort as well as for 1,388 propensity-matched patients. Overall, 82.4% of patients <75 years needing treatment for aortic valve stenosis received SAVR. Patients undergoing TF-TAVR were older and had more comorbidities with higher predicted risk of death. After propensity-matching, in-hospital mortality (1.3% vs. 1.9%, p=0.39), neurologic complications (1.0% vs. 2.1%, p=0.09), and myocardial infarctions (0 vs. 0.3%, p=0.16) were not different after TF-TAVR or SAVR. Postoperative delirium was more frequent after SAVR (8.9% vs. 2.4%, p<0.001), whereas the need for new pacemaker was 4 times higher after TF-TAVR (13.3% vs. 3.5%, p<0.001). CONCLUSIONS: Younger patients <75 years undergoing TF-TAVR or SAVR had similar outcomes with the exception of more frequent need for new pacemaker implantation and less frequent incidence of post-operative dialysis and delirium in TF-TAVR patients. Whether these similar in-hospital outcomes are replicable in the longer-term events in TF-TAVR and SAVR remains to be proven in future studies.

Volume-outcome relationship with transfemoral transcatheter aortic valve implantation (TAVI): insights from the compulsory German Quality Assurance Registry on Aortic Valve Replacement (AQUA).

AIMS: Previous studies have shown lower rates of in-hospital complications and mortality for patients undergoing surgical aortic valve replacement (sAVR) in high-volume compared with lower-volume hospitals. It was the aim of our study to analyse whether there is a similar volume-outcome relationship for transcatheter aortic valve implantation (TAVI), which is increasingly used in clinical practice. METHODS AND RESULTS: We analysed all patients with non-emergent transfemoral (TF) TAVI procedures performed in 2014 in 87 German hospitals. We used the German Aortic Valve score 2.0 to calculate the ratio of observed versus expected (O/E) in-hospital mortality. A total of 9,924 patients (age 81.4±1.1 years, 45.3% male, median log EuroSCORE 18.81%, IQR 4.55) were included. Average observed mortality was 4.3±3.3%, while the expected average mortality was 5.4±1.4% (mean O/E ratio: 0.8). Average in-hospital mortality was 5.6±5.0% (range, 0 to 16.7%) in the lowest volume group of hospitals performing <50 TF-TAVI annually compared to 2.4±1.0% (range, 0.5 to 3.7%) in the highest volume hospitals with ≥200 TF-TAVI procedures per year. There was a continuous, statistically significant association of lower O/E ratios with increasing TF-TAVI volumes (p<0.001), but without a clear-cut threshold. Major complications, neurologic events, and rates of new pacemaker implantation were not different between low- and high-volume hospitals. CONCLUSIONS: Across the spectrum of hospital volumes from 11 to 415 patients undergoing TF-TAVI per year in Germany, there was a continuous, statistically significant association of lower average observed as well as risk-adjusted in-hospital mortality with increasing TF-TAVI volumes.

In-hospital mortality in propensity-score matched low-risk patients undergoing routine isolated surgical or transfemoral transcatheter aortic valve replacement in 2014 in Germany.

AIMS: Recent randomized trials have documented the superiority of TAVR-particularly via transfemoral access-over SAVR in patients with severe aortic stenosis considered to have a high or intermediate operative risk of death. We sought to assess in-hospital outcomes of patients with severe aortic stenosis and a low risk of operative mortality undergoing routine surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: We performed a propensity-score matched comparison of all patients undergoing first-time treatment by SAVR or transfemoral TAVR (TF-TAVR) in 2014 in Germany who had a logistic EuroSCORE (logES) ≤ 10%, considered to reflect low surgical risk. The primary endpoint of our analysis was in-hospital mortality. Of 7624 SAVR and 9969 TF-TAVR procedures, 6844 (89.8%) and 2751 patients (27.6%), respectively, were considered low risk with a logES between 1.505 and 10.0%. Matching yielded 805 TF-TAVR/SAVR patient pairs with identical propensity scores and no difference in pertinent baseline characteristics, except for the logES, which was significantly higher in TF-TAVR patients (6.8 ± 1.7 vs. 4.2 ± 1.3% in SAVR patients, P < 0.001). Observed in-hospital mortalities were 1.7% (95% confidence interval, 1.1-3.0%) in SAVR and 2.0% (1.3-3.3%) in TF-TAVR patients (P = 0.85). CONCLUSION: Our finding of no difference in in-hospital mortality in propensity-score matched low-surgical-risk patients treated by SAVR or TF-TAVR in a routine clinical setting indicates that TF-TAVR can be offered safely to individual patients, despite their operative risk being low. This finding needs to be confirmed in a randomized trial.

In-hospital outcome of transcatheter vs. surgical aortic valve replacement in patients with aortic valve stenosis: complete dataset of patients treated in 2013 in Germany.

BACKGROUND: Transvascular (TV-AVI) or transapical (TA-AVI) aortic valve implantation (TAVI) is a treatment option for patients with aortic stenosis being at high or prohibitive risk for surgical aortic valve implantation (SAVR). Randomized data demonstrated that these subgroups can safely been treated with TAVI. However, a comparison of SAVR and TAVI in intermediate and low-risk patients is missing. Therefore, the aim of the analysis was to compare TAVI and SAVR in all patients who were treated for aortic valve stenosis in Germany throughout 1 year. METHODS: The mandatory quality assurance collects data on the in-hospital outcome from all patients (n = 20,340) undergoing either SAVR or TAVI in Germany. In order to compare the different treatment approaches patients were categorized into four risk groups using the logistic EuroScore I (ES). In-hospital mortality and peri- and postprocedural complications were analyzed. RESULTS: The in-hospital mortality did not differ between TV-AVI and SAVR in the low risk group (ES <10 %: TV-AVI 2.4 %, SAVR 2.0 %, p = 0.302) and was significantly higher for SAVR in all other risk groups (ES 10-20 %: TV-AVI 3.5 %, SAVR 5.3 %; p = 0.025; ES 20-30 %: TV-AVI 5.5 %, SAVR 12.2 %, p < 0.001; ES >30 %: TV-AVI 6.5 %, SAVR 12.9 %, p = 0.008). TA-AVI had a significantly higher mortality in all risk groups compared to TV-AVI. In comparison to SAVR, TA-AVI had a higher mortality in patients with ES <10, comparable mortality in ES 10-20 %, and lower mortality in patients with an ES >20 %. The overall stroke rate was 2.3 %. It occurred more frequently in patients with an ES <10 % treated with a transapical approach (SAVR 1.8 %, TV-AVI 1.9 %, TA-AVI 3.1 %, p < 0.01). There were no statistically significant differences in all other comparisons. CONCLUSIONS: This study demonstrates that TAVI provides excellent outcomes in all risk categories. Compared with SAVR, TV-TAVI yields similar in-hospital mortality among low-risk patients and lower in-hospital mortality among intermediate and high-risk patient populations.

Influence of different approaches of aortic valve replacement on the incidence of post-operative delirium in intermediate risk patients - a matched pair analysis.

OBJECTIVES: Evaluation of the risk for post-operative delirium (POD) after surgical or transfemoral aortic valve replacement (AVR) as an additional decision parameter for the choice of treatment in patients with an EuroScore (ES) between 10% and 20%. BACKGROUND: POD is well known as a not infrequent side effect of cardiac surgery necessitating extracorporeal circulation. In Germany a tendency to treat patients with ES <20% with transfemoral AVR (TF) instead of surgical AVR (SAVR) was observed in 2013. The risk of POD may influence the decision of physician and patient as to which procedure would be appropriate in the individual case. Therefore we performed an analysis of the incidence of POD in patients with comparable risk treated either with surgical or transfemoral aortic valve replacement. METHODS: Patients with elective or urgent need for AVR and EuroScore between 10% and 20% were extracted from the database of all isolated AVR procedures in Germany of 2013. As a result 3407 cases, 771 SAVR patients and 2636 TF patients with EuroScore 10-20%, were extracted from the complete data-base of the German quality insurance registry for heart surgery. Two homogeneous groups with regard to the risk predicted by ES were built by case-control matches and compared for available variables. In a second step two groups with identical risk/co-morbidity profile for 10 variables were identified and analyzed with respect to POD and in-hospital mortality. RESULTS: A total of 763 pairs with EuroScore of 13.5% each could be determined. Mean age was 75.6 years (SAVR, 51.6% male) and 78.8 years (TF, 56.5% male). Incidence of POD with need for therapy (POD-T) was 12.8% after SAVR and 3.8% after TF, resulting in numbers needed to harm of 8 and 26 respectively. In-hospital death rate of patients with POD-T was 5.1% after SAVR and 3.3% after TF, and nearly identical compared with patients without POD-T. POD-T had a negative influence on the regular discharge procedure. Further matching resulted in two groups of 470 patients each with identical co-morbidities and an age difference of 1 year but POD-T rates of 14.5% (SAVR) and 4.9% (TF); in-hospital mortality was 6.2% (SAVR) and 2.3% (TF). LIMITATIONS: The dataset contains valid data only for the period of hospital stay until discharge. Therefore conclusions about the duration and reversibility of POD, which are important parameters of quality of life and resource consumption as well as midterm consequences, cannot be estimated. The documentation of the German Federal Council asks only for POD and POD-T, a predefined definition of POD is not given; this may have some influence on the data. We therefore confined the analysis to only POD-T. In addition only a limited number of co-morbidities are documented. CONCLUSION: In patients with intermediate risk according to EuroScore (10-20%) the risk of post-operative delirium and in-hospital mortality is significantly higher after surgical aortic valve replacement than after transfemoral procedure. This may be considered for patient guidance and the decision as to which procedure is able to achieve the best result including minimizing side effects.

Coronary procedures in German hospitals: a detailed analysis for specific patient clusters.

OBJECTIVES: Evaluation of the classification of the patients with coronary procedures [CP: coronary angiography (CA) and/or percutaneous coronary intervention (PCI)] in Germany to provide valid data as a basis for the evaluation of resource planning and comparison of results from other countries. BACKGROUND: In the case of CP, most data are restricted to procedures related to acute coronary syndrome (ACS), either STEMI or NSTEMI, and does not cover the whole range of coronary angiographies and therapeutic procedures. To contribute to the clarification of this situation, our analysis was performed. METHODS: The data of all patients with CP documented according to § 137 German Social Security Code V (SGB V) by hospitals registered under the requirements of § 108 SGB V were analyzed. By cluster analysis, the most important predictors for four short-term clinical outcomes (intra-procedural and post-procedural events, death, length of hospital stay) were identified. Differences were analyzed on a national, federal state and interstate level. RESULTS: In 2012, 764,233 CP were performed in 733,337 patients (64.7 % males) in 890 hospitals. In 88.2 % of all patients, a cardiac disease was detected; in 11.3 %, it was excluded. 5 clusters were identified which were based on the following parameters: ACS, invasive coronary procedure, cardiac disease (i.e., hypertensive cardiac disease, cardiomyopathy, aortic aneurysm, cardiac valve disease), exclusion of CHD. There were significant differences between the five patient clusters: percentages of patients with diabetes, renal insufficiency and CHF varied between 14.1 and 32.9 %, 9.5 and 31.6 %, and 7.0 and 16.9 %, respectively; average duration of hospitalization and death rates varied between 5.5 (without ACS) and 8 days (ACS) and 0.3 and 4.5 %, respectively. The distribution of patient clusters varied significantly between the German federal states as well as within a federal state. CONCLUSIONS: Five patient clusters with CP showed significantly differing profiles of risk, outcome and resource consumption as well as a regional distribution. This has to be considered for comparisons between hospitals as well as on a regional and international level and hospital planning.