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.

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.

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.

[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.

[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.

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.

[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.

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.

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.

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.

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.).

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.