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Transcatheter aortic valve implantation (TAVI) is already an accepted option to treat elderly patients with severe symptomatic aortic stenosis who are inoperable or at high surgical risk. However, short- and long-term mortality after TAVI remains an important issue, raising the need to further improve the technology of TAVI as well as to identify patients who will not benefit from TAVI. A total of 1,391 patients treated with TAVI at 27 hospitals were included in the German Transcatheter Aortic Valve Interventions – Registry. One-year follow-up data were available for 1,318 patients (94.8%), with a mean follow-up period of 12.9 ± 4.5 months. One-year mortality was 19.9%. Survivors and nonsurvivors showed multiple differences in patient characteristics, indications for interventions, preintervention and interventional characteristics, and postintervention events. A higher logistic European System for Cardiac Operative Risk Evaluation score was associated with higher 1-year mortality (p <0.0001). Cox proportional-hazards analysis revealed the following independent predictors of mortality: among preintervention findings: previous mitral insufficiency ≥II° (p = 0.0005), low-gradient aortic stenosis (p = 0.0008), previous decompensation (p = 0.0061), previous myocardial infarction (p = 0.0138), renal failure (p = 0.0180), previous New York Heart Association class IV (p = 0.0254), and female gender (p = 0.0346); among procedural factors: intraprocedural conversion to surgery (p = 0.0009), peri-intervention stroke (p = 0.0003), and residual aortic insufficiency ≥II° (p = 0.0022); and among postprocedural events: postintervention myocardial infarction (p = 0.0009) and postintervention pulmonary embolism (p = 0.0025). In conclusion, 1-year mortality after TAVI was 19.9% in this series. Patient characteristics and procedural as well as postintervention factors associated with mortality were identified, which may allow better patient selection and better care for these critically ill patients.

Implantation of a defibrillator early after myocardial infarction (MI) in high-risk patients reduced the risk of sudden cardiac death, but there was a reciprocal increase in the risk of nonsudden cardiac death. Overall mortality was not affected by early defibrillator implantation, and therefore this intervention cannot be recommended after MI in high-risk patients. Early after MI Implantation of a defibrillator early after myocardial infarction (MI) in high-risk patients reduced the risk of sudden cardiac death, but there was a reciprocal increase in the risk of nonsudden cardiac death. Despite the general improvement in outcomes among survivors of acute myocardial infarction the rate of death, including sudden cardiac death, remains highest in the weeks after the event. 1 , 2 Sudden cardiac death due to ventricular tachyarrhythmias accounts for approximately 20 to 50% of all deaths in this population. 3 – 5 Therefore, prevention of sudden cardiac death after myocardial infarction remains an important goal. With the exception of beta-blockers, antiarrhythmic drugs do not reduce this risk. Several randomized trials have shown that an implantable cardioverter–defibrillator (ICD) can reduce mortality both among patients who have had sustained ventricular tachyarrhythmias 6 and among selected patients . . .

Resting heart rate (RHR) has prognostic implications in heart failure with reduced ejection fraction, where ≤ 70 bpm is targeted. Whether a RHR > 70 bpm assessed within clinical practice goes along with elevated cardiovascular risk in implantable cardioverter-defibrillator (ICD) / cardiac resynchronization therapy-defibrillator (CRT-D) recipients remains incompletely understood. A total of 1589 patients (ICD n  = 1172 / CRT-D n  = 417, median age 65 years, 22.6% female) undergoing ICD/CRT-D implantation or revision in the prospective German DEVICE multicenter registry were analyzed. RHR was assessed via a 12-channel electrocardiogram at enrollment. 1-year outcomes (all-cause mortality, major cardio- and cerebrovascular events (MACCE), all-cause hospital admission) were compared between patients with a RHR ≤ 70 bpm and > 70 bpm. 733 patients (46.1%) showed a RHR > 70 bpm. Median RHR was 63 (interquartile range 59; 68) bpm (≤ 70 bpm group) and 80 (75; 89) bpm (> 70 bpm group). Heart failure with reduced ejection fraction was present in 76.3%, a prior myocardial infarction in 32.4% and non-ischemic heart disease in 44.9%. One-year all-cause mortality was similar between RHR groups (≤ 70 bpm 5.4% vs. > 70 bpm 5.4%, p  = 0.96), and subgroup analysis regarding patient characteristics and comorbidities revealed only a significantly higher rate of patients with dual chamber ICD in the > 70 bpm group (0.8% vs. 9.2%, p  = 0.003). MACCE (5.9% vs. 6.1%, p  = 0.87) and defibrillator shock rates (9.9% vs. 9.8%, p  = 1.0) were similar. Higher all-cause hospital admission rates were observed in patients with > 70 bpm RHR (23.1% vs. 29.0%, p  = 0.027) driven by non-cardiovascular events (6.0% vs. 11.7%, p  = 0.001). In conclusion, in ICD and CRT-D recipients a RHR at admission > 70 bpm may indicate patients at increased risk of all-cause hospital admission but not of other adverse cardiovascular events or death at 1-year follow-up.

In 2008, the German Cardiac Society (GCS) introduced a certification program for specialized chest pain units (CPUs). In order to benchmark the performance of the certified CPUs, a nationwide German CPU registry was established. Since then, data for more than 34,000 patients have been included. The concept of certified CPUs in Germany has been widely accepted and its success is underlined by its recent inclusion in national and international guidelines. As of December 2019, 286 CPUs have been successfully certified or recertified by the GCS. This review focuses on the data retrieved from the CPU registry during the first decade of certification. As demonstrated by 16 manuscripts stemming from the registry, certified German CPUs demonstrate high quality of care in acute coronary syndrome and beyond. It is also noted that the German CPU registry allowed for further analysis of the gap in guideline adherence. With the current update of the CPU certification criteria, central data collection as a best-practice criterion will be abandoned, and after some productive years the registry has temporarily been stopped.

History of syncope is an independent predictor for sudden cardiac death. Programmed stimulation may be considered for risk stratification, but data remain sparse among different populations. Here, we analyzed the prognostic value of inducible ventricular arrhythmia (VA) regarding clinical outcome in patients with syncope undergoing defibrillator implantation. Among 4196 patients enrolled in the prospective, multi-center German Device Registry, patients with syncope and inducible VA (n = 285, 6.8%) vs. those with a secondary preventive indication (n = 1885, 45.2%), defined as previously documented sustained ventricular tachycardia or ventricular fibrillation, serving as a control group were studied regarding demographics, device implantation and post-procedural adverse events. Patients with syncope and inducible VA (64.9 ± 14.4 years, 81.1% male) presented less frequently with congestive heart failure (15.1% vs. 29.1%; p  < 0.001) and any structural heart disease (84.9% vs. 89.3%; p  = 0.030) than patients with a secondary preventive indication (65.0 ± 13.8 years, 81.0% male). Whereas dilated cardiomyopathy (16.8% vs. 23.8%; p  = 0.009) was less common, hypertrophic cardiomyopathy (5.6% vs. 2.8%; p  = 0.010) and Brugada syndrome (2.1% vs. 0.3%; p  < 0.001) were present more often. During 1-year-follow-up, mortality (5.1% vs. 8.9%; p  = 0.036) and the rate of major adverse cardiac or cerebrovascular events (5.8% vs. 10.0%; p  = 0.027) were lower in patients with syncope and inducible VA. Among patients with inducible VA, post-procedural adverse events including rehospitalization (27.6% vs. 21.7%; p  = 0.37) did not differ between those with vs. without syncope. Taken together, patients with syncope and inducible VA have better clinical outcomes than patients with a secondary preventive defibrillator indication, but comparable outcomes to patients without syncope, which underlines the relevance of VA inducibility, potentially irrespective of a syncope.

ObjectivesChronic kidney disease (CKD) is associated with an increased complication rate after cardiac interventions. Although CKD has a high prevalence among atrial fibrillation patients, the impact of CKD on periprocedural complications and the outcome after an interventional left atrial appendage closure (LAAC) is unclear. The present study, therefore, aimed to investigate whether CKD influences the procedure’s effectiveness and safety.MethodsLAARGE is a prospective, non-randomised registry. LAAC was conducted with different standard commercial devices, and the follow-up period was one year. CKD was defined by an eGFR < 60 mL/min/1.73 m2, and subgroups were further analysed (i.e. eGFR < 15, 15–29, and 30–59 mL/min/1.73 m2, respectively).ResultsTwo hundred ninety-nine of 623 patients (48.0%) revealed a CKD. The prevalence of cardiovascular comorbidity, CHA2DS2-VASc score (4.9 vs. 4.2), and HAS-BLED score (4.3 vs. 3.5) was significantly higher in CKD patients (each p < 0.001). Implantation success was similarly high across all GFR groups (97.9%). Periprocedural MACCE (0.7 vs. 0.3%), and other major complications (4.7 vs. 3.7%) were comparably infrequent. Survival free of stroke was significantly lower among CKD patients within 1 year (82.0 vs. 93.0%; p < 0.001; consistent after adjustment for confounding factors), without significant accentuation in advanced CKD (i.e. eGFR < 30 mL/min/1.73 m2; p > 0.05  vs. eGFR 30–59 mL/min/1.73 m2). Non-fatal strokes were absolutely infrequent during follow-up (0 vs. 1.1%). Severe non-fatal bleedings were observed only among CKD patients (1.4 vs. 0%; p = 0.021).ConclusionsDespite an increased cardiovascular risk profile of CKD patients, device implantation was safe, and LAAC was associated with effective stroke prevention across all CKD stages.

Type 2 diabetes is a major risk factor for cardiovascular diseases, e.g. coronary artery disease (CAD). But it has also been shown that diabetes can cause heart failure independently of ischemic heart disease (IHD) by causing diabetic cardiomyopathy. In contrast to diabetes and IHD, limited data exist regarding patients with diabetes and dilated cardiomyopathy (DCM). EVIdence based TreAtment in Heart Failure (EVITA-HF) comprises web-based case report data on demography, diagnostic measures, adverse events and 1-year follow-up of patients hospitalized for chronic heart failure and an ejection fraction ≤40%. In the present study we focused on the results of patients with diabetes and heart failure. Between February 2009 and November 2015, 4101 patients with chronic heart failure were included in 16 tertiary care centers in Germany. The mortality in patients with diabetes and DCM (n = 323) was more than double (15.2%) than that of DCM patients without diabetes (6.5%, p<0.001, n = 885). In contrast the mortality rate of patients with IHD was not influenced by the presence of diabetes (17.6% in patients with IHD and diabetes n = 945, vs. 14.7% in patients with IHD and no diabetes, n = 1236, p = 0.061). The results also remained stable after performing a multivariable analysis (unadjusted p-value for interaction = 0.002, adjusted p = 0.046). The influence of diabetes on the mortality rate is only significant in patients with DCM not in patients with CAD. Therefore, the underlying mechanisms of this effect should be studied in greater detail to improve patient care and outcome.

Background Digitalis glycosides are employed for rate control of atrial fibrillation and treatment of heart failure. Previous studies suggested potential harmful effects of digitalis therapy. The aim of the present study was to assess the prevalence and potential impact of digitalis therapy on outcomes in patients with systolic failure who were implanted with an ICD‐ or CRT‐ICD system. Methods and Results The German Device Registry is a nationwide, prospective registry with a 1‐year follow‐up investigating 4384 patients receiving either ICD or CRT systems in 52 German centers. The present analysis focused on the presence of digitalis therapy in 3826 patients undergoing device implantation. Patients receiving digitalis therapy (n = 800) presented a more severely impaired left ventricular function, higher NYHA class, and an increased incidence of left bundle branch block. Consequently, the implantation of CRT systems was more common in this group. One‐year mortality did not significantly differ between both groups (9.1% vs. 7.4%, p = 0.14). Similar results were obtained for the combined endpoint, including death, myocardial infarction, and stroke. ICD shock delivery (19.7% vs. 15.0%, p = 0.006) and device revision (11.4% vs. 7.5%, p < 0.004) were more common in digitalis‐treated patients. Conclusion In this study in patients undergoing ICD or CRT implantation, an association of digitalis therapy with an increased risk of device revision was observed. Of note, mortality or severe cardiovascular events did not differ between both groups. Furthermore, an increased risk of ICD shock delivery was observed in digitalis‐treated patients. In the presence of more nonischemic cardiomyopathy and more comorbidities in the digoxin group, digitalis glycosides were associated with an increased risk for rehospitalization or device revision, while no significant differences in mortality or major complications, including stroke or myocardial infarction, were observed.

To assess baseline characteristics and antithrombotic treatment (ATT) prescription patterns in patients enrolled in the third phase of the GLORIA-AF Registry Program, evaluate predictors of treatment prescription, and compare results with phase II. GLORIA-AF is a large, global, prospective registry program, enrolling patients with newly diagnosed nonvalvular atrial fibrillation (AF) at risk of stroke. Patients receiving dabigatran were followed for two years in phase II, and all patients were followed for 3 years in phase III. Phase II started when dabigatran became available; phase III started when the characteristics of patients receiving dabigatran became roughly comparable with those receiving vitamin K antagonists (VKAs). Between 2014 and 2016, 21,241 patients were enrolled in phase III. In total, 82% of patients were prescribed oral anticoagulation ([OAC]; 59.5% novel/nonvitamin K oral anticoagulants [NOACs], 22.7% VKAs). A further 11% of patients were prescribed antiplatelets without OAC and 7% were prescribed no ATT. A high stroke risk was the main driver of OAC prescription. Factors associated with prescription of VKA over NOAC included type of site, region, physician specialty, and impaired kidney function. Over the past few years, data from phase III of GLORIA-AF show that OACs have become the standard treatment option, with most newly diagnosed AF patients prescribed a NOAC. However, in some regions a remarkable proportion of patients remain undertreated. In comparison with phase II, more patients received NOACs in phase III while the prescription of VKA decreased. VKAs were preferred over NOACs in patients with impaired kidney function.

AimPercutaneous left atrial appendage (LAA) closure has been established as alternative stroke prophylaxis in patients with non-valvular atrial fibrillation (AF) and high bleeding risk. However, little is known regarding the outcome after LAA closure depending on the HAS-BLED score.MethodsA sub-analysis of the prospective, multicenter, Left-Atrium-Appendage Occluder Register—GErmany (LAARGE) registry was performed assessing three different groups with respect to the HAS-BLED score (0–2 [group 1] vs. 3–4 [group 2] vs. 5–7 [group 3]).ResultsA total of 633 patients at 38 centers were enrolled. Of them, 9% (n = 59) were in group 1, 63% (n = 400) in group 2 and 28% (n = 174) in group 3. The Kaplan–Meier estimated 1-year composite of death, stroke and systemic embolism was 3.4% in group 1 vs. 10.4% in group 2 vs. 20.1% in group 3, respectively (p log-rank < 0.001). The difference was driven by death since stroke and systemic embolism did not show a significant difference between the groups. The rate of major bleeding at 1 year was 0% vs. 0% vs. 2.4%, respectively (p = 0.016).ConclusionThe present data show that patients had similarly low rates of ischemic complications 1 year after LAA closure irrespective of the baseline bleeding risk. Higher HAS-BLED scores were associated with increased mortality due to higher age and more severe comorbidity of these patients.