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Aim: To compare patient characteristics, safety and efficacy of catheter ablation of supraventricular tachycardia (SVT) in patients with and without structural heart disease (SHD) enrolled in the German ablation registry., Methods and Results: From January 2007 until January 2010, a total of 12,536 patients (37.2% with known SHD) were enrolled and followed for at least one year. Patients with SHD more often underwent ablation for atrial flutter (45.8% vs. 20.9%, p < 0.001), whereas patients without SHD more often underwent ablation for atrioventricular nodal reentrant tachycardia (30.2% vs. 11.8%, p < 0.001) or atrioventricular reentrant tachycardia (9.1% vs. 1.6%, p < 0.001). Atrial fibrillation catheter ablation procedures were performed in a similar proportion of patients with and without SHD (38.1% vs. 36.9%, p = 0.21). Overall, periprocedural success rate was high in both groups. Death, myocardial infarction or stroke occurred in 0.2% and 0.1% of patients with and without SHD (p = 0.066). Major non-fatal complications prior to discharge were rare and did not differ significantly between patients with and without SHD (0.5% vs. 0.4%, p = 0.34). Kaplan-Meier mortality estimate at 1 year demonstrated a significant mortality increase in patients with SHD (2.6% versus 0.7%; p < 0.001)., Conclusion: Patients with and without SHD undergoing SVT ablation exhibit similar success rates and low major complication rates, despite disadvantageous baseline characteristics in SHD patients. These data highlight the safety and efficacy of SVT ablation in patients with and without SHD. Nevertheless Kaplan-Meier mortality estimates at 1 year demonstrate a significant mortality increase in patients with SHD, highlighting the importance of treating the underlying condition and reliable anticoagulation if indicated., (© 2021. The Author(s).)

Background: Non-paroxysmal (NPAF) forms of atrial fibrillation (AF) have been reported to be associated with an increased risk for systemic embolism or death., Methods: Comparison of procedural details and long-term outcomes in patients (pts) with paroxysmal AF (PAF) against controls with NPAF in the prospective, multicentre observational registry of patients undergoing LAAC (LAARGE)., Results: A total of 638 pts (PAF 274 pts, NPAF 364 pts) were enrolled. In both groups, a history of PVI was rare (4.0% vs 1.6%, p = 0.066). The total CHA 2 DS 2 -VASc score was lower in the PAF group (4.4 ± 1.5 vs 4.6 ± 1.5, p = 0.033), while HAS-BLED score (3.8 ± 1.1 vs 3.9 ± 1.1, p = 0.40) was comparable. The rate of successful implantation was equally high (97.4% vs 97.8%, p = 0.77). In the three-month echo follow-up, LA thrombi (2.1% vs 7.3%, p = 0.12) and peridevice leak > 5 mm (0.0% vs 7.1%, p = 0.53) were numerically higher in the NPAF group. Overall, in-hospital complications occurred in 15.0% of the PAF cohort and 10.7% of the NPAF cohort (p = 0.12). In the one-year follow-up, unadjusted mortality (8.4% vs 14.0%, p = 0.039) and combined outcome of death, stroke and systemic embolism (8.8% vs 15.1%, p = 0.022) were significantly higher in the NPAF cohort. After adjusting for CHA 2 DS 2 -VASc and previous bleeding, NPAF was associated with increased death/stroke/systemic embolism (HR 1.67, 95% CI 1.02-2.72, p = 0.041)., Conclusion: Atrial fibrillation type did not impair periprocedural safety or in-hospital MACE patients undergoing LAAC. However, after one year, NPAF was associated with higher mortality., (© 2021. The Author(s).)

Aims: To report hospitalization costs of patients with non-valvular atrial fibrillation (AF) submitted to percutaneous left atrial appendage closure (LAAC) with the Watchman device., Methods: Pre- and post-procedural hospitalization AF-related costs were calculated using the DRG system (diagnosis-related groups) and compared., Results: Between 2012 and 2016, 677 non-valvular AF patients underwent LAAC. Median time from first cardiac hospitalization to LAAC was 5.9 years (IQR 1.6-9.1) and median follow-up after LAAC was 4.8 years (IQR 3.6-5.6). LAAC mortality was 1.3% and follow-up mortality 16.9%. Median pre-LAAC hospitalization cost was € 17,867 (IQR € 7512-35,08) and post-LAAC € 8772 (IQR € 1183-25,159) (p < 0.0001). Annualized cost pre-LAAC was 3773 € (IQR € 1644-8,493) and post-LAAC 2,001 € (IQR € 260-6913) (p < 0.0001). Follow-up survivors had significantly lower post-LAAC costs (p < 0.0001) and after a survival cut-off time of 4.6 years LAAC procedural and post-procedural hospitalization costs achieved parity with pre-LACC costs (AUC 0.64; p = 0.02). CHA2DS2-VASc score (B = 0.04; p = 0.02; 95% CI 0.006-0.08), and HAS-BLED score (B = 0.08; p = 0.004; 95% CI 0.02-0.14) were independent determinants for annualized hospitalization costs post-LAAC. At Cox-regression analysis the DRG mean clinical complexity level (CCL) was the only independent determinant for follow-up mortality (OR = 2.2; p < 0.0001; 95% CI 1.6-2.8) with a cut-off value of 2.25 to predict follow-up mortality (AUC 0.72; p < 0.0001; Spec. 70%; Sens. 70%)., Conclusion: Hospitalization costs pre-LAAC are consistent, and after LAAC, they are significantly reduced. Costs seem related to the patient's risk profile at the time of the procedure. With the increase in post-LAAC survival time, the procedure becomes economically more profitable., (© 2021. Springer-Verlag GmbH Germany, part of Springer Nature.)

Objectives: Chronic 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., Methods: LAARGE 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 m 2 , and subgroups were further analysed (i.e. eGFR < 15, 15-29, and 30-59 mL/min/1.73 m 2 , respectively)., Results: Two hundred ninety-nine of 623 patients (48.0%) revealed a CKD. The prevalence of cardiovascular comorbidity, CHA 2 DS 2 -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 m 2 ; p > 0.05  vs. eGFR 30-59 mL/min/1.73 m 2 ). 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)., Conclusions: Despite an increased cardiovascular risk profile of CKD patients, device implantation was safe, and LAAC was associated with effective stroke prevention across all CKD stages.

Background: In patients with high risk for sudden cardiac death the implantation of a defibrillator is an established treatment. However the benefits and risks for patients in accordance to the number of the leads are not clear. Even in the current guidelines a recommendation to this question is missing. We analyzed advantage and disadvantages of single-chamber implantable cardioverter defibrillators (VVI-ICD) versus dual-chamber implantable cardioverter defibrillators (DDD-ICD) in the prospective German Device Registry., Methods: The data of 2240 patients who underwent ICD implantation in 45 German Centers between January 2007 and March 2011 were included in a prospective device registry (VVI: n = 1629, male = 1358, EF = 34% ± 13%; DDD: n = 611, male = 491, EF = 35% ± 14%)., Results: The in-hospital complications were significantly higher in the DDD-ICD group with higher revision/device complication rates (3.0% vs. 1.2%; p = 0.003) but also higher mortality rate (1.0% vs. 0.1%; p < 0.001). Regarding the adjusted data at 1-year follow-up DDD-ICD caused more device revisions, but no difference in rehospitalization and mortality., Conclusion: It is still unclear whether DDD-ICD may be beneficial for patients with preserved sinus and atrioventricular nodal function. Our data show that the decision of the operator to choose a DDD-ICD in these patients must be taken very carefully. By choosing a DDD-ICD the patient is exposed to a significantly higher periprocedural complication rate and higher in-hospital mortality. In absence of relevant bradycardias implantation of a DDD-ICD is not justified.

Background: Aged patients are underrepresented in clinical trials on catheter ablation of atrial fibrillation (AF). In addition, results of outcomes after repeat ablation in the elderly are lacking. We report the results of first repeat AF ablation procedures of aged patients from a real-world multicenter prospective registry., Methods: Patients undergoing second AF ablation included in the prospective, multicenter German Ablation Registry were divided in two groups (age > 70 years (group 1) and age ≤ 70 years (group 2)) and analyzed for procedural characteristics and clinical follow-up., Results: 738 patients were analyzed (108 patients in group 1, 630 patients in group 2). Significantly more aged patients had structural heart disease (56 patients (51.9%) vs. 203 patients (32.2%), p < 0.001). The majority of the patients underwent repeat pulmonary vein isolation (101 patients (93.5%) vs. 593 patients (94.1%), p = 0.98). More aged patients underwent ablation of left atrial linear lesions (78.1% vs. 57.3% of all linear lesions, p = 0.027). There was no difference in the occurrence of peri-procedural complications (7 patients (6.5%) vs. 24 patients (3.8%), p = 0.30). Recurrence of atrial arrhythmias was documented in 45/105 (42.9%) and 252/603 (41.8%) patients with available follow-up in groups 1 and 2 after a median of 447 (400; 532) and 473 (411; 544) days (p = 0.84). A comparable amount of patients were asymptomatic or reported symptom improvement after repeat ablation in both groups (80% (80/100) in group 1 and 77% (446/576) in group 2; p = 0.57)., Conclusion: Repeat ablation for AF in elderly patients can be performed with safety and efficacy comparable to younger patients.

Background: Digitalis glycosides are employed for rate control of atrial fibrillation. Recent studies suggested potential harmful effects of digitalis monotherapy and combination with antiarrhythmic drugs. The aim of the present study was to assess the prevalence and potential impact of digitalis therapy on outcome in patients undergoing catheter ablation of supraventricular arrhythmias., Methods and Results: The German Ablation Registry is a nationwide, prospective registry with a 1-year follow-up investigating 12,566 patients receiving catheter ablations of supraventricular arrhythmias in 52 German centres. The present analysis focussed on pharmacotherapy in 8608 patients undergoing catheter ablation of atrial tachycardia, atrial fibrillation, or atrial flutter. Patients receiving digitalis therapy (n = 417) were older and presented a significantly increased prevalence of comorbidities including coronary artery disease, heart failure, diabetes, and pulmonary disease. One-year mortality was significantly higher in digitalis-treated patients (4.7% vs. 1.3%, p < 0.001), most strikingly in patients undergoing ablation of atrial flutter. This effect was maintained after adjustment for important risk factors. Similar results were obtained for as the combined endpoint of death, myocardial infarction, stroke and major bleeding (6.6% vs. 2.7%, p < 0.001), and non-fatal rehospitalisations (54.1% vs. 45.1%, p = 0.001)., Conclusion: In the present study of patients undergoing catheter ablation of supraventricular arrhythmias, an association of digitalis therapy with increased mortality and an increased rate of other severe adverse events were observed. The results from this 'real-life' registry are consistent with previously published studies. However, whether digitalis therapy promotes a poorer prognosis or may just serve as a marker for this aspect cannot be thoroughly interpreted.

Background: Heart failure (HF) and atrial fibrillation (AF) often coexist, but data on the prognostic value of differing ablation strategies according to left ventricular ejection fraction (LVEF) are rare., Methods and Results: From January 2007 until January 2010, 728 patients with HF were enrolled in the multi-center German ablation registry prior to AF catheter ablation. Patients were divided into three groups according to LVEF: HF with preserved LVEF (≥ 50%, HFpEF, n = 333), mid-range LVEF (40-49%, HFmrEF, n = 207), and reduced LVEF (< 40%, HFrEF, n = 188). Ablation strategies differed significantly between the three groups with the majority of patients with HFpEF (83.4%) and HFmrEF (78.4%) undergoing circumferential pulmonary vein isolation vs. 48.9% of patients with HFrEF. The latter underwent ablation of the atrioventricular (AV) node in 47.3%. Major complications did not differ between the groups. Kaplan-Meier survival analysis demonstrated a significant mortality increase in patients with HFrEF (6.1% in HFrEF vs. 1.5% in HFmrEF vs. 1.9% in HFpEF, p = 0.009) that was limited to patients undergoing ablation of the AV node., Conclusions: Catheter ablation strategies differ significantly in patients with HFpEF, HFmrEF, and HFrEF. In almost 50% of patients with HFrEF AV-node ablation was performed, going along with a significant increase in mortality rate. These results should raise efforts to further evaluate the prognostic effect of ablation strategies in HF patients.

Introduction: Catheter ablation of focal atrial tachycardia (FAT) can be a challenging procedure and results have been rarely described. The purpose of this study was to determine the characteristics and results of FAT ablation in the large cohort of the German Ablation Registry., Methods: The German Ablation Registry is a nationwide prospective multicenter database including 12566 patients who underwent an ablation procedure between 2007 and 2010. Among them 431 (3.4%) underwent an FAT ablation and 413 patients with documented locations were analyzed. Patients were divided into three groups according to the FAT location: biatrial (BiA, n = 31, 7.5%), left atrial (LA, n = 110, 26.5%), and right atrial (RA, n = 272, 66%)., Results: Acute success rate was 84% (68 vs. 85 vs. 85% in biA, LA, and RA, respectively, p = 0.038). 4.8% of patients had an early recurrence during hospitalization, most in biatrial location (p < 0.001). No major acute complication occurred. At 12 months, 81% were asymptomatic or improved. The incidence of major adverse cardiovascular and cerebrovascular events (MACCE) was 3.7%. Arrhythmia freedom without antiarrhythmic drugs was 58% and was lower in biA (34 vs. 56% in LA vs. 62% in RA, p = 0.019). Early recurrence during hospitalization was an outstanding predictive factor for recurrence during follow-up., Conclusion: In this large patient population, FAT ablation had a relatively high acute success rate with a low complication rate. During follow-up, the recurrence rate was high, particularly in biatrial location. This was frequently predicted by an early recurrence during hospitalization.

Aims: The 6-min walk test (6 MWT) has been established as an important tool for functional assessment in heart failure patients. However, its prognostic impact on the outcome in subjects with mitral regurgitation undergoing transcatheter mitral valve repair is unknown., Methods: This present work represents a sub-analysis of the German, prospective, multicenter, Transcatheter Mitral Valve Interventions (TRAMI) registry. Of the main study cohort (n = 828) 326 patients underwent 6 MWT prior to the procedure. Patients were assigned to two groups depending on the preprocedural 6 MWT distance using the median (< 200 m [group 1] vs. ≥ 200 m [group 2])., Results: No differences regarding procedural success (97 vs. 96%; p = 0.71) and 30-day mortality (3 vs. 4%; p = 0.96) were observed between the groups. With regards to 1-year outcome, patients with a walking distance < 200 m had higher all-cause mortality (26 vs. 14%; p = 0.013) as compared to those with a 6 MWT distance 200 m. After adjustment of baseline risk factors, 6 MWT distance < 200 m still showed a strong trend towards increased 1-year all-cause mortality (HR 1.63, 95% confidence interval 0.96-2.76; p = 0.071)., Conclusions: In the present study preprocedural 6 MWT distance < 200 m showed a strong trend towards increased 1-year mortality in patients undergoing MitraClip implantation.

Background: Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) has been popularized as a precious patients' management tool. We have investigated RM within the premises of a multicenter, prospective, real-world registry, i.e., the German Device II., Methods: We have focused on: (1) CIEDs with RM capabilities implantation rate and (2) actual rate of RM features activation., Results: A cohort of 1223 CIEDs patients were treated from 04/11 to 02/14. Of these, 720 (58.8%) were implanted with RM-capable devices and were presenting significantly more often a clinical diagnosis of dilatative cardiomyopathy and an indication for cardiac resynchronization. At discharge, the RM feature was activated in only 12.6% (91/720) of the total number of patients implanted with RM-capable CIEDs. After adjusting for implanting center, there was no significant correlation between any of the patient clinical characteristics and RM activation. One-year estimated mortality was 9.0% in patients with activated RM, 5.6% in those with not activated RM, and 7.7% in those without RM capability (p = 0.3). The RM feature was still activated in 13.8% of the patients surviving at follow-up. Patients undergoing RM had a trend for higher re-hospitalization rate and less visits in the device outpatient clinic., Conclusions: Although RM in CIEDs may be a clinically valuable technological armamentarium, its activation does not reflect patients' clinical profile. In fact, RM is often not activated, most probably because it is still recognized as a source of increased workload in a reality where reimbursement plans for dedicated human resources are not yet optimized.

The interventional treatment of mitral valve regurgitation by the MitraClip procedure has grown rapidly in Germany and Europe during the past years. The MitraClip procedure has the potential to treat high-risk patients with secondary mitral valve regurgitation and poor left ventricular function. Furthermore, patients with primary mitral valve regurgitation may be treated successfully by the MitraClip procedure in case of high surgical risk or in very old patients. At the same time it has been emphasised that the MitraClip interventional treatment is still at an early stage of clinical development. The largest clinical experience with the MitraClip procedure so far is probably present in some German cardiovascular centers, which here summarise their recommendations on the current indications and procedural steps of the MitraClip treatment. These recommendations of the AGIK and ALKK may present a basis for future development.

Background: Transcatheter aortic valve implantation (TAVI) has been developed to minimize operative morbidity and mortality in high-risk symptomatic patients unfit for open surgery. With the proximity of the aortic valve annulus to the conduction system there is, however, an unknown risk of conduction disturbances necessitating monitoring and often cardiac pacing., Materials and Methods: We enrolled 50 consecutive patients from January 2007 to 2008 in our prospective evaluation of conduction disturbances measured by surface and intracardiac ECG recordings. Baseline parameters, procedural characteristics as well as twelve-lead surface ECG and intracardiac conduction times were revealed pre-interventionally, after TAVI and at 7-day follow-up., Results: TAVI was performed successfully in all patients. During 7 days of follow-up the rate for first-degree AV block raised from 14% at baseline to 44% at day 7 (p < 0.001), while rates for type II second- and third-degree were 0 versus 8% (p < 0.001) and 0 versus 12% (p < 0.001), respectively. Similarly, the prevalence of new left bundle branch block (LBBB) rose from 2 to 54% (p < 0.001). Intracardiac measurements revealed a prolongation of both AH and HV interval from 123.7 ± 41.6 to 136.6 ± 40.5 ms (p < 0.001) and from 54.8 ± 11.7 to 71.4 ± 20.0 ms (p < 0.001), respectively. Pacemaker implantation at a mean follow-up of 4.8 ± 1.2 days was subsequently performed in 23 patients (46%) due to complete AV block (12%) and type II second-degree AV block (8%) while another 13 patients (26%) received a pacemaker for the combination of new LBBB with marked HV prolongation. The high rate of first-degree AV block was primarily driven by an increase in HV interval., Conclusion: Cardiac conduction disturbances were common in the early experience with CoreValve implantation necessitating close surveillance for at least 1 week.

Cardiac manifestation is the major cause of morbidity in patients with hypereosinophilic syndrome (HES). Clinical features range from heart failure to arterial embolism, which are caused by thickening of the endocardium and mural left ventricular thrombosis. Modern magnetic resonance imaging and echocardiography are able to detect fibrosis, eosinophilic infiltrate and thrombi to stage the fibrotic evolution of the disease. Treatment of HES involves standard medication for heart failure, anticoagulant therapy, immunosuppressive therapy and potentially surgical resection. The outcome of HES depends on both the progression of endocardial fibrosis and associated complications and the 5-year mortality is estimated at 30%.