Evaluation of thoracic impedance trends for implant-based remote monitoring in heart failure patients - Results from the (J-)HomeCARE-II Study.

AIMS: Remote monitoring by implantable devices substantially improves management of heart failure (HF) patients by providing diagnostic day-to-day data. The use of thoracic impedance (TI) as a surrogate measure of fluid accumulation is still strongly debated. The multicenter HomeCARE-II study evaluated clinically apparent HF events in the context of remote device diagnostics, focusing on the controversial role of TI. METHODS AND RESULTS: We followed 497 patients (66.6 ±â€¯10.1 years, 77% male, QRS 139.8 ±â€¯36.0 ms, ejection fraction 26.8 ±â€¯7.0%) implanted with a CRT-D (67%) or an ICD (33%) for 21.4 ±â€¯8.1 months. An independent event committee confirmed 171 HF events of which 82 were used to develop a TI-based algorithm for the prediction of imminent cardiac decompensation. Highly inter-individual variations in patterns of TI trends were observed. The algorithm resulted in a sensitivity of 41.5% (50.0%) with 0.95 (1.34) false alerts per patient year, and a positive predictive value of 7.9% overall and 27.9% in the HF event group of patients. Averaged ratio statistics showed a significant pre-hospital decrease and a highly significant in-hospital increase in TI after intensified diuresis. Recurrent decompensations turned out to be preceded by a significantly stronger decrease of TI compared to first events with a higher chance for detection (63.6% sensitivity, p < 0.05). CONCLUSIONS: Overall performance in predicting imminent decompensation by monitoring TI alone is limited due to its high inter-patient variability. TI stand-alone applications should be redirected towards a target population with more advanced symptoms where post-hospital observation aimed to maintain the patient's discharge status might be the most valuable approach. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT00711360 (HomeCARE-II) and NCT01221649 (J-HomeCARE-II).

Long-term symptom improvement and patient satisfaction following catheter ablation of supraventricular tachycardia: insights from the German ablation registry.

AIMS: To analyse outcomes of supraventricular tachycardia (SVT) ablations performed within a prospective German Ablation Quality Registry. METHODS AND RESULTS: Data from 12 566 patients who underwent catheter ablation of SVT between January 2007 and January 2010 to treat atrial fibrillation (AFIB, 37.2% of procedures), atrial flutter (AFL, 29.9%), atrioventricular nodal re-entrant tachycardia (AVNRT, 23.2%), atrioventricular re-entrant tachycardia (6.3%), and focal atrial tachycardia (AT, 3.4%) were prospectively collected. Patients were followed for at least 1 year. The periprocedural success rate was 96.3%, ranging from 84.3% (focal AT) to 98.9% (AVNRT). Kaplan-Meier mortality estimate at 1 year was 1.4% overall, and as high as 2.6% in the AFL group and 2.8% in the focal AT group. Recurrence of ablated or another symptomatic SVT was observed in 3783 (32.6%) of patients, ranging from 17.2% (AVNRT) to 45.6% (AFIB). Repeat ablation was performed in 12.0% of patients. After 1 year, 74.1% of survivors perceived ablation therapy as successful, 15.7% as partly successful, and 9.6% as unsuccessful. Even in those patients with arrhythmia recurrence, 76.0% perceived ablation as successful or partly successful and 89.6% would still undergo repeat ablation in the same institution. CONCLUSION: Ablation therapy for SVT is a safe procedure bringing symptomatic improvement and satisfaction to three quarters of patients after 1 year. Even in patients with arrhythmia recurrence, a high satisfaction level and adherence to the ablating institution could be documented. Strikingly high mortality and stroke rates in follow-up were observed in AFL patients, who apparently need consistent long-term anticoagulation and more medical attention.

Complication Rates of Catheter Ablation of Atrial Fibrillation in Patients Aged ≥75 Years versus <75 Years-Results from the German Ablation Registry.

INTRODUCTION: Despite a rising demand for catheter ablation (CA) of atrial fibrillation (AF) in an elderly population, complication and success rates are not fully elucidated. We sought to compare complication rates of CA of AF in patients ≥75 versus <75 years of age. METHODS AND RESULTS: Patients with symptomatic, drug-refractory AF were prospectively enrolled from January 2007 to 2010 in this multicenter study. A total of 4,449 patients, group 1 ≥75 years and group 2 <75 years (n = 227, age 77.3 ± 2.2 vs. 59.7 ± 9.8 years, 52.0% vs. n = 4,222, 68.9% male, CHA2 DS2 -VASc-Score 3.7 ± 1.0 vs. 1.7 ± 1.2; P < 0.001, respectively), with paroxysmal AF (59.9% in group 1 vs. 63.3% in group 2, P = 0.30), and persistent AF (34.8% in group 1 vs. 29.4% in group 2, P = 0.082) underwent CA of AF. A centralized follow-up was obtained in 4,347 patients by the Institute for Myocardial Infarction Research (IHF, Ludwigshafen). There was a significant difference between periprocedural stroke rates in the elderly versus the younger cohort (1.3% vs. 0.1%, P < 0.01). In-hospital severe nonfatal complications did not differ significantly between the groups (4.4% vs. 2.7%, P = 0.14). Other procedure-related, in-hospital complications were not significantly different. After a mean follow-up of 472 ± 99 days (group 1) and 477 ± 94 days (group 2), no differences were found in complication rates. CONCLUSION: CA of AF in patients ≥75 years is associated with higher in-hospital stroke rates. In a 1-year follow-up, complication rates do not differ between the groups.

The Use of Echocardiography in Certified Chest Pain Units: Results from the German Chest Pain Unit Registry.

OBJECTIVES: To analyze the current usage of transthoracic echocardiography (TTE) as a rapid, noninvasive tool in the early stratification of acute chest pain in certified German chest pain units (CPUs). METHODS: A total of 23,997 patients were enrolled. Analyses comprised TTE evaluation rates in relation to clinical presentation, risk profile, left ventricular impairment, final diagnosis and invasive management. Critical times were assessed. Multivariable analyses for independent determinants for the use of TTE were performed. RESULTS: TTE evaluation was available in CPUs in 70.1% of cases. It was associated with lower rates of invasive management in unstable angina pectoris (UAP) and with higher rates in patients with initially suspected non-cardiac origin of symptoms and/or reduced systolic function (p < 0.05). Non-ST-segment elevation acute coronary syndrome (NSTE-ACS) was an independent determinant favoring TTE evaluation [NSTE-myocardial infarction: odds ratio (OR) 1.62; UAP: OR 1.34; p < 0.001 for both]. Clinical signs of heart failure (OR 1.31; p < 0.001), referral by emergency medical service (OR 1.18; p < 0.001) and kidney failure (OR 1.16; p < 0.05) were independently associated with higher TTE rates. TTE did not delay door-to-balloon times. CONCLUSIONS: About two thirds of the patients admitted to certified CPUs received TTE evaluation, with the highest rates being in ACS patients, and thereby providing diagnostic information supporting or refuting further invasive management.

Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial.

BACKGROUND: An increasing number of patients with heart failure receive implantable cardioverter-defibrillators (ICDs) or cardiac resynchronisation defibrillators (CRT-Ds) with telemonitoring function. Early detection of worsening heart failure, or upstream factors predisposing to worsening heart failure, by implant-based telemonitoring might enable pre-emptive intervention and improve outcomes, but the evidence is weak. We investigated this possibility in IN-TIME, a clinical trial. METHODS: We did this randomised, controlled trial at 36 tertiary clinical centres and hospitals in Australia, Europe, and Israel. We enrolled patients with chronic heart failure, NYHA class II-III symptoms, ejection fraction of no more than 35%, optimal drug treatment, no permanent atrial fibrillation, and a recent dual-chamber ICD or CRT-D implantation. After a 1 month run-in phase, patients were randomly assigned (1:1) to either automatic, daily, implant-based, multiparameter telemonitoring in addition to standard care or standard care without telemonitoring. Investigators were not masked to treatment allocation. Patients were masked to allocation unless they were contacted because of telemonitoring findings. Follow-up was 1 year. The primary outcome measure was a composite clinical score combining all-cause death, overnight hospital admission for heart failure, change in NYHA class, and change in patient global self-assessment, for the intention-to-treat population. The trial is registered with ClinicalTrials.gov, number NCT00538356. FINDINGS: We enrolled 716 patients, of whom 664 were randomly assigned (333 to telemonitoring, 331 to control). Mean age was 65·5 years and mean ejection fraction was 26%. 285 (43%) of patients had NYHA functional class II and 378 (57%) had NYHA class III. Most patients received CRT-Ds (390; 58·7%). At 1 year, 63 (18·9%) of 333 patients in the telemonitoring group versus 90 (27·2%) of 331 in the control group (p=0·013) had worsened composite score (odds ratio 0·63, 95% CI 0·43-0·90). Ten versus 27 patients died during follow-up. INTERPRETATION: Automatic, daily, implant-based, multiparameter telemonitoring can significantly improve clinical outcomes for patients with heart failure. Such telemonitoring is feasible and should be used in clinical practice. FUNDING: Biotronik SE & Co. KG.

Quarterly vs. yearly clinical follow-up of remotely monitored recipients of prophylactic implantable cardioverter-defibrillators: results of the REFORM trial.

AIMS: The rapidly increasing number of patients with implantable cardioverter-defibrillators (ICD) places a large burden on follow-up providers. This study investigated the possibility of longer in-office follow-up intervals in primary prevention ICD patients under remote monitoring with automatic daily data transmissions from the implant memory. METHODS AND RESULTS: Conducted in 155 ICD recipients with MADIT II indications, the study compared the burden of scheduled and unscheduled ICD follow-up visits, quality of life (SF-36), and clinical outcomes in patients randomized to either 3- or 12-month follow-up intervals in the period between 3 and 27 months after implantation. Remote monitoring (Biotronik Home Monitoring) was used equally in all patients. In contrast to previous clinical studies, no calendar-based remote data checks were performed between scheduled in-office visits. Compared with the 3-month follow-up interval, the 12-month interval resulted in a minor increase in the number of unscheduled follow-ups (0.64 vs. 0.27 per patient-year; P = 0.03) and in a major reduction in the total number of in-office ICD follow-ups (1.60 vs. 3.85 per patient-year; P < 0.001). No significant difference was found in mortality, hospitalization rate, or hospitalization length during the 2-year observation period, but more patients were lost to follow-up in the 12-month group (10 vs. 3; P = 0.04). The SF-36 scores favoured the 12-month intervals in the domains 'social functioning' and 'mental health'. CONCLUSION: In prophylactic ICD recipients under automatic daily remote monitoring, the extension of the 3-month in-office follow-up interval to 12 months appeared to safely reduce the ICD follow-up burden during 27 months after implantation. CLINICALTRIALSGOV IDENTIFIER: NCT00401466 (http://www.clinicaltrials.gov/ct2/show/NCT00401466).

Impact of structural heart disease on the acute complication rate in atrial fibrillation ablation: results from the German Ablation Registry.

INTRODUCTION: Catheter ablation (CA) has emerged as a widespread therapeutic option in the treatment of atrial fibrillation (AF). Currently, no safety data with regard to the impact of the underlying structural heart diseases (SHD) are available. We sought to assess the risk for acute and long-term complications during CA of AF in relation to underlying SHD. METHODS AND RESULTS: We included 6,211 patients in a prospective registry undergoing CA of AF in 41 nationwide centers. All patients were divided into 4 groups according to the underlying heart disease: No SHD (69.4%), hypertensive heart disease (HHD) (12.0%), coronary artery disease (CAD) (15.1%), and cardiomyopathy (CM) (3.6%). In univariate analysis, patients with HHD had an overall complication rate of 7.28%, whereas patients without an SHD had a significantly lower rate of 6.01% (P < 0.01). Multivariate analysis revealed that HHD (adjusted odds ratio [OR]: 1.97 [95% confidence interval (CI): 1.02-3.83], P = 0.0442) and age (years; OR: 1.04 [95% CI: 1.01-1.07], P = 0.0155) were independent predictors of severe, nonfatal complications and death. Other SHD including CAD (OR: 1.48 (0.73-3.00), P = 0.2797) and CM (OR: 2.37 [0.70-7.99], P = 0.1630) failed to reach statistical significance. Male sex was protective (OR: 0.47 [95% CI: 0.27-0.81], P = 0.0062). CONCLUSION: In general, CA of AF has a low number of severe complications. In our prospective registry HHD emerged as an independent predictor of severe, nonfatal complications during AF ablation but other SHD including CAD and CM did not. The influence of HHD on the complication rate should be considered in patient selection.

Catheter ablation of stable ventricular tachycardia before defibrillator implantation in patients with coronary heart disease (VTACH): an on-treatment analysis.

BACKGROUND: In the Ventricular Tachycardia Ablation in Coronary Heart Disease (VTACH) study, an intention-to-treat approach was used and may have diminished the observed degree of treatment effect. We present a subanalysis of the VTACH study by treatment actually received. METHODS AND RESULTS: The VTACH study was a prospective, open, randomized controlled trial, undertaken in 16 European centers, comparing defibrillator implantation with and without ventricular tachycardia (VT) ablation in patients with stable VT, previous myocardial infarction, and reduced left-ventricular ejection fraction. Of the 52 patients in the ablation group, 7 (13%) did not receive VT ablation and 19% of patients assigned to implantable cardioverter defibrillator (ICD) only treatment group crossed over and had an ablation. The primary endpoint (first recurrence of any documented VT or ventricular fibrillation [VF]) was reached after a median of 19.5 months in the ablation group and 5.9 months in the ICD only group (P = 0.01). Overall, 685 VT/VF events occurred per year of follow-up in 22 patients of the ablation group and 4,986 events in 43 patients of the control group (P = 0.024). In the ICD only group, median numbers of VT/VF episodes were 25 (IQR 5.8-45.3) and 1.5 (IQR 0-24.8) per patient and year before and after crossover (n = 12), respectively. CONCLUSION: On-treatment analysis of the VTACH study emphasizes the effectiveness of VT ablation in patients receiving ICD treatment because of monomorphic VT post myocardial infarction. VT ablation clearly prolonged time to recurrence of VT/VF episodes and markedly decreased VT/VF burden.

Outcomes After Left Main Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock (from the German ALKK PCI Registry).

Early revascularization therapy with percutaneous coronary intervention (PCI) has been shown to improve outcomes in patients with acute myocardial infarction (AMI) complicated by cardiogenic shock (CS). Data from consecutive patients with AMI and CS treated with PCI enrolled into the prospective Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte-PCI registry were centrally collected and analyzed. Patients were divided into 4 groups with PCI for left main (LM), 1-vessel, 2-vessel, and 3-vessel diseases. Patients' characteristics, procedural features, antithrombotic therapies, and in-hospital complications were compared between the 4 groups. Between 2010 and 2015 a total of 2,348 consecutive patients with AMI and CS were treated by PCI in 51 hospitals, 295 for LM (15 for protected, 280 for unprotected) and single-vessel (n = 491), 2-vessel (n = 524), and 3-vessel disease (n = 1,038). Thrombolysis in myocardial infarction 3 patency of the culprit lesion after PCI was 84.3%, 84.0%, 80.8%, and 84.6% in single-vessel, 2-vessel, 3-vessel disease, and LM PCI, respectively, whereas in-hospital mortality was 27.9%, 33.9%, 46.5%, and 55.9%. Bleeding rates were low (2.0%-2.3 %) and not different between groups. In a multivariate analysis a higher age, thrombolysis in myocardial infarction flow <3 after PCI, 3-vessel disease, and LM PCI were independent predictors of mortality. In conclusion, PCI of the LM is performed in about 12.5% of patients with AMI and CS and was associated with a high procedural success rate, whereas mortality is increased with LM PCI.

Prevention of cerebral thromboembolism by oral anticoagulation with dabigatran after pulmonary vein isolation for atrial fibrillation: the ODIn-AF trial.

BACKGROUND AND OBJECTIVES: Long-term oral anticoagulation (OAC) following successful catheter ablation of atrial fibrillation (AF) remains controversial. Prospective data are missing. The ODIn-AF study aimed to evaluate the effect of OAC on the incidence of silent cerebral embolic events and clinically relevant cardioembolic events in patients at intermediate to high risk for embolic events, free from AF after pulmonary vein isolation (PVI). METHODS: This prospective, randomized, multicenter, open-label, blinded endpoint interventional trial enrolled patients who were scheduled for PVI to treat paroxysmal or persistent AF. Six months after PVI, AF-free patients were randomized to receive either continued OAC with dabigatran or no OAC. The primary endpoint was the incidence of new silent micro- and macro-embolic lesions detected on brain MRI at 12 months of follow-up compared to baseline. Safety analysis included bleedings, clinically evident cardioembolic, and serious adverse events (SAE). RESULTS: Between 2015 and 2021, 200 patients were randomized into 2 study arms (on OAC: n = 99, off OAC: n = 101). There was no significant difference in the occurrence of new cerebral microlesions between the on OAC and off OAC arm [2 (2%) versus 0 (0%); P = 0.1517] after 12 months. MRI showed no new macro-embolic lesion, no clinical apparent strokes were present in both groups. SAE were more frequent in the OAC arm [on OAC n = 34 (31.8%), off OAC n = 18 (19.4%); P = 0.0460]; bleedings did not differ. CONCLUSION: Discontinuation of OAC after successful PVI was not found to be associated with an elevated risk of cerebral embolic events compared with continued OAC after a follow-up of 12 months.

Catheter ablation of stable ventricular tachycardia before defibrillator implantation in patients with coronary heart disease (VTACH): a multicentre randomised controlled trial.

BACKGROUND: In patients with ventricular tachycardia (VT) and a history of myocardial infarction, intervention with an implantable cardioverter defibrillator (ICD) can prevent sudden cardiac death and thereby reduce total mortality. However, ICD shocks are painful and do not provide complete protection against sudden cardiac death. We assessed the potential benefit of catheter ablation before implantation of a cardioverter defibrillator. METHODS: The Ventricular Tachycardia Ablation in Coronary Heart Disease (VTACH) study was a prospective, open, randomised controlled trial, undertaken in 16 centres in four European countries. Patients aged 18-80 years were eligible for enrolment if they had stable VT, previous myocardial infarction, and reduced left-ventricular ejection fraction (LVEF; 30%). Patients were followed up for at least 1 year. The primary endpoint was the time to first recurrence of VT or ventricular fibrillation (VF). Analysis was by intention to treat (ITT). This study is registered with ClinicalTrials.gov, number NCT00919373. FINDINGS: 107 patients were included in the ITT population (ablation group, n=52; control group, n=55). Two patients (one in each group) withdrew consent immediately after randomisation without any follow-up data and one patient (ablation group) was excluded because of a protocol violaton. Mean follow-up was 22.5 months (SD 9.0). Time to recurrence of VT or VF was longer in the ablation group (median 18.6 months [lower quartile 2.4, upper quartile not determinable]) than in the control group (5.9 months [IQR 0.8-26.7]). At 2 years, estimates for survival free from VT or VF were 47% in the ablation group and 29% in the control group (hazard ratio 0.61; 95% CI 0.37-0.99; p=0.045). Complications related to the ablation procedure occurred in two patients; no deaths occurred within 30 days after ablation. 15 device-related complications requiring surgical intervention occurred in 13 patients (ablation group, four; control group, nine). Nine patients died during the study (ablation group, five; control group, four). INTERPRETATION: Prophylactic VT ablation before defibrillator implantation seemed to prolong time to recurrence of VT in patients with stable VT, previous myocardial infarction, and reduced LVEF. Prophylactic catheter ablation should therefore be considered before implantation of a cardioverter defibrillator in such patients. FUNDING: St Jude Medical.

Incidence of silent cerebral thromboembolic lesions after atrial fibrillation ablation may change according to technology used: comparison of irrigated radiofrequency, multipolar nonirrigated catheter and cryoballoon.

INTRODUCTION: Silent cerebral ischemic lesions have recently emerged as the most frequent complications after pulmonary vein isolation (PVI). To reduce thromboembolic complications, new types of catheters and energy source have been introduced in clinical practice. The study purpose is to compare the incidence of new silent cerebral ischemic events in patients with paroxysmal atrial fibrillation (PAF) undergoing PVI with different ablation technologies. METHODS AND RESULTS: One hundred and eight patients (67% men; age 56 ± 9 years) with PAF were enrolled in a consecutive manner to undergo PVI performed with irrigated radiofrequency (RF) catheter (Group 1, 36 patients), multielectrode catheter (PVAC) associated with duty-cycled RF generator (Group 2, 36 patients) and cryoballoon (Group 3, 36 patients). The protocol included a cerebral magnetic resonance imaging before and after the procedure. After PVI, the following patients showed new silent cerebral ischemic lesions at postprocedural cerebral MRI: 3 patients in Group 1 (8.3%), 14 patients in Group 2 (38.9%), 2 patients in Group 3 (5.6%). PVAC related to higher incidence of silent cerebral ischemic events compared to irrigated RF (P = 0.002) and cryoballoon (P = 0.001), whereas no statistical differences were found between irrigated RF catheter and cryoballoon groups (8.3% vs 5.6%, P = 0.5). At the multivariate analysis, the only independent predictor of new ischemic asymptomatic cerebral lesions after PVI was ablation performed with PVAC (OR 1.48 95% CI 1.19-1.62, P < 0.001). CONCLUSION: The incidence of silent cerebral lesions after PVI is different depending on technologies used: PVAC increases the risk of 1.48 times compared to irrigated RF and cryoballoon ablation.

[Reversible severe cardiomyopathy caused by a slow permanent tachycardia]. / Reversible, schwere Kardiomyopathie als Folge einer langsamen, permanenten Schmalkomplextachykardie.

Incessant narrow QRS complex tachycardias may result in severe tachycardia-induced cardiomyopathy even if the heart rate during tachycardia is only moderately elevated. The risk of ventricular deterioration is particularly increased in patients with underlying congenital heart disease. In these patients, drug treatment is often insufficient. Thus, catheter ablation of the arrhythmogenic substrate is required in the majority of patients. After successful ablation, ventricular function may recover completely.

Efficacy and complications of cavo-tricuspid isthmus-dependent atrial flutter ablation in patients with and without structural heart disease: results from the German Ablation Registry.

BACKGROUND: The impact of structural heart disease (SHD) on safety and efficacy of catheter ablation of cavo-tricuspid isthmus-dependent atrial flutter (AFLU) is unclear. In addition, recent data suggest a higher complication rate of AFLU ablation compared to the more complex atrial fibrillation (AF) ablation procedure. METHODS AND RESULTS: Within our prospective multicenter registry, 3526 consecutive patients underwent AFLU ablation at 49 German electrophysiological centers from 2007 to 2010. For the present analysis, the patients were divided into a group with SHD (n = 2164 [61.4%]; median age 69 years; 78.5% male) and a group without SHD (n = 1362 [38.6%]; 65 years; 70.3% male). In our study, SHD mainly encompasses coronary artery disease (52.6%), left ventricular ejection fraction ≤ 50% (47.6%), and hypertensive heart disease (28.0%). The primary ablation success (97%) and the incidence of major (0.2%) or moderate (1.2%) complications did not differ significantly between the two groups (P = 1.0 and 0.87, respectively). Vascular access site complications (0.6%), AV block III° (0.2%), and bleeding (≥ BARC II: 0.2%) were most common. After a median 562 days of follow-up, we observed a 2.92-fold higher one-year mortality (P < 0.0001) in patients with SHD. Patients' satisfaction with the ablation therapy (72.0% satisfied) was close to the overall subjective tachyarrhythmia-free rate (70.7%). CONCLUSIONS: The present analysis demonstrates that ablation of cavo-tricuspid isthmus dependent AFLU in patients with SHD has a comparable, excellent risk-benefit profile in our large "real-world" registry. Mortality rates expectedly are higher in patients with SHD and AFLU compared to patients without SHD. CLINICALTRIALS.GOV: NCT01197638, http://clinicaltrials.gov/ct2/show/NCT01197638.

A randomized controlled trial of secondary prevention of anxiety and distress in a German sample of patients with an implantable cardioverter defibrillator.

OBJECTIVE: To evaluate a minimal, easy, accessible intervention targeting anxiety and reduced quality of life in patients with an implantable cardioverter defibrillator (ICD). An estimated 24% to 87% of patients experience anxiety, and 10% to 15% have reduced quality of life. METHODS: A total of 119 ICD patients were assigned randomly to usual medical aftercare (n = 63) or additional psychological treatment (n = 56) comprising of written information on medical and psychological consequences of an ICD plus 6 months of individual phone counseling. Treatment efficacy was evaluated by comparing T0 (immediately after implantation) and T1 (6 months later) assessments. RESULTS: Although 75% of patients considered the program helpful, age moderated treatment efficacy. As indicated by triple interactions, only in the treatment group, anxiety (HADS-Anxiety, p < .01), psychological distress (SCL-K-9, p < .02), and somatic quality of life (SF-36-PCS, p < .01) improved in ICD patients aged <65 years but deteriorated in older patients (age, 65-75 years). Frequency of ICD discharges was associated with a symptom increase from T0 to T1 in all patients (HADS-Depression, CAQ-Avoidance, and ICD-Constraints; all p < .05). CONCLUSIONS: Our findings confirm that psychological treatments cannot be expected to have uniformly positive effects in ICD patients. Our minimal intervention may have adequately addressed ICD-related concerns in younger patients but may have fostered problems in older patients with fewer concerns. Therefore, our findings warrant custom treatment with particular attention to the elderly as well as patients with frequent ICD discharges.

Ablation of Atrial Fibrillation in Patients with Hypertension-An Analysis from the German Ablation Registry.

BACKGROUND: Hypertension (HTN) constitutes a risk factor for the development of atrial fibrillation (AF), as well as for thromboembolic and bleeding events. We analysed the outcome after catheter ablation of AF in HTN in a cohort from the prospective multicenter German Ablation Registry. METHODS: Between 03/2008 and 01/2010, 626 patients undergoing AF-ablation were analysed. Patients diagnosed with HTN (n = 386) were compared with patients without HTN (n = 240) with respect to baseline, procedural and long-term outcome parameters. RESULTS: Patients with HTN were older and more often presented with persistent forms of AF and cardiac comorbidities. Major and moderate in-hospital complications were low. At long-term follow-up, major cardiovascular events were rare in both groups. Rates of AF-recurrence, freedom from antiarrhythmic medication and repeat ablation were not statistically different between groups. Most patients reported improvement of symptoms and satisfaction with the treatment. However, patients with HTN more frequently complained of dyspnea of New York Heart Association (NYHA) class ≥ II and angina. They were more often rehospitalized, particularly when persistent AF had been diagnosed. CONCLUSION: Catheter ablation of AF is associated with low complication rates and favorable arrhythmia-related results in patients with HTN. Residual clinical symptoms may be due to cardiac comorbidities and require additional attention in this important subgroup of AF-patients.

Symptomatic arrhythmias after catheter ablation of atrioventricular nodal reentrant tachycardia (AVNRT): results from the German Ablation Registry.

BACKGROUND: In atrioventricular nodal reentrant tachycardia (AVNRT), catheter ablation is considered as first-line therapy. Despite high success rates, some patients present with arrhythmia recurrence or develop other types of arrhythmias over time. OBJECTIVE: To assess the incidence of symptomatic arrhythmias after initially successful AVNRT ablation and to analyze their clinical implications in a real-world cohort. METHODS: We included 2,795 patients from the German Ablation Registry undergoing first ablation of AVNRT between 01/2007 and 01/2010. In patients alive at long-term follow-up, patient-specific characteristics and long-term follow-up data were compared between patients with (group A) and without (group B) any symptomatic arrhythmia during follow-up. RESULTS: Symptomatic arrhythmias occurred in 17.2% of patients during a mean follow-up of 678 days after AVNRT ablation. The patients with symptomatic arrhythmias were more often female and suffered from structural heart disease. Arrhythmia occurrence was clinically relevant regarding symptoms and patient satisfaction. Serious adverse events including stroke, transient ischemic attack, pacemaker implantation, as well as continued use of antiarrhythmic medication occurred more often in group A. A second ablation procedure was performed in 26% of symptomatic patients to optimize the symptomatic outcome, whereas cardiovascular events or patient satisfaction were not further improved. CONCLUSION: During long-term follow-up, one out of six patients experienced symptomatic arrhythmias after AVNRT ablation, associated with an increase of serious adverse events. A subset of patients required medical or interventional antiarrhythmic therapy, possibly attributable to the co-existence of other arrhythmias. Screening for arrhythmic and cardiac co-morbidity before and after ablation may support comprehensive therapy planning and outcome.

Guideline-adherence regarding critical time intervals in the German Chest Pain Unit registry.

BACKGROUND: Since 2008, the German Cardiac Society certified 256 Chest Pain Units (CPUs). Little is known about adherence to recommended performance measures in patients with suspected acute coronary syndrome (ACS) presenting to CPUs. We investigated guideline-adherence regarding critical time intervals and selected performance measures in German Chest Pain Units. METHODS: From 2008 to 2014, 23,804 consecutive patients with suspected ACS were prospectively enrolled in the Chest Pain Unit registry of the German Cardiac Society. RESULTS: Median time from symptom onset to first medical contact was 2 h in patients with ST-elevation myocardial infarction (STEMI) and 4 h in patients with unstable angina and non-STEMI (NSTEMI). In patients with STEMI, median time from hospital admission to percutaneous coronary intervention (PCI) was 40 min and median time from first medical contact to PCI was 1 h 35 min. Primary PCI was performed in 94.7% of patients with STEMI, 70.0% of patients with NSTEMI and 37.4% of patients with unstable angina. PCI was performed during the first 24 h in 79.5% of patients with NSTEMI and the first 72 h in 89.0% of patients with unstable angina. Electrocardiograms were performed in 99.5% after a median of 6 min after admission and obtained within 10 min in 71%. Interestingly, 56.1% of patients were found to have non-ACS diagnoses, underlining the importance of access to additional diagnostic modalities including echocardiography, stress testing or computed tomography. CONCLUSIONS: Guideline-adherence regarding critical time intervals and primary PCI rates is good in German Chest Pain Units. More than half of patients admitted with suspected ACS had non-ACS diagnoses. Improvements in pre-hospital time delays through public awareness programmes are warranted.

Role of proinflammatory markers and NT-proBNP in patients with an implantable cardioverter-defibrillator and an electrical storm.

BACKGROUND: Several studies have attempted to identify risk factors for the development of an electrical storm (ES), which is defined as 3 separate ventricular tachyarrhythmic (VT/VF) events, but in the majority of studies no triggers have been found. However, little is known about the role of inflammation and NT-proBNP in patients with ES. The aim of this study was therefore to assess the relationship of Interleukin-6 (IL-6), high-sensitivity C-reactive protein (hs-CRP) and NT-proBNP serum concentrations in ICD-patients with or without single spontaneous ventricular tachyarrhythmic events (VT/VF) and in ES. METHODS: Markers were determined in 51 patients without ICD-intervention, in 15 ICD-patients with single VT/VF-episodes during 9-months follow-up and in 20 ICD-patients with ES (blood sampling performed within 60min after fulfilling ES criteria). VT/VF-episodes were analysed by stored ICD-electrograms. RESULTS: All patients had idiopathic dilated cardiomyopathy (n=23) or coronary artery disease (n=63). Patients with ES revealed significantly higher mean serum concentrations of all markers (IL-6 15.19+/-10.34 pg/mL, hs-CRP 20.12+/-14.4 mg/L, NT-proBNP 4799+/-4596 pg/mL) compared to baseline values of patients with single VT/VF-events during follow-up (IL-6 8.37+/-5.8 pg/mL (p=0.03), hs-CRP 4.7+/-5.3 mg/dL (p<0.001), NT-proBNP 1913+/-2665pg/mL (p=0.04)) and compared to baseline values of ICD-patients without device intervention (IL-6 4.62+/-3.66 pg/mL (p<0.001), hs-CRP 4.1+/-3.4 mg/L (p<0.001), NT-proBNP 1461+/-2281pg/mL (p<0.001)). In 9/20 patients presenting with ES (45%) baseline values were available. All markers were significantly higher during ES compared to event-free determination (IL-6 14.54+/-10.43 vs. 7.03+/-2.83 pg/mL (p=0.04), hs-CRP 19.07+/-16.07 vs. 6.5+/-3.9 mg/L (p=0.02), NT-proBNP 4218+/-2561 vs. 2099+/-1279 pg/mL (p=0.03)). CONCLUSIONS: Electrical storm is associated with significantly elevated IL-6, hs-CRP and NT-proBNP serum concentrations in ICD-patients with structural heart disease. Thus, ES may be triggered by proinflammatory activity. Combined intraindividual elevation of determined markers might help to identify patients at risk of impending electrical storm.

Cryoballoon ablation of paroxysmal atrial fibrillation within the dilated coronary sinus in a case of persistent left superior vena cava.

Trigger sources of paroxysmal atrial fibrillation (PAF) are not limited to a pulmonary vein origin and may be achievable by cardiac vascular structures like the coronary sinus (CS), the vena cava superior and in some rare cases by a persistent left superior vena cava (LSVC). Cryoballoon ablation has been shown to be effective in pulmonary vein isolation. We report an unusual case of using this technique in the dilated CS in case of a persistent LSVC. A 64 year old patient presented PAF recurrences after cryo pulmonary vein isolation 4 months before. A maintaining pulmonary vein isolation could be demonstrated by transseptal mapping. Further bi-atrial mapping localized repetitive atrial trigger activity in a dilated CS proceeding to a LSVC. A cryoballoon was deployed in the CS target area and during cryoablation the triggered activity suspended. Ablation side effects were excluded by coronary angiography. During a follow up time of 8 months the patient has remained free of PAF recurrences. The current report underlines the importance of a patient-tailored ablation approach. Cryothermic balloon technology may be more applicable in delicate cardiac structures by developing new anatomically adapted balloon shapes and sizes.