Study objectives: Aim of the study was to investigate the association between obstructive sleep apnoea (OSA) and cardiovascular morbidity and mortality in a cohort of patients with cardiovascular risk factors. Methods: In this prospective study, 378 patients of the DIAST-CHF cohort were screened for OSA by home polygraphy. Inclusion criteria were risk factors for diastolic heart failure, such as hypertension, diabetes mellitus, atherosclerotic disease, or history of chronic heart failure. Patients were followed up after 1, 2, 5, 9 and 10 years for the occurrence of major adverse cardiac and cerebrovascular events (MACE and MACCE). Results: 344 patients were included in the analysis, of which 60% were diagnosed with OSA (apnoea-hypopnoea index >= 5/h). Overall mortality was higher in the OSA group (14.9% vs. 5.9%; p=0.007), but significance disappeared after adjustment for age and sex (hazard ratio (HR) 1.89, 95% confidence interval (CI) 0.86-4.16, p=0.12). There was no significant difference in the occurrence of MACE or MACCE in patients with OSA compared to those without OSA (MACE: 31% vs. 30%; p=0.61; MACCE: 32% vs. 30%; p=0.53). Conclusion: We did not find evidence of an adverse effect of OSA on cardiovascular morbidity and mortality in a cohort of patients with cardiovascular risk factors.

Methods: In our single centre study 109 consecutive patients were retrospectively analysed.Quality of life has been assessed by a standardized questionnaire (EQ-5D-3L, modified).Additionally, clinical baseline and follow up data and recorded arrhythmic episodes were evaluated.Results: Mean WCD therapy time was 56.2 (6 42.4) days, with a daily wear time of 19.7 (6 5) hours.A total of 3441 arrhythmia episodes were detected.Of these, 27 (1%) were adequate, but did not require shock therapy.Likewise, no inadequate shock therapy occurred.WCD therapy negatively affected quality of life: 43 % of patients reported mental health issues.37 % reported pain or discomfort.Self care and usual activities and mobility were restricted in 17 %, 48 % and 36 %, respectively.29 % were afraid of receiving shock therapy, 64 % indicated to have felt safe during WCD therapy.48 % suffered from disturbance of night sleep.Accordingly, average quality of life was rated 70 / 100 points.Conclusion: In our cohort, no SCD was prevented by WCD therapy.In contrast, quality of life was markedly reduced Thus, careful recommendation of WCD therapy for high risk patients is pivotal. P1221

The clinical effectiveness of primary prevention implantable cardioverter defibrillator (ICD) therapy is under debate. The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU‐CERT‐ICD) aims to assess its current clinical value.

BACKGROUND Catheter ablation of atrial fibrillation (AF) improves left ventricular (LV) function in patients with LV systolic dysfunction, suggestive of underlying arrhythmia-induced adverse remodeling. OBJECTIVES The objectives of this study were to evaluate whether arrhythmia-induced LV remodeling occurs in patients with AF and preserved LV systolic function and to assess whether this remodeling is reversible after restoration of sinus rhythm by catheter ablation. METHODS Forty-three patients with AF and preserved LV systolic function (LV ejection fraction 62% +/- 67%) underwent cardiovascular magnetic resonance (CMR) imaging before catheter ablation including native T1 mapping using a modified Look-Locker inversion recovery sequence. Twenty-five patients underwent follow-up CMR 3 months after catheter ablation. Twenty-two matched controls without AF underwent the same CMR protocol. RESULTS Patients with AF had higher baseline LV native T1 values than did controls (1296 +/- 655 ms vs 1243 +/- 55 ms; P < .01). During a median follow-up of 9 months (interquartile range 4-14 months), 17 patients (40%) experienced AF recurrence. No differences in baseline T1 values were observed between patients with and without AF recurrence. There was a significant decrease in native T1 values in patients with successful restoration of sinus rhythm after catheter ablation at 3 months of follow-up CMR (1300 +/- 45 ms vs 1270 +/- 55 ms; P < .01), while they remain unchanged in patients with AF recurrence (1303 +/- 51 ms vs 1309 +/- 31 ms; P = .64). CONCLUSION These preliminary results suggest that subclinical arrhythmia-induced LV structural remodeling occurs in patients with AF and preserved LV systolic function. This remodeling might be reversible after catheter ablation with successful restoration of sinus rhythm as quantified noninvasively and gadolinium-free by CMR native T1 mapping.

This data article features supplementary figures and tables related to the article "Differential Multivariable risk prediction of appropriate shock vs. competing mortality – a prospective cohort study to estimate benefits from implantable cardioverter defibrillator therapy" (Bergau et al., 2018) [1]. The figures show the clinical study CONSORT graph (data that show the number of patients not-analyzable as well as a distribution of patients by outcomes) and the correlation scatter plot for risk scores of appropriate shock vs. mortality (data that show the calculated score values of the two scores plotted against each other). The tables show the results for the univariate Cox regressions for prediction of mortality and appropriate shock. For further information, please see Bergau et al. (2018) [1].

Background and objectiveWe prospectively investigated combinations of risk stratifiers including multiple EP diagnostics in a cohort study of ICD patients.MethodsFor 672 enrolled patients, we collected history, LVEF, EP study and T-wave alternans testing, 24-h Holter, NT-proBNP, and the eGFR. All-cause mortality and first appropriate ICD shock were predefined endpoints.ResultsThe 635 patients included in the final analyses were 63 ± 13 years old, 81% were male, LVEF averaged 40 ± 14%, 20% were inducible at EP study, 63% had a primary prophylactic ICD. During follow-up over 4.3 ± 1.5 years, 108 patients died (4.0% per year), and appropriate shock therapy occurred in n = 96 (3.9% per year). In multivariate regression, age (p < 0.001), LVEF (p < 0.001), NYHA functional class (p = 0.007), eGFR (p = 0.024), a history of atrial fibrillation (p = 0.011), and NT-pro-BNP (p = 0.002) were predictors of mortality. LVEF (p = 0.002), inducibility at EP study (p = 0.007), and secondary prophylaxis (p = 0.002) were identified as independent predictors of appropriate shocks. A high annualized risk of shocks of about 10% per year was prevalent in the upper quintile of the shock score. In contrast, a low annual risk of shocks (1.8% per year) was found in the lower two quintiles of the shock score. The lower two quintiles of the mortality score featured an annual mortality <0.6%.ConclusionsIn a prospective ICD patient cohort, a very good approximation of mortality versus arrhythmic risk was possible using a multivariable diagnostic strategy. EP stimulation is the best test to assess risk of arrhythmias resulting in ICD shocks.

BACKGROUND:There is evidence that the benefit of a primary prophylactic ICD therapy is not equal in all patients. PURPOSE:To evaluate risk factors of appropriate shocks and all- cause mortality in patients with a primary prophylactic ICD regarding contemporary studies. DATA SOURCE:PubMed, LIVIVO, Cochrane CENTRAL between 2010 and 2016. STUDY SELECTION:Studies were eligible if at least one of the endpoints of interest were reported. DATA EXTRACTION:All abstracts were independently reviewed by at least two authors. The full text of all selected studies was then analysed in detail. DATA SYNTHESIS:Our search strategy retrieved 608 abstracts. After exclusion of unsuitable studies, 36 papers with a total patient number of 47282 were included in our analysis. All-cause mortality was significantly associated with increasing age (HR 1.41, CI 1.29-1.53), left ventricular function (LVEF; HR 1.21, CI 1.14-1.29), ischemic cardiomyopathy (ICM; HR 1.37, CI 1.14-1.66) and co-morbidities such as impaired renal function (HR 2.30, CI 1.97-2.69). Although, younger age (HR 0.96, CI 0.85-1.09), impaired LVEF (HR 1.26, CI 0.89-1.78) and ischemic cardiomyopathy (HR 2.22, CI 0.83-5.93) were associated with a higher risk of appropriate shocks, none of these factors reached statistical significance. LIMITATIONS:Individual patient data were not available for most studies. CONCLUSION:In this meta-analysis of contemporary clinical studies, all-cause mortality is predicted by a variety of clinical characteristics including LVEF. On the other hand, the risk of appropriate shocks might be associated with impaired LVEF and ischemic cardiomyopathy. Further prospective studies are required to verify risk factors for appropriate shocks other than LVEF to help select appropriate patients for primary prophylactic ICD-therapy.

In patients treated with implantable cardioverter defibrillator (ICD), prediction of both overall survival and occurrence of shocks is important if improved patient selection is desired. We prospectively studied the predictive value of biomarkers and indexes of cardiac and renal function and spectral microvolt T-wave alternans testing and 24-hour Holter variables in a population who underwent first ICD implantation. Consecutive patients in sinus rhythm with ischemic or dilated cardiomyopathy scheduled for primary or secondary prophylactic ICD implantation were enrolled. Exercise microvolt T-wave alternans and 24-hour Holter for number of ventricular premature contractions (VPCs), deceleration capacity, heart rate variability, and heart rate turbulence were done. Death of any cause and first appropriate ICD shock were defined as end points. Over 33 ± 15 months of follow-up, 36 of 253 patients (14%) received appropriate shocks and 39 of 253 patients (15%) died. Only 3 of 253 patients (1%) died after receiving at least 1 appropriate shock. In univariate analyses, New York Heart Association class, ejection fraction, N-terminal pro brain-type natriuretic peptide (NT-proBNP), renal function, ICD indication, deceleration capacity, heart rate variability, and heart rate turbulence were predictive of all-cause mortality and VPC number and deceleration capacity predicted first appropriate shock. NT-proBNP (≥1,600 pg/ml) was identified as the only independent predictor of all-cause mortality (hazard ratio 3.0, confidence interval 1.3 to 7.3, p = 0.014). In contrast, VPC number predicted appropriate shocks (hazard ratio 2.3, confidence interval 1.0 to 5.5, p = 0.047) as the only independent risk marker. In conclusion, NT-proBNP is a strong independent predictor of mortality in a typical prospective cohort of newly implanted patients with ICD, among many electrocardiographic and clinical variables studied. Number of VPCs was identified as a predictor of appropriate shocks (clinicaltrials.gov: NCT02010515).

Diagnosing atrial fibrillation (AF) is highly relevant, as specific secondary prevention is of high importance. Recently, insertable cardiac monitors (ICMs) have been introduced for continuous monitoring to detect asymptomatic episodes of AF. The detection of AF remains challenging due to a relevant incidence of artifacts. This study aimed to compare the effectivity of ICM when placed in a subcutaneous or in a submuscular localization, respectively.

Abstract Aims Implantable cardioverter-defibrillators (ICDs) have been shown to improve survival, although a considerable number of patients never receive therapy. Implantable cardioverter-defibrillators are routinely implanted regardless of sex. There is continuing controversy whether major outcomes differ between men and women. Methods and results In this retrospective single-centre study, 1151 consecutive patients (19% women) undergoing ICD implantation between 1998 and 2010 were followed for mortality and first appropriate ICD shock over 4.9 ± 2.7 years. Sex-related differences were investigated using multivariable Cox models adjusting for potential confounders. During follow-up, 318 patients died, a rate of 5.9% per year among men and 4.6% among women (uncorrected P = 0.08); 266 patients received a first appropriate ICD shock (6.3% per year among men vs. 3.6% among women, P = 0.002). After multivariate correction, independent predictors of all-cause mortality were age (hazard ratio, HR = 1.04 per year of age, 95% confidence interval (CI) [1.03–1.06], P < 0.001), left ventricular ejection fraction (HR = 0.98 per %, 95% CI [0.97–1.00], P = 0.025), renal function (HR = 0.99 per mL/min/1.73 m2, 95% CI [0.99–1.00], P = 0.009), use of diuretics (HR = 1.81, 95% CI [1.29–2.54], P = 0.0023), peripheral arterial disease (HR = 2.21, 95% CI [1.62–3.00], P < 0.001), and chronic obstructive pulmonary disease (HR = 1.48, 95% CI [1.13–1.94], P = 0.029), but not sex. Female sex (HR = 0.51, 95% CI [0.33–0.81], P = 0.013), older age (HR = 0.98, 95% CI [0.97–0.99], P < 0.001), and primary prophylactic ICD indication (HR = 0.69, 95% CI [0.52–0.93], P = 0.043) were independent predictors for less appropriate shocks. Conclusion Women receive 50% less appropriate shocks than men having similar mortality in this large single-centre population. These data may pertain to individually improved selection of defibrillator candidates using risk factors, e.g. sex as demonstrated in this study.

AIMS:Only limited comparative data exist on the benefits of fluid monitoring (FM) combined with remote monitoring (RM) regarding morbidity and mortality of heart failure (HF) patients. This prospective single-centre randomized pilot study aimed to estimate the influence of RM in combination with FM on HF hospitalizations as well as ventricular tachyarrhythmias and mortality.METHODS AND RESULTS:Patients with standard indication for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy and defibrillator were implanted with devices capable of RM and FM, and were followed for 15 months. Subjects were randomly allocated to RM including OptiVol and predefined management of alerts (remote group), or standard in-office visits every 3 months (control group). A total of 176 patients (77% male; 66 ± 12 years; left ventricular ejection fraction (LVEF) 32 ± 11%; ischemic cardiomyopathy 50%; CRT device 50%; primary prevention 85%) were analysed. Cox proportional hazard analysis on the time to first HF-related hospitalization showed a hazard ratio of 1.23 [0.62-2.44] (P = 0.551) favouring the control group. In the remote group, 13 patients (15%) experienced ICD shocks vs. 10 patients (11%) in the control group (P = 0.512). The average time to first ICD shock was 212 ± 173 days in the remote arm and 212 ± 143 days in the control arm (P = 0.994). The Kaplan-Meier estimate of mortality after 1 year was 8.6% (eight deaths) in the remote group vs. 4.6% in the control group (six deaths; P = 0.502).CONCLUSION:In a single-centre randomized pilot study of RM in combination with FM, no significant influence on HF-related hospitalizations, ICD shocks, or mortality was found.

BACKGROUND AND AIMS:Implantable cardioverter defibrillator (ICD) remote follow-up and ICD remote monitoring (RM) are established means of ICD follow-up. The reduction of the number of in-office visits and the time to decision is proven, but the true clinical benefit is still unknown. Cost and cost-effectiveness of RM remain leading issues for its dissemination. The MONITOR-ICD study has been designed to assess costs, cost-effectiveness, and clinical benefits of RM versus standard-care follow-up in a prospective multicenter randomized controlled trial.METHODS AND RESULTS:Patients indicated for single- or dual-chamber ICD are eligible for the study and are implanted an RM-capable Biotronik ICD (Lumax VR-T or Lumax DR-T; Biotronik SE & Co KG, Berlin, Germany). Implantable cardioverter defibrillator programming and alert-based clinical responses in the RM group are highly standardized by protocol. As of December 2011, recruitment has been completed, and 416 patients have been enrolled. Subjects are followed-up for a minimum of 12months and a maximum of 24months, ending in January 2013. Disease-specific costs from a societal perspective have been defined as primary end point and will be compared between RM and standard-care groups. Secondary end points include ICD shocks (including appropriate and inappropriate shocks), cardiovascular hospitalizations and cardiovascular mortality, and additional health economic end points.CONCLUSIONS:The MONITOR-ICD study will be an important randomized RM study to report data on a primary economic end point in 2014. Its results on ICD shocks will add to the currently available evidence on clinical benefit of RM.

AIMS:The optimal pharmacological treatment for patients early after ablation of atrial fibrillation (AF) is still not clear. We analyzed if concomitant antiarrhythmic drug (AAD) therapy significantly alters early recurrence of AF/atrial tachycardia (AT) following pulmonary vein ablation (PVA).METHODS:For the first 2 months after PVA, 274 patients (age 62 ± 10 years; 66% male) were individually scheduled for concomitant treatment with beta-adrenergic blocking agents (BB) or AAD therapy. Primary endpoint of this study was a composite of (1) AF/AT lasting more than 30 seconds; (2) symptomatic AF/AT recurrence requiring intervention; or (3) intolerance to the antiarrhythmic agent given. Univariate and multivariate analysis was performed to evaluate predictors for successful AAD therapy.RESULTS:Early after PVA, patients were treated with BB (n = 89), flecainide (n = 99), sotalol (n = 37), dronedarone (n = 29), or amiodarone (n = 115). Ninety-five patients received a combination of AAD therapy and BB. A total of 369 observation periods were analyzed. Over the first 2 months following PVA, AF/AT recurrences were found in 42% of patients. No significant difference regarding freedom from AF/AT recurrence with regard to different drug therapies was observed (P = 0.769). In multivariate analysis, none of the parameters were significant to predict success of AAD therapy. In nine observations, AAD therapy was terminated due to side effects presumably related to the respective agent.CONCLUSIONS:Following PVA, AAD therapy is not superior to BB treatment for the prevention of early atrial arrhythmias. Furthermore and confirmed by multivariate analysis, no drug was superior to another regarding the maintenance of sinus rhythm.

To evaluate passive-fixation lead failure rates and long-term patient survival in subjects implanted with Sprint Fidelis electrodes.We identified 748 subjects who received a Sprint Fidelis (n 429; Medtronic models 6948: 94.8, 6949: 2.6, 6930: 1.9, 6931: 0.7) or a Sprint non-Fidelis implantable cardioverter defibrillator lead (n 319, Medtronic models 6944: 68.6, 6947: 17.9, 6942: 7.8, 6943: 3.4, 6945: 2.2) at our centre between 1998 and 2008. KaplanMeier patient survival was lower in the Fidelis group than in the Control cohort (68.4 vs. 77.0 at 5 years, P 0.0061), but multivariate analyses revealed no significant association between mortality and implanted lead type. Passive-fixation lead failure rate at 5 years was 14.4 (95 confidence interval (CI) [9.2, 19.3]) in the Fidelis (n 414) group and 1.8 (95 CI [0.03.8]) in the Control (n 241) cohort (P 0.001 upon multivariate comparison).Failure rates of passive-fixation Sprint Fidelis leads are increased and similar to those previously reported for active-fixation Fidelis electrodes. Despite the elevated risk for lead failure and its potential sequelae, the Sprint Fidelis has no obvious impact on long-term mortality.

Purpose: Implantable Cardioverter-Defibrillators (ICD) are considered to be an indefinite therapy. A considerable number of patients do not receive appropriate (appr) ICD shocks during a generator life time. The necessity of generator replacement for this specific subgroup of patients is therefore under debate. Using a large single-center database, we investigated the incidence of appr shocks in relation to the timing of ICD replacement. Methods: Patients (pts) undergoing ICD or CRT-D implantation between 1987 and 2010 at our institution were entered in a database. Age, gender, Ischemic (ICM) or non-ischemic heart disease, Primary (PP) or secondary prophylactic indication, LVEF, and other clinical characteristics were retrieved for the implant date. Follow Up (FU) results were collected from the ICD clinic files or by letter contact. Data are given as mean±SD or frequencies (percentages). Groups were compared by Fisher's exact test. Results: A total of 1535 pts [mean age 63±13 years (yrs), 66% ICM, 54% PP] had available FU for appr shocks (as judged by the ICD clinic physician based on review of the available EGMs), and date of generator replacements. Over a mean overall FU of 5.7±3.9 yrs, 477 (31%) received a first appr shock, corresponding to an average annual rate of first appr shock of 5.4%. In contrast, 411/1535 (27%) received first appr shock with the first generator (annual rate of 8.6%). First generator replacement occurred in 402 of the remaining 1124 pts after 4.7±1.9 yrs. In 52/402 (13%), first appr shock by the second generator occurred thereafter (annual rate 6.0%, independent of PP indication; p=0.23; and ICM, p=0.55). Ninety-one of the above 350 ICD pts without prior appr shock received a second generator replacement another 4.3±2.2 yrs later: 13/91 (14%) had appr shock (annual rate 6.3%; PP, p=0.10; ICM, p=0.53). Finally, a third replacement occurred 3.7±1.7 yrs later and in 19/78 pts without prior appr shock, only 1 patient (5%) had an appr shock thereafter. Conclusions: In the background of a relatively low overall incidence of first appr shock per year, an absent appr ICD shock at the time of ICD generator replacement does not imply a subsequent period free of appr shocks. This is even true for patients with a primary prophylactic ICD indication.