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Objective: It is not clear whether patients who received an implantable cardioverter-defibrillator (ICD) for primary prevention should undergo device replacement if they never experienced an appropriate ICD therapy during the first generator longevity. This study evaluated the incidence and predictors of appropriate ICD therapy after device replacement in this specific population. Methods: From two large prospective ICD registries, we identified all primary prevention patients who had a first ICD replacement without previous appropriate ICD therapy. Cox regression analysis was used to identify predictors of appropriate ICD therapy. Results: Of 403 primary prevention patients needing first ICD replacement, 275 patients (68%) had not received previous appropriate ICD therapy. Patients without previous appropriate ICD therapy before first ICD replacement (mean age at replacement 62±12 years, 75% male) had a mean follow-up of 86±24 months after the initial implantation and 30±24 months after device replacement. Following replacement, 3-year cumulative incidence of appropriate ICD therapy was 13.7% (95% CI 8.6 to 18.8%). No predictive factors associated with appropriate ICD therapy after replacement could be identified in spite of including seven clinically relevant factors. Conclusions: A considerable number of primary prevention patients without previous appropriate ICD therapy before first ICD replacement received appropriate ICD therapy after replacement. As there were no predictors of appropriate ICD therapy after replacement, replacing an ICD is still recommended in all primary prevention patients despite the lack of appropriate ICD therapy during first battery service life. [ABSTRACT FROM AUTHOR]

Introduction: Cardiac resynchronization defibrillator (CRT‐D) as primary prevention is known to reduce mortality. At the time of replacement, higher age and comorbidities may attenuate the benefit of implantable cardioverter‐defibrillator (ICD) therapy. The purpose of this study was to evaluate the progression of comorbidities after implantation and their association with mortality following CRT‐D generator replacement. In addition, a risk score was developed to identify patients at high risk for mortality after replacement. Methods and Results: We identified patients implanted with a primary prevention CRT‐D (n = 648) who subsequently underwent elective generator replacement (n = 218) from two prospective ICD registries. The cohort consisted of 218 patients (median age: 70 years, male gender: 73%, mean left ventricular ejection fraction [LVEF]: 36 ± 11% at replacement). Median follow‐up after the replacement was 4.2 years during which 64 patients (29%) died and 11 patients (5%) received appropriate ICD shocks. An increase in comorbidities was observed in 77 patients (35%). The 5‐year mortality rate was 41% in patients with ≥2 comorbidities at the time of replacement. A risk score incorporating age, gender, LVEF, atrial fibrillation, anemia, chronic kidney disease, and history of appropriate ICD shocks at time of replacement accurately predicted 5‐year mortality (C‐statistic 0.829). Patients with a risk score of greater than 2.5 had excess mortality at 5‐year postreplacement compared with patients with a risk score less than 1.5 (57% vs. 6%; p <.001). Conclusion: A simple risk score accurately predicts 5‐year mortality after replacement in CRT‐D patients, as patients with a risk score of greater than 2.5 are at high risk of dying despite ICD protection. [ABSTRACT FROM AUTHOR]

Background: Due to high failure rates, Medtronic withdrew the Sprint Fidelis lead (SFL) from the market. Passive fixation lead models exhibited better survival than active models, but most studies have limited follow‐up. Aim of this study was to give insights into passive lead survival with a follow‐up of 10 years. Methods: In two large Swiss centers, patients with passive SFLs were identified and data from routine implantable cardioverter defibrillator (ICD) follow‐ups were collected. Patients were censored at time of death, last device interrogation (if lost to follow‐up), time of lead revision (in non‐SFL‐related problems), or at database closure (31th December 2017). We defined lead failure as any of the following: lead fracture with inappropriate discharge; sudden increase in low‐voltage impedance to >1500 or high‐voltage impedance to >100 Ω; >300 nonphysiological short VV‐intervals. Results: We identified 145 patients. Age at implant was 60 ± 12 years with a median follow‐up of 10.2 (interquartile range [IQR]: 5.0‐11.2) years. Thirty‐five percent of patients died after 5.4 ± 2.7 years. A total of 19 leads (13%) failed after 6.7 ± 3.2 years (range: 1.2‐12.0). Overt malfunction with shocks existed in four patients (3%). Cumulative lead survival was 93.1% at 6, 88.2% at 8, 83.8% at 10, and 77.6% at 11 years, respectively, with 35% of implanted leads under monitoring at 10 years. Lead survival fits best a Weibull distribution with accelerating failure rates (k = 1.95, 95% CI 1.32‐2.87, P < 0.001). Conclusions: During very long‐term follow‐up, failure rate of the passive SFL shows an increase resulting in an impaired lead survival of 84% at 10 years. [ABSTRACT FROM AUTHOR]

Background Studies have shown that remote patient monitoring (RPM) of implantable cardioverter defibrillators (ICDs) is at least comparable to in-clinic follow-up with regard to clinical outcomes and might be cost-effective, yet RPM is not standard clinical practice within Europe. Better insight into the patient perspective on RPM may aid in its acceptance, implementation, and reimbursement. This narrative review (1) summarizes existing evidence on the impact of RPM on patient-reported outcomes and (2) discusses future directions in examining the patient perspective. Methods and Results Literature review indicated that only five randomized trials on RPM in ICD patients included patient-reported outcomes, with inconclusive results. Observational studies show a trend toward good patient satisfaction and acceptation of RPM. Yet, results should be interpreted with caution due to a number of limitations including a potential selection bias, use of generic/nonvalidated questionnaires, relatively short follow-up durations, and a lack of subgroup identification. Conclusion Although RPM seems to be safe, effective, timely, and efficient, the patient perspective has received little attention so far. The scarce evidence on patient-reported outcomes in RPM studies seems to be positive, but future trials with a follow-up of ≥12 months and validated patient-reported outcome measures are needed. The REMOTE-CIED study from our group is the first prospective randomized controlled trial primarily designed to examine the patient perspective on RPM, and is powered to identify characteristics associated with RPM satisfaction and benefit. Results are expected in 2018 and will add valuable information to the current evidence. [ABSTRACT FROM AUTHOR]

Background Many patients receiving an implantable cardioverter-defibrillator (ICD) also have atrial fibrillation (AF). Shock testing during ICD implantation carries a potential risk of cardioversion to sinus rhythm (SR) and thrombembolic events. We aimed to analyze the recurrence of AF after cardioversion to SR during ICD shock testing. Methods A total of 555 consecutive patients referred to a tertiary hospital in Switzerland for ICD implantation or generator exchange between 02/2002 and 03/2010 were screened for AF. Fifty-seven patients who were in AF at the time of ICD shock testing were included. Results Forty-four patients (77%) were successfully cardioverted from AF to SR. Type of AF (persistent, not permanent 64 vs 31% of cardioverted patients) was the only predictor. Thirty-nine patients (89%) experienced a recurrence of AF/atrial flutter after a median of 54 days (interquartile range 35-251 days). The only predictor for recurrence of AF was previous AF declared as permanent. No ischemic stroke occurred during hospitalization for the procedure. Conclusions For patients in AF undergoing shock testing at the time of ICD implant, there is a high chance of cardioversion from AF to SR, but there is also a high risk of early recurrence. Decisions regarding long-term anticoagulation should not be based on the heart rhythm immediately following shock testing. [ABSTRACT FROM AUTHOR]

Background: The wearable cardioverter defibrillator (WCD) uses surface electrodes to detect arrhythmia before initiating a treatment sequence. However, it is also prone to inappropriate detection due to artefacts. Objective: The aim of this study is to assess the alarm burden in patients and its impact on clinical outcomes. Methods: Patients from the nationwide Swiss WCD Registry were included. Clinical characteristics and data were obtained from the WCDs. Arrhythmia recordings ≥30 s in length were analysed and categorized as VT/VF, atrial fibrillation (AF), supraventricular tachycardia (SVT) or artefact. Results: A total of 10653 device alarms were documented in 324 of 456 patients (71.1%) over a mean WCD wear-time of 2.0 ± 1.6 months. Episode duration was 30 s or more in 2996 alarms (28.2%). One hundred and eleven (3.7%) were VT/VF episodes. The remaining recordings were inappropriate detections (2736 (91%) due to artefacts; 117 (3.7%) AF; 48 (1.6%) SVT). Two-hundred and seven patients (45%) had three or more alarms per month. Obesity was significantly associated with three or more alarms per month (p = 0.01, 27.7% vs. 15.9%). High alarm burden was not associated with a lower average daily wear time (20.8 h vs. 20.7 h, p = 0.785) or a decreased implantable cardioverter defibrillator implantation rate after stopping WCD use (48% vs. 47.3%, p = 0.156). Conclusions: In patients using WCDs, alarms emitted by the device and impending inappropriate shocks were frequent and most commonly caused by artefacts. A high alarm burden was associated with obesity but did not lead to a decreased adherence. [ABSTRACT FROM AUTHOR]

INTRODUCTION: Although radiation exposure has been reduced for some electrophysiological procedures (EP) by the use of mapping systems it still remains a concern for electrophysiologists. The aim was to evaluate the impact of a novel X-ray technology on the radiation doses during EP procedures. PATIENTS AND METHODS: 183 consecutive patients undergoing ablation procedures or implantations of cardiovascular implantable devices were included. Procedures were performed using the Artis Q.zen (AQZ, n=93) and the Artis zee (AZ, n=90) X-ray systems (Siemens, Forchheim, Germany). Patients were categorized into four procedure groups -- pulmonary vein isolation, supraventricular tachycardia ablation, cardiac resynchronization therapy device implantation and pacemaker/ implantable cardioverter defibrillator implantation. For all patients standardized settings for fluoroscopy and cine acquisitions were used. Radiation exposure was compared in total and in every group separately. RESULTS: The baseline patient parameters and procedural parameters, namely the procedure duration, the fluoroscopy and cine time were similar between the two systems. The total dose area product and the air kerma across all procedures was reduced by the use of the AQZ angiography system (1068 versus 1730 µGy*m², p=0.169, and 87.5 versus 172.4 Gy, p=0.019). The difference between the two systems was greatest for cine acquisition with roughly 70% for all radiological parameters of the exposure. CONCLUSIONS: Use of novel X-ray technology for standard EP procedures significantly reduces patient doses. The use of this technology further improves safety of angiography based EP procedures. [ABSTRACT FROM AUTHOR]