Reduction Of Inappropriate Shocks Research Articles

Remote Patient Monitoring: What Have We Learned and Where Are We Going?

Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) is an important part of patient follow-up. The increasing number of patients with CIEDs and the recent pandemic pose several challenges for already limited device clinic resources. This review focuses on recent evolutions in RM and identifies future needs to improve RM. RM has been associated with multiple clinical benefits, including improved survival, early detection of actionable events, reduction in inappropriate shocks, longer battery lives, and more efficient healthcare utilization. The survival benefit was driven by studies using alert-based continuous RM with daily transmissions and fast reaction times. Patients report a high satisfaction rate without significant differences in quality of life between RM and in-office follow-up.The increasing workload, due to the increasing number of CIEDs implanted with daily remote transmissions, results in several challenges for the future of RM. RM requires appropriate reimbursement for RM device clinics to optimize patient/staff ratios, including sufficient non-clinical and administrative support. Universal alert programming and data processing may minimize inter-manufacturer differences, improve the signal-to-noise ratio, and allow the development of standard operating protocols and workflows. In the future, programming by remote control and true remote programming may further improve remote CIED management, patient quality of life, and device clinic workflows. RM should be considered standard of care in management of patients with CIEDs. The clinical benefits of RM can be maximized by an alert-based continuous RM model. Adapted healthcare policies are required to keep RM manageable for the future.

Age-related differences and associated mid-term outcomes of subcutaneous implantable cardioverter-defibrillators: A propensity-matched analysis from a multicenter European registry.

A few limited case series have shown that the subcutaneous implantable cardioverter-defibrillator (S-ICD) system is safe for teenagers and young adults, but a large-scale analysis currently is lacking. The purpose of this study was to compare mid-term device-associated outcomes in a large real-world cohort of S-ICD patients,stratified by age at implantation. Two propensity-matched cohorts of teenagers + young adults (≤30 years old) and adults (>30 years old) were retrieved from the ELISIR Registry. The primary outcome was the comparison of inappropriate shock rate. Complications, freedom from sustained ventricular arrhythmias, and overall and cardiovascular mortality were deemed secondary outcomes. Teenagers + young adults represented 11.0% of the entire cohort. Two propensity-matched groups of 161 patients each were used for the analysis. Median follow-up was 23.1 (13.2-40.5) months. In total, 15.2% patients experienced inappropriate shocks, and 9.3% device-related complications were observed, with no age-related differences in inappropriate shocks (16.1% vs 14.3%; P = .642) and complication rates (9.9% vs 8.7%; P = .701). At univariate analysis, young age was not associated with increased rates of inappropriate shocks (hazard ratio [HR] 1.204 [0.675-2.148]: P = .529). At multivariate analysis, use of the SMART Pass algorithm was associated with a strong reduction in inappropriate shocks (adjusted HR 0.292 [0.161-0.525]; P <.001), whereas arrhythmogenic right ventricular cardiomyopathy (ARVC) was associated with higher rates of inappropriate shocks (adjusted HR 2.380 [1.205-4.697]; P = .012). In a large multicenter registry of propensity-matched patients, use of the S-ICD in teenagers/young adults was safe and effective. The rates of inappropriate shocks and complications between cohorts were not significantly different. The only predictor of increased inappropriate shocks was a diagnosis of ARVC.

Age-related differences and associated outcomes of S-ICD: insights from a large, european, multicenter, real-world registry

Abstract Funding Acknowledgements Type of funding sources: None. Background Young patients often represent the most suitable candidates for an entirely subcutaenous implantable cardioverter defibrillator (S-ICD) system, since they have to face a lifetime of device therapy and they rarely have a pre-existing or concurrent pacing or cardiac resynchronization therapy (CRT) indication. Moreover, S-ICD offers lower rate and a safer management of lead and major procedure-related complications. To date, a few limited case series and experiences with S-ICD in teenagers and young adults have shown that the S-ICD system is safe and feasible in this population, with a rate of inappropriate shocks (IS) comparable to transvenous (TV) ICD, but focused analysis on a large scale are currently lacking in this setting. Purpose The aim of the current study was to compare the age-related differences observed in patient selection, baseline characteristics, and device long-term associated outcomes in a large real world cohort of S-ICD recipients. The primary outcome of the study was defined as the comparisons of the IS rate observed during the entirety of follow up in the teenagers/young adult vs the adult populations. Rate of complications, freedom from sustained ventricular arrhythmic events, overall and cardiovascular mortality were also assessed in the two cohorts and assessed as secondary outcomes. Methods All S-ICD recipients in the ELISIR project were enrolled in the current study. Patients were classified into teenagers + young adults (≤ 30 years old) vs adults (&amp;gt; 30 years old), depending from patient age at device implantation (Figure 1). Rates of device-related complications and IS were compared between the cohorts. Results A total of 1349 patients were extracted from the ELISIR project. Teenagers and young adults represented 12.4% of the registry (n=56 teenagers; n=112 young adults). Patients were followed-up for a median of 23.1 [12.6–37.9] months. Overall, 117 (8.7%) patients experienced inappropriate S-ICD shocks and 100 (7.4%) device related complications were observed, with no age-related differences. IS resulted more frequent in the teenager and young adult cohort (14.3% vs 7.9%; p=0.006). Figure 2 reports Kaplan Meier curves for the occurrence of IS. At univariate analysis, young age was associated with IS, but after correcting for differences in arrhythmic substrate, this association resulted non-significant (aHR: 1.428 [0.883–2.331]; p=0.146). The use of SMART pass algorithm was instead associated to a strong reduction in IS (aHR 0.367 [0.245–0.548]; p&amp;lt;0.001). Conclusion The use of S-ICD in teenagers/young adults resulted safe and effective. Indeed, the rate of complications between teenagers/young adults and adults was not significantly different. Although a higher rate of IS was observed in the teenagers/young adults, when accounting for differences in baseline substrate and comorbidities, young age did not result associated with an increased risk of IS.

Remote Monitoring of Implantable Cardioverter-Defibrillators: A Systematic Review and Meta-Analysis of Clinical Outcomes

BackgroundRemote monitoring (RM) of implantable cardioverter-defibrillators (ICD) is an established technology integrated into clinical practice. One recent randomized controlled trial (RCT) and several large device database studies have demonstrated a powerful survival advantage for ICD patients undergoing RM compared with those receiving conventional in-office (IO) follow-up. ObjectivesThis study sought to conduct a systematic published data review and meta-analysis of RCTs comparing RM with IO follow-up. MethodsElectronic databases and reference lists were searched for RCTs reporting clinical outcomes in ICD patients who did or did not undergo RM. Data were extracted from 9 RCTs, including 6,469 patients, 3,496 of whom were randomized to RM and 2,973 to IO follow-up. ResultsIn the RCT setting, RM demonstrated clinical outcomes comparable with office follow-up in terms of all-cause mortality (odds ratio [OR]: 0.83; p = 0.285), cardiovascular mortality (OR: 0.66; p = 0.103), and hospitalization (OR: 0.83; p = 0.196). However, a reduction in all-cause mortality was noted in the 3 trials using home monitoring (OR: 0.65; p = 0.021) with daily verification of transmission. Although the odds of receiving any ICD shock were similar in RM and IO patients (OR: 1.05; p = 0.86), the odds of inappropriate shock were reduced in RM patients (OR: 0.55; p = 0.002). ConclusionsMeta-analysis of RCTs demonstrates that RM and IO follow-up showed comparable overall outcomes related to patient safety and survival, with a potential survival benefit in RCTs using daily transmission verification. RM benefits include more rapid clinical event detection and a reduction in inappropriate shocks.

Safety and Efficacy of the Totally Subcutaneous Implantable Defibrillator: 2-Year Results From a Pooled Analysis of the IDE Study and EFFORTLESS Registry

BackgroundThe entirely subcutaneous implantable cardioverter-defibrillator (S-ICD) is the first implantable defibrillator that avoids placing electrodes in or around the heart. Two large prospective studies (IDE [S-ICD System IDE Clinical Investigation] and EFFORTLESS [Boston Scientific Post Market S-ICD Registry]) have reported 6-month to 1-year data on the S-ICD. ObjectivesThe objective of this study was to evaluate the safety and efficacy of the S-ICD in a large diverse population. MethodsData from the IDE and EFFORTLESS studies were pooled. Shocks were independently adjudicated, and complications were measured with a standardized classification scheme. Enrollment date quartiles were used to assess event rates over time. ResultsEight hundred eighty-two patients who underwent implantation were followed for 651 ± 345 days. Spontaneous ventricular tachyarrhythmia (VT)/ventricular fibrillation (VF) events (n = 111) were treated in 59 patients; 100 (90.1%) events were terminated with 1 shock, and 109 events (98.2%) were terminated within the 5 available shocks. The estimated 3-year inappropriate shock rate was 13.1%. Estimated 3-year, all-cause mortality was 4.7% (95% confidence interval: 0.9% to 8.5%), with 26 deaths (2.9%). Device-related complications occurred in 11.1% of patients at 3 years. There were no electrode failures, and no S-ICD–related endocarditis or bacteremia occurred. Three devices (0.3%) were replaced for right ventricular pacing. The 6-month complication rate decreased by quartile of enrollment (Q1: 8.9%; Q4: 5.5%), and there was a trend toward a reduction in inappropriate shocks (Q1: 6.9% Q4: 4.5%). ConclusionsThe S-ICD demonstrated high efficacy for VT/VF. Complications and inappropriate shock rates were reduced consistently with strategic programming and as operator experience increased. These data provide further evidence for the safety and efficacy of the S-ICD. (Boston Scientific Post Market S-ICD Registry [EFFORTLESS]; NCT01085435; S-ICD® System IDE Clinical Study; NCT01064076)

Evaluation of defibrillation safety and shock reduction in implantable cardioverter-defibrillator patients with increased time to detection: A randomized SANKS study

The need for ways to minimize the number of implantable cardioverter-defibrillator (ICD) shocks is increasing owing to the risk of its adverse effects on life expectancy. Studies have shown that a longer detection time for ventricular tachyarrhythmia reduces the safety of therapies, in terms of syncope and mortality, but not substantially in terms of the success rate. We aimed to evaluate the effects of increased number of intervals to detect (NID) VF on the safety of ICD shock therapy and on the reduction of inappropriate shocks. The present study was a prospective, multicenter, randomized, crossover study. Randomized VF induction testing with NID 18/24 or 30/40 was performed to compare the success rate of defibrillation with a 25-J shock and the time to detection. Inappropriate shock episodes were simulated retrospectively to evaluate a possibility of episodes avoidable at NID 24/32 and 30/40. Thirty-one consecutive patients implanted with an ICD or cardiac resynchronization therapy-defibrillator (CRT-D) were enrolled in this study. The success rate of defibrillation was 100% in both NID groups at the first shock. The time from VF induction to detection showed a significant increase in the NID 30/40 group (6.16±1.29s vs. 9.00±1.31s, p<0.001). Among the 120 patients implanted with an ICD or CRT-D, 10 experienced 32 inappropriate shock episodes. The inappropriate shock reduction rate was 53.1% and 62.5% with NID 24/32 and 30/40, respectively. The findings of this SANKS study suggest that VF NID 30/40 does not compromise the safety of ICD shock therapy, while decreasing the number of inappropriate shocks.

Reduction of inappropriate shocks through remote monitoring in the ECOST study

Reduction of inappropriate shocks through remote monitoring in the ECOST study

Impactful Clinical Trials of 2012: What Clinicians Need to Know

The results of clinical trials serve to inform cardiovascular (CV) practice. In 2012, a number of clinical trials were reported that have an immediate effect on patient management. We highlight the results of key trials in several areas: interventional cardiology, acute coronary syndromes (ACS), and pharmacologic therapy. The FREEDOM trial, which demonstrated a significant benefit on hard outcomes of coronary artery bypass grafting vs multivessel percutaneous coronary intervention (PCI) in patients with diabetes, answered a long-debated question. The MADIT-RIT trial demonstrated an impressive reduction in inappropriate shocks and mortality in stable implantable cardioverter defibrillator (ICD) patients by altering ICD programming variables. In ACS, prolonged dual antiplatelet therapy (DAPT) with acetylsalicylic acid (ASA) and prasugrel in medically managed patients was not superior to ASA plus clopidogrel, and ongoing trials will assess if there are benefits to use of DAPT beyond 1 year. The WOEST trial compared warfarin plus DAPT vs warfarin plus ASA alone in PCI patients who had an indication for ongoing anticoagulation. Not surprisingly, the major bleeding rate was lower with double compared with triple therapy. However, major CV events were unexpectedly lower with double therapy as well, a finding that warrants confirmation in larger studies. One of the most exciting developments in 2012 was with PCSK9 inhibitors, injectable monoclonal antibodies, that were shown to lower low-density lipoprotein cholesterol by 40%-70% above the effects of maximal dose statin therapy. We now await the results of large outcome trials with this promising class of drugs.

Summary of the Abstracts Contents at Cardiostim 2010

Cardiostim is a congress dedicated to devices, interventional electrophysiology and noninvasive electrophysiology. It was born in 1978, and imagined by Dr Jacques Mugica for educational purposes, and is held traditionally in Nice, French Riviera, on even years. This 2010 edition had 5700 participants coming from 92 countries. A large Japanese attendance was present and two joint sessions were organized with the Japanese Heart Rhythm Society.The program was divided into three sections: updates, education, and presentations based on selected submitted abstracts.Following is a summary of these selected abstracts, which does reflect the trends of our specialty, and of technological advances. For devices, telemedicine, MRI compatibility, full automaticity were the main topics. In cardiac pacing, respect of spontaneous AV conduction is confirmed as being essential, and positioning of the right ventricular lead remains an issue. For ICDs, better definition of candidates, utility of DFT testing, and reduction in inappropriate shocks are the main concerns. In CRT, extension of indications toward earlier stages of HF, implementation of hemodynamic sensors, and new approaches to the left ventricle are at the first row.Ablation techniques benefit from new technologies: interest and limits of cryo‐ablation, new radio‐frequency catheters, visualization of ablative lesions, contact control, and use of imaging techniques. The goals are: to speed up procedures, make them safer, and more efficient.

Summary of the Abstracts Contents at Cardiostim 2010

Cardiostim is a congress dedicated to devices, interventional electrophysiology and noninvasive electrophysiology. It was born in 1978, and imagined by Dr Jacques Mugica for educational purposes, and is held traditionally in Nice, French Riviera, on even years. This 2010 edition had 5700 participants coming from 92 countries. A large Japanese attendance was present and two joint sessions were organized with the Japanese Heart Rhythm Society. The program was divided into three sections: updates, education, and presentations based on selected submitted abstracts. Following is a summary of these selected abstracts, which does reflect the trends of our specialty, and of technological advances. For devices, telemedicine, MRI compatibility, full automaticity were the main topics. In cardiac pacing, respect of spontaneous AV conduction is confirmed as being essential, and positioning of the right ventricular lead remains an issue. For ICDs, better definition of candidates, utility of DFT testing, and reduction in inappropriate shocks are the main concerns. In CRT, extension of indications toward earlier stages of HF, implementation of hemodynamic sensors, and new approaches to the left ventricle are at the first row. Ablation techniques benefit from new technologies: interest and limits of cryo-ablation, new radio-frequency catheters, visualization of ablative lesions, contact control, and use of imaging techniques. The goals are: to speed up procedures, make them safer, and more efficient.