Implantable Cardioverter Defibrillator Devices Research Articles

Efficacy and Complications of Subcutaneous versus Conventional Cardioverter Defibrillators: A Systematic Review and Meta-analysis.

Implantable cardioverter defibrillators are used to prevent sudden cardiac death. The subcutaneous implantable cardioverter-defibrillator was newly developed to overcome the limitations of the conventional implantable cardioverter defibrillator-transvenous device. The subcutaneous implantable cardioverter defibrillator is indicated for young patients with heart disease, congenital heart defects, and poor venous access, who have an indication for implantable cardioverter defibrillator without the need for anti-bradycardic stimulation. We aimed to compare the efficacy and complications of subcutaneous with transvenous implantable cardioverter- defibrillator devices. A systematic review was conducted using different databases. The inclusion criteria were observational and clinical randomized trials with no language limits and no publication date limit that compared subcutaneous with transvenous implantable cardioverter-defibrillators. The selected patients were aged > 18 years with complex ventricular arrhythmia. Five studies involving 2111 patients who underwent implantable cardioverter defibrillator implantation were included. The most frequent complication in the subcutaneous device group was infection, followed by hematoma formation and electrode migration. For the transvenous device, the most frequent complications were electrode migration and infection. Regarding efficacy, the total rates of appropriate shocks were 9.04% and 20.47% in the subcutaneous and transvenous device groups, respectively, whereas inappropriate shocks to the subcutaneous and transvenous device groups were 11,3% and 10,7%, respectively. When compared to the transvenous device, the subcutaneous device had lower complication rates owing to lead migration and less inappropriate shocks due to supraventricular tachycardia; nevertheless, infection rates and improper shocks due to T wave oversensing were comparable for both devices CRD42021251569.

Pooled Analysis of Complications with Transvenous ICD Compared to Subcutaneous ICD in Patients with Catecholaminergic Polymorphic Ventricular Arrhythmia.

Background: Catecholaminergic polymorphic ventricular tachycardia (CPVT) is associated with arrhythmic events which may lead to sudden cardiac death (SCD). A leading therapy for CPVT besides medical treatment with beta-blockers is the use of an implantable cardioverter-defibrillator (ICD). For this paper we compared data from a pooled analysis to get further evidence about the complications of transvenous and subcutaneous ICDs. Methods: We gathered data from a search of PubMed, Web of Science, Cochrane Library and Cinahl. For our analysis, we chose 30 studies with a total number of 784 patients. We compared the data regarding complications caused by different ICD device types. Results: During a mean follow up of 38.9 months for the patients with ICD implantation (n = 337), data showed a complication rate of 101 (30%). A total of 330 (98%) of them received a transvenous-ICD (T-ICD) and 7 (2%) a subcutaneous-ICD (S-ICD). A total of 97 (29.4%) of the T-ICD patients and 4 (57.1%) of the S-ICD patients had at least one complication. Of the 234 complications that occurred in T-ICD patients 152 (65%) were inappropriate shocks due to supraventricular arrhythmias, T/R-wave oversensing or electrode defect, 26 (11.1%) lead fracture/failure, 1 (0.4%) electrode defect, 46 were (19.7%) events of electrical storms, 1 (0.4%) thromboembolic event, 2 (0.8%) cases of endocarditis and 6 (2.6%) infections of the ICD-pocket. Ten (100%) of the complications for the four patients with the S-ICD were an event of an inappropriate shock due to supraventricular arrhythmias, T/R-wave oversensing or electrode defect. Conclusion: Subcutaneous ICDs (S-ICD) show a certain advantage over T-ICDs regarding lead-related complications. Nevertheless, they still show problems with inappropriate shocks and other ICD related complications. Therefore, a case-by-case decision is advised, but the continuous improvement of S-ICD might make it an overall advantageous therapy option in the future.

The electrocardiographic interpretation of ventricular pacing suppression algorithms in the pacemaker

Algorithms designed to reduce the right ventricular (RV) pacing burden are widely available in modern dual-chamber implantable pacing devices. These algorithms allow the atrioventricular delay for sensed ventricular events to be longer than for ventricular paced events. However, since these features are unique to pacemaker manufacturers, they often produce unfamiliar electrocardiographic (ECG) appearances that suggest pacemaker dysfunction. We describe a Vp suppression algorithm used in Biotronik dual-chamber pacemakers and implantable cardioverter-defibrillator devices.

Subcutaneous implantable cardioverter-defibrillators: long-term results of the EFFORTLESS study.

AimsTo report 5-year outcomes of EFFORTLESS registry patients with early generation subcutaneous implantable cardioverter-defibrillator (S-ICD) devices.Methods and resultsKaplan–Meier, trend and multivariable analyses were performed for mortality and late (years 2–5) complications, appropriate shock (AS) and inappropriate shock (IAS) rates. Nine hundred and eighty-four of 994 enrolled patients with diverse diagnoses (28% female, 48 ± 17 years, body mass index 27 ± 6 kg/m2, ejection fraction 43 ± 18%) underwent S-ICD implantation. Median follow-up was 5.1 years (interquartile range 4.7–5.5 years). All-cause mortality was 9.3% (95% confidence interval 7.2–11.3%) at 5 years; 703 patients remained in follow-up on study completion, 171 withdrew including 87 (8.8%) with device explanted, and 65 (6.6%) lost to follow-up. Of the explants, only 20 (2.0%) patients needed a transvenous device for pacing indications. First and final shock efficacy for discrete ventricular arrhythmias was consistent at 90% and 98%, respectively, with storm episode final shock efficacy at 95.2%. Time to therapy remained unaltered. Overall 1- and 5-year complication rates were 8.9% and 15.2%, respectively. Early complications did not predict later complications. There were no structural lead failures. Inappropriate shock rates at 1 and 5 years were 8.7% and 16.9%, respectively. Self-terminating inappropriately sensed episodes predicted late IAS. Predictors of late AS included self-terminating appropriately sensed episodes and earlier AS.ConclusionIn this diverse S-ICD registry population, spontaneous shock efficacy was consistently high over 5 years. Very few patients underwent S-ICD replacement with a transvenous device for pacing indications. Treated and self-terminating arrhythmic episodes predict future shock events, which should encourage more personalized device optimization.

Performance evaluation of implantable cardioverter-defibrillators with SmartShock technology in patients with inherited arrhythmogenic diseases

BackgroundPatients with inherited arrhythmogenic diseases (IADs) are often prescribed preventative implantable cardioverter-defibrillators (ICDs) to manage their increased sudden cardiac arrest risk. However, it has been suggested that ICDs in IAD patients may come with additional risk. We aimed to leverage the PainFree SmartShock Technology dataset to compare inappropriate therapies, appropriate therapies, mortality, and complications in patients with and without IAD. MethodsThis retrospective analysis included extracted, physician-adjudicated, arrhythmic episodes from ICD devices. The incidence of arrhythmic events was estimated with the Kaplan-Meier method using the log-rank test. Cox proportional hazards regression was used to estimate hazard ratios (HRs) with their 95% confidence intervals (CIs). ResultsOf the 1699 ICD patients, 77 patients (4.5%) had IAD. Incidence of inappropriate shock was similar in both patients with (3.2% at 24 months) and without (3.8% at 24 months) IAD (HR: 0.80, CI: 0.19–3.30, p = 0.76). In a multivariable analysis IAD was not significantly associated with reduced mortality (HR: 0.64, CI: 0.08–4.80, p = 0.66). The rates of complications were numerically lower in patients with IAD vs without (8.8% vs 9.6% at 24 months respectively), but not statistically significant (HR: 0.83, CI: 0.20–3.38, p = 0.79). ConclusionsIAD patients showed a very low annual rate of inappropriate therapy. This suggests that newer algorithms, such as the SST algorithm, are equally good at identifying and treating life-threatening arrhythmias in patients regardless of whether they have IAD.

SUBCLAVIAN CRUSH SYNDROME AND INAPPROPRIATE SHOCKS IN PATIENT WITH IMPLANTABLE CARDIOVERTER DEFIBRILATOR

Subclavian crush syndrome may occur when the lead from cardiovascular implantable electronic device (CIED) is trapped between the clavicle and the first rib and the insulation layer is damaged, or conductor has been fractured. This complication carries an even greater risk if it involves a defibrillation electrode. Case report: We describe a case of a 68year old male patient with sudden onset of Implantable cardioverter defibrillator (ICD) activation- shocks delivery, more than ten times in the period of two hours, right before the admission to the emergency unit department. His ECG on admission shows rhythm of pacemaker with normal ventricular capture. The device interrogation revealed 53 episodes of ventricular fibrillation- false detection and delivery of multiple inappropriate shocks. Low impedance was detected of pace/sense electrodes <200Ω, rise in shock impedance, ventricular oversensing episodes, and high pacing threshold. Due to Inappropriate ICD therapy the detection was turned off. Radiography findings have shown interruption of electrode – continuity in a position corresponding to subclavian crush syndrome, thereby implantation of the new system was indicated. The intervention of new system implantation was performed without any complication in standard procedure, using left axillary vein approach. We inserted a new ventricular single coil defibrillation electrode and new ICD device. The patient was discharged in a good clinical condition. Physicians must demonstrate excellent understanding of lead designs, mechanism of lead fracture, diagnosis and management, in order to make the best decision for every individual patient. Inappropriate shocks are medical emergency and must be treated immediately. Individual approach in every patient should be mandatory. Keywords:subclavian crush syndrome, Implantable cardioverter defibrillator, lead fracture.

Sex and Race Disparities in Hypertrophic Cardiomyopathy: Unequal Implantable Cardioverter-Defibrillator Use During Hospitalization

ObjectiveTo evaluate if there are sex and race disparities in use of implantable cardioverter-defibrillator (ICD) devices for prevention of sudden cardiac death in patients with hypertrophic cardiomyopathy (HCM). Patients and MethodsUsing the National Inpatient Sample from January 2003 through December 2014, we identified all adult admissions with a diagnosis of HCM and an ICD implantation. Race was classified as White versus non-White. Trends in ICD use, predictors of ICD implantation, device-related complications, hospitalization costs, and lengths of stay were evaluated. ResultsAmong a total of 23,535 adult hospitalizations for HCM, ICD implantation was performed in 3954 (16.8%) admissions. Over the study period, there was an overall increasing trend in ICD use (11.6% in 2003 to 17.0% in 2014, P<.001). Compared with admissions not receiving an ICD, those receiving an ICD had shorter median lengths of in-hospital stay but higher hospitalization costs (P<.001). Compared with men and White race, female sex (odds ratio, 0.72; 95% CI, 0.66 to 0.78; P<.001) and non-White race (odds ratio, 0.87; 95% CI, 0.79 to 0.96; P<.001) were associated with lower adjusted odds of receiving an ICD. Women and non-White hospitalizations had higher rates of device related complications, longer lengths of in-hospital stay, and higher hospitalization costs compared with men and White race, respectively (all P<.01). ConclusionAmong HCM hospitalizations, ICD devices are underused in women and racial minorities independent of demographics, hospital characteristics, and comorbidities. Women and racial minorities also had higher rates of complications and greater resource use compared with men and those belonging to the White race, respectively.

Abstract 9977: Concerns Raised Around Adverse Event Reporting Associated with the Subcutaneous Implantable Cardioverter Defibrillator Device

Objective: To review adverse events reports for the subcutaneous implantable cardioverter defibrillator (S-ICD) device and understand challenges in its application. Background: The S-ICD is an increasingly popular alternative to transvenous ICD (TV-ICD) devices since FDA approval in 2012. Although we have the benefit of professional guidelines, there are no high-quality trials showing mortality benefit. There are concerns about higher rates of inappropriate shocks with use of S-ICD, which prompted a ‘Smartpass’ firmware upgrade in 2016. The impact of this upgrade on rates of inappropriate shocks remains ill-defined. Methods: Narrative reports of adverse events associated with the S-ICD reported to the FDA MAUDE database were reviewed for reason for reporting and outcomes. These were compared with the total number of devices found on shareholder reports as of October 2020. Results: Of 35,000 S-ICD devices in the US, 9,349 adverse events and 2,521 inappropriate shocks were reported in MAUDE. There were 108 deaths, 21 of which were due to a failure to convert a ventricular arrhythmia. Rates of inappropriate shocks comprised an increasing proportion of adverse events year over year with no decline following the ‘Smartpass’ upgrade. Conclusion: The multiple instances of death following S-ICD failure are alarming as these fatal events are thought to be rare for TV-ICDs. Additionally, even with the introduction of Smartpass, inappropriate shocks have not declined. These findings, taken in conjunction with the lack of data for mortality benefit of the S-ICD and safety concerns surrounding the recent lead recall, should be considered by clinicians in future decisions about S-ICD use.

Abstract 11971: Predicting Significant Cardiomyopathy in Coronary Artery Disease Through Application of Predictive Machine Learning (ML) Algorithms

Introduction: Left ventricular ejection fraction (LVEF) of ≤ 40% in patients with coronary artery disease (CAD) is associated with an increased risk of sudden cardiac death. Accurately predicting LVEF at clinical follow-up can identify patients needing an implantable cardioverter-defibrillator device. Hypothesis: To develop a predictive algorithm using ML methods for predicting LVEF on follow-up echocardiogram for individuals with CAD. Methods: We identified the 10 most significant predictors of follow-up LVEF using a variety of feature selection algorithms from 109 variables based on clinical, demographic, ECG, and echocardiography data from 2116 hospitalized patients diagnosed with CAD. Various predictive ML algorithms were constructed to predict follow-up LVEF at 60 to 730 days from admission through regression, binary classification (LVEF ≤ 40% and LVEF &gt; 40%), and multi-classification analysis. AUC scores, accuracy, precision, F Score, and recall were calculated for each model to evaluate outcome performance. Results: N = 421 patients had LVEF ≤ 40% on presentation and 535 had LVEF ≤ 40% on follow-up. We observed that binary classification tasks outperformed regression and multi-classification tasks (Graph 1). In a binary classification setting, the top-performing models were simple neural networks, random forests, or logistic regression. (Table 1). Discussion: We developed various ML algorithms in multiple settings to optimize predicting follow-up LVEF with patients with CAD. With an enhanced ability to predict reduced LVEF, we aspire to improve the timing and efficiency of appropriate ICD implantation in patients based on current guidelines.

Temporal changes in resting heart rate before and after heart failure decompensation in a large real-world population of patients with reduced ejection fraction

Abstract Background Diagnostic parameters measured in implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRTD) have been shown to change before and after heart failure (HF) events with fluid overload. Purpose We investigated the temporal characteristics of nighttime heart rate, as a surrogate of resting heart rate, before and after HF events in a large real-world cohort of patients with ICD/CRTD devices. Methods We linked a de-identified database of aggregated electronic health record (EHR) data (2007–2017) to a manufacturer's device database with continuous diagnostic monitoring data. Patients with ICD/CRTD implants with HF related diagnostics were included for this study. The device computes nighttime heart rate as the average heart rate between midnight and 4 am. HF event was defined as an inpatient, emergency department, or observation unit stay in a hospital with primary diagnosis of HF and intravenous diuretics administration. Temporal ensemble average of night heart rate in the 60 days pre and post HF events were compared between HF events with and without readmission within 60 days as well as with periods with no HF events. Results A total of 17,886 patients with 1.8±1.2 years of follow-up met inclusion criteria. The average age of patients was 66.6±12.3 years, with 72% being males, and 51% with ICD devices. The average night heart rate pre and post HF events with and without readmission and in follow-ups with no events is shown in Figure. A total of 1174 patients had 1425 HF events with no readmission for HF within 60 days and 282 patients had 295 HF events which were followed by readmission for HF within 60 days. A total of 17,839 patients had no HF events over 86,858 follow-up months. A 3-day average night heart rate increased by &amp;gt;3 bpm in a large proportion of patients in the 30-day period before HF event compared to 30-day periods with no events (28% vs 16%; Odds Ratio: 2.08; p&amp;lt;0.001). Patients who were readmitted for HF have higher average NHR before and after admission compared to patients who are not readmitted. In patients who were not readmitted, the night heart rate recovers to baseline levels on an average within 10 days post discharge. Conclusions In a large real-world population of patients with ICD/CRTD devices, the average night heart rate increases before HF events. Patients who are readmitted are more likely to have higher night heart rate after discharge. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Medtronic Plc

Temporal characteristics of duration of daily activity before and after heart failure hospitalizations in a large real-world population of patients with cardiovascular implanted electronic devices

Abstract Background Diagnostic parameters measured in implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRTD) have been shown to change before and after heart failure (HF) events with fluid overload. Purpose We investigated the temporal characteristics of device measured daily activity duration before and after HF events in a large real-world cohort of patients with ICD/CRTD devices. Methods We linked a de-identified database of aggregated electronic health record (EHR) data (2007–2017) to a manufacturer's device database with continuous diagnostic monitoring data. Patients with ICD/CRTD implants with HF diagnostic feature were included for this study. Device accumulates the total number of active minutes during a 24-hour period with an active minute defined as total number of accelerometer fluctuations reaching a threshold during the minute. HF event was defined as an inpatient, emergency department, or observation unit stay in a hospital with primary diagnosis of HF and intravenous diuretics administration. Temporal ensemble average of daily duration of activity in the 60 days pre and post HF events were compared between HF events with and without readmission within 60 days and with periods with no HF events during follow-up. Results A total of 17,886 patients with 1.8±1.2 years of follow-up met inclusion criteria. The average age of patients was 66.6±12.3 years, with 72% being males, and 51% with ICD devices. The average daily duration of activity in HF events with and without readmission and with no events is shown in Figure. A total of 1174 patients had 1425 HF events with no readmission for HF within 60 days and 282 patients had 295 HF events which were followed by readmission for HF within 60 days. A total of 17,839 patients had no HF events over 86,858 follow-up months. The 7-day average activity duration decreased by &amp;gt;10 minutes in a large proportion of patients in the 30-day period before HF event compared to 30-day periods with no events (43% vs 34%; Odds Ratio: 1.52; p&amp;lt;0.001). A 7-day average activity duration increase of &amp;gt;10 minutes from admission to 30 days after admission happens in a smaller proportion of HF events with versus without HF readmission within 60 days of index admission (24% vs 31%; Odds Ratio: 0.7; p&amp;lt;0.001). Conclusions In a large real-world population of patients with ICD/CRTD devices, the average daily activity duration reduces before HF events. Re-admissions are more likely in patients with smaller increase in activity duration post discharge. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Medtronic Plc

Ten-year follow-up of implantable cardioverter-defibrillator device implantation in non-ischaemic cardiomyopathy – an insight from real world practice in a large district general hospital

Abstract Introduction The benefits of implantable cardioverter-defibrillators (ICDs) in ischaemic cardiomyopathy are well established. The DANISH study, a large randomized controlled trial of prophylactic ICD implantation, found no benefit in preventing all-cause mortality in patients with non-ischaemic cardiomyopathy (NICM). However, ESC guidelines recommend ICDs for patients with NICM and LVEF ≤35% who receive optimal medical therapy (IB recommendation). The 2014 NICE guidelines have similar endorsements but prior to that ICDs were not routinely recommended in NICM in the UK. Purpose We evaluated clinical outcomes of patients who had ICDs implanted prior to 2014 in a NICM population at a large district general hospital. Methods An ICD database of 454 patients at our district general hospital was retrospectively reviewed. We identified 70 patients who had ICD insertion for non-ischaemic cardiomyopathy between 2006 and 2014. Mean follow up time was 9 years 9 months (SD 23 months). 39 patients had an ICD inserted for primary prevention and 31 for secondary prevention. Data was collected from patients' electronic notes and analysed with relation to baseline demographics, mortality, complications and both appropriate and inappropriate therapy in these two subgroups. Results The baseline patient characteristics are presented in Table 1 and show similar characteristics between the primary and secondary prevention groups, except for a higher level of CRT-D implantation in the primary prevention group (p=0.006). Table 2 shows therapy that the device delivered and complication rates. Overall, 16% of patients with an ICD for non-ischaemic cardiomyopathy received a shock for VF. 41% of patients received appropriate therapy (Shocks or Anti-Tachycardia Pacing (ATP)) from their ICD with median time to first therapy of 30 months (IQR 12–66). Shocks for VF were similar in each group (15% vs. 16%, p=0.919). Six patients (8.6%) had inappropriate shocks and two inappropriate ATP (2.9%). 9 (13%) of patients had a complication either at implant or during follow-up; two had pericardial effusions following implant of which one required pericardiocentesis, three required lead replacement due to lead failure, two developed device infections, one was anticoagulated for a lead thrombus and one patient's device failed to treat VF. Conclusion 16% of non-ischaemic cardiomyopathy patients received a shock for VF and 41% received ICD therapy for VT or VF over a mean follow-up period of almost 10 years. This was seen in both primary and secondary prevention. Inappropriate shocks and life-threatening complications were uncommon. Funding Acknowledgement Type of funding sources: None. Table 1. Patient characteristicsTable 2. ICD therapy and complications

Exploring phenotypes in hypertrophic cardiomyopathy with machine learning data integration. A multicentric, multimodality pilot study

Abstract Background Interpreting patient phenotypes is a challenge when screening for hypertrophic cardiomyopathy (HCM). Machine learning (ML) can potentially help with advanced data integration - combining information contained in whole-cardiac cycle echo deformation and velocity profiles with standard clinical variables. The aim is to apply an ML approach to integrate whole cardiac cycle echo data with clinical variables to explore HCM phenotypes. Methods The cohort consisted of 138 participants from two centres: HCM patients (n=91) and relatives (n=47). Echocardiography was performed, whereas magnetic resonance and genetic testing in 48% and 82%, respectively. Whole cardiac cycle echo data (mitral and aortic velocity profiles, and six regional left ventricular (LV) deformation curves) were combined with clinical variables (age, sex, heart rate, e' medial and e' lateral) and used as the ML input. An unsupervised ML algorithm created a representative space where participants were positioned based on integrated data, blinded to disease status. Clustering was used to determine phenogroups and estimate the average characteristics. Data on family history (FHx), genotype, arrhythmias or syncope, implantable cardioverter-defibrillators (ICD), and late gadolinium enhancement (LGE) were used to interpret the phenogroups. As the LA diameter was not available in the dataset, the HCM risk for sudden cardiac death (SCD) was not calculated, however, the Table shows relevant variables to infer clinical risk. Results Clustering divided the participants into 6 phenogroups (P1–6) (Figure). Average echo profiles are shown in the Figure, while the clinical data in the Table. P1/2 was defined by symptomatic patients with a high prevalence of positive genotypes, a positive FHx of SCD, and a burden of comorbidities. Echo findings showed pronounced structural/functional remodeling, and P1 was associated with severe septal hypertrophy and outflow tract obstruction. The high prevalence of ICD devices defined P1/2 as high risk groups. In comparison, patients in P3/4 were younger, with milder LV hypertrophy, but still considerable functional impairment. P3 had a higher burden of FHX and a higher prevalence of pathogenic mutations, whereas P4 a higher incidence of hypertension, high heart rate, mitral inflow fusion and findings of LGE. Finally, P5/6 consisted of younger individuals, predominantly HCM relatives, with a mild phenotype and, thus, low inferred risk. As expected, the majority of patients with the genetic variants of undetermined significance were located in P5. Conclusion ML can help derive clinically interpretable phenotypes in HCM based on the automated integration of whole cardiac cycle deformation and velocity data with conventional clinical parameters. The derived phenogroups correspond with established risk profiles in HCM. An expanded dataset is needed to enable further exploration of the phenotype-genotype relations and to define prognostic value. Funding Acknowledgement Type of funding sources: Public grant(s) – EU funding. Main funding source(s): This work was supported by the Horizon 2020 European Commission Project H2020-MSCA-ITN

EFFECT OF VALVE TYPE ON OUTCOMES OF TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS WITH SEVERE PULMONARY HYPERTENSION: A RETROSPECTIVE COMPARATIVE COHORT STUDY

TOPIC: Cardiovascular Disease TYPE: Original Investigations PURPOSE: A previous study showed that Transcatheter Aortic Valve Replacement (TAVR) is associated with less major adverse cardiovascular events (MACE) than surgical repair in patients with severe pulmonary hypertension (PH). However, it is still unknown whether MACE complicating TAVR is valve independent or not. We aimed to compare the incidence of MACE between two common types of valves in TAVR, Edwards SAPIEN (Edwards Lifesciences LLC, Irvine, CA) and Medtronic CoreValve (MCV). METHODS: We conducted a retrospective cohort study utilizing Jersey Shore University Medical Center Cath Lab database for the years 2012-2020. We identified patients with PH using invasive hemodynamic measurements. MACE were defined as death, myocardial infarction, stroke, hospitalization due to heart failure, or coronary revascularization. We compared the incidence of MACE up to 1 year of follow up. The study protocol was reviewed and approved by Hackensack Meridian Institutional Review Board. An alpha cutoff of 0.05 was used to ascertain statistical significance. RESULTS: We identified a total of 84 patients with severe PH who underwent TAVR (28 received MCV, 56 received SAPIEN). Baseline characteristics, including age, gender, male, race, white, type of Insurance, prior coronary artery bypass graft surgery, prior percutaneous coronary intervention, presence of implantable cardioverter defibrillator device, prior aortic valve repair, prior stroke or transient ischemic attack, prior carotid artery stenosis, peripheral arterial disease, smoking, hypertension, diabetes mellitus, end stage renal disease, chronic lung diseases were comparable between the two study groups. Fourteen percent of the patients who received MCV developed MACE (n=4), as opposed to 11% in patients who received SAPIEN (n=6); however, the difference was not statistically significant (p=0.9). Even after adjusting for the aforementioned baseline characteristics in a multivariable logistic regression model (enter method), type of valve was not independently associated with incidence of MACE. CONCLUSIONS: There is no difference in the incidence of MACE between different types of valves in patients with severe PH undergoing TAVR. CLINICAL IMPLICATIONS: Both Edwards Sapiens and Medtronic CoreValve are equally safe in patients with severe pulmonary hypertension undergoing transcatheter aortic valve replacement. DISCLOSURES: No relevant relationships by Firas Ajam, source=Web Response No relevant relationships by Abbas Alshami, source=Web Response No relevant relationships by Renato Apolito, source=Web Response No relevant relationships by Steven Douedi, source=Web Response No relevant relationships by Daniel Kiss, source=Web Response No relevant relationships by Aref Obagi, source=Web Response No relevant relationships by Matthew Saybolt, source=Web Response No relevant relationships by Vandan Upadhyaya, source=Web Response

Advances in cardiac resynchronization and implantable cardioverter/defibrillator therapy: Medtronic Cobalt and Crome.

Cardiovascular implantable electronic devices have revolutionized the management of heart failure with reduced ejection fraction. New device generations tend to be launched every few years, with incremental improvements in performance and safety and with an expectation that these will improve patient management and outcomes while remaining cost-effective. As a result, today's cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator devices are quite different from the pioneering but often bulky devices of the late 20th century. This review discusses new and improved features developed to target specific needs in managing heart failure patients, some of which are especially pertinent to the current worldwide healthcare situation, with focus on the latest generation of CRTs with defibrillator (CRT-Ds) and implantable cardioverter defibrillators from Medtronic.

LEFT VENTRICULAR LEAD IMPLANTATION FOR DETECTION OF VENTRICULAR ARRHYTHMIAS IN PATIENT WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND LOW R WAVE IN RIGHT VENTRICLE

Dilated cardiomyopathy (DCM) is a disease characterised as left ventricular (LV) or biventricular dilatation with impaired systolic function. Regardless of underlying cause patients with DCM have a propensity to ventricular arrhythmias and sudden cardiac death. Implantable Cardioverter Defibrillator (ICD) implantation for these patients results in significant reduction of sudden cardiac death [1-3]. ICD devices may be limited by right ventricle (RV) sensing dysfunction with low RV sensing amplitude. We present a clinical case of patient with DCM, implanted ICD and low R wave sensing on RV lead.

Clinical outcomes and programming strategies of implantable cardioverter-defibrillator devices in paediatric hypertrophic cardiomyopathy: a UK National Cohort Study.

Sudden cardiac death (SCD) is the most common mode of death in paediatric hypertrophic cardiomyopathy (HCM). This study describes the implant and programming strategies with clinical outcomes following implantable cardioverter-defibrillator (ICD) insertion in a well-characterized national paediatric HCM cohort. Data from 90 patients undergoing ICD insertion at a median age 13 (±3.5) for primary (n = 67, 74%) or secondary prevention (n = 23, 26%) were collected from a retrospective, longitudinal multi-centre cohort of children (<16 years) with HCM from the UK. Seventy-six (84%) had an endovascular system [14 (18%) dual coil], 3 (3%) epicardial, and 11 (12%) subcutaneous system. Defibrillation threshold (DFT) testing was performed at implant in 68 (76%). Inadequate DFT in four led to implant adjustment in three patients. Over a median follow-up of 54 months (interquartile range 28-111), 25 (28%) patients had 53 appropriate therapies [ICD shock n = 45, anti-tachycardia pacing (ATP) n = 8], incidence rate 4.7 per 100 patient years (95% CI 2.9-7.6). Eight inappropriate therapies occurred in 7 (8%) patients (ICD shock n = 4, ATP n = 4), incidence rate 1.1/100 patient years (95% CI 0.4-2.5). Three patients (3%) died following arrhythmic events, despite a functioning device. Other device complications were seen in 28 patients (31%), including lead-related complications (n = 15) and infection (n = 10). No clinical, device, or programming characteristics predicted time to inappropriate therapy or lead complication. In a large national cohort of paediatric HCM patients with an ICD, device and programming strategies varied widely. No particular strategy was associated with inappropriate therapies, missed/delayed therapies, or lead complications.

Temporal characteristics of an integrated diagnostics risk score before and after heart failure hospitalizations in a large real-world population of patients with implantable devices

Abstract Background Diagnostic parameters measured in implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRTD) have been shown to change before and after heart failure (HF) events with fluid overload. Purpose We investigated the temporal characteristics of an integrated diagnostic risk score before and after HF events in a large real-world cohort of patients with ICD/CRTD devices. Methods We linked a de-identified database of aggregated electronic health record (EHR) data (2007–2017) to a manufacturer's device database with continuous diagnostic monitoring data. Patients with ICD/CRTD implants with intra-thoracic impedance diagnostic feature were included for this study. The previously defined integrated diagnostic risk score was derived by combining daily diagnostic data, including intra-thoracic impedance, night-time heart rate, activity, heart rate variability, and atrial fibrillation (AF) burden, ventricular rate during AF, CRT pacing, ventricular tachycardia episodes and shocks, in a Bayesian Belief Network framework. HF event was defined as an inpatient, emergency department, or observation unit stay in a hospital with primary diagnosis of HF and intravenous diuretic administration. Temporal average of daily risk score across all patients in the 60 days pre and post HF events were compared in HF events with and without readmission within 60 days and with no HF event during pre and post follow-up days. Results A total of 17,886 patients with 1.8±1.2 years of follow-up met inclusion criteria. The average age of patients was 66.6±12.3 years, with 72% being males, and 51% with ICD devices. The average integrated diagnostics risk score in HF events with and without readmission and with no events is shown in Figure. A total of 1174 patients had 1425 HF events with no readmission for HF within 60 days and 282 patients had 295 HF events which were followed by readmission for HF within 60 days. A total of 17,839 patients had no HF events over 86,858 follow-up months. The average daily risk score across all patients was higher on all 60 days pre and post HF event with readmission compared to HF events with no readmission (p&amp;lt;0.001) and both were higher compared to follow-up period with no events (p&amp;lt;0.001). The risk score recovers less often after HF events which are followed by readmission within 60 days compared to HF events with no readmission. Conclusions In a large real-world population of patients with ICD/CRTD devices, the average integrated diagnostics risk score was higher before and after HF events with readmission compared to HF events with no readmission. Re-admissions are more likely in patients with smaller risk score recovery after HF events. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Medtronic Plc

ICD implantation and device therapy: Fabry vs hypertrophic cardiomyopathy

Abstract Background Cardiac involvement of Fabry disease (FD) includes left ventricular hypertrophy (LVH), inflammation, arrhythmia and sudden death. There are limited data regarding potential risk predictors and no definitive criteria exist to guide implantation of cardiac devices for primary prevention. Despite phenotypic similarities between FD and hypertrophic cardiomyopathy (HCM), FD is specifically excluded from the ESC sudden cardiac death risk prediction tool used for HCM. Purpose To evaluate differences in device implantation and arrhythmic burden between advanced Fabry cardiomyopathy and HCM. Methods This multi-centre, retrospective study including genetically confirmed FD and age/gender-matched HCM patients all of whom had an implantable cardioverter defibrillator (ICD). Data was collected prior to device implantation on disease characteristics, biomarkers and CMR imaging. Arrhythmia burden and changes in therapy were captured following implantation. Results Of the UK FD population under follow-up, 50/880 had an ICD implanted (80% males, 51% non-classical mutation, mean age at device implantation 57±12 years). A comparator group included 64 age- and gender-matched HCM patients (67% males, mean age at implant 46±39 years). Baseline LV mass was greater in FD (291±97g/m2 vs 218±78g/m2, p=0.012). FD patients had higher troponin (95 vs 19ng/l, p&amp;lt;0.001) but similar NT-pro-BNP (1687 vs 888ng/l, p=0.086) levels. Indications for ICD insertion in FD included: presumed HCM dual pathology 14%, symptomatic NSVT 18%, asymptomatic NSVT 24%, co-existing long QT 2%, CRT-D 14%, no clear indication (primary prevention in the presence of multiple potential arrhythmic risk factors) 28%. All HCM patients were risk stratified and underwent device implantation based on an estimated 5-year SCD risk &amp;gt;4%. All FD patients had a SCD risk &amp;gt;4% using this risk calculator. Arrhythmia were more common in FD over shorter follow-up (37/50, 74% over 4.3±3.0 years vs 28/64 in HCM, 44% over 6.5±2.9 years, p=0.001). Notably, VT requiring anti-tachycardia pacing (ATP) +/− defibrillation therapy from the ICD was more frequent (FD: 14/50, 28% vs HCM: 8/64, 12%, p=0.055), as was immediate shock therapy for sustained VT (p=0.009, figure panel B). FD patients with arrhythmia were often older, had greater LV mass, a larger left atrium and a broader QRS duration. These clinical features tended to occur more frequently in FD than in the HCM group. Conclusion This study has shown that delivery of device therapy in Fabry cardiomyopathy is higher than in HCM. Despite similar rates of asymptomatic NSVT, a higher rate of ventricular arrhythmia requiring ATP/defibrillation therapy occurred in FD. Although both FD and HCM had similar risk percentages according to the ESC calculator, active troponitis in FD was double that of HCM. Funding Acknowledgement Type of funding source: None

Clinical outcomes and programming strategies of implantable cardioverter defibrillator (ICD) devices during childhood in hypertrophic cardiomyopathy: a UK national cohort study

Abstract Background Sudden cardiac death (SCD) is the most common mode of death in childhood hypertrophic cardiomyopathy (HCM). ICDs have been shown to be effective at terminating malignant ventricular arrhythmias but at the expense of a high incidence of complications. The optimal device and programming strategies to reduce complications in this patient group are unknown. Purpose To describe the programming strategies and clinical outcomes of ICD implantation in childhood HCM. Methods Anonymised, non-invasive clinical data were collected from a retrospective, longitudinal multi-centre cohort of children (&amp;lt;16 years) with HCM (n=687) and an ICD in-situ from the United Kingdom. Results 96 patients (61 male (64%), 6 non-sarcomeric (6%)) underwent ICD implantation at a median age 14yr (IQR 11–16, range 3–16) and weight 52.3 kg (IQR 34.8–63.1). Indication for ICD was primary prevention in 72 (75%). 82 (85%) had an endovascular system, 3 (3%) epicardial and 11 (12%) subcutaneous system. 61 patients (74%) were receiving one or more cardioactive medications at implantation [B blockers n=66, 70%, disopyramide n=14, 15%, amiodarone n=7, 7%, calcium channel blocker n=7, 9%, other n=5, 6%]. Programming practices varied: all had VF therapies activated (median 220bpm, IQR 212–230); 70 (73%) had a VT zone programmed (median rate 187 bpm, SD 20.9), of which 26 (27%) had therapies activated. 50 patients (61%) had antitachycardia pacing (ATP) activated. Over a median follow up of 53.6 months (IQR 27.3,108.4), 4 patients (4.2%) died following arrhythmic events despite a functioning device. 25 patients had 53 appropriate therapies (ICD shock n=47, ATP n=8), incidence rate 5.22 (95% CI 3.5–7.8). On univariable analysis, secondary prevention indication for ICD implantation was the only predictor of therapy [16 (64%) vs 8 (11.3%), p value &amp;lt;0.001]. 8 (8.3%) patients had 9 inappropriate therapies (ICD shock n=4, ATP n=5), incidence rate 1.37 (95% CI 0.65–2.8), caused by T wave oversensing (n=2), lead migration (n=1), supraventricular tachycardia (n=1). Device complications were seen in 30 patients (31%), including lead complications (n=16) and infection (n=10). No clinical characteristics predicted time to inappropriate therapy or lead complication. Conclusions In a contemporary cohort of children with HCM, the incidence of inappropriate therapies is lower than previously reported, yet complication rates remain higher than reported in adult patients. No clinical, device or programming strategies were associated with inappropriate therapies or lead complications. Funding Acknowledgement Type of funding source: Other. Main funding source(s): British Heart Foundation