Cardiac Resynchronization Therapy Defibrillator Research Articles

Primary results from the Japanese Heart Failure and Sudden Cardiac Death Prevention Trial (HINODE).

AimsThe HINODE study aimed to analyse rates of mortality, appropriately treated ventricular arrhythmias (VA), and heart failure in Japanese patients and compared with those in Western patients.Methods and resultsAfter treatment decisions following contemporary practice in Japan, patients were prospectively enrolled into four cohorts: (i) internal cardioverter‐defibrillator (ICD), (ii) cardiac resynchronization therapy (CRT) defibrillator (CRT‐D), (iii) standard medical therapy (‘non‐device’: ND), or (iv) pacing (indicated for CRT; received pacemaker or CRT pacing). Cohorts 1–3 required a left ventricular ejection fraction ≤35%, a history of heart failure, and a need for primary prevention of sudden cardiac death based on two to five previously identified risk factors. Endpoint outcomes were adjudicated by the independent committees. ICD and CRT‐D cohorts, considered as high‐voltage (HV) cohorts, were pooled for Kaplan–Meier analysis and propensity‐matched to Multicenter Automatic Defibrillator Implantation Trial‐Reduce Inappropriate Therapy (MADIT‐RIT) arm B and C patients. The study enrolled 354 patients followed for 19.6 ± 6.5 months, with a minimum of 12 months. Propensity‐matched HV cohorts showed comparable VA (P = 0.61) and mortality rates (P = 0.29) for HINODE and MADIT‐RIT. The ND cohort presented a high crossover rate to ICD therapy (6.1%, n = 7/115), and the CRT‐D cohort showed elevated mortality rates. The pacing cohort revealed that patients implanted with pacemakers had higher mortality (26.0%) than those with CRT‐Pacing (8.4%, P = 0.05).ConclusionsThe mortality and VA event rates of landmark trials are applicable to patients with primary prevention in Japan. Patients who did not receive guideline‐indicated CRT devices had poor outcomes.

“Stable” Asystole In A Patient With Left Ventricular Assist Device

The use of Left Ventricular assist devices (LVADs) for mechanical circulatory support has become a standard therapy for some patients with end-stage heart failure. Although presentation and consequences of ventricular arrhythmias (VA) in LVAD supported patients are well described and often stabilized by the mechanical support, presence of asystole is less commonly reported. Our patient is a 75-year-old male with advanced ischemic cardiomyopathy requiring cardiac resynchronization therapy-defibrillator (CRT-D) and ultimately HeartMate II LVAD. Post implantation, his CRT-D was abandoned after it reached the elective replacement indicator as he had no VAs and was not pacer dependent. He now presented with a new onset of low flow alarms that started earlier in the day. He appeared stable, pleasant and in a humorous mood. He reported lightheadedness but denied syncope. While in the ED, the patient was noted to be asystolic. His mean arterial pressure was in the 50s. Physical exam was unremarkable with the expected LVAD hum and lack of pulses. LVAD parameters revealed decreased Flow (2.5 from baseline 5.1) and Pulsatility Index (2.7 from baseline 4.9). Patient subsequently underwent implantation of a new battery with reactivation of his previously abandoned pacemaker leads with resultant hemodynamic improvement. Ultimately, he was discharged home in stable condition. Discussion: Very few cases of asystolic LVAD patients without immediate hemodynamic collapse are described. Similarly to ventricular arrhythmias, the hypothesized physiology for stability is this quasi-Fontan circulation, where low pulmonary vascular resistance with elevated central venous pressure allows pulmonary vasculature perfusion and left atrial filling. In this case, low flow alarms and decreased PI were due to decreased left ventricular preload in the setting of asystole. Ventricular arrhythmias remain common after LVAD implantation, asystole, as in the present case can equally be an issue. This is particularly true as many of LVAD supported patients have CRT-Ds implanted in the setting of pre-existent left bundle branch blocks, which can progress to complete heart block or asystole. Thus, It might not always be the case that LVAD supported patients don't benefit from maintaining ICD function. Conclusion: Traditionally unstable asystole and ventricular arrhythmia can be well tolerated in the LVAD population due to quasi-Fontan physiology. ICD role in LVAD patients is currently unclear, and should be a part of shared decision making with the patient. Yes, there may be such a thing as, "stable" asystole.

Heartlogic Heart Failure Index As Covid Index: Predicting Severity Of Covid-19 In Patients With Advanced Heart Failure

Heart Logic heart failure diagnostic is a personalized, remote heart failure diagnostic and monitoring system using multiple, novel physiologic sensors. It has been proven to have high sensitivity and low-alert burden that combines sensor data into one composite index that provides weeks of advance notice for detecting early signs of worsening heart failure. We present two cases, one with non-ischemic cardiomyopathy, the other with ischemic cardiomyopathy. In both cases, patients had reduced ejection fraction status post cardiac resynchronization therapy defibrillator who were monitored with Heart Logic heart failure diagnostics. In the first case, a rapid increase in sensors alarmed us for impending exacerbation of heart failure and retrospective analysis of differentials led us to diagnosis of COVID-19. The patient developed increase in respiratory rate, mean heart rate and S3 component of heart sound while decrease in thoracic impedance, ultimately with increased Index. Patient was admitted, intubated and successfully recovered. Heart Logic Index helped us making the diagnosis in early stage of COVID-19 and manage effectively. We present another case of ischemic cardiomyopathy with reduced ejection fraction awaiting heart transplant due to severe multi vessel coronary artery disease who tested positive for COVID-19 with milder symptoms. He was monitored prospectively to assess changes in Heart Failure Index which remained normal correlating with the milder symptoms from COVID-19 itself. All the indices including S1, S3, respiratory rate and mean heart rate remained normal. Patient recovered without any major residual effects from COVID 19. Hence, heartlogic index could serve as proactive alert tool like a “COVID index” to suspect, correlate with severity of symptoms and monitor the outcome in patients of heart failure diagnosed with COVID-19.

Case report: Wide-complex tachycardia one week post-CRT-D implantation in a patient with pre-existing left bundle branch block

A 37-year-old female with dilated cardiomyopathy, whose baseline ECG showed sinus rhythm with left bundle branch block pattern, received a cardiac resynchronization therapy defibrillator (CRTD). One week post-implantation, she presented to the emergency department with palpitations, diaphoresis and chest discomfort. ECG showed a wide-complex tachycardia (WCT) episode, which spontaneously converted to sinus rhythm, and was later diagnosed as typical slow-fast atrioventricular nodal re-entrant tachycardia. This report outlines the differential diagnoses for WCT and the reasoning behind the eventual diagnosis, taking into consideration the device interrogation findings and results of the electrophysiology study.

Association of time-varying changes in physical activity with cardiac death and all-cause mortality after ICD or CRT-D implantation.

OBJECTIVETo evaluate the association of longitudinal changes in physical activity (PA) with long-term outcomes after implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) implantation.METHODSPatients with ICD/CRT-D implantation from SUMMIT registry were retrospectively analyzed. Accelerometer-derived PA changes over 12 months post implantation were obtained from the archived home monitoring data. The primary endpoints were cardiac death and all-cause mortality. The secondary endpoints were the first ventricular arrthymia (VA) and first appropriate ICD shock.RESULTSIn 705 patients, 446 (63.3%) patients showed improved PA over 12 months after implantation. During a mean 61.5-month follow-up duration, 99 cardiac deaths (14.0%) and 153 all-cause deaths (21.7%) occurred. Compared to reduced/unchanged PA, improved PA over 12 months could result in significantly reduced risks of cardiac death (improved PA ≤ 30 min: hazard ratio (HR) = 0.494, 95% CI: 0.288−0.848; > 30 min: HR = 0.390, 95% CI: 0.235−0.648) and all-cause mortality (improved PA ≤ 30 min: HR = 0.467, 95%CI: 0.299−0.728; > 30 min: HR = 0.451, 95% CI: 0.304−0.669). No differences in the VAs or ICD shocks were observed across different groups of PA changes. PA changes can predict the risks of cardiac death only in the low baseline PA group, but improved PA was associated with 56.7%, 57.4%, and 62.3% reduced risks of all-cause mortality in the low, moderate, and high baseline PA groups, respectively, than reduced/unchanged PA.CONCLUSIONSImproved PA could protect aganist cardiac death and all-cause mortality, probably reflecting better clinical efficacy after ICD/CRT-D implantation. Low-intensity exercise training might be encouraged among patients with different baseline PA levels.

Paradoxical pacing spikes during a wide complex tachycardia in biventricular defibrillator. What is the mechanism? Is it undersensing due to troubleshooting?

We present the case of a 68‐year‐old man with a cardiac resynchronization therapy‐defibrillator Medtronic device implanted 3 years ago, admitted to our hospital due to a wide complex tachycardia with unexpected pacing spikes inside QRS complexes. Although that could be easily attributed to ventricular undersensing, more complicated mechanisms are involved, including the origin of the tachycardia, the parameters of the device, and the position of the device and the leads.

Implantable device measured objective daily physical activity as a predictor of long-term all-cause mortality and cardiac death in patients with age\u2009>\u200975\u2009years and high risk of sudden cardiac death: a cohort study

BackgroundTo study the relationship between objective daily physical activity (PA), as measured by implantable cardioverter defibrillators (ICDs)/cardiac resynchronization therapy defibrillators (CRTDs), and long-term prognoses in patients with age > 75 years at high risk of sudden cardiac death (SCD).MethodsIn total, 133 patients with age > 75 years old (age 79.52 ± 3.68 years) in the SUMMIT study were retrospectively analysed. The major endpoint was all-cause mortality, and the minor endpoint was cardiac death.ResultsThe mean follow-up time was 57.1 ± 24.2 months (range: from 4 to 96 months). In total, 46 all-cause mortality and 23 cardiac death events occurred. The receiver operating characteristic curve indicated a baseline PA cut-off value of 6.47% (93 min/day) can predict all-cause mortality in patients with age > 75 years, with an area under the curve of 0.670 (95% confidence interval (CI): 0.573–0.767, P = 0.001). The sensitivity was 67.4%, and the specificity was 66.7%. Patients with baseline PA ≤ 6.47% had higher rates of all-cause mortality (51.7% vs 20.5%, P < 0.001) and cardiac death (25.0% vs 11.0%, P = 0.040). The estimated Kaplan-Meier survival curves showed that patients with PA ≤ 6.47% had an increased cumulative incidence of all-cause mortality (Log-rank P < 0.0001) and cardiac death (Log-rank P = 0.0067). Multivariate Cox regression analysis showed that PA ≤ 6.47% was an independent predictor of all-cause mortality (hazard ratio (HR) 3.137, 95% CI: 1.667–5.904, P < 0.001) and cardiac death (HR value 3.345, 95% CI: 1.394–8.028, P = 0.007).ConclusionsDaily PA of about 1.5 h was associated with lower all-cause mortality and cardiac death risk in patients with age > 75 years and high risk of SCD with ICDs/CRTDs. PA monitoring may aid in long-term management of older patients at high risk of SCD.

Long-term quality of life and acceptance of implantable cardioverter-defibrillator therapy: results of the European Heart Rhythm Association survey.

Implantable cardioverter-defibrillator (ICD) may impact patients' life significantly. The aim of this survey was to analyse the impact of the ICD on quality of life (QoL) metrics from the patient's perspective. 'Living with an ICD' was a prospective, multicentre study with an online questionnaire submitted to the European Heart Rhythm Association (EHRA) Research Network centres as well as patient associations from 10 European countries; it was filled-in directly and personally by the patients that were invited to participate, with a minimal interaction or influence from the healthcare professionals. Overall, the questionnaire was completed by 1809 patients (624 women, 34.5%). Patients in their 60s and 70s and from Western Europe were the most represented. The median time from first ICD implantation was 5 years (IQR 2-10). Device-related complications were reported by 505 patients (22.4%), including one or more inappropriate shocks (n = 209, 11.6%). Almost half the respondents reported improved QoL, with a more favourable impact for those receiving cardiac resynchronization therapy-defibrillator (CRT-D), and only a 10th experienced a significant decrease in QoL. The occurrence of complications remained a major predictor of deteriorated QoL (odds ratio 2.1, 95% confidence interval 1.4-3.0, P < 0.001). In conclusion, most patients have a globally positive view and acceptance of ICD therapy, reporting preserved to improved QoL after device implantation. Complications, namely inappropriate shocks, affect the expectation of living a normal life post-implant and are associated with a significant decrease in QoL. Our findings also highlight the importance of a detailed informed consent process and the involvement of the patient in the decision-making process.

Image-Based Modelling of Cardiac Mechanics

The main objective of this study was to model the left ventricle (LV) based on 2D echocardiography imaging technique to assess the cardiac mechanics for group of patients affected by heart failure. A prospective study has been made at Ibn Al-Bitar center for cardiac surgery, for 13 patients with heart failure (HF), 9 patients were males (69%) and 4 females (31%). The mean age was 54±7 years. Those patients were supposed to undergo a CRT-D (Cardiac Resynchronization Therapy Defibrillator) implant as they didn’t respond to drug therapy. Before CRT-D implantation, 2D echocardiography was performed for all the patients, to model the left ventricle and to measure indices that were used to evaluate cardiac mechanics which are LV pressure, wall stresses, global longitudinal strain, and cardiac output. After 3-months of follow-up, 2D echocardiography was re-assessed and the left ventricular mechanics has been re-measured. Post CRT-D implantation, significant improvement in the cardiac mechanics was observed in 54% of the patients which were called responders (patients that respond to CRT-D device) and the other patients were called non-responders. It has been seen that, the circumferential wall stresses were decreased in responder’s group while increased or remain unchanged in non-responders. Global longitudinal strain for the responder’s group were increased while remain unchanged in the non-responders. So, patients were divided into responders and non-responders, based on improvement of the cardiac mechanics after 3-moths of follow up. It has been concluded that the modelling of the left ventricle based on images obtained from 2D echocardiography imaging techniques, was an important computational tool that was used to enhance understanding and support the evaluation, surgical guidance and treatment management of basic biophysics underlying cardiac mechanics.

Cases of Azygous Coil Extraction.

BackgroundProcedural and clinical outcomes of patients undergoing extraction or removal of azygous coils are not well characterized.ObjectiveEvaluate outcomes in patients who undergo device extraction with an azygous coil in situ.MethodsPatients undergoing extraction with an azygous coil in situ between May 2015 and January 2021 were included in this retrospective single-center analysis. Outcomes included procedural success, use of laser and mechanical cutting tools during the procedure, procedural complications, and mortality.ResultsWe identified 2 patients undergoing device extraction with an azygous coil in situ with a dwell time greater than 12 months. The patients were male, aged 73 and 83 years. Both had a history of hypertension, atrial fibrillation, heart failure (ejection fractions <15% and 20%), and cardiomyopathy (nonischemic and ischemic), and presented with an infection (case 1 with a single-chamber ICD and Staphylococcus aureus bacteremia, case 2 with a cardiac resynchronization therapy defibrillator pocket infection). The mean dwell time of all 6 leads extracted was 6.43 years (range 1.33–12.63 years), and the 2 azygous coils had dwell times of 1.33 and 6.04 years. In case 1, the azygous coil was inferior to the cardiac silhouette, while in case 2 it was superior. A 14F laser sheath was employed to remove both azygous coils. Both extractions were a complete procedural success in which all leads were removed completely without intraoperative complications.ConclusionThese cases demonstrate the variable courses of azygous coils, provide proof of concept that they can be removed safely, and illustrate that azygous coils can be removed with the same techniques that are commonly used to remove other types of leads.

309 Upgrading from a dual-chamber pacemaker to a cardiac resynchronization therapy defibrillator in situs inversus totalis with dextrocardia following mitral valve replacement and tricuspid annuloplasty using a left-sided approach

Abstract A 71-year-old female patient was referred to our centre to upgrade a dual-chamber pacemaker to a cardiac resynchronization therapy defibrillator (CRT-D) following the detection of worsened systolic function (ejection fraction: 25–30%) via transthoracic echocardiography. The patient had situs inversus totalis with dextrocardia. She had undergone mitral valve replacement and tricuspid annuloplasty in July 2019, with a concomitant left upper pulmonary lobectomy for neoplasm, detected at cardiac tomography incidentally. In January 2020, we performed an upgrade of the preexisting device to a CRT-D system because the patient developed heart failure, reduction in systolic function, and numerous nonsustained ventricular tachycardias. The right ventricular lead that had been previously implanted was extracted. To facilitate the intervention, we decided to flip the fluoroscopic image, obtained with a right-anterior oblique view, by 180 °C (right–left), creating the optical impression of a levocardial position.

682. Implantable Cardioverter-Defibrillator Lead Vegetation with Long-Standing Actinomyces neuii Bacteremia

BackgroundEndocarditis caused by Actinomyces species is uncommon with only 30 cases reported in contemporary literature. MethodsWe present a novel case of cardiovascular implantable electronic device (CIED) endocarditis secondary to infection by Actinomyces neuii – a unique non-branching member of the species that grows in both anaerobic and aerobic media.ResultsOur patient, a 51-year-old female, with a history of implantable cardioverter-defibrillator (ICD) placement 17 years prior for heart failure, presented with six weeks of fevers and rigors. She was referred to the infectious disease clinic for evaluation of pyrexia of unknown origin. Her examination was unremarkable, and the ICD pocket was uninflamed. Her initial labs revealed mildly elevated inflammatory markers and renal insufficiency. Blood cultures were positive for slow-growing non-branching gram-positive rods in both aerobic and anaerobic media. These were identified as Actinomyces neuii by mass spectrometry. Review of outside records showed positive blood cultures with Actinomyces neuii at another facility two weeks prior to our evaluation which were not acted upon and thought to be bacterial contamination. The patient was further evaluated with a transesophageal echocardiogram that demonstrated a 3.3 x 2.2cm mobile vegetation attached to the ICD lead. She subsequently underwent removal of her Saint Jude cardiac resynchronization therapy defibrillator and leads using laser and snaring techniques, but the tail end of the ventricular lead fractured and could not be retrieved. The ICD pocket was also found to be infected. A planned 6-week course of IV ampicillin was interrupted by 2 weeks of ceftriaxone for treatment of an intercurrent lower respiratory tract infection. The patient regained her baseline health and was discharged 2 weeks after ICD removal with a LifeVest. She is to complete 12 months of oral amoxicillin therapy after completion of IV antibiotics in view of retained lead fragment, and long standing Actinomyces bacteremia - consistent with published management strategies. Figure 1. Transesophageal echocardiogram demonstrating size of vegetation. Figure 2. Three-dimensional view demonstrating vegetation on the ICD lead.ConclusionHere we describe the first known case of Actinomyces neuii CIED endocarditis with a large lead vegetation and long-standing bacteremia, presenting as pyrexia of unknown origin.Disclosures All Authors: No reported disclosures

Lower rate limit for pacing by cardiac resynchronization defibrillators: Should lower rate programming be reconsidered?

No real-world large database associates lower rate limit (LRL) programming and survival of subjects with cardiac resynchronization therapy-defibrillators (CRT-Ds). The purpose of this study was to test the hypothesis that lower LRL programming is independently associated with survival, and that LRL and heart rate score (HrSc) are associated. All dual-chamber CRT-D devices in the Remote Patient Monitoring (RPM) ALTITUDE database (2006-2011) were queried. Baseline HrSc was defined as the percentage of all atrial sensed and paced beats in the tallest 10-beat histogram bin postimplant. LRL was assessed during repeated RPM uploads. Using a Cox model multivariable analysis, relationships between LRL, survival, HrSc, and other variables were evaluated. Survival was determined by query of death indices. Data analyzed included 61,881 subjects (mean follow-up 2.9 years). LRL ranged from 40 to 85 bpm. Baseline lower LRL was associated with younger age, less atrial fibrillation, female sex, and lower HrSc (P <.001 for all covariates). Lower LRL was associated with improved survival, with LRL 40 associated with the largest survival benefit. This was significant for all 3 HrSc subgroups (P<.001). An interaction between HrSc and LRL was observed, with the largest survival difference between HrSc groups observed at LRL-40 (P <.001). LRL programming and HrSc were associated, and lower values of both were associated with improved survival in a large database of CRT-D subjects. Relationships between survival, LRL programming, and HrSc merit further study.

Abstract 13715: Efficacy of Implantable Cardioverter-Defibrillators/Cardiac Resynchronization Therapy Defibrillator Remote Monitoring in Patients With Heart Failure: A Bayesian Meta-Analysis of Randomized Controlled Trials

Introduction: Remote monitoring using implantable cardioverter-defibrillators (ICDs) or cardiac resynchronization therapy defibrillator (CRT-D) can be used as an adjunctive diagnostic tool to traditional hospital and clinic visits to monitor the volume status of patients with heart failure (HF). Methods: We searched PubMed, Cochrane Library, and ClinicalTrials.gov (inception through February 4th, 2021) for randomized controlled trials (RCTs) evaluating ICDs/CRT-D remote monitoring versus standard of care in patients with HF. Of 642 articles retrieved after removing duplicate items, we included 11 RCTs encompassing 5,965 patients. Absolute risk difference (ARD) with 95% credible interval (CrI) was estimated. Pooled (posterior) risk difference was computed using Bayesian hierarchical methods, random effects model and weakly informative prior. Results: The ARD for mortality was centered at -0.01 (95%CrI: -0.03; 0.01, Tau: 0.02), with 82% probability of ARD of ICD/CRT-D remote monitoring with respect to control being less than 0. The ARD for cardiovascular mortality was centered at -0.03 (95%CrI: -0.11; 0.05, Tau: 0.10), with 84% probability of ARD of ICD/CRT-D remote monitoring with respect to control being less than 0. The ARD for HF admissions was centered at -0.00 (95%CrI: -0.07; 0.06, Tau: 0.08), with 57% probability of ARD of ICD/CRT-D remote monitoring with respect to control being less than 0 [Figure]. Conclusions: This meta-analysis suggests that ICD/CRT-D remote monitoring in patients with HF is associated with a higher probability of reduced all-cause mortality, and cardiovascular mortality compared with standard care. However, ICD-CRT/D remote monitoring was associated with minimal probability of difference in HF hospitalizations.

Particle therapy using protons or carbon ions for cancer patients with cardiac implantable electronic devices (CIED): a retrospective multi-institutional study

PurposeTo evaluate the outcomes of particle therapy in cancer patients with cardiac implantable electronic devices (CIEDs).Materials and methodsFrom April 2001 to March 2013, 19,585 patients were treated with proton beam therapy (PBT) or carbon ion therapy (CIT) at 8 institutions. Of these, 69 patients (0.4%, PBT 46, CIT 22, and PBT + CIT 1) with CIEDs (64 pacemakers, 4 implantable cardioverter defibrillators, and 1 with a cardiac resynchronization therapy defibrillator) were retrospectively reviewed. All the patients with CIEDs in this study were treated with the passive scattering type of particle beam therapy.ResultsSix (13%) of the 47 PBT patients, and none of the 23 CIT patients experienced CIED malfunctions (p = 0.105). Electrical resets (7) and over-sensing (3) occurred transiently in 6 patients. The distance between the edge of the irradiation field and the CIED was not associated with the incidence of malfunctions in 20 patients with lung cancer. A larger field size had a higher event rate but the test to evaluate trends as not statistically significant (p = 0.196).ConclusionDifferences in the frequency of occurrence of device malfunctions for patients treated with PBT and patients treated with CIT did not reach statistical significance. The present study can be regarded as a benchmark study about the incidence of malfunctioning of CIED in passive scattering particle beam therapy and can be used as a reference for active scanning particle beam therapy.

Prognostic value of galectin-3 and right ventricular function for long-term mortality in heart failure patients treated with cardiac resynchronization therapy

Recently, associations between the biomarker galectin-3 and numerous pathological processes involved in heart failure (HF) and right ventricular (RV) function have been observed. We aimed to assess the long-term prognostic ability of galectin-3 and RV function parameters for all-cause mortality in HF patients treated with cardiac resynchronization therapy (CRT). We prospectively studied 63 symptomatic HF patients with a left ventricular (LV) ejection fraction (EF) ≤ 35%. The median serum galectin-3 concentration was 13.4 ng/mL (IQR 11.05, 17.15). A detailed assessment of LV and RV geometry and function was performed with echocardiography. CRT defibrillator implantation was achieved in all patients without major complications. The follow-up lasted 5 years. In the multivariable Cox regression model, independent predictors for all-cause mortality were log baseline galectin-3 and baseline RV function expressed as tricuspid annular plane systolic excursion with HR 2.96 (p = 0.037) and HR 0.88 (p = 0.023), respectively. Analysis of subgroups defined by galectin-3 concentration and CRT response showed that patients with high baseline galectin-3 concentrations and a lack of response to CRT had a significantly lower probability of survival. In our patient cohort, the baseline galectin-3 concentration and RV function were independent predictors of long-term all-cause mortality in HFrEF patients following CRT implantation.

One-year mortality after implantable defibrillator implantation: do risk stratification models help improving clinical practice?

The purpose of this study was to assess the available mortality risk stratification models for implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) patients. We conducted a review of mortality risk stratification models and tested their ability to improve prediction of 1-year survival after implant in a database of patients who received a remotely controlled ICD/CRT-D device during routine care and included in the independent Home Monitoring Expert Alliance registry. We identified ten predicting models published in peer-reviewed journals between 2000 and 2021 (Parkash, PACE, MADIT, aCCI, CHA2DS2-VASc quartiles, CIDS, FADES, Sjoblom, AAACC, and MADIT-ICD non-arrhythmic mortality score) that could be tested in our database as based on common demographic, clinical, echocardiographic, electrocardiographic, and laboratory variables. Our cohort included 1,911 patients with left ventricular dysfunction (median age 71, 18.3% female) from sites not using any risk stratification score for systematic patient screening. Patients received an ICD (53.8%) or CRT-D (46.2%) between 2011 and 2017, after standard physician evaluation. There were 56 deaths within 1-year post-implant, with an all-cause mortality rate of 2.9% (95% confidence interval [CI], 2.3-3.8%). Four predicting models (Parkash, MADIT, AAACC, and MADIT-ICD non-arrhythmic mortality score) were significantly associated with increased risk of 1-year mortality with hazard ratios ranging from 3.75 (CI, 1.31-10.7) to 6.53 (CI 1.52-28.0, p ≤ 0.014 for all four). Positive predictive values of 1-year mortality were below 25% for all models. In our analysis, the models we tested conferred modest incremental predicting power to ordinary screening methods.

Cardiac Implantable Electronic Devices: Reoperations and the Competing Risk of Death

The use of cardiac implantable electronic devices (CIED), which includes pacemakers, implantable cardioverter-defibrillators (ICD), cardiac resynchronisation therapy pacemakers (CRT-P) and cardiac resynchronisation therapy defibrillators (CRT-D) has increased over the past 20 years, but there is a lack of real world evidence on the longevity of these devices in the older population which is essential to inform health care delivery and support clinical decisions. We conducted a retrospective cohort study using data from the Australian Government Department of Veterans' Affairs database. The cohort consisted of people who had a CIED procedure between 2005 and 2015. The cumulative risk of generator replacement/reoperations was estimated accounting for the competing risk of death. A total of 16,662 patients were included. In pacemaker recipients with an average age of 85 years, the 5-year risk of reoperation ranged from 2.8% in single chamber, 3.6% in dual chamber to 7.6% in CRT-P recipients, while the 5-year risk of dying with the index pacemaker in situ was 63% in single chamber, 46% in dual chamber and 56% in CRT-P recipients. In defibrillator recipients with an average age of 80 years, the 5-year risk of reoperation ranged from 11% in single chamber, 13% in dual chamber to 24% in CRT-D recipients, while the 5-year risk of dying with the index defibrillator in situ was 46% in single chamber, 40% in dual chamber and 41% in CRT-D recipients. In this cohort of older patients the 5-year risk of generator reoperation was low in pacemaker recipients whereas up to one in four CRT-D recipients would have a reoperation within 5 years.

Prognostic significance of non-sustained ventricular tachycardia on stored electrograms of heart failure patients with cardiovascular implantable electronic devices

Abstract Background Non-sustained ventricular tachycardia (NSVT) is commonly found in patients with structural heart disease and was historically obtained from registers of external ambulatory monitoring. The advent of Cardiac implantable electronic devices (CIEDs) has made it possible to detect asymptomatic NSVT in Heart Failure (HF) patients more frequently, but its true impact in real world is uncertain, and often does not lead to a change in clinical intervention. Purpose To determine the prognostic significance of NSVT detection on stored electrograms of CIEDs in HF patients with systolic left ventricle dysfunction. Methods We retrospectively enrolled 132 consecutive HF patients (mean age 67,5±11,1 years, males 72,0%) with systolic left ventricle dysfunction and CIEDs (biventricular pacemakers with or without cardiac defibrillators). Patients were evaluated through CIEDs interrogation and clinical evaluations and divided into NSVT positive (Group 1) and negative groups (Group 2). Mean follow-up period was 62,8±7,1 months. Results NSVT was detected in 51 (38,6%) patients. 70 (53,0%) had implantable cardiac resynchronization therapy (CRT) defibrillator (CRT-D), 37 (28,0%) transvenous implantable cardioverter defibrillator (ICD), 13 (9,8%) CRT pacemaker (CRT-P) and 12 (9,1%) subcutaneous ICD (S-ICD). Medium left ventricular ejection fraction (LVEF) was 31,1±7,9%, 20,6% were in NYHA III-IV and 47,0% were ischemic (49% Group 1 and 45,7% Group 2, p=0,708). Dyslipidemia was more prevalent in Group 2 (p=0,042). In total 11 (8,3%) patients died, 2 (1,5%) from sudden cardiac death and 5 (3,8%) from cardiovascular death. NSVT was associated with CIEDs treatments (hazard ratio [HR]2,52; 95% confidence interval [CI]1,2–5,1; p=0,001), ventricular fibrillation (VF) (HR: 3,71, 95% CI: 1,19–11,58; p=0,018), sustained ventricular tachycardia (VT) (HR: 9,06, 95% CI: 2,82–29,12; p&amp;lt;0,05) and composite outcome of VT, VF, HF re-admissions and related admissions to emergency department (ED) and death by all causes (HR: 2,52; 95% CI: 1,20–5,10; p=0,011). NSVT at 1 year was associated with HF readmissions at 1 year (p=0,004). Conclusions On extended monitoring possible with CIEDs, NSVT in HF patients was associated with a worse prognosis and may serve as a predictor of significant arrhythmic events, HF hospitalizations and mortality. These findings enhances the importance of remote monitoring and optimization of therapeutic modalities in these patients along with a close supervision. Funding Acknowledgement Type of funding sources: None.

Non-sustained ventricular tachycardia on remote patient monitoring in heart failure patients

Abstract Background Non-sustained ventricular tachycardia (NSVT) is commonly found in patients with structural heart disease and was historically obtained from registers of external ambulatory monitoring. The advent of remote patient monitoring (RPM) in Cardiac implantable electronic devices (CIEDs) has made it possible to detect asymptomatic NSVT in Heart Failure (HF) patients more frequently, but its impact in real world is uncertain. Purpose To determine the clinical impact of NSVT detection in RPM in ischemic and non-ischemic chronic heart failure patients with reduced ejection fraction (HFrEF) and CIEDs. Methods We retrospectively enrolled 121 consecutive patients with HFrEF, CIEDs and RPM. Patients were evaluated through routine episodic CIEDs interrogation, routine clinical evaluations and continuous monitoring data obtained from CIEDs and transmitted remotely to the care team and divided into NSVT positive (Group 1) and negative groups (Group 2). Primary endpoint was admissions to the emergency department by HF decompensation and secondary endpoint was the occurrence of arrhythmic events. A sub-analysis of non-ischemic HF was also performed. Results NSVT was detected in 78 (72,2%) patients. The mean number of episodes of NSVT was 611,68±3271,25 during the follow-up period or 2,445±16,688 in 24 hours. Mean age was 62,40±13,218 years, 71,9% were males and mean follow-up period was 56,30±39,37 months. Fifty-eight patients (47,9%) had transvenous implantable cardioverter defibrillator (ICD), 48 (39,7%) implantable cardiac resynchronization therapy (CRT) defibrillator (CRT-D), 14 (11,6%) subcutaneous ICD (S-ICD) and 1 (0,8%) CRT pacemaker (CRT-P). Medium left ventricular ejection fraction (LVEF) was 34,70±12,53%, 25 (23,14%) were in NYHA III-IV and 46 (39,0%) were ischemic (29 (37,7%) in Group 1 and 11 (37,9%) in Group 2). NSVT was associated with the occurrence of sustained ventricular tachycardia (VT) (1,88±0,186episodes of VT in group 1 and 0,03±0,186 in group 2, p=0,012), ventricular fibrillation (VF) (1,44±5,325 episodes of VT in group 1 and 0,03±0,186 in group 2, p=0,011) and admissions to the emergency department by HF decompensation at 5 years (r=0,310, p=0,011). A sub-analysis in non-ischemic HF patients also showed correlation between NSVT and VT (r=0,602, p&amp;lt;0,05) and admissions to the emergency department by HF decompensation at 5 years (r=0,382, p=0,014). Conclusions On remote patient monitoring with CIEDs, NSVT in HF patients was associated with arrhythmic events and may serve as a predictor for HF decompensations. Funding Acknowledgement Type of funding sources: None.