Cardiac Resynchronization Therapy Defibrillator Research Articles

Abstract 4135142: Sex-Based Differences in In-Hospital Complications Among Older Patients With Prior Myocardial Infarction Undergoing Cardiac Resynchronization Therapy-Defibrillator Implantation; An Analysis of 13695 Procedures in the United States

Introduction: Cardiac Resynchronization Therapy-Defibrillator (CRT-D) use has increased over the past two decades. As this procedure often also involves patients with a prior history of myocardial infarction(MI), we aim to evaluate potential sex-based disparities in short-term complications among the elderly. Methods: Our sample consisted of patients ages >60 years with a prior history of myocardial infarction undergoing CRT-D. The data was extracted via the 2016-2021 National Inpatient Sample(NIS). Adjusted odds ratios(aOR) of in-hospital complications between Females and Males were estimated using multivariable regression analyses, taking into account potential confounders. Results: Out of 13695 CRT-D procedures among older patients (ages >60 years), 2880(21.0%) were Females, with 10815(79.0%) Males. The median age of all patients was 74.0 years(mean of 73.99 years). Females were at higher odds of experiencing cardiogenic shock (aOR 1.231, 95% CI 1.013-1.495, p=0.036), cardiac arrest(aOR 1.413, 95% CI 1.150-1.737, p=0.001), pericardial effusion(aOR 2.334, 95% CI 1.704-3.198,p=0.000), and pneumothorax(aOR 2.107, 95%CI 1.089-4.075, p=0.027) than Males. No differences were reported in events of acute kidney injury (AKI)(aOR 0.923,95%CI 0.832-1.024, p=0.132), acute ischemic stroke (AIS)(aOR 1.166, 95%CI 0.585-2.324,p=0.662), pleural effusion(aOR 0.827,95%CI 0.618-1.107, p=0.203), and sepsis(aOR 0.743,95%CI 0.506-1.092,p=0.130) between the two sexes. Furthermore, we found sex-based disparities in mortality as 1.6% of Females (vs. 1.0% of Males, aOR 1.729, 95% CI 1.161-2.576, p<0.01) did not survive their hospitalization. Finally, our analysis noted that Males and Females did not have any differences in mean lengths of stay(LOS)(Males: 6.06 days vs. Females: 6.26 days, p=0.056). Conclusion: Our results confirm that among the elderly with a prior history of MI, Females are prone to a poor prognosis with multiple complications during CRT-D implantations, including pericardial effusion, cardiac arrest, cardiogenic shock, and all-cause mortality. It is vital to advocate for additional studies to understand the various factors predisposing females to these complications and bring forward adequate measures to prevent them.

Abstract 4135273: Frailty increases the risk of in-hospital mortality and post-procedural complications in patients undergoing Cardiac Implantable Electronic Devices placement

Background: Heart failure with reduced ejection fraction (HFrEF) often necessitates the use of cardiac implantable electronic devices (CIED) such as cardiac resynchronization therapy defibrillators (CRT-D) or implantable cardioverter-defibrillators (ICD). These devices are proven to reduce mortality, prevent hospitalizations, and improve symptoms and quality of life. Frailty, characterized by an age-associated decline in physiological reserve, significantly impacts outcomes in these patients. This study uses the Hospital Frailty Risk Score (HFRS) to assess the effect of frailty on mortality and post-procedural complications in HFrEF patients undergoing CIED implantation. Hypothesis: Frail patients with HFrEF have worse in-hospital outcomes after CIED placement Methods: We conducted a retrospective cohort study using the 2020 National Inpatient Sample database from the Healthcare Utilization Project. Our population included patients aged 18 years or older with HFrEF who underwent CRT-D or ICD placement, identified using ICD-10 procedure codes. The primary risk factor was frailty, classified by an HFRS score of ≥5 (frail) or <5 (not frail). The primary outcome was in-hospital mortality, and the secondary outcome was the composite of post-procedural complications. Multivariate regression analysis was used to estimate the odds ratio. Results: Out of 24,809 patients who underwent ICD or CRT-D placement, 48.8% were frail. Non-Frail patients had lower mean age compared to Frail patients (66.2 vs 67.3 years old, p=0.003). In-hospital mortality was 1.1%, and 7% experienced post-procedural complications. In-hospital mortality was higher in frail patients compared to non-frail patients (2% vs 0.3%, p<0.001). In the multivariate analysis, frail patients had higher odds of in-hospital mortality compared to the non-frail group subset (OR=5.97; 95% CI: 2.77-12.88, p<0.001). Additionally, frailty was associated with higher odds of post-procedural complications (OR=1.28; 95% CI: 1.01-1.63, p<0.001), increased length of stay (5 vs 11.6 days, p<0.001), and total hospital charges (215,668 vs 324,474 , p<0.001). Conclusion: Frailty significantly increases the risk of in-hospital mortality and post-procedural complications in HFrEF patients. This highlights the importance of considering frailty as part of a pre-procedural risk stratification assessment and tailoring management strategies to improve outcomes for these high-risk patients.

Abstract 4123956: Upgrade to Implantable Cardioverter-Defibrillator in Patients Diagnosed with Cardiac Sarcoidosis after Permanent Pacemaker Implantation for High-Grade Atrioventricular Block

Introduction: Unexplained high-grade AV block (AVB) in patients age <65 years is among the salient features of cardiac sarcoidosis (CS). Guidelines recommend that CS patients with high-grade AVB should receive an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D) rather than a permanent pacemaker (PPM). However, in clinical practice, CS may be recognized after PPM implantation for high-grade AVB. Aims: To evaluate the characteristics and outcomes of patients diagnosed with CS after PPM implantation for high-grade AVB and assess the decision-making and rationale for upgrade to ICD/CRT-D. Methods: Retrospective review of the Mayo Clinic Sarcoid Registry (n=848) was performed to identify all patients for which a PPM was implanted for high-grade AVB prior to the diagnosis of CS. Baseline clinical and imaging characteristics were collected during index evaluation at our institution. Decision-making for ICD upgrade, lead management strategy, immunosuppression initiation, and outcomes were assessed. Results: Overall, 29 of 848 (3.4%) of CS patients (62% probable/definite CS; 77% male; median (IQR) age 56 (48-61) years; and median (IQR) LVEF 58% (50-62) received a PPM for high-grade AVB prior to a CS diagnosis. Median (IQR) interval between PPM implant and index evaluation was 10 (3-23) months. Eight of 29 patients underwent upgrade to ICD (n=4) or CRT-D (n=4). Among them, the pacing lead was extracted in 4. All patients were upgraded for primary prevention of sudden cardiac death (SCD), with 3 of them also having LVEF<50% requiring upgrade to CRT-D. Twenty-two (79%) patients in the total cohort were treated with immunosuppression. During median (IQR) follow-up 37 months (11-74), 1 patient in the upgrade group had sustained VT appropriately treated with anti-tachycardia pacing. No events were documented among patients in the non-upgrade group. At last follow-up, 6 (75%) patients in the upgrade group and 12 (57%) in the non-upgrade group were pacemaker dependent. Median LVEF change was 0% in patients who underwent upgrade to CRT-D and –0.2% in those who underwent upgrade to ICD or no upgrade. Conclusions: In this cohort of patients diagnosed with CS several months after a PPM had been implanted for high-grade AVB, incident VT/VF was infrequent with contemporary CS management. In the absence of other SCD risk factors, CS patients who received a PPM for high-grade AVB prior to their CS diagnosis may not require ICD upgrade.

Abstract 4136884: Incidence and Characteristics of Peri-Procedural Complications of Cardiac Implantable Electrical Devices in Breast Cancer Survivors

Introduction: Breast cancer (BC) is the most common non-cutaneous cancer in women. Several BC treatments increase the risk of conduction abnormalities and heart failure, potentially requiring cardiac implantable electrical devices (CIEDs). Due to vascular access devices, surgical management, and chest wall radiation, these patients are subject to upper extremity vascular alterations. There is limited data regarding CIED use in this population. Research question: Do patients with BC and CIEDs have different procedural approaches or complications compared to the general population? Aims: This study aimed to evaluate CIED placement and periprocedural complications in patients with a history of BC. Methods: This was a retrospective study of CIEDs placed at our institution between 2005 and 2023. Patients with a diagnosis of BC prior to time of placement were included. Complications included those within 30 days of the procedure. Results: We analyzed 109 female patients (median age of 73 years, IQR 66-80) who received pacemaker (PPM, 58.7%), cardiac resynchronization therapy defibrillator (CRT-D, 22%), implantable cardioverter defibrillator (ICD, 16.5%), or cardiac resynchronization therapy pacemaker (CRT-P, 2.8%). The median time from cancer diagnosis to device placement was 13 years (IQR 7-21). Oncologic therapies are included in Figure 1. In patients with unilateral cancer, most devices (78.4%) were placed contralaterally, with 32% of all devices being right sided. Anatomy related to chemotherapy port altered intraoperative approach in 2 cases and bilateral lymph node dissection necessitated subcutaneous ICD in 1 case. Complications were noted in 12 patients (11%) and included hematoma, lead revision, upper extremity DVT, pericardial effusion, stress cardiomyopathy, perforation, site infection, and worsening of chronic lymphedema. Conclusions: BC survivors undergoing CIED placement appear to be at higher risk of periprocedural complications when compared to the general population. They are more likely to undergo right sided device placement to avoid vascular access ipsilateral to prior surgery or radiation. Further studies are required to understand the long-term outcomes of CIED placement in this cohort of patients.

Long-term clinical outcomes of remote monitoring for implantable cardioverter-defibrillators in Singapore.

Remote monitoring (RM) for cardiac implantable electronic devices is on the rise and has been shown to reduce the burden of in-clinic follow-up visits. We aimed to investigate the long-term clinical outcomes of RM versus no RM. This was a prospective, single-centre cohort study of consecutive patients with an implantable cardioverter-defibrillator (ICD) or cardiac resynchronisation therapy-defibrillator (CRT-D) followed up from 2018 to 2023. Patients who received non-ICD devices were excluded. In general, RM was offered to all patients, but uptake depended on patient preference. For data analysis, patients were stratified according to whether RM was used. The primary outcome was all-cause mortality; secondary outcomes were hospitalisation for heart failure and device therapy (shocks and electrical storm). Of 551 patients, 284 (51.5%) received RM and 267 (49.5%) did not. Baseline demographics were similar between the two arms. All-cause mortality was significantly lower in RM versus non-RM patients (hazard ratio [HR] 0.45, 95% confidence interval [CI] 0.33-0.60, P <0.001), as was hospitalisation for heart failure (HR 0.39, 95% CI 0.25-0.59, P <0.001); these remained significant after adjustment for baseline covariates. More patients on RM received appropriate antitachycardia pacing (ATP) (17.6% vs. 10.7%, P = 0.035) and appropriate shocks (24.1% vs. 14.7%, P = 0.017). The incidences of inappropriate ATP, inappropriate shocks and electrical storm were similar. More patients on RM underwent pulse generator change (34.1% vs. 10.1%, P <0.001). Remote monitoring was associated with significantly lower mortality in both ICDs and CRT-Ds and in primary and secondary indications, as well as fewer heart failure hospitalisations. This supports current guidelines recommending the use of RM in all patients with ICD or CRT-D.

Similar incidence of ICD-shocks in diabetic compared to non-diabetic patients receiving implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D)

Abstract Background and aims Recent studies have suggested that diabetes patients with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D) may experience a reduced incidence of appropriate ICD-shocks and an increased mortality rate. This study aims to assess whether there is parity in ATP-treatment and ICD-shocks between patients with and without type 2 diabetes mellitus (T2DM), and to analyze associated mortality rates. Methods Using the Danish pacemaker and ICD registry we included patients who received a first-time ICD or CRT-D implantation with a primary or secondary prophylactic indication, between January 1st 2000 to December 31st 2018. Outcomes were analyzed individually for each outcome. Cause specific Cox was used for i) appropriate ATP therapy or ICD-shock, ii) inappropriate ATP therapy or ICD-shock, and a standard Cox regression model was used for iii) all-cause mortality, iv) mortality rate following an ATP-therapy or ICD-shock. Cumulative incidence curves, generated using the Aalen Johansen estimator, were utilized to compare the incidence rates for ATP therapy and ICD-shock while accounting for competing risk of death, while Kaplan-Meier methodology was utilized for survival curves. Analyses were conducted in the total population and in subgroups divided on indication and device type. Results Out of 14 747 patients who received an ICD or CRT-D, 4377 (30%) had T2DM, 4593 (31%) patients received first-time appropriate ATP therapy or ICD-shock, and 1244 (8,4%) experienced first-time inappropriate treatments, 5 112 (35%) experienced death during the follow-up time (mean 3.9 years (SD 2.7)). T2DM patients were more likely to be male (85% vs 80%), slightly older (66 vs 65 years) and burdened with more comorbidities. No significant differences were seen between T2DM and non-T2DM patients for appropriate ATP therapy (HR 0.96[0.88:1.04] p=0.31), appropriate ICD-shock (HR 0.95[0.86:1.05] p=0.32), inappropriate ATP therapy (HR 0.92 [0.77;1.09] p=0.32) and inappropriate ICD-shock (HR 0.96 [0.78;1.18] p=0.71). In the subgroup analyses, no difference was seen in the primary prophylactic subgroups (Figure 1.), only significant difference was observed in the secondary prophylactic ICD group who received less ATP-therapy at 5-year follow-up (HR0.83[0.70;0.99] p=0.04), and in the secondary prophylactic CRT-D group, were T2DM patients seemed to experience more appropriate ICD-shock treatments (HR 2.07[1.23;3.48] p=0.006). Further, we found a higher mortality rate in T2DM with primary prophylactic ICD (HR 1.46[1.31;1.62] p&amp;lt;0.001) and secondary prophylactic ICD (HR 1.30[1.13;1.51] p&amp;lt;0.001), (Figure 2.) this mortality rate remained largely unchanged post appropriate ATP or ICD-shock in the ICD subgroups. Conclusions Despite similar incidence of ATP-therapy and ICD-shocks, T2DM patients with ICD-device experienced a significantly higher post-treatment mortality and all-cause mortality rate.

LBBAP versus conventional CRT reimplantation after transvenous lead extraction: report from a monocentric experience

Abstract Background Cardiac resynchronization therapy – defibrillator (CRT-D) reimplantation after transvenous lead extraction (TLE) can be challenging due to fibrotic remnants and absence of target veins. Left bundle branch area pacing (LBBAP) is emerging as an alternative to conventional CRT, but data is lacking about its feasibility after TLE. Purpose To explore the feasibility and safety of LBBAP as alternative to conventional CRT though epicardial pacing (EP) in patients undergoing CRT-D TLE. Methods We prospectively enrolled all patients admitted for complete CRT-D extraction and replacement from July 2022 to September 2023. At the moment of reimplantation, the choice between EP and LBBAP was made on the basis of posterolateral CS branches viability at post-extraction CS venography. Procedural success was defined as effective stimulation and absence of major complications while the primary endpoints were procedural time, QRS complex duration and electrical lead parameters. Patients undergoing LBBAP and EP reimplantation were compared. Results Twenty-six patients were enrolled (mean age 68.3 ± 7.2 years, p = 0.538; 12% females, p = 0.859). The most frequent cause of device extraction was pocket infection (58%, p = 0.773). Seventeen (65%, p = 0.783) patients had estimated high risk of procedural severe complications measured by EROS score. Overall, 80 leads were extracted. Mechanical extractors and snares were deemed necessary in 35 cases (43%, p = 0.917) and in 2 cases, respectively. Almost all patients (n=25, 96%) underwent right-sided reimplantation. Procedural success was achieved in 24 cases (92%). Compared to standard CRT through EP, LBBAP reimplantation accounted for a faster procedure (109.5 ± 34.2 vs. 126.5 ± 46.8 min; p = &amp;lt;0.001), less radiologic exposure (877.0 ± 234.6 vs. 1332.0 ± 515.1 sec, p &amp;lt;0.001) and better ventricular pacing thresholds (0.7± 0.1 vs. 1.8± 0.6 V, p &amp;lt;0.001). Despite a similar pre-extraction paced QRS duration (127.4 ± 13.8 vs. 133.0 ± 14.4 msec; p = 0.610), LBBAP reported significant improvement in final QRS duration (105.0 ± 13.1 vs. 127.1 ± 10.4 msec, p &amp;lt; 0.001) with major reduction in QRS duration (- 10.9 ± 7.5 vs - 6.8 ± 10.1, p &amp;lt; 0.001). Conclusion After a CRT TLE procedure, LBBAP reimplantation accounted for lower procedure duration, lower radiologic exposure, narrower QRS and lower ventricular pacing thresholds, demonstrating to be a valuable alternative to EP.

Prognostic yield of echocardiographic measures of cardiac structure and function in HFrEF patients with vs without an ICD or CRT-D

Abstract Background Selected echocardiographic measures of cardiac structure and function are known to be associated with mortality in patients with Heart Failure with reduced Left Ventricular (LV) Ejection Fraction (HFrEF). Whether the predictive ability of measures of cardiac structure and function remain after implantation of an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D) is unknown among patients with HFrEF. Purpose To compare the predictive ability of echocardiographic measures of cardiac structure and function in HFrEF patients with or without an ICD/CRT-D. Methods Echocardiographic examinations were performed between 2003 and 2013 and retrieved from 2168 patients with HFrEF. Patients that had an ICD or CRT-D implanted during follow-up were identified through registries. The endpoint was all-cause mortality and follow-up was 100% to date. Images were analyzed offline in accordance with current guidelines. Associations were assessed by Cox multivariable regression and Cox univariable interaction models. Results After a median of 169 days, 677 patients had an ICD or CRT-D implanted. In total, 68% vs 80% of patients with and without an ICD, respectively, were men (p&amp;lt;0.001) and the median age were 70 vs 71 years (p=0.192). There was a significant difference in resting heart rate (median 74 vs 69, p&amp;lt;0.001) and frequency of ischemic heart disease (64% vs 81%, p&amp;lt;0.001) between the groups. Patients with an ICD had a higher mortality rate (69 per 1000 people/year vs 92 per 1000 people/year, p&amp;lt;0.001) and died significantly faster (median 9.3 vs 8.2 years, p&amp;lt;0.001). Patients with an ICD had higher Left Atrial (LA) End Systolic Volume (59.2 vs 67.3, p&amp;lt;0.001), LA Volume Index (28.5 vs 33.9, p&amp;lt;0.001), LV End Diastolic Volume (137.7 vs 153.7, p&amp;lt;0.001), and LV Mass Index (114.5 vs 124.5, p&amp;lt;0.001), as well as lower LA strain (9.8 vs 6.3, p&amp;lt;0.001) and TAPSE (2.0 vs 1.7, p&amp;lt;0.001). In patients without an ICD, Right Ventricular strain was associated with mortality (HR = 1.05 per 1% decrease mm/m2 [1.005, 1.11] when adjusting for covariates whereas in patients with an ICD, LA Volume Index (HR 1.14 per 1 increase [1.03, 1.25], and LV Ejection Fraction (HR 0.96 per 1% increase [0.92, 0.99]) were associated with mortality when adjusting for covariates. ICD/CRT-D implantation significantly modified the prognostic yield of LV End Diastolic Volume (HR per 1 ml increase: 0.99 without vs 1.01 with an ICD/CRT-D, p=0.005) and LV Mass Index (HR per 1 g/m2 increase: 1.00 without and 1.01 with an ICD/CRT-D, p=0.031). Conclusion Different echocardiographic measures were stronger prognosticators in HFrEF patients with and without an ICD or CRT-D, respectively, and ICD implantation modified the prognostic yield of LV End Diastolic Volume and LV Mass Index in HFrEF patients.Table 1Forest plot

Cost impact of the use of a universal cardiac implantable electronic devices remote monitoring solution: results of the Evidence RM study

Abstract Background Remote monitoring (RM) is considered the standard of care for patients with cardiac implantable electronic devices (CIED). In 2023 the HRS/EHRA/APHPRS/LAHRS expert consensus highlighted the potential interest of alert-based monitoring and the use of a third-party platform for RM management. By lightening the RM workload for clinical staff, valuable time and resources can be redirected towards patient care. Purpose This study aims to assess the impact on healthcare expenditures of the adoption of a Universal, vendor-neutral, and alert-focused remote monitoring (RM) platform for CIED in France, as opposed to the Conventional RM conducted via device specific manufacturers' platforms. Methods This study utilizes the French National Health Database (SNDS) to evaluate the effectiveness of RM solutions among patients with implantable cardioverter defibrillators (ICD), including cardiac resynchronization therapy defibrillators (CRT-D). All patients under RM were categorized based on the type of monitoring, either the Universal RM or the Conventional RM. The analysis was conducted on year 2019 and included only patients maintaining consistent RM solutions and device types throughout the entirety of the study period. To mitigate potential biases, costs were adjusted according to age, gender, device type, year of first implantation, year of RM initiation, medical center experience with RM, and Elixhauser score for comorbidities. Results Study cohort consisted of 36,401 patients (age 67.3 ± 13.0 years / male 78.4% / CRT-D 40.1%), 1,482 patients followed using the Universal RM platform and 34,419 patients monitored with the Conventional RM solutions. The study findings revealed a 4% decrease in corrected total costs and a notable 17.8% reduction in hospital costs among patients utilizing the Universal RM. Analysis further identified that this decrease in hospital expenses was primarily influenced by a reduction of the costs associated with cardiovascular diseases. Conversely, the group utilizing the Universal RM experienced a 7.9% increase in total outpatient costs compared to Conventional RM, while ambulatory visit costs remained unchanged. As costs incurred by patients were not included, total costs may however be underestimated. Patients under the Universal RM solution may benefit of more proactive preventive measures delivered through outpatient care. By addressing issues preemptively, critical conditions may be averted, enhancing overall patient management, and diminishing hospital costs. The adoption of a third-party Universal platform may thus yield to cost savings, exemplified by a negative Incremental Cost-Effectiveness Ratio (ICER) of -103€ per Day Alive and Out of Hospital (DAOH) as observed in this study. Conclusions The use of a third-party Universal RM platform showed a positive impact in terms of costs reduction for the French healthcare system on this ICD population.

Prediction of CRT response using a novel CRT responder score in an Asian patient population

Abstract Introduction Cardiac Resynchronization Therapy (CRT) guidelines, derived from trials among U.S. and European patients, assign weaker recommendations to those with midrange QRS duration (&amp;lt;150ms). Patient height and body size may modulate CRT efficacy. Moreover, these factors may affect CRT utilization and efficacy in Asia. Aim The purpose of this analysis was to determine the prediction scoring system model for CRT responders in a Japanese patient population. Methods We analyzed the database of the Multicenter Prospective Pilot Study to Test LV Intracardiac Conduction Time as a Predictor of CRT Response (BIO|SELECT) which was a single-arm study conducted at 28 hospitals in Japan. This study enrolled patients eligible for a de-novo CRT-defibrillator (CRT-D) based on current guideline indications, who had no recent or planned cardiac surgery and were planned to receive a Sentus ProMRI OTW quadripolar LV lead and a BIOTRONIK CRT-D with multipole pacing feature. Patients were followed for 7 months after implantation. Four accepted parameters to define CRT response [LVESV (cut-off -15%), LVEF (+5%), BNP (-25%), and NYHA class (one class improvement)] were combined into a composite benefit index (CBI) by forming the normalized sum, with CBI = 4.0 meaning response. The CBI was found to be more robust than the individual 4 parameters due to the reduced influence of noise and measurement errors in single parameters. Several factors were studied to create the scoring tool. The CRT responder score was the sum of these individual scores (range 0-100). To construct a predictive scoring system, logistic regression analysis was performed with a backward selection procedure. In addition, the Akaike information criterion (AIC) was applied to determine the best model among those tested. The score was then assigned employing the β coefficient of each variable divided by the reference value. The model's calibration was assessed using the Hosmer-Lemeshow goodness-of-fit test. Results A total of 196 patients were enrolled in this study (mean age 69 years, mean LVEF 30%, left bundle-branch block [LBBB] 58%). The Ooccurrence of CRT response during the 7-month follow-up was 54%. Future CRT responders were significantly predicted by low age (&amp;lt; 70 years)(18 points), female (19 points), prior heart failure hospitalization (16 points), body mass index (&amp;lt;20) (17 points), QRS/height (&amp;lt;0.858)(30 points). This score predicted CRT response well (area under curve 0.72; 95% CI 0.643-0.798). When the cut-off of 63 points or more was applied the sensitivity was 0.56, the specificity was 0.72, and the negative predictive value was 0.58. Conclusions The CRT responder score is a novel approach for the prediction of CRT response, but should be validated and further improved to increase its predictive value. This approach highlights the role of preventing the development of severe heart failure and could help to identify individuals who might benefit from CRT.

All-cause mortality and incidence of appropriate therapy from a primary preventive implantable cardioverter defibrillator in patients with non-ischemic dilated cardiomyopathy

Abstract Background The DANISH study published in 2016 indicated limited benefit of primary prevention implantable cardioverter-defibrillator (ICD) in patients with non-ischemic dilated cardiomyopathy (niDCM). We aimed to investigate the long-term outcome and incidence of ICD therapy in patients with niDCM implanted on primary prevention indication during 2014-2022. Methods A total of 116 patients with niDCM were prospectively included for primary prevention ICD implantation between 2014 and 2022 in the multicenter IMPROVE study (clinical trials NCT02286908). All patients were examined with electrocardiogram, echocardiography and blood sampling at inclusion. The primary outcome was all-cause mortality, and the secondary outcome was appropriate ICD therapy. Outcomes were compared in patients included from 2014 to end of 2016 (DCM2014-16, n=49) and from 2017-2022 (DCM2017-22, n=67). Results At inclusion, patients in DCM2017-22 were younger (54 years [interquartile range (IQR) 44-68] vs. 64 years [IQR 55-70], p=0.001), had higher left ventricular ejection fraction (LVEF) (33% [IQR 25-38] vs. 24% [IQR 21-31], p&amp;lt;0.001) and less frequently received cardiac-resynchronization therapy defibrillator (6% vs. 29%, p=0.001) compared to DCM2014-16. Over a median 4.4-year follow-up, the all-cause mortality was 14%, of which 10% occurred in the DCM2017-22 patients (2.6 events/100 person-years), and 18% in the DCM2014-16 patients (4.0 events/100 person-years), p=0.38. There was no difference in appropriate ICD therapy between the two groups (p=0.90). Conclusion Patients receiving primary prevention ICD for niDCM after publication of the DANISH study were younger with higher LVEF, indicating a change in clinical practice after the publication. Despite this, there was no significant reduction in all-cause mortality or difference in appropriate ICD therapies. Unchanged mortality and event-rates may indicate the correct identification of high-risk patients.

Smartphone App-Based Remote Monitoring Challenges in Patients with Cardiac Resynchronization Therapy Defibrillators-A Multicenter Study.

Background/Objectives: Remote monitoring (RM) cardiac implantable electronic devices for adults delivers improved patient outcomes. However, previously used bedside transmitters are not optimal due to deficient patient adherence. The goal of this study was to evaluate the efficacy of RM regarding the connectivity of smartphone app-based solutions, adherence to scheduled automatic follow-ups, and prevalence of alert-based events. Methods: We evaluated the adult heart failure (HF) population with an implanted cardiac resynchronization therapy defibrillator (CRT-D) divided into two arms: with app-based RM (abRM) and without app-based RM (control). Results: A total of 81 patients (median age of 69.0) were included in our study. Sixty-five patients received a CRT-D with abRM functionality, and sixteen did not. Twelve patients had no smartphone, and two provided no consent, resulting in their transfer to the control group. Finally, the abRM arm consisted of 51 patients, while 30 patients were in the control group. The median period of follow-up lasted 12 months. Among abRM patients, 98.0% successfully transmitted their first scheduled follow-up, and 80.4% were continuously monitored. Alert-based events were mainly related to arrhythmic events and device functionality with significantly shorter median times to notification (1 day vs. 101 days; p < 0.0001) in the abRM group. Conclusions: Our study showed a high level of compliance with timely initial transmission and adherence to scheduled remote follow-ups. Patient enrollment eligibility was a major challenge due to the limited accessibility of smartphones in the population. App-based RM demonstrated an accurate notification of events and patient-initiated transmissions in emergencies, regardless of location.

Right ventricular systolic pressure predicts outcomes in patients with cardiac resynchronization therapy-defibrillators.

Right ventricular systolic pressure predicts outcomes in patients with cardiac resynchronization therapy-defibrillators.

7576 A Rare and Atypical Presentation of Bladder Paraganglioma in a Patient on Long-Term Left Ventricular Assist Device

Abstract Disclosure: S.D. Leungsuwan: None. S.J. Lee: None. S.D. Lim: None. L. Loh: None. Background: Paragangliomas (PGLs) are rare neuroendocrine tumors arising from chromaffin cells. Capable of producing catecholamines, functional PGLs often cause a myriad of autonomic symptoms and complications, including cardiomyopathy. We report a case of bladder PGL in a patient on Left Ventricular Assist Device (LVAD). Clinical Case: A 64-year-old Chinese Female with a history of non-ischaemic cardiomyopathy on long-term continuous LVAD and Cardiac Resynchronisation Therapy Defibrillator (CRT-D) was admitted for recurrent low LVAD flow &amp;lt;2 Litres per minute and labile mean arterial pressure (MAP) 57-151mmHg. She has been on long-term Nebivolol, Entresto, Hydralazine, and Sildenafil without recent dose adjustment. Workup for acute illnesses was non-contributory. 24-hour urine metanephrine and normetanephrine (NM) were 939nmol/d [normal 400-1500nmol/d] and 33883nmol/d [normal 600-1900nmol/d] respectively. Plasma free metanephrine and NM were 0.37nmol/L [normal &amp;lt;0.33nmol/L] and &amp;gt;10.00nmol/L [normal &amp;lt;0.99nmol/L] accordingly. A review of previous ultrasonography and Computed Tomography (CT) imaging revealed a right adnexal mass indenting the bladder which the patient formerly declined further assessment; adrenal glands were normal. FDG-PET CT was done and showed an isolated focus of increased tracer uptake corresponding with the right pelvic mass. An impression of likely bladder PGL was made. A multidisciplinary team including Cardiology, Anaesthesiology, Interventional Radiology (IR), Urology, Gynaecology, and Endocrinology was convened; the patient was recommended surgical resection of the tumor. Preoperatively, she was started on phenoxybenzamine 10mg BD and advised judicious fluid and salt intake. Nebivolol was continued while hydralazine was stopped. This achieved targets of i) MAP 70-80mmHg, ii) approximately 10mmHg MAP postural fluctuation, iii) sitting and standing heart rates 60-70 beats-per-minute (BPM) and 70-80BPM, and iv) no more than 1 PVC every 5 minutes. Two weeks later, she underwent IR-guided angioembolisation and tumor resection uneventfully. Intraoperatively, the patient had haemodynamic fluctuations requiring dynamic administrations of phentolamine, norepinephrine, epinephrine, vasopressin, glyceryl trinitrate, and sodium nitroprusside. Histopathology was consistent with PGL with intact SDH-A and SDH-B expression. Postoperatively, phenoxybenzamine was discontinued and no recurrent LVAD low flow was noted. Subsequent plans for repeat plasma metanephrines and genetic studies were made. Discussion: This case is the first to report an atypical presentation of PGL with LVAD low flow and labile blood pressure. The significant elevations of urine NM (17.8x upper normal limit) and plasma NM (&amp;gt;10.1x upper normal limit) also underline the concept of fold-elevations and post-test probability of PGL. Presentation: 6/3/2024

Predictors of death without prior appropriate therapy in ICD recipients: the comorbidities, frailty and functional status (COMFFORT study)

ObjectiveMost patients who have an implantable cardioverter-defibrillator (ICD) implant do not receive life-prolonging therapy from it. Little research has been undertaken to determine which patients benefit the least from ICD...

Feasibility of a Cardiac Magnetic Resonance Protocol for "off-on" Cardiac Resynchronization Therapy Evaluation.

Cardiac resynchronization therapy (CRT) is a standard treatment for patients with heart failure and electrical dyssynchrony. Cardiac magnetic resonance (CMR) is the gold standard for assessing left ventricular (LV) function. However, the feasibility of using CMR with active CRT is still uncertain. To assess the feasibility of a CRT "off-on" protocol during CMR and measure the acute effects of CRT interruption on LV function. Patients underwent CMR before (pre-CRT) and 6 months after (post-CRT) an MR-conditional CRT defibrillator implantation. The post-CRT scan included two complete sets of cine images, one with inactive (post-CRTOFF) and one with active CRT (post-CRTON), maintaining a continuous connection between device and programmer. Out of 29 enrolled patients, 8 (28%) had complete and analyzable post-CRT data. Unsuccessful procedures were attributed to connection problems between the CRT device and the programmer (n = 10), poor image quality (n = 7), and lack of patient cooperation (n = 4). LV ejection fraction significantly increased between pre-CRT scan (28.1%) and both post-CRTOFF (37.9%; p = 0.046) and post-CRTON CMR (35.0%; p = 0.037), with a nonstatistically significant trend toward decreased LV volumes. No adverse events or significant changes in device electrical parameters (including battery level) were detected during the post-CMR scan period. A CRT "off-on" protocol during CMR studies can be safely executed in patients with an MR-conditional CRT defibrillator. However, technical improvements are needed to facilitate high-quality scans during active CRT. Favorable changes in LV function induced by CRT remodeling were not acutely reversed with the interruption of electrical therapy.

Cost savings associated with extended battery longevity in cardiac resynchronization therapy defibrillators (CRT-D)

BackgroundCardiac resynchronization therapy-defibrillators (CRT-D) are devices established as treatment for symptomatic heart failure patients at risk of sudden cardiac death. Battery depletion poses a significant clinical and economic burden; extended service life may reduce costs due to generator changes and associated complications. ObjectiveThis study estimated cost-savings associated with extended battery longevity in Medicare patients receiving CRT-D implantation. MethodsA decision tree was used to explore three battery capacities: 1.0 ampere-hours (Ah), 1.6Ah, and 2.1Ah. Yearly risk of all-cause mortality, device-related complications, and end of battery life were estimated. Over 6 years, estimated costs included device implantation, replacement, follow-up appointments, and complications. ResultsThe average total costs to Medicare over 6 years were $41,527, $48,515, and $56,647 per person (USD 2023) for the 2.1Ah, 1.6Ah, and 1.0Ah, respectively. The total per-person replacement cost for the 1.0Ah devices was more than 4 times that of the 2.1Ah devices ($20,126 versus $5,006). When extrapolated to the total number of CRT-D implants over a 6-year period, the difference in costs between 2.1Ah1.0Ah battery capacity exceeded $500 million. ConclusionExtended longevity CRT-D batteries demonstrate significant cost savings to Medicare over 6 years. These data indicate long-term economic considerations should be included in device selection.

Spanish pacemaker registry. 21st official report of Heart Rhythm Association of the Spanish Society of Cardiology (2023)

IntroductionData on implants of cardiac pacing systems in Spain in 2023 are presented. MethodsThe registry is based on the information provided by centers to the recording platform of the Heart Rhythm Association after device implantations, through Cardiodispositivos, the online platform of the National Registry. Other information sources include: a) data transfers from the manufacturing and marketing industry; b) the European pacemaker patient card; and c) local databases submitted by the implanting centers. ResultsIn 2023, 112 hospitals participated in the registry (30 more than in 2022). A total of 24 343 device implantations were reported (48.1% more than in 2022) compared with 45 120 reported by Eucomed (European Confederation of Medical Suppliers Associations). Of these, 1646 were cardiac resynchronization therapy pacemakers. The devices showing the largest increases were leadless pacemakers, with 963 devices implanted, representing an 18.1% increase over 2022. The most frequent indication was atrioventricular block followed, for the first time, by atrial tachyarrhythmia with slow ventricular response. The number of devices included in remote monitoring also increased (cardiac resynchronization therapy defibrillators, 71%; cardiac resynchronization therapy pacemakers, 63%; and conventional pacemakers, 28%), although more moderately. ConclusionsIn 2023, there was an increase in the number of institutions participating in the registry. The reporting of device implantations rose by 48.1%, and the implantation of leadless pacemakers grew by 18.1%. Remote monitoring also experienced modest growth compared with previous years.

Characterization and natural history of patients with LMNA-related dilated cardiomyopathy in the phase 3 REALM-DCM trial.

LMNA-related dilated cardiomyopathy (DCM) is a rare disease with an incompletely defined phenotype. The phase 3 REALM-DCM trial evaluated a potential disease-modifying therapy for LMNA-related DCM but was terminated due to futility without safety concern. This study utilized pooled data from REALM-DCM to descriptively characterize the phenotype and progression of LMNA-related DCM in a contemporary cohort of patients using common heart failure (HF) measures. REALM-DCM enrolled patients with stable LMNA-related DCM, an implanted cardioverter defibrillator or cardiac resynchronization therapy defibrillator, and New York Heart Association (NYHA) Class II/III HF symptoms. Between 2018 and 2022, 77 patients took part in REALM-DCM. The median patient age was 53years (range: 23-72), and 57% were male. Overall, 88% of patients had a pathogenic or likely pathogenic LMNA variant, and 12% had a variant of uncertain significance with a concordant phenotype. Among patients with confirmed sequencing, 55% had a missense variant. Atrial fibrillation was present in 60% of patients; 79% of all patients had NYHA Class II and 21% had NYHA Class III HF symptoms at baseline. Median (range) left ventricular ejection fraction (LVEF), 6min walk test (6MWT) distance, Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score and N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration at baseline were 42% (23-62), 403m (173-481), 67 (18-97) and 866pg/mL (57-5248), respectively. LVEF, 6MWT distance and KCCQ-OS score were numerically lower in patients who had NYHA Class III versus II symptoms at baseline (LVEF: 38% vs. 43%; 6MWT distance: 326 vs. 413m; and KCCQ-OS score: 43 vs. 70), whereas NT-proBNP concentration was higher (1216 vs. 799pg/mL). Median follow-up was 73weeks (range: 0.4-218; 73 in NYHA Class II and 75 in NYHA Class III). Patients displayed variable change from baseline in 6MWT, KCCQ-OS and NT-proBNP values during follow-up. Overall, 25% of patients experienced ventricular tachycardia, and 8% had ventricular fibrillation. Ten (13%) patients met the composite endpoint of worsening HF (adjudicated HF-related hospitalization or urgent care visit) or all-cause death; six had NYHA Class II and four had NYHA Class III at baseline. All-cause mortality occurred in 6 (8%) patients; three had NYHA Class II and three had NYHA Class III symptoms at baseline. Findings confirm the significant morbidity and mortality associated with LMNA-related DCM despite the standard of care management. Typical measures of HF, including 6MWT distance, KCCQ-OS score and NT-proBNP concentration, were variable but correlated with NYHA class. An unmet treatment need remains among patients with LMNA-related DCM. NCT03439514.

Feasibility of Single-lead Cardiac Resynchronization and Defibrillation Therapy in an Animal Model.

Conduction system pacing (CSP) has emerged as an alternative to cardiac resynchronization therapy (CRT); however, there is limited experience with CSP using implantable cardiac defibrillator (ICD) leads. The achievement of CSP with an ICD lead may yield comparable results to cardiac resynchronization therapy defibrillator (CRT-D) therapy using fewer leads. We implanted the Biotronik Linox DX "VDD"-programmable ICD lead in a swine model to investigate the feasibility of "single-lead" CRT-D implantation. With the lead embedded in the basal right ventricular septum, morphologic criteria for CSP were achieved, and successful defibrillation was performed while maintaining atrial sensing. Future work may assure reproducibility of these findings and further determine the feasibility of a single-lead CRT-D.