Defibrillator Patients Research Articles

Patients with an implantable cardioverter defibrillator at risk of poorer psychological health during 24 months of follow-up (results from the Danish national DEFIB-WOMEN study)

ObjectiveIdentify implantable cardioverter defibrillator (ICD) patients at risk of distress (i.e., depression, anxiety, and ICD concerns) and associated risk factors. MethodFirst-time ICD patients (n = 1503) from the Danish national DEFIB-WOMEN study completed questionnaires at baseline, 3, 6, 12 and 24 months. ResultsOf patients with low scores on distress, only 4%–7.2% experienced an increase in distress during 24 months of follow-up (FU), while 30.5%–52.5% with increased levels were likely to maintain increased levels at FU. Higher education, higher age, female sex, and good physical functioning at baseline were associated with less depression, anxiety and ICD concerns at FU. Previous psychological problems, smoking, Type D personality, NYHA class III-IV – all assessed at baseline – and shocks during FU were associated with depression, anxiety and ICD concerns. ConclusionsGenerally, patients' psychological health improved, but patients with increased baseline scores were more likely to have increased scores at FU. We need to be vigilant if patients report elevated distress, particularly if they have depression at baseline, as depression seems more persistent. Given the impact of depression on health-related quality of life and prognosis, they should be screened and monitored closely.

New atrial arrhythmia occurrence in single chamber implantable cardioverter defibrillator patients: A real-world investigation.

A current limitation of single chamber implantable cardioverter defibrillators (ICDs) is the lack of an atrial lead to reliably detect atrial fibrillation (AF) episodes. A novel ventricular based atrial fibrillation (VBAF) detection algorithm was created for single chamber ICDs to assess R-R variability for detection of AF. Patients implanted with Visia AF™ ICDs were prospectively enrolled in the Medtronic Product Surveillance Registry from December 15, 2015 to January 23, 2019 and followed with at least 30 days of monitoring with the algorithm. Time to device-detected daily burden of AF ≥ 6 min, ≥6 h, and ≥23 h were reported. Clinical actions after device-detected AF were recorded. A total of 291 patients were enrolled with a mean follow-up of 22.5 ± 7.9 months. Of these, 212 (73%) had no prior history of AF at device implant. However, 38% of these individuals had AF detected with the VBAF algorithm with daily burden of ≥6 min within two years of implant. In these 80 patients with newly detected AF by their ICD, 23 (29%) had a confirmed clinical diagnosis of AF by their provider. Of patients with a clinical diagnosis of AF, nine (39%) were newly placed on anticoagulation, including five of five (100%) patients having a burden >23 h. Continuous AF monitoring with the new VBAF algorithm permits early identification and actionable treatment for patients with undiagnosed AF that may improve patient outcomes.

Can the Norton Scale Score Be Used as an Adjunct Tool for Implantable Defibrillator Patient Selection? A Retrospective Single-Center Cohort Study.

(1) Background: Implantable cardioverter defibrillators (ICDs) have become the standard of care in the prevention of sudden cardiac death, yet studies have shown that competing causes of death may limit ICD benefits. The Norton scale is a pressure ulcer risk score shown to have prognostic value in other fields. The purpose of this study was to assess the use of the Norton scale as an aid for ICD patient selection; (2) Methods: The study was comprised of consecutive patients who underwent defibrillator implantation at Sheba Medical Center between 2008 and 2016. A competing risk analysis was performed to assess the likelihood of death prior to device therapy; (3) Results: 695 patients were included. A total of 59 (8.5%) patients had low admission Norton scale score (ANSS) (≤14), 81 (11.7%) had intermediate ANSS (15−17), and the remainder (79.8%) had high (18−20) ANSS. The cumulative probability of all-cause mortality within one year of ICD implantation in patients with low ANSS was 30%, compared with 20% and 7% among the intermediate- and high-ANSS groups, respectively. Moreover, the one-year mortality rate without ICD therapy in low-ANSS patients was over four-fold compared with that of high-ANSS patients (33% versus 7%, p < 0.0001); (4) Conclusions: The Norton scale could be a useful additional tool in predicting the life expectancy of ICD candidates, thereby improving patient selection.

Abstract 05: Hospital Variation In Epinephrine Administration Prior To Defibrillation For Cardiac Arrest Due To Shockable Rhythm

Background: Contrary to guidelines, we recently found that epinephrine administration before first defibrillation for in-hospital cardiac arrest (IHCA) due to a shockable rhythm is not uncommon. However, the extent to which the above practice varies across hospitals and its association with hospital-level survival is unknown. Methods: Using 2000-19 data from the Get With The Guidelines ® -Resuscitation (GWTG-R) registry, we identified 57,816 adult patients (521 sites) with an index IHCA due to an initial shockable rhythm who received at least 1 defibrillation prior to achieving return of spontaneous circulation. We constructed multivariable hierarchical regression models to examine site-level variation in epinephrine before first defibrillation and its association with hospital survival. Results: Overall, the median rate of epinephrine before defibrillation was 18.8% and varied markedly across hospitals (range: 0%-70.6%, median odds ratio [OR] 1.50; 95% C.I. 1.43 - 1.57). Compared to hospitals in the lowest quartile (Q1) for epinephrine before defibrillation, hospitals in the highest quartile (Q4) were more likely to be major teaching hospitals and have more hospital beds. After adjusting for baseline variables, the median risk-standardized survival was 42.5% (IQR: 39.2%-46.0%). Compared to Q1 hospitals (epinephrine first rate of 0-12.4%), there was a stepwise decline in risk-standardized survival at hospitals with higher rates of epinephrine before first defibrillation: Q2: RR 0.95 [0.90-0.99]; Q3: RR 0.91 [0.87-0.96]; Q4: RR 0.81 [0.77-0.86]; P value for trend &lt;0.001. Conclusions: For patients with shockable IHCA, there is marked hospital variation in epinephrine administration prior to first defibrillation, and this practice is associated with lower rates of survival to discharge. Hospital efforts to prioritize immediate defibrillation for patients with shockable IHCA are urgently needed.

Ventricular arrhythmia burden in patients with implantable cardioverter defibrillator and remote patient monitoring during different time intervals of the COVID-19 pandemic

PurposeThe current study investigated whether the changes in patient care in times of the COVID-19 pandemic, especially the reduction of in-person visits, would result in a deterioration of the arrhythmic and clinical condition of patients with an implantable cardioverter defibrillator (ICD) and remote patient monitoring.MethodsData were obtained from a local ICD registry. 140 patients who received ICD implantation at our department and had remote patient monitoring were included. The number of patients with ventricular arrhythmias, appropriate ICD therapy, the number of visits to our outpatient clinic and hospitalization due to acute coronary syndrome, stroke or heart failure were compared during three time intervals of the COVID-19 pandemic (first (LD1) and second (LD2) national lockdown in Germany and the time after the first lockdown (postLD1)) and a time interval 1 year before the pandemic began (preCOV). Each time interval was 49 days long.ResultsPatients had significantly fewer visits to our outpatient clinic during LD1 (n = 13), postLD1 (n = 22) and LD2 (n = 23) compared to the time interval before the pandemic (n = 43, each p ≤ 0.05). The number of patients with sustained ventricular arrhythmias, appropriate ICD therapy and clinical events showed no significant difference during the time intervals of the COVID-19 pandemic and the time interval 1 year prior.ConclusionsThe lockdown measures necessary to reduce the risk of infection during the COVID-19 pandemic, led to a reduction of in-person patient visits, but did not result in a deterioration of the arrhythmic and clinical condition of ICD patients with remote patient monitoring.

The development of a decision aid for shared decision making in the Dutch implantable cardioverter defibrillator patient population: A novel approach to patient education.

BackgroundCounseling of Implantable Cardioverter-defibrillator (ICD) patients with regard to individual risks and benefits is challenging. An evidence-based decision aid tailored to the needs of Dutch ICD patients is not yet available. The objective of this pilot project was to structurally evaluate the current clinical practice in The Netherlands and the ICD patient experience, in order to develop an online decision aid to facilitate shared decision making in ICD procedures.MethodsBetween June 2016 and December 2017, a Dutch web-based decision aid was developed according to the Patient Decision Aid Standards (IPDAS) using the RAND-UCLA/multi-stepped Delphi model. Development process consisted of 5 stages in which the Dutch clinical practice was reviewed (stage 1), patients’ needs and their history of decision making was structurally assessed (stages 2A and B) and a modified Delphi consensus process was performed with an expert panel consisting of representatives from different medical fields (stage 3). Results from stages 1–3 were used to design and structure the content of an online-based decision aid (stage 4) which was finally evaluated in a usability testing by patients in stage 5.Results and conclusionThis study describes the evidence-based approach to the development of the Dutch ICD decision aid. In our population, levels of shared decision-making experience were low. The ICD decision aid was structurally developed for the Dutch ICD patient population. Our upcoming multicenter stepped wedge clustered randomized trial will further evaluate the ICD decision aid in clinical practice.

Diabetes may modify the efficacy of primary prevention implantable cardioverter-defibrillators in non-ischemic systolic heart failure: an extended follow-up of the DANISH trial

Abstract Background Since patients with both diabetes and heart failure (HF) have a substantially worse prognosis than those with each of these alone, the efficacy of implantable cardioverter defibrillator (ICD) implantation in patients with systolic HF may be modified by diabetes status. Purpose In this extended follow-up analysis of the Danish Study to Assess the Efficacy of primary prevention of Implantable Cardioverter Defibrillators in Patients with Non-ischemic Systolic Heart failure on Mortality (DANISH), adding four years of additional follow-up, we examined the long-term effects of primary prophylactic ICD implantation, compared with usual clinical care, in patients with non-ischemic systolic HF according to diabetes status. Methods In DANISH, 1,116 patients with non-ischemic systolic HF were randomized to receive an ICD (N=556) or usual clinical care (N=550). Outcomes were analyzed according to diabetes status at baseline. The primary outcome was death from any cause. Secondary outcomes were cardiovascular death and sudden cardiovascular death. Results Of the 1,116 patients randomized in DANISH, 211 (18.9%) had diabetes at baseline (median age 64 year-old, 159 males, median left ventricular ejection fraction 25%). There was a statistically significant interaction between diabetes and the effect of ICD implantation on death from any cause and cardiovascular death. There was a trend toward a reduction in both outcomes with ICD implantation, compared with usual clinical care; in patients without diabetes (death from any cause, HR 0.81 [95% CI, 0.65–1.01]; cardiovascular death, HR 0.77 [0.59–1.01]), but not in those with diabetes (death from any cause, HR 1.19 [0.81–1.74]; cardiovascular death, HR 1.20 [0.79–1.82]) (P for interaction = 0.04 and 0.04 for death from any cause and cardiovascular death, respectively). Although there was no statistically significant interaction between diabetes and the effect of ICD implantation on sudden cardiovascular death, ICD implantation significantly reduced the rate of sudden cardiovascular death in patients without diabetes (HR 0.51 [0.31–0.85]), but not in those with diabetes (HR 0.91 [0.41–1.99]) (P for interaction = 0.15). Conclusions In patients with non-ischemic systolic HF, there was a significant interaction between diabetes and the effect of ICD implantation on death from any cause and cardiovascular death, suggesting that individuals without diabetes may derive greater benefit from ICD implantation. Funding Acknowledgement Type of funding sources: None.

Implantable defibrillator-detected heart failure status predicts ventricular tachyarrhythmias

Abstract Background The occurrence of ventricular tachyarrhythmias is associated with increased mortality and hospitalizations for heart failure in implantable cardioverter defibrillator (ICD) patients. Nonetheless, the temporal relationship between heart failure worsening and ventricular tachyarrhythmias has been scarcely explored so far. Purpose We hypothesized that in patients with heart failure and reduced ejection fraction with ICDs, physiological sensor-based heart failure status, as reflected in the HeartLogic index, would predict appropriate device therapies for ventricular tachyarrhythmias (shocks and antitachycardia pacing). Methods and results 568 patients implanted with ICDs (n=410, 72%) or cardiac resynchronization therapy-defibrillators (CRT-D, n=158, 28%) endowed with the HeartLogic algorithm were included in this prospective observational multicenter analysis. Over a follow-up of 25 [25th-75th percentile: 15–35] months, 122 (21%) patients received an appropriate device therapy (shock, n=74, 13%), while the HeartLogic index crossed the threshold value 1200 times (0.71 alerts/patient-year) in 370 subjects (65%). The occurrence of at least one HeartLogic alert was significantly associated with both appropriate shocks (HR: 2.44, 95% CI: 1.49–3.97, p=0.003) and any ICD therapies (HR: 1.95, 95% CI: 1.37–2.85, p=0.003). Using a time-dependent Cox model, the weekly IN-alert state was the strongest predictor of ICD shocks (HR: 2.94, 95% CI: 1.73–5.01, p&amp;lt;0.001), after correction for age, secondary prevention, and use of CRT. As compared to clinically stable subjects with no therapies, patients experiencing shocks had significantly higher baseline values of the HeartLogic index, third heart sound amplitude, and respiratory rate. Beginning about one month prior to the arrhythmic event, we noticed further increase of the combined index and the third heart sound amplitude, a decrease of thoracic impedance, and higher resting heart rate (Figure 1). Conclusions The HeartLogic index is an independent predictor of appropriate defibrillator therapies. The combined index and its individual physiological components change well before the arrhythmic event, suggesting the existence of a window of opportunity to prevent shocks. Funding Acknowledgement Type of funding sources: None.

Clinical phenotyping of implantable cardioverter defibrillator patients to identify the association of remote device monitoring on survival benefit: a cluster analysis

Abstract Background/Introduction Over the past decade, various studies have demonstrated an association between remote device monitoring (RM) in implantable cardioverter-defibrillator (ICD) patients and all-cause mortality. However, it is unclear which clinical phenotypes account for this survival benefit. Purpose We aimed to identify clinical phenotypes within an ICD population on RM and conventional follow-up (NRM), and evaluate differences in long-term survival per clinical phenotype. Methods This is a single-center, retrospective, observational study of de novo ICD implantations (single- and dual chamber, biventricular and subcutaneous) between 2010 and 2021 in patients ≥18 years old. Data was extracted from electronic health records. Unsupervised two-step cluster analysis (TSC) was performed to identify distinct clinical phenotypes in the RM and NRM cohorts. Multinomial logistic regression analysis was performed to identify cluster characteristics, differences among the different clusters were analysed by Chi-squared test. Variable importance was evaluated for each of the 18 included clinical variables. Survival analysis was performed using the Kaplan-Meier method, log-rank was used to compare survival between groups. Results A total of 1872 ICD patients were analysed using TCS, comprising 1265 RM and 607 NRM patients, respectively. TCS for a mean follow-up duration of 5.4±3.1 years partitioned the RM and NRM groups into six clusters (Table 1). Clusters RM1 (n=444) and NRM3 (n=220) represented a predominantly primary prevention and DCM phenotype. Clusters RM2 (n=300) and NRM2 (n=173) indicated young and secondary prevention phenotypes. Clusters RM3 (n=220) and NRM1 (n=214) comprised an older, male and ischaemic cardiomyopathy (ICM) phenotype. In survival analysis 5-year cumulative incidence of mortality for the subsequent clusters was 7.4%, 4.5%, 11.6%, 41.4%, 29.8%, and 25.1%, respectively (log rank p-value &amp;lt;0.001, Figure 1). Thus, younger and DCM phenotypes (often with genetic aetiologies) experienced superior survival and high rates on RM, whereas older, male and ICM phenotypes with low rates on RM were associated with worse survival. In addition, between-group cluster-comparison of patients on RM only demonstrated important differences in long-term survival, where RM3 (comprising older, male with predominantly ICM) had poorer survival compared to young patients with a high prevalence of DCM, primary arrhythmia syndrome and low proportions of comorbidities (i.e. atrial arrhythmias, cerebral vascular accidents, diabetes mellitus). Conclusion We identify novel clinical phenotypes (clusters) of ICD patients on RM and having conventional follow-up with large differences in long-term survival. Future studies should further explore if these differences reflect benefit from RM, or the underlying natural history of each phenotype. These results may accordingly guide monitoring strategies tailored to specific ICD patient profiles. Funding Acknowledgement Type of funding sources: Public hospital(s). Main funding source(s): Public funding

Prevalence of One-Year Mortality after Implantable Cardioverter Defibrillator Placement: An Opportunity for Palliative Care?

Background: Current guidelines recommend against placement of implantable cardioverter defibrillators in patients with a life expectancy less than one year. These patients may benefit from early palliative care services; however, identifying this population is challenging. Objective: Determine whether a validated prognostic tool, based on patient factors and health care utilization from electronic medical records, accurately predicts one-year mortality at the time of implantable cardioverter defibrillator placement. Design: We used the United States (U.S.) Veterans Administration's "Care Assessment Needs" one-Year Mortality Score to identify patients at high risk of mortality (score ≥95) before their procedure. Data were extracted from the Corporate Data Warehouse. Logistic regression was used to assess the odds of mortality at different score levels. Setting/Subjects: Patients undergoing a new implantable cardioverter defibrillator procedure between October 1, 2015 and September 30, 2017 in the U.S. Veterans Administration. Results: Of 3194 patients with a new implantable cardioverter defibrillator placed, 657 (21.8%) had a score ≥95. The mortality rate among these patients was 151/657 (22.9%) compared with 281/3194 (8.8%) for all patients undergoing a new implantable cardioverter defibrillator procedure. Patients with a score ≥95 had 14.0 (95% confidence interval 8.0-24.4) higher odds of death within one year of the procedure compared with those with a score ≤60. Conclusions: The "Care Assessment Needs" Score is a valid predictor of one-year mortality following implantable cardioverter defibrillator procedures. Integrating its use into the management of Veterans Administration (VA) patients considering implantable cardioverter defibrillators may improve shared decision making and engagement with palliative care.

Radiographic Identification of Cardiac Implantable Electronic Device Manufacturer: Smartphone Pacemaker-ID Application Versus X-ray Logo.

Radiographic identification of the cardiac implantable electronic device (CIED) manufacturer facilitates urgent interrogation of an unknown CIED. In the past, we relied on visualizing a manufacturer-specific X-ray logo. Recently, a free smartphone application (“Pacemaker-ID”) was made available. A photograph of a chest X-ray was subjected to an artificial intelligence (AI) algorithm that uses manufacturer characteristics (canister shape, battery design) for identification. We sought to externally validate the accuracy of this smartphone application as a point-of-care (POC) diagnostic tool, compare on-axis to off-axis photo accuracy, and compare it to X-ray logo visualization for manufacturer identification. We reviewed operative reports and chest X-rays in 156 pacemaker and 144 defibrillator patients to visualize X-ray logos and to test the application with 3 standard (on-axis) and 4 non-standard (off-axis) photos (20° cranial; caudal, leftward, and rightward). Contingency tables were created and chi-squared analyses (P < .05) were completed for manufacturer and CIED type. The accuracy of the application was 91.7% and 86.3% with single and serial application(s), respectively; 80.7% with off-axis photos; and helpful for all manufacturers (range, 85.4%–96.6%). Overall, the application proved superior to the X-ray logo, visualized in 56% overall (P < .0001) but varied significantly by manufacturer (range, 7.7%–94.8%; P < .00001). The accuracy of the Pacemaker-ID application is consistent with reports from its creators and superior to X-ray logo visualization. The accuracy of the application as a POC tool can be enhanced and maintained with further AI training using recent CIED models. Some manufacturers can enhance their X-ray logos by improving placement and design.

Impact of coronavirus disease 19 outbreak on arrhythmic events and mortality among implantable cardioverter defibrillator patients followed up by remote monitoring: a single center study from the Veneto region of Italy.

The 2020 severe acute respiratory syndrome coronavirus 2 outbreak entailed reduced availability of traditional (in-office) cardiology consultations. Remote monitoring is an alternative way of caring that may potentially mitigate the negative effects of the epidemic to the care of cardiovascular diseases. We evaluated the outcome of implantable cardioverter defibrillator (ICD) carriers followed up remotely in 2020 (epidemic period) versus 2019 (control). We included all patients with an ICD who remained remotely monitored from the beginning to the end of each year. The combined end point included: new-onset atrial fibrillation; sustained ventricular tachycardia >170 bpm without ICD intervention; appropriate ICD intervention (either shock or antitachycardia pacing); any-cause death. Multiple events in the same patients were counted separately if occurring ≥48 h apart. In 2020, 52 end points occurred in 37 of 366 (10%) ICD carriers [0.14/patient (95% confidence interval [CI] = 0.11-0.19)] versus 43 end points in 32 of 325 (10%) ICD carriers in 2019 [0.13/patient (95% CI = 0.10-0.18) P = 0.75]. There was no difference between the distribution of any individual end point in 2020 versus 2019 although a nonsignificant mortality increase was observed (from 2.8% to 4.6%, P = 0.19). The lowest weekly event rate occurred during the national lock down in spring 2020 but a similar trend occurred also in 2019 suggesting that the effect may not be linked to social distancing measures. We did not observe an increase in a combined end point including arrhythmic events and mortality in ICD carriers who were remotely monitored in 2020, compared to 2019, despite the negative impact of the coronavirus disease 2019 outbreak on the healthcare system.

Empfehlungen zur Strukturierung der Herzschrittmacher- und Defibrillatortherapie – Update 2022

This interdisciplinary position paper of the German Cardiac Society (DGK) and the German Society for Thoracic and Cardiovascular Surgery (DGTHG) formulates evidence-based recommendations for the structuring and performance of device interventions. These are intended to create a Germany-wide basis for the infrastructural and personnel conditions of these operations. The necessary requirements for training centers and instructors are addressed, which should lead to a comparable quality in obtaining the additional qualification. The equally necessary infrastructural requirements of the institutions for the performance of the operations are defined. Thus, information is provided on personnel, spatial and hygiene requirements of the operating rooms as well as recommendations on radiological equipment and radiation protection. Also presented are procedural recommendations on clinical procedures, such as patient sedation and anesthesia, structuring emergency management, revision and extraction procedures, performing outpatient procedures, and implanting transcatheter leadless pacemakers. Last but not least, recommendations for the management of MRI examinations in device patients, remote follow-up of pacemaker and defibrillator patients, handling of safety notices and recalls, and German quality assurance of device interventions are described.

Predictors of right ventricular pacing-induced left ventricular dysfunction in pacemaker recipients with preserved ejection fraction

Pacing is an effective treatment in the management of patients with bradyarrhythmias. Chronic right ventricular pacing may cause electrical and mechanical dyssynchrony leading to adeterioration of left ventricular ejection fraction (LVEF). This deterioration of LVEF has been described as pacing-induced cardiomyopathy (PICM). The incidence of PICM has been described by many studies, ranging between 10% and 26%. Predictors for PICM are not yet established-studies were limited by variations in the definition of PICM and the follow-up period. The authors studied the incidence and predictors of PICM in patients with preserved LVEF who underwent pacemaker implantation. This retrospective study included 320patients that underwent single- or dual-chamber pacemaker implantation, with amean follow up period of 4.7 ± 2.0years. Implantable cardioverter defibrillator and cardiac resynchronization therapy patients were excluded from this study. Individuals that had abaseline LVEF ≥ 50% before implantation in transthoracic echocardiography were included in the study. Of the 320patients included in the study, 45% were male, with amean age 55.5years. The incidence of PICM was 7.5%. Wider native QRS duration, particularly > 140 ms (P < 0.001), wider paced QRS (pQRS) duration > 150 ms (P < 0.001), low normal ejection fraction < 56% pre-implantation (P = 0.023) and increased LV end diastolic diameter (LVEDD) > 53 mm and LV end systolic diameter (LVESD) > 38 mm (P < 0.001) predicted the development of PICM. There was no association between burden of right ventricular pacing (P = 0.782) or pacing site (P = 0.876) and the development of pacemaker-induced cardiomyopathy. Right ventricular pacing-induced left ventricular dysfunction is not uncommon, with an incidence of 7.5%. Wider native and paced QRS durations, low normal ejection fraction (< 56%) pre-implantation and increased LVEDD and LVESD post implantation are the most important predictors for the development of PICM.

Feasibility, efficacy and safety of subcutaneous implantable cardioverter defibrillator in patients with a previous median sternotomy

Abstract Funding Acknowledgements Type of funding sources: None. Background Subcutaneous implantable cardioverter defibrillator (S-ICD) has been shown to be an effective therapy for prevention of sudden cardiac death (SCD) with improved outcomes and fewer lead-related complications compared to transvenous cardioverter defibrillator (TV-ICD). Patients who previously underwent cardiac surgery with median sternotomy (MS) may be at risk of SCD and require ICD implantation. However, there are no data on the performance of the S-ICD in this patient cohort. Purpose To assess feasibility, periprocedural and long-term complications associated with implantation of S-ICD in patients with a previous MS. Methods All 128 patients who received a S-ICD at our Centre were enrolled in the study. Baseline and procedural characteristics and complications were collected and retrospectively analyzed. Long-term outcomes were considered as appropriate and inappropriate shocks (IAS), and complications during follow-up. To estimate arrhythmia-free survival, Kaplan–Meier curves were constructed. Cox regression was performed to analyze multivariate predictors of recurrences. Results Among 128 patients (79.7% male sex; mean age 50±15 years), 18 of them had a previous MS. Coronary artery disease was present in 26.6% of the total population, while not ischemic aetiology was present in the 75.4% of them; among this cohort, the most prevalent pathology was hypertrophic cardiomyopathy (21.9%). Primary prevention cohort was the 61.1% in the MS group and the 77.3% in the no MS group. S-ICD implant was successful in 100% of cases. No periprocedural complications were registered. After a median follow up of 3.9 years, no one of the 101 patients had sternal complications. There were no differences in delivery of appropriate shocks (12.5% in MS group vs 7.69% in no MS group, p=0.583) neither in delivery of IAS (6.25% in MS group vs 9.89% in no MS group, p=0.594). At the univariate analysis on IAS there were no differences between the group with or without MS (10% vs 16.38%, p=0.594), but there were significative differences between patients with or without arrhythmogenic right ventricular dysplasia (ARVC; 20% vs 2%, p=0.006), between patients with or without diabetes (30% vs 9.89%, p=0.03), between patients with or without chronic obstructive pulmonary disease (30% vs 4.39%, p=0.002) and between patients who used to smoke and patient who did not (40% vs 16.48%, p=0.03). At multivariate analysis, advanced age (hazard ratio 1.033; 95% CI, 1.014 to 1.053; p=0.001) and ARVC (hazard ratio 5.133; 95% CI, 1.515 to 17.399; p=0.009) were significantly associated with delivery of IAS. Conclusion Implanting a S-ICD is feasible, safe and effective as in patients without a previous MS; in patients who underwent a S-ICD, a previous MS is not associated with a major risk of sternal complications or delivery of IAS; advanced age and ARVC are independently associated with a major risk of delivery of IAS.

The subcutaneous defibrillator in patients with low BMI - insights from a large European multicenter registry

Abstract Funding Acknowledgements Type of funding sources: None. Background The subcutaneous implantable cardioverter defibrillator (S-ICD) has become an alternative to transvenous ICDs (tv-ICD), especially in young patients without a need for pacing. One of the current limitations of the S-ICD is the relatively large size of the generator compared to tv-ICDs. There is little evidence whether the size of the current S-ICD generator is associated with an elevated risk of device-related complications in patients with a low body mass index (BMI). Purpose To compare the device-related complications and long-term outcomes in a large real world cohort of S-ICD recipients in patients with a BMI &amp;lt;18 kg/m2 compared to patients with a BMI &amp;gt;18 kg/m2. Methods The iSuSI registry is a European, multi-center, open-label, independent, and physician-initiated observational registry. A total of twenty-two Public and Private Healthcare Institutions from 4 different countries in Europe were involved in the registry. All consecutive patients meeting current guideline indications for ICD implantation and undergoing implantation of a S-ICD device (Boston Scientific, Marlborough, Massachusetts, USA) at 21 European institutions enrolled in the registry were used for the current analysis. Patients were classified into two cohorts, depending on the BMI at the time of device implantations: BMI &amp;lt; 18 kg/m2 versus &amp;gt; 18 kg/m2. Results Out of a total of 1497 pts, 58 pts (3.9%) had a BMI &amp;lt; 18 kg/m2. Patients with BMI &amp;lt;18 kg/m2 were younger (44.6±2.4 vs 50.8±0.4; p=0.004) and more frequently female (58.6% vs 22.3%, p&amp;lt;0.001). No differences in any of the other baseline characteristic were observed. Implantation techniques resulted comparable between the groups (Rates of 2-incision technique: 87.8% vs 91.9%; p=0.256; inter-muscular placement: 89.7% vs 83.3%; p=0.198). Of note, the mean PRAETORIAN score at implantation of patients with BMI &amp;lt;18 kg/m2 was significantly lower (33.8±9.1 vs 54.1±47.3; p=0.035), although the vast majority of pts in both cohorts qualify as at low risk of conversion failure (100% vs 91.4%; p=0.436). Over a median follow up time of 22.4 [11.6–36.8] months, both overall device-related complications (5.2% vs 7.4%) and rates of inappropriate shocks (12.0% vs 8.8%) resulted comparable between the two groups (p =0.517 and p=0.385, respectively). Figure1 reports Kaplan-Meier curves reporting the combined incidence of device-related complications and inappropriate shocks in the two groups (log-rank p = 0.576). Conclusion No difference in device-related complications and long-term outcomes after S-ICD implantation were observed in patients with BMI &amp;lt;18 kg/m2 compared to the remaining recipients from a large, multi-centered S-ICD registry. Figure 1: Kaplan-Meier-survival curve for the combined endpoint of inappropriate shocks (IAS) and device-related complications (DRC)

PO-633-01 THE EFFECT OF DEFIBRILLATOR ON MORTALITY IN NON-ISCHEMIC CARDIOMYOPATHY WITH RESYNCHRONIZATION THERAPY

Recent studies have questioned the role of defibrillators in non-ischemic cardiomyopathy (NICM). This meta-analysis assessed the long-term outcomes of cardiac resynchronization therapy (CRT) with or without defibrillation in patients with NICM.

Prognostic Impact of Implantable Cardioverter Defibrillators in Patients with Continuous Flow Left Ventricular Assist Devices

Purpose Preventative implantation of implantable cardioverter defibrillators (ICD) improves survival of symptomatic heart failure (HF) patients with reduced left ventricular ejection fraction. Nevertheless, the prognostic impact of ICD therapy in continuous flow left ventricular assist device (LVAD) recipients remains controversial. Methods 162 consecutive HF patients underwent LVAD implantation at our institution between 2010 and 2019. All patients were evaluated according to the presence (n=94, ICD-group) or absence (n=68, Control-group) of ICDs prior to LVAD implantation. Apart from clinical baseline and follow-up parameters, adverse events related to ICD therapy and overall survival rates were retrospectively analyzed. Results Predominantly male patients (87.0%) with a median age of 57 (48.8-64.0) years were mainly treated with the Medtronic HVAD device (87.0%). Ischemic cardiomyopathy (60.3% vs. 38.3%, p=0.007) and severe HF symptoms (e.g., NYHA-class IV 85.5% vs. 59.6%, p=0.001) were more prevalent within the Control-group. Furthermore, the preoperative use of short-term circulatory support devices (e.g., IABP, ECMO, Impella) was higher within the Control-group (54.4% vs. 13.8%, p <0.001). Nevertheless, baseline severity of LV and RV dysfunction (LVEF 20%, TAPSE 15mm; p=0.87) was similar. Apart from an increased rate of temporary RVAD implantation within the Control-group (45.6% vs. 17.0%; p<0.001), procedural characteristics and 30-day mortality rates were comparable. Furthermore, overall-survival during a median follow-up of 14 (3.0-36.5) months was similar within both study-groups (35.1% ICD-group vs. 33.8% Control-group; p=0.46). During the first 2 years after LVAD implantation 49 ICD-related adverse events occurred within the ICD-group. Thereof, lead-dysfunction occurred in 18 patients and unplanned ICD-reintervention in 10 patients. Furthermore, in 16 patients adequate, but awake shocks occurred, whereas inadequate shocks occurred in 5 patients. Conclusion ICD therapy in LVAD recipients was not associated with a survival benefit or reduced morbidity after LVAD implantation. Furthermore, in the majority of LVAD recipients ICD-related adverse events occurred during follow-up. A randomized controlled trial is essential to elucidate the role of ICD therapy in LVAD recipients. Preventative implantation of implantable cardioverter defibrillators (ICD) improves survival of symptomatic heart failure (HF) patients with reduced left ventricular ejection fraction. Nevertheless, the prognostic impact of ICD therapy in continuous flow left ventricular assist device (LVAD) recipients remains controversial. 162 consecutive HF patients underwent LVAD implantation at our institution between 2010 and 2019. All patients were evaluated according to the presence (n=94, ICD-group) or absence (n=68, Control-group) of ICDs prior to LVAD implantation. Apart from clinical baseline and follow-up parameters, adverse events related to ICD therapy and overall survival rates were retrospectively analyzed. Predominantly male patients (87.0%) with a median age of 57 (48.8-64.0) years were mainly treated with the Medtronic HVAD device (87.0%). Ischemic cardiomyopathy (60.3% vs. 38.3%, p=0.007) and severe HF symptoms (e.g., NYHA-class IV 85.5% vs. 59.6%, p=0.001) were more prevalent within the Control-group. Furthermore, the preoperative use of short-term circulatory support devices (e.g., IABP, ECMO, Impella) was higher within the Control-group (54.4% vs. 13.8%, p <0.001). Nevertheless, baseline severity of LV and RV dysfunction (LVEF 20%, TAPSE 15mm; p=0.87) was similar. Apart from an increased rate of temporary RVAD implantation within the Control-group (45.6% vs. 17.0%; p<0.001), procedural characteristics and 30-day mortality rates were comparable. Furthermore, overall-survival during a median follow-up of 14 (3.0-36.5) months was similar within both study-groups (35.1% ICD-group vs. 33.8% Control-group; p=0.46). During the first 2 years after LVAD implantation 49 ICD-related adverse events occurred within the ICD-group. Thereof, lead-dysfunction occurred in 18 patients and unplanned ICD-reintervention in 10 patients. Furthermore, in 16 patients adequate, but awake shocks occurred, whereas inadequate shocks occurred in 5 patients. ICD therapy in LVAD recipients was not associated with a survival benefit or reduced morbidity after LVAD implantation. Furthermore, in the majority of LVAD recipients ICD-related adverse events occurred during follow-up. A randomized controlled trial is essential to elucidate the role of ICD therapy in LVAD recipients.

NT-proBNP and ICD in Nonischemic Systolic Heart Failure: Extended Follow-Up of the DANISH Trial

ObjectivesIn this extended follow-up study of the DANISH (Danish Study to Assess the Efficacy of Implantable Cardioverter Defibrillators in Patients with Non-ischemic Systolic Heart Failure on Mortality) trial, adding 4 years of additional follow-up, we examined the effect of implantable cardioverter-defibrillator (ICD) implantation according to baseline N-terminal pro–B-type natriuretic peptide (NT-proBNP) level. BackgroundIn the DANISH trial, NT-proBNP level at baseline appeared to modify the response to ICD implantation. MethodsIn the DANISH trial, 1,116 patients with nonischemic systolic HF were randomized to receive an ICD (N = 556) or usual clinical care (N = 550). Outcomes were analyzed according to NT-proBNP levels (below/above median) at baseline. The primary outcome was death from any cause. ResultsAll 1,116 patients in the DANISH trial had an available NT-proBNP measurement at baseline (median: 1,177 pg/mL; range: 200-22,918 pg/mL). There was a trend toward a reduction in all-cause death with ICD implantation, compared with usual clinical care, in patients with NT-proBNP levels lower than the median (HR: 0.75 [95% CI: 0.55-1.03]), but not in those with higher NT-proBNP levels (HR: 0.95 [95% CI: 0.74-1.21]) (Pinteraction = 0.28). Similarly, ICD implantation significantly reduced the rate of cardiovascular (CV) and sudden cardiovascular death (SCD) in patients with NT-proBNP levels lower than the median (CV death, HR: 0.69 [95% CI: 0.47-1.00]; SCD, HR: 0.37 [95% CI: 0.19-0.75]), but not in those with higher levels (CV death, HR: 0.94 [95% CI: 0.70-1.25]; SCD, HR: 0.86 [95% CI: 0.49-1.51]) (Pinteraction = 0.20 and 0.08 for CV death and SCD, respectively). ConclusionsLower baseline NT-proBNP levels could identify patients with nonischemic systolic HF who may derive benefit from ICD implantation. (Danish Study to Assess the Efficacy of Implantable Cardioverter Defibrillators in Patients with Non-ischemic Systolic Heart Failure on Mortality [DANISH]; NCT00542945)

NAG: potential cardiorenal biomarker indicates the progression of chronic kidney disease in implantable cardioverter defibrillator patients, contrary to KIM-1.

Aim: NAG and KIM-1 as markers of tubular damage are suggested as potential biomarkers for the cardiorenal syndrome. The aim of the study was to assess the prognostic capability of NAG and KIM-1 regarding progression of chronic kidney disease (CKD) in patients with implantable cardioverter defibrillator(ICD). Materials & methods: We included 313 patients with an ICD and collected plasma and urine samples. Follow-up was performed after 51months (interquartile range [IQR]: 25-55). The outcome of interest was continuous CKD progression defined as persistent decline in estimated glomerular filtration rate category accompanied by a ≥25% drop of baseline estimatedglomerular filtration rate. Results: An average of four (IQR: 2-6) follow-up values of serum creatinine per patient were obtained. During follow-up 29 patients (9%) developed a continuous CKD progression. NAG was shown as independent predictor for continuous CKD progression (p=0.01), opposite to KIM-1 (p=n.s.). Conclusion: NAG was shown as predictor for a progressive and real deterioration of kidney function in patients with ICD.