ICD Implantation Research Articles

Recurrent syncope of unknown origin after ICD implantation: a case report

对于合并多种晕厥危险因素、出现过晕厥事件，且植入植入式心脏转复除颤器（ICD）二级预防的患者，再发晕厥时的诊疗和鉴别诊断颇具挑战性。本文报道因既往反复室性心动过速合并长QT综合征植入ICD的患者再发晕厥，最终溯因为肺血栓栓塞症的1例病例，并复习相关文献，以探讨合并多种晕厥危险因素时的优化晕厥诊疗模式。.

Influence of Atrial Fibrillation on Two-Year Survival of Patients with Implanted Cardioverter Defibrillator

Abstract Implantable cardioverter defibrillators (ICD) effectively reduce risk of sudden cardiac death in both primary and secondary prevention, but only a small proportion of patients included in the clinical trials had atrial fibrillation. It is still unclear whether patients with atrial fibrillation have the same benefit from ICD implantation as patients in sinus rhythm. This is a clinical, prospective study which included 210 patients in the period 2014-2018. ICD was implanted in the Clinical Center Kragujevac and a two-year follow-up was performed. Patients were divided into 2 groups: a group in sinus rhythm and a group of patients with atrial fibrillation (paroxysmal, persistent and permanent). At the end of the two-year follow-up, there was no difference in survival between the compared groups. The total number of cardioverter defibrillator activations did not differ between the groups, but a significantly higher number of inappropriate cardioverter defibrillator activations was registered in the group with atrial fibrillation. In most patients who had inappropriate defibrillator activation during the two-year follow-up, appropriate defibrillator activation was also registered.

Programming of implantable cardioverter defibrillators for primary prevention: outcomes at centers with high vs. low concordance with guidelines.

While ICD therapy reduction programming strategies are recommended in current multi-society guidelines, concerns remain about a possible trade-off between the benefits of ICD therapy reduction and failure to treat episodes of ventricular arrhythmias. The study is to evaluate the outcomes of primary prevention patients followed in centers with high and low concordance with the 2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement and 2019 focused update on optimal ICD programming and testing guidelines. Consecutive patients with primary prevention ICD implantation from two centers between 2014 and 2016 were included. One center was classified as high guideline concordance center (HGC) with 47% (146/310) of patients with initial ICD concordant with the guidelines, and the other center was classified as low guideline concordance center (LGC) with only 1% (2/178) of patients with guideline-concordant initial ICD programming. Cox proportional hazard models were used to assess risk of first ICD therapy (ATP or shock), first ICD shock, and mortality. A total of 488 patients were included (mean age, 66 ± 13years). During a mean follow-up of 1.9 ± 0.9years, patients followed at HGC were 63% less likely to receive any ICD therapy (adjusted HR [aHR] 0.37, 95% CI 0.42-0.99). There were no significant differences in the rate of first ICD shock (aHR 0.72, 95% CI 0.34-1.52) or mortality (aHR 1.19, 95% CI, 0.47-3.05). Compared to primary prevention patients followed at LGC, primary prevention ICD patients followed at HGC received a significantly lower rate of ICD therapy, mainly from ATP reduction, without a difference in mortality during follow-up.

Abstract 13825: Clinical and Echocardiographic Outcomes Associated With Early Initiation of Beta Blockers Use Among Patients With Recently Diagnosed Non-Ischemic Cardiomyopathy Treated With a Wearable Cardioverter Defibrillator

Introduction: Beta-blocker (BB) therapy was shown to improve clinical outcomes among heart failure patients with reduced ejection fraction. However, there are limited data on the efficacy of BB use among patients with recently diagnosed non-ischemic heart cardiomyopathy (NICM) who are treated with the wearable cardioverter defibrillator (WCD) until a decision on the need for an ICD is made. Aim: Determine if BB use is associated with improved outcomes in patients with NICM treated with the WCD. Methods: The study population comprised 1195 patients with recently diagnosed NICM enrolled in the prospective WEARIT-II Registry. Clinical data, arrhythmia events, ICD implantation, and improvement in left ventricular ejection fraction (LVEF) were captured. Multivariate logistic regression was used to estimate the odds ratio (OR) of LVEF improvement to >35% by BB usage. The risk of death at 1-year by BB use was assessed using a multivariate cox-proportional hazards modeling. Results: Patients treated with BBs at baseline were more likely to experience an improvement in LVEF to >35% that patients who did not receive treatment with BB (43% vs 29%, respectively; adjusted OR=1.67 95% CI [1.15-2.41] p=0.007; Figure: panel A and were less likely to receive an ICD at the end of the WCD use (37% vs 47%; adjusted OR=0.64 95% CI [0.46-0.90] p=0.024; Figure: panel B). At 12 months of follow-up the probability of death was significantly lower among patients who received BB therapy during WCD use vs. those who did not.,(p=0.007 Figure: panel C), corresponding to a significant 59% lower risk of death at one year associated with early BB use (adjusted HR=0.41 95% CI [0.21-0.80] p<0.01). Conclusions: Among patients newly diagnosed NICM who are treated with a WCD until a decision on the need for an ICD is made, early initiation of BB is independently associated with a greater likelihood of improvement in EF, a lower probability of needing an ICD at end of WCD use, and a lower risk of death at 1-year.

Abstract 12453: Tricuspid Regurgitation After ICD Implantation is Rather Due to the Transvenous Lead Than Natural Progression

Introduction: Transvenous implantable cardioverter-defibrillators (TV-ICDs) are associated with greater tricuspid regurgitation (TR) severity, which leads to increased mortality. The pathophysiology is often assumed to be lead-related, hence, treatment includes lead extraction and alternative defibrillation strategies. However, TR may also be naturally occurring in the ICD population with a high risk of secondary TR, or may be caused by right ventricular pacing. Purpose: We aimed to evaluate the effect of ICD type (with or without lead) and pacing percentage on post-implantation TR severity. Methods: In this retrospective cohort study, we included consecutive patients with a first S-ICD or TV-ICD implantation between December 2009 until December 2019 and who underwent an echocardiography study ≤3 months before and ≤3 years post-implantation. TR severity at follow-up was adjusted for potential confounders using ordinal regression analysis. Results: 118 patients were included (mean age 52±21; 29% female), of whom 31 (26%) with an S-ICD and 87 (74%) with a TV-ICD. Follow-up echocardiography was performed median 20 months (IQR 14-29 months) after implantation. Worsening TR between pre- and post-implantation echocardiography was found in 11/31 (34%) patients with an S-ICD and 45/87 (52%) patients with a TV-ICD (p=0.15). Adjusted for age, atrial fibrillation, baseline TR and mitral regurgitation, ventricular pacing percentage and time since ICD implantation, TV-ICDs were significantly associated with greater TR severity at follow-up (OR 8.38, p=0.002). Ventricular pacing percentage was very low (5/118 [4%] were paced >10%), and not significantly associated with greater TR severity (OR 0.97, p=0.123). Conclusions: Our results suggest that greater TR severity in ICD patients is mainly caused by the transvenous lead, rather than natural progression in the ICD population.

Abstract 14028: Predictors of Atrial Fibrillation Free Survival in Patients With Implantable Cardiac Devices

Introduction: Improvement of atrial fibrillation (AF) burden can be occasionally observed after pacemaker (PM) implant in patients with tachy-brady syndrome. On the other hand, patients may develop AF after the implant, even without prior history. We studied whether pre-implant parameters affect the risk of death or AF after device implant. Methods Data from 200 consecutive patients who underwent Medtronic dual (DDD) or triple chamber/cardiac resynchronization therapy (CRT) PM or ICD implants were analyzed. Pre-implant data included demographics, vitals, medications, comorbidities, labs, EKG, characteristics of any prior AF, echocardiographic parameters, and planned device type. Follow-up duration was planned as 12 months; survival and AF data (episodes >5 minutes) were collected from device follow-up data. Survival analysis was performed for death and first AF occurrence. Results Average age was 75±10 years, 37% were female. Comorbidities included history of AF (26% paroxysmal, 13.5% persistent), coronary artery disease 48.5%, hypertension 83.5%, diabetes 37.5%, sleep apnea 26%, drug or alcohol abuse 12.5%, heart failure 43%, prior cerebrovascular event 9.5%. PM was implanted in 70%, ICD in 30% of patients; DDD devices in 83.5%, CRT in 16.5%.Follow-up duration was 338±111 days, mortality was 13%, 38.5% of patients had new onset or recurrent AF. There was no difference in mortality between the PM vs. ICD group (11.4% vs. 16.7%, p=0.597) and the DDD vs. CRT group (12.6% vs. 15.2%, p=0.781). The cumulative AF incidence was higher in the PM vs. ICD group (46.7% vs. 21.7%, p=0.037) and in the DDD vs. CRT group (41.9% vs. 21.2%, p=0.039). Conclusion: The type of implanted device, guided by pre-implant clinical parameters affects post-implant AF occurrence. Although ICDs and CRT are utilized in sicker patients, these groups had better AF outcomes - beneficial effects of cardiac resynchronization and routine use of goal-directed medical therapy in these patients prior to and after the implant may play a role.

Abstract 14365: In-Hospital Outcomes of Septal Myectomy versus Alcohol Septal Ablation for Hypertrophic Cardiomyopathy - An Update and Insights From the National Inpatient Sample

Introduction: Septal Myectomy (SM) and Alcohol Septal Ablation (ASA) improve symptoms in patients with Hypertrophic Cardiomyopathy (HCM), however, outcomes data in this population is predominantly from specialized centers. Methods: The National Inpatient Database was queried from 2011- 2019 for relevant ICD-9 and -10 diagnostic and procedural codes. Baseline characteristics and in-hospital outcomes of patients with HCM who underwent SM vs. ASA were compared. A p-value <0.001 was considered statistically significant. Results: We identified 17,245 patients who underwent septal reduction therapies, of whom 62.5% underwent SM and 37.5% underwent ASA. Patients who underwent SM had higher all-cause mortality (OR:2.2 [1.7-2.9]), post procedure ischemic stroke (OR: 2.4 [1.8-3.2]), acute kidney injury (OR: 1.9 [1.7-2.2]), vascular complications (OR: 4 [2.8-5.7]), ventricular septal defect (OR: 4.6 [3.5-6.1]), aortic dissection/aneurysm (OR: 1.6 [1.3-2.1]), cardiogenic shock (OR: 2 [1.5-2.6]), sepsis (OR:5.2 [3.3-8.1]), and left bundle branch block (OR: 3.2 [2.8-3.7]) (p<0.001 for all), compared to ASA. Patients who underwent ASA had higher post procedure complete heart block (OR: 1.2 [1.1-1.4]), 2 nd -degree AV Block (OR: 2 [1.4-3]), right bundle branch block (OR: 6.4 [5.3-7.8]), ventricular tachycardia (OR:2 [1.8-2.3]), supraventricular tachycardia (OR: 1.4 [1.2-1.7]), and more commonly required pacemaker (OR: 1.4 [1.2-1.6]) or implantable cardioverter-defibrillator (OR: 1.3 [1.1-1.5]) (p<0.001 for all) insertion compared to SM. Conclusions: This nationwide analysis evidenced patients undergoing SM had higher in-hospital mortality and periprocedural complications compared to ASA, however, those undergoing ASA had higher post-procedure conduction abnormalities and pacemaker or ICD implantation. The implications of these findings warrant further investigation in regards to patient selection strategies for these therapies.

Abstract 15632: Rv Dysfunction and the Risk of Mortality in Cardiomyopathy Patients Who Suffered a Cardiac Arrest

Background: Right ventricular (RV) dysfunction has been associated with higher mortality in patients who suffer a cardiac arrest. However, the role of RV dysfunction in patients with known cardiomyopathy (CM) (EF<50%) who suffer cardiac arrest from a shockable rhythm is not well examined. Aim: To assess the relationship between RV dysfunction and mortality in patients with cardiac arrest from a shockable rhythm without an ICD. Methods: We included patients with CM of any etiology who were hospitalized for the first time with cardiac arrest at a tertiary care center between 2011 and 2017. We examined in-hospital as well as long-term mortality. RV dysfunction was defined based on standard echo parameters. Results: A total of 208 patients were admitted to the hospital with cardiac arrest from a shockable rhythm (VT/VfIb) and 139 of those had no ICD at the time of the cardiac arrest. Out of those 139 patients, 48 had RV dysfunction. Patients with RV dysfunction had higher in-hospital mortality (44.7% vs 15.1%, p<.001). Over a mean follow-up of 2.9±3.2 years, patients with RV dysfunction had higher long-term mortality rates (72.9 vs 53.8%, p=.029) as well as shorter mean survival time (33.2, CI [20.6-45.8], vs 66.0 [53-78.9] months, p=0.005, Figure). In a Cox regression model, patients with RV dysfunction had higher long-term mortality rates when adjusting for EF, initiation of new AAD, electrolyte abnormalities and new ischemia (HR 1.68, 95% CI [1.05-2.69], p=.028). During hospitalization, patients with RV dysfunction needed advanced HF treatment options (inotropes, OHT) more frequently compared to patients without RV dysfunction (70.8 vs 46.2%, p=.005). Conclusions: RV dysfunction is an independent predictor of mortality in patients with cardiac arrest from a shockable rhythm who do not have an ICD. Further studies should investigate whether the presence of RV dysfunction alone should be taken into consideration for decisions on ICD implantation in patients with CM.

Abstract 13141: Age of Onset and Clinical Outcomes in RBM20 -Mediated Arrhythmogenic Dilated Cardiomyopathy

Introduction: Pathogenic loss-of-function variants in the RBM20 -encoded RNA-binding motif 20 splicing regulator cause a severe form of arrhythmogenic dilated cardiomyopathy (DCM). Erroneous splicing of TTN -encoded titin contributes to the pathogenesis of RBM20 -mediated disease. However, studies exploring the clinical course of RBM20 -mediated arrhythmogenic DCM alone or in comparison to TTN -mediated DCM, the most common familial cause of DCM, are lacking. Methods: The Mayo Clinic Genetic Arrhythmogenic Cardiomyopathy Registry (n=391) was used to identify all patients with a pathogenic/likely pathogenic (P/LP) variant in either RBM20 or TTN . For the purposes of this study, a ventricular arrhythmia (VA) event was defined as sudden cardiac arrest, sustained ventricular arrhythmia, or an appropriate ICD shock and an advanced heart failure (AHF) event was defined as ventricular assist device implantation or heart transplantation. Results: Overall, 40 patients with a P/LP variant in RBM20 (50% female) and 70 patients with a P/LP variant in TTN (43% female) were identified. The prevalence of a cardiac phenotype in patients with RBM20- and TTN -mediated disease was 88% and 83%, respectively. RBM20 patients were more likely to have a family history of sudden cardiac arrest (78% vs 34%; p < 0.0001) and cardiomyopathy (90% vs 61%; p=0.001). No difference in rate of ICD implantation (35% versus 33%) was observed. Interestingly, the prevalence of AHF events (10% vs 6%; p=0.5) and VA events (28% vs 24%; p=0.7) was similar between RBM20 - and TTN -positive patients. However, RBM20 patients were younger than TTN patients at the time of their event (37 ± 18 years vs 50 ± 17; p=0.0004). Time-to-event analysis showed RBM20 patients had an earlier time to AHF event (p=0.05) and time to VA event (p=0.03) than TTN patients. The mean age for AHF events was 25 years for RBM20 patients (N=4) and 47 years for TTN patients (N=4). The mean age for VA events was 29 years for RBM20 patients (N=10) and 42 years for TTN patients (N=14). Conclusions: RBM20 -mediated arrhythmogenic DCM represents a highly penetrant genetic heart disease with potentially life-threatening VAs and end stage heart failure manifestations occurring at a significantly younger age in comparison to TTN -mediated DCM.

Abstract 12796: An Unusual Case of Rapidly Progressive Severe Bioprosthetic Aortic Valve Stenosis: A Valve-In Valve Tavr Experience

Case Presentation 69-year-old male with chronic HFrEF and VHD secondary to infective endocarditis in 1981; severe AR with SAVR in 2016 (Bioprosthetic Edwards Perimount size #25) who presented with worsening shortness of breath. Initial assessment with hypotension and crescendo-decrescendo holosystolic murmur (Grade V/VI). Shortly after admission, he had one episode of pulseless monomorphic VT. Laboratory showed NT Pro-BNP at 2,780 pg/mL. TTE: LVEF of 25% and severe AS (peak gradient 75 mmHg, mean gradient 47 mmHg, and dimensionless valve index: 0.16 cm/m 2 ) (A). TEE confirmed severity of AS caused by prosthetic valve thickening and calcification (B-C). A post-SAVR TTE in 2017 showed normal EF and valve gradients. Right heart catheterization was significant for a peak gradient: 61 mmHg, mean gradient: 45 mmHg, and aortic valve area of 0.59 cm 2 . After multidisciplinary evaluation our patient underwent a valve-in-valve (ViV) TAVR (Evolut Pro Plus prosthetic valve, size #29) and ICD implantation for secondary prevention. Post-procedure TTE showed normal bioprosthetic valve function with dimensionless valve index of 0.4 cm/m 2 . Rest of hospital stay was uneventful with rapid resolution of symptoms Discussion Prosthetic valve restenosis is a common complication of aortic valve repair but this is expected to develop at around 10-15 years following implant, early bioprostetic valve dysfunction is commonly related to valve thrombosis, in this case a TEE and pre-operative CT failed to showed findings of thrombosis. Patient was deemed high risk for a repeat SAVR based on comorbidities and hemodynamic instability at presentation (STS risk stratification: 7.4% risk of mortality). A ViV TAVR was considered as a viable option, with a pre-procedural gated CTA showing favorable valve morphology (D)

Abstract 15513: Angiovac as an Alternative to Surgical Excision of a Large Infective Endocarditis Vegetation

Background: Angiovac device is a suction cannula inserted percutaneously or surgically connected to extracorporeal circuit approved for removal of fresh soft thrombi/emboli. Cardiac surgery is indicated in Infective Endocarditis (IE) when the vegetation is >10 mm. Angiovac is used for IE in nonsurgical candidates. Here, we present 2 cases of successful use of Angiovac in treating large IE vegetation. Presentation: (1) A 70-year-old male with HFrEF and inducible VF on electrophysiological study requiring ICD implantation admitted for sepsis with Corynebacterium stratum bacteremia. TTE revealed mobile echo-density, 24 X 14 mm attached to the RV ICD lead. (2) 67-year-old female with sinus node dysfunction requiring permanent pacemaker who presented with constitutional symptoms. Blood culture grew coagulase-negative Staphylococcus. TEE revealed echodense coating around the RV lead, 15 mm in thickness. Management: Patient 1 was deemed nonsurgical candidate by cardiothoracic surgery. Instead, Angiovac was performed. Intraoperative TEE revealed a 30x20mm right atrial ICD lead vegetation. Angiovac catheter was advanced under TEE guidance to the right atrium. Once the catheter was abutting the infected thrombus multiple aspiration harvesting embolic material as in the picture. A postprocedural TTE demonstrated the absence of the RA echodensity. A subsequent laser lead extraction was performed. Patient 2 was given IV vancomycin. Angiovac procedure was successfully performed with subsequent laser lead extraction planning. Conclusion: AngioVac is a minimally invasive and effective procedure in the management of large vegetations in nonsurgical candidate patients.

Abstract 12931: Contemporary Trends of Subcutaneous Implantable Cardioverter Defibrillator Utilization in the United States: Insights From the National Inpatient Sample 2016-2019

Introduction: The subcutaneous implantable cardioverter defibrillator (S-ICD) has emerged as an alternative to the transvenous ICD with comparable efficacy and complication rates in clinical trials. Adoption of this technology and real-world clinical experience are less well described. Methods: This was a retrospective descriptive cohort study using data from National Inpatient Sample (NIS) for calendar years 2016-2019. Outcomes were cardiovascular adverse events, all-cause mortality, 30-day readmission, and resource utilization in patients who had S-ICD implantation. Results: We identified 6655 patients who had S-ICD implantation between 2016-2019. S-ICD implant rates remained between 10-12% of total ICD implants in the US over the study period (Figure 1a), though hospital implant rates were widely distributed (Figure 1b). The mean (SD) age of the population was 56.1 ± 15.9 years, and 2002 patients (30.1%) were female. Median length of stay (IQR) was 6.0 (4.0, 10.0). Hospitalization costs were $ 245937.1 ± 206047.3. Adverse cardiovascular events associated with the hospitalization were: pericardial perforation/cardiac tamponade (0.2%), hemothorax/pneumothorax (1.1%), stroke/TIA (0.5%), cardiogenic shock (8.6%), cardiac arrest (11%), and vascular complications (1.3%). A total of 48 patients (0.7%) died. Non-elective readmission within 30 days post-procedure occurred in 15.7% of cases. Conclusion: S-ICD implant rates were stable over time but varied widely among hospitals. Hospitalization-associated adverse cardiovascular events may be more a reflection of the vulnerable population undergoing S-ICD implant than risk of the procedure.

Impairment of Quality of Life in Patients with Implanted Subcutaneous Cardioverter Defibrillator (S-ICD) Compared to Implanted Transvenous Cardioverter Defibrillator Therapy.

The subcutaneous cardioverter defibrillator (S-ICD) has been shown to be a viable alternative to transvenous ICDs (TV-ICD) in all patients at risk of sudden cardiac death (SCD) but without pacing indication. The aim of this study was to examine the impact of therapy with current S-ICD devices on quality of life (QoL) in comparison to patients with TV-ICD devices. In our single-centre study, 52 consecutive patients with S-ICD and 52 matched patients with TV-ICD were analysed. QoL has been assessed by a standardized questionnaire (EQ-5D-3L, modified). Additionally, clinical baseline and follow-up data were evaluated. Two-thirds of the total study population reported restrictions in daily routine compared to their life before ICD implantation. A total of 27.7% of S-ICD patients stated to expect an improvement of QoL by deactivation or explantation of their defibrillator compared to only 6.4% of patients with TV-ICD (p=0.006), which was mainly caused by discomfort and pain from the S-ICD pocket (relevant discomfort and pain in 32.6% vs 11.5%; p<0.01). Main limitation of the study is that quality of life was assessed for one single time point only and time since implantation differed significantly between S-ICD and TV-ICD. Furthermore our collective is younger, and, due to the high proportion of patients without cardiomyopathy, the mean EF is better than usual ICD collective. The absence of heart failure in about the half of our patients might have relevant impact on our QoL analysis. A relevant proportion of S-ICD patients expects an improvement of QoL by explantation of the device. Of note, this impression was not driven by the fear of receiving shocks but mainly by discomfort and pain caused by the pulse generator.

Use of Sacubitril/Valsartan Prior to Primary Prevention Implantable Cardioverter Defibrillator Implantation

BackgroundImplantable cardioverter defibrillators (ICDs) are an adjunct to guideline-directed medical therapy for heart failure with reduced ejection fraction. The uptake of sacubitril/valsartan in this population is not well described. We report the uptake and factors associated with sacubitril/valsartan use in patients with left ventricular dysfunction undergoing ICD implantation. MethodsA retrospective chart review was performed on all patients with left ventricular dysfunction who underwent de novo primary prevention ICD implantation between October 2015 and December 2021 (n = 422) at Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada. Pre-procedure sacubitril/valsartan use was determined. Logistic regression analysis was performed to examine factors associated with sacubitril/valsartan use. A Bayesian estimator of abrupt change was employed to determine a time period in which a change in the rate of sacubitril/valsartan use occurred. ResultsLoop diuretic use (odds ratio [OR] = 2.20) and higher severity of New York Heart Association class symptoms (OR = 1.62) were associated with sacubitril/valsartan use. Sacubitril/valsartan use increased during the study period, to 59% in December 2021. This increase was larger among those aged ≥ 65 years (OR = 1.09). A change in the rate of sacubitril/valsartan use occurred 3 years after drug approval, 1 year after provincial drug coverage became available, and 6 months after being strongly recommended in clinical guidelines. ConclusionsIn a contemporary cohort of ICD patients, sacubitril/valsartan use increased between 2015 and 2021, notably in those aged ≥ 65 years and after government drug coverage became available. Understanding barriers to sacubitril/valsartan use in ICD patients is recommended to improve clinical outcomes and survival in this population.

Utilization and in-hospital complications associated with implantation of dual versus single chamber implantable cardioverter defibrillator for primary prevention of sudden cardiac death

Abstract Introduction Multiple studies showed no clinical benefit in implantation of a dual compared to a single chamber implantable cardioverter defibrillator (dICD vs. sICD) for primary prevention of sudden cardiac death (SCD), in patients with no pacing indication. We aimed to investigate the extent of utilization and complications in sICD vs. dICD implantations in the US, using the National In-Patient Sample (NIS) database. Methods Using the NIS database, we identified patients who underwent an elective ICD implantation in the US between 2015 (last quarter)-2019. Patients who had concurrent conduction disorders or indication for atrial pacing were excluded. Baseline demographics, clinical characteristics, cardiomyopathy etiologies as well as outcomes including in-hospital complications, length of stay and mortality were collected. Multivariable logistic regression models were used to identify predictors of complications. Results and discussion An estimated total of 15940 patients, who underwent elective ICD implantation for primary prevention of SCD were identified, 8860 (55.6%) of them received a dICD. Forty percent of patients had ischemic cardiomyopathy. The mean age was 64 years and 66% were males. The complication rates documented in the dICD and sICD groups were 13% and 11%, respectively (p&amp;lt;0.001),driven by increased rate of pneumothorax (4.8% vs 3.2%, p&amp;lt;0.001) and lead dislodgement (3.6% vs 2.3%, p&amp;lt;0.001, Table 1). Multivariate analysis confirmed adding an atrial lead as an independent risk factor for “any complication” during ICD implantation [OR 1.13 (1.02–1.25), p=0.022] as well as for pneumo/hemothorax [OR 1.21 (1.03–1.44), p=0.025] and lead dislodgement [OR 1.41 (1.16–1.72), p&amp;lt;0.001]. Conclusion Despite significant evidence for lack of clinical benefit in adding an atrial lead to a primary prevention ICD implantation, significant proportion of the patients in the US are implanted with a dICD. We show increased risk for complications for dICD compared with sICD implantation in the US in recent years, driven by higher incidence of pneumo/hemothorax and lead dislodgement. Funding Acknowledgement Type of funding sources: None.

Cardiac resynchronisation therapy and implantable cardioverter-defibrillator in non-ischaemic systolic heart failure: extended follow-up of the DANISH trial

Abstract Background In the Danish Study to Assess the Efficacy of Implantable Cardioverter-Defibrillators [ICDs] in Patients with Non-ischaemic Systolic Heart Failure on Mortality (DANISH) trial, ICD implantation did not provide an overall survival benefit in patients with non-ischaemic systolic heart failure. A high proportion of patients in the DANISH trial received a cardiac resynchronisation therapy (CRT) device, which improves the prognosis in patients with heart failure. Therefore, it is of interest to examine whether the effect of ICD implantation in patients with non-ischaemic systolic heart failure is modified by CRT. Purpose Adding 4 years of additional follow-up to the DANISH trial, we examined the effect of ICD implantation according to status with respect to CRT implantation at baseline. Methods In the DANISH trial, 556 patients with non-ischaemic systolic heart failure were randomised to receive an ICD and 560 to receive usual clinical care (control). Patients fulfilling indications for a CRT device received a CRT-defibrillator (if randomised to ICD arm) or CRT-pacemaker (if randomised to control arm). In the ICD group, 322 patients (57.9%) received a CRT device; in the control group, 323 patients (57.7%) received a CRT device. In this extended follow-up study, patients were followed until May 18, 2020. The primary outcome was death from any cause; secondary outcomes were cardiovascular death and sudden cardiovascular death. Results During a median follow-up of 9.5 years, the ICD group did not have significantly lower all-cause mortality compared with the control group (hazard ratio [HR] 0.89 [95% CI, 0.74–1.08]). The results were independent of whether the patient received a CRT device at randomisation (patients with a CRT device: HR 0.92 [95% CI, 0.72–1.18]; patients without a CRT device: HR 0.86 [95% CI, 0.64–1.14]; P for interaction, 0.72). Similarly, ICD implantation did not reduce rates of cardiovascular death overall (HR 0.87 [95% CI, 0.70–1.09]), and this association was not modified by CRT (patients with a CRT device: HR 0.89 [95% CI, 0.66–1.19]; patients without a CRT device: HR 0.85 [95% CI, 0.60–1.20]; P for interaction, 0.86). The ICD group had significantly lower rates of sudden cardiovascular death in the overall population (HR, 0.60 [95% CI, 0.40–0.92]), and this association was not modified by CRT (patients with a CRT device: HR 0.69 [95% CI, 0.40–1.21]; patients without a CRT device: HR 0.51 [95% CI, 0.26–0.97]; P for interaction, 0.47). See Figure 1 for all results. Conclusions In this extended follow-up study of the DANISH trial, the effect of ICD implantation in patients with non-ischaemic systolic heart failure was not modified by CRT. Funding Acknowledgement Type of funding sources: Foundation. Main funding source(s): The DANISH trial was supported by unrestricted grants from Medtronic, St Jude Medical, Tryg Fonden, and the Danish Heart Foundation. No further funding was obtained for this follow-up study.

High prevalence of malignant ventricular arrhythmias in patients with early-stage left ventricular noncompaction

Abstract Background Early-stage left ventricular non compaction (LVNC) is a nonischemic cardiomyopathy characterized with nondilated phenotype and unpredictable risk of malignant ventricular arrhythmias (MVA). Purpose To report the occurrence of MVA in patients with early-stage LVNC. Methods Consecutive patients (n=63) diagnosed with LVNC according to recognized criteria either on transthoracic echocardiogram or cardiac magnetic resonance were retrospectively enrolled. Patients with late-stage LVNC, defined by a coexistent dilated cardiomyopathy phenotype, were excluded (n=49). Patient-tailored medical treatment, as well as ICD implantation strategies, were based on the updated ESC guidelines integrated by the experience of a referral center for arrhythmia management. The study endpoint was the occurrence of MVA (defined as sustained VT, VF, or appropriate ICD therapy) by 5-year follow-up. Results The study cohort consisted of 14 patients (mean age 37±17 y, 64% males), presenting with palpitation (n=4), syncope (n=4), or dyspnea on effort (n=6). LVNC was diagnosed by echocardiogram and cardiac magnetic resonance in 13 and 1 patients, respectively. Because of nonmalignant VA, seven patients (50%) underwent ICD implant before discharge. By 5-year follow-up, 5 patients (36%) experienced MVA, including VF or appropriate ICD shocks for fast VT. Left ventricular ejection fraction (LVEF) ≥45% was the only factor associated with the occurrence of MVA (5/11 event in cases with LVEF ≥45% vs. 0/3 events in controls with LVEF &amp;lt;45%; p=0.145). Baseline features, including age, gender, NC/C ratio, and clinical presentation were comparable between cases with LVEF ≥45% and controls, all p&amp;gt;0.05. Drug treatment, including RAAS inhibitors, betablockers and antiarrhythmics was also comparable. Conclusions Our preliminary data show that in early-stage LVNC the occurrence of MVA is higher for patients with LVEF ≥45%. Efforts are needed to identify earlier predictors of arrhythmic risk, to improve patient selection for ICD implant. Funding Acknowledgement Type of funding sources: None.

Driving restrictions following defibrillator implantation significantly affect recipients' ability to maintain employment

Abstract Background Following defibrillator implantation or in case of ICD therapy, ICD recipients are subject to temporary driving restrictions for private driving. Moreover, the current European recommendations permanently ban professional driving which can significantly alter the recipients' daily life and ability to maintain employment. Aim and methods To investigate Danish ICD recipients' perspective on driving restrictions following ICD implantation we distributed a questionnaire to all living ICD patients with a first-time implantation between 2013 and 2016 (n=3913). We linked questionnaire responses with relevant nationwide Danish registers. Results Among the 2741 ICD recipients who responded to the questionnaire (response rate 71%, 47% primary prevention, 83% male, median age 67 years), 2513 (92%) held a valid private driver's license at time of implantation and 175 (7%) were actively using a professional driver's license. Almost all (n=2344, 94%) had resumed driving following device implantation. Among those with a driving ban of at least 1 month following either ICD implantation or ICD therapy (n=911), 26% stated the restrictions had severely impeded their daily life, significantly more in the professional drivers group compared with the private drivers (32% vs 24%, p=0.01). Including only patients working prior to implantation (n=465), 27% stated they were very limited and 20% somewhat limited in maintaining employment following implantation due to the driving restrictions. Likewise, 23% were very limited and 19% somewhat limited in getting to their job. Among the active professional drivers (n=175), 58 (33%) stated they had lost their job as a direct consequence of the post-implantation driving restrictions. Conclusion Every fourth Danish ICD recipient is severely limited in their daily life due to the driving restrictions. Both professional and private drivers are significantly affected with regards to maintaining employment following implantation, which should be a key focus in rehabilitation programs. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): The Danish Heart Foundation and Arvid Nilssons Fond

Distribution and cardiac outcomes of neuromuscular disorders referred to an inherited cardiac disease unit

Abstract Backgroud Neuromuscular disorders may present with varied cardiac involvement, including myocardial and conduction tissue disease. Sudden death is a common adverse event of cardiomyopathy Purpose The objective was to present clinical characteristics of neuromuscular disorders referred to a dedicated inherited cardiac disease unit with special interest in the mode of presentation, clinical course and cardiac complications. Methods Cardiological anamnesis, 12-lead electrocardiogram and bidimensional echocardiogram were performed to every individual. Gadolinium cardiac MRI/24 hour-Holter/coronariography were performed in particular cases where results of previous tests made it mandatory. Results 199 patients (aged 43.1±18.1 years, 45.2% females, 54.8% males) with neurological disorders evaluated in an inherited cardiac disease clinic from 2003–2021 were included. There were 20 (10.1%) dystrophynopathies, 20 (10.1%) limb girdle muscular dystrophy, 14 (7.0%) other muscular dystrophies (Emery-Dreifuss, facio-scapulo-humeral, oculopharyngeal), 70 (35.2%) myotonic myopathies (Steinert myotonic dystrophy, Becker myotonia congenita, Thomsen myotonia congenita), 7 (3.5%) myofibrillar myopathies, 14 (7.0%) congenital myopathies, 18 (9.0%) metabolic myopathies, 12 (6.0%) unknown origin inherited myopathies, 24 (12.1%) non-myopathic neurological diseases. There were 44 (22.11%) patients affected with a cardiomyopathy. 51/199 (25.6%) had conduction disturbances. 33/51 had pathological cardiac findings without clinical cardiomyopathy. Age of diagnosis of neurological and cardiomyopathy conditions were 28.4±20.4 and 40.6±18.4 years old respectively. Reasons for diagnosis were symptoms (164, 82.4%), family screening (27, 13.6%), incidental finding (7, 3.5%), sudden death (1, 0.5%). 31 (15.6%) had atrial fibrillation, 17 (8.5%) required pacemaker and 15 (7.5%) ICD implantation. 32 (16.1%) patients died or had severe cardiac outcome. 7 (3.5%) had sudden death or equivalent, 3 (1.5%) heart-failure-death, 1 (0.5%) received cardiac transplantation, 18 (9.1%) had other-disease-related-death and 3 (1.5%) other disease non-cadiac-related-death). Conclusion Neuromuscular diseases require periodic cardiac evaluation. Despite onset of neurological symptoms usually precede cardiac involvement, the burden of cardiac involvement and complications is highly significant. Cause of death in neurological conditions with cardiac involvement is mostly driven by the severity of the cardiomyopathy. Funding Acknowledgement Type of funding sources: None.

Cardiotoxicity in Ewing- and osteosarcoma: a 40 year experience from a tertiary sarcoma center

Abstract Background While malignant bone sarcoma is rare in the general population, it is the second most common malignancy among children and young adults. (Neo)adjuvant systemic treatment carries a significant risk of cardiotoxicity (CTx) in the form of late-onset left ventricular dysfunction and heart failure. There are several long-term follow up protocols in place for survivors of childhood and adolescent cancers, but when sarcoma is diagnosed at higher age the best follow up practice is less clear and there is little known about the long-term risk and mode of onset of CTx. Purpose To evaluate the effect of age at sarcoma diagnosis on incidence of cardiotoxicity (CTx) and time-to-CTx. Methods This single-center retrospective analysis of CTx of sarcoma treatment was performed at a tertiary sarcoma center in the Netherlands (Leiden University Medical Center, LUMC) among patients with a high-grade osteosarcoma (OS) and Ewing sarcoma (ES). All patients were diagnosed and treated over a 36-year period (1982 and 2018) at LUMC, and followed up until August 2021. The main inclusion criterium was exposure to doxorubicin-containing chemotherapy regimens. The exposure of interest was age at cancer diagnosis with a cut-off for older age at ≥30 years (age30+) The primary study endpoint was incident clinically relevant CTx at follow up, defined as composite of pharmacological heart failure (HF) treatment initiation, HF admissions and ICD implantation. Cause-specific Cox modeling was performed to calculate the hazard ratio (HR) of age group and incidence of both the primary study endpoint and competing risk of all cause death. Results The study population consisted of 556 patients (69.0% OS, 31.0% ES) with a median age at sarcoma diagnosis of 19 [p25-p75: 15–30] years and the majority of patients were male (60.4%). 146 patients were in the age30+ group (26.3%). In a median follow up time of 5.5 [2.0–13.2] years, 27 patients reached the primary endpoint (4.9%). In 7/27 cases an urgent HF hospitalization was the first manifestation of HF and the remaining cases met the primary endpoint due to pharmacological HF treatment imitation. At the end of follow up mortality was 49.3% of patients. The vast majority of patients died of malignancy-related causes (95.6%). When correcting for female sex and sarcoma type, age30+ at sarcoma diagnosis was associated with a near 3.5 fold increased risk of HF compared to when sarcoma was diagnosed below 30: HR 3.39 (95% CI: 1.57–7.31), p=0.019. For the age30+ group whom experienced CTx the time-to-event was shorter compared to those diagnosed below 30 years at: respectively 5.5 years vs. 12.6 years (see Figure 1; Wilcoxon rank-sum test: p=0.012). Conclusions Sarcoma patients above 30 years at diagnosis have an increased risk of CTx and time to development of CTx was significantly shorter. Funding Acknowledgement Type of funding sources: None.