Outcomes Of Implantable Cardioverter-defibrillator Research Articles

Global and Temporal Trends in Utilization and Outcomes of Implantable Cardioverter Defibrillators in Hypertrophic Cardiomyopathy.

Over the past decades, hypertrophic cardiomyopathy has become a contemporary treatable disease. However, limited data exist on the global trends of implantable cardioverter defibrillator (ICD) utilization and its impact on mortality/morbidity burden reduction. Electronic databases were systematically searched up to March 2024 for studies reporting on ICD utilization rates in hypertrophic cardiomyopathy. A random effects model was used to pool study estimates across time-era, geographic region, and age group. Primary outcome was global trends in ICD utilization. Secondary outcomes included trends of sudden cardiac death, appropriate/inappropriate shocks, and ICD-related complications. In total, 234 studies (N=92 500, 514 748 patient-years) met inclusion criteria. Mean age was 46.2 (12.4) years and 37.49% were women. A total of 12 139 patients (16.43%) received an ICD over 429 766 person-years of follow-up, with an ICD implantation rate of 2.79%/y ([95% CI, 2.35%-3.32%] I²=97.80%). Rates of ICD implantation steadily increased over time from 1990 (1.09%) to 2021 (4.01%; P=0.002), with noticeable geographic variation (P=0.008). The overall rate of appropriate ICD discharges and ICD-related complications was 3.44%/y ([95% CI, 3.08%-3.84%] I²=88.40%) and 1.98%/y ([95% CI, 1.52%-2.59%] I²=90.44%), respectively, with no significant trend over time. The overall rate of inappropriate discharges was 3.58%/y ([95% CI, 3.08%-4.16%] I2=88.03%), and declined significantly over time (P=0.044). There was a significant decline in the rates of sudden cardiac death from 1990 (0.84%/y) to 2020 (0.31%/y). Dramatic increases in ICD utilization have occurred, representing a 3.7-fold increase, with appropriate therapies occurring in 3.44%/y. Dramatic increases in ICD utilization have occurred, representing a 3.7-fold increase, with appropriate therapies occurring in 3.44%/y, In parallel a significant reduction in sudden cardiac death was observed, but there are insufficient data to demonstrate that a causative relationship exists. Geographic disparities in ICD utilization were evident, highlighting the need to improve access to specialized care for patients with hypertrophic cardiomyopathy. Geographic disparities in ICD utilization were evident, highlighting the need to improve access to specialized care for patients with hypertrophic cardiomyopathy. URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD42023407126.

3D is superior to 2D echocardiography in identifying high risk patients with heart failure with reduced ejection fraction and indication for device therapy

Abstract Background In patients with heart failure with reduced ejection fraction (HFrEF), a left ventricular ejection fraction (LVEF) less than 35% has been identified as a significant risk factor for increased mortality. As a result, all studies assessing the indications and outcomes of implantable cardioverter-defibrillators and cardiac resynchronization therapy in HFrEF used this cut-off, measured by 2-dimensional echocardiography (2DE). However, many patients with HFrEF and a LVEF >35% by 2DE, who do not qualify for device therapy, still experience significant mortality. Purpose To investigate whether, in patients hospitalized with both ischemic and non-ischemic HFrEF, the LVEF measured by 3-dimensional echocardiography (3DE) could identify better patients at high risk of death, thereby indicating the need for device therapy. Methods 322 consecutive patients (60±11 years, 72% men), hospitalized for HFrEF or HFmrEF, were assessed using both 2DE and 3DE, including full-volume acquisitions of the LV. From 2D datasets, LV end-systolic (LVESV) and LV end-diastolic (LVEDV) volumes, and LVEF were estimated. From the 3D volumes, the same parameters were measured. Patients were discharged on optimal HF treatment, according to current ESC guidelines, and were followed for 24±8 months after the initial event. The primary outcome was cardiovascular death (CD). Results At admission, 43% patients were in NYHA class II, 25% in NYHA class III, and 33% in NYHA class IV. There was a similar burden of ischemic and non-ischemic etiology (52% vs 48%). Mean 2D LVEF was 31±11%, while mean 3D LVEF was 30±10% (p=NS). There were 62 CD (19%) during follow-up. Binary logistic regression for the 2D and 3DE parameters showed that only 3D LVEF was a significant predictor of death (β=-0.04, OR 0.96, 95%CI 0.93-0.98, p=0.003). By 2DE, 206 patients (64%) had LVEF <35%, of whom 47 patients died (23%) and 159 patients survived (77%), whereas by 3DE, 215 patients (67%) had LVEF <35%, of whom 60 patients died (28%) and 155 patients survived (72%). Consequently, 2D LVEF <35% identified 47 out of 62 deaths (76%), whereas 3D LVEF <35% identified 60 out of 62 deaths (97%). By ROC Analysis, 3DE was superior to 2DE for prediction of survival: AUC 0.62, p=0.03 for 3D LVEF vs. AUC 0.56, p=0.09 for 2D LVEF. Kaplan-Meier analysis (Figure) showed that 2D LVEF <35% discriminated between survivors and non-survivors with a Chi-square of 6.8, p=0.01, whereas 3D LVEF <35% discriminated between survivors and non-survivors with a Chi-square of 30.3, p<0.001. Conclusion 3DE assessment of LVEF and its cut-off of 35% enhances the identification of patients with HFrEF at high risk of death. This suggests that 3DE should be utilized for risk stratification in HFrEF, potentially leading to more accurate indications for device therapy. Survival according to 2D vs 3D LVEF

Outcomes of implantable cardioverter-defibrillators in patients with a left ventricular assist device: a systematic review and meta-analysis

Abstract Introduction Implantable Cardioverter-Defibrillators (ICDs) improve survival in advanced heart failure with reduced ejection fraction (HFrEF) and prevent sudden cardiac death. However, the prognostic benefits of ICDs among patients with a Left Ventricular Assist Device (LVAD) remain uncertain and controversial. Therefore, we conducted a systematic review and meta-analysis to assess the effectiveness and safety of ICD implantation among LVAD recipients. Methods We performed a systematic review and meta-analysis following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We searched PubMed and EMBASE for the peer-reviewed articles published in English assessing the impact of ICD implantation among LVAD recipients, till 10/01/2024. ICD implantation was defined as implantation before LVAD, simultaneous implantation with LVAD, or within 30 days of LVAD insertion. Two independent review authors assessed the quality and risk of bias of the included studies. A random-effect model was used to combine data in forest plots. The primary outcome was all-cause mortality associated with ICD implantation compared to no ICD implantation, and the secondary outcomes included ventricular arrhythmia (VT), and hemorrhagic stroke. Heterogeneity was assessed using Q test and I2, with I2 > 50% indicating marked heterogeneity. Results A total of 13 observational studies comprising 54571 recipients of LVAD were included in the analysis of the primary outcome. All-cause mortality was similar among patients with ICD versus no ICD (Odds Ratio [OR]= 0.77; 95% CI, 0.57-1.04, I2= 89%, P=0.09), as shown in Figure 1. Likewise, ICD implantation was associated with similar rates of VT and hemorrhagic stroke (VT: OR= 1.81, 95% Cl, 0.82-4.01, I2= 90%, P=0.14; hemorrhagic stroke: OR= 1.01, 95% Cl, 0.81-1.25, I2= 0%, P= 0.95). Conclusion Among patients with HFrEF and LVAD as advanced heart failure therapy, ICD implantation didn’t provide additional prognostic survival benefit, suggesting possible use of LVAD without ICD implantation.Figure 1.Forest plot of mortality

Long-Term Clinical Outcomes of Implantable Cardioverter Defibrillator Recipients in New Zealand: A Subanalysis by Sex, Age Group, and Ethnicity

The long-term clinical outcomes of implantable cardioverter defibrillator (ICD) recipients across New Zealand are unknown. This study provides a detailed subanalysis of long-term clinical outcomes of ICD recipients by sex, age group, and ethnicity. All patients with an ICD implant between 2010 and 2019 were identified using the National Minimum Dataset, which collects all public hospital admissions in New Zealand using International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification (ICD10-AM) procedure coding. There were 4,261 patients with a mean follow-up of 4.85±2.76 years. The median age was 62 years and 78.9% were male. The all-cause mortality was higher in males compared with females (23.1% vs 17.2%; p<0.001). There was no significant difference by primary and secondary prevention indication ICD in each sex group. Heart failure (HF) hospitalisation was higher in males compared with females (29.4% vs 26.6%; p=0.009). All-cause mortality was highest in the age group of ≥80 years and lowest in those <40 years (44.1% vs 8.4%, p<0.001). HF hospitalisation was highest in the age group of 70–79 years and lowest in the age group <40 years (36.5% vs 16.1%; p<0.001). All-cause mortality was highest in Māori and lowest in Asians (26.7% vs 15.9%; p<0.001). Heart failure hospitalisation was highest in Māori and lowest in Europeans (36.1% vs 26.3%; p<0.001). In New Zealand, all-cause mortality and HF hospitalisation was highest in males and Māori ICD recipients. These disparities in clinical outcomes warrant further investigation.

Long-term Clinical Outcomes of Implantable Cardioverter Defibrillator Recipients in New Zealand

The long-term clinical outcomes of implantable cardioverter defibrillator (ICD) recipients across New Zealand are unknown. This study provides a detailed analysis of long-term clinical outcomes of ICD recipients in New Zealand over the past decade. All patients with an ICD implant between 2010 and 2019 were identified using the National Minimum Dataset, which collects all public hospital admissions in New Zealand using International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification (ICD10-AM) procedure coding. There were 4,261 patients with a mean follow-up of 4.85±2.76 years. There were 1,739 (40.8%) primary prevention and 2,522 (59.2%) secondary prevention ICD recipients. The median age was 62 years and 78.9% were male. There was no significant difference in all-cause mortality between primary prevention or secondary prevention ICD recipients (21.7% vs 21.9%, p=0.99). In the primary prevention ICD group, heart failure (HF) hospitalisation more frequently occurred (32.7% vs 26.1%, p<0.001) but hospitalisations with ventricular arrhythmia (VA) were less common (16.7% vs 27.1%, p<0.001). Compared with ICD recipients with non-ischaemic aetiology for HF, those with ischaemic HF had higher all-cause mortality (30.0% vs 16.1%, p<0.001), HF hospitalisation (38.0% vs 22.4%, p<0.001), and hospitalisation with VA (27.9% vs 19.4%, p<0.001). In New Zealand ICD recipients, there was no difference in all-cause mortality between primary prevention and secondary prevention ICD implants. However, ICD recipients with ischaemic aetiology for HF had significantly higher all-cause mortality, HF hospitalisation, and hospitalisation with VA.

Mechanical extraction of implantable cardioverter-defibrillator leads with a dwell time of more than 10 years: insights from a single high-volume centre.

To analyze and compare the effectiveness and safety of transvenous lead extraction (TLE) of implantable cardioverter-defibrillator (ICD) leads with a dwell time of >10 years (Group A) vs. younger leads (Group B) using mechanical extraction systems. Between October 2011 and July 2022, we performed TLE in 318 patients. Forty-six (14.4%) extracted ICD leads in 46 (14.5%) patients that had been implanted for >10 years. The median dwell time of all extracted ICD leads was 5.9 years. Cardiovascular implantable electronic device-related infection was an indication for TLE in 31.8% of patients. Complete ICD leads removal and complete procedural success in both groups were similar (95.7% in Group A vs. 99.6% in Group B, P = 0.056% and 95.6% in Group A vs. 99.6% in Group B, P = 0.056, respectively). We did not find a significant difference between major and minor complication rates in both groups (6.5% in Group A vs. 1.5% in Group B and 2.2% in Group A vs. 1.8% in Group B, P = 0.082, respectively). One death associated with the TLE procedure was recorded in Group B. The TLE procedures involving the extraction of old ICD leads were effective and safe. The outcomes of ICD lead removal with a dwell time of >10 years did not differ significantly compared with younger ICD leads. However, extraction of older ICD leads required more frequent necessity for utilizing multiple extraction tools, more experience and versatility of the operator, and increased surgery costs.

Outcomes of implantable cardioverter-defibrillator implantation in HIV-infected patients: A single-center retrospective cohort study.

BackgroundHIV‐infected individuals have a known increased risk of sudden cardiac death (SCD) compared to uninfected individuals. Implantable cardioverter‐defibrillators (ICDs) are standard therapy for preventing SCD; however, there is limited data on the outcomes of ICDs in HIV‐infected individuals.HypothesisHIV‐infected subjects receive a higher number of appropriate ICD therapies than uninfected controls.MethodsThis is a retrospective cohort study of 35 consecutive HIV‐Infected patients and 36 uninfected controls matched by age, race, and gender who were treated at the University of North Carolina Medical Center in the outpatient or inpatient setting from 2014 to the present and had undergone ICD implantation. For HIV‐infected subjects, a multivariate Poisson regression analysis was performed to evaluate the association between covariates and ICD therapies.ResultsAmong HIV‐infected subjects, the mean CD4 count was 582.5 cells/mm3 and 69% had an undetectable viral load. The median follow‐up was 6.4 years. HIV‐infected subjects had both a higher number of appropriate ICD shocks or antitachycardia pacing (ATP) therapy per person‐year as well as a higher number of inappropriate ICD shocks per person‐year than uninfected controls (1.512 vs. 0.590 and 0.122 vs. 0.0166, respectively, p < .001 for both comparisons). After multivariate adjustment, the presence of detectable/unsuppressed viral load at the time of ICD implantation was an independent predictor of both of the following in HIV‐infected subjects: (1) appropriate ICD discharge (p = .004), and (2) appropriate ICD discharge or appropriate ATP therapy (p < .001).ConclusionHIV‐infected subjects had a higher number of appropriate ICD discharge or ATP therapy per person‐year than matched uninfected controls.

Implantable Cardioverter Defibrillators in Infants and Toddlers: Indications, Placement, Programming, and Outcomes

Limited data exist regarding implantable cardioverter defibrillator (ICD) usage in infants and toddlers. This study evaluates ICD placement indications, procedural techniques, programming strategies, and outcomes of ICDs in infants and toddlers. This is a single-center retrospective review of all patients ≤3 years old who received an ICD from 2009 to 2021. Fifteen patients received an ICD at an age of 1.2 years (interquartile range [IQR], 0.1-2.4; 12 [80%] women; weight, 8.2 kg [IQR, 4.2-12.6]) and were followed for a median of 4.28 years (IQR, 1.40-5.53) or 64.2 patient-years. ICDs were placed for secondary prevention in 12 patients (80%). Diagnoses included 8 long-QT syndromes (53%), 4 idiopathic ventricular tachycardias/ventricular fibrillations (VFs; 27%), 1 recurrent ventricular tachycardia with cardiomyopathy (7%), 1 VF with left ventricular noncompaction (7%), and 1 catecholaminergic polymorphic ventricular tachycardia (7%). All implants were epicardial, with a coil in the pericardial space. Intraoperative defibrillation safety testing was attempted in 11 patients (73%), with VF induced in 8 (53%). Successful restoration of sinus rhythm was achieved in all tested patients with a median of 9 (IQR, 7.3-11.3) J or 0.90 (IQR, 0.68-1.04) J/kg. Complications consisted of 1 postoperative chylothorax and 3 episodes of feeding intolerance. VF detection was programmed to 250 (IQR, 240-250) ms with first shock delivering 10 (IQR, 5-15) J or 1.1 (IQR, 0.8-1.4) J/kg. Three patients (20%) received appropriate shocks for ventricular tachycardia/VF. No patient received an inappropriate shock. There were 2 (13%) ventricular lead fractures (at 2.6 and 4.2 years post-implant), 1 (7%) pocket-site infection, and 2 (13%) generator exchanges. All patients were alive, and 1 patient (7%) received a heart transplant. ICDs can be safely and effectively placed for sudden death prevention in infants and toddlers with good midterm outcomes.

Mode of death and outcomes of implantable cardioverter defibrillators in transthyretin amyloid cardiomyopathy

IntroductionTransthyretin cardiac amyloidosis (ATTR-CM) may associate with sudden cardiac death. We report on the mode of death and outcomes with implantable cardioverter defibrillators (ICDs) in a cohort with ATTR-CM. MethodsA single center observational cohort study of patients with ATTR-CM diagnosed between 2005 and 2019. ICD implant was at discretion of treating cardiologists. Medians are expressed with 25th,75th percentiles. ResultsEighty-four patients with ATTR-CM (age 73.5 ± 9.7 years, 94% male, median follow-up 21.1 months (11.4–38.1). Nineteen patients (23%) underwent ICD implantation – 18 for primary and 1 for secondary prevention. In the primary prevention ICD group, 1 patient had 2 inappropriate shocks, 1 patient had appropriate ATP on 3 occasions. One patient (mixed ischemic cardiomyopathy and ATTR-CM) with secondary prevention ICD had 15 appropriate shocks in 3 episodes of VT storm. In patients without ICD, ambulatory monitoring review (14,764 h) did not reveal sustained ventricular arrhythmia. Excluding the one patient with secondary prevention ICD, 5 (28%) in the primary prevention ICD group and 22 (34%) in the non-ICD group died, p = 0.14. Mode of death did not vary between both groups. ConclusionsPatients with ATTR-CM and primary prevention ICD infrequently receive appropriate device therapy without differing in mode of death, which was mainly related to progressive heart failure, compared to those without ICD.

Implantable cardioverter defibrillators in adult congenital heart disease: long-term follow up of therapies, complications and clinical events

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Adults with congenital heart disease (ACHD) at increased risk for sudden cardiac death (SCD) often undergo implantable cardioverter defibrillator (ICD) implantation at young ages. Data evaluating the long-term outcomes of ICD in this population remain scarce. We aimed to characterize the population with ACHD and an ICD. Methods Consecutive ACHD submitted to an ICD implantation in a single tertiary center were evaluated. Data on baseline clinical features, heart defect, indication for ICD, type of device, ICD-related complication and therapies and mortality during follow-up were collected. Results A total of 34 patients (P) were evaluated. Median age at implant was 39.3 years (interquartile range [IQR] 29-5-53.6) and median left ventricular ejection fraction (LVEF) was 43.5% (IQR 28.0-53.3). The most common heart defect was tetralogy of Fallot (11P;32,3%), followed by dextro-transposition of the great arteries, ostium secundum atrial septal defect (ASD) and ventricular septal defect (Figure 1). All P were submitted to surgical correction (median age at surgery 12.5 years [IQR 3.0-29.1]). Sixteen P underwent ICD implantation for primary prevention of SCD, owing to complex cardiopathy and ventricular dysfunction, and 18P due to spontaneous ventricular tachyarrhythmias. The implantable devices were a single-chamber ICD in 55.9%, a double-chamber ICD in 17.6%, a subcutaneous ICD in 20.6% and a CRT-D in 5.9%. During a median follow-up of 4.5 years (IQR 2.1-8.8), 52.9% of the P received appropriate ICD therapies, corresponding to 37.5% and 66.7% of primary and secondary prevention P, respectively. Median time to first arrhythmic event was 25.3 months (IQR 13.7-52.9). Six P (17.6%) suffered ICD-related complications and 20.6% received inappropriate therapies due to supraventricular tachyarrhythmias. During follow-up, 8.8% were submitted to heart transplant and 29.4% died (Table 1). ICD therapies were associated with a composite of death, cardiac transplantation and hospital admission (OR 5.0, 95% CI 1.0-24.3). Conclusion ACHD with ICD experience high rate of appropriate therapies, including those implanted for primary prevention. The long-term burden of ICD-related complications and inappropriate shocks underlines the need for careful risk stratification and close monitoring. The increased survival of this population justifies collecting data on long-term outcomes to improve its care. Abstract Figure.

Comparison of cost-effectiveness of implantable cardioverter defibrillator therapy in patients for primary prevention in Latin America: an analysis using the Improve SCA study

Objective The mortality benefit of implantable cardioverter defibrillators (ICDs) for primary prevention (PP) of sudden cardiac arrest (SCA) has been well-established, but ICD therapy remains globally underutilized. The results of the Improve SCA study showed a 49% relative risk reduction in all-cause mortality among ICD patients with 1.5 primary prevention (1.5PP) characteristics (patients with one or more risk factors, p < 0.0001). We evaluated the cost-effectiveness of ICD compared to no ICD therapy among patients with 1.5PP characteristics in three Latin American countries and analyzed the factors involved in cost-effectiveness. Methods We used a published Markov model that compares costs and outcomes of ICD to no ICD therapy from local payers’ perspective and included country-specific and disease-specific inputs from the Improve SCA study and current literature. We used WHO-recommended willingness-to-pay (WTP) thresholds to assess cost-effectiveness and compared model outcomes between countries. Results Incremental costs per QALY (quality-adjusted life year) saved by ICD compared to no ICD therapy are Colombian Pesos COP$46,729,026 in Colombia, Mexican Pesos MXN$246,016 in Mexico, and Uruguayan Pesos UYU$1,213,614 in Uruguay in the base case scenario; all three figures are between 1–3-times GDP per capita for each country. One-way and probabilistic sensitivity analyses confirm the base case scenario results. Non-cardiac accumulated deaths are lower in Mexico, resulting in a comparatively increased cost-effective ICD therapy. Limitations The Improve SCA study was not randomized, so clinical results could be biased; however, measures were taken to reduce this bias. Costs and benefits were modelled beyond the timeline of direct observation in the Improve SCA study. Conclusions ICD therapy is cost-effective in Mexico and Uruguay and potentially cost-effective in Colombia for a 1.5PP population. Variability in ICER estimates by country can be explained by differences in non-cardiac deaths and cost inputs.

Short and long-term outcomes of medical management of patients with a first episode of arrhythmic storm

Abstract Introduction There is few data about long-term outcomes of conservative management (without catheter ablation) of patients with a first episode of arrhythmic storm (AS) in the current context. This study analyzes the short and long-term outcomes of implantable cardioverter defibrillator (ICD) patients with a first episode of AS receiving non-interventional management. Methods Consecutive patients admitted with a first episode of AS between January 2008 and June 2019 receiving medical management without catheter ablation were included. AS was defined as 3 or more appropriate ICD therapies occurring during a 24 h span. Medical management included: correction of triggers, sedation/mechanical ventilation, antiarrhythmic drugs, ICD reprogramming and neuraxial modulation. Baseline clinical characteristics and follow-up data were recorded. All patients were followed every 6 months at the ICD office. The primary end-point was all-cause mortality. Results 60 patients (81% male, 62.8±16.2 years, 43% ischaemic, LVEF 35.4±14%) with a first episode of AS treated conservatively were included. Thirty-day survival was 96.5% and 1-year survival was 82%. During a median (interquartilic range) follow-up of 31 (6–69) months, 31 (51.7%) patients died (51.6% due to cardiovascular aetiology) and 35 (58.3%) patients were readmitted (48.5% due to recurrent arrhythmic events and 45.7% due to heart failure). Age [HR 1.05 (95% confidence interval: 1.01–1.08)] and end-diastolic diameter [HR 1.05 (95% confidence interval: 1–2)] were the strongest independent predictors of all-cause mortality. Conclusion Despite the severity of this entity, medical management (without catheter ablation) of a first episode of AS is reasonable given its good 30-day and 1-year survival. However, a high rate of AS recurrence and readmissions are observed during long-term follow-up. Efforts are needed in order to identify those patients with a first episode of AS that could benefit from an early catheter ablation strategy. Funding Acknowledgement Type of funding source: None

P505Short and long-term outcomes of medical management of patients with a first episode of arrhythmic storm

Abstract INTRODUCTION There is few data about long-term outcomes of conservative management (without catheter ablation) of patients with a first episode of arrhythmic storm (AS) in the current context. This study analyzes the short and long-term outcomes of implantable cardioverter defibrillator (ICD) patients with a first episode of AS receiving non-interventional management. METHODS Consecutive patients admitted with a first episode of AS between January 2008 and June 2019 receiving medical management without catheter ablation were included. AS was defined as ≥ 3 appropriate ICD therapies occurring during a 24h span. Medical management included: correction of triggers, sedation/mechanical ventilation, antiarrhythmic drugs, ICD reprogramming and neuraxial modulation. Baseline clinical characteristics and follow-up data were recorded. All patients were followed every 6 months at the ICD office. The primary end-point was all-cause mortality. RESULTS 60 patients (81% male, 62.8 ± 16.2 years, 43% ischaemic, LVEF 35.4 ± 14%) with a first episode of AS treated conservatively were included. Thirty-day survival was 96.5% and 1-year survival was 82%. During a median (interquartilic range) follow-up of 31 (6-69) months 31 (51.7%) patients died (51.6% due to cardiovascular aetiology) and 35 (58.3%) patients were readmitted (48.5% due to recurrent arrhythmic events and 45.7% due to heart failure). Age [HR 1.05 (95% confidence interval: 1.01-1.08)] and end-diastolic diameter [HR 1.05 (95% confidence interval: 1-2)] were the strongest independent predictors of all-cause mortality. CONCLUSION Despite the severity of this entity, medical management (without catheter ablation) of a first episode of AS is reasonable given its good 30-day and 1-year survival. However, a high rate of AS recurrence and readmissions are observed during long-term follow-up. Efforts are needed in order to identify those patients with a first episode of AS that could benefit from an early catheter ablation strategy.

916The impact of anesthesia choice on subcutaneous implantable cardioverter defibrillator outcomes: acute and one year results from the post approval study

Abstract Funding Acknowledgements This study was financially supported by Boston Scientific The influence of anesthesia technique on the outcomes of subcutaneous implantable cardioverter defibrillator (SICD) implantation has not been prospectively evaluated. The aim of the present analysis was to characterize the effect of anesthesia choice acutely and over a year follow-up in the large "real-world" cohort of the SICD Post Approval Study (SICD-PAS). Patients received either general anesthesia (GA), conscious sedation (CS), or monitored anesthesia care (MAC) at the implanting physicians" discretion. Acute results and complications over one year were compared between GA, CS and MAC. 1,631 patients were studied. 64.3% received GA , 29.2% received CS and 6.6% received MAC. Procedure times were shortest for MAC versus GA and CS (Table 1). Cross-over from CS and MAC to GA occurred in 2.9% and 1.9% of procedures, respectively. The mean left ventricular ejection fraction (LVEF) was lower in the MAC cohort compared with GA and CS. GA patients were less often discharged the same day than CS and MAC. Patients who had GA were more likely to have had intra-operative DFT testing, while successful DFT testing at implant did not differ among groups (Table 1). At one year, freedom from total complications did not differ between groups (93.3% for GA, 92.9% for CS and 87.8% for MAC, p = 0.095) nor did freedom from inappropriate shocks (94% for GA, 94.2% for CS, 88.9% for MAC, p = 0.138) nor appropriate shocks (95.8% for GA, 95% for CS, 95% for MAC, p = 0.747). All three anesthesia techniques had similar acute and one year outcomes but, despite having worse LVEF, patients who received MAC had shorter procedure times and infrequently required conversion to GA. GA was associated with higher rates of next day patient discharge. These results suggest that MAC may be preferred for the majority of patients. This observation should be confirmed with prospective trials. Table 1:Characteristics and Outcomes Parameter Conscious Sedation General Anesthesia Monitored Anesthesia Care P value Gender[%(N/Total)] Male 68.1 (324/476) 69.3 (726/1048) 66.4 (71/107) 0.77 Age (years) mean ± SD 54 ± 15 53 ± 15 54 ± 13 0.61 Body Mass Index mean ± SD 30 ± 7 30 ± 8 29 ± 6 0.41 Creatinine (mg/dL) mean ± SD 2 ± 2 2 ± 4 2 ± 2 0.43 LVEF (%) mean ± SD 33 ± 15 32 ± 15 26 ± 9 &amp;lt;0.001 Procedure Time (min) mean ± SD 85 ± 42 75 ± 33 65 ± 30 &amp;lt;0.001 Same Day Discharge % 70.3% 64.3% 72.6% 0.03 DFT Attempted % 84% 89.1% 81.3% 0.004 Successful DFT % 98.7% 98.6% 98.8% 0.97

Periprocedural Risk and Survival Associated With Implantable Cardioverter-Defibrillator Placement in Older Patients With Advanced Heart Failure

Little is known about the utilization rates and outcomes of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) placement among patients with advanced heart failure (HF). To examine utilization rates, patient characteristics, and outcomes of ICD and CRT-D placements among patients with advanced HF. This cohort study was a post hoc analysis of 81 492 Medicare fee-for-service beneficiaries enrolled in the National Cardiovascular Data Registry ICD Registry between January 2010 and December 2014. Inclusion criteria were patients who had received an HF diagnosis, had a left ventricular ejection fraction of 35% or lower, and showed evidence of advanced HF, which was defined as New York Heart Association (NYHA) class IV symptoms, inotrope use within the last 60 days, left ventricular assist device in situ, or orthotopic heart transplant listing. The comparator group included patients with NYHA class II and no HF hospitalization within the last 12 months, no left ventricular assist device, no orthotopic heart transplant listing, and no current or recent inotrope use. All eligible patients underwent first-time ICD or CRT-D placement for primary prevention of sudden cardiac death. Data were analyzed from January 2010 to December 2014. All-cause mortality and periprocedural complications. Of 81 492 Medicare patients, 3343 had advanced HF (4.1%) and 19 424 were in the comparator group (23.8%). Among the advanced HF population, the mean (SD) age of patients was 74 (9) years, and patients were predominantly white individuals (81.5%) and men (71.1%). The all-cause mortality rate at 30 days was 3.1% (95% CI, 2.6%-3.8%) in the advanced HF group vs 0.5% (0.4%-0.6%) in the comparator group (P < .001). In the advanced HF population, the aggregate in-hospital periprocedural complication rate was 3.74% (95% CI, 3.12%-4.44%) vs 1.10% (95% CI, 0.95%-1.25%) in the comparator group (P < .001). Most adverse events in this group were in-hospital fatality (1.82%; 95% CI, 1.40%-2.34%) and resuscitated cardiac arrest (1.05%; 95% CI, 0.73%-1.45%). Patients with NYHA class IV (hazard ratio, 1.40; 95% CI, 1.02-1.93; P = .04), ischemic heart disease (hazard ratio, 1.24; 95% CI, 1.04-1.48; P = .02), or diabetes (hazard ratio, 1.17; 95% CI, 1.04-1.33; P = .01) had a higher risk of death. Among patients undergoing ICD or CRT-D placement for primary prevention of sudden cardiac death, only a small proportion had advanced HF. These patients experienced clinically important periprocedural complication rates associated with in-hospital death and cardiac arrest relative to patients with nonadvanced HF.

Prospective survey of implantable defibrillator shock anxiety in Japanese patients: Results from the DEF-Chiba study.

Patient-reported outcomes of implantable cardioverter defibrillator (ICD), such as those with shock anxiety, have emerged as important endpoints that are related to quality of life (QOL), but they have not been well studied in a sample of the Japanese population. Therefore, we prospectively examined changes in shock anxiety in a large sample of Japanese patients with an ICD. We recruited 214 consecutive patients with an ICD who visited the outpatient clinic. At registration and 12 months later, all patients completed the Florida Shock Anxiety Scale (FSAS) questionnaire to allow us to examine changes in shock anxiety over the course of the first year after registration. During the 12-month follow-up period, 10.5% of the patients received ICD shock therapy. Female sex, secondary prevention, and experience of ICD shock therapy were associated with high FSAS scores at registration. The FSAS scores in both patients with appropriate and inappropriate shock were significantly higher at the 12-month follow-up interval than at registration, and there was no significant difference in the extent of changes in FSAS scores (Δ = 5.2 ± 5.1 and Δ = 6.3 ± 9.9, respectively, P=0.62). Female sex, secondary prevention, and experience of ICD shock therapy are important risk factors affecting shock anxiety in Japanese patients. Attention should be paid to the after-effects of ICD shock in these patients, regardless of the shock type, with particular attention to women and patients who require secondary prevention.

Implantable cardioverter-defibrillator use in catecholaminergic polymorphic ventricular tachycardia: A systematic review

The implantable cardioverter-defibrillator (ICD) may be associated with a high risk of complications in patients with catecholaminergic polymorphic ventricular tachycardia (CPVT). However, ICDs in this population have not been systematically evaluated. The purpose of this study was to characterize the use and outcomes of ICDs in CPVT. We conducted a systematic review using Embase, MEDLINE, PubMed, and Google Scholar to identify studies that included patients with CPVT who had an ICD. Fifty-three studies describing 1429 patients with CPVT were included. In total, 503 patients (35.2%) had an ICD (median age 15.0 years; interquartile range 11.0-21.0 years). Among ICD recipients with a reported medication status, 96.7% were prescribed β-blockers and 13.2% flecainide. Sympathetic denervation was performed in 23.2%. Nearly half of patients received an ICD for primary prevention (47.3%), and 12.8% were prescribed optimal antiarrhythmic therapy. During follow-up, 40.1% had ≥1 appropriate shock, 20.8% experienced ≥1 inappropriate shock, 19.6% had electrical storm, and 7 patients (1.4%) died. An ICD-associated electrical storm was implicated in 4 deaths. Additional complications such as lead failure, endocarditis, or surgical revisions were observed in 96 of 296 patients (32.4%). A subanalysis of the 10 studies encompassing 330 patients with the most detailed ICD-related data showed similar trends. In this population with CPVT, ICDs were common and associated with a high burden of shocks and complications. The reliance on primary prevention ICDs, and poor uptake of adjuvant antiarrhythmic therapies, suggests that improved adherence to guideline-directed management could reduce ICD use and harm.

Patient understanding of disease and the use and outcome of implantable cardioverter defibrillators in hypertrophic cardiomyopathy.

Hypertrophic cardiomyopathy (HCM) is the most common cause of sudden cardiac death (SCD) in young individuals. Implantable cardioverter defibrillators (ICD) are the primary therapy for sudden death prevention; however, are associated with both physical and psychological complications. We sought to determine factors associated with ICD understanding and patient satisfaction. This was a cross-sectional study, using patient/parent answered questionnaires distributed to patients enrolled in the Hypertrophic Cardiomyopathy Association. Patient characteristics and satisfaction data were obtained via questionnaire. Patients were compared based on age at diagnosis and presence of ICD. ICD patients with high satisfaction were compared to those with low satisfaction to determine factors associated with poor satisfaction. A total of 538 responses were obtained (53 ± 16 years); 46% were females. Seventy patients (13%) were diagnosed with HCM<18 years of age and 356 (66%) had an ICD. Compared to those without an ICD, patients with ICDs were younger at age of diagnosis (P=0.001) and time of study (P=0.008). Patients with ICDs were more likely to have presented with syncope and have family history of ICD, SCD, or HCM-related death. Nineteen patients (5%) felt that issues surrounding their ICD outweighed its benefit. Compared to patients with a favorable satisfaction, the only significant difference was the preimplant ICD discussion (P<0.001) and history of lead replacement (P=0.01). In conclusion, the majority of HCM patients with ICDs are satisfied with their ICD management and feel the benefits of ICDs outweigh issues associated with ICDs. Additionally, these data highlight the importance of the preimplant patient-physician discussion around the need for ICD prior to implantation.

Survival After Secondary Prevention Implantable Cardioverter-Defibrillator Placement

This study sought to define the characteristics and risks of death of patients receiving a physician-designated secondary prevention implantable cardioverter-defibrillator (ICD) in contemporary clinical practice. Data on utilization and outcomes of ICDs for the secondary prevention of sudden cardiac death (SCD) are limited. Patients enrolled in the National Cardiovascular Data Registry's (NCDR) ICD Registry from 2006 to 2009 with a physician-designated secondary prevention indication for ICD implantation were identified and linked to the Social Security Death Master File. Those patients with a history either of tachycardic arrest or sustained ventricular tachycardia (SCD/VT) or of syncope without SCD/VT were included. Kaplan-Meier survival analysis was used to assess mortality. Cox proportional hazards survival modeling was used to assess the risk of death in these groups, adjusting for patient characteristics. In the study cohort of 46,685 patients (mean age 66 ± 14 years, 73.5% male, 85% white), 78% had SCD/VT and 22% had syncope. Overall mortality was 10.4% at 1 year and 16.4% at 2 years. Compared with patients having SCD/VT, the adjusted hazard of death at 1 year was lower in the patients having syncope (hazard ratio: 0.89; 95%confidence interval: 0.83 to 0.96) but was not significantly different by 2 years (hazard ratio: 0.96; 95% confidence interval: 0.90 to 1.01). Nearly 9 of 10 patients receiving a secondary prevention ICD in clinical practice are alive 1 year after implantation. The risk of death varies by indication and is highest among patients who survive SCD or sustained VT inthefirst year after device implantation.

Psychological correlates, allostatic overload and clinical course in patients with implantable cardioverter defibrillator (ICD)

BackgroundImplantable cardioverter defibrillator (ICD) is a key treatment option for both primary and secondary prevention of sudden cardiac death. Despite this, there is a growing number of studies showing that ICD is often associated with post-implantation deleterious psychosocial effects, even in the absence of medical complications. Knowledge about the predictive role of pre-ICD psychological profile is scant. The present research aims to describe patients' pre-ICD psychological profile, focusing on acute and chronic distress, such as anxiety, depression, type D personality, psychosomatic syndromes and allostatic overload (AO), and to evaluate if these psychological variables could affect ICD outcomes and survival. Methods117 consecutive patients (74.4% males; mean age=63.1±13.7years) underwent psychological assessment prior to ICD implantation. Data on ICD-related complications and death were collected up to 26months after the intervention. ResultsAt baseline, 36.8% of the sample had anxiety and 17.9% depression. Among psychosomatic syndromes, psychological factors affecting medical conditions were the most frequent (37.6%). 12.8% presented with type D personality, whereas 16.2% showed moderate AO and 4.3% severe AO. 25.6% of the patients had post-ICD complications and 6% died. Severe AO was the only predictor of survival. ConclusionOur findings show that a reliable evaluation of stress and the inability to cope with it (allostatic overload) may help to identify patients at higher risk of post-ICD complications and death. Such sensitive index, more than traditional psychiatric diagnostic criteria, may help the physician to identify easily manifestations of distress and clinically relevant information, which could affect medical illness outcomes.