Implantable Cardioverter-defibrillator Therapy For Primary Prevention Research Articles

Seattle proportional risk model in GISSI-HF: Estimated benefit of ICD in patients with EF less than 50%

BackgroundThe Seattle Proportional Risk Model (SPRM) estimates the proportion of sudden cardiac death (SCD) in heart failure (HF) patients, identifying those most likely to benefit from implantable cardioverter-defibrillator (ICD) therapy (those with ≥50% estimated proportion of SCD). The GISSI-HF trial tested fish oil and rosuvastatin in HF patients. We used the SPRM to evaluate its accuracy in this cohort in predicting potential ICD benefit in patients with EF ≤50% and an SPRM-predicted proportion of SCD either ≥50% or <50%. MethodsThe SPRM was estimated in patients with EF ≤50% and in a logistic regression model comparing SCD with non-SCD. ResultsWe evaluated 6,750 patients with EF ≤50%. There were 1,892 all-cause deaths, including 610 SCDs. Fifty percent of EF ≤35% patients and 43% with EF 36% to 50% had an SPRM of ≥50%. The SPRM (OR: 1.92, P < 0.0001) accurately predicted the risk of SCD vs non-SCD with an estimated proportion of SCD of 44% vs the observed proportion of 41% at 1 year.By traditional criteria for ICD implantation (EF ≤35%, NYHA class II or III), 64.5% of GISSI-HF patients would be eligible, with an estimated ICD benefit of 0.81. By SPRM >50%, 47.8% may be eligible, including 30.2% with EF >35%. GISSI-HF participants with EF ≤35% with SPRM ≥50% had an estimated ICD HR of 0.64, comparable to patients with EF 36% to 50% with SPRM ≥50% (HR: 0.65). ConclusionsThe SPRM discriminated SCD vs non-SCD in GISSI-HF, both in patients with EF ≤35% and with EF 36% to 50%. The comparable estimated ICD benefit in patients with EF ≤35% and EF 36% to 50% supports the use of a proportional risk model for shared decision making with patients being considered for primary prevention ICD therapy.

Lack of Prognostic Value of T-Wave Alternans for Implantable Cardioverter-Defibrillator Benefit in Primary Prevention.

New methods to identify patients who benefit from a primary prophylactic implantable cardioverter-defibrillator (ICD) are needed. T-wave alternans (TWA) has been shown to associate with arrhythmogenesis of the heart and sudden cardiac death. We hypothesized that TWA might be associated with benefit from ICD implantation in primary prevention. In the EU-CERT-ICD (European Comparative Effectiveness Research to Assess the Use of Primary Prophylactic Implantable Cardioverter-Defibrillators) study, we prospectively enrolled 2327 candidates for primary prophylactic ICD. A 24-hour Holter monitor reading was taken from all recruited patients at enrollment. TWA was assessed from Holter monitoring using the modified moving average method. Study outcomes were all-cause death, appropriate shock, and survival benefit. TWA was assessed both as a contiguous variable and as a dichotomized variable with cutoff points <47 μV and <60 μV. The final cohort included 1734 valid T-wave alternans samples, 1211 patients with ICD, and 523 control patients with conservative treatment, with a mean follow-up time of 2.3 years. TWA ≥60 μV was a predicter for a higher all-cause death in patients with an ICD on the basis of a univariate Cox regression model (hazard ratio, 1.484 [95% CI, 1.024-2.151]; P=0.0374; concordance statistic, 0.51). In multivariable models, TWA was not prognostic of death or appropriate shocks in patients with an ICD. In addition, TWA was not prognostic of death in control patients. In a propensity score-adjusted Cox regression model, TWA was not a predictor of ICD benefit. T-wave alternans is poorly prognostic in patients with a primary prophylactic ICD. Although it may be prognostic of life-threatening arrhythmias and sudden cardiac death in several patient populations, it does not seem to be useful in assessing benefit from ICD therapy in primary prevention among patients with an ejection fraction of ≤35%.

Left ventricular ejection fraction and myocardial fibrosis in survivors of ventricular fibrillation and ventricular tachycardia

Abstract Background Primary prevention implantable cardioverter defibrillator (ICD) therapy is indicated in patients with a LVEF&amp;lt;35%. Increasing evidence suggests that LVEF is a poor predictor or ventricular arrhythmias, such as ventricular tachycardia (VT) or fibrillation (VF). Methods Patients hospitalized for VF (55.4%) or VT with hemodynamic compromise underwent late gadolinium enhancement cardiovascular magnetic resonance (CMR). Patients with congenital heart disease, channelopathies, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy and chemotherapy-induced cardiomyopathy were excluded. Results Among patients (n=111, aged 62.1 ± 14.6 years [mean ± SD]) hospitalized for VF (55.4%) or VT with hemodynamic compromise (44.5%) only 29/111 (43.6%) had a history of cardiac disease. At the index hospitalization, an ischemic cause was identified in 69.3%, a non-ischemic cause in 24.8% and no cause emerged in 5.9%. The LVEF (39.1 ± 17.2%) was ≤35% in 55.4% and &amp;gt;35% in 44.6%. Myocardial fibrosis was present in 85.1% (LVEF≤35%: 91.1%; LVEF&amp;gt;35%: 77.8%; p = 0.0619). Conclusions A large proportion of sustained VT or VF survivors would not have previously met LVEF primary prevention criteria for ICD therapy. In this 'ICD treatment gap', myocardial fibrosis was more prevalent than a LVEF≤35%. Further studies are needed to determine whether myocardial scar rather than LVEF≤35% should be used as an indication for primary prevention ICD therapy.

Abstract 15930: Using Charlson Comorbidity Index to Predict 1-Year All-Cause Mortality in ICD Recipients

Introduction: Primary prevention implantable cardioverter-defibrillators (PP-ICD) are indicated in patients with left ventricular ejection fraction (LVEF) ≤ 35% despite 3 months of maximally tolerated guideline directed medical therapy (GDMT), who are expected to survive at least 1 year. The Seattle Heart Failure Score, commonly used for evaluation of 1 year survival, only addresses heart failure mortality. The Charlson Comorbidity Index (CCI) is a validated model of comorbid conditions used to predict 1-year all-cause mortality. Objectives: We aimed to create a predictive model using the CCI to guide eligibility for PP-ICD based on predicted 1-year all-cause mortality in patients with severe cardiomyopathy. Methods: We analyzed clinical data from the University of Pittsburgh Medical Center, a large multi-hospital system, between January 2010 and July 2021. Patients receiving PP-ICD were included. We used a logistical regression model based on patients’ CCI, age, race, mean number of GDMT medications, the presence of coronary artery disease (CAD), and baseline LVEF. Results: Of the total cohort of 2,864 patients (mean age 67±12 years; Male 69%; White 85%; LVEF 24±7%; CAD 62%), 235 (8.2%) patients died within 1 year. Patients were on average prescribed 2.0±0.8 GDMT agents and had a mean CCI of 1.4± 1.6. CCI was significantly associated with adjusted 1-year mortality (OR 1.41 per standard deviation of CCI, 95% CI 1.35-1.71, p&lt; 0.001). A receiver operator curve was generated (Figure 1) and a CCI cutoff of 1.54, yielded a sensitivity of 71% and a specificity of 59% (AUC 0.70). Conclusions: Our data demonstrate that a model incorporating the CCI can predict 1-year all-cause mortality in PP-ICD recipients with modest accuracy and could therefore assist in shared-decision making around PP-ICD therapy. Future work should focus on refining the model for higher predictive accuracy.

Comparison and predictors of implantable cardioverter-defibrillator therapy for primary and secondary prevention.

Implantable cardioverter-defibrillators (ICDs) are effective in detecting and treating ventricular arrhythmias. Studies on ICD therapy for different indications (primary and secondary prevention) and possible predictors of ICD therapy are limited. In this study, the incidence and type of ICD therapy were related to the indication and the underlying cardiac pathology. Asingle-centre, retrospective and observational study was performed of 482patients who underwent ICD implantation for primary (53.3%) or secondary prevention (46.7%) between 2015 and 2020 at the Radboud University Medical Centre. During amedian follow-up of 2.4years (interquartile range 0.2-3.9), the occurrence of appropriate ICD therapy for primary versus secondary prevention was 9.7% and 27.6%, respectively (p < 0.001). Time to appropriate ICD therapy was significantly shorter in the secondary prevention group (p < 0.001). No difference in ICD therapy was seen for different underlying aetiologies. In the majority of cases (70%) ICD therapy was given for ventricular tachycardia (VT). The occurrence of adverse events (16.3% vs 17.3%, p = 0.772), hospitalisation for cardiovascular reasons (29.2% vs 35.1%, p = 0.559) and all-cause mortality (12.5% vs 11.6%, p = 0.763) were similar in both groups. Male gender (3.53, 95% confidence interval (CI) (1.003, 12.403), p = 0.049) and secondary prevention indication (4.90, 95% CI (1.495, 16.066), p = 0.009) were predictors of appropriate ICD therapy. The risk associated with appropriate ICD therapy is higher in secondary prevention patients, who have their first therapy within ashorter time frame after device implantation. Rates of complications, hospitalisation and all-cause mortality are comparable. Future treatment options should target the prevention of ICD therapy, mainly by preventing the recurrence of VT.

Multimodality Imaging-Based Therapeutic Decision in Ischemic Cardiomyopathy and Ventricular Tachycardia – a Case Report

Abstract Introduction In patients with ischemic heart disease and coronary chronic total occlusion, it is extremely important to assess the presence of myocardial viability via different cardiac imaging techniques in order to predict a potential functional recovery following revascularization. Multimodality cardiac imaging techniques estimate the risk of sudden cardiac death and personalize patient selection for primary prevention implantable cardioverterdefibrillator therapy. Case presentation A 61-year-old patient with a history of an extensive anterior myocardial infarction with conservative management (8 years before the current presentation, when the coronary angiography revealed two-vessel chronic total occlusion) presented to our outpatient service for fast-paced palpitations at home and fatigue. At the time of the index hospitalization, the patient refused coronary artery bypass grafting. During this period, he did not undergo any cardiovascular evaluation, but he did follow the pharmacological recommendations from the initial hospital discharge. Given the detection of multiple premature ventricular contractions and numerous episodes of nonsustained ventricular tachycardia during this medical visit, a multimodal imaging evaluation was conducted, which further guided the implementation of a personalized therapy. Conclusions In patients with ischemic heart failure and coronary chronic total occlusion, presenting with ventricular tachycardia, the therapeutic decision should be based on the results of a multi-modality cardiac imaging evaluation.

Role of N-terminal pro-B type natriuretic peptide as a predictor of poor outcomes in patients with HFrEF receiving primary prevention implantable cardioverter-defibrillator therapy: a systematic review and dose–response meta-analysis

IntroductionSeveral studies have demonstrated that combining left ventricular ejection fraction and New York Heart Association functional class is insufficient for predicting risk of appropriate implantable cardioverter-defibrillator (ICD) shock in primary...

Sex Differences in the Risk of First and Recurrent Ventricular Tachyarrhythmias Among Patients Receiving an Implantable Cardioverter-Defibrillator for Primary Prevention

Current guidelines for primary implantable cardioverter-defibrillator (ICD) therapy do not account for sex differences in arrhythmic risk in ICD candidates. To evaluate the association between sex and risk of ventricular tachyarrhythmia (VTA) and mortality. This cohort study compared differences in the risk of VTA and mortality between 4506 men and women enrolled in the 4 Multicenter Automatic Defibrillator Implantation Trials (MADIT) between July 1, 1997, and December 31, 2011. Data from prospective randomized controlled multicenter studies were analyzed retrospectively. Men and women with an ICD or cardiac resynchronization therapy defibrillator who were enrolled in all MADIT studies were included. Data were analyzed between January 10 and June 10, 2021. ICD implant. The primary end point was sustained VTA, defined as ICD-recorded, treated or monitored VTA at least 170/min or ventricular fibrillation. Secondary VTA end points included VTA at least 200/min, appropriate ICD shocks, and appropriate antitachycardia pacing. All end points were included in a first and recurrent event analysis. Of the 4506 study participants, 3431 were men (76%). Mean (SD) age of the cohort was 64 (12) years. For women vs men, the mean (SD) age (64 [12] years vs 64 [11] years) and left ventricular ejection fraction (24% vs 25%) were similar, but women exhibited a higher frequency of nonischemic cardiomyopathy (454 of 1075 women [42%] vs 2535 of 3431 men [74%]). Women had significantly lower 3-year cumulative probability of sustained VTA (16% vs 26%), fast VTA (9% vs 17%), and appropriate ICD shocks (7% vs 15%) compared with men (P < .001 for all). Multivariable analysis showed that female sex was independently associated with at least 40% lower risk of all first and recurrent VTA end points (P < .001 for all), including the primary end point (first event, HR = 60 [95% CI, 50-73], P < .001; recurrent event, HR = 49 [95% CI, 43-55], P < .001), after accounting for the competing risk of all-cause mortality and nonarrhythmic mortality. The lower VTA risk associated with female sex was consistent in risk subsets but was significantly more pronounced in patients with nonischemic cardiomyopathy (female vs male in the ischemic group: hazard ratio, 0.73 [95% CI, 0.56-0.95], P = .02; nonischemic group: hazard ratio, 0.50 [95% CI, 0.38-0.66], P < .001; P = .03 for interaction between female sex and cardiomyopathy). Findings suggest that women display a significantly lower risk of first and recurrent life-threatening VTA events than men, and that it is more pronounced in patients with nonischemic cardiomyopathy, suggesting a need for sex-specific risk assessment for primary prevention ICD therapy.

Underrepresentation of women in implantable cardioverter defibrillator trials

There are sex differences in the epidemiology and presentation of ventricular arrhythmias. Sudden cardiac death (SCD) is less common in women than in men. Women have been under-represented in implantable cardioverter defibrillator (ICD) trials evaluating the benefit of ICD therapy for primary and secondary prevention of SCD. Following ICD implantation, women are less likely to experience appropriate ICD therapy for ventricular arrhythmias, consistent with epidemiological findings of a lower rate of SCD in women. Sex differences in ICD implantation rates have also been noted for primary and secondary prevention of SCD in registries and large observational cohort studies. Reasons for these differences are unclear. Age and comorbidities at the time of presentation may be partially responsible, although sex bias, patient preference, or contribution of social determinants of health cannot be excluded. There are many unanswered questions regarding reasons for sex differences in ICD usage and under-representation of women in clinical device trials. Additional investigation is needed to better understand these differences to improve outcome of all patients who are at risk for sudden cardiac arrest.

Arrhythmic and Mortality Outcomes Among Ischemic Versus Nonischemic Cardiomyopathy Patients Receiving Primary ICD Therapy.

This study sought to determine the association of cardiomyopathy etiology with the likelihood of ventricular arrhythmias, appropriate implantable cardioverter-defibrillator (ICD) therapy, and mortality. There are conflicting data on the benefit of primary prevention ICD therapy in patients with ischemic versus nonischemic cardiomyopathy (ICM/NICM). The study population comprised 4803 patients with ICM (n=3,106) or NICM (n=1,697) with a primary prevention ICD enrolled in 5 randomized trials conducted between 1997 and 2017. The primary end point was sustained ventricular tachycardia (VT)≥200 beats/min or ventricular fibrillation (VF). Secondary end points included appropriate ICD therapy and all-cause mortality. Differences in cause-specific mortality, including noncardiac, sudden cardiac, and non-sudden cardiac death, were also examined. Patients with ICM were significantly older and had more comorbid conditions, whereas those with NICM had a more advanced heart failure class at enrollment and were more often prescribed medical or cardiac resynchronization therapy for heart failure. Multivariate analysis showed that ICM versus NICM had a similar risk of VT/VF events (HR: 0.98 [95%CI: 0.79-1.20]) and appropriate ICD therapy (HR: 1.03 [95%CI: 0.87-1.22]), whereas the risk of all-cause mortality was 1.8-fold higher among ICM versus NICM patients (HR: 1.84 [95%CI: 1.42-2.38]), dominated by non-sudden cardiac mortality. Combined data from 5 landmark ICD clinical trials show that ICM patients experience a similar risk of life-threatening ventricular arrhythmic events but have an increased risk of all-cause mortality, dominated by non-sudden cardiac death, compared with NICM patients.

EACVI survey on hypertrophic cardiomyopathy

The European Association of Cardiovascular Imaging (EACVI) Scientific Initiatives Committee performed a global survey to evaluate current practice for the assessment and management of patients with hypertrophic cardiomyopathy (HCM). A total of 213 centres from 38 different countries (87% European) responded to the survey. One hundred twenty-one (57%) centres followed HCM patients in a general cardiology outpatient clinic and 85 (40%) centres in a specialized HCM/cardiomyopathy clinic. While echocardiography was the primary imaging modality, cardiovascular magnetic resonance (CMR) has become an important complementary tool. Cardiac anatomy, left ventricular (LV) systolic, and diastolic function were assessed according to current European guidelines and recommendations. To evaluate LV obstruction, 49% of the centres performed bedside provocation manoeuvres in every patient and 55% of the centres used exercise stress echocardiography. The majority of centres used the 5-year risk assessment of sudden cardiac death (SCD) calculated with the HCM Risk-SCD score. However, 34% of the centres also used extensive non-infarct late gadolinium enhancement on CMR and 27% the presence of LV apical aneurysm to help select patients for primary prevention implantable cardioverter-defibrillator therapy. Ninety-nine percent of the responding centres performed regular imaging follow-up of HCM patients. Most centres followed European guidelines and recommendations for the diagnosis and management of patients with HCM. The importance of bedside provocation manoeuvres and exercise stress echocardiography to diagnose LV outflow obstruction requires emphasis. Additional risk markers for SCD are used in many centres and might indicate the need for an update of current European recommendations.

Effects of obesity on survival in patients with implantable cardioverter defibrillator

Abstract Background Studies have shown that increased body weight and obesity may be associated with an increased risk of arrhythmic events. However, studies conducted in patients with implantable cardioverter-defibrillator (ICD) have found that low body mass index (BMI) is associated with higher mortality. The aim of this study is to evaluate the effect of obesity on the risk of arrhythmic events, hospitalization and death in patients receiving ICD therapy for primary or secondary prevention. Methods The study was designed as a single-center prospective and observational. Patients with BMI &amp;lt;30 kg/m2 were classified as non-obese and patients with ≥30 kg/m2 as obese. The primary endpoints were all-cause mortality, cardiac mortality, and cardiac rehospitalization. Results Among the total of 340 patients, 78.2% were male, 21.8% were female, and the mean age of the patients was 60.9 years. Among all patients, there were 30.6% normal weight, 47.4% overweight and 22.1% obese patients. AF recording was significantly higher in obese patients compared to the normal weight patient group (p=0.02). Shock, appropriate shock, and liquid load sensing were statistically higher in obese than non-obese patients (p=0.042, p=0.011 and p=0.007). In the primary prevention group, all-cause mortality and cardiac mortality rates were lower in the obesity group (p=0.022, p=0.037). Conclusion Our findings showed that although cardiac arrhythmic events are more common in obese patients, mortality and hospitalization events are less common in obese patients. These findings are consistent with the reverse epidemiology that has been demonstrated previously between obesity and mortality Funding Acknowledgement Type of funding sources: None. Events obtained from device controlSurvival normal weight and overweight

P1147Complications in young ICD patients - a retrospective analysis

Abstract Introduction In specific situations implantable cardioverter defibrillator (ICD) therapy is recommended for patients under the age of 40 years. Due to the active lifestyle of this patient population, complication rates in devices with conventional transvenous electrodes may be higher than for the remaining population. Methods The ICD-YOUNG study is a retrospective analysis of consecutive patients ≤ 40 years undergoing transvenous or subcutaneous ICD (s-ICD) implantation, device change or lead revision at our centre between July 2006 and December 2017. Rehospitalization for lead failure or device battery depletion was documented. Results Out of 586 patients undergoing ICD implantation, 35 patients (6.0%) were ≤ 40 years. Mean age was 30.0 ± 7.2 years, 48.6% were female, 37.1% received ICD therapy for primary prevention and 11.4% primarily received s-ICD. Median follow up was 7.3 (interquartile range, 1.8-12.0) years, with a lower follow up duration in s-ICD patients than conventional ICD patients (median, 2.9 vs. 9.0 years). Over the course of follow-up, 37.1% received successful anti-tachycardia therapy. 19.4% of patients in the conventional ICD group had right ventricular lead problems requiring intervention, while none of the s-ICD patients had to be revised. Time to first device change due to battery depletion and/or device upgrade was similar in young and remaining patients (median 5.4 vs 6.0 years, p = 0.23). Discussion Young patients requiring ICD have a high rate of lead problems. In most young patients, s-ICD therapy is an encouraging alternative to conventional ICD therapy with a lower lead failure rate.

Electrocardiogram as a predictor of survival without appropriate shocks in primary prophylactic ICD patients: A retrospective multi-center study

BackgroundAbnormal 12-lead electrocardiogram (ECG) can predict cardiovascular events, including sudden cardiac death. We tested the hypothesis that ECG provides useful information on guiding implantable cardioverter defibrillator (ICD) therapy into individuals with impaired left ventricular ejection fraction (LVEF). MethodsRetrospective data of primary prevention ICD implantations from 14 European centers were gathered. The registry included 5111 subjects of whom 1687 patients had an interpretable pre-implantation ECG available (80.0% male, 63.3 ± 11.4 years). Primary outcome was survival without appropriate ICD shocks or heart transplantation. A low-risk ECG was defined as a combination of ECG variables that were associated with the primary outcome. ResultsA total of 1224 (72.6%) patients survived the follow-up (2.9 ± 1.7 years) without an ICD shock, 224 (13.3%) received an appropriate shock and 260 (15.4%) died. Low-risk ECG defined as QRS duration <120 ms, QTc interval <450 ms for men and <470 ms for women, and sinus rhythm, were met by 515 patients (30.5%). Multivariable Cox regression showed that the hazard (HR) for death, heart transplantation or appropriate shock were reduced by 42.5% in the low-risk group (HR 0.575; 95% CI 0.45–0.74; p < 0.001), compared to the high-risk group. The HR for the first appropriate shock was 42.1% lower (HR 0.58; 95% CI 0.41–0.82; p = 0.002) and the HR for death was 48.0% lower (HR 0.52; 95% CI 0.386–0.72; p < 0.001) in the low-risk group. ConclusionSinus rhythm, QRS <120 ms and normal QTc in standard 12-lead ECG provides information about survival without appropriate ICD shocks and might improve patient selection for primary prevention ICD therapy.

Clinical Impact of Implantable Cardioverter-Defibrillator Therapy and Mortality Prediction Model for Effective Primary Prevention in Korean Patients.

BackgroundStudies on the efficacy of implantable cardioverter-defibrillator (ICD) therapy for primary prevention in Asian patients are relatively lacking compared to those for secondary prevention. Also, it is important to stratify which patients will benefit from ICD therapy for primary prevention.MethodsOf 483 consecutive patients who received new implantation of ICD in 9 centers in Korea, 305 patients with reduced left ventricular systolic function and/or documented ventricular fibrillation/tachycardia were enrolled and divided into primary (n = 167) and secondary prevention groups (n = 138).ResultsDuring mean follow-up duration of 2.6 ± 1.6 years, appropriate ICD therapy occurred in 78 patients (25.6%), and appropriate ICD shock and anti-tachycardia pacing occurred in 15.1% and 15.1% of patients, respectively. Appropriate ICD shock rate was not different between the two groups (primary 12% vs. secondary 18.8%, P = 0.118). However, appropriate ICD therapy rate including shock and anti-tachycardia pacing was significantly higher (primary 18% vs. secondary 34.8%, P = 0.001) in the secondary prevention group. Type of prevention and etiology, appropriate and inappropriate ICD shock did not affect all-cause death. High levels of N-terminal pro-B-type natriuretic peptide, New York Heart Association functional class, low levels of estimated glomerular filtration ratio, and body mass index were associated with death before appropriate ICD shock in the primary prevention group. When patients were categorized in 5 risk score groups according to the sum of values defined by each cut-off level, significant differences in death rate before appropriate ICD shock were observed among risk 0 (0%), 1 (3.6%), 2 (3%), 3 (26.5%), and 4 (40%) (P < 0.001).ConclusionIn this multicenter regional registry, the frequency of appropriate ICD therapy is not low in the primary prevention group. In addition, combination of poor prognostic factors of heart failure is useful in risk stratification of patients who are not benefiting from ICD therapy for primary prevention.

Documentation of shared decision making around primary prevention defibrillator implantations.

Patients eligible for primary prevention implantable cardioverter-defibrillator (ICD) therapy are faced with a complex decision that needs a clear understanding of the risks and benefits of such an intervention. In this study, our goal was to explore the documentation of primary prevention ICD discussions in the electronic medical records (EMRs) of eligible patients. In 1523 patients who met criteria for primary prevention ICD therapy between 2013 and 2015, we reviewed patient charts for ICD-related documentation: "mention" by physicians or "discussion" with patient/family. The attitude of the physician and the patient/family toward ICD therapy during discussions was categorized into negative, neutral, or positive preference. Patients were followed to the end-point of ICD implantation. Over a median follow-up of 442 days, 486 patients (32%) received an ICD. ICD was mentioned in the charts of 1105 (73%) patients, and a discussion with the patient/family about the risks and benefits of ICD was documented in 706 (46%) charts. On multivariable analyses, positive cardiologist (hazard ratio [HR]: 7.9, 95% confidence of intervals [CI]: 1.0-59.7, P<.05), electrophysiologist (HR: 7.7, 95% CI: 1.9-31.7, P<.001), and patient/family (HR: 9.9, 95% CI: 6.2-15.7, P<.001) preferences toward ICD therapy during the first documented ICD discussion were independently associated with ICD implantation. In a large cohort of patients eligible for primary prevention ICD therapy, a discussion with the patient/family about the risks and benefits of ICD implantation was documented inless than50% of the charts. More consistent documentation of the shared decision making around ICD therapy is needed.

Prognostic role of NYHA class in heart failure patients undergoing primary prevention ICD therapy.

AimsConcerns about the prognostic value of NYHA functional class (FC) in heart failure (HF) patients carrying a prophylactic implantable cardioverter defibrillator (ICD) are still present. We aimed to compare whether mortality and arrhythmic risk were different, in a cohort of HF patients undergoing ICD‐only implant, according to their FC.Methods and resultsHF patients with left ventricle ejection fraction (LVEF) ≤35%, undergoing first prophylactic ICD‐only implant were collected from a multicentre nationwide registry (2006–2015). Six hundred and twenty‐one patients were identified (101 patients in NYHA I; 411 in NYHA II; 109 in NYHA III). After a mean follow‐up of 4.4 years (±2.1), 126 patients died (20.3%). All‐cause mortality risk was higher in symptomatic patients: 13.9% in NYHA I patients, 18.3% in NYHA II patients (HR: 1.8, 95% CI 1.1–3.2), and 32.9% in NYHA III patients (HR: 3.9, 95% CI 2.1–7.3). Seventy‐eight out of all deaths were due to cardiovascular causes (12.6%). Cardiovascular mortality risk was also higher in symptomatic patients: 6.9% in NYHA I patients, 11% in NYHA II patients (HR: 2.2, 95% CI 1.1–4.9), and 23.9% in NYHA III (HR: 5.5, 95% CI 2.4–12.7). One hundred and seventeen patients received a first appropriate ICD therapy (19.4%). Arrhythmia free survival did not differ among study groups [20.8% in NYHA I patients, 18.7% in NYHA II (HR: 1.1, 95% CI 0.6–1.7) and 20.8% in NYHA III patients (HR: 1.3, 95% CI 0.7–2.5)]. NYHA class independently predicted cardiovascular mortality (NYHA III vs. NYHA I: HR, 4.7; 95% CI, 1.7–12.8, P = 0.002; NYHA II vs. NYHA I: HR, 2.1, 95% CI, 1.0–5.6, P = 0.05) but not all‐cause death (NYHA III vs. NYHA I: HR: 1.8, 95% CI 0.8–3.9, P = 0.11; NYHA II vs. NYHA I: HR, 1.1, 95% CI 0.6–2.2, P = 0.71;). Atrial fibrillation, chronic kidney disease, and diabetes emerged as predictors of both all‐cause death [(HR: 1.8, 95% CI 1.2–2.8, P = 0.005), (HR: 2.2, 95% CI 1.4–3.4, P < 0.001), (HR: 2.0, 95% CI 1.3–3.1, P = 0.001), respectively] and cardiovascular mortality [(HR: 1.8, 95% CI 1.1–3.1, P = 0.02), (HR: 3.1, 95% CI 1.8–5.4, P < 0.001), (HR: 1.7, 95% CI 1.1–3, P = 0.032), respectively].ConclusionsMortality in HF patients undergoing prophylactic ICD implantation was higher in symptomatic patients. NYHA functional class along with other comorbidities might be helpful to identify a subgroup of ICD carriers with poorer prognosis and higher risk of cardiovascular death.

Predictors of appropriate interventions and mortality in patients with implantable cardioverter-defibrillators.

Additional risk assessment in patients with heart failure referred for implantable cardioverter‑defibrillator (ICD) implantation as primary prevention is needed. A reduction in left ventricular ejection fraction (LVEF) seems to lack sufficient sensitivity and specificity to be used for identification of patients at the highest risk of sudden cardiac death. The aim of this study was to identify short- and long‑term predictors of appropriate implantable cardioverter‑defibrillator therapy as well as predictors of long‑term mortality in patients with an ICD or cardiac resynchronization therapy defibrillator (CRT‑D). In this retrospective study, data from 457 patients who had an ICD or CRT‑D implanted between 2011 and 2017 were analyzed. During the median follow‑up of 31 months (interquartile range, 17-52 months), 153 patients died (33.9%) and 140 had appropriate interventions (31%). In a multivariate Cox regression analysis, implantation for secondary prevention (hazard ratio [HR], 2.49; P <0.001), severe mitral valve disease (HR, 2.17; P <0.001), and previous myocardial infarction (HR, 1.68; P = 0.009) were predictors of appropriate intervention. Resynchronization therapy (HR, 0.59; P = 0.025) and severe mitral valve disease (HR, 2.42; P <0.001) were predictors of appropriate intervention in primary prevention. Body mass index, hemoglobin concentrations, LVEF, diabetes, and left atrial diameter were significant predictors of death. Implantation of ICD or CRT‑D as secondary prevention was a potent predictor of appropriate intervention, while resynchronization therapy and severe mitral regurgitation predicted ICD therapy in primary prevention. In patients with ICD or CRT-D, independent predictors of mortality included: body mass index, hemoglobin concentrations, LVEF, diabetes, and left atrial diameter.

Comparison of Ventricular Tachyarrhythmia Characteristics in Patients with Non-Ischaemic vs. Ischaemic Cardiomyopathy with Defibrillators

Introduction: The benefits of an implantable cardioverter-defibrillator (ICD) in significantly reducing sudden cardiac death in ischaemic (ICM) and non-ischaemic cardiomyopathy (NICM) patients has been well demonstrated. Our study investigated the characteristics of ventricular tachycardias (VT) between ICM and NICM patients who received ICD therapy. Methods: Between August 2015 and August 2017, 58 patients (male = 50; age = 66 ± 16 years; ICM = 26, NICM = 32) presented with ICD device therapy (anti-tachycardia pacing (ATP) or shock). Cycle length of the tachyarrhythmia (TCL) and time from implant to first presentation were analysed, as were VT/VF occurrences and electrical storm events. Results: 152 patients had ICD implanted (74 NICM, 78 ICM). Ejection fraction and duration of follow up in both groups was similar. 32 presented with therapy (17 ATP, 15 Shock) in NICM and 26 in ICM. 4 in ICM and 4 in NICM presented with VT storm. TCL was significantly faster in NICM patients versus ICM patients (272 ± 48 ms vs. 307 ± 47 ms; p = 0.01). There was no significant difference in time from implant to first presentation (27 ± 24 months vs. 25 ± 25 months; p = 0.83). Conclusion: NICM and ICM patients had the same rate of ICD therapy for primary prevention of SCD. NICM patients had a faster TCL compared to ICM patients. There was no difference between groups in terms of time from implant to first presentation. These findings have implications for the approach to catheter ablation and appropriate programming of ICD therapies.

Improving the Use of Primary Prevention Implantable Cardioverter-Defibrillators Therapy With Validated Patient-Centric Risk Estimates.

The authors previously developed the Seattle Proportional Risk Model (SPRM) in systolic heart failure patients without implantable cardioverter-defibrillators (ICDs)to predict the proportion of deaths that were sudden. They subsequently validated the SPRM in 2 observational ICD data sets. The objectives in the present study were to determine whether this validated model could improve identification of clinically important variations in the expected magnitude of ICD survival benefit by using a pivotal randomized trial of primary prevention ICD therapy. Recent data show that<50% of nominally eligible subjects receive guideline- recommended primary prevention ICDs. In the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial), a placebo-controlled ICD trial in 2,521 patients with an ejection fraction≤35% and symptomatic heart failure, we tested the use of patient-level SPRM-predicted probability of sudden death (relative to that of non-sudden death) as a summary measurement of the potential for ICD benefit. A Cox proportional hazards model was used to estimate variations in the relationship between patient-level SPRM predictions and ICD benefit. Relative to use of mortality predictions with the Seattle Heart Failure Model, the SPRM was much better at partitioning treatment benefit from ICD therapy (effect size was 2- to 3.6-fold larger for the ICD×SPRM interaction). ICD benefit varied significantly across SPRM-predicted risk quartiles: for all-cause mortality, a+10% increase with ICD therapy in the first quartile (highest risk of death, lowest proportion of sudden death) to a decrease of 66% in the fourth quartile (lowest risk of death, highest proportion of sudden death; p= 0.0013); for sudden death mortality, a 19% reduction in SPRM quartile 1 to 95% reduction in SPRM quartile 4 (p< 0.0001). In symptomatic systolic heart failure patients with a Class I recommendation for primary prevention ICD therapy, the SPRM offers a useful patient-centric tool for guiding shared decision making.