First implantable cardiac defibrillator insertions in New South Wales, 2005-2020: an analysis of linked administrative data.

OBJECTIVES: To determine the annual numbers of first ICD insertions in New South Wales during 2005-2020; to examine health outcomes for people who first received ICDs during this period. STUDY DESIGN: Retrospective cohort study; analysis of linked administrative health data. SETTING, PARTICIPANTS: All first insertions of ICDs in NSW, 2005-2020. MAIN OUTCOME MEASURES: Annual numbers of first ICD insertions, and of emergency department presentations and hospital re-admissions 30 days, 90 days, 365 days after first ICD insertions; all-cause and disease-specific mortality (to ten years after ICD insertion). RESULTS: During 2005-2020, ICDs were first inserted into 16 867 people (18.5 per 100 000 population); their mean age was 65.7 years (standard deviation, 13.5 years; 7376 aged 70 years or older, 43.7%), 13 214 were men (78.3%). The annual number of insertions increased from 791 in 2005 to 1256 in 2016; the first ICD insertion rate increased from 15.5 in 2005 to 18.9 per 100 000 population in 2010, after which the rate was stable until 2019 (19.8 per 100 000 population). Of the 16 778 people discharged alive from hospital after first ICD insertions, 54.4% presented to emergency departments within twelve months, including 1236 with cardiac arrhythmias (7.4%) and 434 with device-related problems (2.6%); 56% were re-admitted to hospital, including 1944 with cardiac arrhythmias (11.5%) and 2045 with device-related problems (12.1%). A total of 5624 people who received first ICDs during 2005-2020 (33.3%) died during follow-up (6.7 deaths per 100 person-years); the survival rate was 94.4% at one year, 76.5% at five years, and 54.2% at ten years. CONCLUSIONS: The annual number of new ICDs inserted in NSW has increased since 2005. A substantial proportion of recipients experience device-related problems that require re-admission to hospital. The potential harms of ICD insertion should be considered when assessing the likelihood of preventing fatal ventricular arrhythmia.

Validation of CalECG software for primary prevention heart failure patients: Reducing inter-observer measurement variability.

BACKGROUND: In primary prevention heart failure patients the 12­lead electrocardiogram (ECG) may be useful for the prediction of ventricular arrhythmias. However, inter-observer measurement variability first needs to be identified and any software used, validated. OBJECTIVE: To compare manual ECG measures with CalECG software and to assess the reliability of visual recognition of fragmented QRS (fQRS) by advanced cardiology trainees. METHODS: 30 pre-implant ECGs were assessed on patients who met guidelines for primary prevention Implantable Cardiac Defibrillator. Parameters included RR, PR, QT, QRS duration, axis location, fQRS and T wave peak to T wave end (TpTe). ECGs were analyzed by members of the cardiology department with different levels of experience, and compared to CalECG software. Interobserver agreement was assessed using Fleiss' Kappa (κ) and intraclass correlation coefficients (ICC). Pearson correlation coefficient (r) was used to compare human and software measures. RESULTS: Strong/very strong correlation was recorded across manual ECG measures (ICC = 0.749-0.979, p ≤ 0.0001) with moderate/strong correlation for TpTe (ICC = 0.547-0.765, p ≤ 0.001). Advanced cardiology trainees demonstrated substantial agreement on ECG interpretation (κ = 0.788, p ≤ 0.0001), however, reliability of fQRS assessment was only moderate for identification (κ = 0.5, p ≤ 0.0001) and fair for location (κ = 0.295, p = 0.001). CalECG software showed strong/very strong correlation with manual measurement for standard measures (r = 0.756-0.977, p ≤ 0.001). Concordance between human and software TpTe measurements varied between leads, with V5 showing a non-significant weak correlation (r = 0.197). CONCLUSION: CalECG software showed strong/very strong correlation with standard manual measures which affirms its use in ECG analysis. Advanced cardiology trainees showed greater variability in the identification and location of fQRS.

Fragmented QRS is associated with ventricular arrhythmias in heart failure patients: A systematic review and meta-analysis.

INTRODUCTION: Many primary prevention heart failure (HF) patients with an implantable cardiac defibrillator (ICD) rarely experience life-threatening ventricular arrhythmias (VA). New strategies are required to identify patients most at risk of VA and sudden cardiac death who would benefit from an ICD. One potential method is the detection of fragmented QRS (fQRS) on the electrocardiogram. The aim was to assess the predictive capacity of fQRS for VA and mortality in ischemic (ICM) and non-ischemic cardiomyopathy (NICM) primary prevention HF patients. METHODS AND RESULTS: A systematic review and meta-analysis of studies examining fQRS in HF patients with or without an ICD who met primary prevention indications with reduced ejection fraction ≤40%. Outcome measures were VA (or appropriate ICD therapy) and all-cause mortality. Ten studies involving 3885 patients were included for analysis. Most patients were male with non-fQRS patients being significantly younger (-1.5[-2.66, -0.42], p = .03). Diabetes was more likely in fQRS patients (1.12[1.01, 1.25], p = .03) while non-fQRS patients were 28% more likely to have a history of atrial fibrillation (0.82[0.67,1.00], p = .05). Ventricular arrhythmias were significantly 1.5 times more likely in patients with fQRS (1.51[1.02, 2.25], p = .04). HF patients were 1.7 times more likely to die of any cause if fQRS was present (1.68[1.13, 2.52], p = .01). NICM patients with fQRS have a significant 2.6-fold increased incidence of death compared with ICM patients (2.55[1.63, 3.98], p < .0001). CONCLUSION: fQRS is associated with VA and all-cause mortality and may be a novel marker in the risk stratification of primary prevention HF patients indicated for ICD implantation.

Primary Prevention Implantable Cardiac Defibrillators: A Townsville District Perspective.

Background: Despite major advances in treating patients with severe heart failure, deciding who should receive an implantable cardiac defibrillator (ICD) remains challenging. Objective: To study the risk factors and mortality in patients after receiving an ICD (January 2008-December 2015) in a regional hospital in Australia. Methods: Eighty-two primary prevention patients received an ICD for ischemic cardiomyopathy (ICM, n = 41) and non-ischemic cardiomyopathy (NICM, n = 40) with 4.8-yrs follow-up. One patient had mixed ICM/NICM indications. Ventricular arrhythmias were assessed using intracardiac electrograms. Statistical analysis compared the total population and ICM and NICM groups using Kaplan-Meier for survival, Cox regression for mortality predictors, and binary logistic regression for predictors of ventricular arrhythmias (p < 0.05). Results: Major risk factors were hypercholesterolemia (70.7%), hypertension (47.6%), and obesity (41.5%). Severe obstructive sleep apnea (OSA) was found exclusively in NICM patients (23.7%, p = 0.001). Mortality was 30.5% after 4.8-yrs. The majority of patients (n=67) had no sustained ventricular arrhythmias yet 28% received therapy (n = 23), 18.51% were appropriate (n = 15), and 13.9% inappropriate (n = 11). Patients receiving ≥2 incidences of inappropriate shocks were 18-times more likely to die (p = 0.013). Three sudden cardiac deaths (SCD) (3.7%) were prevented by the ICD. Conclusion: Patients implanted with an ICD in Townsville had 30.5% all-cause mortality after 4.8-yrs. Only 28% of patients received ICD therapy and 13.9% were inappropriate. OSA may have contributed to the fourfold increase in inappropriate therapy in NICM patients. Our study raises important efficacy, ethical and healthcare cost questions about who should receive an ICD, and possible regional and urban center disparities.