Incidence Of Implantable Cardioverter-defibrillator Therapy Research Articles

Predictors of adoption and impact of evidence-based programming on the incidence of implantable cardioverter-defibrillator therapies

Introduction and objectivesThe ADVANCE III trial showed that a delayed-detection strategy reduces implantable cardioverter-defibrillator (ICD) therapies. Here, we describe the adherence to and predictors of ADVANCE adoption and compare ICD therapy rates between patients with and without ADVANCE programming. MethodsThis observational retrospective study analyzed patients implanted with Medtronic ICDs included from 2005 to 2016 in a Spanish national multicenter registry (UMBRELLA database; ClinicalTrials.gov, NCT01561144). Changes in ADVANCE programming adoption were described in relation to a) publication of the ADVANCE trial, b) implementation of an “ADVANCE awareness” campaign, and c) publication of an expert consensus statement. Multivariate logistic regression identified predictors of adoption. Therapy incidence rates were compared between groups by estimating the adjusted incidence rate ratio (aIRR) using negative binomial regression. ResultsA total of 3528 patients were included. An ADVANCE strategy was used in 20% overall and in 44% at the end of the study. ADVANCE III adoption increased after trial publication, with less growth after an “ADVANCE awareness” campaign and after expert consensus statement publication. Predictors of ADVANCE adoption were as follows: ICD device with a nominal number of intervals to detect 30/40 (aOR, 4.4; 95%CI, 3.5-5.4), implantation by an electrophysiologist (aOR, 1.7; 95%CI, 1.4-2.2), and secondary prevention (aOR, 3.2; 95%CI, 2.6-3.9). Dual-chamber ICDs (aOR, 0.6; 95%CI, 0.5-0.8) and cardiac resynchronization-defibrillators (aOR, 0.5; 95%CI, 0.4-0.7) were associated with lower adoption. ADVANCE programming was associated with reduced total therapy burden (aIRR, 0.77; 95%CI, 0.69-0.86) and fewer inappropriate shocks (aIRR, 0.66; 95%CI, 0.52-0.85). ConclusionsADVANCE adoption remains modest and can be improved through evidence-driven selection of nominal ICD settings. ADVANCE programming is associated with reduced therapy rates in real-world ICD recipients.

Outcomes following implantable cardioverter–defibrillator generator replacement in adults: A systematic review

Randomized trials inform the use of implantable cardioverter-defibrillators (ICDs) for prevention of sudden cardiac death, yet management of patients considering ICD generator replacement procedures remains largely dependent on clinical judgment. Thus, we performed a systematic review of all studies evaluating outcomes associated with ICD generator replacement. We queried PubMed, Embase, Web of Science, and the Cochrane Database of Systematic Reviews for relevant studies with a prespecified search and adjudication strategy (PROSPERO registration number CRD42018100818) to evaluate outcomes including (1) survival; (2) clinical complications (eg, infection, hematoma); or (3) incidence of ICD therapy. From 1607 unique titles, 37 studies met inclusion criteria, describing outcomes for 238,949 patients. Procedural mortality was rare, but complications including reoperation (median 4.57%; range 0.38%-10.31%), infections (median 2.01%; range 0.03%-9.27%), and hematoma (median 1.22%, range 0.17%-2.53%) were observed in a small fraction of patients. Appropriate ICD therapy after generator replacement was common (median rate 23.03%; range 10.9%-31.4%), with an overall annualized event rate of 8.52% at median duration of follow-up of 32.4 months. Appropriate ICD therapy continued to occur at a significant annual rate even in patients who no longer met implantation criteria (5.27%) and in patients who never previously received ICD therapy (4.87%). This analysis of published observational data regarding ICD generator replacement procedures identifies relatively low risks of procedural complications and clinically meaningful rates of appropriate ICD therapies. These estimates may guide clinical decisions and inform the design of definitive trials.

Influence of Multimorbidity on Burden and Appropriateness of Implantable Cardioverter-Defibrillator Therapies.

To determine whether burden of multiple chronic conditions (MCCs) influences the risk of receiving inappropriate vs appropriate device therapies. Retrospective cohort study. Seven US healthcare delivery systems. Adults with left ventricular systolic dysfunction receiving an implantable cardioverter-defibrillator (ICD) for primary prevention. Data on 24 comorbid conditions were captured from electronic health records and categorized into quartiles of comorbidity burden (0-3, 4-5, 6-7 and 8-16). Incidence of ICD therapies (shock and antitachycardia pacing [ATP] therapies), including appropriateness, was collected for 3 years after implantation. Outcomes included time to first ICD therapy, total ICD therapy burden, and risk of inappropriate vs appropriate ICD therapy. Among 2235 patients (mean age = 69 ± 11 years, 75% men), the median number of comorbidities was 6 (interquartile range = 4-8), with 98% having at least two comorbidities. During a mean 2.2 years of follow-up, 18.3% of patients experienced at least one appropriate therapy and 9.9% experienced at least one inappropriate therapy. Higher comorbidity burden was associated with an increased risk of first inappropriate therapy (adjusted hazard ratio [HR] = 1.94 [95% confidence interval {CI} = 1.14-3.31] for 4-5 comorbidities; HR = 2.25 [95% CI = 1.25-4.05] for 6-7 comorbidities; and HR = 2.91 [95% CI = 1.54-5.50] for 8-16 comorbidities). Participants with 8-16 comorbidities had a higher total burden of ICD therapy (adjusted relative risk [RR] = 2.12 [95% CI = 1.43-3.16]), a higher burden of inappropriate therapy (RR = 3.39 [95% CI = 1.67-6.86]), and a higher risk of receiving inappropriate vs appropriate therapy (RR = 1.74 [95% CI = 1.07-2.82]). Comorbidity burden was not significantly associated with receipt of appropriate ICD therapies. Patterns were similar when separately examining shock or ATP therapies. In primary prevention ICD recipients, MCC burden was independently associated with an increased risk of inappropriate but not appropriate device therapies. Comorbidity burden should be considered when engaging patients in shared decision making about ICD implantation.

Super-responders to cardiac resynchronization therapy remain at risk for ventricular arrhythmias and benefit from defibrillator treatment.

Mortality and ventricular arrhythmias are reduced in patients responding to cardiac resynchronization therapy (CRT). This response is accompanied by improvement in LVEF, and some patients even outgrow original eligibility criteria for implantable cardioverter-defibrillator (ICD) implantation. It is however unclear if these patients still benefit from ICD treatment. The current study aimed to evaluate if the incidence of ICD therapy is related to the extent of CRT response. All patients who underwent primary prevention CRT-defibrillator implantation were included. They were divided into subgroups according to the reduction in LV end-systolic volume (LVESV) 6 months after implantation. Pre-defined subgroups were: negative responders (increased LVESV), non-responders (decreased LVESV 0-14%), responders (decreased LVESV 15-29%), and super-responders (decreased LVESV ≥30%). During a median follow-up of 57 months (25th-75th percentile 39-84), 512 patients were studied [101 (20%) negative responders, 101 (20%) non-responders, 149 (29%) responders, and 161 (31%) super-responders]. In the first year of follow-up super-responders received significantly less appropriate ICD therapy (3% vs. 12%; P < 0.001). The 5-year cumulative incidence of appropriate ICD therapy was 31% [95% confidence interval (CI) 19-43] in negative responders, 39% (95% CI 25-53) in non-responders, 34% (95% CI 25-43) in responders, and 27% (95% CI 18-35) in super-responders, respectively (p = 0.13). The extent of CRT response was associated with a parallel reduction of appropriate device therapy during the first year of follow-up. Thereafter, no association was observed. Furthermore, 23% of super-responders were treated for potentially life-threatening arrhythmias and benefit from ICD treatment.

Usefulness of Sleep-Disordered Breathing to Predict Occurrence of Appropriate and Inappropriate Implantable-Cardioverter Defibrillator Therapy in Patients With Implantable Cardioverter-Defibrillator for Primary Prevention of Sudden Cardiac Death

Advanced heart failure (HF) is associated with severe sleep-disordered breathing (SDB). In addition, most patients with HF are treated with an implantable cardioverter-defibrillator (ICD) for primary prevention of sudden cardiac death. The incidence of ICD therapy in such a patient cohort with SDB has never been investigated. The present study sought to determine the effect of SDB on the incidence of appropriate and inappropriate ICD therapy in patients with a categorical primary prevention ICD indication. A total of 133 consecutive ICD patients with New York Heart Association class II-III HF and depressed left ventricular function (≤35%) with no history of ventricular arrhythmia underwent a sleep study before ICD implantation and were followed for 24 ± 8 months, prospectively. A relevant SDB was defined as an apnea-hypopnea index of ≥10 events/hour. Of these 133 patients, 82 (62%) had SDB. Overweight (body mass index >29.1 vs 24.7 kg/m(2); p <0.001) was identified as the only independent risk factor for SDB. Appropriate ICD therapy intervention was significantly greater among patients with SDB than among patients without SDB (54% vs 34%, p = 0.03). Inappropriate ICD therapy intervention was documented more often in patients with SDB (n = 24 [29%] vs 7 [14%]; p = 0.04). An apnea-hypopnea index >10 events/hour was an independent predictor of appropriate ICD therapy on multivariate analysis (odds ratio 2.5, 95% confidence interval 1.8 to 4.04; p = 0.01). In conclusion, the present study is the first trial exploring the effect of SDB on the incidence of appropriate and inappropriate ICD therapy in patients with HF with a primary prevention indication. These results indicate that a preimplantation sleep study will identify patients with HF prone to receive appropriate and inappropriate ICD therapy.

Left Ventricular Ejection Fraction as Criterion for Implantation of an Implantable Cardioverter‐Defibrillator in Heart Failure Patients Undergoing Surgical Left Ventricular Reconstruction

Besides implantation of an implantable cardioverter-defibrillator (ICD), a proportion of patients with left ventricular (LV) dysfunction due to ischemic cardiomyopathy are potential candidates for surgical LV reconstruction (Dor procedure), which changes LV ejection fraction (LVEF) considerably. In these patients, LVEF as selection criterium for ICD implantation may be difficult. This study aimed to determine the value of LVEF as criterium for ICD implantation in heart failure patients undergoing surgical LV reconstruction. Consecutive patients with end-stage heart failure who underwent ICD implantation and LV reconstruction were evaluated. During admission, two-dimensional (2D) echocardiography (LV volumes and LVEF) was performed before surgery and was repeated at 3 months after surgery. Over a median follow-up of 18 months, the incidence of ICD therapy was evaluated. The study population consisted of 37 patients (59 +/- 11 years). At baseline, mean LVEF was 23 +/- 5%. Mean left ventricular end-systolic volume (LVESV) and left ventricular end-diastolic volume (LVEDV) were 175 +/- 73 mL and 225 +/- 88 mL, respectively. At 3-month follow-up, mean LVEF was 41 +/- 9% (P < 0.0001 vs. baseline), and mean LVESV and LVEDV were 108 +/- 65 mL and 176 +/- 73 mL, respectively (P < 0.0001 vs. baseline). During 18-month follow-up, 12 (32%) patients had ventricular arrhythmias, resulting in appropriate ICD therapy. No significant relations existed between baseline LVEF (P = 0.77), LVEF at 3-month follow-up (P = 0.34), change in LVEF from baseline to 3-month follow-up (P = 0.28), and the occurrence of ICD therapy during 18-month follow-up. LVEF before and after surgical LV reconstruction is of limited use as criterium for ICD implantation in patients with end-stage heart failure.