Influence of Diabetes Mellitus on Inappropriate and Appropriate Implantable Cardioverter-Defibrillator Therapy and Mortality in the Multicenter Automatic Defibrillator Implantation Trial–Reduce Inappropriate Therapy (MADIT-RIT) Trial

Abstract

T he Multicenter Automatic Defibrillator Implantation TrialReduce Inappropriate Therapy (MADIT-RIT) showed that innovative implantable cardioverter-defibrillator (ICD) programming was associated with a reduction in inappropriate therapy and mortality.1 The MADIT-RIT trial randomized patients with a primary prophylactic ICD indication to 3 different types of ICD programming: conventional programming with a ventricular tachycardia (VT) zone of 170 to 199 bpm, high-rate cutoff with a VT zone ≥200 bpm, or 60-seconddelayed therapy during a VT zone of 170 to 199 bpm. Clinical Perspective on p 701Background-The relationship between diabetes mellitus and risk of inappropriate or appropriate therapy in patients receiving an implantable cardioverter-defibrillator (ICD) and resynchronization therapy has not been investigated thoroughly. The effect of innovative ICD programming on therapy delivery in these patients is unknown. Methods and Results-The Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) randomized patients with a primary prophylactic ICD indication to 3 different types of ICD programming: conventional programming with a ventricular tachycardia zone of 170 to 199 bpm (arm A), high-rate cutoff with a ventricular tachycardia zone ≥200 bpm (arm B), or 60-second-delayed therapy (arm C). The end points of inappropriate therapy, appropriate therapy, and death were assessed among 485 patients with and 998 without diabetes mellitus. Innovative ICD programming reduced the risk of inappropriate therapy regardless of diabetes mellitus, although a trend toward a more pronounced effect of high-rate cutoff programming was seen in patients without diabetes mellitus (P for interaction=0.06). Diabetes mellitus was associated with a decreased risk of inappropriate therapy (hazard ratio, 0.54; 95% confidence interval, 0.36-0.80; P=0.002) and increased risk of appropriate therapy (hazard ratio,1.58; 95% confidence interval, 1.17-2.14; P=0.003). In diabetic patients, there was significantly increased risk of death in those who had inappropriate therapy (hazard ratio, 4.17; 95% confidence interval, 1.52-11.40; P=0.005) and appropriate therapy (hazard ratio, 2.49; 95% confidence interval, 1.06-5.87; P=0.037) compared with those who did not. Conclusions-Innovative high-rate cutoff or delayed ICD programming was associated with a reduction in inappropriate therapy in patients with and without diabetes mellitus. Diabetes mellitus was associated with lower risk of inappropriate therapy but higher risk of appropriate therapy. Ruwald et al Diabetes Mellitus and ICD Programming and Therapy 695Diabetes mellitus is a growing burden to the healthcare system. It affects 25.8 million of the US population (8.3%) and is a major cause of heart disease and stroke. In ICD patients, diabetes mellitus is associated with an increased risk of hospitalization for heart failure, sudden cardiac death, and all-cause mortality 2-6 ; however, the association between diabetes mellitus and inappropriate and appropria...

Early Experience with the Subcutaneous ICD

“…Both arms (ii) and (iii) were associated with a significant reduction in appropriate and inappropriate ICD therapy [29•]. In addition to more ICD shocks, there was a significant three-five fold greater use of ATP in the conventional programming control arm versus the comparator arms.…”

Incidence, Predictors, and Outcomes of Implantable Cardioverter‐Defibrillator Discharge Among People Living With HIV

“…For example, in a study of 194 006 patients with an ICD, Saxon and colleagues reported an ICD discharge rate of ≈18% over a similar follow‐up period 44. The mechanisms for the small differences in ICD discharge rate in our presumed uninfected population are unclear but are likely, in part, mediated by a high background prevalence of diabetes mellitus,46 cocaine use,26 and the lower rate of cardiac resynchronization therapy use 47. Finally, the interpretation of the ICD data was derived from the EHR from the interpretation of a board‐certified electrophysiologist and was not independently reviewed.…”

176-54: Characteristics and Outcomes of Diabetic Patients with an Implantable Cardioverter Defibrillator in a Real World Setting: Results From the Israeli ICD Registry

“…This is in concordance with the post hoc sub group analyses of the comparison of medical therapy, pacing, and defibrillation in heart failure (COMPANION) and multicenter automatic defibrillator implantation trial (MADIT)II trials that did not find an increased rate of appropriate therapies in the DM cohort [28,29]. However, a recent sub-study of the multicenter automatic defibrillator implantation trial-reduce inappropriate therapy (MADIT RIT) did find that DM patients had a 58% increased risk of appropriate therapy (p = 0.003), but a 46% decreased risk of inappropriate therapy (p = 0.002) compared to no DM patients during a mean follow up of 17 months [14]. The authors suggested that the increased risk for appropriate ICD therapy might be explained by a reduced autonomic function or vulnerable myocardium resulting from ischemia and fibrosis in DM patients rendering the myocardium more prone to produce ventricular arrhythmias.…”

“…DM is a risk factor for development of atrial fibrillation [7,13,[36][37][38] and indeed, more of our patients had atrial fibrillation (Table 1), a major cause of inappropriate shocks, and it would be anticipated that the rate of inappropriate shocks would be increased. Evidence based programming of these devices has greatly decreased the rate of inappropriate therapies especially in diabetics [14] and indeed several centers contributing to the registry were participants in successful programming trials during the course of follow up, which may explain why there was no difference in the rate of inappropriate therapies [14,39].…”

“…Patients with diabetes mellitus (DM) are at increased risk for sudden cardiac death and heart failure [7][8][9][10][11][12][13][14]; a previous study suggests that diabetes mellitus may affect appropriate and inappropriate ICD discharge [14]. In addition, patients with obesity and overweight derived more benefit from CRT.…”