Background Some patients with an automatic implantable cardioverter-defibrillator (ICD) suffer multiple appropriate, consecutive, high-energy discharges (MCDs) during follow-up. Such events might represent resistant ventricular arrhythmias and might have prognostic significance. Methods and Results Eighty consecutive patients with an ICD were followed up for up to 82 months (mean, 21±19 months). Thirty-eight patients had survived an out-of-hospital cardiac arrest and 42 had recurrent ventricular tachycardia. During follow-up, 16 patients had MCD (group A), 26 patients had episodes of single appropriate discharges (group B), and 38 patients had no appropriate discharges (group C). Group A patients had worse functional status ( P =.001), lower left ventricular ejection fractions (LVEFs) ( P =.001), and lower survival rates (log rank, P =.003) than the remaining two groups of patients. Cox analysis showed LVEF ( P =.001) to be an independent predictor of MCD. Independent predictors of death or heart transplant were MCD ( P =.001), female sex ( P =.001), age ( P =.001), history of cardiac arrest ( P =.003), and functional status ( P =.003). The only independent predictor of total mortality was female sex ( P =.002). Independent predictors of cardiac death were MCD ( P =.007) and female sex ( P =.018). Independent predictors of arrhythmic death were age ( P =.001), female sex ( P =.02), and MCD ( P =.023). Conclusions In patients with an ICD, the development of MCD is an independent predictor of cardiac and arrhythmic mortality. If this finding is confirmed in larger studies, it may help to identify patients in whom other therapeutic alternatives, ie, heart transplantation, should be considered during follow-up after ICD implantation.

Remote follow-up (FU) of implantable cardiac defibrillators (ICDs) allows for fewer in-office visits in combination with earlier detection of relevant findings. Its implementation requires investment and reorganization of care. Providers (physicians or hospitals) are unsure about the financial impact. The primary end-point of this randomized prospective multicentre health economic trial was the total FU-related cost for providers, comparing Home Monitoring facilitated FU (HM ON) to regular in-office FU (HM OFF) during the first 2 years after ICD implantation. Also the net financial impact on providers (taking national reimbursement into account) and costs from a healthcare payer perspective were evaluated. A total of 312 patients with VVI- or DDD-ICD implants from 17 centres in six EU countries were randomised to HM ON or OFF, of which 303 were eligible for data analysis. For all contacts (in-office, calendar- or alert-triggered web-based review, discussions, calls) time-expenditure was tracked. Country-specific cost parameters were used to convert resource use into monetary values. Remote FU equipment itself was not included in the cost calculations. Given only two patients from Finland (one in each group) a monetary valuation analysis was not performed for Finland. Average age was 62.4 ± 13.1 years, 81% were male, 39% received a DDD system, and 51% had a prophylactic ICD. Resource use with HM ON was clearly different: less FU visits (3.79 ± 1.67 vs. 5.53 ± 2.32; P < 0.001) despite a small increase of unscheduled visits (0.95 ± 1.50 vs. 0.62 ± 1.25; P < 0.005), more non-office-based contacts (1.95 ± 3.29 vs. 1.01 ± 2.64; P < 0.001), more Internet sessions (11.02 ± 15.28 vs. 0.06 ± 0.31; P < 0.001) and more in-clinic discussions (1.84 ± 4.20 vs. 1.28 ± 2.92; P < 0.03), but with numerically fewer hospitalizations (0.67 ± 1.18 vs. 0.85 ± 1.43, P = 0.23) and shorter length-of-stay (6.31 ± 15.5 vs. 8.26 ± 18.6; P = 0.27), although not significant. For the whole study population, the total FU cost for providers was not different for HM ON vs. OFF [mean (95% CI): €204 (169–238) vs. €213 (182–243); range for difference (€−36 to 54), NS]. From a payer perspective, FU-related costs were similar while the total cost per patient (including other physician visits, examinations, and hospitalizations) was numerically (but not significantly) lower. There was no difference in the net financial impact on providers [profit of €408 (327–489) vs. €400 (345–455); range for difference (€−104 to 88), NS], but there was heterogeneity among countries, with less profit for providers in the absence of specific remote FU reimbursement (Belgium, Spain, and the Netherlands) and maintained or increased profit in cases where such reimbursement exists (Germany and UK). Quality of life (SF-36) was not different. For all the patients as a whole, FU-related costs for providers are not different for remote FU vs. purely in-office FU, despite reorganized care. However, disparity in the impact on provider budget among different countries illustrates the need for proper reimbursement to ensure effective remote FU implementation.

To assess the performance of AF-QoL, a quality of life questionnaire for patients with atrial fibrillation (AF). Observational, prospective, multicentre study in 29 Spanish centres. Three patients' groups were identified at baseline visit: AF patients receiving a new therapeutic intervention according to physician criteria (intervention group); AF clinically stable patients according to physician evaluation (clinically stable group); and patients in a stable condition for more than 1 year after a myocardial infarction (control group). All patients were ≥18 years. Follow-up visit was at 1 month (clinically stable group) and 3 ± 1 months (intervention group). Sociodemographic and clinical information was gathered. AF-QoL, SF-36, and patient self-perception of general health status were administered. A total of 417 patients was included. Mean (SD) age was 61.2 (12.4), 31.4% women. AF-QoL mean overall score in AF patients (43.6) was lower (worse health-related quality of life, HRQoL) than in the control group (51.7) ( P < 0.05). At baseline, patients with higher frequency of symptoms ( P < 0.05) and worse NYHA functional class ( P < 0.01) reported lower AF-QoL scores. AF-QoL and SF-36 correlated in all of their domains ( r = 0.14–0.8, P < 0.01). AF-QoL showed good internal consistency (0.92) and test–retest reliability (0.86). AF-QoL is a valid and reliable HRQoL measure. Further investigation is recommended before using it in clinical practice.

Intravenous procainamide and amiodarone are drugs of choice for well-tolerated ventricular tachycardia. However, the choice between them, even according to Guidelines, is unclear. We performed a multicentre randomized open-labelled study to determine the safety and efficacy of intravenous procainamide and amiodarone for the acute treatment of tolerated wide QRS complex (probably ventricular) tachycardia. Patients were randomly assigned to receive intravenous procainamide (10 mg/kg/20 min) or amiodarone (5 mg/kg/20 min). The primary endpoint was the incidence of major predefined cardiac adverse events within 40 min after infusion initiation. Of 74 patients included, 62 could be analysed. The primary endpoint occurred in 3 of 33 (9%) procainamide and 12 of 29 (41%) amiodarone patients (odd ratio, OR = 0.1; 95% confidence interval, CI 0.03–0.6; P = 0.006). Tachycardia terminated within 40 min in 22 (67%) procainamide and 11 (38%) amiodarone patients (OR = 3.3; 95% CI 1.2–9.3; P = 0.026). In the following 24 h, adverse events occurred in 18% procainamide and 31% amiodarone patients (OR: 0.49; 95% CI: 0.15–1.61; P: 0.24). Among 49 patients with structural heart disease, the primary endpoint was less common in procainamide patients (3 [11%] vs. 10 [43%]; OR: 0.17; 95% CI: 0.04–0.73, P = 0.017). This study compares for the first time in a randomized design intravenous procainamide and amiodarone for the treatment of the acute episode of sustained monomorphic well-tolerated (probably) ventricular tachycardia. Procainamide therapy was associated with less major cardiac adverse events and a higher proportion of tachycardia termination within 40 min.