EuroEco (European Health Economic Trial on Home Monitoring in ICD Patients): a provider perspective in five European countries on costs and net financial impact of follow-up with or without remote monitoring.

AIM: 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. METHODS AND RESULTS: 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. CONCLUSION: 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.

Workload and usefulness of daily, centralized home monitoring for patients treated with CIEDs: results of the MoniC (Model Project Monitor Centre) prospective multicentre study.

AIM: Automated, daily Home Monitoring (HM) of pacemaker and implantable cardioverter-defibrillator (ICD) patients can improve patient care. Yet, HM introduction to routine clinical practice is challenged by resource allocation for regular HM data review. We tested the feasibility, safety, workload, and clinical usefulness of a centralized HM model consisting of one monitor centre and nine satellite clinics. METHODS AND RESULTS: Having no knowledge about patients' clinical data, a telemonitoring nurse (TN) and a supporting physician at the monitor centre screened and filtered HM data in 62 pacemaker and 59 ICD patients from nine satellite clinics for over 1 year. Basic screening of arrhythmic and technical events required 25.7 min (TN) and 0.7 min (physician) per working day, normalized for 100 patients monitored. Communication of relevant events to satellite clinics per email or phone required additional 4.3 min (TN) and 0.4 min (physician). Telemonitoring nurse also screened for abnormal developments in longitudinal data trends weekly for 3 months after implantation, and then monthly; one patient session lasted 4.0 ± 2.9 min. To handle transmission-gap notifications, TN needed additional 2.8 min daily. Satellite clinics received 231.3 observations from the monitor centre per 100 patients/year, which prompted 86.3 patient contacts or intensive HM screening periods by the satellite clinic itself (37.3% response rate), 51.7 extra follow-up controls (22.3%), and 30.1 clinical interventions (13.0%). CONCLUSION: Centralized HM was feasible, reliable, safe, and clinically useful. Basic screening and communication of relevant arrhythmic and technical events required a total of 30 min (TN) and 1.1 min (physician) daily per 100 patients monitored.

[Current aspects of electrical cardioversion in patients with persistent atrial fibrillation]. / Aktuelle Aspekte der Elektrokardioversion bei Patienten mit persistierendem Vorhofflimmern.

BACKGROUND: Results of recent studies suggest new aspects in the concept of the management of patients with atrial fibrillation. Current trials comparing rhythm control by cardioversion followed by antiarrhythmic drug therapy with heart rate control only showed that rhythm control was not superior to rate control. SPECIAL ASPECTS OF ELECTRICAL CARDIOVERSION: However, some subgroups of patients with frequent or severe symptoms and younger patients with structurally normal hearts may benefit from cardioversion. In patients with persistent atrial fibrillation, sinus rhythm can be restored in approximately 90% by direct current transthoracic cardioversion. Transthoracic cardioversion is effective and safe, if anticoagulation is used. Attempts have been made to improve the success rate by new techniques. However, definition of subgroups and stabilization of sinus rhythm are ongoing issues of debate.

Relationship between selected overdrive parameters and the therapeutic outcome and tolerance of atrial overdrive pacing.

There is a paucity of information on the influence of selected overdrive parameters on the clinical efficacy and tolerance of atrial overdrive algorithms to suppress atrial tachyarrhythmias. Data from a completed clinical trial investigating a new DDD+ overdrive algorithm implemented in a permanent pacemaker were analyzed. One-hundred patients with standard pacing indications and atrial tachyarrhythmias were enrolled and followed for 6 months in DDD and 6 months in DDD+ mode in a randomized, crossover fashion. The overdrive step size was programmed at the discretion of the investigators between 4 and 12 beats/min, overdrive plateau length between 10 and 32 beats, and maximum overdrive rate between 100 and 160 beats/min. The effects of DDD+ versus DDD mode on burden and incidence of atrial tachyarrhythmias stored in the mode switch memory were examined as a function of the programmed overdrive parameters. An overdrive step size between 7 and 12 beats/min, and higher a maximum overdrive rate between 121 and 160 beats/min were slightly more effective than lower programmed values, though > 500 randomized, crossover observations would have been necessary to verify statistical significance. Overdrive pacing related symptoms mandated early manual deactivation of overdrive pacing in 4.7% of 85 evaluated patients. Overdrive was disabled without testing tolerability of less aggressive overdrive values. There was no link between patient symptoms and programmed overdrive step size or overdrive plateau length values.