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: Atotal of 312 patients with VVI-or DDD-ICD implants from 17 centres in six EU countries were randomised to HMON 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): (sic)204 169-238) vs. (sic)213 (182-243); range for difference ((sic)-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 (sic)408 (327-489) vs. (sic)400 (345-455); range for difference ((sic)-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

Right versus left atrial pacing in patients with sick sinus syndrome and paroxysmal atrial fibrillation (Riverleft study)

_Background:_ The incidence of sick sinus syndrome will increase due to population ageing. Consequently, this will result in an increase in the number of pacemaker implantations. The atrial lead is usually implanted in the right atrial appendage, but this position may be ineffective for prevention of atrial fibrillation. It has been suggested that pacing distally in the coronary sinus might be more successful in preventing atrial fibrillation episodes. The aim of this trial is to study the efficacy of distal coronary sinus versus right atrial appendage pacing in preventing atrial fibrillation episodes in patients with sick sinus syndrome. _Methods/Design:_ This study is designed as a multicenter, randomized controlled trial. Patients with sick sinus syndrome and at least one atrial fibrillation episode of 30 seconds or more in the six months before recruitment will be eligible for participation in this study. _Discussion:_ This randomized controlled trial is the first in which home monitoring will be used to compare atrial fibrillation recurrences between pacing in the distal coronary sinus or right atrial appendage. Home monitoring gives the opportunity to accurately detect atrial fibrillation episodes and to study characteristics of atrial fibrillation episodes. Should distal coronary sinus pacing significantly diminish atrial fibrillation recurrences, this study will redefine the preferential location of an atrial lead for preventive pacing

Cardiac resynchronization therapy in persistent left superior vena cava: Can you do it two-leads-only?

Cardiac resynchronization therapy in persistent left superior vena cava: Can you do it two-leads-only

Direct comparison of steroid and non-steroid eluting small surface pacing leads: Randomized, multicenter clinical trial

BACKGROUND: The aim of the study was to evaluate the effi cacy and safety of small surface steroid-eluting atrial and ventricular pacing leads in comparison to non-steroid leads using remote monitoring system (Biotronik Home Monitoring(R)). METHODS: In this randomized multicenter prospective trial, SIELLO T steroid-eluting ventricular leads (n = 42) were compared to BPPU T non-steroid leads (n = 46) and SIELLO JT steroid-eluting atrial leads (n = 24) to BPPU JT non-steroid leads (n = 27) (Biotronik, Berlin, Germany) in pacemaker devices with remote monitoring capabilities. Lead parameters were evaluated during implantation, at 1-week and 1, 3, 6-month outpatient follow-up. Remote monitoring data were collected weekly. RESULTS: Atrial and ventricular steroid-eluting leads had stable sensing and impedance as compared to non-steroid leads at implantation and during follow-up. Patients with non-steroid atrial leads had signifi cantly higher threshold compared to steroid leads at 1-week and at 1, 3, 6-month follow-up with a peak at 1-month (1-month 1.4 +/- 0.6 vs. 0.7 +/- 0.3 V at 0.4 ms, p < 0.001; 6-month 0.3 +/- 0.5 vs. 0.2 +/- 0.3 V at 0.4 ms, p = 0.002). Patients with non-steroid ventricular leads had signifi cantly higher threshold compared to steroid leads at 1, 3, 6-month (6-month 1.0 +/- 0.3 vs. 0.6 +/- 0.2 V at 0.4 ms, p < 0.001). Remote monitoring confi rmed consistent results. During the study, 3 patients died of non-lead-related death. Lead repositioning was necessary in 2 atrial, 2 ventricular steroid leads and in 1 ventricular non-steroid lead. CONCLUSIONS: Atrial and ventricular pacemaker leads with steroid showed signifi cantly lower pacing threshold compared to non-steroid leads, confi rmed by remote monitoring

Capacity of dental equipment to interfere with cardiac implantable electrical devices

Patients with cardiac implantable electrical devices should take precautions when exposed to electromagnetic fields. Possible interference as a result of proximity to electromagnets or electricity flow from electronic tools employed in clinical odontology remains controversial. The objective of this study was to examine in vitro the capacity of dental equipment to provoke electromagnetic interference in pacemakers and implantable cardioverter defibrillators. Six electronic dental instruments were tested on three implantable cardioverter defibrillators and three pacemakers from different manufacturers. A simulator model, submerged in physiological saline, with elements that reproduced life-size anatomic structures was used. The instruments were analyzed at differing distances and for different time periods of application. The dental instruments studied displayed significant differences in their capacity to trigger electromagnetic interference. Significant differences in the quantity of registered interference were observed with respect to the variables manufacturer, type of cardiac implant, and application distance but not with the variable time of application. The electronic dental equipment tested at a clinical application distance (20 cm) provoked only slight interference in the pacemakers and implantable cardioverter defibrillators employed, irrespective of manufacturer

Rationale and design of BERLIN VT study: a multicenter randomised trial comparing preventive versus deferred ablation of ventricular tachycardia

Introduction Catheter ablation ( CA) has shown to effectively reduce the burden of ventricular tachycardia in patients with implanted cardioverter-defibrillator (ICD). However, in patients with ICD implantation for secondary prevention of ventricular tachycardia (VT), the appropriate time point of CA and its effect on mortality and heart failure progression remains a matter of debate. Methods and analysis We present the design of the ongoing preventive aBlation of vEntriculartachycaRdia in patients with myocardiaLINfarction (BERLIN VT) study that aims to prospectively enrol 208 patients with a stable ischaemic cardiomyopathy, a left ventricular ejection fraction of 30% to 50% and documented ventricular tachycardia. Patients will be 1: 1 randomised to undergo CA at the time of ICD implantation or CA after the third appropriate ICD shock for ventricular tachycardia. ICD implantation will be performed in all patients. The primary endpoint is defined as the time to first event comprising all-cause mortality and unplanned hospital admission for congestive heart failure or for symptomatic VT/ventricular fibrillation. The patients will be followed until study termination according to the event driven design. Completion of enrolment is expected for mid of 2019. Ethics and dissemination The study had been approved by the "Ethik-kommission der Landesarztekammer Hamburg" as well as the local institutional review boards for each of the participation sites. The results of the trial will be published in peer-reviewed journal

Direct comparison of steroid and non-steroid eluting small surface pacing leads: Randomized, multicenter clinical trial

Background: The aim of the study was to evaluate the effi cacy and safety of small surfacesteroid-eluting atrial and ventricular pacing leads in comparison to non-steroid leads usingremote monitoring system (Biotronik Home Monitoring®).Methods: In this randomized multicenter prospective trial, SIELLO T steroid-eluting ventricularleads (n = 42) were compared to BPPU T non-steroid leads (n = 46) and SIELLOJT steroid-eluting atrial leads (n = 24) to BPPU JT non-steroid leads (n = 27) (Biotronik,Berlin, Germany) in pacemaker devices with remote monitoring capabilities. Lead parameterswere evaluated during implantation, at 1-week and 1, 3, 6-month outpatient follow-up. Remotemonitoring data were collected weekly.Results: Atrial and ventricular steroid-eluting leads had stable sensing and impedance ascompared to non-steroid leads at implantation and during follow-up. Patients with non-steroidatrial leads had signifi cantly higher threshold compared to steroid leads at 1-week and at1, 3, 6-month follow-up with a peak at 1-month (1-month 1.4 ± 0.6 vs. 0.7 ± 0.3 V at 0.4 ms,p &lt; 0.001; 6-month 0.3 ± 0.5 vs. 0.2 ± 0.3 V at 0.4 ms, p = 0.002). Patients with non-steroidventricular leads had signifi cantly higher threshold compared to steroid leads at 1, 3, 6-month(6-month 1.0 ± 0.3 vs. 0.6 ± 0.2 V at 0.4 ms, p &lt; 0.001). Remote monitoring confi rmed consistentresults. During the study, 3 patients died of non-lead-related death. Lead repositioningwas necessary in 2 atrial, 2 ventricular steroid leads and in 1 ventricular non-steroid lead.Conclusions: Atrial and ventricular pacemaker leads with steroid showed signifi cantly lowerpacing threshold compared to non-steroid leads, confi rmed by remote monitoring

Embolisation von Katheterbeschichtung in das Myokard

Zusammenfassung: Interventionelle kardiovaskuläre Eingriffe nehmen stetig zu. Die verwendeten Führungskatheter sind mit hydrophilem Material beschichtet, das Einführen wie Kontrolle der Katheter erleichtert und gleichzeitig vaskuläre Spasmen verhindert. Wir berichten von 2Fällen, bei denen die Verwendung eines ChoICE®-PT-Führungskatheters bei Koronarangiographie zu einer Embolisation dieser hydrophilen Beschichtung mit nachfolgendem Verschluss kleiner intramyokardialer Arterien führt