Detection of atrial fibrillation using an implantable loop recorder in patients with previous cryptogenic stroke: the SPIDER-AF registry (Stroke Prevention by Increasing DEtection Rates of Atrial Fibrillation).

BACKGROUND: The use of implantable loop recorder (ILR) to detect atrial fibrillation (AF) in patients with a history of cryptogenic stroke (CS) has seldom been investigated in "real-world" settings. OBJECTIVE: This study aimed to present the results of the Stroke Prevention by Increasing DEtection Rates of Atrial Fibrillation (SPIDER-AF) registry. METHOD: SPIDER is a multicentric, observational registry, including 35 facilities all over Germany. It enrolled outpatients without AF history and with CS before ILR implantation. RESULTS: We included 500 patients (mean age 63.1 ± 12.7 years), 304 (60.8%) were males, with previous stroke (72.6%) and TIA (27.4%). After inclusion, all were followed for at least 12 months. AF was detected in 133 (26.8%), 25.3% of patients with previous stroke and 29.9% with TIA (p = 0.30). AF was detected after a median of 121.5 days (IQR 40.5-223.0). AF was primarily paroxysmal (95.7% after stroke, 100% after TIA). In 19.5% (n = 26) anticoagulation was not administered after AF detection. Mean CHA2DS2-VASc score (OR 1.22; CI 1.01-1.49; p = 0.037) and age > 70 years (OR 0.41; CI 0.19-0.88; p = 0.0020) correlated with AF. Repeat cerebrovascular events at follow-up (28; 5.6%) correlated with AF (OR = 2.17; CI 1.00-4.72; p = 0.049). AF (p = 0.91) and recurrent events (p = 0.43) occurred similarly in females and males. CONCLUSIONS: In the context of cryptogenic strokes ILRs are a valuable tool for early detection of AF. In a real-world scenario, the anticoagulation therapy remains inadequate despite diagnosed AF in a relevant subset of patients requiring optimization of patient management.

Impedance-based remote monitoring in patients with heart failure and concomitant chronic kidney disease.

AIMS: Remote monitoring (RM) of thoracic impedance represents an early marker of pulmonary congestion in heart failure (HF). Chronic kidney disease (CKD) may promote fluid overload in HF patients. We investigated whether concomitant CKD affected the efficacy of impedance-based RM in the OptiLink HF trial. METHODS AND RESULTS: Among HF patients included in the OptiLink HF trial, time to the first cardiovascular hospitalization and all-cause death according to the presence of concomitant CKD was analysed. CKD was defined as GFR < 60 mL/min/1.73 m2 at enrolment. Of the 1002 patients included in OptiLink HF, 326 patients (33%) had HF with concomitant CKD. The presence of CKD increased transmission of telemedical alerts (median of 2 (1-5) vs. 1 (0-3); P = 0.012). Appropriate contacting after alert transmission was equally low in patients with and without CKD (57% vs. 59%, P = 0.593). The risk of the primary endpoint was higher in patients with CKD compared with patients without CKD (hazard ratio (HR), 1.62 [95% confidence interval (CI), 1.16-2.28]; P = 0.005). Impedance-based RM independently reduced primary events in HF patients with preserved renal function, but not in those with CKD (HR 0.68 [95% CI, 0.52-0.89]; P = 0.006). CONCLUSIONS: The presence of CKD in HF patients led to a higher number of telemedical alert transmissions and increased the risk of the primary endpoint. Inappropriate handling of alert transmission was commonly observed in patients with chronic HF and CKD. Guidance of HF management by impedance-based RM significantly decreased primary event rates in patients without CKD, but not in patients with CKD.

Differences in management of telemedicine alerts on weekdays and public holidays: Results from the OptiLink heart failure trial.

BACKGROUND: In the OptiLink heart failure study, timely and appropriate reactions to telemedicine alerts improved clinical outcomes in heart failure patients. This analysis investigates the relation between the weekday of alert transmission and the subsequent patient contact. METHODS: In patients enrolled in the intervention arm of the OptiLink heart failure study (n = 505, age 66.1 ± 10.1, 77.2% male, left-ventricular ejection fraction 26.7% ± 6.1%), fluid index threshold crossing alerts were analysed according to the weekday of the transmission. Transmissions on Mondays-Thursdays were categorized as TD1, Fridays-Sundays as well as public holidays as TD2. RESULTS: Of 1365 transmitted alerts, 867 (63.5%) were categorized as TD1 and 498 (36.5%) as TD2. Same day telephone contacts were more frequent in TD1 (46.2%) than in TD2 (18.3%; p < 0.001). Accordingly, the median time to contact was significantly longer in TD2 compared with TD1 (2(1-3) vs 0(0-1) days; p < 0.001). Rates of no telephone contact were no different between the groups (12.1% vs 12.4%; p = 0.866). Although signs of worsening heart failure were prevalent in 32.4% in TD1 versus 32.1% in TD2 (p = 0.996), initiation of a pharmacological intervention occurred more likely in TD1 compared with TD2 (27.9% vs 22.9%; p = 0.041). No differences existed concerning hospitalization for heart failure within 30 days after alert transmission (3.9% vs 3.4%; p = 0.636). CONCLUSION: Alert transmissions during weekends and public holidays were less likely associated with timely patient contacts and initiation of pharmacological interventions than during the week. Telemedical centres providing 24/7 remote monitoring service and specific education programmes for physicians might help to optimize patient care.

Do implantable loop recorders impact the survival of patients with recurrent unexplained syncope?

Aim: This study compares the outcomes of patients who receive an implantable loop recorder (ILR) for unexplained syncope to a control group without the diagnostic device in German claims data. Methods and materials: Patients with ILR were matched to a control group based on prior syncope events, age, gender and Charlson Comorbidity index (CCI). Survival, syncope hospitalizations, treatment and costs were compared. Results/conclusion: Four hundred and twelve ILR patients were matched with controls, mean age was 68, mean CCI was 2.7, 42% females. ILR patients lived on average 1.2 years longer than patients in the control group. Twenty-five percent of ILR patients received a therapeutic device compared with 5% in the control group. ILRs might help to diagnose and treat patients with positive impact on survival.

Remote Monitoring With Appropriate Reaction to Alerts Was Associated With Improved Outcomes in Chronic Heart Failure: Results From the OptiLink HF Study.

BACKGROUND: Impedance-based remote monitoring (RM) failed to reduce clinical events in the OptiLink heart failure (HF) trial. However, rates of alert-driven interventions triggered by intrathoracic fluid index threshold crossings (FTC) were low indicating physicians' inappropriate reactions to alerts. METHODS: We separated appropriate from inappropriate contacts to FTC transmissions in the OptiLink HF trial (Optimization of Heart Failure Management Using OptiVol™ Fluid Status Monitoring and CareLink™). Appropriate contacts had to meet the following criteria: (1) initial telephone contact within 2 working days after FTC transmission, (2) follow-up contacts according to study protocol, and (3) medical intervention initiated after FTC due to cardiac decompensation. We compared time to cardiovascular death or HF hospitalization between RM patients contacted appropriately or inappropriately and patients with usual care. RESULTS: In the RM group, at least one FTC alert was transmitted in 356 patients (70.5%; n=505). Of note, only 55.5% (n=758) of all transmitted FTCs (n=1365) were followed by an appropriate contact. While 113 patients (31.7%; n=356) have been contacted appropriately after every FTC, in 243 patients (68.3%; n=356) at least one FTC was not responded by an appropriate contact. Compared with usual care, RM with appropriate contacts to FTC alerts independently reduced the risk of the primary end point (hazard ratio, 0.61 [95% CI, 0.39-0.95]; P=0.027). CONCLUSIONS: RM appropriate reactions to FTC alerts are associated with significantly improved clinical outcomes in patients with advanced HF and implantable cardioverter-defibrillators.

[Iron deficiency in heart failure. A new diagnostic therapy algorithm - evidence-tested and workable]. / Eisenmangel bei Herzinsuffizienz ­ neuer Diagnose-Therapie-Algorithmus, evidenzgeprüft und praktikabel.

BACKGROUND: Iron deficiency is a diagnostic and therapy-requiring comorbidity in heart failure with a negative impact on the prognosis. Even without signs of anemia, iron deficiency can lead to reduced performance with physical weakness and dyspnoea in patients with chronic heart failure. METHOD: Well-known cardiologists discussed this at an expert meeting on the topic of iron deficiency in heart failure. RESULTS AND CONCLUSIONS: Despite the high relevance for patients' outcome, this complication is still under-addressed, although specific diagnosis and effective therapy are possible and are also recommended in current ESC guidelines. A new evidence-tested algorithm should now help to facilitate diagnosis and therapy in everyday practice. The prerequisite is that it can be well integrated into clinical routine.

[Active cardiac implantable electronic devices: What is possible in ambulatory health care in 2017?] / Aktive kardiale Rhythmusimplantate: Was ist 2017 in der Praxis möglich?

Telemonitoring (TM) features are implemented in nearly all cardiac implantable electronic devices (CIEDs) that have recently been released to the market. In combination with pacemakers, defibrillators and systems for cardiac resynchronization it is a safe and efficient method for routine technical aftercare of the devices as well as for monitoring heart failure and arrhythmias. Using TM has the potential to optimize patient care with regard to economic, clinical and safety aspects. Despite the good availability of existing data and clear recommendations of the responsible scientific societies, it is often seen as an isolated solution which is not fully integrated into standard care, although it has its own EBM number for implantable cardioverter-defibrillators and cardiac resynchronization therapy systems. The reasons are not only the unsatisfactory reimbursement of costs, different IT structures and the borders between clinics and medical practices, but also acceptance problems of physicians and legal aspects. The compensation of cardiac pacemakers and 'event recorders' is unsolved. TM provides the prospect for optimal and cross-sectoral patient care. Furthermore it has the potential to become the standard method for the care for patients with a CIED.

Fluid status telemedicine alerts for heart failure: a randomized controlled trial.

AIMS: Hospital admissions are frequently preceded by increased pulmonary congestion in heart failure (HF) patients. This study evaluated whether early automated fluid status alert notification via telemedicine improves outcome in HF patients. METHODS AND RESULTS: Patients recently implanted with an implantable cardioverter defibrillator (ICD) with or without cardiac resynchronization therapy were eligible if one of three conditions was met: prior HF hospitalization, recent diuretic treatment, or recent brain natriuretic peptide increase. Eligible patients were randomized (1:1) to have fluid status alerts automatically transmitted as inaudible text message alerts to the responsible physician or to receive standard care (no alerts). In the intervention arm, following a telemedicine alert, a protocol-specified algorithm with remote review of device data and telephone contact was prescribed to assess symptoms and initiate treatment. The primary endpoint was a composite of all-cause death and cardiovascular hospitalization. We followed 1002 patients for an average of 1.9 years. The primary endpoint occurred in 227 patients (45.0%) in the intervention arm and 239 patients (48.1%) in the control arm [hazard ratio, HR, 0.87; 95% confidence interval (CI), 0.72-1.04; P = 0.13]. There were 59 (11.7%) deaths in the intervention arm and 63 (12.7%) in the control arm (HR, 0.89; 95% CI, 0.62-1.28; P = 0.52). Twenty-four per cent of alerts were not transmitted and 30% were followed by a medical intervention. CONCLUSION: Among ICD patients with advanced HF, fluid status telemedicine alerts did not significantly improve outcomes. Adherence to treatment protocols by physicians and patients might be challenge for further developments in the telemedicine field.

Fluid status monitoring with a wireless network to reduce cardiovascular-related hospitalizations and mortality in heart failure: rationale and design of the OptiLink HF Study (Optimization of Heart Failure Management using OptiVol Fluid Status Monitoring and CareLink).

AIMS: The Optimization of Heart Failure Management using OptiVol Fluid Status Monitoring and CareLink (OptiLink HF) study is designed to investigate whether OptiVol fluid status monitoring with an automatically generated wireless CareAlert notification via the CareLink Network can reduce all-cause death and cardiovascular hospitalizations in an HF population, compared with standard clinical assessment. Methods Patients with newly implanted or replacement cardioverter-defibrillator devices with or without cardiac resynchronization therapy, who have chronic HF in New York Heart Association class II or III and a left ventricular ejection fraction ≤35% will be eligible to participate. Following device implantation, patients are randomized to either OptiVol fluid status monitoring through CareAlert notification or regular care (OptiLink 'on' vs. 'off'). The primary endpoint is a composite of all-cause death or cardiovascular hospitalization. It is estimated that 1000 patients will be required to demonstrate superiority of the intervention group to reduce the primary outcome by 30% with 80% power. CONCLUSION: The OptiLink HF study is designed to investigate whether early detection of congestion reduces mortality and cardiovascular hospitalization in patients with chronic HF. The study is expected to close recruitment in September 2012 and to report first results in May 2014.