Remote monitoring of patients with implantable cardioverter-defibrillators: Can results from large clinical trials be transposed to clinical practice?

SummaryBackgroundRemote monitoring (RM) is increasingly used to follow up patients with implantable cardioverter-defibrillators (ICDs). Randomized control trials provide evidence for the benefit of this intervention, but data for RM in daily clinical practice with multiple-brands and unselected patients is lacking.AimsTo assess the effect of RM on patient management and clinical outcome for recipients of ICDs in daily practice.MethodsWe reviewed ICD recipients followed up at our institution in 2009 with RM or with traditional hospital only (HO) follow-up. We looked at the effect of RM on the number of scheduled ambulatory follow-ups and urgent unscheduled consultations, the time between onset of asymptomatic events to clinical intervention and the clinical effectiveness of all consultations. We also evaluated the proportion of RM notifications representing clinically relevant situations.ResultsWe included 355 patients retrospectively (RM: n=144, HO: n=211, 76.9% male, 60.3±15.2years old, 50.1% with ICDs for primary prevention and mean left ventricular ejection fraction 35.5±14.5%). Average follow-up was 13.5months. The RM group required less scheduled ambulatory follow-up consultations (1.8 vs. 2.1/patient/year; P<0.0001) and a far lower median time between the onset of asymptomatic events and clinical intervention (7 vs. 76days; P=0.016). Of the 784 scheduled ambulatory follow-up consultations carried out, only 152 (19.4%) resulted in therapeutic intervention or ICD reprogramming. We also found that the vast majority of RM notifications (61.9%) were of no clinical relevance.ConclusionRM allows early management of asymptomatic events and a reduction in scheduled ambulatory follow-up consultations in daily clinical practice, without compromising safety, endorsing RM as the new standard of care for ICD recipients

Current clinical evidence for remote patient management.

International audiencePacemaker (PM) and implantable cardioverter defibrillator (ICD) patients are ideally suited to remote management in the form of remote follow-up as well as of remote monitoring, which are both acts of telemedicine. Large randomized trials, such as TRUST, COMPAS, CONNECT, ECOST and EVOLVO, and the huge ALTITUDE registry provided a high level of evidence for the multiple advantages of remote management. These trials demonstrated the capability of early detection of events, the ability to reduce the incidence of inappropriate shocks and also of all charged shocks and this despite fewer in-clinic visits for the patients. The studies also demonstrated the safety of remote management of ICD and PM patients and moreover its positive impact on the survival of patients. Thereby, remote monitoring is clinically much more effective and efficient than conventional follow-up

Incidence of Early Adverse Events Surrounding Direct Current Cardioversion of Persistent Atrial Fibrillation. A Cohort Study of Practices

Aims. To establish the incidence of early adverse events surrounding direct current (DC) cardioversion of persistent atrial fibrillation in an unselected patient cohort and to describe and analyse these complications. Methods. Prospective study over a three-month period (February, March and April 2000). Outcome measures included all serious adverse events during the hospitalisation for DC cardioversion. Six hundred and eighty-four DC cardioversion were performed on 659 patients. Results. The rate of adverse events was 4.4% including 1.3% bradycardia, 0.3% ventricular arrhythmia, 0.3% QT increase, 1% serious haemorrhages, 0.4% death and 1.2% miscellaneous adverse events. Conclusion. The perceived tolerance to DC cardioversion in atrial fibrillation should be amended with the 4.4% serious early adverse events

Daily remote monitoring of implantable cardioverter-defibrillators:insights from the pooled patient-level data from three randomized controlled trials (IN-TIME, ECOST, TRUST)

Abstract Aims Remote monitoring of implantable cardioverter-defibrillators may improve clinical outcome. A recent meta-analysis of three randomized controlled trials (TRUST, ECOST, IN-TIME) using a specific remote monitoring system with daily transmissions [Biotronik Home Monitoring (HM)] demonstrated improved survival. We performed a patient-level analysis to verify this result with appropriate time-to-event statistics and to investigate further clinical endpoints. Methods and results Individual data of the TRUST, ECOST, and IN-TIME patients were pooled to calculate absolute risks of endpoints at 1-year follow-up for HM vs. conventional follow-up. All-cause mortality analysis involved all three trials (2405 patients). Other endpoints involved two trials, ECOST and IN-TIME (1078 patients), in which an independent blinded endpoint committee adjudicated the underlying causes of hospitalizations and deaths. The absolute risk of death at 1 year was reduced by 1.9% in the HM group (95% CI: 0.1–3.8%; P = 0.037), equivalent to a risk ratio of 0.62. Also the combined endpoint of all-cause mortality or hospitalization for worsening heart failure (WHF) was significantly reduced (by 5.6%; P = 0.007; risk ratio 0.64). The composite endpoint of all-cause mortality or cardiovascular (CV) hospitalization tended to be reduced by a similar degree (4.1%; P = 0.13; risk ratio 0.85) but without statistical significance. Conclusion In a pooled analysis of the three trials, HM reduced all-cause mortality and the composite endpoint of all-cause mortality or WHF hospitalization. The similar magnitudes of absolute risk reductions for WHF and CV endpoints suggest that the benefit of HM is driven by the prevention of heart failure exacerbation. </jats:sec