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INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients with Remotely Monitored Implanted
Claudius Hansen1, Christian Loges2, Karlheinz Seidl3
1Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem, Humboldtallee 6, 37073, Göttingen, Germany. hansen@hgz-goettingen.de.
Insights
Remote monitoring for heart failure patients with defibrillators is as effective as in-person visits. Adding phone calls to remote monitoring did not provide additional clinical benefits for these patients.
Area of Science:
- Cardiology
- Medical Technology
- Heart Failure Management
Background:
- Remote monitoring in heart failure (HF) patients with implantable cardioverter defibrillators (ICD) or cardiac resynchronisation therapy defibrillators (CRT-D) has demonstrated non-inferior outcomes compared to in-clinic visits.
- Further evidence is needed to confirm these findings and evaluate the impact of supplementary telephone follow-ups.
Purpose of the Study:
- To provide further evidence on the efficacy of remote monitoring versus in-clinic visits for HF patients with ICDs/CRT-Ds.
- To assess whether adding telephone follow-ups to remote monitoring influences patient outcomes.
Main Methods:
- Prospective, randomized, multicentre study (InContact).
- Comparison of quarterly automated follow-up (telemetry group) versus personal physician contact.
- Personal contact group divided into automated follow-up plus telephone call (remote+phone) or in-clinic visits.
Main Results:
- 34.8% of patients experienced clinical deterioration over 12 months, with no significant difference between telemetry, remote+phone, or in-clinic visit groups (non-inferiority criteria met).
- Mortality (5.2%) and HF-hospitalisation (11.0%) rates were comparable across all groups.
- Unscheduled follow-ups were nominally higher in telemetry and remote+phone groups compared to the visit group.
Conclusions:
- Quarterly remote follow-up alone is non-inferior to regular personal contact in HF patients with ICDs/CRT-Ds over 12 months.
- Adding quarterly telephone follow-ups to remote monitoring does not appear to offer additional clinical advantages.
Background:
In heart failure (HF) patients with implantable cardioverter defibrillators (ICD) or cardiac resynchronisation therapy defibrillators (CRT-D), remote monitoring has been shown to result in at least non-inferior outcomes relative to in-clinic visits. We aimed to provide further evidence for this effect, and to assess whether adding telephone follow-ups to remote follow-ups influenced outcomes.
Methods:
InContact was a prospective, randomised, multicentre study. Subjects receiving quarterly automated follow-up only (telemetry group) were compared to those receiving personal physician contact. Personal contact patients were further divided into those receiving automated follow-up plus a telephone call (remote+phone subgroup) or in-clinic visits only.
Results:
Two hundred and ten patients underwent randomisation (telemetry n = 102; personal contact n = 108 [remote+phone: n = 53; visit: n = 55]). Baseline characteristics were comparable between groups and subgroups. Over 12 months, 34.8% of patients experienced deterioration of their Packer Clinical Composite Response, with no significant difference between the telemetry group and personal care (p > 0.999), remote+phone (p = 0.937) or visit (p = 0.940) patients; predefined non-inferiority criteria were met. Mortality rates (5.2% overall) were comparable between groups and subgroups (p = 0.832/p = 0.645), as were HF-hospitalisation rates (11.0% overall; p = 0.605/p = 0.851). The proportion of patients requiring ≥1 unscheduled follow-up was nominally higher in telemetry and remote+phone groups (42.2 and 45.3%) compared to the visit group (29.1%). Overall, ≥ 1 ICD therapy was delivered to 15.2% of patients.
Conclusion:
In HF patients with ICDs/CRT-Ds, quarterly remote follow-up only over 12 months was non-inferior to regular personal contact. Addition of quarterly telephone follow-ups to remote monitoring does not appear to offer any clinical advantage.
Trial Registration:
clinicaltrials.gov: NCT01200381 (retrospectively registered on September 13th 2010).
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