INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients with Remotely Monitored Implanted Cardioverter Defibrillators SysTems (InContact).
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ABSTRACT: 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).
SUBMITTER: Hansen C
PROVIDER: S-EPMC6025705 | biostudies-literature | 2018 Jun
REPOSITORIES: biostudies-literature
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