INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients with Remotely Monitored Implanted Cardioverter Defibrillators SysTems (InContact)

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).

Keywords: Cardiac resynchronisation therapy defibrillator; Heart failure; Implantable cardioverter defibrillator; Packer heart failure clinical composite response; Remote monitoring.

Fig. 1

Study groups and patient flow. Legend: FU, follow-up. Reasons for device explantation (both remote+phone patients) were a floating structure at the atrial electrode and successful heart transplantation

Fig. 2

Change in Packer score at 13 months vs. 1 month. Legend: Proportions are relative to the number of patients in each group/subgroup with all relevant data available (telemetry: n = 92; personal contact: n = 92 including remote+phone: n = 44 and visit: n = 48). The distribution of the type of change in Packer score (worse, unchanged or improved) was not significantly different between telemetry vs. personal care (p = 0.855) or telemetry vs. remote+phone vs. visit groups/subgroups (p = 0.967)

Fig. 3

Unscheduled follow-ups between 1 and 13 months. Legend: unsched., unscheduled; FU, follow-up. The percentages displayed in the table and graph are proportional to the total number of patients within the respective group/subgroup that had ≥1 unscheduled follow-up. The three initiation types are not exclusive and any one patient may be represented by multiple bars. The distribution of initiation types was not significantly different between telemetry vs. personal care or telemetry vs. remote+phone vs. visit groups/subgroups. Follow-ups could be in-house or remote