INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients with Remotely Monitored Implanted Cardioverter Defibrillators SysTems (InContact).
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).
['Hansen|Claudius|C|', 'Loges|Christian|C|', 'Seidl|Karlheinz|K|', 'Eberhardt|Frank|F|', 'Tröster|Herbert|H|', 'Petrov|Krum|K|', 'Grönefeld|Gerian|G|', 'Bramlage|Peter|P|0000-0002-4121-6866', 'Birkenhauer|Frank|F|', 'Weiss|Christian|C|']
D000368:Aged D017147:Defibrillators, Implantable D004554:Electric Countershock D005858:Germany D006333:Heart Failure D006801:Humans D008875:Middle Aged D009819:Office Visits D011237:Predictive Value of Tests D011446:Prospective Studies D058998:Remote Sensing Technology D013686:Telemetry D013689:Telephone D013997:Time Factors D016896:Treatment Outcome
Heart failure Remote monitoring Implantable cardioverter defibrillator Cardiac resynchronisation therapy defibrillator Packer heart failure clinical composite response