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

BMC Cardiovascular Disorders

Frank Birkenhauer¹  Gerian Grönefeld²  Frank Eberhardt³  Claudius Hansen⁴  Peter Bramlage⁵  Karlheinz Seidl⁶  Krum Petrov⁷  Herbert Tröster⁸  Christian Loges⁹  Christian Weiss^1,10 

[1] Abbott - St. Jude Medical GmbH;Asklepios Klinik Barmbek;Evangelisches Krankenhaus Kalk;Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem;Institut für Pharmakologie und Präventive Medizin;Klinikum Ingolstadt;Kreiskliniken Böblingen Standort Sindelfingen;Marienhospital Stuttgart;SLK-Kliniken Heilbronn Klinikum am Plattenwald;Städtisches Klinikum Lüneburg gGmbH;

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

DOI  :  10.1186/s12872-018-0864-7

来源: DOAJ

【 摘 要 】

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).

【 授权许可】

Unknown