Home Monitoring Shown to Safely and Efficiently Replace Face-To-Face Follow-Ups for Pacemaker Patients

Results just published in Circulation Arrhythmia and Electrophysiology confirm that BIOTRONIK Home Monitoring^® provides safe and cost-effective remote management of pacemaker patients,¹ indicating that it can safely replace the common practice of routine in-office follow-ups for pacemaker recipients. This is particularly significant in practicing social distancing during COVID-19 and helping relieve pressure in hospitals and clinics.

The multi-center “at Home” study* examined whether remote follow-ups are as safe as in-office follow-ups and whether visits can be reduced through remote follow-up. The investigators analyzed the post-implant management of 1,108 pacemaker patients over a two-year-period. It is the largest randomized trial with the longest follow-up of remote only management of pacemaker patients.

The patients were randomly assigned to two groups with different follow-up schemes: remote follow-up (RFU) or conventional in-office follow-up (CFU). Both groups were monitored through daily automatic transmissions using Home Monitoring. While the CFU group underwent in-clinic evaluations every six months, the RFU group did not attend regular face-to-face follow-ups.

Some key findings:

• No significant difference between RFU and CFU groups in regards to safety (primary endpoint determined as a composite of mortality, stroke or cardiovascular surgical procedure)
• A 69.5% reduction in in-office follow-ups (710 in the RFU group compared to CFU’s 2,275)
• An 11% reduction in costs associated with pacemaker follow-ups (18,800 Yen annual average in the RFU group compared to 21,400 Yen in the CFU group)

“Remote monitoring is useful and essential in the management of pacemaker patients,” explained lead investigator Dr. Eiichi Watanabe, Fujita Health University School of Medicine, Aichi, Japan. “It lowered the number of face-to-face visits without increasing adverse events and reduced the amount of medical expenses. This approach offers advantages for all relevant groups: patients save time and expenses of travelling to the hospital, the hospitals have less workload and pressure in clinics, and medical insurers save costs on redundant diagnostic procedures.”

These results support findings in studies such as TRUST, COMPAS and RM-ALONE* which demonstrate the reduction of face-to-face follow ups with the active use of Home Monitoring^2-4.

“As the pioneer remote monitoring system in cardiac rhythm management, Home Monitoring has a record in helping improve patient outcomes while streamlining healthcare,” said Klaus Contzen, Vice-President Clinical Affairs CRM/EP at BIOTRONIK. “It helps physicians detect events early by providing daily automatic transmissions, allowing for early intervention so patients can get the care they need sooner.”

References:

^{1 Watanabe, E et al. Safety and Efficacy of the Management of Pacemaker Patients via Home Monitoring versus Conventional In-Office Follow-ups. CIRCEP, 2020. Doi: 10.1161/CIRCEP.119.007734}

^{2 Varma N et al. Circulation. 2010 Jul 27;122(4):325-32 doi: 10.1161/CIRCULATIONAHA.110.937409}

^{3 Mabo p et al. European Heart Journal (2012) 33, 1105–1111 doi:10.1093/eurheartj/ehr419}

^{4 Slotwiner D et al. Heart Rhythm. 2015;12:e69-e100 doi.org/10.1016/j.hrthm.2015.05.008}

*Disclaimer: This study utilized remote only follow-up of patients for 24 months. Remote only follow-up for 24 months has not yet been approved for the product labeling and cannot be recommended by BIOTRONIK at this time.