Fewer clinic visits but no clinical benefit of remote monitoring CRT
ESC 2016 - Rome
MORE-CARE - Effects of remote monitoring on outcomes and use of healthcare resources in heart failure patients with biventricular defibrillatorsPresented at the ESC congress 2016 by: Giuseppe Boriani (Modena, Italy)
BackgroundCardiac resynchronisation therapy (CRT) has been shown to lower mortality and rehospitalisation in certain patients with heart failure (HF), but the risk of hospital admissions remains high. Remote monitoring (RM) of implantable cardiac devices facilitates device follow-up and quick preventive action aiming to improve HF outcomes. It is, however, unclear whether RM can improve clinical outcomes and results in a favourable economic situation.
The MORE-CARE study aimed to evaluate whether RM provides more clinical and/or economic value in comparison with standard follow-up strategies in the context of management of systolic HF patients with a CRT-D. It was an international, multicentre (64 centres), randomised study with two arms, including 917 patients with a CRT-ICD indication according to the ESC 2009 guidelines (LVEF<37%, NYHA class III-IV, QRS>120 ms, optimalised medical therapy), no permanent AT/AF and with a first implant of CRT-D. The ‘remote’ group was first follow-up remotely during 4 months, then there was a follow-up period of 8 months in clinic, after which 12 more months with remote follow-up. The control group had all follow-up visits in clinic.
The study was ended prematurely due to slow inclusion, because of which the power was insufficient for the primary endpoint.
- No difference was seen between groups in the primary endpoint of all-cause mortality, CV or device-related hospitalisations (2 year event rates: 130/437 (29.7%) in remote, 123/428 (28.7%) in control group, HR: 1.02, 95%CI: 0.80-1.30, P=0.889).
- Concerning use of health resources, hospitalization for all reasons were comparable in both groups (2 year event rates 96 in 707 FU-years in the remote arm, vs. 90 events in 696 FU-years (Adj RR: 1.02, P=0.833).
- In the remote group, fewer visit to the emergy room that did not lead to admission were seen (11.4 events per 707 FU-years vs. 16.0 per 696 FU-years, adj RR: 0.72, 95%CI: 0.53-0.98, P=0.037).
- Use of health resources for CV reasons was 48% lower in the remote group (2-years event rates of 3.7 vs. 6.0 per 100 patients, P<0.001).
- A cost saving with RM of €2899 per 100 patients over 2 years was calculated, which could almost entirely be ascribed to the decrease in clinic visits, (incidence rate ratio (IRR): 0.59, 95%CI: 0.56-0.62, P<0.001), despite an increase of unplanned visits in the RM-arm (IRR: 2.80, 95%CI: 2.16-3.63, P<0.001).
- A travel saving of €145 per patient over 2 years was seen with RM as compared with standard follow-up.
- There were no differences between groups in safety quality of life measures.
ConclusionIn HF patients with a CRT-D implanted, remote monitoring of the device did not reduce mortality or the risk of CV or device-related hospitalisation. Use of RM did have a favourable impact on use of health resources, by a decrease of 41% of clinic visits, without limiting patient safety. The favourable profile of cost saving was from both the perspectives of the health care system and the patient.
“Our new findings show that this did not reduce mortality or hospitalisation outcomes. Many of our subjects had significant comorbidities, and about two thirds of the hospitalisations in this study were related to comorbidities rather than cardiovascular reasons per se. Real-world data suggest co-morbidities may therefore mitigate the impact of remote monitoring. Nevertheless, our data show that remote monitoring is safe and does not compromise outcome,” said Giuseppe Boriani in a press release.
Our reporting is based on the information provided during the ESC congress –