No favourable effect on mortality was observed with STS HM .
Similar reductions were observed in all-cause hospitalisations for TM interventions , whereas STS interventions had no major effect .
STS HM was dominated by usual care .
Similar results were observed in scenario analyses performed using higher costs of usual care , higher costs of STS HH and lower costs of TM during office hours .
As a result , the economic model developed scenarios for different RM classifications and their costs were estimated using bottom-up costing methods .
Despite wide variation in usual care and RM strategies , cost-effectiveness analyses suggest that TM during office hours was an optimal strategy ( in most costing scenarios ) .
However , clarity was lacking among descriptions of the components of RM packages and usual care and there was a lack of robust estimation of costs .
BACKGROUND Remote monitoring ( RM ) strategies have the potential to deliver specialised care and management to patients with heart failure ( HF ) .
OBJECTIVE To determine the clinical effectiveness and cost-effectiveness of home telemonitoring ( TM ) or structured telephone support ( STS ) strategies compared with usual care for adult patients who have been recently discharged ( within 28 days ) from acute care after a recent exacerbation of HF .
The review included r and omised controlled trials ( RCTs ) or observational cohort studies with a contemporaneous control group that included the following RM interventions : ( 1 ) TM ( including cardiovascular implanted monitoring devices ) with medical support provided during office hours or 24/7 ; ( 2 ) STS programmes delivered by human-to-human contact ( HH ) or human-to-machine interface ( HM ) .
Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial
BACKGROUND Results of previous studies support the hypothesis that implantable haemodynamic monitoring systems might reduce rates of hospitalisation in patients with heart failure . We undertook a single-blind trial to assess this approach . METHODS Patients with New York Heart Association ( NYHA ) class III heart failure , irrespective of the left ventricular ejection fraction , and a previous hospital admission for heart failure were enrolled in 64 centres in the USA . They were r and omly assigned by use of a central ised electronic system to management with a wireless implantable haemodynamic monitoring ( W-IHM ) system ( treatment group ) or to a control group for at least 6 months . Only patients were masked to their assignment group . In the treatment group , clinicians used daily measurement of pulmonary artery pressures in addition to st and ard of care versus st and ard of care alone in the control group . The primary efficacy endpoint was the rate of heart-failure-related hospitalisations at 6 months . The safety endpoints assessed at 6 months were freedom from device-related or system-related complications ( DSRC ) and freedom from pressure-sensor failures . All analyses were by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00531661 . FINDINGS In 6 months , 83 heart-failure-related hospitalisations were reported in the treatment group ( n=270 ) compared with 120 in the control group ( n=280 ; rate 0·31 vs 0·44 , hazard ratio [ HR ] 0·70 , 95 % CI 0·60 - 0·84 , p<0·0001 ) . During the entire follow-up ( mean 15 months [ SD 7 ] ) , the treatment group had a 39 % reduction in heart-failure-related hospitalisation compared with the control group ( 153 vs 253 , HR 0·64 , 95 % CI 0·55 - 0·75 ; p<0·0001 ) . Eight patients had DSRC and overall freedom from DSRC was 98·6 % ( 97·3 - 99·4 ) compared with a prespecified performance criterion of 80 % ( p<0·0001 ) ; and overall freedom from pressure-sensor failures was 100 % ( 99·3 - 100·0 ) . INTERPRETATION Our results are consistent with , and extend , previous findings by definitively showing a significant and large reduction in hospitalisation for patients with NYHA class III heart failure who were managed with a wireless implantable haemodynamic monitoring system . The addition of information about pulmonary artery pressure to clinical signs and symptoms allows for improved heart failure management . FUNDING CardioMEMS
No favourable effect on mortality was observed with STS HM .
Similar reductions were observed in all-cause hospitalisations for TM interventions , whereas STS interventions had no major effect .
STS HM was dominated by usual care .
Similar results were observed in scenario analyses performed using higher costs of usual care , higher costs of STS HH and lower costs of TM during office hours .
As a result , the economic model developed scenarios for different RM classifications and their costs were estimated using bottom-up costing methods .
Despite wide variation in usual care and RM strategies , cost-effectiveness analyses suggest that TM during office hours was an optimal strategy ( in most costing scenarios ) .
However , clarity was lacking among descriptions of the components of RM packages and usual care and there was a lack of robust estimation of costs .
BACKGROUND Remote monitoring ( RM ) strategies have the potential to deliver specialised care and management to patients with heart failure ( HF ) .
OBJECTIVE To determine the clinical effectiveness and cost-effectiveness of home telemonitoring ( TM ) or structured telephone support ( STS ) strategies compared with usual care for adult patients who have been recently discharged ( within 28 days ) from acute care after a recent exacerbation of HF .
The review included r and omised controlled trials ( RCTs ) or observational cohort studies with a contemporaneous control group that included the following RM interventions : ( 1 ) TM ( including cardiovascular implanted monitoring devices ) with medical support provided during office hours or 24/7 ; ( 2 ) STS programmes delivered by human-to-human contact ( HH ) or human-to-machine interface ( HM ) .