Wireless hemodynamic monitoring associated with less hospitalization
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A wireless implantable hemodynamic monitoring system showed a significant reduction in hospitalizations for heart failure patients, researchers found.
Patients (n=550) from 64 American centers in a single-blind trial were randomly assigned to receive a wireless implantable pulmonary artery hemodynamic monitoring system or to a control group receiving standard care for at least six months. Patients had New York Heart Association class III heart failure, irrespective of the left ventricular ejection fraction, and a previous hospital admission for heart failure. Only patients were masked to their assignment group. Results were released online Feb. 10 in The Lancet.
The primary efficacy endpoint was the rate of heart-failure-related hospitalizations at six months. In six months, 83 heart-failure-related hospitalizations 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 to 0.84; P<0.0001). During a mean follow-up of 15 months, the treatment group had a 39% reduction in heart-failure-related hospitalization compared with the control group (153 vs. 253; HR, 0.64; 95% CI, 0.55 to 0.75; P<0.0001). Non-heart-failure-related hospitalizations were not different between the groups.
The treatment group had a greater reduction in pulmonary artery mean pressure, more days alive outside the hospital, and better quality of life than the control group during six months of follow-up. Survival rates in the treatment and control groups at six months were similar (255 [94%] vs. 260 [93%]; HR, 0.77; 95% CI, 0.40 to 1.51; P=0.45).
Length of stay for heart-failure-related hospitalizations was 2.2 days (SD, 6.8) in the treatment group versus 3.8 days (SD, 11.1) in the control group (P=0.02). The treatment group had a significantly greater number of changes to drugs for heart failure (2,468; mean, 9.1 per patient [SD, 7.4]) than did the control group (1,061; 3.8 per patient [SD, 4.5]; P<0.0001).
The first primary safety endpoint of the study was device-related or system-related complications (DSRCs). These were defined as adverse events related to the wireless pressure sensor or external electronics that required invasive treatment other than an intramuscular drug administration or a right-heart catheterization. Patients had 98.6% freedom from DSRC (95% CI, 97.3 to 99.4).
The second primary safety endpoint was pressure-sensor failure, defined as an inability to obtain readings. No pressure-sensor failures occurred. There were 15 serious adverse events, eight related to DSRC and seven related to the implantation procedure.