Telemonitoring for heart failure: Patient characteristics and first results - TEN-HMS

Description:

Study comparing usual care to nurse telephone follow-up and telemonitoring based follow-up for outpatient management of congestive heart failure due to systolic dysfunction.

Hypothesis:

Telemonitoring in the management of congestive heart failure would lead to fewer admissions to the hospital, improve quality of life, reduce cost, and increase use of beneficial medications.

Study Design

Patients Enrolled: 427 (85 usual care, 173 nurse follow-up, 169 telemonitoring)
NYHA Class: NYHA Class II-IV (Class III/IV 33-46%)
Mean Follow Up: >190,000 patient days. Mean 1.2 years
Mean Patient Age: >50% over 70 years
Female: 23%
Mean Ejection Fraction: 25%

Patient Populations:

1) Treatment with loop diuretic equivalent to >40 mg of furosemide/day 2) LVEF <40% and dilation >30 mm/m2 3) Planned or recent discharge (<6 weeks) for heart failure to home 4) At least one prior admission in the last 2 years for heart failure or LVEF <25% and >100 mg/day furosemide

Exclusions:

Not routinely attending the hospital >1x per week.

Drug/Procedures Used:

1) Patients randomized to telemonitoring received in-home telemonitoring devices that recorded telemetry, weight, and blood pressure. Data was transmitted via telephone lines to a hospital-based network of physicians and nurses OR 2) patient received usual care from PCP OR 3) patients received treatment plan from PCP along with monthly follow-up from a nurse to improve adherence and implementation. Patients were randomized in a 1:2:2 ratio.

Concomitant Medications:

ACE inhibitors (67-75%), Furosemide (37-41%), Beta-blockers 47-51%), Spironolactone (51-57%).

Principal Findings:

Mortality at 200 days was lower in patients with telemonitoring or nurse follow-up compared to usual care (16% usual care v. 8% nurse follow-up and 8% telemonitoring;p=0.03).

The number of admissions was higher in the telemonitoring group, but the duration of admission was shorter than the other groups. The percent days alive and out of the hospital during follow-up were not significantly different between nurse follow-up (86%) and telemonitoring (87%), but were higher than usual care (79%).

Interpretation:

This is the first trial evaluating telemonitoring in the management of congestive heart failure. While no significant difference was noted in the primary outcome (fewer admissions to the hospital etc.), this trial did demonstrate that frequent follow-up either with a nurse or with telemonitoring is associated with improved clinical outcomes. Telemonitoring had no advantage in decreasing days alive out of the hospital compared to nurse follow-up, but may be beneficial in reducing length of stay in the hospital. The differences in this trial may simply be due to chance or to differences in baseline variables (e.g. use of ACE inhibitors, NYHA functional class). Future prospective trials are necessary to identify any advantage of telemonitoring over nurse follow-up and to determine if medical therapy and outcomes in congestive heart failure can be improved using telemonitoring.

References:

Cleland JG, Louis AA, Rigby AS, Janssens U, Balk AH; TEN-HMS Investigators. Noninvasive home telemonitoring for patients with heart failure at high risk of recurrent admission and death: the Trans-European Network-Home-Care Management System (TEN-HMS) study. J Am Coll Cardiol. 2005 May 17;45(10):1654-64. 

Presented by J.G.F. Cleland at the Annual Meeting of the European Society of Cardiology, September 1, 2002.

Keywords: Follow-Up Studies, Quality of Life, Telephone, Heart Failure, Telemetry, Disease Management, Blood Pressure, Sodium Potassium Chloride Symporter Inhibitors, Patient Discharge, Furosemide, Length of Stay


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