Optimization of Heart Failure Management Using OptiVol Fluid Status Monitoring and CareLink - OptiLink HF

Sep 01, 2015
Font Size
A
A
A
Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Medtronic
Date Presented:
09/01/2015
Original Posted Date:
09/01/2015
References

Description:

The goal of the trial was to evaluate a strategy of telemonitoring of fluid status compared with no telemonitoring among subjects who received an implantable cardioverter-defibrillator (ICD). Implanted ICDs had the capability to monitor fluid status and send alerts to physicians based on pre-established fluid criteria.

Contribution to the Literature: The OptiLink-HF trial failed to show that telemonitoring of heart failure patients through ICDs improved outcomes.

Study Design

  • Randomized
  • Parallel
  • Stratified

Subjects with heart failure who underwent implantation of an ICD were randomized to telemonitoring (n = 505) versus no telemonitoring (n = 497).

Inclusion criteria:

  • Implantation of an ICD or cardiac resynchronization therapy (CRT)-ICD and one additional high-risk characteristic:
    • Heart failure hospitalization within the last 12 months
    • Diuretic therapy within the last 30 days
    • Increased B-type natriuretic peptide (BNP) or N-terminal pro-BNP within the last 30 days
  • Total number of enrollees: 1,002
  • Duration of follow-up: mean 23 months
  • Mean patient age: 66 years
  • Percentage female: 23%

Exclusion criteria:

  • Serum creatinine >2.5 mg/dl or hemodialysis
  • Chronic obstructive pulmonary disease

Principal Findings:

Approximately 75% of alerts were successfully transmitted from the patient’s ICD to a physician, with a resultant medication change in 30%.

The primary outcome of all-cause mortality or cardiovascular hospitalization occurred in 45.0% of the telemonitoring group versus 48.1% of the no telemonitoring group (p = 0.13). There was no treatment interaction among tested subgroups.

Secondary outcomes:

  • All-cause death: 6.2% with telemonitoring vs. 8.5% with no telemonitoring (p = 0.52)
  • Cardiovascular hospitalization: 42.4% with telemonitoring vs. 44.5% with no telemonitoring (p = 0.22)

Interpretation:

Among patients with heart failure and implantation of an ICD capable of monitoring fluid status and sending alerts to physicians, telemonitoring did not improve outcomes compared with standard care. Optimal management of advanced heart failure patients remains challenging.

References:

Presented by Dr. Michael Boehm at the European Society of Cardiology Congress, London, September 1, 2015.

Keywords: Arrhythmias, Cardiac, Cardiac Resynchronization Therapy, Defibrillators, Implantable, Diuretics, Heart Failure, Natriuretic Peptide, Brain, Peptide Fragments, Renal Dialysis, ESC Congress


< Back to Listings