Overview

With the OptiVol™ 2.0 fluid status monitoring feature (available on select CRT-D devices), you can track intrathoracic impedance changes over time to help you assess congestion in heart failure patients.1,2

  • The OptiVol™ 2.0 fluid status monitoring feature has been updated to OptiVol™ 2.0 to account for individual patient variation, including allowing the Fluid Index to increase or decrease based on recent thoracic impedance measurements.
  • The OptiVol™ 2.0 fluid status monitoring feature may not provide early warning for all fluid-related decompensations. Therefore, patients should be instructed to seek medical attention immediately any time they feel ill and need help, even if the OptiVol™ fluid monitoring features of their device or monitor indicate acceptable pulmonary fluid status conditions.
  • The OptiVol™ 2.0 fluid status monitoring feature is an additional source of information for patient management and does not replace assessments that are part of standard clinical practice.
  • For more information on the OptiVol™ 2.0 fluid status monitoring feature, visit Medtronic Academy.


Performance data

Many trials have looked at the clinical utility of OptiVol™ 2.0 as a tool in managing heart failure patients.

Topic

Clinical evidence Main supporting trials

Impedance monitoring

Intrathoracic impedance:

  • Declines with increased ventricular volumes and pressures.1,3–13
  • Is inversely correlated with PCWP, fluid balance and NT-pro BNP.14,15
  • Precedes patient’s symptoms and heart failure hospitalizations by two weeks.1
  • Decreases as fluid retention increases.16

MID-HeFT Trial1

Heart failure hospitalization

OptiVol™ fluid index threshold crossings:

  • Patients with crossings are twice as likely to have a heart failure adverse event.17
  • Frequent or sustained events identified patients at risk for acute decompensated heart failure hospitalizations.18

Combined/integrated diagnostics:

  • Use of multiple device diagnostic parameters increased the ability to identify patients at risk of heart failure events beyond the use of impedance alone.17
  • Patients with two or more diagnostics observations were 5.5 times more likely to have heart failure hospitalization in next 30 days.18

PARTNERS HF17 OFISSER18

Weight monitoring, 6-MHW, BNP marker

  • OptiVol™ detects three times more heart failure events than weight monitoring alone.19
  • OptiVol™ Fluid Index increases are associated with worsening 6-MHW and BNP.20

AST19

Heart failure readmissions

  • Device-derived heart failure diagnostic criteria identified patients at significantly higher risk of a heart failure event within 30 days post discharge.17–19, 21–23
  • Device diagnostics may help identify the patients at greatest risk of heart failure re-admission.22,23

PARTNERS HF,17 OFFISER18 FAST,19 CONNECT21

Arrhythmias

  • Intrathoracic impedance changes can precede VT/VF episodes.24
  • Decreases in intrathoracic impedance can precede storms of VT.25
  • AT episodes preceded (43%) or occurred almost simultaneously (22%) with the threshold crossing in greater than half the patients.26

See references for supporting studies and case studies

Mortality risk

  • Diagnostic data was analyzed from 21,217 patients who were remotely monitored for > 6 months.27
  • Patients who experienced threshold crossings within the initial six months of remote monitoring had a 2.15-fold increased long-term mortality risk.27

Study by the Heart and Vascular Institute at the Cleveland Clinic27


OptiVol™ 2.0 trends are viewable on the Cardiac Compass™ report.