OptiVol 2.0 Fluid Status Monitoring Cardiac Device Features

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 3 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 HF¹⁷, OFFISER¹⁸ FAST¹⁹, 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 6 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