OptiVol 2.0 Fluid Status Monitoring Cardiac Device Features

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 go to: https://www.medtronicacademy.com/features/optivol-fluid-status-trend-feature

 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 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

OptiVol 2.0 trends are viewable on the Cardiac Compass™ Report

Image of Cardiac Compass Report


*

Additional trials support these statements, see references for additional information.


1

Yu CM, et al. Circulation. 2005;112:841-848.

2

Abraham WT, et al. J Card Fail. 2009;15:813.

3

Germany R, et al. Am J Cardiol. 2007;99:11G-16G.

4

Small RS, et al. Am J Cardiol. 2007;99:17G-22G.

5

Vollmann D, et al. Eur Heart J. 2007;28:1835-1840.

6

Repoley J, et al. J Card Fail. 2006;12(suppl): S66.

7

Patient Case: LV Lead Dislodgement and Pocket Revision. Courtesy of R. Ward Pulliam and Jill Repoley, NP. The Heart Group and Lancaster General Hospital, Lancaster, PA. 2006 Medtronic Inc., data on file, UC200602091 EN

8

Small R, et al. J Card Fail. 2007;13(suppl):S113-S114.

9

Tang W, et al. J Card Fail. 2007;13(suppl):S182.

10

Braunschweig F, et al. Am J Cardiol. 2005;95:1104-1107.

11

Rathman L. Am J Cardiol. 2007;99:29G-33G.

12

Wang L. Am J Cardiol. 2007;99:3G-10G.

13

Abraham W, et al. Heart Rhythm. 2005;2(suppl):S65-S66.

14

Wang L, et al. Pacing Clin Electrophysiol. 2005;28:404-411.

15

Lüthje L, et al. Eur J Heart Fail. 2007;9:716-722.

16

Medtronic Viva XT CRT-D System Reference Guides.

17

Whellan DJ, et al. J Am Coll Cardiol. 2010;55:1803-1810.

18

Small RS, et al. J Card Fail. 2009;15:475-481.

19

Abraham WT, et al. Congest Heart Fail. 2011;17:51-55.

20

Gulati SK, et al. J Card Fail. 2010;16(suppl):S65.

21

Crossley GH, et al. J Am Coll Cardiol. 2011;57:1181-1190.

22

Whellan DJ, et al. Am J Cardiol. 2013;111:79-84.

23

Small RS, et al. J Card Fail. 2012;18(8 Suppl):S50. (abstract HFSA).

24

Moore HJ, et al. Pacing Clin Electrophysiol. 2010 33:960-966.

25

Andriulli J, et al. Int J Cardiol. 2008;123:333-334.

26

Jhanjee R, et al. Circ Arrhythm Electrophysiol. 2009;2:488-494.

27

Tang WH, et al. Eur Heart J. 2012;33:2189-2196.

Sources: Medtronic Protecta™ XT DR Clinician Manual; Medtronic Protecta™ XT CRT-D Clinician Manual