Unique Features

Implantable Cardiac Devices

OptiVol Fluid Status Monitoring

OptiVol^® Fluid Status Monitoring is the only tool available that provides clinicians with daily fluid status monitoring through intrathoracic impedance measurements.

Clinical Need for Fluid Status Monitoring

Heart failure (HF) affects approximately 5.8 million Americans, and is the primary reason for over 1.1 million hospital admissions every year. The estimated direct and indirect cost of heart failure in the US for 2010 was $39.2 billion.¹

Approximately 50% of HF costs can be attributed to hospitalizations for acute decompensated HF.²
Fluid volume overload (congestion) is a major complication for patients with moderate-to-severe HF and a frequent cause of hospital readmissions^.3
Fluid accumulation in HF patients is often detected too late to avert hospitalization.⁴

Current Monitoring

Assessing heart failure congestion is challenging.⁵
Regular monitoring using body weight, blood pressure, and clinical symptoms does not always provide clarity and adequate time to prevent hospitalization.^6-10

Patient Compliance Remains a Concern

Nearly half of hospital readmissions for HF were caused by medication or dietary nonadherence.⁹

OptiVol Fluid Status Monitoring Does Not Rely on Patient Compliance

OptiVol monitoring, together with Cardiac Compass^® Report, is a tool that objectively tracks fluid status and several other physiologic trends, without relying on patient compliance.

Expand All

How It Works

OptiVol Fluid Status Monitoring

OptiVol monitoring provides clinicians an opportunity to assess the patient's fluid status via daily impedance measurements taken by an implantable CRT-D or ICD device.1

Many times during the day, electrical impulses travel from the right ventricular lead to the implanted device can. OptiVol Fluid Status Monitoring uses this electrical impulse vector to measure impedance across the thoracic cavity. Trended daily impedance data has been shown to correlate well with pulmonary capillary wedge pressure (PCWP),¹pulmonary artery diastolic pressure (ePAD)² and worsening heart failure.^3-5

pdf Clinical Application of the HF Diagnostic Trends (.pdf)

OptiVol Monitoring measures fluid (not just in the lungs)¹

MID-HeFT study

The increase in impedance during diuretic therapy was strongly correlated with Pulmonary Capillary Wedge Pressure (PCWP) and net fluid loss.

Thoracic impedance measurements are a part of the recommended factors to consider in management of chronic heart failure – in the Heart Rhythm Society Expert Consensus [ACC/AHA/HRS] on the Monitoring of Cardiovascular Implantable Electronic Devices.⁶

OptiVol Fluid Index and Impedance Monitoring

OptiVol Monitoring can provide an early indication of heart failure¹

OptiVol Monitoring can provide an early indication of heart failure allowing time for clinical intervention.

Intrathoracic impedance decreases on average 15 days before symptom onset and 18 days before hospitalization
Symptom onset occurs only 3 days before hospitalization

OptiVol monitoring, together with Cardiac Compass^® Report,* is a tool that objectively tracks fluid status and several other physiologic trends:

Atrial tachycardia (AT)/atrial fibrillation (AF) burden
Ventricular rate during AT/AF
Patient activity
Average ventricular rate (day/night)
Heart rate variability
Percent pacing per day
Daily shocks and treated ventricular tachycardia/ventricular fibrillation episodes per day

When used collectively, these data can help clinicians identify patients who are at risk for worsening heart failure.

OptiVol Monitoring is not intended to replace assessments which are part of standard clinical practice.

OptiVol Monitoring has been proven to predict worsening heart failure in multiple clinical studies with over 2500 patients ^1-9

Risk stratify your HF patients for more frequent follow-up with OptiVol and Cardiac Compass trends in office or remotely
OptiVol Monitoring automatically tracks fluid status and does not rely on patient compliance

* Heart Failure Management Report

References

Yu CM, Wang L, Chau E, et al. Intrathoracic impedance monitoring in patients with heart failure: correlation with fluid status and feasibility of early warning preceding hospitalization. Circulation. August 9, 2005;112(6):841-848. [MID-Heft]

Vanderheyden M, Houben R, Verstreken S, et al. Pressures in patients with heart failure continuous monitoring of intra-thoracic impedance and right ventricular. Circ Heart Fail published online Mar 2, 2010.

Small RS, Wickemeyer W, Germany R, et al. Changes in intrathoracic impedance are associated with subsequent risk of hospitalizations for acute decompensated heart failure: clinical utility of implanted device monitoring without a patient alert. J Card Fail. August 2009;15(6):475-481.

⁴

Whellan DJ, Al-Khatib SM, Kloosterman EM, et al. Changes in intrathoracic fluid index predict subsequent adverse events: Results of the multi-site program to access and review Trending INformation and Evaluate CoRelation to Symptoms in Patients with Heart Failure (PARTNERS HF) Trial. J Card Fail. 2008;14(9):799. [PARTNERS HF]

⁵

Abraham WT. Superior performance of intrathoracic impedance-derived fluid index versus daily weight monitoring in heart failure patients. Results of the Fluid Accumulation Status Trial. Late Breaking Clinical Trials. J Card Fail. Vol. 15 No. 9 2009, p 813. (FAST).

⁶

Wilkoff BL, Auricchio A, Brugada J, et al. HRS/EHRA/ACC/AHA/HFSA expert consensus on the monitoring of cardiovascular implantable electronic devices (CIEDs): description of techniques, indications, personnel, frequency and ethical considerations. Heart Rhythm. June 2008;5(6):907-925.

⁷

Vollmann D, Nägele H, Schauert P, et al. Clinical utility of intrathoracic impedance monitoring to alert patients with an implanted device of deteriorating chronic heart failure. Eur Heart J. August 2007;28(15):1835-1840.

⁸

Catanzariti D, Lunati M, Landolina M, et al. Monitoring intrathoracic impedance with an implantable defibrillator reduces hospitalizations in patients with heart failure. PACE. March 2008;32(3):363-370.

⁹

Perego GB, Landolina M, Vergara G, et al. Implantable CRT device diagnostics identify patients with increased risk for heart failure hospitalization. J Interv Card Electrophysiol. December 2008;23(3):235-242. [Italian Clinical Service OptiVol-CRT Group]

OptiVol 2.0

Evidence

Clinical Evidence

Extensive clinical evidence shows the value of Medtronic diagnostics in identifying patients at risk for decompensation and hospitalization.

	Select Studies	Key Takeaway
2005	MID-HeFT (n-=33)¹	Proof of concept. Impedance is correlated with PCWP and fluid I/O.
2009	FAST (n=156)²	OptiVol^® was 3 times more accurate than daily weight monitoring.
2009	OFISSER (n=326)³	Frequent or sustained fluid index threshold crossings predicted significantly higher risk of subsequent HF hospitalizations.
2010	PARTNERS (n=1,024)⁴	OptiVol/HFMR identified patients were 5.5 times as likely to be hospitalized within 30 days.
2012	OptiVol and Mortality (n=21,217)⁵	OptiVol crossings identify increased mortality risk.
2012	30-Day HF Readmission Risk Stratification at Hospital Discharge (n=1,561)⁶	OptiVol/HFMR identified patients on *discharge day* were 4.1 times as likely to be re-hospitalized within 30 days.
2013	30-Day HF Readmission Risk Stratification 7 Days Post-Discharge (n=1,561)⁷	OptiVol/HFMR identified patients *7 days post-discharge* were 22 times as likely to be re-hospitalized within 30 days.

References

⁴

Whellan DJ, Ousdigian KT, Al-Khatib SM, et al. Combined heart failure device diagnostics identify patients at higher risk of subsequent heart failure hospitalizations: results from PARTNERS HF (Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients with Heart Failure) study. J Am Coll Cardiol. 2010;55(17):1803-1810.

⁵

Tang WH, Warman EN, Johnson JW, et al. Threshold crossing of device-based intrathoracic impedance trends identifies relatively increased mortality risk. Eur Heart J. 2012;33(17):2189-2196.

⁶

Small RS, Whellan DJ, Boyle A, et al. Implantable device diagnostics on the day of discharge from a heart failure hospitalization can predict 30 day readmission risk. J Card Fail. 2012;18(8 Suppl):S50.

⁷

Whellan DJ, Sarkar S, Koehler J, et al. Development of a method to risk stratify patients with heart failure for 30-day readmission using implantable device diagnostics. Am J Cardiol. 2013;111(1):79-84.

Readmissions

30-Day Readmissions

Heart failure patients experience a high incidence of early hospital readmissions, resulting in medical and financial challenges to the U.S. healthcare system.¹ Medtronic’s OptiVol Fluid Status Monitoring has been shown to help identify worsening heart failure symptoms in at-risk patients before more serious symptoms develop.² Earlier identification can potentially avert more serious heart failure events.^3-7

Recent clinical experience has shown a correlation between very early identification of high-risk patients and early heart failure readmissions.^8,9

Device Diagnostics on Day of Discharge

A study by Small et al. showed that device diagnostics on the day of discharge identified patients at risk of early readmission to the hospital. Patients in the high-risk group were four times more likely than patients in the low-risk group to be readmitted to the hospital for heart failure complications within the next 30 days.⁸

Detail - Hazard Ratio (30 day)

Device Diagnostics One Week after Discharge

Whellan et al. showed that data gathered at a 7-day post-discharge device follow-up identified heart failure patients at risk of readmission. Patients in the high-risk group were 22 times more likely than patients in the low-risk group to have an HF readmission within the next 30 days.⁹

Detail - Hazard Ratios (30-day readmission for HF)

References

Hospital Compare Database—data reported for discharges July 2008–June 2009; http://www.hospitalcompare.hhs.gov/staticpages/help/hospital-resources.aspx

⁴

⁵

Small R, Tang W, Wickemeyer R, et al. Managing heart failure patients with intra-thoracic impedance monitoring: a multi-center US evaluation. J Card Fail. 2007;13(6 Suppl):S113-S114.

⁶

Abraham WT, Compton S, Haas G, et al. Superior performance of intrathoracic impedance-derived fluid index versus daily weight monitoring in heart failure patients. Results of the Fluid Accumulation Status Trial. Late Breaking Clinical Trials. J Card Fail. 2009;15:813.

⁷

Perego GB, Landolina M, Vergara G, et al. CRT device diagnostics identify patients with increased risk for heart failure hospitalization. J Interv Card Electrophysiol. 2008;23:235-242.

⁸

Small RS, Whellan DJ, Boyle A, et al. Implantable device diagnostics on the day of discharge from a heart failure hospitalization can predict 30 day readmission risk. J Card Fail. August 2012;18(8 Suppl):S50.

⁹

Mortality Risk

Case Studies

Common Patient Cases

Courtesy of The Heart Group and Lancaster General Hospital, Lancaster, PA.

pdf Clinicians Practical Guide for using OptiVol and the Cardiac Compass® trends (.pdf)

Downloadable guide for using OptiVol and the Cardiac Compass trends.

2.1MB

OptiVol Trending in a stable, well managed patient

Stable Patient Case

Almost half the patients will not have a fluid index threshold crossing within the first year. This is useful clinical data verifying the patients have been stable. This is very similar to the clinical utility of BNP.

Medical Nonadherence Patient Case

Medication nonadherence is often characterized by monthly changes in impedance.

Note the cyclical changes in impedance. In this case, the intrathoracic impedance decline led to OptiVol Threshold crossing which was associated with a worsening heart failure. Upon questioning the patient, it was related to medication nonadherence.

Commonly, lapses in the medications regimen happen monthly. The root cause could be associated with financial inability to fill prescriptions. These events are shown in the report as monthly impedance decline and fluid index rise (peaks).

This is a good opportunity to probe the patient, educate on medication adherence, and find alternatives for medication access.

Dietary Nonadherence Patient Case

Commonly, events such as dietary nonadherence are due to vacation, holidays, and special occasions leading to a decrease in impedance and rise in the fluid index that resembles a trend like this.

This is a good opportunity to probe the patient and educate on diet adherence.

Isolated changes in impedance are commonly associated with dietary nonadherence. Look for these changes especially during the holiday season and summer.

Cardiac Compass Trends Help Clinicians Assess the Condition of Patients with Implantable Cardiac Rhythm Devices

Heart Failure and Atrial Fibrillation Patient Case

For cardiac resynchronization device patients, the maximum benefit is realized with over 92% of biventricular pacing.¹ Atrial arrhythmias have been shown to be the number one cause of reduced CRT.^2-4 The association between chronic heart failure and atrial fibrillation (AF) is well documented but the factors that predispose to the onset of the arrhythmia and its impact are not well understood.⁵

OptiVol Fluid Status Monitoring with Cardiac Compass Report can be used to assess the relationship between AF and worsening heart failure in device patients.⁶ The clinician can review 14 months of trending to assess the effectiveness of rate control, AF burden and percentage biventricular pacing.

This case is a good example of using the Cardiac Compass Report to assess a patient with a drop in impedance, indications of worsening heart failure and corresponding atrial fibrillation.

Temporally aligned trending can help a clinician assess the patient’s condition and see if the AF episodes correspond to a reduction in biV pacing and level of patient activity, as well as a drop in impedance, indicating an increase in fluid and potentially worsening heart failure.

OptiVol is not intended to replace assessments which are part of standard clinical practice.

References

Koplan BA, Kapla AJ, Weiner S, et al. Heart Failure Decompensation and All-Cause Mortality in Relation to Percent Biventricular Pacing in Patients With Heart Failure Is a Goal of 100% Biventricular Pacing Necessary? J Am Coll Cardiol 2009;53:355–60.

Knight BP, Desai A, Coman J, et al. Long-term retention of cardiac resynchronization therapy. J Am Coll Cardiol. July 7, 2004;44(1):72-77.

Ousdigian KT, Thompson D, Qi D, et al. A single day of AF with poor rate control predicts a subsequent week of reduced CRT. [abstract PO6-68]. Heart Rhythm. 2007;4(Suppl 5S):S379.

⁴

Koplan BA, Kaplan AJ, Weiner S, et al. Heart Failure Decompensation and All-Cause Mortality in Relation to Percent Biventricular Pacing in Patients With Heart Failure Is a Goal of 100% Biventricular Pacing Necessary? J Am Coll Cardiol 2009;53:355–60).

⁵

Pozzoli M, Cioffi G, Traversi E, et al., Predictors of Primary Atrial Fibrillation and Concomitant Clinical and Hemodynamic Changes in Patients With Chronic Heart Failure: A Prospective Study in 344 Patients With Baseline Sinus Rhythm. J Am Coll Cardiol 1998;32:197–204

⁶

Jhanjee R, Templeton GA, Sattiraju S, et al. Assessment by Implanted Transpulmonary Impedance Monitoring Relationship of Paroxysmal Atrial Tachyarrhythmias to Volume Overload: Assessment by Implanted Transpulmonary Impedance Monitoring. Circ Arrhythm Electrophysiol 2009;2;488-494

CPT Coding

CPT^® codes have been established for cardiac device monitoring, including codes that apply to the review of physiologic data from the OptiVol^®/Cardiac Compass Report.¹

The CPT codes related to OptiVol are for device interrogations of physiologic (rather than rhythm) data and not for programming.
An interrogation includes physician analysis, review, and report.
Implantable cardiac monitor (ICM) interrogations can be performed remotely using the Medtronic CareLink^® system or in clinic.

OptiVol and diagnostic data for heart failure accessed remotely with CareLink Network

Diagnostic Data Access

OptiVol information can be obtained via:

Medtronic CareLink Programmer in the device clinic
Medtronic CareLink Network remotely

CMS to Track Heart Failure Readmissions

CMS will track heart failure readmissions within 30 days of discharge. As hospitals partner with physicians to reduce rehospitalization, OptiVol may be a clinically useful tool to help them manage their heart failure population.^2,3

Reference

It is important to refer to the CPT code descriptions in order to ensure that a billed code meets the specific requirements defined for each individual code. You should contact your local Medicare contractor/payer for interpretation of applicable policies. Furthermore, please check the National Correct Coding Initiative (NCCI) edits.

For CPT codes other than for remote monitoring, the Global CPT codes comprise the Professional and Technical Components. If both components of care are rendered in an office setting (POS 11),* it is not necessary to append a modifier to the code. However, the remote monitoring codes require two different CPT codes to be billed together. One code represents the Professional service and another code represents the Technical service (e.g., CPT 93294 and 93296, 93295 and 93296, 93297 and 93299, and 93298 and 93299) when billing a global service.

The Professional Component reflects physician time and intensity in furnishing the service, including activities before and after direct patient contact.** When only the professional component is performed, modifier –26 should be added to the appropriate CPT code to identify the service. The –26 modifier would not be appended if the code represents only the professional services of the CPT code description (e.g., CPT 93294, 93295, 93297, and 93298).

The Technical Component refers to the resources used in furnishing the service, such as office rent, wages of personnel, and other office practice expenses. Modifier –TC*** should be added to the appropriate CPT code when only the technical component is performed. Modifier –TC would not be appended if the CPT code description represents only the technical support and service (e.g., CPT 93296 and 93299).

* Medicare Place of Service (POS) information is located in Chapter 26 of the Medicare Claims Processing Manual at: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c26.pdf.

** Social Security Act Section 1848(c) (1) (A) and (B).

*** Section 410.32(b) of the Code of Federal Regulations (CFR).

Whellan DJ, Sarkar S, Koehler J, et al. Development of a method to risk stratify patients with heart failure for 30-day readmission using implantable device diagnostics. Am J Cardiol. January 1,2013;111(1):79-84.

References

American Heart Association. Heart Disease and Stroke Statistics – 2010 Update.

American Heart Association. Heart Disease and Stroke Statistics – 2004 Update. Dallas, TX: American Heart Association. 2004.

Sackner-Bernstein J. What is heart failure and what are the treatment options? Complex questions. In: Hayes DL, Wang PJ, Sackner-Bernstein J, Asirvatham SJ, eds. Resynchronization and Defibrillation for Heart Failure: A Practical Approach. Oxford, England: Blackwell Publishing; 2004:1-2.

⁴

Small RS. Integrating device-based monitoring into clinical practice: insights from a large heart failure clinic. Am J Cardiol. May 21, 2007;99(10A):17G-22G.

⁵

Fonarow GC. How well are chronic heart failure patients being managed? Rev Cardiovasc Med. 2006;7(suppl 1):S3-11.

⁶

Friedman MM. Older adults’ symptoms and their duration before hospitalization for heart failure. Heart Lung 1997;26:169 –176.

⁷

Evangelista LS, Dracup K, Doering LV. Treatment-seeking delays in heart failure patients. J Heart Lung Transplant 2000;19:932–938.

⁸

Stevenson LW, Perloff JK. The limited reliability of physical signs for estimating hemodynamics in chronic heart failure. JAMA 1989;261: 884–888.

⁹

Vinson JM, Rich MW, Sperry JC, Shah AS, McNamera T. Early readmission of elderly patients with congestive heart failure. J Am Geriatr Soc 1990;38:1290 –1295.

¹⁰

Unique Features

OptiVol Fluid Status Monitoring

Clinical Need for Fluid Status Monitoring

Current Monitoring

Patient Compliance Remains a Concern

OptiVol Fluid Status Monitoring Does Not Rely on Patient Compliance

OptiVol Fluid Status Monitoring

OptiVol Monitoring measures fluid (not just in the lungs)1

MID-HeFT study

OptiVol Monitoring can provide an early indication of heart failure1

OptiVol Monitoring has been proven to predict worsening heart failure in multiple clinical studies with over 2500 patients 1-9

References

OptiVol 2.0 Fluid Status Monitoring

OptiVol 2.0 Reduces Unexplained Detections by 40%1

Important Safety Information

References

Clinical Evidence

References

30-Day Readmissions

Device Diagnostics on Day of Discharge

Device Diagnostics One Week after Discharge

References

Identifying Risk of Long-term Mortality

References

Common Patient Cases

Stable Patient Case

Medical Nonadherence Patient Case

Dietary Nonadherence Patient Case

Heart Failure and Atrial Fibrillation Patient Case

References

CPT Coding

Diagnostic Data Access

CMS to Track Heart Failure Readmissions

Reference

References

OptiVol Monitoring measures fluid (not just in the lungs)¹

OptiVol Monitoring can provide an early indication of heart failure¹

OptiVol Monitoring has been proven to predict worsening heart failure in multiple clinical studies with over 2500 patients ^1-9

OptiVol 2.0 Reduces Unexplained Detections by 40%¹