We’ve developed the Sensydia Cardiac Performance System™ (CPS) to support key decision points in the diagnosis and management of heart failure, and make valuable hemodynamic insights more accessible in routine care.

CPS is the only platform designed to provide Cardiac Output (CO), Pulmonary Artery Pressure (PAP), Pulmonary Artery Occlusion Pressure (PAOP), and Ejection Fraction (EF) measurements together in a portable, non-invasive, point of care system. In the setting of heart failure, CPS can be used to help:

• Detect cardiac abnormalities
• Differentiate between different causes of heart failure
• Optimize therapy towards hemodynamic goals in relation to patient symptoms
• Predict worsening heart function and provide clinicians with the insight they need to intervene before hospitalization is required
• Guide therapy decisions in the setting of acute decompensated heart failure (ADHF)

 

Hemodynamics In Heart Failure

Today, invasive diagnostic methods are required to access these insights. This limitation frequently defers the collection of valuable hemodynamic information until patients are critically ill or hospitalized. Sensydia’s non-invasive approach to hemodynamic measurement is designed to support clinical decisions in virtually any care setting: in the hospital, in the office, and even over telemedicine.

With the disruptive CPS platform, imagine a future where routine hemodynamic screening is a mainstay in heart failure management, and healthcare providers are equipped with the real-time information they need to make informed decisions and improve heart failure outcomes. Continue reading to learn more about the critical role of hemodynamic measurement in heart failure.

The Heart Failure Epidemic

Heart failure is the leading cause of hospitalization in people over age 65 [1] and the 7th most prevalent chronic disease in the United States [2]. Heart failure occurs when the heart doesn’t pump as well it should. Functionally, the disease is characterized by structural heart changes that alter pressure and flow at various points throughout the cardiac cycle.

People with Heart Failure in the U.S.

Annual Healthcare Expenditure

Cause of Hospitalization

Re-hospitalization Rate Within 6 Months

Hospitalization is a chief concern in the management of heart failure. Roughly 1 in 4 hospitalized heart failure patients in the Medicare-eligible population are readmitted within 30 days of hospitalization, and nearly half are readmitted within 6 months [1]. Every heart failure hospitalization marks a major decline in patient quality of life and burdens the healthcare system with yet another costly episode of care. In 2012, heart failure costed the nation an estimated $30.7 billion, and prevalence has continued to increased sharply since then [3].

Hemodynamic Measurements in Heart Failure

Hemodynamic measurements play a central role in the diagnosis and management of heart failure. Abnormal hemodynamic readings can indicate an underlying cardiac abnormality, help establish a differential diagnosis, and even predict an impending heart failure hospitalization. Hemodynamic insights are also used to guide therapy decisions and monitor patient response to new medications.

With access to vital hemodynamic measurements, physicians can diagnose heart failure early, improve quality of life, help prevent undue hospitalizations, and better manage acute heart failure patients.

Detecting Cardiac Abnormalities

Since the advent of diagnostic right heart catheterization in the 1950s [4], hemodynamic measurements have been used to determine the cause of heart failure and related symptoms. Elevated intracardiac pressure readings can indicate that the heart is subjected to abnormal stress, and the affected anatomy (e.g. right ventricle, pulmonary artery, or pulmonary wedge) is telling of the underlying pathology. Reduced or elevated cardiac output can also inform diagnosis and complement pressure insights (Table 1).

Table 1: Underlying heart failure pathology associated with abnormal hemodynamic readings [5].

Differential Diagnosis

Even when heart failure status is known, the primary underlying pathology may be difficult to determine. In these cases, hemodynamic measurement can provide information that changes the direction of therapy. In practice, hemodynamic measurements are needed to help differentiate between concomitant pulmonary disease and heart failure, acute coronary syndrome and chronic heart failure, or right ventricular failure and left ventricular failure [6].

Optimizing Medications

Heart failure specialists have several medications in their arsenal to modify hemodynamics and reduce cardiac stress (Table 2). Hemodynamic screening can inform which medications may be most suitable for a specific heart failure patient, and can also be used to evaluate whether or not a patient is responding to therapy [7].

Hemodynamic goals have been developed to guide therapy in patients with advanced heart failure, and are used to re-design therapy in the event that a patient is refractory to their current regimen (Table 3).

Table 2: Hemodynamic effects of selected medications commonly prescribed in the setting of heart failure [8].

Table 3: Heart failure hemodynamic goals proposed by Puckett and Mudd [7].

Figure 1: Preventing heart failure hospitalization with proactive hemodynamic monitoring.

Guiding Therapy in Acute Decompensated Heart Failure

Acute decompensated heart failure (ADHF) is defined as the sudden or gradual onset of the signs or symptoms of heart failure requiring an unplanned office visit, emergency room visit, or hospitalization [12]. When heart failure is confirmed, the first step for healthcare providers is to determine the cause of deterioration.

Successful ADHF management pivots on an accurate assessment of congestion, volume status, and perfusion. Where an analysis of symptoms is sometimes sufficient to determine the underlying pathology, hemodynamic measurements provide an objective way to differentiate between different types of heart failure (Table 4). Hemodynamic measurements are also used in this context to identify what treatments are appropriate and to monitor how a patient responds to aggressive therapy in real-time [13].

Table 4: Use of hemodynamic measurements to guide therapy decisions in ADHF [13,14].

Preventing Hospitalization

The failing heart is especially sensitive to hemodynamic fluctuations. The medical community has come to appreciate that most heart failure hospitalizations are related to the heart’s inability to handle excess circulating fluid, driven by a progressive rise in intracardiac filling pressures [1]. This state is commonly referred to as ‘volume overload,’ and is the driving force behind the worsening peripheral edema, difficulty breathing, abdominal distention, and fatigue that lead to hospital admission [9].

Hemodynamic readings can reliably predict congestive symptoms and heart failure related hospitalization. Diastolic pulmonary artery pressure (dPAP) increases gradually for multiple weeks before symptoms develop, allowing physicians to intervene with a revised treatment strategy before hospitalization is necessary (Figure 1) [10,11].

Existing Solutions

Hemodynamic measurements can be difficult to acquire—especially at the level of accuracy required to confidently inform care. Today, clinicians use a variety of invasive and non-invasive tools to piece together hemodynamic insights in different clinical scenarios.

Diagnostic Right Heart Catheterization / Pulmonary Artery Catheterization

Diagnostic right heart catheterization is the ‘gold standard’ for cardiac output and pulmonary artery pressure measurements, but the cost and risk associated with invasive catheterization limits the collection of valuable hemodynamic information to patients with more advanced disease (‘very sick’ patients) that have been hospitalized or are refractory to previous treatment attempts [15]. The technical requirements of catheterization also preclude it from being used in routine hemodynamic screening, which could help optimize therapy, improve patient quality of life, and prevent undue hospitalization.

Implantable Intracardiac Pressure Monitoring

Implantable pressure monitoring devices are approved for use in symptomatic patients that have had a previous heart failure hospitalization event. When implanted, this device allows the patient to frequently record their pulmonary artery pressure at home and send the results to their physician. This approach has proven to reduce hospitalizations in controlled clinical trials and in real-world registry data [16], demonstrating that diligent hemodynamic monitoring can reliably predict and help prevent worsening heart failure symptoms.

The downside of the implant approach is that it requires an expensive procedure to place the device and pulmonary artery catheterization to set the baseline for the sensor—neither of which are required with a non-invasive solution. Another limitation with implanted monitoring devices is that they only provide information on pulmonary artery pressure, where additional hemodynamic measurements could provide additional information.

Echocardiography

Echocardiography is a frequent first-line diagnostic tool when symptoms are consistent with a structural heart disease. Ultrasound imaging is the primary function of echo, allowing a skilled operator to look at anatomy, volume, and flow patterns at various points throughout the heart.

Approximated echo measurements can also be used to derive useful hemodynamic calculations like ejection fraction and estimates of more advanced metrics like cardiac output and pulmonary artery pressure [18]. These estimates are rarely sufficient on their own to confidently inform clinical decisions, but they can be useful to rule-in or rule-out the need for further testing. Another important consideration is that accuracy with echo is operator-dependent, and quantitative techniques with echo suffer from inter-operator variability [17].

Non-Invasive Cardiac Output Systems

Non-invasive and minimally invasive technologies have been developed to monitor cardiac output in the intensive care setting, but are generally not available for outpatient or low-acuity hospital settings. Although these monitoring solutions are not as accurate as catheter-based methods [19], they can help manage fluid loading in heart failure patients [20]. Outside of critical care, the diagnostic utility of non-invasive cardiac output measurement on its own is currently limited [21].

INVESTIGATIONAL DEVICE DISCLAIMER: The Sensydia Cardiac Performance System (CPS) is an investigational device. It is currently undergoing clinical evaluation under Food and Drug Administration’s Investigational Device Exemption and is not approved for commercial use.

References

[1] Desai, A. S., Bhimaraj, A., Bharmi, R., Jermyn, R., Bhatt, K., Shavelle, D., … Heywood, J. T. (2017). Ambulatory Hemodynamic Monitoring Reduces Heart Failure Hospitalizations in “Real-World” Clinical Practice. Journal of the American College of Cardiology, 69(19), 2357–2365.

[2] Centers for Medicare & Medicaid Services. Chronic Conditions Prevalence State/County Table: All Fee-for-Service Beneficiaries. 2015. Retrieved from https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Chronic-Conditions/CC_Main

 

[3] Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, et al. Heart disease and stroke statistics—2019 update: a report from the American Heart Association. Circulation. 2019;139(10):e56–528.

[4] Kahwash, R., Leier, C. V., & Miller, L. (2009). Role of the Pulmonary Artery Catheter in Diagnosis and Management of Heart Failure. Heart Failure Clinics, 5(2), 241–248.

[5] Silvestry, F. E., & Fleitman, J. (2020). Pulmonary artery catheterization: Interpretation of hemodynamic values and waveforms in adults - UpToDate. Retrieved from https://www.uptodate.com/contents/pulmonary-artery-catheterization-interpretation-of-hemodynamic-values-and-waveforms-in-adults

[6] Stevenson, L. W., & Le Jemtel, T. H. (2006). Hemodynamic goals are relevant. Circulation, 113(7), 1020–1033.

[7] Puckett, C., & Mudd, J. O. (2016). Tailoring Therapies in Advanced Heart Failure. Heart Failure Clinics, 12(3), 375–384.

[8] Lippincott NursingCenter. (2019). Heart Failure: Guideline-Directed Management and Therapy. Lippincott NursingCenter, (January).

[9] Houston, B. A., Kalathiya, R. J., Kim, D. A., & Zakaria, S. (2015). Volume Overload in Heart Failure: An Evidence-Based Review of Strategies for Treatment and Prevention. Mayo Clinic Proceedings, 90(9), 1247–1261.

[10] Zile M.R., Bennett T.D., St John Sutton M., et al. (2008) Transition from chronic compensated to acute decompensated heart failure: pathophysiological insights obtained from continuous monitoring of intracardiac pressures. Circulation 118:1433–1441

 

[11] Bourge R.C., Abraham W.T., Adamson P.B., et al., for the COMPASS-HF Study Group (2008) Randomized controlled trial of an implantable continuous hemodynamic monitor in patients with advanced heart failure: the COMPASS-HF study. J Am Coll Cardiol 51:1073–1079.

 

[12] Rocha, B. M. L., & Menezes Falcão, L. (2016). Acute decompensated heart failure (ADHF): A comprehensive contemporary review on preventing early readmissions and postdischarge death. International Journal of Cardiology, 223, 1035–1044.

[13] Fonarow, G. (2017). Evaluation of the Patient with Decompensated Heart Failure. CardiologyAdvisor. Retrieved from https://www.thecardiologyadvisor.com/home/decision-support-in-medicine/cardiology/evaluation-of-the-patient-with-decompensated-heart-failure/

[14] Ponikowski, P., Voors, A. A., Anker, S. D., Bueno, H., Cleland, J. G. F., Coats, A. J. S., … Davies, C. (2016). 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. European Heart Journal, 37(27), 2129–2200m. http://doi.org/10.1093/eurheartj/ehw128

[15] Monnet, X., & Teboul, J. L. (2017). Transpulmonary thermodilution: Advantages and limits. Critical Care, 21(1), 1–12.

 

[16] Desai, A. S., Bhimaraj, A., Bharmi, R., Jermyn, R., Bhatt, K., Shavelle, D., … Heywood, J. T. (2017). Ambulatory Hemodynamic Monitoring Reduces Heart Failure Hospitalizations in “Real-World” Clinical Practice. Journal of the American College of Cardiology, 69(19), 2357–2365.

[17] De Geer, L., Oscarsson, A., & Engvall, J. (2015). Variability in echocardiographic measurements of left ventricular function in septic shock patients. Cardiovascular Ultrasound, 13(1), 1–8. http://doi.org/10.1186/s12947-015-0015-6

[18] Schiller, N. B. (2019). Hemodynamics derived from transesophageal echocardiography (TEE). UpToDate. Retrieved from https://www.uptodate.com/contents/hemodynamics-derived-from-transesophageal-echocardiography

 

[19] Joosten, A., Desebbe, O., Suehiro, K., Murphy, L. S. L., Essiet, M., Alexander, B., … Cannesson, M. (2017). Accuracy and precision of non-invasive cardiac output monitoring devices in perioperative medicine: A systematic review and meta-analysis. British Journal of Anaesthesia, 118(3), 298–310.

 

[20] Mackenzie, D. C., & Noble, V. E. (2014). Assessing volume status and fluid responsiveness in the emergency department. Clinical and Experimental Emergency Medicine, 1(2), 67–77.

 

[21] Charman, S. J., Okwose, N. C., Stefanetti, R. J., Bailey, K., Skinner, J., Ristic, A., … Jakovljevic, D. G. (2018). A novel cardiac output response to stress test developed to improve diagnosis and monitoring of heart failure in primary care. ESC Heart Failure, 5(4), 703–712.

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