Clinical Impact of Non-invasive Hemodynamic Monitoring

B. BACKGROUND:

Nearly five million Americans experience heart failure (HF) and greater than 250,000 die
annually. 1 The prevalence has continued to increase with the aging of the US population and
HF is now the leading cause of hospitalization among adults >65 in the United states. Despite
remarkable improvements in medical therapy, the prognosis of patients with myocardial failure
remains poor, with almost 20% of patients dying within 1 year of initial diagnosis and > 80%
8-year mortality. 2 In addition patients who are admitted to the hospital for heart failure
have over a 50% readmission rate within six months of discharge. 3,4 These patients require
routine clinical care and often require diagnostic and therapeutic procedures. This project
seeks to assess if the use of hemodynamic (HD) monitoring technologies (ClearSight/Nexfin)
that are currently used in the intraoperative and critical care settings can provide
additional patient benefit if used more longitudinally for the patients' "routine" medical
care.

This project is designed to assess the impact of non-invasive hemodynamic monitoring
technologies to improve care of heart failure patients. Currently, these patients are
assessed in the outpatient setting with no routine ability to assess hemodynamics related to
contractility (dp/dt, stroke volume, cardiac output) or vascular resistance. Rather, the
health care provider relies on their patient history, physical exam, and static vital signs
(heart rate and blood pressure) to make their patient care decisions. This is despite the
large body of evidence suggesting how poor these markers are at determining cardiac function
and volume status. The investigators seek to "assist" the management of these high-risk
patients by providing "routine" parameters of contractility and vascular resistance (via the
ClearSight/Nexfin) system to the health care providers during the patients' clinic visits.

Nexfin system This device provides continuous blood pressure monitoring and parameters of
heart function (stroke volume, cardiac output, stroke volume variation, systemic vascular
resistance and dp/dt) via finger cuff that contains photo-plethysmograph sensor to monitor
arterial volume and pressure. The sensor is a small, 6 by 3 cm cuff, that is placed over the
middle of the finger (see picture below). The parameters from the device have been validated
to traditional non-invasive blood pressure measurements 5 and traditional cardiac output
assessment devices 6. The device inflates to a pressure that allows for assessment of the
pulsatility of the arteries of the digit. It is important to note that the device does not
significantly reduce perfusion to the digit and has been FDA approved for over two hours of
continuous use (www.
http://www.edwards.com/eu/products/mininvasive/pages/clearsightsystem.aspx). For this study
the device will be placed on the patient for no more than 5 minutes.

Figure 1: ClearSight / Nexfin System

C. STUDY HYPOTHESIS & AIMS

This study seeks to assess the utility of "routine" flow guided HD monitoring via the Nexfin
systems for patients with known heart failure. Patients enrolled in the study will include
those who are classified as New York Heart Association (NYHA) Functional Classification of
three or greater and have Objective Assessment Classification of B or greater. Once
consented, the patients will have the device placed for 5 minutes during their clinic visits.
The care team will have the data displayed to them to evaluate the device. It is important to
note that this study is an observational survey study to evaluate if heart failure
specialists find the device useful. The data shown to the team will not be used to guide
treatment and it will not be captured in the chart. Rather the clinicians will be surveyed to
evaluate the clinical utility of this device (see primary outcome marker above). It is the
hope of the investigators that the heart failure specialists do report to find the device
useful based on the results of this study. If so the investigators will submit for a research
study (new IRB submission) to evaluate the clinical impact of implementing this device in
this setting.

Outcome data will be collected using our electronic medical records. The primary marker will
be the heart failure clinicians' evaluation surveys on the hemodynamic device. Secondary
markers will include: patient comfort survey results, heart failure classification, renal
function, blood pressure, cardiac function tests, and pulmonary function tests. Patients'
medical records will reviewed for up to six months after consent secondary to ensure that all
relevant cardiac and pulmonary function tests are captured to correlate to the data from the
Nexfin system.

Figure 2: New York Heart Association Heart Failure Classification

D: RESEARCH METHODOLOGY/STUDY PROCEDURES

Study Protocol:

Phase 1:

The initial phase of the study will involve a 2-month trial period in which the
ClearSight/Nexfin device will be used for all consented patients. This period will allow for
all providers to become familiar with the device and determine the logistics for which
outpatient setting will be best suited to have the two study devices available during the
week. In addition, the health care provider will fill out a survey (included with this
submission) for each consented patient, evaluating the utility of this device. As this
technology is a limited resource (only 2 devices available), the survey will allow the
research team to determine which providers and which clinical settings will maximize its
utility to carry out the below described study protocol.

E. INVESTIGATIONAL DEVICE:

The are no investigational devices being tested for this study. The ClearSight/Nexfin System
is an FDA approved device that is widely used in the perioperative setting. To restate, this
study is similar assessing its utility in the outpatient heart failure clinics. All devices
used for this study will be cleared by biomedical engineering prior to use as per hospital
equipment protocol.

9. DATA COLLECTION

How will patient data be collected and stored? Data that will be collected will include
clinical documents (Both paper and electronic), electronic patient medical records, patient
comfort surveys, and physician surveys. Who is responsible for the collection of study data?
The department has a research coordinator and research manager that controls access to all
study data. The team of research assistants will collect and store research data (both paper
and electronic) in a secure locked area. All patient electronic research data will be stored
on the research Intranet that is monitored and protected by the university.

Inclusion Criteria:

1. patients seen in Loma Linda heart failure clinics classified as New York Heart
Association (NYHA) Functional Classification of 3 or greater

2. Objective Assessment Classification of B or greater (further details explained below).

Exclusion Criteria:

1. Age < 18 years of age,

2. pregnancy,

3. known severe peripheral artery disease,

4. poor perfusion to fingers (as defined as a perfusion index less than 0.5%-
www.Masimo.com),

5. history of Raynaud's,

6. refusal to provide written consent.