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    Low PA Pressures (Hypo-volemic)

                    Hypo-volemic Definitions
                       Subject symptoms: poor perfusion in absence of signs and symptoms of congestion
                       CardioMEMS HF System Parameters: below the acceptable range
                       Daily trends: decrease in trend data outside the acceptable range
                       Weekly trends: decrease in trend data
                    Treatment Recommendations
                       Lower or discontinue diuretic
                       -   If on a thiazide diuretic with loop diuretic, lower or discontinue the dose of thiazide (and adjust electrolyte replacement)
                       -   If on only loop diuretic, lower the dose or discontinue
                       -   Consider liberalization of oral fluid restriction and salt restriction
                       If postural hypotension, hold or lower vasodilators and/or oral nitrates, especially if hypotensive when sitting or supine
                       If worsening renal function, hold or lower ACE/ARB dose, especially if hypotensive
                       If subject had signs and symptoms of poor perfusion (cold) in addition to being hypo-volemic:
                       -   Consider admission if clinical evidence suggests need for IV fluid repletion, telemetry monitoring or the use of IV
                           therapeutic agents
                       -   Consider invasive hemodynamic monitoring for determination of Cardiac Output, if indicated
                    Recommended Frequency of CardioMEMS HF System Review

                    Subject Status         Weekly                At least 2– 3 times per week   At least 2 – 3 times per week
                                                                 until optivolemic      until pressure stabilizes
                    Acceptable PA Pressure (Opti-  X
                    volemic)
                    Elevated PA Pressure (Hyper-                 X
                    volemic)
                    Low PA Pressure (Hypo-                       X
                    volemic)
                    Medication modifications                                            X
                    Significant deviations in trend                                     X
                    data

                    Clinical Study Information

                    Introduction
                    Heart failure (HF) is a major public health problem in the United States affecting over 5 million people with over 1 million HF
                    hospitalizations per year. Elevated pulmonary artery (PA) pressures may occur prior to signs and symptoms of HF decompensation
                    and can provide a sound physiologic basis for HF patient management.
                    The CardioMEMS HF System provides a novel method for measuring PA pressure using a wireless pressure sensor implanted into
                    the PA, an external communication device, and a patient database. The CardioMEMS HF System provides physicians knowledge of
                    PA pressure while the patient is at home allowing them to manage patients proactively with the goal of reducing heart failure
                    hospitalizations.
                    CHAMPION (CardioMEMS HF Sensor Allows Monitoring of Pressures to Improve Outcomes in NYHA Functional Class III Heart
                    Failure Patients) was a prospective, multicenter, single-blind, randomized, clinical trial in 550 patients across 64 centers in the
                    United States.
                    Purpose
                    The goal of CHAMPION was to determine if physicians could reduce HF hospitalizations by managing patient PA pressures using the
                    CardioMEMS HF System.
                    Methods
                    Study Design
                    550 patients with NYHA Class III HF and a prior HF hospitalization within 12 months were randomized to standard of care plus the
                    CardioMEMS HF System (Treatment group; 270 patients) or to standard of care only (Control group; 280 patients). All patients were
                    implanted with the PA sensor and took daily readings from home. Patients were enrolled regardless of their baseline ejection fraction
                    so that patients with both reduced and preserved systolic function were included. Physicians had access to PA pressure information
                    for patients in the Treatment group but not for patients in the Control group.
                    Following the completion of Randomized Access, patients transitioned to a period of Open Access, during which PA pressures were
                    provided to physicians for patients in both the Treatment and the Control groups. Specifically, physicians continued to have access to
                    the Treatment group’s PA pressures in an unchanged manner, whereas access to the Control group’s PA pressure was provided for
                    the first time.
                    Follow-Up Schedule

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