The CardioMEMS™ HF System may be considered medically necessary for individuals that meet ALL of the following indications:
- Diagnosis of New York Heart Association (NYHA) Class III HF symptoms predominantly present over the previous months, despite maximally tolerated guideline directed medical and device therapies; and
- At least one (1) HF related hospitalization within the previous 12 months; and
- Able to take dual anti-platelet or anticoagulants for one (1) month post-implant; and
- Greater than or equal to 18 years of age; and
- Diagnosis of HF greater than or equal to three (3) months, with either preserved or reduced left ventricular ejection fraction; and
- PA branch diameter sized between seven (7) mm and 15 mm; and
- Body mass index (BMI) of less than or equal to 35; or
- If BMI is greater than 35, a measurement of chest circumference at axillary level is required. If the chest circumference is greater than 165 cm, the sensor should not be implanted due to poor signal strength.
Monitoring must occur at least once weekly in all individuals implanted with CardioMEMS™. Weekly monitoring is acceptable as long as the individual maintains acceptable PA pressure (opti-volemic).
If PA pressure is not opti-volemic:
- Monitoring must occur at least two (2) - three (3) times per week until opti-volemic in cases where the individual has elevated PA pressure (hyper-volemic) or low PA pressure (hypo-volemic); and
- Monitoring must occur at least two (2) - three (3) times per week until pressure stabilizes in cases where the individual receives medication modifications or exhibits significant deviations in trend data.
The CardioMEMS™ HF System is considered experimental/investigational and, therefore, non-covered for any other indication. The safety and/or effectiveness cannot be established by review of the published peer-reviewed literature.