Health Problem: Heart failure (HF) is a chronic condition that develops over time due to circumstances that overwork and damage the heart. The primary causes include coronary heart disease, high blood pressure, and diabetes. HF is characterized by the inability of the heart to pump blood efficiently. HF is estimated to affect approximately 5.7 million people in the United States.

Technology Description: The CardioMEMS Implantable Hemodynamic Monitor (CM-IHM) system includes an implantable pulmonary artery pressure (PAP) sensor, a transvenous catheter delivery system, a patient home-monitoring electronic system, and a secure Internet-accessible database that allows clinicians to access patient data. The CM-IHM system provides measurement of the systolic, diastolic, and mean PAP, intending to allow for adjustment of HF medical therapy based on pressure trends and specified pressure goals.

Controversy: Concerns have been raised by the Food and Drug Administration (FDA) regarding potential biases in the pivotal randomized controlled trial (RCT) that served as the basis for premarket approval of the CM-IHM system. The primary issue raised by the FDA concerns a lack of robust statistical analysis. While the FDA granted approval of the CM-IHM in May 2014, the approval was conditional on the manufacturer conducting postapproval studies to address these issues.

Key Questions:

  • Is the CardioMEMS system effective in monitoring adults with HF?
  • How does the CardioMEMS system compare with other monitoring systems (e.g., standard medical management, echocardiography, or Swan-Ganz catheterization)?
  • Is the CardioMEMS system safe?
  • Have definitive patient selection criteria been identified for the CardioMEMS system?

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