What are the eligibility criteria for CardioMEMS pulmonary‑artery pressure sensor implantation in adult (≥ 18 years) heart‑failure patients with New York Heart Association class III symptoms despite guideline‑directed medical therapy (including an ACE inhibitor or angiotensin‑receptor blocker or angiotensin‑receptor‑neprilysin inhibitor, a beta‑blocker, and a mineralocorticoid‑receptor antagonist unless contraindicated), who have had at least one heart‑failure hospitalization or emergency‑department visit for worsening heart failure in the past 12 months, regardless of left‑ventricular ejection fraction, who have suitable pulmonary‑artery anatomy (mean pulmonary‑artery pressure ≤ 35 mm Hg, no severe pulmonary hypertension, no right‑ventricular outflow obstruction, and no recent pulmonary‑artery interventions), and who have no contraindications such as active systemic infection, uncontrolled coagulopathy, recent major bleeding, end‑stage renal disease requiring dialysis, or inability to perform daily remote transmissions (e.g., severe cognitive impairment, lack of compatible home Wi‑Fi or cellular connection, or inability to operate the handheld device), and who are able and willing to adhere to daily transmission, attend follow‑up visits, and cooperate with the multidisciplinary heart‑failure team?

CardioMEMS Approval Requirements in Heart Failure

Primary FDA-Approved Indication

CardioMEMS is FDA-approved for patients with NYHA class III heart failure who have had at least one heart failure hospitalization in the previous 12 months, regardless of left ventricular ejection fraction. 1, 2

Mandatory Eligibility Criteria

Clinical Status Requirements

• NYHA class III symptoms must be present despite optimization of guideline-directed medical therapy 1, 2, 3
• At least one heart failure hospitalization or emergency department visit for worsening heart failure within the past 12 months is required 1, 2, 3
• The indication applies to both HFrEF and HFpEF patients—ejection fraction does not restrict eligibility 1, 2, 3

Medical Therapy Optimization

• Patients with reduced ejection fraction must be on stable guideline-directed pharmacotherapy including:
  • ACE inhibitor, angiotensin-receptor blocker, or ARNI
  • Beta-blocker
  • Mineralocorticoid receptor antagonist (unless contraindicated)
  • These medications must be at maximally tolerated doses for at least 3 months 3, 4

Anatomic and Hemodynamic Requirements

• Mean pulmonary artery pressure ≤ 35 mm Hg at baseline (no severe pulmonary hypertension) 2
• Suitable pulmonary artery anatomy without right ventricular outflow obstruction 2
• No recent pulmonary artery interventions that would preclude safe sensor placement 2

Absolute Contraindications

Medical Contraindications

• Active systemic infection at time of implantation 2
• Uncontrolled coagulopathy or recent major bleeding episode 2
• End-stage renal disease requiring dialysis 2

Technical and Compliance Contraindications

• Inability to perform daily remote transmissions due to:
  • Severe cognitive impairment preventing device operation
  • Lack of compatible home Wi-Fi or cellular connection
  • Physical inability to operate the handheld transmission device 2
• Unwillingness or inability to adhere to daily transmission requirements 2
• Inability to attend follow-up visits or cooperate with the multidisciplinary heart failure team 2

Implementation Requirements for Clinical Benefit

Monitoring Infrastructure (Critical for Efficacy)

• Daily review of transmitted pressure data by trained personnel must be established—the device alone does not reduce hospitalizations 2
• Predetermined pressure thresholds that trigger clinical alerts must be defined in advance 2
• Medication adjustment algorithms based on pressure trends must be in place before implantation 2
• A multidisciplinary team with clearly defined roles for responding to hemodynamic changes is mandatory 2

Common Pitfall to Avoid

• Do not delay implantation while attempting indefinite "optimization" of medical therapy in patients who already meet FDA criteria—early hemodynamic guidance is the mechanism of benefit, and delaying implantation diminishes the opportunity for pre-emptive intervention 2

Clinical Evidence Supporting These Criteria

• The CHAMPION trial demonstrated a 28-30% reduction in heart failure hospitalizations (0.49 vs 0.69 events/patient-year, p < 0.001) in NYHA class III patients meeting these criteria 1, 2
• Benefit was consistent across both HFrEF and HFpEF subgroups, justifying the ejection fraction-agnostic indication 2
• The reduction in hospitalizations requires active medication titration based on pressure data—passive monitoring without therapeutic response does not replicate the trial results 2

Referral Pathway

• Prompt referral to an advanced heart failure specialist is recommended for any NYHA class III patient with ≥1 hospitalization in the past year to coordinate CardioMEMS evaluation, establish the monitoring protocol, and assess for additional advanced therapies (CRT, ICD, transplant evaluation) 2