Abstract 4367586: Safety Profile of the CardioMEMS HF System in Pulmonary Arterial Hypertension: A Pooled Adverse Event Analysis from Three Clinical Studies

Abstract

Introduction: Pulmonary arterial hypertension (PAH) is a progressive disease. Continuous hemodynamic monitoring may help manage more severe PAH. The CardioMEMS HF System, an implantable pulmonary artery pressure (PAP) monitoring device, has shown promise in PAH management. However, its safety in patients with PAH remains undefined. Hypothesis: The use of the CardioMEMS is associated with an acceptable safety profile in patients with PAH. Methods: Adverse event data were combined from the completed CS1-003 (NCT05224531), on-going ARTISAN (NCT05203510), and on-going FIT_PH (NCT04078243) studies. Baseline assessments included demographics, hemodynamics, N-terminal pro B-type natriuretic peptide (NT-proBNP), 6-minute walk test (6MWT), and WHO Functional Class. Safety data were collected throughout each study. Results: At the time of analysis, 129 patients had received a CardioMEMS implant across the CS1-003 (n=25), ARTISAN (n=49), and FIT_PH (n=55) studies. All patients were diagnosed with PAH, with idiopathic, heritable, or drug/toxin-induced etiologies accounting for 81.4% of the cases, and connective tissue disease for 14.7%. The mean age was 54.6 years (range: 19-84), with 73.6% female patients. Most patients (77.5%) were classified as WHO Functional Class III or IV. The pooled means of baseline hemodynamic parameters were as follows: mean PAP of 47.9 mmHg (range: 23–81), mean right atrial pressure of 8.2 mmHg (range: 1–25), pulmonary artery wedge pressure of 10.0 mmHg (range: 1– 16), the cardiac output (CO) of 5.1 L/min (range: 1.3–10.9), and pulmonary vascular resistance of 8.4 Wood Units (range: 2–21). The average of baseline 6MWT was 336 meters (range: 10–930) and mean NT-proBNP was 978.6 ng/L (range: 18-11006). Based on the REVEAL 2.0 or Lite 2 risk scores (mean: 7, range: 2–14), the cohort was categorized at intermediate risk. A total of 71 (55%) patients completed at least 12 months of follow-up. Only five adverse events were reported as possibly related to the CardioMEMS implant procedure, including one serious adverse event. No unexpected adverse events, CardioMEMS device- or system-related adverse events, or sensor failures were reported by study sites throughout each study. Conclusions: The use of CardioMEMS in this combined PAH cohort has demonstrated a favorable safety profile, with few procedure-related adverse events and no enduring consequences. Future studies are warranted to investigate its long-term safety and efficacy in this population.