For patients with severe pulmonary arterial hypertension with right-sided heart failure (HF), the CardioMEMS™ HF System demonstrated safe short-term and long-term monitoring of pulmonary arterial hypertension, according to a publication in Chest.
This study combined data from 2 studies to evaluate the safety and feasibility of using the CardioMEMS Heart Failure System to monitor cardiac outputs in patients with severe pulmonary arterial hypertension with right-sided HF failure.
Patients with a New York Heart Association or World Health Organization functional class of III or IV, and who had been previously hospitalized for right-side HF were included in the study. After implantation of the CardioMEMS™ HF System, patients were asked to transmit data at least weekly. The primary study end point was safety at 1 year post-implantation, and the secondary end point was the feasibility of using the system to monitor cardiac outputs and alter therapy as needed.
Quality-of-life questionnaires, vital signs, physical examinations, and laboratory measurements were collected peri-implant and at months 1, 4, 7, 12, and 24 post-implant; safety was assessed peri-implant and at months 1, 4, and 12 post-implant.
Of the 26 patients included in this study, 92% were women, 81% had a New York Heart Association class of III, and the mean age was 51.3 years old. In general, 65.5% of the patients transmitted data from the CardioMEMS™ HF System daily and 94.9% transmitted data weekly. Only 1 periprocedural safety complication occurred and no post-procedural complication or device-related serious adverse event occurred by the 1-year follow-up.
Significant hemodynamic responses included a reduction in pulmonary artery pressure, elevations in cardiac output, right ventricular stroke volume, and total pulmonary resistance. These led to changes in medications that were made possible because of the monitoring with the CardioMEMS™ HF System.
In addition to the hemodynamic changes, improvements were observed in the mean New York Heart Association class status (P <.001), natriuretic peptides (P <.01), quality-of-life scores (P <.001), and the 6-minute walk distance.
Limitations of this study include its exploratory design without a control group. Future studies need to examine validity and safety in a larger, controlled trial.
The researchers concluded, “[in] summary, the use of an [implantable hemodynamic monitor] in [pulmonary arterial hypertension] patients was observed to be safe and feasible in monitoring hemodynamic changes and safe, if appropriate patient selection and anatomy is mandated and standardized.”
This study was partially funded by Abbott and several authors report multiple associations with pharmaceutical companies. Please see the original reference for a full list of authors’ disclosures.
Benza RL, Doyle M, Lasorda D, et al. Monitoring pulmonary arterial hypertension using an implantable hemodynamic sensor [published online June 29, 2019]. Chest. doi:10.1016/j.chest.2019.06.010