Pulmonary artery sensor for patients with heart failure beats performance goals
Key takeaways:
- A pulmonary artery sensor for patients with heart failure beat performance goals related to clinical outcomes.
- The device also was linked to improvements in quality of life and functional capacity.
Management of patients with heart failure guided by a pulmonary artery sensor exceeded performance goals and was linked to improved quality of life and functional capacity compared with historical performance goals, researchers reported.
PROACTIVE-HF trial results of the sensor (Cordella, Endotronix) for patients with NYHA class III HF were presented at the Technology and Heart Failure Therapeutics (THT) annual meeting.
‘A more proactive approach’
“The Cordella system is a comprehensive platform that enables heart failure patients to perform a daily health assessment to evaluate congestion (pulmonary artery pressures), vital signs (blood pressure, weight, heart rate) and symptoms. This information is available to the patient’s cardiology team so they can regularly optimize medications to improve the health status of patients by lowering pulmonary artery pressures,” Liviu Klein, MD, section chief of advanced heart failure, mechanical circulatory support, pulmonary hypertension and heart transplant at the University of California, San Francisco, who presented the data, told Healio. “The CardioMEMS sensor (Abbott) does not include vital signs and requires patients to take their reading lying on their back. The Cordella reader allows patients to take their reading upright in a seated position, which is more realistic of a patient’s real-life pulmonary artery pressures. This enables a more proactive approach (rather than alert-oriented) and is more comprehensive (providing additional data) in order to allow a customized approach for patients. Lastly, the Cordella system is more engaging by giving patients feedback of their vital signs and pulmonary artery pressures on their tablets.”
PROACTIVE-HF, which included 456 patients (mean age, 64 years; 40% women; 18% Black), was changed from a randomized, single-blind study to a single-arm, open-label one after consultation with the FDA, according to the presentation. The primary effectiveness outcome was incidence of HF hospitalization or all-cause mortality at 6 months compared with a performance goal, and the primary safety endpoints were freedom from device- or system-related complications and freedom from pressure sensor failure, both at 6 months.
Freedom from device- or system-related complications occurred in 99.2% of patients at 6 months, and the lower confidence limit of 97.9% beat the performance goal of 90%, whereas freedom from pressure sensor failure occurred in 99.8% of patients at 6 months, and the lower confidence limit of 98.6% beat the performance goal of 95%, Klein said during the presentation.
For the primary effectiveness endpoint, the upper confidence bound of the event rate had to be lower than 0.43 events per patient per 6 months and the event rate itself had to be lower than 0.37 events per patient per 6 months, and those goals were met with an event rate of 0.15 events per patient per 6 months (95% CI, 0.12-0.2; P < .0001), Klein said.
All prespecified subgroups exceeded the performance goals, he said.
At 6 months, the cohort improved in Kansas City Cardiomyopathy Questionnaire overall summary score (+5 points; P < .0001), 6-minute walk distance (+23.7 m; P = .001), NYHA class (32% improved; P < .0001) and N-terminal pro-B-type natriuretic peptide (–98.9 pg/mL; P = .06), according to the researchers.
‘Builds on the robust evidence’
“The key message of the PROACTIVE-HF trial is that patients using the Cordella system received excellent care, demonstrating that pulmonary artery pressure-guided heart failure management with Cordella was safe and resulted in low rates of heart failure hospitalization and improvement in quality of life,” Klein told Healio. “This study builds on the robust evidence supporting pulmonary artery pressure-guided heart failure management to reduce hospitalizations in patients with NYHA functional class III symptoms. Future areas of study include expanding evidence into less-sick patients with NYHA functional class II symptoms and enabling additional patient engagement and possibly patient self-management. These research questions are being assessed in a follow-up study that has just been launched, called PROACTIVE-HF 2.
“It has been a long time since there has been innovation in the implantable hemodynamic sensing space,” Klein told Healio. “I believe the new innovative approach from Endotronix will expand the usage of this technology once it is approved by the FDA for commercialization. In turn, it can broaden the patient population due to its ease of use for both the clinician and the patients.”
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Klein L, et al. Featured late-breaking clinical science abstracts II. Presented at: Technology and Heart Failure Therapeutics (THT); March 4-6, 2024; Boston.