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March 13, 2024
3 minute read
Important points:
- Pulmonary artery sensors for heart failure patients achieve performance goals related to clinical outcomes.
- The device also improved quality of life and functional ability.
The researchers reported that managing heart failure patients with pulmonary artery sensors exceeded performance goals and led to improvements in quality of life and functional capacity compared to historical performance goals.
Results from the PROACTIVE-HF study of sensors (Cordella, Endotronix) in NYHA Class III HF patients were presented at the Technology and Heart Failure Therapeutics (THT) Annual Meeting.
“A more proactive approach”
“The Cordella system is a comprehensive platform that allows heart failure patients to perform daily health assessments to assess congestion (pulmonary artery pressure), vital signs (blood pressure, weight, heart rate) and symptoms. This information With access to the patient’s cardiology team, we can regularly optimize medications and improve patient health by lowering pulmonary artery pressure.” Dr. Liviu Klein, “We’re trying to find a way to improve our patients’ health,” the head of the Department of Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension, and Heart Transplantation at the University of California, San Francisco, who submitted the data, told Healio. “CardioMEMS sensors (Abbott) do not contain vital signs and require the patient to take measurements while lying on their back. With the Cordella reader, the patient can take readings in a seated upright position. , can more realistically reproduce the patient’s actual pulmonary artery pressure, which allows for a more proactive (rather than alert-oriented) approach and allows for a customized approach for the patient. It becomes more comprehensive (providing additional data). Finally, the Cordella system becomes more appealing by providing feedback of the patient’s vital signs and pulmonary artery pressure on a tablet.”
PROACTIVE-HF, which included 456 patients (mean age 64 years, 40% women, 18% black), was converted from a randomized, single-blind study to a single-arm, open-label study following consultation with the FDA. . According to the presentation. The primary efficacy outcome was the incidence of heart failure hospitalization or all-cause death at 6 months compared to performance goals, and the primary safety endpoint was the incidence of any device- or system-related complications at 6 months. There were no signs of illness and no malfunction of the pressure sensor.
Device- or system-related complications occurred in 99.2% of patients at 6 months, and the lower confidence limit of 97.9% exceeded the performance goal of 90%, but pressure sensor failure occurred in 99.2% of patients at 6 months. It occurred in 99.8% of patients. , and the confidence floor of 98.6% exceeds his 95% performance goal, Klein said during his presentation.
For the primary efficacy endpoint, the upper confidence limits for event rate should be less than 0.43 events per patient per 6 months, and the event rate itself should be less than 0.37 events per patient per 6 months. Yes, these goals were achieved. Event rate per patient per 6 months was 0.15 (95% CI, 0.12-0.2; P < .0001), Klein said.
He said all pre-specified subgroups exceeded their performance targets.
After 6 months, the cohort’s Kansas City Cardiomyopathy Questionnaire overall summary score improved (+5 points; P < .0001), 6 minute walk distance (+23.7 m; P = .001), NYHA class (32% improvement; P < .0001) and N-terminal pro-B-type natriuretic peptide (-98.9 pg/mL; P = .06), according to the researchers.
“Built on solid evidence.”
Lviv Klein
“Key messages from the PROACTIVE-HF trial are that patients using the Cordella system received excellent care, that pulmonary artery pressure-guided heart failure management with Cordella was safe, had low heart failure hospitalization rates, and improved quality of life. ”, Klein told Helio. “This study builds on the strong evidence supporting pulmonary artery pressure-induced heart failure management to reduce hospitalizations in patients with NYHA functional class III symptoms. Areas for future research include These include extending the evidence to mildly symptomatic patients, enabling additional patient involvement, and possibly enabling patient self-management. These research questions are called PROACTIVE-HF 2. It is being evaluated in a recently initiated follow-up study.
“It has been a long time since there has been any innovation in the implantable hemodynamic sensing space,” Klein told Helio. “We believe that Endotronix’s new innovative approach will expand the use of this technology if approved for commercialization by the FDA. I can.”
Information source/disclosure information
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Klein L et al. Featured Latest Clinical Science Abstracts II. Presentation location: Technology and Heart Failure Therapies (THT); March 4-6, 2024. Boston.
Disclosure: This study was funded by Endotronix. Mr. Klein has received consulting fees and honoraria from Abbott, Boston Scientific, and Medtronic, and has worked with Ancora Heart, Axon Therapies, Edwards Lifesciences, Impulse Dynamics, V-Wave, and Reports that he has received research grants from Medical and Zoll.
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