PAP-guided management system appears safe in patients with HF

A pulmonary artery pressure (PAP)-guided heart failure (HF) management system named the Cordella PA Sensor System was safe and may be effective in patients with HF and NYHA class III symptoms, according to the results of the single-arm, open-label PROACTIVE-HF trial.

The Cordella PA Sensor System is a PAP-guided HF management system for patients with HF. The PROACTIVE-HF trial (NCT04089059) evaluated outcomes of this type of remote management, which provides access to body weight, blood pressure, heart rate, blood oxygen saturation, PAP, and HF symptoms [1]. PROACTIVE-HF skipped a predesigned standard-of-care control arm to become a single-arm, open-label trial with blinded endpoint assessment.

The primary cohort consisted of 465 participants with HF and NYHA class III symptoms, recent HF hospitalisation, and/or elevated NT-proBNP. The primary effectiveness endpoint was the 6-month incidence of HF hospitalisation or all-cause mortality. The performance goal was derived from the results of previous haemodynamic-monitoring trials.

All criteria for primary effectiveness success were met. The event rate was less than the performance goal: 0.15 versus 0.43 (P<0.0001); this was also less than the event rate in a historical control group arm, which was set at 0.37.

The primary safety endpoint was 2-fold: 6-month freedom from device-related or system-related complications, met by 99.2% of participants; and freedom from pressure-sensor failure, met by 99.8%. Access to the Cordella PA Sensor System also permitted further dose titration and optimisation of HF medication. Cumulatively, there were 2,956 medication changes, of which 69% were for diuretics, 27% guideline-directed medical therapy, and 4% vasodilators. The authors believe that decreased PAP and reductions in clinical events were likely primarily driven by increased diuretic dosing, as the guideline-directed medical therapy was optimised at baseline. Clinical decision-making appeared to be steered mainly by PAP.

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   1. Kiernan MS, et al. A prospective, multi-center, open label, single arm clinical trial evaluating the safety and efficacy of the Cordella PA Sensor System in NYHA class III heart failure patients. Late breaking clinical trials: devices, Heart Failure 2024, 11–14 May, Lisbon, Portugal.

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Posted on 16 July 2024