Patient And Clinician Engagement With Remote Pulmonary Artery Pressures: 12-month Data From Substudy Of The Proactive-hf Trial

• Published in: Journal of cardiac failure Vol. 30; no. 1; p. 226
• Main Authors: Cowger, Jennifer A., Guichard, Jason, Miranda, David, Kiernan, Michael, Khumri, Taiyeb, Macaluso, Gregory, Craig, William, Saraon, Tajinderpal, mullens, wilfried, Chaparro, Sandra, Mahr, Claudius, Klein, Livu
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.01.2024
• ISSN: 1071-9164; 1532-8414
• DOI: 10.1016/j.cardfail.2023.10.263

PROACTIVE-HF was redesigned from a randomized control trial to a single-arm trial, with pre-specified safety and efficacy endpoints. All patients enrolled were implanted with a pulmonary artery pressure (PAP) sensor, provided with a system allowing for vital sign measurements (blood pressure (BP), weight, and heart rate (HR)), and, initially, randomized 1:1 to either treatment or control groups. In the control arm, only vital signs were visible to the clinicians and patients. At the time of trial redesign, patients and clinicians in the control group were unblinded to PAP and patients were managed by protocol using seated mean PAP (mPAP). In these former control patients, we examined the trend in seated mPAP, BP, weight, and HR in the 12 months following unblinding. Additionally, heart failure hospitalizations (HFH) and patient surveys regarding PAP were examined. Changes in PAP, BP, weight, and HR were assessed in the 12 months following unblinding patients and clinicians to PAP using a mixed linear model regression method. We compared HFH in the 12 months following unblinding to the 12 months prior to PAP sensor implant. Patients were surveyed on their experience with PAP following unblinding. There were 72 patients enrolled in the former control group. At the time of this analysis, 42 patients had completed 12 months of unblinding with all follow-up data (all will be completed by 6/2023). Of the 42 patients, 23 (57.6%) were men, 19 (45.2%) had HF with preserved ejection fraction, and mean BMI was 35.5 kg/m2. For the PAP and vital sign analysis, 3 patients were excluded due to sparse data. In the 12 months following unblinding, seated mPAP, BP, and weight all saw significant decreases (all p values < 0.001). Subgroup analyses indicated that the mPAP decline was driven by patients above target mPAP at un-blinding (p < 0.001) compared to patients who were at target mPAP at unblinding (p = 0.57). HR saw a significant increase over the course of 12 months (p =0.001) (Figure 1A-B). The average number of HFH was significantly higher in the 12 months prior to PAP sensor implant than in the 12 months post unblinding (1.2 ± 0.9 vs 0.2 ± 0.7, p < 0.001). Following unblinding, subjects were surveyed on their engagement with PAP and 76% reported making lifestyle choices based on their PAP trends and 86% reported that PAP readings and resultant clinician care had a positive impact on their health. Unblinding patients and clinicians to PAP was associated with significant decreases in seated mPAP, BP, and weight over the following 12 months while HR increased. Patients reported positive impacts from PAP management, and HFH were significantly reduced compared to the year prior to implant.