Patient engagement with daily pulmonary artery pressure readings shows benefit in HF
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Key takeaways:
- Engagement in daily pulmonary artery pressure readings may benefit patients with heart failure.
- Patients made lifestyle improvements and lowered pulmonary artery pressure, especially those above target range.
Patients with HF who viewed their daily pulmonary artery pressure made informed lifestyle choices, decreased weight and improved their pressure, especially those above target range, a speaker reported.
The PROACTIVE-HF substudy, presented at the Heart Failure Society of America Annual Scientific Meeting, evaluated the impact of patient access to daily mean pulmonary artery pressure measures from an implanted sensor (Cordella, Endotronix) in those with HF.
“At HFSA in Cleveland ... Endotronix shared 12-month outcomes data on a substudy in advance of the full study data, which is expected next year. The substudy consisted of 63 patients who had early access to their daily pulmonary artery pressure and vitals data — BP, heart rate, weight — and daily trends,” Jennifer A. Cowger, MD, section head of advanced heart failure and medical director of the Mechanical Circulatory Support Program at Henry Ford Hospital in Detroit, told Healio. “Patients are eager to get involved in their care, and we need to look for opportunities to educate and empower them. These data suggest that patient engagement in pulmonary artery pressure monitoring may afford positive clinical outcomes. ... While the findings give insight into the value of patient engagement in remote heart failure management, it does need further substantiation in a larger study, which is why Endotronix kicked off the PROACTIVE-HF 2 trial at HFSA.”
For the present PROACTIVE-HF substudy, the trial was redesigned from a randomized trial to a single-arm study with both patients and clinicians having access to mean pulmonary artery pressure data.
The study included 63 patients in the former control group who had access to daily BP, heart rate, weight measurements (mean age, 66 years; 40% women; 14% Black). The researchers analyzed changes in mean pulmonary artery pressure, HF medications and HF hospitalizations before and during the 12-month period after a median masking of 167 days.
During the masked period, average seated pulmonary artery pressure increased (P = .02) and there were no significant changes in patients’ weight (P = .795).
During the unmasked period, the researchers observed decreased mean seated pulmonary artery pressure for patients above target (P = .03) — defined as more than 20 mm Hg — while seated pulmonary artery pressure remained unchanged among those already in target range (P = .105).
Patients’ weight also decreased during the unmasked period (P = .024), according to the presentation.
The researchers observed no significant change in BP and heart rate during the masked and unmasked periods.
Cowger and colleagues reported that HF hospitalizations were higher in the 12 months before pulmonary artery sensor implant compared with the 12 months after unmasking (P < .0001).
Moreover, the researchers reported good patient engagement with daily monitoring of pulmonary artery pressures, with 88% of patients reporting they understood what pulmonary artery pressure is and why it is important; 78% reported making lifestyle changes based on their monitoring trends; 86% reported a positive impact of pulmonary artery pressure management on their health; and 55% understood what their normal pulmonary artery pressure range was.
“As clinicians, we know that HF management requires regular medication adjustments to keep patients healthy and out of the hospital,” Lynne Warner Stevenson, MD, director of cardiomyopathy at Vanderbilt University Medical Center in Nashville, Tennessee, and global principal investigator of the PROACTIVE-HF 2 clinical trial, told Healio. “Pulmonary artery pressure monitoring is a great early indicator of worsening HF, and with Cordella we combine it with daily trended health data, including heart rate, BP and weight. This gives clinicians the comprehensive information they need to easily titrate medications remotely for effective management.
“With Cordella, we have the added benefit that patients can see their health data. This allows them to internalize how eating pizza the night before impacts their health and make lifestyle adjustments, one of the most difficult parts of heart failure management,” Stevenson told Healio. “Cordella provides a daily health check-in for patients that encourages them to make better choices like eating better and taking a walk. And we saw in the 12-month data from the PROACTIVE cohort A, that patients want this important feedback and are making smart choices based on it.”
Endotronix announced in a press release that it received investigational device exemption approval from the FDA to conduct PROACTIVE-HF 2, designed as a prospective, multicenter, open-label, controlled two-arm trial: one arm to evaluate whether pulmonary artery sensor system improved pulmonary artery pressure and guideline-directed medical therapy adherence compared with telemonitoring, and the other to assess whether a clinician-directed patient self-management strategy to lower pulmonary artery pressure improved all-cause mortality and HF hospitalization in patients with NYHA functional class III HF.
The rationale and design of PROACTIVE-HF 2 were published in the Journal of Cardiac Failure and presented at the HFSA Annual Scientific Meeting.
“I have been taking care of patients with HF for 40 years, during which we have focused too much on HF in the hospital, both in how we treat patients and how we test our treatments,” Stevenson said. “Patients do not want to take HF lying down and they want to live active and rewarding lives outside of the hospital. Cordella is designed to enhance daily activity and patient confidence of control over their lives with HF. Instead of measuring pulmonary artery pressure lying down, as we have done in the hospital, the Cordella handheld reader measures pressures in patients sitting up and will increasingly be used to measure pulmonary artery pressure during standing and exercise.”
References:
- Endotronix receives IDE approval for the market expanding PROACTIVE-HF 2 clinical trial. https://endotronix.com/endotronix-receives-ide-approval-for-the-market-expanding-proactive-hf-2-clinical-trial. Published Oct. 9, 2023. Accessed Oct. 11, 2023.
- Guichard JL, et al. J Card Fail. 2023;doi:10.1016/j.cardfail.2022.09.006.
- Guichard JL, et al. Poster CTC-009. Presented at: The Heart Failure Society of America Annual Scientific Meeting; Oct. 6-9, 2023; Cleveland.
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Cowger J, et al. Poster 253. Presented at: The Heart Failure Society of America Annual Scientific Meeting; Oct. 6-9, 2023; Cleveland.
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