Search

Women have been underrepresented in heart failure (HF) trials, including key trials for implantable pulmonary artery pressure (PAP) sensors. Sex-specific analysis of the use of ambulatory hemodynamic monitoring devices are lacking. Hemodynamic Frontiers in Heart Failure (HF2) is an academic consortium of 14 US centers that has developed a registry to collect data on patients following PAP sensor implantation. We analyzed patients with at least 12 months of hemodynamic monitoring data and compared patients based on reported sex. Clinical events including ED visits, HF hospitalizations, and death have been captured. Baseline demographic and implant hemodynamic data were compared using independent samples t-test (IBM SPSS Statistics Version 29.0). The registry has IRB approval from individual sites and is supported by CTSA Award UL1TR002366. Of 238 patients, 100 (42%) were female. Women were more likely to have lower creatinine, higher BMI and ejection fraction (Table 1). They were less likely to have ischemic etiology or baseline SGLT2 inhibitor use. There were no significant differences in baseline hemodynamics. Female patients had fewer total events than their male counterparts (1.49 vs 1.91 events/person-year) and fewer HF hospitalizations (Figure 1). The majority of ED visits were non-cardiac and the majority of hospitalizations were not HF-related. There were 5 deaths total: 3 HF-related in males, 1 HF-related in a female and 1 non-cardiac in a female. Four patients progressed to LVAD, 3 of which were males. Three patients progressed to ESRD, all males. The HF2 Registry is a real-world, multi-center registry of an approved PAP sensor. As compared to key trials leading to initial and expanded indications for the devices, this registry houses a higher proportion of female patients. Although there were no differences in baseline hemodynamics, there were substantial sex-based variations in other demographics and in outcomes. More research is needed to understand potential sex-specific effects and to encourage higher female representation in HF device trials and utilization. [ABSTRACT FROM AUTHOR]

An implantable pulmonary artery pressure (PAP) sensor is approved to reduce heart failure hospitalizations (HFH) in symptomatic patients. Key trials have excluded those with advanced chronic kidney disease (CKD), or eGFR <25 mL/min per 1.73 m². Real-world use of ambulatory hemodynamic monitoring in advanced CKD has not been well-described. Hemodynamic Frontiers in Heart Failure (HF2) is an academic consortium of 14 US centers that developed a registry to collect data on patients following implantation with a PAP sensor, including demographics, hemodynamics, and clinical events (ED visits, HFH, or death). We analyzed patients with at least 12 months of hemodynamic monitoring data, comparing events in patients with normal kidney function (eGFR ≥60), mild to moderate CKD (eGFR 30-59), and advanced CKD (eGFR <30). Baseline demographic and implant hemodynamic data were compared using One-Way ANOVA test (IBS SPSS Statistics Version 29.0). In time-to-event analysis, patients who had no events were censored at their 12 month follow up as their last seen date. Those with an event > 12 months from the implant date were censored. The Registry has IRB approval from individual sites and is supported by CTSA Award UL1TR002366. Of 236 total patients, 70 (29.7%) had advanced and 112 (47.5%) had mild to moderate CKD (Table 1A). Those with CKD were more likely to be older, diabetic, and with higher baseline right atrial and pulmonary artery mean pressures. Patients with CKD had more frequent hospitalizations and those with advanced CKD had more frequent death and progression to LVAD/transplant or ESRD/dialysis (Table 1B). Of those with advanced CKD, only 2 (1.5%) progressed to ESRD. Longitudinal real-world data from the HF2 Registry demonstrates use of PAP sensors in patients with a broad range of kidney function. Although ambulatory hemodynamic monitoring has been shown to reduce HFH, the same may not be true for those with advanced CKD. More research is needed in this high-risk population. [ABSTRACT FROM AUTHOR]

Ambulatory hemodynamic monitoring (AHM) using an implantable pulmonary artery pressure sensor (CardioMEMS) is effective in improving outcomes for patients with heart failure. The operations of AHM programs are crucial to clinical efficacy of AHM yet have not been described. An anonymous, voluntary, web-based survey was developed and emailed to clinicians at AHM centers in the United States. Survey questions were related to program volume, staffing, monitoring practices, and patient selection criteria. Fifty-four respondents (40%) completed the survey. Respondents were 44% (n = 24) advanced HF cardiologists and 30% (n = 16) advanced nurse practitioners. Most respondents practice at a center that implants left ventricular assist devices (70%) or performs heart transplantation (54%). Advanced practice providers provide day-to-day monitoring and management in most programs (78%), and use of protocol-driven care is limited (28%). Perceived patient nonadherence and inadequate insurance coverage are cited as the primary barriers to AHM. Despite broad US Food and Drug Administration approval for patients with symptoms and at increased risk for worsening heart failure, the adoption of pulmonary artery pressure monitoring is concentrated at advanced heart failure centers, and modest numbers of patients are implanted at most centers. Understanding and addressing the barriers to referral of eligible patients and to broader adoption in community heart failure programs is needed to maximize the clinical benefits of AHM. [ABSTRACT FROM AUTHOR]