SURPASS-HF was a 90-day, single-center, single-arm, prospective feasibility study asking whether adults with heart failure and an implanted pulmonary artery (PA) pressure sensor can safely share in managing their own diuretic (water pill) dosing. Participants were already implanted with a CardioMEMS PA pressure sensor and managed by a single cardiovascular team using a previously published hemodynamic treatment algorithm. Each participant received a simplified treatment guide (sliding scale) prescribing how to adjust diuretic doses based on their own PA pressure readings, which were relayed to them daily through the Epic MyChart patient portal. Protocol-mandated laboratory testing followed each diuretic adjustment. The study measured safety (hospitalizations, urgent visits, kidney injury, syncope, electrolyte disturbances) and effectiveness (heart failure hospitalizations, average PA diastolic pressure, and how often the care team needed to intervene) over 90 days, with quality of life assessed by the Minnesota Heart Failure Questionnaire. A separate retrospective chart-review cohort of 31 CardioMEMS patients served as a comparison group.
Non-randomized, prospective, single-center feasibility study. Participants who complete the study function as their own comparative controls. Planned screening of 30 patients with planned enrollment of 15; actual enrollment was 21. Per protocol addendum, a retrospective chart-review cohort (N=31 patients with a CardioMEMS device and 6 months of data from implant date, not included in the prospective arm) serves as a control/baseline comparison using data already in the medical record; no additional visits, questionnaires, or blood draws were required for that cohort. Adverse events were pre-defined in the protocol as: hypokalemia, hospitalization, syncope, urgent clinic/ER visit, and acute kidney injury.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
21
Participants received a simplified treatment guide / sliding scale with instruction to adjust diuretic dosing according to remotely obtained pulmonary artery pressures, relayed to the patient daily via the Epic MyChart portal, under a previously published hemodynamic treatment algorithm with protocol-mandated laboratory testing after diuretic augmentation.
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, United States
Hospitalization(s)
All cause and adjudicated heart failure specific hospitalization(s)
Time frame: 90 days
Urgent office visit(s)
Unscheduled visits to outpatient office, urgent care, or emergency department for heart failure symptom or management of consequence directly related to heart failure management.
Time frame: 90 days
Adverse event(s)
Events include syncope, acute kidney injury/failure, or significant electrolyte derangements requiring intravenous corrective therapy that were directly due to heart failure treatment(s).
Time frame: 90 days
Diastolic pulmonary artery pressure average
Cohort wide average PA diastolic pressure during the first two weeks and last two weeks of study period.
Time frame: 90 days
Provider/treatment team intervention(s)
Either by request from patient or necessity deemed by provider/treatment team, intervention that was not explicitly outlined in the patient specific protocol/therapy titration adjustment plan.
Time frame: 90 days
Time in optimal PA pressure range (TIR-PAP)
within +/- 5mmHg of individual patient PA diastolic goal
Time frame: 90 days
Diuretic burst frequency
Determined by episodes of sustained pressure deviations from goal range which require a patient self-adjustment/burst of medication(s) according to their individualized treatment plan.
Time frame: 90 days
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