Background: Many patients admitted for acutely decompensated heart failure (ADHF) are discharged with persistent congestion. Furthermore, the early post-discharge period carries a particularly high risk of readmission and is known as the vulnerable phase. Methods: We used a device designed to enhance fluid and salt expulsion via the eccrine sweat glands for decongestion of patients admitted for ADHF. Patients were treated for 1-6 days in the hospital. Following discharge, home therapy continued for 30-60 days at a rate of 1-4 treatments/week. The primary efficacy endpoint for the in-hospital phase was fluid loss of ≥500 mL per ≥4h treatment. Secondary performance endpoints including fluid loss, changes in congestion score, and changes in NT-pro-BNP levels were evaluated for each phase separately. Results: We studied 15 patients, 12 completing both the hospital and home phases. During the in-hospital and home phases, median weight change due to device therapy was 2.4 Kg [IQR 2.20-3.77] and 3.1Kg [IQR 7.4-0.6 Kg] respectively, and the primary endpoint was met in 93% of patients. During the home treatment, median weight loss was 3.1 Kg [IQR 7.4-0.6 Kg]. Congestion score declined from 6 [IQR 6-7] to 4 [IQR 3-6] during the hospital phase (P=0.0007) and to 1 [IQR 1-1.5] at the end of home therapy (P=0.002). Median NT-proBNP levels decreased from 7732 [IQR 4694-9746] to 4984 pg/mL [IQR 3559-8950](P=0.01) during the hospital phase and to 3596 ng/mL [IQR 1640-5742](P=0.02) at the end of home therapy. Renal function remained stable. Conclusion: The AquaPass device is useful in enhancing decongestion in hospitalized ADHF patients. Following hospital discharge, device therapy was associated with additional improvement in decongestion without worsening of renal function.

Doron Aronson, William T. Abraham, and Daniel Burkhoff are consultants for AquaPass Yaacov Nitzan is the CEO of AquaPass

NCT05843201

The study was funded by AquaPass LTD.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study was conducted under the approval of the institutional review boards at the Rambam Medical Center, Haifa, Israel and the Rabin Medical Center, Petah Tikva, Israel. Written informed consent was obtained from all study participants prior to study procedures. The protocol was registered at ClinicalTrials.gov (Unique identifier: NCT05843201).

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All data produced in the present study are available upon reasonable request to the authors