JACC. Heart failure · 2025
Mechanically Reducing Cardiac Preload With the preCARDIA System in Acutely Decompensated Heart Failure.
СтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Yousefzai Rayan, Bhimaraj Arvind, Kiernan Michael S, Abraham Jacob, Gorgoshvili Irakli, Tedford Ryan J, Desai Shashank, Vorovich Esther E, Benzuly Keith H, Miranda David, Kanwar Manreet K, Sauer Andrew J, Rinde-Hoffman Debbie A, Dumitru Ioana, Hernandez-Montfort Jaime, Aghili Nima, Sheikh Farooq H, Basuray Anupam, Bodnar Jason, Curran Jerry, Burkhoff Daniel, Kapur Navin K
Аннотация
BACKGROUND: The preCARDIA device is a novel intervention designed to mechanically reduce cardiac filling pressures in patients with acute decompensated heart failure (ADHF) by regulating flow through the superior vena cava.
OBJECTIVES: The VENUS-HF (SVC Occlusion in Subjects With Acute Decompensated Heart Failure; NCT03836079) Early Feasibility Study tested the safety and feasibility of the next-generation preCARDIA system, which includes updates to the sheath, catheter, and console.
METHODS: In a multicenter, prospective, single-arm safety and feasibility study, 60 subjects with ADHF received preCARDIA support for up to 24 hours. Primary and secondary endpoints testing the safety and technical feasibility of the device were analyzed.
RESULTS: Freedom from device- or procedure-related major adverse events was observed in 98.3% (n = 59/60), and successful device deployment and removal in all subjects (N = 60). No statistically significant difference in major adverse events was observed between recipients of the original (0%, n = 0/30) and newest (3.3%, n = 1/30) generation preCARDIA devices. In subjects with 24 ± 3 hours of preCARDIA duration (n = 52), paired right atrial and pulmonary capillary wedge pressures decreased by 23% (18 ± 6 vs 11 ± 6 mm Hg, P < 0.0001) and 18% (30 ± 8 vs 24 ± 9 mm Hg, P < 0.0001), respectively, from baseline to end of device use. Compared with 24 hours before device initiation, net urine output increased during the 24-hour period during device use (-1.5 ± 0.9 vs -3.4 ± 2.4 L, P < 0.001).
CONCLUSIONS: Use of the preCARDIA system in patients with ADHF was feasible and well tolerated, with early exploratory signals of significantly reduced cardiac filling pressures and increased urine output. These findings provide a foundation for larger, prospective studies, such as the upcoming COR-ADHF (Cardiovascular UnlOading with preCARDIA in Acute Decompensated Heart Failure) trial, to determine clinical efficacy. (SVC Occlusion in Subjects With Acute Decompensated Heart Failure [VENUS-HF]; NCT03836079).
OBJECTIVES: The VENUS-HF (SVC Occlusion in Subjects With Acute Decompensated Heart Failure; NCT03836079) Early Feasibility Study tested the safety and feasibility of the next-generation preCARDIA system, which includes updates to the sheath, catheter, and console.
METHODS: In a multicenter, prospective, single-arm safety and feasibility study, 60 subjects with ADHF received preCARDIA support for up to 24 hours. Primary and secondary endpoints testing the safety and technical feasibility of the device were analyzed.
RESULTS: Freedom from device- or procedure-related major adverse events was observed in 98.3% (n = 59/60), and successful device deployment and removal in all subjects (N = 60). No statistically significant difference in major adverse events was observed between recipients of the original (0%, n = 0/30) and newest (3.3%, n = 1/30) generation preCARDIA devices. In subjects with 24 ± 3 hours of preCARDIA duration (n = 52), paired right atrial and pulmonary capillary wedge pressures decreased by 23% (18 ± 6 vs 11 ± 6 mm Hg, P < 0.0001) and 18% (30 ± 8 vs 24 ± 9 mm Hg, P < 0.0001), respectively, from baseline to end of device use. Compared with 24 hours before device initiation, net urine output increased during the 24-hour period during device use (-1.5 ± 0.9 vs -3.4 ± 2.4 L, P < 0.001).
CONCLUSIONS: Use of the preCARDIA system in patients with ADHF was feasible and well tolerated, with early exploratory signals of significantly reduced cardiac filling pressures and increased urine output. These findings provide a foundation for larger, prospective studies, such as the upcoming COR-ADHF (Cardiovascular UnlOading with preCARDIA in Acute Decompensated Heart Failure) trial, to determine clinical efficacy. (SVC Occlusion in Subjects With Acute Decompensated Heart Failure [VENUS-HF]; NCT03836079).