Six-month results from the ATHENS-HF FIH trial of the Adona Medical adjustable, biatrial pressure sensing interatrial shunt
L Klein, G Singh, P Sorajja, R Sharma, K P Rommel, G Khabeishvili, I Gogorishvili, M Vannan, N Hamid, C Haeffele, E Aman, G StoneAbstract
Background
Several interatrial shunt devices are being tested in patients with heart failure (HF) with mixed results to date. Although the postulated mechanism is a decrease in left-sided filling pressures, the optimal size of such a device remains unclear due to the heterogeneity of patients’ phenotypes. Moreover, the lack of long-term remote hemodynamic data during therapy hampers a true understanding of the therapy’s efficacy and early detection of adverse clinical events. To address these shortcomings, Adona Medical developed the Delphi System, a novel, adjustable interatrial shunt (5-12 mm) with integrated bi-atrial pressure sensors that can transmit hemodynamic data remotely.
Purpose
The ATHENS-HF study reports the first-in-human (FIH) experience with the Delphi HF Management System in HF patients with reduced or preserved ejection fraction (HFrEF/HFpEF) who remain symptomatic despite a stable medication regimen.
Methods
The primary efficacy endpoints are procedure success (shunt implantation without in-hospital major adverse cardiovascular or neurovascular events (MACNE)), and the ability to adjust shunt size at the index procedure and 90 days. The primary safety endpoint is the freedom from MACNE at 30 days. Secondary endpoints assessed changes in New York Heart Association (NYHA) class, Kansas City Cardiomyopathy Questionnaire (KCCQ), six-minute walk distance (6MWD), and NT-proBNP between enrollment and 6 months. We used the McNemar and the Wilcoxon rank test to compare changes in secondary endpoints.
Results
Ten HF patients were enrolled and implanted with the Delphi system (Table). The primary safety and efficacy endpoint of procedure success was achieved in all 10 patients. The primary efficacy endpoint of shunt adjustment at index and 90 days was achieved in all patients attempted (9/9). Pressure data were successfully transmitted from both bi-atrial sensors, and shunt patency was achieved in all patients at 90 days (10/10). There were no HF events, strokes, or deaths through 6 months. At six-months there was a 40% improvement in NYHA class (4 patients changed from class III □ II), a 33 m increase in 6MWT (246 -> 279 m), a 7-point increase in KCCQ (43 -> 50), and a 19% decrease in NT-proBNP (1730 -> 1407 pg/mL).
Conclusions
ATHENS-HF is the first investigation of an adjustable interatrial shunt with bi-atrial pressure-sensing capability, allowing physicians to respond to changes over time to optimize shunt flow and hemodynamics. The 6-month results demonstrate strong safety and initial efficacy with the potential to provide a tailored, individualized approach to HF treatment.Baseline clinical and echo dataFor image description, please refer to the figure legend and surrounding text.