Remote LVFP monitoring using the Seerlinq system resulted in a 1.7% rate of HF hospitalization or all-cause mortality at 3 months, significantly lower than the 6.3% performance goal (p=0.012).
Observational (n=176)
Open-label
Yes
Does non-invasive remote LVFP monitoring using the Seerlinq system reduce the composite of heart failure hospitalization or all-cause mortality in heart failure patients?
Non-invasive remote LVFP monitoring using the Seerlinq system was associated with a significantly lower rate of heart failure hospitalization or all-cause mortality compared to a historical performance goal.
Absolute Event Rate: 1.7% vs 6.3%
p-value: p=0.012
Abstract Background Left ventricular filling pressure (LVFP) monitoring has been shown to improve quality of life, survival, and reduce heart failure hospitalization (HFH) rates in randomized trials and meta-analyses. However, the adoption of current devices has been very limited, partly due to their invasive nature and associated high costs. Seerlinq is a novel, CE-certified, non-invasive system for remote LVFP monitoring that leverages photoplethysmography (PPG) and advanced signal analysis. Purpose To evaluate the effectiveness of the Seerlinq system in a real-world HF patient population. Methods These are preliminary results from a multi-center, prospective, single-arm, open-label trial with a prespecified effectiveness endpoint, conducted at 3 sites in Slovakia. Consecutive HF patients, diagnosed according to the latest ESC guidelines, were included regardless of ejection fraction (EF). Patients were instructed to record a PPG signal using a standard pulse oximeter connected to a smartphone every other day. Data were uploaded remotely and analyzed using the Seerlinq system. The primary effectiveness endpoint at 3 months was the composite rate of HFH or all-cause mortality, with a predefined performance goal of 6.3 events per 100 patients, based on Slovak epidemiological data. Results Between November 2023 and February 2025, 176 patients were enrolled (35% female; mean age 69 ± 12 years; HF phenotypes: 52% HFpEF, 13% HFmrEF, 35% HFrEF; NYHA I: 20%, II: 54%, III: 24%, IV: 2%; 26% with prior HFH). During a mean follow-up of 3 months, 3 patients died from non-cardiac causes (oncological disease progression), while no cardiac deaths or HFH occurred. The event rate was 1.7% (95% CI: 0.58–4.89%), significantly lower than the predefined performance goal (1.7% vs. 6.3%, p = 0.012). No adverse events were reported. On average, 9.6 telemedical interventions and 0.8 in-person check-ups per 100 patients per month were performed. Similar outcomes were observed in the NYHA III+IV subgroup (n=44): 0 HFH, 2 non-cardiac deaths. Conclusion(s) Remote, non-invasive monitoring of LVFP using the novel Seerlinq system in a real-world HF population is safe, enables preventive therapeutic interventions, and is associated with low HFH and mortality rates. Further studies are warranted to determine whether the Seerlinq system could serve as a non-invasive, cost-effective alternative to implantable monitors.
Bohm et al. (Sat,) conducted a observational in Heart failure (n=176). Seerlinq system (non-invasive remote LVFP monitoring) vs. Predefined performance goal was evaluated on Composite rate of heart failure hospitalization or all-cause mortality at 3 months (95% CI 0.58-4.89, p=0.012). Remote LVFP monitoring using the Seerlinq system resulted in a 1.7% rate of HF hospitalization or all-cause mortality at 3 months, significantly lower than the 6.3% performance goal (p=0.012).