SEISMIC-HF I - Exploring non-invasive methods for monitoring intracardiac filling pressures
Reported from AHA 2024
Luis Ortega provides his take on the SEISMIC-HF I study presented by Liviu Klein at AHA 2024, in Chicago.
Study rationale and objective
The SEISMIC-HF I study aimed to evaluate a novel approach for estimating pulmonary capillary wedge pressure (PCWP) using a wearable sensor (CardioTag) integrated with a machine learning algorithm.
This study addresses the limitations of implanted artery pressure (PAP) sensors, such as cost and procedural risks.
SEISMIC-HF I aimed to assess the accuracy and practicality of this non-invasive technology in patients with heart failure (HF).
Methodology
This multicenter observational study included 310 participants with a diagnosis of heart failure who were scheduled for right heart catheterization (RHC). The wearable CardioTag sensor data were paired with PCWP measurements obtained during RHC to develop and train the algorithm. The study included participants with reduced ejection fraction (HFrEF). Eligible participants were adults aged ≥ 21, free from mechanical circulatory or ventilatory support.
Exclusion criteria included conditions such as chest wall wounds or hemodynamic instability. In particular, the algorithm performance was compared against RHC, the standard for intracardiac pressure measurement.
Key findings
The algorithm displayed high accuracy, with an average error of 1.04 ± 5.57 mmHg compared to RHC-derived PCWP measurements. The limits of agreement ranged from -9.9 to 11.9 mmHg, comparable to the accuracy of FDA-approved implantable monitors. These results suggest that the CardioTag device could be reliable and non-invasive for estimating PCWP in HFrEF patients.
Relevance to clinical practice
The SEISMIC-HF I approach offers a safer and more economical alternative for hemodynamic monitoring by replacing invasive procedures with wearable technology. Of note was that the participant cohort was diverse, increasing the external validity of the results.
However, the readers must consider some limitations. The study focused only on PCWP without considering other hemodynamic parameters like PAP, which were unexplored.
Additionally, the algorithm was trained exclusively on patients with reduced ejection fraction, making further development necessary for those with preserved ejection fraction (HFpEF).
Future research perspective
The algorithm can be improved by expanding the scope of the model to include other hemodynamic parameters and HFpEF participants.
Furthermore, comparative studies analyzing this technology against other non-invasive tools are necessary to prove its added value in clinical practice. Moreover, whether this technology will be useful in guiding and preventing adverse cardiovascular events is still unknown.
References
- Abraham WT, Stevenson LW, Bourge RC, et al. Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomised trial. Lancet. 2016;387(10017):453-461.
- Lindenfeld J, Zile MR, Desai AS, et al. Haemodynamic-guided management of heart failure (GUIDE-HF): a randomised controlled trial. Lancet. 2021;398(10304):991-1001.
- Schmier JK, Ong KL, Fonarow GC. Cost-Effectiveness of Remote Cardiac Monitoring With the CardioMEMS Heart Failure System. Clin Cardiol. 2017;40(7):430-436.
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