Monitoring of early hemodynamic changes after transcatheter aortic valve replacement using a wearable, non-invasive device

Julia Hanisch (Düsseldorf)1, O. Maier (Düsseldorf)1, G. Wolff (Düsseldorf)1, R. R. Bruno (Düsseldorf)1, D. Kanschik (Düsseldorf)1, V. Veulemans (Düsseldorf)1, A. Lichtenberg (Düsseldorf)2, M. Scherner (Düsseldorf)2, T. Zeus (Düsseldorf)1, M. Kelm (Düsseldorf)1, C. Jung (Düsseldorf)1

1Universitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie und Angiologie Düsseldorf, Deutschland; 2Universitätsklinikum Düsseldorf Klinik für Herzchirurgie Düsseldorf, Deutschland

 

Background: 
Severe aortic stenosis induces abnormalities in cardiac function, aortic pressure and the systemic circulation. Treatment of artic stenosis by transcatheter aortic valve replacement (TAVR) is associated with improved clinical outcomes, but detailed short-term hemodynamic effects have not been investigated so far. Continuous hemodynamic assessment following TAVR may allow better differentiation of patients according to their hemodynamic responses. This advanced monitoring is usually based on invasive catheters with need for intensive care surveillance and risk for vascular complications.
 
Purpose: 
We investigated short-term hemodynamic changes following TAVR using a wearable, non-invasive chest-patch device for multi-parameter hemodynamic assessment.
 
Methods: 
A total of 100 patients undergoing transfemoral TAVR under local anesthesia were enrolled between April 2023 and September 2023. TAVR was conducted with self-expanding (63%) and balloon-expanding prostheses (27%) by experienced implanters. A wearable, non-invasive, photoplethysmography-based chest-patch sensor (Biobeat Technologies Ltd., Petah Tikva, Israel) was used for continuous monitoring of numerous vital signs including cardiac output (CO), mean arterial pressure (MAP) and systemic vascular resistance (SVR). Hemodynamic parameters were assessed every 15 minutes 24h before and for 48h after TAVR procedure. Data were uploaded via a smartphone-based app to a cloud server, enabling remote patient monitoring and data analysis. Based on the change of cardiac output during the first 24h after TAVR, the cohort was divided into two subgroups with regard to present hemodynamic response (CO increase >6%, n=49) or missing response (CO increase <6%, n=51).
 
Results: 
100 patients completed three days of in-hospital monitoring with wearable chest-patch sensors (100% successful data collection). The mean age was 82.3 ± 6.0 years, 56 patients (56%) were male. In the total cohort, CO increased in the first 24h after TAVR (24h pre-TAVR vs. 24h post-TAVR: 5.51 ± 1.07 L/min vs. 5.81 ± 1.00 L/min; p<0.001) without any further change during the second day after TAVR (24h post-TAVR vs. 48h post-TAVR: 5.81 ± 1.00 L/min vs. 5.69 ± 1.04 L/min; p=0.420). Compared to the baseline measurement, MAP decreased 48h after TAVR (24h pre-TAVR vs. 48h post-TAVR: 92.4 ± 15.2 mmHg vs. 88.2 ± 14.2 mmHg; p=0.024). Likewise, SVR decreased significantly following TAVR (24h pre-TAVR vs. 48h post-TAVR: 1354.2 ± 261.4 dyn*sec*cm-5 vs. 1229.9 ± 229.8 dyn*sec*cm-5; p<0.001). The CO non-responder subgroup (CO increase <6%, n=51) showed higher cardiac risk profile compared to the CO responder subgroup (CO increase >6%, n=49) with higher EuroSCORE II (3.9 ± 3.6% vs. 2.8 ± 1.4%; p=0.048) and lower left ventricular ejection fraction (53.9 ± 11.1% vs. 58.0 ± 9.5%; p=0.046). Furthermore, the CO non-responder subgroup had higher levels of NT-proBNP at hospital admission (4810 ± 7808 pg/mL vs. 2775 ± 5800 pg/mL; p=0.066) and numerically longer total in-hospital stay (8.4 ± 3.2 days vs. 7.4 ± 2.2 days; p=0.068).
 
Conclusion: 
TAVR exerted a measurable hemodynamic effect, with improvement of cardiac output and decrease of systemic vascular resistance. Wearable, non-invasive patch sensors are feasible to discriminate the hemodynamic response of patients after TAVR allowing full mobilization.
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