TY - JOUR
T1 - Multiparameter diagnostic sensor measurements during clinically stable periods and worsening heart failure in ambulatory patients
AU - Gardner, Roy S.
AU - Thakur, Pramodsingh
AU - Hammill, Eric F.
AU - Nair, Devi G.
AU - Eldadah, Zayd
AU - Stančák, Branislav
AU - Ferrick, Kevin
AU - Sriratanasathavorn, Charn
AU - Duray, Gábor Zoltán
AU - Wariar, Ramesh
AU - Zhang, Yi
AU - An, Qi
AU - Averina, Viktoria
AU - Boehmer, John P.
N1 - Funding Information:
R. S. G. is a consultant for Abbott, Boston Scientific, Novartis, and Vifor. D. G. N. reports research grants and consulting fees from Medtronic Inc, Boston Scientific Corporation, Abbott, Biosense Webster, Jansen and Jansen. G. Z. D. received lecture fees and consultant honoraria from Boston Scientific, Biotronik, Biosense Webster, Medtronic, and ReplantMed, and has served on advisory boards for Biotronik and Medtronic. J. P. B. is a consultant for Abbott, Boston Scientific, and Medtronic. P. T., E. F. H., R. W., Y. Z., Q. A., and V. A. are employees of Boston Scientific. The remaining authors report nothing to disclose.
Funding Information:
The MultiSENSE clinical study was funded by Boston Scientific (Marlborough, MA).
Publisher Copyright:
© 2021 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.
PY - 2021/4
Y1 - 2021/4
N2 - Aims: This study aims to characterize the range of implantable device-based sensor values including heart sounds, markers of ventilation, thoracic impedance, activity, and heart rate for patients with heart failure (HF) when patients were deemed to be in clinically stable periods against the time course of acute decompensation and recovery from HF events. Methods and results: The MultiSENSE trial followed 900 patients implanted with a COGNIS CRT-D for up to 1 year. Chronic, ambulatory diagnostic sensor data were collected and evaluated during clinically stable periods (CSP: unchanged NYHA classification, no adverse events, and weight change ≤2.27 kg), and in the timeframe leading up to and following HF events (HF admissions or unscheduled visits with intravenous HF treatment). Physiologic sensor data from 1667 CSPs occurring in 676 patients were compared with those data leading up to and following 192 HF events in 106 patients. Overall, the mean age was 66.6 years, and the population were predominantly male (73%). Patients were primarily in NYHA II (67%), with a mean LVEF of 29.6% and median NT-proBNP of 754.5 pg/mL. Sensor values during CSP were poorer in patients who had HF events during the study period than those without HF events, including first heart sound (S1: 2.18 ± 0.84 mG vs. 2.62 ± 0.95 mG, P = 0.002), third heart sound (S3: 1.13 ± 0.36 mG vs. 0.91 ± 0.30 mG, P < 0.001), thoracic impedance (45.66 ± 8.78 Ohm vs. 50.33 ± 8.43 Ohm, P < 0.001), respiratory rate (19.09 ± 3.10 br/min vs. 17.66 ± 2.39 br/min, P = 0.002), night time heart rate (73.39 ± 8.36 b.p.m. vs. 69.56 ± 8.09 b.p.m., P = 0.001), patient activity (1.69 ± 1.84 h vs. 2.56 ± 2.20 h, P = 0.006), and HeartLogic index (11.07 ± 12.14 vs. 5.31 ± 5.13, P = 0.001). Sensor parameters measured worsening status leading up to HF events with recovery of values following treatment. Conclusions: Device-based physiologic sensors not only revealed progressive worsening leading up to HF events but also differentiated patients at increased risk of HF events when presumed to be clinically stable.
AB - Aims: This study aims to characterize the range of implantable device-based sensor values including heart sounds, markers of ventilation, thoracic impedance, activity, and heart rate for patients with heart failure (HF) when patients were deemed to be in clinically stable periods against the time course of acute decompensation and recovery from HF events. Methods and results: The MultiSENSE trial followed 900 patients implanted with a COGNIS CRT-D for up to 1 year. Chronic, ambulatory diagnostic sensor data were collected and evaluated during clinically stable periods (CSP: unchanged NYHA classification, no adverse events, and weight change ≤2.27 kg), and in the timeframe leading up to and following HF events (HF admissions or unscheduled visits with intravenous HF treatment). Physiologic sensor data from 1667 CSPs occurring in 676 patients were compared with those data leading up to and following 192 HF events in 106 patients. Overall, the mean age was 66.6 years, and the population were predominantly male (73%). Patients were primarily in NYHA II (67%), with a mean LVEF of 29.6% and median NT-proBNP of 754.5 pg/mL. Sensor values during CSP were poorer in patients who had HF events during the study period than those without HF events, including first heart sound (S1: 2.18 ± 0.84 mG vs. 2.62 ± 0.95 mG, P = 0.002), third heart sound (S3: 1.13 ± 0.36 mG vs. 0.91 ± 0.30 mG, P < 0.001), thoracic impedance (45.66 ± 8.78 Ohm vs. 50.33 ± 8.43 Ohm, P < 0.001), respiratory rate (19.09 ± 3.10 br/min vs. 17.66 ± 2.39 br/min, P = 0.002), night time heart rate (73.39 ± 8.36 b.p.m. vs. 69.56 ± 8.09 b.p.m., P = 0.001), patient activity (1.69 ± 1.84 h vs. 2.56 ± 2.20 h, P = 0.006), and HeartLogic index (11.07 ± 12.14 vs. 5.31 ± 5.13, P = 0.001). Sensor parameters measured worsening status leading up to HF events with recovery of values following treatment. Conclusions: Device-based physiologic sensors not only revealed progressive worsening leading up to HF events but also differentiated patients at increased risk of HF events when presumed to be clinically stable.
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U2 - 10.1002/ehf2.13261
DO - 10.1002/ehf2.13261
M3 - Article
C2 - 33619893
AN - SCOPUS:85101259603
SN - 2055-5822
VL - 8
SP - 1571
EP - 1581
JO - ESC heart failure
JF - ESC heart failure
IS - 2
ER -