Lindenfeld J, Zile MR, Desai AS, et al. - In the overall study analysis, hemodynamic-guided heart failure management did not result in a lower composite endpoint rate of mortality and total heart failure events compared with the control group. A pre-COVID-19 impact analysis, on the other hand, suggested a possible benefit of hemodynamic-guided management on the primary outcome in the pre-COVID-19 period, owing to a lower heart failure hospitalization rate compared with the control group.

• Between March 15, 2018, and December 20, 2019, 1,022 patients were recruited, with 1,000 patients implanted successfully, and follow-up was completed on January 8, 2021.

• There were 253 primary endpoint events (0·563 per patient-year) in 497 patients in the hemodynamic-guided management group (treatment group) and 289 (0·640 per patient-year) in 503 individuals in the control group.

• A pre-specified COVID-19 sensitivity analysis comparing events before COVID-19 and during the pandemic using a time-dependent variable revealed a treatment interaction due to a change in the primary endpoint event rate during the pandemic phase of the trial, necessitating a pre-COVID-19 impact analysis.

• There were 177 primary events (0·553 per patient-year) in the intervention group and 224 events (0·682 per patient-year) in the control group in the pre-COVID-19 impact analysis.

• During COVID-19, the difference in primary events nearly vanished, with a 21% decrease in the control group (0·536 per patient-year) compared with pre-COVID-19, virtually no change in the treatment group (0·597 per patient-year), and no difference between groups.

• In the overall research analysis, hemodynamic-guided management did not reduce the cumulative incidence of heart failure events, but it did in the pre-COVID-19 impact analysis.

• There were no device or system-related complications in 1,014 (99%) of 1,022 patients.