Abstract: TH-PO250
Legacy Effect of a Lung-Ultrasound Intervention on the Risk for Death and Cardiovascular Events in Dialysis Patients
Session Information
- Hemodialysis: Volume, Metabolic Complications, Clinical Outcomes
November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 801 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- Zoccali, Carmine, Renal Research Institute, New York, New York, United States
- Torino, Claudia, Istituto di Fisiologia Clinica Consiglio Nazionale delle Ricerche Sezione di Reggio Calabria, Reggio Calabria, Calabria , Italy
- Tripepi, Rocco, Istituto di Fisiologia Clinica Consiglio Nazionale delle Ricerche Sezione di Reggio Calabria, Reggio Calabria, Calabria , Italy
- Tripepi, Giovanni, Istituto di Fisiologia Clinica Consiglio Nazionale delle Ricerche Sezione di Reggio Calabria, Reggio Calabria, Calabria , Italy
- Mallamaci, Francesca, Grande Ospedale Metropolitano (GOM), Reggio Calabria, Calabria , Italy
Group or Team Name
- On Behalf of the LUST Workgroup.
Background
In the “LUng water by Ultra-Sound Guided Treatment (LUST) to Prevent Death and Cardiovascular Complications in High Risk ESRD Patients with Cardiomyopathy” trial (NCT02310061)”, this treatment strategy was not more effective than a usual care strategy in improving the primary end point of the study over two years. Since robust long-term effects of intensive haemodialsyis in the frequent haemodialysis trial, we designed a post-trial, observational analysis extended up to 4.4 years.
Methods
We included in this analysis 315 HD patients. In patients in the active arm of the trial (n=157) ultrafiltration prescription was guided by lung US, while in the control arm (n=158) ultrafiltration was prescribed on the basis of standard clinical criteria. After the trial, patients were followed-up for 2 additional years, but no intervention was applied (observational phase). Since fluid volume is higher in men than in women, by protocol we tested the effect modification of male sex on the response to the lung-US intervention.
Results
Among the 315 HD patients, 223 (71%) were males. During the long-term observation (up to 4.4 years), the combined event occurred in 88 patients (56%) in the active arm and 100 (63%) in the control arm. Like in the LUST trial, the 16% risk reduction registered in the observational extension of the trial failed to achieve significance (HR: 0.84, 95% CI: 0.63-1.12, P=0.23). Sex emerged as a robust modifier [P for effect modification 0.02] of the effect of the lung US intervention on the combined end-point. Indeed, the intervention produced a 35% risk reduction in men [HRmen: 0.65, 95%CI: 0.46-0.93, P=0.02] but not in women [HRwomen: 1.40, 95%CI: 0.84-2.34, P=0.20].
Conclusion
In an observational extension to 4.4 years of the LUST trial, the treatment strategy guided by lung-US was associated with a 35% reduction of the risk of the combined end-point of the trial in men while no such an effect emerged in women. These results are in keeping with biological knowledge indicating that in the hemodialysis population, men have higher fluid volume and cardiovascular risk than women.