Non-invasive Lung IMPEDANCE-Guided Preemptive Treatment in Chronic Heart Failure Patients: a Randomized Controlled Trial (IMPEDANCE-HF trial). - The 63rd Annual Conference of the Israel Heart Society in association with the Israel Society of Cardiothoracic Surgery 12-13 April 2016, David Intercontinental Hotel, Tel-Aviv, Israel

Michael Shochat ^1,2 Avraham Shotan ^1,2 David S Blondheim ^1,2 Mark Kazatsker ^1,2 Iris Dahan ^1,2 Aya Asif ^1,2 Yoseph Rozenman ^1,2,3 Ilia Kleiner ^4,5 Jean Marc Weinstein ⁵ Aaron Frimerman ¹ Lubov Vasilenko ^1,2 Simcha Meisel ^1,2

¹Heart Institute, Hillel Yaffe Medical Center, Hadera
²Rappaport School of Medicine,, Technion, Haifa
³Cardiovascular Institute, Wolfson Medical Center, Holon
⁴Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv
⁵Cardiology Department, Soroka University Medical Center, Beer Sheva

Background Previous investigations have suggested that lung impedance (LI)-guided treatment reduces hospitalizations for acute heart failure (AHF). A single-blind two-center trial was performed to evaluate this hypothesis (ClinicalTrials.gov-NCT01315223).

Methods Study population included 256 patients from 2 medical centers with chronic heart failure (CHF) and left ventricular ejection fraction ≤35% in New York Heart Association class II-IV, who were admitted for AHF within 12 months prior to recruitment. Patients were randomized to a control group treated by clinical assessment and a monitored group whose therapy was also assisted by LI, and followed for at least 12 months. Noninvasive LI measurements were performed with a new high-sensitive device. Patients, blinded to their assignment group, were scheduled for monthly visits in the outpatient-clinics. The primary efficacy endpoint was AHF hospitalizations, while the secondary endpoints were

all-cause hospitalizations and mortality.

Results There were 67 vs. 158 AHF hospitalizations during the first year (p<0.001) and 211 vs. 386 AHF hospitalizations (p<0.001) during the entire follow-up among the monitored patients (48±32 months) and control patients (39±26 months, p=0.01), respectively. During the follow-up there were 42 and 59 deaths (HR=0.52, 95% CI: 0.35-0.78, p=0.002) with 13 and 31 of them due to heart failure (HR=0.30, 95% CI 0.15-0.58 p<0.0001) in the monitored and control groups, respectively. The incidence of non-cardiovascular death was similar.

Conclusion Our results seem to validate the concept that LI-guided preemptive treatment of CHF patients reduces hospitalizations for AHF, as well as the incidence of heart failure, cardiovascular and all-cause mortality.