PMID- 35598154
OWN - NLM
STAT- MEDLINE
DCOM- 20220817
LR  - 20221016
IS  - 1879-0844 (Electronic)
IS  - 1388-9842 (Print)
IS  - 1388-9842 (Linking)
VI  - 24
IP  - 8
DP  - 2022 Aug
TI  - Endovascular ablation of the right greater splanchnic nerve in heart failure with 
      preserved ejection fraction: early results of the REBALANCE-HF trial roll-in 
      cohort.
PG  - 1410-1414
LID - 10.1002/ejhf.2559 [doi]
AB  - AIMS: In heart failure (HF) with preserved ejection fraction (HFpEF), excessive 
      redistribution of blood volume into the central circulation leads to elevations 
      of intracardiac pressures with exercise limitations. Splanchnic ablation for 
      volume management (SAVM) has been proposed as a therapeutic intervention. Here we 
      present preliminary safety and efficacy data from the initial roll-in cohort of 
      the REBALANCE-HF trial. METHODS AND RESULTS: The open-label (roll-in) arm of 
      REBALANCE-HF will enrol up to 30 patients, followed by the randomized, 
      sham-controlled portion of the trial (up to 80 additional patients). Patients 
      with HF, left ventricular ejection fraction (LVEF) >/=50%, and invasive peak 
      exercise pulmonary capillary wedge pressure (PCWP) >/=25 mmHg underwent SAVM. 
      Baseline and follow-up assessments included resting and exercise PCWP, New York 
      Heart Association (NYHA) class, Kansas City Cardiomyopathy Questionnaire (KCCQ), 
      6-min walk test, and N-terminal pro-B-type natriuretic peptide (NT-proBNP). 
      Efficacy and safety were assessed at 1 and 3 months. Here we report on the first 
      18 patients with HFpEF that have been enrolled into the roll-in, open-label arm 
      of the study across nine centres; 14 (78%) female; 16 (89%) in NYHA class III; 
      and median (interquartile range) age 75.2 (68.4-81) years, LVEF 61.0 
      (56.0-63.2)%, and average (standard deviation) 20 W exercise PCWP 36.4 (+/-8.6) 
      mmHg. All 18 patients were successfully treated. Three non-serious moderate 
      device/procedure-related adverse events were reported. At 1-month, the mean PCWP 
      at 20 W exercise decreased from 36.4 (+/-8.6) to 28.9 (+/-7.8) mmHg (p < 0.01), NYHA 
      class improved by at least one class in 33% of patients (p = 0.02) and KCCQ score 
      improved by 22.1 points (95% confidence interval 9.4-34.2) (p < 0.01). 
      CONCLUSION: The preliminary open-label results from the multicentre REBALANCE-HF 
      roll-in cohort support the safety and efficacy of SAVM in HFpEF. The findings 
      require confirmation in the ongoing randomized, sham-controlled portion of the 
      trial.
CI  - (c) 2022 The Authors. European Journal of Heart Failure published by John Wiley & 
      Sons Ltd on behalf of European Society of Cardiology.
FAU - Fudim, Marat
AU  - Fudim M
AD  - Duke University Medical Center, Durham, NC, USA.
FAU - Fail, Peter S
AU  - Fail PS
AD  - Cardiovascular Institute of the South, Houma, LA, USA.
FAU - Litwin, Sheldon E
AU  - Litwin SE
AD  - Medical University of South Carolina and Ralph H. Johnson, Veterans Affairs 
      Medical Center, Charleston, SC, USA.
FAU - Shaburishvili, Tamaz
AU  - Shaburishvili T
AD  - Tbilisi Heart and Vascular Clinic, Tbilisi, Georgia.
FAU - Goyal, Parag
AU  - Goyal P
AD  - Weill Cornell Medicine, New Yok, NY, USA.
FAU - Hummel, Scott L
AU  - Hummel SL
AD  - Michigan School of Medicine, University of Michigan, Ann Arbor, MI, USA.
FAU - Borlaug, Barry A
AU  - Borlaug BA
AD  - Mayo Clinic, College of Medicine, Rochester, MN, USA.
FAU - Mohan, Rajeev C
AU  - Mohan RC
AD  - Scripps Clinic, La Jolla, CA, USA.
FAU - Patel, Ravi B
AU  - Patel RB
AD  - Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
FAU - Mitter, Sumeet S
AU  - Mitter SS
AD  - Mount Sinai Hospital - Icahn School of Medicine at Mount Sinai, New York, NY, 
      USA.
FAU - Klein, Liviu
AU  - Klein L
AD  - University of California San Francisco, San Francisco, CA, USA.
FAU - Rocha-Singh, Krishna
AU  - Rocha-Singh K
AD  - Prairie Heart Institute at St. John's Hospital, Springfield, IL, USA.
FAU - Patel, Manesh R
AU  - Patel MR
AD  - Duke University Medical Center, Durham, NC, USA.
FAU - Reddy, Vivek Y
AU  - Reddy VY
AD  - Mount Sinai Hospital - Icahn School of Medicine at Mount Sinai, New York, NY, 
      USA.
FAU - Burkhoff, Daniel
AU  - Burkhoff D
AD  - Cardiovascular Research Foundation, New York, NY, USA.
FAU - Shah, Sanjiv J
AU  - Shah SJ
AD  - Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
LA  - eng
GR  - R01 HL107577/HL/NHLBI NIH HHS/United States
GR  - R01 HL127028/HL/NHLBI NIH HHS/United States
GR  - R01 HL140731/HL/NHLBI NIH HHS/United States
GR  - U54 HL160273/HL/NHLBI NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, Non-P.H.S.
DEP - 20220529
PL  - England
TA  - Eur J Heart Fail
JT  - European journal of heart failure
JID - 100887595
SB  - IM
MH  - Aged
MH  - Female
MH  - *Heart Failure/surgery
MH  - Humans
MH  - Male
MH  - Pulmonary Wedge Pressure
MH  - Splanchnic Nerves
MH  - Stroke Volume
MH  - Ventricular Function, Left
PMC - PMC9388552
MID - NIHMS1808587
OTO - NOTNLM
OT  - Clinical trial
OT  - Heart failure with preserved ejection fraction
OT  - Splanchnic nerve ablation
OT  - Therapeutics
EDAT- 2022/05/23 06:00
MHDA- 2022/08/18 06:00
PMCR- 2022/10/07
CRDT- 2022/05/22 06:02
PHST- 2022/05/12 00:00 [revised]
PHST- 2022/05/03 00:00 [received]
PHST- 2022/05/15 00:00 [accepted]
PHST- 2022/05/23 06:00 [pubmed]
PHST- 2022/08/18 06:00 [medline]
PHST- 2022/05/22 06:02 [entrez]
PHST- 2022/10/07 00:00 [pmc-release]
AID - EJHF2559 [pii]
AID - 10.1002/ejhf.2559 [doi]
PST - ppublish
SO  - Eur J Heart Fail. 2022 Aug;24(8):1410-1414. doi: 10.1002/ejhf.2559. Epub 2022 May 
      29.