PMID- 35855646
OWN - NLM
STAT- MEDLINE
DCOM- 20221229
LR  - 20230413
IS  - 1879-0844 (Electronic)
IS  - 1388-9842 (Print)
IS  - 1388-9842 (Linking)
VI  - 24
IP  - 12
DP  - 2022 Dec
TI  - Cardiac contractility modulation therapy improves health status in patients with 
      heart failure with preserved ejection fraction: a pilot study (CCM-HFpEF).
PG  - 2275-2284
LID - 10.1002/ejhf.2619 [doi]
AB  - AIMS: This pilot study aimed to assess the potential benefits of cardiac 
      contractility modulation (CCM) in patients with heart failure with preserved 
      ejection fraction (HFpEF). METHODS AND RESULTS: This was a prospective, 
      multicentre, single-arm, pilot study of CCM therapy in patients with HFpEF and 
      New York Heart Association (NYHA) class II or III. Echocardiographic parameters 
      were measured by an echo core laboratory to determine study eligibility. After 
      CCM device implantation, patients were followed for 24 weeks. Overall, 47 
      patients (mean age 74.3 +/- 4.4 years, 70.2% female) were enrolled, with left 
      ventricular ejection fraction of 59 +/- 4.4%, 63.8% with hypertension, 46.8% with 
      atrial fibrillation, 40.4% with diabetes, 31.9% with at least one heart failure 
      hospitalization in the prior year, 61.7% in NYHA class III, and Kansas City 
      Cardiomyopathy Questionnaire (KCCQ) overall summary score of 48.9 +/- 21.7. The 
      primary efficacy endpoint (mean change in the KCCQ overall summary score) 
      improved by 18.0 +/- 16.6 points (p < 0.001) and there was an event-free rate of 
      93.6% for the primary safety endpoint (device- and procedure-related 
      complications), as adjudicated by an independent physician committee. CONCLUSION: 
      This pilot study demonstrates that the benefits of CCM may extend to the HFpEF 
      patient population. The significant improvement in health status observed, with 
      no obvious impact on safety, suggests that utilization of CCM for patients with 
      HFpEF could prove to be promising.
CI  - (c) 2022 The Authors. European Journal of Heart Failure published by John Wiley & 
      Sons Ltd on behalf of European Society of Cardiology.
FAU - Linde, Cecilia
AU  - Linde C
AD  - Heart, Vascular and Neurology Theme, Karolinska University Hospital and the 
      Karolinska Institutet, Stockholm, Sweden.
FAU - Grabowski, Marcin
AU  - Grabowski M
AD  - Department of Cardiology, Medical University of Warsaw, Department of Cardiology, 
      Warsaw, Poland.
FAU - Ponikowski, Piotr
AU  - Ponikowski P
AD  - Impulse Dynamics (USA), Inc, Marlton, NJ, USA.
FAU - Rao, Ishu
AU  - Rao I
AD  - Department of Heart Diseases, Medical University, Wroclaw University Centre for 
      Heart Diseases, University Hospital, Wroclaw, Poland.
FAU - Stagg, Angela
AU  - Stagg A
AD  - Clinical and Data Operations, Impulse Dynamics (USA), Inc, Marlton, NJ, USA.
FAU - Tschope, Carsten
AU  - Tschope C
AD  - Berlin Institute of Health Center for Regenerative Therapies, and Department of 
      Cardiology, Charite University Medicine Berlin, Campus Virchow Klinikum, Berlin, 
      Germany.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220811
PL  - England
TA  - Eur J Heart Fail
JT  - European journal of heart failure
JID - 100887595
SB  - IM
CIN - Eur J Heart Fail. 2022 Dec;24(12):2285-2286. PMID: 36036708
MH  - Humans
MH  - Female
MH  - Aged
MH  - Male
MH  - *Heart Failure/therapy
MH  - Stroke Volume
MH  - Pilot Projects
MH  - Prospective Studies
MH  - Ventricular Function, Left
MH  - Health Status
PMC - PMC10087783
OTO - NOTNLM
OT  - Cardiac contractility modulation
OT  - Device therapy
OT  - Health status
OT  - Heart failure
OT  - Heart failure with preserved ejection fraction
OT  - Kansas City Cardiomyopathy Questionnaire
EDAT- 2022/07/21 06:00
MHDA- 2022/12/30 06:00
PMCR- 2023/04/11
CRDT- 2022/07/20 03:33
PHST- 2022/07/06 00:00 [revised]
PHST- 2022/04/26 00:00 [received]
PHST- 2022/07/08 00:00 [accepted]
PHST- 2022/07/21 06:00 [pubmed]
PHST- 2022/12/30 06:00 [medline]
PHST- 2022/07/20 03:33 [entrez]
PHST- 2023/04/11 00:00 [pmc-release]
AID - EJHF2619 [pii]
AID - 10.1002/ejhf.2619 [doi]
PST - ppublish
SO  - Eur J Heart Fail. 2022 Dec;24(12):2275-2284. doi: 10.1002/ejhf.2619. Epub 2022 
      Aug 11.