PMID- 17888974
OWN - NLM
STAT- MEDLINE
DCOM- 20071221
LR  - 20191210
IS  - 1552-6259 (Electronic)
IS  - 0003-4975 (Linking)
VI  - 84
IP  - 4
DP  - 2007 Oct
TI  - Clinical evaluation of the CorCap Cardiac Support Device in patients with dilated 
      cardiomyopathy.
PG  - 1226-35
AB  - BACKGROUND: Left ventricular (LV) remodeling is related to adverse outcomes in 
      heart failure. The CorCap Cardiac Support Device (CSD; Acorn Cardiovascular, Inc, 
      St. Paul, MN) is an implantable device that attenuates LV remodeling. METHODS: 
      The Acorn trial assessed the safety and efficacy of the CSD in 300 heart failure 
      patients. Patients needing mitral surgery (n = 193) were randomized to mitral 
      surgery alone or mitral surgery plus CSD. Patients who did not need mitral 
      surgery (n = 107) were randomized to medical therapy or medical therapy plus CSD. 
      The primary endpoint was a clinical composite based on changes in patient vital 
      status, the need for major cardiac procedures for worsening heart failure, and a 
      change in New York Heart Association (NYHA) class. RESULTS: The proportional odds 
      ratio for the primary endpoint favored treatment with the CSD (1.73 confidence 
      interval [CI]: 1.07 to 2.79; p = 0.024). The CSD-treated patients received 
      significantly (p = 0.01) fewer cardiac procedures indicative of worsening heart 
      failure and had an improvement in New York Heart Association class (p = 0.049). 
      There was no significant difference in survival between groups (p = 0.85). 
      Treatment with the CSD led to a decrease in LV end-diastolic (p = 0.009) and 
      end-systolic volumes (p = 0.017), an increase in the LV sphericity index (p = 
      0.026), an improvement in the Minnesota Living with Heart Failure score (p = 
      0.04), and the Short Form-36 Questionnaire (p = 0.015). There was no evidence for 
      a significant difference (p = 0.43) in serious adverse events between the 
      treatment and control groups. CONCLUSIONS: The results of the Acorn trial support 
      the hypothesis that preventing LV remodeling with a CSD favorably impacts the 
      untoward natural history of heart failure.
FAU - Mann, Douglas L
AU  - Mann DL
AD  - Baylor College of Medicine, Houston, Texas, USA. dmann@bcm.tmc.edu
FAU - Acker, Michael A
AU  - Acker MA
FAU - Jessup, Mariell
AU  - Jessup M
FAU - Sabbah, Hani N
AU  - Sabbah HN
FAU - Starling, Randall C
AU  - Starling RC
FAU - Kubo, Spencer H
AU  - Kubo SH
CN  - Acorn Trial Principal Investigators and Study Coordinators
LA  - eng
PT  - Evaluation Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Netherlands
TA  - Ann Thorac Surg
JT  - The Annals of thoracic surgery
JID - 15030100R
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Cardiomyopathy, Dilated/diagnosis/*mortality/*surgery
MH  - Confidence Intervals
MH  - Female
MH  - Follow-Up Studies
MH  - Heart Valve Prosthesis Implantation/*methods/mortality
MH  - *Heart-Assist Devices
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Mitral Valve Insufficiency/diagnosis/*surgery
MH  - Odds Ratio
MH  - Postoperative Complications/mortality
MH  - Probability
MH  - Prospective Studies
MH  - Prosthesis Design
MH  - Risk Assessment
MH  - Severity of Illness Index
MH  - Survival Analysis
MH  - Treatment Outcome
MH  - Ventricular Remodeling/physiology
EDAT- 2007/09/25 09:00
MHDA- 2007/12/22 09:00
CRDT- 2007/09/25 09:00
PHST- 2007/01/15 00:00 [received]
PHST- 2007/03/12 00:00 [revised]
PHST- 2007/03/19 00:00 [accepted]
PHST- 2007/09/25 09:00 [pubmed]
PHST- 2007/12/22 09:00 [medline]
PHST- 2007/09/25 09:00 [entrez]
AID - S0003-4975(07)00892-2 [pii]
AID - 10.1016/j.athoracsur.2007.03.095 [doi]
PST - ppublish
SO  - Ann Thorac Surg. 2007 Oct;84(4):1226-35. doi: 10.1016/j.athoracsur.2007.03.095.