PMID- 21762937
OWN - NLM
STAT- MEDLINE
DCOM- 20120604
LR  - 20240323
IS  - 1097-685X (Electronic)
IS  - 0022-5223 (Print)
IS  - 0022-5223 (Linking)
VI  - 143
IP  - 5
DP  - 2012 May
TI  - Beneficial effects of the CorCap cardiac support device: five-year results from 
      the Acorn Trial.
PG  - 1036-42
LID - 10.1016/j.jtcvs.2011.06.014 [doi]
AB  - BACKGROUND: The CorCap cardiac support device (Acorn Cardiovascular, Inc, St 
      Paul, Minn) is the first device that specifically addresses ventricular 
      remodeling in heart failure by reducing wall stress. We previously reported 
      outcomes from the Acorn randomized trial to a common closing date (22.9 months of 
      follow-up). This report summarizes results of extended followup to 5 years. 
      METHODS: A total of 107 patients were enrolled in the no-mitral valve 
      repair/replacement stratum including 57 in the CorCap treatment group and 50 in 
      the control (optimal medical therapy alone) group. Patients were assessed every 
      year, until completing 5 years of follow-up, for survival, adverse events, major 
      cardiac procedures, New York Heart Association (NYHA) functional status, and 
      echocardiograms, which were read at a core laboratory. RESULTS: Overall survivals 
      were similar between the treatment and control groups, demonstrating no late 
      adverse effect on mortality. The treatment group had significant reductions in 
      left ventricular end-diastolic volume (P = .029) as well as a small increase in 
      sphericity index. More patients in the treatment group improved by at least 1 
      NYHA functional class (P = .0005). There was no difference in rates of adverse 
      events. In a subgroup of patients with an intermediate left ventricular 
      end-diastolic dimension, there was a significant reduction in the Kaplan-Meier 
      estimate of the freedom from the composite end point of death and major cardiac 
      procedures (P = .04). CONCLUSIONS: These cumulative data demonstrate the 
      sustained reverse remodeling of the left ventricle and the long-term safety and 
      efficacy of the CorCap cardiac support device as an adjunctive therapy for 
      patients with heart failure who remain symptomatic despite optimal medical 
      therapy.
CI  - Copyright (c) 2012. Published by Mosby, Inc.
FAU - Mann, Douglas L
AU  - Mann DL
AD  - Division of Cardiology, Washington University School of Medicine, 660 S. Euclid 
      Ave, Campus PO Box 8086, St Louis, MO 63110-1093, USA. dmann@dom.wustl.edu
FAU - Kubo, Spencer H
AU  - Kubo SH
FAU - Sabbah, Hani N
AU  - Sabbah HN
FAU - Starling, Randall C
AU  - Starling RC
FAU - Jessup, Mariell
AU  - Jessup M
FAU - Oh, Jae K
AU  - Oh JK
FAU - Acker, Michael A
AU  - Acker MA
LA  - eng
GR  - P01 HL074237/HL/NHLBI NIH HHS/United States
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20110716
PL  - United States
TA  - J Thorac Cardiovasc Surg
JT  - The Journal of thoracic and cardiovascular surgery
JID - 0376343
SB  - IM
MH  - Biomechanical Phenomena
MH  - Female
MH  - Heart Failure/mortality/pathology/physiopathology/*therapy
MH  - *Heart-Assist Devices
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Prosthesis Design
MH  - Recovery of Function
MH  - Risk Assessment
MH  - Risk Factors
MH  - Stress, Mechanical
MH  - Time Factors
MH  - Treatment Outcome
MH  - United States
MH  - *Ventricular Function, Left
MH  - *Ventricular Remodeling
PMC - PMC3790142
MID - NIHMS515870
EDAT- 2011/07/19 06:00
MHDA- 2012/06/05 06:00
PMCR- 2013/10/04
CRDT- 2011/07/19 06:00
PHST- 2010/11/20 00:00 [received]
PHST- 2011/05/06 00:00 [revised]
PHST- 2011/06/07 00:00 [accepted]
PHST- 2011/07/19 06:00 [entrez]
PHST- 2011/07/19 06:00 [pubmed]
PHST- 2012/06/05 06:00 [medline]
PHST- 2013/10/04 00:00 [pmc-release]
AID - S0022-5223(11)00633-7 [pii]
AID - 10.1016/j.jtcvs.2011.06.014 [doi]
PST - ppublish
SO  - J Thorac Cardiovasc Surg. 2012 May;143(5):1036-42. doi: 
      10.1016/j.jtcvs.2011.06.014. Epub 2011 Jul 16.