PMID- 11568068
OWN - NLM
STAT- MEDLINE
DCOM- 20011004
LR  - 20190623
IS  - 1524-4539 (Electronic)
IS  - 0009-7322 (Linking)
VI  - 104
IP  - 12 Suppl 1
DP  - 2001 Sep 18
TI  - Passive containment and reverse remodeling by a novel textile cardiac support 
      device.
PG  - I270-5
AB  - BACKGROUND: Progressive remodeling and dilation of cardiac chambers is 
      responsible in part for myocardial dysfunction in chronic heart failure. 
      Preclinical studies with suitable animal models indicate that a passive cardiac 
      constraint device can promote reverse remodeling, with improvement in cardiac 
      function. We hypothesize that such a device could provide benefit for stable 
      heart failure patients in New York Heart Association (NYHA) class II and III. 
      METHODS AND RESULTS: From April 1999 to March 2000, 27 patients received Acorn's 
      Cardiac Support Device (CSD) during an initial safety/feasibility study. In 11 
      patients, the only surgical measure was CSD placement. Most patients suffered 
      from idiopathic cardiomyopathy; 4 were in NYHA class II, one was in class II/III, 
      and 6 were in class III. All were stable on intensive medical treatment. The CSD, 
      a textile polyester device, was fitted snugly around the heart during surgery. 
      All patients survived surgery and recovered smoothly. Three months after surgery, 
      56% of patients were in NYHA class I, 33% were in class II, and 11% were in class 
      II/III. Echocardiography showed an improvement in left ventricular ejection 
      fraction from an average of 22% to 28% and 33% at 3 and 6 months, respectively. 
      Simultaneously, the left ventricular end-diastolic dimension decreased from 74 mm 
      to 68 mm and 65 mm, respectively. Mitral valve regurgitation (on a scale of 0 to 
      4+) decreased from 1.3 to 0.7 by 3 months. Quality-of-life indices correlated 
      with the apparent reversal of ventricular remodeling. Preoperative cardiac 
      medications remained virtually unchanged after implant. CONCLUSIONS: In the 
      short- and intermediate-term, CSD implantation seems to ameliorate symptoms and 
      improve cardiac and functional performance in heart failure patients. Worldwide 
      randomized trials are currently underway.
FAU - Konertz, W F
AU  - Konertz WF
AD  - Department of Cardiovascular Surgery, Charite, Berlin, Germany. 
      wolfgang.konertz@charite.de
FAU - Shapland, J E
AU  - Shapland JE
FAU - Hotz, H
AU  - Hotz H
FAU - Dushe, S
AU  - Dushe S
FAU - Braun, J P
AU  - Braun JP
FAU - Stantke, K
AU  - Stantke K
FAU - Kleber, F X
AU  - Kleber FX
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Circulation
JT  - Circulation
JID - 0147763
SB  - IM
MH  - Adult
MH  - Aged
MH  - Cardiac Surgical Procedures/*instrumentation/methods
MH  - Cardiomyopathies/complications/diagnostic imaging/*surgery
MH  - Chronic Disease
MH  - Equipment Safety
MH  - Exercise Test
MH  - Feasibility Studies
MH  - Female
MH  - Follow-Up Studies
MH  - *Heart-Assist Devices/adverse effects
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Mitral Valve Insufficiency/complications/diagnostic imaging
MH  - Quality of Life
MH  - Remission Induction
MH  - Severity of Illness Index
MH  - Stroke Volume
MH  - *Surgical Mesh
MH  - Survival Rate
MH  - Treatment Outcome
MH  - Ultrasonography
MH  - *Ventricular Remodeling
EDAT- 2001/09/25 10:00
MHDA- 2001/10/05 10:01
CRDT- 2001/09/25 10:00
PHST- 2001/09/25 10:00 [pubmed]
PHST- 2001/10/05 10:01 [medline]
PHST- 2001/09/25 10:00 [entrez]
AID - 10.1161/hc37t1.094525 [doi]
PST - ppublish
SO  - Circulation. 2001 Sep 18;104(12 Suppl 1):I270-5. doi: 10.1161/hc37t1.094525.