One-year clinical experience with the Acorn CorCap cardiac support device: results of a limited market release safety study in Italy and Sweden.
BACKGROUND
The Acorn CorCap cardiac support device (CSD) is a mesh-like device intended to provide end-diastolic support and reduce ventricular wall stress. Animal studies with the CorCap CSD have demonstrated beneficial reverse remodeling, and preliminary safety studies in patients with heart failure have shown that the device is safe and associated with improved left ventricular (LV) structure and function. The objective of the current study was to further evaluate the safety and efficacy of the CorCap CSD in patients with advanced heart failure.


METHODS
Twenty-four patients with dilated cardiomyopathy, severe LV dysfunction, and advanced heart failure (NYHA class II-IV) were enrolled at four centers in Italy and Sweden. All patients underwent CorCap CSD implantation either alone (n = 3) or in combination with mitral valve repair/replacement (n = 13), coronary artery bypass surgery (n = 6), combined mitral valve repair/coronary artery bypass surgery (n = 1) or aneurysmectomy (n = 1).


RESULTS
The LV end-diastolic diameter decreased from 69.3 +/- 7.2 to 60.1 +/- 9.0 mm at 3 months, 60.9 +/- 9.6 mm at 6 months, and 58.9 +/- 8.0 mm at 12 months (all p < 0.05). A trend toward an improved LV ejection fraction (28.8 +/- 10.5% at baseline and 32.4 +/- 12.7, 33.1 +/- 10.8, and 33.8 +/- 13.9% at 3, 6 and 12 months respectively) was also noted. The NYHA functional class, 6-min walking distance, and quality of life as measured using Uniscale were all improved. There were no differences in response among the patients submitted to the different types of concomitant surgery.


CONCLUSIONS
In agreement with earlier safety studies, even the present investigation demonstrated improvements in cardiac structure and function as well as in patient functional status after Cor Cap CSD implantation. Randomized controlled trials are in progress.
Livi
Ugolino
U
Department of Cardiovascular Sciences, S. Maria della Misericordia Hospital, Udine. chircardio@aoud.sanita.fvg.it
Alfieri
Ottavio
O
Vitali
Ettore
E
Russo
Claudio
C
Frigerio
Maria
M
Tursi
Vincenzo
V
Albanese
Maria Cecilia
MC
De Bonis
Michele
M
Fragasso
Gabriele
G
Franco-Cereceda
Anders
A
Forssell
Gunilla
G
Rorke
Rebecca
R
Kubo
Spencer H
SH
D000328:Adult; D000368:Aged; D006348:Cardiac Surgical Procedures / Q000379:methods* / Q000401:mortality; D002311:Cardiomyopathy, Dilated / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D018618:Echocardiography, Doppler, Color; D017548:Echocardiography, Transesophageal; D004867:Equipment Design; D004869:Equipment Safety; D005500:Follow-Up Studies; D006333:Heart Failure / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D006352:Heart Ventricles / Q000000981:diagnostic imaging / Q000503:physiopathology; D006353:Heart-Assist Devices / Q000592:standards*; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008875:Middle Aged; D019919:Prosthesis Implantation / Q000295:instrumentation*; D012189:Retrospective Studies; D013318:Stroke Volume / Q000502:physiology; D013526:Surgical Mesh / Q000592:standards; D015996:Survival Rate; D013548:Sweden / Q000453:epidemiology; D016896:Treatment Outcome; D020257:Ventricular Remodeling / Q000502:physiology