One-year clinical experience with the Acorn CorCap™ cardiac support device: Results of a limited market release safety study in Italy and Sweden

Ugolino Livi, Ottavio Alfieri, Ettore Vitali, Claudio Russo, Maria Frigerio, Vincenzo Tursi, Maria Cecilia Albanese, Michele De Bonis, Gabriele Fragasso, Anders Franco-Cereceda, Gunilla Forssell, Rebecca Rorke, Spencer H. Kubo

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)59-65
Number of pages7
JournalItalian Heart Journal
Volume6
Issue number1
Publication statusPublished - Jan 2005

Keywords

  • Cardiac support device
  • Coronary artery surgery
  • Heart failure
  • Mitral regurgitation
  • Ventricular remodeling

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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