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

Italian Heart Journal

Volumn 6, Issue 1, 2005, Pages 59-65

  Livi, Ugolino ^a   Alfieri, Ottavio ^b   Vitali, Ettore ^c   Russo, Claudio ^c   Frigerio, Maria ^c   Tursi, Vincenzo ^a   Albanese, Maria Cecilia ^a   De Bonis, Michele ^b   Fragasso, Gabriele ^b   Franco Cereceda, Anders ^d   Forssell, Gunilla ^d   Rorke, Rebecca ^e   Kubo, Spencer H ^e  

^a SANTA MARIA DELLA MISERICORDIA UNIVERSITY HOSPITAL   (Italy)

^b SAN RAFFAELE HOSPITAL   (Italy)

^c OSPEDALE NIGUARDA CA GRANDA   (Italy)

^d KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^e Acorn Cardiovascular Inc   (United States)

Author keywords

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

Indexed keywords

ADULT; AGED; ARTICLE; CLINICAL TRIAL; COMPARATIVE STUDY; CONGESTIVE CARDIOMYOPATHY; CONGESTIVE HEART FAILURE; DOPPLER ECHOCARDIOGRAPHY; ECHOGRAPHY; EQUIPMENT; EQUIPMENT DESIGN; FOLLOW UP; HEART ASSIST DEVICE; HEART STROKE VOLUME; HEART SURGERY; HEART VENTRICLE; HEART VENTRICLE REMODELING; HUMAN; IMPLANTATION; INSTRUMENTATION; ITALY; METHODOLOGY; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; PATHOPHYSIOLOGY; PHYSIOLOGY; RETROSPECTIVE STUDY; STANDARD; SURGICAL EQUIPMENT; SURVIVAL RATE; SWEDEN; TRANSESOPHAGEAL ECHOCARDIOGRAPHY; TREATMENT OUTCOME;

ADULT; AGED; CARDIAC SURGICAL PROCEDURES; CARDIOMYOPATHY, DILATED; ECHOCARDIOGRAPHY, DOPPLER, COLOR; ECHOCARDIOGRAPHY, TRANSESOPHAGEAL; EQUIPMENT DESIGN; EQUIPMENT SAFETY; FOLLOW-UP STUDIES; HEART FAILURE, CONGESTIVE; HEART VENTRICLES; HEART-ASSIST DEVICES; HUMANS; ITALY; MIDDLE AGED; PROSTHESIS IMPLANTATION; RETROSPECTIVE STUDIES; STROKE VOLUME; SURGICAL MESH; SURVIVAL RATE; SWEDEN; TREATMENT OUTCOME; VENTRICULAR REMODELING;

EID: 19844380673     PISSN: 1129471X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (14)

1. Mann DL. Mechanisms and models of heart failure: a combinatorial approach. Circulation 1999; 100: 999-1088.
2. Goldstein S, Ali AS, Sabbah H. Ventricular remodeling. Mechanisms and prevention. Cardiol Clin 1998; 16: 623-32.
3. Starling RC, McCarthy PM, Buda T, et al. Results of partial left ventriculectomy for dilated cardiomyopathy: hemodynamic, clinical and echocardiographic observations. J Am Coll Cardiol 2000; 36: 2098-103.
4. Dor V, Saab M, Coste P, Kornaszewska M, Montiglio F. Left ventricular aneurysm: a new surgical approach. Thorac Cardiovasc Surg 1989; 37: 11-9.
5. Saavedra WF, Tunin RS, Paolocci N, et al. Reverse remodeling and enhanced adrenergic reserve from passive external support in experimental dilated heart failure. J Am Coll Cardiol 2002; 39: 2069-76.
6. Power JM, Raman J, Dornom A, et al. Passive ventricular constraint amends the course of heart failure: a study in an ovine model of dilated cardiomyopathy. Cardiovasc Res 1999; 44: 549-55.
7. Pilla JJ, Blom AS, Brockman DJ, et al. Ventricular constraint using the Acorn cardiac support device reduces myocardial akinetic area in an ovine model of acute infarction. Circulation 2002; 106 (Suppl 1): I207-I211.
8. Sabbah HN, Sharov VG, Gupta RC, et al. Reversal of chronic molecular and cellular abnormalities due to heart failure by passive mechanical ventricular containment. Circ Res 2003; 93: 1095-101.
9. Konertz WF, Shapland JE, Hotz H, et al. Passive containment and reverse remodeling by a novel textile cardiac support device. Circulation 2001; 104 (Suppl 1): I1270-I1275.
10. Oz MC, Konertz WF, Kleber FX, et al. Global surgical experience with the Acorn cardiac support device. J Thorac Cardiovasc Surg 2003; 126: 983-91.
11. Konertz WF, Sonntag S, Dushe S, Hotz H, Kleber FX. Efficacy trends with the Acorn cardiac support device: 3-year follow-up. (abstr) Circulation 2003; 108 (Suppl): II-298.
12. Mann DL, Acker MA, Jessup M, Sabbah HN, Starling RC, Kubo SH, for the Acorn Investigators and Study Coordinators. Rationale, design, and methods for a pivotal randomized clinical trial for the assessment of a cardiac support device in patients with New York Heart Association class IIIIV heart failure. J Card Fail 2004; 10: 185-92.
13. Kleber FX, Sonntag S, Krebs H, Stantke K, Konertz W. Follow-up on passive cardiomyoplasty in congestive heart failure: influence of the acorn cardiac support device on left ventricular function. (abstr) J Am Coll Cardiol 2001; 37 (Suppl I): A143.
14. Kono T, Sabbah HN, Rosman H, Alam M, Jafri S, Goldstein S. Left ventricular shape is the primary determinant of functional mitral regurgitation in heart failure. J Am Coll Cardiol 1992; 20: 1594-8.