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(Circulation. 2001;104:I-270.)
© 2001 American Heart Association, Inc.

Thoracic Transplantation and Ventricular Assist Devices

Passive Containment and Reverse Remodeling by a Novel Textile Cardiac Support Device

Wolfgang F. Konertz, MD, PhD; J. Edward Shapland, PhD; Holger Hotz, MD; Simon Dushe, MD; Jan Peter Braun, MD; Katrin Stantke, MD; Franz Xaver Kleber, MD, PhD

Department of Cardiovascular Surgery, Charité, Berlin, Germany (W.F.K., H.H., S.D., J.P.B.); the Department of Cardiology, Unfallkrankenhaus, Berlin, Germany (K.S., F.X.K.); and Acorn Cardiovascular, Inc, St Paul, Minn (J.E.S.).

Correspondence to Wolfgang F. Konertz, MD, PhD, Chairman, Department of Cardiovascular Surgery, Klinik für Kardiovasculare Chirurgie, Schumannstrasse 20/21, 10098 Berlin, Germany. E-mail wolfgang.konertz{at}charite.de

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.

Key Words: cardiomyopathy • heart-assist device • heart failure • remodeling