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.

Catheter-guided open ligation of a pulmonary artery to left atrium connection.

Congenital malformations causing mild cyanosis can be overlooked. A large intrapulmonary right pulmonary artery to left atrium connection was the unusual etiology of arterial oxygen desaturation and erythrocytosis in an asymptomatic 30-year-old patient. The shunt was not possible to detect at echocardiography. It was closed via a median sternotomy without the aid of cardiopulmonary bypass. A novel technique was to use an angiographic catheter inserted through the wide shunt into the left atrium before the operation to securely identify it at the surgical dissection.

Early results with cardiac support device implant in patients with ischemic and non-ischemic cardiomyopathy.

OBJECTIVE: To evaluate the possible beneficial echocardiographic, functional and quality of life improving effects of passive containment surgery using the CorCap Cardiac Support Device in heart failure patients with dilated cardiomyopathy. DESIGN: Eight patients with dilated cardiomyopathy subjected to cardiac surgery received the Cardiac Support Device. Patients with ischemic cardiomyopathy (n = 4) underwent coronary artery bypass surgery receiving one to three bypass grafts. In the idiopathic cardiomyopathy group (n = 4) mitral valve plasty was performed in two patients while two patients received the Cardiac Support Device only. RESULTS: All patients survived the surgery and were discharged to home. There was a gradual, sustained improvement in cardiac dimensions (left ventricular end-diastolic diameter, left ventricular end-systolic diameter) and functional improvement (ejection fraction, 6-min walk, NYHA functional class) as well as quality of life. These beneficial effects developed more rapidly and more extensively in the idiopathic cardiomyopathy group. CONCLUSION: Addition of the Cardiac Support Device to conventional cardiac surgery, or applied alone, is safe and simple. The device seems to reverse ventricular dilatation and improve functional capacity and well-being of heart failure patients with dilated cardiomyopathy. Further studies will delineate what patient population will best benefit from passive containment surgery using the CorCap Cardiac Support Device.