The CorInnova Implantable Cardiac Assist System for Direct Cardiac Compression

Abstract

The CorInnova cardiac compression device (CorInnova, Inc., Houston, TX, USA) is designed to provide direct biventricular support, increase cardiac output, and improve ventricular unloading in patients with heart failure. Placed within the pericardium and surrounding both ventricles, the device has two concentric sets of thin-film polyurethane chambers: (1) inner (epicardial) saline-filled chambers that conform intimately to the epicardial surface, eradicating any gaps in the interface between the device and the heart; and (2) outer air-filled chambers cycled to provide epicardial compression during systole and negative epicardial pressure during diastole, consistent with physiological cardiac contraction and relaxation. A superelastic, collapsible Nitinol frame gives the device structure, enables minimally invasive self-deployment, and enhances diastolic filling. Preclinical testing has been extremely promising, with improvements in cardiac output and other cardiac parameters in animal heart failure models. This potentially transformative technology is moving rapidly toward first-in-human use. The CorInnova device may provide an effective device-based solution for patients with heart failure who currently have few or limited mechanical cardiac support options, including patients with biventricular cardiac failure, those with right heart failure, those who are older, and those who are of smaller size. It can be removed easily and requires minimal maintenance. An important, unique feature of this technology is that it provides mechanical cardiac assistance without blood contact or need for anticoagulation. The CorInnova device may be particularly important for those patients who have contraindications to anticoagulation due to allergy, neurological bleeds, or preexisting hemorrhage. No other mechanical circulatory support device addresses these underserved heart-failure populations.

Keywords: assisted circulation; cardiac output; cardiopulmonary resuscitation; heart-assist devices; minimally invasive surgical procedures; stroke volume.

Fig. 1.

CorInnova device in place and encircling both left and right ventricles. The Nitinol frame supports inner saline-filled chambers and outer air-filled chambers that inflate and deflate cyclically. The driveline extends outwards from the device’s apex. Image courtesy of CorInnova, Inc.

Fig. 2.

The “Anstadt Cup” device for direct mechanical ventricular actuation. The glass assistor cup was held in place by suction [26]. Reproduced with permission from [27] McCabe JB, Ventriglia WJ, Anstadt GL, Nolan DJ. Direct mechanical ventricular assistance during ventricular fibrillation. Ann Emerg Med. 1983; 12: 739–44.

Fig. 3.

Diagram of dynamic cardiomyoplasty with latissimus dorsi wrapped around both ventricles. Reproduced with permission from [34] Letsou GV, Austin L, Grandjean PA, Braxton JH, Elefteriades JA. Dynamic cardiomyoplasty. Cardiology Clinics. 1995; 13: 121–124.

Fig. 4.

Acorn CorCap cardiac support device in place, covering both ventricles. Reproduced with permission from [36] Sabbah HN. The Cardiac Support Device and the Myosplint: treating heart failure by targeting left ventricular size and shape. Annals of Thoracic Surgery. 2003; 75: S13–19.

Fig. 5.

Cross-section of cardiac ventricles showing the positioning of the Myosplint device. (Top) Three deployed transventricular splints that bisect the left ventricle. (Bottom) Myosplint components: fixed pad (1), tension member (2), and deployable pad (3). Reproduced with permission from [36] Sabbah HN. The Cardiac Support Device and the Myosplint: treating heart failure by targeting left ventricular size and shape. Annals of Thoracic Surgery. 2003; 75: S13–19.

Fig. 6.

The CorInnova device. Left: The cup-shaped device is deployed inside the pericardial sac around the ventricles. Shown is a side view of the device around a 3D-printed ovine heart. Middle: Top view of device, which consists of a Nitinol frame that allows self-deployment. Right: The device includes an inner (epicardial) fluid-filled polyurethane film buffering component and an outer polyurethane film active assist component [44, 45]. Images courtesy of CorInnova, Inc.

Fig. 7.

Fluoroscopic imaging and contour tracings of the heart surface and CorInnova device in acute animal studies. Unlike previous epicardial assist devices, the CorInnova device assists without inverting native heart curvature (A,B). The device becomes intrinsically pneumatically coupled to the heart as soon as the fluid component is filled (C) and free air is evacuated from the chest, so that the heart is not ejected from the device during assist (D). This allows the device to be implanted without invasive attachment methods, such as suturing or vacuum). Reproduced with permission from [47] Moreno MR, Biswas S, Harrison LD, Pernelle G, Miller MW, Fossum TW, Nelson DA, Criscione JC. Assessment of Minimally Invasive Device that Provides Simultaneous Adjustable Cardiac Support and Active Synchronous Assist in an Acute Heart Failure Model. The Journal of Medical Devices. 2011; 5(4): 041008.

Fig. 8.

CorInnova device delivery. (A–C) Fluoroscopic images showing use of the deployment tube and self-deploying wire frame to successfully place the device in the pericardial sac. (D) The surgeon pushes the device out of the delivery tube and into the pericardial sac. Deployment with this method has a success rate of 100% to date and an average placement time of 20 seconds once the tube is placed at the pericardial opening. Fig. 8A–C, adapted from [44] Hord EC, Bolch CM, Tuzun E, Cohn WE, Leschinsky B, Criscione JC. Evaluation of the CorInnova heart assist device in an acute heart failure model. The Journal of Cardiovascular Translational Research. 2019; 12: 155–163, under Creative Commons License CC BY 4.0 (http://creativecommons.org/licenses/by/4.0/). Fig. 8D courtesy of CorInnova, Inc.