Feasibility of a No-Implant Approach to Interatrial Shunts: Preclinical and Early Clinical Studies.

Background: Heart failure with preserved ejection fraction represents a major unmet clinical need with limited treatment options. Recent device therapies under investigation have focused on decompression of the left atrium through an implantable interatrial shunt. Although these devices have shown favorable safety and efficacy signals, an implant is required to maintain shunt patency, which may increase the patient risk profile and complicate subsequent interventions requiring transseptal access.

Preservation of native aortic valve flow and full hemodynamic support with the TORVAD using a computational model of the cardiovascular system.

This article describes the stroke volume selection and operational design for the toroidal ventricular assist device (TORVAD), a synchronous, positive-displacement ventricular assist device (VAD). A lumped parameter model was used to simulate hemodynamics with the TORVAD compared with those under continuous-flow VAD support. Results from the simulation demonstrated that a TORVAD with a 30 ml stroke volume ejecting with an early diastolic counterpulse provides comparable systemic support to the HeartMate II (HMII) (cardiac output 5.

Verification of a computational cardiovascular system model comparing the hemodynamics of a continuous flow to a synchronous valveless pulsatile flow left ventricular assist device.

The purpose of this investigation is to use a computational model to compare a synchronized valveless pulsatile left ventricular assist device with continuous flow left ventricular assist devices at the same level of device flow, and to verify the model with in vivo porcine data. A dynamic system model of the human cardiovascular system was developed to simulate the support of a healthy or failing native heart from a continuous flow left ventricular assist device or a synchronous pulsatile valveless dual-piston positive displacement pump. These results were compared with measurements made during in vivo porcine experiments.

Improved left ventricular unloading and circulatory support with synchronized pulsatile left ventricular assistance compared with continuous-flow left ventricular assistance in an acute porcine left ventricular failure model.

Objective: Controversy exists regarding the optimal pumping method for left ventricular assist devices. The purpose of this investigation was to test the hypothesis that pulsatile left ventricular assist synchronized to the cardiac cycle provides superior left ventricular unloading and circulatory support compared with continuous-flow left ventricular assist devices at the same level of ventricular assist device flow.

Methods: Seven male pigs were used to evaluate left ventricular assist device function using the TORVAD synchronized pulsatile-flow pump (Windmill Cardiovascular Systems, Inc, Austin, Tex) compared with the Bio-Medicus BPX-80 continuous-flow centrifugal pump (Medtronic, Inc, Minneapolis, Minn).