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. Methods: The Alleviant System is a no-implant approach to creating an interatrial shunt using radiofrequency energy to securely capture, excise, and extract a precise disk of tissue from the interatrial septum. Acute preclinical studies in healthy swine (n = 5) demonstrated the feasibility of the Alleviant System to repeatably create a 7 mm interatrial orifice with minimal collateral thermal effect and minimal platelet and fibrin deposition observed histologically. Results: Chronic animal studies (n = 9) were carried out to 30- and 60-day time points and exhibited sustained shunt patency with histology demonstrating completely healed margins, endothelialization, and no trauma to adjacent atrial tissue. Preliminary clinical safety and feasibility were validated in a first-in-human study in patients with heart failure with preserved ejection fraction (n = 15). All patients demonstrated shunt patency by transesophageal echocardiographic imaging at 1, 3, and 6 months, as well as cardiac computed tomography imaging at 6-month follow-up timepoints. Conclusions: Combined, these data support the safety and feasibility of a novel no-implant approach to creating an interatrial shunt using the Alleviant System. Continued follow-up and subsequent clinical studies are currently ongoing.

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 5.7 L/min up from 3.1 L/min in simulated heart failure). By taking the advantage of synchronous pulsatility, the TORVAD delivers full hemodynamic support with nearly half the VAD flow rate (2.7 L/min compared with 5.3 L/min for the HMII) by allowing the left ventricle to eject during systole and thus preserving native aortic valve flow (3.0 L/min compared with 0.4 L/min for the HMII, down from 3.1 L/min at baseline). The TORVAD also preserves pulse pressure (26.7 mm Hg compared with 12.8 mm Hg for the HMII, down from 29.1 mm Hg at baseline). Preservation of aortic valve flow with synchronous pulsatile support could reduce the high incidence of aortic insufficiency and valve cusp fusion reported in patients supported with continuous-flow VADs.

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. Results from the simulation model and from the in vivo counterpart show that the pulsatile pump provides higher cardiac output, left ventricular unloading, cardiac pulsatility, and aortic valve flow as compared with the continuous flow model at the same level of support. The dynamic system model developed for this investigation can effectively simulate human cardiovascular support by a synchronous pulsatile or continuous flow ventricular assist device.

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). Experiments were carried out under general anesthesia, and animals were instrumented via a median sternotomy. Hemodynamic measurements were obtained in the control state and with left ventricular assistance using the TORVAD and BPX-80 individually. Left ventricular failure was induced with suture ligation of the mid-left anterior descending coronary artery, and hemodynamic measurements were repeated. RESULTS: During left ventricular assist device support, mean aortic pressure and total cardiac output were higher and left atrial pressure was lower with pulsatile compared with continuous flow at the same ventricular assist device flow rate. During ischemic left ventricular failure, pulsatile left ventricular support resulted in higher total cardiac output (5.58 ± 1.58 vs 5.12 ± 1.19, P < .05), higher mean aortic pressure (67.8 ± 14 vs 60.2 ± 10, P < .05), and lower left atrial pressure (11.5 ± 3.5 vs 13.9 ± 6.0, P < .05) compared with continuous flow at the same left ventricular assist device flow rate. CONCLUSION: Synchronized, pulsatile left ventricular assistance produces superior left ventricular unloading and circulatory support compared with continuous-flow left ventricular assist at the same flow rates.