Shengqiang Gao

Transcatheter heart valve with variable geometric configuration: in vitro evaluation.

Clinically, the current transcatheter aortic valve (TAV) technology has shown a propensity for paravalvular leakage; studies have correlated this flaw to increased calcification at the implantation site and with nonideal geometry of the stented valve. The present study evaluated the hydrodynamics of different geometric configurations, in particular the intravalvular considerations. Three TAV devices were made to create a representative, size 26 mm TAV. Hydrodynamics were assessed using a pulse duplicator. The geometries tested were composed of the nominal, elliptical, triangular, and undersized shapes; along with half-constriction, a conformation in which only a portion of the stent was constrained. The TAVs were assessed for transvalvular pressure gradient (TVG), effective orifice area (EOA), and regurgitant fraction. The nominal-sized shape posed a larger TVG (6.2 ± 0.3 mm Hg) than other configurations (P < 0.001) except the undersized valves. EOA of the nominal sized TAV (1.7 ± 0.1 cm(2) ) was smaller than that of the triangular and half-elliptical versions (P < 0.001). The half- and full-undersized geometries had EOAs smaller than the nominal type (P < 0.001). Nominal shape had smaller regurgitation (6.7 ± 1.4%) than all configurations (P < 0.001) except for the half-undersized (4.0 ± 0.7, P < 0.001) with no statistically significant difference from the full-undersized (6.8 ± 1.3, P = 0.724). The testing of variable geometries showed significant differences from the nominal geometry with respect to TVG, EOA, and regurgitant fraction. In particular, many of these nonideal configurations demonstrated an increased intravalvular regurgitation.

Performance of Extracorporeally Adjustable Ventricular Assist Device Inflow Cannula

PURPOSE This study evaluated the feasibility and efficacy of a newly developed adjustable left ventricular assist device inflow cannula in a short-term calf model. DESCRIPTION In this inflow cannula, the angle between the cannula body and the inflow cannula tip can be altered extracorporeally by manipulating 2 externalized cables connected to the cannula. The cannula tip is adjustable in any plane to a maximum of ±15 degrees. EVALUATION After initial prototyping in 4 calf cadavers, a Cleveland Heart left ventricular assist device was implanted with the adjustable inflow cannula placed in the left ventricular apex and the outlet to the descending aorta. Under hypovolemic conditions, the angle of the cannula tip could be changed to induce varying degrees of ventricular suction and then eliminate it, as evidenced by recorded pump and native left ventricular flows. Epicardial echocardiography and fluoroscopy in the closed-chest condition documented extracorporeal adjustments of the inflow cannula position. CONCLUSIONS This extracorporeally adjustable inflow cannula was effective in preventing or controlling left ventricular suction.

Early in vivo experience with the pediatric continuous-flow total artificial heart

BACKGROUND Heart transplantation in infants and children is an accepted therapy for end-stage heart failure, but donor organ availability is low and always uncertain. Mechanical circulatory support is another standard option, but there is a lack of intracorporeal devices due to size and functional range. The purpose of this study was to evaluate the in vivo performance of our initial prototype of a pediatric continuous-flow total artificial heart (P-CFTAH), comprising a dual pump with one motor and one rotating assembly, supported by a hydrodynamic bearing. METHODS In acute studies, the P-CFTAH was implanted in 4 lambs (average weight: 28.7 ± 2.3 kg) via a median sternotomy under cardiopulmonary bypass. Pulmonary and systemic pump performance parameters were recorded. RESULTS The experiments showed good anatomical fit and easy implantation, with an average aortic cross-clamp time of 98 ± 18 minutes. Baseline hemodynamics were stable in all 4 animals (pump speed: 3.4 ± 0.2 krpm; pump flow: 2.1 ± 0.9 liters/min; power: 3.0 ± 0.8 W; arterial pressure: 68 ± 10 mm Hg; left and right atrial pressures: 6 ± 1 mm Hg, for both). Any differences between left and right atrial pressures were maintained within the intended limit of ±5 mm Hg over a wide range of ratios of systemic-to-pulmonary vascular resistance (0.7 to 12), with and without pump-speed modulation. Pump-speed modulation was successfully performed to create arterial pulsation. CONCLUSION This initial P-CFTAH prototype met the proposed requirements for self-regulation, performance, and pulse modulation.

Novel technique for airless connection of artificial heart to vascular conduits

Successful implantation of a total artificial heart relies on multiple standardized procedures, primarily the resection of the native heart, and exacting preparation of the atrial and vascular conduits for pump implant and activation. Achieving secure pump connections to inflow/outflow conduits is critical to a successful outcome. During the connection process, however, air may be introduced into the circulation, traveling to the brain and multiple organs. Such air emboli block blood flow to these areas and are detrimental to long-term survival. A correctly managed pump-to-conduit connection prevents air from collecting in the pump and conduits. To further optimize pump-connection techniques, we have developed a novel connecting sleeve that enables airless connection of the Cleveland Clinic continuous-flow total artificial heart (CFTAH) to the conduits. In this brief report, we describe the connecting sleeve design and our initial results from two acute in vivo implantations using a scaled-down version of the CFTAH.

New Cardioscope-Based Platform for Minimally Invasive and Percutaneous Beating Heart Interventions

With heart disease increasing worldwide, demand for new minimally invasive techniques and transcatheter technologies to treat structural heart disease is rising. Cardioscopy has long been considered desirable, as it allows direct tissue visualization and intervention to deliver therapy via a closed chest, with real-time fiber-optic imaging of intracardiac structures. Herein, the feasibility of the advanced cardioscopic platform, allowing both transapical and fully percutaneous access is reported. The latter technique, in particular, is believed to represent a milestone in the development of the cardioscope. Cardioscope prototypes were used in 7 bovine models (77.2-101.1 kg) for transapical or percutaneous insertion. Miniature custom-built, water-sealed cameras (diameters: Storz, 7 Fr; Medigus, 1.2 mm) were used. For percutaneous cardiopulmonary bypass, the pulmonary artery was occluded by a balloon catheter (Intraclude, 10.5 Fr, 100 cm) and perfused with a crystalloid solution. Cameras were inserted transapically (n = 4) through the left ventricular apex or percutaneously (n = 5) via the carotid artery. Insertion of the optimized cardioscope devices was feasible via either approach. Intracardiac structures (left ventricle, mitral valve opening/closure, chordal apparatus, aortic valve leaflets, and regurgitation) were visualized clearly and without deformation. Catheter tips were successfully bent >180° inside the left ventricle; rotation and navigation to view various intracardiac structures were feasible in all cases. This study showed the technical feasibility of direct cardioscopic visualization using transapical and percutaneous approaches. This advanced cardioscopic instrumentarium represents a promising platform for future interventions and surgery under direct visualization of the beating heart.