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.

New Technology Mimics Physiologic Pulsatile Flow During Cardiopulmonary Bypass.

The VentriFlo True Pulse Pump (Design Mentor, Inc., Pelham, NH, USA) is the first blood pump designed to mimic human arterial waveforms in a standard oxygenation circuit. Our aim was to demonstrate the feasibility and safety of this pump in preparation for future studies to determine possible clinical advantages. We studied four piglets (41.4-46.2 kg): three with an implanted VentriFlo pulsatile pump and one with the nonpulsatile ROTAFLOW pump (MAQUET Holding B.V. & Co. KG, Rastatt, Germany) as a control. Hemodynamics was monitored during 6-h cardiopulmonary bypass (CPB) support and for 2 h after weaning off CPB. The VentriFlo demonstrated physiologic arterial waveforms with arterial pulse pressure of 24.6 ± 5.7 mm Hg. Pump flows (2.0 ± 0.1 L/min in ROTAFLOW; 1.9 ± 0.1 L/min in VentriFlo) and plasma free hemoglobin levels (27.9 ± 12.5 mg/dL in ROTAFLOW; 28.5 ± 14.2 mg/dL in VentriFlo) were also comparable, but systemic O2 extraction (as measured by arterial minus venous O2 saturation) registered slightly higher with the VentriFlo (63.2 ± 6.9%) than the ROTAFLOW (55.4 ± 6.5%). Histological findings showed no evidence of ischemic changes or thromboembolism. This pilot study demonstrated that the VentriFlo system generated pulsatile flow and maintained adequate perfusion of all organs during prolonged CPB.

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.

Moderate hypothermia technique for chronic implantation of a total artificial heart in calves.

The benefit of whole-body hypothermia in preventing ischemic injury during cardiac surgical operations is well documented. However, application of hypothermia during in vivo total artificial heart implantation has not become widespread because of limited understanding of the proper techniques and restrictions implied by constitutional and physiological characteristics specific to each animal model. Similarly, the literature on hypothermic set-up in total artificial heart implantation has also been limited. Herein we present our experience using hypothermia in bovine models implanted with the Cleveland Clinic continuous-flow total artificial heart.

Deairing Techniques for Double-Ended Centrifugal Total Artificial Heart Implantation.

The unique device architecture of the Cleveland Clinic continuous-flow total artificial heart (CFTAH) requires dedicated and specific air-removal techniques during device implantation in vivo. These procedures comprise special surgical techniques and intraoperative manipulations, as well as engineering design changes and optimizations to the device itself. The current study evaluated the optimal air-removal techniques during the Cleveland Clinic double-ended centrifugal CFTAH in vivo implants (n = 17). Techniques and pump design iterations consisted of developing a priming method for the device and the use of built-in deairing ports in the early cases (n = 5). In the remaining cases (n = 12), deairing ports were not used. Dedicated air-removal ports were not considered an essential design requirement, and such ports may represent an additional risk for pump thrombosis. Careful passive deairing was found to be an effective measure with a centrifugal pump of this design. In this report, the techniques and design changes that were made during this CFTAH development program to enable effective residual air removal and prevention of air embolism during in vivo device implantation are explained.

Simplified perfusion strategy for removing retroperitoneal tumors with extensive cavoatrial involvement.

OBJECTIVES: Our objective was to compare effectiveness and safety of a simplified approach for removing retroperitoneal tumors with extensive cavoatrial involvement using beating-heart cardiopulmonary bypass (CPB) versus hypothermic circulatory arrest (HCA). METHODS: From January 1984 to January 2009, 144 patients underwent radical nephrectomy and inferior vena caval tumor thrombectomy, 56 (39%) using CPB and 88 (61%) HCA. Compared with HCA patients, CPB patients were of similar age (62 ± 10 vs 60 ± 11 years, P = .4) and gender (39% vs 39% female, P > .9), with similar stroke history (3.6% vs 2.3%, P =.6), but had less pulmonary disease (18% vs 33%, P = .06) and lower preoperative creatinine concentration (1.3 ± 0.72 vs 1.5 ± 0.86 mg · dL(-1), P = .04). RESULTS: Complete tumor removal was achieved in all patients by both strategies. Compared with HCA procedures, CPB times were shorter (50 ± 33 vs 94 ± 40 minutes, P < .0001). CPB patients required fewer blood transfusions (36% no transfusion vs 17%, and 45% ≥4 units vs 72%; P = .003) and had no statistical difference in morbidity, including reoperation for bleeding (3.8% vs 8.0%, P = .3), renal failure requiring dialysis (3.6% vs 10%, P = .14), respiratory insufficiency (21% vs 19%, P = .8), sepsis (5.4% vs 10%, P = .3), stroke (5.4% vs 1.1%, P = .13), and in-hospital mortality (7.1% vs 13%, P = .3). Ten-year survival (22% vs 22%, P > .9) and freedom from cancer recurrence (24% vs 28%, P = .8) were similar. CONCLUSIONS: Radical nephrectomy and removal of inferior vena caval tumor-thrombus can be simply, effectively, and safely performed with beating-heart CPB, avoiding the deleterious effects of HCA and providing clinical benefit without increasing morbidity or mortality.

Performance and reliability of the CPB/ECMO Initiative Forward Lines Casualty Management System.

The Cleveland Clinic Foundation CPB/ECMO Initiative Forward Casualty Management System is an economical, compact, transportable, disposable system designed to permit a rapid expansion of trauma management services requiring cardiopulmonary bypass (CPB) or extracorporeal membrane oxygenation (ECMO) pulmonary support. The system, composed of a rotary blood pump, a pump motor driver, and an electronic control console as the blood pumping subsystem, also includes commonly used compatible commercial oxygenators, venous reservoirs, and cannulae. In vitro durability testing accumulated over 100 hours without failure. In vivo reliability was tested in 10 calves under general anesthesia during 6 hours of CPB and ECMO under full heparinization at nominal operating conditions of 4-5 l/min and 2-4 l/min blood flow respectively, and mean arterial pressures between 65 and 100 mm Hg. A mean time to failure of 57 hours was reached during the animal series. Results of these test series demonstrated that this system has the capability to reliably operate during a 6-hour conventional CPB or ECMO procedure, while providing flexibility and ease of use for the operator.