Upper cavo-pulmonary anastomosis by transcatheter technique.

OBJECTIVES: The aim of this animal study was to establish a shunt connection between superior vena cava (SVC) and right pulmonary artery (RPA) by transvascular intervention solely. BACKGROUND: After initial shunt creation, the establishment of the upper cavo-pulmonary anastomosis (UCPA) is the second out of three open chest operations young infants with univentricular anatomy are subjected to. To avoid the risks of reoperation with cardiovascular bypass, we sought to replace this surgical step by an interventional technique. METHODS: After cannulation of jugular and femoral veins in four piglets (mean body weight of 12.5 kg) an UCPA was created by radiofrequency perforation from the SVC across the right atrium into the RPA and subsequent implantation of covered stents. The perforation was guided by biplane fluoroscopy and the perforation wire premounted with a coaxial catheter was advanced into the distal pulmonary artery and exchanged for a stiffer wire. A long sheath was brought into the RPA and an 80 mm long expanded poly-tetra-fluoro-ethylene (ePTFE)-covered Cheatham Platinum stent was then implanted connecting the SVC with the RPA. RESULTS: Immediate angiography showed antegrade flow from SVC to RPA. Angiographic re-evaluation after a median period of 4 weeks showed partial in-stent stenosis but patent lumina. Additionally, veno-venous collaterals from the SVC to the right atrium had developed. Histology of the explanted stents revealed parietal thrombi and mild to moderate pseudo intima proliferation inside the lumina. CONCLUSIONS: The transvascular creation of an upper unidirectional cavo-pulmonary anastomosis in piglets is technically feasible using standard catheterization equipment.

Cavopulmonary assist: (em)powering the univentricular fontan circulation.

Since the Fontan/Kreutzer procedure was introduced, evolutionary clinical advances via a staged surgical reconstructive approach have markedly improved outcomes for patients with functional single ventricle. However, significant challenges remain. Early stage mortality risk seems impenetrable. Serious morbidities - construed as immutable consequences of palliation - have hardly been addressed. Late functional status is increasingly linked to pathophysiologic consequences of prior staged procedures. As more single-ventricle patients survive into adulthood, Fontan failure is emerging as an intractable problem for which there is no targeted therapy. Incremental solutions to address these ongoing problems have not had a measurable impact. Therefore, a fundamental reconsideration of the overall approach is reasonable and warranted. The ability to provide a modest pressure boost (2 to 6 mmHg) to existing blood flow at the total cavopulmonary connection can effectively restore more stable biventricular status. This would impact not only treatment of late Fontan failure, but also facilitate early surgical repair. A realistic means to provide such a pressure boost has never been apparent. Recent advances are beginning to unravel the unique challenges that must be addressed to realize this goal, with promise to open single-ventricle palliation to new therapeutic vistas.

Intracardiac cavopulmonary connection in patients with univentricular heart using intra-atrial lateral tunnel and intra-atrial conduit techniques.

BACKGROUND: In this study, we analyzed the time course of hemodynamic efficiency and follow-up in Fontan candidates who underwent the bidirectional Glenn procedure for staged intracardiac cavopulmonary connection (ICPC). METHODS: Between 1991 and 2008, 52 patients with univentricular heart (mean age, 3.3 years; range, 2-8 years; 27 female patients [51.9%]) underwent ICPC. The cardiac malformations were as follows: tricuspid atresia, 25 cases (48.0%); common ventricle, 16 cases (30.7%); and pulmonary atresia with intact ventricular septum, 11 cases (21.1%). The intracardiac cavopulmonary procedure was indicated for all 52 cases. In 42 patients (80.7%), an intra-atrial lateral tunnel was constructed with a bovine pericardium patch. In the last 10 consecutive cases (19.3%), we performed a modified surgical technique in which we implanted an intra-atrial corrugated bovine pericardium tube sutured around the superior and inferior vena cava ostium. In all cases, a 4-mm fenestration was made to reduce the intratunnel pressure. All 52 patients had previously undergone a Glenn operation. RESULTS: There were 2 hospital deaths (3.8%) and no recorded late deaths. During the follow-up, all patients were medicated with antiplatelet drugs. To evaluate the hemodynamic performance, we used Doppler echocardiography, computed tomography, and magnetic nuclear resonance studies. There were no prosthesis thromboses during this followup period. To evaluate cardiac arrhythmias, we conducted a Holter study. The last 10 patients with an intra-atrial conduit (IAC) presented with sinus rhythm and no arrhythmias during the last 4 years. The 50 surviving patients (96.1%) have been followed up for 6 to 204 months; all these patients are free of reoperation. CONCLUSION: The Glenn operation, which is performed at an early age, prepares the pulmonary bed to receive the ICPC. The midterm results of the intracardiac Fontan procedure seem to be good. The modified surgical procedure (IAC) can be a good alternative technique to the Fontan procedure in suitable patients.

Creation of transcatheter aortopulmonary and cavopulmonary shunts using magnetic catheters: feasibility study in swine.

Surgical shunts are the basic form of palliation for many types of congenital heart disease. The Glenn shunt (superior cavopulmonary connection) and central shunt (aortopulmonary connection) represent surgical interventions that could potentially be accomplished by transcatheter techniques. We sought to investigate the efficacy of using neodymium iron boron (NdFeB) magnetic catheters to create transcatheter cavopulmonary and aortopulmonary shunts. NdFeB magnets were machined and integrated into catheters. "Target" catheters were placed in the pulmonary arteries (PAs), and radiofrequency "perforation" catheters were placed in either the descending aorta (DAo) for central shunts or the superior vena cava (SVC) for Glenn shunts. The magnet technique or "balloon target" method was used to pass wires from the DAo or the SVC into the PA. Aortopulmonary and cavopulmonary connections were then created using Atrium iCAST covered stents. Magnet catheters were used to perforate the left pulmonary artery from the DAo, thereby establishing a transcatheter central shunt. Given the orientation of the vasculature, magnetic catheters could not be used for SVC-to-PA connections; however, perforation from the SVC to the right pulmonary artery was accomplished with a trans-septal needle and balloon target. Transcatheter Glenn or central shunts were successfully created in four swine.

Chronic In Vivo Test of a Right Heart Replacement Blood Pump for Failed Fontan Circulation.

An implantable rotary blood pump was developed to provide long-term mechanical right heart support for patients who have failing Fontan circulation. The objective of this study was to evaluate the pump in vivo in a 30 day sheep study. Pump speed was set at 3,900 rpm for the duration of the study, and pump power was between 4.3 and 4.6 W. The pump inlet pressures for the superior vena cava (SVC) and inferior vena cava (IVC) were 14 ± 15 and 11 ± 15 mm Hg, respectively, over the duration of the study. Hematocrit remained stable at 30% ± 4%. Partial thromboplastin time (PTT) steadily increased from 30 s preoperatively to a high of 59 s on postoperative day 20, while prothrombin time (PT) remained at 20 ± 2 s for the duration of the study. The implantation and postoperative recovery were successful, and the animal demonstrated normal physiologic pulmonary and venous pressures and cardiac output. On pump inspection, the IVC and SVC inlets were completely clear of any deposits, but there were small thrombi (approximately 0.5 mm diameter) between each of the three rotor blades and along 20% of the parting line of the two volute halves. A complete right heart bypass was performed, postoperative recovery was successful, and the pump demonstrated adequate circulatory support and normal physiologic pulmonary and venous pressures. This study was the first successful test of a right heart replacement device in a chronic animal study.

Trendelenburg position, simulated Valsalva maneuver, and liver compression do not alter the size of the right internal jugular vein in patients with a bidirectional Glenn shunt.

BACKGROUND: Ultrasound is increasingly used to facilitate right internal jugular vein (RIJV) cannulation in children. In children without cardiac disease, position changes and enhancement maneuvers increase RIJV cross-sectional area (CSA) and further facilitate cannulation. We investigated the effect of these maneuvers on RIJV CSA in children with a bidirectional Glenn (BDG) shunt presenting for a Fontan procedure. METHODS: The CSA (cm(2)) of the RIJV in 21 children with a BDG shunt presenting for a Fontan procedure was assessed by ultrasonic planimetry (SonoSite). Two positions, supine (S) and 15 degrees Trendelenburg (T); and two enhancements maneuvers, manual liver compression (L) and a simulated Valsalva maneuver (V) were utilized in combination. Eight separate measurements (S, S + L, S + V, S + L + V, T, T + L, T + V, T + L + V) were made in each patient. Data were analyzed using one-way analysis of variance with repeated measures and with Tukey post hoc pairwise comparison analysis. RESULTS: No significant change in the RIJV CSA or % change in CSA from baseline (S) was observed. CONCLUSIONS: Position changes and enhancement maneuvers are unlikely to facilitate RIJV cannulation in BDG shunt patients presenting for Fontan procedure because these interventions do not increase RIJV CSA.

Total cavopulmonary connection with a new bioabsorbable vascular graft: First clinical experience.

OBJECTIVES: To assess safety and clinical performance of a novel bioabsorbable vascular graft in pediatric patients with univentricular cardiac malformation who received surgical correction via an extracardiac cavopulmonary conduit. METHODS: The implanted graft material is designed to attract patient's own cells and proteins, which trigger a cascade of physiological events leading to endogenous tissue restoration. As the graft resorbs progressively after implantation, components of native tissue including collagen, endothelial lining, and capillary blood vessels develop and organize into a natural tissue. Five patients (aged 4-12 years) received this new vascular graft as interposition between the inferior vena cava and the pulmonary artery. They were followed up to 12 months after surgery. The conduit was assessed by echocardiography, computed tomography and magnetic resonance imaging, including 4-dimensional flow. RESULTS: All patients recovered from the procedure without complications. No device-related adverse events were reported. Two patients required interventional occlusion of aortopulmonary collaterals. At 12 months, there was a significant improvement in the patients' general condition. Imaging studies demonstrated anatomical (conduit diameter, length and wall thickness) and functional (blood flow pattern) stability of the bioabsorbable grafts in all patients with no significant changes at 12 months compared with early postoperative data. CONCLUSIONS: Initial clinical experience with a novel absorbable graft underlines the potential of this new material to improve cardiac and vascular surgical procedures. In addition, better biocompatibility may reduce permanent implant-related complications. A longer follow-up is needed to assess the long-term effectiveness of biodegradable vascular grafts, including their ability to grow.

A Gore-Tex 'new-innominate' vein: a surgical option for complicated bilateral cavopulmonary shunts.

A bilateral bidirectional cavopulmonary shunt was performed in a cyanotic 14-month-old girl who had tricuspid and pulmonary valve atresia, with right pulmonary artery (RPA) hypoplasia (3 mm), bilateral superior vena cavae and a ductus arteriosus-dependent pulmonary blood flow. Because of 62% postoperative arterial oxygen saturation and a right superior vena cava (RSVC) pressure of 30 mmHg, a 5 mm Gore-Tex tube was interposed to connect the two superior venae cavae. The creation of a 'new-innominate' vein allowed decompression of the right superior vena cava and an increase in arterial oxygen saturation to 86%.

Novel materials and devices in the transcatheter creation of vascular anastomosis--the future comes slowly (part 2).

Completion of the total cavopulmonary connection and creation of the majority of vascular anastomoses are currently usually performed surgically. The major disadvantage of the surgical approach, however, is its invasiveness, as patients undergoing cardiac surgery generally need sternotomy and cardiopulmonary bypass - often with cardiac arrest - commonly resulting in a prolonged and complicated postoperative intensive care period. Transcatheter procedures, in contrast, have a lower risk of complications, shorter intensive care and total hospital stays, and do not need a cardiopulmonary bypass or sternotomy. The second part of our review focuses on new advances in transcatheter technology, which will allow safe and effective percutaneous management of patients requiring the creation of an intervascular anastomosis and completion of the total cavopulmonary connection. It will create a therapeutic alternative able to reduce the surgical burden on this group of patients.

Magnetic Resonance Imaging-Guided Transcatheter Cavopulmonary Shunt.

OBJECTIVES: The aim of this study was to test the hypothesis that real-time magnetic resonance imaging (MRI) would enable closed-chest percutaneous cavopulmonary anastomosis and shunt by facilitating needle guidance along a curvilinear trajectory, around critical structures, and between a superior vena cava "donor" vessel and a pulmonary artery "target." BACKGROUND: Children with single-ventricle physiology require multiple open heart operations for palliation, including sternotomies and cardiopulmonary bypass. The reduced morbidity of a catheter-based approach would be attractive. METHODS: Fifteen naive swine underwent transcatheter cavopulmonary anastomosis and shunt creation under 1.5-T MRI guidance. An MRI antenna-needle was advanced from the superior vena cava into the target pulmonary artery bifurcation using real-time MRI guidance. In 10 animals, balloon-expanded off-the-shelf endografts secured a proximal end-to-end caval anastomosis and a distal end-to-side pulmonary anastomosis that preserved blood flow to both branch pulmonary arteries. In 5 animals, this was achieved with a novel, purpose-built, self-expanding device. RESULTS: Real-time MRI needle access of target vessels (pulmonary artery), endograft delivery, and superior vena cava shunt to pulmonary arteries were successful in all animals. All survived the procedure without complications. Intraprocedural real-time MRI, post-procedural MRI, x-ray angiography, computed tomography, and necropsy showed patent shunts with bidirectional pulmonary artery blood flow. CONCLUSIONS: MRI guidance enabled a complex, closed-chest, beating-heart, pediatric, transcatheter structural heart procedure. In this study, MRI guided trajectory planning and reproducible, reliable bidirectional cavopulmonary shunt creation.

Multiscale modeling of the cardiovascular system: application to the study of pulmonary and coronary perfusions in the univentricular circulation.

The objective of this study is to compare the coronary and pulmonary blood flow dynamics resulting from two configurations of systemic-to-pulmonary artery shunts currently utilized during the Norwood procedure: the central (CS) and modified Blalock Taussig (MBTS) shunts. A lumped parameter model of the neonatal cardiovascular circulation and detailed 3-D models of the shunt based on the finite volume method were constructed. Shunt sizes of 3, 3.5 and 4 mm were considered. A multiscale approach was adopted to prescribe appropriate and realistic boundary conditions for the 3-D models of the Norwood circulation. Results showed that the average shunt flow rate is higher for the CS option than for the MBTS and that pulmonary flow increases with shunt size for both options. Cardiac output is higher for the CS option for all shunt sizes. Flow distribution between the left and the right pulmonary arteries is not completely balanced, although for the CS option the discrepancy is low (50-51% of the pulmonary flow to the right lung) while for the MBTS it is more pronounced with larger shunt sizes (51-54% to the left lung). The CS option favors perfusion to the right lung while the MBTS favors the left. In the CS option, a smaller percentage of aortic flow is distributed to the coronary circulation, while that percentage rises for the MBTS. These findings may have important implications for coronary blood flow and ventricular function.

Coupling pediatric ventricle assist devices to the Fontan circulation: simulations with a lumped-parameter model.

In pediatric ventricular assist device (VAD) design, the process of matching device characteristics and dimensions to the relevant disease conditions poses a formidable challenge because the disease spectrum is more highly varied than for adult applications. One example arises with single-ventricle congenital defects, which demand palliative surgeries that create elevated systemic venous pressure and altered pulmonary hemodynamics. Substituting a mechanical pump as a right ventricle has long been proposed to eliminate the associated early and postoperative anomalies. A pulsatile lumped-parameter model of the single-ventricle circulation was developed to guide the preliminary design studies. Two special modules, the pump characteristics and the total cavopulmonary connection (TCPC) module, are introduced. The TCPC module incorporates the results of three-dimensional patient-specific computational fluid dynamics calculations, where the pressure drop in the TCPC anastomosis is calculated at the equal vascular lung resistance operating point for different cardiac outputs at a steady 60/40 inferior vena cava/superior vena cava flow split. Preliminary results obtained with the adult parameters are presented with no ventricle remodeling or combined larger-size single ventricle. A detailed literature review of single-ventricle function is provided. Coupling a continuous pump to the single-ventricle circulation brought both the pulmonary and systemic venous pressures back to manageable levels. Selected VADs provided an acceptable cardiac output trace of the single left ventricle, after initial transients. Remodeling of the systemic venous compliance plays a critical role in performance and is included in this study. Pulsatile operation mode with rotational speed regulation highlighted the importance of TCPC and pulmonary artery compliances. Four different pumps and three patient-specific anatomical TCPC pathologies were studied. Magnitudes of the equivalent TCPC resistances were found to be comparable to the vascular resistances of the normal baseline circulation, significantly affecting both the VAD design and hemodynamics.

Cavopulmonary assist: circulatory support for the univentricular Fontan circulation.

BACKGROUND: Following Fontan palliation, the univentricular circulation is notable for coexisting systemic venous hypertension and pulmonary arterial hypotension. Assisted cavopulmonary blood flow to overcome this pressure gradient would restore the circulation to one more closely resembling normal two-ventricle physiology. We hypothesized that mechanical augmentation of cavopulmonary blood flow would provide physiologic stability in a model of cavopulmonary diversion and univentricular circulation. METHODS: Yearling sheep (n = 13, mean weight 56.5 kg) underwent total cavopulmonary diversion on cardiopulmonary bypass. The superior and inferior vena cavae were anastomosed directly to the right pulmonary artery. Axial flow pumps were positioned within both vena cavae to assist blood flow from the systemic venous circulation into the pulmonary vasculature. Baseline ventilation was resumed, cardiopulmonary bypass was weaned, and pump support was titrated to obtain normal physiologic measurement. Cardiopulmonary data were collected for 6 hours. RESULTS: All animals demonstrated hemodynamic stability without need for volume loading, inotropic support, or pulmonary vasodilator therapy. Cardiac output, pulmonary vascular resistance, pulmonary arterial pressure, inferior vena caval pressure, and arterial pCO(2) and pO(2) values 6 hours after intervention were similar to baseline values. Arterial lactate levels steadily decreased throughout the cavopulmonary assist period. CONCLUSIONS: Cavopulmonary assist with a percutaneous pump provides physiologic stability in a model of total cavopulmonary diversion and univentricular Fontan circulation without altering regional volume distribution or cardiac output. This mode of circulatory support may have potential to benefit patients with marginal Fontan hemodynamics in both the early and late time periods.

New technique of right heart bypass in congenital heart surgery with autologous lung as oxygenator.

BACKGROUND: Modifications have been made in cardiopulmonary circuit to reduce the inflammatory deleterious effects and cost. We present our experience of one such right heart bypass (RHB) circuit utilizing autologus lung as oxygenator. METHODS: From September 2001 to December 2002, 15 patients underwent congenital heart surgery with this technique. Bypass circuit consisted of a reservoir and a roller pump along with a cardiotomy sucker. The left pulmonary artery and main pulmonary artery were used for arterial return, and venous drainage was achieved with innominate vein cannulation. Inferior vena cava cannulation was performed when needed. Thirteen patients underwent bidirectional Glenn shunt surgery (12 to 24 months, 6 to 10 kg). One patient (26 years old) underwent central shunt with enlargement of confluence and left pulmonary artery. Another patient (18 months old) underwent 1.5 ventricle repair. RESULTS: There were no hospital deaths. Mean flow achieved on RHB was 0.57 +/- 0.3 L/min/m(2), central venous pressure was 3.3 +/- 1.8 mm Hg (0 to 7 mm Hg), and mean arterial pressure could be maintained satisfactorily in all patients (54 +/- 14 mm Hg). Mean RHB time was 54 +/- 14 min. Mean central venous pressure was 10.1 +/- 2.4 mm Hg after procedure and saturation was similar to that on (RHB 88% +/- 8%). The mean amount of drainage was 9.1 +/- 4.2 mL/kg per 24 hours. Avoiding an oxygenator and reducing the number of tubings achieved a combined cost savings of 40% for all procedures. CONCLUSIONS: Right heart bypass is a simple, safer, and less expensive alternative to conventional cardiopulmonary bypass. This technique allows effective decompression of superior vena cava, adequate oxygenation, and predicts saturation after Glenn shunt. It can also be applied for central shunts and pulmonary artery reconstructions with cost containment.

Pitfalls in creation of left atrial pressure-area relationships with automated border detection.

Creation of pressure-area relationships (loops) with automated border detection (ABD) involves correction for the variable inherent delay in the ABD signal relative to the pressure recording. This article summarizes (1) the results of in vitro experiments performed to define the range of, and factors that might influence, the ABD delay; (2) the difficulties encountered in evaluating a thin-walled structure like the left atrium in the dog model; and (3) the solutions to some of the difficulties found. The in vitro experiments showed that the ABD delay relative to high-fidelity pressure recordings ranges from 20 to 34 msec and 35 to 57 msec at echocardiographic frame rates of 60/sec and 33/sec, respectively. The delay was not influenced significantly by the type of transducer used, distance from the target area, or size of the target area. The delay in the ABD signal, relative to the echocardiographic image, ranges from nil to less than one frame duration, whereas it is delayed one to two frame durations relative to the electrocardiogram processed by the imaging system. In the dog model, inclusion of even small areas outside the left atrium rendered curves with apparent physiologic contour but inappropriately long delays of 90 to 130 msec. To exclude areas outside the left atrial cavity, time-gain compensation and lateral gain compensation were used much more extensively than during left ventricular ABD recording. By changing the type of sonomicrometers used in our experiments, we were able to record simultaneously ABD and ultrasonic crystal data. However, both spontaneous contrast originating from a right-sided heart bypass pump and electronic noise from the eletrocautery severely interferred with ABD recording.

Obliteration of a competitive forward flow from the ventricle after a bidirectional cavopulmonary shunt with an Amplatzer duct occluder.

A 7-month-old boy who was status post-bidirectional Glenn shunt implantation with residual ventricular flow to the pulmonary arteries (PA) presented with massive edema of the head and systemic desaturation soon after surgery. After test occlusion, an Amplatzer duct occluder was implanted at the PA banding site with subsequent decrease in the PA pressure, resolution of the edema and extubation.

Heparin surface coated hard shell venous reservoirs: experimental evaluation ex vivo.

The present study was designed for ex vivo evaluation of a heparin coated hard shell venous reservoir in comparison to uncoated control reservoirs. An open chest bovine right heart bypass model (n = 9, bodyweight 72 +/- 6 kg) with passive blood drainage from the right atrium into the venous reservoir and active retransfusion into the pulmonary artery (roller pump) was selected for this purpose. Clear priming was used for the open perfusion circuit. No heparin was given before or during the evaluation period which was scheduled for 6 hours. Reservoir blood flow was at the beginning 3.5 +/- 0.6 l/min for coated versus 3.4 +/- 0.3 l/min for uncoated (NS). After 6 hours, blood flow was 3.3 +/- 0.1 l/min for coated versus 2.7 +/- 0.4 l/min for uncoated (p < 0.05). Hematocrit moved from a baseline level of 30 +/- 2% for coated versus 28 +/- 3% for uncoated (NS) to 28 +/- 3% for coated versus 27 +/- 5% for uncoated (NS) after 6 hours. Prebypass platelet levels of 100% in both groups moved to 84 +/- 3% for coated versus 78 +/- 23% for uncoated (NS) after 6 hours. Activated coagulation time (ACT) before bypass was 148 +/- 12 s for coated and 153 +/- 6 s for uncoated (NS). After 6 hours, ACT was 160 +/- 9 s for coated versus 152 +/- 5 s for uncoated (NS). Thrombin time before bypass was 15 +/- 2 s for coated versus 16 +/- 2 s for uncoated (NS).(ABSTRACT TRUNCATED AT 250 WORDS)

Transcatheter fenestration of a total cavopulmonary connection baffle.

Transcatheter creation of a de novo fenestration of a total cavopulmonary connection baffle has not been previously reported from India. We present our experience with such a procedure in a 4-year-old child with recurrent pleural effusions in the early postoperative period.

[Experience of coronary artery bypass grafting on the beating heart with right heart bypass; 3 cases of octogenarian].

Right heart bypass (RHB) yields more stable hemodynamics by increasing left ventricular preload and collapse right ventricular chamber during the displacement of the heart on beating heart coronary artery bypass grafting (CABG). Recently beating heart CABG gaining popularity, and the indications for CABG have increasingly expanded to elderly person. Using RHB while exposing posterior branches by displacing the beating heart, we have attempted to make total revascularization in beating heart CABG. We performed beating heart CABG with RHB in 3 cases of octogenarian. All patients had left main trunk lesion and needed revascularization of posterior vessels. Introduction of RHB enabled us to approach to posterior target vessels in better exposure and under greater hemodynamic stability. All three patients had no complications postoperatively. Strictly speaking CABG with RHB is not off-pump CABG, but RHB system does not include either artificial lung or manipulation of the aorta. Therefore we think it is very effective support system which enables multiple coronary revascularization for elderly person.

Wang-Zwische double-lumen cannula leads to total cavopulmonary support in a failing Fontan sheep model.

BACKGROUND: We are developing a total cavopulmonary support system for failing Fontan physiology using the percutaneous Wang-Zwische double-lumen cannula (DLC). METHODS: We developed a sheep model of failing Fontan physiology through a right thoracotomy in 5 sheep. An extracardiac conduit was anastomosed to the inferior vena cava and superior vena cava, and a graft was applied to connect the conduit and the right pulmonary artery (PA) to create total vena cava-to-PA diversion, excluding the right heart. The DLC (commercialized as AvalonElite, Avalon Laboratories LLC, Rancho Dominguez, CA) was coupled with a CentriMag pump (Levitronix Waltham, MA) to form a cavopulmonary support system. The DLC was inserted through the right jugular vein and the superior vena cava into the extracardiac conduit with the infusion lumen opening aligned with the right PA bridge. Blood was withdrawn from the superior vena cava and the inferior vena cava through the drainage lumen and pumped into the right PA through the infusion lumen, with flow adjusted to 4.0±0.5 L/min. RESULTS: A successful Fontan model was created without cardiopulmonary bypass. After total venous blood diversion from the vena cava to the right PA artery, failing Fontan physiology developed, evidenced by elevated central venous pressure and dropping mean PA pressure and systolic arterial pressure. The DLC was successfully inserted, and hemodynamics were normalized in all 5 sheep for the duration of the 2-hour study. CONCLUSIONS: We created a model of failing Fontan circulation in sheep without cardiopulmonary bypass. The DLC system achieved total cavopulmonary support for 2 hours in our failing Fontan sheep model.