Wang-Zwische Double-Lumen Cannula Leads to Total Cavopulmonary Support in a Failing Fontan Sheep Model

doi:10.1016/j.athoracsur.2011.02.031

The Annals of Thoracic Surgery

Volume 91, Issue 6, June 2011, Pages 1956-1960

Presented at the Basic Science Forum of the Fifty-seventh Annual Meeting of the Southern Thoracic Surgical Association, Orlando, FL, Nov 3–6, 2010.

https://doi.org/10.1016/j.athoracsur.2011.02.031 Get rights and content

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 Blood was withdrawn from the superior vena cava and the inferior vena cava through the drainage lumen and pumped into the right PA through the infusion lumen, with flow adjusted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.

Section snippets

The DLC-Based CPAD

Our percutaneous CPAD consists of our patented DLC (AvalonElite, Avalon Laboratories LLC, Rancho Dominguez, CA) and a compact CentriMag pump (Levitronix Waltham, MA). The DLC is the critical component and is inserted from the jugular vein into the SVC and extracardiac conduit. The infusion opening is aligned with the right PA (RPA), the proximal drainage openings are positioned in SVC above the Fontan anastomosis for upper body venous drainage, and the distal end drainage openings are

Results

A successful failing Fontan model was created in the 5 sheep without cardiopulmonary bypass support (Fig 1B). After clamps were placed on the SVC and IVC between the right atrium and anastomosis, total venous blood was diverted from the SVC/IVC to the RPA through the extracardiac conduit into the pulmonary system, bypassing the right atrium and RV. Because there is no RV in the pulmonary circulation, an elevated CVP cannot overcome the high resistance from the long conduit and the limited size

Comment

The Fontan procedure is lifesaving for many patients but confers high morbidity and mortality both short-term and long-term because of failing Fontan circulation. Venoarterial ECMO is currently the best option to assist the patient with failing Fontan circulation [6, 7, 8]. However, ECMO has a time limit, is labor intensive, expensive, and traumatic to the blood. The bulky ECMO system includes an oxygenator, complex circuit, and full anticoagulation. ECMO is also nonambulatory and is associated

References (17)

C.A. Bermudez et al.
Initial experience with single cannulation for venovenous extracorporeal oxygenation in adults
Ann Thorac Surg
(2010)
A.J. Rogers et al.
Extracorporeal membrane oxygenation for postcardiotomy cardiogenic shock in children
Ann Thorac Surg
(1989)
K.L. Booth et al.
Extracorporeal membrane oxygenation support of the Fontan and biodirectional Glenn circulations
Ann Thorac Surg
(2004)
M. Chaudhari et al.
Rescue cardiac transplantation for early failure of the Fontan-type circulation in children
J Thorac Cardiovasc Surg
(2005)
M.D. Rodefeld et al.
Cavopulmonary assist: circulatory support for the univentricular Fontan circulation
Ann Thorac Surg
(2003)
A.L. Throckmorton et al.
Performance of a 3-bladed propeller pump to provide cavopulmonary assist in the failing Fontan circulation
Ann Thorac Surg
(2008)
M.D. Rodefeld et al.
Cavopulmonary assist for the univentricular Fontan circulation: von Karman viscous impeller pump
J Thorac Cardiovasc Surg
(2010)
R. Pretre et al.
Right-sided univentricular cardiac assistance in a failing Fontan circulation
Ann THorac Surg
(2008)

There are more references available in the full text version of this article.

Cited by (22)

Current Understanding and Future Directions of Transcatheter Devices to Assist Failing Fontan
2024, Journal of the Society for Cardiovascular Angiography and Interventions
Even if the Fontan operation is the surgical treatment of choice in patients with univentricular physiology, it remains a palliative strategy. Consequently, when Fontan patients reach adulthood, the majority of them develop late clinical sequelae of a failing cavo-pulmonary circuit (eg, liver failure, protein-losing enteropathy, and arrhythmias). Although heart transplantation represents the gold standard to treat this condition, Fontan patients usually accede to this therapy late, when risk of mortality is significantly increased, and a shortage of donor hearts limits transplantation in this special population. Mechanical circulatory support is an emerging field, but it is still in the experimental stage. Current mechanical circulatory devices have been used in Fontan circulation but are associated with the need for high-risk redo surgery. Percutaneous pumps are an emerging field that is still under investigation, with multiple prototypes developed. This review aims to analyze the hemodynamic profile of the developed intravascular pumps and their application in the preclinical scenario in the Fontan circulation.
Large Animal Models of Heart Failure: A Translational Bridge to Clinical Success
2020, JACC: Basic to Translational Science
Citation Excerpt :
One example is the CentriMag Circulatory ventricular assist device (Abbott Laboratories, Abbott Park, Illinois), which was recalled due to a calibrating system error linked to electromagnetic interference, which caused the device to stop (https://www.fda.gov/medical-devices/medical-device-recalls/abbott-recalls-centrimag-circulatory-support-system-motor-due-pump-and-motor-issues). Difficulties with the device occurred after FDA approval, despite several preclinical studies in both sheep (164−166) and pigs (167), 3 registered clinical trials (Table 2) (CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass; NCT00819793 [completed]; CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients; NCT01171950 [withdrawn]; and CentriMag RVAS U.S. Post-approval Study Protocol [CMagRVAS]; NCT01568424 [completed]), and a multicenter study that showed short-term support with low incidence of device-related complications and no device failure in cardiogenic shock patients 30 days after CentriMag implantation (168). These findings are not meant to undermine the importance of integrating preclinical and clinical studies for assessing safety and feasibility during development, but rather to highlight that work still remains regarding optimization of current systems that facilitate testing and/or approval of new therapies and devices.
Preclinical large animal models of heart failure (HF) play a critical and expanding role in translating basic science findings to the development and clinical approval of novel therapeutics and devices. The complex combination of cardiovascular events and risk factors leading to HF has proved challenging for the development of new treatments for these patients. This state-of-the-art review presents historical and recent studies in porcine, ovine, and canine models of HF and outlines existing methodologies and physiological phenotypes. The translational importance of large animal studies to clinical success is also highlighted with an overview of recent devices approved by the Food and Drug Administration, together with preclinical HF animal studies used to aid both development and safety and/or efficacy testing. Increasing the use of large animal models of HF holds significant potential for identifying the novel mechanisms underlying the clinical condition and to improving physiological and economical translation of animal research to successfully treat human HF.
Computational fluid dynamic simulations of a cavopulmonary assist device for failing Fontan circulation
2019, Journal of Thoracic and Cardiovascular Surgery
Adult patients who have undergone the Fontan procedure are highly vulnerable to gradual, progressive circulatory failure, and options to reverse this situation are few. A cavopulmonary assist device could decongest the venous and lymphatic systems, overcome elevated pulmonary vascular resistance, increase cardiac output, and support some of these patients to heart transplant. This study characterizes the performance and challenges of a novel multilumen cannula coupled to an external blood pump proposed as a potential Fontan cavopulmonary assist strategy.
Computational fluid dynamic simulations were conducted for 3 extracardiac Fontan geometries consisting of 1 idealized model and 2 patient-specific models. A range of physiologic flow rates and pump assist levels were simulated to calculate the pressure gain provided by the multilumen cannula. Hemolysis index was estimated for the idealized model with Lagrangian particle tracking and 2 variations of the power-law. Wall shear stresses were also examined.
Pressure gains up to 4 and 9 mm Hg were achieved for the idealized and patient-specific models, respectively. Pressure gains increased with both higher cardiac output and larger pump intake through the external pump. Flow-weighted hemolysis show hemoglobin damage levels to be several times lower than the 2% threshold at the highest pump intake flow cases. Wall shear stress predictions depict elevated areas in the pulmonary vessels and regions of the cannula device.
The cannula tested in this study shows promise as a percutaneous option to bridge support in some patients with a failing extracardiac Fontan. Limitations identified will be addressed in future design iterations and in ongoing experimental tests.
Heart transplantation in adults for Fontan failure
2016, Progress in Pediatric Cardiology
Citation Excerpt :
Case reports in the literature describe off-label use of ventricular assist devices in univentricular patients [23], with a higher complication rate than two ventricular patients [24–26]. Wang et al. developed a failing Fontan sheep model to test cavopulmonary assist devices [27]. Impella-like devices specifically designed for Fontan circulation show the most promise [28,29].
Physics-driven impeller designs for a novel intravascular blood pump for patients with congenital heart disease
2016, Medical Engineering and Physics
Citation Excerpt :
Flow is provided by an external CentriMag pump and the umbrellas are collapsible in the event of pump failure [27]. The device has been tested in sheep models [27-29]. Recirculation regions exist around the inlets to the cannula as well as stagnation regions on both sides of the umbrellas that may lead to thrombus formation.
Mechanical circulatory support offers an alternative therapeutic treatment for patients with dysfunctional single ventricle physiology. An intravascular axial flow pump is being developed as a cavopulmonary assist device for these patients. This study details the development of a new rotating impeller geometry. We examined the performance of 8 impeller geometries with blade stagger or twist angles varying from 100° to 800° using computational methods. A refined range of blade twist angles between 300° and 400° was then identified, and 4 additional geometries were evaluated. Generally, the impeller designs produced 4–26 mmHg for flow rates of 1–4 L/min for 6000–8000 RPM. A data regression analysis was completed and found the impeller with 400° of blade twist to be the superior performer. A hydraulic test was conducted on a prototype of the 400° impeller, which generated measurable pressure rises of 7–28 mmHg for flow rates of 1–4 L/min at 6000–8000 RPM. The findings of the numerical model and experiment were in reasonable agreement within approximately 20%. These results support the continued development of an axial-flow, mechanical cavopulmonary assist device as a new clinical therapeutic option for Fontan patients.
Effect of mechanical assistance of the systemic ventricle in single ventricle circulation with cavopulmonary connection
2014, Journal of Thoracic and Cardiovascular Surgery
Citation Excerpt :
The inherent inefficiencies of the Fontan circulation, however, have led to delayed Fontan failure in some patients and can lead to late mortality and morbidity.6-9 Previous reports have focused on mechanical assistance for this failing circulation using subpulmonary blood pumps to drive the blood forward through the pulmonary circuit4,5,10-14 or a viscous impeller pump, based on the Von Karman principle.3,15 Although clinical success10 has been seen with this approach of pushing blood through the pulmonary circuit, significant surgical modifications to the existing cavopulmonary circuit, or custom-made pumps are required to implement this strategy.
Previous attempts to support single ventricle circulation mechanically have suggested that a custom-built assist device is needed to push, rather than pull, through the pulmonary circulation. We hypothesized that using a conventional ventricular assist device, with or without conversion of a total cavopulmonary connection to a bidirectional Glenn cavopulmonary connection, would allow assistance by pulling blood through the circuit and improve the cardiac index (CI).
Cavopulmonary connections were established in each of 5 Yorkshire pigs (25 kg) using ePTFE conduits in a Y configuration with appropriate clamping of the limbs of the Y to achieve a total cavopulmonary Fontan connection (TCPC), superior vena cava cavopulmonary connection (SVC Glenn), and inferior vena cava cavopulmonary connection (IVC Glenn). A common atrium had been established previously by balloon septostomy. Mechanical circulatory assistance of the single systemic ventricle was achieved using a centrifugal pump with common atrial inflow and proximal ascending aortic outflow. The CI was calculated using an ultrasonic flow meter placed on the distal ascending aorta and compared between the assisted and nonassisted circulation for 3 conditions: TCPC, SVC Glenn, and IVC Glenn. The mean pulmonary artery pressure, common atrial pressure, arterial oxygen saturation, partial pressure of arterial oxygen, and oxygen delivery were calculated.
The unassisted SVC Glenn CI tended to be greater than the TCPC or IVC Glenn CI. Significant augmentation of total CI was achieved with mechanical assistance for SVC Glenn (109% ± 24%, P = .04) and TCPC (130% ± 109%, P = .01). The assisted CI achieved at least a mean baseline biventricular CI for all 3 support modes. Oxygen delivery was greatest for assisted SVC Glenn (1786 ± 1307 mL/L/min) and lowest for TCPC (1146 ± 386 mL/L/min), with a trend toward lower common atrial and pulmonary artery pressures for SVC Glenn.
SVC bidirectional Glenn circulation might allow optimal augmentation of the CI and oxygen delivery in a failing single ventricle using a conventional pediatric ventricular assist device. The results from our model also suggest that the Fontan circulation itself can be supported with systemic ventricular assistance of the single ventricle.

View all citing articles on Scopus

View full text

Original articlePediatric cardiacWang-Zwische Double-Lumen Cannula Leads to Total Cavopulmonary Support in a Failing Fontan Sheep Model

Background

Methods

Results

Conclusions

Section snippets

The DLC-Based CPAD

Results

Comment

Ann Thorac Surg

Ann Thorac Surg

Ann Thorac Surg

J Thorac Cardiovasc Surg

Ann Thorac Surg

Ann Thorac Surg

J Thorac Cardiovasc Surg

Ann THorac Surg

Original article
Pediatric cardiac
Wang-Zwische Double-Lumen Cannula Leads to Total Cavopulmonary Support in a Failing Fontan Sheep Model