Patient-specific tissue engineered vascular graft for aortic arch reconstruction.

Objectives: The complexity of aortic arch reconstruction due to diverse 3-dimensional geometrical abnormalities is a major challenge. This study introduces 3-dimensional printed tissue-engineered vascular grafts, which can fit patient-specific dimensions, optimize hemodynamics, exhibit antithrombotic and anti-infective properties, and accommodate growth. Methods: We procured cardiac magnetic resonance imaging with 4-dimensional flow for native porcine anatomy (n = 10), from which we designed tissue-engineered vascular grafts for the distal aortic arch, 4 weeks before surgery. An optimal shape of the curved vascular graft was designed using computer-aided design informed by computational fluid dynamics analysis. Grafts were manufactured and implanted into the distal aortic arch of porcine models, and postoperative cardiac magnetic resonance imaging data were collected. Pre- and postimplant hemodynamic data and histology were analyzed. Results: Postoperative magnetic resonance imaging of all pigs with 1:1 ratio of polycaprolactone and poly-L-lactide-co-ε-caprolactone demonstrated no specific dilatation or stenosis of the graft, revealing a positive growth trend in the graft area from the day after surgery to 3 months later, with maintaining a similar shape. The peak wall shear stress of the polycaprolactone/poly-L-lactide-co-ε-caprolactone graft portion did not change significantly between the day after surgery and 3 months later. Immunohistochemistry showed endothelization and smooth muscle layer formation without calcification of the polycaprolactone/poly-L-lactide-co-ε-caprolactone graft. Conclusions: Our patient-specific polycaprolactone/poly-L-lactide-co-ε-caprolactone tissue-engineered vascular grafts demonstrated optimal anatomical fit maintaining ideal hemodynamics and neotissue formation in a porcine model. This study provides a proof of concept of patient-specific tissue-engineered vascular grafts for aortic arch reconstruction.

In vitro investigation of axial mechanical support devices implanted in the novel convergent cavopulmonary connection Fontan.

OBJECTIVES: The 2 opposing inflows and 2 outflows in a total cavopulmonary connection make mechanical circulatory support (MCS) extremely challenging. We have previously reported a novel convergent cavopulmonary connection (CCPC) Fontan design that improves baseline characteristics and provides a single inflow and outflow, thus simplifying MCS. This study aims to assess the feasibility of MCS of this novel configuration using axial flow pumps in an in vitro benchtop model. METHODS: Three-dimensional segmentations of 12 single-ventricle patients (body surface area 0.5-1.75 m2) were generated from cardiovascular magnetic resonance images. The CCPC models were designed by connecting the inferior vena cava and superior vena cava to a shared conduit ascending to the pulmonary arteries, optimized in silico. The 12 total cavopulmonary connection and their corresponding CCPC models underwent in vitro benchtop characterization. Two MCS devices were used, the Impella RP® and the PediPump. RESULTS: MCS successfully and symmetrically reduced the pressure in both vena cavae by >20 mmHg. The devices improved the hepatic flow distribution balance of all CCPC models (Impella RP®P = 0.045, PediPump P = 0.055). CONCLUSIONS: The CCPC Fontan design provides a feasible MCS solution for a failing Fontan by balancing hepatic flow distribution and symmetrically decompressing the central venous pressure. Cardiac index may also improve with MCS. Additional studies are needed to evaluate this concept for managing Fontan failure.

Virtual Planning and Patient-Specific Graft Design for Aortic Repairs.

PURPOSE: Patients presenting with coarctation of the aorta (CoA) may also suffer from co-existing transverse arch hypoplasia (TAH). Depending on the risks associated with the surgery and the severity of TAH, clinicians may decide to repair only CoA, and monitor the TAH to see if it improves as the patient grows. While acutely successful, eventually hemodynamics may become suboptimal if TAH is left untreated. The objective of this work aims to develop a patient-specific surgical planning framework for predicting and assessing postoperative outcomes of simple CoA repair and comprehensive repair of CoA and TAH. METHODS: The surgical planning framework consisted of virtual clamp placement, stenosis resection, and design and optimization of patient-specific aortic grafts that involved geometrical modeling of the graft and computational fluid dynamics (CFD) simulation for evaluating various surgical plans. Time-dependent CFD simulations were performed using Windkessel boundary conditions at the outlets that were obtained from patient-specific non-invasive pressure and flow data to predict hemodynamics before and after the virtual repairs. We applied the proposed framework to investigate optimal repairs for six patients (n = 6) diagnosed with both CoA and TAH. Design optimization was performed by creating a combination of a tubular graft and a waterslide patch to reconstruct the aortic arch. The surfaces of the designed graft were parameterized to optimize the shape. RESULTS: Peak systolic pressure drop (PSPD) and time-averaged wall shear stress (TAWSS) were used as performance metrics to evaluate surgical outcomes of various graft designs and implantation. The average PSPD improvements were 28% and 44% after the isolated CoA repair and comprehensive repair, respectively. Maximum values of TAWSS were decreased by 60% after CoA repair and further improved by 22% after the comprehensive repair. The oscillatory shear index was calculated and the values were confirmed to be in the normal range after the repairs. CONCLUSION: The results showed that the comprehensive repair outperforms the simple CoA repair and may be more advantageous in the long term in some patients. We demonstrated that the surgical planning and patient-specific flow simulations could potentially affect the selection and outcomes of aorta repairs.

In-vivo evaluation of catheter integrity with the use of a novel catheter torque tool.

INTRODUCTION: Electrophysiology studies and ablation procedures require strength, steadiness, and dexterity to manipulate catheters. We have previously described a novel catheter torque tool (Peritorq) that improves torqueability and stability and decreases user muscle fatigue. The objective was to evaluate measures of catheter integrity with and without the torque tool in place using multiple diagnostic and ablation catheters in an adult porcine model. METHODS: Diagnostic and ablation catheters were inserted through the femoral or jugular vein into areas of the right atrium, coronary sinus (CS), and right ventricle. Electrical measurements including impedance, sensing, and capture thresholds were obtained with and without the torque tool. Ablation lesions (30 s) were given at different locations using both irrigated and nonirrigated catheters and measurements were recorded with and without the torque tool. RESULTS: Procedures were performed in eight adult pigs. Measurements with and without the torque tool in all locations did not differ significantly using any of the catheters. With the nonirrigated ablation catheter there was a significant difference in maximum (mean 1.7 W, p = .03) and average power (mean 9.1 W, p = .04) delivery at the PS tricuspid valve, but there were no other differences with the irrigated or nonirrigated catheters. Subjective assessment by the operator revealed a substantial improvement in maneuverability, ability to transfer torque, and stability within the cardiac space. CONCLUSION: In an in-vivo environment, a novel catheter torque tool subjectively improved catheter manipulation and did not have a significant impact on the integrity of electrophysiologic catheters. Further study including additional catheters and in-vivo human testing is indicated.

Percutaneous epicardial pacing in infants using direct visualization: A feasibility animal study.

BACKGROUND: Pacemaker implantation in infants and small children is limited to epicardial lead placement via open chest surgery. We propose a minimally invasive solution using a novel percutaneous access kit. OBJECTIVE: To evaluate the acute safety and feasibility of a novel percutaneous pericardial access tool kit to implant pacemaker leads on the epicardium under direct visualization. METHODS: A custom sheath with optical fiber lining the inside wall was built to provide intrathoracic illumination. A Veress needle inside the illumination sheath was inserted through a skin nick just to the left of the xiphoid process and angled toward the thorax. A needle containing a fiberscope within the lumen was inserted through the sheath and used to access the pericardium under direct visualization. A custom dilator and peel-away sheath with pre-tunneled fiberscope was passed over a guidewire into the pericardial space via modified Seldinger technique. A side-biting multipolar pacemaker lead was inserted through the sheath and affixed against the epicardium. RESULTS: Six piglets (weight 3.7-4.0 kg) had successful lead implantation. The pericardial space could be visualized and entered in all animals. Median time from skin nick to sheath access of the pericardium was 9.5 (interquartile range [IQR] 8-11) min. Median total procedure time was 16 (IQR 14-19) min. Median R wave sensing was 5.4 (IQR 4.0-7.3) mV. Median capture threshold was 2.1 (IQR 1.7-2.4) V at 0.4 ms and 1.3 (IQR 1.2-2.0) V at 1.0 ms. There were no complications. CONCLUSION: Percutaneous epicardial lead implantation under direct visualization was successful in six piglets of neonatal size and weight with clinically acceptable acute pacing parameters.

The convergent cavopulmonary connection: A novel and efficient configuration of Fontan to accommodate mechanical support.

Objective: The current total cavopulmonary connection Fontan has competing inflows and outflows, creating hemodynamic inefficiencies that contribute to Fontan failure and complicate placement and efficiency of mechanical circulatory support. We propose a novel convergent cavopulmonary connection (CCPC) Fontan design to create a single, converged venous outflow to the pulmonary arteries, thus increasing efficiency and mechanical circulatory support access. We then evaluate the feasibility and hemodynamic performance of the CCPC in various patient sizes using computational fluid dynamic assessments of computer-aided designs. Methods: Cardiac magnetic resonance imaging data from 12 patients with single ventricle (10 total cavopulmonary connection, 2 Glenn) physiology (body surface area, 0.5-2.0 m2) were segmented to create 3-dimensional replicas of all thoracic structures. Surgically feasible CCPC shapes within constraints of anatomy were created using iterative computational fluid dynamic and clinician input. Designs varied based on superior and inferior vena cava conduit sizes, coronal attachment height, coronal entry angle, and axial entry angle of the superior vena cava to the inferior vena cava. CCPC designs were optimized based on efficiency (indexed power loss), risk of arteriovenous malformations (hepatic flow distribution), and risk of flow stasis (% nonphysiologic wall shear stress). Results: All CCPC designs met hemodynamic performance thresholds for indexed power loss and hepatic flow distribution. CCPC designs showed improvements in reducing % nonphysiologic wall shear stress and balancing HFD. Conclusions: CCPC is physiologically and surgically feasible in various patient sizes using validated computational fluid dynamic models. CCPC configuration has analogous indexed power loss, hepatic flow distribution, and % nonphysiologic wall shear stress compared with total cavopulmonary connection, and the single inflow and outflow may ease mechanical circulatory support therapies. Further studies are required for design optimization and mechanical circulatory support institution.

A novel videoscope and tool kit for percutaneous pericardial access under direct visualization.

BACKGROUND: Pericardial access is necessary for the application of epicardial cardiac therapies including ablation catheters, pacing and defibrillation leads, and left atrial appendage closure systems. Pericardial access under fluoroscopic guidance is difficult in patients without pericardial effusions and may result in coronary artery damage, ventricular injury, or perforation with potentially life-threatening pericardial bleeding in up to 10% of cases. There is a clinical need for a pericardial access technique to safely deliver epicardial cardiac therapies. METHODS: In this paper, we describe the design and evaluation of a novel videoscope and tool kit to percutaneously access the pericardial space under direct visualization. Imaging is performed by a micro-CMOS camera with an automatic gain adjustment software to prevent image saturation. Imaging quality is quantified using known optical targets, while tool performance is evaluated in pediatric insufflation and pericardial access simulators. Device safety and efficacy is demonstrated by infant porcine preclinical studies (N = 6). RESULTS: The videoscope has a resolution of 400 × 400 pixels, imaging rate of 30 frames per second, and fits within the lumen of a 14G needle. The tool can resolve features smaller than 39.4 µm, achieves a magnification of 24x, and has a maximum of 3.5% distortion within the field of view. Successful pericardial access was achieved in pediatric simulators and acute in vivo animal studies. During in vivo testing, it took the electrophysiologist an average of 66.83 ± 32.86 s to insert the pericardial access tool into the thoracic space and visualize the heart. After visualizing the heart, it took an average of 136.67 ± 80.63 s to access the pericardial space under direct visualization. The total time to pericardial access measured from needle insertion was 6.7 × quicker than pericardial access using alternative direct visualization techniques. There was no incidence of ventricular perforation. CONCLUSIONS: Percutaneous pericardial access under direct visualization is a promising technique to access the pericardial space without complications in simulated and in vivo animal models.

Interprofessional Extracorporeal Membrane Oxygenation Cardiopulmonary Resuscitation Simulations Aimed at Decreasing Actual Cannulation Times: A Longitudinal Study.

BACKGROUND: Since 2013, the cardiac intensive care unit (CICU) at Children's National has conducted annual extracorporeal membrane oxygenation cardiopulmonary resuscitation (ECPR) simulations that focus on team dynamics, room setup, and high-quality CPR. In 2019 and 2020, the simulations were expanded to include the surgical and extracorporeal membrane oxygenation (ECMO) teams in an effort to better understand and improve this process. METHODS: During a 4-week period in 2019, 7 peripheral ECPR simulations were conducted, and through a 3-week period in 2020, 7 central ECPR simulations were conducted. Participants in each session included: 8 to 10 CICU nurses, 1 CICU attending, 1 to 2 ICU or cardiology fellows, 1 cardiovascular surgery fellow or attending, and 1 ECMO specialist. For each session, the scenario continued until the simulated patient was on full cardiopulmonary bypass. An ECMO trainer was used for peripheral simulations and a 3-dimensionally-printed heart was used for central cannulations. An ECMO checklist was used to objectively determine when the patient and room were fully prepared for surgical intervention, and simulated cannulation times were recorded for both groups. A retrospective chart review was conducted to compare actual cannulation times before and after the intervention period, and video was used to review the events and assist in dividing them into medical versus surgical phases. Control charts were used to trend the total ECPR times before and after the intervention period, and mean and P values were calculated for both ECPR times and for all other categorical data. RESULTS: Mean peripheral ECPR times decreased significantly from 71.7 to 45.1 minutes ( P = 0.036) after the intervention period, and this was reflected by a centerline shift. Although we could not describe a similar decrease in central ECPR times because there were only 6 postintervention events, the times for each of these events were shorter than the historical mean of 37.8 minutes. There was a trend in improved survival, which did not meet significance both among patients undergoing peripheral ECPR (15.4% ± 10% to 43.8% ± 12.4%, P = 0.10) and central ECPR (36.4% ± 8.4% to 50% ± 25%, P = 0.60). The percentage of time dedicated to the medical phases of the actual versus simulated procedures was very consistent among both peripheral (33.0% vs. 31.9%) and central (39.6% vs. 39.8%) cannulations. CONCLUSIONS: We observed a significant decrease in peripheral cannulation times at our institution after conducting interprofessional ECPR simulations taken to the establishment of full cardiopulmonary bypass. The use of an ECMO trainer and a 3-dimensionally-printed heart allowed for both the medical and surgical phases of the procedure to be studied in detail, providing opportunities to streamline and improve this complex process. Larger multisite studies will be needed in the future to assess the effect of efforts like these on patient survival.

Design and Functionality of a Multilumen Thoracic Access Port for Pericardial Access Under Direct Visualization.

Small vasculature, venous obstruction, or congenital anomalies can preclude transvenous access to the heart, often resulting in open chest surgery to implant cardiac therapy leads for pacing, defibrillation, or cardiac resynchronization. A minimally invasive approach under direct visualization could reduce tissue damage, minimize pain, shorten recovery time, and obviate the need for fluoroscopy. Therefore, PeriPath was designed as a single-use, low-cost pericardial access tool based on clinical requirements. Its mechanical design aids in safe placement of conductive leads to the pericardium using a modified Seldinger technique. The crossed working channels provide an optimal view of the surgical field under direct visualization. Finite element analysis (FEA) confirms that the device is likely not to fail under clinical working conditions. Mechanical testing demonstrates that the tensile strength of its components is sufficient for use, with minimal risk of fracture. The PeriPath procedure is also compatible with common lead implantation tools and can be readily adopted by interventional cardiologists and electrophysiologists, allowing for widespread implementation. Prior animal work and a physician preliminary validation study suggest that PeriPath functions effectively for minimally invasive lead implantation procedures.

Muscle usage and workload assessment of cardiac ablation procedure with the use of a novel catheter torque tool in a pediatric simulator.

BACKGROUND: Cardiac ablation catheters are small in diameter and pose ergonomic challenges that can affect catheter stability. Significant finger dexterity and strength are necessary to maneuver them safely. We evaluated a novel torque tool to reduce muscle activation when manipulating catheters and improve perceived workload of ablation tasks. The objective was to evaluate measurable success, user perception of workload, and muscle usage when completing a simulated ablation task with and without the use of a catheter torque tool. METHODS: Cardiology attendings and fellows were fitted with surface electromyographic (EMG) sensors on 6 key muscle groups in the left hand and forearm. A standard ablation catheter was inserted into a pediatric cardiac ablation simulator and subjects navigated the catheter tip to 6 specific electrophysiologic targets, including a 1-min simulated radiofrequency ablation lesion. Time to complete the task, number of attempts required to complete the lesion, and EMG activity normalized to percentage of maximum voluntary contraction were collected throughout the task. The task was completed 4 times, twice with and twice without the torque tool, in semi-randomized order. A NASA Task Load Index survey was completed by the participant at the conclusion of each task. RESULTS: Time to complete the task and number of attempts to create a lesion were not altered by the tool. Subjectively, participants reported a significant decrease in physical demand, effort, and frustration, and a significant increase in performance. Muscle activation was decreased in 4 of 6 muscle groups. CONCLUSION: The catheter torque tool may improve the perceived workload of cardiac ablation procedures and reduce muscle fatigue caused by manipulating catheters. This may result in improved catheter stability and increased procedural safety.

An infant phantom for pediatric pericardial access and electrophysiology training.

Background: Cardiac procedures in infants and children require a high level of skill and dexterity owing to small stature and anatomy. Lower incidence of procedure volume in this population results in fewer clinical opportunities for learning. Simulators have grown in popularity for education and training, though most existing simulators are often cost-prohibitive or model adult anatomy. Objective: Develop a low-cost simulator for practicing the skills to perform percutaneous pericardial access and cardiac ablation procedures in pediatric patients. Methods: We describe 2 simulators for practicing cardiac procedures in pediatric patients, with a total cost of less than $500. Both simulators are housed within an infant-size doll. The first simulator is composed of an infant-size heart and a skin-like covering to practice percutaneous pericardial access to the heart. Participants obtained sheath access to the heart under direct visualization. The second simulator houses a child-size heart with 7 touch-activated targets to practice manipulating a catheter through a small heart. This can be performed under direct visualization and with 3-dimensional mapping via CARTO. Participants manipulated a catheter to map the heart by touching the 6 positive targets, avoiding the negative target. Results: Physicians-in-training improved their time to complete the task between the first and second attempts. Physicians experienced with the tools took less time to complete the task than physicians-in-training. Conclusion: This inexpensive simulator is anatomically realistic and can be used to practice manipulating procedure tools and develop competency for pediatric cardiac procedures.

Virtual Reality Cardiac Surgical Planning Software (CorFix) for Designing Patient-Specific Vascular Grafts: Development and Pilot Usability Study.

BACKGROUND: Patients with single ventricle heart defects receive 3 stages of operations culminating in the Fontan procedure. During the Fontan procedure, a vascular graft is sutured between the inferior vena cava and pulmonary artery to divert deoxygenated blood flow to the lungs via passive flow. Customizing the graft configuration can maximize the long-term benefits. However, planning patient-specific procedures has several challenges, including the ability for physicians to customize grafts and evaluate their hemodynamic performance. OBJECTIVE: The aim of this study was to develop a virtual reality (VR) Fontan graft modeling and evaluation software for physicians. A user study was performed to achieve 2 additional goals: (1) to evaluate the software when used by medical doctors and engineers, and (2) to explore the impact of viewing hemodynamic simulation results in numerical and graphical formats. METHODS: A total of 5 medical professionals including 4 physicians (1 fourth-year resident, 1 third-year cardiac fellow, 1 pediatric intensivist, and 1 pediatric cardiac surgeon) and 1 biomedical engineer voluntarily participated in the study. The study was pre-scripted to minimize the variability of the interactions between the experimenter and the participants. All participants were trained to use the VR gear and our software, CorFix. Each participant designed 1 bifurcated and 1 tube-shaped Fontan graft for a single patient. A hemodynamic performance evaluation was then completed, allowing the participants to further modify their tube-shaped design. The design time and hemodynamic performance for each graft design were recorded. At the end of the study, all participants were provided surveys to evaluate the usability and learnability of the software and rate the intensity of VR sickness. RESULTS: The average times for creating 1 bifurcated and 1 tube-shaped graft after a single 10-minute training session were 13.40 and 5.49 minutes, respectively, with 3 out 5 bifurcated and 1 out of 5 tube-shaped graft designs being in the benchmark range of hepatic flow distribution. Reviewing hemodynamic performance results and modifying the tube-shaped design took an average time of 2.92 minutes. Participants who modified their tube-shaped graft designs were able to improve the nonphysiologic wall shear stress (WSS) percentage by 7.02%. All tube-shaped graft designs improved the WSS percentage compared to the native surgical case of the patient. None of the designs met the benchmark indexed power loss. CONCLUSIONS: VR graft design software can quickly be taught to physicians with no engineering background or VR experience. Improving the CorFix system could improve performance of the users in customizing and optimizing grafts for patients. With graphical visualization, physicians were able to improve WSS percentage of a tube-shaped graft, lowering the chance of thrombosis. Bifurcated graft designs showed potential strength in better flow split to the lungs, reducing the risk for pulmonary arteriovenous malformations.

Computational Fontan Analysis: Preserving Accuracy While Expediting Workflow.

Background: Postoperative outcomes of the Fontan operation have been linked to geometry of the cavopulmonary pathway, including graft shape after implantation. Computational fluid dynamics (CFD) simulations are used to explore different surgical options. The objective of this study is to perform a systematic in vitro validation for investigating the accuracy and efficiency of CFD simulation to predict Fontan hemodynamics. Methods: CFD simulations were performed to measure indexed power loss (iPL) and hepatic flow distribution (HFD) in 10 patient-specific Fontan models, with varying mesh and numerical solvers. The results were compared with a novel in vitro flow loop setup with 3D printed Fontan models. A high-resolution differential pressure sensor was used to measure the pressure drop for validating iPL predictions. Microparticles with particle filtering system were used to measure HFD. The computational time was measured for a representative Fontan model with different mesh sizes and numerical solvers. Results: When compared to in vitro setup, variations in CFD mesh sizes had significant effect on HFD (P = .0002) but no significant impact on iPL (P = .069). Numerical solvers had no significant impact in both iPL (P = .50) and HFD (P = .55). A transient solver with 0.5 mm mesh size requires computational time 100 times more than a steady solver with 2.5 mm mesh size to generate similar results. Conclusions: The predictive value of CFD for Fontan planning can be validated against an in vitro flow loop. The prediction accuracy can be affected by the mesh size, model shape complexity, and flow competition.

Surgical Planning and Optimization of Patient-Specific Fontan Grafts With Uncertain Post-Operative Boundary Conditions and Anastomosis Displacement.

OBJECTIVE: Fontan surgical planning involves designing grafts to perform optimized hemodynamic performance for the patient's long-term health benefit. The uncertainty of post-operative boundary conditions (BC) and graft anastomosis displacements can significantly affect optimized graft designs and lead to undesirable outcomes, especially for hepatic flow distribution (HFD). We aim to develop a computation framework to automatically optimize patient-specific Fontan grafts with the maximized possibility of keeping post-operative results within clinical acceptable thresholds. METHODS: The uncertainties of BC and anastomosis displacements were modeled using Gaussian distributions according to prior research studies. By parameterizing the Fontan grafts, we built surrogate models of hemodynamic parameters taking the design parameters and BC as input. A two-phase reliability-based robust optimization (RBRO) strategy was developed by combining deterministic optimization (DO) and optimization under uncertainty (OUU) to reduce computational cost. RESULTS: We evaluated the performance of the RBRO framework by comparing it with the DO method in four cases of Fontan patients. The results showed that the surgical plans computed from the proposed method yield up to 79.2% improvement in the reliability of the HFD than those of the DO method ( ). The mean values of indexed power loss (iPL) and the percentage of non-physiologic wall shear stress (%WSS) for the optimized surgical plans met the clinically acceptable thresholds. CONCLUSION: This study demonstrated the effectiveness of our RBRO framework to address the uncertainties of BC and anastomosis displacements for Fontan surgical planning. SIGNIFICANCE: The technique developed in this paper demonstrates a significant improvement in the reliability of the predicted post-operative outcomes for Fontan surgical planning. This planning technique is immediately applicable as a building block to enable technology for optimal long-term outcomes for pediatric Fontan patients and can also be used in other pediatric and adult cardiac surgeries.

Location matters: Offset in tissue-engineered vascular graft implantation location affects wall shear stress in porcine models.

Objective: Although surgical simulation using computational fluid dynamics has advanced, little is known about the accuracy of cardiac surgical procedures after patient-specific design. We evaluated the effects of discrepancies in location for patient-specific simulation and actual implantation on hemodynamic performance of patient-specific tissue-engineered vascular grafts (TEVGs) in porcine models. Methods: Magnetic resonance angiography and 4-dimensional (4D) flow data were acquired in porcine models (n = 11) to create individualized TEVGs. Graft shapes were optimized and manufactured by electrospinning bioresorbable material onto a metal mandrel. TEVGs were implanted 1 or 3 months postimaging, and postoperative magnetic resonance angiography and 4D flow data were obtained and segmented. Displacement between intended and observed TEVG position was determined through center of mass analysis. Hemodynamic data were obtained from 4D flow analysis. Displacement and hemodynamic data were compared using linear regression. Results: Patient-specific TEVGs were displaced between 1 and 8 mm during implantation compared with their surgically simulated, intended locations. Greater offset between intended and observed position correlated with greater wall shear stress (WSS) in postoperative vasculature (P < .01). Grafts that were implanted closer to their intended locations showed decreased WSS. Conclusions: Patient-specific TEVGs are designed for precise locations to help optimize hemodynamic performance. However, if TEVGs were implanted far from their intended location, worse WSS was observed. This underscores the importance of not only patient-specific design but also precision-guided implantation to optimize hemodynamics in cardiac surgery and increase reproducibility of surgical simulation.

Right ventricular afterload in repaired D-TGA is associated with inefficient flow patterns, rather than stenosis alone.

Treatment of D- transposition of great arteries (DTGA) involves the Arterial Switch Operation (ASO), which can create PA branch stenosis (PABS) and alter PA blood flow energetics. This altered PA flow may contribute to elevated right ventricular (RV) afterload more significantly than stenosis alone. Our aim was to correlate RV afterload and PA flow characteristics using 4D flow cardiac magnetic resonance (CMR) imaging of a mock circulatory system (MCS) incorporating 3D printed replicas. CMR imaging and clinical characteristics were analyzed from 22 ASO patients (age 11.9 ± 8.7 years, 68% male). Segmentation was performed to create 3D printed PA replicas that were mounted in an MRI-compatible MCS. Pressure drop across the PA replica was recorded and 4D flow CMR acquisitions were analyzed for blood flow inefficiency (energy loss, vorticity). In post-ASO patients, there is no difference in RV mass (p = 0.07), nor RV systolic pressure (p = 0.26) in the presence or absence of PABS. 4D flow analysis of MCS shows energy loss is correlated to RV mass (p = 0.01, r = 0.67) and MCS pressure differential (p = 0.02, r = 0.57). Receiver operating characteristic curve shows energy loss detects elevated RV mass above 30 g/m2 (p = 0.02, AUC 0.88) while index of PA dimensions (Nakata) does not (p = 0.09, AUC 0.79). PABS alone does not account for differences in RV mass or afterload in post-ASO patients. In MCS simulations, energy loss is correlated with both RV mass and PA pressure, and can moderately detect elevated RV mass. Inefficient PA flow may be an important predictor of RV afterload in this population.

Semi-Automatic Planning and Three-Dimensional Electrospinning of Patient-Specific Grafts for Fontan Surgery.

This paper proposes a semi-automatic Fontan surgery planning method for designing and manufacturing hemodynamically optimized patient-specific grafts. Fontan surgery is a palliative procedure for patients with a single ventricle heart defect by creating a new path using a vascular graft for the deoxygenated blood to be directed to the lungs, bypassing the heart. However, designing patient-specific grafts with optimized hemodynamic performance is a complex task due to the variety of patient-specific anatomies, confined surgical planning space, and the requirement of simultaneously considering multiple design criteria for vascular graft optimization. To address these challenges, we used parameterized Fontan pathways to explore patient-specific vascular graft design spaces and search for optimal solutions by formulating a nonlinear constrained optimization problem, which minimizes indexed power loss (iPL) of the Fontan model by constraining hepatic flow distribution (HFD), percentage of abnormal wall shear stress (%WSS) and geometric interference between Fontan pathways and the heart models (InDep) within clinically acceptable thresholds. Gaussian process regression was employed to build surrogate models of the hemodynamic parameters as well as InDep and [Formula: see text] (conduit model smoothness indicator) for optimization by pattern search. We tested the proposed method on two patient-specific models (n=2). The results showed the automatically optimized (AutoOpt) Fontan models hemodynamically outperformed or at least are comparable to manually optimized Fontan models with significantly reduced surgical planning time (15 hours versus over 2 weeks). We also demonstrated feasibility of manufacturing the AutoOpt Fontan conduits by using electrospun nanofibers.

Altered hemodynamics by 4D flow cardiovascular magnetic resonance predict exercise intolerance in repaired coarctation of the aorta: an in vitro study.

BACKGROUND: Coarctation of the aorta (CoA) is associated with decreased exercise capacity despite successful repair. Altered flow patterns have been identified due to abnormal aortic arch geometry. Our previous work demonstrated aorta size mismatch to be associated with exercise intolerance in this population. In this study, we studied aortic flow patterns during simulations of exercise in repaired CoA using 4D flow cardiovascular magnetic resonance (CMR) using aortic replicas connected to an in vitro flow pump and correlated findings with exercise stress test results to identify biomarkers of exercise intolerance. METHODS: Patients with CoA repair were retrospectively analyzed after CMR and exercise stress test. Each aorta was manually segmented and 3D printed. Pressure gradient measurements from ascending aorta (AAo) to descending aorta (DAo) and 4D flow CMR were performed during simulations of rest and exercise using a mock circulatory flow loop. Changes in wall shear stress (WSS) and secondary flow formation (vorticity and helicity) from rest to exercise were quantified, as well as estimated DAo Reynolds number. Parameters were correlated with percent predicted peak oxygen consumption (VO2max) and aorta size mismatch (DAAo/DDAo). RESULTS: Fifteen patients were identified (VO2max 47 to 126% predicted). Pressure gradient did not correlate with VO2max at rest or exercise. VO2max correlated positively with the change in peak vorticity (R = 0.55, p = 0.03), peak helicity (R = 0.54, p = 0.04), peak WSS in the AAo (R = 0.68, p = 0.005) and negatively with peak WSS in the DAo (R = - 0.57, p = 0.03) from rest to exercise. DAAo/DDAo correlated strongly with change in vorticity (R = - 0.38, p = 0.01), helicity (R = - 0.66, p = 0.007), and WSS in the AAo (R = - 0.73, p = 0.002) and DAo (R = 0.58, p = 0.02). Estimated DAo Reynolds number negatively correlated with VO2max for exercise (R = - 0.59, p = 0.02), but not rest (R = - 0.28, p = 0.31). Visualization of streamline patterns demonstrated more secondary flow formation in aortic arches with better exercise capacity, larger DAo, and lower Reynolds number. CONCLUSIONS: There are important associations between secondary flow characteristics and exercise capacity in repaired CoA that are not captured by traditional pressure gradient, likely due to increased turbulence and inefficient flow. These 4D flow CMR parameters are a target of investigation to identify optimal aortic arch geometry and improve long term clinical outcomes after CoA repair.

Aorta size mismatch predicts decreased exercise capacity in patients with successfully repaired coarctation of the aorta.

OBJECTIVE: Coarctation of the aorta (CoA) is associated with decreased exercise capacity despite successful repair with no residual stenosis; however, the hemodynamic mechanism remains unknown. This study aims to correlate aortic arch geometry with exercise capacity in patients with successfully repaired CoA and explain hemodynamic changes using 3-dimensional-printed aorta models in a mock circulatory flow loop. METHODS: A retrospective chart review identified patients with CoA repair who had cardiac magnetic resonance imaging and an exercise stress test. Measurements included aorta diameters, arch height to diameter ratio, left ventricular function, and percent descending aorta (%DAo) flow. Each aorta was printed 3-dimensionally for the flow loop. Flow and pressure were measured at the ascending aorta (AAo) and DAo during simulated rest and exercise. Measurements were correlated with percent predicted peak oxygen consumption (VO2 max). RESULTS: Fifteen patients (mean age 26.8 ± 8.6 years) had a VO2 max between 47% and 126% predicted (mean 92 ± 20%) with normal left ventricular function. DAo diameter and %DAo flow positively correlated with VO2 (P = .007 and P = .04, respectively). AAo to DAo diameter ratio (DAAo/DDAo) negatively correlated with VO2 (P < .001). From flow loop simulations, the ratio of %DAo flow in exercise to rest negatively correlated with VO2 (P = .02) and positively correlated with DAAo/DDAo (P < .01). CONCLUSIONS: This study suggests aorta size mismatch (DAAo/DDAo) is a novel, clinically important measurement predicting exercise capacity in patients with successful CoA repair, likely due to increased resistance and altered flow distribution. Aorta size mismatch and %DAo flow are targets for further clinical evaluation in repaired CoA.

A Novel Virtual Reality Medical Image Display System for Group Discussions of Congenital Heart Disease: Development and Usability Testing.

BACKGROUND: The complex 3-dimensional (3D) nature of anatomical abnormalities in congenital heart disease (CHD) necessitates multidisciplinary group discussions centered around the review of medical images such as magnetic resonance imaging. Currently, group viewings of medical images are constrained to 2-dimensional (2D) cross-sectional displays of 3D scans. However, 2D display methods could introduce additional challenges since they require physicians to accurately reconstruct the images mentally into 3D anatomies for diagnosis, staging, and planning of surgery or other therapies. Virtual reality (VR) software may enhance diagnosis and care of CHD via 3D visualization of medical images. Yet, present-day VR developments for medicine lack the emphasis on multiuser collaborative environments, and the effect of displays and level of immersion for diagnosing CHDs have not been studied. OBJECTIVE: The objective of the study was to evaluate and compare the diagnostic accuracies and preferences of various display systems, including the conventional 2D display and a novel group VR software, in group discussions of CHD. METHODS: A total of 22 medical trainees consisting of 1 first-year, 10 second-year, 4 third-year, and 1 fourth-year residents and 6 medical students, who volunteered for the study, were formed into groups of 4 to 5 participants. Each group discussed three diagnostic cases of CHD with varying structural complexity using conventional 2D display and group VR software. A group VR software, Cardiac Review 3D, was developed by our team using the Unity engine. By using different display hardware, VR was classified into nonimmersive and full-immersive settings. The discussion time, diagnostic accuracy score, and peer assessment were collected to capture the group and individual diagnostic performances. The diagnostic accuracies for each participant were scored by two experienced cardiologists following a predetermined answer rubric. At the end of the study, all participants were provided a survey to rank their preferences of the display systems for performing group medical discussions. RESULTS: Diagnostic accuracies were highest when groups used the full-immersive VR compared with the conventional and nonimmersive VR (χ22=9.0, P=.01) displays. Differences between the display systems were more prominent with increasing case complexity (χ22=14.1, P<.001) where full-immersive VR had accuracy scores that were 54.49% and 146.82% higher than conventional and nonimmersive VR, respectively. The diagnostic accuracies provided by the two cardiologists for each participant did not statistically differ from each other (t=-1.01, P=.31). The full-immersive VR was ranked as the most preferred display for performing group CHD discussions by 68% of the participants. CONCLUSIONS: The most preferred display system among medical trainees for visualizing medical images during group diagnostic discussions is full-immersive VR, with a trend toward improved diagnostic accuracy in complex anatomical abnormalities. Immersion is a crucial feature of displays of medical images for diagnostic accuracy in collaborative discussions.