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

Supervised autonomous robotic soft tissue surgery.

Supervised autonomous in vivo robotic surgery is possible on soft tissues and outperforms standard clinical techniques in a dynamic preclinical environment.</jats:p

Role of surgeon intuition and computer-aided design in Fontan optimization: a computational fluid dynamics simulation study

OBJECTIVE: Customized Fontan designs, generated by computer-aided design (CAD) and optimized by computational fluid dynamics simulations, can lead to novel, patient-specific Fontan conduits unconstrained by off-the-shelf grafts. The relative contributions of both surgical expertise and CAD to Fontan optimization have not been addressed. In this study, we assessed hemodynamic performance of Fontans designed by both surgeon\u27s unconstrained modeling (SUM) and by CAD. Methods: Ten cardiac magnetic resonance imaging datasets were used to create 3-dimensional (3D) models of Fontans. Baseline computational fluid dynamics simulations assessed Fontan indexed power loss (iPL), hepatic flow distribution, and percentage of conduit surface area with abnormally low wall shear stress for venous flow (\u3c1 dyne/cm2). Fontans not meeting thresholds were redesigned using 2 methods: SUM (ie, original venous anatomy without the Fontan was 3D printed and sent to surgeon for Fontan redesign with clay modeling) and CAD (ie, the same 3D geometry was sent to engineers for iterative Fontan redesign guided by computational fluid dynamics). Both groups were blinded to each other\u27s results. RESULTS: Eight Fontans were redesigned by SUM and CAD methods. Both SUM and CAD redesigns met iPL thresholds. SUM had lower iPL, whereas CAD demonstrated balanced hepatic flow distribution and lower wall shear stress percentage. Wall shear stress percentage shared an inverse relationship with iPL, preventing oversized Fontan designs. CONCLUSIONS: Customized Fontan conduits with low iPL can be created by either a surgeon or CAD. CAD can also improve hepatic flow distribution and prevent oversized Fontan designs. Future studies should investigate workflows that combine SUM and CAD to optimize Fontan conduits

Design and Evaluation of an Eye Mountable AutoDALK Robot for Deep Anterior Lamellar Keratoplasty

Partial-thickness corneal transplants using a deep anterior lamellar keratoplasty (DALK) approach has demonstrated better patient outcomes than a full-thickness cornea transplant. However, despite better clinical outcomes from the DALK procedure, adoption of the technique has been limited because the accurate insertion of the needle into the deep stroma remains technically challenging. In this work, we present a novel hands-free eye mountable robot for automatic needle placement in the cornea, AutoDALK, that has the potential to simplify this critical step in the DALK procedure. The system integrates dual light-weight linear piezo motors, an OCT A-scan distance sensor, and a vacuum trephine-inspired design to enable the safe, consistent, and controllable insertion of a needle into the cornea for the pneumodissection of the anterior cornea from the deep posterior cornea and Descemet’s membrane. AutoDALK was designed with feedback from expert corneal surgeons and performance was evaluated by finite element analysis simulation, benchtop testing, and ex vivo experiments to demonstrate the feasibility of the system for clinical applications. The mean open-loop positional deviation was 9.39 µm, while the system repeatability and accuracy were 39.48 µm and 43.18 µm, respectively. The maximum combined thrust of the system was found to be 1.72 N, which exceeds the clinical penetration force of the cornea. In a head-to-head ex vivo comparison against an expert surgeon using a freehand approach, AutoDALK achieved more consistent needle depth, which resulted in fewer perforations of Descemet’s membrane and significantly deeper pneumodissection of the stromal tissue. The results of this study indicate that robotic needle insertion has the potential to simplify the most challenging task of the DALK procedure, enable more consistent surgical outcomes for patients, and standardize partial-thickness corneal transplants as the gold standard of care if demonstrated to be more safe and more effective than penetrating keratoplasty

Development and Error Analysis of a Novel Robotic System for Photodynamic Therapy

Photodynamic therapy has the potential to not only treat tumors directly but also to reduce incidental damage caused by large surgical margins and radiation therapy. In this study, a novel robotic system of delivering light was developed using a cartesian robot. Human input was limited to a computer input and no physical positioning of the light delivery system was required during testing. Error analysis was conducted to ensure the system\u27s applicability to a clinical environment. Error involved in both the outlining and coverage of the targeted areas was examined. The average outlining error and standard deviation were 0.23 +/-0.16mm, and the coverage time error was below 4%. These results indicate that a robotic light delivery system for photodynamic therapy can consistently provide light delivery with sub-millimeter errors when testing with ex-vivo phantoms

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