Clinical Outcomes and Associations With Radial to Femoral Crossover in ST-Elevation Myocardial Infarction.

Radial access during primary percutaneous coronary intervention is associated with reduced mortality and major bleeding compared with femoral access and is the recommended access site. Nevertheless, failure to secure radial access may necessitate crossover to femoral access. This study aimed to identify the associations with crossover from radial to femoral access in all comers with ST-elevation myocardial infarction and to compare the clinical outcomes with those patients who did not require crossover. From 2016 to 2021, a total of 1,202 patients presented to our institute with ST-elevation myocardial infarction. Associations, clinical outcomes, and independent predictors of crossover from radial to femoral access were identified. From 1,202 patients, radial access was used in 1,138 patients (94.7%) and crossover to femoral access occurred in 64 patients (5.3%). Patients who required crossover to femoral access had higher rates of access site complications and longer length of stay in the hospital. Inpatient mortality was higher in the group requiring a crossover. This study identified 3 independent predictors of crossover from radial to femoral access in primary percutaneous coronary intervention: cardiogenic shock, cardiac arrest before arrival at the catheterization laboratory, and previous coronary artery bypass grafting. Biochemical infarct size and peak creatinine was also found to be higher in those requiring crossover. In conclusion, crossover in this study portended an increased rate of access site complications, greatly prolonged length of stay, and a significantly higher risk of death.

Design and Evaluation of a Percutaneous Fragment Manipulation Device for Minimally Invasive Fracture Surgery.

Reduction of fractures in the minimally invasive (MI) manner can avoid risks associated with open fracture surgery. The MI approach requires specialized tools called percutaneous fragment manipulation devices (PFMD) to enable surgeons to safely grasp and manipulate fragments. PFMDs developed for long-bone manipulation are not suitable for intra-articular fractures where small bone fragments are involved. With this study, we offer a solution to potentially move the current fracture management practice closer to the use of a MI approach. We investigate the design and testing of a new PFMD design for manual as well as robot-assisted manipulation of small bone fragments. This new PFMD design is simulated using FEA in three loading scenarios (force/torque: 0 N/2.6 Nm, 75.7 N/3.5 N, 147 N/6.8 Nm) assessing structural properties, breaking points, and maximum bending deformations. The PFMD is tested in a laboratory setting on Sawbones models (0 N/2.6 Nm), and on ex-vivo swine samples (F = 80 N ± 8 N, F = 150 ± 15 N). A commercial optical tracking system was used for measuring PFMD deformations under external loading and the results were verified with an electromagnetic tracking system. The average error difference between the tracking systems was 0.5 mm, being within their accuracy limits. Final results from reduction maneuvers performed both manually and with the robot assistance are obtained from 7 human cadavers with reduction forces in the range of (F = 80 N ± 8 N, F = 150 ± 15 N, respectively). The results show that structurally, the system performs as predicted by the simulation results. The PFMD did not break during ex-vivo and cadaveric trials. Simulation, laboratory, and cadaveric tests produced similar results regarding the PFMD bending. Specifically, for forces applied perpendicularly to the axis of the PFMD of 80 N ± 8 N deformations of 2.8, 2.97, and 3.06 mm are measured on the PFMD, while forces of 150 ± 15 N produced deformations of 5.8, 4.44, and 5.19 mm. This study has demonstrated that the proposed PFMD undergoes predictable deformations under typical bone manipulation loads. Testing of the device on human cadavers proved that these deformations do not affect the anatomic reduction quality. The PFMD is, therefore, suitable to reliably achieve and maintain fracture reductions, and to, consequently, allow external fracture fixation.

Image-Guided Surgical Robotic System for Percutaneous Reduction of Joint Fractures.

Complex joint fractures often require an open surgical procedure, which is associated with extensive soft tissue damages and longer hospitalization and rehabilitation time. Percutaneous techniques can potentially mitigate these risks but their application to joint fractures is limited by the current sub-optimal 2D intra-operative imaging (fluoroscopy) and by the high forces involved in the fragment manipulation (due to the presence of soft tissue, e.g., muscles) which might result in fracture malreduction. Integration of robotic assistance and 3D image guidance can potentially overcome these issues. The authors propose an image-guided surgical robotic system for the percutaneous treatment of knee joint fractures, i.e., the robot-assisted fracture surgery (RAFS) system. It allows simultaneous manipulation of two bone fragments, safer robot-bone fixation system, and a traction performing robotic manipulator. This system has led to a novel clinical workflow and has been tested both in laboratory and in clinically relevant cadaveric trials. The RAFS system was tested on 9 cadaver specimens and was able to reduce 7 out of 9 distal femur fractures (T- and Y-shape 33-C1) with acceptable accuracy (≈1 mm, ≈5°), demonstrating its applicability to fix knee joint fractures. This study paved the way to develop novel technologies for percutaneous treatment of complex fractures including hip, ankle, and shoulder, thus representing a step toward minimally-invasive fracture surgeries.

Intra-operative fiducial-based CT/fluoroscope image registration framework for image-guided robot-assisted joint fracture surgery.

PURPOSE: Joint fractures must be accurately reduced minimising soft tissue damages to avoid negative surgical outcomes. To this regard, we have developed the RAFS surgical system, which allows the percutaneous reduction of intra-articular fractures and provides intra-operative real-time 3D image guidance to the surgeon. Earlier experiments showed the effectiveness of the RAFS system on phantoms, but also key issues which precluded its use in a clinical application. This work proposes a redesign of the RAFS's navigation system overcoming the earlier version's issues, aiming to move the RAFS system into a surgical environment. METHODS: The navigation system is improved through an image registration framework allowing the intra-operative registration between pre-operative CT images and intra-operative fluoroscopic images of a fractured bone using a custom-made fiducial marker. The objective of the registration is to estimate the relative pose between a bone fragment and an orthopaedic manipulation pin inserted into it intra-operatively. The actual pose of the bone fragment can be updated in real time using an optical tracker, enabling the image guidance. RESULTS: Experiments on phantom and cadavers demonstrated the accuracy and reliability of the registration framework, showing a reduction accuracy (sTRE) of about [Formula: see text] (phantom) and [Formula: see text] (cadavers). Four distal femur fractures were successfully reduced in cadaveric specimens using the improved navigation system and the RAFS system following the new clinical workflow (reduction error [Formula: see text], [Formula: see text]. CONCLUSION: Experiments showed the feasibility of the image registration framework. It was successfully integrated into the navigation system, allowing the use of the RAFS system in a realistic surgical application.

Navigation system for robot-assisted intra-articular lower-limb fracture surgery.

PURPOSE: In the surgical treatment for lower-leg intra-articular fractures, the fragments have to be positioned and aligned to reconstruct the fractured bone as precisely as possible, to allow the joint to function correctly again. Standard procedures use 2D radiographs to estimate the desired reduction position of bone fragments. However, optimal correction in a 3D space requires 3D imaging. This paper introduces a new navigation system that uses pre-operative planning based on 3D CT data and intra-operative 3D guidance to virtually reduce lower-limb intra-articular fractures. Physical reduction in the fractures is then performed by our robotic system based on the virtual reduction. METHODS: 3D models of bone fragments are segmented from CT scan. Fragments are pre-operatively visualized on the screen and virtually manipulated by the surgeon through a dedicated GUI to achieve the virtual reduction in the fracture. Intra-operatively, the actual position of the bone fragments is provided by an optical tracker enabling real-time 3D guidance. The motion commands for the robot connected to the bone fragment are generated, and the fracture physically reduced based on the surgeon's virtual reduction. To test the system, four femur models were fractured to obtain four different distal femur fracture types. Each one of them was subsequently reduced 20 times by a surgeon using our system. RESULTS: The navigation system allowed an orthopaedic surgeon to virtually reduce the fracture with a maximum residual positioning error of [Formula: see text] (translational) and [Formula: see text] (rotational). Correspondent physical reductions resulted in an accuracy of 1.03 ± 0.2 mm and [Formula: see text], when the robot reduced the fracture. CONCLUSIONS: Experimental outcome demonstrates the accuracy and effectiveness of the proposed navigation system, presenting a fracture reduction accuracy of about 1 mm and [Formula: see text], and meeting the clinical requirements for distal femur fracture reduction procedures.

The shape of the urine stream--from biophysics to diagnostics.

We develop a new computational model of capillary-waves in free-jet flows, and apply this to the problem of urological diagnosis in this first ever study of the biophysics behind the characteristic shape of the urine stream as it exits the urethral meatus. The computational fluid dynamics model is used to determine the shape of a liquid jet issuing from a non-axisymmetric orifice as it deforms under the action of surface tension. The computational results are verified with experimental modelling of the urine stream. We find that the shape of the stream can be used as an indicator of both the flow rate and orifice geometry. We performed volunteer trials which showed these fundamental correlations are also observed in vivo for male healthy volunteers and patients undergoing treatment for low flow rate. For healthy volunteers, self estimation of the flow shape provided an accurate estimation of peak flow rate (± 2%). However for the patients, the relationship between shape and flow rate suggested poor meatal opening during voiding. The results show that self measurement of the shape of the urine stream can be a useful diagnostic tool for medical practitioners since it provides a non-invasive method of measuring urine flow rate and urethral dilation.