Feasibility of Intraoperative Breast MRI and the Role of Prone Versus Supine Positioning in Surgical Planning for Breast-Conserving Surgery.

We assessed the feasibility of supine intraoperative MRI (iMRI) during breast-conserving surgery (BCS), enrolling 15 patients in our phase I trial between 2012 and 2014. Patients received diagnostic prone MRI, BCS, pre-excisional supine iMRI, and postexcisional supine iMRI. Feasibility was assessed based on safety, sterility, duration, and image-quality. Twelve patients completed the study; mean duration = 114 minutes; all images were adequate; no complications, safety, or sterility issues were encountered. Substantial tumor-associated changes occurred (mean displacement = 67.7 mm, prone-supine metric, n = 7). We have demonstrated iMRI feasibility for BCS and have identified potential limitations of prone breast MRI that may impact surgical planning.

Smart stylet: the development and use of a bedside external ventricular drain image-guidance system.

BACKGROUND: Placement accuracy of ventriculostomy catheters is reported in a wide and variable range. Development of an efficient image-guidance system may improve physician performance and patient safety. OBJECTIVE: We evaluate the prototype of Smart Stylet, a new electromagnetic image-guidance system for use during bedside ventriculostomy. METHODS: Accuracy of the Smart Stylet system was assessed. System operators were evaluated for their ability to successfully target the ipsilateral frontal horn in a phantom model. RESULTS: Target registration error across 15 intracranial targets ranged from 1.3 to 4.6 mm (mean 3.1 mm). Using Smart Stylet guidance, a test operator successfully passed a ventriculostomy catheter to a shifted ipsilateral frontal horn 20/20 (100%) times from the frontal approach in a skull phantom. Without Smart Stylet guidance, the operator was successful 4/10 (40%) times from the right frontal approach and 6/10 (60%) times from the left frontal approach. In a separate experiment, resident operators were successful 2/4 (50%) times when targeting the shifted ipsilateral frontal horn with Smart Stylet guidance and 0/4 (0%) times without image guidance using a skull phantom. CONCLUSIONS: Smart Stylet may improve the ability to successfully target the ventricles during frontal ventriculostomy.

Comparative study of NOTES alone versus NOTES guided by a new image registration system for navigation in the mediastinum: a study in a porcine model.

BACKGROUND: Natural orifice transluminal endoscopic surgery (NOTES) mediastinoscopy (MED) through the esophagus has proved to be feasible in the animal model. However, injury of the adjacent pleura and pneumothorax has been reported as a frequent adverse event when using a blind access. OBJECTIVE: To assess the utility and safety of a CT-based image registration system (IRS) for navigation in the mediastinum. DESIGN: Prospective, randomized, controlled trial in 30 Yorkshire pigs. Thirty-minute MEDs were performed: 15 MEDs were performed with IRS guidance (MED-IRS), and 15 MEDs were performed with a blind access. SETTING: Animal research laboratory. INTERVENTIONS: In both groups, the mediastinum was accessed through a 10-cm submucosal tunnel in the esophageal wall. Timed exploration was performed with identification of 8 mediastinal structures. MAIN OUTCOME MEASUREMENTS: Technical feasibility, adverse events, and the number of mediastinal structures identified. RESULTS: Thirty animals weighing 31.5 ± 3.5 kg were included in this study. MED was not possible in 2 animals in the "MED with blind access" group but was possible in all MEDs performed with IRS. The mean number of identified organs was slightly higher in "with IRS-MED" (6.13 ± 1.3) than with MED with blind access (4.7 ± 2.3; P = .066). Moreover, the right atrium and vena cava were identified in more cases with IRS-MED than in MED with blind access (13 vs 3 and 15 vs 11, P = .000 and P = .03, respectively). There were 3 (23%) adverse events with IRS-MED and 4 (27%) with "MED with blind access" (P = not significant), with pneumothorax being the most frequent (2 and 3, respectively). LIMITATIONS: Nonsurvival animal study. CONCLUSIONS: This study demonstrates that the IRS system appears feasible in natural orifice transluminal endoscopic surgery MED and suggests that IRS guidance might be useful for selected procedures.

Factors associated with external ventricular drain placement accuracy: data from an electronic health record repository.

BACKGROUND: We evaluated external ventricular drain placement for factors associated with placement accuracy. Data were acquired using an electronic health record data requisition tool. METHOD: Medical records of all patients who underwent ventriculostomy from 2003 to 2010 were identified and evaluated. Patient demographics, diagnosis, type of guidance and number of catheter passes were searched for and recorded. Post-procedural hemorrhage and/or infection were identified. A grading scale was used to classify accuracy of catheter placements. A multiple logistic regression model was developed to assess features associated with accurate catheter placement. RESULTS: One hundred nine patients who underwent 111 ventriculostomies from 2003 to 2010 were identified. Patient diagnoses were classified into vascular (63 %), tumor (21 %), trauma (14 %), and cyst (2 %). Procedures were performed freehand in 90 (81 %), with the Ghajar guide in 17 (15 %), and with image guidance in 4 (4 %) patients. Eighty-eight (79 %) catheters were placed in the correct location. Trauma patients were more likely to have catheters misplaced (p = 0.007) whereas patients in other diagnostic categories were not significantly associated with misplaced catheters. Post-procedural hemorrhage was noted in 2 (1.8 %) patients on post-procedural imaging studies. Five (4.5 %) definite and 6 (5.4 %) suspected infections were identified. CONCLUSIONS: External ventricular drain placement can be performed accurately in most patients. Patients with trauma are more likely to have catheters misplaced. Further development is required to identify and evaluate procedure outcomes using an electronic health record repository.

Surgery, virtual reality, and the future.

MMVR has provided the leading forum for the multidisciplinary interaction and development of the use of Virtual Reality (VR) techniques in medicine, particularly in surgical practice. Here we look back at the foundations of our field, focusing on the use of VR in Surgery and similar interventional procedures, sum up the current status, and describe the challenges and opportunities going forward.

Evaluation of colonoscopy technical skill levels by use of an objective kinematic-based system.

BACKGROUND: Colonoscopy requires training and experience to ensure accuracy and safety. Currently, no objective, validated process exists to determine when an endoscopist has attained technical competence. Kinematics data describing movements of laparoscopic instruments have been used in surgical skill assessment to define expert surgical technique. We have developed a novel system to record kinematics data during colonoscopy and quantitatively assess colonoscopist performance. OBJECTIVE: To use kinematic analysis of colonoscopy to quantitatively assess endoscopic technical performance. DESIGN: Prospective cohort study. SETTING: Tertiary-care academic medical center. POPULATION: This study involved physicians who perform colonoscopy. INTERVENTION: Application of a kinematics data collection system to colonoscopy evaluation. MAIN OUTCOME MEASUREMENTS: Kinematics data, validated task load assessment instrument, and technical difficulty visual analog scale. RESULTS: All 13 participants completed the colonoscopy to the terminal ileum on the standard colon model. Attending physicians reached the terminal ileum quicker than fellows (median time, 150.19 seconds vs 299.86 seconds; p<.01) with reduced path lengths for all 4 sensors, decreased flex (1.75 m vs 3.14 m; P=.03), smaller tip angulation, reduced absolute roll, and lower curvature of the endoscope. With performance of attending physicians serving as the expert reference standard, the mean kinematic score increased by 19.89 for each decrease in postgraduate year (P<.01). Overall, fellows experienced greater mental, physical, and temporal demand than did attending physicians. LIMITATION: Small cohort size. CONCLUSION: Kinematic data and score calculation appear useful in the evaluation of colonoscopy technical skill levels. The kinematic score appears to consistently vary by year of training. Because this assessment is nonsubjective, it may be an improvement over current methods for determination of competence. Ongoing studies are establishing benchmarks and characteristic profiles of skill groups based on kinematics data.

Image registration assists novice operators in ultrasound assessment of abdominal trauma.

Transcutaneous ultrasound imaging may be used to detect abdominal hemorrhage in the field setting. The Focused Assessment with Sonography for Trauma (FAST) examination was developed to characterize blunt abdominal trauma and has been shown to be effective for assessing penetrating trauma as well. However, it is unlikely that a minimally trained operator could perform a diagnostic examination. In our system, the operator is be supported by real-time 3D volume displays. The operator will be directed through the examination by prompts from a computer system or outside expert, potentially with knowledge of the anatomy of the injured patient. The key elements of the tele-operated FAST exam capability have been demonstrated; the exam is performed with real-time guidance from anatomic images registered to the body. It appears likely that Image Registration will assist hemorrhage detection at the point of injury or in the initial evaluation by a trauma response team.

Oriented speckle reducing anisotropic diffusion.

Ultrasound imaging systems provide the clinician with noninvasive, low-cost, and real-time images that can help them in diagnosis, planning, and therapy. However, although the human eye is able to derive the meaningful information from these images, automatic processing is very difficult due to noise and artifacts present in the image. The speckle reducing anisotropic diffusion filter was recently proposed to adapt the anisotropic diffusion filter to the characteristics of the speckle noise present in the ultrasound images and to facilitate automatic processing of images. We analyze the properties of the numerical scheme associated with this filter, using a semi-explicit scheme. We then extend the filter to a matrix anisotropic diffusion, allowing different levels of filtering across the image contours and in the principal curvature directions. We also show a relation between the local directional variance of the image intensity and the local geometry of the image, which can justify the choice of the gradient and the principal curvature directions as a basis for the diffusion matrix. Finally, different filtering techniques are compared on a 2-D synthetic image with two different levels of multiplicative noise and on a 3-D synthetic image of a Y-junction, and the new filter is applied on a 3-D real ultrasound image of the liver.

Natural Orifice Transluminal Endoscopic Surgery (NOTES): an opportunity for augmented reality guidance.

Laparoscopic techniques have gained wide acceptance because they offer a safe and less invasive alternative to open surgery. To further reduce the invasiveness of peritoneal access, the next logical step is to eliminate the incision through the abdominal wall using natural orifices as entry points. This Natural Orifice Transluminal Endoscopic Surgery (NOTES) approach has the potential to replace or augment current techniques. Several research groups have cut through the stomach or colon wall (per-oral transgastric or per-anal transcolonic) to perform organ resections in animal models, and some procedures in humans have been reported anecdotally. Widespread use of these techniques will depend on providing the physician with adequate visual feedback, clear indicators of instrument location and orientation, and support in the recognition of anatomic structures. Compared with laparoscopy, successful endoscopy must accommodate several additional complexities: (1) The flexibility of the endoscope tip complicates the understanding of its distal orientation. Successful navigation inside the stomach and in the abdominal cavity generally requires two years of sub-specialty training. (2) Several surgical targets lie in a retrograde position with respect to an incision in the stomach wall. Efficient and safe access to the pancreas, gall bladder, or the kidneys requires detailed knowledge of the tip placement relative to adjacent anatomic structures. (3) Since there is limited direct access to the abdomen, iatrogenic injuries, such as the accidental cutting of an artery, will be more dangerous and difficult to manage. We present here approaches to resolving these limitations though augmented reality techniques using pre-procedure CT or MRI imaging, real time tracking and reference image registration, and display to the operating physician. As an example, the utility of image registration techniques for orientation for the gastric access puncture is discussed in detail. It is anticipated that such augmentation will make intra-cavitary interventional techniques easier to master and use in practice, and thus more likely to be widely adopted.

Beyond VR: creating the augmented physician.

The ongoing shift of high tech capability from the specialist to the primary physician and the merging of medical and surgical therapies will demand more sophisticated measurement and control, but more positively, it will be possible to differentiate each individual situation and tailor treatment to provide an optimum result for each person, for each condition, in each environment, if these could all be measured, understood, and effected. The effective augmentation of the caregiver's physical, sensory, and cognitive capabilities will require more transparent, nuanced, and adaptive interfaces to information and to its therapeutic application. While the enhancement and classification of digitized findings is a beginning, the key may be better tracking and presentation of the chronological course, particularly the prior events which set the physiologic or morphologic data in context. Systems engineering approaches will define paths toward optimized, autonomous treatment, where the most rapid progress may be made through functional partitioning using scale-independent models, and the delineation of intermediate stages between today's macroscopic presentation of disease and molecular-scale treatment. These stages will comprise the steps toward useful patient avatars; our task is to fill in, with successively more powerful models, the convergence of large scale and small scale information, as it is used to support diagnostic and therapeutic decisions.

The concept of image-guided therapy.

Parallel with current applications in minimally invasive surgery, the introduction of new imaging modalities, and the availability of high-performance computing, new image-guided therapies are being developed at an impressive rate. Indeed, across a broad front of imaging technologies, rapid advances are being realized. Vastly refined technology for processing and using images, as well as improved therapeutic end-effectors, have no doubt hastened this remarkable progress. At the same time, advances in clinical evaluation and complementary technologies will provide the necessary infrastructure through which IGT can be applied in diverse therapeutic settings--from the already well-established neurosurgical applications to the thermal ablation of tumors in organs other than the brain. That IGT is more efficient and effective and less expensive than conventional surgery has been confirmed both in extensive, long-term studies and in ongoing, revolutionary applications in the operating room. We have laid critical groundwork with this extraordinary technology and have now begun to realize quantifiable benefits in terms of improved surgical and patient outcomes.

Moore's Law, disruptive technologies, and the clinician.

The advancement of technical power described by Moore's Law offers great potential for enabling more cost-effective medical devices and systems. However, progress has been slow. Many factors for this failure have been cited, including the anti-rational economic structure of healthcare and the complexity and long time scale of medical development. Christensen et al. suggest that "disruptive technologies" may circumvent some of these difficulties. "Disruptive Technologies" are defined as those that are established in one market, but then penetrate and overwhelm another market. These incursions are accelerated by economic factors, and capitalize on functionality, reliability, and advancements supported by the original market. Christensen has cited many examples from industrial and service businesses, but few examples can be found yet in healthcare. We argue that positive technology impacts in medicine occur most readily when innovators augment the skills of and collaborate with caregivers, rather than seeking to displace them. In the short term, a new approach may improve efficiency or quality. In the longer term, such approaches may obviate human tasks at lower-skill levels, and even permit task automation. One successful example has been the introduction of flexible monitoring for physiologic information. Systems for computer-aided diagnosis, which have failed to impact complex decision making, have succeeded in simpler specialty areas such as the interpretation of EKG's and mammograms, and may do the same with analysis of some pathology images. The next frontier may the operating room, and the adoption of such systemic technologies by caregivers in emergency medicine and general care may then have an even wider "disruptive" effect. Responding to time and cost pressures, and the desire to move care to the patient, other workers, such as radiologists, will drive the trend away from isolated, complex, large-scale devices, and toward integrated, modular, and simpler networked technologies. In summary, technological "push" will continue in the demanding cutting-edge application areas as always, but the "disruption" will occur through wider application of lower-cost technologies, pulled by the users. The capabilities described by Moore's Law will allow the advancements necessary to facilitate this dissemination of capability and its ultimate benefit, so long sought.

Statistical Learning Algorithm for in situ and invasive breast carcinoma segmentation.

Dynamic Contrast Enhanced MRI (DCE-MRI) has proven to be a highly sensitive imaging modality in diagnosing breast cancers. However, analyzing the DCE-MRI is time-consuming and prone to errors due to the large volume of data. Mathematical models to quantify contrast perfusion, such as the black box methods and pharmacokinetic analysis, are inaccurate, sensitive to noise and depend on a large number of external factors such as imaging parameters, patient physiology, arterial input function, and fitting algorithms, leading to inaccurate diagnosis. In this paper, we have developed a novel Statistical Learning Algorithm for Tumor Segmentation (SLATS) based on Hidden Markov Models to auto-segment regions of angiogenesis, corresponding to tumor. The SLATS algorithm has been trained to identify voxels belonging to the tumor class using the time-intensity curve, first and second derivatives of the intensity curves ("velocity" and "acceleration" respectively) and a composite vector consisting of a concatenation of the intensity, velocity and acceleration vectors. The results of SLATS trained for the four vectors has been shown for 22 Invasive Ductal Carcinoma (IDC) and 19 Ductal Carcinoma In Situ (DCIS) cases. The SLATS trained for the velocity tuple shows the best performance in delineating the tumors when compared with the segmentation performed by an expert radiologist and the output of a commercially available software, CADstream.

On mixed reality environments for minimally invasive therapy guidance: systems architecture, successes and challenges in their implementation from laboratory to clinic.

Mixed reality environments for medical applications have been explored and developed over the past three decades in an effort to enhance the clinician's view of anatomy and facilitate the performance of minimally invasive procedures. These environments must faithfully represent the real surgical field and require seamless integration of pre- and intra-operative imaging, surgical instrument tracking, and display technology into a common framework centered around and registered to the patient. However, in spite of their reported benefits, few mixed reality environments have been successfully translated into clinical use. Several challenges that contribute to the difficulty in integrating such environments into clinical practice are presented here and discussed in terms of both technical and clinical limitations. This article should raise awareness among both developers and end-users toward facilitating a greater application of such environments in the surgical practice of the future.

A colon video analysis framework for polyp detection.

This paper presents an automated video analysis framework for the detection of colonic polyps in optical colonoscopy. Our proposed framework departs from previous methods in that we include spatial frame-based analysis and temporal video analysis using time-course image sequences. We also provide a video quality assessment scheme including two measures of frame quality. We extract colon-specific anatomical features from different image regions using a windowing approach for intraframe spatial analysis. Anatomical features are described using an eigentissue model. We apply a conditional random field to model interframe dependences in tissue types and handle variations in imaging conditions and modalities. We validate our method by comparing our polyp detection results to colonoscopy reports from physicians. Our method displays promising preliminary results and shows strong invariance when applied to both white light and narrow-band video. Our proposed video analysis system can provide objective diagnostic support to physicians by locating polyps during colon cancer screening exams. Furthermore, our system can be used as a cost-effective video annotation solution for the large backlog of existing colonoscopy videos.

Towards real time 2D to 3D registration for ultrasound-guided endoscopic and laparoscopic procedures.

PURPOSE: A method to register endoscopic and laparoscopic ultrasound (US) images in real time with pre-operative computed tomography (CT) data sets has been developed with the goal of improving diagnosis, biopsy guidance, and surgical interventions in the abdomen. METHODS: The technique, which has the potential to operate in real time, is based on a new phase correlation technique: LEPART, which specifies the location of a plane in the CT data which best corresponds to the US image. Validation of the method was carried out using an US phantom with cyst regions and with retrospective analysis of data sets from animal model experiments. RESULTS: The phantom validation study shows that local translation displacements can be recovered for each US frame with a root mean squared error of 1.56 +/- 0.78 mm in less than 5 sec, using non-optimized algorithm implementations. CONCLUSION: A new method for multimodality (preoperative CT and intraoperative US endoscopic images) registration to guide endoscopic interventions was developed and found to be efficient using clinically realistic datasets. The algorithm is inherently capable of being implemented in a parallel computing system so that full real time operation appears likely.

Assessing technical skill in surgery and endoscopy: a set of metrics and an algorithm (C-PASS) to assess skills in surgical and endoscopic procedures.

Historically, the performance of surgeons has been assessed subjectively by senior surgical staff in both training and operating environments. In this work, the position and motion of surgical instruments are analyzed through an objective process, denoted C-PASS, to measure surgeon performance of laparoscopic, endoscopic, and image-guided procedures. To develop C-PASS, clinically relevant performance characteristics were identified. Then measurement techniques for parameters that represented each characteristic were derived, and analytic techniques were implemented to transform these parameters into explicit, robust metrics. The metrics comprise the C-PASS performance assessment method, which has been validated over the last 3 years in studies of laparoscopy and endoscopy. These studies show that C-PASS is straightforward, reproducible, and accurate. It is sufficiently powerful to assess the efficiency of these complex processes. It is likely that C-PASS and similar approaches will improve skills acquisition and learning and also enable the objective comparison of systems and techniques.

EUS with CT improves efficiency and structure identification over conventional EUS.

BACKGROUND: EUS is complicated because of the subtleties of US interpretation, small fields of observation, and uncertainty of probe position and orientation. OBJECTIVE: Improved EUS performance is sought by providing contextual information to support US probe positioning and identification of features in US images. Our aims were to demonstrate the feasibility of the image registered gastroscopic US (IRGUS) system in a porcine model and to compare the effectiveness and the efficiency of IRGUS with traditional EUS. DESIGN: Animal feasibility study. INTERVENTIONS: The IRGUS system uses preprocedure CT and miniature US probe trackers to create real-time synthetic displays of the position of the probe tip and a matched slice of CT data for comparison with the US image. Participants used EUS and IRGUS systems in a porcine model to evaluate the speed and accuracy of structure identification. MAIN OUTCOME MEASUREMENTS: The performance and utility of IRGUS were determined by the number of correctly identified structures in a timed trial, kinematic variables, and a structured survey. RESULTS: IRGUS was twice as effective as EUS in localizing and identifying individual structures. In timed trials, IRGUS users identified over 25% more structures than EUS users. Improvement in examination efficiency and accuracy of feature identification was statistically significant, and 90% of the users preferred IRGUS to EUS for these tasks. CONCLUSIONS: IRGUS appears feasible and may be superior to conventional EUS in efficiency and accuracy of probe positioning and in image interpretation. IRGUS has the potential to shorten the EUS learning curve and to broaden the adoption of EUS techniques by gastroenterologists.