(C.J.W); frank.pigula@ulp.org (F.A.P.) Overline: Cardiovascular diseaseOne Sentence Summary: A soft robotic sleeve modeled on the structure of the human heart assists cardiovascular function in an ex vivo and in vivo porcine model of heart failure. Abstract:There is much interest in form-fitting, low modulus, implantable devices or soft robots that can mimic or assist in complex biological functions such as the contraction of heart muscle. Here we present a soft robotic sleeve that is implanted around the heart and actively compresses and twists to act as a cardiac ventricular assist device. The sleeve does not contact blood, obviating the need for anticoagulation therapy or blood thinners, and reduces complications with current ventricular assist devices such as clotting and infection. Our approach used a biologically inspired design to orient individual contracting elements or actuators in a layered helical and circumferential fashion, mimicking the orientation of the outer two muscle layers of the mammalian heart. The resulting implantable soft robot mimicked the form and function of the native heart, with a stiffness value of the same order of magnitude as native heart tissue. We demonstrated feasibility of this soft sleeve device for supporting heart function in a porcine model of acute heart failure. The soft robotic sleeve can be customized to patient-specific needs and may have the potential to act as a bridge to transplant for patients with heart failure.

This paper reports the design, development, and magnetic resonance imaging (MRI) compatibility evaluation of an actuated transrectal prostate robot for MRI-guided needle intervention in the prostate. The robot performs actuated needle MRI-guidance with the goals of providing (i) MRI compatibility, (ii) MRI-guided needle placement with accuracy sufficient for targeting clinically significant prostate cancer foci, (iii) reducing interventional procedure times (thus increasing patient comfort and reducing opportunity for needle targeting error due to patient motion), (iv) enabling real-time MRI monitoring of interventional procedures, and (v) reducing the opportunities for error that arise in manually actuated needle placement. The design of the robot, employing piezo-ceramic-motor actuated needle guide positioning and manual needle insertion, is reported. Results of a MRI compatibility study show no reduction of MRI signal-to-noise-ratio (SNR) with the motors disabled. Enabling the motors reduces the SNR by 80% without RF shielding, but SNR is only reduced by 40% to 60% with RF shielding. The addition of radio-frequency shielding is shown to significantly reduce image SNR degradation caused by the presence of the robotic device. An accuracy study of MRI-guided biopsy needle placements in a prostate phantom is reported. The study shows an average in-plane targeting error of 2.4 mm with a maximum error of 3.7 mm. These data indicate the system’s needle targeting accuracy is similar to that obtained with a previously reported manually actuated system, and is sufficient to reliably sample clinically significant prostate cancer foci under MRI-guidance.

The contents of this manuscript are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health.q RSNA, 2014 Purpose:To determine the detection rate, clinical relevance, Gleason grade, and location of prostate cancer (PCa) diagnosed with and the safety of an in-bore transperineal 3-T magnetic resonance (MR) imaging-guided prostate biopsy in a clinically heterogeneous patient population. Materials and Methods:This prospective retrospectively analyzed study was HIPAA compliant and institutional review board approved, and informed consent was obtained. Eighty-seven men (mean age, 66.2 years 6 6.9) underwent multiparametric endorectal prostate MR imaging at 3 T and transperineal MR imaging-guided biopsy. Three subgroups of patients with at least one lesion suspicious for cancer were included: men with no prior PCa diagnosis, men with PCa who were undergoing active surveillance, and men with treated PCa and suspected recurrence. Exclusion criteria were prior prostatectomy and/or contraindication to 3-T MR imaging. The transperineal MR imaging-guided biopsy was performed in a 70-cm wide-bore 3-T device. Overall patient biopsy outcomes, cancer detection rates, Gleason grade, and location for each subgroup were evaluated and statistically compared by using x 2 and one-way analysis of variance followed by Tukey honestly significant difference post hoc comparisons. Results:Ninety biopsy procedures were performed with no serious adverse events, with a mean of 3.7 targets sampled per gland. Cancer was detected in 51 (56.7%) men: 48.1% (25 of 52) with no prior PCa, 61.5% (eight of 13) under active surveillance, and 72.0% (18 of 25) in whom recurrence was suspected. Gleason pattern 4 or higher was diagnosed in 78.1% (25 of 32) in the no prior PCa and active surveillance groups. Gleason scores were not assigned in the suspected recurrence group. MR targets located in the anterior prostate had the highest cancer yield (40 of 64, 62.5%) compared with those for the other parts of the prostate (P , .001). Conclusion:In-bore 3-T transperineal MR imaging-guided biopsy, with a mean of 3.7 targets per gland, allowed detection of many clinically relevant cancers, many of which were located anteriorly.q RSNA, 2014

Purpose To demonstrate the utility of a robotic needle-guidance template device as compared to a manual template for in-bore 3T transperineal MR-guided prostate biopsy. Materials and Methods This two-arm mixed retrospective-prospective study included 99 cases of targeted transperineal prostate biopsies. The biopsy needles were aimed at suspicious foci noted on multiparametric 3T MRI using manual template (historical control) as compared with a robotic template. The following data was obtained: the accuracy of average and closest needle placement to the focus, histologic yield, percentage of cancer volume in positive core samples, complication rate, and time to complete the procedure. Results 56 cases were performed using the manual template, and 43 cases were performed using the robotic template. The mean accuracy of the best needle placement attempt was higher in the robotic group (2.39 mm) than the manual group (3.71 mm, p<0.027). The mean core procedure time was shorter in the robotic (90.82min) than the manual group (100.63min, p<0.030). Percentage of cancer volume in positive core samples was higher in robotic group (p<0.001). Cancer yields and complication rates were not statistically different between the two sub-groups (p = 0.557 and p=0.172 respectively). Conclusion The robotic needle-guidance template helps accurate placement of biopsy needles in MRI-guided core biopsy of prostate cancer.