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Background: Magnetic resonance imaging (MRI) is recommended in patients with upper tract urothelial carcinoma (UTUC) only when computed tomography (CT) is contraindicated. However, CT does not allow distinguishing ureter wall layers, making impossible to assess muscle invasion, a factor contributing to differentiate high- from low-risk UTUCs, which require different therapeutic approaches. We investigated the feasibility of MRI assessment of UTUC muscle invasion., Methods: From June 2022 to March 2023, we prospectively enrolled patients suspected of UTUC, i.e., with positive urinary tract ultrasound and/or ureteroscopy, or positive urinary cytology and/or hematuria but negative cystoscopy and bladder ultrasound at two Italian centers. They underwent CT followed by MRI (≤ 24 h apart), independently reported by two experienced radiologists, blinded from histopathology results. After imaging confirmation, they all underwent nephroureterectomy and histopathology analysis. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, and area under the receiver operating characteristic curve (AUC) were calculated., Results: Thirty-nine lesions were detected in 30 patients on both CT and MRI. Muscle-invasive UTUC prevalence was 81% (21/26) among patients with MRI suspicion and 8% (1/13) among those without MRI suspicion (p < 0.001). Considering the assessment of muscle-layer invasion, the more experienced reader achieved 95% sensitivity (95% confidence interval 82-100), 71% specificity (47-88), 81% PPV (63-93), 92% NPV (70-100), 85% accuracy (67-96), and 0.84 AUC (0.70-0.98). Inter-reader agreement was substantial (κ = 0.73)., Conclusions: MRI showed a promising diagnostic performance for the assessment of UTUC risk of muscle invasion., Relevance Statement: Resulting feasible both in technical and clinical terms, MRI could be helpful for upper tract urothelial carcinomas pre-operative risk stratification, to allow a personalized patients' management. These results play in favor of promoting preoperative MRI for UTUC, as already proven for bladder cancer., Key Points: • Muscle invasion is a crucial information for tailored treatments of upper tract urothelial carcinomas. • CT does not distinguish ureter wall layers, making muscle invasion risk assessment not feasible. • MRI was shown to reliably diagnose muscle-layer invasion by upper tract urothelial carcinomas (sensitivity 95%, specificity 71%)., (© 2024. The Author(s).)

Purpose: The aim of the study was to determine the impact of using a semi-automatic commercially available AI-assisted software (Quantib® Prostate) on inter-reader agreement in PI-RADS scoring at different PI-QUAL ratings and grades of reader confidence and on reporting times among novice readers in multiparametric prostate MRI., Methods: A prospective observational study, with a final cohort of 200 patients undergoing mpMRI scans, was performed at our institution. An expert fellowship-trained urogenital radiologist interpreted all 200 scans based on PI-RADS v2.1. The scans were divided into four equal batches of 50 patients. Four independent readers evaluated each batch with and without the use of AI-assisted software, blinded to expert and individual reports. Dedicated training sessions were held before and after each batch. Image quality rated according to PI-QUAL and reporting times were recorded. Readers' confidence was also evaluated. A final evaluation of the first batch was conducted at the end of the study to assess for any changes in performance., Results: The overall kappa coefficient differences in PI-RADS scoring agreement without and with Quantib® were 0.673 to 0.736 for Reader 1, 0.628 to 0.483 for Reader 2, 0.603 to 0.292 for Reader 3 and 0.586 to 0.613 for Reader 4. Using PI-RADS ≥ 4 as cut-off for biopsy, the AUCs with AI ranged from 0.799 (95 % CI: 0.743, 0.856) to 0.820 (95 % CI: 0.765, 0.874). Inter-reader agreements at different PI-QUAL scores were higher with the use of Quantib, particularly for readers 1 and 4, with Kappa coefficient values showing moderate to slight agreement., Conclusion: Quantib® Prostate could potentially be useful in improving inter-reader agreement among less experienced to completely novice readers if used as a supplement to PACS., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Objective: To investigate the impact of an artificial intelligence (AI) software and quantitative ADC (qADC) on the inter-reader agreement, diagnostic performance, and reporting times of prostate biparametric MRI (bpMRI) for experienced and inexperienced readers., Materials and Methods: A total of 170 multiparametric MRI (mpMRI) of patients with suspicion of prostate cancer (PCa) were retrospectively reviewed by one experienced and one inexperienced reader three times, following a wash-out period. First, only the bpMRI sequences, including T2-weighted imaging (T2WI), diffusion-weighted imaging (DWI) sequences, and apparent diffusion coefficient (ADC) maps, were used. Then, bpMRI and quantitative ADC values were used. Lastly, bpMRI and the AI software were used. Inter-reader agreement between the two readers and between each reader and the mpMRI original reports was calculated. Detection rates and reporting times were calculated for each group., Results: Inter-reader agreement with respect to mpMRI was moderate for bpMRI, Quantib, and qADC for both the inexperienced (weighted k of 0.42, 0.45, and 0.41, respectively) and the experienced radiologists (weighted k of 0.44, 0.46, and 0.42, respectively). Detection rate of PCa was similar between the inexperienced (0.24, 0.26, and 0.23) and the experienced reader (0.26, 0.27 and 0.27), for bpMRI, Quantib, and qADC, respectively. Reporting times were lower for Quantib (8.23, 7.11, and 9.87 min for the inexperienced reader and 5.62, 5.07, and 6.21 min for the experienced reader, for bpMRI, Quantib, and qADC, respectively)., Conclusions: AI and qADC did not have a significant impact on the diagnostic performance of both readers. The use of Quantib was associated with lower reporting times., (© 2022. The Author(s).)

Purpose: To evaluate the safety, efficacy, and clinical impact of preoperative cone-beam computed tomography (CT)-guided selective embolization of endophytic renal tumors with the fluorescent dye indocyanine green (ICG) and ethiodized oil in patients undergoing robot-assisted partial nephrectomy (RAPN) using near-infrared fluorescence imaging (NIR-FI)., Materials and Methods: Patients with renal endophytic tumors eligible for RAPN and transarterial embolization with ICG and ethiodized oil were prospectively enrolled. Technical success was defined as the completion of the embolization procedure. Radiographic success, defined as ethiodized oil accumulation in the nodule, was classified as poor, moderate, good, or optimal on the basis of postembolization cone-beam CT. Surgical visibility of the tumors during RAPN with the use of NIR-FI was classified as follows: (a) not visible, (b) visible with poorly defined margins, and (c) visible with well-defined margins., Results: Forty-one patients underwent preoperative selective embolization. Technical success was 100%. Ethiodized oil accumulation on cone-beam CT was poor in 2 (4.9%), moderate in 6 (14.6%), good in 25 (61.0%), and optimal in 8 (19.5%) of 41 patients. During RAPN with NIR-FI, tumors were visible with well-defined margins in 26 (63.4%), visible with blurred margins in 14 (34.1%), and not visible in 1 (2.4%) of 41 cases. There were no adverse events following endovascular embolization., Conclusions: Preoperative transarterial superselective embolization of endophytic renal tumors with ICG and ethodized oil in patients undergoing RAPN is safe and effective, allowing accurate intraoperative visualization and resection of endophytic tumors., (Copyright © 2022 SIR. Published by Elsevier Inc. All rights reserved.)

Objectives: To compare the detection rates of overall prostate cancer (PCa) and clinically significant PCa (csPCa) and the median percentage of cancer per biopsy core between MRI-guided In-bore and MRI-TRUS fusion-targeted biopsy (TBx)., Methods: In this retrospective study, 223 patients who underwent prostate multiparametric MRI (mpMRI) and subsequent MR-directed biopsy were included. For PCa and csPCa detection rate (DR), contingency tables were tested via the Pearson's chi-squared to explore the variance of the outcome distribution. The percentage of cancer per biopsy core was tested with a two-tailed Mann-Withney test., Results: One hundred and seventeen and 106 patients underwent MRI-TRUS fusion or MRI In-bore TBx, respectively. 402 MRI biopsy targets were identified, of which 206 (51.2%) were biopsied with the MRI-TRUS TBx and 196 (48.8%) with the MRI In-bore TBx technique. Per-patient PCa and csPCa detection rates were 140/223 (62.8%) and 97/223 (43.5%), respectively. PCa-DR was 73/117 (62.4%) and 67/106 (63.2%) for MRI-TRUS and MRI In-Bore TBx ( p = 0.9), while csPCa detection rate reached 50/117 (42.7%) and 47/106 (44.3%), respectively ( p = 0.81). The median per-patient percentage of malignant tissue within biopsy cores was 50% (IQR: 27-65%) for PCa and 60% (IQR: 35-68%) for csPCa, with a statistically significant difference between the techniques., Conclusion: No statistically significant difference in the detection rate of MRI In-bore and MRI-TRUS fusion TBx was found. MRI In-bore TBx showed higher per-core percentage of malignant cells., Advances in Knowledge: MRI In-bore biopsy might impact risk stratification and patient management considering the higher per-core percentage of malignant cells, especially for patients eligible for active surveillance or focal therapy.

Background: Prostate magnetic resonance imaging (MRI) is technically demanding, requiring high image quality to reach its full diagnostic potential. An automated method to identify diagnostically inadequate images could help optimize image quality., Purpose: To develop a convolutional neural networks (CNNs) based analysis pipeline for the classification of prostate MRI image quality., Study Type: Retrospective., Subjects: Three hundred sixteen prostate mpMRI scans and 312 men (median age 67)., Field Strength/sequence: A 3 T; fast spin echo T2WI, echo planar imaging DWI, ADC, gradient-echo dynamic contrast enhanced (DCE)., Assessment: MRI scans were reviewed by three genitourinary radiologists (V.P., M.D.M., S.C.) with 21, 12, and 5 years of experience, respectively. Sequences were labeled as high quality (Q1) or low quality (Q0) and used as the reference standard for all analyses., Statistical Tests: Sequences were split into training, validation, and testing sets (869, 250, and 120 sequences, respectively). Inter-reader agreement was assessed with the Fleiss kappa. Following preprocessing and data augmentation, 28 CNNs were trained on MRI slices for each sequence. Model performance was assessed on both a per-slice and a per-sequence basis. A pairwise t-test was performed to compare performances of the classifiers., Results: The number of sequences labeled as Q0 or Q1 was 38 vs. 278 for T2WI, 43 vs. 273 for DWI, 41 vs. 275 for ADC, and 38 vs. 253 for DCE. Inter-reader agreement was almost perfect for T2WI and DCE and substantial for DWI and ADC. On the per-slice analysis, accuracy was 89.95% ± 0.02% for T2WI, 79.83% ± 0.04% for DWI, 76.64% ± 0.04% for ADC, 96.62% ± 0.01% for DCE. On the per-sequence analysis, accuracy was 100% ± 0.00% for T2WI, DWI, and DCE, and 92.31% ± 0.00% for ADC. The three best algorithms performed significantly better than the remaining ones on every sequence (P-value < 0.05)., Data Conclusion: CNNs achieved high accuracy in classifying prostate MRI image quality on an individual-slice basis and almost perfect accuracy when classifying the entire sequences., Evidence Level: 4 TECHNICAL EFFICACY: Stage 1., (© 2021 The Authors. Journal of Magnetic Resonance Imaging published by Wiley Periodicals LLC on behalf of International Society for Magnetic Resonance in Medicine.)

Bladder cancer (BCa) is among the ten most frequent cancers globally. It is the tumor with the highest lifetime treatment-associated costs, and among the tumors with the heaviest impacts on postoperative quality of life. The purpose of this article is to review the current applications and future perspectives of the Vesical Imaging Reporting and Data System (VI-RADS). VI-RADS is a newly developed scoring system aimed at standardization of MRI acquisition, interpretation, and reporting for BCa. An insight will be given on the BCa natural history, current MRI applications for local BCa staging with assessment of muscle invasiveness, and clinical implications of the score for disease management. Future applications include risk stratification of nonmuscle invasive BCa, surveillance, and prediction and monitoring of therapy response. LEVEL OF EVIDENCE: 3 TECHNICAL EFFICACY STAGE: 2., (© 2020 International Society for Magnetic Resonance in Medicine.)

Purpose: The aim of the study was to prospectively evaluate the agreement between chest magnetic resonance imaging (MRI) and computed tomography (CT) and to assess the diagnostic performance of chest MRI relative to that of CT during the follow-up of patients recovered from coronavirus disease 2019., Materials and Methods: Fifty-two patients underwent both follow-up chest CT and MRI scans, evaluated for ground-glass opacities (GGOs), consolidation, interlobular septal thickening, fibrosis, pleural indentation, vessel enlargement, bronchiolar ectasia, and changes compared to prior CT scans. DWI/ADC was evaluated for signal abnormalities suspicious for inflammation. Agreement between CT and MRI was assessed with Cohen's k and weighted k. Measures of diagnostic accuracy of MRI were calculated., Results: The agreement between CT and MRI was almost perfect for consolidation (k = 1.00) and change from prior CT (k = 0.857); substantial for predominant pattern (k = 0.764) and interlobular septal thickening (k = 0.734); and poor for GGOs (k = 0.339), fibrosis (k = 0.224), pleural indentation (k = 0.231), and vessel enlargement (k = 0.339). Meanwhile, the sensitivity of MRI was high for GGOs (1.00), interlobular septal thickening (1.00), and consolidation (1.00) but poor for fibrotic changes (0.18), pleural indentation (0.23), and vessel enlargement (0.50) and the specificity was overall high. DWI was positive in 46.0% of cases., Conclusions: The agreement between MRI and CT was overall good. MRI was very sensitive for GGOs, consolidation and interlobular septal thickening and overall specific for most findings. DWI could be a reputable imaging biomarker of inflammatory activity., (© 2021. The Author(s).)

Objective: To evaluate the safety and efficacy of the Phil liquid embolic agent in non-neurological embolization procedures. M&M: Thirty-five patients with a mean age of 62.5 years underwent percutaneous embolization using Phil for the treatment of visceral arterial bleedings in 20/35 patients (including three gluteal, one bladder, two superior mesenteric, three epigastric, one deep femoral, five internal iliac, four intercostal, and one lingual arteries), splanchnic pseudoaneurysms in 11/35 patients (including three hepatic, five splenic, and three renal arteries), pancreatic bleeding metastasis in 1/35 patient, and gastric bleeding varices in 3/35 patients. Phil is composed of a non-adhesive copolymer dissolved in DMSO (Anhydrous Dimethyl Sulfoxide) with different viscosity. Procedures were performed slowly under continuous fluoroscopic guidance to avoid embolization of non-target vessels., Results: Clinical success was obtained with a single intervention in 34 cases (97.15%), while a repeated procedure was required in one case (2.85%). No technical complications nor non-target embolization occurred. A case of post-embolic syndrome was noted (2.85%) in one patient. DMSO administration-related pain was successfully controlled by medical therapy., Conclusion: Phil can be considered a safe and effective embolic agent for the treatment of non-neurologic bleeding.

Objectives: (I) To determine Vesical Imaging-Reporting and Data System (VI-RADS) score 5 accuracy in predicting locally advanced bladder cancer (BCa), so as to potentially identify those patients who could avoid the morbidity of deep transurethral resection of bladder tumour (TURBT) in favour of histological sampling-TUR prior to radical cystectomy (RC). (II) To explore the predictive value of VI-RADS score 5 on time-to-cystectomy (TTC) outcomes., Patients and Methods: We retrospectively reviewed patients' ineligible or refusing cisplatin-based combination neoadjuvant chemotherapy who underwent multiparametric magnetic resonance imaging (mpMRI) of the bladder prior to staging TURBT followed by RC for muscle-invasive BCa. Sensitivity, specificity, positive and negative predictive values (PPV, NPV) were calculated for VI-RADS score 5 vs. score 2-4 cases to assess the accuracy of mpMRI for extravesical BCa detection (≥pT3). VI-RADS score performance was assessed by receiver operating characteristics curve analysis. A Κ statistic was calculated to estimate mpMRI and pathological diagnostic agreement. The risk of delayed TTC (i.e. time from initial BCa diagnosis of >3 months) was assessed using multivariable logistic regression model., Results: A total of 149 T2-T4a, cN0-M0 patients (VI-RADS score 5, n = 39 vs VI-RADS score 2-4, n = 110) were examined. VI-RADS score 5 demonstrated sensitivity, specificity, PPV and NPV, in detecting extravesical disease of 90.2% (95% confidence interval [CI] 84-94.3), 98.1% (95% CI 94-99.6), 94.9% (95% CI 89.6-97.6) and 96.4% (95% CI 91.6-98.6), respectively. The area under the curve was 94.2% (95% CI 88.7-99.7) and inter-reader agreement was excellent (Κ inter 0.89). The mean (SD) TTC was 4.2 (2.3) and 2.8 (1.1) months for score 5 vs 2-4, respectively (P < 0.001). VI-RADS score 5 was found to independently increase risk of delayed TTC (odds ratio 2.81, 95% CI 1.20-6.62)., Conclusion: The VI-RADS is valid and reliable in differentiating patients with extravesical disease from those with muscle-confined BCa before TURBT. Detection of VI-RADS score 5 was found to predict significant delay in TTC independently from other clinicopathological features. In the future, higher VI-RADS scores could potentially avoid the morbidity of extensive primary resections in favour of sampling-TUR for histology. Further prospective, larger, and multi-institutional trials are required to validate clinical applicability of our findings., (© 2020 The Authors BJU International © 2020 BJU International Published by John Wiley & Sons Ltd.)

The Vesical Imaging-Reporting and Data System (VI-RADS) has been introduced to provide preoperative bladder cancer staging and has proved to be reliable in assessing the presence of muscle invasion in the pre-TURBT (trans-urethral resection of bladder tumor). We aimed to assess through a systematic review and meta-analysis the inter-reader variability of VI-RADS criteria for discriminating non-muscle vs. muscle invasive bladder cancer (NMIBC, MIBC). PubMed, Web of Science, Cochrane, and Embase were searched up until 30 July 2020. The Quality Appraisal of Diagnostic Reliability (QAREL) checklist was utilized to assess the quality of included studies and a pooled measure of inter-rater reliability (Cohen's Kappa [κ] and/or Intraclass correlation coefficients (ICCs)) was calculated. Further sensitivity analysis, subgroup analysis, and meta-regression were conducted to investigate the contribution of moderators to heterogeneity. In total, eight studies between 2018 and 2020, which evaluated a total of 1016 patients via 21 interpreting genitourinary (GU) radiologists, met inclusion criteria and were critically examined. No study was considered to be significantly flawed with publication bias. The pooled weighted mean κ estimate was 0.83 (95%CI: 0.78-0.88). Heterogeneity was present among the studies (Q = 185.92, d.f. = 7, p < 0.001; I2 = 92.7%). Meta-regression analyses showed that the relative % of MIBC diagnosis and cumulative reader's experience to influence the estimated outcome (Coeff: 0.019, SE: 0.007; p = 0.003 and 0.036, SE: 0.009; p = 0.001). In the present study, we confirm excellent pooled inter-reader agreement of VI-RADS to discriminate NMIBC from MIBC underlying the importance that standardization and reproducibility of VI-RADS may confer to multiparametric magnetic resonance (mpMRI) for preoperative BCa staging.

Accurate staging of bladder cancer (BC) is critical, with local tumor staging directly influencing management decisions and affecting prognosis. However, clinical staging based on clinical examination, including cystoscopy and transurethral resection of bladder tumor (TURBT), often understages patients compared to final pathology at radical cystectomy and lymph node (LN) dissection, mainly due to underestimation of the depth of local invasion and the presence of LN metastasis. MRI has now become established as the modality of choice for the local staging of BC and can be additionally utilized for the assessment of regional LN involvement and tumor spread to the pelvic bones and upper urinary tract (UUT). The recent development of the Vesical Imaging-Reporting and Data System (VI-RADS) recommendations has led to further improvements in bladder MRI, enabling standardization of image acquisition and reporting. Multiparametric magnetic resonance imaging (mpMRI) incorporating morphological and functional imaging has been proven to further improve the accuracy of primary and recurrent tumor detection and local staging, and has shown promise in predicting tumor aggressiveness and monitoring response to therapy. These sequences can also be utilized to perform radiomics, which has shown encouraging initial results in predicting BC grade and local stage. In this article, the current state of evidence supporting MRI in local, regional, and distant staging in patients with BC is reviewed. LEVEL OF EVIDENCE: 3 TECHNICAL EFFICACY STAGE: 2 J. Magn. Reson. Imaging 2020;52:649-667., (© 2020 International Society for Magnetic Resonance in Medicine.)

OBJECTIVE. The purpose of this article is to review the natural history and management of bladder cancer, with insight into MRI applications for the assessment of muscle invasiveness of bladder cancer using the newly developed Vesical Imaging Reporting and Data System (VI-RADS) score. CONCLUSION. Multiparametric MRI and the VI-RADS score have been consistently validated across several different institutions as appropriate tools for local staging of bladder cancer and have been proven to contribute to the diagnostic workup and management of urinary bladder cancer.

Purpose of Review: Accurate staging of bladder cancer is essential to guide appropriate management. In this review, we discuss the principles, applications and performance of multiparametric MRI (mpMRI) and PET-computer tomography (PET-CT) for local and distant staging of bladder cancer., Recent Findings: Bladder mpMRI has a high diagnostic performance in local staging of bladder cancer, superior to other imaging modalities. It can accurately differentiate muscle invasive bladder cancer (MIBC) from non-MIBC (NMIBC), as well as ≤T2 from ≥T3 stages. mpMRI can be used to assess pelvic lymph nodes, although its sensitivity is relatively low. For the assessment of the upper urinary tract, CT urography is the imaging modality of choice. magnetic resonance urography is a viable alternative to CT in selected cases. Although PET-CT is accurate for nodal and distant staging of bladder cancer, there is no clear evidence on its superior diagnostic performance compared with contrast-enhanced CT., Summary: mpMRI is the most accurate imaging modality for local staging of bladder cancer, capable to accurately distinguish MIBC from NMIBC. Nodal and distant staging relies primarily on contrast-enhanced CT.

Objectives: We aimed to determine the interobserver reproducibility of the Prostate Cancer Radiological Estimation of Change in Sequential Evaluation (PRECISE) criteria for magnetic resonance imaging in patients on active surveillance (AS) for prostate cancer (PCa) at two different academic centres., Methods: The PRECISE criteria score the likelihood of clinically significant change over time. The system is a 1-to-5 scale, where 1 or 2 implies regression of a previously visible lesion, 3 denotes stability and 4 or 5 indicates radiological progression. A retrospective analysis of 80 patients (40 from each centre) on AS with a biopsy-confirmed low- or intermediate-risk PCa (i.e. ≤ Gleason 3 + 4 and prostate-specific antigen ≤ 20 ng/ml) and ≥ 2 prostate MR scans was performed. Two blinded radiologists reported all scans independently and scored the likelihood of radiological change (PRECISE score) from the second scan onwards. Cohen's κ coefficients and percent agreement were computed., Results: Agreement was substantial both at a per-patient and a per-scan level (κ = 0.71 and 0.61; percent agreement = 79% and 81%, respectively) for each PRECISE score. The agreement was superior (κ = 0.83 and 0.67; percent agreement = 90% and 91%, respectively) when the PRECISE scores were grouped according to the absence/presence of radiological progression (PRECISE 1-3 vs 4-5). Higher inter-reader agreement was observed for the scans performed at University College London (UCL) (κ = 0.81 vs 0.55 on a per-patient level and κ = 0.70 vs 0.48 on a per-scan level, respectively). The discrepancies between institutions were less evident for percent agreement (80% vs 78% and 86% vs 75%, respectively)., Conclusions: Expert radiologists achieved substantial reproducibility for the PRECISE scoring system, especially when data were pooled together according to the absence/presence of radiological progression (PRECISE 1-3 vs 4-5)., Key Points: • Inter-reader agreement between two experienced prostate radiologists using the PRECISE criteria was substantial. • The agreement was higher when the PRECISE scores were grouped according to the absence/presence of radiological progression (i.e. PRECISE 1-3 vs PRECISE 4 and 5). • Higher inter-reader agreement was observed for the scans performed at UCL, but the discrepancies between institutions were less evident for percent agreement.

Background: We performed a qualitative study to investigate the experiences of participants in a multicentre randomized controlled trial on a home-based palliative approach (HPA) for adults with severe multiple sclerosis (MS) and their caregivers. Our aim was to explore the strengths and challenges of the intervention, and circumstances that may have influenced its efficacy., Methods: Participants to the qualitative study were the patients, their caregivers, patient referring physicians, and the teams who delivered the HPA intervention. We performed semi-structured one-on-one interviews with 12 patients and 15 informal caregivers chosen using a maximum variation strategy, two focus group meetings with patient referring physicians (4 participants each), and one with the HPA teams (9 participants)., Results: From data analysis (framework method) 38 sub-categories emerged, which were grouped into 10 categories and 3 themes: 'expectations,' 'met and unmet needs', and 'barriers'. Intervention benefits were improved control of symptoms and reduced sense of isolation of the patient-caregiver dyads. Limitations were: factors related to experimental design (difficulty of dyads in identifying examiner and team roles, additional burden for caregivers); team issues (insufficient team building /supervision, competing priorities); limitations of the intervention itself (insufficient length, lack of rehabilitation input); and external factors (resource limitations, under-responsive services/professionals). The referring physician focus groups provided little experiential data., Conclusions: The HPA reduced patient symptoms and sense of isolation in patients and caregivers. The indirect role of the HPA teams, and insufficient length of the intervention were key limitations. The experimental design imposed additional burdens on the dyads. Key barriers were the paucity of available services, the demanding administrative procedures, and lack of networking facilities. These findings suggest that two major requirements are necessary for home palliative care to be effective in this patient population: HPA teams well-connected with MS rehabilitation services, and care delivered over the long-term, with variable intensity., Trial Registration: Current Controlled Trials ISRCTN73082124 (Registered 19/06/2014)., Competing Interests: FP has received speaking honoraria from, and has been a board member of: Alimirall, Bayer, Biogen, Celgene, Merck, Novartis, Roche, Sanofi Genzyme, and Teva. VTC has been a board member of Merck, Novartis, Sanofi Genzyme. She has received travel expenses from Almirall, Biogen, Merck; speaking/writing honoraria from Almirall, Merck, and Teva; and support from Almirall for a research project. AS has been a board member of Biogen, Merck, and Novartis; she has received speaker honoraria from Almirall, Excemed, Merck, Sanofi Genzyme, and Teva. The authors confirm that this declaration does not alter the authors’ adherence to all PLOS ONE policies on sharing data and materials.

Purpose: To evaluate 2-year results of the Zilver PTX (Cook Medical, Bloomington, Indiana) drug-eluting stent (DES) for femoropopliteal peripheral artery disease (PAD) in patients with no continuous patent infrapopliteal runoff arteries compared with patients with ≥ 1 continuous patent runoff vessels., Materials and Methods: A retrospective analysis of patients with femoropopliteal PAD enrolled in the Zilver PTX Post-Market Surveillance Study in Japan was performed. There were no exclusion criteria. Outcomes, including freedom from target lesion revascularization (TLR), patency, and clinical benefit, for the no-runoff group (n = 54) were compared with the runoff group (n = 846)., Results: The 2 groups were similar in terms of demographics, lesion characteristics, and comorbidities (P > .05). There was a higher incidence of critical limb ischemia in the no-runoff group compared with the runoff group (44.8% vs 19.7%; P < .01). There were 3 amputations (5.6%) in the no-runoff group versus 7 amputations (0.8%) in the runoff group (P = .02). At 2 years, freedom from TLR rates were 81.3% versus 83.8% (P = .87), patency rates were 68.4% versus 70.7% (P = .95), and clinical benefit rates were 73.7% versus 80.0% (P = .16) in the no-runoff versus runoff group, respectively., Conclusions: Results in patients with no continuous patent tibial runoff were favorable through 2 years and similar to results for patients with ≥ 1 continuous patent runoff vessels, indicating that the Zilver PTX DES may be a valid treatment option for patients with these difficult-to-treat lesions., (Copyright © 2017 SIR. Published by Elsevier Inc. All rights reserved.)