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Objective To assess the value of opportunistic biomarkers derived from chest CT performed at hospital admission of COVID-19 patients for the phenotypization of high-risk patients. Methods In this multicentre retrospective study, 1845 consecutive COVID-19 patients with chest CT performed within 72 h from hospital admission were analysed. Clinical and outcome data were collected by each center 30 and 80 days after hospital admission. Patients with unknown outcomes were excluded. Chest CT was analysed in a single core lab and behind pneumonia CT scores were extracted opportunistic data about atherosclerotic profile (calcium score according to Agatston method), liver steatosis (≤ 40 HU), myosteatosis (paraspinal muscle F Results The final cohort included 1669 patients (age 67.5 [58.5–77.4] yo) mainly men 1105/1669, 66.2%) and with reduced oxygen saturation (92% [88–95%]). Pneumonia severity, high Agatston score, myosteatosis, liver steatosis, and osteoporosis derived from CT were more prevalent in patients with more aggressive treatment, access to ICU, and in-hospital death (always p p = 0.0198) to predict patient death (AUC 0.815 vs 0.800; p = 0.001). Conclusion Opportunistic biomarkers derived from chest CT can improve the characterization of COVID-19 high-risk patients. Clinical relevance statement In COVID-19 patients, opportunistic biomarkers of cardiometabolic risk extracted from chest CT improve patient risk stratification. Key Points •In COVID-19 patients, several information about patient comorbidities can be quantitatively extracted from chest CT, resulting associated with the severity of oxygen treatment, access to ICU, and death. •A prediction model based on multiparametric opportunistic biomarkers derived from chest CT resulted superior to a model including only clinical variables in a large cohort of 1669 patients suffering from SARS- CoV2 infection. •Opportunistic biomarkers of cardiometabolic comorbidities derived from chest CT may improve COVID-19 patients’ risk stratification also in absence of detailed clinical data and laboratory tests identifying subclinical and previously unknown conditions.

Objectives Enlarged main pulmonary artery diameter (MPAD) resulted to be associated with pulmonary hypertension and mortality in a non-COVID-19 setting. The aim was to investigate and validate the association between MPAD enlargement and overall survival in COVID-19 patients. Methods This is a cohort study on 1469 consecutive COVID-19 patients submitted to chest CT within 72 h from admission in seven tertiary level hospitals in Northern Italy, between March 1 and April 20, 2020. Derivation cohort (n = 761) included patients from the first three participating hospitals; validation cohort (n = 633) included patients from the remaining hospitals. CT images were centrally analyzed in a core-lab blinded to clinical data. The prognostic value of MPAD on overall survival was evaluated at adjusted and multivariable Cox’s regression analysis on the derivation cohort. The final multivariable model was tested on the validation cohort. Results In the derivation cohort, the median age was 69 (IQR, 58–77) years and 537 (70.6%) were males. In the validation cohort, the median age was 69 (IQR, 59–77) years with 421 (66.5%) males. Enlarged MPAD (≥ 31 mm) was a predictor of mortality at adjusted (hazard ratio, HR [95%CI]: 1.741 [1.253–2.418], p p = 0.005), together with male gender, old age, high creatinine, low well-aerated lung volume, and high pneumonia extension (c-index [95%CI] = 0.826 [0.796–0.851]). Model discrimination was confirmed on the validation cohort (c-index [95%CI] = 0.789 [0.758–0.823]), also using CT measurements from a second reader (c-index [95%CI] = 0.790 [0.753;0.825]). Conclusion Enlarged MPAD (≥ 31 mm) at admitting chest CT is an independent predictor of mortality in COVID-19. Key Points •Enlargement of main pulmonary artery diameter at chest CT performed within 72 h from the admission was associated with a higher rate of in-hospital mortality in COVID-19 patients. •Enlargement of main pulmonary artery diameter (≥ 31 mm) was an independent predictor of death in COVID-19 patients at adjusted and multivariable regression analysis. •The combined evaluation of clinical findings, lung CT features, and main pulmonary artery diameter may be useful for risk stratification in COVID-19 patients.

Objective: To calculate by means of a computer-aided tool the volumes of healthy residual lung parenchyma, of emphysema, of ground glass opacity (GGO) and of consolidation on chest computed tomography (CT) in patients with suspected viral pneumonia by COVID-19. Materials and methods: This study included 116 patients that for suspected COVID-19 infection were subjected to the reverse transcription real-time fluorescence polymerase chain reaction (RT-PCR) test. A computer-aided tool was used to calculate on chest CT images healthy residual lung parenchyma, emphysema, GGO and consolidation volumes for both right and left lung. Expert radiologists, in consensus, assessed the CT images using a structured report and attributed a radiological severity score at the disease pulmonary involvement using a scale of five levels. Nonparametric test was performed to assess differences statistically significant among groups. Results: GGO was the most represented feature in suspected CT by COVID-19 infection; it is present in 102/109 (93.6%) patients with a volume percentage value of 19.50% and a median value of 0.64 L, while the emphysema and consolidation volumes were low (0.01 L and 0.03 L, respectively). Among quantified volume, only GGO volume had a difference statistically significant between the group of patients with suspected versus non-suspected CT for COVID-19 (p < < 0.01). There were differences statistically significant among the groups based on radiological severity score in terms of healthy residual parenchyma volume, of GGO volume and of consolidations volume (p < < 0.001). Conclusion: We demonstrated that, using a computer-aided tool, the COVID-19 pneumonia was mirrored with a percentage median value of GGO of 19.50% and that only GGO volume had a difference significant between the patients with suspected or non-suspected CT for COVID-19 infection.

Purpose To develop and validate an effective and user-friendly AI platform based on a few unbiased clinical variables integrated with advanced CT automatic analysis for COVID-19 patients’ risk stratification. Material and Methods In total, 1575 consecutive COVID-19 adults admitted to 16 hospitals during wave 1 (February 16-April 29, 2020), submitted to chest CT within 72 h from admission, were retrospectively enrolled. In total, 107 variables were initially collected; 64 extracted from CT. The outcome was survival. A rigorous AI model selection framework was adopted for models selection and automatic CT data extraction. Model performances were compared in terms of AUC. A web–mobile interface was developed using Microsoft PowerApps environment. The platform was externally validated on 213 COVID-19 adults prospectively enrolled during wave 2 (October 14-December 31, 2020). Results The final cohort included 1125 patients (292 non-survivors, 26%) and 24 variables. Logistic showed the best performance on the complete set of variables (AUC = 0.839 ± 0.009) as in models including a limited set of 13 and 5 variables (AUC = 0.840 ± 0.0093 and AUC = 0.834 ± 0.007). For non-inferior performance, the 5 variables model (age, sex, saturation, well-aerated lung parenchyma and cardiothoracic vascular calcium) was selected as the final model and the extraction of CT-derived parameters was fully automatized. The fully automatic model showed AUC = 0.842 (95% CI: 0.816–0.867) on wave 1 and was used to build a 0–100 scale risk score (AI-SCoRE). The predictive performance was confirmed on wave 2 (AUC 0.808; 95% CI: 0.7402–0.8766). Conclusions AI-SCoRE is an effective and reliable platform for automatic risk stratification of COVID-19 patients based on a few unbiased clinical data and CT automatic analysis.

Hypertension is associated with more severe disease and adverse outcomes in COVID-19 patients. Recent investigations have indicated that hypertension might be an independent predictor of outcomes in COVID-19 patients regardless of other cardiovascular and noncardiovascular comorbidities. We explored the significance of coronary calcifications in 694 hypertensive patients in the Score-COVID registry, an Italian multicenter study conducted during the first pandemic wave in the Western world (March-April 2020). A total of 1565 patients admitted with RNA-PCR-positive nasopharyngeal swabs and chest computed tomography (CT) at hospital admission were included in the study. Clinical outcomes and cardiovascular calcifications were analyzed independently by a research core lab. Hypertensive patients had a different risk profile than nonhypertensive patients, with more cardiovascular comorbidities. The deceased hypertensive patients had a greater coronary calcification burden at the level of the anterior descending coronary artery. Hypertension status and the severity cutoffs of coronary calcifications were used to stratify the clinical outcomes. For every 100-mm3 increase in coronary calcium volume, hospital mortality in hypertensive patients increased by 8%, regardless of sex, age, diabetes, creatinine, and lung interstitial involvement. The coronary calcium score contributes to stratifying the risk of complications in COVID-19 patients. Cardiovascular calcifications appear to be a promising imaging marker for providing pathophysiological insight into cardiovascular risk factors and COVID-19 outcomes.

To investigate the effectiveness and safety of SoracteLite™—transperineal percutaneous laser ablation (TPLA) in the treatment of patients with symptomatic benign prostatic hyperplasia (BPH) at 6 and 12 months follow-up. Patients with urinary symptoms secondary to BPH underwent TPLA under local anesthesia in four centers. Under US guidance, up to four 21G applicators were inserted in the prostatic tissue. Each treatment was performed with diode laser operating at 1064 nm changing the illumination time according to prostate size. The primary end-points of this study were change in IPSS, PVR, Qmax, QoL, and prostatic volume at 6 an 12 months from SoracteLiteTM TPLA treatment. Secondary end-point was the assessment of complications. Analysis was performed on data 160 patients (mean age 69.8 ± 9.6 years) with at least 6 months follow and of 83 patients (mean age 67.9 ± 8.7 years) with at least 12 months follow-up. At 6 months, IPSS improved from 22.5 ± 5.1 to 7.7 ± 3.3 (P

Recent clinical and demographical studies on COVID-19 patients have demonstrated that men experience worse outcomes than women. However, in most cases, the data were not stratified according to gender, limiting the understanding of the real impact of gender on outcomes. This study aimed to evaluate the disaggregated in-hospital outcomes and explore the possible interactions between gender and cardiovascular calcifications. Data was derived from the sCORE-COVID-19 registry, an Italian multicentre registry that enrolled COVID-19 patients who had undergone a chest computer tomography scan on admission. A total of 1683 hospitalized patients (mean age 67±14 years) were included. Men had a higher prevalence of cardiovascular comorbidities, a higher pneumonia extension, more coronary calcifications (63% vs.50.9%, p3, pp=0.001), but the death event tended to occur earlier in women (15±7 vs. 8±7 days, p= 0.07). Non-survivors had a higher coronary, thoracic aorta, and aortic valve calcium score. Female sex, a known independent predictor of a favorable outcome in SARS-CoV2 infection, was not protective in women with a coronary calcification volume greater than 100 mm3. There were significant differences in cardiovascular comorbidities and vascular calcifications between men and women with SARS-CoV2 pneumonia. The differences in outcomes can be at least partially explained by the different cardiovascular profiles. However, women with poor outcomes had the same coronary calcific burden as men. The presumed favorable female sex bias in COVID-19 must therefore be reviewed in the context of comorbidities, especially cardiovascular ones.

To assess the performance of the second reading of chest compute tomography (CT) examinations by expert radiologists in patients with discordance between the reverse transcription real-time fluorescence polymerase chain reaction (RT-PCR) test for COVID-19 viral pneumonia and the CT report. Three hundred and seventy-eight patients were included in this retrospective study (121 women and 257 men, 71 years median age, with a range of 29&ndash, 93 years) and subjected to RT-PCR tests for suspicious COVID-19 infection. All patients were subjected to CT examination in order to evaluate the pulmonary disease involvement by COVID-19. CT images were reviewed first by two radiologists who identified COVID-19 typical CT patterns and then reanalyzed by another two radiologists using a CT structured report for COVID-19 diagnosis. Weighted k values were used to evaluate the inter-reader agreement. The median temporal window between RT-PCRs execution and CT scan was zero days with a range of (&minus, 9, 11) days. The RT-PCR test was positive in 328/378 (86.8%). Discordance between RT-PCR and CT findings for viral pneumonia was revealed in 60 cases. The second reading changed the CT diagnosis in 16/60 (26.7%) cases contributing to an increase the concordance with the RT-PCR. Among these 60 cases, eight were false negative with positive RT-PCR, and 36 were false positive with negative RT-PCR. Sensitivity, specificity, positive predictive value and negative predictive value of CT were respectively of 97.3%, 53.8%, 89.0%, and 88.4%. Double reading of CT scans and expert second readers could increase the diagnostic confidence of radiological interpretation in COVID-19 patients.

BACKGROUND: Coronavirus disease 2019 (COVID-19) has spread worldwide determining dramatic impacts on healthcare systems. Early identification of high-risk parameters is required in order to provide the best therapeutic approach. Coronary, thoracic aorta and aortic valve calcium can be measured from a non-gated chest computer tomography (CT) and are validated predictors of cardiovascular events and all-cause mortality. However, their prognostic role in acute systemic inflammatory diseases, such as COVID-19, has not been investigated. OBJECTIVES: The aim was to evaluate the association of coronary artery calcium and total thoracic calcium on in-hospital mortality in COVID-19 patients. METHODS: 1093 consecutive patients from 16 Italian hospitals with a positive swab for COVID-19 and an admission chest CT for pneumonia severity assessment were included. At CT, coronary, aortic valve and thoracic aorta calcium were qualitatively and quantitatively evaluated separately and combined together (total thoracic calcium) by a central Core-lab blinded to patients' outcomes. RESULTS: Non-survivors compared to survivors had higher coronary artery [Agatston (467.76 ​± ​570.92 vs 206.80 ​± ​424.13 ​mm2, p ​

Background and aims The potential impact of coronary atherosclerosis, as detected by coronary artery calcium, on clinical outcomes in COVID-19 patients remains unsettled. We aimed to evaluate the prognostic impact of clinical and subclinical coronary artery disease (CAD), as assessed by coronary artery calcium score (CAC), in a large, unselected population of hospitalized COVID-19 patients undergoing non-gated chest computed tomography (CT) for clinical practice. Methods SARS-CoV 2 positive patients from the multicenter (16 Italian hospitals), retrospective observational SCORE COVID-19 (calcium score for COVID-19 Risk Evaluation) registry were stratified in three groups: (a) “clinical CAD” (prior revascularization history), (b) “subclinical CAD” (CAC >0), (c) “No CAD” (CAC=0). Primary endpoint was in-hospital mortality and the secondary endpoint was a composite of myocardial infarction and cerebrovascular accident (MI/CVA). Results Amongst 1625 patients (male 67.2%, median age 69 [interquartile range 58-77] years), 31%, 57.8% and 11.1% had no, subclinical and clinical CAD, respectively. Increasing rates of in-hospital mortality (11.3% vs. 27.3% vs. 39.8%, p400, respectively, p, Graphical abstract Image 1

Background and aims Several studies reported a high incidence of pulmonary embolism (PE) among patients with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection, but detailed data about clinical characteristics, risk factors of these patients and prognostic role of PE are still lacking. We aim to evaluate the occurrence of pulmonary embolism among patients with SARS-CoV-2 infection, and to describe their risk factors, clinical characteristics, and in-hospital clinical outcomes. Methods This is a multicenter Italian study including 333 consecutive SARS-CoV-2 patients admitted to seven hospitals from February 22 to May 15, 2020. All the patients underwent computed tomography pulmonary angiography (CTPA) for PE detection. In particular, CTPA was performed in case of inadequate response to high-flow oxygen therapy (Fi02≥0.4 to maintain Sp02≥92%), elevated D-dimer (>0.5μg/mL), or echocardiographic signs of right ventricular dysfunction. Clinical, laboratory and radiological data were also analyzed. Results Among 333 patients with laboratory confirmed SARS-CoV-2 pneumonia and undergoing CTPA, PE was detected in 109 (33%) cases. At CTPA, subsegmental, segmental, lobar and central thrombi were detected in 31 (29%), 50 (46%), 20 (18%) and 8 (7%) cases, respectively. In-hospital death occurred in 29 (27%) patients in the PE-group and in 47 (21%) patients in the non-PE group (p = 0.25). Patients in PE-group had a low rate of traditional risk factors and deep vein thrombosis was detected in 29% of patients undergoing compression ultrasonography. In 71% of cases with documented PE, the thrombotic lesions were located in the correspondence of parenchymal consolidation areas. Conclusions Despite a low rate of risk factors for venous thromboembolism, PE is present in about 1 out 3 patients with SARS-CoV-2 pneumonia undergoing CTPA for inadequate response to oxygen therapy, elevated D-dimer level, or echocardiographic signs of right ventricular dysfunction. In most of the cases, the thromboses were located distally in the pulmonary tree and were mainly confined within pneumonia areas.

Purpose: To compare different commercial software in the quantification of Pneumonia Lesions in COVID-19 infection and to stratify the patients based on the disease severity using on chest computed tomography (CT) images. Materials and methods: We retrospectively examined 162 patients with confirmed COVID-19 infection by reverse transcriptase-polymerase chain reaction (RT-PCR) test. All cases were evaluated separately by radiologists (visually) and by using three computer software programs: (1) Thoracic VCAR software, GE Healthcare, United States, (2) Myrian, Intrasense, France, (3) InferRead, InferVision Europe, Wiesbaden, Germany. The degree of lesions was visually scored by the radiologist using a score on 5 levels (none, mild, moderate, severe, and critic). The parameters obtained using the computer tools included healthy residual lung parenchyma, ground-glass opacity area, and consolidation volume. Intraclass coefficient (ICC), Spearman correlation analysis, and non-parametric tests were performed. Results: Thoracic VCAR software was not able to perform volumes segmentation in 26/162 (16.0%) cases, Myrian software in 12/162 (7.4%) patients while InferRead software in 61/162 (37.7%) patients. A great variability (ICC ranged for 0.17 to 0.51) was detected among the quantitative measurements of the residual healthy lung parenchyma volume, GGO, and consolidations volumes calculated by different computer tools. The overall radiological severity score was moderately correlated with the residual healthy lung parenchyma volume obtained by ThoracicVCAR or Myrian software, with the GGO area obtained by the ThoracicVCAR tool and with consolidation volume obtained by Myrian software. Quantified volumes by InferRead software had a low correlation with the overall radiological severity score. Conclusions: Computer-aided pneumonia quantification could be an easy and feasible way to stratify COVID-19 cases according to severity, however, a great variability among quantitative measurements provided by computer tools should be considered.

The authors present a case of angioleiomyoma situated in the posterior knee. A 47-year-old Caucasian woman presented in 2011 with recurrent stabbing pain on the lateral aspect of her right knee. She reported having pain for the last 6 years. She had no history of trauma. In 2008 she was treated with a diagnostic arthroscopy and transposition of the tibial tuberosity, with no benefit to her symptoms. Electromyography of the lower limbs showed asymmetry of the amplitude of sensitive action potential of the superficial fibular nerve. Based on the clinical suspicion of entrapment of the common fibular nerve at its bifurcation, a surgical exploration was performed, but pain persisted. In 2014, ultrasonography localized at the trigger point showed a solid ovular formation of 1 cm in diameter situated on the posterior aspect of the external femoral condyle in proximity to the joint capsule, which was confirmed by magnetic resonance imaging (MRI). Surgical excision of the 1-cm diameter tumor mass relieved the symptoms immediately and permanently. Histology evidenced the presence of a solid-type angioleiomyoma. The presence of an angioleiomyoma at the knee joint is very rare and few cases are reported in the literature. To the authors' knowledge this is the first time an angioleiomyoma in the posterior knee has been described. In case of unexplained and persistent pain in and around the knee, clinicians should be aware of the atypical locations of this tumor, considering that its surgical excision alone may relieve symptoms permanently.

To assess the feasibility and safety of transperineal laser ablation (TPLA) for treating benign prostatic hyperplasia (BPH). Institutional review board approval was obtained for this prospective non-randomized trial. Eightteen patients (age 71.7 ± 9.4 years) with urinary symptoms secondary to BPH underwent TPLA under local anesthesia. Under US guidance, up to four 21G applicators were inserted in the prostatic tissue. Each treatment was performed with diode laser operating at 1064 nm changing the illumination time according to prostate size. Primary endpoints were technical success and safety of TPLA. Secondary endpoints included operation time, ablation time, energy deployed, hospitalization time, catheterization time, and change in International Prostate Symptom Score (IPSS), Quality of Life (QoL), peak urinary flow rate (Q max), post-void residual (PVR), and prostatic volume at 3 months. χ 2 and Fisher exact tests were used. All procedures were technically successful. No complications occurred. Mean operation time was 43.3 ± 8.7 min, mean ablation time 15.9 ± 3.9 min, mean energy deployed 10,522 ± 3290.5 J, mean hospital stay 1.5 ± 0.4 days, and mean catheterization time 17.3 ± 10.0 days. At 3 months, IPSS improved from 21.9 to 10.7 (P

The spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has already assumed pandemic proportions, affecting over 100 countries in few weeks. A global response is needed to prepare health systems worldwide. Covid-19 can be diagnosed both on chest X-ray and on computed tomography (CT). Asymptomatic patients may also have lung lesions on imaging. CT investigation in patients with suspicion Covid-19 pneumonia involves the use of the high-resolution technique (HRCT). Artificial intelligence (AI) software has been employed to facilitate CT diagnosis. AI software must be useful categorizing the disease into different severities, integrating the structured report, prepared according to subjective considerations, with quantitative, objective assessments of the extent of the lesions. In this communication, we present an example of a good tool for the radiologist (Thoracic VCAR software, GE Healthcare, Italy) in Covid-19 diagnosis (Pan et al. in Radiology, 2020. https://doi.org/10.1148/radiol.2020200370). Thoracic VCAR offers quantitative measurements of the lung involvement. Thoracic VCAR can generate a clear, fast and concise report that communicates vital medical information to referring physicians. In the post-processing phase, software, thanks to the help of a colorimetric map, recognizes the ground glass and differentiates it from consolidation and quantifies them as a percentage with respect to the healthy parenchyma. AI software therefore allows to accurately calculate the volume of each of these areas. Therefore, keeping in mind that CT has high diagnostic sensitivity in identifying lesions, but not specific for Covid-19 and similar to other infectious viral diseases, it is mandatory to have an AI software that expresses objective evaluations of the percentage of ventilated lung parenchyma compared to the affected one.

Treatment of symptoms of the lower urinary tract due to benign prostatic obstruction (LUTS/BPH) in men with transperineal laser ablation (TPLA) may offer advantages in terms of functional outcome and safety compared to current standard therapies. Because the technique is relatively new, the indications and outcomes for this treatment are being investigated. However, it is already applied outside of clinical trials. The results of the feasibility study are excellent in terms of both clinical and safety improvements. No significant procedural, periprocedural, and distant complications have been reported so far. In particular, severe complications such as incontinence, erectile dysfunction, retrograde ejaculation, and urethral stenosis have not yet been reported. It is necessary to acquire clinical information from these treatments to plan future research.

Image-guided laser ablation therapy (LAT) of benign thyroid nodules demonstrated favorable results in randomized trials with fixed modalities of treatment. The aim of this retrospective multicenter study was to assess the effectiveness, tolerability, and complications of LAT in a large consecutive series of patients from centers using this technique in their routine clinical activity.Clinical records of 1534 consecutive laser-treated nodules in 1531 patients from eight Italian thyroid referral centers were assessed. Inclusion criteria were as follows: solid or mixed nodules with fluid component up to 40%; benign cytological findings; and normal thyroid function.LAT was performed with a fixed-power protocol, whereas the number of applicators and illumination times were different according to target size. From one to three illuminations with pullback technique and with a total energy delivery based on the nodule volume were performed during the same session. Patients were evaluated during LAT, within 30 days, and 12 months after the procedure.Total number of treatments was 1837; 1280 (83%) of nodules had a single LAT session. Mean nodule volume decreased from 27 ± 24 mL at baseline to 8 ± 8 mL 12 months after treatment (P.001). Mean nodule volume reduction was 72% ± 11% (range 48%-96%). This figure was significantly greater in mixed nodules (79% ± 7%; range 70%-92%) because they were drained immediately before laser illumination. Symptoms improved from 49% to 10% of cases (P.001) and evidence of cosmetic signs from 86% to 8% of cases (P.001). Seventeen complications (0.9%) were registered. Eight patients (0.5%) experienced transitory voice changes that completely resolved at the ear-nose-throat examination within 2-84 days. Nine minor complications (0.5%) were reported. No changes in thyroid function or autoimmunity were observed.Real practice confirmed LAT as a clinically effective, reproducible, and rapid outpatient procedure. Treatments were well tolerated and risk of major complications was very low.

Purpose To evaluate the feasibility, efficacy, and safety of catheter-based radiofrequency renal sympathetic denervation for treatment of resistant hypertension. Materials and Methods Twenty-four patients with essential hypertension unresponsive to at least three antihypertensive agents underwent renal denervation (RDN). Three patients had variant renal anatomy. Comorbidities included diabetes (n = 11), renal failure (n = 4), and obstructive sleep apnea (n = 2). The effect on 24-hour ambulatory blood pressure (BP) was assessed at 6 months. Patients with a decrease in systolic BP of at least 10mm Hg were considered responders. Results RDN was bilateral in 19 patients and single-sided in five. The 19 patients with bilateral RDN showed mean reductions in 24-hour ambulatory BP of 20.7/8.7mm Hg±18.1/9.9 (systolic/diastolic; P = .0001/ P = .0012). Sixteen bilaterally treated patients (84.2%) showed a systolic BP reduction of at least 10mm Hg and were considered responders, whereas only one of the five patients with single-sided RDN showed a response. Two responders with sleep apnea showed improvement in polysomnography indices, and one with left concentric ventricular hypertrophy showed complete cardiac remodeling 11 months after the RDN procedure. Renal function remained unchanged in all patients, including those with renal failure. Optical coherence tomography of the renal arteries in one patient showed sporadic endothelial scarring. Renal angiograms at 9 months (one patient) and 12 months (two patients) had normal findings. Conclusions Catheter-based RDN was carried out safely, even in patients with comorbidities, abnormal renal arteries, or anatomic variants. The response rate for bilateral RDN (84.2%) was comparable to previous reports.

Purpose In view of the promising results of a phase I trial, this phase II trial was conducted to study the efficacy and safety of intraarterial induction chemotherapy with a novel nanoparticle albumin–bound paclitaxel formulation in advanced head and neck cancer. Materials and Methods Sixty previously untreated patients with locally advanced squamous-cell carcinoma (SCC) of the oral cavity, oropharynx, or hypopharynx in stage T3/4 and any nodal stage received two to four cycles of nanoparticle albumin–bound paclitaxel by infusion into the external carotid artery or one of its branches, without premedication, at an initial dose of 230 mg/m 2 and subsequently a reduced dose of 150 mg/m 2 . Response was evaluated by physical examination and multidetector computed tomography in all patients, and also by positron emission tomography with [ 18 F]fluorodeoxyglucose in 38 patients. Definitive treatment was surgery, chemotherapy, radiation therapy, or chemoradiation therapy. Results Intraarterial chemotherapy had a low incidence of complications and produced complete or partial responses in 45 of 60 treated patients (75%). Seven patients (11.67%) had stable disease and eight (13.33%) had disease progression. High-grade bone marrow depression was rare. An unexpected toxicity was reversible facial nerve palsy on the side of infusion, which occurred in six patients at initial dosage. Reduction of the dose eliminated this specific toxicity without any loss of efficacy. Conclusion The promising response rates and tolerability of intraarterial chemotherapy with nanoparticle albumin–bound paclitaxel justify further investigation of this formulation, alone or in combination with other agents, in advanced SCC of the head and neck.

BACKGROUND This study was designed to determine the feasibility, maximum tolerated dose, and toxicities of intraarterial administration of paclitaxel-albumin nanoparticles in patients with advanced head and neck and recurrent anal canal squamous cell carcinoma. Antitumor activity also was assessed. METHODS Forty-three patients (31 with advanced head and neck and 12 with recurrent anal canal squamous cell carcinoma) were treated intraarterially with ABI-007 every 4 weeks for 3 cycles. In total, 120 treatment cycles were completed, 86 in patients with head and neck carcinoma (median, 3 cycles; range, 1–4) and 34 in patients with anal canal carcinoma (median, 3 cycles; range, 1–4). ABI-007 was compared preliminarily with Taxol® for in vitro cytostatic activity. Increasing dose levels from 120 to 300 mg/m2 were studied in 18 patients. Pharmacokinetic profiles after intraarterial administration were obtained in a restricted number of patients. RESULTS The dose-limiting toxicity of ABI-007 was myelosuppression consisting of Grade 4 neutropenia in 3 patients. Nonhematologic toxicities included total alopecia (30 patients), gastrointestinal toxicity (3 patients, Grade 2), skin toxicity (5 patients, Grade 2), neurologic toxicity (4 patients, Grade 2) ocular toxicity (1 patient, Grade 2), flu-like syndrome (7 patients, Grade 2; 1 patient, Grade 3). In total, 120 transfemoral, percutaneous catheterization procedure–related complications occurred only during catheterization of the neck vessels in 3 patients (2 TIA, 1 hemiparesis) and resolved spontaneously. CONCLUSIONS Intraarterial administration of ABI-007 by percutaneous catheterization does not require premedication, is easy and reproducible, and has acceptable toxicity. The maximum tolerated dose in a single administration was 270 mg/m2. Most dose levels showed considerable antitumor activity (42 assessable patients with 80.9% complete response and partial response). The recommended Phase II dose is 230 mg/m2 every 3 weeks. Cancer 2001;92:2592–602. © 2001 American Cancer Society.

Purpose: To evaluate the efficiency of a new high-capacity pump for systemic venous chemotherapy and to verify the quality of implantation by interventional radiology staff. Methods: A total of 47 infusion pumps with a 60-ml reservoir and variable flow rates (2, 6, 8, or 12 ml/24 hr) were implanted by radiologists in 46 patients with solid tumor metastases requiring treatment with a single, continuously infused cytostatic agent. The reservoir was refilled transcutaneously, usually once weekly. The flow accuracy of the pump was assessed from actual drug delivery recorded on 34 patients over a minimum observation period of 180 days. Results: No early complications occurred in any of the 47 implants in 46 patients. A total of 12 (25.53%) complications occurred between 3 and 24 months after implantation. Seven (14.90%) of these were due to the external design of the pump, while five (10.63%) were related to the central venous catheter. In the 34 patients available for pump evaluation (follow-up of at least 180 days), the system was used for a total of 14,191 days (range 180–911 days, mean 417.38 days), giving an overall complication rate of 0.84 per 1000 days of operation. The mean flow rate accuracy was 90.26%. Conclusion: The new implantable pump showed good flow rate accuracy and reliable operation. The pump-related complications were related to its external design and have now been corrected by appropriate modifications. From a radiologic and surgical viewpoint, the venous implantation procedure is identical to that of conventional vascular access devices and can be performed by radiologists familiar with these techniques. The current limitations lie in the high cost of the pump and, for certain drugs, the short time between refills.

Purpose To evaluate a retrievable inferior vena cava (IVC) filter in combination with low-intensity oral anticoagulation for prevention of pulmonary embolism (PE) in patients with malignancy complicated by thromboembolic disease. Materials and Methods From October 2005 to December 2009, 107 Bard G2 filters were placed in 106 patients. Forty-eight patients had deep vein thrombosis (DVT) alone, 53 had PE with DVT, and five had PE with no evidence of DVT. After an initial period of anticoagulation with heparin, low-intensity oral anticoagulant therapy to achieve a target International Normalized Ratio of 1.5–2.0 was instituted. Follow-up computed tomography to evaluate the pulmonary circulation, IVC, and lower limbs was performed at 3 and 6 months. Results PE recurred in three of 58 patients (5.2%). None of the 48 patients with DVT alone developed PE, nor was there any recurrence of DVT. The filter was removed in 14 patients (13.2%). No complications occurred during the retrieval procedure. A total of 16 complications occurred in seven patients: one migration (0.9%); four cases of vena cava thrombosis (3.7%), three of which were associated with recurrent PE (2.8%); one filter fracture (0.9%); and one IVC penetration (0.9%). Filter tilting greater than 15° occurred in six patients (5.7%) and was associated with other complications in five (4.7%). Conclusions In patients with malignancies complicated by venous thromboembolic disease, an IVC filter together with low-intensity anticoagulation may be a possible treatment strategy for PE prophylaxis. Controlled studies are warranted.

We investigated the effect of iodinated contrast medium concentration on increased neoplastic lesion enhancement and its direct relation to diagnostic efficacy in biphasic spiral computed tomography for detection of hepatocellular carcinoma. A pilot, single-center, randomized, double-blind, crossover, comparative study was performed and included 22 participants. Each patient underwent two separate biphasic contrast-enhanced spiral computed tomographic examinations. Scans were performed with iomeprol containing 400 (iomeprol 400) or 300 (iomeprol 300) mg of iodine per milliliter (Iomeron, Bracco Imaging SpA, Milan, Italy) with a 2- to 12-day window scan; patients were given an equal total dose of 45 g of iodine at a fixed injection rate of 4 mL/s. Comparison included assessment of quantitative and qualitative parameters. Lesion density and lesion-to-liver contrast increased more markedly with the higher concentration of contrast medium during the arterial phase (p = 0.0016 and 0.0005, respectively). There was no significant difference in any parameter between the two concentrations during the portal phase. Number of lesions detected during the arterial phase increased from 37 with iomeprol 300 to 42 with iomeprol 400; in the portal phase, the respective numbers were 34 and 36. Even though a small number of patients was examined, our study suggests that, in patients with cirrhosis, an increased concentration of iodine improves liver-to-lesion contrast and may improve the detection of hepatocellular carcinoma.

Aims and background Vascular access through a vein draining into the superior vena cava is commonly used for long-term infusion of drugs inr cancer chemotherapy; prolonged cannulation of the inferior vena cava is generally considered as having an excessively high complication rate. Methods Prolonged cisplatin infusion via the inferior vena cava by means of a Groshong catheter was evaluated in 20 consecutive patients with thoracic malignancies showing evidence of superior vena cava infiltration or obstruction. Results We achieved 1,291 catheter days for our survey with a mean duration of vascular access of 64.5 days per patient and a mean duration of infusion time of 40 days. There were 2 complications, a catheter obstruction after a 7-day rest period and an ileo-femoral thrombosis 6 days after catheter placement. Conclusions Our experience compared favourably with the results obtained by long-term central venous access via the supraumbilical route, and demonstrated the reliability and safety of this approach in cases where the superior vena cava cannulation is technically difficult or impossible.

32 patients with 37 ovarian expansive lesions (18 cystic, 19 solid or mixed) were evaluated by color-Doppler examination and the RI (resistive index) was calculated. If the RI was >0.40 the lesion was considered benign, if it was

65 patients with multimetastatic kidney cancer were treated by continuous infusional chemotherapy using a totally subcutaneous implantable pump. They were given from 8 to 78 fortnight cycles of fluorodeoxyuri-dine (FUDR) at doses ranging from 0.15 to 0.30 mg/kg/day. The sites of metastases were: lungs, liver, bone, lymph nodes, brain; moreover some patients had a contralateral kidney cancer or a recurrent disease at the site of the previous nephrectomy. The response rate was comparable to that of conventional iv chemotherapy, but to its comparison we obtained a dramatic decrease in side effects (6.1% anemia, 4.6% mucositis, 3% hepatitis-nausea-diarrhea). The infusional therapy is now being studied in a protocol including patients who were excluded from the IL-2/IFN protocol or showed a progressive disease during it.

Breast calcifications pose a significant diagnostic and procedural dilemma. We evaluated en bloc stereotactic excision of indeterminate and suggestive microcalcifications for histologic diagnosis using a large-bore cannula biopsy device.We retrospectively reviewed 61 groups of microcalcifications removed with a large-bore cannula biopsy device from 59 patients (age range, 35-72 years old). The cannula diameter was 20 mm in 47 cases, 15 mm in nine cases, and 10 mm in five cases. The median lesion diameter was 6.6 mm (range, 4-17 mm). The procedure was performed by radiologists in an outpatient setting, with patients undergoing local anesthesia. All patients with a diagnosis of malignancy underwent surgery.In all instances, microcalcifications were removed in a single pass, in a single intact tissue specimen, through a maximum skin incision of 2 cm (0.8 inch). Twenty-five malignancies, 34 benign lesions, and two cases of lobular carcinoma in situ were identified. Sixteen malignancies were noninvasive and nine were invasive. No residual tumor was found at surgery in six of the 18 cases with involved margins and in five of the seven cases with uninvolved margins. One case of lobular carcinoma in situ with involvement of the margins additionally showed ductal carcinoma in situ at surgery.Mammographically identified microcalcifications are excised en bloc with the large-bore cannula biopsy device, providing a stereotactically localized tissue sample that is comparable with that obtained with open surgical biopsy and allows evaluation of the margins. This surgical radiologic procedure may represent a valid alternative, in selected patients, to conventional surgical biopsy after radiologic localization.

The Advanced Breast Biopsy Instrumentation (ABBI) system, which uses surgical cannulas up to 20 mm in diameter, is an alternative to conventional surgical biopsy for the diagnosis of non-palpable breast lesions. Since the need for radiological skill outweighs the surgical content of the technique, we evaluated the feasibility of complete management of the procedure by interventional radiologists. 35 of the 111 patients originally scheduled for the procedure were excluded, three because the lesion could not be visualized and 32 because of insufficient thickness of the compressed breast. The procedure had to be abandoned in one case due to a technical failure. 77 stereotactic excisional breast biopsy procedures were performed using the ABBI system in 75 patients with suspicious non-palpable mammographic lesions. The procedure was carried out under local anaesthesia in the radiology department, using a dedicated Lorad (R) radiographic system. 31 (40%) masses without calcifications, 11 (14%) masses with calcifications and 35 (46%) clusters of microcalcifications without tumour mass were sampled. 43 (56%) benign lesions and 34 (44%) malignant lesions were diagnosed. The overall mean diameter of the lesions was 8.7 mm (range 3-22 mm). All 34 patients with malignancies and lobular carcinoma in situ subsequently underwent surgery, the results of which are reported. Three (4%) haematomas were detected and aspirated percutaneously. Two technical problems occurred: an ABBI cannula malfunction, and a computer failure of the digital imaging system during the procedure. The average procedure time was 80 min and the cost of each procedure was 2,800,000 Italian lire (1555 US$). It is concluded that tissue sampling with the ABBI system can be performed entirely by radiologists without significant problems. The procedure was well tolerated by all patients. The quality of the biopsy specimen was identical to that of a surgical specimen but with the advantages of stereotactic precision for localization of the lesion.

Our goal was to investigate the feasibility of inserting long-term central venous access devices in outpatients using a simple technique that minimizes the risks of complications linked to venipuncture and errors in management.We placed 147 central venous catheters (CVCs) in 134 patients under local anesthesia. No sedation was used, and all procedures were done in our radiology department. Of the 134 patients, 101 patients were included in the follow-up. Overall follow-up of patients was 24,596 catheter days (mean, 243.52 days). Percutaneous access, mostly by the subclavian vein, was done by micropuncture technique under fluoroscopic guidance. Six CVCs were untunneled, 36 were connected to totally subcutaneous ports, and 105 were tunneled.The only immediate complication was pneumothorax (3%). Late complications, expressed per 1000 catheter days, included CVC breakage (0.12), vascular thrombosis (0.08), catheter occlusion (0.04), dislodgment (0.24), and local or systemic infections (0.40).Outpatient CVC placement is feasible because the procedure is not adversely affected when the patient is not hospitalized. The drawbacks are identical to those faced by inpatients. Improved materials and more extensive information on the management of patients with long-term CVCs would help reduce complications further.

Aims and background The aim of this work is to demonstrate the usefulness of carbon dioxide, used as contrast agent, in special indications in vascular interventional oncological procedures. Methods We studied 40 patients with digital subtraction angiography enhanced with CO2 as a contrast agent. At the same time we utilized also, in all cases, jodinated contrast agent to evaluate the different opacification gradient, the different viscosity range and the different perfusion. Results The low viscosity of CO2 allows demonstration of the presence of even minimal blood losses in gastrointestinal tumors and enhances arteriovenous shunts in hepatocellular carcinoma. Carbon dioxide can also be employed to assess the patency of small-sized catheters for chemotherapy infusion which do not allow easy injection of the traditional iodinated contrast agents characterized by high viscosity. Conclusion Carboangiographic study combined to digital subtraction angiography can clear some diagnostic problems and is further method to assess the outcome of angiographic interventional procedures in oncology.

To evaluate the diagnostic efficacy of computed tomography (CT) after hepatic intraarterial injection of iodized oil in patients with hepatocellular carcinoma (HCC).Forty patients who underwent CT with iodized oil before orthotopic liver transplantation (OLT) were evaluated prospectively. All patients underwent digital subtraction angiography and injection of iodized oil during chemoembolization. CT during arterial portography (CTAP) was performed in 34 patients. The number of neoplastic nodules was assessed in explanted livers and compared with the radiologic results.Sixty-six HCC nodules were present in the explanted livers. CT with iodized oil enabled correct diagnosis in 38 of 66 lesions (58%), and the results were false-positive in two lesions (3%). Digital subtraction angiography had a sensitivity of 67% (44 of 66 nodules) and CTAP had a sensitivity of 85% (45 of 53 nodules). Four (6%) false-positive diagnoses were made at digital subtraction angiography and three (6%) at CTAP. The diagnostic efficacy of CT with iodized oil was significantly related to lesion diameter greater than 2 cm (P.0001) and hypervascularity (P.0001).CT with iodized oil failed to provide any substantial information in the pre-OLT staging of HCC: It was inaccurate for small HCC nodules (2 cm) and intrahepatic metastases. Its sensitivity matched that of digital subtraction angiography and was statistically significantly inferior to that of CTAP.