Patients' Perceptions and Attitudes to the Use of Artificial Intelligence in Breast Cancer Diagnosis: A Narrative Review.

Breast cancer remains the most prevalent cancer among women worldwide, necessitating advancements in diagnostic methods. The integration of artificial intelligence (AI) into mammography has shown promise in enhancing diagnostic accuracy. However, understanding patient perspectives, particularly considering the psychological impact of breast cancer diagnoses, is crucial. This narrative review synthesizes literature from 2000 to 2023 to examine breast cancer patients' attitudes towards AI in breast imaging, focusing on trust, acceptance, and demographic influences on these views. Methodologically, we employed a systematic literature search across databases such as PubMed, Embase, Medline, and Scopus, selecting studies that provided insights into patients' perceptions of AI in diagnostics. Our review included a sample of seven key studies after rigorous screening, reflecting varied patient trust and acceptance levels towards AI. Overall, we found a clear preference among patients for AI to augment rather than replace the diagnostic process, emphasizing the necessity of radiologists' expertise in conjunction with AI to enhance decision-making accuracy. This paper highlights the importance of aligning AI implementation in clinical settings with patient needs and expectations, emphasizing the need for human interaction in healthcare. Our findings advocate for a model where AI augments the diagnostic process, underlining the necessity for educational efforts to mitigate concerns and enhance patient trust in AI-enhanced diagnostics.

Role of Flex-Dose Delivery Program in Patients Affected by HCC: Advantages in Management of Tare in Our Experience.

Background: Introduced in the latest BCLC 2022, endovascular trans-arterial radioembolization (TARE) has an important role in the treatment of unresectable hepatocellular carcinoma (HCC) as a "bridge" or "downstaging" of disease. The evolution of TARE technology allows a more flexible and personalized target treatment, based on the anatomy and vascular characteristics of each HCC. The flex-dose delivery program is part of this perspective, which allows us to adjust the dose and its radio-embolizing power in relation to the size and type of cancer and to split the therapeutic dose of Y90 in different injections (split-bolus). Methods: From January 2020 to January 2022, we enrolled 19 patients affected by unresectable HCC and candidates for TARE treatment. Thirteen patients completed the treatment following the flex-dose delivery program. Response to treatment was assessed using the mRECIST criteria with CT performed 6 and 9 months after treatment. Two patients did not complete the radiological follow-up and were not included in this retrospective study. The final cohort of this study counts eleven patients. Results: According to mRECIST criteria, six months of follow-up were reported: five cases of complete response (CR, 45.4% of cases), four cases of partial response (PR, 36.4%), and two cases of progression disease (PD, 18.2%). Nine months follow-up reported five cases of complete response (CR, 45.4%), two cases of partial response (PR, 18.2%), and four cases of progression disease (PD, 36.4%). No intra and post-operative complications were described. The average absorbed doses to the hepatic lesion and to the healthy liver tissue were 319 Gy (range 133-447 Gy) and 9.5 Gy (range 2-19 Gy), respectively. Conclusions: The flex-dose delivery program represents a therapeutic protocol capable of "saving" portions of healthy liver parenchyma by designing a "custom-made" treatment for the patient.

Exploring the Potential of Artificial Intelligence in Breast Ultrasound.

Breast ultrasound has emerged as a valuable imaging modality in the detection and characterization of breast lesions, particularly in women with dense breast tissue or contraindications for mammography. Within this framework, artificial intelligence (AI) has garnered significant attention for its potential to improve diagnostic accuracy in breast ultrasound and revolutionize the workflow. This review article aims to comprehensively explore the current state of research and development in harnessing AI's capabilities for breast ultrasound. We delve into various AI techniques, including machine learning, deep learning, as well as their applications in automating lesion detection, segmentation, and classification tasks. Furthermore, the review addresses the challenges and hurdles faced in implementing AI systems in breast ultrasound diagnostics, such as data privacy, interpretability, and regulatory approval. Ethical considerations pertaining to the integration of AI into clinical practice are also discussed, emphasizing the importance of maintaining a patient-centered approach. The integration of AI into breast ultrasound holds great promise for improving diagnostic accuracy, enhancing efficiency, and ultimately advancing patient's care. By examining the current state of research and identifying future opportunities, this review aims to contribute to the understanding and utilization of AI in breast ultrasound and encourage further interdisciplinary collaboration to maximize its potential in clinical practice.

How young radiologists use contrast media and manage adverse reactions: an international survey.

OBJECTIVES: To collect real-world data about the knowledge and self-perception of young radiologists concerning the use of contrast media (CM) and the management of adverse drug reactions (ADR). METHODS: A survey (29 questions) was distributed to residents and board-certified radiologists younger than 40 years to investigate the current international situation in young radiology community regarding CM and ADRs. Descriptive statistics analysis was performed. RESULTS: Out of 454 respondents from 48 countries (mean age: 31.7 ± 4 years, range 25-39), 271 (59.7%) were radiology residents and 183 (40.3%) were board-certified radiologists. The majority (349, 76.5%) felt they were adequately informed regarding the use of CM. However, only 141 (31.1%) received specific training on the use of CM and 82 (18.1%) about management ADR during their residency. Although 266 (58.6%) knew safety protocols for handling ADR, 69.6% (316) lacked confidence in their ability to manage CM-induced ADRs and 95.8% (435) expressed a desire to enhance their understanding of CM use and handling of CM-induced ADRs. Nearly 300 respondents (297; 65.4%) were aware of the benefits of contrast-enhanced ultrasound, but 249 (54.8%) of participants did not perform it. The preferred CM injection strategy in CT parenchymal examination and CT angiography examination was based on patient's lean body weight in 318 (70.0%) and 160 (35.2%), a predeterminate fixed amount in 79 (17.4%) and 116 (25.6%), iodine delivery rate in 26 (5.7%) and 122 (26.9%), and scan time in 31 (6.8%) and 56 (12.3%), respectively. CONCLUSION: Training in CM use and management ADR should be implemented in the training of radiology residents. CRITICAL RELEVANCE STATEMENT: We highlight the need for improvement in the education of young radiologists regarding contrast media; more attention from residency programs and scientific societies should be focused on training about contrast media use and the management of adverse drug reactions. KEY POINTS: • This survey investigated training of young radiologists about use of contrast media and management adverse reactions. • Most young radiologists claimed they did not receive dedicated training. • An extreme heterogeneity of responses was observed about contrast media indications/contraindications and injection strategy.

Is it a complication or a consequence - a new perspective on adverse outcomes in Interventional Radiology.

The aim of the article is to introduce a new term in post-procedural events related to the procedure itself. All the Societies and Councils report these events as complications and they are divided in mild, moderate and severe or immediate and delayed.On the other hand the term error is known as the application of a wrong plan, or strategy to achieve a goal.For the first time, we are trying to introduce the term "consequence"; assuming that the procedure is the only available and the best fit to clinical indication, a consequence should be seen as an expected and unavoidable occurrence of an "adverse event" despite correct technical execution.

Guidelines on the diagnosis, treatment and management of visceral and renal arteries aneurysms: a joint assessment by the Italian Societies of Vascular and Endovascular Surgery (SICVE) and Medical and Interventional Radiology (SIRM).

The objective of these Guidelines is to provide recommendations for the classification, indication, treatment and management of patients suffering from aneurysmal pathology of the visceral and renal arteries. The methodology applied was the GRADE-SIGN version, and followed the instructions of the AGREE quality of reporting checklist. Clinical questions, structured according to the PICO (Population, Intervention, Comparator, Outcome) model, were formulated, and systematic literature reviews were carried out according to them. Selected articles were evaluated through specific methodological checklists. Considered Judgments were compiled for each clinical question in which the characteristics of the body of available evidence were evaluated in order to establish recommendations. Overall, 79 clinical practice recommendations were proposed. Indications for treatment and therapeutic options were discussed for each arterial district, as well as follow-up and medical management, in both candidate patients for conservative therapy and patients who underwent treatment. The recommendations provided by these guidelines simplify and improve decision-making processes and diagnostic-therapeutic pathways of patients with visceral and renal arteries aneurysms. Their widespread use is recommended.

Clinical Impact of a Protocol Involving Cone-Beam CT (CBCT), Fusion Imaging and Ablation Volume Prediction in Percutaneous Image-Guided Microwave Ablation in Patients with Hepatocellular Carcinoma Unsuitable for Standard Ultrasound (US) Guidance.

PURPOSE: to evaluate the clinical impact of a protocol for the image-guided percutaneous microwave ablation (MWA) of hepatocellular carcinoma (HCC) that includes cone-beam computed tomography (CBCT), fusion imaging and ablation volume prediction in patients with hepatocellular carcinoma unsuitable for standard ultrasound (US) guidance. MATERIALS AND METHODS: this study included all patients with HCC treated with MWA between January 2021 and June 2022 in a tertiary institution. Patients were divided into two groups: Group A, treated following the protocol, and Group B, treated with standard ultrasound (US) guidance. Follow-up images were reviewed to assess residual disease (RD), local tumor progression (LTP) and intrahepatic distant recurrence (IDR). Ablation response at 1 month was also evaluated according to mRECIST. Baseline variables and outcomes were compared between the groups. For 1-month RD, propensity score weighting (PSW) was performed. RESULTS: 80 consecutive patients with 101 HCCs treated with MWA were divided into two groups. Group A had 41 HCCs in 37 patients, and Group B had 60 HCCs in 43 patients. Among all baseline variables, the groups differed regarding their age (mean of 72 years in Group A and 64 years in Group B, respectively), new vs. residual tumor rates (48% Group A vs. 25% Group B, p < 0.05) and number of subcapsular tumors (56.7% Group B vs. 31.7% Group A, p < 0.05) and perivascular tumors (51.7% Group B vs. 17.1% Group A, p < 0.05). The protocol led to repositioning the antenna in 49% of cases. There was a significant difference in 1-month local response between the groups measured as the RD rate and mRECIST outcomes. LTP rates at 3 and 6 months, and IDR rates at 1, 3 and 6 months, showed no significant differences. Among all variables, logistic regression after PSW demonstrated a protective effect of the protocol against 1-month RD. CONCLUSIONS: The use of CBCT, fusion imaging and ablation volume prediction during percutaneous MWA of HCCs provided a better 1-month tumor local control. Further studies with a larger population and longer follow-up are needed.

Performance and Safety of a Reflux-Control Microcatheter Used to Perform DEB-TACE with LUMITM Beads in HCC Patients: Preliminary Experience.

PURPOSE: The present study aims to evaluate the effectiveness and safety of the anti-reflux microcatheter during DEB-TACE with DC Bead LUMITM (radiopaque beads) for the treatment of hepatocellular carcinoma (HCC). METHODS: We performed an observational longitudinal prospective monocentric study to analyze all patients with HCC who underwent to DEB-TACE with DC Bead LUMITM and anti-reflux microcatheter. Technical success, the presence of residual disease, and clinical success were evaluated. The performance of the anti-reflux microcatheter on the basis of the percentage of tumor covered and the non-target embolization (NTE) was also evaluated. RESULTS: Twenty patients underwent DEB-TACE with DC Bead LUMITM and an anti-reflux microcatheter. Technical success was achieved in all cases. Residual disease in the target tumor was observed in 11/20 (55%) of cases and no residual disease was found in 9/20 (45%) of cases. The clinical response at 1-month follow-up was of PD 4/20 (20%), SD 7/20 (35%), and CR 9/20 (45%). No major complications were recorded, and 10% of cases had minor complications. The distribution of beads on post-procedural CBCT, classified according to the percentage of target nodule coverage, was ≥50% in 70% (14/20) of cases and between 30-50% in 30% of cases (6/20). NTE was never registered.

Advancements in Standardizing Radiological Reports: A Comprehensive Review.

Standardized radiological reports stimulate debate in the medical imaging field. This review paper explores the advantages and challenges of standardized reporting. Standardized reporting can offer improved clarity and efficiency of communication among radiologists and the multidisciplinary team. However, challenges include limited flexibility, initially increased time and effort, and potential user experience issues. The efforts toward standardization are examined, encompassing the establishment of reporting templates, use of common imaging lexicons, and integration of clinical decision support tools. Recent technological advancements, including multimedia-enhanced reporting and AI-driven solutions, are discussed for their potential to improve the standardization process. Organizations such as the ACR, ESUR, RSNA, and ESR have developed standardized reporting systems, templates, and platforms to promote uniformity and collaboration. However, challenges remain in terms of workflow adjustments, language and format variability, and the need for validation. The review concludes by presenting a set of ten essential rules for creating standardized radiology reports, emphasizing clarity, consistency, and adherence to structured formats.

Efficacy and safety of vacuum-assisted excision (VAE) of fibroadenomas: experience in a tertiary centre.

PURPOSE: To evaluate the technical success and efficacy rates of US-guided percutaneous vacuum-assisted excision (VAE) of breast fibroadenomas, also assessing procedural complications and long-term patient satisfaction rates. MATERIALS AND METHODS: The institutional database of a tertiary breast cancer referral centre was retrospectively reviewed to retrieve all women with fibroadenomas who underwent US-guided VAE between May 2011 and September 2019. We subsequently included in this study all fibroadenomas with a maximum diameter of 3 cm at US and an available histological confirmation obtained by core-needle biopsy before VAE. Immediately after VAE, technical success (defined as the correct VAE execution) and the occurrence of procedural complications were evaluated. Imaging follow-up (US ± mammography) after 6, 12, 24 and 36 months was performed to evaluate technical efficacy (defined as the absence of fibroadenoma recurrence at 6-month follow-up). Long-term patient satisfaction was evaluated with telephonic interviews in October 2022. RESULTS: We retrospectively included 108 women (median age 46 years) with 110 fibroadenomas diagnosed at core-needle biopsy with a median lesion size at US of 12 mm. Technical success was obtained in 110/110 VAEs (100%). Minor procedural complications (haematomas) occurred in 7/110 VAEs (6%), whereas 8/110 patients had a fibroadenoma recurrence at 6-month follow-up, resulting in a 93% technical efficacy (102/110 VAEs). All patients available for telephonic follow-up (104/104, 100%) reported high satisfaction with VAE results. CONCLUSION: US-guided VAE is a safe and effective procedure for the excision of fibroadenomas, representing a viable alternative to surgery, with a low complication rate and high patient satisfaction.

Efficacy and Safety of Transarterial Chemoembolization with DC Beads LUMI in the Treatment of HCC: Experience from a Tertiary Centre.

PURPOSE: The aim of this study was to describe the safety and efficacy profiles of TACE using DC Beads LUMI. MATERIALS AND METHODS: We retrospectively analyzed 90 patients with HCC who underwent TACE with DC Bead LUMI™ between November 2018 and November 2020 at Fondazione IRCCS Cà Granda Policlinico Hospital in Milan, Italy. Patient- and tumour-related factors were registered, including the number of treated lesions, dose of DC Beads LUMI™, dose of Epirubicin, DC Beads LUMI™ target tumour coverage (LC) according to the percentage of target nodule involvement (LC1-0%-25%, LC2-25%-50%, LC3-50%-75%, LC4 75%-100%). Treatment efficacy was obtained through reviewing the follow-up imaging for evidence of response in target lesion(s), according to modified response criteria in solid tumours (mRECIST) criteria with the following outcomes: complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD). Safety assessment was based on the quantitative and qualitative recording of the adverse events, classified according to CIRSE classification. RESULTS: Seventy-two patients were enrolled, and 95 procedures were carried out. We observed a target tumour response rate at 1 month with CR in 68%, PR in 10.3% 11.8%, SD in 13%, PD in 7.2%, and an overall tumour(s) (whole liver) response at 1 month with CR in 58.9%, PR in 12.6%, SD in 10.5% and PD in 18%. We found a significant association (p < 0.01) between tumour response CR or CR + PR and the number of the target lesion(s). CIRSE classification grade I and grade II complications were recorded, respectively, in 11 (11.6%) and 6 (6.3%) procedures. No grade III-IV-V complications occurred. CONCLUSION: TACE using DC Beads LUMI is a safe and effective treatment option for patients with HCC.

Percutaneous Application of High Power Microwave Ablation With 150†W for the Treatment of Tumors in Lung, Liver, and Kidney: A Preliminary Experience.

OBJECTIVE: The aim of this study is to evaluate the feasibility, safety, and short-term effectiveness of a high-power (150 W) microwave ablation (MWA) device for tumor ablation in the lung, liver, and kidney. METHODS: Between December 2021 and June 2022, patients underwent high-power MWA for liver, lung, and kidney tumors. A retrospective observational study was conducted in accordance with the Declaration of Helsinki. The MWA system utilized a 150-W, 2.45-GHz microwave generator (Emprint™ HP Ablation System, Medtronic). The study assessed technical success, safety, and effectiveness, considering pre- and post-treatment diameter and volume, lesion location, biopsy and/or cone beam computed tomography (CBCT) usage, MWA ablation time, MWA power, and dose-area product (DAP). RESULTS: From December 2021 to June 2022, 16 patients were enrolled for high-power MWA. Treated lesions included hepatocellular carcinoma (10), liver metastasis from colon cancer (1), liver metastasis from pancreatic cancer (1), squamous cell lung carcinoma (2), renal cell carcinoma (1), and renal oncocytoma (1). Technical success rate was 100%. One grade 1 complication (6.25%) was reported according to CIRSE classification. Overall effectiveness was 92.8%. Pre- and post-treatment mean diameters for liver lesions were 19.9 mm and 37.5 mm, respectively; for kidney lesions, 34 mm and 35 mm; for lung lesions, 29.5 mm and 31.5 mm. Pre- and post-treatment mean volumes for liver lesions were 3.4 ml and 24 ml, respectively; for kidney lesions, 8.2 ml and 20.5 ml; for lung lesions, 10.2 ml and 32.7 ml. The mean ablation time was 48 minutes for liver, 42.5 minutes for lung, and 42.5 minutes for renal ablation. The mean DAP for all procedures was 40.83 Gcm2. CONCLUSION: This preliminary study demonstrates the feasibility, safety, and effectiveness of the new 150 W MWA device. Additionally, it shows reduced ablation times for large lesions.

Percutaneous Microwave Ablation of Hepatocellular Carcinoma with "Double Fusion" Technique: Technical Note and Single-Center Preliminary Experience.

Percutaneous image-guided thermal ablation is included in most society guidelines for treatment of hepatocellular carcinoma (HCC). The results of this treatment in terms of efficacy depend on the ability to precisely place the device into the target tumor. Ultrasound (US) is a commonly used imaging guidance modality for its real-time feedback. However, an accurate device deployment remains challenging in some clinical scenarios, including cases of tumors that are undetectable or not clearly visible by US. To overcome this problem, fusion imaging techniques have been developed, which combine images from different modalities. The most widely known technique combines pre-procedural contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) with real-time US scans. Cone beam CT (CBCT) is a technology that can provide intra-procedural cross-sectional images, which can be registered to images from other modalities, including preprocedural CT/MR scans. The aim of our study is to report the preliminary experience on percutaneous microwave ablation (MWA) of patients with HCC that were treated using the "double fusion" technique, which combines the use of US fusion imaging and CBCT fusion imaging. We describe the technical details, feasibility, safety and short-term efficacy of this technique in a small series of eight patients with 11 HCCs.

The Non-Invasive Diagnosis of Chronic Coronary Syndrome: A Focus on Stress Computed Tomography Perfusion and Stress Cardiac Magnetic Resonance.

Coronary artery disease is still a major cause of death and morbidity worldwide. In the setting of chronic coronary disease, demonstration of inducible ischemia is mandatory to address treatment. Consequently, scientific and technological efforts were made in response to the request for non-invasive diagnostic tools with better sensitivity and specificity. To date, clinicians have at their disposal a wide range of stress-imaging techniques. Among others, stress cardiac magnetic resonance (S-CMR) and computed tomography perfusion (CTP) techniques both demonstrated their diagnostic efficacy and prognostic value in clinical trials when compared to other non-invasive ischemia-assessing techniques and invasive fractional flow reserve measurement techniques. Standardized protocols for both S-CMR and CTP usually imply the administration of vasodilator agents to induce hyperemia and contrast agents to depict perfusion defects. However, both methods have their own limitations, meaning that optimizing their performance still requires a patient-tailored approach. This review focuses on the characteristics, drawbacks, and future perspectives of these two techniques.

Emergent vessel embolization for major traumatic and non-traumatic hemorrhage: Indications, tools and outcomes.

Endovascular embolization of bleeding vessels in trauma and non-trauma patients is frequently used and is an important tool for bleeding control. It is included in the EVTM (endovascular resuscitation and trauma management) concept and its use in patients with hemodynamic instability is increasing. When the correct embolization tool is chosen, a dedicated multidisciplinary team can rapidly and effectively achieve bleeding control. In this article, we will describe the current use and possibilities for embolization of major hemorrhage (traumatic and non-traumatic) and the published data supporting these techniques as part of the EVTM concept.

The Role of Non-Invasive Multimodality Imaging in Chronic Coronary Syndrome: Anatomical and Functional Pathways.

Coronary artery disease (CAD) is one of the major causes of mortality and morbidity worldwide, with a high socioeconomic impact. Currently, various guidelines and recommendations have been published about chronic coronary syndromes (CCS). According to the recent European Society of Cardiology guidelines on chronic coronary syndrome, a multimodal imaging approach is strongly recommended in the evaluation of patients with suspected CAD. Today, in the current practice, non-invasive imaging methods can assess coronary anatomy through coronary computed tomography angiography (CCTA) and/or inducible myocardial ischemia through functional stress testing (stress echocardiography, cardiac magnetic resonance imaging, single photon emission computed tomography-SPECT, or positron emission tomography-PET). However, recent trials (ISCHEMIA and REVIVED) have cast doubt on the previous conception of the management of patients with CCS, and nowadays it is essential to understand the limitations and strengths of each imaging method and, specifically, when to choose a functional approach focused on the ischemia versus a coronary anatomy-based one. Finally, the concept of a pathophysiology-driven treatment of these patients emerged as an important goal of multimodal imaging, integrating 'anatomical' and 'functional' information. The present review aims to provide an overview of non-invasive imaging modalities for the comprehensive management of CCS patients.

Detection and quantification of breast arterial calcifications on mammograms: a deep learning approach.

OBJECTIVE: Breast arterial calcifications (BAC) are a sex-specific cardiovascular disease biomarker that might improve cardiovascular risk stratification in women. We implemented a deep convolutional neural network for automatic BAC detection and quantification. METHODS: In this retrospective study, four readers labelled four-view mammograms as BAC positive (BAC+) or BAC negative (BAC-) at image level. Starting from a pretrained VGG16 model, we trained a convolutional neural network to discriminate BAC+ and BAC- mammograms. Accuracy, F1 score, and area under the receiver operating characteristic curve (AUC-ROC) were used to assess the diagnostic performance. Predictions of calcified areas were generated using the generalized gradient-weighted class activation mapping (Grad-CAM++) method, and their correlation with manual measurement of BAC length in a subset of cases was assessed using Spearman ρ. RESULTS: A total 1493 women (198 BAC+) with a median age of 59 years (interquartile range 52-68) were included and partitioned in a training set of 410 cases (1640 views, 398 BAC+), validation set of 222 cases (888 views, 89 BAC+), and test set of 229 cases (916 views, 94 BAC+). The accuracy, F1 score, and AUC-ROC were 0.94, 0.86, and 0.98 in the training set; 0.96, 0.74, and 0.96 in the validation set; and 0.97, 0.80, and 0.95 in the test set, respectively. In 112 analyzed views, the Grad-CAM++ predictions displayed a strong correlation with BAC measured length (ρ = 0.88, p < 0.001). CONCLUSION: Our model showed promising performances in BAC detection and in quantification of BAC burden, showing a strong correlation with manual measurements. CLINICAL RELEVANCE STATEMENT: Integrating our model to clinical practice could improve BAC reporting without increasing clinical workload, facilitating large-scale studies on the impact of BAC as a biomarker of cardiovascular risk, raising awareness on women's cardiovascular health, and leveraging mammographic screening. KEY POINTS: • We implemented a deep convolutional neural network (CNN) for BAC detection and quantification. • Our CNN had an area under the receiving operator curve of 0.95 for BAC detection in the test set composed of 916 views, 94 of which were BAC+ . • Furthermore, our CNN showed a strong correlation with manual BAC measurements (ρ = 0.88) in a set of 112 views.

Advances in Imaging Guidance During Percutaneous Ablation of Renal Tumors.

Currently, minimally invasive ablative techniques for the treatment of renal tumors have become a more common and feasible treatment option. New imaging technologies have been implemented and successfully merged with each other to improve the guidance of tumor ablation. In the present review, an overview of the real-time fusion of multiple imaging modalities, robotic and electromagnetic navigation and the application of artificial intelligence software, in field of tumor renal ablation treatment, are analyzed.

Effectiveness and Safety of Different Vascular Closure Devices: Multicentre Prospective Observational study.

AIM: The aim of this prospective, multicentre, observational study was to compare the efficacy and safety of balloon-based and non-balloon-based vascular closure devices (VCDs). MATERIALS AND METHODS: From March 2021 to May 2022, 2373 participants from 10 different centres were enrolled. Among them, 1672 patients with 5-7 Fr accesses were selected. Successful haemostasis, failure and safety were evaluated. Successful haemostasis was defined as the possibility to obtain complete haemostasis with the use of VCDs, without any complication. Failure management was defined as the need of manual compression. Safety was defined as the rate of complications. Cases of haematomas/pseudoaneurysms (PSA) and artero-venous fistula (AVF) were collected. RESULTS: VCDs mechanism of action is statistically significant associated with the outcome. Non-balloon-based VCDs demonstrated a statistically significant better outcome: successful haemostasis was obtained in 96.5% vs. 85.9%, of cases when compared to balloon occluders (p < 0.001). The incidence of AVF was statistically more frequent using non-balloon occluders devices (1.57% vs 0%, p: 0.007). No significant statistical difference was found in comparing haematoma and PSA occurrence. Thrombocytopenia, coagulation deficit, BMI, diabetes mellitus and anti-coagulation were demonstrated to be independent predictors of failure management. CONCLUSION: Our study suggests a better outcome with the same complication rate, except that for AVF incidence for non-balloon collagen plug device if compared to balloon occluders vascular closure devices.