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Introduction: Both cone-beam computed tomography (CBCT) and surface-guided radiotherapy (SGRT) are used for breast patient positioning verification before treatment delivery. SGRT may reduce treatment time and imaging dose by potentially reduce the number of CBCT needed. The aim of this study was to compare the displacements resulting in positioning from the Image Guided Radiation Therapy (IGRT) 3D and SGRT methods and to design a clinical workflow for SGRT implementation in breast radiotherapy to establish an imaging strategy based on the data obtained., Methods: For this study 128 breast cancer patients treated with 42.5 Gy in 16 fractions using 3D conformal radiotherapy with free breathing technique were enroled. A total of 366 CBCT images were evaluated for patient setup verification and compared with SGRT. Image registrations between planning CT images and CBCT images were performed in mutual agreement and in online mode by three health professionals. Student's paired t-test was used to compare the absolute difference in vector shift, measured in mm, for each orthogonal axis (x, y, z) between SGRT and CBCT methods. The multidisciplinary team evaluated a review of the original clinical workflow for SGRT implementation and data about patients treated with the updated workflow were reported., Results: Comparison of the shifts obtained with IGRT and SGRT for each orthogonal axis (for the x-axes the average displacement was 0.9 ± 0.7 mm, y = 1.1 ± 0.8 mm and z = 1.0 ± 0.7 mm) revealed no significant statistical differences (p > 0.05). Using the updated workflow the difference between SGRT and IGRT displacements was <3 mm in 91.4 % of patients with a reduction in total treatment time of approximately 20 %, due to the reduce frequency of the CBCT images acquisition and matching., Conclusions: This study has shown that IGRT and SGRT agree in positioning patients with breast cancer within a millimetre tolerance. SGRT can be used for patient positioning, with the advantages of reducing radiation exposure and shorter overall treatment time., (Copyright © 2023. Published by Elsevier Inc.)

Background: The PARTNER 3 trial demonstrated clinical benefits of transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 device, over surgical aortic valve replacement (SAVR) in patients with severe symptomatic aortic stenosis (sSAS) at low risk of surgical mortality. Using PARTNER 3 outcomes and Italy-specific costs data, this cost-utility analysis from the perspective of the Italian National Health System aimed to determine the cost-effectiveness of SAPIEN 3 TAVI versus SAVR in low risk sSAS patients in Italy., Methods: A two-stage cost-utility model was developed to estimate changes in both direct healthcare costs and health-related quality of life using TAVI with SAPIEN 3 compared with SAVR. Early adverse events associated with TAVI were captured utilising the PARTNER 3 dataset. These data fed into a Markov model that captured longer-term outcomes of patients, following TAVI or SAVR intervention., Results: Analysis findings estimated that TAVI with SAPIEN 3 offers benefits over SAVR in terms of increased quality-adjusted life years (QALYs) with only a small increase in costs, representing an incremental cost-effectiveness ratio/QALY gained of €2989 per patient. The results were robust, with TAVI with SAPIEN 3 remaining cost-effective across several scenarios and in probabilistic sensitivity analyses., Conclusions: This model demonstrated that TAVI with SAPIEN 3 is likely to be cost effective compared with SAVR for the treatment of patients with sSAS who are at low risk of surgical mortality. These findings can inform policy makers to facilitate policy development in Italy on intervention selection for this patient population., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

THV aortic embolization can be managed percutaneously by snaring the prosthesis in a stable position in ascending aorta. We report two cases of embolized Acurate NEO with extreme mobility of devices in ascending aorta in which a bailout supra-aortic trunk stenting with consistent aortic protrusion were performed stabilizing the devices., Competing Interests: Declaration of competing interest The performance of this study was supported exclusively by internal institutional funds. With regards to the present manuscript, Dr. F. Bedogni and Dr. F. De Marco are proctors and consultant for Boston Scientific. All other authors have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Coronary artery calcifications are always challenging scenarios for interventional cardiologists. Calcium content in coronary tree directly correlates with male sex, age, Caucasian ethnicity, diabetes, and chronic kidney disease. Intracoronary imaging is useful and necessary to understand calcific lesion features and plan the best percutaneous coronary intervention strategy. Thus, accurate evaluation of patient and lesion characteristics is crucial. For this reason, definition of calcific arc, length, and thickness can suggest the best procedure before stenting and final optimization. In our modern era, different devices are available and all are surprisingly promising., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Calcified coronary lesions still represent a challenge for coronary angioplasty, with sub-optimal acute PCI results causing more frequent late stent failure., Purpose: The study aimed at the evaluation of the immediate procedural outcome in a real-world consecutive population of a selective use of lithotripsy based on the intravascular imaging assessment with IVUS or OCT., Methods and Results: Thirty-one calcified stenoses (28 patients) out of a total of 455 lesions (370 patients) treated between November 2018 and May 2019 received IVL under intravascular imaging guidance. The majority of the IVL lesions had angiographically severe calcifications and were selected after intravascular imaging. A smaller group was identified by poor expansion after high-pressure balloon dilatation, in one case despite preliminary small burr Rotablation. After IVL, when OCT was performed calcium fractures were observed in 71% of cases. After OCT/IVUS guided stent optimization a satisfactory lumen enlargement (minimal stent area 7.09 ± 2.77 mm 2 ) was observed with good stent expansion (residual area stenosis<20% in 29 lesions, 93.5%) Peri-procedural complications were limited to one dissection at the distal edge requiring an additional stent and 3 peri-procedural myocardial infarctions. There were no periprocedural coronary perforations or pericardial effusions, and no in-hospital or 30 days stent thrombosis. When patients were divided into two subgroups according to a calcium arc ≤180° (Group A: 10 lesions, calcium arc 140 ± 24°; Group B: 21 lesions, calcium arc 289 ± 53°), at OCT Group B presented also a higher number of calcium fractures post IVL than group A (group A: 38% vs group B: 92%, p = 0.03). The in-stent minimum lumen diameter (MSD), the in stent minimal lumen area (MSA) and the acute gain, however, were similar between the two groups (acute gain group A: 1.22 ± 0.29 mm; group B: 1.31 ± 0.52 mm, p = 0.63)., Conclusions: A standardized algorithm applying intravascular imaging guidance of IVL facilitated second generation DES expansion delivers excellent immediate lumen expansion and patient outcome, both in concentric and eccentric calcifications., (Copyright © 2020. Published by Elsevier Inc.)

Background: Residual aortic regurgitation (AR) complicates a not negligible number of transcatheter aortic valve replacement (TAVR) procedures, and its entity is not always clear at intraprocedural angiographic and echocardiographic control. We applied a minimally invasive hemodynamic monitoring system (Pressure Recording Analytical Method, PRAM) in the setting of TAVR, with the aim of identifying parameters that may help in detection and quantification of residual AR., Methods: We performed hemodynamic monitoring with PRAM in 43 patients undergoing trans-femoral TAVR. Investigated parameters were systolic (Psys, mm Hg), diastolic (Pdia, mm Hg), mean (MAP, mm Hg) and dicrotic pressure (Pdic, mm Hg), cardiac output (CO, L/min), stroke volume (SV, mL), cardiac cycle efficiency (CCE, Units), dP/dt max&#95;rad (mm Hg/ms), MAP-Pdic (mm Hg)., Results: Procedural success was achieved in 86% of the patients; vascular complications occurred in 3 (6.9%), death in 2 (4.7%). Twenty (46.5%) patients had at least mild residual AR. CO, SV, CCE and dP/dt max&#95;rad changed significantly (p < 0.001) between baseline and end of procedure in the overall population, with more evident modifications in the subgroup without residual AR. MAP-Pdic variations were statistically significant only in the subgroup without AR (p = 0.05)., Conclusions: TAVR determined an improvement in hemodynamic parameters such as CO, SV, CCE, dP/dt max&#95;rad . MAP-Pdic was able to discriminate patients with significant residual AR. Hemodynamic monitoring with PRAM system during TAVR is easy and fast to obtain and may help in clinical decision-making in controversial cases., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objectives: This study sought to evaluate the feasibility, safety, and efficacy of intracardiac echocardiography (ICE)-guided versus transesophageal echocardiography (TEE)-guided left atrial appendage occlusion (LAAO) by the use of Amplatzer Cardiac Plug or Amulet devices included in a large Italian registry., Background: TEE is widely used for LAAO procedure guidance. ICE may be a potential alternative imaging modality in LAAO., Methods: Data from 604 LAAO procedures performed in 16 Italian centers were reviewed. ICE-guided LAAO was performed in 187 patients, whereas TEE was used in 417 patients. Procedural success was defined as LAAO without occurrence of pericardial tamponade, stroke, systemic embolism with end organ damage, major bleeding, and device embolization. Stroke, transient ischemic attack, major bleeding, overall and cardiovascular death were analyzed., Results: CHA 2 DS 2 -VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65 to 74 years, sex category) and HAS-BLED (hypertension, abnormal renal and liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol) scores were similar between the ICE and TEE groups. TEE implied lower procedural (delta 12 min) and fluoroscopy time (delta 5 min) when compared with ICE. Procedural success was similarly high (≥94%) between the TEE and ICE groups with a complication rate of 6.5% for TEE versus 4.2% for ICE (odds ratio: 1.468; 95% confidence interval: 0.681 to 3.166; p = 0.327). At median follow-up of 451 days (interquartile range: 162 to 899 days), the rate of cerebral ischemic events was similar between TEE-guided and ICE-guided procedures., Conclusions: ICE-guided LAAO by means of Amplatzer devices may represent a second alternative imaging modality after an appropriate learning curve and bearing in mind that pre-procedural computed tomography imaging is mandatory. When comparing ICE with TEE, TEE remains the gold standard., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Left atrial appendage occlusion (LAAO) has been proven to be effective for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF). We aim to assess the safety and efficacy of LAAO by AMPLATZER™ devices in a large, multicenter, single-nation cohort of NVAF patients at high-risk of stroke and bleeding., Methods: From December 2008 to April 2015 613 NVAF patients (75.1±8.0years, 62.5% male) underwent LAAO in 15 Italian centers by AMPLATZER™ devices. There were no restrictions on any personal/institutional protocols with respect to indications, pre-procedural planning, device implantation, drug therapy and follow-up. All the baseline characteristics, imaging, procedural and follow-up data were collected in a single dataset., Results: AMPLATZER™ devices were successfully implanted in 95.4% of cases. Major complications occurred during 38 procedures (6.2%) and included more frequently major bleeding (3.3%) and pericardial tamponade (2.0%). At a mean follow-up of 20months, the overall annual rates of stroke and thromboembolic events, including those periprocedural, was 1.67% and 2.90%, respectively, consisting in a reduction in the rate of stroke and TIA of 66% compared with the risk-based expectation. Among the 218 patients undergoing transesophageal echocardiography at 6months of follow-up, device thrombosis was present in 1.8% of the patients whilst a significant or mild to moderate peri-device leak was found in 0.5% and 11.9% of cases, respectively., Conclusions: In this large, multicenter, single-nation study, LAAO with the AMPLATZER™ devices showed high procedural success, early safety and mid-term efficacy for the prevention of NVAF-related thromboembolism., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Aims: To compare the effects of two thrombus aspiration devices, the manual catheter Export® and the more complex and expensive mechanical Angiojet®, on several indices of reperfusion in acute ST-elevation myocardial infarction (STEMI)., Methods and Results: Clinical, hemodynamic and procedural characteristics of 185 STEMI patients, randomized to treatment with Export (n=95) or Angiojet (n=90) during primary percutaneous coronary intervention (PPCI) were analyzed. The primary endpoint was ST-segment elevation reduction 90 min after culprit vessel re-opening. Secondary endpoints included variations in some angiographic parameters (TIMI Flow, TIMI Frame Count and Myocardial Blush Grade) and Infarct Size and Severity at myocardial scintigraphy. A significant reduction in ST-elevation was observed in both groups after PPCI without significant differences between the two groups. No significant difference between Angiojet vs. Export was observed in ST-segment resolution >50% and ≥ 70%, in TIMI Flow, TIMI Frame Count and Myocardial Blush Grade before vs. after PPCI and in Infarct Size and Severity., Conclusions: PPCI with thrombus aspiration was effective in both groups of patients, without differences in myocardial reperfusion and necrosis indices. These results could support the routine use of manual devices during PPCI, reserving the more expensive Angiojet in case of manual device failure and persistent or massive intracoronary thrombosis, with favorable implications in terms of cost containment., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

BVS polymeric struts are transparent to the light so that the vessel wall contour can be easily visualized using optical coherence tomography (OCT). Therefore OCT represents a unique tool for both the evaluation of the resorption process and for the assessment of acute BVS mechanical failure. Similarly, the metal-free struts allow unrestricted coronary computed tomography angiography (CCTA), thus this non invasive method might become the gold standard for a non invasive assessment of BVS. In this case we show the ability of CCTA, performed with a low X-Ray dose, to provide a good evaluation of scaffold expansion. The quantitative measurements were in agreement with those obtained with OCT., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objectives: This dual-center study sought to demonstrate the utility and safety of intracardiac echocardiography (ICE) in providing adequate imaging guidance as an alternative to transesophageal echocardiography (TEE) during Amplatzer Cardiac Plug device implantation., Background: Over 90% of intracardiac thrombi in atrial fibrillation originate from the left atrial appendage (LAA). Patients with contraindications to anticoagulation are potential candidates for LAA percutaneous occlusion. TEE is typically used to guide implantation., Methods: ICE-guided percutaneous LAA closure was performed in 121 patients to evaluate the following tasks typically achieved by TEE: assessment of the LAA dimension for device sizing; guidance of transseptal puncture; verification of the delivery sheath position; confirmation of location and stability of the device before and after release and continuous monitoring to detect procedural complications. In 51 consecutive patients, we compared the measurements obtained by ICE and fluoroscopy to choose the size of the device., Results: The device was successfully implanted in 117 patients, yielding a technical success rate of 96.7%. Procedural success was achieved in 113 cases (93.4%). Four major adverse events (3 cardiac tamponades and 1 in-hospital transient ischemic attack) occurred. There was significant correlation in the measurements for device sizing assessed by angiography and ICE (r = 0.94, p < 0.0001)., Conclusions: ICE imaging was able to perform the tasks typically provided by TEE during implantation of the Amplatzer Cardiac Plug device for LAA occlusion. Therefore, we provide evidence that the use of ICE offered accurate measurements of LAA dimension in order to select the correct device sizes., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Percutaneous closure of a paravalvular leak is a challenging procedure that often presents with multiple simultaneous hurdles. We report a case of percutaneous retrograde paravalvular leak closure in a patient with a coexistent monoleaflet mechanical aortic valve. The leak was crossed and occluded using a combination of techniques deriving from the coronary and peripheral angioplasty fields., (Copyright © 2014 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background and Purpose: Although several studies reported that drug-eluting stents (DES) are able to reduce restenosis incidence without increasing mortality, concerns still exist about their safety in ST-segment elevation myocardial infarction (STEMI) patients mainly for a possible higher rate of in-stent thrombosis. Recent evidence suggests a better safety profile of second-generation DES, but data on their outcome in STEMI are still poor. In this study we evaluated the impact on mortality and target lesion revascularization (TLR) of DES or bare metal stent (BMS) implantation in STEMI patients submitted to primary angioplasty., Methods and Subjects: We analyzed mortality and TLR in 1150 STEMI patients during a mean 43-month follow-up after DES (44.6%) or BMS (55.4%) implantation. A propensity score method was used to minimize bias. During follow-up, 223 deaths occurred., Essential Results: Unadjusted for potential confounders, DES implantation was associated with a significant reduction in all-cause mortality [hazard ratio (HR) 0.40; 95%CI 0.30-0.54] and TLR (HR 0.55; 95%CI 0.36-0.86); this latter was confirmed after propensity score analysis (HR 0.39; 95%CI 0.21-0.67). Second- (n=179) vs. first- (n=337) generation DES showed a further reduction in TLR (HR 0.17; 95%CI 0.05-0.57). Adjusted analyses showed a significant reduction in the combined end-point of all-cause mortality or TLR after both first- and second-generation DES vs. BMS implantation with a trend to a lower risk for second- vs. first-generation DES., Principal Conclusions: DES implantation in STEMI patients showed a significant reduction in TLR and in the combined endpoint of TLR or mortality. Second-generation DES showed a more protective effect on the combined endpoint, suggesting that they would be preferred in this setting., (Copyright © 2013 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.)

Papillary muscle rupture in the absence of coronary stenoses is a rare event. An isolated infarction of the papillary muscle is involved in most cases, but the pathogenesis is still debated. We describe an anterolateral papillary muscle rupture complicating acute pancreatitis in a patient without significant coronary stenoses and with evidence of coronary spasm. This suggests that an increased susceptibility to coronary spasm and thrombosis, triggered by an acute systemic inflammatory response, may represent a mechanism of selective papillary muscle infarction., (Copyright © 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)