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Background\ud Cardiac implantable electronic device (CIED) therapy contributes to an improvement in morbidity and mortality across all patient demographics. Patient age is a recognized risk factor for unfavorable outcomes in invasive procedures. This is the largest series of non-laser transvenous lead extraction (TLE) evaluating the association between patient age and procedure outcomes.\ud \ud Methods\ud Data of 2205 (3849 leads) patients was collected retrospectively from six European TLE centers between January 2005–December 2018 in the PROMET study. Of these, 153 patients with 319 leads were excluded for incomplete data. A comparison of outcomes was performed between the age groups young [< 50 years], young intermediate [50–69 years], older intermediate [70–79 years], and octogenarian [≥80 years].\ud \ud Results\ud Infection was most common indication for TLE in the octogenarian cohort, less common in the younger population (60.1% vs. 33.2%, respectively, p < .01). High-voltage leads were extracted most frequently from young patients, less frequently from octogenarians (31.6% vs. 10%, p < .001), while the opposite was evident for pacemaker leads (p < .001). Rotational sheath use was equally prevalent across all patient groups (p = .79). Minor and major complications across all the age groups were statistically similar, as was procedural success; the 30-day mortality was most significant in the octogenarian and least in the young patients (4.9% vs. 0.4%, p = .005). Propensity matching multivariate analysis found systemic infection, lead dwell time, and patient age (p = .013, OR 1.064 [1.013–1.116]) increased risk of 30-day mortality.\ud \ud Conclusion\ud TLE is safe and effective across all age groups. 30-day mortality risk is significantly higher in the older patients.

This case shows how interaction between imaging experts and interventionists allowed us to overcome the challenge of plug-prosthesis interaction in a complex procedure.

An increasing number of foreigners was observed in Italy even among chronic dialysis patients. We compared demographic, clinical, treatment characteristics and survival probability between groups of Italian and foreign patients with chronic dialysis in Lazio.We analysed data from the Lazio Dialysis and Transplantation Registry from 2004 to 2012 (4,076 prevalent chronic dialysis patients in 31-12-2012). Among 7,970 incident patients, we evaluated, by country of birth, survival probability by using Kaplan-Meier method and mortality risk, through multiple Cox regression.We observed an increase of foreigners among chronic dialysis patients in Lazio from 2004 (4.4%) up to 2012 (7.6%, test for trend: p0,001). Compared with Italians, foreign patients were younger (53.816.3 vs. 68.713.6) and more frequently: women (42.7% vs. 37.7%), HbsAg-positive (18.1% vs. 13.9%), not vaccinated if HBV susceptible (26.8% vs. 20.9%), late referral (21.6% vs. 12.9%) and suitable for kidney transplantation (21.7% vs. 9.9%). Foreigners compared with Italians had higher survival probability at 1 year (91.9% vs. 84.7%) and 5 years (74,6% vs. 51,5%) after chronic dialysis has been started. We observed a lower mortality risk (HR=0.71;IC95%:0.58-0.87) among foreign patients even after adjustment for many potential confounding factors. Our findings suggest that health status and treatment of end stage renal disease, including access to kidney transplantation, were similar between groups of Italian and foreign patients in Lazio. Observed differences in patients' characteristics were probably attributable to younger age of foreigners. However, further analyses are needed to fully explain higher survival probability in chronic dialysis among foreigners compared with Italians.

Over the past two decades interest in mitral valve regurgitation has increased as a result of the development of new technologies that have expanded the number of patients who can potentially benefit from mitral regurgitation treatments. To develop new devices for the treatment of mitral regurgitation, the focus has been placed on the functional anatomy and pathophysiology of the mitral valve, with the use of the most advanced methods of cardiac imaging that allow the best visualization of the mitral valve and a perfect understanding of the complexity of a specific disease. Mitral regurgitation is still underdiagnosed and undertreated in a substantial number of patients who have poor survival. Therefore, the priority should be to identify and treat these patients to increase their survival and quality of life. To achieve this goal, general physicians and cardiologists must be aware of all the treatment options that are currently available in dedicated centres of excellence. Patients referred to these centres can benefit from a tailored heart team-based approach. The aim of this Review is to analyse the basic principles of mitral regurgitation, discussing new concepts on the pathophysiology of the mitral valve that have been developed to facilitate the selection of patients for transcatheter procedures. We also describe the indications and timing of treatment, contemporary surgical and transcatheter techniques and the heart team approach, and highlight the need for centres of excellence. In this Review, Alfieri and colleagues focus on new concepts on mitral valve pathophysiology and patient risk profile assessment to guide the indication and timing of the management of mitral valve regurgitation. The authors also describe new imaging modalities and contemporary surgical and transcatheter techniques, highlighting the need for a multidisciplinary approach.

Background Left atrial appendage (LAA) thrombosis increases the risk of stroke and its management has to be assessed. The aim of the present study is to evaluate short and long-term safety and efficacy of a standardized approach of percutaneous left atrial appendage closure (LAAC) routinely using a cerebral protection device (CPD) in patients with LAA thrombosis or sludge (LAAT). Methods we prospectively enrolled 14 consecutive patients with atrial fibrillation complicated by LAAT presenting in a high-volume tertiary center. In seven patients (50%) LAAT was found after anticoagulant withdrawal for severe bleedings and in the remaining half LAAT was found despite appropriate anticoagulant therapy. All patients were treated with a standardized interventional approach of LAAC routinely using a CPD and guided by transoesophageal echocardiography. Results Mean age was 68±14 years and 9 patients (64%) were male. Mean CHA2 DS2 -VASc and HAS-BLED scores were 3.3±1.6 and 2.3±1.1, respectively. Six patients (42.8%) presented organized thrombi while 8 LAA sludge (57.1%). In 13 patients (92.8%) CPD was positioned through a right radial arterial access. Procedural success was achieved in all patients. In one patient we assisted to embolization of the thrombus during deployment of the device in the absence of neurological consequences. During a mean follow up of 426±307 days, one patient died for non-cardiac cause while no embolic event or major bleeding were reported. Conclusion in an unselected cohort, LAAC with the systematic use of CPD was a feasible, safe and effective therapeutic option for LAAT both acutely and after long-term follow-up. This article is protected by copyright. All rights reserved.

Background: Limited clinical data exist describing the use of direct oral anticoagulants (DOACs) in patient with extreme body weight. Thus, the International Society of Thrombosis and Haemostasis (ISTH) recommends avoiding DOACs in patients with weight >120Kg, and on the contrary, no restrictions exist for underweight patients. Objective: To evaluate the effects of extreme body weight on DOAC activity and to compare the clinical outcomes of patients with an extreme body weight versus patients with a normal weight (61-119Kg) treated with DOACs. Methods: Single tertiary care Italian centre multidisciplinary registry including nonvalvular atrial fibrillation (NVAF) patients treated with DOACs. Based on weight, three subcohorts were defined: (i) underweight patients (≤60Kg); (ii) patients with a normal weight (61-119Kg, as control group); and (iii) overweight patients (≥120Kg). Primary efficacy endpoint was 2-year rate of thromboembolic events. Primary safety endpoint was 2-year rate of major bleeding. Event-free survival curves among groups were compared using Cox-Mantel test. Results: 812 NVAF patients were included, 108 patients weighed ≤60Kg (13%, underweight), 688 weighed between 61 and 119Kg (85%, normal weight), and 16 weighed ≥120Kg (2%, overweight). In particular, among underweight patients, dabigatran was prescribed in 26% patients, apixaban in 27%, rivaroxaban in 28% and edoxaban in 22% ones. Instead, among overweight patients, 44% were treated with dabigatran, 25% with apixaban, 25% with rivaroxaban and 4% with edoxaban. Underweight patients were older, more frequently women, with lower creatinine clearance and a history of previous strokes, resulting in higher CHA2DS2-VASc score than in both remaining groups. Up to 2years, no statistically significant difference was observed between the three groups of weight for thromboembolic events (P=.765) and for overall bleeding (P=.125), but a trend towards decreased overall bleeding rates was noticed as weight increased (24.1% vs 16.7% vs 12.5%, respectively). Conclusion: In this tertiary care centre registry, 15% of patients treated with DOACs presented an extreme weight. Compared to patients with a normal weight, no significant rates of thromboembolic events were observed for underweight or overweight patients. A trend towards decreased overall bleeding frequency as weight increased was highlighted up to 2years. The present results should be considered as preliminary and hypothesis generating.

Newer approaches in transcatheter tricuspid valve replacement (TTVR) have recently showed optimistic data of efficacy and safety in patients at high risk for surgery. However, the absence of residual regurgitation (and subsequently higher likelihood for developing afterload mismatch) with TTVR compared with transcatheter tricuspid valve intervention may become a critical concern if RV dysfunction is misdiagnosed. Indeed, such sudden increase in afterload on the right ventricle (RV) may not be tolerable, resulting in higher risk of acute right heart failure in the early postoperative period. In this context, strain imaging may find a further application to provide a more comprehensive stratification of the severity of RV dysfunction and thus help to better define the eligibility criteria and timing for TTVR. Meanwhile, it is of paramount importance to underline the contribution given by the Trivalve study on the understanding of the role of RV function in TTVI, that so far was largely undefined, being evaluated only in small noncontrolled cohorts.

Background: Myocardial injury (MI) can be detected during the acute phase of Coronavirus disease 19 (COVID-19) and is associated with a dismal prognosis. Recent imaging studies described the persistence of cardiac abnormalities after the recovery. The aim of the study was to investigate the spectrum of cardiac abnormalities at mid-term follow-up in patients recovered from COVID-19 using clinical assessment, laboratory tests, and imaging evaluation with comprehensive echocardiography. Methods: This is an observational, cross-sectional study assessing an unselected cohort of consecutive patients recovered from COVID-19. MI was defined by elevated plasma levels of high sensitive troponin T (hsTnT). At the follow-up, a complete examination including echocardiography was performed. Results: The 123 patients included were divided into two groups according to the presence of MI during hospitalization: group A (without MI) and group B (with MI). After a median of 85 days, group B patients were more frequently symptomatic for dyspnea and had significantly higher values of hsTnT and N-Terminal prohormone of Brain Natriuretic Peptide (NT-proBNP), compared to Group A. No differences between the two groups in left nor right ventricle dimension and ejection fraction were found. However, in group B a significant reduction of mean left ventricle global longitudinal strain was observed (-15.7±.7vs -18.1±.3 in group A, p&nbsp

Background Whether fluoroscopic-echocardiographic fusion imaging (FI) might offer added value for intraprocedural guidance during transcatheter edge-to-edge mitral valve repair is yet unknown, and few data exist regarding the safety and feasibility of this novel technology. Methods The aim of this single-center study was to test and validate a FI protocol for intraprocedural monitoring of transcatheter edge-to-edge mitral valve repair and assess its clinical usefulness. Eighty patients underwent MitraClip implantation using FI guidance (FI+) for either degenerative (35%) or functional (65%) mitral regurgitation and were compared with the last 80 patients before FI introduction, treated using conventional echocardiography and fluoroscopic monitoring (FI−). Results The number of patients treated for functional and degenerative mitral regurgitation was similar between the FI+ and FI− groups, as well as the number of devices implanted (1.51 ± 0.5 vs 1.58 ± 0.6, P = .46). The prevalence of complex mitral anatomy for percutaneous repair was high (32.5%, up to 39.2% in the hybrid arm). Fluoroscopy time was significantly lower in FI+ patients (37.3 ± 14.6 vs 48.3 ± 28.3 min, P = .003), but not kerma area product (91.5 ± 74.1 vs 108.8 ± 105.0 Gy · cm2, P = .23) or procedural time (92.2 ± 36.1 vs 103.1 ± 42.7 min, P = .086). After adjusting for confounding factors (MitraClip XT device and complex anatomy), FI reduced fluoroscopy time (coefficient = −10.4 min; 95% CI, −18.03 to −2.82; P = .007) and improved procedural success at the end of the procedure (odds ratio, 2.87; 95% CI, 1.00 to 8.24; P = .049) and discharge (odds ratio, 2.24; 95% CI, 1.04 to 4.80; P = .039). Rates of periprocedural complications were similar in both groups (8.9% vs 13.0%, P = .40). Conclusions The authors describe the systematic use of an FI protocol for intraprocedural guidance during transcatheter edge-to-edge mitral valve repair, demonstrating a reduction in fluoroscopy time and an improvement in procedural success in a population with a high prevalence of challenging mitral anatomy for percutaneous repair.

Aims: Aortic stenosis (AS) grading by 2D-transthoracic echocardiography (2D-TTE) aortic valve area (AVA) calculation is limited by left ventricular outflow tract (LVOT) area underestimation. The combination of Doppler parameters with 3D LVOT area obtained by multidetector computed tomography (MDCT) can improve AS grading, reconciling discordant 2D-TTE findings. This study aimed to systematically evaluate the role of 3D-transesophageal echocardiography (3D-TEE) in AS grading using MDCT as reference standard. Methods and results: 288 patients (81±6.3years, 52.4% female) with symptomatic AS underwent 2D-TTE, 3D-TEE, and MDCT for transcatheter aortic valve implantation. Doppler parameters were combined with 3D LVOT areas measured by manual and semi-automated software 3D-TEE and by MDCT to calculate AVA, reassessing AS severity. Both 3D-TEE modalities demonstrated good correlation with MDCT, with excellent intra-observer and inter-observer variability. Compared to MDCT, 3D-TEE measurements significantly underestimated AVA (PANOVA&nbsp

Aims: A significant number of patients with non-valvular atrial fibrillation (NVAF) are ineligible for nonvitamin K oral anticoagulants (NOACs) due to previous major bleeding or because they are at high bleeding risk (HBR). In this setting the indication for percutaneous left atrial appendage closure (LAAO) is a valuable alternative. We aimed to evaluate the efficacy and safety of NOACs versus LAAO indication in NVAF patients at HBR (HAS-BLED ≥3). Methods and results: All consecutive patients who underwent successful LAAO (n=193) and those treated with NOACs (n=189) (dabigatran, apixaban or rivaroxaban) were included. A 1:1 propensity score matching (PSM) was used to match LAAO and NOACs patients. At baseline, patients in the LAAO group had higher HAS-BLED (4.2% vs 3.3%, p

Patients with non-valvular atrial fibrillation (NVAF) and chronic kidney disease (CKD) are at increased risk of stroke and bleeding. Although direct oral anticoagulant (DOAC) trials excluded patients with severe CKD, a growing portion of CKD patients have been starting DOACs and limited data from real-world outcome in this high-risk setting are available. The INSigHT registry included 632 consecutive NVAF patients that started apixaban (256 patients, 41%), dabigatran (245, 39%) and rivaroxaban (131, 20%) between 2012 and 2015. Based on creatinine clearance, two sub-cohorts were defined: (1) non-CKD group (CrCl 60–89 mL/min, 413 patients) and (2) CKD group (15–59 ml/min, 219). Compared to non-CKD patients, those with CKD, were at higher ischemic (CHA2DS2-VASc 4.5 vs 2.9, p

A 46-year-old woman underwent percutaneous patent foramen ovale closure at another institution for recurrent cerebral transient ischemic attacks in the context of hereditary thrombophilia. Because anatomy was considered appropriate, the novel suture-based “deviceless” NobleStitch EL (Kardia

Aim The aim of this study is to describe our 9-year experience in transcatheter aortic valve replacement (TAVR) using transthoracic echocardiography (TTE) as a routine intra-procedural imaging modality with trans-oesophageal echocardiography (TEE) as a backup. Methods and results From January 2008 to December 2017, 1218 patients underwent transfemoral TAVR at our Institution. Except the first 20 cases, all procedures have been performed under conscious sedation, with fluoroscopic guidance and TTE imaging monitoring. Once the TTE resulted suboptimal for final result assessment or a complication was either suspected or identified on TTE, TEE evaluation was promptly performed under general anaesthesia. Only 24 (1.9%) cases required a switch to TEE: 6 cases for suboptimal TTE prosthetic valve leak (PVL) quantification; 12 cases for haemodynamic instability; 2 cases for pericardial effusion without haemodynamic instability; 4 cases for urgent TAVR. The 30-days and 1-year all-cause mortality were 2.1% and 10.2%, respectively. Cardiac mortality at 30-days and 1-year follow-up were 0.6% and 4.1%, respectively. Intra-procedural and pre-discharge TT evaluation showed good agreement for PVL quantification (k agreement: 0.827, P = 0.005). Conclusion TTE monitoring seems a reasonable imaging tool for TAVR intra-procedural monitoring without delay in diagnosis of complications and a reliable paravalvular leak assessment. However, TEE is undoubtedly essential in identifying the exact mechanism in most of the complications.