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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. [ABSTRACT FROM AUTHOR]

Aims: Infection by SARS-CoV-2 may result in a systemic disease and a proportion of patients ranging 15%-44% experienced cardiac injury (CI) diagnosed by abnormal troponin levels. The aim of the present study was to analyse the clinical characteristics of a large series of hospitalized patients for COVID-19 in order to identify predisposing and/or protective factors of CI and the outcome., Methods and Results: This is an observational, retrospective study on patients hospitalized in two Italian centres (San Raffaele Hospital and Cremona Hospital) for COVID-19 and at least one high-sensitivity cardiac troponin (hs-cTnt) measurement during hospitalization. CI was defined if at least one hs-cTnt value was above the 99th percentile. The primary end-point was the occurrence of CI during hospitalization. We included 750 patients (median age 67, IQR 56-77 years; 69% males), of whom 46.9% had history of hypertension, 14.7% of chronic coronary disease and 22.3% of chronic kidney disease (CKD). Abnormal troponin levels (median troponin 74, IQR 34-147 ng/l) were detected in 390 patients (52%) during the hospitalization. At multivariable analysis age, CKD, cancer, C-reactive protein (CRP) levels were independently associated with CI. Independent predictors of very high troponin levels were chronic kidney disease and CRP levels. Patients with CI showed higher rate of all-cause mortality (40.0% vs. 9.1%, p = 0.001) compared to those without CI., Conclusion: This large, multicentre Italian study confirmed the high prevalence of CI and its prognostic role in hospitalized patients with COVID-19, highlighting the leading role of systemic inflammation for the occurrence of CI., (© 2021 Stichting European Society for Clinical Investigation Journal Foundation. Published by John Wiley & Sons Ltd.)

Background: Limited real-world data are available regarding the outcome of patients treated with inappropriate dose of nonvitamin-K antagonist oral anticoagulants (NOACs)., Objective: To assess the prevalence and factors associated with inappropriate dose prescription of NOACs and to evaluate adverse events that come from this inappropriate prescription., Methods: Single-center multidisciplinary registry including nonvalvular atrial fibrillation patients treated with NOACs. Based on guidelines criteria for dose reduction, two subcohorts were defined as treated with appropriate or inappropriate NOACs dose. 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: A total of 760 nonvalvular atrial fibrillation patients were included; 32% patients were treated with dabigatran, 34% with apixaban, 24% with rivaroxaban and 10% with edoxaban. An inappropriate dose was prescribed in 96 patients (12.6%), and in most cases (68%) it was too low. Rivaroxaban (15%) and apixaban (18.5%) were the most frequently prescribed with an inappropriate dose. Patients treated with an inappropriate dose were elderly people, with low-creatinine clearance value, who had experienced previous bleeding and with a high CHADS2 VASc score. In 2 years, a trend for higher numbers of thromboembolic events (5.2 vs. 3.3%, P = 0.348) and less major bleeding (2.1 vs. 4.2%, P = 0.316) has been observed in patients with inappropriate NOACs prescriptions., Conclusion: Nearly 13% of patients were treated with an inappropriate dose of NOACs, in this single-center study. A trend for higher numbers of thromboembolic events was observed in these patients. The results should be considered as hypothesis generating.

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 (CHA 2 DS 2 -VASc 4.5 vs 2.9, p < 0.001) and hemorrhagic risk (HAS-BLED 2.4 vs 1.8, p < 0.001). At 2-year follow-up, the overall ISTH-major bleeding and thromboembolic event rates were 5.2% and 2.3% and no significant difference between non-CKD and CKD patients for both efficacy and safety endpoints were observed. In non-CKD patients, the 2-year ISTH-major bleeding rates were higher in rivaroxaban group (HR 2.9, 95% CI 1.1-7.3; p = 0.047) while dabigatran showed non-significant excess in thromboembolic events (HR 4.3, 95% CI 0.9-20.8; p = 0.068). In CKD patients, a significantly higher rate of thromboembolic events was observed in rivaroxaban (HR 6.3, 95% CI 1.1-38.1; p = 0.044). This real-world, non-insurance database registry shows remarkable 2-year safety and efficacy profile of DOACs even in patients with moderate to severe CKD. Head to head differences between DOACs are exploratory, hypothesis generating and warrant further investigation in larger studies.

Objective: The aim of this study is to evaluate the long-term risk of cardiac death and sudden cardiac death (SCD) and/or sustained ventricular arrhythmias (SVAs) in patients with coronary chronic total occlusions (CTO) revascularised versus those with CTO not revascularised by percutaneous coronary intervention (PCI)., Methods: From a cohort of 1357 CTO-PCI patients, 1162 patients who underwent CTO PCI attempt were included in this long-term analysis: 837 patients were revascularised by PCI (CTO-R group) and 325 were not revascularised (CTO-NR group). Primary adverse endpoint was the incidence of cardiac death; secondary endpoint was the cumulative incidence of SCD/SVAs., Results: Up to 12-year follow-up (median 6 year), compared with CTO-R patients, those with CTO-NR had significantly higher rate of cardiac death (13%[43/325]vs6%[48/837]; p<0.001) and SCD/SVAs (7.5%[24/325]vs2.5%[20/837]; p<0.001). The risk of cardiac death and SCD/SVAs was mainly driven by the subgroup of infarct-related artery (IRA) CTO patients and was significantly higher only in IRA CTO-NR patients (18%vs7%, p<0.001, 14%vs5%, p=0.001; IRA CTO-NR vs IRA CTO-R, respectively). At multivariable Cox hazards regression analysis, CTO-NR remains one of the strongest independent predictors of higher risk of cardiac death and of SCD/SVAs in the overall population and in IRA CTO patients., Conclusions: At long-term follow-up, patients with CTO not revascularised by PCI had worse outcomes compared with those with CTO revascularised, with >2-fold risk of cardiac death and threefold risk of SCD/SVAs. The presence of an infarct-related artery (IRA CTO) not revascularised identified the category of patients with the highest rate of adverse events ., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Aims: The aim of this prospective multicentre study is to evaluate safety and efficacy of the new bidirectional rotational mechanical lead extraction (LE) sheath (Evolution RL, Cook Medical, USA) in chronically implanted leads (>1-year-old leads)., Methods and Results: Between September 2013 and June 2016, a total of 238 leads in 124 consecutive patients were removed by using the new Evolution RL rotational mechanical sheath. Indications for LE were cardiac device infection in 63 (50.8%) cases, lead malfunction in 41 (33.1%), upgrade in 1 (0.8%) case and for other reasons in the remaining 19 cases (15.3%). Ninety-one leads (38.2%) were implantable cardioverter defibrillator leads (81 dual coil vs. 10 single coil), 38 (16%) right ventricular leads, 86 (36.1%) right atrial leads, and 23 (9.7%) coronary sinus leads. The mean implant duration was 92.2 ± 52.9 months (range 12-336). 91.6% of the leads (218/238) were extracted completely with the Evolution RL alone, with the complete success rate rising to 98.7% (235/238 leads) with combined use of a snare. Overall clinical success rate was 100%. No Evolution sheath-related complications were noted. There were no deaths or major complications. Five minor complications (4%) were encountered. In cases of companion leads no wrapping or lead damage were observed., Conclusion: On the basis of our prospective multicentre study, the new hand-powered bidirectional rotational mechanical LE sheath is an effective and safe tool for the extraction of chronically implanted leads without major complications and lead wrapping or lead damage.