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Left atrial appendage closure (LAAC) is a crucial intervention for stroke prevention in patients with non-valvular atrial fibrillation who are unsuitable for long-term anticoagulation. Amulet and Watchman are the most implanted devices worldwide for performing LAAC, and the aim of this review is to provide a comprehensive comparison focusing on their efficacy, safety, and short- and long-term outcomes. The Watchman device, the first to gain FDA approval, has been extensively studied and demonstrates significant reductions in stroke and systemic embolism rates. The Amulet device, a newer alternative, promises enhanced design features for more efficient appendage sealing. Current data highlight that both devices offer similar efficacy and safety for LAAC. While the two devices differ in terms of intraprocedural complication rates, they offer similar short- to long-term outcomes in terms of peri-device leaks, device-related thrombosis, and mortality. Both devices are indicated for patients who are unable to tolerate OAC, given their similar risk and safety profiles. Newer clinical studies are directed at establishing the efficacy of both devices as the primary method for stroke prevention in AF as an alternative to OAC. [ABSTRACT FROM AUTHOR]

This study aimed to compare the peri-procedural success and complication rate within a large registry of intra-cardiac echocardiography (ICE)- vs. transesophageal echocardiography (TEE)-guided left atrial appendage occlusion (LAAO) procedures with a Watchmann FLX device. Data from 772 LAAO procedures, performed at 26 Italian centers, were reviewed. Technical success was considered as the final implant of a Watchmann FLX device in LAA; the absence of pericardial tamponade, peri-procedural stroke and/or systemic embolism, major bleeding and device embolization during the procedure was defined as a procedural success. One-year stroke and major bleeding rates were evaluated as outcome. ICE-guided LAA occlusion was performed in 149 patients, while TEE was used in 623 patients. Baseline characteristics were similar between the ICE and TEE groups. The technical success was 100% in both groups. Procedural success was also extremely high (98.5%), and was comparable between ICE (98.7%) and TEE (98.5%). ICE was associated with a slightly longer procedural time (73 ± 31 vs. 61.9 ± 36 min, p = 0.042) and shorter hospital stay (5.3 ± 4 vs. 5.8 ± 6 days, p = 0.028) compared to the TEE group. At one year, stroke and major bleeding rates did not differ between the ICE and TEE groups. A Watchmann FLX device showed high technical and procedural success rate, and ICE guidance does not appear inferior to TEE. [ABSTRACT FROM AUTHOR]

Background: Concomitant mitral transcatheter edge-to-edge repair (M-TEER) and left atrial appendage closure (LAAC) showed to be a feasible approach to optimize the treatment of patients eligible for both procedures, but mid-term outcomes are unclear. Methods: We retrospectively analyzed consecutive patients undergoing M-TEER and enrolled in the local prospective Getting Reduction of Mitral Insufficiency by Percutaneous Clip Implantation (GRASP) registry. We compared patients undergoing isolated M-TEER (n = 58, 58.5%) with those undergoing concomitant M-TEER and LAAC (n = 41, 41.5%) from January 2018 to December 2022. The primary endpoint was a composite of all-cause death, stroke or systemic embolism, hospitalization for heart failure, and bleeding at 1 year. The co-primary endpoint was procedural success. Results: The primary endpoint was similar between patients undergoing concomitant M-TEER+LAAC or isolated M-TEER (Kaplan Meier (KM) estimates 36.6% vs. 44.8%; plog-rank = 0.75). Procedural success was also similar (92.7% vs. 94.8%; p = 0.69). At 1- year, minor bleeds were lower in patients undergoing concomitant M-TEER and LAAC (KM estimates 0.0% vs. 18.9%; plog-rank < 0.01). Conclusion: In patients with concomitant MR and AF and eligible for M-TEER and LAAC treatment, a combined approach of M-TEER and LAAC was as safe as an M-TEER-alone strategy and associated with lower minor bleeding at 1 year. [ABSTRACT FROM AUTHOR]

Aim: Randomized controlled trials comparing the use of the MitraClip device in addition to guideline directed medical therapy (GDMT) to GDMT alone in patients with secondary mitral regurgitation (MR) have shown conflicting results. However, if these differences could be due to the underlying MR aetiology is still unknown. Therefore, we aimed to evaluate if the effects of percutaneous edge‐to‐edge repair with MitraClip implantation could differ in patients with ischaemic (I‐MR) and non‐ischaemic mitral regurgitation (NI‐MR). Methods and results: PubMed, Embase, BioMed Central, and the Cochrane Central Register of Controlled Trials were searched for all studies including patients with secondary MR treated with the MitraClip device. Data were pooled using a random‐effects model. Primary endpoint was the composite of all‐cause death and heart failure‐related hospitalization. Secondary endpoints were the single components of the primary endpoint, New York Heart Association functional Classes III and IV, and mitral valve re‐intervention. Seven studies enrolling 2501 patients were included. Patients with I‐MR compared with patients with NI‐MR had a similar risk of the primary endpoint (odds ratio: 1.17; 95% confidence interval: 0.93 to 1.46; I2: 0%). The risk of all‐cause death was increased in patients with I‐MR (odds ratio: 1.31; 95% confidence interval: 1.07 to 1.62; I2: 0%), while no differences were observed between the two groups in terms of the other secondary endpoints. Conclusions: The risk of mortality after MitraClip implantation is lower in patients with NI‐MR than in those with I‐MR. No absolute differences in the risk of heart failure related hospitalization were observed between groups. [ABSTRACT FROM AUTHOR]

OBJECTIVES We sought to develop and validate a novel risk assessment tool for the prediction of 30-day mortality after surgical aortic valve replacement incorporating a patient's frailty. METHODS Overall, 4718 patients from the multicentre study OBSERVANT was divided into derivation (n  = 3539) and validation (n  = 1179) cohorts. A stepwise logistic regression procedure and a criterion based on Akaike information criteria index were used to select variables associated with 30-day mortality. The performance of the regression model was compared with that of European System for Cardiac Operative Risk Evaluation (EuroSCORE) II. RESULTS At 30 days, 90 (2.54%) and 35 (2.97%) patients died in the development and validation data sets, respectively. Age, chronic obstructive pulmonary disease, concomitant coronary revascularization, frailty stratified according to the Geriatric Status Scale, urgent procedure and estimated glomerular filtration rate were independent predictors of 30-day mortality. The estimated OBS AVR score showed higher discrimination (area under curve 0.76 vs 0.70, P  < 0.001) and calibration (Hosmer–Lemeshow P  = 0.847 vs P  = 0.130) than the EuroSCORE II. The higher performances of the OBS AVR score were confirmed by the decision curve, net reclassification index (0.46, P  = 0.011) and integrated discrimination improvement (0.02, P  < 0.001) analyses. Five-year mortality increased significantly along increasing deciles of the OBS AVR score (P  < 0.001). CONCLUSIONS The OBS AVR risk score showed high discrimination and calibration abilities in predicting 30-day mortality after surgical aortic valve replacement. The addition of a simplified frailty assessment into the model seems to contribute to an improved predictive ability over the EuroSCORE II. The OBS AVR risk score showed a significant association with long-term mortality. [ABSTRACT FROM AUTHOR]

Extracranial internal carotid artery (EICA) kinking and coiling are the most frequently reported carotid anomalies in the literature. Embryogenic and acquired causes for such anomalies have been postulated but the prevalence of kinking and coiling has not been well characterized across age categories. The aim of this study is to evaluate the prevalence of EICA coiling and kinking among different age groups to better understand its potential causes and changes during the course of life. A total of 2856 subjects aged 0 to 96 years were studied by echo-color Doppler (ECD). Morphology and anatomical anomalies of the EICA were assessed. Patients with anatomical anomalies were stratified by age groups and the prevalence of EICA abnormalities was calculated. The maximal velocity recorded at the level of the kinking was compared with that measured in the common carotid artery and the peak systolic velocity kinking ratio (PSVKR) was calculated. A total of 284 subjects (9.94% of the sample) were found to have kinking or coiling of the EICA. The prevalence was significantly higher at the extremes of age (≤ 20 and > 60 years old, p < 0.001) supporting the hypothesis of a reduction with growth and a new increase in the elderly. PSVKR was higher in subjects with more severity kinking. This study showed a higher prevalence of EICA coiling and kinking in the very young and in the elderly. This bimodal prevalence distribution supports the hypothesis of a congenital anomaly that resolves with somatic growth, while advanced age with its many anatomical changes leads to its reappearance or worsening. Studies with longitudinal follow-up and paired observation are required to support this hypothesis. [ABSTRACT FROM AUTHOR]

Although optical coherence tomography (OCT) proved to be able to identify macrophage clusters, there are no available data on the possibility to obtain reproducible measurements of their circumferential extension and location. The purpose of the present post-hoc analysis of the CLIMA study was to revise the clinical and demographic variables of patients having coronary plaques with macrophages and to investigate the reproducibility of their quantitative assessment. A total of 577 patients out of 1003 undergoing OCT showed macrophage accumulation. Three groups were identified; group 1 (426 patients) without macrophages, group 2 (296) patients with low macrophage content (less than median value [67°] of circumferential arc) and group 3 (281) with high macrophage content arc [> 67°]. Patients with macrophages (groups 2 and 3) showed a higher prevalence of family history for coronary artery disease and hypercholesterolemia and had a significantly larger body mass index. Furthermore, group 3 had more commonly triple vessel disease and higher value of LDL cholesterol levels compared to the two other groups. The inter-observer agreement for macrophage interpretation was good: R values were 0.97 for the circumferential arc extension, 0.95 for the minimum distance and 0.98 for the mean distance. A non-significant correlation between circumferential extension of macrophages and hsCRP values was found (R = 0.013). Quantitative assessment of macrophage accumulations can be obtained with high reproducibility by OCT. The presence and amount of macrophages are poorly correlated with hsCRP and identify patients with more advanced atherosclerosis and higher LDL cholesterol levels. [ABSTRACT FROM AUTHOR]

Introduction: Data on the early and late outcome following transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) in obese patients are limited. We investigated whether TAVI may be superior to SAVR in obese patients.Material and Methods: Obese patients (body mass index ≥ 30 kg/m2) who underwent either SAVR or TAVI were identified from the nationwide OBSERVANT registry, and their in-hospital and long-term outcomes were analysed. Propensity score matching was employed to identify two cohorts with similar baseline characteristics.Results: The propensity score matching provided 142 pairs balanced in terms of baseline risk factors. In-hospital and 30-day mortality did not differ between SAVR and TAVI obese patients (4.6% vs. 3.3%, p = 0.56, and 5.2% vs. 3.2%, p = 0.41, respectively). Obese SAVR patients experienced a higher rate of renal failure (12.4% vs. 3.6%, p = 0.0105) and blood transfusion requirement (60.3% vs. 25.7%, p < 0.0001) in comparison with TAVI patients. A higher rate of permanent pacemaker implantation (14.4% vs. 3.6%, p = 0.0018), and major vascular injuries (7.4% vs. 0%, p = 0.0044) occurred in the TAVI group. Five-year survival was higher in the SAVR group compared to the TAVI patient cohort (p = 0.0046), with survival estimates at 1, 3 and 5 years of 88.0%, 80.3%, 71.8% for patients undergoing SAVR, and 85.2%, 69.0%, 52.8% for those subjected to TAVI procedures.Conclusions: In obese patients, both SAVR and TAVI are valid treatment options, although in the long term SAVR exhibited higher survival rates. [ABSTRACT FROM AUTHOR]

Aims  In the last decade, transcatheter aortic valve (TAV) replacement determined a paradigm shift in the treatment of patients with severe symptomatic aortic stenosis. Data on long-term TAV performance are still limited. We sought to evaluate the clinical and haemodynamic outcomes of the CoreValve self-expandable valve up to 8-year follow-up (FU). Methods and results  Nine hundred and ninety inoperable or high-risk patients were treated with the CoreValve TAV in eight Italian Centres from June 2007 to December 2011. The median FU was 4.4 years (interquartile range 1.4–6.7 years). Longest FU reached 11 years. A total of 728 died within 8-year FU (78.3% mortality from Kaplan–Meier curve analysis). A significant functional improvement was observed in the majority of patients and maintained over time, with 79.3% of surviving patients still classified New York Heart Association class ≤ II at 8 years. Echocardiographic data showed that the mean transprosthetic aortic gradient remained substantially unchanged (9 ± 4 mmHg at discharge, 9 ± 5 mmHg at 8 years, P  = 0.495). The rate of Grade 0/1 paravalvular leak was consistent during FU with no significant change from post-procedure to FU ≥5 years in paired analysis (P  = 0.164). Structural valve deterioration (SVD) and late bioprosthetic valve failure (BVF) were defined according to a modification of the 2017 EAPCI/ESC/EACTS criteria. In cumulative incidence functions at 8 years, moderate and severe SVD were 3.0% [95% confidence interval (CI) 2.1–4.3%] and 1.6% (95% CI 0.6–3.9%), respectively, while late BVF was 2.5% (95% CI 1.2–5%). Conclusion  While TAVs are questioned about long-term performance and durability, the results of the present research provide reassuring 8-year evidence on the CoreValve first-generation self-expandable bioprosthesis. Open in new tab Download slide Open in new tab Download slide [ABSTRACT FROM AUTHOR]

Aim: To evaluate sex difference in culprit plaque features at optical coherence tomography (OCT) and major adverse cardiovascular events at follow-up. Patients and methods: We analyse data from the OCT-FORMIDABLE (OCT-Features Of moRphology, coMposItion anD instABility of culprit and pLaquE in acute coronary syndrome [ACS] patients) registry. A total of 285 patients (20%, 58 females) were included. Results: Females with ST segment elevation myocardial infarction showed a longer ruptured area of the plaque (8.6 ± 7.6 vs 4.6 ± 5.4; p = 0.003) and a major necrotic core macrophage infiltration (43 vs 17%; p = 0.017). Females with non-ST segment elevation-ACS had less lipidic plaques (62 vs 80%; p = 0.04). No between-group sex differences in major adverse cardiovascular events emerged at follow-up (5 vs 9%; p = 0.88 in ST segment elevation myocardial infarction group and 19 vs 15%; p = 0.6 in non-ST segment elevation-ACS group). At multivariate analysis, female sex was not a major risk of plaque rupture (hazard ratio [HR]: 1.59, CI: 0.44-5.67; p = 0.48). Conclusion: Female sex seems to have no significant impact. ClincalTrial. gov registration number: NCT02486861. [ABSTRACT FROM AUTHOR]

The Absorb bioresorbable vascular scaffold (BVS) promised to avoid some of the disadvantages of its metal predecessors. Even though it has been taken off the market, limited data is available about its use in coronary chronic total occlusion (CTO) and its performance in overlap segments, which would be of special research interest due to its large thickness. This data is still pertinent since the platform of bioresorbable devices has not been abandoned, with several companies working on it. We aimed to compare healing and performance between overlap (OL) and non-overlap regions (NOL) of CTO lesions treated with BVS, using optical coherence tomography (OCT). Fourteen patients with overlapping BVS were included from the GHOST-CTO registry, resulting in 25 OL and 38 NOL regions. OCT based parameters were compared between OL and NOL groups at baseline (post-implantation) and 12-month follow-up. The mean age was 61.7 ± 7.2 years and 12 (86%) were males. Twelve (86%) patients underwent PCI for stable coronary artery disease and 2 (14%) had unstable angina. At 12-month follow-up, mean lumen area decreased in both NOL and OL regions, but the decrease was significantly larger in the OL region (NOL - 0.7 ± 1.33 vs. OL - 2.4 ± 1.54 mm2; p = 0.002). Mean scaffold area increased in both regions, but increased significantly more in NOL ( + 1.1 ± 1.54 vs. + 0.4 ± 1.16 mm2; p = 0.016). The percent of uncovered struts was lower in the OL group (5.0 ± 6.6% vs. 3.75 ± 8.7%, p = 0.043), whereas the percentage of malapposed struts was similar (0.3 ± 0.5% vs. 0.7 ± 2.3%, p = 0.441). Neointimal hyperplasia (NIH) was more pronounced in the OL region (0.13 ± 0.04 vs. 0.24 ± 0.10 mm2, p = 0.001). The OL and NOL segments showed comparable healing in terms of coverage and malapposition. However, NIH was more prominent in OL region. The long-term clinical implications of these findings needs further evaluation. The present study provides important insights for future development of BVS technology. [ABSTRACT FROM AUTHOR]

Guidelines recommend the use of neurohormonal antagonists for all patients with heart failure and mitral regurgitation (MR) as an initial treatment strategy.1,2 Patients with symptoms despite maximally tolerated neurohormonal antagonist treatment, evidence-based therapy (EBT), and moderate-to-severe MR who are surgery-ineligible may undergo transcatheter mitral valve repair with the MitraClip (Abbott Vascular, Abbott Park, IL, USA) system. Patients undergoing the MitraClip procedure for secondary MR with EBT are at lower risk of death compared to patients without EBT. In the era of surgical and transcatheter treatment options, the importance of medications may be neglected when severe MR is present in a patient with heart failure. [Extracted from the article]

We sought to determine whether the chronic total occlusions (CTO) recanalization results differ between circumflex artery (CX) and other coronary arteries in our center. The study dataset encompassed 428 consecutive procedures. J-CTO score was highest in the right coronary artery (RCA) and lowest in CX lesions. After adjusting for the J-CTO score, age, body mass index, baseline creatinine, diabetes, dyslipidemia and hypertension the odds ratio for procedural success in CX compared to the other arteries was not statistically significant. We found no difference in success rates of recanalizing CTO in CX compared to other coronary arteries. [ABSTRACT FROM AUTHOR]

Introduction: Transcatheter aortic valve implantation (TAVI) is the treatment of choice for a large proportion of patients with severe aortic stenosis. Despite numerous technological and clinical advances, TAVI remains associated with thrombotic complications requiring antithrombotic pharmacotherapy, which exposes to the risk of bleeding, especially in elderly individuals. The optimal antithrombotic regimen following TAVI is uncertain and several investigations are ongoing. Areas covered: Clinical guidelines are mostly driven by observational trials and experts' opinions, thus resulting into low-grade level of evidence. The aim of the current review is to critically explore the epidemiology, pathophysiology and prognostic value of thrombotic and bleeding events after TAVI, and to review the current literature on antithrombotic strategies following the procedure. Expert opinion: Thrombotic and bleeding events remain major complications occurring in the frail population that is currently offered TAVI. Waiting for upcoming evidence from ongoing randomized clinical trials, tailoring antithrombotic therapies based on patients' characteristics, values and circumstances is a preferable approach. [ABSTRACT FROM AUTHOR]

Aims In the Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX (MATRIX) trial, adults with acute coronary syndrome undergoing coronary intervention who were allocated to radial access had a lower risk of bleeding, acute kidney injury (AKI), and all-cause mortality, as compared with those allocated to femoral access. The mechanism of the mortality benefit of radial access remained unclear. Methods and results We used multistate and competing risk models to determine the effects of radial and femoral access on bleeding, AKI and all-cause mortality in the MATRIX trial and to disentangle the relationship between these different types of events. There were large relative risk reductions in mortality for radial compared with femoral access for the transition from AKI to death [hazard ratio (HR) 0.55, 95% confidence interval (CI) 0.31–0.97] and for the pathway from coronary intervention to AKI to death (HR 0.49, 95% CI 0.26–0.92). Conversely, there was little evidence for a difference between radial and femoral groups for the transition from bleeding to death (HR 1.05, 95% CI 0.42–2.64) and the pathway from coronary intervention to bleeding to death (HR 0.84, 95% CI 0.28–2.49). Conclusion The prevention of AKI appeared predominantly responsible for the mortality benefit of radial as compared with femoral access in the MATRIX trial. There was little evidence for an equally important, independent role of bleeding. View large Download slide View large Download slide [ABSTRACT FROM AUTHOR]