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Contrast-associated acute kidney injury can occur after percutaneous coronary intervention (PCI). Prediction of the contrast-associated acute kidney injury risk is important for a tailored prevention and mitigation strategy. We sought to develop a simple risk score to estimate contrast-associated acute kidney injury risk based on a large contemporary PCI cohort. Consecutive patients undergoing PCI at a large tertiary care centre between Jan 1, 2012, and Dec 31, 2020, with available creatinine measurements both before and within 48 h after the procedure, were included; only patients on chronic dialysis were excluded. Patients treated between 2012 and 2017 comprised the derivation cohort and those treated between 2018 and 2020 formed the validation cohort. The primary endpoint was contrast-associated acute kidney injury, defined according to the Acute Kidney Injury Network. Independent predictors of contrast-associated acute kidney injury were derived from multivariate logistic regression analysis. Model 1 included only pre-procedural variables, whereas Model 2 also included procedural variables. A weighted integer score based on the effect estimate of each independent variable was used to calculate the final risk score for each patient. The impact of contrast-associated acute kidney injury on 1-year deaths was also evaluated. 32 378 PCI procedures were performed and screened for inclusion in the present analysis. After the exclusion of patients without paired creatinine measurements, patients on chronic dialysis, and multiple procedures, 14 616 patients were included in the derivation cohort (mean age 66·2 years, 29·2% female) and 5606 were included in the validation cohort (mean age 67·0 years, 26·4% female). Contrast-associated acute kidney injury occurred in 860 (4·3%) patients. Independent predictors of contrast-associated acute kidney injury included in Model 1 were: clinical presentation, estimated glomerular filtration rate, left ventricular ejection fraction, diabetes, haemoglobin, basal glucose, congestive heart failure, and age. Additional independent predictors in Model 2 were: contrast volume, peri-procedural bleeding, no flow or slow flow post procedure, and complex PCI anatomy. The occurrence of contrast-associated acute kidney injury in the derivation cohort increased gradually from the lowest to the highest of the four risk score groups in both models (2·3% to 34·9% in Model 1, and 2·0% to 38·8% in Model 2). Inclusion of procedural variables in the model only slightly improved the discrimination of the risk score (C-statistic in the derivation cohort: 0·72 for Model 1 and 0·74 for model 2; in the validation cohort: 0·84 for Model 1 and 0·86 for Model 2). The risk of 1-year deaths significantly increased in patients with contrast-associated acute kidney injury (10·2% vs 2·5%; adjusted hazard ratio 1·76, 95% CI 1·31–2·36; p=0·0002), which was mainly due to excess 30-day deaths. A contemporary simple risk score based on readily available variables from patients undergoing PCI can accurately discriminate the risk of contrast-associated acute kidney injury, the occurrence of which is strongly associated with subsequent death. None.

ObjectivesDifferences in terms of safety and efficacy of percutaneous edge-to-edge mitral repair between patients with functional and degenerative mitral regurgitation (MR) are not well established. We performed a systematic review and meta-analysis to clarify these differences.MethodsPubMed, EMBASE, Google scholar database and international meeting abstracts were searched for all studies about MitraClip. Studies with <25 patients or where 1-year results were not delineated between MR aetiology were excluded. This study is registered with PROSPERO.ResultsA total of nine studies investigating the mid-term outcome of percutaneous edge-to-edge repair in patients with functional versus degenerative MR were included in the meta-analysis (n=2615). At 1 year, there were not significant differences among groups in terms of patients with MR grade≤2 (719/1304 vs 295/504; 58% vs 54%; risk ratio (RR) 1.12; 95% CI: 0.86 to 1.47; p=0.40), while there was a significantly lower rate of mitral valve re-intervention in patients with functional MR compared with those with degenerative MR (77/1770 vs 80/818; 4% vs 10%; RR 0.60; 95% CI: 0.38 to 0.97; p=0.04). One-year mortality rate was 16% (408/2498) and similar among groups (RR 1.26; 95% CI: 0.90 to 1.77; p=0.18). Functional MR group showed significantly higher percentage of patients in New York Heart Association class III/IV (234/1480 vs 49/583; 16% vs 8%; p<0.01) and re-hospitalisation for heart failure (137/605 vs 31/220; 23% vs 14%; p=0.03). No differences were found in terms of single leaflet device attachment (25/969 vs 20/464; 3% vs 4%; p=0.81) and device embolisation (no events reported in both groups) at 1 year.ConclusionsThis meta-analysis suggests that percutaneous edge-to-edge repair is likely to be an efficacious and safe option in patients with both functional and degenerative MR. Large, randomised studies are ongoing and awaited to fully assess the clinical impact of the procedure in these two different MR aetiologies.

Vitamin D is rightly recognized as an essential key factor in the regulation of calcium and phosphate homeostasis, affecting primary adequate bone mineralization. In the last decades, a more complex and wider role of vitamin D has been postulated and demonstrated. Cardiovascular diseases have been found to be strongly related to vitamin D levels, especially to its deficiency. Pre-clinical studies have suggested a direct role of vitamin D in the regulation of several pathophysiological pathways, such as endothelial dysfunction and platelet aggregation; moreover, observational data have confirmed the relationship with different conditions, including coronary artery disease, heart failure, and hypertension. Despite the significant evidence available so far, most clinical trials have failed to prove any positive impact of vitamin D supplements on cardiovascular outcomes. This discrepancy indicates the need for further information and knowledge about vitamin D metabolism and its effect on the cardiovascular system, in order to identify those patients who would benefit from vitamin D supplementation.

Severe mitral regurgitation (MR) is one of the most common valvular heart diseases and is frequently associated with advanced left ventricular (LV) systolic dysfunction. Transcatheter edge-to-edge repair (TEER) offers effective symptom relief but may induce abrupt hemodynamic changes leading to afterload mismatch and acute LV failure. Levosimendan may help mitigate this complication by improving contractility, yet evidence supporting its use in this setting is scarce. Therefore, the aim of this study was to systematically evaluate the evidence on the effects of Levosimendan in patients with severe MR and LV dysfunction undergoing TEER. We performed a comprehensive search of PubMed, Embase, Scopus, and Google Scholar. Primary outcomes were postprocedural LV ejection fraction (LVEF) and systolic pulmonary artery pressure (sPAP). Secondary outcomes included procedural success, procedure duration, and in-hospital complications. Five studies comprising 315 patients (n = 141 Levosimendan, n = 174 controls) met the inclusion criteria. Pooled analysis showed no significant difference in postprocedural LVEF between Levosimendan-treated patients and controls (mean difference 0.45%, 95% CI [−1.46–2.35] p = 0.65) and no significant change from baseline. Similarly, postprocedural sPAP did not differ significantly. Procedural success was higher with Levosimendan, and procedure duration was shorter. These hypothesis-generating findings highlight the need for larger, prospective randomized trials to clarify the role of Levosimendan in this setting.

Background Diabetic patients undergoing percutaneous coronary intervention (PCI) frequently have complex coronary artery disease (CAD) and suboptimal outcomes with drug-eluting stents (DES). Sirolimus-coated balloons (SCB) have recently been introduced, but comparative data versus DES in diabetic patients with de novo CAD are lacking. Methods The SIMPLE-DM study is a pooled analysis of five observational registries including all-comer diabetic patients undergoing PCI for de novo CAD. Patients in the SCB cohort were treated with the phospholipid nanocarrier Magic Touch SCB, while those in the DES cohort received current-generation DES. Propensity score (PS) adjustment was used to balance clinical and angiographic characteristics. The primary endpoint was the 2-year cumulative incidence of target lesion failure (TLF), defined as the composite of cardiac death, target vessel MI (TV-MI), or target lesion revascularization (TLR). Results A total of 1838 patients were included, 599 treated with SCB-based PCI and 1239 with DES-only PCI. At 2 years, TLF occurred in 9.1% of SCB and 9.9% of DES patients (adj. hazard ratio HR 0.88, 95% confidence interval CI 0.43–1.81, p  = 0.736). No significant differences were found in cardiac death, TV-MI or TLR. SCB-based PCI was associated with more favourable outcomes in patients with chronic kidney disease ( p for interaction = 0.042) and long lesions ( p for interaction = 0.003), whereas DES-only PCI performed better in those with short lesions. Conclusions In diabetic patients undergoing PCI for de novo CAD, an SCB-based strategy was associated with comparable 2-year outcomes to DES-only PCI, with signals of potential benefit in the highest clinical and anatomical risk subsets. Graphical abstract Abbreviations: ACS, acute coronary syndrome; ASTUTE, Amphilimus Italian multicentre registry; BP, biodegradable-polymer; CCS, chronic coronary syndrome; CKD, chronic kidney disease; DES, drug-eluting stent; EASTBOURNE, All-Comers Sirolimus-Coated Balloon European Registry; HR, hazard ratio; IDDM, insulin-dependent diabetes mellitus; PCI, percutaneous coronary intervention; PF, polymer-free; RUDI-FREE, Polymer-free biolimus-eluting stent implantation in all-comers population; SCB, sirolimus-coated balloon; TLF, target lesion failure; TLR, target lesion revascularization; TVF, target vessel failure; TV-MI, target vessel myocardial infarction; ULISSE, ULtimaster Italian multicenter all comerS Stent rEgistry.

BackgroundAcute kidney injury (AKI) often complicates percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG). However, evidence on the incidence and prognostic impact of AKI after revascularisation for left main coronary artery disease (LMCAD) is scant, especially in terms of subsequent risk of persistent renal dysfunction (RD).MethodsAll consecutive patients undergoing PCI or CABG for LMCAD in two European institutions from 2015 to 2022 were enrolled. The coprimary endpoints were AKI, defined as an increase in serum creatinine (sCr) levels ≥0.3 mg/dL or increase by >50% as compared with baseline levels, and persistent RD, defined as a persistent increase of sCr at 1 year. The secondary endpoint was all-cause mortality. The risk of AKI with PCI versus CABG was assessed with multivariable logistic regression and inverse probability of treatment weighting (IPTW). The prognostic impact of transient and persistent RD at 1 year was evaluated with Cox regression analysis.Results1047 patients were included (PCI: 617, CABG: 430). Patients undergoing PCI were older, more often male and affected by chronic kidney disease. AKI occurred in 17% and 28% of patients after PCI and CABG, respectively (adjusted OR 2.82; 95% CI 1.89 to 4.21). Consistent findings were observed after IPTW. AKI was associated with increased 1-year risk of all-cause death, irrespective of revascularisation strategy, but only persistent RD (HR 9.56; 95% CI 4.06 to 22.53) worsened patients’ prognosis, unlike AKI with only transient RD (HR 0.65; 95% CI 0.08 to 5.04).ConclusionsAKI is common after LMCAD revascularisation and occurred more frequently following CABG than PCI. AKI has a substantial prognostic impact irrespective of revascularisation modality, but only when resulting in persistent RD.

Patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) are at increased risk for thrombotic and bleeding complications compared to patients with chronic coronary syndrome (CCS). The academic research consortium (ARC) recently suggested a set of criteria to identify patients at high bleeding risk (HBR). We sought to evaluate the performance of the ARC-HBR criteria among patients undergoing PCI according to clinical presentation. We included all consecutive patients undergoing PCI at a tertiary-care center. Patients were deemed at HBR if they fulfilled ≥ 1 major or ≥ 2 minor ARC-HBR criteria. The primary bleeding endpoint was a composite of in-hospital or post-discharge bleeding at 1-year follow-up. Secondary outcomes included all-cause death and myocardial infarction. Out of 6068 patients, 1391 (22.9 %) presented with AMI and were more often at HBR than those with CCS (46.9 % vs. 43.0 %, p = 0.01). HBR patients had a higher risk for the primary bleeding endpoint than non-HBR, irrespective of the clinical indication for PCI (AMI: 19.5 % vs. 5.5 %; HR 3.86, 95 % CI 2.63–5.69; CCS: 6.8 % vs. 2.6 %; HR 2.65, 95 % CI 1.92–3.68; p-interaction = 0.11). Secondary outcomes followed a similar trend. After multivariable adjustment, AMI presentation remained significantly associated with increased risk for bleeding at 1 year (HR 1.64, 95 % CI 1.13–2.38, p = 0.01). The ARC-HBR criterion associated with the highest bleeding risk was severe/end-stage chronic kidney disease in AMI and moderate/severe anemia in CCS. The ARC-HBR framework successfully identified AMI and CCS patients with increased risk for bleeding complications at 1 year post-PCI.

Aims Aortic stenosis (AS) and cardiac amyloidosis (CA) are typical diseases of the elderly. Up to 16% of older adults with severe AS referred to transcatheter aortic valve replacement (TAVR) have a concomitant diagnosis of CA. CA‐AS population suffers from reduced functional capacity and worse prognosis than AS patients. As the prognostic impact of TAVR in patients with CA‐AS has been historically questioned and in light of recently published evidence, we aim to provide a comprehensive synthesis of the efficacy and safety of TAVR in CA‐AS patients. Methods and results We performed a systematic review and meta‐analysis of studies: (i) evaluating mortality with TAVR as compared with medical therapy in CA‐AS patients and (ii) reporting complications and clinical outcomes of TAVR in CA‐AS patients as compared with patients with AS alone. A total of seven observational studies were identified: four reported mortality with TAVR, and four reported complications and clinical outcomes after TAVR of patients with CA‐AS compared with AS alone patients. In patients with CA‐AS, the risk of mortality was lower with TAVR (n = 44) as compared with medical therapy (n = 36) [odds ratio (OR) 0.23, 95% confidence interval (CI) 0.07–0.73, I2 = 0%, P = 0.001, number needed to treat = 3]. The safety profile of TAVR seems to be similar in patients with CA‐AS (n = 75) as compared with those with AS alone (n = 536), with comparable risks of stroke, vascular complications, life‐threatening bleeding, acute kidney injury, and 30 day mortality, although CA‐AS was associated with a trend towards an increased risk of permanent pacemaker implantation (OR 1.76, 95% CI 0.91–4.09, I2 = 0%, P = 0.085). CA is associated with a numerically higher rate of long‐term mortality and rehospitalizations following TAVR in patients with CA‐AS as compared with those with AS alone. Conclusions TAVR is an effective and safe procedure in CA‐AS patients, with a substantial survival benefit as compared with medical therapy, and a safety profile comparable with patients with AS alone except for a trend towards higher risk of permanent pacemaker implantation.

BackgroundCardiogenic shock (CS) induced by severe aortic stenosis (AS) is a life-threatening condition with high mortality. Despite advancements in emergency interventions, the optimal treatment approach remains uncertain.AimThis study aimed to systematically review and analyse the existing evidence on outcomes of emergency transcatheter aortic valve implantation (eTAVI) and emergency balloon aortic valvuloplasty (eBAV) in CS patients.MethodsA systematic literature review and meta-analysis was performed. The primary endpoint was mortality at 30 days. Secondary endpoints were in-hospital mortality, 1-year mortality, bleeding, major vascular complications, myocardial infarction, stroke, incidence of pacemaker implantation, acute kidney injury and aortic regurgitation.ResultsSeventeen studies were included, totalling 2811 patients. The analysis revealed a 30-day mortality pooled estimated rate for eTAVI of 19% (CI 0.17 - 0.20) and for eBAV 39% (CI 0.32 - 0.46). In-hospital mortality pooled estimated rates were 11% for eTAVI (CI 0.06 - 0.18) and for eBAV 40% (CI 0.28 - 0.54). One-year mortality pooled estimated rates for eTAVI were 29% (CI 0.20 - 0.40) and for eBAV 67% (CI 0.58 - 0.74). Pooled estimated rates of any bleeding were 12% for eTAVI (CI 0.06 - 0.20) and 15% for eBAV (CI 0.10 - 0.21). The rate of major vascular complications for eTAVI was 8% (CI 0.07 - 0.10) and 3% for eBAV (CI 0.0 - 0.23).ConclusionsThis meta-analysis indicates that mortality in CS due to AS remains high despite emergency interventional treatment. These findings offer critical insights for clinical decision-making optimising patient care in this critically ill population.

Tricuspid regurgitation (TR) has a considerable prevalence in the overall population, that further increases in selected categories of patients. Three morphologic types of TR prevail, namely primary, secondary and atrial TR, mostly, but not always, occurring in different subsets of patients. Recent evidences demonstrate a negative impact of TR on outcomes, irrespective of etiology and even when less than severe in grading. Unfortunately, current surgical standards are void of strong prospective evidence of positive impact on clinical outcomes. While on one hand recent advances in diagnosis and risk stratification of patients with TR are shedding light onto the population that may benefit from intervention and its appropriate timing, on the other hand the arrival on stage of percutaneous treatment options is widening even more the therapeutic options for such population. In this review we will address and discuss the available evidence on the prognostic impact of TR in different clinical contexts encountered in practice.