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Nickel is one of the most common contact allergens worldwide; it is used as the main component of the devices used for atrial septal defects (ASDs) and patent foramen ovale (PFO) closure. Developing nickel hypersensitivity after PFO/ASD occlusion is significantly rarer described in medical literature than typical nickel contact sensitization. The exact pathophysiological mechanism of this "device syndrome" remains unknown, and many question the real incidence or even the existence of this clinical entity. Nevertheless, it has been associated with a wide spectrum of symptoms, including chest pain, migraines, palpitation, and dyspnea. Skin patch tests are the first-line approach to diagnose nickel hypersensitivity. However, diagnostic criteria for the device syndrome have not been developed, and diagnosis in reported cases is established by a process of elimination. Management-drug therapy (corticosteroids, clopidogrel, etc.) or even surgical explantation in severe cases-of patients developing such clinical manifestations after percutaneous PFO/ASD occlusion is empirical. Undoubtedly, endocardiac device-related nickel hypersensitivity requires more focused research to discover the underlying mechanism as well as to develop reliable prognostic tests for detecting high-risk patients and preventing severe nickel hypersensitivity reactions.

The role of adipose tissue (AT) in arterial inflammation in familial dyslipidaemias is poorly studied. We investigated the relationship between AT and arterial inflammation in patients with heterozygous familial hypercholesterolemia (heFH) and familial combined hyperlipidemia (FCH). A total of 40 patients (20 heFH/20 FCH) and a subgroup of 20 of non-heFH/FCH patients were enrolled. Participants underwent blood sampling for serum adipokine measurements and Fluorine-18 fluorodeoxyglucose (18F-FDG) PET/CT imaging. Abdominal visceral (VAT) and subcutaneous (SAT) AT volumes and AT and abdominal aorta 18F-FDG uptake were quantified. FCH patients had increased VAT (pANOVA = 0.004) and SAT volumes (pANOVA = 0.003), lower VAT metabolic activity (pANOVA = 0.0047), and lower adiponectin levels (pANOVA = 0.007) compared to heFH or the control group. Log(Serum adiponectin) levels were correlated with aortic TBR (b = − 0.118, P = 0.038). In mediation analysis, VAT volume was the major determinant of circulating adiponectin, an effect partly mediated via VAT TBR. Clustering of the population of heFH/FCH by VAT volume/TBR and serum adiponectin identified two distinct patient clusters with significant differences in aortic TBR levels (2.11 ± 0.06 vs 1.89 ± 0.05, P= 0.012). VAT phenotype (increased VAT volume and/or high VAT TBR) and hypoadiponectinemia may account for the observed differences in arterial inflammation levels between heFH and FCH patients.

The study of arterial properties in patients with aortic valve stenosis who undergo transcatheter aortic valve implantation (TAVI) remains challenging and results so far seem equivocal. We sought to investigate the acute and long-term effect of TAVI on arterial stiffness and wave reflections.We enrolled 90 patients (mean age 80.2 ± 8.1 years, 50% males) with severe symptomatic aortic stenosis undergoing TAVI. Arterial stiffness was assessed by carotid-femoral and brachial-ankle pulse wave velocity (cfPWV and baPWV). Augmentation index corrected for heart rate (AIx@75), central pressures and subendocardial viability ratio (SEVR) were assessed with arterial tonometry. Measurements were conducted at baseline, after TAVI and at 1 year.Immediately after TAVI there was an increase in arterial stiffness (7.5 ± 1.5 m/s vs 8.4 ± 1.7 m/s, p = .001 for cfPWV and 1773 ± 459 vs 2383 ± 645 cm/s, p .001 for baPWV) that was retained at 1 year (7.5 ± 1.5 m/s vs 8.7 ± 1.7 m/s, p .001 and 1773 ± 459 cm/s vs 2286 ± 575, p .001). Post-TAVI we also observed a decrease in AIx@75 (32.2 ± 12.9% vs 27.9 ± 8.4%, p = .016) that was attenuated 1 year later (32.2 ± 12.9% vs 29.8 ± 9.1%, p = .38), and an increase in SEVR (131.2 ± 30.0% vs 148.4 ± 36.1%, p = .002), which remained improved at 1 year (131.2 ± 30.0% vs 146.0 ± 32.2%, p = .01).After TAVI the arterial system exhibits an increase of stiffness in response to the acute relief of the obstruction, which is retained in the long term.

The ACURATE neo transcatheter aortic valve is a self-expanding device. Several studies have investigated safety and efficacy, but meta-analysis and pooled data are lacking. We aimed to provide a comprehensive systematic review and meta-analysis on the clinical outcomes of transcatheter aortic valve implantation with the ACURATE neo valve. A systematic literature search for eligible records was conducted. The primary endpoint was device success as designated by Valve Academic Research Consortium-2 criteria. The secondary endpoints (time frame: 30 days) were all-cause mortality, stroke, myocardial infarction, need for new permanent pacemaker, major vascular complications, major bleeding, acute kidney injury stage II or III and paravalvular regurgitation grade moderate or severe (II or III). Our search yielded a total of 355 records, 20 of those (n = 5,858 ACURATE neo receivers) were included in our meta-analysis. Device success was achieved in 94.5% (95%CI: 91.4-96.5) of the patients. The 30-day all-cause mortality incidence proportion was 1.8% (95%CI: 1.3-2.4). New pacemaker implantation was required in 7.7% (95%CI: 6.4-9.2) of the patients, stroke occurred in 1.9% (95%CI: 1.6-2.3), myocardial infarction in 0.5% (95%CI: 0.3-0.7), major bleeding in 5.0% (95%CI: 3.9-6.5), major vascular complication in 5.6% (95%CI: 4.0-7.8), acute kidney injury stage ≥2 in 2.5% (95%CI: 1.8-3.4) and paravalvular leak grade ≥moderate was observed in 4.3% (95%CI: 3.0-6.2). Balloon predilatation and postdilatation incidence was 93.9% (95%CI: 87.0-97.3) and 43.2% (95%CI: 37.9-48.6) respectively. ACURATE neo appears to be safe and effective in our analysis with high device success incidence, low mortality and low new pacemaker implantations.

Background Significant sinus bradycardia (SB) in the context of sinus node dysfunction (SND) has been associated with neurological symptoms. The objective was to evaluate the effect of permanent pacing on the incidence of syncope in patients with rather mild degrees of SB, unexplained syncope, and “positive” invasive electrophysiologic testing. Methods This was an observational study based on a prospective registry of 122 consecutive mild SB patients (61.90 ± 18.28 years, 61.5% male, 57.88 ± 7.73 bpm) presenting with recurrent unexplained pre and syncope attacks admitted to our hospital for invasive electrophysiology study (EPS). Τhe implantation of a permanent antibradycardia pacemaker (ABP) was offered to all patients according to the results of the EPS. Eighty patients received the ABP, while 42 denied. Results The mean of reported syncope episodes was 2.23 ± 1.29 (or presyncope 2.36 ± 1.20) in the last 12 months before they were referred for a combined EP guided diagnostic and therapeutic approach. Over a mean follow‐up of approximately 4 years (50.39 ± 32.40 months), the primary outcome event (syncope) occurred in 18 of 122 patients (14.8%), 6 of 80 (7.5%) in the ABP group as compared to 12 of 42 (28.6%) in the no pacemaker group (P = .002). Conclusions Among patients with mild degree of SB and a history of unexplained syncope, a set of positivity criteria for the presence of EPS defined SND after differentiating reflex syncope, identifies a subset of patients who will benefit from permanent pacing., Among patients with mild degree of sinus bradycardia and a history of unexplained syncope, a set of positivity criteria for the presence of electrophysiology study defined sinus node dysfunction, identifies a subset of patients who will benefit from permanent pacing.

OBJECTIVES We compared the long-term outcomes of percutaneous coronary intervention with second-generation drug-eluting stents (PCI-DES) and coronary artery bypass graft surgery (CABG) with the left internal mammary artery in stable angina patients with isolated single-vessel proximal left anterior descending artery (pLAD) disease. BACKGROUND Long-term outcomes of second-generation PCI-DES and CABG in isolated pLAD lesions have not been extensively studied. METHODS We included 631 PCI-DES patients and 379 CABG patients. Unadjusted and adjusted hazard ratios (HRs) were derived for major adverse cardiac events (MACEs), their components (cardiac death, nonfatal myocardial infarction [MI] not attributed to a non-target vessel, target-lesion revascularization), and patient-related outcome (PRO, composed of all-cause mortality, any MI, any revascularization). RESULTS In the unadjusted and adjusted analyses, no significant difference was observed between the two groups at follow-up (mean:4.6 ± 2.5 years) for MACEs (HR: 1.45, 95% CI: 0.92-2.28, p = .11; HR:1.43, 95% CI: 0.91-2.26, p = .13), PRO (HR: 1.18, 95%CI: 0.86-1.61, p = .30; HR: 1.18, 95% CI: 0.86-1.62, p = .31), cardiac death (HR: 0.97, 95% CI: 0.46-2.05, p = .93; HR: 0.79, 95% CI: 0.36-1.72, p = .56) and MI (HR: 1.43, 95% CI: 0.49-4.13, p = .51; HR: 1.57, 95% CI: 0.53-4.64, p = .42). Compared with CABG, PCI-DES had a borderline significantly greater risk of repeat revascularization (HR: 1.99, 95% CI: 1.00-3.94, p = .05; HR: 1.95, 95% CI: 0.98-3.9, p = .06). Angina recurred more often after PCI (p

The risk of cardiovascular (CV) disease is increased among patients with systemic autoimmune rheumatic diseases and remains an underserved area of medical need. Although traditional risk factors for CV disease, such as hypertension, smoking, dyslipidemia and obesity contribute to endothelial dysfunction in rheumatoid arthritis (RA), they are not enough on their own to explain the observed excess CV risk. Rather, systemic inflammation seems to play a pivotal role in both disease states. Considering the inflammatory process in autoimmune diseases, scientific interest has focused on recently introduced biologic disease-modifying agents (bDMARDS) such as inhibitors of Tumor Necrosis Factor- α (ΤΝF-α), Interleukins -1 (IL-1) and -6 (IL-6). Despite the widespread use of bDMARDS in RA and other chronic autoimmune inflammatory diseases, their precise impact on CV disease and outcome remains to be elucidated, while prospective randomized control trials assessing their impact on hard CV endpoints are scarce. In this review, we summarize current knowledge concerning the effect of bDMARDs on CV outcome and on the risk of developing CV disease in patients with systemic autoimmune rheumatic diseases.

Purpose In the current case series, we present our experience with the self-expanding CoreValve or Evolut R (Medtronic Inc.) in patients with severe symptomatic aortic valve stenosis and concomitant mitral valve prosthesis. Methods Twelve patients with previous mitral valve prosthesis underwent transcatheter aortic valve replacement for severe symptomatic aortic valve stenosis and/or aortic valve regurgitation. All patients underwent evaluation with an echocardiogram, computed tomography and coronary angiogram. After the index intervention and before discharge all patients underwent transthoracic echocardiography. All outcomes were defined according to the Valve Academic Research Consortium-2 criteria. Results Eleven patients underwent transcatheter aortic valve replacement for severe symptomatic aortic valve stenosis and one patient for severe aortic valve regurgitation. There was immediate improvement of patients' hemodynamic status; no cases of procedural death, stroke, myocardial infarction, or urgent cardiac surgery occurred. There was no 30-day mortality and all patients improved, with 91.6% in functional New York Heart Association class I-II. Conclusion The current study demonstrates that in patients with severe aortic valve stenosis or regurgitation and mitral valve prosthesis, the implantation of a self-expanding aortic valve via the transfemoral route is safe and feasible, with maintained long-term results.

We describe a case of trans-femoral trans-catheter aortic valve implantation (TF-TAVI) wherein the use of a novel collagen plug-based device (i.e. Manta© device) was very successful in arterial 16 French sheath hemostasis despite an extremely hostile peripheral vessel anatomy due to calcification.

Introduction Transcatheter aortic valve implantation is the treatment of choice in a consistently expanding group of patients with severe aortic valve stenosis. Tricuspid and mitral annular dilatation with consequent valvular regurgitation are associated with adverse outcome. Computed tomography angiography (CTA) is routinely performed for preprocedural evaluation of vascular access and prosthesis sizing. Purpose To evaluate the impact of mitral and tricuspid annular dimensions in preprocedural CTA on prognosis of patients undergoing TAVI with a self-expanding valve. Methods CTAs of consecutive patients undergoing TAVI in a single high-volume center between 2016 and 2019 were retrospectively evaluated. Maximal septolateral tricuspid annular diameters (TAD) and mitral annular diameters (MAD) were obtained and measured from properly angulated three dimensional CTA datasets. Moreover, maximal pulmonary artery diameter perpendicular to the long axis was measured in every patient. Patients were followed up by clinical visits or telephone contacts. As clinical events were defined all-cause mortality, stroke and heart failure hospitalization. Results In total 123 patients were included in the study. The mean follow-up duration was 875±383 days and 21 clinical events were recorded. There was a moderate but statistical significant correlation between TAD and both pulmonary artery diameter (r=0.39, p Conclusions TAD and MAD were associated with heart failure rehospitalization and clinical events respectively in patients undergoing TAVI with a self-expanding valve. Further larger prospective studies are warranted to evaluate the prognostic value of these CTA markers. Funding Acknowledgement Type of funding sources: None.

Aims Paravalvular leak (PVL) remains a frequent complication after transcatheter aortic valve implantation (TAVI) and seems to affect short- and long-term survival. Purpose The aim of this study was: 1) to identify anatomical predictors of PVL after TAVI and 2) assess the impact of PVL on cumulative survival. Methods and results Patients with severe and symptomatic aortic stenosis [effective orifice area (EOA) ≤1cm2] referred for TAVI at our institution were consecutively enrolled. Prospectively collected demographic, laboratory and echocardiographic data were retrospectively analyzed. Patients were stratified into two groups according to the presence of PVL after TAVI and were followed up postoperatively with clinical and echocardiographic assessment. Primary clinical endpoint was all-cause mortality, as defined by the criteria proposed by the Valve Academic Research Consortium 2. In total, 291 patients were included (male: 50.2%, mean age: 80±7.6 years) in our study. Of these, 165 (56,8%) presented at least mild PVL after TAVI (mild: 85,5%, moderate: 13.3% and severe: 1.2%). The median follow-up period was 27.3 [min. 0, max 113 months. Two patients with severe PVL were excluded from the analysis. In the follow up period, there was no significant difference regarding all-cause mortality between patients with and those without PVL after TAVI, independently from the degree of PVL (log rank: 0.991 - Figure 1). Severe aortic annulus calcification, the presence of a bicuspid aortic valve and aortic root angulation, as assessed by computed tomography (CT), were found to associate with PVL after TAVI in univariate analysis. In the multivariate analysis, severe aortic annulus calcification was found to be the only independent predictor of mild or moderate PVL after TAVI [Exp(B): 1.540, 95% Confidence Interval: 1.067–2.224, B=0.432, p=0.021]. Conclusion The presence of mild or moderate PVL after TAVI was not found to affect cumulative survival in the 27 months of follow up period. Severe annulus calcification assessed by CT-scan, was found to be the only independent predictor of PVL after TAVI. Funding Acknowledgement Type of funding sources: None.

Background/Introduction Arterial stiffness and aortic hemodynamics are independent predictors of adverse cardiovascular events. Indications for transcatheter aortic valve implantation (TAVI) are expanding and aortic valve calcifications (AVC) are an important prognostic factor of the success of TAVI. Purpose We sought to investigate the associations between AVC and aortic vascular function/hemodynamics. Methods Fifty-two high-risk patients (mean age 80.4±8.5 years, 27 male) with severe symptomatic aortic stenosis undergoing TAVI were included. Arterial stiffness was estimated through carotid-femoral pulse wave velocity (cfPWV) and brachial-ankle pulse wave velocity (baPWV). Aortic hemodynamics (aortic pressures, aortic augmentation index corrected for heart rate [AIx@75]) were also measured. Measurements were conducted prior to the implantation and at discharge. In all patients, a native and contrast-enhanced multislice cardiac computed tomography were performed pre-interventionally. AVC were then graded semi-quantitatively as follows: grade 1 – no calcification; grade 2 – mildly calcified (small isolated spots); grade 3 – moderately calcified (multiple larger spots); grade 4 – severely calcified (extensive calcification of all cusps). Results Group 1 (subjects with none/mild AVC, n=29) did not significantly differ in age, gender and body-mass index compared to group 2 (subjects with moderate/severe AVC, n=23). As far as the traditional cardiovascular risk factors were concerned, only hypertension (p=0.008), coronary artery disease (p=0.016), atrial fibrillation (p=0.075) and insulin-dependent diabetes mellitus (p=0.068) were found to be more prevalent in group 2. Group 2 had significantly higher both cfPWV and baPWV (8.3±1.7 vs 7.2±1.2 m/s and 1750±484 cm/s vs. 2101±590 cm/s with p=0.008 and p=0.022 respectively) compared to Group 1 (Figure 1). Even after adjustment for age, gender and systolic blood pressure, aortic stiffness indices were higher in Group 2 compared to Group 1 (p=0.038 and p=0.048, respectively). There was no statistically significant difference in peripheral or aortic pressures as well as in wave reflections indices between the two groups. Conclusion Our study shows that in patients with aortic valve stenosis there is a correlation between increased aortic stiffness and a greater extent of damage of aortic valvular leaflets as well as calcifications. Funding Acknowledgement Type of funding sources: None. Figure 1. PWV and aortic valve calcifications

Background: Microwave radiometry (MWR) assesses non-invasive carotid artery temperatures reflecting inflammation. In the present study, we aimed to investigate the impact of hypolipidemic therapy either with simvastatin or with combination simvastatin plus ezetimibe on carotid artery temperatures of patients with familial hyperlipidemia syndromes (FHS). Methods: Consecutive patients with diagnosis of either familial heterozygous hypercholesterolemia (heFH) or familial combined hyperlipidemia (FCH) were included in the study. Patients were assigned to either simvastatin 40 mg or simvastatin 40 mg plus ezetimibe 10 mg, according to the discretion of the physician. FHS patients who refused statin therapy were used as a control group. Common carotid intima-media thickness (ccIMT) was measured and ΔΤ (maximum-minimum) temperature measurements were performed across each carotid during MWR evaluation. RESULTS: In total, 115 patients were included in the study. Of them, 40 patients received simvastatin (19 heFH and 21 FCH), 41 simvastatin + ezetimibe (31 heFH and 10 FCH), and 34 (21 heFH and 13 FCH) no statin. Carotid artery temperatures were significantly reduced at 6 months in FH patients who received hypolipidemic treatment (0.83 ± 0.34 versus 0.63 ± 0.24 °C, p = 0.004 for simvastatin, 1.00 ± 0.38 versus 0.69 ± 0.23 °C, p &lt, 0.001 for simvastatin + ezetimibe), but no change was recorded in controls (0.72 ± 0.26 versus 0.70 ± 0.26 °C, p = 0.86). Conclusions: Hypolipidemic therapy reduced carotid temperatures in FHS patients.

Background Many patients undergoing transcatheter aortic valve implantation (TAVI) have concomitant mitral regurgitation (MR) of moderate grade or more. The impact of coexistent tricuspid regurgitation (TR) remains to be determined. Methods Patients with severe and symptomatic aortic stenosis [effective orifice area (EOA)≤1cm2] referred for TAVI at our institution were consecutively enrolled. Prospectively collected demographic, laboratory and echocardiographic data were retrospectively analysed. Patients were divided into 4 groups according to MR and TR severity pre-procedurally: no/mild MR and TR, moderate/severe MR, moderate/severe TR, moderate/severe MR and TR. Primary clinical endpoint was all-cause mortality, as defined by the criteria proposed by the Valve Academic Research Consortium2. Results A total of 244 consecutive patients were enrolled in the study: 148 (60.7%) patients no/mild MR and TR, 32 (13.1%) moderate/severe MR, 35 (14.3%) moderate/severe TR, 29 (11.9%) moderate/severe MR and TR pre-procedurally. There was significant difference in pre-procedural pulmonary artery systolic pressure (PASP) among groups (no/mild MR and TR: 40.8±10 mmHg, moderate/severe MR: 46.6±11.2 mmHg, moderate/severe TR: 49.9±13mmHg, moderate/severe MR and TR: 59.8±15.2mmHg, p Conclusion The presence of concomitant moderate or severe mitral and tricuspid valve regurgitation was associated with the higher mortality. This suggests that a thorough evaluation of the mechanisms underlying concomitant mitral and tricuspid valve regurgitation should be performed to determine the best strategy for avoiding TAVI-related futility. Funding Acknowledgement Type of funding sources: None.

Introduction: Ideal management of concomitant carotid and coronary artery occlusive disease remains under investigation. Although researchers have advocated the potential benefits of varying treatment strategies based on either concomitant or staged surgical treatment, there is no consensus in treatment guidelines. With emerging data suggesting favorable outcome of carotid artery stenting (CAS) compared to carotid endarterectomy (CEA) in patients with critical coronary artery disease, physicians must consider these diverging therapeutic options. Areas covered: This review presents current evidence regarding the prevalence of carotid stenosis in patients with coronary artery disease, the common pathophysiologic links with an emphasis on the diverse mechanisms of stroke in the coronary artery bypass grafting (CABG) setting and discusses the contemporary registries and observational studies comparing outcomes of various revascularization strategies in high-risk patients. Authors conducted a literature search in two bibliographic databases including papers published from 1983 until 2018 (PubMed, Scopus). Expert opinion: Symptoms should drive the need to intervene on carotid stenosis in patients undergoing coronary revascularization. Carotid artery stenting has gained significant ground, especially among those individuals considered of high surgical risk. PCI may be considered as an alternative option for the management of severe concurrent coronary disease.

Aortic valve stenosis is one of the most common valvular heart disorders and the prevalence will rise as the population ages. Once symptomatic patients with aortic valve stenosis tend to fare worse with high mortality rates. Aortic valve replacement is indicated in these patients and besides the standard surgical replacement, a less invasive approach, transcatheter aortic valve implantation, has gained momentum and has showed promising and solid results in patients with high surgical risk. An important aspect of evaluating patients with aortic valve stenosis is the ability to choose the best possible candidate for the procedure. In addition, predicting the short and long-term clinical outcomes after the valve replacement could offer the treating physicians a better insight and provide information for optimal therapy. Biomarkers are biological parameters that can be objectively measured and evaluated as indicators of normal biological processes and are easily monitored. The aim of this review is to critically assess some of the most widely used biomarkers at present (natriuretic peptides, troponins, C-reactive protein) and provide an insight in novel biomarkers that are currently being investigated (galectin-3, growth differentiation factor-15, microRNAs) for possible diagnostic and prognostic use in aortic valve stenosis and transcatheter aortic valve implantation respectively.