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Background/Objectives : To date, data regarding the characteristics and management of obstructive, stable coronary artery disease (CAD) encountered in patients undergoing transcatheter aortic valve implantation (TAVI) are sparse. The aim of the study was to analyze granular details, treatment, and outcomes of patients undergoing TAVI with obstructive, stable CAD from real-world practice. Methods : REVASC-TAVI (Management of myocardial REVASCularization in patients undergoing Transcatheter Aortic Valve Implantation with coronary artery disease) is an investigator-initiated, multicenter registry, which collected data from patients undergoing TAVI with obstructive stable CAD found during the pre-TAVI work-up. Results : A total of 2025 patients from 30 centers worldwide with complete follow-up were included in the registry. Most patients had single-vessel CAD (56.1%). An involvement of proximal coronary tracts was detected in 62.5% of cases, with 12.0% of patients having CAD in left main (LM). Most patients received percutaneous coronary intervention (PCI) (n = 1617, 79.9%), especially those with proximal CAD (90.4%). At 2 years, the rates of all-cause death [Kaplan-Meier (KM) estimates 20.1% vs. 18.8%, p log-rank = 0.86] and of the composite of all-cause death, stroke, myocardial infarction, and rehospitalization for heart failure (KM estimates 29.7% vs. 27.5%, p log-rank = 0.82) did not differ between patients undergoing PCI and those who were not. Conclusions : Patients undergoing TAVI with obstructive CAD more commonly had a single-vessel disease and an involvement of proximal coronary tracts. They were commonly treated with PCI, with similar outcomes compared to those treated conservatively., Competing Interests: Thomas Pilgrim received research grants to the institution from Biotronik, Boston Scientific, and Edwards Lifesciences; and speaker/consultancy fees from Medtronic, Boston Scientific, Biotronik, and HighLifeSAS. Ole De Backer received institutional research grants and/or consulting fees from Abbott and Boston Scientific. Lars Sondergaard received consultant fees and/or institutional research grants from Abbott, Boston Scientific, Medtronic, and SMT. Maurizio Taramasso is a consultant for Abbott, Edwards Lifesciences, Boston Scientific, Shenqi Medical, CoreMedic, MEDIRA, 4tech, Simulands, Occlufit, and MTEX. Corrado Tamburino is a consultant for Medtronic. All other authors have nothing to disclose.

Background: Despite the use of two crossed Perclose ProGlide™ (Abbott Vascular Devices) is the most widespread technique to close the main arterial access in transfemoral transcatheter aortic valve implantation (TF-TAVI), the safest and most effective strategy still remains much debated., Aims: The aim of the present study was to evaluate the performance of a single Perclose ProGlide suture-mediated closure device to obtain femoral hemostasis after sheathless implantation of self-expanding transcatheter heart valves through their 14 F-equivalent fix delivery systems., Methods: This prospective observational study included 439 patients undergoing TF-TAVI at the "Montevergine" Clinic of Mercogliano, Italy. All patients underwent hemostasis of the large-bore access using a single Perclose ProGlide with preclose technique, after sheathless implantation of self-expanding transcatheter heart valves through 14 F-equivalent fix delivery systems. A multidetector computed tomography analysis of size, tortuosity, atherosclerotic, and calcification burdens of the ilio-femoral access route was made by a dedicated corelab. Vascular complications (VCs), percutaneous closure device (PCD) failure, and bleedings were adjudicated by a clinical events committee., Results: A total of 81 different VCs were observed in 60 patients (13.7%); among these, 41 (5% of patients) were categorized as major. PCD failure occurred in 14 patients (3.2%). At the logistic regression analysis, no predictors of PCD failure have been identified., Conclusion: This registry suggests that the use of a single suture-mediated closure device could be considered a safe and efficient technique to achieve access site hemostasis in patients undergoing TF-TAVI through 14 F-equivalent fix delivery systems., (© 2024 Wiley Periodicals LLC.)

One of the most common complications of tricuspid valve replacement is atrioventricular block (AVB), often requiring permanent pacing. The endocardial pacemaker lead, placed in the right ventricle, may sometimes interfere with the implanted prosthesis, causing its early dysfunction and the need for alternative sites of pacing. To the best of our knowledge, we present the first case of a successful combined percutaneous procedure consisting of the implantation of two leads in the coronary sinus for univentricular bifocal pacing and a transcatheter tricuspid valve-in-valve implantation in a young patient with severe dysfunction of the tricuspid bioprosthesis, requiring permanent pacing for a postsurgical complete atrioventricular block.

Background and Aim: Our aim was to evaluate the fluoroscopy time (FT), procedure time (PT) safety and efficacy when using intracardiac echocardiography (ICE) in comparison to transesophageal echocardiography (TEE) guidance for transcatheter closure of Ostium Secundum Atrial Septal Defect (OS-ASD)., Method: Ninety patients (n = 90) diagnosed with OS-ASD underwent transcatheter closure between March 2006 and October 2021. Fifty-seven patients were treated under ICE guidance, while 33 patients were treated under TEE guidance., Results: Mean age was 43 ± 15 years and 42 ± 10 years in the ICE and TEE groups, respectively. The majority of patients had a centrally placed defect. Median FT was 8.40 min versus 11.70 min (p < .001) in the ICE group compared to the TEE group, respectively. Median PT was 43 min versus 94 min (p < .001) in the ICE group compared to the TEE group, respectively. Both ICE and TEE provided high quality images. All interventions were completed successfully, except for one patient in the ICE group who experienced a device migration, the development of atrial tachycardia in one patient and atrial fibrillation in two patients in the ICE group which spontaneously cardioverted. There were no other complications., Conclusion: This study on a consistent cohort of patients with OS-ASD undergoing percutaneous closure suggests that use of ICE is safe and efficacious. Compared to TEE, ICE demonstrated significantly shorter FT and PT, decreasing the entire duration of the procedure and x-ray exposure. No relevant differences were observed in terms of success rate and complications., (© 2023 Wiley Periodicals LLC.)

Background: Transcatheter aortic valve replacement (TAVR) is an almost totally cine-fluoroscopic guided procedure. The amount of radiation used during the procedure is strictly related to the fluoroscopy time (FT), that has already been demonstrated to be associated with outcomes and complexity of coronary procedures. The aim of our study is to demonstrate the relationship between FT and the short-term outcomes after TAVR defined by to the Valve Academic Research Consortium (VARC)-2 and -3 consensus documents., Methods: After splitting 1797 consecutive patients into tertiles of FT, the composite endpoint early safety (ES) was adjudicated according to VARC-2 and VARC-3 definitions, whereas the composite endpoints device success (DS) and technical success (TS) according to VARC-3 criteria., Results: The absence of all these outcomes (VARC-2 ES amd VARC-3 TS, DS, and ES) was significantly associated with longer FT: this association was independent from both intraprocedural complications and other intraprocedural factors linked to longer FT, and still persisted after propensity score matching analysis. Notwithstanding, after receiver operating characteristic analysis, FT had adequate diagnostic accuracy in identifying the absence of only VARC-3 TS and VARC-2 ES., Conclusion: Longer FT is related with periprocedural and short-term outcomes after the procedure, especially in those that are more challenging. A FT duration of more than 30 min has an adequate accuracy in identifying VARC-3 technical failure (TS and DS) and absence of VARC-2 ES, selecting patients who are likely to take advantage from more careful in-hospital follow-up.

Background: Surgical mortality risk scores, even if not properly designed and rarely tested in the transcatheter aortic valve implantation (TAVI) setting, still guide the heart team in managing significant aortic stenosis., Methods: After splitting 1763 consecutive patients retrospectively based on their mortality risk thresholds, the composite endpoint early safety (ES) was adjudicated according to Valve Academic Research Consortium (VARC)-2 and -3 consensus documents., Results: ES incidence was higher if VARC-2 rather than VARC-3 defined. Despite only patients showing VARC-2 ES had significantly lower absolute values of all three main risk scores, these last still failed to foresee both VARC-2 and -3 ES in intermediate-risk patients. The receiver operating characteristic analysis also showed a significant correlation, but with poor diagnostic accuracy, among the three scores and only VARC-2 ES; moreover, the absence of VARC-2 ES and low-osmolar contrast media administration were identified as independent predictors of 1-year mortality and absence of VARC-3 ES, respectively. Finally, even a single complication included in the ES definition could significantly affect 1-year mortality., Conclusion: Currently, the most used mortality risk scores do not have adequate diagnostic accuracy in predicting ES after TAVI. The absence of VARC-2, instead of VARC-3, ES is an independent predictor of 1-year mortality.

Background: The best management of stable coronary artery disease (CAD) in patients undergoing transcatheter aortic valve implantation (TAVI) is still unclear due to the marked inconsistency of the available evidence., Methods: The REVASC-TAVI registry (Management of Myocardial Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation With Coronary Artery Disease) collected data from 30 centers worldwide on patients undergoing TAVI who had significant, stable CAD at preprocedural work-up. For the purposes of this analysis, patients with either complete or incomplete myocardial revascularization were compared in a propensity score matched analysis, to take into account of baseline confounders. The primary and co-primary outcomes were all-cause death and the composite of all-cause death, stroke, myocardial infarction, and rehospitalization for heart failure, respectively, at 2 years., Results: Among 2407 patients enrolled, 675 pairs of patients achieving complete or incomplete myocardial revascularization were matched. The primary (21.6% versus 18.2%, hazard ratio' 0.88 [95% CI, 0.66-1.18]; P =0.38) and co-primary composite (29.0% versus 27.1%, hazard ratio' 0.97 [95% CI, 0.76-1.24]; P =0.83) outcome did not differ between patients achieving complete or incomplete myocardial revascularization, respectively. These results were consistent across different prespecified subgroups of patients (< or >75 years of age, Society of Thoracic Surgeons score > or <4%, angina at baseline, diabetes, left ventricular ejection fraction > or <40%, New York Heart Association class I/II or III/IV, renal failure, proximal CAD, multivessel CAD, and left main/proximal anterior descending artery CAD; all P values for interaction >0.10)., Conclusions: The present analysis of the REVASC-TAVI registry showed that, among TAVI patients with significant stable CAD found during the TAVI work-up, completeness of myocardial revascularization achieved either staged or concomitantly with TAVI was similar to a strategy of incomplete revascularization in reducing the risk of all cause death, as well as the risk of death, stroke, myocardial infarction, and rehospitalization for heart failure at 2 years, regardless of the clinical and anatomical situations.

Background: Surgical aortic valve replacement with a rapid deployment valve (RDV) is a relatively recent treatment option. The aim of this study was to compare the hemodynamic performance of balloon-expandable (BE)-RDVs and BE-transcatheter heart valves (THVs) in a high surgical risk and frail-elderly population., Methods: BE-THVs and BE-RDVs were implanted in 138 and 47 patients, respectively, all older than 75 years and with a Canadian Study of Health and Aging category of 5 or above. Echocardiographic assessment was performed at discharge and six months later., Results: At discharge, transprosthetic pressure gradients and indexed effective orifice area (iEOA) were similar in both cohorts. At six-month follow-up, BE-RDVs showed lower peak (14.69 vs. 20.86 mmHg; p < 0.001) and mean (7.82 vs. 11.83 mmHg; p < 0.001) gradients, and larger iEOA (1.05 vs. 0.84 cm 2 /m 2 ; p < 0.001). Similar findings were also shown considering only small-sized valves. Moderate-to-severe paravalvular leakage was more prevalent in BE-THVs at discharge (14.49 vs. 0.00%; p = 0.032) and, considering exclusively small prostheses, at six months too (57.69 vs. 15.00%; p = 0.014). Nevertheless, BE-THVs determined amelioration in left ventricular ejection fraction (53.79 vs. 60.14%; p < 0.001), pulmonary artery systolic pressure (35.81 vs. 33.15 mmHg; p = 0.042), and tricuspid regurgitation severity (40.58 vs. 19.57%; p = 0.031), from discharge to mid-term follow-up., Conclusions: BE-RDVs showed better hemodynamic performance, especially when implanted in small annuli. Despite their worse baseline conditions, transcatheter patients still exhibited a greater improvement of their echocardiographic profile at mid-term follow-up., (Copyright © 2022 Hellenic Society of Cardiology. Published by Elsevier B.V. All rights reserved.)

Long-COVID-19 refers to the signs and symptoms that continue or develop after the “acute COVID-19” phase. These patients have an increased risk of multiorgan dysfunction, readmission, and mortality. In Long-COVID-19 patients, it is possible to detect a persistent increase in D-Dimer, NT-ProBNP, and autonomic nervous system dysfunction. To verify the dysautonomia hypothesis in Long-COVID-19 patients, we studied heart rate variability using 12-lead 24-h ECG monitoring in 30 Long-COVID-19 patients and 20 No-COVID patients. Power spectral analysis of heart rate variability was lower in Long-COVID-19 patients both for total power (7.46 ± 0.5 vs. 8.08 ± 0.6; p < 0.0001; Cohens-d = 1.12) and for the VLF (6.84 ± 0.8 vs. 7.66 ± 0.6; p < 0.0001; Cohens-d = 1.16) and HF (4.65 ± 0.9 vs. 5.33 ± 0.9; p = 0.015; Cohens-d = 0.76) components. The LF/HF ratio was significantly higher in Long-COVID-19 patients (1.46 ± 0.27 vs. 1.23 ± 0.13; p = 0.001; Cohens-d = 1.09). On multivariable analysis, Long-COVID-19 is significantly correlated with D-dimer (standardized β-coefficient = 0.259), NT-ProBNP (standardized β-coefficient = 0.281), HF component of spectral analysis (standardized β-coefficient = 0.696), and LF/HF ratio (standardized β-coefficient = 0.820). Dysautonomia may explain the persistent symptoms in Long COVID-19 patients. The persistence of a procoagulative state and an elevated myocardial strain could explain vagal impairment in these patients. In Long-COVID-19 patients, impaired vagal activity, persistent increases of NT-ProBNP, and a prothrombotic state require careful monitoring and appropriate intervention.

Diabetes mellitus (DM) represents an independent risk factor for chronic AF and is associated with unfavorable outcomes. We aimed to evaluate the efficacy and safety of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF), with and without diabetes mellitus (DM), using a new risk index (RI) defined as: RI =Rate&nbsp;of&nbsp;EventsRate&nbsp;of&nbsp;Patients&nbsp;at&nbsp;Risk. In particular, an RI lower than 1 suggests a favorable treatment effect. We searched MEDLINE, MEDLINE In-Process, EMBASE, PubMed, and the Cochrane Central Register of Controlled Trials. The risk index (RI) was calculated in terms of efficacy (rate of stroke/systemic embolism (stroke SEE)/rate of patients with and without DM; rate of cardiovascular death/rate of patients with and without DM) and safety (rate of major bleeding/rate of patients with and without DM) outcomes. AF patients with DM (n = 22,057) and 49,596 without DM were considered from pivotal trials. DM doubles the risk index for stroke/SEE, major bleeding (MB), and cardiovascular (CV) death. The RI for stroke/SEE, MB, and CV death was comparable in patients treated with warfarin or DOACs. The lowest RI was in DM patients treated with Rivaroxaban (stroke/SEE, RI = 0.08; CV death, RI = 0.13). The RIs for bleeding were higher in DM patients treated with Dabigatran (RI110 = 0.32; RI150 = 0.40). Our study is the first to use RI to homogenize the efficacy and safety data reported in the DOACs pivotal studies against warfarin in patients with and without DM. Anticoagulation therapy is effective and safe in DM patients. DOACs appear to have a better efficacy and safety profile than warfarin. The use of DOACs is a reasonable alternative to vitamin-K antagonists in AF patients with DM. The RI can be a reasonable tool to help clinicians choose between DOACs or warfarin in the peculiar set of AF patients with DM.

Background: Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is frequent and associated with adverse outcomes and mortality; to date, in such setting of patients there is no consistent evidence that either low-osmolar contrast media (LOCM) or iso-osmolar contrast medium (IOCM) are superior to the other in terms of renal safety., Methods: 697 consecutive patients not in hemodialysis treatment who underwent TAVI (327 males, mean age 81.01 ± 5.75 years, mean european system for cardiac operative risk evaluation II 6.17 ± 0.23%) were enrolled. According to osmolality of the different iodinated CM, the population was divided in 2 groups: IOCM (n = 370) and LOCM group (n = 327). Preoperatively, 40.54% of patients in IOCM vs 39.14% in LOCM group (p = 0.765) suffered from chronic kidney disease (CKD)., Results: The incidence of AKI was significantly lower with IOCM (9.73%) than with LOCM (15.90%; p = 0.02), and such significant difference (p < 0.001) in postprocedural change of renal function parameters persisted at discharge too. The incidence of AKI was also significantly lower with IOCM in younger patients, without diabetes, anemia, coronary artery disease history, CKD, chronic or persistent atrial fibrillation, left ventricular ejection fraction ≤35%, and in patients with low operative mortality risk scores, receiving lower amounts of dye (p < 0.05 for all). Importantly, multivariate analysis identified LOCM administration as an independent risk factor for both AKI (p = 0.006) and 1-year mortality (p = 0.001)., Conclusions: The use of IOCM have a favorable impact on renal function with respect to LOCM, but it should be considered especially for TAVI patients at lower AKI risk., Competing Interests: Declaration of Competing Interest Gaetano Contegiacomo serves as transcatheter heart valve proctor for Abbott and Meril; the remaining authors have no conflicts of interest to declare., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Inflammatory bowel disease (IBD) is a pathological condition that first involves the gastrointestinal wall but can also trigger a systemic inflammatory state and thus extraintestinal manifestations. Systemic inflammation is probably secondary to the passage of bacterial products into the bloodstream because of altered intestinal permeability and the consequent release of proinflammatory mediators. Inflammation, through several diverse pathophysiological pathways, determines both a procoagulative state and systemic endothelial dysfunction, which are both deemed to be responsible for venous and arterial thromboembolic adverse events. The management of systemic thrombotic complications is particularly challenging in this category of patients, who also present a high bleeding risk; what is more, both bleeding and thrombotic risks peak during the active phases of the disease. The literature suggests that treating physicians have been, so far, more heavily influenced by concerns about bleeding than by the thrombotic risk. Despite the absence of data provided by large cohorts or randomized studies, the high risk of arterial and venous atherothrombosis in patients with IBD seems unquestionable. Moreover, several reports suggest that when arterial thromboembolism involves the coronary vessels, causing acute coronary syndromes, ischemic complications from antithrombotic drug undertreatment are frequent and severe. This review aims to shed light on the tricky balance between the ischemic and hemorrhagic risks of patients with IBD and to highlight how difficult it is for clinicians to define a tailored therapy based on a case-by-case, careful, and unprejudiced clinical evaluation., (© 2020 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

A comprehensive description of baseline characteristics, procedural features and outcomes related to the development of acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is reported in our research paper ( Impact of contrast medium osmolality on the risk of acute kidney injury after transcatheter aortic valve implantation: insights from the Magna Graecia TAVI registry. Int J Cardiol. DOI: 10.1016/j.ijcard.2020.12.049 ). Three Italian heart centers were involved in this multicentric observational study. Between March 2011 and February 2019, a total of 888 patients underwent TAVI; according to the inclusion and exclusion criteria, 697 patients were included in the post-hoc analysis. This Data in Brief paper aims to report demographic, clinical, laboratory, echocardiographic, intraprocedural, periprocedural, postprocedural and follow-up data; all of them were prospectively collected from each patient's health record, whereas the analysis was performed retrospectively. Targets of this data analysis were: 1) to evaluate the impact of contrast medium (CM) osmolality on TAVI-related AKI; 2) to identify the most of risk factors involved in the development of such complication, and consequently in the occurrence of 1-year mortality; 3) to estimate the impact of CM osmolality on AKI in specific patient subgroups., Competing Interests: Gaetano Contegiacomo serves as transcatheter heart valve proctor for Abbott and Meril; the remaining authors have no conflicts of interest to declare. This research received no specific grants from any funding agency in the public, commercial or not-for-profit sectors., (© 2021 The Authors.)

Objective: Approximately 3.4% of adults aged >75 years suffer from aortic stenosis (AS). Guideline indications for aortic valve replacement (AVR) distinguish between patients with symptomatic and asymptomatic severe AS. The present analysis aims to assess contemporary practice in the treatment of severe AS across Europe and identify characteristics associated with treatment decisions, namely denial of AVR in symptomatic patients and assignment of asymptomatic patients to AVR., Methods: Participants of the prospective, multinational IMPULSE database of patients with severe AS were grouped according to AS symptoms, and stratified into subgroups based on assignment to/denial of AVR., Results: Of 1608 symptomatic patients, 23.8% did not undergo AVR and underwent medical treatment. Denial was independently associated with multiple factors, including severe frailty (p=0.024); mitral (p=0.002) or tricuspid (p=0.004) regurgitation grade III/IV, and the presence of renal impairment (p=0.017). Of 392 asymptomatic patients, 86.5% had no prespecified indication for AVR. Regardless, 36.3% were assigned to valve replacement. Those with an indexed aortic valve area (AVA; p=0.045) or left ventricular ejection fraction (LVEF; p<0.001) below the study median; or with a left ventricular end systolic diameter above the study median (p=0.007) were more likely to be assigned to AVR., Conclusions: There may be considerable discrepancies between guideline-based recommendations and clinical practice decision-making in the treatment of AS. It appears that guidelines may not fully capture the complete clinical spectrum of patients with AS. Thus, there is a need to find ways to increase their acceptance and the rate of adoption., Competing Interests: Competing interests: Peter Bramlage received research funding from Edwards Lifesciences, Nyon, Switzerland. Norbert Frey, Rick Steeds and David Messika-Zeitoun have received honoraria for advisory board meetings and Tanja Rudolph speakers’ honoraria from Edwards Lifesciences. The institutions of these three and those of the remaining authors representing study centres have received funding for employing a study nurse., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Aims: There is an increasing awareness of gender-related differences in patients with severe aortic stenosis and their outcomes after surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI)., Methods: Data from the IMPULSE registry were analysed. Patients with severe aortic stenosis (AS) were enrolled between March 2015 and April 2017 and stratified by gender. A subgroup analysis was performed to assess the impact of age., Results: Overall, 2171 patients were enrolled, and 48.0% were female. Women were characterised by a higher rate of renal impairment (31.7 vs 23.3%; p<0.001), were at higher surgical risk (EuroSCORE II: 4.5 vs 3.6%; p=0.001) and more often in a critical preoperative state (7.0vs 4.2%; p=0.003). Men had an increased rate of previous cardiac surgery (9.4 vs 4.7%; p<0.001) and a reduced left ventricular ejection fraction (4.9 vs 1.3%; p<0.001). Concomitant mitral and tricuspid valve disease was substantially more common among women. Symptoms were highly prevalent in both women and men (83.6 vs 77.3%; p<0.001). AVR was planned in 1379 cases. Women were more frequently scheduled to undergo TAVI (49.3 vs 41.0%; p<0.001) and less frequently for SAVR (20.3 vs 27.5%; p<0.001)., Conclusions: The present data show that female patients with severe AS have a distinct patient profile and are managed in a different way to males. Gender-based differences in the management of patients with severe AS need to be taken into account more systematically to improve outcomes, especially for women., Competing Interests: Competing interests: PB is the representative of the IPPMed, Cloppenburg, Germany. NF, RPS and DM-Z have received honoraria for advisory board meetings and TKR speakers’ honoraria from Edwards Lifesciences. The institutions of these three and those of the remaining authors representing study centres have received funding for employing a study nurse. JK and MT are employees of the funder of this registry. As this is a disease registry, neither the type of intervention (SAVR, TAVI or medical management) nor on the valves to be used was pre-specified., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background Despite the availability of guidelines for the performance of transcatheter aortic valve implantation (TAVI), current treatment pathways vary between countries and institutions, which impact on the mean duration of postprocedure hospitalization. Methods and Results This was a prospective, multicenter registry of 502 patients to validate the appropriateness of discharge timing after transfemoral TAVI, using prespecified risk criteria from FAST-TAVI (Feasibility and Safety of Early Discharge After Transfemoral [TF] Transcatheter Aortic Valve Implantation), based on hospital events within 1-year after discharge. The end point-a composite of all-cause mortality, vascular access-related complications, permanent pacemaker implantation, stroke, cardiac rehospitalization, kidney failure, and major bleeding-was reached in 27.0% of patients (95% CI, 23.3-31.2) within 1 year after intervention; 7.5% (95% CI, 5.5-10.2) had in-hospital complications before discharge and 19.6% (95% CI, 16.3-23.4) within 1 year after discharge. Overall mortality within 1 year after discharge was 7.3% and rates of cardiac rehospitalization 13.5%, permanent pacemaker implantation 4.2%, any stroke 1.8%, vascular-access-related complications 0.7%, life-threatening bleeding 0.7%, and kidney failure 0.4%. Composite events within 1 year after discharge were observed in 18.8% and 24.3% of patients with low risk of complications/early (≤3 days) discharge and high risk and discharged late (>3 days) (concordant discharge), respectively. Event rate in patients with discordant discharge was 14.3% with low risk but discharged late and increased to 50.0% in patients with high risk but discharged in ≤3 days. Conclusions The FAST-TAVI risk assessment provides a tool for appropriate, risk-based discharge that was validated with the 1-year event rate after transfemoral TAVI. Registration URL: https://www.ClinicalTrials.gov; Unique identifier: NCT02404467.

Background: Contemporary data regarding the impact of comorbidities on the clinical presentation and management of patients with severe aortic stenosis (AS) are scarce., Methods: Prospective registry of severe patients with AS across 23 centres in nine European countries., Results: Of the 2171 patients, chronic kidney disease (CKD 27.3%), left ventricular ejection fraction (LVEF) <50% (22.0%), atrial fibrillation (15.9%) and chronic obstructive pulmonary disease (11.4%) were the most prevalent comorbidities (49.3% none, 33.9% one and 16.8% ≥2 of these). The decision to perform aortic valve replacement (AVR) was taken in a comparable proportion (67%, 72% and 69%, in patients with 0, 1 and ≥2 comorbidities; p=0.186). However, the decision for TAVI was more common with more comorbidities (35.4%, 54.0% and 57.0% for no, 1 and ≥2; p<0.001), while the decision for surgical AVR (SAVR) was decreased with increasing comorbidity burden (31.9%, 17.4% and 12.3%; p<0.001). The proportion of patients with planned AVRs that were performed within 3 months was significantly higher in patients with 1 or ≥2 comorbidities than in those without (8.7%, 10.0% and 15.7%; p<0.001). Furthermore, the mean time to AVR was significantly shorter in patients with one (30.5 days) or ≥2 comorbidities (30.8 days) than in those without (35.7 days; p=0.012). Patients with reduced LVEF tended to be offered an AVR more frequently and with a shorter delay while patients with CKD were less frequently treated., Conclusions: Comorbidities in severe patients with AS affect the presentation and management of patients with severe AS. TAVI was offered more often than SAVR and performed within a shorter time period., Competing Interests: Competing interests: PB is the representative of the IPPMed, Cloppenburg, Germany. NF, RPS, DM-Z and TKR are consultants to Edwards Lifesciences. The institutions of these three and those of the remaining authors representing study centres have received funding for employing a study nurse., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

We explored the significance of the L-Arginine/asymmetric dimethylarginine (L-Arg/ADMA) ratio as a biomarker of endothelial dysfunction in stroke patients. To this aim, we evaluated the correlation, in terms of severity, between the degree of endothelial dysfunction (by L-Arg/ADMA ratio), the methylene tetrahydrofolate reductase (MTHFR) genotype, and the interatrial septum (IAS) phenotype in subject with a history of stroke. Methods and Results: L-Arg, ADMA, and MTHFR genotypes were evaluated; the IAS phenotype was assessed by transesophageal echocardiography. Patients were grouped according to the severity of IAS defects and the residual enzymatic activity of MTHFR-mutated variants, and values of L-Arg/ADMA ratio were measured in each subgroup. Of 57 patients, 10 had a septum integrum (SI), 38 a patent foramen ovale (PFO), and 9 an ostium secundum (OS). The L-Arg/ADMA ratio differed across septum phenotypes ( p ≤ 0.01), and was higher in SI than in PFO or OS patients ( p ≤ 0.05, p ≤ 0.01, respectively). In the PFO subgroup a negative correlation was found between the L-Arg/ADMA ratio and PFO tunnel length/height ratio ( p ≤ 0.05; r = - 0.37; R 2 = 0.14). Interestingly, the L-Arg/ADMA ratio varied across MTHFR genotypes ( p ≤ 0.0001) and was lower in subgroups carrying the most impaired enzyme with respect to patients carrying the conservative MTHFR ( p ≤ 0.0001, p ≤ 0.05, respectively). Consistently, OS patients carried the most dysfunctional MTHFR genotypes, whereas SI patients the least ones. Conclusions: A low L-Arg/ADMA ratio correlates with impaired activity of MTHFR and with the jeopardized IAS phenotype along a severity spectrum encompassing OS, PFO with long/tight tunnel, PFO with short/large tunnel, and SI. This infers that genetic MTHFR defects may underlie endothelial dysfunction-related IAS abnormalities, and predispose to a cryptogenic stroke. Our findings emphasize the role of the L-Arg/ADMA ratio as a reliable marker of stroke susceptibility in carriers of IAS abnormalities, and suggest its potential use both as a diagnostic tool and as a decision aid for therapy.

Purpose of Review: To summarize epidemiology, pathophysiology, prognostic relevance, and treatment options of coronary artery disease (CAD) when coupled with severe aortic stenosis (SAS). In regard to treatment options, we focused on the most recently adopted therapeutic approaches and on the future perspectives in light of the latest percutaneous and surgical technical improvements in the field of both CAD and SAS management., Recent Findings: Nowadays, SAS is the most common valve disease requiring intervention, either surgical or percutaneous. On the other side, CAD is one of the leading causes of death in the developed countries. CAD and degenerative SAS share several predisposing factors and are often concurrently found in clinical practice. Despite in the last years the transcatheter aortic valve replacement (TAVR) has been deeply changing the therapeutic approach to SAS, the correct management of patients with concomitant CAD remains controversial due to limited and heterogeneous data in the literature. Coronary revascularization is often performed in patients with concomitant CAD and SAS. Complete surgical approach is still the standard of care according to international guidelines. However, in light of the recent results of TAVR trials, the therapeutic approach is expected to change. To date, percutaneous coronary intervention performed before TAVR is safe and feasible even if the optimal timing for revascularization remains debated. Due to the great complexity of the patients affected by SAS and CAD and until unquestionable truths will come from large randomized trials, the role of the Heart Team in the decision-making process is of primary importance to guarantee the best tailored therapeutic strategy for the single patient.

Background and Objective: Sacubitril/valsartan improved the prognosis of patients with heart failure with reduced ejection fraction in the PARADIGM-HF study. Recently, the TRANSITION and PIONEER-HF studies demonstrated the safety and efficacy of sacubitril/valsartan in patients hospitalized for acute decompensated heart failure, with treatment initiated after hemodynamic and clinical stabilization. In this case series study, we assessed the short-term effects of sacubitril/valsartan on exercise capacity, inflammation, and biomarkers in patients with acute decompensated heart failure., Methods: Patients admitted for acute decompensated heart failure to the Department of Internal Medicine of Telese Terme Hospital and Cardiovascular Department, University of Bari, from 9 March, 2017 to 9 June, 2018 were enrolled. Following hemodynamic stabilization, patients initiated sacubitril/valsartan 24/26 mg twice a day for 4 weeks, with up-titration to 49/51 mg twice a day based on tolerability after 1 week. Efficacy outcomes included the 6-min walking test, N-terminal pro-B-type natriuretic peptide, high-sensitivity C-reactive protein, and lymphocyte count. Safety outcomes included renal function, hyperkalemia, and symptomatic hypotension., Results: In total, 40 patients completed the study and 27 (67.5%) patients were up-titrated. Compared with baseline, exercise capacity and relative lymphocyte count increased significantly after 4 weeks of treatment, while N-terminal pro-B-type natriuretic peptide and high-sensitivity C-reactive protein decreased significantly. N-terminal pro-B-type natriuretic peptide and relative lymphocyte count independently predicted the 6-min walking test distance (p = 0.021). No patients experienced any relevant side effects., Conclusions: Early initiation of sacubitril/valsartan in patients with heart failure with reduced ejection fraction after acute decompensated heart failure may be safe and effective in terms of functional capacity and biomarkers.

Cardiogenic shock (CS) is a state of critical end-organ hypoperfusion primarily due to cardiac dysfunction. This condition is the most common cause of death in patients affected by acute myocardial infarction (AMI). Despite early revascularization, prompt optimal medical therapy, and up-to-date mechanical circulatory supports, mortality of patients with CS remains high.The objective of this review is to summarize epidemiology, pathophysiology, and treatment options of CS in light of the new European Society of Cardiology (ESC) recommendations. The latest European guidelines on myocardial revascularization have reviewed the previous guidelines with respect to early multivessel revascularization and routine use of intra-aortic balloon pump (IABP) in patients with AMI-related CS.Most of the current evidences come partly from randomized trials, but mostly from observational registries because of the difficulty to test different treatments in this life-threatening clinical setting.Some of the latest studies highlight the potential crucial benefit of newly introduced mechanical circulatory support devices, although evidences are not sufficient to definitely assess the benefit/risk ratio of the different systems.Many questions remain unanswered in this field, and further trials are advocated to better elucidate the best medical, reperfusion, and circulatory support approaches aimed to improve the poor prognosis of patients with CS after AMI.

Objective: Contemporary data on patients with previously undiagnosed severe aortic stenosis (AS) are scarce. We aimed to address this gap by gathering data from consecutive patients diagnosed with severe AS on echocardiography., Methods: This was a prospective, multicentre, multinational, registry in 23 tertiary care hospitals across 9 European countries. Patients with a diagnosis of severe AS were included using echocardiography (aortic valve area (AVA) <1 cm 2 , indexed AVA <0.6 cm 2 /m 2 , maximum jet-velocity (V max ) >4 m/s and/or mean transvalvular gradient >40 mm Hg)., Results: The 2171 participants had a mean age of 77.9 years and 48.0% were female. The mean AVA was 0.73 cm 2 , V max 4.3 m/s and mean gradient 47.1 mm Hg; 62.1% had left ventricular hypertrophy and 27.3% an ejection fraction (EF) <50%. 1743 patients (80.3%) were symptomatic (shortness-of-breath 91.0%; dizziness 30.2%, chest pain 28.9%). Patients had a EuroSCORE II of 4.0; 25.3% had a creatinine clearance <50 mL/min, and 3.2% had an EF <30%. Symptomatic patients were older and had more comorbidities than asymptomatic patients. Despite European Society of Cardiology 2017 valvular heart disease guideline class I recommendation, in only 76.2% a decision was made for an intervention (transcatheter 50.4%, surgical aortic valve replacement 25.8%). In asymptomatic patients, 57.7% with a class I/IIa indication were scheduled for a procedure, while 36.3% patients without an indication had their valve replaced., Conclusions: The majority of patients with severe AS presented at an advanced disease stage. Management of severe AS remained suboptimal in a significant proportion of contemporary patients with severe AS., Trial Registration Number: NCT02241447;Results., Competing Interests: Competing interests: PB is the representative of the IPPMed. NF, RPS, TKR and DM-Z have received speakers’ honoraria from Edwards Lifesciences. The institutions of these three and those of the remaining authors representing study centers have received funding from the sponsor for employing a study nurse for the duration of the study. IPPMed designed and executed the study, collected and analysed the data and drafted/revised the manuscript in collaboration with the other authors., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Background Many patients with severe aortic stenosis are referred late with advanced symptoms or inappropriately denied intervention. The objective was to investigate whether a structured communication to referring physicians (facilitated data relay) might improve the rate and timeliness of intervention. Methods and Results A prospective registry of consecutive patients with severe aortic stenosis at 23 centers in 9 European countries with transcatheter as well as surgical aortic valve replacement being available was performed. The study included a 3-month documentation of the status quo (phase A), a 6-month intervention phase (implementing facilitated data relay), and a 3-month documentation of a legacy effect (phase-B). Two thousand one hundred seventy-one patients with severe aortic stenoses were enrolled (phase A: 759; intervention: 905; phase-B: 507). Mean age was 77.9±10.0 years, and 80% were symptomatic, including 52% with severe symptoms. During phase A, intervention was planned in 464/696 (67%), 138 (20%) were assigned to watchful waiting, 8 (1%) to balloon aortic valvuloplasty, 60 (9%) were listed as not for active treatment, and in 26 (4%), no decision was made. Three hundred sixty-three of 464 (78%) patients received the planned intervention within 3 months. Timeliness of the intervention improved as shown by the higher number of aortic valve replacements performed within 3 months (59% versus 51%, P =0.002) and a significant decrease in the time to intervention (36±38 versus 30±33 days, P =0.002). Conclusions A simple, low-cost, facilitated data relay improves timeliness of treatment for patients diagnosed with severe aortic stenosis, resulting in a shorter time to transcatheter aortic valve replacement. This effect was mainly driven by a significant improvement in timeliness of intervention in transcatheter aortic valve replacement but not surgical aortic valve replacement. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02241447.

Percutaneous closure of atrial septal defect (ASD)/patent foramen ovale (PFO) can influence systemic hemodynamics. The aim of this research was to evaluate the influence of the closure procedure on morphological and functional characteristics of systemic vascular walls. Fourteen ASD (mean age 40 ± 16 years) and 14 PFO (45 ± 8 years) patients were enrolled in this retrospective study. All underwent percutaneous closure procedure; physical, clinical and biochemical evaluations; echocardiography; carotid evaluation; and brachial artery flow-mediated vasodilatation (FMD). All the evaluations were performed at the time of enrollment, 24 h post-procedure, at 1-6-12-month follow-up. FMD at enrollment was higher in PFO patients as compared to ASD (8.5% [7.6-10.7%] versus 6.5% [5.6-7.6%], p < 0.0001). FMD values in ASD patients significantly increased during follow-up (enrollment: 6.5% [5.6-7.6%], 12-month follow-up: 8.8% [7.2-10.3%], p < 0.01). PFO patients showed reduced FMD values 24 h after the procedure (enrollment: 8.5% [7.6-10.7%], 24 h post-procedure: 7% [6.3-9%], p < 0.001), while recovering endothelial function during follow-up period to baseline values (FMD at 12-month follow-up: 8.2% [7.6-10.5%]). At one-year follow-up, FMD remained inversely related to systolic pulmonary arterial pressure and right and left atrial/ventricle chambers dimensions (RV proximal diameter efflux tract, right atrium [RA] longitudinal diameter, RA transverse diameter, RA area, left ventricle [LV] end-diastolic diameter, left atrium [LA] anteroposterior diameter, LA area; p < 0.01) in ASD patients. Endothelial function improved after percutaneous closure of ASD, while remaining stable after PFO closure. Therefore, ASD patients seem to improve their cardiovascular risk profile after percutaneous closure of their defect.

We aim to compare Polymer-Free Biolimus-Eluting Stent (PF-BES) with Durable Polymer Everolimus-Eluting stent (DP-EES) in unselected patients. PF-BES showed a favorable profile in high-bleeding risk patients who underwent percutaneous coronary intervention. Limited data are available on PF-BES compared with second-generation durable polymer-coated drug-eluting stents in patients eligible for standard dual antiplatelet therapy. A total of 848 consecutive patients were enrolled: 306 patients were treated with PF-BES and 542 with DP-EES. Stent performance was tested in a propensity score-matched population and in a Complex Higher-Risk and Indicated Patients (CHIP) subpopulation. A per-lesion analysis on 1,204 lesions (PF-BES = 424 vs DP-EES = 780) was also performed. At a medium follow-up of 18.5 ± 5.0 months, no differences in the matched population were found in terms of major adverse cardiac events (PF-BES 9.0% vs DP-EES 4.5%; p 0.091), myocardial infarction (PF-BES 6.2% vs DP-EES 2.3%; p 0.111), stent restenosis (PF-BES 2.3% vs DP-EES 0.0%; p 0.123), definite or probable stent thrombosis (PF-BES 2.8% vs DP-EES 1.1%; p 0.448). A significant inferior rate of restenosis was observed in the DP-EES arm in the whole (PF-BES 2.3% vs DP-EES 0.6%; p 0.041) and CHIP populations (PF-BES 4.3% vs DP-EES 0.5%; p 0.023), as well as in the per-lesion analysis (DP-EES 0.4% vs PF-BES 1.7%; p 0.039). In conclusion, in a real-world cohort PF-BES performed similarly to DP-EES in terms of restenosis and stent thrombosis in the matched population. Nonetheless, in the whole and CHIP populations, as well as in the per-lesion analysis, restenosis occurrence resulted higher in the PF-BES group., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Aims: Treatment pathway optimisation in TAVI should include timely patient discharge with a minimised risk for out-of-hospital adverse events. The aim of this study was to define a standardised set of risk criteria that allows a safe and timely discharge, to validate their appropriateness prospectively in different centres and multiple European countries, and to assess post-discharge outcomes., Methods and Results: We defined and validated the adequacy of a set of discharge criteria and its ability to predict timely and safe discharge properly after the intervention in a prospective, European, multicentre registry. A total of 502 unselected patients were enrolled at 10 sites in three countries. The primary endpoint, defined as a composite of all-cause mortality, vascular access-related complications, permanent pacemaker implantation, stroke, re-hospitalisation due to cardiac reasons, kidney failure and major bleeding at 30 days, was reached in 12.9% of patients (95% CI: 11.3-16.5). The overall 30-day mortality was 1.1% (95% CI: 0.2-2.0), and the rates of stroke/TIA 1.7% (95% CI: -0.6 to 4.0), PPI 7.3% (95% CI: 5.8-8.9), major vascular complications 1.9% (95% CI: 0.7-3.1), major/life-threatening bleeding 2.4% (95% CI: 1.0-3.8) and cardiac re-hospitalisation 3.7% (95% CI: 1.4-6.0). Patients appropriately discharged early had a significantly lower risk of the primary endpoint (7.0 vs. 26.4%; p<0.001) which was reflected in some of its relevant components: stroke (0.0 vs. 2.8%; p=0.015), PPI (4.3 vs. 15.9%; p<0.001), major vascular complications (0.3 vs. 4.7%; p=0.004) and major/life-threatening bleeding (0.3 vs. 6.5%; p<0.001)., Conclusions: We validated the appropriateness of a pre-specified set of risk criteria that allows a safe and timely discharge. The rate of 30-day complications did not reveal any risk increase with this strategy compared with the reported outcomes in major TAVI trials and registries. ClinicalTrials.gov Identifier: NCT02404467.

Objectives: The aim of this observational study was to determine the benefits of the novel, orally delivered P2Y 12 -inhibitors (Is) in terms of angiographic endpoints and in relation to the time of the loading dose (LD) administration., Background: The goal of ST-elevation myocardial infarction (STEMI) treatment is timely reperfusion. The P2Y 12 -Is prasugrel and ticagrelor have improved the angiographic outcome of primary percutaneous coronary intervention (pPCI) and patients' prognosis. However, their onset of action is impaired in STEMI and delayed by their oral administration., Methods: The 328 eligible patients with STEMI consecutively referred for pPCI were divided into three groups depending on the interval of "P2Y 12 -I LD administration-to-balloon time": Group 2 included patients that received P2Y 12 -I LD at least 60 min prior to pPCI, Group 1 within 60 min prior to pPCI, and Group 0 at the moment of pPCI. Angiographic, clinical, and biochemical parameters were evaluated. Pre- and post-pPCI TIMI flow grade (TFG) and ST resolution (STR) were used as outcome measures to determine efficacy and optimal timing of pretreatment., Results: Pre-pPCI TFG improved with increasing P2Y 12 -I LD administration-to-balloon time; pre-PCI TFG 0/1 was 74.5% in Group 0, 65.5% in Group 1 and 54.9% in Group 2 (P < 0.002). Post-pPCI TFG 3 results also differed significantly between the three groups: 85.2% in Group 0, 88.1% in Group 1, 97.6% in Group 2 (P < 0.013). ST resolution rates were also positively associated with longer pretreatment intervals., Conclusions: This observational study suggests that the angiographic benefit of P2Y 12 -I administration is time-dependent: longer pretreatment improves coronary reperfusion in terms of pre- and post-pPCI TFG and STR., (© 2018 Wiley Periodicals, Inc.)

Transcatheter aortic valve implantation (TAVI) has revolutionized the management of patients with symptomatic severe aortic stenosis and has become the standard of care for inoperable patients and the preferred therapy for those at increased surgical risk with peculiar clinical and anatomic features. Technology advances, growing experience and accumulating data prompted the update of the 2011 Italian Society of Interventional Cardiology (SICI-GISE) position paper on institutional and operator requirements to perform TAVI. The main objective of this document is to provide a guidance to assess the potential of institutions and operators to initiate and maintain an efficient TAVI program.

Aims: Hyperglycemia is frequent in patients with ST elevation myocardial infarction (STEMI) and is associated with adverse outcome. Aim of our study was to evaluate the correlation between admission plasma glucose level (PGL) and coronary arteries flow velocity., Methods: We enrolled 149 STEMI patients successfully treated with primary percutaneous coronary intervention (pPCI). The study population was divided into two groups based on PGL (< or >140 mg/dl) and on history of diabetes, and the groups compared in terms of corrected TIMI frame count (cTFC)., Results: Hyperglycemic patients had a significantly higher cTFC in both the culprit (p < 0.0001) and non-culprit vessel (p: 0.0002); diabetes history impairs as well cTFC of the culprit (p < 0.0001) and non-culprit vessel (p: 0.0001). Within the subpopulation of diabetic patients hyperglycemic ones showed higher cTFC in both the culprit (p 0.0013) and non-culprit vessel (p: 0.0006). Moreover in the whole population cTFC values of both arteries increase linearly with the increment of admission PGL., Conclusions: Admission PGL affects coronary flow of both culprit and non-culprit vessel. The impairment of coronary flow is also demonstrated in known diabetic patients, suggesting to consider hyperglycemia an additional risk factor. We finally demonstrated for the first time a positive linear relationship between PGL and cTFC., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Mitral regurgitation (MR) is the most prevalent valvular heart disease (VHD) and represents an important cause of heart failure. Medical therapy has a limited role in improving symptoms and does not hinder the progression of valvular disease. Surgery is the treatment of choice for severe symptomatic MR; valve repair is currently the preferred surgical approach because it reduces peri-operative mortality and ensures a good medium- to long-term survival outcome. Nevertheless, a non-negligible proportion of patients with indications for surgical correction are considered to be at prohibitive perioperative risk, mainly because of old age and multiple comorbidities. The introduction of percutaneous interventions to clinical practice has changed the natural history of this population. Percutaneous edge-to-edge transcatheter mitral valve repair (Mitraclip®, Abbott Vascular, Menlo Park, CA) is a state-of-the-art therapy for approaching MR in patients with a high surgical risk. Despite having been only recently introduced, this transvenous transfemoral percutaneous intervention has already been performed in more than 40,000 subjects worldwide, with reassuring post-operative results in terms of safety, feasibility, mortality and morbidity. Since Mitraclip® is considered to be minimally invasive, it is currently indicated in "frail" patients with severe comorbidities. We provide a critical review of the literature to clarify current indications, procedural details, patient selection criteria, and future perspectives for this innovative technique.

Cryptogenic stroke is the final diagnosis in almost 40% of ischemic acute cerebrovascular events. There is currently no definitive clinical evidence that percutaneous closure of patent foramen ovale (PFO) can prevent the recurrence of stroke or transient ischemic attack (TIA). Identification of the causes of neurologic ischemic syndromes is essential for any strategy intended to prevent the catastrophic consequences of cerebral infarction. Since the initial reports of an unexpectedly high prevalence of PFO in younger patients with cryptogenic stroke in 1988, there has been growing interest and experience in diagnosing and treating these patients, both medically and/or with percutaneous closure, in particular for the potential to eliminate paradoxical embolism via PFO, which is a likely mechanism for stroke in these patients. Selection of the appropriate occluder device is of paramount importance for the success of the procedure. While devices like the Amplatzer™ PFO Occluder (St. Jude Medical), which, based on the extended follow-up of the RESPECT Trial, was approved by the U.S. Food and Drug Administration last year for recurrent stroke prevention, have become generally accepted as being better than medical therapy for patients needing treatment, concerns remain regarding device- and procedure-related complications. NobleStitch™ EL is a novel device that offers a simple non-prosthetic implant method of PFO closure without the inherent risks seen with septal occluders: no risk of device embolization, device thrombosis or late erosion, and probably no risk of arrhythmia. Futhermore, there is no material that would hinder future access to the left atrium and no requirement for anti-coagulation.

Takotsubo cardiomyopathy (TTC) is characterized by transient systolic ventricular dysfunction. It is supposed to be caused by a cathecolaminergic wave which leads to myocardial stunning through a massive action on beta2-adrenoreceptor. Moreover, beta2-receptor hyperactivity negatively influences endothelial function. It can be detected by brachial flow mediated dilation (b-FMD) which assesses endothelium regulated vasomotility. The study aim is to analyze the b-FMD variability during hospitalization in 50 patients admitted with TTC. In addition, we investigated a possible correlation between b-FMD at admission and both length of hospital stay (LOHS) and troponin I peak. We detected b-FMD by measuring the hypoxic induced vasoreactivity through assessing brachial artery dilation after 5 min of iatrogenic ischemia obtained by inflating a sphygmomanometer cuff. Artery diameter modifications were assessed by high-resolution ultrasound, and a dedicated software calculated accurately the percentage of dilation after ischemia by comparing it to the basal. These values were measured at admission and on discharge. The obtained values were compared for each patient to explore their variability during hospitalization. Moreover, the correlation between the b-FMD at admission and both the troponin I peak and the LOHS was investigated. There was a statistical significant difference between mean FMD measured at admission and at discharge (respectively 1.54 ± 0.34 and 8.92 ± 2.48%; p < 0.001). Moreover, we found a significant negative correlation between troponin I peak and FMD values at admission (r = - 0.7645; p < 0.001) and a significant inverse correlation between FMD at admission and LOHS (r = - 0.7543; p < 0.001). There is a significant improvement of b-FMD during hospitalization in patients admitted for Tako-Tsubo Cardiomyopathy. Moreover, for the first time, a direct correlation among b-FMD, troponin I peak and LOHS has been detected.

Aims: Preliminary data on Sapien 3 valve (S3-THV) use for transcatheter aortic valve implantation have shown an increased permanent pacemaker implantation (PPMI) rate with respect to Sapien XT valve. Aim of this study was to investigate the role of S3-THV position in the left ventricular outflow tract (LVOT) on electrocardiographic changes suggestive of atrioventricular (ΔPR) and/or intraventricular (ΔQRS) conduction abnormalities and 30 days PPMI rate., Methods and Results: Eighty-six consecutive patients treated with S3-THV were included in the study. All patients underwent clinical and electrocardiogram evaluation. Left ventricular outflow tract prosthesis depth was assessed by fluoroscopy and expressed quantitatively (mm) and as aorto-ventricular ratio (AVR). Eight patients (9.3%) needed PPMI at 30 days. A low AVR (≤60/40) predicted PPMI (OR = 6.09, 95% CI 1.19-31.01, P = 0.030) and resulted into higher PPMI rate, compared with higher AVR (30.0 vs. 6.6%, P = 0.017). For each millimetre increase in the LVOT prosthesis depth PPMI risk increased by 1.41 times (95% CI 1.06-1.87, P = 0.017). In patients with low AVR, ΔPR was higher than in those with higher AVR (33.4 ± 56.7 vs. 12.1 ± 19.4 ms, P = 0.021) and ΔPR was associated to LVOT prosthesis depth (β = 0.286, P = 0.009). Furthermore, ΔPR was associated with risk of PPMI (OR = 1.03, 95% CI 1.01-1.06, P = 0.024)., Conclusions: A low AVR is associated to higher ΔPR and PPMI rates. The correlation between LVOT prosthesis depth with ΔPR and higher PPMI rate suggests the need of a careful S3-THV implantation., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.)

Background: There is an increasing trend towards shorter hospital stays after transcatheter aortic valve implantation (TAVI), in particular for patients undergoing the procedure via transfemoral (TF) access. Preliminary data suggest that there exists a population of patients that can be discharged safely very early after TF-TAVI. However, current evidence is limited to few retrospective studies, encompassing relatively small sample sizes., Methods: The Feasibility And Safety of early discharge after Transfemoral TAVI (FAST-TAVI) registry is a prospective observational registry that will be conducted at 10 sites across Italy, the Netherlands and the UK. Patients will be included if they have been scheduled to undergo TF-TAVI with the balloon-expandable SAPIEN 3 transcatheter heart valve (THV; Edwards Lifesciences, Irvine, CA). The primary endpoint is a composite of all-cause mortality, vascular-access-related complications, permanent pacemaker implantation, stroke, re-hospitalisation due to cardiac reasons, kidney failure and major bleeding, occurring during the first 30 days after hospital discharge. Patients will be stratified according to whether they were high or low risk for early discharge (≤3 days) (following pre-specified criteria), and according to whether or not they were discharged early. Secondary endpoints will include time-to-event (Kaplan-Meier) analysis for the primary outcome and its individual components, analysis of the relative costs of early and late discharge, and changes in short- and long-term quality of life. Multivariate logistic regression will be used to identify factors that indicate that a patient may be suitable for early discharge., Discussion: The data gathered in the FAST-TAVI registry should help to clarify the safety of early discharge after TF-TAVI and to identify patient and procedural characteristics that make early discharge from hospital a safe and cost-effective strategy., Trial Registration: ClinicalTrials.gov Identifier: NCT02404467 (registration first received March 23rd 2015).

Aortic injury is a rare but severe complication that may occur during transcatheter aortic valve implantation (TAVI). Few patients with type A dissection are treated surgically because of the high rate of postoperative mortality and neurological complications in this high-risk population; thoracic endovascular aortic repair is rare too, and technically challenging because of the anatomical variations of spiral type A aortic dissection. Sometimes a watchful waiting strategy could be the best solution. We report the case of an acute, extended aortic type A dissection occurred during a TAVI procedure, probably due to the rupture of the dedicated sheath, and conservatively managed.

Introduction: Transcatheter aortic valve implantation (TAVI) technique represents a real revolution in the field of interventional cardiology and medicine, in particular for the treatment of severe aortic valve stenosis in elderly patients or in patients when the periprocedural risk for the traditional surgical option is considered too high, as an alternative to the traditional aortic valve replacement. Although experience on the valves of the last generation is still limited in terms of time, the data currently available are definitely moving in the direction of a minimum hospital mortality (1%) as well as a drastic reduction in the incidence of complications when compared to the devices of the previous generation. Finally, the evolution of specified materials of the newest generation have greatly enhanced safety and efficacy of TAVI procedures in the last years. In order to ensure the selection of the most appropriate valve and the success of the procedure, the role of cardiac imaging (computed tomography scan evaluation and angiography) is crucial. These examinations require the use of contrast medium in patients suffering from renal dysfunction at the baseline. The need for fluoroscopy and angiography using contrast agents to aid positioning of the valve may lead to contrast-induced nephropathy (CIN) as one form or one etiology of acute kidney injury (AKI), which is associated with increased morbidity and mortality. The aim of our study is to investigate the accuracy of intravascular ultrasound (IVUS-a technique which does not need contrast) for the assessment of native valve measures in patients undergoing TAVI by comparing values obtained with IVUS to those ones previously obtained in the same patients with computed tomography (CT) scans., Material and Methods: We enrolled 25 consecutive patients (10 males, average age 81.3±5,1 years) who underwent TAVI with femoral access in our Cardiac Surgery Cath-Lab (University of Bari) from January to October 2015 (Logistic EuroSCORE 21.6±15.4%; STS score mortality 20.9±14.9%). Each patient scheduled for TAVI underwent coronary angiography and high resolution angio-CT in order to obtain a complete evaluation (diameters, perimeters, and areas at annulus level, -3mm level, +15mm level, height of coronary ostia, shape, and conformation of left ventricle outflow tract, conformation, and calcifications of aortic and ileo-femoral axis) to choose the most suitable prosthetic aortic valve for each patient. In all patients, during the procedure (before the prosthetic valve implantation), we executed a manual IVUS pullback (from left ventricle outflow tract to ascending aorta) by using a 7F IVUS probe (Volcano Corporation, San Diego, CA). On the recorded IVUS pullback, a second operator (who did not know the values obtained by CT measurements) identified the aortic annulus and, at this level, measured: minimum and maximum diameter; perimeter; derived perimeter, and area. The t-student test has been used to compare the averages of these IVUS values to the CT ones. A p value< 0.05 was considered as statistically significant., Results: Independently from the kind and size of implanted prosthetic valve, no statistical differences were found when the averages of all considered parameters (obtained both with CT and IVUS) were compared. The following are the results obtained: minimum diameter (CT: 19,62mm±1,10 vs. IVUS: 19,55mm±1,40; p=0.41); maximum diameter (CT: 24,73mm±2,42 vs. IVUS: 25,9mm±1,80; p=0.08); perimeter (CT: 72,05mm±4,36 vs. IVUS: 73,32mm±6,09; p=0.164); derived perimeter (CT: 22,94mm±1,40 vs. IVUS: 23,32mm ± 1,95; p=0,198); and area (CT: 3,99cm2 ±0,97 vs. IVUS: 4,06 cm2 ± 0,47; p=0,073) (Figs. 1-3)., Conclusions: These preliminary data suggest accurate IVUS measures when compared to CT in the evaluation of valve parameters considered (minimum and maximum diameters, area, perimeter, and derived perimeter at the annulus level). In order to confirm these findings and to give them statistical significance, it will be necessary to increase the sample size.

Left ventricular noncompaction (LVNC) is a myocardial disorder probably due to the arrest of normal embryogenesis of the left ventricle. It could be isolated or associated with other extracardiac and cardiac abnormalities, including coronary artery anomalies. Despite the continuous improvement of imaging resolution quality, this cardiomyopathy still remains frequently misdiagnosed, especially if associated with other heart diseases. We report a case of LVNC association with both malposition of the great arteries and a very original coronary artery pattern.

To report the use of endografts to manage multiple aneurysms due to Cogan syndrome (CS). A 38-year-old woman with descending thoracic aorta and right common carotid artery aneurysms due to CS was treated with endovascular grafts. After 4 years, angio computed tomography scan demonstrated complete exclusion of the aneurysms with no signs of endoleak, whereas echo color Doppler showed patency of the carotid graft, no signs of restenosis, no progression of the disease in the landing zones, and complete aneurysm exclusion. Endovascular repair seems to have favorable long-term outcomes and should be considered a viable alternative to surgery in unfit for open surgery patients, even if they are young, and when the aneurysm size and location would pose a higher risk of perioperative and postoperative complications after an open surgical procedure., (Copyright © 2015 Elsevier Inc. All rights reserved.)

The stent graft is a noncompliant system inserted in a semi-compliant structure. This generates a mismatch. The media also shows a composite movement and is oriented 45° resulting in an arterial spiral movement that contributes to maintaining the clockwise orientation of laminar flow with an 80° deflection. Our multilayer stent is constituted by a single Nitinol thread, worked on 3 surfaces in order to realize a proper exoskeleton that reproduces the architecture of the tunica media, in particular its flexo-torsional forces, thus restoring the energy transmission and the match between the wall and the blood flow. A first in vivo implantation was performed by using an experimental pig model in our veterinary department. The pig underwent general anesthesia and the right femoral artery was surgically exposed in order to accommodate a 12F long introducer sheath. Under fluoroscopy three multilayer stents were consecutively implanted from the aortic isthmus to the iliac bifurcation in an overlap fashion. All the intercostal artery and visceral branches were covered by the overlapped stents. The final control angiography revealed an optimal sealing of the implanted stent with an evident flexotorsional oscillatory movement, which follows the conical architecture of the thoracic aorta and the complete patency of all the branches that arise from the aorta. After two months, the multilayer showed a normal endothelialization process with an optimal adhesion to the aortic wall both proximally and distally without provoking any inflammatory response or thickness wall alterations. The perfect and homogenous endothelialization preserved the patency of all the collateral branches arising from the treated aorta, in particular all the intercostal arteries, celiac trunk, and renal arteries. The disease of the aorta essentially concerns the tunica media as it causes disruption of the media components. This exoskeleton works like a neo-tunica media, is perfectly endothelialized, and seems to optimally transmit the flexotorsional forces, restoring the match between wall and flow that represents the primary condition for laminar flow and branch perfusion.

Background: Coronary artery disease (CAD) commonly coexists with degenerative aortic stenosis. The impact of CAD in patients undergoing transcatheter aortic valve implantation (TAVI) raises concerns due to the lack of comprehensive and consistent data on this topic. We sought to evaluate the impact of CAD on clinical outcomes in patients undergoing TAVI., Methods: Consecutive patients(N=663) who underwent TAVI with the 18-French CoreValve ReValving System (CRS) (Medtronic Inc, MN USA) from June 2007 through December 2009 at 14 institutions across Italy were included in this prospective web-based registry. Four patients were excluded from the analysis due to failure to successfully release the prosthesis inside the native aortic valve. Previous percutaneous or surgical myocardial revascularizations were used to identify the existence of concomitant CAD (N=251; 38%). The primary endpoint was the incidence of Major Adverse Cerebrovascular and Cardiac Events (MACCE) and all-cause death in CAD and no-CAD groups., Results: Patients with CAD were no more likely to develop MACCE within 12-months of the procedure than those who did not (CAD group vs no-CAD group, 15.7% vs 18.3%; adjusted hazard ratio [HR] 0.76; 95% confidence interval [CI] 0.42 to 1.36; p=0.353). The 12-month mortality was 14.5% and 15.9% in CAD group and no-CAD group, respectively (adjusted HR 0.74; 95% CI 0.40 to 1.36; p=0.331)., Conclusions: Coexisting CAD does not impact procedural outcomes and mid-term incidence of MACCE and survival in elderly patients undergoing TAVI with CRS prosthesis., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Aortic injury from sudden deceleration is the most common traumatic condition of the thoracic aorta encountered clinically. Open surgical repair is still associated today with a high-risk setting. Recently, stent-graft treatment is emerging as an alternative to conventional surgery due to its less traumatic nature in patients affected by traumatic aortic lesions, especially in concomitance with multiple associated lesions. From March 1999 to June 2009, 57 patients admitted with a diagnosis of acute and chronic aortic lesions underwent endovascular repair. In 38 cases, traumatic aortic rupture was detected in the acute phase and associated lesions were present at various grade in all patients, whereas in 19 cases aortic injury was identified in the chronic phase. The endovascular treatment was successful in all cases affected both by acute and chronic aortic injury. None of the patients died during the follow-up, as well as no cases of perigraft leakage have been detected so far. Endovascular repair represents the first choice of treatment in patients with traumatic aortic lesions. Indeed, the severity of co-existing lesions could be adversely affected by conventional surgical treatment, also with consideration of its high morbidity rate due to thoracotomy.

The The aim of our study is to investigate the molecular mechanisms of diabetic cardiomyopathy through the identification of remarkable genes for the myocardial function that are expressed differently between diabetic and normal subjects. Moreover, we intend to characterize both in human myocardial tissue and in the related cardiac progenitor cells the pattern of gene expression and the levels of expression and protein activation of molecular effectors involved in the regulation of the myocardial function and differentiation to clarify whether in specific human pathological conditions (type 2 diabetes mellitus, cardiac failure, coronary artery disease) specific alterations of the aforementioned factors could take place. Thirty-five patients scheduled for coronary artery bypass grafting (CABG) or for aortic or mitral valve replacement were recruited into the study. There were 13 men and 22 women with a mean age of 64.8 +/- 13.4 years. A list of anamnestic, anthropometric, clinical, and instrumental data required for an optimal phenotypical characterization of the patients is reported. The small cardiac biopsy specimens were placed in the nourishing buffer, in a sterile tube provided the day of the procedure, to maintain the stability of the sample for several hours at room temperature. The cells were isolated by a dedicated protocol and then cultured in vitro. The sample was processed for total RNA extraction and levels of gene expression and protein activation of molecular effectors involved in the regulation of function and differentiation of human myocardium was analyzed. In particular, cardiac genes that modulate the oxidative stress response or the stress induced by pro-inflammatory cytokines (p66Shc, SOCS-1, SOCS-3) were analyzed. From a small sample of myocardium cardiac stem cells and cardiomyoblasts were also isolated and characterized. These cells showed a considerable proliferative capacity due to the fact that they demonstrate stability up to the eleventh passage. Analysis of gene expression in a subgroup of subjects showed the trend of a decrease in levels of expression of cardiac-specific transcription genes and oxidative stress-related proteins in tissues of diabetic patients compared with controls subjects. This trend is not confirmed in isolated cells. As for the coronary artery disease, diabetic cardiomyopathy could be associated with a reduction of the cardiac stem and progenitor cells pool. The expansion of the cardiac resident cells pool could be associated with a preservation of cardiac performance, suggesting that a preserved stamina compartment can counteract the impact of diabetes on the myocardium.

With the increased use of the endovascular approach, the management and outcome of traumatic aortic injuries have changed dramatically over the past 10 years. Understanding pathogenic mechanism underlying aortic injury is critical in choosing the kind of stent-graft to be used. The possible mechanisms of non-penetrating blunt trauma of the aorta have been studied for a long time and are not completely clarified yet. The principal hypotheses concern the differential acceleration and deceleration movements exerting in horizontal and/or longitudinal planes, associated with the abrupt increase of endoluminal pressure and direct or indirect compression of the thoracic aorta from the ribcage structures. When blunt chest trauma causes direct compression of the sternum and spine with a sudden increase in endoluminal pressure, the rupture more frequently involves the ascending aorta or the descending thoracic aorta downstream the isthmus area. On the other hand, when the trauma generates differential acceleration and deceleration movements the rupture involves more frequently the isthmus because this region represents one of the points of fixity of the aorta through the junction of the ligamentum arteriosus and the first ribs. The following presentation is aimed at illustrating some of the possible pathophysiological mechanisms of post-traumatic blunt rupture of the aorta and the indications for its endovascular treatment.