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Patienten mit Vorhofflimmern sind einem signifikant erhohten Risiko fur thromboembolische Ereignisse, insbesondere fur ischamische Schlaganfalle, ausgesetzt. Eine orale Antikoagulation reduziert dieses Risiko zuverlassig, ist jedoch aus unterschiedlichen Grunden nicht bei jedem Patienten einsetzbar und geht mit einer relevanten Erhohung des Blutungsrisikos einher. Alternativ bestehen zur Prophylaxe thromboembolischer Ereignisse bei Patienten mit Vorhofflimmern unterschiedliche Moglichkeiten eines Vorhofohrverschlusses. Anhand einer Ubersicht der aktuell verfugbaren Systeme zum Vorhofohrverschluss, eines Leitfadens zur Patientenauswahl und einer Zusammenfassung der aktuellen wissenschaftlichen Datenlage sollen die Moglichkeiten des interventionellen Vorhofohrverschlusses erlautert sowie die geeignete Patientenklientel charakterisiert werden. Fur Patienten mit Vorhofflimmern und relativer oder absoluter Kontraindikation einer oralen Antikoagulation stellt der interventionelle Verschluss des Vorhofohrs nach sorgfaltiger Patientenselektion eine sichere Alternative zum Schutz vor thromboembolischen Ereignissen dar. Die aktuell verfugbare wissenschaftliche Evidenz aus randomisierten, kontrollierten Studien ist gering. Umfangreiche Registerstudiendaten lassen dennoch einen eindeutigen Nutzen vermuten, wahrend die Ergebnisse mehrerer groser randomisierter, kontrollierter Studien in den kommenden Jahren erwartet werden.

Unenhanced chest CT can identify incidental findings (IFs) leading to management strategy change. We report our institutional experience with routine chest-CT as preoperative screening tool during the COVID-19 pandemic, focusing on the impact of IFs.All patients scheduled for cardiac surgery from May 1st to December 31Out of 447, 278 patients were included. IFs rate was 7.2% (20/278): a solid mass (11/20, 55%), lymphoproliferative disease (1/20, 5%), SARS-CoV-2 pneumonia (2/20, 10%), pulmonary artery chronic thromboembolism (1/20, 5%), anomalous vessel anatomy (2/20, 10%), voluminous hiatal hernia (1/20, 5%), mitral annulus calcification (1/20, 5%), and porcelain aorta (1/20, 5%) were reported. Based on IFs, 4 patients (20%-4/278, 1.4%) were not operated, 8 (40%-8/278, 2.9%) underwent a procedure different from the one originally planned one, and 8 (40%-8/278, 2.9%) needed additional preoperative investigations before undergoing the planned surgery. At univariate regression, coronary artery disease, atrial fibrillation, and history of cancer were significantly more often present in patients presenting with significant IFs. History of malignancy was identified as the only independent determinant of significant IFs at chest-CT (OR=4.27 IQR: [1.14-14.58], P=0.0227).Unenhanced chest-CT as a preoperative screening tool in cardiac surgery led to incidental detection of significant clinical findings, which justified even procedures cancellation. Malignancy history is a determinant for CT incidental findings and could support a tailored screening approach for high-risk patients.

Background Heart failure patient management guided by invasive intra-cardiac and pulmonary pressure measurements through permanent intra-cardiac micro-sensors has recently been published as a strategy to individualize the therapy of patients with chronic heart failure to reduce re-hospitalization and optimize quality of life. Furthermore, the use of telemedicine could have an important impact on infective disease spread during the current coronavirus disease-2019 pandemic. Case summary Emergent hospitalization of a patient with acute on chronic heart failure, who is currently in self-isolation as a result of his comorbid profile that exposes him to high risk for severe course and mortality in case of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was prevented using a last generation telemedicine tool. Discussion Further implementation of invasive telemedicine could prevent hospitalization for acute decompensated heart failure and consecutive exposure to a potential hospital infection with SARS-CoV-2 in high-risk patients.

The predictive role of chest radiographs in patients with suspected coronary artery disease (CAD) is underestimated and may benefit from artificial intelligence (AI) applications.To train, test, and validate a deep learning (DL) solution for detecting significant CAD based on chest radiographs.Data of patients referred for angina and undergoing chest radiography and coronary angiography were analysed retrospectively. A deep convolutional neural network (DCNN) was designed to detect significant CAD from posteroanterior/anteroposterior chest radiographs. The DCNN was trained for severe CAD binary classification (absence/presence). Coronary angiography reports were the ground truth. Stenosis severity of ≥70% for non-left main vessels and ≥ 50% for left main defined severe CAD.Information of 7728 patients was reviewed. Severe CAD was present in 4091 (53%). Patients were randomly divided for algorithm training (70%; n = 5454) and fine-tuning/model validation (10%; n = 773). Internal clinical validation (model testing) was performed with the remaining patients (20%; n = 1501). At binary logistic regression, DCNN prediction was the strongest severe CAD predictor (p 0.0001; OR: 1.040; CI: 1.032-1.048). Using a high sensitivity operating cut-point, the DCNN had a sensitivity of 0.90 to detect significant CAD (specificity 0.31; AUC 0.73; 95% CI DeLong, 0.69-0.76). Adding to the AI chest radiograph interpretation angina status improved the prediction (AUC 0.77; 95% CI DeLong, 0.74-0.80).AI-read chest radiographs could be used to pre-test significant CAD probability in patients referred for suspected angina. Further studies are required to externally validate our algorithm, develop a clinically applicable tool, and support CAD screening in broader settings.

Patients with atrial fibrillation are at a significantly increased risk of thromboembolic events, especially ischemic strokes. Oral anticoagulation reduces this risk, but cannot be used in some patients for various reasons and is associated with a relevantly increased risk of bleeding. As an alternative for prophylaxis of thromboembolic events in patients with atrial fibrillation, there are different options of left atrial appendage closure.This article explains the possibilities of interventional atrial occlusion as well as the suitable patient clientele using an overview of the currently available systems for atrial occlusion, a guideline for patient selection and a summary of the current scientific data.In carefully selected patients suffering from atrial fibrillation with relative or absolute contraindications for oral anticoagulation, interventional closure of the atrial appendage is a safe alternative for prophylaxis against thromboembolic events. The currently available scientific evidence from randomized controlled trials is sparse. Nevertheless, extensive amounts of registry study data suggest a benefit, while the results of several large randomized controlled trials are expected in the coming years.HINTERGRUND: Patienten mit Vorhofflimmern sind einem signifikant erhöhten Risiko für thromboembolische Ereignisse, insbesondere für ischämische Schlaganfälle, ausgesetzt. Eine orale Antikoagulation reduziert dieses Risiko zuverlässig, ist jedoch aus unterschiedlichen Gründen nicht bei jedem Patienten einsetzbar und geht mit einer relevanten Erhöhung des Blutungsrisikos einher. Alternativ bestehen zur Prophylaxe thromboembolischer Ereignisse bei Patienten mit Vorhofflimmern unterschiedliche Möglichkeiten eines Vorhofohrverschlusses.Anhand einer Übersicht der aktuell verfügbaren Systeme zum Vorhofohrverschluss, eines Leitfadens zur Patientenauswahl und einer Zusammenfassung der aktuellen wissenschaftlichen Datenlage sollen die Möglichkeiten des interventionellen Vorhofohrverschlusses erläutert sowie die geeignete Patientenklientel charakterisiert werden.Für Patienten mit Vorhofflimmern und relativer oder absoluter Kontraindikation einer oralen Antikoagulation stellt der interventionelle Verschluss des Vorhofohrs nach sorgfältiger Patientenselektion eine sichere Alternative zum Schutz vor thromboembolischen Ereignissen dar. Die aktuell verfügbare wissenschaftliche Evidenz aus randomisierten, kontrollierten Studien ist gering. Umfangreiche Registerstudiendaten lassen dennoch einen eindeutigen Nutzen vermuten, während die Ergebnisse mehrerer großer randomisierter, kontrollierter Studien in den kommenden Jahren erwartet werden.

Liver transplantation (LT) is a life-saving strategy for patients with end-stage liver disease, hepatocellular carcinoma, and acute liver failure. LT success can be hampered by several short-term and long-term complications. Among them, bacterial infections, especially those due to multidrug-resistant germs, are particularly frequent, with a prevalence between 19 and 33% in the first 100 days after transplantation. In the last decades, a number of studies have highlighted how the gut microbiota (GM) is involved in several essential functions to ensure intestinal homeostasis, becoming one of the most important virtual metabolic organs. The GM works through different axes with other organs, and the gut-liver axis is among the most relevant and investigated ones. Any alteration or disruption of the GM is defined as dysbiosis. Peculiar phenotypes of GM dysbiosis have been associated with several liver conditions and complications, such as chronic hepatitis, fatty liver disease, cirrhosis, and hepatocellular carcinoma. Moreover, there is growing evidence of the crucial role of the GM in shaping the immune response, both locally and systemically, against pathogens. This paves the way to the manipulation of the GM as a therapeutic instrument to modulate infectious risk and outcome. In this minireview, we provide an overview of the current understanding of the interplay between the gut microbiota and the immune system in liver transplant recipients and the role of the former in infections.

Background Left atrial appendage closure (LAAC) is a safe and efficacious alternative to oral anticoagulation (OAC) therapy in patients with non-valvular atrial fibrillation (AF) who are at high risk for both stroke and bleeding. Data on cost-effectiveness of LAAO are limited and existing studies on the topic are based on simulation model approaches rather than on real-world costs. Purpose To compare actual management costs in patients with non-valvular AF treated with LAAC or OAC only. Methods Percutaneous LAAC was performed only in patients with at least one cerebral thromboembolic event, one major bleeding episode while under OAC, and with absolute contraindication to prolonged OAC. AF patients undergoing percutaneous LAAC were matched with AF patients treated with OAC only. Matching variables were gender, age, and Diagnosis Related Groups (DRG) clinical complexity level. Costs for cardiovascular outpatient clinic visits and hospitalizations were derived from the actual medical claims and reimbursement records. Data were prospectively collected and retrospectively analyzed. Results Between 1/2012 and 12/2016, 8478 patients with non-Valvular AF were referred to our institution: 7801 (92%) were managed with OAC only and 677 (8%) with LAAC. A total of 559 patients (279 per group) were matched. Mean age was 74.9±7.5 years, 244 were female (43.7%), and mean DRG clinical complexity level was 1.8±1.1. Median annualized management cost before LAAC was €3110 (IQR €1281–8127). Median hospitalization cost for LAAC was €9601 (IQR: €9393–10007). After a mean follow-up of 4.5±1.4 years, median annualized management cost was €1297 (€607–2735) in patients with sole OAC and €1013 (IQR €0–4770) in patients after LAAC (p=0.003). Undergoing LAAC was the strongest independent determinant to reduce follow-up management costs (linear regression: beta = −0.335; CI: −1.09 to −0.682; p Conclusion LAAC significantly reduces management costs of patients with non-valvular AF. In patients referred for percutaneous LAAC, the drastic reduction in management costs following LAAC justifies the procedural costs. In spite of their complex comorbid profile, LAAC patients show a follow-up survival rate similar to those of patients solely treated with OAC. Management costs of patients solely on OAC are significantly higher than management costs of patients after LAAC. Future studies are necessary to investigate the potential net economic and clinical benefit of LAAC in patients that are treated with OAC only. Funding Acknowledgement Type of funding sources: None.

Patients with heart failure (HF) are at an increased risk of hospital admissions. The aim of this report is to describe the feasibility, safety and accuracy of a novel wireless left atrial pressure (LAP) monitoring system in patients with HF.The V-LAP Left Atrium Monitoring systEm for Patients With Chronic sysTOlicDiastolic Congestive heart Failure (VECTOR-HF) study is a prospective, multicenter, single-arm, open-label, first-in human clinical trial to assess the safety, performance and usability of the V-LAP system (Vectorious Medical Technologies) in patients with New York Heart Association class III HF. The device was implanted in the interatrial septum via a percutaneous, trans-septal approach guided by fluoroscopy and echocardiography. Primary endpoints included the successful deployment of the implant, the ability to perform initial pressure measurements and safety outcomes.To date, 24 patients have received implants of the LAP-monitoring device. No device-related complications have occurred. LAP was reported accurately, agreeing well with wedge pressure at 3 months (Lin concordance correlation coefficient = 0.850). After 6 months, New York Heart Association class improved in 40% of the patients (95% CI = 16.4%-63.5%), while the 6-minute walk test distance had not changed significantly (313.9 ± 144.9 vs 232.5 ± 129.9 meters; P = 0.076).The V-LAP left atrium monitoring system appears to be safe and accurate.

Background Bendamustine, used for the treatment of indolent B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia, is known to cause prolonged myelosuppression and lymphocytopenia and has been associated with the risk of developing serious and fatal infections. While reports of localized CMV infections in asymptomatic patients exist, disseminated CMV disease has not been described. Case presentation We report the first case of disseminated CMV infection in a 75-year-old male diagnosed with lymphoplasmacytic lymphoma/Waldenström macroglobulinemia with massive bone marrow infiltration. Despite 6-cycle R-bendamustine chemotherapy resulted in a good partial response, the patient developed persistent fever and severe weight loss. Analysis of cerebrospinal fluid and peripheral blood revealed the presence of CMV-DNA, while the fundus oculi examination revealed bilateral CMV retinitis. Treatment with induction and maintenance drugs was complicated by neutropenia and deterioration of renal function with electrolyte imbalance. From an immunological standpoint, we observed a profound imbalances in phenotype and function of B- and T-cell subsets, with a high proportion of circulating total, activated CD69+ and CD80+ B-cells, a low γ/δ T-cell frequency with a high proportion of CD69- and CD38-expressing cells, and hyperactivated/exhausted CD4+ and CD8+ T-cell phenotypes unable to face CMV challenge. Conclusions We hereby describe a severe form of disseminated CMV disease after R-bendamustine treatment. Our observations strongly support the careful clinical monitoring of CMV reactivation/infection in oncologic patients undergoing this therapeutic regimen.

The objectives of the study were to evaluate the impact of aortic angulation (AA) on success of transcatheter aortic valve replacement (TAVR) with a new generation self-expandable prosthesis (Medtronic Evolut R®). Specific anatomical conditions, such as for example the presence of a horizontal aorta with elevated AA, have seemed to pose a significant challenge for the correct positioning and consequent functioning of self-expandable TAVR prostheses. We assessed 146 patients treated with Evolut R. AA was measured at computed tomography and two groups were identified using as cutoff the mean AA value. Acute outcomes were collected and compared. AA mean value was 49.6 ± 9.4° (AA ≥ 50°: 76 and AA

Background: We present our initial institutional experience with transaortic (TAo) transcatheter aortic valve implantation (TAVI) using a self-expanding aortic bioprosthesis. Methods: A total of 106 patients underwent TAo TAVI with Medtronic CoreValve through a small partial upper sternotomy. We focus our analysis on the overall perioperative results, procedural learning curve (first 30 patients), and midterm follow-up outcomes. Results: VARC-2 device success was achieved in 95 patients (89%), and there were no intraoperative deaths. Nine patients (8.4%) required a second valve and conversion to standard surgery was required in 2 patients (1.8%). The final aortic insufficiency was grade 0 in 65 patients (62%) and grade 1 in 39 (37%). Although patients treated in the TAo TAVI learning phase required a significantly longer radiation time and contrast agent use, device success (93.4% versus 88.2%; P = .7) and prostheses hemodynamics were similar. All-cause mortality at 30 days was 12% (13/106). At a median follow-up of 392 days (IQR: 216-494 days) estimated overall 1-year survival was 72%. No significant differences were reported in terms of 30-day and 1-year observed mortality, and estimated 1-year survival in the learning and later phase of TAo TAVI. Conclusion: TAo TAVI can be performed safely even in the very early phase of the learning curve. Although satisfactory results can be achieved from the beginning, a significant reduction in contrast agent use and radiological exposure are expected as the technique is mastered. Good hemodynamics have been documented and should be further improved with modifications achieved in the TAVI self-expandable valves technology.

During the Italian Phase-2 of the coronavirus pandemic, it was possible to restart elective surgeries. Because hospitals were still burdened with coronavirus disease 2019 (COVID-19) patients, it was focal to design a separate "clean path" for the surgical candidates and determine the possible effects of major surgery on previously infected patients.From May to July 2020 (postpandemic peak), 259 consecutive patients were scheduled for elective cardiac surgery in three different centers. Our original roadmap with four screening steps included: a short item questionnaire (STEP-1), nasopharyngeal swab (NP) (STEP-2), computed tomography (CT)-scan using COVID-19 reporting and data system (CO-RADS) scoring (STEP-3), and final NP swab before discharge (STEP-4).Two patients (0.8%) resulted positive at STEP-2: one patient was discharged home for quarantine, the other performed a CT-scan (CO-RADS:2), and underwent surgery for unstable angina. Chest-CT was positive in 6.3% (15/237) with mean CO-RADS of 2.93 ± 0.8. Mild-moderate lung inflammation (CO-RADS: 2-4) did not delay surgery. Perioperative mortality was 1.15% (3/259), and cumulative incidence of pulmonary complications was 14.6%. At multivariable analysis, only age and cardiopulmonary bypass (CPB) time were independently related to pulmonary complications composite outcome (age75 years: odds ratio [OR]: 2.6; 95% confidence interval [CI]: 1.25-5.57; p = 0.011; CPB 90 min. OR: 4.3; 95% CI: 1.84-10.16; p = 0.001). At 30 days, no periprocedural contagion and rehospitalization for COVID-19 infections were reported.Our structured roadmap supports the safe restarting of an elective cardiac surgery list after a peak of a still ongoing COVID-19 pandemic in an epicenter area. Mild to moderate CT residuals of coronavirus pneumonia do not justify elective cardiac surgery procrastination.

Percutaneous mitral valve repair with MitraClip XTR (Abbott Vascular) has been proposed in patients with Barlow's disease, as the extended length of the MitraClip XTR may facilitate "grasping" and limit the number of clips. However, the design of the MitraClip XTR includes arms that 3 mm longer than the NTR device as well as 2 additional frictional elements, and requires a patient selection based mainly on mitral valve tissue quality. We summarize our rationale for using the shorter and smaller MitraClip NTR in patients with Barlow's disease.

Background: We explored the long-term effects of cART on markers of gut damage, microbial translocation, and paired gut/blood microbiota composition, with a focus on the role exerted by different drug classes.Methods: We enrolled 41 cART naïve HIV-infected subjects, undergoing blood and fecal sampling prior to cART (T0) and after 12 (T12) and 24 (T24) months of therapy. Fifteen HIV-uninfected individuals were enrolled as controls. We analyzed: (i) T-cell homeostasis (flow cytometry); (ii) microbial translocation (sCD14, EndoCab, 16S rDNA); (iii) intestinal permeability and damage markers (LAC/MAN, I-FABP, fecal calprotectin); (iv) plasma and fecal microbiota composition (alpha- and beta-diversity, relative abundance); (v) functional metagenome predictions (PICRUSt).Results: Twelve and twenty four-month successful cART resulted in a rise in EndoCAb (p = 0.0001) and I-FABP (p = 0.039) vis-à-vis stable 16S rDNA, sCD14, calprotectin and LAC/MAN, along with reduced immune activation in the periphery. Furthermore, cART did not lead to substantial modifications of microbial composition in both plasma and feces and metabolic metagenome predictions. The stratification according to cART regimens revealed a feeble effect on microbiota composition in patients on NNRTI-based or INSTI-based regimens, but not PI-based regimens.Conclusions: We hereby show that 24 months of viro-immunological effective cART, while containing peripheral hyperactivation, exerts only minor effects on the gastrointestinal tract. Persistent alteration of plasma markers indicative of gut structural and functional impairment seemingly parallels enduring fecal dysbiosis, irrespective of drug classes, with no effect on metabolic metagenome predictions.

Background There is extensive evidence to show that pre-exposure prophylaxis (PrEP) using tenofovir disoproxil fumarate (TDF)-based formulations dramatically reduces the risk of HIV acquisition among individuals without HIV infection. Here, the authors aim to compare tenofovir plasma predose concentrations in subjects taking PrEP daily versus on demand and using different TDF-based generic formulations. Methods Subjects providing informed signed consent for the measurement of tenofovir plasma levels were included in the study. Predose drug concentrations were stratified according to PrEP administration and the type of TDF-based formulation. The control group consisted of patients with HIV infection who were matched for renal function and were administered branded TDF that was not combined with boosted-antiretroviral drugs. Results The study consisted of 100 subjects (mean age, 39 ± 10 years; body weight, 77 ± 11 kg). A wide distribution in tenofovir predose concentrations was observed, with values ranging from 17 to 297 ng/mL (coefficient of variation 77%). No significant differences were noted in tenofovir predose concentrations between subjects who were administered PrEP daily (n = 75) or on demand (n = 25) [94 (35-255) versus 104 (37-287) ng/mL; P = 0.476]. Comparable tenofovir predose concentrations were found between patients with HIV infection (n = 220) who were administered branded TDF and those without HIV infection who were treated with 5 different generic TDF-based formulations with generics-to-branded ratios. These were always within the range of 80%-125% and were used to define bioequivalence. Conclusions The marketed generic formulations of TDF delivered tenofovir plasma predose concentrations comparable with those delivered by branded formulations.

Background: Out-of-center extracorporeal membrane oxygenation (ECMO) and extracorporeal life support (ECLS) implantation for the treatment of acute cardiorespiratory failure with subsequent transport to a tertiary care center has been introduced successfully into the medical practice. However, due to the very specific and resource intensive nature of this therapeutic concept, it seems important to generate algorithms for adequate patient selection. The aim of our study was to analyze the impact of patients’ gender on early clinical outcome in this specific therapeutic scenario. Methods: Ninety-seven consecutive patients treated by out-of-center ECMO/ECLS implantation and subsequent transport and treatment in our tertiary care cardiovascular center within the Hallesche Extracorporeal Life Support Program (HELP) retrospectively were analyzed, regarding the impact of patients’ gender on early clinical outcome. Results: Mechanical circulatory support successfully was weaned in two-thirds of the male patients. This result was achieved in only one-third of the female patients (59.4% in male vs. 33.3% in female, P = .0267). Overall survival significantly was higher in the male group (62.5% in male versus 30.3% in female, P = .0052). In uni- and multivariate logistic regression analysis, female gender was an independent predictor of in-hospital mortality (uni: OR:3.833, CI:1.597-9.745, P = .0034; multi: OR:3.477, CI:1.146-11.494, P = .0322). Worse outcome also was associated with following independent predictors, age, SOFA score, lactate and ventilation time pre-ECMO/ECLS implantation. Conclusion: The current study demonstrates a worse early survival for women, following emergent out-of-center ECMO/ECLS implantation and subsequent transport and treatment in our tertiary care cardiovascular center. Gender should be included in patient selection algorithms while basic research approaches are needed to better understand the mechanisms underlying these gender-specific outcome disparities.

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. The most feared complication of AF is thromboembolism. Oral anticoagulation (OAC) is the standard treatment to reduce thromboembolism occurrence in patients with AF. The rate of relevant bleeding, medical interactions and incompliance under OAC remains consistent. In this context, patients with AF at high risk for thromboembolism and with a contraindication to OAC may be considered as candidates for percutaneous left atrial appendage closure. In this review, we discuss the rationale, indications, technical aspects and clinical results of left atrial appendage closure by means of the WATCHMAN® (Boston Scientific, MA, USA) device.

Objective: The association between chronic autoimmune thyroiditis (CAT) and differentiated thyroid cancer (DTC) remains controversial. The incidence of DTC increases when screening procedures are implemented, as typically occurs in CAT patients being routinely submitted to thyroid ultrasound (US). The aim of this study was to longitudinally evaluate the long-term development of DTC in patients with CAT. Design and methods: A retrospective longitudinal cohort study was designed. For the study, 510 patients with chronic autoimmune thyroiditis (CAT) with a 10-year follow-up were enrolled. Patients were divided in two groups according to the presence (CAT+ NOD+; n = 115) or absence (CAT+ NOD−; n = 395) of co-existent nodules at diagnosis. The main outcome measures were appearance of new thyroid-nodules and development of DTC during follow-up. Results: During a 10-year median follow-up period, new thyroid-nodules were detected in 34/115 (29.5%) patients in the CAT+ NOD+ group and in 41/395 (10.3%) in the CAT+ NOD− group (P Conclusions: In our series of CAT patients, the appearance of new thyroid-nodules was frequent, but none of them were found to be malignant. The presence of CAT appears to be associated with a negligible risk of developing clinically overt DTC.

Background Permanent pacemaker implantation (PPMI) after transcatheter aortic valve implantation (TAVI) remains an issue open for criticism. Aim of this study is to investigate a strategy to reduce PPMI rate after TAVI in general and more specifically after implantation of the LOTUS® prosthesis. Methods Through our learning curve, we have developed a structured protocol to reduce PPMI rate. The protocol includes: shallow implantation depth within the native annulus, strict adherence to the international guidelines for PPMI, PPMI not earlier than 5 days after TAVI, and intravenous chronotropic and steroidal treatment (orciprenaline 0.6–1.7 mg/h i.v. and dexamethasone 25 mg/day i.v. for a maximum of 5 days) in case of acute onset of intraventricular and/or atrio-ventricular conduction disturbances after TAVI. Results The first 35 patients (group A) were managed as per routine in our early stage experience with the LOTUS valve. The PPMI reduction protocol was applied in the second phase on the last 31 patients (group B). The PPMI rate was reduced from 34.3% (12/35) to 9.7% (3/31) (p = 0.02). At logistic regression analysis being treated in the second phase of our experience (group B) had a protective effect against PPMI (p = 0.05; OR = 0.1; CI = 0.01–1.0). Prosthesis implantation depth was directly related to PPMI (p = 0.005; OR = 2.0; CI = 1.2–3.2). Receiver operating characteristic curve analysis confirmed that a LOTUS implantation depth > 4.8 mm was the cut-off to predict PPMI (AUC = 0.8; p = 0.003; CI = 0.6–0.9) with maximal sensitivity (78.6%) and specificity (73.2%). Conclusions PPMI rate after LOTUS can be reduced with experience by applying specific clinical and operative strategies.

Severe aortic valve stenosis (AVS) and mitral valve regurgitation (MVR) often coexist. Although a fully percutaneous treatment for the two conditions, by means of transcatheter aortic valve implantation (TAVI) followed by MitraClip, can be appealing in selected high-risk candidates, critical and strategical reasoning should be applied. In a 3-year period we have developed a single-centre experience of 14 patients who were managed with a staged percutaneous approach to treat severe AVS and MVR. The average interval from TAVI to MitraClip repair was 101 ± 12 days. Success for TAVI was 100% and 92.9% (13/14) for MitraClip. At late follow-up, 3 patients developed MVR 3+. Estimated 1‑year survival was 66.5%. Freedom from 1‑year endpoint (death, stroke, major bleeding, myocardial infarction, and cardiac re-hospitalisation) was 57.9%. In our view, a fully transcatheter approach for mitro-aortic pathology is feasible and should be performed only as a staged procedure in those patients that remain symptomatic, in spite of successful TAVI. It should be emphasised that although the periprocedural success rate is satisfactory, follow-up mortality and re-hospitalisation rates remain high, even at mid-term follow-up. This most probably results from the advanced clinical picture at time of referral for treatment.

AIMS The aim of this study was to identify the impact of previous aortic valve replacement (AVR) in MitraClip (MC) patients. METHODS AND RESULTS Data from the German transcatheter mitral valve interventions (TRAMI) registry were analysed in the light of previous AVR by means of either standard AVR (SAVR) or transcatheter AVR (TAVR). Out of 791 MC patients, 68 (8.6%) had been submitted to AVR (68.4% SAVR and 31.6% TAVR). The AVR group was significantly older (77.2±8.0 years vs. 75.1±8.6 years; p

We study variations of Hodge structures over a Picard modular surface, and compute the weights and types of their degenerations through the cusps of the Baily-Borel compactification. The main tool is a theorem of Burgos and Wildeshaus., final version

Background Data concerning the effect of chronic right ventricular pacing in patients with normal left ventricular ejection fraction (LVEF%) are contradictory. The aim of this study is to evaluate the prevalence of pacing-induced cardiomyopathy (PICM) at midterm follow-up after permanent pacemaker implantation (PPM). Methods A series of 170 patients were submitted to PPM within our facility. Inclusion criteria were the absence of structural heart disease and a preserved LVEF% (> 45%) at the time of PPM. A midterm clinical and echocardiographic follow-up was performed, and data were collected and analyzed retrospectively. PICM was defined as follow-up LVEF ≤ 45%, dyskinesia during RV pacing, and the absence of other known causes of cardiomyopathy. Results At a median echocardiographic follow-up of 24.5 months (IQR 10.0–43.0 months), the overall mean LVEF% decreased from a preimplantation value of 66.7% (± 8.6%) to 63.2% (± 10.6%) (p

In the present study, we have focused upon rates and clinical determinants of inappropriate shock (IS) after implantable cardioverter-defibrillator (ICD).Data were collected prospectively in the German Device II Registry.A total of 783 patients were included. Three sub-groups were identified: non-shock (NS) included 725 patients (92.6%), IS 24 (3.1%), and appropriate shock (AS) 34 (4.3%). IS patients were younger (AS 68 (58-77); IS 59 (51-68); NS 66 (56-75) years; p = 0.03), had been mainly referred for primary prophylaxis (AS 42.4%; IS 70.8%; NS 67.3%; p = 0.01), had a higher resting heart rate (AS 70 (63-80); IS 80 (71-98); NS 70 (60-81) BPM; p = 0.003), had more often atrial fibrillation (AF) (AS 14.7%; IS 45.8%; NS 18.8%; p = 0.006), and shorter QRS duration (AS 100 (90-120); IS 95 (90-100); NS 120 (98-150) msec.; p = 0.001). VVI-ICD was more common in IS (AS 64.7%; IS 83.3%; NS 49.8%; p = 0.002). At a follow-up of 18.2 months (75% IQR 13.6-22.4), no deaths were observed in the IS group, one (2.9%) in the AS, and 36 (4.9%) in the NS (p = 0.9). At logistic regression, VVI-ICD implantation was the strongest IS independent determinant (OR 5.0; 95% CI 1.6-15.9; p = 0.004) together with age 70 years (OR 4.6; CI 1.4-14.7; p = 0.009), AF at time of ICD implantation (OR 3.5; CI 1.3-9.1; p = 0.01), and resting heart rate 70/min (OR 2.8; CI 1.0-7.3; p = 0.03).In a contemporary setting, some specific conditions such as VVI-ICD, younger age, and faster resting heart rates remain important IS determinants after ICD implantation.

Background and Objective Despite integrase strand transfer inhibitor (INSTI)-containing regimens now being considered a preferred option for both initial therapy and switching strategies in virologically suppressed patients, their effects on lymphocyte phenotypes and functions in the course of effective combination antiretroviral therapy (cART) are still unclear. Thus, we investigated the effect of a 24-week elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/c/FTC/TDF) regimen on the T cell compartment and HIV reservoirs in HIV-infected patients switching from a suppressive protease inhibitor-based regimen. Methods Thirty HIV-positive patients receiving suppressive tenofovir disoproxil fumarate/emtricitabine (TDF + FTC) (for a median of 5 years) in association with either darunavir/ritonavir (DVR/r) (47%) or atazanavir/ritonavir (ATV/r) (53%) were followed up for 24 weeks after switching to EVG/c/FTC/TDF. At baseline (week 0 [W0]) and after 12 (W12) and 24 (W24) weeks we analyzed HLA-DR (human leukocyte antigen–DR isotype)/CD38/Ki67/CCR7 (C-C chemokine receptor type 7)/CD45RA/CD127/PD-1 (programmed cell death-1) on CD4/CD8, interferon (IFN)-γ/interleukin (IL)-2 after HIV/Staphylococcal enterotoxin B (SEB) exposure (flow cytometry); total, integrated, and unintegrated HIV-DNA; and residual low-level HIV viremia (quantitative polymerase chain reaction [qPCR]). Results While EVG/c/FTC/TDF introduction resulted in a stable CD4+ and CD8+ count, residual low-level HIV-RNA viremia, and HIV reservoirs, we observed a significant reduction in both activated CD4+ (p = 0.016) and CD8+ (p = 0.048) T cells, coupled with an increase in IL-2 and IFN-γ release by CD4+ and CD8+ effector memory T cells, and a decrease in cytokine production by terminally differentiated CD8+ T cells following SEB exposure. Furthermore, the magnitude of the reduction of activated HLA-DR + CD38 + CD8+ T cells (r = − 0.63, p = 0.014) inversely correlates with the amount of total HIV-DNA at W24. Conclusions Our data show a favorable effect of EVG/c/FTC/TDF switch to preserve immune activation-driven damage to T cell homeostasis, restore the multifunctional properties of effector T cells, and possibly contain cell-associated HIV viral burden in already virologically suppressed patients.

Objectives We present our single-centre experience with the direct flow medical (DFM) trans-catheter aortic valve implantation (TAVI) prosthesis addressing the impact of learning curve upon outcomes. Background The DFM has been recently introduced for TAVI. The prosthesis presents original design and implantation features. Methods Patients were divided into three groups according to the chronological implantation sequence that reflected technical skills acquisition of the entire team. Results Group I included the first 20 patients (early learning phase), group II the second 20 patients (proctoring to other members of the team), and group III the following 93 patients (technique consolidation). Differences in baseline and procedural variables were analysed. Nonparametric correlation and linear regression were used to identify changes according to institutional cumulative experience. There was a significant correlation between catheterisation time and institutional experience (rho = −0.4; p < 0.0001) confirmed at linear regression (beta = −0.2; p = 0.001; CI: −0.3 – −0.08). Moreover, there was lower rate of valve retrieval in group III (15% vs. 20% vs. 10%; p = 0.5). No intra-procedural mortality was reported and improved early safety (at 30 days) was observed (80% vs. 85% vs. 87.1; p = 0.7). At hospital discharge, valve haemodynamic performance was satisfactory with only mild regurgitation in 10% (I), 20% (II), and 9.7% (III) (p = 0.8). Conclusions DFM adequate sizing and implantation can be achieved after the early learning phases. A significant reduction in catheterisation time is reported after the first 20 patients. Results remain satisfactory during the proctoring and technical consolidation phase.

Objectives We present our single center experience with the direct flow medical (DFM) prosthesis addressing the impact of native aortic valve (AV) calcification degree on outcomes. Background The DFM® has been introduced for transcatheter aortic valve implantation (TAVI). The valve has a nonmetallic and inflatable support structure. Methods Patients were divided in two groups according to preoperative cardiac computed tomography (CT): group I moderate calcification and group II heavy calcification of the total AV area. We evaluated 118 patients: 53 (45%) group I and 65 (55%) group II. Results Preoperative trans-AV gradient and calcification extension across the aortic unit were significantly higher in group II (P = 0.008 and P

OBJECTIVES To analyze our single center experience with the Direct Flow Medical (DFM). BACKGROUND The DFM has been recently introduced to the market and large real world experiences are lacking. METHODS A total of 126 patients with severe aortic valve stenosis (AVS) were treated by the same team from March 2013 to May 2015. Device success and procedural safety were classified, according to valve academic research consortium (VARC) criteria, for the entire cohort, including patients treated in the early phases of our learning curve. RESULTS Clinical and trans-thoracic echocardiography follow-up was performed (median duration 279 days; 36-761 days). Mean age was 80.9 ± 5.5 years and median logistic Euro-SCORE was 15.9 (5.5-84.2). Cardiovascular 30-day mortality was 4.8% (6/126), device success 89.6% (113/126), and early safety 85.7% (108/126). At discharge, no aortic regurgitation (AR) was present in 85.7% and mild AR in 14.3% of the patients. Estimated 1-year follow-up survival was 91%. At follow-up, no AR was present in 87.3%, mild AR in 10.9%, and moderate AR in 1.8%. Mean gradient of 15.1 ± 6.3 mm Hg and prosthesis effective orifice area of 1.6 ± 0.6 cm2 were reported. CONCLUSIONS In this single center experience, the DFM valve showed satisfactory clinical and hemodynamic results. Short-term follow-up confirmed the consistent clinical results, with low rates of AR and acceptable trans-prosthetic gradients and prosthetic effective orifice area. © 2016 Wiley Periodicals, Inc.

Background Second-generation TAVI prostheses may enhance the procedure reducing operative time and complications rate, maintaining adequate valve hemodynamic performance. We present our results with 2 new generation trans-catheter aortic valve (TAVI) prostheses in obese patients. Methods A series of 172 patients underwent trans-femoral TAVI with new generation prostheses (Direct Flow Medical, DFM®, and LOTUS®). Two groups were identified according to body mass index (BMI): group NO (125) BMI 2 and group O (47) BMI≥30kg/m 2 . Results Trans-femoral approach was possible in all patients without conversion to conventional surgery/cardiopulmonary bypass. Operative/fluoroscopy time and contrast use were comparable. Vascular and bleeding complications were also equally represented in the 2 groups. Thirty-day mortality was 7.2% in group NO and 6.4% in group O (p=0.9). At discharge, aortic regurgitation was absent/mild in 96% of group NO and in all patients in group O (p=0.3). Mild prosthetic stenosis was reported in 3.8% of the patients in group NO and 2.2% in group O. No moderate/severe prosthetic stenosis was reported. Estimated 1-year survival was 93.1% in group NO and 83.2% in group O (p=0.6). Estimated 1-year freedom from MACCE was 74.7% in group NO and 62.8% in group O (p=0.4). At follow-up echocardiography no significant differences were noticed in the 2 groups. Conclusions Second generation TAVI prostheses allow for safe and effective procedures in obese patients. In spite of patient's body habitus, agile prosthesis placement will lead to optimized hemodynamics. Valve and clinical performance are confirmed at follow-up.

Hemodynamic alterations occur when the elephant trunk (ET) technique is adopted to treat extensive aortic aneurysms. In planning the 2nd stage operation to complete ET repair, surgeons must weigh an adequate recovery time after initial surgery against the risk of postoperative ET-related complications. The purpose of this study was to understand the mechanistic link between the flow alteration caused by the ET graft and the development of premature aortic rupture before the 2nd stage operation. Specifically, fluid-structure interaction (FSI) analysis was performed using the CT imaging data of aorta at different stages of ET repair, and then computational variables were compared to those observed in patients who underwent a prophylactic 2nd stage operation to complete aortic repair. Results show that intramural stress exerted near the distal ET anastomosis (IMS=37.5 kPa) at the time of urgent intervention was comparable to that of the extensive aortic aneurysm (IMS=47.4 kPa) at initial in-hospital admission, but was considerably higher than that occurring after the 1st stage procedure (IMS=3.5 kPa). Pressure index suggested higher peri-graft pressurization than aortic lumen pressure during diastole, imparting an apparent risk of aortic dilatation. These critical hemodynamic and structural parameters are related to the impending rupture of descending aorta observed clinically and can thus guide prophylactic intervention and optimal timing for the 2nd stage operation of a ET technique.