Aortopathy and aortic valve surgery in patients with bicuspid aortic valve with and without raphe.

AIM: To evaluate the association between raphe in bicuspid aortic valve (BAV) patients and valve dysfunction, aortopathy and aortic valve surgery in the REBECCA registry [REgistro della valvola aortica Bicuspide della Società Italiana di ECocardiografia e CArdiovascular Imaging (SIECVI)]. METHODS: Prevalence of aortic valve dysfunction and aortopathy was investigated in BAV patients with and without raphe. Aortic valve dysfunction (regurgitation or stenosis) was categorized as mild, moderate and severe. Aortopathy was defined as annulus ≥14 mm/m2; root ≥20 mm/m2; sinotubular junction ≥16 mm/m2; ascending aorta ≥17 mm/m2, and classified in Type A, isolated ascending aorta dilatation; Type B, aortic root and ascending aorta dilatation; and Type C, isolated aortic root dilatation. RESULTS: Overall, 695 patients with BAV were enrolled; 520 (74.8%) with raphe and 175 (25.2%) without raphe. BAV patients with raphe presented more frequently with moderate or severe aortic stenosis than BAV patients without raphe (183 [35.2%] vs 34 [19.4%], p < 0.001). A higher prevalence of aortopathy, particularly Type B, was observed in patients with vs without raphe. At multivariable analysis, raphe was a predictor of aortic valve surgery at three-year follow-up (odds ratio 2.19, 95% confidence interval 1.08-4.44, p < 0.001). CONCLUSIONS: Patients with BAV and raphe have a higher prevalence of significant aortic stenosis, aortopathy, especially Type B, and a higher risk of undergoing aortic valve surgery at three-year follow-up.

Clinical Features and Mortality Rate of Infective Endocarditis in Intensive Care Unit: A Large-Scale Study and Literature Review.

BACKGROUND: Large-scale multicentric studies reported that, despite advances in diagnosis, antibiotics, and surgical treatment, infective endocarditis (IE) in-hospital mortality remains high. Most data have been obtained from patients treated in infective disease wards, internal medicine, cardiology, or cardiac surgery departments and are therefore heterogeneous. The few studies focused on complicated IE patients leading to intensive care unit (ICU) admission have reported different methodologies and results. The aim of our study was to describe the epidemiological, clinical, and microbial features of critically ill patients admitted to the ICU with a definite IE diagnosis. METHODS: We conducted a prospective case-series population study from January 1, 1998, to December 31, 2020. Patients were divided into 2 groups: 'Ward' (group 1) and 'ICU' patients (group 2), and a 1-year follow-up was performed. RESULTS: After performing a univariate and multivariate logistic regression analysis, we found that the independent predictors of ICU admission were vegetation diameter >10 mm, abnormal PaO2/FiO2 ratio, and acute heart failure. Five independent mortality risk factors were identified: SOFA score >14, not performing surgery, age >70 years, acute heart failure, and embolic complications. CONCLUSIONS: Infective endocarditis in-hospital mortality remains high. ICU admission and mortality can be predicted by independent risk factors.

Frequency and Clinical Significance of Atrial Cavities in situ Thrombosis: A Large-Scale Study and Literature Review.

Background: Atrial tachyarrhythmias are the main cause of atrial thrombosis, and are usually in the left appendage. The prevalence and causes of endocavitarian thrombosis have not been investigated in recent large-scale studies. Aim of our work was to describe the epidemiology, the clinical characteristics and predisposing factors of "extra-appendicular" atrial thrombosis and to report a systematic review of recent literature. Methods and Results: 5,862 consecutive adult patients referred to a transesophageal echocardiographic exam, were enrolled. A total of 175 subjects with Atrial Thrombosis were found with a prevalence of 2.98%; among those 22 was found in left (0.38%) and 2 in the right (0.03%) atrium. Among the 22 patients with left atrial thrombosis, 8 were associated with prosthetic valves, 4 with mitral stenosis and the remaining with hypercoagulative conditions (cancer, septic shock, eosinophilic pneumonia, cardiogenic shock and warfarin under-dosage in permanent atrial fibrillation and decompensated heart failure). Cancer was associated in one of the two patients with a right atrial clot. The review of the literature from 2000 to December 2019 revealed conflicting results of 48 case reports of atrial cavity thrombosis; pooling this data proved the rarity of extra-appendage thrombosis and confirmed its association with a valvular heart disease or a systemic hypercoagulable state. Conclusions: Atrial "extra-appendage" thrombosis is a rare condition usually associated to "valvular" atrial fibrillation (such as prosthetic valves and mitral stenosis). A minority, but significant, cases are secondary to a thrombophilic conditions. In absence of valvular heart disease an underlying condition should be sought.

Left Atrial Thrombus-Are All Atria and Appendages Equal?

Although the left atrial appendage (LAA) seems useless, it has several critical functions that are not fully known yet, such as the causes for being the main origin of cardioembolic stroke. Difficulties arise due to the extreme range of LAA morphologic variability, making the definition of normality challenging and hampering the stratification of thrombotic risk. Furthermore, obtaining quantitative metrics of its anatomy and function from patient data is not straightforward. A multimodality imaging approach, using advanced computational tools for their analysis, allows a complete characterization of the LAA to individualize medical decisions related to left atrial thrombosis patients.

COVID-19 severity appears to be reduced in spring/summer.

BACKGROUND: because of different human behaviours, SARS-CoV-2 spread may be lower in spring/summer. On the contrary, it is not clearly known whether the clinical course/severity of hospitalized patients infected by SARS-CoV-2 can be different in the various seasons.. OBJECTIVES: to understand whether there were differences in severity of COVID-19 in patients who had contracted the infection in winter versus those infected in spring/summer. DESIGN: observational retrospective cohort study. SETTING AND PARTICIPANTS: from the administrative database of the SARS-CoV-2 surveillance system and that of hospital discharge, a cohort of patients (8,221, 653 of which were hospitalized) who tested positive to the RT-PCR test for SARS-CoV-2 between 01.12.2020 and 31.07.2021 in the Grosseto province (Tuscany Region, Central Italy) was selected and analysed. MAIN OUTCOME MEASURES: hospitalization rate and length, continuous positive airway pressure (CPAP) or non-invasive ventilation (NIV) use, Intensive Care Unite (ICU) admissions, intra-hospital mortality and PaO2/FiO2 values were measured and compared between subjects infected in winter and those who developed COVID-19 in spring/summer. Viral load (cycle threshold, Ct), vitamin D, serum ferritin, IL-6, procalcitonin, D-dimer, and C-reactive protein measured in the two periods were also compared. RESULTS: in the considered months, the hospitalization rate among 8,221 patients with COVID-19 was 8%: 370 (8.5%) individuals were hospitalized in winter and 283 (7,3%; p=0.31) in spring/summer; 62 (16.8%), 88 (23.8%), and 63 (17%) in winter and 28 (9.9%), 40 (14.1%), and 36 (12.7%) in spring/summer were admitted in ICU (p=0.01), used CPAP/NIV (p=0.002) and died (p=0.13), respectively. Hospitalization days were 14.5±11.6 in winter and 10.3±8.84 in spring/summer (p=0.001), while minimum PaO2/FiO2, measured during hospital stays was 123.2±38.6 in spring/summer and 112.6±40.8 in winter (p=0.054). Multivariate analysis (adjusted for all confounding factors) also confirmed reduced risks of having ICU admissions (0.53; 95%CI 0.32;0.88; p=0.01) and of using CPAP/NIV (0.48; 95%CI 0.32;0.75; p=0.001) in spring/summer when compared to winter. Hospitalization days and minimum PaO2/FiO2 were also lower in spring/summer (ß= -3.9; 95%CI -5.5;-2.2; p=0.001) and winter (ß= -17; 95%CI -0.93;35; p=0.06), respectively. The adjusted hazard ratio of mortality in winter, obtained with a Cox model, was higher of about 38% compared to spring/summer. No Ct values (viral load) differences were found either in winter (19.45±6.18) or spring/summer (20.3±6.7; p=0.343). IL-6, ferritin, procalcitonin, D-dimer were similar. Conversely, CRP was lower whereas vitamin D was higher in the warmer seasons. CONCLUSIONS: COVID-19 may be less severe during spring/summer in hospitalized patients. This does not seem to be influenced by different SARS-CoV-2 viral load in the different periods considered. C-reactive protein was found to be lower whereas vitamin D higher in the warmer months. It can be hypothesized that higher levels of vitamin D in spring/summer, compared to winter, may be associated to a positive modulation of COVID-19 induced inflammation with a possible disease severity reduction during spring/summer.

Sex differences in excessive oral corticosteroid exposure in poor adherent adult asthmatics overusing short-acting ß-2 agonists.

BACKGROUND: We know that excessive short-acting ß2-agonists (SABA) use in asthma may be associated to high exacerbation risks. We studied whether such excessive SABA consumption is connected with different higher oral corticosteroid (OC) prescriptions in the two sexes. METHODS: In our prescribing database, we searched subjects aged 18-40 years that were prescribed at least one SABA package/year and/or at least two ICS or two ICS/LABA boxes/year to identify asthmatics. Their OC prescriptions/year were also examined. Subjects were divided into 4 groups according to SABA packages/year prescribed (0, 1-2,3-6 and ≥7), considering sexes separately. RESULTS: Individuals recruited were 9,102. Subjects with at least one OC prescription were higher in each group and were females (P<0.001). The OC packages/year number was also more elevated in women especially those with >7 SABA prescriptions/year (0.96 in males vs. 2.64 in females, P<0.001). 94.7%/93.6% males/females, who never used SABA, took at least one ICS/LABA (mean 5.84/5.48 packages/year), while the subject percentage adhering to ICS/LABA dropped to 28-47% (mean 0.94-3.82 packages/year) in those who used SABA (P<0.001). Higher SABA prescriptions were associated with an increasing OC dispensation (ß=0.057, P<0.0001). We observed also a greater risk of using >3 OC packages/year in subjects with 3-6 (OR: 2.98 [95% CI: 2.19-4.06], P<0.001) and ≥7 (OR: 3.49 [95% CI: 2.39-5.10], P<0.001) SABA prescriptions compared to those that never used SABA. Besides, we found that using ICS (OR:0.51 [95% CI: 0.35-0.75], P<0.001) or ICS/LABA (OR:0.07 [95% CI: 0.05-0.09], P<0.001) may significantly reduce SABA prescriptions. CONCLUSIONS: Poor adherence to maintenance treatment appears to associated with excessive SABA prescriptions that may lead to a higher OC consumption particularly noticeable in women.

Left Atrial Thrombus-Are All Atria and Appendages Equal?

Although the left atrial appendage (LAA) seems useless, it has several critical functions that are not fully known yet, such as the causes for being the main origin of cardioembolic stroke. Difficulties arise due to the extreme range of LAA morphologic variability, making the definition of normality challenging and hampering the stratification of thrombotic risk. Furthermore, obtaining quantitative metrics of its anatomy and function from patient data is not straightforward. A multimodality imaging approach, using advanced computational tools for their analysis, allows a complete characterization of the LAA to individualize medical decisions related to left atrial thrombosis patients.

Ventricular tachycardia ablation guided or aided by scar characterization with cardiac magnetic resonance: rationale and design of VOYAGE study.

BACKGROUND: Radiofrequency ablation has been shown to be a safe and effective treatment for scar-related ventricular arrhythmias (VA). Recent preliminary studies have shown that real time integration of late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) images with electroanatomical map (EAM) data may lead to increased procedure efficacy, efficiency, and safety. METHODS: VOYAGE is a prospective, randomized, multicenter controlled open label study designed to compare in terms of efficacy, efficiency, and safety a CMR aided/guided workflow to standard EAM-guided ventricular tachycardia (VT) ablation. Patients with an ICD or with ICD implantation expected within 1 month, with scar related VT, suitable for CMR and multidetector computed tomography (MDCT) will be randomized to a CMR-guided or CMR-aided approach, whereas subjects unsuitable for imaging or with image quality deemed not sufficient for postprocessing will be allocated to standard of care ablation. Primary endpoint is defined as VT recurrences (sustained or requiring appropriate ICD intervention) during 12 months follow-up, excluding the first month of blanking period. Secondary endpoints will include procedural efficiency, safety, impact on quality of life and comparison between CMR-guided and CMR-aided approaches. Patients will be evaluated at 1, 6 and 12 months. DISCUSSION: The clinical impact of real time CMR-guided/aided ablation approaches has not been thoroughly assessed yet. This study aims at defining whether such workflow results in more effective, efficient, and safer procedures. If proven to be of benefit, results from this study could be applied in large scale interventional practice. Trial registrationClinicalTrials.gov, NCT04694079, registered on January 1, 2021.

Incidence and clinical relevance of left atrial appendage membranes: a new congenital heart disease?

AIMS: Left atrial appendage (LAA) membranes are rare congenital anomalies. Those involving the appendage orifice may obstruct its emptying flows, thus promoting blood stasis and clot formation. However, the epidemiology of LAA membranes has never been studied and a correlation with appendage thrombosis has never been proved. Very few case reports described LAA membranes, therefore, their frequency and clinical significance are not known. Moreover, their presence and degree are of crucial importance in planning LAA percutaneous closure, a procedure whose indication is evolving, and whether their presence can represent technical issues during the device implantation is not known. This study aimed to evaluate the incidence and the clinical significance of LAA membranes. METHODS AND RESULTS: A population of 6030 consecutive transoesophageal echo (TOE) studies has been retrospectively reviewed in order to find those patients in whom an LAA membrane has been found. A literature research has been performed to review previous described cases. Among 6030 TOE cases, an LAA membrane has been described in 6 (prevalence of 1/1000). In one case, the membrane was associated to a severe LAA hypoplasia and in another case to an LAA thrombus (these represent the first cases ever described). All patients had an atrial fibrillation (AF) history and two were in AF during the TOE exam. CONCLUSION: LAA membranes are rare congenital abnormalities occasionally discovered during a TOE exam, frequently in patients affected by AF. In half of the cases, they obstruct the LAA flow, thus theoretically pre-disposing to clot formation. They may be rarely associated to an appendage hypoplasia. During a TOE exam, cardiac imagers should always rule out their presence.

Which LABA/LAMA should be chosen in COPD patients in real life?

BACKGROUND: Given COPD heterogeneity, we do not know if some LABA/LAMAs are more suitable for some COPD phenotypes. This real-life database study aimed to evaluate retrospectively the 4 LABA/LAMA effectiveness and highlight possible specificities that could better guide us in choosing the right LABA/LAMA to be used. METHODS: We searched for subjects (1,779) adherent to umeclidinium/vilanterol (UM/VI), indacaterol/glycopyrronium (IND/GLY), aclidinium/formoterol (ACLI/FOR) and tiotropium/olodaterol (TIO/OLO) treatments in our prescribing/dispensing database. Prescriptions for systemic corticosteroids (SC), antibiotics and salbutamol during one year of LABA/LAMA treatment were analyzed. RESULTS: A better adherence was found in individuals taking IND/GLY (10.42 ± 1.86 packages/year) compared with UM/VI (10.09 ± 1.9; p = 0.008), ACLI/FOR (9.8 ± 1.8; p = 0.001) and TIO/OLO (10.1 ± 2.1; p = 0.047). The number of patients that were prescribed at least one package of SC/year and their package numbers/year were similar in males/females, across age groups and in "non-frequent exacerbators" with the 4 LABA/LAMAs. More SC were taken by frequent exacerbators, whereas fewer SC/antibiotic packages were prescribed to subjects aged >80 years with all treatments. In patients treated with ACLI/FOR or TIO/OLO, lower risks to having antibiotic prescriptions were observed when UM/VI (0.698[0.516-0.945] and 0.696[0.491-0.985; p = 0.020 and p = 0.041) and IND/GLY (0.597[0.445-0.802] and 0.595[0.423-0.836]; p = 0.001 and p = 0.003) were considered as landmarks. Lower risks for salbutamol prescriptions were detected with UM/VI (0.678[0.480-0.958]; p = 0.027) and TIO/OLO (0.585[0.365-0.937]; p = 0.026) when ACLI/FOR was used as a reference. CONCLUSION: According to our retrospective database study, each LABA/LAMA could have a specific efficacy profile in COPD that might be considered for personalized therapy. However, head-to-head targeted trials aimed to assess the impact of different LABA/LAMAs on COPD are needed to confirm/disprove such results.

Reshaping of Italian Echocardiographic Laboratories Activities during the Second Wave of COVID-19 Pandemic and Expectations for the Post-Pandemic Era.

BACKGROUND: Cardiology divisions reshaped their activities during the coronavirus disease 2019 (COVID-19) pandemic. This study aimed to analyze the organization of echocardiographic laboratories and echocardiography practice during the second wave of the COVID-19 pandemic in Italy, and the expectations for the post-COVID era. METHODS: We analyzed two different time periods: the month of November during the second wave of the COVID-19 pandemic (2020) and the identical month during 2019 (November 2019). RESULTS: During the second wave of the COVID-19 pandemic, the hospital activity was partially reduced in 42 (60%) and wholly interrupted in 3 (4%) echocardiographic laboratories, whereas outpatient echocardiographic activity was partially reduced in 41 (59%) and completely interrupted in 7 (10%) laboratories. We observed an important change in the organization of activities in the echocardiography laboratory which reduced the operator-risk and improved self-protection of operators by using appropriate personal protection equipment. Operators wore FFP2 in 58 centers (83%) during trans-thoracic echocardiography (TTE), in 65 centers (93%) during transesophageal echocardiography (TEE) and 63 centers (90%) during stress echocardiography. The second wave caused a significant reduction in number of echocardiographic exams, compared to November 2019 (from 513 ± 539 to 341 ± 299 exams per center, -34%, p < 0.001). On average, there was a significant increase in the outpatient waiting list for elective echocardiographic exams (from 32.0 ± 28.1 to 45.5 ± 44.9 days, +41%, p < 0.001), with a reduction of in-hospital waiting list (2.9 ± 2.4 to 2.4 ± 2.0 days, -17%, p < 0.001). We observed a large diffusion of point-of-care cardiac ultrasound (88%), with a significant increase of lung ultrasound usage in 30 centers (43%) during 2019, extended to all centers in 2020. Carbon dioxide production by examination is an indicator of the environmental impact of technology (100-fold less with echocardiography compared to other cardiac imaging techniques). It was ignored in 2019 by 100% of centers, and currently it is considered potentially crucial for decision-making in cardiac imaging by 65 centers (93%). CONCLUSIONS: In one year, major changes occurred in echocardiography practice and culture. The examination structure changed with extensive usage of point-of-care cardiac ultrasound and with lung ultrasound embedded by default in the TTE examination, as well as the COVID-19 testing.

Imaging Quality Control, Methodology Harmonization and Clinical Data Management in Stress Echo 2030.

Stress echo (SE) 2030 study is an international, prospective, multicenter cohort study that will include >10,000 patients from ≥20 centers from ≥10 countries. It represents the logical and chronological continuation of the SE 2020 study, which developed, validated, and disseminated the "ABCDE protocol" of SE, more suitable than conventional SE to describe the complex vulnerabilities of the contemporary patient within and beyond coronary artery disease. SE2030 was started with a recruitment plan from 2021 to 2025 (and follow-up to 2030) with 12 subprojects (ranging from coronary artery disease to valvular and post-COVID-19 patients). With these features, the study poses particular challenges on quality control assurance, methodological harmonization, and data management. One of the significant upgrades of SE2030 compared to SE2020 was developing and implementing a Research Electronic Data Capture (REDCap)-based infrastructure for interactive and entirely web-based data management to integrate and optimize reproducible clinical research data. The purposes of our paper were: first, to describe the methodology used for quality control of imaging data, and second, to present the informatic infrastructure developed on RedCap platform for data entry, storage, and management in a large-scale multicenter study.

Stepwise approach for visualization and reconstruction of pulmonary valve with intracardiac echocardiography.

Ventricular tachycardia and premature ventricular complexes (PVCs) arising from right ventricular outflow tract (RVOT) are the most common type of ventricular arrhythmias (VAs) in patients without structural heart disease. Radiofrequency ablation is now the gold standard of treatment in this setting due to high efficacy rates and optimal safety profile. During the last few years, the pulmonary valve (PV) and the pulmonary artery (PA) have attracted much attention as reliable sites of origin of RVOT-type arrhythmias. In the mean while intracardiac echocardiogram (ICE) has undoubtedly improved our understanding of the cardiac anatomy. Aim of this paper is to provide an illustrated step-by-step guide on how to use ICE with the CARTOSOUND module to visualize and reconstruct 3D shell of the RV, the PV, as well of other contiguous anatomical structures (i.e., the aortic valve and coronary arteries) to perform aware and safe ablation in this region.

Body mass index is related to unsuccessful puncture attempts and failure to axillary vein cannulation during ultrasound-guided cardiac electronic device implantation.

PURPOSE: Ultrasound (US)-guided axillary vein cannulation is effective and safe during cardiac implantable electronic devices (CIEDs). It is a reasonable alternative to other techniques in order to shorten procedural time and decrease perioperative complications. However, in this context, the short-axis (out-of-plane) visualization to guide the vein puncture is the most used technique. The aim of our study is to describe a single-center experience with the US long-axis (in-plane) technique defining predictors of unsuccessful puncture attempts and failure to axillary vein cannulation in a cohort of patients undergoing CIEDs procedures. METHODS: From November 2017 to June 2019, consecutive patients undergoing CIEDs procedures were enrolled in the study. US-guided long axis (in-plane) view to guide axillary vein cannulation was used in all subjects. Unsuccessful puncture attempts (UAs) and complete failures to cannulate the vein were collected for each procedure. All patients were evaluated on a daily basis until hospital discharge and at 1-month follow up visit. RESULTS: Among 119 subjects (M: F = 75:44), mean age was 79 ± 9 years, mean BMI 25.7 ± 4.3 kg/m2, and mean BSA 1.74 ± 0.4 m2. We placed 95 pacemakers (32 single-, 61 dual-, and 2 triple-chamber) and 20 ICDs (7 single, 6 dual, 7 triple chambers). An upgrade from dual-chamber to triple-chamber device was carried out with the addition of a new lead in 3 patients. During a system revision, one new electrode was implanted. The overall leads inserted were 204. There were 33 initial unsuccessful attempts in 22/119 patients. US-guided axillary access was finally successful in 94.9% of patients (113/119). In the other cases (6/119), cephalic vein was isolated or blinded subclavian puncture was performed. Interestingly, at univariate analysis, an increasing BMI and BSA, male sex, and anticoagulant therapy were predictors of unsuccessful attempts or failure to cannulate the vein with US. Among those subjects, the multivariate logistic regression showed significant correlations only between BMI and unsuccessful attempts: odds ratio (OR) = 1.16, p = 0.009 [95% CI = 1.04-1.31], and BMI with failure to cannulate the vein: OR = 1.21, p = 0.03 [95%CI = 1.01-1.45]. The receiver operating characteristic (ROC) curves individuated the best BMI value cutoff point at 27 kg/m2 (area under the curve [AUC]: 68.6%) having a sensitivity of 63.6% and a specificity of 66.5% for unsuccessful puncture attempts; a BMI value of 28 kg/m2 (AUC 74.9%) had a sensitivity of 66.7% and a specificity of 66.7% for failure to cannulate the vein with the US-guided approach. CONCLUSIONS: Axillary vein long-axis (in-plane) US-guided cannulation during CIEDs implantation is characterized by a high success rate (94.9%). An elevated BMI is significantly related to unsuccessful puncture attempts or failure to cannulation. The higher is the BMI, the more are the chances to have difficult vein puncture or cannulation failure and to switch from US-guided approach to another technique.

Discordant Echocardiographic Grading in Low Gradient Aortic Stenosis (DEGAS Study) From the Italian Society of Echocardiography and Cardiovascular Imaging Research Network: Rationale and Study Design.

BACKGROUND: Low-gradient aortic stenosis (LG-AS) is characterized by the combination of an aortic valve area compatible with severe stenosis and a low transvalvular mean gradient with low-flow state (i.e., indexed stroke volume <35 mL/m2) in the presence of reduced (classical low-flow AS) or preserved (paradoxical low-flow AS) ejection fraction. Furthermore, the occurrence of a normal-flow LG-AS is still advocated by many authors. Within this diagnostic complexity, the diagnosis of severe AS remains challenging. OBJECTIVE: The general objective of the Discordant Echocardiographic Grading in Low-gradient AS (DEGAS Study) study will be to assess the prevalence of true severe AS in this population and validate new parameters to improve the assessment and the clinical decision-making in patients with LG-AS. METHODS AND ANALYSES: The DEGAS Study of the Italian Society of Echocardiography and Cardiovascular Imaging is a prospective, multicenter, observational diagnostic study that will enroll consecutively adult patients with LG-AS over 2 years. AS severity will be ideally confirmed by a multimodality approach, but only the quantification of calcium score by multidetector computed tomography will be mandatory. The primary clinical outcome variable will be 12-month all-cause mortality. The secondary outcome variables will be (i) 30-day mortality (for patients treated by Surgical aortic valve replacement or TAVR); (ii) 12-month cardiovascular mortality; (iii) 12-month new major cardiovascular events such as myocardial infarction, stroke, vascular complications, and rehospitalization for heart failure; and (iv) composite endpoint of cardiovascular mortality and hospitalization for heart failure. Data collection will take place through a web platform (REDCap), absolutely secure based on current standards concerning the ethical requirements and data integrity.

[Balloon aortic valvuloplasty and transcatheter valve implantation in a patient with unicuspid aortic valve and cardiogenic shock due to severe aortic stenosis]. / Un raro caso di stenosi aortica severa su valvola monocuspide trattato in emergenza con valvuloplastica e impianto transcatetere di protesi valvolare aortica.

We report a case of cardiogenic shock due to severe aortic stenosis in a 55-year-old patient with a congenital unicuspid aortic valve (UAV). An emergent aortic valvuloplasty was performed in the spoke catheterization laboratory which allowed to achieve transient stabilization of the hemodynamic parameters and to move the patient to the nearest hub hospital with on-site cardiac surgery. Since the surgical risk of an aortic valve replacement was deemed too high, a transcatheter procedure was performed with implantation of a self-expandable prosthesis. The final result was suboptimal due to a moderate residual paravalvular leak, but the patient experienced rapid recovery and was discharged 10 days after the procedure. Just a few cases of transcatheter aortic valve replacement due to severe aortic stenosis in UAV have been described but, to the best of our knowledge, this is the first one in a clinical setting of cardiogenic shock. Although the gold standard treatment for UAV is surgical intervention, this case demonstrates that the transcatheter procedure is feasible and may play a role as a bridge to definitive surgical replacement.