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BACKGROUND: The present study is a sub-analysis of the multicenter, randomized PERSIST-AVR trial (PERceval Sutureless Implant versus Standard Aortic Valve Replacement) comparing the in-hospital and 1-year results of sutureless versus conventional stented bioprostheses in isolated surgical aortic valve replacement (SAVR) within two different surgical approaches: mini-sternotomy (MS) and full-sternotomy (FS).METHODS: A total of 819 patients (per-protocol population) underwent preoperative randomization to sutureless or stented biological valve at 47 centers worldwide. Sub-analysis on isolated SAVR was performed. Results were compared between sutureless and stented within the two different surgical approaches.RESULTS: 285 patients were implanted with Perceval (67% in MS) and 293 with stented valves (65% in MS). Sutureless group showed significantly reduced surgical times both in FS and MS. In-hospital results show no differences between Perceval and stented valves in FS, while a lower incidence of new-onset of atrial fibrillation (3.7% vs 10.8%) with Perceval in MS. After 1-year, use of sutureless valve showed a significant reduction of MACCE (5.2% vs 10.8%), stroke rate (1.0% vs 5.4%), new-onset of atrial fibrillation (4.2% vs 11.4%) and re-hospitalizations (21.8 days vs 47.6 days), compared to stented valves but presented higher rate of pacemaker implantation (11% vs 1.6%).CONCLUSIONS: Sutureless bioprosthesis showed significantly reduced procedural times during isolated SAVR in both surgical approaches. Patients with sutureless valves and MS access showed also better 1-year outcome regarding MACCEs, stroke, re-hospitalization and new-onset atrial fibrillation, but presented a higher rate of permanent pacemaker implantation compared to patients with stented bioprosthesis.

The current standard biomarker for myocardial infarction (MI) is high‐sensitive troponin. Although powerful in clinical setting, search for new markers is warranted as early diagnosis of MI is associated with improved outcomes. Extracellular vesicles (EVs) attracted considerable interest as new blood biomarkers. A training cohort used for diagnostic modelling included 30 patients with STEMI, 38 with stable angina (SA) and 30 matched‐controls. Extracellular vesicle concentration was assessed by nanoparticle tracking analysis. Extracellular vesicle surface‐epitopes were measured by flow cytometry. Diagnostic models were developed using machine learning algorithms and validated on an independent cohort of 80 patients. Serum EV concentration from STEMI patients was increased as compared to controls and SA. EV levels of CD62P, CD42a, CD41b, CD31 and CD40 increased in STEMI, and to a lesser extent in SA patients. An aggregate marker including EV concentration and CD62P/CD42a levels achieved non‐inferiority to troponin, discriminating STEMI from controls (AUC = 0.969). A random forest model based on EV biomarkers discriminated the two groups with 100% accuracy. EV markers and RF model confirmed high diagnostic performance at validation. In conclusion, patients with acute MI or SA exhibit characteristic EV biomarker profiles. EV biomarkers hold great potential as early markers for the management of patients with MI.

Cardiovascular (CV) disease represents the most common cause of death in developed countries. Risk assessment is highly relevant to intervene at individual level and implement prevention strategies. Circulating extracellular vesicles (EVs) are involved in the development and progression of CV diseases and are considered promising biomarkers. We aimed at identifying an EV signature to improve the stratification of patients according to CV risk and likelihood to develop fatal CV events. EVs were characterized by nanoparticle tracking analysis and flow cytometry for a standardized panel of 37 surface antigens in a cross-sectional multicenter cohort (n = 486). CV profile was defined by presence of different indicators (age, sex, body mass index, hypertension, hyperlipidemia, diabetes, coronary artery disease, cardiac heart failure, chronic kidney disease, smoking habit, organ damage) and according to the 10-year risk of fatal CV events estimated using SCORE charts of European Society of Cardiology. By combining expression levels of EV antigens using unsupervised learning, patients were classified into 3 clusters: Cluster-I (n = 288), Cluster-II (n = 83), Cluster-III (n = 30). A separate analysis was conducted on patients displaying acute CV events (n = 82). Prevalence of hypertension, diabetes, chronic heart failure, and organ damage (defined as left ventricular hypertrophy and/or microalbuminuria) increased progressively from Cluster-I to Cluster-III. Several EV antigens, including markers for platelets (CD41b-CD42a-CD62P), leukocytes (CD1c-CD2-CD3-CD4-CD8-CD14-CD19-CD20-CD25-CD40-CD45-CD69-CD86), and endothelium (CD31-CD105) were independently associated with CV risk indicators and correlated to age, blood pressure, glucometabolic profile, renal function, and SCORE risk. EV profiling, obtained from minimally invasive blood sampling, allows accurate patient stratification according to CV risk profile.

Inflammatory response following SARS-CoV-2 infection results in substantial increase of amounts of intravascular pro-coagulant extracellular vesicles (EVs) expressingtissue factor(CD142) on their surface. CD142-EV turned out to be useful as diagnostic biomarker in COVID-19patients. Here we aimed at studying the prognostic capacity of CD142-EV in SARS-CoV-2 infection. Expression of CD142-EV was evaluated in 261 subjects admitted tohospitalfor pneumonia and with a positive molecular test for SARS-CoV-2. The study population consisted of a discovery cohort of selected patients (n=60) and an independent validation cohort including unselected consecutive enrolled patients (n=201). CD142-EV levels were correlated with post-hospitalization course of the disease and compared to the clinically available 4C Mortality Score as referral. CD142-EV showed a reliable performance to predict patient prognosis in the discovery cohort (AUC=0.906) with an accuracy of 81.7%, that was confirmed in the validation cohort (AUC=0.736). Kaplan-Meier curves highlighted a high discrimination power in unselected subjects with CD142-EV being able to stratify the majority of patients according to their prognosis. We obtained a comparable accuracy, being not inferior in terms of prediction of patients' prognosis and risk of mortality, with 4C Mortality Score. The expression of surface vesicular CD142 and its reliability as prognostic marker was technically validated using different immunocapture strategies and assays. The detection of CD142 on EV surface gains considerable interest asrisk stratificationtool to support clinical decision making in COVID-19.

Background: Surgical aortic valve replacement with rapid deployment bioprosthesis guarantees good hemodynamic results but carries the risk of paravalvular leaks. To address this issue, an annulus stabilization technique has been recently developed. Methods: Clinical and hemodynamic parameters from patients treated for aortic valve replacement with the rapid deployment bioprosthesis and a concomitant annulus stabilization technique were prospectively collected and retrospectively analyzed. Echocardiographic data at discharge and at 1-year follow-up were collected and analysed. Results: A total of 57 patients (mean age 74.3 ± 6.1 years) with symptomatic aortic valve stenosis underwent aortic valve replacement with the rapid deployment bioprosthesis and concomitant annulus stabilization technique (mean valve size: 23.8 ± 1.9 mm). Combined procedures accounted for 56.1%. Hospital mortality was 1.8% and a new pacemaker for conduction abnormalities was implanted in 10 patients. The pre-discharge echocardiographic control showed absence of paravalvular leaks of any degree in all patients with mean valve gradient of 9.6 ± 4.0 mmHg. The 1-year echocardiographic control confirmed the good valve hemodynamic (mean gradient of 8.0 ± 2.8 mmHg) and absence of leaks. Conclusion: In this preliminary clinical experience, the annulus stabilization technique prevents postoperative paravalvular leaks after rapid deployment aortic valve implantation, up to 1-year postoperatively. Studies on larger series are of paramount importance to confirm the long-term efficacy of this new surgical technique.

Background Coronavirus-2 (SARS-CoV-2) infection causes an acute respiratory syndrome accompanied by multi-organ damage that implicates a prothrombotic state leading to widespread microvascular clots. The causes of such coagulation abnormalities are unknown. The receptor tissue factor, also known as CD142, is often associated with cell-released extracellular vesicles (EV). In this study, we aimed to characterize surface antigens profile of circulating EV in COVID-19 patients and their potential implication as procoagulant agents. Methods We analyzed serum-derived EV from 67 participants who underwent nasopharyngeal swabs molecular test for suspected SARS-CoV-2 infection (34 positives and 33 negatives) and from 16 healthy controls (HC), as referral. A sub-analysis was performed on subjects who developed pneumonia (n = 28). Serum-derived EV were characterized for their surface antigen profile and tested for their procoagulant activity. A validation experiment was performed pre-treating EV with anti-CD142 antibody or with recombinant FVIIa. Serum TNF-α levels were measured by ELISA. Findings Profiling of EV antigens revealed a surface marker signature that defines circulating EV in COVID-19. A combination of seven surface molecules (CD49e, CD209, CD86, CD133/1, CD69, CD142, and CD20) clustered COVID (+) versus COVID (-) patients and HC. CD142 showed the highest discriminating performance at both multivariate models and ROC curve analysis. Noteworthy, we found that CD142 exposed onto surface of EV was biologically active. CD142 activity was higher in COVID (+) patients and correlated with TNF-α serum levels. Interpretation In SARS-CoV-2 infection the systemic inflammatory response results in cell-release of substantial amounts of procoagulant EV that may act as clotting initiation agents, contributing to disease severity. Funding Cardiocentro Ticino Institute, Ente ospedaliero Cantonale, Lugano-Switzerland.

Background We investigated hospital and midterm outcome of patients operated for an aortic valve replacement (AVR) with a pericardial Perimount or a Porcine Hancock-II valve. Methods We analyzed 353 patients with Perimount Magna (n = 189) or Hancock-II valves (n = 164). Echocardiographic data, hospital outcome, and follow-up were collected and compared. The role of the type of valve on perioperative and midterm outcome was investigated. Results Mean age was 75.3 ± 6.8 and 74.3 ± 7.1 years (P = .17) for Perimount and Hancock-II group, respectively. Fifty-four Perimount (28.6%) and 24 patients with Hancock-II (14.6%) required urgent procedures (P = .002), including six type-A dissections and five endocarditis. EuroSCORE-II was 3.1 ± 2.7% (Perimount) and 2.7 ± 2.2% (Hancock-II). Combined procedures were performed in 115 Perimount (60.8%) and 71 patients with Hancock (43.3%); redo procedures counted for 1% and 2.4%, respectively (P = .42). Mean valve size was 23.2 ± 1.8 mm for pericardial and 23.6 ± 1.9 mm for porcine valves (P = .08). Hospital mortality (6.3% vs 2.4%; P = .05), kidney failure (11.6% vs 9.8%; P = .73), and new pacemaker implantation rates (6.3% vs 3.0%; P = .21) were higher in the Perimount group reflecting the fact that more urgent, combined, and critical procedures were implanted with a Perimount Magna. Overall, 51 patients died over 60 months (34 Perimount, 17 Hancock), corresponding to a mortality of 5.3 per 100-persons year (95% confidence interval [CI]: 3.8-7.4) and 3.0 (95% CI: 1.8-4.8), respectively. Survival at 5 years was 76% (95% CI: 68-82) and 83% (95% CI: 74-89) in the Perimount and Hancock groups (log-rank test; P = .099). Conclusions We confirm a good clinical outcome of patients with AVR with modern pericardial or a porcine bioprosthesis. Despite better hemodynamic, the Perimount does not improve the midterm clinical outcome compared with the porcine valve.

Trans-carotid access for trans-catheter aortic valve replacement is a valid alternative in patients with aortic valve dysfunction, severe peripheral vascular disease, and high-risk for surgery. However, in the event of the need for a bailout valve-in-valve procedure, the safety of this access site is uncertain. We report a patient with aortic regurgitation, previous coronary surgery, peripheral vascular disease, and impaired ventricular function who underwent a CoreValve Evolut-R (Medtronic Inc, Minneapolis, MN) implantation through the left carotid artery followed by a successful valve-in-valve procedure with a 26-mm Edwards Sapien3 valve (Edwards Lifesciences, Irvine, CA) through the same carotid access site.

Objective To compare the outcome and the 1-year hemodynamic results of the rapid-deployment Intuity valve versus the Perimount Magna bioprosthesis in matched populations. Methods Between March 2014 and May 2015, 32 patients underwent aortic valve replacement with the Intuity valve (Intuity-group). These patients were compared to a matched population of Perimount valves implanted during the same period of time (Perimount-group). Clinical data were compared and echocardiographic 1-year follow-up was performed. Results There were more female patients in the Intuity-group (47% vs 22%, p = 0.035); mean age was 78 ± 5.6 and 72.5 ± 6 years in the Intuity-group and Perimount-group (p

Delayed aortic regurgitation following Valsalva sinus re-dissection is a well-known complication that can occur at any time after surgery for type-A aortic dissection without root replacement. We describe a case of acute type-A dissection in an 81-year-old lady successfully treated with aortic valve resuspension and ascending aorta replacement with a 28-mm vascular graft. A month later, the patient was readmitted for worsening heart failure and a transthoracic echocardiogram showed severe aortic regurgitation secondary to non-coronary Valsalva sinus re-dissection and non-coronary aortic valve leaflet prolapse also confirmed at computed tomography scan. The patient successfully underwent a transfemoral transcatheter aortic valve implantation with a 29-mm CoreValve Evolut R and concomitant planned extracorporeal membrane oxygenation support.