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Several electrocardiogram (ECG) criteria have been proposed to predict the location of the culprit occlusion in specific subsets of patients presenting with ST-segment elevation myocardial infarction (STEMI). The aim of this study was to develop, through an independent validation of currently available criteria, a comprehensive and easy-to-use ECG algorithm, and to test its diagnostic performance in real-world clinical practice.We analyzed ECG and angiographic data from 419 consecutive STEMI patients submitted to primary percutaneous coronary intervention over a one-year period, dividing the overall population into derivation (314 patients) and validation (105 patients) cohorts. In the derivation cohort, we tested60 previously published ECG criteria, using the decision-tree analysis to develop the algorithm that would best predict the infarct-related artery (IRA) and its occlusion level. We further assessed the new algorithm diagnostic performance in the validation cohort.In the derivation cohort, the algorithm correctly predicted the IRA in 88% of cases and both the IRA and its occlusion level (proximal vs mid-distal) in 71% of cases. When applied to the validation cohort, the algorithm resulted in 88% and 67% diagnostic accuracies, respectively. In a real-world comparative test, the algorithm performed significantly better than expert physicians in identifying the site of the culprit occlusion (P = .026 vs best cardiologist and P.001 vs best emergency medicine doctor).Derived from an extensive literature review, this comprehensive and easy-to-use ECG algorithm can accurately predict the IRA and its occlusion level in all-comers STEMI patients.

Background: New permanent pacemaker implantation (new-PPI) remains a compelling issue after Transcatheter Aortic Valve Replacement (TAVR). Previous studies reported the relationship between a short MS length and the new-PPI post-TAVR with a self-expanding THV. However, this relationship has not been investigated in different currently available THV. Therefore, the aim of this study was to investigate the association between membranous septum (MS)-length and new-PPI after TAVR with different Transcatheter Heart Valve (THV)-platforms. Methods: We included patients with a successful TAVR-procedure and an analyzable pre-procedural multi-slice computed tomography. MS-length was measured using a standardized methodology. The primary endpoint was the need for new-PPI within 30 days after TAVR. Results: In total, 1811 patients were enrolled (median age 81.9 years [IQR 77.2–85.4], 54% male). PPI was required in 275 patients (15.2%) and included respectively 14.2%, 20.7% and 6.3% for Sapien3, Evolut and ACURATE-THV(p ​< ​0.01). Median MS-length was significantly shorter in patients with a new-PPI (3.7 ​mm [IQR 2.2–5.1] vs. 4.1 ​mm [IQR 2.8–6.0], p ​= ​20%), MS length 3–7 ​mm intermediate risk for PPI (10–20%) and MS length > 7 ​mm defined a low risk for PPI (

Transcatheter aortic valve implant (TAVI) is gaining momentum in the treatment of severe, symptomatic aortic valve stenosis, and its indication is expanding to lower surgical risk individuals, who are generally younger and have a long life expectancy. Therefore, transcatheter bioprostheses durability appears of critical importance. Aim of the present study is to evaluate mid-term outcomes of TAVI in a high-volume single center cohort.We analyzed all consecutive patients (n = 408) who underwent transfemoral TAVI at a single, high-volume center, between 2007 and 2014. Study objectives were all-cause death and bioprosthetic valve failure (BVF) at long term follow-up. Structural valve deterioration (SVD), BVF and valve-related death were defined according to current international standards. Follow-up was performed by in person visit and transthoracic echocardiography, which was obtained only in a minority of patients, or phone call as per patient preference.At a median follow-up of 1821 days, overall mortality was 64.5%, with cardiovascular disease accounting for roughly half of total deaths. Valve-related deaths occurred in 10 patients. Seventeen patients were diagnosed with BVF, and 15 required repeat intervention. Moderate and severe SVD were observed in 10 and 7 patients, respectively. In the subgroup of patients with echocardiographic mid-term follow-up (n = 76), no significant increase of transprosthetic gradients nor increase of significant regurgitation was detected.In the present unselected, all-comers cohort, TAVI bioprostheses appeared to have excellent durability at long-term follow-up.

In contemporary Cardiac Intensive Care Unit (CICU), bedside intra-aortic balloon pump (IABP) insertion under echocardiographic guidance may be an attractive option for selected patients with cardiogenic shock (CS). Currently available data on this approach are limited.This study aimed to assess the feasibility and safety of bedside IABP insertion, as compared to fluoroscopic-guided insertion in the Catheterization Laboratory (CathLab), and to describe the clinical features of patients receiving bedside IABP insertion using a standardized technique in real-world CICU practice.We prospectively evaluated all patients admitted the CICU who received transfemoral IABP between June 2020 and October 2021. The overall study cohort was divided according to implant strategy in bedside and CathLab groups. The primary outcome was correct radiographic IABP positioning at the first bedside chest X-ray obtained after insertion. Secondary outcomes included IABP-related complications.Among 115 patients, bedside IABP insertion was performed in 35 (30.4%) cases, mainly presenting with CS-related to acute decompensated heart failure (ADHF) (68.6 vs 33.8%; p 0.001), with lower LVEF, higher proportion of right ventricular involvement and higher need of inotropes/vasopressors, compared to those receiving CathLab insertion. Bedside IABP insertion resulted feasible and safe, with similar rates of correct IABP positioning (82.9 vs. 82.5%; p = 0.963) and IABP-related major vascular complications (5.7 vs. 5.0%; p = 0.874), as compared to CathLab positioning.This study suggests the feasibility and safety of bedside IABP insertion, which could be of relevant interest in patients with ADHF-related CS who may not need coronary angiography or other urgent CathLab procedures.

Background and aim Measurement of cardiac index (CI) is crucial in the hemodynamic assessment of critically ill patients in the intensive care unit (ICU). The most reliable trans-thoracic echocardiography (TTE) technique for CI estimation is the left ventricular outflow tract (LVOT) Doppler method that requires, among other parameters, the LVOT cross-sectional area (CSA) measurement. However, geometrical assumptions inherent limitations and practical disadvantages related to the ICU setting, hamper LVOT-CSA assessment. In this study, we aimed to validate a simplified formula, leveraging only on LVOT-velocity time integral (VTI) and heart rate (HR) variables, for the non-invasive estimation of CI in ICU patients. Methods and Results We prospectively enrolled 50 consecutive patients admitted to our ICU requiring PAC over a one-year period. For each patient we measured the CI by PAC (CIPAC) and TTE. The latter was obtained both with the “traditional formula” (traditional CITTE), requiring LVOT-CSA assessment, and our new “simplified formula” (simplified CITTE). The correlation between the simplified CITTE and CIPAC was strong (r = 0.81) and resulted significantly greater than the traditional CITTE and CIPAC correlation (r = 0.70; p < 0.05 for Pearson r coefficients comparison). Both TTE-based CI showed an acceptable agreement (+0.19±0.48 L/min/m2 for simplified CITTE and -0.18±0.58 L/min/m2 for traditional CITTE) with the reference CIPAC. Conclusion In this study, we propose an easy-to-use and practical approach, leveraging on TTE LVOT-VTI and HR only, for non-invasive estimation of CI in ICU patients.

Measurement of cardiac index (CI) is crucial in the hemodynamic assessment of critically ill patients in the intensive care unit (ICU). The most reliable trans-thoracic echocardiography (TTE) technique for CI estimation is the left ventricular outflow tract (LVOT) Doppler method that requires, among other parameters, the LVOT cross-sectional area (CSA) measurement. However, inherent and practical disadvantages, mostly related to the ICU setting, hamper LVOT-CSA assessment. In this study, we aimed to validate a simplified formula, leveraging on LVOT-velocity time integral (VTI) and heart rate (HR) only, for non-invasive estimation of CI in ICU patients.We prospectively enrolled 50 consecutive patients admitted to our ICU requiring pulmonary artery catheterization (PAC) over a one-year period. For each patient we measured the CI by PAC (CIIn this study, we validated a practical approach, leveraging on TTE LVOT-VTI and HR only, for non-invasive estimation of CI in ICU patients.

Background Intracranial hemorrhage (ICH) represents the most serious complication of oral anticoagulant therapy (OAT) in patients with atrial fibrillation (AF), and AF patients with previous ICH are a challenge for clinicians. Left atrial appendage (LAA) occlusion has emerged as an alternative option for AF patients not suitable for OAT. Currently, few data are available on long term outcomes after LAA occlusion in this population. We evaluated the safety and efficacy of LAA occlusion in a cohort of patients with AF and previous ICH. Methods This is a multicenter, observational, retrospective study involving 5 LAA occlusion centers in Italy. It includes all consecutive patients (n = 120) with previous ICH who underwent LAA occlusion for nonvalvular AF and high thromboembolic risk. Procedural outcomes, post-procedural therapies and 12-months follow-up data were analyzed. Results The device was successfully implanted in 100% of cases, with a 6% of major peri-procedural complications. 59% had a prior ICH during OAT. The sample had a high risk of stroke (5.18%/year) and bleeding (6.62%/year). 30% were discharged on single and 54.2% on dual antiplatelet therapy. The expected annual risk for thromboembolism was 5.1%. Excluding periprocedural ischemic complications, the stroke annual rate was 1.8%. The expected annual risk of bleeding was 6.7%. The observed annual bleeding rate was 5.45%. Conclusions Percutaneous LAA occlusion is an effective option for AF patients and previous intracranial hemorrhage. After LAA occlusion, a single antiplatelet therapy strategy could be considered for patients with the highest risk of recurrent bleeding.

Extracorporeal membrane oxygenation (ECMO) represents a therapeutic option for cardiopulmonary support in patients with high-risk pulmonary embolism (PE); however, no definite consensus exists on ECMO use in high-risk PE. Hence, we aim to provide insights into its real-world use pooling together all available published experiences. We performed a systematic review and pooled analysis of all published studies (up to April 17, 2020) investigating ECMO support in high-risk PE. All studies including at least four patients were collectively analyzed. Study outcomes were early all-cause death (primary endpoint) and relevant in-hospital adverse events. A total of 21 studies were included in the pooled analysis (n = 635 patients). In this population (mean age 47.8 ± 17.3 years, 44.5% females), ECMO was indicated for cardiac arrest in 62.3% and immediate ECMO support was pursued in 61.9% of patients. Adjunctive reperfusion therapies were implemented in 57.0% of patients. Pooled estimate rate of early all-cause mortality was 41.1% (95% CI 27.7%-54.5%). The most common in-hospital adverse event was major bleeding, with an estimated rate of 28.6% (95%CI 21.0%-36.3%). At meta-regression analyses, no significant impact of multiple covariates on the primary endpoint was found. In this systematic review of patients who received ECMO for high-risk PE, pooled all-cause mortality was 41.1%. Principal indication for ECMO was cardiac arrest, cannulation was chiefly performed at presentation, and major bleeding was the most common complication.

ObjectiveTo assess the prevalence, characteristics and prognostic value of pulmonary hypertension (PH) and right ventricular dysfunction (RVD) in hospitalised, non-intensive care unit (ICU) patients with coronavirus disease 2019 (COVID-19).MethodsThis single-centre, observational, cross-sectional study included 211 patients with COVID-19 admitted to non-ICU departments who underwent a single transthoracic echocardiography (TTE). Patients with poor acoustic window (n=11) were excluded. Clinical, imaging, laboratory and TTE findings were compared in patients with versus without PH (estimated systolic pulmonary artery pressure >35 mm Hg) and with versus without RVD (tricuspid annular plane systolic excursion ResultsA total of 200 patients were included in the final analysis (median age 62 (IQR 52–74) years, 65.5% men). The prevalence of PH and RVD was 12.0% (24/200) and 14.5% (29/200), respectively. Patients with PH were older and had a higher burden of pre-existing cardiac comorbidities and signs of more severe severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (radiological lung involvement, laboratory findings and oxygenation status) compared with those without PH. Conversely, patients with RVD had a higher burden of pre-existing cardiac comorbidities but no evidence of more severe SARS-CoV-2 infection compared with those without RVD. The presence of PH was associated with a higher rate of in-hospital death or ICU admission (41.7 vs 8.5%, pConclusionsAmong hospitalised non-ICU patients with COVID-19, PH (and not RVD) was associated with signs of more severe COVID-19 and with worse in-hospital clinical outcome.Trial registration numberNCT04318366

Dual antiplatelet therapy combining aspirin with a P2Y12-receptor inhibitor reduces atherothrombotic events following an acute coronary syndromes (ACS), but the relative merits of different P2Y12 inhibitors remain unclear, despite several recent large-scale trials. We performed a network meta-analysis, representing the largest evidence to date to inform P2Y12 inhibitor choice in patients with ACS. Fourteen studies were included, for a total population of 145,019 patients. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were used in this systematic review. A network meta-analysis using a frequentist approach with surface under the cumulative ranking probability calculation was performed. Major adverse cardiovascular events (MACE), all-cause death, myocardial infarction (MI), definite stent thrombosis (ST) and major bleeding at 30-day and 1-year all-cause death and MI were the study endpoints. At 30-day, prasugrel was superior to both clopidogrel and ticagrelor in MACE, all-cause death and definite ST endpoints. Both prasugrel and ticagrelor were superior to clopidogrel in MI endpoint. Ticagrelor also reduced all-cause death compared with clopidogrel. Ticagrelor, prasugrel, and clopidogrel resulted equivalent in terms of the safety outcome of 30-day major bleeding. No significant difference was found among clopidogrel, prasugrel, and ticagrelor with respect to 1-year MACE outcome. Both prasugrel and ticagrelor reduced the occurrence of 1-year all-cause death compared with clopidogrel. Prasugrel reduced 1-year MI rate as compared with clopidogrel, while ticagrelor did not. At probability analyses, prasugrel ranked best in all 30-day and 1-year efficacy and safety endpoints. In conclusion, in this network meta-analysis, prasugrel showed the highest efficacy in reducing adverse outcomes in ACS patients and had the highest probability of being the best P2Y12 inhibitor to reduce hard adverse events both at 30-day and 1-year follow-up.

Background The ULISSE registry evaluated the real-world performance of the Ultimaster® biodegradable polymer sirolimus-eluting stent (BP-SES) in a multicenter-independent cohort of patients undergoing percutaneous coronary intervention, including a large proportion of diabetes mellitus (DM) patients. Methods In this subgroup analysis, 1,660 consecutive patients, 2,422 lesions, treated with BP-SES enrolled in the ULISSE registry were divided in two groups: DM (485 patients, 728 lesions) and non-DM (1,175 patients, 1,694 lesions). Primary endpoint was target lesion failure (TLF), a composite endpoint of cardiac-death, target-vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR) at 1-year. Secondary endpoint was TLR at 1-year. Results At 1-year follow-up TLF occurred in 5% overall patients and was significantly higher in DM patients (8 vs. 3.7%; p = .001), due to more cardiac deaths (3.4 vs. 1.1%; p = .002). TLR occurred in 3.2% overall patients, and it was not significantly higher in DM compared to non-DM patients (4.4 vs. 2.8%; p = .114). The incidence of stent thrombosis was low and similar between groups (0.4 vs. 0.9%; p = .526). Insulin-treated DM (ITDM) patients showed higher rate of TLF as compared to non-ITDM patients (13 vs. 6.5%; p = .041), but similar rate of TLR (6 vs. 4%; p = .405). After adjustment for relevant comorbidities, DM was not significantly associated with TLF or cardiac death in patients undergoing BP-SES implantation. Conclusions This study is the first all-comers evaluation of BP-SES in DM patients. Our findings show that DM patients, mostly those with ITDM, still represent a vulnerable population and experience significantly higher rate of TLF. Overall BP-SES efficacy is considerable, although not statistically significant higher rate of TLR is still present in DM compared to non-DM patients.

Pulmonary embolism (PE) represents the third leading acute cardiovascular syndrome in the world and it is burdened with high mortality and morbidity rates. Percutaneous or catheter-based treatments of high- and intermediate-risk patients have garnered interest because of the limitations of both systemic thrombolysis and anticoagulation strategies. However, data on these techniques are heterogeneous and limited to small non-randomized evidences.This survey was jointly performed by the GISE Young Committee with the support of the SICI-GISE Society and ICOT group with the aim of evaluating the view of the cardiology community on interventional therapies for PE. A web-based questionnaire based on 19 questions was distributed to SICI-GISE and ICOT members.The survey was distributed to 1550 physicians with 220 (14%) responses, 65% from North Italy. Multidisciplinary diagnostic and therapeutic pathways for patients with PE were not available in most centers (56%), and transcatheter treatment was available in 55% of centers, most of them at low volume (5 percutaneous treatments/year). Among the devices used, mechanical thrombectomy was the predominant one (62%) in the absence of significant differences in the availability of devices within the three Italian geographic macro-areas. Respondents recognize the theoretical benefits of percutaneous treatment of PE, including: improving a prompt hemodynamic stabilization and respiratory exchange (89%) in high-risk patients, avoiding hemodynamic deterioration (39%) and right ventricular dysfunction (51%) in intermediate-risk patients, and reducing hemorrhagic complications related to systemic thrombolysis (36%). According to participants' judgement, the main factors limiting the use of percutaneous transcatheter treatment of PE in clinical practice are the lack of specific operator training (60%), lack of solid clinical data to support it (39%), difficult patient selection (34%), high costs (30%), and risk of procedural complications (26%).Currently, transcatheter treatment of PE appears to be widely supported but poorly used in clinical practice. Solid evidences are needed regarding the safety and efficacy profile of the different available devices, the identification of patient selection criteria, alongside the enhancement of the availability of techniques and technologies.

Background The placebo effect is a well described phenomenon in blinded studies evaluating anti-anginal therapeutics, although its impact on clinical research metrics remains unknown. We conducted a systematic review and meta-analysis to quantify the impact of placebo on endpoints of symptoms, life-quality and functional outcomes in randomized placebo-controlled trials (RCTs) of symptomatic stable coronary artery disease. Methods We systematically reviewed MEDLINE, EMBASE, and the Cochrane database for double-blind RCTs of anti-angina therapeutics. Patients randomized to the placebo-arm were the study population. Main outcomes were the changes in exercise performance (exercise treadmill test [ETT] parameters), quality of life (Seattle Angina Questionnaire domains), symptoms (Canadian Cardiovascular Society angina class) and drug usage (nitroglycerin tabs/week) between baseline and following placebo. The primary outcome was ETT total duration time. Data were pooled with a random effect model. Results Seventy-eight RCTs (83% drug-controlled, 17% procedure-controlled) were included encompassing 4,925 patients randomized to placebo. ETT total duration time was significantly improved following placebo as compared to baseline (mean [95% confidence interval]: 29.2 [20.6-37.8] seconds) with evidence of high heterogeneity (I 2 = 98%) At subgroup analysis, crossover design was associated with a smaller placebo effect on ETT performance than parallel study design (p for interaction=0.001). A significant placebo effect was observed for all secondary outcomes with overall high heterogeneity. Conclusion A substantial placebo effect was present in angina RCTs across a variety of functional and life-quality metrics. High variability in placebo effect size was present, mostly unexplained by differences in study and patient characteristics (PROSPERO CRD42019132797).

Trials on intra-aortic balloon pump (IABP) use in cardiogenic shock related to acute myocardial infarction have shown disappointing results. The role of IABP in cardiogenic shock treatment remains unclear, and new (potentially more potent) mechanical circulatory supports with arguably larger device profile are emerging. A reappraisal of the physiological premises of intra-aortic counterpulsation may underpin the rationale to maintain IABP as a valuable therapeutic option for patients with acute decompensated heart failure and tissue hypoperfusion. Several pathophysiological features differ between myocardial infarction- and acute decompensated heart failure–related hypoperfusion, encompassing cardiogenic shock severity, filling status, systemic vascular resistances rise, and adaptation to chronic (if preexisting) left ventricular dysfunction. IABP combines a more substantial effect on left ventricular afterload with a modest increase in cardiac output and would therefore be most suitable in clinical scenarios characterized by a disproportionate increase in afterload without profound hemodynamic compromise. The acute decompensated heart failure syndrome is characterized by exquisite afterload-sensitivity of cardiac output and may be an ideal setting for counterpulsation. Several hemodynamic variables have been shown to predict response to IABP within this scenario, potentially guiding appropriate patient selection. Finally, acute decompensated heart failure with hypoperfusion may frequently represent an end stage in the heart failure history: IABP may provide sufficient hemodynamic support and prompt end-organ function recovery in view of more definitive heart replacement therapies while preserving ambulation when used with a transaxillary approach.

Introduction Based on recent data, the indication for transcatheter aortic valve implantation (TAVI) is expanding to individuals at lower surgical risk, who are generally younger than subjects historically treated for severe aortic stenosis. Indeed, younger patients have traditionally been under-represented in current TAVI literature. The aim of the present study is to report about clinical features, procedural outcomes and mid-term outcomes of patients younger than 70 who underwent TAVI in a single high-volume center. Materials and methods Consecutive patients younger than 70 years of age who underwent TAVI for severe, symptomatic aortic stenosis between 2007 and 2019 at a single, tertiary referral center have been included in this retrospective study. Procedural and mid-term outcomes were analyzed, comparing 1st generation with 2nd generation devices. Results Between 2007 and 2019, 1740 TAVI procedures were performed in our center. Among these, one hundred twenty-nine (7.4%) patients were younger than 70 years at the time of the intervention and were included in the present analysis. Fifty-eight patients (45%) were implanted with a 1st generation prosthesis while seventy-one patients (55%) were implanted with a 2nd generation device. Reasons which lead to a transcatheter approach in this population were: previous CABG (27.9%); porcelain aorta (24%); severe left ventricular systolic dysfunction (21.7%); prior chest radiation (19.4%); severe lung disease (8.5%); hemodynamic instability (7.0%); advanced liver disease (4.6%) and active cancer (3.9%). Overall device success rate was 89%, with no differences among 1st and 2nd generation devices. Threeyears all-cause mortality was 34%, with no difference among the two groups. Low incidence of aortic-valve re-intervention was observed at mid-term follow-up (late valve re-intervention = 2.3%). Conclusions TAVI in young patient with appropriate indication for intervention is a safe procedure, associated with low rate of in hospital mortality and low rate of severe complications both with 1st and with 2nd generation devices. When considering long term durability, more data are needed; in our case series long-term follow up shows a good survival and also an extremely low rate of valve re-intervention.

(1) Background: Patent foramen ovale (PFO) is a congenital abnormality present in up to 25% of the general population, and it is a relevant cause of cryptogenic stroke. We applied the hospital-based HTA model (AdHopHTA) to conduct a multidimensional assessment of NobleStitch EL, an innovative suture-mediated PFO closure device. We compared it to Amplatzer PFO Occluder (APO) to provide evidence to inform technologies’ governance in hospital settings. (2) Methods: For each AdHopHTA dimension we: systematically retrieved available evidence from the literature applying the PRISMA guidelines and then analyzed original clinical and cost data of a NobleStitch EL device at San Raffaele research hospital in Milan (Italy). The economic dimension was analyzed through activity-based costing and a cost analysis. We conducted semi-structured interviews with selected healthcare professionals to explore the organizational, legal, social, and ethical impact. (3) Results: A single study was included for the NobleStitch EL, with 10 for APO. Both literature data and original data showed comparable safety. Efficacy data analysis found that the PFO closure was at 89% for NobleStitch EL vs. 89–97% for APO. APO has a better impact on the budget and minor process costs. Consulted experts reported that the organizational impact of NobleStitch EL in the short and the long run as null, albeit a better impact under the social and the ethical aspects. (4) Conclusion: We suggest that there is inadequate evidence to conclude the relative efficacy of NobleStitch EL as compared to APO. Nevertheless, this report shows a good safety profile and higher costs for NobleStitch EL, with no organizational or legal impact. Further studies in selected population are recommended.

Background There is controversy as to whether iso-osmolar contrast media (IOCM) are associated with lower risk of contrast-induced acute kidney injury (CI-AKI), compared with low-osmolar contrast media (LOCM). We aimed to evaluate if a differential risk of CI-AKI exists after percutaneous coronary intervention (PCI) according to different contrast media (CM) types. Methods We performed a single-center retrospective study in a cohort of all-comers undergoing PCI between January 2012 and December 2016. CI-AKI was defined as an increase in serum creatinine ≥0.3 mg/dl or ≥50% within 72 h from PCI. IOCM were represented by iodixanol, whereas four different LOCM were utilized (ioversol, iopromide, iomeprol, iobitridol). Multiple-treatment inverse probability of treatment weighting (IPTW)-adjusted logistic regression analysis was performed to identify whether CM type was an independent predictor of CI-AKI. Results We included 2648 subjects (ioversol, n = 272; iopromide, n = 818; iomeprol, n = 611; iobitridol, n = 460; iodixanol, n = 487). CI-AKI occurred in 300 patients (11.7%) overall, with no differences across CM groups (ioversol 13.0%, iopromide 11.5%, iomeprol 10.2%, iobitridol 13.9%, iodixanol 11.3%; p = 0.42). CI-AKI requiring dialysis was observed in 8 patients (0.3%) overall (p = 0.50). On IPTW-adjusted analysis, none of the LOCM was associated with a significantly different risk of CI-AKI compared with iodixanol: ioversol OR 0.986 (95% confidence interval [CI] 0.611–1.591), iopromide OR 0.870 (95% CI 0.606–1.250), iomeprol OR 0.904 (95% CI 0.619–1.319), iobitridol OR 1.258 (95% CI 0.850–1.861). Conclusions In a large cohort of all-comers undergoing PCI, there were no differences in the adjusted risk of CI-AKI across 4 LOCM, compared with iodixanol.

AIM Coronary sinus (CS) reducer implantation is associated with symptomatic relief of patients with refractory angina. However, 15% to 30% of the patients do not respond to this treatment. Aim if this study was to evaluate the effect of CS size in the effectiveness of the device. METHODS Prior to device implantation and at 4-month resting ventricular function was assessed by stress cardiac magnetic resonance. Ischemia was assessed by the myocardial perfusion reserve index (MPRI). RESULTS Fifteen patients (66 ± 10 years) underwent successful CS Reducer implantation, with improvements in angina class and exercise tolerance. Patients with a smaller CS size (

Background The aim of the study was to demonstrate the safety and effectiveness of a suture-mediated vascular closure device to perform hemostasis after an axillary artery access during endovascular procedures on the aortic valve, the aorta and its side branches. Methods A physician-initiated, international, multicenter, retrospective registry was designed to evaluate the success rate (VARC-2 reporting standards) of percutaneous transaxillary access closure with a suture-mediated closure device. Secondary end points were minor access vascular complications, transient peripheral nerve injury, stroke, and influence on periprocedural outcomes of puncture technique. Results Three hundred thirty-one patients (median age, 76 years; 69.2% males) in 11 centers received a percutaneous transaxillary access during endovascular cardiac (n = 166) or vascular (n = 165) procedures. The closure success rate was 84.6%, with 5 open conversions (1.5%), 45 adjunctive endovascular procedures (13.6%), and 1 nerve injury (0.3%). Secondary closure success was obtained in 325 patients (98%) after 7 bare stenting, 37 covered stenting, and 1 thrombin injection. Introducer sheaths 16F or larger (odds ratio, 3.70; 95% confidence interval, 1.22-11.42) and balloon-assisted hemostasis (odds ratio, 4.45; 95% confidence interval, 1.27-15.68) were associated with closure failure. A threshold of five percutaneous axillary accesses was associated with decreased rates of open conversion, but not with increased primary closure success. Primary closure success was 90.3% in the 175 patients with sheaths smaller than 16F, performed after the first 5 procedures in each center. Temporary nerve injury and stroke were observed in 2% and 4% of patients, respectively. Conclusions Percutaneous transaxillary aortic procedures, in selected patients, can be performed with low rates of open conversion. The need for additional endovascular bailout procedures is not negligible when introducers sheaths 16F or larger are required.

To the best of our knowledge, this is the first description of intravascular-ultrasound guided coronary lithotripsy on saphenous vein graft because of severely calcific in-stent restenosis, showing good result without procedural complications.

OBJECTIVES Among patients undergoing transcatheter mitral valve repair with the MitraClip device, a relevant proportion (2–6%) requires open mitral valve surgery within 1 year after unsuccessful clip implantation. The goal of this review is to pool data from different reports to provide a comprehensive overview of mitral valve surgery outcomes after the MitraClip procedure and estimate in-hospital and follow-up mortality. METHODS All published clinical studies reporting on surgical intervention for a failed MitraClip procedure were evaluated for inclusion in this meta-analysis. The primary study outcome was in-hospital mortality. Secondary outcomes were in-hospital adverse events and follow-up mortality. Pooled estimate rates and 95% confidence intervals (CIs) of study outcomes were calculated using a DerSimionian–Laird binary random-effects model. To assess heterogeneity across studies, we used the Cochrane Q statistic to compute I2 values. RESULTS Overall, 20 reports were included, comprising 172 patients. Mean age was 70.5 years (95% CI 67.2–73.7 years). The underlying mitral valve disease was functional mitral regurgitation in 50% and degenerative mitral regurgitation in 49% of cases. The indication for surgery was persistent or recurrent mitral regurgitation (grade >2) in 93% of patients, whereas 6% of patients presented with mitral stenosis. At the time of the operation, 80% of patients presented in New York Heart Association functional class III–IV. Despite favourable intraoperative results, in-hospital mortality was 15%. The rate of periprocedural cerebrovascular accidents was 6%. At a mean follow-up of 12 months, all-cause death was 26.5%. Mitral valve replacement was most commonly required because the possibility of valve repair was jeopardized, likely due to severe valve injury after clip implantation. CONCLUSIONS Surgical intervention after failed transcatheter mitral valve intervention is burdened by high in-hospital and 1-year mortality, which reflects reflecting the high-risk baseline profile of the patients. Mitral valve replacement is usually required due to leaflet injury.

Background Prosthetic valve infolding is a rare but severe complication of transcatheter aortic valve implantation (TAVI) with self-expanding valves. However, currently available clinical data are limited and fragmented. Objectives This report aims to provide a comprehensive overview of this complication focusing on predisposing factors, clinical presentation, diagnostic findings, treatment and clinical outcomes. Methods A systematic review of the literature was performed to identify cases of infolding occurring during TAVI with self-expanding valves published until August 2020. These data were pooled with all the retrospectively identified infolding cases occurred at San Raffaele Scientific Institute between December 2014 and August 2020. Results A total of 34 cases were included. Among patients with available data, 38% received a first-generation CoreValve, and 62% a second-generation Evolut R (82%) or Evolut PRO (18%). Infolding occurred mostly with ≥29-mm valves (94%). Predisposing factors included resheathing of a second-generation valve (82%), heavy calcification of the native valve (65%), lack of predilatation (16%), Sievers type-1 bicuspid aortic valve (11%), and improper valve loading (5%). Infolding resulted in severe PVL causing hemodynamic instability (29%) or cardiac arrest (12%). Postdilatation was the treatment strategy in 68%, while prosthesis replacement with a new device in 23% of cases. Device success rate was 82%. Death and stroke occurred in 3% and 12% of cases. Conclusions Prosthetic valve infolding is typically observed after resheathing of a large-size self-expanding TAVI. When infolding is timely diagnosed, prosthesis removal and replacement should be pursued. Further studies are required to precisely define predisposing factors to prevent this complication.

Background Women have worse outcomes than men after PCI, with some studies suggesting a lower mortality of CABG vs PCI in females. Purpose To assess the outcomes of CABG and PCI according to sex in a large registry population of patients with unprotected left main coronary artery (ULMCA) disease. Methods The DELTA and DELTA 2 registries are two multicentric, prospective registries evaluating the outcomes of subjects undergoing coronary revascularization for ULMCA disease. Results Total population was 6253 patients, 27% women. Table 1 shows baseline clinical characteristics. Median follow up was of 880 days. Women undergoing CABG had lower incidence of death, myocardial infarction (MI) or cerebrovascular accidentc (CVA) (HR 0.53, 95% CI 0.35–0.79) and a lower risk of death (HR 0.40, 95% CI 0.24–0.67). No significant differences were observed in men (Figure 1A). SIgnificant interaction was observed between sex and revascularization strategy for both outcomes (p Conclusions In women undergoing coronary revascularization for ULMCA disease, CABG is associated to lower risk of death, MI or CVA. Further dedicated studies are needed to determine the optimal revascularization strategy in women with ULMCA disease. Figure 1 Funding Acknowledgement Type of funding source: None

Background High-risk acute pulmonary embolism (PE) is burdened by a mortality as high as 65%. VenoArterial ExtraCorporeal Membrane Oxygenation (VA-ECMO) may offer a cardiopulmonary support and a precious time window to ensure pulmonary reperfusion therapies. No definite consensus exists on the use of VA-ECMO in high-risk PE patients as only sparse observational studies are available yielding conflicting outcomes. Purpose To provide insights on the use of ECMO in acute high-risk PE pooling together all available published experiences to date. Methods Two authors (LB, AB) searched PubMed, Embase, BioMedCentral and Google Scholar, from inception to 18/09/2019. All published clinical studies investigating ECMO support in patients with high-risk acute PE were evaluated for inclusion. Results Literature search identified 384 observational studies: a total of 66 were included for 584 acute high-risk PE patients receiving ECMO support. Mean age was 46.8±16.8 years (44% female). Most patients presented with cardiac arrest (56%) or obstructive shock (42%). Diagnosis of PE was confirmed by computed tomography (CT) in 72%, performed before ECMO cannulation in 65%. Echocardiography was obtained in 89%. Right ventricle dilatation or dysfunction was found in 90% and 87%. ECMO was primarily employed as upfront treatment (63%), in the VA-ECMO configuration (94%). ECMO was equally employed in conjunction with interventional/surgical pulmonary reperfusion treatments (38%), with thrombolysis (35%) and without adjunctive procedures (40%). Mean ECMO support duration was 100.3±12.9 hours. Notably, 92% received thrombolysis before ECMO cannulation. ECMO bailout implant was mostly adopted in patients receiving thrombolysis (81% vs 19%; p=0.010), as a rescue therapy. Most common reperfusion procedures were surgical embolectomy (28%), catheter-directed thrombolysis (12%) and transcatheter embolectomy (12%). The majority of these procedures (81%) took place after ECMO cannulation. Mean total hospital stay was 17.8±11.6 days. Hospital survival rate was 54% and did not differ in upfront vs bailout ECMO (p=0.184) and between thrombolysis, interventional procedure and ECMO alone recipients (p=0.423). Neurologic death and non-fatal neurologic injury occurred both in 10%. Most patients (70%) were successfully weaned off ECMO, while 30% died on support and 7% died after ECMO removal. Acute kidney injury was the most common complication (47%). Major bleeding occurred in 19% and was fatal for 5%. Patients undergoing thrombolysis had a tendency towards higher rates of major bleeding (48% vs 23%; p=0.05). At a mean follow-up of 365.0 (IQR 202.5–365.9) days, overall survival rate was 85% in those surviving hospitalization. Conclusions In this pooled population consisting mostly of cardiac arrest/obstructive shock PE patients, ECMO strategy was associated with acceptable in-hospital survival and was frequently used in conjunction with other reperfusion treatments. Central Illustration Funding Acknowledgement Type of funding source: None

The coronavirus disease-2019 (COVID-19) pandemic has caused an enormous strain on healthcare systems and society on a global scale. We report a new phenomenon of medical care avoidance among patients with acute coronary syndrome, which is due to concerns about contracting severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection during hospital stay, ultimately leading to dire clinical outcomes. (Level of Difficulty: Beginner.), Graphical abstract, The coronavirus disease-2019 (COVID-19) pandemic has caused an enormous strain on health care systems and society on a global scale. We report a new…

Aims: Aortic stenosis (AS) grading by 2D-transthoracic echocardiography (2D-TTE) aortic valve area (AVA) calculation is limited by left ventricular outflow tract (LVOT) area underestimation. The combination of Doppler parameters with 3D LVOT area obtained by multidetector computed tomography (MDCT) can improve AS grading, reconciling discordant 2D-TTE findings. This study aimed to systematically evaluate the role of 3D-transesophageal echocardiography (3D-TEE) in AS grading using MDCT as reference standard. Methods and results: 288 patients (81±6.3years, 52.4% female) with symptomatic AS underwent 2D-TTE, 3D-TEE, and MDCT for transcatheter aortic valve implantation. Doppler parameters were combined with 3D LVOT areas measured by manual and semi-automated software 3D-TEE and by MDCT to calculate AVA, reassessing AS severity. Both 3D-TEE modalities demonstrated good correlation with MDCT, with excellent intra-observer and inter-observer variability. Compared to MDCT, 3D-TEE measurements significantly underestimated AVA (PANOVA&nbsp

SARS-CoV-2 outbreak has rapidly reached a pandemic proportion and has become a major threaten to global health. Although the predominant clinical feature of COVID-19 is an acute respiratory syndrome of varying severity, ranging from mild symptomatic interstitial pneumonia to acute respiratory distress syndrome, the cardiovascular system can be involved with several facets. As many as 40% hospitalized patients presenting with COVID-19 have pre-existing history of cardiovascular disease and current estimates report a proportion of myocardial injury in COVID-19 patients ranging up to 12%. Multiple pathways have been advocated to explain this finding and the related clinical scenarios, encompassing local and systemic inflammatory response and oxygen supply-demand imbalance. From a clinical point of view, cardiac involvement during COVID-19 may present a wide spectrum of severity ranging from subclinical myocardial injury to well-defined clinical entities (myocarditis, myocardial infarction, pulmonary embolism and heart failure), whose incidence and prognostic implications are currently largely unknown due to a significant lack of imaging data. The use of integrated heart and lung multimodality imaging plays a central role in different clinical settings and is essential in diagnosis, risk stratification and management of COVID-19 patients. Aim of this review is to summarize imaging-oriented pathophysiological mechanisms of lung and cardiac involvement in COVID-19 and to provide a guide for an integrated imaging assessment in these patients., Graphical abstract, Highlights • Although lung injury is predominant, cardiac involvement is present in up to 12% of COVID-19 patients. • Heart and lung multimodality imaging plays an essential role in different clinical settings in COVID-19 patients. • Multimodality imaging findings are useful in diagnosis, risk stratification and management of COVID-19 patients. • Strategies for preventing SARS-CoV-2 transmission during examinations in Imaging Departments must be adopted.