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Debulking lesions with severe coronary artery calcification (CAC) is highly recommended to obtain good procedural and long-term success. Utilization and performance of coronary intravascular lithotripsy (IVL) after rotational atherectomy (RA) has not been thoroughly studied. This study aimed to evaluate the efficacy and safety of IVL with the Shockwave Coronary Rx Lithotripsy System in lesions with severe CAC as elective or bail-out strategy after RA. This observational, prospective, single-arm, multicenter, international, open-label Rota-Shock registry included patients with symptomatic coronary artery disease and lesions with severe CAC treated by percutaneous coronary intervention, including lesion preparation with RA and IVL, at 23 high-volume centers. Primary efficacy end point was procedural success, defined as final diameter stenosis National Heart, Lung and Blood Institute type B dissection, perforation, abrupt closure, slow or no flow, final thrombolysis in myocardial infarction flow National Heart, Lung and Blood Institute type B occurred in 3 patients (1.9%), whereas slow or no flow occurred in 8 (5.0%), final thrombolysis in myocardial infarction flow

Background: Hydroxychloroquine (HCQ) may be an effective, safe, and affordable treatment for Covid-19 that can be used in selected patients. However, more evidence on its association when it is used in different stages of the disease with clinical outcomes is required. This observational study investigates the association between treatment with HCQ and mortality in patients with Covid-19. Methods: The data from 6217 patients who died or were discharged from 24 Spanish hospitals were analyzed. Propensity matching scores (PMS) were used. Results: 5094 patients received HCQ. Death was recorded for 17.5% of those who had HCQ and 34.1% of those who did not have it. Mortality was lower for those who had HCQ, OR=0.41 (95% CI=0.34-0.48). The PMS analysis also showed that mortality was lower for those receiving HCQ, OR=0.47 (95%CI=0.36-0.62). PMS analysis for categories revealed an association between HCQ and lowered mortality for patients over 65 years of age, with a past medical history of hypertension, for those who were diagnosed during admission with sepsis related organ failure or pneumonia, and for those with lymphocytopenia, raised troponin, LDH, ferritin and D-dimer. No increase in mortality associated with HCQ was observed in any category of any of the variables investigated. Conclusions: HCQ could be associated with lower mortality for older patients, those with more severe disease and raised inflammatory markers. Further RCTs, observational studies, and summaries of both types of evidence on this topic are necessary to select the precise profile of patients that may benefit from HCQ.

Background Cardiac masses are commonly classified as neoplastic (primary and secondary) or non-neoplastic (e.g., thrombus or vegetation). Cardiac tumors are rare, and primary tumors are even rarer, with an estimated autopsy prevalence of < 0.1%. Differentiating between these masses is of paramount importance as treatment options greatly differ. Case presentation A 46-year-old male patient, current smoker, with family history of CAD and new onset hyperlipidemia and hypertension, underwent electrocardiogram (ECG) screening for an episode of chest pain. His ECG showed sinus rhythm with Q waves in inferior leads. The laboratory tests did not reveal any abnormality. His transthoracic echocardiogram showed normal biventricular function, and a lobular mass of 30×20 mm, that seemed in continuity with the antero-lateral (A-L) papillary muscle. For the presence of multiple cardiovascular risk factor, the patient underwent diagnostic coronary angiography which showed normal coronary arteries. Differential diagnoses were: hypertrophic cardiomyopathy with isolated hypertrophy of the A-L papillary muscle and LV mass. Cardiac magnetic resonance (CMR) was performed and demonstrated a pedunculated mobile non-enhancing 30×18mm mass within the LV anterior apex, that in the systolic phase contracts close relationships with the A-L papillary muscle which appears dislocated. This encapsulated formation determined a mild systolic obliteration of the LV cavity at the mid-apical portion. T1 imaging with and without suppression of adipose tissue, were compatible with cardiac intraventricular lipoma. The case was discussed in a multi-disciplinary heart team, and in accordance with the cardiac surgeon the patient underwent conservative management and follow up with echocardiography at 6 months and CMR at 1 year. Discussion Cardiac lipomas are rare benign primary cardiac tumors. They are usually indolent, asymptomatic and incidentally-discovered. Symptoms such as dyspnea, syncope or palpitations can occur if the tumor grows and causes LV obstruction, LV dysfunction or invasion of the conduction system. Sudden cardiac death has been reported, but the true incidence is unknown given its rarity. The most common location for cardiac lipomas is the inter-atrial septum, followed by endocardium of RA and LV. CMR is the imaging modality of choice when available and lipomas have a homogeneous appearance of increased signal intensity on T1-weighted imaging, with a reduction in signal intensity in fat-saturated sequences. As the prevalence of cardiac lipomas is very low, there are no randomized clinical trials or large prospective cohorts to provide guidance for optimal treatment. Embolization or infiltration of the myocardium are not common. For large lesions causing obstruction, surgical resection is usually indicated. Conclusion Cardiac lipoma is a rare primary tumor of the heart. The comprehensive evaluation is highly dependent on multimodality imaging methods. The best treatment strategy is still not clear and should be individualized.

Background The impact of complete revascularization (CR) on survival and occurrence of heart failure (HF) after ACS is still unsettled. Goal of this study was to evaluate the impact of CR on HF hospitalization and adverse outcomes in patients with ACS and multivessel coronary artery disease undergoing PCI. Methods Consecutive ACS patients with multivessel disease from the CORALYS registry were included. First hospitalization for HF or cardiovascular (CV) death was the primary endpoint. Patients were stratified according to CR. Results Of 14699 patients in the CORALYS registry, 5054 had multivessel disease. 1473 (29.2%) underwent CR, while 3581 (70.8%) did not. Over 5 years follow-up, CR was associated with a reduced incidence of the primary endpoint (adjusted HR 0.66, 95% CI 0.51-0.85), first HF hospitalization (adj HR 0.67, 95% CI 0.49-0.90), CV death (adj HR 0.56, 95% CI 0.38-0.84) and all-cause death (adj HR 0.74, 95% CI 0.56-0.97). The results were consistent in the matched population and in the IPTW analysis. The benefit of CR was consistent across ACS presentations (HR 0.59, 95% CI 0.39-0.89 for STEMI and HR 0.71, 95% CI 0.50-0.99 for NSTE-ACS) and in patients with LVEF>40% (HR 0.52; 95% CI 0.37-0.72), while no significant benefit was observed in patients with LVEF≤40% (HR 0.77; 95% CI 0.37-1.10, p for interaction 0.04). Conclusions In patients with ACS and multivessel disease, CR reduced the risk of first hospitalization for HF and CV death, as well as first HF hospitalization, CV and overall death. When feasible, CR should be performed in all patients with ACS to reduce the incidence of HF and death. Future studies are needed to assess the evidence of CR in patients with depressed LVEF.

Purpose: Higher risk of bleeding with ticagrelor over clopidogrel in elderly patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI) has been suggested. We assessed the incidence of major bleedings (MB), reinfarction (re-MI), and all-cause death to evaluate safety and efficacy of ticagrelor versus clopidogrel in such population. Methods: Real-world registries RENAMI and BleeMACS were merged. The pooled cohort was divided into two groups, clopidogrel versus ticagrelor. Statistical analysis considered patients

Background The use of Renin-Angiotensin system inhibitors (RASi) in patients with coronavirus disease 2019 (COVID-19) has been questioned because both share a target receptor site. Methods HOPE-COVID-19 (NCT04334291) is an international investigator-initiated registry. Patients are eligible when discharged after an in-hospital stay with COVID-19, dead or alive. Here, we analyze the impact of previous and continued in-hospital treatment with RASi in all-cause mortality and the development of in-stay complications. Results We included 6503 patients, over 18 years, from Spain and Italy with data on their RASi status. Of those, 36.8% were receiving any RASi before admission. RASi patients were older, more frequently male, with more comorbidities and frailer. Their probability of death and ICU admission was higher. However, after adjustment, these differences disappeared. Regarding RASi in-hospital use, those who continued the treatment were younger, with balanced comorbidities but with less severe COVID19. Raw mortality and secondary events were less frequent in RASi. After adjustment, patients receiving RASi still presented significantly better outcomes, with less mortality, ICU admissions, respiratory insufficiency, need for mechanical ventilation or prone, sepsis, SIRS and renal failure (p

BackgroundSmoking has been associated with poorer outcomes in relation to COVID-19. Smokers have higher risk of mortality and have a more severe clinical course. There is paucity of data available on this issue, and a definitive link between smoking and COVID-19 prognosis has yet to be established.MethodsWe included 5224 patients with COVID-19 with an available smoking history in a multicentre international registry Health Outcome Predictive Evaluation for COVID-19 (NCT04334291). Patients were included following an in-hospital admission with a COVID-19 diagnosis. We analysed the outcomes of patients with a current or prior history of smoking compared with the non-smoking group. The primary endpoint was all-cause in-hospital death.ResultsFinally, 5224 patients with COVID-19 with available smoking status were analysed. A total of 3983 (67.9%) patients were non-smokers, 934 (15.9%) were former smokers and 307 (5.2%) were active smokers. The median age was 66 years (IQR 52.0–77.0) and 58.6% were male. The most frequent comorbidities were hypertension (48.5%) and dyslipidaemia (33.0%). A relevant lung disease was present in 19.4%. In-hospital complications such sepsis (23.6%) and embolic events (4.3%) occurred more frequently in the smoker group (pConclusionSmoking has a negative prognostic impact on patients hospitalised with COVID-19.

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.

Background: Intravascular lithotripsy (IVL) showed to be effective in dilating heavily calcified de novo coronary lesions but little is known about its performance in under-expanded stents management. Aim of this study was to assess the feasibility, effectiveness and safety of IVL for the treatment of stent underexpansion refractory to balloon dilatation. Methods: A multicentre, retrospective cohort analysis was performed in patients undergoing IVL to treat under-expanded stents following non-compliant balloon expansion failure. Primary endpoint was successful IVL dilatation defined as IVL balloon delivery and application at the target site followed by an increase of at least 1 mm2 in minimal stent cross-sectional area (MSA) on intracoronary imaging or an increase of at least 20% in minimal stent diameter (MSD) by quantitative coronary analysis (QCA). Results: Thirty-nine under-expanded stents (34 patients) were included. Two cases (5.1%) of multiple stent layers and one (2.5%) acutely under-expanded stent were treated. The median IVL balloon diameter was 3.1 mm (IQR: 2.5–3.5 mm) while the number of pulses emitted was 56.7 (IQR: 30–80). IVL was successful in 34 cases (87.1%), with significant improvement in MSD (post: 3.23 mm [IQR: 3–3.5 mm] vs. pre: 0.81 mm [IQR: 0.35–1.2], p < 0.00001) and MSA (post: 7.61mm2 [IQR: 6.43–7.79mm2] vs. pre: 3.35 [IQR: 2.8–4 mm2], p < 0.00001). Non-fatal peri-procedural ST-elevation myocardial infarction occurred in one case (2.5%) due to IVL balloon rupture. No cardiac death, target lesion revascularization and stent thrombosis occurred in-hospital and at 30-day follow-up. Conclusions: Bailout IVL was feasible, efficacious and safe to improve refractory stent under-expansion.

Stent underexpansion increases the risk of cardiac adverse events. At present, there are limited options to treat refractory stent underexpansion. In this context, the intravascular lithotripsy (IVL) system might be a safe and effective strategy.We aimed to evaluate the safety and efficacy of IVL in addressing resistant stent underexpansion due to heavy underlying calcification.This was an international multicentre registry including patients receiving IVL therapy to treat stent underexpansion from December 2017 to August 2020. Angiographic and intracoronary imaging data were collected. The efficacy endpoint was device success (technical success with a final percentage diameter stenosis50%). The safety endpoint was in-hospital major adverse cardiac events (MACE).Seventy patients were included, the mean age was 73±9.2 years and 76% were male. The median time from stent implantation to IVL therapy was 49 days (0-2,537). Adjuvant treatment with non-compliant balloon dilatations pre- and post-IVL was performed in 72.3% and 76.8% of patients, respectively, and additional stenting was performed in 22.4%. Device success was 92.3%. Minimum lumen diameter increased from 1.49±0.73 mm to 2.41±0.67 mm (p0.001) and stent expansion increased by 124.93±138.19% (p=0.016). No IVL-related procedural complications or MACE were observed. The use of bailout IVL therapy directly after stenting and the presence of ostial underexpanded lesions negatively predicted lumen diameter gain.Coronary lithotripsy is safe and effective in increasing lumen and stent dimensions in underexpanded stents secondary to heavily calcified lesions.

Background Underexpanded stent in heavily calcified coronary lesion is common and persists over years. It is related to long-term failure and negative outcomes. Treatment of this situation after many years with intracoronary lithotripsy (ICL-Shockwave®) could be an option. Case summary We report a case of a man with underexpanded coronary stent implanted 11 years earlier. Optical coherence tomography highlighted the mechanism of stent underexpansion showing the presence of calcium stones under the old struts. Intracoronary lithotripsy crushed calcium under the stent struts causing its geometric change (from elliptical to round shape) and a consequent better transmission of the true radial force of the old stent. Discussion Heavily calcified coronary lesions lead to stent underexpansion which persists over years. Intracoronary lithotripsy could be a very late option to manage this unfavourable common result.

Background: Treatment of long coronary stenoses (LCS) with long tapered drug-eluting stents (LT-DES) would offer clinical and economic benefits. However, the feasibility of an interventional strategy based upon the systematic LCS treatment with an LT-DES has not been evaluated so far. Methods: We performed a multicenter prospective study including consecutive patients with: 1) An LCS > 25 mm at coronary angiography; 2) An attempt to fix the LCS with a single BioMime Morph ™ stent, a novel LT-DES available from 30 to 60 mm long. The primary efficacy endpoint was procedural success. The secondary safety endpoints were post-procedural TIMI3 flow, stent detachment during delivery, acute stent thrombosis and in-hospital mortality. Results: From February 2017 to March 2018, we recorded 272 patients with an LCS and an attempt to deploy an LT-DES during percutaneous coronary intervention (PCI) (69.3 ± 11.4 years, 75.7% males, 25.7% diabetic and 43.8% with acute coronary syndromes, mean LCS length 48.8 ± 9.5 mm). LT-DES deployment was successful in 262 patients (96.3%), and failure occurred without stent detachment or other complications. Final TIMI3 flow was present in 270 (99.3%) patients. In-hospital death occurred in five patients (1.8%), with no case of acute stent thrombosis, recurrent myocardial infarction or repeated revascularization. Conclusion: In this real-world study, a strategy of fixing LCS with a single LT-DES was feasible and safe, with a high rate of procedural success and a low rate of in-hospital complications. More extensive randomized studies are warranted to assess the potential clinical and economic benefits of LT-DES. Cardiol Res. 2020;11(4):219-225 doi: https://doi.org/10.14740/cr1055

Aims Whether patients with spontaneous coronary artery dissection (SCAD) should undergo an initial conservative management or immediate revascularization through percutaneous coronary intervention (PCI) remains debated. To investigate the frequency and predictors of choosing a strategy of immediate PCI for SCAD, and to compare the clinical outcomes of immediate PCI patients with those undergoing an initial strategy of medical management. Methods and results 369 patients enrolled in the multicentre international DIssezioni Spontanee COronariche (DISCO) registry between January 2009 and December 2020 were included. The primary endpoint was major adverse cardiovascular events (MACE), a composite of cardiac death, non-fatal myocardial infarction (MI) and any PCI. 240 (65%) patients underwent initial medical management, whereas 129 (35%) had immediate PCI. PCI patients presented more frequently with ST segment-elevation myocardial infarction (STEMI) (68.2% vs. 35%, P Conclusions The choice between an immediate medical or PCI management of SCAD is mostly driven by clinical presentation and procedural aspects. In the DISCO cohort, the primary treatment approach was not associated with the risk of short-to-midterm adverse events.

BackgroundStandard therapy for COVID-19 is continuously evolving. Autopsy studies showed high prevalence of platelet-fibrin-rich microthrombi in several organs. The aim of the study was therefore to evaluate the safety and efficacy of antiplatelet therapy (APT) in hospitalised patients with COVID-19 and its impact on survival.Methods7824 consecutive patients with COVID-19 were enrolled in a multicentre international prospective registry (Health Outcome Predictive Evaluation-COVID-19 Registry). Clinical data and in-hospital complications were recorded. Data on APT, including aspirin and other antiplatelet drugs, were obtained for each patient.ResultsDuring hospitalisation, 730 (9%) patients received single APT (93%, n=680) or dual APT (7%, n=50). Patients treated with APT were older (74±12 years vs 63±17 years, pConclusionsAPT during hospitalisation for COVID-19 could be associated with lower mortality risk and shorter duration of mechanical ventilation, without increased risk of bleeding.Trial registration numberNCT04334291.

To investigate the impact of pulmonary artery catheter (PAC) monitoring on survival of cardiogenic shock(CS), in the light of the controversies in available evidence.MEDLINE, EMBASE, Cochrane library and Web of Science were systematically screened to identify most relevant studies on patients with CS comparing PAC use to non-use during hospital stay. Short-term mortality was the primary endpoint and the use of Mechanical Circulatory Support (MCS) devices was the secondary one.Six observational studies including 1,166,762 patients were selected. The most frequent etiology of CS was post-myocardial infarction (75% [95% CI 55-89%] in PAC-group and 81%[95% CI 47-95%] in non-PAC group). Overall, PAC was used in 33%(95% CI 24-44%) of cases. Pooling data adjusted for confounders, a significant association between the PAC-group and a reduction in short-term mortality emerged when compared to the non-PAC group (36%[95% CI 27-45%] vs 47%[95% CI 35-59%];AdjustedOR 0.71, 95% CI 0.59-0.87, p0.01). MCS use was significantly higher in PAC vs non-PAC group (59% [95% CI 54-65%]) vs 48% [95% CI 43-53%]);OR 1.60 [95% CI 1.27-2.02, p0.01]).PAC was associated with lower incidence of short-term mortality in CS pooling adjusted observational studies. Prospective studies are needed to confirm our hypothesis and better clarify the mechanisms of this potential prognostic benefit.

Gender-related differences in COVID-19 clinical presentation, disease progression, and mortality have not been adequately explored. We analyzed the clinical profile, presentation, treatments, and outcomes of patients according to gender in the HOPE-COVID-19 International Registry. Among 2,798 enrolled patients, 1,111 were women (39.7%). Male patients had a higher prevalence of cardiovascular risk factors and more comorbidities at baseline. After propensity score matching, 876 men and 876 women were selected. Male patients more often reported fever, whereas female patients more often reported vomiting, diarrhea, and hyposmia/anosmia. Laboratory tests in men presented alterations consistent with a more severe COVID-19 infection (eg, significantly higher C-reactive protein, troponin, transaminases, lymphocytopenia, thrombocytopenia, and ferritin). Systemic inflammatory response syndrome, bilateral pneumonia, respiratory insufficiency, and renal failure were significantly more frequent in men. Men more often required pronation, corticosteroids, and tocilizumab administration. A significantly higher 30-day mortality was observed in men vs women (23.4% vs 19.2%; P = .039). Trial Numbers: NCT04334291/EUPAS34399.

Background Left atrial appendage (LAA) closure is an alternative to chronic oral anticoagulation for stroke prevention in patients with atrial fibrillation (AF) at high bleeding risk. Patients with a previous percutaneous closure of a patent foramen ovale (PFO) present an increased risk for developing AF during their life, and the presence of an atrial septal device renders future percutaneous left atrial access more challenging. Very few cases of LAA occlusion in patients with a preexisting PFO closure device have been previously reported. Case summary A 74-years old woman was admitted to our hospital for symptomatic severe anaemia during direct oral anticoagulant treatment. Her past medical history reported an ischaemic stroke at the age of 55, at that time a PFO was diagnosed and a STARFlex™ PFO occluder (NMT Medical, Boston, MA, USA) was implanted. During the current hospitalization, the patient underwent a colonoscopy that showed colonic angiodysplasias unsuitable for endoscopic treatment and LAA closure was indicated for stroke prevention. After a multimodality pre-procedural planning that included a transoesophageal echocardiogram, a cardiac computed tomography scan and a three-dimensional cardiac model printing, the procedure was planned and the LAA successfully occluded. Discussion LAA closure can be performed safely and effectively in patients carrying a previously implanted PFO occlusion device. In complex settings, a pre-procedural multimodality imaging is critical for improving the procedural safety and success rate. We describe the first case of percutaneous LAA closure in a patient with a prior PFO occlusion with the implantation of a STARflex™ septal occlusion device.

Background COronaVIrus Disease 19 (COVID-19) led to the reorganization of Cardiology Units in terms of working spaces and healthcare personnel. In this scenario, both outpatient visits and elective interventional cardiology procedures were suspended and/or postponed. We aimed to report the impact of COVID-19 on interventional coronary and structural procedures in Piedmont, Italy. Methods The number of coronary angiographies (CAG), percutaneous coronary interventions (PCI), primary PCI (pPCI), transcatheter aortic valve replacements (TAVR) and Mitraclip performed in Piedmont between March 1st and April 20th, 2020 (CoV-time) were collected from each catheterization laboratory and compared to the number of procedures performed the year before in the same months (NoCoV-time). Results Procedural data from 18 catheterization laboratories were collected. Both coronary (5498 versus 2888: difference: −47.5%; mean 305.4 VS 160.4; p = 0.002) and structural (84 versus 17: difference: −79.8%; mean 4.7 Vs 0.9; p, Highlights • COronaVIrus Disease 19 (COVID-19) led to the reorganization of Cardiology Units • Interventional procedures during COVID-19 suffered a dramatic decrease in Piedmont • Structured clinical pathways should be created, together with awareness campaigns.

Introduction The impact of Covid-19 on the survival of patients presenting with acute coronary syndrome (ACS) remains to be defined. Methods Consecutive patients presenting with ACS at 18 Centers in Northern-Italy during the Covid-19 outbreak were included. In-hospital all-cause death was the primary outcome. In-hospital cardiovascular death along with mechanical and electrical complications were the secondary ones. A case period (February 20, 2020-May 3, 2020) was compared vs. same-year (January 1–February 19, 2020) and previous-year control periods (February 20–May 3, 2019). ACS patients with Covid-19 were further compared with those without. Results Among 779 ACS patients admitted during the case period, 67 (8.6%) tested positive for Covid-19. In-hospital all-cause mortality was significantly higher during the case period compared to the control periods (6.4% vs. 3.5% vs. 4.4% respectively; p 0.026), but similar after excluding patients with COVID-19 (4.5% vs. 3.5% vs. 4.4%; p 0.73). Cardiovascular mortality was similar between the study groups. After multivariable adjustment, admission for ACS during the COVID-19 outbreak had no impact on in-hospital mortality. In the case period, patients with concomitant ACS and Covid-19 experienced significantly higher in-hospital mortality (25% vs. 5%, p Conclusion ACS patients presenting during the Covid-19 pandemic experienced increased all-cause mortality, driven by Covid-19 positive status due to higher rates of cardiogenic shock and sustained ventricular tachycardia. No differences in cardiovascular mortality compared to non-pandemic scenarios were reported.

Background: SARS-CoV-2 infection has caused a global pandemic. Many of the medications identified to treat COVID-19 could be connected with QTc prolongation and its consequences. Methods: Non-ICU hospitalized patients of the three centres involved in the study from the 19th of March to the 1st of May were included in this retrospective multicentre study. Relevant clinical data were digitally collected. The primary outcome was the incidence of QTc prolongation ≥ 500 ms, the main secondary outcomes were the Tisdale score ability to predict QTc prolongation and the incidence of ventricular arrhythmias and sudden deaths. Results: 196 patients were analysed. 20 patients (10.2%) reached a QTc ≥ 500 ms. Patients with QTc ≥ 500 ms were significantly older (66.7 ± 14.65 vs 76.6 ± 8.77 years p: 0.004), with higher Tisdale score (low 56 (31.8%) vs 0; intermediate 95 (54.0%) vs 14 (70.0%); high 25 (14.2%) vs 6 (30.0%); p: 0.007) and with higher prognostic lab values (d-dimer 1819 ± 2815 vs 11486 ± 38554 ng/ml p: 0.010; BNP 212.5 ± 288.4 vs 951.3 ± 816.7 pg/ml p

Aims The recent coronavirus disease 19 (COVID‐19) pandemic outbreak forced the adoption of restraint measures, which modified the hospital admission patterns for several diseases. The aim of the study is to investigate the rate of hospital admissions for heart failure (HF) during the early days of the COVID‐19 outbreak in Italy, compared with a corresponding period during the previous year and an earlier period during the same year. Methods and results We performed a retrospective analysis on HF admissions number at eight hospitals in Italy throughout the study period (21 February to 31 March 2020), compared with an inter‐year period (21 February to 31 March 2019) and an intra‐year period (1 January to 20 February 2020). The primary outcome was the overall rate of hospital admissions for HF. A total of 505 HF patients were included in this survey: 112 during the case period, 201 during intra‐year period, and 192 during inter‐year period. The mean admission rate during the case period was 2.80 admissions per day, significantly lower compared with intra‐year period (3.94 admissions per day; incidence rate ratio, 0.71; 95% confidence interval [CI], 0.56–0.89; P = 0.0037), or with inter‐year (4.92 admissions per day; incidence rate ratio, 0.57; 95% confidence interval, 0.45–0.72; P

BackgroundThe COVID-19 pandemic has seriously challenged worldwide healthcare systems and limited intensive care facilities, leading to physicians considering the use of non-invasive ventilation (NIV) for managing SARS-CoV-2-related acute respiratory failure (ARF).MethodsWe conducted an interim analysis of the international, multicentre HOPE COVID-19 registry including patients admitted for a confirmed or highly suspected SARS-CoV-2 infection until 18 April 2020. Those treated with NIV were considered. The primary endpoint was a composite of death or need for intubation. The components of the composite endpoint were the secondary outcomes. Unadjusted and adjusted predictors of the primary endpoint within those initially treated with NIV were investigated.Results1933 patients who were included in the registry during the study period had data on oxygen support type. Among them, 390 patients (20%) were treated with NIV. Compared with those receiving other non-invasive oxygen strategy, patients receiving NIV showed significantly worse clinical and laboratory signs of ARF at presentation. Of the 390 patients treated with NIV, 173 patients (44.4%) met the composite endpoint. In-hospital death was the main determinant (147, 37.7%), while 62 patients (15.9%) needed invasive ventilation. Those requiring invasive ventilation had the lowest survival rate (41.9%). After adjustment, age (adjusted OR (adj(OR)) for 5-year increase: 1.37, 95% CI 1.15 to 1.63, p2 saturation ConclusionNIV was used in a significant proportion of patients within our cohort, and more than half of these patients survived without the need for intubation. NIV may represent a viable strategy particularly in case of overcrowded and limited intensive care resources, but prompt identification of failure is mandatory to avoid harm. Further studies are required to better clarify our hypothesis.Trial registration numbersNCT04334291/EUPAS34399.

Background the coronavirus disease 2019 (COVID-19) is characterized by poor outcomes and mortality, particularly in older patients. Methods post hoc analysis of the international, multicentre, ‘real-world’ HOPE COVID-19 registry. All patients aged ≥65 years hospitalised for COVID-19 were selected. Epidemiological, clinical, analytical and outcome data were obtained. A comparative study between two age subgroups, 65–74 and ≥75 years, was performed. The primary endpoint was all cause in-hospital mortality. Results about, 1,520 patients aged ≥65 years (60.3% male, median age of 76 [IQR 71–83] years) were included. Comorbidities such as hypertension (69.2%), dyslipidaemia (48.6%), cardiovascular diseases (any chronic heart disease in 38.4% and cerebrovascular disease in 12.5%), and chronic lung disease (25.3%) were prevalent, and 49.6% were on ACEI/ARBs. Patients aged 75 years and older suffered more in-hospital complications (respiratory failure, heart failure, renal failure, sepsis) and a significantly higher mortality (18.4 vs. 48.2%, P < 0.001), but fewer admissions to intensive care units (11.2 vs. 4.8%). In the overall cohort, multivariable analysis demonstrated age ≥75 (OR 3.54), chronic kidney disease (OR 3.36), dementia (OR 8.06), peripheral oxygen saturation at admission 1 (OR 8.31) to be independent predictors of mortality. Conclusion patients aged ≥65 years hospitalised for COVID-19 had high rates of in-hospital complications and mortality, especially among patients 75 years or older. Age ≥75 years, dementia, peripheral oxygen saturation 1 were independent predictors of mortality in this population.

Background Presence of thrombus in the left atrial appendage (LAA) remains a severe contraindication to the percutaneous left atrial appendage closure procedure (LAAC), due to increased embolic risk. Recently, the experience developed in cerebral protection device in transcatheter aortic valve implantation (TAVI) procedure was translated in LAAC to address this issue. Aim To evaluate efficacy and safety of Sentinel cerebral protection system (CPS) in supporting LAAC in real-world patient with persistent LAA thrombus. Methods and results The study retrospectively enrolled consecutive patients with non-valvular atrial fibrillation (NVAF) and thrombus in LAA who underwent LAAC supported by Sentinel CPS in seven European high-volume centres. Twenty-seven patients were included with a median age of 69.1 ± 9.7 years old, with median CHA2 DS2 -VASc and HAS-BLEED scores 3 [2-5] and 3 [2.75-4], respectively. Technical and procedural success was achieved in all patients. No periprocedural TIA, stroke, or supra-aortic trunks dissection was recorded. Conclusions In this multicenter registry, LAAC supported by Sentinel CPS in patients with LAA persistent thrombus seems to be a safe and efficacious treatment.

Background: There are limited data regarding the impact of final kissing balloon (FKI) in patients treated with percutaneous coronary intervention using ultrathin stents in left main or bifurcations. Methods: All patients undergoing left main or bifurcations percutaneous coronary intervention enrolled in the RAIN registry (Very Thin Stents for Patients With MAIN or BiF in Real Life: The RAIN, a Multicenter Study) evaluating ultrathin stents were included. Major adverse cardiac event (a composite of all-cause death, myocardial infarction, target lesion revascularization, and stent thrombosis) was the primary end point, while its components, along with target vessel revascularization, were the secondary end points. The main analysis was performed comparing patients with and without FKI after adjustment with inverse probability of treatment weighting. Subgroup analyses were performed according to FKI (short [ Results: Two thousand seven hundred forty-two patients were included. At 16 months (8–20) follow-up, inverse probability of treatment weighting adjusted rates of major adverse cardiac event were similar between FKI and no-FKI group (15.1% versus 15.5%; P =0.967), this result did not change with use of imaging, proximal optimization technique, or routine versus bail-out FKI. In the 2-stent subgroup, FKI was associated with lower rates of target vessel revascularization (7.8% versus 15.9%; P =0.030) and target lesion revascularization (7.3% versus 15.2%; P =0.032). Short overlap FKI was associated with a lower rate of target lesion revascularization compared with no FKI (2.6% versus 5.4%; P =0.034), while long overlap was not (6.8% versus 5.4%; P =0.567). Conclusions: In patients with bifurcations or unprotected left main treated with ultrathin stents, short overlap FKI is associated with less restenosis. In a 2-stent strategy, FKI was associated with less target vessel revascularization and restenosis. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03544294.

Incidence and predictors of adverse events after dual antiplatelet therapy (DAPT) cessation in patients treated with thin stents (

Background A large trial established the favorable profile of a new polymer-free biolimus A9-eluting stent (PF-BES) with a 1-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients. This is the first study comparing outcomes for a 1-month versus longer DAPT strategies following PF-BES-percutaneous coronary intervention (PCI). Methods All patients undergoing PF-BES-PCI (January 2016 to July 2018) were included in the multicenter CHANCE registry. Patients were stratified according to DAPT strategy at discharge (planned 1-month vs. planned >1-month). Primary outcomes were the 390-day estimates of a patient-oriented and of a device-oriented composite endpoints (POCE: death, myocardial infarction [MI] or target vessel revascularization; DOCE: cardiac death, target vessel-MI or ischemia-driven target lesion revascularization). Landmark analyses from 1-month post-PCI were carried. Results Following PF-BES-PCI, 328(40.3%) and 485(59.6%) patients were discharged with 1-month and longer DAPT (12 months [6-12]), respectively. Patients with a previous or index MI were less likely to be discharged on 1-month DAPT. Patients prescribed with 1-month DAPT were more likely to be at HBR than those with longer DAPT (90.2% vs. 69.9%, p = .001). No between-groups differences in the primary outcomes (planned 1-month vs. planned >1-month DAPT: POCE 11.9% vs. 13.2%, p = .747; DOCE: 4.8% vs. 8.1%, p = .500) were observed, also after adjusting for confoundings (POCE: adjusted-hazard ratio [adj-HR] 1.26, 95%CI 0.74-2.13; DOCE: adj-HR 1.00, 95%CI 0.49-1.99). Landmark analyses showed similar results. Conclusions In a large all-comers registry of PF-BES PCI, no interaction of planned DAPT strategy (1-month vs. >1-month) with outcomes was found. This observation warrants investigation in adequately powered randomized studies (ClinicalTrials.gov NCT03622203).

Background Coronary Aneurysms are a focal dilatation of an artery segment >1.5-fold the normal size of adjacent segments. Although some series have suggested a prevalence of 0.3–12%, data are lacking. In addition, they are not mentioned in practice guidelines. Our aim was investigate its prevalence, management and long-term outcomes. Methods and results The coronary artery aneurysm registry (CAAR) involved 32 hospitals across 9 countries in America and Europe. We reviewed 436,467 consecutive angiograms performed over the period 2004–2016. Finally, 1565 patients were recruited. Aneurysm global prevalence was 0.35%. Most patients were male (78.5%) with a mean age of 65 years and frequent cardiovascular risk factors. The main indication for angiogram was an acute coronary syndrome, 966 cases. The number of aneurisms was ≤2 per patient in 95.8% of the cases, mostly saccular, most frequently found in the left anterior descending and with numbers proportional with coronary stenosis. Aortopathies were related with more aneurysms too. Most patients received any revascularization procedure (69%), commonly percutaneous (53%). After a median follow-up of 37.2 months, 485 suffered a combined event (MACE) and 240 died. Without major differences comparing CABG vs PCI, MACE and death were more frequent in patients who received bare metal stents. Conclusions Coronary artery aneurysms are not uncommon. Usually, they are associated with coronary stenosis and high cardiovascular risk. Antiplatelet therapy seems reasonable and a percutaneous approach is safe and effective.

Acute Coronary Syndrome during Covid-19 Outbreak During the Covid-19 outbreak in northern Italy, the daily rate of admissions for acute coronary syndrome at 15 hospitals was significantly lower tha...

Background: Anxiety disorders are more common in Takotsubo syndrome (TS) than in acute coronary syndrome patients. The aim of this study was to investigate whether pre-existing anxiety disorders predispose to TS triggered by exclusively emotional stressful events. Methods: Triggering events were compared in 58 TS patients with and without pre-existing anxiety disorders; clinical, electrocardiographic and echocardiographic data were also collected. Results: Thirty-one (53%) patients had a previous history of anxiety disorders. The exclusively emotional stressful event-rate was higher in TS patients with pre-existing anxiety disorder (74% vs. 30%, p = 0.001), while TS caused by an undetermined trigger were significantly higher in patients without anxiety disorders (33% vs. 10%, p = 0.027). Moreover, in TS patients without a previous history of anxiety disorders, a trend of higher prevalence of physical events was found (16% vs. 37%, p = 0.07). Conclusions: In patients with pre-existing anxiety disorders, TS was predominantly triggered by exclusively emotional stressful events, thereby suggesting a possible relationship between anxiety and emotional cardiac frailty in TS patients.

Aims The differential impact on ischaemic and bleeding events of the type of drug-eluting stent [durable polymer stents [DES] vs. biodegradable polymer stents vs. bioresorbable scaffolds (BRS)] and length of dual antiplatelet therapy (DAPT) remains to be defined. Methods and results Randomized controlled trials comparing different types of DES and/or DAPT durations were selected. The primary endpoint was Major Adverse Cardiovascular Events (MACE) [a composite of death, myocardial infarction (MI), and target vessel revascularization]. Definite stent thrombosis (ST) and single components of MACE were secondary endpoints. The arms of interest were: BRS with 12 months of DAPT (12mDAPT), biodegradable polymer stent with 12mDAPT, durable polymer stent [everolimus-eluting (EES), zotarolimus-eluting (ZES)] with 12mDAPT, EES/ZES with 12 months of DAPT (DAPT > 12 m). Sixty-four studies with 150 arms and 102 735 patients were included. After a median follow-up of 20 months, MACE rates were similar in the different arms of interest. EES/ZES with DAPT > 12 m reported a lower incidence of MI than the other groups, while BRS showed a higher rate of ST when compared to EES/ZES, irrespective of DAPT length. A higher risk of major bleedings was observed for DAPT > 12 m as compared to shorter DAPT. Conclusion Durable and biodegradable polymer stents along with BRS report a similar rate of MACE irrespective of DAPT length. Fewer MI are observed with EES/ZES with DAPT > 12 m, while a higher rate of ST is reported for BRS when compared to EES/ZES, independently from DAPT length. Stent type may partially affect the outcome together with DAPT length.

Transradial access (TRA) is often avoided in favor of the transfemoral access (TFA) during percutaneous coronary interventions of the unprotected left main coronary artery (ULM), due to technical and safety concerns. The aim of this study was to compare the performance of TRA and TFA in the treatment of ULM with second-generation drug-eluting stents. Consecutive patients who underwent percutaneous coronary intervention on ULM with second-generation drug-eluting stents were retrospectively enrolled in the multicenter Failure in Left Main Study With 2nd Generation Stents (FAILS 2) registry. Patients were stratified according to the arterial access. The choice between TRA and TFA was left to each operator's preferences. Bleedings during index hospitalization were the primary end point. Secondary end points were major adverse cardiovascular events (a composite of death, reinfarction, and target lesion revascularization), the single components of major adverse cardiovascular events at follow-up and stent thrombosis. Propensity score matching was executed to account for possible confounding. Overall, 1,247 patients were enrolled (23.2% [289] of female gender, mean age 70.2 ± 10.2 years). Diagnosis at presentation was stable angina in 603 (48.7%) cases, non–ST-segment elevation acute coronary syndrome in 465 (37.3%), ST-segment elevation myocardial infarction in 117 (9.5%). Mean follow-up was 726 ± 654 days. After propensity score with matching, 354 patients were included. The primary end point was significantly reduced in patients treated with TRA (2.0% vs 4.0%, p = 0.042), whereas no differences emerged pertaining the secondary end points, including target lesion revascularization and reinfarction. In conclusion, TRA may reduce in-hospital bleedings in patients undergoing percutaneous treatment of the ULM, without increasing the rate of adverse cardiovascular events at follow-up, and may therefore be safely used in the treatment of the ULM.

Incidence, predictors, and impact on prognosis of target lesion revascularization (TLR) for patients treated with second-generation drug-eluting stents (DESs) on unprotected left main (ULM) remain to be defined. The present study is a multicenter study including patients treated with a second-generation DES on ULM from June 2007 to January 2015. Rate of TLR was the primary end point. All cause death, myocardial infarction, target vessel revascularization, and stent thrombosis were the secondary end points. A total of 1,270 patients were enrolled: after a follow-up of 650 days (230 to 1,170), 47 (3.7%) of them underwent a re–percutaneous coronary intervention TLR on the left main, 22 during a planned angiographic follow-up. Extent of coronary artery disease was similar among groups (median value of Syntax of 27 ± 10 vs 26 ± 9, p = 0.45), as localization of the lesion in the ULM. Of patients reporting with TLR on ULM, 56% presented with a focal restenosis, 33% diffuse and 10% proliferative. At multivariate analysis, insulin-dependent diabetes mellitus increased risk of TLR (hazard ratio [HR] 2.0: 1.1 to 3.6, p = 0.04), whereas use of intravascular ultrasound resulted protective (HR 0.5: 0.3 to 0.9, p = 0.02). At follow-up, rates of cardiovascular death did not differ among the 2 groups (4% vs 4%, p = 0.95). At multivariate analysis, TLR on LM did not increase risk of all cause death (HR 0.4: 0.1 to 1.6, p = 0.22), whereas cardiogenic shock and III tertile of Syntax portended a worse prognosis (HR 4.5: 2.1 to 10.2, p = 0.01 and HR 1.4: 1.1 to 1.6, p = 0.03, respectively). In conclusion, repeated revascularization after implantation of second-generation DES on ULM represents an unfrequent event, being increased in insulin-dependent patients and reduced by intravascular ultrasound. Impact on prognosis remains neutral, being related to clinical presentation and extent of coronary artery disease.

Coronary artery aneurysm is defined as a coronary dilation that exceeds the diameter of adjacent segments or the diameter of the patient's largest normal coronary vessel by 1.5×. It is an uncommon disease that has been diagnosed with increasing frequency since the widespread appearance of coronary angiography. The published incidence varies from 1.5% to 5%, suggesting male dominance and a predilection for the right coronary artery. Although several causes have been described, atherosclerosis accounts for ≥50% of coronary aneurysms in adults. Reported complications include thrombosis and distal embolization, rupture, and vasospasm, causing ischemia, heart failure, or arrhythmias. The natural history and prognosis remain unknown, as definitive data are scarce. Controversies persist regarding the use of medical management (antithrombotic therapy) or interventional/surgical procedures. Only some case reports or small case series are available about this condition. The Coronary Artery Aneurysm Registry (CAAR; http://www.ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT02563626","term_id":"NCT02563626"}}NCT02563626) is a multicenter international ambispective registry that aims to provide insights on anatomic, epidemiologic, and clinical aspects of this substantially unknown entity. In addition, the registry will assess management strategies (conservative, interventional, or surgical) and their short‐ and long‐term results in a large cohort of patients. Clinical Trial registration: ClinicalTrials.gov. Unique identifier: {"type":"clinical-trial","attrs":{"text":"NCT02563626","term_id":"NCT02563626"}}NCT02563626.

Aims To assess whether radial compared with femoral access is associated with consistent outcomes in patients with ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation acute coronary syndrome (NSTE-ACS). Methods and results In the Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX (MATRIX) programme patients were randomized to radial or femoral access, stratified by STEMI (2001 radial, 2009 femoral) and NSTE-ACS (2196 radial, 2198 femoral). The 30-day co-primary outcomes were major adverse cardiovascular events (MACE), defined as death, myocardial infarction, or stroke, and net adverse clinical events (NACE), defined as MACE or major bleeding In the overall study population, radial access reduced the NACE but not MACE endpoint at the prespecified 0.025 alpha. MACE occurred in 121 (6.1%) STEMI patients with radial access vs. 126 (6.3%) patients with femoral access [rate ratio (RR) = 0.96, 95% CI = 0.75–1.24; P = 0.76] and in 248 (11.3%) NSTE-ACS patients with radial access vs. 303 (13.9%) with femoral access (RR = 0.80, 95% CI = 0.67–0.96; P = 0.016) (Pint = 0.25). NACE occurred in 142 (7.2%) STEMI patients with radial access and in 165 (8.3%) patients with femoral access (RR = 0.86, 95% CI = 0.68–1.08; P = 0.18) and in 268 (12.2%) NSTE-ACS patients with radial access compared with 321 (14.7%) with femoral access (RR = 0.82, 95% CI = 0.69–0.97; P = 0.023) (Pint = 0.76). All-cause mortality and access site-actionable bleeding favoured radial access irrespective of ACS type (Pint = 0.11 and Pint = 0.36, respectively). Conclusion Radial as compared with femoral access provided consistent benefit across the whole spectrum of patients with ACS, without evidence that type of presenting syndrome affected the results of the random access allocation.

AIM To determine the potential clinical impact of OCT (Optical Coherence Tomography) during primary percutaneous coronary intervention in patients presenting with ACS (Acute Coronary Syndrome). METHODS AND RESULTS FORMIDABLE is a multicentre retrospective registry enrolling all patients presenting with ACS and treated with an OCT-guided approach, while the USZ registry enrolled patients treated with a standard angiography guided approach. Multivariate adjustment was performed via a propensity score matching. The number stents useds was the primary outcome, while the incidence of MACE (a composite of death, myocardial infarction, target vessel revascularization, and stent thrombosis) was the secondary endpoint. A total of 285 patients OCT-guided and 1,547 angiography guided patients were enrolled, resulting in 270 for each cohort after propensity score with matching. Two stents were used in 12% versus 34%; 3 stents in 8% versus 38% of the patients (P

International audience; OBJECTIVES:Evaluate safety and efficacy of polymer-free biolimus-eluting stents (PF-BESs) versus ultrathin stents in unprotected left main (ULM) or bifurcation.BACKGROUND:PF-BESs due to reduced length of dual antiplatelet therapy (DAPT) are increasingly used. However, there are limited data about safety and efficacy for ULM or bifurcation.METHODS:We selected all-patients treated for ULM or bifurcation from two multicenter real life registries (RAIN [NCT03544294] evaluating ultrathin stents, CHANCE [NCT03622203] appraising PF-BES). After propensity score with matching, the primary endpoint was major adverse cardiac events (MACE; a composite of all-cause death, myocardial infarction, target lesion revascularization [TLR], and stent thrombosis [ST]), while its components along with target vessel revascularization (TVR) secondary endpoints.RESULTS:Three thousand and three patients treated with ultrathin stents and 446 with PF-BESs, resulting respectively in 562 and 281 after propensity score with matching (33 and 22%, respectively, with ULM disease). After 12 (8-20) months, rates of MACE were similar (9 vs. 8%, p = 0.56) without difference in TLR and ST (3.0 vs. 1.7%, p = .19 and 1.8 vs. 1.1%, p = .42). These results were consistent for ULM group (3 vs. 1.7% and 1.8 vs. 1.1%, p = .49 and .76), for non-ULM group (2.1 vs. 3.4%, p = .56 and 1.2 vs. 1.7%, p = .78) and for two-stent strategy (8.7 vs. 4.5% and 4.3 vs. 3.2%, p = .75 and .91). Among patients treated with 1 month of DAPT in both groups, those with ultrathin stents experienced higher rates of MACE related to all-cause death (22 vs. 12%, p = .04) with higher although not significant rates of ST (3 vs. 0%, p = .45).CONCLUSIONS:PF-BES implanted on ULM or BiF offered freedom from TLR and ST comparable to ultrathin stents. PF-BESs patients assuming DAPT for 1 month experienced a lower despite not significant incidence of ST.