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BACKGROUND: Sudden cardiac death (SCD) is a serious consequence of a myocardial infarction (MI), but identifying patients at risk of developing SCD remains a major clinical challenge especially in the case of juvenile MI. The aim of this study was to identify predictors of SCD after early-onset MI using long-term follow-up data relating to a large nationwide patient cohort. METHODS: The Italian Genetic Study on Early-onset MI enrolled 2,000 patients experiencing a first MI before the age of 45 years, who were followed up for a median of 19.9 years. Fine-Gray proportional hazard models were used to assess the associations between their clinical, demographic and index event data and the occurrence of SCD. RESULTS: SCD occurred in 195 patients, who were more frequently males, hypertensive and/or diabetic; had a history of previous thromboembolic events with a greater atherosclerotic burden; and had a lower left ventricular ejection fraction (LVEF) after the index event. Multivariable analysis showed that the independent predictors of SCD were diabetes, hypertension, previous thromboembolic events, higher Syntax score, and a lower LVEF. There was no clear evidence of the clustering of SCD events during follow-up. SCD was the first post-MI clinical event in 101 patients; the remaining 94 experienced SCD after a non-fatal MI or hospitalisation for coronary revascularisation. CONCLUSIONS: SCD frequently occurs during the 20 years after early-onset MI. The nature of the identified predictors and the absence of clustering suggests that the pathophysiological basis of SCD may be related to progressive coronary atherosclerosis.
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Background: Cardiac tamponade is a life-threatening compression of the heart caused by the accumulation of fluid in the pericardial sac. Although central venous catheters (CVCs) are essential in modern medicine, they carry a certain risk of complications including cardiac tamponade. Case summary: A 12-year-old female was involved in a road accident reporting multiple severe traumatic injuries, including a left humerus fracture and subdural haemorrhage. After 2 days in the intensive care unit, she suddenly developed hypotension and cardiac tamponade was diagnosed. Analysis of the pericardial fluid showed high glucose levels comparable to the parenteral nutrition that she was receiving. Retraction of the CVC allowed resolution of the effusion. Discussion: Cardiac tamponade is a rare but serious adverse event after CVC insertion, mostly among younger patients. Awareness of this risk allows physicians to promptly recognize and treat this dangerous complication.
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BACKGROUND: Withdrawal of life-sustaining therapy (WLST) performed in the circulatory determination of death (DCD) donors leads to cardiac arrest, challenging the utilization of the myocardium for transplantation. The rapid initiation of normothermic regional perfusion or extracorporeal membrane oxygenation after death helps to optimize organs before implantation. However, additional strategies to mitigate the effects of stress response during WLST, hypoxic/ischemic injury, and reperfusion injury are required to allow myocardium recovery. METHODS: To this aim, our team routinely used a preconditioning protocol for each DCD donation before and during the WLST and after normothermic regional perfusion/extracorporeal membrane oxygenation. The protocol includes pharmacological treatments combined to reduce oxidative stress (melatonin, N -acetylcysteine, and ascorbic acid), improve microcirculation (statins), and mitigate organ's ischemic injury (steroids) and organ ischemia/reperfusion injury (remifentanil and sevoflurane when the heart is available for transplantation). RESULTS: This report presents the first case of recovery of cardiac function, with the only support of normothermic regional reperfusion, following 20 min of a no-touch period and 41 min of functional warm ischemic time in a DCD donor after the preconditioning protocol. CONCLUSIONS: Our protocol seems to be effective in abolishing the stress response during WLST and, on the other hand, particularly organ protective (and heart protective), giving a chance to donate organs less impaired from ischemia/reperfusion injury.
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Oxigenación por Membrana Extracorpórea , Recuperación de la Función , Humanos , Masculino , Donantes de Tejidos , Trasplante de Corazón , Factores de Tiempo , Perfusión/métodos , Resultado del Tratamiento , Estrés Oxidativo , Muerte , Persona de Mediana Edad , Adulto , Isquemia Tibia/efectos adversosRESUMEN
BACKGROUND: Pulmonary capillary wedge pressure (PCWP) assessment is fundamental for managing dilated cardiomyopathy (DCM) patients. Although cardiovascular magnetic resonance (CMR) has become the gold-standard imaging technique for evaluating cardiac chamber volume and function, PCWP is not routinely assessed with CMR. Therefore, this study aimed to validate the left atrial expansion index (LAEI), a LA reservoir function parameter able to estimate filling pressure with echocardiography, as a novel CMR-measured parameter for non-invasive PCWP estimation in DCM patients. METHODS: We performed a retrospective, single-center, cross-sectional study. We included electively admitted DCM patients referred to our tertiary center for further diagnostic evaluation that underwent a clinically indicated right heart catheterization (RHC) and CMR within 24 h. PCWP invasively measured during RHC was used as the reference. LAEI was calculated from CMR-measured LA maximal and minimal volumes as LAEI = ( (LAVmax-LAVmin)/LAVmin) × 100. RESULTS: We enrolled 126 patients (47 ± 14 years; 68% male; PCWP = 17 ± 9.3 mmHg) randomly divided into derivation (n = 92) and validation (n = 34) cohorts with comparable characteristics. In the derivation cohort, the log-transformed (ln) LAEI showed a strong linear correlation with PCWP (r = 0.81, p < 0.001) and remained a strong independent PCWP determinant over clinical and conventional CMR parameters. Moreover, lnLAEI accurately identified PCWP ≥ 15 mmHg (AUC = 0.939, p < 0.001), and the optimal cut-off identified (lnLAEI ≤ 3.85) in the derivation cohort discriminated PCWP ≥ 15 mmHg with 82.4% sensitivity, 88.2% specificity, and 85.3% accuracy in the validation cohort. Finally, the equation PCWP = 52.33- (9.17xlnLAEI) obtained from the derivation cohort predicted PCWP (-0.1 ± 5.7 mmHg) in the validation cohort. CONCLUSIONS: In this cohort of DCM patients, CMR-measured LAEI resulted in a novel and useful parameter for non-invasive PCWP evaluation.
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Fibrilación Atrial , Cardiomiopatía Dilatada , Humanos , Masculino , Femenino , Presión Esfenoidal Pulmonar , Estudios Retrospectivos , Cardiomiopatía Dilatada/diagnóstico por imagen , Estudios Transversales , Valor Predictivo de las Pruebas , Espectroscopía de Resonancia MagnéticaRESUMEN
Pulmonary capillary wedge pressure (PCWP) non-invasive evaluation is limited in patients with mitral valve (MV) stenosis, prosthesis, and surgical repair. This study aimed to assess the left atrial expansion index (LAEI) measured through transthoracic echocardiography (TTE) as a novel parameter for estimating PCWP in these challenging cardiac conditions. We performed a retrospective, cross-sectional study, including chronic cardiac patients receiving within 24 h a clinically indicated right heart catheterization (RHC) and transthoracic echocardiographic (TTE) exam. PCWP measured during RHC was used as the reference. TTE measurements were performed offline, blinded to RHC results. LAEI was calculated as LAEI = [(LAmaxVolume-LAminVolume)/LAminVolume] × 100. We included 167 patients (age = 73 ± 11.5 years; PCWP = 18 ± 7.7 mmHg) with rheumatic mitral valve (MV) stenosis (16.2%), degenerative MV stenosis (51.2%), MV prosthesis (18.0%), and MV surgical repair (13.8%). LAEI correlated logarithmically with PCWP, and the log-transformed LAEI (lnLAEI) showed a good linear association with PCWP (r = - 0.616; p < 0.001). lnLAEI was an independent PCWP determinant, providing added predictive value over conventional clinical (age, atrial fibrillation, heart rate, MV subgroups) and echocardiographic variables (LVEF, MV effective orifice area, MV mean gradient, net atrioventricular compliance, and pulmonary arterial systolic pressure). lnLAEI identified PCWP > 12 mmHg with AUC = 0.870, p < 0.001; and PCWP > 15 mmHg with AUC = 0.797, p < 0.001, with an optimal cut-off of lnLAEI < 3.69. The derived equation PCWP = 36.8-5.5xlnLAEI estimated the invasively measured PCWP ± 6.1 mmHg. In this cohort of patients with MV stenosis, prosthesis, and surgical repair, lnLAEI resulted in a helpful echocardiographic parameter for PCWP estimation.
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Fibrilación Atrial , Estenosis de la Válvula Mitral , Humanos , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Presión Esfenoidal Pulmonar/fisiología , Estenosis de la Válvula Mitral/diagnóstico por imagen , Estenosis de la Válvula Mitral/cirugía , Estudios Retrospectivos , Estudios Transversales , Constricción Patológica , Valor Predictivo de las Pruebas , Cateterismo Cardíaco , Prótesis e ImplantesRESUMEN
Objectives: The UEFA 2020 European Football Championship held in multiple cities across Europe from June 11 to July 11, 2021, was won by Italy, providing an opportunity to examine the relationship between emotional stress and the incidence of acute cardiovascular events (ACE). Methods and results: Cardiovascular hospitalizations in the Cardiac Care Units of 49 hospital networks in Italy were assessed by emergency physicians during the UEFA Euro 2020 Football Championship. We compared the events that occurred during matches involving Italy with events that occurred during the remaining days of the championship as the control period. ACE was assessed in 1,235 patients. ACE during the UEFA Euro 2020 Football Championship semifinal and final, the most stressful matches ended with penalties and victory of the Italian team, were assessed. A significant increase in the incidence of Takotsubo Syndrome (TTS) by a factor of 11.41 (1.6-495.1, P < 0.003), as compared with the control period, was demonstrated during the semifinal and final, whereas no differences were found in the incidence of ACS [IRR 0.93(0.74-1.18), P = 0.57]. No differences in the incidence of ACS [IRR 0.98 (0.87-1.11; P = 0.80)] or TTS [IRR 1.66(0.80-3.4), P = 0.14] were found in the entire period including all matches of the UEFA Euro 2020 compared to the control period. Conclusions: The data of this national registry demonstrated an association between the semifinal and final of UEFA Euro 2020 and TTS suggesting that it can be triggered by also positive emotions such as the victory in the European Football Championship finals.
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BACKGROUND: This guideline (GL) on carotid surgery as updating of "Stroke: Italian guidelines for Prevention and Treatment" of the ISO-SPREAD Italian Stroke Organization-Group, has recently been published in the National Guideline System and shared with the Italian Society of Vascular and Endovascular Surgery (SICVE) and other Scientific Societies and Patient's Association. METHODS: GRADE-SIGN version, AGREE quality of reporting checklist. Clinical questions formulated according to the PICO model. Recommendations developed based on clinical questions by a multidisciplinary experts' panel and patients' representatives. Systematic reviews performed for each PICO question. Considered judgements filled by assessing the evidence level, direction, and strength of the recommendations. RESULTS: The panel provided indications and recommendations for appropriate, comprehensive, and individualized management of patients with carotid stenosis. Diagnostic and therapeutic processes of the best medical therapy, carotid endarterectomy (CEA), carotid stenting (CAS) according to the evidences and the judged opinions were included. Symptomatic carotid stenosis in elective and emergency, asymptomatic carotid stenosis, association with ischemic heart disease, preoperative diagnostics, types of anesthesia, monitoring in case of CEA, CEA techniques, comparison between CEA and CAS, post-surgical carotid restenosis, and medical therapy are the main topics, even with analysis of uncertainty areas for risk-benefit assessments in the individual patient (personalized medicine [PM]). CONCLUSIONS: This GL updates on the main recommendations for the most appropriate diagnostic and medical-surgical management of patients with atherosclerotic carotid artery stenosis to prevent ischemic stroke. This GL also provides useful elements for the application of PM in good clinical practice.
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Estenosis Carotídea , Endarterectomía Carotidea , Accidente Cerebrovascular , Humanos , Estenosis Carotídea/complicaciones , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/cirugía , Endarterectomía Carotidea/efectos adversos , Endarterectomía Carotidea/métodos , Medicina de Precisión , Medición de Riesgo , Factores de Riesgo , Stents , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Resultado del TratamientoRESUMEN
Importance: There is growing awareness of sex-related differences in cardiovascular risk profiles, but less is known about whether these extend to pre-menopausal females experiencing an early-onset myocardial infarction (MI), who may benefit from the protective effects of estrogen exposure. Methods: A nationwide study involving 125 Italian Coronary Care Units recruited 2,000 patients between 1998 and 2002 hospitalized for a type I myocardial infarction before the age of 45 years (male, n = 1,778 (88.9%). Patients were followed up for a median of 19.9 years (IQR 18.1-22.6). The primary composite endpoint was the occurrence of cardiovascular death, non-fatal myocardial re-infarction or non-fatal stroke, and the secondary endpoint of hospitalization for revascularisation by means of a percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG). Results: ST-elevation MI was the most frequent presentation among both men and women (85.1 vs. 87.4%, p = ns), but the men had a greater baseline coronary atherosclerotic burden (median Duke Coronary Artery Disease Index: 48 vs. 23; median Syntax score 9 vs. 7; both p < 0.001). The primary composite endpoint occurred less frequently among women (25.7% vs. 37.0%; adjusted hazard ratio: 0.69, 95% CI 0.52-0.91; p = 0.01) despite being less likely to receive treatment with most secondary prevention medications during follow up. Conclusions: There are significant sex-related differences in baseline risk factors and outcomes among patients with early-onset MI: women present with a lower atherosclerotic disease burden and, although they are less frequently prescribed secondary prevention measures, experience better long-term outcomes. Trial Registration: 4272/98 Ospedale Niguarda, Ca' Granda 03/09/1998.
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BACKGROUND: The itAlian pRospective Study on CANGrELOr (ARCANGELO) was aimed to assess the safety of using cangrelor during percutaneous coronary intervention (PCI) in patients with acute coronary syndromes (ACS) in the daily practice. HYPOTHESIS: The safety of cangrelor after the transition to oral P2Y12 inhibitors was evaluated as the incidence of bleeding outcomes in the 30 days following PCI according to postauthorization safety study guidelines. METHODS: Adults with ACS who were treated with cangrelor in one of the 28 centers involved in the study. Patients who consented to participate were followed in the 30 days following their PCI. Bleedings (Bleeding Academic Research Consortium [BARC] classification), major adverse cardiac events (MACEs), and adverse events were recorded. The interim results at two-thirds of the enrollment period are presented. RESULTS: A total of 17 bleedings were observed in the 320 patients who completed the study at this stage. All bleedings were classified as BARC Type 1-2, except for one case of Type 3a (vessel puncture site hematoma). Four patients experienced MACEs (2 acute myocardial infarctions, 1 sudden cardiac death, 1 noncardiovascular death due to respiratory distress, and multiorgan failure). None of the bleedings was rated as related to cangrelor. CONCLUSIONS: The interim results of the ARCANGELO study provide a preliminary confirmation that the use of cangrelor on patients with ACS undergoing PCI is not associated with severe bleedings.
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Síndrome Coronario Agudo , Intervención Coronaria Percutánea , Síndrome Coronario Agudo/cirugía , Adenosina Monofosfato/análogos & derivados , Adulto , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Humanos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Inhibidores de Agregación Plaquetaria/efectos adversos , Estudios Prospectivos , Antagonistas del Receptor Purinérgico P2Y/efectos adversos , Resultado del TratamientoRESUMEN
BACKGROUND: Acute myocardial infarction with non-obstructive coronary artery disease (MINOCA) is frequent in patients experiencing an early-onset MI, but data concerning its long-term prognosis are limited and conflicting. METHODS: The Italian Genetic Study on Early-onset MI enrolled 2000 patients experiencing a first MI before the age of 45 years, and had a median follow-up of 19.9 years. The composite primary endpoint was cardiovascular (CV) death, non-fatal MI, and non-fatal stroke (MACE); the secondary endpoint was rehospitalisation for coronary revascularisation. RESULTS: MINOCA occurred in 317 patients (15.9%) and, during the follow-up, there was no significant difference in MACE rates between them and the patients with obstructive coronary artery disease (MICAD: 27.8% vs 37.5%; adjusted hazard ratio [HR] 0.79, 95% confidence interval [CI] 0.57-1.09;p = 0.15). The CV death rate was lower in the MINOCA group (4.2% vs 8.4%, HR 0.26, 95%CI 0.08-0.86;p = 0.03), whereas the rates of non-fatal reinfarction (17.3% vs 25.4%; HR 0.76, 95%CI 0.52-1.13;p = 0.18), non-fatal ischemic stroke (9.5% vs 3.7%; HR 1.79, 95%CI 0.87-3.70;p = 0.12), and all-cause mortality (14.1% vs 20.7%, HR 0.73, 95%CI 0.43-1.25;p = 0.26) were not significantly different in the two groups. The rate of rehospitalisation for coronary revascularisation was lower among the MINOCA patients (6.7% vs 27.7%; HR 0.27, 95% CI 0.15-0.47;p < 0.001). CONCLUSIONS: MINOCA is frequent and not benign in patients with early-onset MI. Although there is a lower likelihood of CV death,the long-term risk of MACE and overall mortality is not significantly different from that of MICAD patients.
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Enfermedad de la Arteria Coronaria , Infarto del Miocardio , Angiografía Coronaria/efectos adversos , Enfermedad de la Arteria Coronaria/complicaciones , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/cirugía , Vasos Coronarios , Humanos , MINOCA , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/epidemiología , Infarto del Miocardio/cirugía , Pronóstico , Factores de RiesgoRESUMEN
BACKGROUND AND AIMS: In order to systematically review the latest evidence on anesthesia, intraoperative neurologic monitoring, postoperative heparin reversal, and postoperative blood pressure management for carotid endarterectomy. The present review is based on a single chapter of the Italian Health Institute Guidelines for diagnosis and treatment of extracranial carotid stenosis and stroke prevention. METHODS AND RESULTS: A systematic article review focused on the previously cited topics published between January 2016 and October 2020 has been performed; we looked for both primary and secondary studies in the extensive archive of Medline/PubMed and Cochrane library databases. We selected 14 systematic reviews and meta-analyses, 13 randomized controlled trials, 8 observational studies, and 1 narrative review. Based on this analysis, syntheses of the available evidence were shared and recommendations were indicated complying with the GRADE-SIGN version methodology. CONCLUSIONS: From this up-to-date analysis, it has emerged that any type of anesthesia and neurological monitoring method is related to a better outcome after carotid endarterectomy. In addition, insufficient evidence was found to justify reversal or no-reversal of heparin at the end of surgery. Furthermore, despite a low evidence level, a suggestion for blood pressure monitoring in the postoperative period was formulated.
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BACKGROUND: The optimal treatment of aneurysmal or ectatic culprit vessels in the setting of acute myocardial infarction is still matter of debate, as revascularization with either percutaneous intervention or surgery is associated with low procedural success and poor outcomes. CASE SUMMARY: We report the case of a 55-year-old male patient, admitted for inferior ST-elevation myocardial infarction, who underwent successful percutaneous implantation of a micro-mesh self-expanding nitinol carotid stent in a right coronary aneurysm with intravascular ultrasonography measured diameter of 9 mm and massive thrombus apposition. DISCUSSION: The technical characteristics of the micro-mesh self-expanding nitinol carotid stent allow for adequate plaque coverage and good apposition even in large vessels, making this device particularly suitable for the treatment of coronary lesions with high thrombus burden, when severe coronary ectasia or aneurysms are present.
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Neoplasias Cardíacas/complicaciones , Lipoma/complicaciones , Taquicardia Ventricular/etiología , Adulto , Procedimientos Quirúrgicos Cardíacos/métodos , Ecocardiografía/métodos , Electrocardiografía Ambulatoria , Femenino , Neoplasias Cardíacas/diagnóstico , Neoplasias Cardíacas/cirugía , Ventrículos Cardíacos , Humanos , Lipoma/diagnóstico , Lipoma/cirugía , Imagen por Resonancia Cinemagnética/métodos , Taquicardia Ventricular/fisiopatología , Tomografía Computarizada por Rayos X/métodosRESUMEN
Carotid artery stenting (CAS) is a valid and effective alternative to endoatherectomy when performed by experienced operators. The conventional approach used is the transfemoral one, but in the last 10 years a transradial (TR) approach, the standard access for cardiac catheterization, became widely adopted for peripheral vascular interventions, included the extracranial carotids. Preliminary experiences suggest this approach as safe and effective, especially in specific anatomical and clinical settings that have been shown to be associated with high risk of complications from the femoral route. Lacking international guidelines, this document, promoted by the Italian Society of Interventional Cardiology - Gruppo Italiano Studi Emodinamici (SICI-GISE), was drawn-up by a panel of interventional cardiologists with a documented experience on the subject, focusing on the indications, techniques and materials that should be used for this type of intervention and the most recent literature on the subject.
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Cardiología , Stents , Arterias Carótidas , Humanos , Italia , Arteria Radial/diagnóstico por imagen , Arteria Radial/cirugía , Resultado del TratamientoRESUMEN
In 2020, the coronavirus disease 2019 (COVID-19) pandemic has led to a decrease in interventional treatment for structural heart disease worldwide. In this context, the management of patients with symptomatic severe aortic stenosis (AS) or bioprosthetic valve dysfunction (BVD) represents a clinical challenge, as a delay in aortic valve replacement procedures may increase short-term morbidity and mortality. We report four cases of TAVR performed in patients with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection. All of them were discharged in good clinical conditions and no adverse events were reported at 30 days follow-up. Our experience suggests that in selected patients with mild SARS-CoV-2 infection and symptomatic native AS or BVD, TAVR has a favorable short-term outcome.
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Estenosis de la Válvula Aórtica , COVID-19 , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Estudios de Factibilidad , Humanos , Factores de Riesgo , SARS-CoV-2 , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoRESUMEN
Minimization of hospital lengths of stay has always been a key goal for healthcare systems. More so during the current COVID-19 pandemic. In fact, we have faced a reduction in no-COVID-19 admissions with the generation of huge backlogs. Low-risk patients undergoing elective percutaneous coronary intervention (PCI) can be candidate for short-term hospitalization, with consequent reduction of waiting lists. Several single-center and multicenter observational studies, multiple randomized trials and some meta-analyses have addressed this topic.In this position paper, we present a proposal for short hospitalization for elective PCI procedures in selected patients who present complications only exceptionally and exclusively immediately after the procedure, if the inclusion and exclusion criteria are met. Each Center can choose between admission in day surgery or one day surgery, extending hospital length of stay only for patients who present complications or who are candidate for urgent surgery. Short-term hospitalization considerably reduces costs even if, with the current model, it generally results in a parallel reduction in reimbursement. Hence, we present an actual model, already tested successfully in an Italian hospital, that warrants sustainability. This approach can then be tailored to single Centers.
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COVID-19 , Cardiología , Intervención Coronaria Percutánea , Hospitalización , Humanos , Tiempo de Internación , Pandemias/prevención & control , Intervención Coronaria Percutánea/efectos adversosRESUMEN
BACKGROUND: Redo surgical mitral valve replacement (SMVR) is the current standard of care for patients with failed bioprosthetic mitral valve (MV). Transcatheter mitral valve-in-valve replacement (TMViV) is arising as an alternative to SMVR in high risk patients. We sought to evaluate procedural safety, early and mid-term outcomes of patients who underwent transseptal TMViV (TS-TMViV), transapical TMViV (TA-TMViV), or redo-SMVR. METHODS: We identified patients with failed bioprosthetic MV who underwent TS-TMViV, TA-TMViV, or SMVR at four Italian Centers. Clinical and echocardiographic data were codified according to Mitral Valve Academic Research Consortium definition (MVARC), except for significant valve stenosis. RESULTS: Between December 2012 and September 27, 2019 patients underwent TS-TMViV, 22 TA-TMViV, and 29 redo-SMVR. TS-TMViV and TA-TMViV patients presented higher mean age and surgical risk scores compared with SMVR group (77.8 ± 12 years, 77.3 ± 7.3 years, 67.8 ± 9.4 years, p < .001; STS PROM 8.5 ± 7.2; 8.9 ± 4.7; 3.6 ± 2.6, p < .001). TS-TMViV procedure was associated with shorter intensive care unit time and total length of stay (LOS) compared with TA-TMViV and SMVR group. There were no differences in MVARC procedural success at 30-days (74.1, 72.7, and 51.7%, p = .15) and one-year all-cause mortality between groups (14.8, 18.2, and 17.2%, p = 1.0). MV mean gradient was similar between TS-TMViV, TA-TMViV, and SMVR groups at 30 days and 12 months. CONCLUSIONS: For the selected patients, TS-TMViV and TA-TMViV are to be considered a valid alternative to redo-SMVR with comparable 1-year survival. TS-TMViV is the less invasive strategy and has the advantage of shortening the LOS compared with TA-TMViV.
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Bioprótesis , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Cateterismo Cardíaco/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Resultado del TratamientoRESUMEN
BACKGROUND: The optimal timing to administer a P2Y12 inhibitor in patients presenting with a non-ST elevation acute coronary syndrome remains a topic of debate. Pretreatment with ticagrelor before coronary anatomy is known as a widely adopted strategy. However, there is poor evidence on how this compares with administration of a P2Y12 inhibitor after defining coronary anatomy (i.e., downstream administration). Moreover, there are limited head-to-head comparisons of the two P2Y12 inhibitors-ticagrelor and prasugrel-currently recommended by the guidelines. STUDY DESIGN: DUBIUS is a phase 4, multicenter, parallel-group, double randomized study conducted in NSTE-ACS patients designed to compare a pretreatment strategy (including only ticagrelor) versus a downstream strategy (including prasugrel or ticagrelor) and to compare downstream prasugrel with downstream ticagrelor. A total of 2520 patients will be randomly assigned to pretreatment with ticagrelor or to no pretreatment. The PCI group of the downstream arm will be further randomized to receive prasugrel or ticagrelor. The two primary hypotheses are that the downstream strategy is superior to the upstream strategy and that downstream ticagrelor is non-inferior to downstream prasugrel, both measured by the incidence of a composite efficacy and safety endpoint of death from vascular causes, non-fatal MI, or non-fatal stroke, and Bleeding Academic Research Consortium (BARC) type 3, 4, and 5 bleedings. CONCLUSIONS: The DUBIUS study will provide important evidence related to the benefits and risks of pretreatment with ticagrelor compared with a strategy of no pretreatment. Moreover, the clinical impact of using downstream ticagrelor compared with downstream prasugrel will be assessed. TRIAL REGISTRATION: ClinicalTrials.gov NCT02618837 . Registered on 1 December 2015.