Coronariografía urgente en los pacientes con parada cardiaca extrahospitalaria sin elevación del segmento ST. Ensayo clínico COUPE / Coronary angiography in patients without ST-segment elevation following out-of-hospital cardiac arrest. COUPE clinical trial

Introducción y objetivos El papel de la coronariografía urgente y angioplastia, si procede, en los pacientes con parada cardiaca extrahospitalaria (PCEH) recuperada que no presentan elevación del segmento ST es controvertido. Nuestro objetivo fue evaluar si la coronariografía urgente y la angioplastia mejoran la supervivencia con buen pronóstico neurológico en esta población. Métodos En este ensayo clínico multicéntrico, aleatorizado, abierto, incluimos 69 pacientes supervivientes a una PCEH sin elevación del ST y se aleatorizaron a recibir una coronariografía urgente (CU) o diferida (CD). El objetivo primario de eficacia fue el combinado de supervivencia hospitalaria libre de dependencia. El objetivo de seguridad fue un compuesto de eventos cardiacos mayores, incluyendo muerte, reinfarto, sangrado y arritmias ventriculares. Resultados Se incluyó a 66 pacientes en el análisis primario (95,7%). La supervivencia hospitalaria fue 62,5% en el grupo CU y 58,8% en el grupo CD (HR = 0,96; IC95%, 0,45-2,09; p=0,93). La supervivencia hospitalaria con buen pronóstico neurológico fue 59,4% en el grupo CU y 52,9% en el grupo CD (HR = 1,29; IC95%, 0,60-2,73; p=0,4986). No se encontraron diferencias en los objetivos secundarios, salvo por la incidencia de fracaso renal agudo, que fue más frecuente en el grupo CU (15,6 frente a 0%, p=0,002) y de infecciones, más prevalentes en el grupo CD (46,9 frente a 73,5%, p=0,003). Conclusiones En este estudio aleatorizado de pacientes con una PCEH sin elevación del ST, una CU no fue beneficiosa en términos de supervivencia con buen pronóstico neurológico comparada con una CD (AU)

Introduction and objectives The role of emergency coronary angiography (CAG) and percutaneous coronary intervention (PCI) following out-of-hospital cardiac arrest (OHCA) in patients without ST-segment elevation myocardial infarction (STEMI) remains unclear. We aimed to assess whether emergency CAG and PCI would improve survival with good neurological outcome in this population. Methods In this multicenter, randomized, open-label, investigator-initiated clinical trial, we randomly assigned 69 survivors of OHCA without STEMI to undergo immediate CAG or deferred CAG. The primary efficacy endpoint was a composite of in-hospital survival free of severe dependence. The safety endpoint was a composite of major adverse cardiac events including death, reinfarction, bleeding, and ventricular arrhythmias. Results A total of 66 patients were included in the primary analysis (95.7%). In-hospital survival was 62.5% in the immediate CAG group and 58.8% in the delayed CAG group (HR, 0.96; 95%CI, 0.45-2.09; P=.93). In-hospital survival free of severe dependence was 59.4% in the immediate CAG group and 52.9% in the delayed CAG group (HR, 1.29; 95%CI, 0.60-2.73; P=.4986). No differences were found in the secondary endpoints except for the incidence of acute kidney failure, which was more frequent in the immediate CAG group (15.6% vs 0%, P=.002) and infections, which were higher in the delayed CAG group (46.9% vs 73.5%, P=.003). Conclusions In this underpowered randomized trial involving patients resuscitated after OHCA without STEMI, immediate CAG provided no benefit in terms of survival without neurological impairment compared with delayed CAG (AU)

Coronary angiography in patients without ST-segment elevation following out-of-hospital cardiac arrest. COUPE clinical trial.

INTRODUCTION AND OBJECTIVES: The role of emergency coronary angiography (CAG) and percutaneous coronary intervention (PCI) following out-of-hospital cardiac arrest (OHCA) in patients without ST-segment elevation myocardial infarction (STEMI) remains unclear. We aimed to assess whether emergency CAG and PCI would improve survival with good neurological outcome in this population. METHODS: In this multicenter, randomized, open-label, investigator-initiated clinical trial, we randomly assigned 69 survivors of OHCA without STEMI to undergo immediate CAG or deferred CAG. The primary efficacy endpoint was a composite of in-hospital survival free of severe dependence. The safety endpoint was a composite of major adverse cardiac events including death, reinfarction, bleeding, and ventricular arrhythmias. RESULTS: A total of 66 patients were included in the primary analysis (95.7%). In-hospital survival was 62.5% in the immediate CAG group and 58.8% in the delayed CAG group (HR, 0.96; 95%CI, 0.45-2.09; P=.93). In-hospital survival free of severe dependence was 59.4% in the immediate CAG group and 52.9% in the delayed CAG group (HR, 1.29; 95%CI, 0.60-2.73; P=.4986). No differences were found in the secondary endpoints except for the incidence of acute kidney failure, which was more frequent in the immediate CAG group (15.6% vs 0%, P=.002) and infections, which were higher in the delayed CAG group (46.9% vs 73.5%, P=.003). CONCLUSIONS: In this underpowered randomized trial involving patients resuscitated after OHCA without STEMI, immediate CAG provided no benefit in terms of survival without neurological impairment compared with delayed CAG. CLINICALTRIALS: gov Identifier: NCT02641626.

One-year cardiovascular outcomes after coronavirus disease 2019: The cardiovascular COVID-19 registry.

BACKGROUND: The long-term cardiovascular (CV) outcomes of COVID-19 have not been fully explored. METHODS: This was an international, multicenter, retrospective cohort study conducted between February and December 2020. Consecutive patients ≥18 years who underwent a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) for SARS-CoV2 were included. Patients were classified into two cohorts depending on the nasopharyngeal swab result and clinical status: confirmed COVID-19 (positive RT-PCR) and control (without suggestive symptoms and negative RT-PCR). Data were obtained from electronic records, and clinical follow-up was performed at 1-year. The primary outcome was CV death at 1-year. Secondary outcomes included arterial thrombotic events (ATE), venous thromboembolism (VTE), and serious cardiac arrhythmias. An independent clinical event committee adjudicated events. A Cox proportional hazards model adjusted for all baseline characteristics was used for comparing outcomes between groups. A prespecified landmark analysis was performed to assess events during the post-acute phase (31-365 days). RESULTS: A total of 4,427 patients were included: 3,578 (80.8%) in the COVID-19 and 849 (19.2%) control cohorts. At one year, there were no significant differences in the primary endpoint of CV death between the COVID-19 and control cohorts (1.4% vs. 0.8%; HRadj 1.28 [0.56-2.91]; p = 0.555), but there was a higher risk of all-cause death (17.8% vs. 4.0%; HRadj 2.82 [1.99-4.0]; p = 0.001). COVID-19 cohort had higher rates of ATE (2.5% vs. 0.8%, HRadj 2.26 [1.02-4.99]; p = 0.044), VTE (3.7% vs. 0.4%, HRadj 9.33 [2.93-29.70]; p = 0.001), and serious cardiac arrhythmias (2.5% vs. 0.6%, HRadj 3.37 [1.35-8.46]; p = 0.010). During the post-acute phase, there were no significant differences in CV death (0.6% vs. 0.7%; HRadj 0.67 [0.25-1.80]; p = 0.425), but there was a higher risk of deep vein thrombosis (0.6% vs. 0.0%; p = 0.028). Re-hospitalization rate was lower in the COVID-19 cohort compared to the control cohort (13.9% vs. 20.6%; p = 0.001). CONCLUSIONS: At 1-year, patients with COVID-19 experienced an increased risk of all-cause death and adverse CV events, including ATE, VTE, and serious cardiac arrhythmias, but not CV death. STUDY REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT04359927.

"Impact of age on management and prognosis of resuscitated sudden cardiac death patients".

Background: Sudden cardiac death (SCD) has a great impact on healthcare due to cardiologic and neurological complications. Admissions of elderly people in Cardiology Intensive Care Units have increased. We assessed the impact of age in presentation, therapeutic management and in vital and neurological prognosis of SCD patients. Methods: We carried out a retrospective, observational, multicenter registry of patients who were admitted with a SCD in 5 tertiary hospitals from January 2013 to December 2020. We divided our cohort into two groups (patients < 80 years and ≥ 80 years). Clinical, analytical and hemodynamic variables as well as in-hospital management were registered and compared between groups. The degree of neurological dysfunction, vital status at discharge and the influence of age on them were also reviewed. Results: We reviewed 1160 patients admitted with a SCD. 11.3% were ≥ 80 years. Use of new antiplatelet agents, performance of a coronary angiography, use of pulmonary artery catheter and temperature control were less carried out in the elderly. Age, non-shockable rhythm, Killip class > 1 at admission, time to CPR initiation > 5 min, time to ROSC > 20 min and lactate > 2 mmol/L were independent predictors for in-hospital mortality. Non-shockable rhythm, Killip class > 1 at admission, time to CPR initiation > 5 min and time to ROSC > 20 min but not age were independent predictors for poor neurological outcomes. Conclusions: Age determined a less aggressive management and it was associated with a worse vital prognosis in patients admitted with a SCD. Nevertheless, age was not associated with worse neurological outcomes.

Conservative, surgical, and percutaneous treatment for mitral regurgitation shortly after acute myocardial infarction.

AIMS: Severe mitral regurgitation (MR) following acute myocardial infarction (MI) is associated with high mortality rates and has inconclusive recommendations in clinical guidelines. We aimed to report the international experience of patients with secondary MR following acute MI and compare the outcomes of those treated conservatively, surgically, and percutaneously. METHODS AND RESULTS: Retrospective international registry of consecutive patients with at least moderate-to-severe MR following MI treated in 21 centres in North America, Europe, and the Middle East. The registry included patients treated conservatively and those having surgical mitral valve repair or replacement (SMVR) or percutaneous mitral valve repair (PMVR) using edge-to-edge repair. The primary endpoint was in-hospital mortality. A total of 471 patients were included (43% female, age 73 ± 11 years): 205 underwent interventions, of whom 106 were SMVR and 99 PMVR. Patients who underwent mitral valve intervention were in a worse clinical state (Killip class ≥3 in 60% vs. 43%, P < 0.01), but yet had lower in-hospital and 1-year mortality compared with those treated conservatively [11% vs. 27%, P < 0.01 and 16% vs. 35%, P < 0.01; adjusted hazard ratio (HR) 0.28, 95% confidence interval (CI) 0.18-0.46, P < 0.01]. Surgical mitral valve repair or replacement was performed earlier than PMVR [median of 12 days from MI date (interquartile range 5-19) vs. 19 days (10-40), P < 0.01]. The immediate procedural success did not differ between SMVR and PMVR (92% vs. 93%, P = 0.53). However, in-hospital and 1-year mortality rates were significantly higher in SMVR than in PMVR (16% vs. 6%, P = 0.03 and 31% vs. 17%, P = 0.04; adjusted HR 3.75, 95% CI 1.55-9.07, P < 0.01). CONCLUSIONS: Early intervention may mitigate the poor prognosis associated with conservative therapy in patients with post-MI MR. Percutaneous mitral valve repair can serve as an alternative for surgery in reducing MR for high-risk patients.

A simple combination of biomarkers for risk stratification in octogenarians with acute myocardial infarction.

The aim of this observational study was to assess long-term prognosis of a contemporary octogenarian population admitted to an Intensive Cardiac Care Unit with acute myocardial infarction (MI), and the prognostic value of two simple biomarkers obtained at admission: glucose blood level (ABG) and estimated glomerular filtration rate (eGFR). A total of 293 consecutive patients were included (202 with ST elevation MI and 91 with non-ST elevation MI) with median age 83.9 years, 172 (58.7%) male. The optimal cut-off points for all-cause death defined by ROC curves were ABG >186 mg/dL and eGFR <50 mL/min/1.73 m2. The cohort was segregated into 3 groups according to these values: no biomarker present (group 1), either of the two biomarkers present (group 2) or both biomarkers present (group 3). Patients in group 3 were more frequently female, with worse Charlson index, Killip class and ventricular function, and higher GRACE scores. PCI was performed in 248 patients (84.6%). The highest in-hospital and long-term mortality, and composite MACE was observed in groups 2 and 3. All-cause mortality (median follow-up 2.2 years) was 44%. In multivariate analysis, ABG >186 mg/dL and eGFR <50 mL/min/1.73 m2 were associated with a 4.2 odds ratio (OR) (Model 1: medical history variables) and 2.6 OR (Model 2: admission event variables) of mortality. The addition of these variables to ROC curves improved long-term risk prediction for Model 1 (C-statistics 0.718 versus 0.780, p = 0.006) and reclassification and discrimination in both models.

Long-term effects of coronavirus disease 2019 on the cardiovascular system, CV COVID registry: A structured summary of a study protocol.

BACKGROUND: Patients presenting with the coronavirus-2019 disease (COVID-19) may have a high risk of cardiovascular adverse events, including death from cardiovascular causes. The long-term cardiovascular outcomes of these patients are entirely unknown. We aim to perform a registry of patients who have undergone a diagnostic nasopharyngeal swab for SARS-CoV-2 and to determine their long-term cardiovascular outcomes. STUDY AND DESIGN: This is a multicenter, observational, retrospective registry to be conducted at 17 centers in Spain and Italy (ClinicalTrials.gov number: NCT04359927). Consecutive patients older than 18 years, who underwent a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) for SARS-CoV2 in the participating institutions, will be included since March 2020, to August 2020. Patients will be classified into two groups, according to the results of the RT-PCR: COVID-19 positive or negative. The primary outcome will be cardiovascular mortality at 1 year. The secondary outcomes will be acute myocardial infarction, stroke, heart failure hospitalization, pulmonary embolism, and serious cardiac arrhythmias, at 1 year. Outcomes will be compared between the two groups. Events will be adjudicated by an independent clinical event committee. CONCLUSION: The results of this registry will contribute to a better understanding of the long-term cardiovascular implications of the COVID19.

Safety and Feasibility of MitraClip Implantation in Patients with Acute Mitral Regurgitation after Recent Myocardial Infarction and Severe Left Ventricle Dysfunction.

Patients with severe mitral regurgitation (MR) after myocardial infarction (MI) have an increased risk of mortality. Transcatheter mitral valve repair may therefore be a suitable therapy. However, data on clinical outcomes of patients in an acute setting are scarce, especially those with reduced left ventricle (LV) dysfunction. We conducted a multinational, collaborative data analysis from 21 centers for patients who were, within 90 days of acute MI, treated with MitraClip due to severe MR. The cohort was divided according to median left ventricle ejection fraction (LVEF)-35%. Included in the study were 105 patients. The mean age was 71 ± 10 years. Patients in the LVEF < 35% group were younger but with comparable Euroscore II, multivessel coronary artery disease, prior MI and coronary artery bypass graft surgery. Procedure time was comparable and acute success rate was high in both groups (94% vs. 90%, p = 0.728). MR grade was significantly reduced in both groups along with an immediate reduction in left atrial V-wave, pulmonary artery pressure and improvement in New York Heart Association (NYHA) class. In-hospital and 1-year mortality rates were not significantly different between the two groups (11% vs. 7%, p = 0.51 and 19% vs. 12%, p = 0.49) and neither was the 3-month re-hospitalization rate. In conclusion, MitraClip intervention in patients with acute severe functional mitral regurgitation (FMR) due to a recent MI in an acute setting is safe and feasible. Even patients with severe LV dysfunction may benefit from transcatheter mitral valve intervention and should not be excluded.

Methods to assess bioresorbable vascular scaffold devices behaviour after implantation.

Bioresorbable vascular scaffolds (BRS) represent a novel approach for coronary revascularization offering several advantages as compared to current generation DES, potentially reducing rate of late adverse events and avoiding permanent vessel caging. Nevertheless, safety concerns have been raised for an increased risk of scaffold thrombosis (ScT) in both early and late phases, probably related to a suboptimal scaffold implantation. In this context, the use of different imaging methodologies has been strongly suggested in order to guarantee an optimal implantation. We herein analyze the different imaging methodologies available to assess BRS after implantation and at follow-up.