Immediate versus staged complete revascularisation in patients presenting with STEMI and multivessel disease.

BACKGROUND: Complete revascularisation is supported by recent trials in patients with ST-elevation myocardial infarction (STEMI) and multivessel disease (MVD) without cardiogenic shock. However, the optimal timing of non-culprit lesion revascularisation is currently debated. AIMS: This prespecified analysis of the BioVasc trial aims to determine the effect of immediate complete revascularisation (ICR) compared to staged complete revascularisation (SCR) on clinical outcomes in patients with STEMI. METHODS: Patients presenting with STEMI and MVD were randomly assigned to ICR or SCR. The primary endpoint was the composite of all-cause mortality, myocardial infarction, any unplanned ischaemia-driven revascularisation, or cerebrovascular events at 1-year post-index procedure. RESULTS: Between June 2018 and October 2021, 608 (ICR: 305, SCR: 303) STEMI patients were enrolled. No significant differences between ICR and SCR were observed at 1-year follow-up in terms of the primary endpoint (7.0% vs 8.3%, hazard ratio [HR] 0.84, 95% confidence interval [CI]: 0.47-1.50; p=0.55): all-cause mortality (2.3% vs 1.3%, HR 1.77, 95% CI: 0.52-6.04; p=0.36), myocardial infarction (1.7% vs 3.3%, HR 0.50, 95% CI: 0.17-1.47; p=0.21), unplanned ischaemia-driven revascularisation (4.1% vs 5.0%, HR 0.80, 95% CI: 0.38-1.71; p=0.57) and cerebrovascular events (1.4% vs 1.3%, HR 1.01, 95% CI: 0.25-4.03; p=0.99). At 30-day follow-up, a trend towards a reduction of the primary endpoint in the ICR group was observed (ICR: 3.0% vs SCR: 6.0%, HR 0.50, 95% CI: 0.22-1.11; p=0.09). ICR was associated with a reduction in overall hospital stay (ICR: median 3 [interquartile range {IQR} 2-5] days vs SCR: median 4 [IQR 3-6] days; p<0.001). CONCLUSIONS: Clinical outcomes at 1 year were similar for STEMI patients who had undergone ICR and those who had undergone SCR.

The enigma of the 'smoker's paradox': Results from a single-center registry of patients with STEMI undergoing primary percutaneous coronary intervention.

BACKGROUND: Smoker's paradox usually refers to the observation of a favorable outcome of smoking patients in acute myocardial infarction. METHODS: From April 2006 to December 2018 a population of 2456 patients with ST segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI) were prospectively enrolled in the MATRIX registry. Ischemic time, clinical, demographics, angiographic data, and 1-year follow-up were collected. RESULTS: Among 2546 patients admitted with STEMI, 1007 (41 %) were current smokers. Smokers were 10 years younger and had lower crude in-hospital and 1-year mortality (1.5 % vs 6 %, p < 0.0001 and 5 % vs 11 %, p < 0.0001), shorter ischemic time (203 [147-299] vs 220 [154-334] minutes, p = 0.002) and shorter decision time (60 [30-135] vs 70 [36-170] minutes, p = 0.0063). Smoking habit [OR:0.37(95 % CI:0.18-0.75)-p < 0.01], younger age [OR 1.06 (95%CI:1.04-1.09)-p < 0.001] and shorter ischemic time [OR:1.01(95%CI:1.01-1.02)-p < 0.05] were associated to lower in-hospital mortality. Only smoking habit [HR:0.65(95 % CI: 0.44-0.9)-p = 0.03] and younger age [HR:1.08 (95%CI:1.06-1.09)-p < 0.001] were also independently associated to lower all-cause death at 1-year follow-up. After propensity matching, age, cardiogenic shock and TIMI flow <3 were associated with in-hospital mortality, while smoking habit was still associated with reduced mortality. Smoking was also associated with reduced mortality at 1-year follow-up (HR 0.54, 95 % CI [0.37-0.78]; p < 0.001). CONCLUSIONS: Smoking patients show better outcome after PCI for STEMI at 1-year follow-up. Although "Smoking paradox" could be explained by younger age of patients, other factors may have a role in the explanation of the phenomenon.

State-of-the-Art of Transcatheter Left Atrial Appendage Occlusion.

Left atrial appendage occlusion (LAAO) is an increasingly used alternative to oral anticoagulation in patients with atrial fibrillation, especially in patients with absolute/relative contraindications to these therapies. This review will cover three main aspects of the procedure. In the fist part of the manuscript, we focus on patient selection. We describe three main categories of patients with primary indication to LAAO, namely patients with previous or at a high risk of intracerebral bleeding, patients with a history of major gastrointestinal bleeding and patients with end-stage renal disease and absolute contraindication to novel oral anticoagulants. Some other potential indications are also described. In the second part of the manuscript, we review available devices, trying to highlight different aspects and potential specific advantages. The last section overviews different ways for pre-, intra- and postprocedural imaging, in order to improve procedural safety and efficacy and ameliorate patient outcome. The characteristics of available contemporary devices and the role of imaging in procedural planning, intraprocedural guidance and follow-up are described.

A Novel Frailty Score Based on Laboratory Parameters (FIMS Score) for the Management of Older Patients with Severe Aortic Stenosis.

This study aimed to develop a novel score based on common laboratory parameters able to identify frail and sarcopenic patients as well as predict mortality in elderly patients with severe aortic stenosis (AS) for tailored clinical decision-making. A total of 109 patients (83 ± 5 years; females, 68%) with AS underwent a multidisciplinary pre-operative assessment and finalized a "frailty-based management" for the AS interventional treatment. Laboratory parameters of statistically significant differences between sarcopenic and non-sarcopenic individuals were tested in the structural equation model (SEM) to build a Frailty Inflammation Malnutrition and Sarcopenia score (FIMS score). Mortality at 20 months of follow-up was considered an outcome. FIMS score, in particular, the cut-off value ≥ 1.28 was able to identify "frail" and "early frail" patients and predict mortality with a sensitivity of 83.3% and 82.6%, respectively (p = 0.001) and was an independent determinant associated with a higher risk of mortality (HR 5.382; p-value = 0.002). The FIMS score, easily achievable and usable in clinical practice, was able to identify frail and sarcopenic patients as well as predict their adverse clinical outcomes. This score could provide appropriate guidance during decision-making regarding elderly patients with severe AS.

Periprocedural outcome in patients undergoing left atrial appendage occlusion with the Watchman FLX device: The ITALIAN-FLX registry.

Introduction: The Watchman FLX is a novel device for transcatheter left atrial appendage occlusion (LAAO) specifically designed to improve procedural performance in more complex anatomies with a better safety profile. Recently, small prospective non-randomized studies have shown good procedural success and safety compared with previous experiences. Results from large multicenter registries are needed to confirm the safety and efficacy of the Watchman FLX device in a real-world setting. Methods: Italian FLX registry is a retrospective, non-randomized, multicentric study across 25 investigational centers in Italy including consecutive patients undergoing LAAO with the Watchman FLX between March 2019 and September 2021 (N = 772). The primary efficacy outcome was the technical success of the LAAO procedure (peri-device flow ≤ 5 mm) as assessed by intra-procedural imaging. The peri-procedural safety outcome was defined as the occurrence of one of the following events within 7 days after the procedure or by hospital discharge: death, stroke, transient ischemic attack, major extracranial bleeding (BARC type 3 or 5), pericardial effusion with tamponade or device embolization. Results: A total of 772 patients were enrolled. The mean age was 76 ± 8 with a mean CHA2DS2-VASc score of 4.1 ± 1.4 and a mean HAS-BLED score of 3.7 ± 1.1. Technical success was achieved in 772 (100%) patients with the first device implanted in 760 (98.4%) patients. A peri-procedural safety outcome event occurred in 21 patients (2.7%) with major extracranial bleeding being the most common (1.7%). No device embolization occurred. At discharge 459 patients (59.4%) were treated with dual antiplatelet therapy (DAPT). Conclusions: The Italian FLX registry represents the largest multicenter retrospective real-world study reporting periprocedural outcome of LAAO with the Watchman FLX device, resulting in a procedural success rate of 100% and a low incidence of peri-procedural major adverse events (2.7%).

Prognostic role of CRP-independent inflammatory patterns in patients undergoing primary percutaneous interventions.

BACKGROUND: Despite the key pathophysiological role of inflammation in the development of coronary artery disease (CAD), the evaluation of inflammatory status has not been clearly established in patients presenting with acute coronary syndrome (ACS). The aim of this study is to evaluate the prevalence of CRP-independent inflammatory patterns in patients referred for primary percutaneous coronary intervention (pPCI) and to determine their one-year relationship with adverse clinical outcomes. METHODS: We carried out a single-centre, observational study consecutively enrolling all patients presenting at a large-volume PCI hub with a diagnosis of ST-segment elevation myocardial infarction (STEMI) and treated with pPCI. Systemic immune-inflammatory index (SII) was calculated at admission and discharge. According to different SII trajectories patients were divided into four patterns: 'persistent-low', 'down-sloping', 'up-sloping' and 'persistent-high' patterns. The primary endpoint was a composite of all-cause of death and myocardial infarction (MI) at a one-year follow-up. RESULTS: Among the total 2353 subjects enrolled, 44% of them belonged to 'persistent-low', 31% to 'down-sloping', 4% to 'up-sloping' and 21% to 'persistent-high' pattern. The primary endpoint was observed in 8% of patients with a 'persistent-low', 12% with a 'down-sloping', 27% with an 'up-sloping' and 25% with a persistent-high pattern (p = 0.001). After multivariate analysis, 'up-sloping' (OR: 3.2 [1.59-3.93]; p = 0.001) and 'persistent-high' (OR: 4.1 [3.03-4.65]; p = 0.001) patterns emerged as independent predictors of one-year adverse events. CONCLUSIONS: 'Persistent-high' and 'up-sloping' CRP-independent inflammatory patterns in patients undergoing primary PCI are associated with an increased risk of adverse events at one-year follow-up. The prognostic value of these inflammatory patterns might be helpful to individualize potential therapeutic targets.

Balloon Fracture During TAVR: Effective and Repeatable Technique Not Written in the Textbook.

An 88-year-old man was referred to transcatheter aortic valve replacement for severe symptomatic aortic stenosis. Edwards 26-mm Sapien bioprosthetic valve (Sapien) implantation was planned after accurate computed tomography-based procedure planning. When the valve was released, the inflation pressure decreased rapidly due to the balloon bursting. (Level of Difficulty: Advanced.).

Female gender and mortality in ST-segment-elevation myocardial infarction treated with primary PCI.

AIMS: To investigate gender difference in mortality among patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous angioplasty (PPCI). METHODS: We analyzed data from the prospective registries of two hub PPCI centres over a 10-year period to assess the role of female gender as an independent predictor of both all-cause and cardiac death at 30 days and 1 year. To account for all confounding variables, a propensity score (PS)-adjusted multivariable Cox regression model and a PS-matched comparison between the male and female were used. RESULTS: Among 4370 consecutive STEMI patients treated with PPCI at participating centres, 1188 (27.2%) were women. The survival rate at 30 days and 1 year were significantly lower in women (Log-rank P-value < 0.001). At PS-adjusted multivariable Cox regression analysis, female gender was independently associated with an increased risk of 30-day all-cause death [hazard ratio (HR) = 2.09; 95% confidence interval (CI): 1.45-3.01, P < 0.001], 30-day cardiac death (HR = 2.03;95% CI:1.41-2.93, P < 0.001), 1-year all-cause death (HR = 1.45; 95% CI:1.16-1.82, P < 0.001) and 1-year cardiac death (HR = 1.51; 95% CI:1.15-1.97, P < 0.001). For the study outcome, we found a significant interaction of gender with the multivessel disease in females who were at increased risk of mortality in comparison with men in absence of multivessel disease. After the PS matching procedure, a subset of 2074 patients were identified. Women still had a lower survival rate and survival free from cardiac death rate both at 30-day and at 1-year follow-up. CONCLUSION: As compared with men, women with STEMI treated with PPCI have higher risk of both all-cause death and cardiac mortality at 30-day and 1-year follow-up.

Gender difference in left atrial appendage occlusion outcomes: Results from the Amplatzer™ Amulet™ Observational Study.

BACKGROUND: Percutaneous LAAO represents an alternative for stroke prevention in patients not tolerating anticoagulation. While women are at higher risk of complications during percutaneous coronary or valvular interventions, the impact of gender on LAAO outcomes is not well characterized. The current study assessed potential gender-related differences in procedural and long-term outcomes following left atrial appendage occlusion (LAAO). METHODS: 1088 AF patients were enrolled in the prospective, multicenter, Amplatzer™ Amulet™ Observational Study and followed for 2 years with scheduled adverse event assessments. The prespecified primary outcome was ischemic stroke, systemic embolism or cardiovascular (CV) death at 2 years. We also compared the rate of procedural success, device-related thrombus (DRT) and major bleeding between genders. RESULTS: 702 men and 386 women underwent LAAO. Implant successwas high, and similar between men and women (98.9 vs 99.5%, p = 0.58). Similarly, no difference was observed in the primary outcome (12.0 vs 12.5%, p = 0.82). Compared to the CHA2DS2-VASc predicted rate, we observed a numerically greater absolute risk reduction of ischemic stroke in women (from 7.6 to 2.1%/year) than men (from 6.2 to 2.2%/year). DRT through 2 years was similar between groups (1.6%, p = 0.96). We found no significant gender difference in terms of periprocedural or long-term (7.1 vs 7.6%/year) major bleeding. CONCLUSIONS: In this large group of patients undergoing LAAO using the Amplatzer™ Amulet™ device we found no significant gender difference in terms of procedural or long-term clinical outcomes. Similarly to oral anticoagulation, device-based LAA occlusion renders AF-related stroke risk similar in women and men. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02447081.https://clinicaltrials.gov/ct2/show/NCT02447081.

ImpaCt of an Optimal Implantation Strategy on Absorb Long-Term Outcomes: The CIAO Registry.

AIM: To compare the long-term outcomes of patients implanted with Absorb bioresorbable scaffold (BRS) with optimal versus suboptimal technique. METHODS AND RESULTS: All patients who received an Absorb between March 2012 and January 2016 were selected from 19 Italian centers databases to assess the impact of an optimal implantation technique (CIAO criteria) on long-term device-oriented composite end-point (DOCE) - including cardiac death (CD), target-vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) - on its single components and on scaffold thrombosis (ScT). CIAO criteria consist of predilation (balloon/vessel ratio 1:1), correct sizing (BRS/proximal reference vessel diameter -RVD- ratio 0.8-1.2) and high-pressure postdilation with non-compliant (NC) balloon (≥20 atm for balloon/BRS ratio 1:1 or ≥16 atm for a 0.25-0.5 mm oversized balloon). Among the 1.434 patients analyzed, 464 (32.4%) fulfilled all CIAO criteria for every BRS implanted (CIAO 3 group), while 970 (67.6%) did not in at least one of the received BRS (CIAO 0-1-2 group). At 31.0 (interquartile range -IQR- 24.8-38.5) months follow-up, CIAO criteria did not impact on DOCE (8.2% vs. 8.0%, p = 0.92), ID-TLR (6.9% vs. 7.1%, p = 0.72) or ScT (1.9% vs. 1.8%, p = 0.80) in the overall population. At multivariate analysis overall BRS length (p = 0.001), severely calcified lesions (p = 0.03) and absence of CIAO criteria (CIAO 0, p = 0.005) were independent predictors of DOCE in long-term follow-up. CONCLUSION: Our data suggest that strict application of an optimal Absorb implantation technique doesn't improve long-term DOCE or ScT but may mitigate the worse outcome of patients with calcific lesions.

Custom-made endograft with left subclavian artery branch in a patient with Takayasu aortitis complicated by type-B dissection and inflammatory involvement of the epiaortic vessels.

Type-B aortic dissection in a patient affected by Takayasu disease is a rarely described condition and its management can be challenging. A 47-year-old woman with Takayasu aortitis and previous aortic valve and ascending aorta replacement was admitted to hospital for type-B aortic dissection. The recent instabilization of aortic disease, the persistence of episodes of transient chest pain and the largest size of the aneurismatic tract of thoracic descending aorta rendered an invasive approach mandatory. Since the patient presented a complete bilateral occlusion of the subclavian artery just after the origin of the vertebral artery and a subcritical, smooth, bilateral stenosis of the common carotid artery, a custom-made endograft with left subclavian artery branch was successfully positioned, thus allowing the preservation of antegrade left vertebral circulation. This is the first case reporting an entirely endovascular exclusion of type-B dissection in a patient affected by Takayasu aortitis using a custom-made endograft with a subclavian branch allowing the preservation of the antegrade flow to left vertebral artery.

Lugar de acceso y tipo de anticoagulante en pacientes con síndrome coronario agudo en clase Killip avanzada o con parada cardiaca extrahospitalaria / Choice of access site and type of anticoagulant in acute coronary syndromes with advanced Killip class or out-of-hospital cardiac arrest

INTRODUCCIÓN Y OBJETIVOS: A menudo se excluye de los ensayos clínicos a los pacientes hemodinámica o eléctricamente vulnerables, por lo que escasea la información sobre el acceso vascular y el tratamiento antitrombótico óptimos. En este trabajo se estudia la evolución de los pacientes vulnerables con síndrome coronario agudo tratados invasivamente según el acceso fuera radial o femoral y el tratamiento fuera con bivalirudina o con heparina no fraccionada (HNF). MÉTODOS: El estudio MATRIX aleatorizó a 8.404 pacientes a acceso radial o femoral y a 7.213 pacientes a bivalirudina o a HNF. Se consideró vulnerables a 934 pacientes (11,1%) debido a clase Killip avanzada (808), parada cardiaca (168) o ambas a la vez (42). El objetivo primario compuesto a 30 días fueron los eventos cardiovasculares y cerebrovasculares mayores (MACE: muerte, infarto de miocardio e ictus) y los eventos clínicos adversos netos (NACE: MACE o hemorragia grave). RESULTADOS: El acceso radial, comparado con el femoral, redujo los MACE y NACE de modo similar en pacientes vulnerables y no vulnerables. El acceso radial se asoció con un claro beneficio relativo en la mortalidad total y cardiovascular y las hemorragias BARC 3 o 5, con mayor beneficio absoluto en los pacientes vulnerables. Los efectos de la bivalirudina comparada con la HNF en MACE y NACE concuerdan entre pacientes vulnerables y no vulnerables. La bivalirudina se asoció con menores mortalidad cardiovascular y por todas las causas en pacientes vulnerables, pero no en los no vulnerables, con test de interacción en el límite. La bivalirudina redujo las hemorragias en ambos grupos de pacientes, con un beneficio absoluto mayor en el caso de los pacientes vulnerables. CONCLUSIONES: En pacientes con síndrome coronario agudo sometidos a tratamiento invasivo, los efectos de los tratamientos aleatorizados fueron concordantes entre los pacientes vulnerables y los no vulnerables, pero la reducción del riesgo absoluto del acceso radial y bivalirudina fue mayor en los vulnerables, con una reducción de 5 a 10 veces en el número de pacientes que es necesario tratar

INTRODUCTION AND OBJECTIVES: Patients who are vulnerable to hemodynamic or electrical disorders (VP) are often excluded from clinical trials and data on the optimal access-site or antithrombotic treatment are limited. We assessed outcomes of transradial vs transfemoral access and bivalirudin vs unfractionated heparin (UFH) in VP with acute coronary syndrome undergoing invasive management. METHODS: The MATRIX trial randomized 8404 patients to radial or femoral access and 7213 patients to bivalirudin or UFH. Among them, 934 (11.1%) were deemed VP due to advanced Killip class (n = 808), cardiac arrest (n = 168), or both (n = 42). The 30-day coprimary outcomes were major adverse cardiovascular and cerebrovascular events (MACE: death, myocardial infarction, or stroke) and net adverse clinical events (NACE: MACE or major bleeding). RESULTS: MACE and NACE were similarly reduced with radial vs femoral access in VP and non-VP. Transradial access was also associated with consistent relative benefits in all-cause and cardiovascular mortality or Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding with greater absolute benefits in VP. The effects of bivalirudin vs UFH on MACE and NACE were consistent in VP and non-VP. Bivalirudin was associated with lower all-cause and cardiovascular mortality in VP but not in non-VP, with borderline interaction testing. Bivalirudin reduced bleeding in both VP and non-VP with a larger absolute benefit in VP. CONCLUSIONS: In acute coronary syndrome patients undergoing invasive management, the effects of randomized treatments were consistent in VP and non-VP, but absolute risk reduction with radial access and bivalirudin were greater in VP, with a 5- to 10-fold lower number needed to treat for benefits

Choice of access site and type of anticoagulant in acute coronary syndromes with advanced Killip class or out-of-hospital cardiac arrest.

INTRODUCTION AND OBJECTIVES: Patients who are vulnerable to hemodynamic or electrical disorders (VP) are often excluded from clinical trials and data on the optimal access-site or antithrombotic treatment are limited. We assessed outcomes of transradial vs transfemoral access and bivalirudin vs unfractionated heparin (UFH) in VP with acute coronary syndrome undergoing invasive management. METHODS: The MATRIX trial randomized 8404 patients to radial or femoral access and 7213 patients to bivalirudin or UFH. Among them, 934 (11.1%) were deemed VP due to advanced Killip class (n = 808), cardiac arrest (n = 168), or both (n = 42). The 30-day coprimary outcomes were major adverse cardiovascular and cerebrovascular events (MACE: death, myocardial infarction, or stroke) and net adverse clinical events (NACE: MACE or major bleeding). RESULTS: MACE and NACE were similarly reduced with radial vs femoral access in VP and non-VP. Transradial access was also associated with consistent relative benefits in all-cause and cardiovascular mortality or Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding with greater absolute benefits in VP. The effects of bivalirudin vs UFH on MACE and NACE were consistent in VP and non-VP. Bivalirudin was associated with lower all-cause and cardiovascular mortality in VP but not in non-VP, with borderline interaction testing. Bivalirudin reduced bleeding in both VP and non-VP with a larger absolute benefit in VP. CONCLUSIONS: In acute coronary syndrome patients undergoing invasive management, the effects of randomized treatments were consistent in VP and non-VP, but absolute risk reduction with radial access and bivalirudin were greater in VP, with a 5- to 10-fold lower number needed to treat for benefits. Trial registry number: NCT01433627.

Different inflammatory profile in young and elderly STEMI patients undergoing primary percutaneous coronary intervention (PPCI): Its influence on no-reflow and mortality.

BACKGROUND: Coronary no-reflow phenomenon in ST-segment elevation myocardial infarction (STEMI) is associated with a poor clinical prognosis. Although its pathophysiology is not fully elucidated, a deregulated systemic inflammatory response plays an important role. Specifically, the relationship between age-associated differences in inflammatory markers and either no-reflow or mortality in STEMI patients undergoing primary percutaneous coronary intervention (pPCI) has never been investigated. METHODS AND RESULTS: We retrospectively enrolled 625 consecutive STEMI patients undergoing pPCI for whom a complete laboratory inflammatory pattern was available. Routinely blood measured laboratory parameters were collected at the moment of admission. No reflow was defined as Thrombolysis in Myocardial Infarction (TIMI) flow-grade lower than 3. The population was divided into two groups using a cut-off centered at 65 years. Compared to younger patients, elderly patients had higher mean values of fibrinogen, brain natriuretic peptide (BNP), leukocytes, neutrophil-to-lymphocyte ratio (NLR), C reactive protein/albumin ratio (CAR). Conversely, lymphocyte count and albumin levels were higher in young patients. In elderly patients, the values of NLR, CAR as well as leukocytes, fibrinogen and neutrophils were associated with no-reflow, while in young patients only BNP value was associated. At multivariate Cox regression analysis, only BNP and NLR resulted as independent predictors of all-cause mortality in the whole population and in elderly patients. CONCLUSIONS: Elderly STEMI patients on admission had a higher acute pro-inflammatory profile than young patients, associated to coronary no-reflow and mortality outcome. These results suggest that a different therapeutic approach between elderly and young STEMI patients should be agreed.

Usefulness of Triiodothyronine Replacement Therapy in Patients With ST Elevation Myocardial Infarction and Borderline/Reduced Triiodothyronine Levels (from the THIRST Study).

The aim of the study was to investigate whether TH replacement therapy is safe and impact infarct size, left ventricular (LV) volumes and function in patients with acute myocardial infarction (AMI) and low T3 syndrome (LT3S). Thirty-seven AMI/LT3S patients were randomly treated or untreated with liothyronine (T3) therapy (maximum dosage 15 mcg/m2/die) in addition to standardized treatment (T3-treated group, n = 19; untreated group, n = 18). TH and thyroxine (TSH) during hospital stay and at 1-month and 6 months were evaluated. At discharge and at 6 months LV volumes, ejection fraction, wall motion score index (WMSI) and infarct extent were measured by cardiac MR. T3-treated patients had a significant increase in fT3 (p = 0.003 and p <0.001) at discharge and 1-month. These patients had no signs or symptoms of hyperthyroidism or arrhythmias. At follow-up, there was a significant reduction in WMSI in both groups (T3-treated group: Δ = -0.12, p = 0.001; untreated group: Δ = -0.04, p = 0.04) and the difference value (discharge/follow-up) was significantly higher in T3-treated group than in untreated group (mean difference between groups = 0.08, 95% confidence interval [CI]: 0.01 to 0.15, p = 0.05). Also, stroke volume increased significantly in the T3-treated group (Δ = 3.4, 95% CI: 0.8 to 6, p <0.01) at follow-up. In conclusion, this is the first pilot experience in which T3 replacement therapy resulted safe and able to improve regional dysfunction in patients with STEMI/LT3S.

Development and validation of a risk stratification score for new-onset atrial fibrillation in STEMI patients undergoing primary percutaneous coronary intervention.

AIM: New-onset atrial fibrillation (NOAF) is a complication not infrequent in patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI) and has been associated with worse in-hospital and long-term prognosis. We aimed to develop and validate a risk score based on common clinical risk factors and routine blood biomarkers to assess the early incidence of NOAF post-pPCI, before discharge. METHODS: The risk score for NOAF occurrence during hospitalisation (about 5 days) was developed in a cohort of 1135 consecutive STEMI patients undergoing pPCI while was externally validated in a temporal cohort of 771 STEMI patients. Biomarkers and clinical variables significantly contributing to predicting NOAF were assessed by multivariate Cox-regression analysis. RESULTS: Independent predictors of NOAF were age ≥80 years (6.97 [3.40-14.30], hazard ratio [95% CI], P < .001), leukocyte count > 9.68 × 103 /µL (2.65 [1.57-4.48], P < .001), brain natriuretic peptide (BNP) > 80 ng/L (2.37 [1.13-4.95], P = .02) and obesity (2.07 [1.09-3.92], P = .03). By summing the hazard ratios of these predictors we derived the ALBO (acronym derived from: Age, Leucocyte, BNP and Obesity) risk score which yielded high C-statistics in both the derivation (0.734 [0.675-0.793], P < .001) and validation cohort (0.76 [0.688-0.831], P < .001). In both cohorts, using Kaplan-Meier risk analysis, the ALBO score identified a tertile of patients at highest risk (ALBO >4 points), with percentages of NOAF incidence of 30.8% and 27.4% in the derivation and validation cohort, respectively. CONCLUSION: The ALBO risk score, comprising biomarkers and clinical variables that can be assessed in hospital setting, could help to identify high-risk patients for NOAF after pPCI so that a prompter action can be taken.

Left atrial appendage closure using AMPLATZER™ devices: A large, multicenter, Italian registry.

BACKGROUND: Left atrial appendage occlusion (LAAO) has been proven to be effective for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF). We aim to assess the safety and efficacy of LAAO by AMPLATZER™ devices in a large, multicenter, single-nation cohort of NVAF patients at high-risk of stroke and bleeding. METHODS: From December 2008 to April 2015 613 NVAF patients (75.1±8.0years, 62.5% male) underwent LAAO in 15 Italian centers by AMPLATZER™ devices. There were no restrictions on any personal/institutional protocols with respect to indications, pre-procedural planning, device implantation, drug therapy and follow-up. All the baseline characteristics, imaging, procedural and follow-up data were collected in a single dataset. RESULTS: AMPLATZER™ devices were successfully implanted in 95.4% of cases. Major complications occurred during 38 procedures (6.2%) and included more frequently major bleeding (3.3%) and pericardial tamponade (2.0%). At a mean follow-up of 20months, the overall annual rates of stroke and thromboembolic events, including those periprocedural, was 1.67% and 2.90%, respectively, consisting in a reduction in the rate of stroke and TIA of 66% compared with the risk-based expectation. Among the 218 patients undergoing transesophageal echocardiography at 6months of follow-up, device thrombosis was present in 1.8% of the patients whilst a significant or mild to moderate peri-device leak was found in 0.5% and 11.9% of cases, respectively. CONCLUSIONS: In this large, multicenter, single-nation study, LAAO with the AMPLATZER™ devices showed high procedural success, early safety and mid-term efficacy for the prevention of NVAF-related thromboembolism.

The left atrial appendage: from embryology to prevention of thromboembolism.

The left atrial appendage (LAA) is the main source of thromboembolism in patients with non-valvular atrial fibrillation (AF). As such, the LAA can be the target of specific occluding device therapies. Optimal management of patients with AF includes a comprehensive knowledge of the many aspects related to LAA structure and thrombosis. Here we provide baseline notions on the anatomy and function of the LAA, and then focus on current imaging tools for the identification of anatomical varieties. We also describe pathogenetic mechanisms of LAA thrombosis in AF patients, and examine the available evidence on treatment strategies for LAA thrombosis, including the use of non-vitamin K antagonist oral anticoagulants and interventional approaches.