A real-world multicenter study on left atrial appendage occlusion: The Italian multi-device experience.

Background: Transcatheter left atrial appendage occlusion (LAAO) has emerged as an alternative treatment for stroke prevention in patients with atrial fibrillation (AF) at high risk of thromboembolism, who cannot tolerate long-term oral anticoagulation (OAC). Questions persist regarding effectiveness and safety of this treatment and the optimal post-interventional antithrombotic regimen after LAAO. Methods: We retrospectively gathered data from 428 patients who underwent percutaneous LAAO in 6 Italian high-volume centres, aimed at describing the real-world utilization, safety, and effectiveness of LAAO procedures, also assessing the clinical outcomes associated with different antithrombotic strategies. Results: Among the entire population, 20 (4.7 %) patients experienced a combination of pericardial effusion and periprocedural major bleeding: 8 (1.9 %) pericardial effusion, 1 (0.3 %) fatal bleeding, and 3 (0.7 %) non-fatal procedural major bleeding. Patients were discharged with different antithrombotic regimens: dual (DAPT) (27 %) or single (SAPT) (26 %) antiplatelet therapy, OAC (27 %), other antithrombotic regimens (14 %). Very few patients were not prescribed with antithrombotic drugs (6 %). At a medium 523 ± 58 days follow-up, 14 patients (3.3 %) experienced all-cause death, 6 patients (1.4 %) cardiovascular death, 3 patients (0.7 %) major bleeding, 10 patients (2.6 %) clinically relevant non-major bleeding, and 3 patients (0.7 %) ischemic stroke. At survival analysis, with DAPT as the reference group, OAC therapy was associated with better outcomes. Conclusions: Our findings confirm that LAAO is a safe procedure. Different individualized post-discharge antithrombotic regimens are now adopted, likely driven by the perceived thrombotic and hemorrhagic risk. The incidence of both ischemic and bleeding events tends to be low.

Risk Score for Prediction of Dialysis After Transcatheter Aortic Valve Replacement.

BACKGROUND: Dialysis is a rare but serious complication after transcatheter aortic valve replacement. We analyzed the large multicenter TRITAVI (transfusion requirements in transcatheter aortic valve implantation) registry in order to develop and validate a clinical score assessing this risk. METHODS AND RESULTS: A total of 10 071 consecutive patients were enrolled in 19 European centers. Patients were randomly assigned (2:1) to a derivation and validation cohort. Two scores were developed, 1 including only preprocedural variables (TRITAVIpre) and 1 also including procedural variables (TRITAVIpost). In the 6714 patients of the derivation cohort (age 82±6 years, 48% men), preprocedural factors independently associated with dialysis and included in the TRITAVIpre score were male sex, diabetes, prior coronary artery bypass graft, anemia, nonfemoral access, and creatinine clearance <30 mL/min per m2. Additional independent predictors among procedural features were volume of contrast, need for transfusion, and major vascular complications. Both scores showed a good discrimination power for identifying risk for dialysis with C-statistic 0.78 for TRITAVIpre and C-statistic 0.88 for TRITAVIpost score. Need for dialysis increased from the lowest to the highest of 3 risk score groups (from 0.3% to 3.9% for TRITAVIpre score and from 0.1% to 6.2% for TRITAVIpost score). Analysis of the 3357 patients of the validation cohort (age 82±7 years, 48% men) confirmed the good discrimination power of both scores (C-statistic 0.80 for TRITAVIpre and 0.81 for TRITAVIpost score). Need for dialysis was associated with a significant increase in 1-year mortality (from 6.9% to 54.4%; P=0.0001). CONCLUSIONS: A simple preprocedural clinical score can help predict the risk of dialysis after transcatheter aortic valve replacement.

Coronary angiography- or fractional flow reserve-guided complete revascularization in multivessel disease STEMI: A Bayesian hierarchical network meta-analysis.

AIMS: To identify the best strategy to achieve complete revascularization (CR) in patients with ST-elevation myocardial infarction (STEMI) and multi-vessel disease (MVD). METHODS AND RESULTS: We systematically reviewed the literature for randomized controlled trials (RCTs) comparing IRA-only PCI and CR guided by angiography or fractional flow reserve (FFR) in MVD-STEMI. Both frequentist (classical) and Bayesian network meta-analysis were performed, including a comparative hierarchy estimation of the probability to reduce the primary composite endpoint of all-cause death and new myocardial infarction (MI). We identified 11 RCTs, including 8193 STEMI patients. Compared with IRA-only strategy, CR significantly reduced the primary endpoint (OR: 0.73; 95%CI0.55-0.97). We observed non-significant difference between angiography and FFR guidance in reducing the primary endpoint (OR: 0.73, 95% CI 0.35-1.57). The Bayesian probability analysis ranked angio-guided CR as the best intervention yielding lowest risk of all-cause death or new MI (SUCRA92%). CONCLUSIONS: In patients with MVD-STEMI, CR is associated with a reduction in all-cause mortality and new MI compared with IRA-only PCI. Angio-guided CR is associated with the lowest risk of all-cause death or new MI, therefore the role of FFR-guidance in this setting is questionable. CONDENSED ABSTRACT: Both frequentist and Bayesian network meta-analysis were performed to compare infarct-related artery (IRA)-only percutaneous coronary intervention (PCI) and complete revascularization (CR) guided by angiography or fractional flow reserve (FFR) in multivessel disease (MVD) and acute ST-elevation myocardial infarction (STEMI). Eleven randomized controlled trials were identified, including 8193 STEMI patients. Compared with IRA-only strategy, CR significantly reduced the incidence of the composite endpoint of all-cause death and new myocardial infarction without significant difference in angio-guided and FFR-guided CR. The Bayesian probability analysis ranked angio-guided CR as the best intervention yielding lowest risk of the composite endpoint and, therefore the role of FFR-guidance in this setting is questionable.

Impact of dual antiplatelet therapy duration on clinical outcome after coronary bifurcation stenting: results from the EuroBifurcation Club registry.

BACKGROUND: Optimal duration of dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) of a bifurcation stenosis is still debated. We evaluated the impact of DAPT duration on clinical outcomes in all-comers patients undergoing bifurcation PCI included in the European Bifurcation Club (EBC) registry. METHODS: We enrolled 2284 consecutive patients who completed at least 18 months follow-up. The cumulative occurrence of major adverse cardiac and cardiovascular events (MACCE), defined as a composite of overall-death, non-fatal myocardial infarction (MI), target vessel revascularization (TVR) and stroke were evaluated. Bleedings classified as Bleeding Academic Research Consortium (BARC) ≥3 were evaluated too. RESULTS: Patients were divided into 3 groups: short DAPT (<6-months, N.=375); standard DAPT (≥6-months but ≤12-months, N.=636); prolonged DAPT (>12-months, N.=1273). At 24 months follow-up MACCE-free survival was significantly lower in short DAPT patients (Log-Rank: 45.23, P for trend <0.001). MACCE occurred less frequently in the prolonged DAPT group (148 [11.6%]) as compared with both the short (83 [22.1%] HR: 0.48 [0.37-0.63], P<0.001) and standard DAPT groups (137 [21.5%] HR:0.51 [0.41-0.65], P<0.001). These differences remain after propensity score adjustment (respectively, HR: 0.27 [0.20-0.36] and HR: 0.44 [0.34-0.57]). Such finding was consistent in patients presenting with both acute and chronic coronary syndromes. BARC≥3 bleedings were 0.3% in the standard DAPT, 1.6% in short and 1.9% in prolonged DAPT groups. CONCLUSIONS: In the "real-world" EBC registry of patients undergoing PCI of coronary artery bifurcation stenosis, a prolonged DAPT duration was associated with a significantly lower risk of MACCE and a potential increased risk of major bleedings.

On site cardiac surgery for structural heart interventions: a fence to mend?

Current evidence supports device-based transcatheter interventions for the management of patients with structural heart disease, proving well their safety and efficacy; transcatheter aortic valve implantation (TAVI), transcatheter edge-to-edge repair (TEER) of mitral or tricuspid valves, and left atrial appendage occlusion (LAAO) are expanding their role in contemporary practice. Currently, guidelines recommend performing TAVI in 'Heart Valve Center' with interventional cardiology and institutional on-site cardiac surgery (iOSCS), while no site limitation has been defined for TEER and LAAO. The growing number of candidates for transcatheter interventions generates long waiting times with negative consequences on mortality, morbidity, hospitalization, and functional deterioration. Therefore, a debate on the feasibility of TAVI in centres without iOSCS has been set up. Data from randomized controlled trials and registries failed to document any difference in outcomes and in conversion rate to emergent surgical bailout in centres with or without iOSCS; on the other hand, a direct relationship with TAVI complications has been clearly documented for learning curve and centre volume. Therefore, the role of iOSCS for TAVI, as well as for other transcatheter interventions, should be carefully explored.

Predictive Value of Left Atrial and Ventricular Strain for the Detection of Atrial Fibrillation in Patients With Cryptogenic Stroke.

Background and Aims: Cryptogenic stroke (CS) is associated with a high rate of recurrences and adverse outcomes at long-term follow-up, especially due to its unknown etiology that often leads to ineffective secondary prevention. Asymptomatic atrial fibrillation (AF) could play an important pathophysiological role. Some studies have pointed to left atrial (LA) and left ventricular (LV) systolic and diastolic dysfunction as surrogate markers of AF. The aim of the study is to evaluate the relationship between echocardiographic parameters of LA and LV function, and the occurrence of AF revealed by continuous ECG monitoring in a cohort of patients with CS. Methods: Single-center prospective cohort study. Seventy-two patients with CS with insertable cardiac monitors (ICM) underwent transthoracic echocardiography (TTE). TTE was focused on LA and LV function, including both standard and longitudinal strain-derived parameters. All detected AF episodes lasting more than 2 min were considered. Results: Continuous ECG monitoring revealed subclinical AF in 23 patients (32%) at an average of 6.5 months after ICM implantation. Many echocardiographic parameters, indicating LA volume and LV systolic/diastolic function, were significantly associated with the occurrence of AF, suggesting the worst atrial function in the AF group. Furthermore, multivariable regression analysis revealed that peak atrial contraction strain and left ventricular strain were independently associated with AF (adjusted OR = 0.72, CI 95% 0.48-0.90, p = 0.005, and adjusted OR = 0.69, CI 95% 0.46-0.95, p = 0.041, respectively). Conclusion: In patients with CS, LA and LV strain analysis add predictive value for the occurrence of AF over clinical and morpho-functional echocardiographic parameters. Impaired booster pump strain and LV longitudinal strain are strong and independent predictors of AF.

Impact of dual antiplatelet therapy duration on clinical outcome after coronary bifurcation stenting: results from the euro bifurcation club registry

BACKGROUND: Optimal duration of Dual Antiplatelet Therapy (DAPT) following percutaneous coronary intervention (PCI) of a bifurcation stenosis is still debated. We evaluated the impact of DAPT duration on clinical outcomes in all-comers patients undergoing bifurcation PCI included in the European Bifurcation Club (EBC) registry. METHODS: We enrolled 2284 consecutive patients who completed at least 18 months follow-up. The cumulative occurrence of Major Adverse Cardiac and Cardiovascular Events (MACCE), defined as a composite of overall-death, non-fatal myocardial infarction (MI), target vessel revascularization (TVR) and stroke were evaluated. Bleedings classified as BARC ≥ 3 were evaluated too. RESULTS: Patients were divided into 3 groups: Short DAPT (<6-months, n=375); Standard DAPT (≥6-months but ≤12-months, n=636); Prolonged DAPT (>12- months, n=1273). At 24 months follow-up MACCE-free survival was significantly lower in Short DAPT patients (Log-Rank: 45.23, p for trend <0.001). MACCE occurred less frequently in the Prolonged DAPT group (148 (11.6%)) as compared with both the Short (83 (22.1%) HR:0.48 (0.37-0.63), p<0.001) and Standard DAPT groups (137 (21.5%) HR:0.51 (0.41-0.65), p<0.001). These differences remain after propensity score adjustment (respectively, HR: 0.27 (0.20-0.36) and HR: 0.44 (0.34-0.57)). Such finding was consistent in patients presenting with both acute and chronic coronary syndromes. BARC ≥ 3 bleedings were 0.3% in the Standard DAPT, 1.6% in Short and 1.9% in Prolonged DAPT groups. CONCLUSIONS: In the "real-world" EBC registry of patients undergoing PCI of coronary artery bifurcation stenosis, a prolonged DAPT duration was associated with a significantly lower risk of MACCE and a potential increased risk of major bleedings.

Timing of mechanical circulatory support during primary angioplasty in acute myocardial infarction and cardiogenic shock: Systematic review and meta-analysis.

OBJECTIVES: We aim to define whether the timing of microaxial left ventricular assist device (IMLVAD) implantation might impact on mortality in acute myocardial infarction (AMI) cardiogenic shock (CS) patients who underwent primary percutaneous coronary intervention (PPCI). BACKGROUND: Despite the widespread use of PPCI, mortality in patients with AMI and CS remains high. Mechanical circulatory support is a promising bridge to recovery strategy, but evidence on its benefit is still inconclusive and the optimal timing of its utilization remains poorly explored. METHODS: We compared clinical outcomes of upstream IMLVAD use before PPCI versus bailout use after PPCI in patients with AMI CS. A systematic review and meta-analysis of studies comparing the two strategies were performed. Effect size was reported as odds ratio (OR) using bailout as reference group and a random effect model was used. Study-level risk estimates were pooled through the generic inverse variance method (random effect model). RESULTS: A total of 11 observational studies were identified, including a pooled population of 6759 AMI-CS patients. Compared with a bailout approach, upstream IMLVAD was associated with significant reduction of 30-day (OR = 0.65; 95% confidence interval [CI] = 0.51-0.82; I2 = 43%, adjusted OR = 0.54; 95% CI = 0.37-0.59; I2 = 3%, test for subgroup difference p = 0.30), 6-month (OR = 0.51; 95% CI = 0.27-0.96; I2 = 66%), and 1-year (OR = 0.56; 95% CI = 0.39-0.79; I2 = 0%) all-cause mortality. Incidence of access-related bleeding, acute limb ischemia and transfusion outcomes were similar between the two strategies. CONCLUSION: In patients with AMI-CS undergoing PPCI, upstream IMLVAD was associated with reduced early and midterm all-cause mortality when compared with a bailout strategy.

Factors for heterogeneous outcomes of angina and myocardial ischemia without obstructive coronary atherosclerosis.

BACKGROUND AND OBJECTIVES: The absence of obstructive coronary artery disease (CAD) in patients with angina is common, but its prognosis is debated. We investigated outcomes of such patients to identify predictors of cardiovascular events. METHODS: We selected 1014 patients with angina, evidence of myocardial ischemia at the electrocardiogram (ECG) exercise test or imaging stress tests, and nonobstructive CAD (absence of lumen diameter reduction ≥50%) at coronary angiography between 1999 and 2015. Note that, 1905 age- and risk factors-matched asymptomatic subjects served as "real-world" comparators. The primary endpoint was the occurrence of all-cause death or myocardial infarction. RESULTS: At 6-years median follow-up (interquartile range, 3-9 years), the primary endpoint occurred in 53 patients (5.5%, 0.92/100 person-years). Besides similar event rates compared with asymptomatic subjects (hazard ratio [HR] 0.85, 95% confidence interval [CI] 0.62-1.15, p = 0.28), the index population showed a very heterogeneous prognosis. Patients with nonobstructive CAD (HR 1.85, 95% CI 1.02-3.37, p = 0.04, compared with "normal" coronary arteries) and ischemia at imaging tests (HR 2.11, 95% CI 1.07-4.14, p = 0.03, compared with ischemia detected only at the ECG exercise test) were at higher risk and those with both these components showing even >10-fold event rates as compared with the absence of both. Three-hundred and twenty-five patients (34%) continued to experience angina, 69 (7.2%) underwent repeat coronary angiography, and 14 (1.5%) had consequent coronary revascularization for atherosclerosis progression. CONCLUSION: Apart from the impaired quality of life, angina without obstructive CAD has an overall benign but very heterogeneous prognosis. Nonobstructive CAD and myocardial ischemia at imaging tests both confer a higher risk.

Sex based analysis of the impact of red blood cell transfusion and vascular or bleeding complications related to TAVI - The TRITAVI-Women Study.

BACKGROUND: Women present specific risks for transcatheter aortic valve replacement (TAVI) but there are scarce sex-based analysis. The aim of this study was to explore the risk of vascular/bleeding complications in females vs. males that underwent TAVI and the impact of red blood cell (RBC) transfusion. METHODS: TRITAVI-Women is a retrospective analysis in 13 European institutions. Propensity score based on pairs of different sex was performed and global outcomes, vascular/bleeding risk factors were determined. Afterwards, the female population of the study was divided into two groups according to the need of RBC transfusion and the risk for mortality, AKI, MI, stroke at 30-days and at 1-year were compared as a combined endpoint (primary endpoint) and separately (secondary endpoints). RESULTS: The global study population included 5837 patients. Females presented more advanced NYHA class, chronic kidney disease, and baseline anemia. Vascular/bleeding complications and RBC transfusion were more common in women. However, 1-year mortality was lower for women in the matched cohort (8.1% vs.10.3%, p = 0.028). The need for RBC transfusion was an independent predictor of higher incidence of the primary endpoint at 30-day and 1-year. The main predictor of RBC transfusion in women was the presence of baseline anemia. CONCLUSIONS: Women present lower risk of mortality than men at 1-year follow up, but not at 30-day due to higher rates of vascular/bleeding complications. RBC transfusion was also more often required in women and was an independent predictor or poorer outcomes. The treatment of pre-existing anemia before TAVI might improve the short-term results in women.

The 'dreaded PFO': anatomical and functional features of high risk for stroke.

Patent foramen ovale (PFO) has a high prevalence in general population and can be implicated in cryptogenic stroke among young people. Recent trials have shown that transcatheter PFO closure is superior to medical treatment in the secondary prevention of ischaemic stroke. The benefit in the reduction of stroke recurrence is particularly evident in patients who have documentation of a PFO with high-risk characteristics. Therefore, after the assessment of a clear causal relationship with the event, a thoughtful documentation of anatomic (height, length, presence of an aneurysmatic or a floppy atrial septum, a prominent Eustachian valve or Chiari's network, an acute angle with the inferior vena cava) and functional high-risk characteristics is mandatory.

Early Adverse Impact of Transfusion After Transcatheter Aortic Valve Replacement: A Propensity-Matched Comparison From the TRITAVI Registry.

BACKGROUND: There is no consensus on the benefit of red blood cell (RBC) transfusion after transcatheter aortic valve replacement. METHODS: The multicenter Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) registry retrospectively included patients after transfemoral transcatheter aortic valve replacement; propensity score-matching identified pairs of patients with and without RBC transfusion. The primary end point was 30-day mortality; nonfatal myocardial infarction, cerebrovascular accident, and stage 2 to 3 acute kidney injury at 30 days were secondary end points. We repeated propensity score-matching according to the hemoglobin nadir, hemoglobin drop, and in the subgroup of uncomplicated patients, without major vascular complications or major bleeding. RESULTS: Among 2587 patients, RBC transfusion was administered in 421 cases (16%). The primary end point occurred in 104 (4.0%) patients, myocardial infarction in 9 (0.4%), cerebrovascular accident in 38 (1.5%), and acute kidney injury in 125 (4.8%) cases. In the 842 propensity-matched patients, RBC transfusion was associated with increased mortality (hazard ratio, 2.07 [95% CI, 1.06-4.05]; P=0.034) and acute kidney injury (hazard ratio, 4.35 [95% CI, 2.21-8.55]; P<0.001). Interaction testing between RBC transfusion and mortality was not statistically significant in the above-mentioned subgroups, and such association was not documented in the corresponding propensity score-matched cohorts. In the multivariable Cox proportional hazards regression model, major vascular complications (P=0.044), major bleeding (P=0.041), and RBC transfusion (P=0.048) were independent correlates of 30-day mortality. CONCLUSIONS: RBC transfusion correlates with increased mortality and acute kidney injury early after transcatheter aortic valve replacement and is an independent predictor of 30-day mortality, irrespective of periprocedural major bleeding and vascular complications. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03740425.