Prevalence and predictors of left atrial thrombosis in atrial fibrillation patients treated with non-vitamin K antagonist oral anticoagulants.

BACKGROUND: Few data are available regarding the prevalence of left atrium (LA) thrombi in atrial fibrillation (AF) patients treated with non-vitamin K antagonist oral anticoagulants (NOACs). Methods: We evaluated the prevalence and predictors of LA/LA appendage (LAA) thrombi in non-valvular AF patients treated with NOACs referring to a single centre for a scheduled electrical cardioversion (ECV) or catheter ablation (CA). Transesophageal echocardiography (TEE) was performed within 12 h prior to the index procedure. RESULTS: A total of 352 consecutive patients with non-valvular AF treated with NOACs were included in this analysis (ECV group n = 176 and CA group n = 176) between 2013 and 2018. 85 patients (24.2%) were on dabigatran, 150 (42.7%) on rivaroxaban, 104 (29.6%) on apixaban and 13 (3.7%) on edoxaban. A LA/LAA thrombus was detected by TEE in 27 (7.7%) patients, 18 in the ECV group and nine in the ablation group; 18 (5.1%) patients presented dense LA/LAA spontaneous echo contrast (SEC). Predictors of LA/LAA thrombi were a CHA2DS2-VASc score > 3 (OR 4.54, 95% CI 1.50 - 13.70, p value = .007) and obesity (OR 6.01, 95% CI 1.95 - 18.50, p value = .001). CONCLUSIONS: Among real-world patients with non-valvular AF treated with NOACs, we found a high incidence of LA/LAA thrombi compared to previous reports. The main predictors of LA/LAA thrombosis were a CHA2DS2-VASc score > 3 and obesity.

Prognostic role of left atrial enlargement in patients with implantable cardioverter defibrillators for primary prevention.

PURPOSE: Left atrial volume index (LAVI) is a predictor of heart failure and adverse events, irrespective of left ventricular systolic function. The role of LAVI in the prediction of appropriate implantable cardioverter-defibrillator (ICD) therapies is currently unclear and was the focus of this study. METHODS: Consecutive heart failure patients with ischaemic (ICM) or idiopathic (DCM) aetiology receiving ICD for primary prevention were included. The primary endpoint was the occurrence of appropriate ICD therapies (ATs): shocks or antitachycardia pacing (ATP). Inappropriate ICD shocks were also assessed as secondary endpoint. RESULTS: Among 198 included patients, severe left atrial dilatation (SLAE = LAVI ≥ 60 ml/m2) was present in 54 (27%). SLAE patients had a higher prevalence of NYHA class ≥ III, severe mitral regurgitation and atrial fibrillation history. During a median follow-up of 45 months (IQR 25-68), ATs occurred more frequently in SLAE group (33% vs. 15%, p = .007) as well as appropriate shocks (24% vs. 10%, p = .014). At multivariate analysis SLAE was an independent predictor of ATs (OR 3.19, 95% CI 1.38-7.38, p = .007). Inappropriate shocks were associated with AF during implantation (p = .03), but not with SLAE (p = .009). CONCLUSION: In DCM or ICM patients candidate to receive an ICD for primary prevention, a severely enlarged left atrium is a predictive factor for ATs (shocks or ATP). The risk of inappropriate shocks was increased in patients with atrial fibrillation, rather than SLAE.

Long-term efficacy and impact on quality of life of atrial fibrillation catheter ablation in competitive athletes.

BACKGROUND: Limited data are available on the efficacy of catheter ablation (CA) for sport-associated atrial fibrillation (AF), in particular at long term follow-up. Moreover, the impact of AF CA on Quality of Life (QoL) in this population remains unknown. We aimed to determine AF CA efficacy in athletes, to assess the impact on athletes' QoL (with SF36 score) and on training capabilities in a long-term follow-up (FU). METHODS: A total of 1215 AF patients' candidates to CA between January 2007 and December 2012, were retrospectively screened. Athletes were defined as patients performing ≥5 h/week of vigorous sports, achieving a total of ≥1500 h lifetime sport activity, for at least one year before AF first symptomatic episode. RESULTS: Out of 1215 AF patients, 133 were considered competitive athletes and underwent CA. Overall, 43% of our cohort showed typical or atypical atrial flutter, which required a more extensive ablation procedure. Before AF, athletes used to practice for a mean of 8.5±2.7 h/week, while after the first AF episode the mean practice duration decreased to 2.8±2.5 h/week. At 10-year follow-up, 83% of athletes did not present any recurrent event, and training capabilities increased up to 5.6±3.6 h/week after the procedure. Moreover, intense physical activity before AF CA was related to long-term AF recurrence rates (P=0.05). QoL scores significantly improved in each single domain (P<0.05). CONCLUSIONS: AF CA represents an effective procedure to maintain sinus rhythm in athletes, with a significant improvement in QoL.

Electrocardiographic and clinical predictors for permanent pacemaker requirement after transcatheter aortic valve implantation: a 10-year single center experience.

BACKGROUND: The aim of this study is to identify clinical, electrocardiographic (ECG) and procedural predictors for permanent pacemaker (PPM) requirement after transaortic valve implantation (TAVI). METHODS: All consecutive patients with severe symptomatic aortic stenosis (SSAS) undergoing TAVI at our single center were included in the study and prospectively followed. All patients had standard 12-leads ECGs recordings before and after TAVI and continuous ECG monitoring during hospital stay. Primary endpoint was to identify electrocardiographic predictors of PPM implantation after TAVI; secondary endpoint was to ascertain other clinical or procedure-related predictive factors of PPM need. PPM implantation was further arbitrarily divided into early and late one (beyond the 3rd day). RESULTS: Among the 431 patients undergoing TAVI between 2008 and 2018, 77 (18%) needed PPM implantation; 47 (11%) had an early procedure, and 30 (7%) a late implant. Preoperative right bundle branch block (RBBB) implies more than five-fold increase of the risk of PPM implantation (OR 5.19, CI 1.99-13.56, P=0.001), whereas the use of a self-expandable prosthesis is associated with an almost three-fold increase of the risk (OR 2.60, CI 1.28-5.28, P=0.008). In the late PPM implantation subgroup, only the history of syncope retains a significant association with such an increased risk (OR 2.71, CI 1.09-6.75, P=0.032). CONCLUSIONS: The need of a PPM in the individual TAVI patient is hardly predictable. However, the finding of pre-existing RBBB, the use of self-expandable prosthesis and history of syncope can individuate patients at increased risk.

Zero-fluoroscopy atrial fibrillation ablation in the presence of a patent foramen ovale: a multicentre experience.

INTRODUCTION: Atrial fibrillation ablation has historically been guided by fluoroscopy, with the related enhanced risk deriving from radiation. Fluoroscopy exposure may be confined to guide the transseptal puncture. Small sample size study presented a new methodology to perform a totally fluoroless atrial fibrillation ablation in the case of a patent foramen ovale (PFO). We evaluated this methodology in a large sample size of patients and a multicentre experience. METHODS AND RESULTS: Two hundred and fifty paroxysmal atrial fibrillation patients referred for first atrial fibrillation ablation with a CARTO3 electroanatomic mapping system were enrolled. In 58 out of 250 patients, a PFO allowed crossing of the interatrial septum, and a completely fluoroless ablation was performed applying the new method (Group A). In the remaining patients, a standard transseptal puncture was performed (Group B). Pulmonary vein isolation was achieved in all patients with comparable procedural and clinical outcomes at short- and long-term follow-up. CONCLUSION: The presence of a PFO may allow a completely fluoroless well tolerated and effective atrial fibrillation ablation. Probing the fossa ovalis looking for the PFO during the procedure is desirable, as it is not time-consuming and can potentially be done in every patient undergoing atrial fibrillation ablation.

Efficacy and Safety of Clopidogrel, Prasugrel and Ticagrelor in ACS Patients Treated with PCI: A Propensity Score Analysis of the RENAMI and BleeMACS Registries.

INTRODUCTION: Real-life data comparing clopidogrel, prasugrel, and ticagrelor for unselected patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) are lacking, as are data for the temporal distribution of ischemic and bleeding risks. METHODS: A total of 19,825 patients were enrolled from the RENAMI and BleeMACS registries. Both were multicenter, retrospective, observational registries including the data and outcomes of consecutive patients with ACS who underwent primary PCI and were discharged with dual antiplatelet therapy (DAPT). We evaluated the long-term outcome stratified by the different antiplatelet agents. RESULTS: A total of 14,105 patients (71.2%) were treated with clopidogrel, 2364 patients (11.9%) with prasugrel and 3356 patients (16.9%) with ticagrelor. After propensity score matching, at 1 year, prasugrel reduced the incidence of net adverse clinical events (NACE; a composite endpoint of all-cause death, myocardial infarction [MI] and Bleeding Academic Research Consortium [BARC] 3-5 bleeding) (4.2% vs.7.6%, p = 0.002) and of major adverse cardiovascular events (MACE; a composite endpoint of death and MI) compared with clopidogrel (2.6% vs. 5.2%, p = 0.007). Ticagrelor decreased rates of MACE compared with clopidogrel (2.7% vs. 6.2%, p < 0.001), but not of NACE (6.6% vs. 8.7%, p = 0.07). Ticagrelor presented similar performance in terms of MACE compared with prasugrel (2.8% vs. 2.4%, p = 0.56), with a trend towards a reduction in MI (0.2% vs. 0.4%, p = 0.56), but with higher risk of BARC 3-5 bleedings (3.8% vs. 1.7%, p = 0.04). In the daily risk analysis, clopidogrel presented a binomial distribution with a peak of ischemic risk at 3 months, which decreased towards bleedings; prasugrel had a constant equivalence between opposite risks; and ticagrelor constantly reduced recurrent MIs despite higher risk of BARC 3-5 events. CONCLUSION: In real life, ticagrelor is more effective in reducing ischemic events during the first year after ACS, despite an increased risk of major bleedings, while prasugrel assures a better balance between ischemic and bleeding recurrent events.

P2Y12 inhibitors in acute coronary syndrome patients with renal dysfunction: an analysis from the RENAMI and BleeMACS projects.

AIMS: The aim of the present study was to establish the safety and efficacy profile of prasugrel and ticagrelor in real-life acute coronary syndrome (ACS) patients with renal dysfunction. METHODS AND RESULTS: All consecutive patients from RENAMI (REgistry of New Antiplatelets in patients with Myocardial Infarction) and BLEEMACS (Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome) registries were stratified according to estimated glomerular filtration rate (eGFR) lower or greater than 60 mL/min/1.73 m2. Death and myocardial infarction (MI) were the primary efficacy endpoints. Major bleedings (MBs), defined as Bleeding Academic Research Consortium bleeding types 3 to 5, constituted the safety endpoint. A total of 19 255 patients were enrolled. Mean age was 63 ± 12; 14 892 (77.3%) were males. A total of 2490 (12.9%) patients had chronic kidney disease (CKD), defined as eGFR <60 mL/min/1.73 m2. Mean follow-up was 13 ± 5 months. Mortality was significantly higher in CKD patients (9.4% vs. 2.6%, P < 0.0001), as well as the incidence of reinfarction (5.8% vs. 2.9%, P < 0.0001) and MB (5.7% vs. 3%, P < 0.0001). At Cox multivariable analysis, potent P2Y12 inhibitors significantly reduced the mortality rate [hazard ratio (HR) 0.82, 95% confidence interval (CI) 0.54-0.96; P = 0.006] and the risk of reinfarction (HR 0.53, 95% CI 0.30-0.95; P = 0.033) in CKD patients as compared to clopidogrel. The reduction of risk of reinfarction was confirmed in patients with preserved renal function. Potent P2Y12 inhibitors did not increase the risk of MB in CKD patients (HR 1.00, 95% CI 0.59-1.68; P = 0.985). CONCLUSION: In ACS patients with CKD, prasugrel and ticagrelor are associated with lower risk of death and recurrent MI without increasing the risk of MB.

Comparative external validation of the PRECISE-DAPT and PARIS risk scores in 4424 acute coronary syndrome patients treated with prasugrel or ticagrelor.

BACKGROUND: The PRECISE-DAPT and PARIS risk scores (RSs) were recently developed to help clinicians at individualizing the optimal dual antiplatelet therapy duration (DAPT) after percutaneous coronary intervention (PCI). Nevertheless, external validation of these RSs it has not yet been performed in ACS (acute coronary syndrome) patients treated with prasugrel or ticagrelor in a real- world scenario. METHODS: 4424 ACS patients who underwent PCI and survived to hospital discharge, from January 2012 to December 2016 at 12 European centers, were included. PRECISE-DAPT and PARIS bleeding RS, as well as PARIS ischemic RS, were computed, and their performance at predicting major bleeding (MB; BARC type 3 or 5) and ischemic events (MI and stent thrombosis) during follow up was compared. RESULTS: After a median follow-up of 14 (interquartile range 12-20.9) months, 83 (1.88%) patients developed MB and 133 (3.0%) suffered an ischemic episode. PRECISE-DAPT performed better than PARIS bleeding RS (c-statistic = 0.653 vs. 0.593; p = .01 for comparison) in predicting MB. The RSs performance for MB prediction remained consistent in STEMI patients (c-statistic = 0.632 vs 0.575) or in those treated with prasugrel (c-statistic = 0.623 vs 0.586). PARIS ischemic RS exhibited superior discrimination in predicting ischemic complications compared to PRECISE-DAPT (c-statistic = 0.604 vs 0.568 p = .05 for comparison). CONCLUSION: Our data provide support to the use of PRECISE-DAPT in MB risk stratification for patients receiving DAPT in form of aspirin and prasugrel or ticagrelor whereas the PARIS ischemic RS has potential to complement the risk prediction with respect to ischemic events.

Prevalence and prognosis of lead masses in patients with cardiac implantable electronic devices without infection.

BACKGROUND: Finding of intracardiac lead masses in patients with cardiac implantable electronic devices remains controversial, as such masses have been observed in cases of exclusively local infections whereas they have not been recognized in patients with positive cultures of intravascular lead fragments. In this study, we aim to describe the prevalence of intracardiac lead masses in true asymptomatic patients with cardiac implantable electronic devices, to identify their predictive factors and to define their prognostic impact at long-term follow-up. METHODS: Seventy-eight consecutive patients admitted over a 6-month period for elective generator replacement without clinical evidence of infection were evaluated by transthoracic and transesophageal echocardiography and prospectively followed at in-clinic follow-up visits. RESULTS: Lead masses were found in 10 patients (12.8%). These patients had more frequently right ventricular dysfunction at univariate analysis (OR 2.71, P = 0.010) and after baseline variables adjustment (hazard ratio 6.25, P = 0.012). At 5-year follow-up without any specific therapy, none of the patients suffered from any cardiac device infections, or developed clinical signs of infections. CONCLUSION: There is an evidence of clinical lead masses in asymptomatic patients with cardiac implantable electronic devices. The value of these findings is still debated for aetiological interpretation and for therapeutic strategy, but they are not necessarily associated with an infection.

In-hospital and long-term outcomes of HIV-positive patients undergoing PCI according to kind of stent: a meta-analysis.

BACKGROUND: Pathogenesis of cardiovascular disease in HIV-positive patients is related to the interaction between traditional and HIV-specific factors. Limited data are available regarding the prognosis of HIV-positive patients undergoing percutaneous coronary intervention (PCI). METHODS: All observational studies evaluating the prognosis of HIV-positive patients treated with PCI were included. In-hospital and long-term major adverse cardiac events (MACE) [composite endpoint of all-cause death or myocardial infarction (MI)] were the primary endpoints, whereas in-hospital and long-term all-cause death, cardiovascular death, MI, stent thrombosis, target vessel revascularization (TVR), target lesion revascularization (TLR), and bleeding complications were the secondary ones. FINDINGS: In all, 1243 patients in nine studies were included, with a mean age of 54 years. Among them, 12% were female and 91% were admitted for acute coronary syndromes. In-hospital MACE occurred in 6.0% (5.4-6.6), death in 4.2% (2.6-5.9), and MI in 1.3% (0-2.8), whereas major bleeding occurred in 2.0% (1.7-2.3) of the patients. After 2 years (1.6-3.1), long-term MACE occurred in 17.4% (11.9-22.3), all-cause death in 8.7% (3.2-14.2), and MI in 7.8% (5.5-10.1) of the patients, whereas stent thrombosis and TVR in 3.4% (1.5-5.3) and 10.5% (7.5-13.4), respectively. In patients treated with drug-eluting stents (DES), the rate of long-term MACE was 22.3% (10.1-34.4), with an incidence of 4.9% (0.0-11.4) of MI and 5.7% (2.3-13.7, all 95% confidence intervals of TLR. INTERPRETATION: HIV-positive patients have a high risk of in-hospital and long-term MACE after PCI, partially reduced by the use of DES. Further studies on the risk of recurrent ischemic events with current generation stents are needed, to offer a tailored therapy in this high-risk population.

Beta-blocker therapy reduces mortality in patients with coronary artery disease treated with percutaneous revascularization: a meta-analysis of adjusted results.

AIMS: The long-term impact of beta blockers on prognosis in patients treated with contemporary therapies for coronary artery disease remains to be defined. METHODS AND RESULTS: All observational studies evaluating the impact of beta blockers in patients treated with coronary revascularization and contemporary therapies and adjusted with multivariate analysis were included. All-cause death was the primary endpoint, while Major Adverse Cardiac Events (MACE) (composite endpoint of all-cause death or myocardial infarction, MI) and MI were secondary endpoints. A total of 26 studies were included, with 863 335 patients. After 3 (1-4.3) years, long-term risk of all-cause death was lower in patients on beta blockers [odds ratio, OR 0.69 (0.66-0.72)], both for Acute Coronary Syndrome (ACS) [OR 0.60 (0.56-0.65)], and stable angina patients [OR 0.84 (0.78-0.91)], independently from ejection fraction [OR 0.64 (0.42-0.98) for reduced ejection fraction and OR 0.79 (0.69-0.91) for preserved ejection fraction]. The risk of long-term MACE was lower but NS for ACS patients treated with beta blockers [OR 0.83 (0.69-1.00)], as in stable angina. Similarly, risk of MI did not differ between patients treated with beta blockers or without beta blockers [OR 0.99 (0.89-1.09), all 95% confidence intervals]. Using meta-regression analysis, the benefit of beta blockers was increased for those with longer follow-up. The number needed to treat was 52 to avoid one event of all-cause death for ACS patients and 111 for stable patients. CONCLUSION: Even in percutaneous coronary intervention era, beta blockers reduce mortality in patients with coronary artery disease, confirming their protective effect, which was consistent for both ACS and stable patients indifferently of preserved or reduced ejection fraction.

Incidence of thromboembolic events following atrial fibrillation catheter ablation and rate control strategies according to the kind of oral anticoagulation: A systematic review and meta-analysis.

INTRODUCTION: Anticoagulantion therapy (OAT) represents the cornerstone to reduce thromboembolic events for atrial fibrillation (AF). Recent studies suggest that AF catheter ablation on top of OAT may be useful to further reduce the thromboembolic risk in AF patients. The aim of the present study is to compare the long-term risk of thromboembolic events and treatment-related complications in patients with AF treated by OAT strategies and catheter ablation. METHODS: Pubmed, Cochrane and Google Scholar were searched for studies including >500 patients evaluating AF patients treated with OAT (VKA: vitamin K antagonist or DOAC: Direct oral anticoagulants) and/or AF ablation. Pooled incidence of stroke/year was the primary end point, while that of stroke, of all cause bleeding and of major bleeding the secondary ones. All the analyses were stratified according to the CHADS2 score of included patients. RESULTS: Overall, 27 studies were selected, including 50,973 patients in the AF catheter ablation group; 281,595 patients in the VKA group; 54,811 patients in the DOAC group. After a mean follow-up of 2.4 (1.5-3.8) years, the overall incidence of stroke and thromboembolic events was 0.63 per 100 patients/year in AF ablation group, 2.09 per 100 patients/year in VKA group and 1.24 per 100 patients/year in DOAC group (p < 0.001). After stratification in 4 groups according to CHADS2 score, the incidence of thromboembolic events remained lower in patients included in the AF ablation, followed by DOAC and VKA respectively (p < 0.001), for each CHADS2 cluster. Both the incidence of all cause bleedings and major bleedings resulted lower in AF ablation group (p < 0.001). The incidence of all-cause mortality in the AF ablation group was significant lower than in the group of OAT (p < 0.0001). CONCLUSION: AF catheter ablation significantly reduces the incidence of long-term thromboembolic events compared to both VKA and DOAC. This reduction is maintained in all CHADS2 score clusters and is strengthened by the concomitant reduction in hemorrhagic complications provided by AF ablation.

Evaluation of coronary features of HIV patients presenting with ACS: The CUORE, a multicenter study.

BACKGROUND AND AIMS: The risk of recurrence of myocardial infarction (MI) in HIV patients presenting with acute coronary syndrome (ACS) is well known, but there is limited evidence about potential differences in coronary plaques compared to non-HIV patients. METHODS: In this multicenter case-control study, HIV patients presenting with ACS, with intravascular-ultrasound (IVUS) data, enrolled between February 2015 and June 2017, and undergoing highly active antiretroviral therapy (HAART), were retrospectively compared to non-HIV patients presenting with ACS, before and after propensity score with matching, randomly selected from included centers. Primary end-point was the prevalence of multivessel disease. Secondary end-points were the prevalence of abnormal features at IVUS, the incidence of major-acute-cardiovascular-events (MACE), a composite end point of cardiovascular death, MI, target lesion revascularization (TLR), stent thrombosis (ST), non-cardiac death and target vessel revascularization (TVR). For each end-point, a subgroup analysis was conducted in HIV patients with CD4 cell count <200/mm3. RESULTS: Before propensity score, 66 HIV patients and 120 non-HIV patients were selected, resulting in 20 and 40 after propensity score. Patients with multivessel disease were 11 and 17, respectively (p = 0.56). IVUS showed a lower plaque burden (71% vs. 75%, p < 0.001) and a higher prevalence of hyperechoic non-calcified plaques (100% vs. 35%, p < 0.05) in HIV patients; a higher prevalence of hypoechoic plaques (7% vs. 0%, p < 0.05), a higher incidence of MACE (17.4% vs. 9.1% vs. l'8.0%, p < 0.05), MI recurrence (17.2% vs. 0.0% vs. 2.3%, p < 0.05), and ST (6.7% vs. 0.3% vs. 03%, p < 0.05) in HIV patients with CD4 < 200/mm3. CONCLUSIONS: Our study may provide a part of the pathophysiological basis of the differences in coronary arteries between HIV-positive and HIV-negative patients, suggesting that the former present with peculiar morphological features at IVUS, even after adjustment for clinical variables. Furthermore, we confirmed that an advanced HIV infection is associated with a high risk of non-calcific plaques and with a worse prognosis, including cardiovascular events and ACS recurrence.

Impact of chronic kidney disease on mortality in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention. A long-term single-center mortality study.

BACKGROUND: Chronic kidney disease (CKD) is associated with increased risk of mortality. We examined the impact of moderate and severe CKD at presentation on short- and long-term mortality among unselected patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PPCI). METHODS: The study cohort consists of 501 patients (pts), enrolled from October 2005 to December 2012. The median follow-up was 46.52±25.58 months (range 8-99). A severe CKD (estimated Glomerular Filtration Rate [eGFR] <30 mL/min/1.73 m2) was detected in 16 pts (3.19%), a moderate CKD (eGFR 30-59 mL/min/1.73 m2) in 110 (21.96%) and a normal kidney function (eGFR >60 mL/min/1.73 m2) in 375 (74.85%). RESULTS: The crude in-hospital mortality rate resulted significantly higher in pts with severe and moderate CKD compared to pts with normal renal function (50% and 19.08% versus 2.93%, P<0.0001), as well as the long-term mortality rate (57.14% and 46.34% versus 8.77%, P<0.0001). After adjustment for confounding variables, severe and moderate CKD resulted the main independent predictors of in-hospital (odds ratio [OR]=21.815, P<0.0001 for severe CKD and OR= 4.203, P=0.002 for moderate CKD) and long-term (hazard ratio [HR]= 5.272, P=0.001; HR= 1.978, P=0.006) mortality. CONCLUSIONS: CKD is a frequent condition in patients with STEMI treated with PPCI and it is associated to an excess of mortality, resulting the main independent negative prognostic predictor.