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The PASCAL system is a novel device for transcatheter mitral valve repair based on the edge-to-edge concept. The unique features of this device might have a relevant impact on the repair outcomes. There are few data on clinical outcomes in real-life registries. The aim of this study was to report the early Iberian experience (Spain and Portugal) of the PASCAL system.Procedural and 30-day outcomes were investigated in consecutive patients with symptomatic severe mitral regurgitation (MR) treated with the PASCAL system at 10 centers. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE) at 30 days.We included 68 patients (age, 75 [68-81] years; 38% women; EuroSCORE II 4.5%). MR etiology was degenerative in 25%, functional in 65%, and mixed in 10%. A total of 71% of patients were in New York Heart Association (NYHA) functional class≥III. Technical success was achieved in 96% and independent capture was used in 73% of procedures. In the treated population, MR at discharge was≤2+ in 100%, with no in-hospital deaths. At 30 days, the MAE rate was 5.9%, the all-cause mortality rate was 1.6%, 98% were in NYHA functional class≤II, and 95% had MR≤2+ (P.001).Transcatheter mitral valve repair with the PASCAL system was safe and effective, with high procedural success and low rates of MAE. At 30 days, MR was significantly reduced, with a significant improvement in functional status.

BACKGROUND: Cardiac computed tomography angiography (CCTA) appears to be an appropriate imaging technique for device surveillance after left atrial appendage occlusion (LAAO). However, the available experience is limited. AIMS: The aim of this study was to determine the prevalence, mechanisms and clinical impact of left atrial appendage (LAA) patency and device-related thrombosis (DRT) following LAAO utilising a novel CCTA-based classification. METHODS: Consecutively enrolled patients who underwent LAAO with an AMPLATZER device were followed up with CCTA. Mechanisms and frequency of residual patency were evaluated and correlated with clinical events. Atrial-side device thrombus, device positioning and presence of signs of device stability were also analysed. RESULTS: A total of 137 patients were included. LAA patency was observed in 56.9% (n=78). Mechanisms and frequency of patency were: malapposition of proximal segment of the device lobe (55.1%), peri-device leak (PDL, 34.6%) and fabric permeability (5.8%). Lobe-LAA axis misalignment was the only independent predictor of device patency after LAAO (HR 38.3, 95% CI: 13.6-107.0; p

Background: Left atrial appendage occlusion (LAAO) is an accepted strategy for cardioembolic events prevention in patients with non-valvular atrial fibrillation (AF) unsuitable for anticoagulation. However, uncertainties persist regarding the benefit of LAAO in highly-comorbid patients. The aim of this study was to assess the impact of the CHA(2)DS(2)-VASc score beyond thromboembolic risk in predicting clinical outcomes in patients undergoing LAAO. Methods: 160 patients who underwent LAAO were included and categorized into two groups according to their stroke risk (89 with CHA(2)DS(2)-VASc >4 vs. 71 with lower risk). The coprimary endpoints were death and stroke at follow-up. Thromboembolic and bleeding events were compared to those predicted from CHA(2)DS(2)-VASc and HAS-BLED scores. Results: Over a median follow-up of 679 days, CHA(2)DS(2)-VASc >4 was associated with increased all-cause mortality compared with patients with lower thromboembolic risk (HR: 3.23; 95% CI: 1.28-8.19; p < 0.001). However, the rates of stroke after LAAO were not significantly different between risk groups. The observed annual rates of stroke and major bleeding were lower than predicted. Conclusions: Despite increased long-term mortality in patients with CHA(2)DS(2)-VASc >4, LAAO remains beneficial in reducing stroke and bleeding events in high-risk AF patients unsuitable for anticoagulation. (C) 2020 Elsevier B.V. All rights reserved.

Resumen Introduccion y objetivos La reparacion de la valvula mitral transcateter (RVMT) con el sistema MitraClip es un tratamiento para los pacientes con insuficiencia mitral (IM) grave de alto riesgo quirurgico. El objetivo principal fue analizar los resultados del RVMT en pacientes con IM grave, segun la etiologia. Metodos Estudio observacional, prospectivo y multicentrico con inclusion de pacientes consecutivos. El objetivo primario fue el combinado de mortalidad por todas las causas y reingresos hospitalarios por insuficiencia cardiaca al ano. Se compararon las caracteristicas clinicas y del procedimiento y los eventos para cada grupo de IM. Se realizo un analisis multivariable para determinar las variables asociadas con el objetivo primario. Resultados Se incluyo a 558 pacientes; 364 (65,2%) tenian etiologia funcional; 111 (19,9%), degenerativa, y 83 (14,9%), mixta. La media de edad fue 72,8 ± 11,1 anos y eran varones el 70,3%. Respecto al objetivo primario, hubo 95 (17%) eventos en toda la serie. No hubo diferencias significativas entre los 3 grupos en el numero de eventos del objetivo primario: 11 (11,3%) en la IM degenerativa, 71 (21,3%) en la funcional y 13 (18,1%) en la mixta (p = 0,101). Los predictores independientes fueron la clase funcional (p = 0,029), la revascularizacion quirurgica previa (p = 0,031), el EuroSCORE II (p = 0,003), la diabetes mellitus (p = 0,037) y la fraccion de eyeccion del ventriculo izquierdo (p = 0,015). Conclusiones Este trabajo confirma con datos de la practica clinica la seguridad y la eficacia de la RVMT independientemente de la etiologia de la IM y se documentan los principales factores asociados con el pronostico durante el primer ano de seguimiento.

Resumen Introduccion y objetivos A pesar de la eficacia de los anticoagulantes orales (ACO), algunos pacientes mantienen una alto riesgo residual y presentan ictus aun estando en tratamiento con ACO, y falta evidencia sobre el tratamiento de estos pacientes. El objetivo del estudio es analizar la seguridad y la eficacia del cierre percutaneo de la orejuela izquierda (OI) como prevencion secundaria para pacientes con fibrilacion auricular no valvular que han experimentado un ictus/accidente isquemico transitorio a pesar de los ACO (ictus resistente [IR]). Metodos Se estudio a 1.047 pacientes consecutivos con fibrilacion auricular no valvular sometidos a cierre percutaneo de la OI incluidos en el registro multicentrico Amplatzer Cardiac Plug. Se selecciono a los pacientes con IR como indicacion para el cierre de la OI, y se los comparo con pacientes con otras indicaciones. Resultados En un total de 115 pacientes (11%) se produjo un IR. Las escalas CHA2DS2-VASc y HAS-BLED eran significativamente mas altas en el grupo de IR (5,5 ± 1,5 frente a 4,3 ± 1,6; p Conclusiones Los pacientes con IR sometidos a cierre percutaneo de la OI presentaron resultados de seguridad similares que los pacientes sin IR, con una reduccion significativa de los eventos de ictus/accidente isquemico transitorio y hemorragia mayor durante el seguimiento.

INTRODUCTION AND OBJECTIVES: Despite the efficacy of oral anticoagulant (OAC) therapy, some patients continue to have a high residual risk and develop a stroke on OAC therapy (resistant stroke [RS]), and there is a lack of evidence on the management of these patients. The aim of this study was to analyze the safety and efficacy of left atrial appendage occlusion (LAAO) as secondary prevention in patients with nonvalvular atrial fibrillation who have experienced a stroke/transient ischemic attack despite OAC treatment. METHODS: We analyzed data from the Amplatzer Cardiac Plug multicenter registry on 1047 consecutive patients with nonvalvular atrial fibrillation undergoing LAAO. Patientes with previous stroke on OAC therapy as indication for LAAO were identified and compared with patients with other indications. RESULTS: A total of 115 patients (11%) with RS were identified. The CHA2DS2-VASc and the HAS-BLED score were significantly higher in the RS group (respectively 5.5±1.5 vs 4.3±1.6; P

INTRODUCTION AND OBJECTIVES: Transthyretin cardiac amyloidosis (ATTR-CA) patients often have atrial fibrillation and increased bleeding/thrombogenic risks. We aimed to evaluate outcomes of left atrial appendage closure (LAAC) compared with patients without a known diagnosis of CA.; METHODS: Comparison at long-term of patients diagnosed with ATTR-CA who underwent LAAC between 2009 and 2020 and those without a known diagnosis ofCA.; RESULTS: We studied a total of 1159 patients. Forty patients (3.5%) were diagnosed with ATTR-CA; these patients were older and had more comorbidities, higher HAS-BLED and CHA2DS2-VASc scores, and lower left ventricular function. Successful LAAC was achieved in 1137 patients (98.1%) with no differences between groups. Regarding in-hospital and follow-up complications, there were no differences between the groups in ischemic stroke (5% vs 2.5% in those without a known diagnosis of CA; P=.283), hemorrhagic stroke (2.5% and 0.8% in the control group; P=.284), major or minor bleeding. At the 2-year follow-up, there were no significant differences in mortality (ATTR-CA: 20% vs those without known CA: 13.6%, 0.248); however, the at 5-year follow-up, ATTR-CA patients had higher mortality (40% vs 19.2%; P< .001) but this difference was unrelated to hemorrhagic complications or ischemic stroke.; CONCLUSIONS: LAAC could reduce the risk of bleeding complications and ischemic cerebrovascular events without increasing the rate of early or mid-term complications. Although long-term survival was impaired in ATTR-CA patients, it was comparable to that of patients without a known diagnosis of CA at the 2-year follow-up, suggesting that LAAC for patients with ATTR-CA might not be futile. Copyright © 2022 Sociedad Espanola de Cardiologia. Published by Elsevier Espana, S.L.U. All rights reserved.

Background and aim: Recent randomized data comparing percutaneous mitral valve repair (PMVR) versus optimal medical treatment in patients with functional MR (FMR) seemed to highlight the importance of the learning curve not only for procedural outcomes but also for patient selection. The aim of the study was to compare a contemporary series of patients undergoing PMVR using a second-generation Mitraclip device (Mitraclip NT) with previous cohorts treated with a first-generation system. Methods: This multicenter study collected individual data from 18 centers between 2012 and 2017. The cohort was divided into three groups according to the use of the first-generation Mitraclip during the first (control-1) or second half (control-2) or the Mitraclip NT system. Results: A total of 545 consecutive patients were included in the study. Among all, 182 (33.3%), 183 (33.3%), and 180 (33.3%) patients underwent mitral repair in the control-1, control-2, and NT cohorts, respectively. Procedural success was achieved in 93.3% of patients without differences between groups. Major adverse events did not statistically differ among groups, but there was a higher rate of pericardial effusion in the control-1 group (4.3%, 0.6%, and 2.6%, respectively, p = 0.025). The composite endpoint of death, surgery, and admission for congestive heart failure (CHF) at 12 months was lower in the NT group (23.5% in control-1, 22.5% in control-2, and 8.3% in the NT group, p = 0.032). Conclusions: The present paper shows that contemporary clinical outcomes of patients undergoing PMVR with the Mitraclip system have improved over time.

Background The clinical significance of conduction disturbances after transcatheter aortic valve implantation has been described; however, little is known about the influence of baseline ECGs in the prognosis of these patients. Our aim was to study the influence of baseline ECG parameters, including interatrial block (IAB), in the prognosis of patients treated with transcatheter aortic valve implantation. Methods and Results The BIT (Baseline Interatrial Block and Transcatheter Aortic Valve Implantation) registry included 2527 patients with aortic stenosis treated with transcatheter aortic valve implantation. A centralized analysis of baseline ECGs was performed. Patients were divided into 4 groups: normal P wave duration (P =0.010]) and of the composite end point (death/stroke/new atrial fibrillation) (HR, 1.51; 95% CI, 1.17–1.94 [ P =0.001]). Conclusions Baseline ECG characteristics influence the prognosis of patients with aortic stenosis treated with transcatheter aortic valve implantation. Advanced IAB is present in about an eighth of patients and is associated with all‐cause death and the composite end point of death, stroke, and new atrial fibrillation during follow‐up.

Left atrial appendage occlusion (LAAO) is an accepted strategy for cardioembolic events prevention in patients with non-valvular atrial fibrillation (AF) unsuitable for anticoagulation. However, uncertainties persist regarding the benefit of LAAO in highly-comorbid patients. The aim of this study was to assess the impact of the CHA160 patients who underwent LAAO were included and categorized into two groups according to their stroke risk (89 with CHAOver a median follow-up of 679 days, CHADespite increased long-term mortality in patients with CHA

Introduction and objectives: Transcatheter mitral valve repair (TMVR) with MitraClip is a therapeutic option for high surgical risk patients with severe mitral regurgitation (MR). The main objective of this study was to analyze differences in outcomes in patients with severe MR according to the cause of MR. Methods: Observational, multicenter, and prospective study with consecutive patient inclusion. The primary endpoint was the combination of all-cause mortality and new readmissions due to heart failure after 1 year. We compared clinical and procedural characteristics and the event rate for each MR group. We performed a multivariate analysis to identify predictive variables for the primary endpoint. Results: A total of 558 patients were included: 364 (65.2%) with functional etiology, 111 (19.9%) degenerative and 83 (14.9%) mixed. The mean age was 72.8 +/- 11.1 years and 70.3% of the sample were men. There were 95 (17%) events in the overall sample. No significant differences were found in the 3 groups in the number of primary outcome events: 11 (11.3%) in degenerative MR, 71 (21.3%) in functional MR, and 13 (18.1%) in mixed MR (P=.101). Independent predictors were functional class (P=.029), previous surgical revascularization (P=.031), EuroSCORE II (P=.003), diabetes mellitus (P=.037), and left ventricular ejection fraction (P=.015). Conclusions: This study confirms the safety and efficacy of TMVR with MitraClip irrespective of MR etiology in real-life data and shows the main factors related to prognosis during the first year of follow up. (C) 2019 Sociedad Espanola de Cardiologia. Published by Elsevier Espana, S.L.U. All rights reserved.

History A 54-year-old woman presented with typical chest pain during physical training at the gym. She had a history of hypertension controlled with hydrochlorothiazide, without any other cardiovascular risk factor and with neither personal nor family history of ischemic heart disease. She was postmenopausal and had a long-standing history of migraine headaches without hormonal or drug therapy. The patient had no history of clinically important thoracic trauma or invasive chest interventions. Initial electrocardiography (ECG) showed signs of ongoing anterior ST segment elevation myocardial infarction, and emergent coronary angiography with angioplasty and intravascular US were performed ( Fig 1 ). Maximal level of high-sensitive T troponins was 820 ng/L (normal,13 ng/L), while echocardiography showed a normal left ventricular ejection fraction, with no apparent regional wall motion abnormalities. General physical examination findings were unremarkable, excluding ligamentous hyperlaxity and joint instability. C-reactive protein, rheumatoid factor, antinuclear antibody, cytoplasmic antineutrophil cytoplasmic antibody, and angiotensin-converting enzyme blood test results were negative. For further evaluation, arterial phase ECG-synchronized CT angiography from the skull base to the pubis symphysis was performed ( Fig 2 ). Figure 1a: Coronary angiography of the left anterior descending (LAD) and left circumflex (LCX) arteries (30° right anterior oblique and 20° caudally angulated projection) and intravascular US of the LCX artery were performed.

This study sought to assess the relative merit of surgical correction (SC) versus transcatheter reduction on long-term outcomes in patients with significant paravalvular leak (PVL) refractory to medical therapy.PVL is the most frequent dysfunction following prosthetic valve replacement. Although repeat surgery is the gold standard, transcatheter reduction (TR) of PVL has been associated with reduced mortality.From 1994 to 2014, 231 patients underwent SC (n = 151) or TR (n = 80) PVL correction. Propensity matching and Cox proportional hazards regression models were used to assess the effect of either intervention on long-term rates of all-cause death or hospitalization for heart failure. Survival after TR and SC were further compared with the survival in a matched general population and to matched patients undergoing their first surgical valve replacement.Over a median follow-up of 3.5 years, SC was associated with an important reduction in all-cause death or hospitalization for heart failure compared with TR (hazard ratio: 0.28; 95% confidence interval: 0.18 to 0.44; p 0.001). There was a trend towards reduced all-cause death following SC versus TR (hazard ratio: 0.61; 95% confidence interval: 0.37 to 1.02; p = 0.06). Neither intervention normalized survival when compared with a general population or patients undergoing their first surgical valve replacement.In patients with significant prosthetic PVL, surgery is associated with better long-term outcomes compared with transcatheter intervention, but results in important perioperative mortality and morbidity. Future studies are needed in the face of increasing implementation of transcatheter PVL interventions across the world.

espanolA pesar del importante avance que significa la promulgacion de la Ley 14/2010, de 27 de mayo, sobre los Derechos y Oportunidades en la Infancia y la Adolescencia, este articulo problematiza los efectos que ha tenido su desarrollo normativo y tecnico posterior, y se pregunta hasta que punto la implementacion de las politicas de infancia y adolescencia esta logrando los objetivos que la Ley proyectaba, identificando los deficits que se observan desde el ambito local y planteando las lagunas que deben afrontar los profesionales en el proceso de intervencion. Asimismo, apunta los retos que deberian afrontarse para garantizar la salvaguarda de los derechos de la infancia y la adolescencia, senalando a la administracion local como el agente que, desde la proximidad, tiene una posicion optima para abordar la reduccion del riesgo social y para garantizar la salvaguarda de los derechos de ninos y adolescentes. euskara14/2010 Legea, maiatzaren 27koa, haur eta nerabeen eskubide eta aukerei buruzko araudiaren promulgazioak aurrerabide garrantzitsua ekarri arren, artikulu honetan arazo gisara azaltzen da ondoren garatu den garapen normatibo eta teknikoa, eta bertan jakin nahi da haur eta nerabeen aldeko politiken ezarpenek zenbateraino lortu ote dituzten Legeak aurreikusitako asmoak, identifikatzen dira tokiko eremutik nabarmentzen diren gabeziak, eta azaltzen dira eskuartzerako prozesu horietan profesionalek aurre egin beharreko izaten dituzten hutsuneak zeintzuk diren. Halaber, bertan azaltzen dira haur eta nerabeen babesa bermatzeko betebeharrekoak diren erronkak zeintzuk diren, eta horretarako nabarmentzen da tokiko administrazioaren garrantzia, gertutasunaren ondorioz, arrisku soziala murriztu eta haur eta nerabeen eskubideak babesteko egoera optimoan dagoen eragile gisara.

The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted.

Mitral repair using the MitraClip device is on ongoing expansion and has been evaluated in different patterns of mitral regurgitation. Nevertheless, surgical approaches to mitral regurgitation remain the standard of care, at least in absence of contraindication. We report the first Canadian experience of mitral valve repair with the MitraClip following surgical mitral annuloplasty failure. Therapeutic considerations and potential challenges are discussed.

Objectives To report the initial clinical experience with a novel atrial septal defect (ASD) closure device, the GORE® CARDIOFORM ASD Occluder (GCO). Background Transcatheter closure has become the treatment of choice for secundum ASD. A wide range of occluder devices are available, but concern has been raised about the risk of cardiac erosion associated with rigid devices and future access to the left atrium Methods Retrospective chart review of patients treated with the GCO at three Canadian centers. Primary outcomes were procedural success and residual shunting at follow-up, as well as 30-day major adverse events. Secondary outcomes included new onset atrial arrhythmias, wire frame fractures (WFF), and all cause mortality. Clinical, echocardiographic, procedural data, and follow-up outcome variables were collected in each participating hospital. Results Between February and December 2015, 26 patients (5 children and 21 adults) underwent transcatheter ASD closure with the GCO and were included in the study cohort. Procedural success was achieved in 22 of 26 patients (85%) and no major procedural complications were observed. Two patients (8%) presented new onset atrial tachyarrhythmia during early follow-up (0–30 days). Follow-up echocardiography (median of 119 days [IQR: 92–146]) demonstrated no residual shunt in all implanted patients. After a median clinical follow-up of 174 days (IQR: 135–239), one patient died of an unrelated cause, there were no documented major adverse cardiovascular events. Fluoroscopic imaging of the device was performed in 20 patients (91%), and WFF was noted in five cases. No clinical consequence or device dysfunction was observed in these patients. Conclusions In this first-in-man multicenter study, the GCO was safe and effective for ASD closure, with no major adverse events or residual shunt at follow-up. © 2017 Wiley Periodicals, Inc.

Background Atrial myocardial infarction may be a risk for atrial fibrillation. However, the electrophysiological and structural characteristics of the infarcted atrial myocardium are not well known. This study aimed to analyse the changes in local atrial electrograms and myocardial structure in an experimental model of isolated atrial myocardial infarction. Methods Five anesthetized, open-chest pigs were submitted to 4 hours of acute atrial myocardial ischemia induced by direct surgical clamping of atrial coronary branches originating from the right coronary artery. In all cases, we recorded simultaneously the 12-lead surface electrocardiogram (ECG) and the epicardial mapping of local atrial electrograms (17 x 12.5 mm patches containing 128 electrodes, with 1 mm inter-electrode distance) in a region close to the occluded branches and in control non-treated atria. The changes in local atrial QRS-ST segment and the amplitude of the P-wave of the ECG were sequentially analysed (Figure). The hearts were removed and processed for anatomopathological examination. Results Selective atrial coronary branch occlusion induced a patchy atrial myocardial necrosis with an irregular and abrupt border zone (circled areas in the Figure). During the first 15 min of ischemia, the local atrial electrograms showed increasing R waves, widening of QRS complex, and ST segment elevation leading to monophasic potentials (maximal ST segment at 30 min: from 0.2±0.7 mV to 1.9±1.4 mV, ANOVA p Structural and electrical atrial changes Conclusion Selective occlusion of atrial coronary branches induced patchy atrial myocardial necrosis with abrupt anatomical and electrical border zone. The overt QRS and ST segment changes in local atrial electrograms resembled those described in acute ventricular myocardial ischemia, and were associated with widening of the P-wave on the surface ECG. Although acute ischemic arrhythmias were not observed, the atrial structural alterations might set the substrate for re-entrant arrhythmias late after the healing over process. Acknowledgement/Funding Supported by grants from ISCI-MINECO (FISPI17/00069), CIBERCV (CB16/11/00276), FEDER and Fundaciό “La Maratό” TV3 (20150830).

HistoryA 54-year-old woman presented with typical chest pain during physical training at the gym. She had a history of hypertension controlled with hydrochlorothiazide, without any other cardiovascular risk factor and with neither personal nor family history of ischemic heart disease. She was postmenopausal and had a long-standing history of migraine headaches without hormonal or drug therapy. The patient had no history of clinically important thoracic trauma or invasive chest interventions. Initial electrocardiography (ECG) showed signs of ongoing anterior ST segment elevation myocardial infarction, and emergent coronary angiography with angioplasty and intravascular US were performed. Maximal level of high-sensitive T troponins was 820 ng/L (normal

Aims: Percutaneous treatment of coronary chronic total occlusion (CTO) is associated with important arterial remodelling after successful recanalisation. Bioresorbable vascular scaffold (BVS) implantation in CTO has been shown to be feasible and can be of interest when the scaffold achieves complete bioresorption. We sought to evaluate the three-year results in terms of clinical events, serial imaging outcomes and vasomotion response in CTO lesions successfully treated with BVS. Methods and results: A total of 33 patients (35 CTO lesions) successfully treated with BVS were included in the ABSORB-CTO study. Clinical outcomes, quantitative coronary angiography (QCA) and optical coherence tomography (OCT) assessment were analysed at one- and three-year follow-up. Vasomotion examination was also performed at three years. At three years, cumulative target vessel reocclusion was observed in four lesions (11.4%). By QCA, the in-scaffold segment presented a lumen loss of 0.23 +/- 0.46 mm compared with the baseline procedure (p=0.001) and a lumen gain of 0.05 +/- 0.29 mm between one and three years (p=0.220). By OCT, the mean neointimal area stenosis progressed from 11.45% at 12 months to 17.10% at 36 months (p

Cardioembolic strokes are generally more lethal and disabling than other source of strokes. Data from PROTECT AF (Watchman Left Atrial Appendage Closure Technology for Embolic Protection in Patients With Atrial Fibrillation) suggest that strokes after left atrial appendage occlusion (LAAO) with the Watchman device are less disabling than those in the warfarin group. No data assessing the severity of strokes after LAAO with the AMPLATZER Cardiac Plug (ACP) are available. The objective of the study was to evaluate the severity of cerebrovascular events after LAAO with the ACP in a population mostly characterized by an absolute or relative contraindication to oral anticoagulation. Data from the ACP multicenter registry were analyzed. Disabling strokes were defined as those with a modified Rankin score of 3 to 6 at 90 days after the event. A total of 1,047 subjects were included. The mean age and CHADS2 score were 75 ± 8 years and 2.8 ± 1.3, respectively. Procedural success was achieved in 97.3% and 4.9% of the patients presented procedural major adverse events. Clinical follow-up was complete in 98.2% of patients with a median of 13 months. There were 9 strokes (0.9%), 9 transient ischemic attacks (0.9%), and no intracranial hemorrhages (0%) at follow-up. After excluding 2 patients with pre-LAAO disability, functional assessment showed disabling events in 3 (19%) of the remaining 16 patients. The median time of presentation was 420 days (interquartile range 234 to 671) after LAAO, and 17 patients (94%) were on single-antiplatelet therapy when the event occurred. According to our results, cerebrovascular events after LAAO with the ACP system were infrequent and mostly nondisabling.

Factors influencing the management of patients with chronic total occlusion (CTO) are poorly described. We sought to analyze the clinical and angiographic variables influencing the decision-making process of patients with CTO. Consecutive patients with at least 1 coronary artery CTO were included and categorized as managed either by percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), or medical therapy (MT). Patients with previous CABG were excluded. The CTO SYNTAX score (CTO-SS) was defined as the ratio between the score attributed to the CTO lesion in the SYNTAX score calculation and the total SYNTAX score. Independent predictors of management strategies were sought. A total of 510 patients were included (CTO incidence: 20%): 9% were treated with PCI, 34% with CABG, and 57% with MT. SYNTAX score was lowest in PCI (14.8 [11.0 to 18.5]) and highest in CABG (31.5 [25.0 to 38.8], p0.0001). PCI was attempted more often in patients with higher CTO-SS (i.e., those with higher contribution to the overall SYNTAX score from the CTO lesion; 88% had a CTO-SS0.5). Conversely, CABG was preferred in subjects with lower CTO-SS (61% had a CTO-SS ≤0.5, p0.0001). Age, ejection fraction, SYNTAX score, and age of the CTO were independent predictors of revascularization. At mid-term follow-up, unsuccessful revascularization or MT was independently associated with death (hazard ratio 7.2, p = 0.0005). In conclusion, CTOs are frequently documented in clinical practice. However, less than a half is revascularized. Management strategies are influenced by angiographic variables such as the SYNTAX score and the newly proposed CTO-SS.

Background Vascular complications (VC) are a serious and frequent complication of transfemoral transcatheter aortic valve implantation (TAVI) and result in increased morbidity and mortality. It has been suggested that newly developed vascular sheaths may increase the ability to perform transfemoral TAVI in patients with normal and access-limiting peripheral artery disease (PAD) and reduce vascular complications. Aims We sought to assess the safety and efficacy of the 19 French (F) SoloPath balloon-expandable transfemoral vascular access system in patients who underwent transfemoral TAVI at our center between 2011 and 2014. Methods and results Single-center retrospective study of 90 patients who underwent transfemoral TAVI with the use of the SoloPath sheath. Patients were categorized into two groups according to a sheath to femoral artery ratio (SFAR) of less than or equal to 1.05, or greater than 1.05. Overall, the incidence of major bleeding complications was low, 4.4%. No significant differences were found in technical or procedural success rates (100% in both groups and 100% vs. 91.3; P = 0.09; respectively), total vascular complications (20.8 vs. 21.7; P = 0.92) or total bleeding complications (20.8 vs. 30.4; P = 0.36 between those with SFAR greater or less than 1.05. Conclusions The use of the SoloPath balloon-expandable sheath is feasible and safe even in patients with SFAR > 1.05, showing no increased vascular or bleeding complications compared to patients with larger vascular access. © 2016 Wiley Periodicals, Inc.

Objectives To evaluate the impact of baseline left ventricular (LV) function on the clinical outcomes of patients with functional mitral regurgitation (FMR) treated with MitraClip. Background It is unknown whether patients with significant FMR and severe LV dysfunction benefit from MitraClip. Methods A cohort of 77 patients with significant FMR undergoing MitraClip procedure between December 2010 and January 2015 was categorized by baseline LV ejection fraction (LVEF) into tertiles: LVEF 37% (n = 25). We sought to evaluate the impact of LVEF on all-cause mortality at follow-up. Results There were no significant differences in baseline comorbidities, medical treatment and MR severity among tertiles of LVEF. Overall procedural success was 94%, with no differences among groups (LVEF 37%: 92%; P = 0.25). Median follow-up was 372 days (interquartile range: 128–627 days). MR severity improved in all three groups, as compared to baseline. There were no differences in the prevalence of MR ≤2+ on follow-up (P = 0.40). Mortality was highest in patients with LVEF 37% (4%), P = 0.004. Patient who died had a lower baseline LVEF compared to those who survived (24.8 ± 7.7% versus 35.5 ± 13.7%, P

Subclavian stenosis affects up to 5% of patients referred for coronary artery bypass grafting. Albeit usually asymptomatic, this condition can cause myocardial ischemia due to a steal phenomenon from the distal subclavian artery when the left internal mammary artery is used as a coronary bypass. We describe a case of proximal subclavian artery angioplasty complicated with aortic dissection and subsequent life-threatening mesenteric ischemia. For the first time, we illustrate an endovascular approach to both complications consisting in urgent stenting of the celiac trunk and the superior mesenteric artery followed by staged thoracic endovascular aortic repair due to progressive aortic dilatation.

Objectives This study aimed at comparing direct stenting (DS) versus stenting with pre-dilation (SP) in patients with ST-elevation myocardial infarction (STEMI), using a systematic review and meta-analysis of published evidence. Background There is conflicting evidence whether stenting strategy impacts clinical outcomes in patients with STEMI. Methods We searched EMBASE, MEDLINE, and CENTRAL, from inception to December 2014. The primary endpoint was mortality. Secondary endpoints included major adverse cardiac events (MACEs), ST-segment resolution, and angiographic outcomes. Results A total of 9,331 patients enrolled in 12 studies (3 randomized controlled trials, RCTs; 9 non-randomized studies, NRSs) were included. DS was associated with lower mortality (OR 0.55; 95%CI: 0.33–0.94; P = 0.03) in NRSs, and overall (OR 0.56; 95%CI: 0.37–0.86; P = 0.008). Mortality was non-significantly reduced in RCTs (OR 0.56; 95%CI: 0.26–1.23; P = 0.15). DS was also associated with lower MACE rate (OR 0.71; 95%CI 0.60–0.84; P

Background Significant paravalvular leak (PVL) after surgical valve replacement can result in intractable congestive heart failure and hemolytic anemia. Because repeat surgery is performed in only few patients, transcatheter reduction of PVL is emerging as an alternative option, but its safety and efficacy remain uncertain. In this study we sought to assess whether a successful transcatheter PVL reduction is associated with an improvement in clinical outcomes. Methods We identified 12 clinical studies that compared successful and failed transcatheter PVL reductions in a total of 362 patients. A Bayesian hierarchical meta-analysis was performed using cardiac mortality as a primary end point. The combined occurrence of improvement in New York Heart Association functional class or hemolytic anemia and the need for repeat surgery, were used as secondary end points. Results A successful transcatheter PVL reduction was associated with a lower cardiac mortality rate (odds ratio [OR], 0.08; 95% credible interval [CrI], 0.01-0.90) and with a superior improvement in functional class or hemolytic anemia, compared with a failed intervention (OR, 9.95; 95% CrI, 2.10-66.73). Fewer repeat surgeries were also observed after successful procedures (OR, 0.08; 95% CrI, 0.01-0.40). Conclusions A successful transcatheter PVL reduction is associated with reduced all-cause mortality and improved functional class in patients deemed unsuitable for surgical correction.

Vascular complications (VC) are a serious and frequent complication of transfemoral transcatheter aortic valve implantation (TAVI) and result in increased morbidity and mortality. It has been suggested that newly developed vascular sheaths may increase the ability to perform transfemoral TAVI in patients with normal and access-limiting peripheral artery disease (PAD) and reduce vascular complications.We sought to assess the safety and efficacy of the 19 French (F) SoloPath balloon-expandable transfemoral vascular access system in patients who underwent transfemoral TAVI at our center between 2011 and 2014.Single-center retrospective study of 90 patients who underwent transfemoral TAVI with the use of the SoloPath sheath. Patients were categorized into two groups according to a sheath to femoral artery ratio (SFAR) of less than or equal to 1.05, or greater than 1.05. Overall, the incidence of major bleeding complications was low, 4.4%. No significant differences were found in technical or procedural success rates (100% in both groups and 100% vs. 91.3; P = 0.09; respectively), total vascular complications (20.8 vs. 21.7; P = 0.92) or total bleeding complications (20.8 vs. 30.4; P = 0.36 between those with SFAR greater or less than 1.05.The use of the SoloPath balloon-expandable sheath is feasible and safe even in patients with SFAR 1.05, showing no increased vascular or bleeding complications compared to patients with larger vascular access. © 2016 Wiley Periodicals, Inc.

To evaluate the impact of baseline left ventricular (LV) function on the clinical outcomes of patients with functional mitral regurgitation (FMR) treated with MitraClip.It is unknown whether patients with significant FMR and severe LV dysfunction benefit from MitraClip.A cohort of 77 patients with significant FMR undergoing MitraClip procedure between December 2010 and January 2015 was categorized by baseline LV ejection fraction (LVEF) into tertiles: LVEF27% (n = 27), LVEF 27-37% (n = 25), and LVEF37% (n = 25). We sought to evaluate the impact of LVEF on all-cause mortality at follow-up.There were no significant differences in baseline comorbidities, medical treatment and MR severity among tertiles of LVEF. Overall procedural success was 94%, with no differences among groups (LVEF27%: 89%; LVEF 27-37%: 100%; LVEF37%: 92%; P = 0.25). Median follow-up was 372 days (interquartile range: 128-627 days). MR severity improved in all three groups, as compared to baseline. There were no differences in the prevalence of MR ≤2+ on follow-up (P = 0.40). Mortality was highest in patients with LVEF27% (41%), as compared with LVEF 27-37% (16%) and LVEF37% (4%), P = 0.004. Patient who died had a lower baseline LVEF compared to those who survived (24.8 ± 7.7% versus 35.5 ± 13.7%, P 0.001). An LVEF27% was an independent predictor of mortality after adjusting for procedural success: hazard ratio 3.4 (95% CI: 1.1 to 10.0; P = 0.030).MitraClip is effective in FMR patients regardless of the severity of LV dysfunction. However, low baseline LVEF is associated with increased mortality, despite procedural success. © 2016 Wiley Periodicals, Inc.