Determinants of adverse outcomes following patent foramen ovale closure in elderly patients.

BACKGROUND: Limited data are available on transcatheter patent foramen ovale (PFO) closure outcomes in the elderly. AIMS: Through this study, we aimed to determine the incidence and predictors of adverse events (recurrent cerebrovascular events [CVE] and atrial fibrillation [AF]) post-PFO closure in older patients with cryptogenic events. METHODS: This multicentre international study included patients over 60 years undergoing PFO closure for cryptogenic thromboembolic events. A dedicated database compiled baseline, procedural, and follow-up data. Competing risk and adjusted outcome predictor analyses were conducted. RESULTS: A total of 689 patients were included (median age 65 years, 41.2% female, mean Risk of Paradoxical Embolism [RoPE] score 4.5). The procedural success rate was 99.4%. After a median follow-up of 2 (interquartile range 1-5) years, 66 patients (9.6%) had died. CVE and stroke rates were 1.21 and 0.55 per 100 patient-years, respectively. Diabetes (hazard ratio [HR] 3.89, 95% confidence interval [CI]: 1.67-9.07; p=0.002) and atrial septal aneurysm (ASA; HR 5.25, 95% CI: 1.56-17.62; p=0.007) increased the CVE risk. New-onset AF occurred at a rate of 3.30 per 100 patient-years, with 51.3% within one month post-procedure. Older age (HR 1.05 per year, 95% CI: 1.00-1.09; p=0.023) and the absence of hypertension (HR 2.04, 95% CI: 1.19-3.57; p=0.010) were associated with an increased risk of AF. CONCLUSIONS: Older patients undergoing PFO closure had a relatively low rate of CVE and new-onset AF after a median follow-up of 2 years. The presence of diabetes, ASA, and a more advanced age determined an increased risk of adverse clinical events. These factors may be considered in the clinical decision-making process regarding PFO closure in this challenging population.

Early and late hospital readmissions after percutaneous left atrial appendage closure.

INTRODUCTION AND OBJECTIVES: Percutaneous left atrial appendage closure (LAAC) has emerged as a nonpharmacological alternative for thromboembolic event prevention in patients with nonvalvular atrial fibrillation. However, there are few data on readmissions after LACC. The aim of this study was to determine the rate of early (≤ 30 days) and late (31-365 days) readmission after LAAC, and to assess the predictors and clinical impact of rehospitalization. METHODS: This multicenter study included 1419 consecutive patients who underwent LAAC. The median follow-up was 33 [17-55] months, and follow-up was complete in all but 54 (3.8%) patients. The primary endpoint was readmissions for any cause. Logistic regression and Cox regression analysis were performed to determine the predictors of readmission and its clinical impact. RESULTS: A total of 257 (18.1%) patients were readmitted within the first year after LAAC (3.2% early, 14.9% late). The most common causes of readmission were bleeding (24.5%) and heart failure (20.6%). A previous gastrointestinal bleeding event was associated with a higher risk of early readmission (OR, 2.65; 95%CI, 1.23-5.71). The factors associated with a higher risk of late readmission were a lower body mass index (HR, 0.96-95%CI, 0.93-0.99), diabetes (HR, 1.38-95%CI, 1.02-1.86), chronic kidney disease (HR, 1.60; 95%CI, 1.21-2.13), and previous heart failure (HR, 1.69; 95%CI, 1.26-2.27). Both early (HR, 2.12-95%CI, 1.22-3.70) and late (HR, 1.75; 95%CI, 1.41-2.17) readmissions were associated with a higher risk of 2-year mortality. CONCLUSIONS: Readmissions within the first year after LAAC (primary endpoint) were common (18.1%), were mainly related to bleeding and heart failure events, and were associated with the patients' comorbidity burden. Readmission after LAAC confers a higher risk of mortality during the first 2 years after the procedure.

Clinical impact of complex percutaneous coronary intervention in the pre-TAVR workup.

INTRODUCTION AND OBJECTIVES: In patients undergoing percutaneous coronary intervention (PCI) in the workup pre-transcatheter aortic valve replacement (TAVR), the clinical impact of coronary revascularization complexity remains unknown. This study sought to examine the impact of PCI complexity on clinical outcomes after TAVR in patients undergoing PCI in the preprocedural workup. METHODS: This was a multicenter study including consecutive patients scheduled for TAVR with concomitant significant coronary artery disease. Complex PCI was defined as having at least 1 of the following features: 3 vessels treated, ≥ 3 stents implanted, ≥ 3 lesions treated, bifurcation with 2 stents implanted, total stent length >60mm, or chronic total occlusion. The rates of major adverse cardiac events (MACE), including cardiovascular mortality, myocardial infarction, and coronary revascularization were evaluated. RESULTS: A total of 1550 patients were included, of which 454 (29.3%) underwent complex PCI in the pre-TAVR workup. After a median follow-up period of 2 [1-3] years after TAVR, the incidence of MACE was 9.6 events per 100 patients-years. Complex PCI significantly increased the risk of cardiac death (HR, 1.44; 95%CI, 1.01-2.07), nonperiprocedural myocardial infarction (HR, 1.52; 95%CI, 1.04-2.21), and coronary revascularization (HR, 2.46; 95%CI, 1.44-4.20). In addition, PCI complexity was identified as an independent predictor of MACE after TAVR (HR, 1.31; 95%CI, 1.01-1.71; P=.042). CONCLUSIONS: In TAVR candidates with significant coronary artery disease requiring percutaneous treatment, complex revascularization was associated with a higher risk of MACE. The degree of procedural complexity should be considered a strong determinant of prognosis in the PCI-TAVR population.

Cierre percutáneo del foramen oval permeable en pacientes mayores de 60 años con ictus criptogénico / Transcatheter closure of patent foramen ovale in patients older than 60 years of age with cryptogenic embolism

INTRODUCCIÓN Y OBJETIVOS: Estudios aleatorizados han mostrado la eficacia del cierre percutáneo del foramen oval permeable (FOP) en pacientes de edad ≤ 60 años con ictus criptogénico. El objetivo de este estudio es determinar la seguridad y la eficacia a largo plazo del cierre percutáneo del FOP en pacientes mayores de 60 años con ictus criptogénico. MÉTODOS: De 475 pacientes consecutivos con ictus criptogénico que se sometieron al cierre del FOP, 90 eran mayores de 60 años (media, 66+/-5 años) y se los comparó con los 385 del grupo de edad ≤ 60 años (media, 44+/-10 años). RESULTADOS: Los pacientes mayores de 60 años tuvieron mayor prevalencia de factores de riesgo cardiovascular (FRCV) (hipertensión, dislipemia y diabetes; p <0,01). No hubo diferencias en cuanto a complicaciones periprocedimiento. El seguimiento medio fue de 8 (4-12) años y hubo 17 muertes, todas de causa no cardiovascular (el 7,8% de los mayores de 60 años y el 2,6% de los de edad ≤ 60 años; HR=4,12; IC95%, 1,56-10,89). Tuvieron un ictus recurrente 4 pacientes (el 2,2% de los mayores de 60 años frente al 0,5% de los de edad ≤ 60 años; HR=5,08; IC95%, 0,71-36,2), y un accidente isquémico transitorio (AIT) 12 pacientes (el 3,3 frente al 2,3%; HR=1,71; IC95%, 0,46-6,39). Hubo tendencia a una mayor incidencia de ictus/AIT en los mayores de 60 años (el 5,5 frente al 2,6%; HR=2,62; IC95%, 0,89-7,75; p = 0,081), que no persistió tras ajustar por FRCV (HR=1,97; IC95%, 0,59-6,56; p = 0,269). CONCLUSIONES: El cierre percutáneo del FOP en pacientes mayores de 60 años con ictus criptogénico resultó seguro y se asoció con una baja incidencia de eventos isquémicos a largo plazo. Sin embargo, en los pacientes mayores de 60 años se observó una tendencia a mayor incidencia de ictus/AIT probablemente relacionada con mayor prevalencia de FRCV

INTRODUCTION AND OBJECTIVES: Randomized trials have shown the efficacy of transcatheter closure of patent foramen ovale (PFO) in patients aged ≤ 60 years with cryptogenic embolism. We aimed to assess the long-term safety and efficacy of PFO closure in patients aged> 60 years. METHODS: Of 475 consecutive patients with cryptogenic embolism who underwent PFO closure, 90 older patients aged> 60 years (mean, 66+/-5 years) were compared with 385 younger patients aged ≤ 60 years (mean, 44+/-10 years). RESULTS: Older patients had a higher prevalence of cardiovascular risk factors (CVRF) (hypertension, dyslipidemia, diabetes; P <.01 for all vs younger patients). There were no differences in periprocedural complications between the 2 groups. During a median follow-up of 8 (4-12) years, there were a total of 17 deaths, all from noncardiovascular causes (7.8% and 2.6% in the older and younger patient groups, respectively; HR, 4.12; 95%CI, 1.56-10.89). Four patients had a recurrent stroke (2.2% and 0.5% in the older and younger patient groups, respectively; HR, 5.08; 95%CI, 0.71-36.2), and 12 patients had a transient ischemic attack (TIA) (3.3% and 2.3% in the older and younger patient groups, respectively; HR, 1.71; 95%CI, 0.46-6.39). There was a trend toward a higher rate of the composite of stroke/TIA in older patients (5.5% vs 2.6%; HR, 2.62; 95%CI, 0.89-7.75; P=.081), which did not persist after adjustment for CVRF (HR, 1.97; 95%CI, 0.59-6.56; P=.269). CONCLUSIONS: In older patients with cryptogenic embolism, PFO closure was safe and associated with a low rate of ischemic events at long-term. However, older patients exhibited a tendency toward a higher incidence of recurrent stroke/TIA compared with younger patients, likely related to a higher burden of CVRF

Impact of Preexisting Left Bundle Branch Block in Transcatheter Aortic Valve Replacement Recipients

BACKGROUND: The impact of preexisting left bundle branch block (LBBB) in transcatheter aortic valve replacement (TAVR) recipients is unknown. The aim of this study was to determine the impact of preexisting LBBB on clinical outcomes after TAVR. METHODS AND RESULTS: This multicenter study evaluated 3404 TAVR candidates according to the presence or absence of LBBB on baseline ECG. TAVR complications and causes of death were defined according to Valve Academic Research Consortium-2 definitions. Follow-up outpatient visits or telephone interviews were conducted at 30 days, 12 months, and yearly thereafter. Echocardiography examinations were performed at baseline, at hospital discharge, and at 1-year follow-up. Preexisting LBBB was present in 398 patients (11.7%) and was associated with an increased risk of permanent pacemaker implantation (PPI; 21.1% versus 14.8%; adjusted odds ratio, 1.51; 95% CI, 1.12­2.04) but not death (7.3% versus 5.5%; adjusted odds ratio, 1.33; 95% CI, 0.84­2.12) at 30 days. At a mean follow-up of 22±21 months, there were no differences between patients with and without preexisting LBBB in overall mortality (adjusted hazard ratio, 0.94; 95% CI, 0.75­1.18) and cardiovascular mortality (adjusted hazard ratio, 0.90; 95% CI, 0.68­1.21). In a subanalysis of 2421 patients without PPI at 30 days and with complete follow-up about the PPI, preexisting LBBB was not associated with an increased risk of PPI or sudden cardiac death. Patients with preexisting LBBB had a lower left ventricular ejection fraction (LVEF) at baseline and at 1-year follow-up (P <0.001 for both), but those with low LVEF exhibited a similar increase in LVEF over time after TAVR compared with patients with no preexisting LBBB (P=0.327). CONCLUSIONS: Preexisting LBBB significantly increased the risk of early (but not late) PPI after TAVR, without any significant effect on overall mortality or cardiovascular mortality. Preexisting LBBB was associated with lower LVEF pre-TAVR but did not prevent an increase in LVEF post-TAVR similar to patients without LBBB.

The relationship between adiposopathy and glucose-insulin homeostasis is not affected by moderate-intensity aerobic training in healthy women with obesity

The contribution of adiposopathy to glucose-insulin homeostasis remains unclear. This longitudinal study examined the potential relationship between the adiponectin/leptin ratio (A/L, a marker of adiposopathy) and insulin resistance (IR: homeostasis model assessment (HOMA)), insulin sensitivity (IS: Matsuda), and insulin response to an oral glucose tolerance test before and after a 16-week walking program, in 29 physically inactive pre- and postmenopausal women with obesity (BMI, 29-35 kg/m2; age, 47-54 years). Anthropometry, body composition, VO2max, and fasting lipid-lipoprotein and inflammatory profiles were assessed. A/L was unchanged after training (p = 0.15), despite decreased leptin levels (p < 0.05). While the Matsuda index tended to increase (p = 0.07), HOMA decreased (p < 0.05) and fasting insulin was reduced (p < 0.01) but insulin area under the curve (AUC) remained unchanged (p = 0.18) after training. Body fatness and VO2max were improved (p < 0.05) while triacylglycerols increased and HDL-CHOL levels decreased after training (p < 0.05). At baseline, A/L was positively associated with VO2max, HDL-CHOL levels, and Matsuda (0.37 < ρ < 0.56; p < 0.05) but negatively with body fatness, HOMA, insulin AUC, IL-6, and hs-CRP levels (− 0.41 < ρ < − 0.66; p < 0.05). After training, associations with fitness, HOMA, and inflammation were lost. Multiple regression analysis revealed A/L as an independent predictor of IR and IS, before training (partial R2 = 0.10 and 0.22), although A/L did not predict the insulin AUC pre- or post-intervention. A significant correlation was found between training-induced changes to A/L and IS (r = 0.38; p < 0.05) but not with IR or insulin AUC. Although changes in the A/L ratio could not explain improvements to glucose-insulin homeostasis indices following training, a relationship with insulin sensitivity was revealed in healthy women with obesity

Válvulas Portico y SAPIEN XT en el tratamiento de pacientes con anillo aórtico pequeño: comparación de resultados hemodinámicos / Self-expanding Portico valve versus balloon-expandable SAPIEN XT valve in patients with small aortic annuli: comparison of hemodynamic performance

Introducción y objetivos: La válvula autoexpandible Portico es una nueva válvula de implante transcatéter que ha mostrado resultados prometedores en estudios preliminares; sin embargo, no existen estudios que comparen este dispositivo con sistemas previos de válvula aórtica transcatéter. El objetivo de este estudio es comparar los resultados hemodinámicos de la válvula autoexpandible Portico con los de la válvula expandible mediante balón SAPIEN XT en un estudio de casos apareados con análisis en un laboratorio central de ecocardiografía Métodos: Se emparejó a 22 pacientes tratados mediante implante transcatéter de la válvula Portico de 23 mm con 40 pacientes tratados con la válvula SAPIEN XT de 23 mm, según los siguientes parámetros: área y diámetro medio del anillo aórtico por tomografía computarizada multidetector, fracción de eyección del ventrículo izquierdo, área de superficie corporal e índice de masa corporal. El diámetro medio del anillo aórtico fue de 19,6 ± 1,3 mm por ecocardiografía transtorácica y de 21,4 ± 1,2 mm por tomografía computarizada, sin diferencias significativas entre los grupos. Se obtuvieron imágenes de ecocardiografía Doppler antes de la intervención y en el seguimiento realizado al cabo de 1 mes y se analizaron en un laboratorio central de ecocardiografía. Resultados: No se objetivaron diferencias significativas entre los grupos en el gradiente transaórtico medio residual (SAPIEN XT, 10,4 ± 3,7 mmHg; Portico, 9,8 ± 1,1 mmHg; p = 0,49) ni en el área efectiva del orificio valvular (SAPIEN XT, 1,36 ± 0,27 cm2; Portico, 1,37 ± 0,29 cm2; p = 0,54). La incidencia del desajuste protésico (área efectiva del orificio valvular < 0,65 cm2/m2) fue similar en ambos grupos (el 13,5 frente al 10,0%; p = 0,56). No se observaron diferencias entre los grupos en cuanto a la incidencia de fugas paravalvulares moderadas o graves (el 5,0 frente al 4,8%; p = 0,90). Conclusiones: El implante transcatéter de la válvula autoexpandible Portico produjo resultados hemodinámicos a corto plazo similares a los de la válvula expandible por balón SAPIEN XT en el tratamiento de pacientes con estenosis aórtica grave y anillo aórtico pequeño. Son necesarios estudios prospectivos con seguimiento a más largo plazo y en pacientes con anillo aórtico mayor (AU)

Introduction and objectives: The self-expanding Portico valve is a new transcatheter aortic valve system yielding promising preliminary results, yet there are no comparative data against earlier generation transcatheter aortic valve systems. The aim of this study was to compare the hemodynamic performance of the Portico and balloon-expandable SAPIEN XT valves in a case-matched study with echocardiographic core laboratory analysis. Methods: Twenty-two patients underwent transcatheter aortic valve implantation with the Portico 23-mm valve and were matched for aortic annulus area and mean diameter measured by multidetector computed tomography, left ventricular ejection fraction, body surface area, and body mass index with 40 patients treated with the 23-mm SAPIEN XT. Mean aortic annulus diameters were 19.6 ± 1.3 mm by transthoracic echocardiography and 21.4 ± 1.2 mm by computed tomography, with no significant between-group differences. Doppler echocardiographic images were collected at baseline and at 1-month of follow-up and were analyzed in a central echocardiography core laboratory. Results: There were no significant between-group differences in residual mean transaortic gradients (SAPIEN XT: 10.4 ± 3.7 mmHg; Portico: 9.8 ± 1.1 mmHg; P = .49) and effective orifice areas (SAPIEN XT: 1.36 ± 0.27 cm2; Portico, 1.37 ± .29 cm2; P = .54). Rates of severe prosthesis-patient mismatch (effective orifice area < 0.65 cm2/m2) were similar (SAPIEN XT: 13.5%; Portico: 10.0%; P = .56). No between-group differences were found in the occurrence of moderate-severe paravalvular leaks (5.0% vs 4.8% of SAPIEN XT and Portico respectively;P = .90). Conclusions: Transcatheter aortic valve implantation with the self-expanding Portico system yielded similar short-term hemodynamic performance compared with the balloon-expandable SAPIEN XT system for treating patients with severe aortic stenosis and small annuli. Further prospective studies with longer-term follow-up and in patients with larger aortic annuli are required (AU)

Obstrução coronária após implante de válvula aórtica por cateter para o tratamento de bioprótese valvular cirúrgica com disfunção: revisão sistemática da literatura / Coronary obstruction following transcatheter aortic valve implantation for degenerative bioprosthetic surgical valves: A systematic literature review

INTRODUÇÃO: Há poucos dados na literatura que avaliam a obstrução coronária após implante transcateter de válvula aórtica (TAVI, do inglês transcatheter aortic valve implantation) para o tratamento de disfunção de bioprótese aórtica (valve-in-valve - ViV). O presente estudo avaliou, por meio de revisão sistemática da literatura, as características clínicas, o manejo e os desfechos clínicos de pacientes com obstrução coronária após TAVI-ViV. MÉTODOS: Estudos publicados entre 2002 e 2013 avaliando a obstrução coronária como complicação de TAVI-ViV foram identificados por meio de busca eletrônica sistemática. Foram avaliados dados basais sobre as características clínicas e do procedimento, manejo da complicação e desfechos clínicos. RESULTADOS: Foram identificadas, no total, quatro publicações descrevendo sete pacientes. A maioria dos pacientes era do sexo feminino (71%), sendo a média de idade de 82 ± 5 anos, com STS-PROM de 9,4 ± 2,6%. As médias da altura do tronco da artéria coronária esquerda (TCE) e o diâmetro médio da raiz aórtica foram de 8,8 ± 1,5 mm e 28,0 ± 5,0 mm, respectivamente. A maioria dos pacientes apresentava biopróteses com suporte e folhetos montados externamente, ou eram próteses sem suporte (stentless) e o TCE foi envolvido em todos os casos. A intervenção coronária percutânea (ICP) foi tentada em todos os pacientes, tendo sucesso em quatro deles (57%). A mortalidade intra-hospitalar foi 42,9% (três casos), todos após ICP sem sucesso. CONCLUSÕES: A obstrução coronária após TAVI-ViV ocorreu mais frequentemente em mulheres com bioprótese com suporte e folheto montado externamente ou com bioprótese sem suporte. O TCE foi envolvido em todos os casos e a ICP foi realizada com sucesso em 60% deles. Esforços contínuos poderão auxiliar na detecção dos fatores associados a essa complicação, no intuito de se implementarem medidas apropriadas para sua prevenção.

BACKGROUND: Very few data exist on coronary obstruction following transcatheter aortic valve implantation (TAVI) for degenerative bioprosthetic valves (valve-in-valve - ViV). The present study evaluated, through a systematic review of the literature, the clinical characteristics, management and clinical outcomes of patients with coronary obstruction after ViV-TAVI. METHODS: Studies published between 2002 and 2013 evaluating coronary obstruction as a complication of ViV-TAVI were identified using a systematic electronic search. Data on the clinical and procedural characteristics, management of the complication, and clinical outcomes were analyzed. RESULTS: A total of four publications describing seven patients were identified. Most patients (71%) were women, with mean age of 82 ± 5 years, and STS-PROM score of 9.4 ± 2.6%. Mean left coronary artery (LCA) ostium height and aortic root width were 8.8 ± 1.5 mm and 28.0 ± 5.0 mm, respectively. Most patients had stented bioprosthetic valves with externally mounted leaflets or stentless aortic bioprosthesis, and the LCA was involved in all patients. Percutaneous coronary intervention (PCI) was attempted in all patients and was successful in four (57%). In-hospital mortality was 42.9% (three cases), all of them after failed PCI. CONCLUSIONS: Coronary obstruction following ViV-TAVI occurred more frequently in women with stented bioprosthetic valves with externally mounted leaflets or with stentless bioprosthesis. The LCA was involved in all cases and PCI was successful in 60% of them. Continued efforts may help identify the factors associated with this complication so that appropriate prevention measures may be implemented.