Cost-effectiveness analysis of dyevert™ Power XT in patients with chronic kidney disease undergoing percutaneous coronary intervention procedures in Spain.

OBJECTIVE: To assess the efficiency of Dyevert™ Power XT compared to the standard clinical practice when used for percutaneous coronary interventions (PCI). METHODS: A Markov model was developed to estimate, over 3-month cycles and a lifetime time horizon, the cumulative costs and health outcomes (life years gained [LYG] and quality-adjusted life years [QALY]) in a hypothetical cohort of 1,000 patients with chronic kidney disease (CKD) 3b-4 and an average age of 72 years. The incidence of contrast-induced acute kidney injury for these patients is 18.89% in routine practice and 7.78% with Dyevert. QALYs were estimated by applying utilities by health state. Transitions between states and utilities were obtained from the literature. Overall all-cause and state-specific mortality were considered. The total cost (€2,022) estimated with the National Health System perspective included cost of the procedure and of CKD management. The parameters were validated by a panel of experts. A discount rate (3% per year) was applied to costs and outcomes. RESULTS: The use of Dyevert yielded more health benefits (34.60 LYG and 5.69 QALYs) compared to the current standard practice (33.11 LYG and 5.38 QALYs). Lifetime cost accumulated at the end of the simulation resulted €30,211/patient with Dyevert and €33,895/patient with current standard clinical practice. CONCLUSIONS: The use of Dyevert™ Power XT resulted dominant option, due to its higher effectiveness and lower cost as compared to standard clinical practice and, therefore, a preferred option in patients with CKD stages 3b-4 undergoing PCI in Spain.

Prognostic Role of TAPSE to PASP Ratio in Patients Undergoing MitraClip Procedure.

BACKGROUND: Transcatheter mitral valve repair (TMVR) is an effective therapy for high-risk patients with severe mitral regurgitation (MR) but heart failure (HF) readmissions and death remain substantial on mid-term follow-up. Recently, right ventricular (RV) to pulmonary arterial (PA) coupling has emerged as a relevant prognostic predictor in HF. In this study, we aimed to assess the prognostic value of tricuspid annular plane systolic excursion (TAPSE) to PA systolic pressure (PASP) ratio as a non-invasive measure of RV-to-PA coupling in patients undergoing TMVR with MitraClip (Abbott, CA, USA). METHODS: Multicentre registry including 228 consecutive patients that underwent successful TMVR with MitraClip. The sample was divided in two groups according to TAPSE/PASP median value: 0.35. The primary combined endpoint encompassed HF readmissions and all-cause mortality. RESULTS: Mean age was 72.5 ± 11.5 years and 154 (67.5%) patients were male. HF readmissions and all-cause mortality were more frequent in patients with TAPSE/PASP ≤ 0.35: Log-Rank 8.844, p = 0.003. On Cox regression, TAPSE/PASP emerged as a prognostic predictor of the primary combined endpoint, together with STS-Score. TAPSE/PASP was a better prognostic predictor than either TAPSE or PASP separately. CONCLUSIONS: TAPSE/PASP ratio appears as a novel prognostic predictor in patients undergoing MitraClip implantation that might improve risk stratification and candidate selection.

Transcatheter Mitral Repair for Functional Mitral Regurgitation According to Left Ventricular Function: A Real-Life Propensity-Score Matched Study.

BACKGROUND: Transcatheter mitral valve repair (TMVR) could improve survival in functional mitral regurgitation (FMR), but it is necessary to consider the influence of left ventricular ejection fraction (LVEF). Therefore, we compare the outcomes after TMVR with Mitraclip® between two groups according to LVEF. METHODS: In an observational registry study, we compared the outcomes in patients with FMR who underwent TMVR with and without LVEF <30%. The primary endpoint was the combined one-year all-cause mortality and unplanned hospital readmissions due to HF. The secondary end-points were New York Heart Association (NYHA) functional class and mitral regurgitation (MR) severity. Propensity-score matching was used to create two groups with the same baseline characteristics, except for baseline LVEF. RESULTS: Among 535 FMR eligible patients, 144 patients with LVEF <30% (group 1) and 144 with LVEF >30% (group 2) had similar propensity scores and were included in the analyses. The primary study endpoint was significantlly higher in group 1 (33.3% vs. 9.4%, p = 0.002). There was a maintained improvement in secondary endpoints without significant differences among groups. CONCLUSION: FMR patients with LVEF <30% treated with MitraClip® had higher mortality and readmissions than patients with LVEF ≥30% treated with the same device. However, both groups improved the NYHA functional class and MR severity.

Reducción de eventos a largo plazo tras el cierre de la orejuela izquierda. Resultados del Registro Ibérico II / Long-term event reduction after left atrial appendage closure. Results of the Iberian Registry II

Introducción y objetivos: Muchos pacientes con fibrilación auricular no valvular tienen contraindicados los anticoagulantes orales. El objetivo es estimar la incidencia de eventos tromboembólicos y hemorrágicos en pacientes con fibrilación auricular no valvular y cierre de la orejuela izquierda con seguimiento a largo plazo, y determinar los factores asociados con mayor mortalidad a largo plazo. Métodos: Cohorte prospectiva de pacientes reclutados desde 2009 a 2015. Se compararon los eventos tromboembólicos y hemorrágicos con los esperados según las escalas CHA2DS2-VASc y HAS-BLED. Se realizó un análisis multivariable para determinar las variables asociadas con la mortalidad. Resultados: Se reclutó a 598 pacientes (1.093 pacientes-año) con contraindicación de anticoagulantes (mediana de edad, 75,4 años). La tasa de éxito del cierre de la orejuela izquierda fue del 95,8%; 30 pacientes (5%) presentaron complicaciones. Las tasas de eventos (cada 100 pacientes-año) durante el seguimiento (media, 22,9 meses; mediana, 16,1 meses) fueron: muerte, 7,0%; ictus isquémico, 1,6% (frente al 8,5% esperado según CHA2DS2-VASc; p < 0,001); hemorragia intracraneal, 0,8%; hemorragia gastrointestinal, 3,2%, y hemorragia grave, 3,9% (frente al 6,3% esperado por HAS-BLED; p = 0,002). Estos resultados incluso mejoraron en el subgrupo de 176 pacientes con seguimiento > 24 meses (media, 46,6 meses; 683 pacientes-año) para las hemorragias graves, el 2,6% (frente al 6,3% esperado por HAS-BLED; p < 0,033). La edad (HR = 1,1), las hemorragias intracraneales (HR = 6,8) y el ictus (HR = 2,7) se asociaron con mayor mortalidad. Conclusiones: El cierre de la orejuela izquierda redujo significativamente las incidencias de ictus y de eventos hemorrágicos graves y el beneficio se mantuvo. La edad, las hemorragias intracraneales y el ictus se asociaron con mayor mortalidad

Introduction and objectives: Many patients with nonvalvular atrial fibrillation are still left without protection due to a contraindication for anticoagulants. This study aimed to establish the occurrence of stroke and major bleeding events in patients with nonvalvular atrial fibrillation and left atrial appendage closure with long-term follow-up and to explore the factors associated with higher long-term mortality. Methods: Analysis of a multicenter single cohort prospectively recruited from 2009 to 2015. Thromboembolic and bleeding events were compared with those expected from CHA2DS2-VASc and HAS-BLED scores. Multivariate analysis examined variables associated with mortality during follow-up. Results: A total of 598 patients (1093 patient-years) with a contraindication for anticoagulants were recruited (median 75.4 years). The success rate of left atrial appendage closure device implantation was 95.8%. Thirty patients (5%) experienced periprocedural complications. The rate of events (per 100 patient-years) during follow-up (mean 22.9 months; median 16.1 months) was as follows: death 7.0%; ischemic stroke 1.6% (vs 8.5% expected according to CHA2DS2-VASc; P < .001); intracranial hemorrhage 0.8%; gastrointestinal bleeding 3.2%; severe bleeding 3.9% (vs 6.3% expected by HAS-BLED, P = .002). These results were improved in the subgroup of 176 patients with follow-up > 24 months (mean follow-up 46.6 months, 683 patient-years) for severe bleeding 2.6% (vs 6.3% expected by HAS-BLED, P < .033). The factors significantly associated with higher mortality were age (HR, 1.1), intracranial hemorrhage (HR, 6.8), and stroke during follow-up (HR, 2.7). Conclusions: Left atrial appendage closure significantly reduced the incidence of stroke and bleeding events and the benefit was maintained. Intracranial hemorrhage, age and stroke were associated with higher mortality

Long-term Event Reduction After Left Atrial Appendage Closure. Results of the Iberian Registry II.

INTRODUCTION AND OBJECTIVES: Many patients with nonvalvular atrial fibrillation are still left without protection due to a contraindication for anticoagulants. This study aimed to establish the occurrence of stroke and major bleeding events in patients with nonvalvular atrial fibrillation and left atrial appendage closure with long-term follow-up and to explore the factors associated with higher long-term mortality. METHODS: Analysis of a multicenter single cohort prospectively recruited from 2009 to 2015. Thromboembolic and bleeding events were compared with those expected from CHA2DS2-VASc and HAS-BLED scores. Multivariate analysis examined variables associated with mortality during follow-up. RESULTS: A total of 598 patients (1093 patient-years) with a contraindication for anticoagulants were recruited (median 75.4 years). The success rate of left atrial appendage closure device implantation was 95.8%. Thirty patients (5%) experienced periprocedural complications. The rate of events (per 100 patient-years) during follow-up (mean 22.9 months; median 16.1 months) was as follows: death 7.0%; ischemic stroke 1.6% (vs 8.5% expected according to CHA2DS2-VASc; P < .001); intracranial hemorrhage 0.8%; gastrointestinal bleeding 3.2%; severe bleeding 3.9% (vs 6.3% expected by HAS-BLED, P = .002). These results were improved in the subgroup of 176 patients with follow-up > 24 months (mean follow-up 46.6 months, 683 patient-years) for severe bleeding 2.6% (vs 6.3% expected by HAS-BLED, P < .033). The factors significantly associated with higher mortality were age (HR, 1.1), intracranial hemorrhage (HR, 6.8), and stroke during follow-up (HR, 2.7). CONCLUSIONS: Left atrial appendage closure significantly reduced the incidence of stroke and bleeding events and the benefit was maintained. Intracranial hemorrhage, age and stroke were associated with higher mortality.

Seguridad del MitraClip en pacientes con cable endocárdico de resincronización cardiaca en el ventrículo izquierdo a través del septo interventricular / Safety of MitraClip implantation in patients with a left ventricular endocardial lead for cardiac resynchronization therapy through the interventricular septum

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TIOMAX: A Spanish Multicenter Registry of the real-world use of the TItanium OptiMAX® biostent: TIOMAX: Registro Español Multicéntrico Del Biostent De Titanio OptiMAX® En La Vida Real.

OBJECTIVES: To compare the safety and efficacy of the new cobalt-chromium bioactive stent Titan Optimax® (Hexacath, France) with its predecessor, Titan-2® . BACKGROUND: The TIOMAX registry includes 784 patients who underwent percutaneous coronary intervention with these stents in 21 Spanish hospitals. METHODS: Analysis of all patients in the registry without exclusion criteria, candidates for revascularization (March-2013/July-2014). Initially 273 patients received Titan-2® , and the next 511 received the Optimax® after its launch. RESULTS: Mean age was 65.8 ± 13.0 (78.1% men); 49.2% were STEACS patients (n = 322), 29.8% NSTEACS, and 27.3% had stable angina or silent ischemia. Most STEACS patients (76.4% of n = 322) were treated <24 hr after developing symptoms. All-cause death (D), cardiac death (CD), acute myocardial infarction (AMI), and stent thrombosis (ST) at 1 month were 1.1, 0.8, 0.1, and 0.5%, respectively, with no significant differences between groups. At 1 year, the death rate was 5.5% for Titan-2 vs. 4.1% for Optimax® , CD was 1.8% for both groups, ST 1.1 vs. 0.6%, new AMI 3.3 vs. 2.5% and target lesion revascularization (TLR) 3.7 vs. 2.9%. The primary endpoint of the composite event (CE) of D/AMI/TLR/ST occurred in 10.3% vs. 7.6% (p = 0.211). Patients with STEACS (N = 322: Titan-2/Optimax: 103/209) had better outcomes for secondary events, device-oriented failure CD/AMI/TLR (7.8% vs. 5.0%; p = 0.330), and non-fatal CE of AMI/ST/TLR (7.8% vs. 2.7%, p = 0.039). CONCLUSIONS: The Titan Optimax retains the efficacy and safety of Titan 2. It appears to perform better in the subgroup of STEACS patients, by reducing the non-fatal CE of AMI/ST/TLR.

Percutaneous balloon mitral valvuloplasty and closure of the left atrial appendage: Synergy of two procedures in one percutaneous intervention.

Mitral stenosis (MS) is frequently associated with the development of atrial fibrillation (AF) as a consequence of hemodynamic and inflammatory changes in the left atrium. Both conditions predispose to thrombus formation, with frequent involvement of the left atrial appendage (LAA), and consequent increase in the incidence of systemic thromboembolic events. Percutaneous mitral valvuloplasty (PMV) reduces the risk of thromboembolism in patients with significant mitral stenosis. Percutaneous LAA closure is also associated with a reduction in thromboembolic risk in patients with AF, but there are no data regarding the use of this technique in patients with significant mitral valve disease. We report the case of a 57-year-old-woman with significant MS and permanent AF, in New York Heart Association functional class II, who despite adequate oral anticoagulation with acenocoumarol, presented several clinical episodes of systemic thromboembolism in the last four years. It was decided to perform a combined percutaneous procedure, including both PMV and percutaneous LAA closure with the Amplatzer Cardiac Plug device. No significant acute complications occurred and the patient was discharged on indefinite treatment with acenocoumarol associated with aspirin 100 mg/d for three months. After a one-year follow-up, there have been no new embolic episodes or other complications.

Comparison of the Efficacy of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With In-Stent Restenosis (from the RIBS IV and V Randomized Clinical Trials).

Treatment of patients with in-stent restenosis (ISR) remains a challenge. This study sought to compare the efficacy of everolimus-eluting stents (EESs) and drug-eluting balloons (DEBs) with paclitaxel in patients with ISR. A pooled analysis of the Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent (RIBS IV) and Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent (RIBS V) randomized trials was performed using patient-level data. In both trials, EESs were compared with DEBs in patients with ISR (RIBS V included 189 patients with bare-metal ISR; RIBS IV included 309 patients with drug-eluting ISR). Inclusion and exclusion criteria were identical in both trials. A total of 249 patients were allocated to EES and 249 to DEB. Clinical follow-up at 1 year was obtained in all (100%) patients and late angiography (median 249 days) in 91% of eligible patients. Compared with patients treated with DEBs, patients treated with EESs obtained better short-term results (postprocedural minimal lumen diameter 2.28 ± 0.5 vs 2.12 ± 0.4 mm, p <0.0001). At follow-up, patients treated with EESs had larger in-segment minimal lumen diameter (primary end point 2.16 ± 0.7 vs 1.88 ± 0.6 mm, p <0.0001; absolute mean difference 0.28 mm; 95% confidence interval [CI] 0.16 to 0.40) and net lumen gain (1.33 ± 0.6 vs 1.00 ± 0.7 mm, p <0.0001) and had lower %diameter stenosis (19 ± 21% vs 28 ± 22%, p <0.0001) and binary restenosis rate (8.7% vs 15.7%, p = 0.02). Consistent results were observed in the in-lesion analysis. No interactions were found between the underlying stent type and treatment effects. At 1-year clinical follow-up, the composite of cardiac death, myocardial infarction, and target vessel revascularization was significantly reduced in the EES arm (8.8% vs 14.5%, p = 0.03; hazard ratio 0.59, 95% CI 0.31 to 0.94) mainly driven by a lower need for target vessel revascularization (6% vs 12.4%, p = 0.01, hazard ratio 0.46, 95% CI 0.25 to 0.86). This pooled analysis of the RIBS IV and RIBS V randomized trials demonstrates the superiority of EES over DEB in the treatment of patients with ISR.

Immediate and Long-Term Results of Drug-Eluting Stents in Mammary Artery Grafts.

UNLABELLED: Percutaneous intervention of a coronary graft is the treatment of choice when the graft fails. The objective is to report the long-term results of drug-eluting stents (DES) in mammary artery grafts (MAG). Patients who had been treated with DES for MAG in 27 centers were selected. The baseline and procedural clinical data were included prospectively, and the follow-up was performed with the patients, families, and medical records. Two hundred and sixty-eight patients were included: age 65.5 ± 10.1 years, diabetes 47.8%, ejection fraction 55.5 ± 14.9%. INDICATION: stable angina 28.4%, unstable angina 38.1%, non-ST-elevation myocardial infarction 21.6%, ST-elevation myocardial infarction 5.3%, and heart failure 6.7%; 1.19 ± 0.59 stents/patient were implanted measuring 18.8 ± 8.8 mm in length and 2.68 ± 0.35 mm in diameter. Rapamycin was used in 78 cases (29.1%), paclitaxel in 77 (28.7%), everolimus in 70 (26.1%), zotarolimus in 34 (12.7%), and biolimus in 9 (3.4%). All cases were successful except for 1 in which the patient died 30 minutes after the procedure. There were no other inhospital events. After a follow-up of 41 months (Q25: 23.7 to Q75: 57.8), 24 patients (9%) died of heart-related causes and 20 (7.5%) of noncardiac causes. Repeat revascularization was necessary in 31 cases, and in 1 additional patient, there was total occlusion, which was not treated. These 32 patients represented 11.9% of the total. In conclusion, the implantation of DES in MAG shows very high procedural success and also low long-term event rates.

Estudio aleatorizado para comparar el stentbioactivo de titanio con el stent de everolimus en pacientes diabéticos (TITANIC XV), resultados a 1 año / A Randomized Study to Compare Bioactive Titanium Stents and Everolimus-eluting Stents in Diabetic Patients (TITANIC XV): 1-year Results

Introducción y objetivos Hasta un 25% de los pacientes sometidos a intervencionismo coronario percutáneo presentan alguna limitación para la utilización de los stents farmacoactivos. Nuestro objetivo es evaluar si el stent bioactivo de titanio y óxido nítrico podía ser una buena alternativa al stent de everolimus para pacientes diabéticos.MétodosSe aleatorizó a 173 pacientes diabéticos con lesiones de riesgo de reestenosis intermedio (criterios de exclusión: diámetro < 2,5 mm o longitud > 28 mm en vasos < 3 mm, oclusión crónica): 83 pacientes en el grupo con titanio y 90 en el grupo con everolimus.ResultadosLas variables basales estaban bien equilibradas, el 28,3% eran insulinodependientes. Al año, las incidencias de eventos adversos cardiacos mayores (muerte, infarto de miocardio no fatal, ictus o nueva revascularización del vaso tratado) eran significativamente más frecuente en el grupo con titanio que en el grupo con everolimus (total, el 14,5 frente al 4,4%; p = 0,02; subgrupo no insulinodependiente, el 9,7 frente al 3,2%; p = 0,14; insulinodependiente, el 28,6 frente al 7,1%; p = 0,04) y de muerte, infarto de miocardio no fatal, ictus o cualquier revascularización, del 16,9% en el grupo con titanio y el 7,8% en el grupo con everolimus (p = 0,06). La revascularización de la lesión diana se produjo en el 8,4 frente al 3,3% (p = 0,15), y la del vaso tratado, el 13,3 frente al 3,3% (p = 0,01). El seguimiento angiográfico a 9 meses mostró una pérdida luminal tardía significativamente menor en el grupo con everolimus (en el segmento, 0,52 ± 0,58 frente a -0,05 ± 0,32 mm; en el stent, 0,76 ± 0,54 frente a 0,13 ± 0,31 mm; p < 0,0001). ConclusionesEl stent de everolimus fue superior al titanio en pacientes diabéticos incluso con lesiones de riesgo de eventos clínicos y angiográficos intermedio (AU)

Introduction and objectives Up to 25% of patients who undergo a percutaneous coronary intervention show some limitation in the use of drug-eluting stents. The aim of this study was to evaluate if titanium-nitride-oxide-coated stents could be a good alternative to everolimus-eluting stents in diabetic patients.MethodsA total of 173 diabetic patients with lesions at moderate risk of restenosis (exclusion criteria: diameter < 2.5 mm or length > 28 mm in vessels < 3 mm, chronic occlusion) were randomized to a titanium group (83 patients) or an everolimus group (90 patients).ResultsBaseline characteristics were well balanced; 28.3% of patients were insulin dependent. At 1 year, the incidence of major adverse cardiac events (death, nonfatal myocardial infarction, stroke, or repeat target vessel revascularization) was significantly higher in the titanium group than in the everolimus group (total, 14.5% vs 4.4%; P = .02; noninsulin-dependent subgroup, 9.7% vs 3.2%; P = .14; insulin-dependent subgroup, 28.6% vs 7.1%; P = .04). The incidence of death, nonfatal myocardial infarction, stroke, or any revascularization was 16.9% in the titanium group and 7.8% in the everolimus group (P = .06). Target lesion and vessel revascularizations occurred in 8.4% compared with 3.3% (P = .15) and in 13.3% compared with 3.3% (P = .01) in the titanium and everolimus groups, respectively. Angiographic follow-up at 9 months showed significantly less late lumen loss in the everolimus group (in-segment, 0.52 [standard deviation, 0.58) mm vs -0.05 [0.32] mm; in-stent, 0.76 [0.54] mm vs 0.13 [0.31] mm; P < .0001).ConclusionsThe everolimus-eluting stent is superior to the titanium stent for clinical and angiographic end points in diabetic patients with lesions at moderate risk of restenosis (AU)

A randomized study to compare bioactive titanium stents and everolimus-eluting stents in diabetic patients (TITANIC XV): 1-year results.

INTRODUCTION AND OBJECTIVES: Up to 25% of patients who undergo a percutaneous coronary intervention show some limitation in the use of drug-eluting stents. The aim of this study was to evaluate if titanium-nitride-oxide-coated stents could be a good alternative to everolimus-eluting stents in diabetic patients. METHODS: A total of 173 diabetic patients with lesions at moderate risk of restenosis (exclusion criteria: diameter < 2.5 mm or length > 28 mm in vessels < 3mm, chronic occlusion) were randomized to a titanium group (83 patients) or an everolimus group (90 patients). RESULTS: Baseline characteristics were well balanced; 28.3% of patients were insulin dependent. At 1 year, the incidence of major adverse cardiac events (death, nonfatal myocardial infarction, stroke, or repeat target vessel revascularization) was significantly higher in the titanium group than in the everolimus group (total, 14.5% vs 4.4%; P = .02; noninsulin-dependent subgroup, 9.7% vs 3.2%; P = .14; insulin-dependent subgroup, 28.6% vs 7.1%; P = .04). The incidence of death, nonfatal myocardial infarction, stroke, or any revascularization was 16.9% in the titanium group and 7.8% in the everolimus group (P = .06). Target lesion and vessel revascularizations occurred in 8.4% compared with 3.3% (P = .15) and in 13.3% compared with 3.3% (P = .01) in the titanium and everolimus groups, respectively. Angiographic follow-up at 9 months showed significantly less late lumen loss in the everolimus group (in-segment, 0.52 [standard deviation, 0.58) mm vs -0.05 [0.32] mm; in-stent, 0.76 [0.54] mm vs 0.13 [0.31] mm; P < .0001). CONCLUSIONS: The everolimus-eluting stent is superior to the titanium stent for clinical and angiographic end points in diabetic patients with lesions at moderate risk of restenosis.

Anatomical classification of left atrial appendages in specimens applicable to CT imaging techniques for implantation of amplatzer cardiac plug.

BACKGROUND: Certain anatomical characteristics of the left atrial appendage (LAA) are associated with complexity in the implantation of occluder devices. OBJECTIVE: The aim was to define characteristics measurable by three-dimensional imaging that would predict complexities both in the implantation procedure and the selection of the appropriate device size. METHODS: An anatomical study was performed of 50 postmortem hearts, of which 15 had a history of atrial fibrillation, and of 30 consecutive patients undergoing LAA occlusion with the Amplatzer cardiac plug (ACP). The specimens were classified according to variables that can be visualized using computerized tomography (CT). The CT scans of 30 consecutive patients were classified according to the level of the LAA ostium, the left lateral ridge (LLR), the LAA limbus and distance from LAA to the mitral annulus before undergoing LAA occlusion, and the results were correlated. RESULTS: Three types of LAA orifice were defined: type I, with a usually higher, anterior LAA ostium, a short, flattened and wide LLR and almost nonexistent limbus; type II, presenting a long, pointed and narrow LLR, and a longer, more defined limbus; type III, with a lower LAA ostium, close to the left atrium floor and the mitral annulus, a marked separation from the left pulmonary vein orifices and a limbus of intermediate length. CONCLUSION: LAA with lower ostia are more difficult to occlude. Types II and III have very prominent LLRs with longer limbi, which may increase the difficulty of inserting the guide and making measurements for selection of the right ACP size.

A randomized comparison of drug-eluting balloon versus everolimus-eluting stent in patients with bare-metal stent-in-stent restenosis: the RIBS V Clinical Trial (Restenosis Intra-stent of Bare Metal Stents: paclitaxel-eluting balloon vs. everolimus-eluting stent).

OBJECTIVES: This study sought to compare the efficacy of drug-eluting balloons (DEB) with that of everolimus-eluting stents (EES) in patients with bare-metal stents (BMS) in-stent restenosis (ISR). BACKGROUND: Treatment of patients with ISR remains a challenge. METHODS: This was a prospective, multicenter, randomized trial comparing DEB with EES in patients with bare-metal stents (BMS) in-stent restenosis (ISR). The primary endpoint was the minimal lumen diameter at 9 months' follow-up. RESULTS: A total of 189 patients with BMS-ISR from 25 Spanish sites were included (95 were allocated to DEB and 94 to EES). Procedural success was achieved in all patients. At late angiography (median 249 days; 92% of eligible patients), patients in the EES arm had a significantly larger minimal lumen diameter (2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm, p < 0.001; absolute mean difference: 0.35 mm; 95% confidence interval [CI]: 0.16 to 0.53) and a lower percent of diameter stenosis (13 ± 17% vs. 25 ± 20%, p < 0.001). However, late loss (0.04 ± 0.5 mm vs. 0.14 ± 0.5 mm, p = 0.14) and binary restenosis rate (4.7% vs. 9.5%, p = 0.22) were very low and similar in both groups. Clinical follow-up (median 365 days) was obtained in all (100%) patients. Occurrences of the combined clinical outcome measure (cardiac death, myocardial infarction, and target vessel revascularization; 6% vs. 8%; hazard ratio [HR]: 0.76; 95% CI: 0.26 to 2.18, p = 0.6) and the need for target vessel revascularization (2% vs. 6%; HR: 0.32: 95% CI: 0.07 to 1.59, p = 0.17) were similar in the 2 groups. CONCLUSIONS: In patients with BMS-ISR, both DEB and EES provided excellent clinical results with a very low rate of clinical and angiographic recurrences. However, compared with DEB, EES provide superior late angiographic findings. (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs. Everolimus-eluting Stent [RIBS V]; NCT01239953).

Resultados inmediatos y a más de un año en 35 pacientes consecutivos a los que se realiza cierre de orejuela izquierda con el dispositivo Amplatzer Cardiac Plug / Immediate and one-year results in 35 consecutive patients after closure of left atrial appendage with the amplatzer cardiac plug

Introducción y objetivos. El cierre del apéndice auricular izquierdo puede ser una opción terapéutica atractiva para pacientes con fibrilación auricular no valvular y contraindicación para tomar anticoagulantes orales, siempre que se obtengan buenos resultados durante la implantación y en el seguimiento. Métodos. Se analizó a 35 pacientes consecutivos y no elegibles para los estudios aleatorizados con anticoagulantes orales a los que se implantó el dispositivo oclusor Amplatzer. Tras los primeros 5 casos, se incorporó una técnica de imagen 3D. Se analizaron los resultados de la implantación y de seguimiento durante 1 año. Resultados. La media de edad era 74,65 ± 7,61 años, con un CHADS2 de 2,41 ± 1,53 y un CHA2DS2-VASc de 3,17 ± 1,60. No se pudo implantar el dispositivo en 1 caso y en 5 fue necesario cambiar la medida seleccionada. No hubo ninguna complicación cardiaca durante la implantación ni durante la estancia hospitalaria. Hubo una complicación vascular (fístula arteriovenosa). Se realizó seguimiento con ecocardiografía transesofágica a las 24 h y tras 1, 3, 6 y 12 meses; se documentaron 5 trombos, que se resolvieron con heparina. En el seguimiento de 21,14 ± 10,09 meses, hubo 3 muertes de pacientes mayores de 80 años, ninguna de ellas cardiológica, y un accidente isquémico transitorio sin secuelas. Conclusiones. El cierre del apéndice auricular izquierdo por un operador con cierta experiencia puede ser una opción terapéutica con pocas complicaciones y con resultados a más de 1 año eficaces en la reducción de complicaciones tromboembólicas y hemorrágicas, incluso en poblaciones de muy alto riesgo (AU)

Introduction and objectives. Left atrial appendage closure can be an attractive option for patients with nonvalvular atrial fibrillation and a contraindication to oral anticoagulants, provided that satisfactory results can be achieved during implantation and follow-up. Methods. Thirty-five consecutive patients, not eligible for randomized trials with oral anticoagulants, had an Amplatzer occlusion device implanted under general anesthesia. After the first 5 patients, 3-dimensional imaging was incorporated. The results of the implantation and the follow-up were analyzed over a 1-year period. Results. The mean age was 74.65 (7.61) years, with a CHADS2 score of 2.41 (1.53) and a CHA2DS2-VASc score of 3.17 (1.60). Implantation failed in 1 patient and 5 needed a change in the selected plug size. There were no cardiac complications during the implantation or hospital stay. There was 1 vascular complication (arteriovenous fistula). Transesophageal echocardiography monitoring was performed at 24h, 1, 3, 6, and 12 months and we found 5 thrombi which were resolved with heparin. In the follow-up period of 21.14 (10.09) months, 3 patients aged>80 years died, none of them due to heart problems, and one transient ischemic stroke without further consequences. Conclusions. Left atrial appendage closure by an experienced operator can be a treatment option with few complications and with efficient results at>1 year in reducing thromboembolic and hemorrhagic complications, even in very high-risk groups (AU)

Immediate and one-year results in 35 consecutive patients after closure of left atrial appendage with the Amplatzer cardiac plug.

INTRODUCTION AND OBJECTIVES: Left atrial appendage closure can be an attractive option for patients with nonvalvular atrial fibrillation and a contraindication to oral anticoagulants, provided that satisfactory results can be achieved during implantation and follow-up. METHODS: Thirty-five consecutive patients, not eligible for randomized trials with oral anticoagulants, had an Amplatzer occlusion device implanted under general anesthesia. After the first 5 patients, 3-dimensional imaging was incorporated. The results of the implantation and the follow-up were analyzed over a 1-year period. RESULTS: The mean age was 74.65 (7.61) years, with a CHADS2 score of 2.41 (1.53) and a CHA2DS2-VASc score of 3.17 (1.60). Implantation failed in 1 patient and 5 needed a change in the selected plug size. There were no cardiac complications during the implantation or hospital stay. There was 1 vascular complication (arteriovenous fistula). Transesophageal echocardiography monitoring was performed at 24h, 1, 3, 6, and 12 months and we found 5 thrombi which were resolved with heparin. In the follow-up period of 21.14 (10.09) months, 3 patients aged>80 years died, none of them due to heart problems, and one transient ischemic stroke without further consequences. CONCLUSIONS: Left atrial appendage closure by an experienced operator can be a treatment option with few complications and with efficient results at>1 year in reducing thromboembolic and hemorrhagic complications, even in very high-risk groups.

Implantation of a drug-eluting stent with a different drug (switch strategy) in patients with drug-eluting stent restenosis. Results from a prospective multicenter study (RIBS III [Restenosis Intra-Stent: Balloon Angioplasty Versus Drug-Eluting Stent]).

OBJECTIVES: This study sought to assess the effectiveness of a strategy of using drug-eluting stents (DES) with a different drug (switch) in patients with DES in-stent restenosis (ISR). BACKGROUND: Treatment of patients with DES ISR remains a challenge. METHODS: The RIBS-III (Restenosis Intra-Stent: Balloon Angioplasty Versus Drug-Eluting Stent) study was a prospective, multicenter study that aimed to assess results of coronary interventions in patients with DES ISR. The use of a different DES was the recommended strategy. The main angiographic endpoint was minimal lumen diameter at 9-month follow-up. The main clinical outcome measure was a composite of cardiac death, myocardial infarction, and target lesion revascularization. RESULTS: This study included 363 consecutive patients with DES ISR from 12 Spanish sites. The different-DES strategy was used in 274 patients (75%) and alternative therapeutic modalities (no switch) in 89 patients (25%). Baseline characteristics were similar in the 2 groups, although lesion length was longer in the switch group. At late angiographic follow-up (77% of eligible patients, median: 278 days) minimal lumen diameter was larger (1.86 ± 0.7 mm vs. 1.40 ± 0.8 mm, p = 0.003) and recurrent restenosis rate lower (22% vs. 40%, p = 0.008) in the different-DES group. At the last clinical follow-up (99% of patients, median: 771 days), the combined clinical endpoint occurred less frequently (23% vs. 35%, p = 0.039) in the different-DES group. After adjustment using propensity score analyses, restenosis rate (relative risk: 0.41, 95% confidence interval [CI]: 0.21 to 0.80, p = 0.01), minimal lumen diameter (difference: 0.41 mm, 95% CI: 0.19 to 0.62, p = 0.001), and the event-free survival (hazard ratio: 0.56, 95% CI: 0.33 to 0.96, p = 0.038) remained significantly improved in the switch group. CONCLUSIONS: In patients with DES ISR, the implantation of a different DES provides superior late clinical and angiographic results than do alternative interventional modalities.

Determinación del índice tobillo-brazo en pacientes con dolor torácico agudo de posible origen coronario / Ankle-brachial index in patients with chest pain and suspected acute coronary syndrome

Fundamento y objetivo: El dolor torácico agudo (DTA) es un síntoma inespecífico que puede ser expresión de cardiopatía isquémica (CI). La arteriosclerosis frecuentemente está presente en más de un territorio vascular. El índice tobillo-brazo (ITB) es una herramienta útil en el diagnóstico de enfermedad arterial periférica (EAP). Nuestro objetivo fue evaluar la utilidad del ITB en pacientes con DTA en los que se sospecha CI. Pacientes y método: Estudio transversal de 94 pacientes consecutivos, con una edad media (DE) de 57,4 (12,2) años, ingresados por DTA con sospecha de CI, en los que se determinó el ITB y se investigó la presencia de CI.Resultados: La CI estuvo presente en 22 pacientes (23,4%) y estuvo ausente en 72 pacientes (76,6%). La EAP asintomática (ITB≤0,9) estuvo presente en 6 pacientes (27,2%) en el grupo con CI y en 7 pacientes (9,7%) en el grupo sin CI. Encontramos diferencias significativas en el ITB según la presencia o no de CI (0,9 [0,23] frente a 1,17 [0,15]; p<0,001). Evaluamos el valor diagnóstico del ITB en la detección de CI: el área bajo la curva ROC (receiver operating characteristic) fue de 0,8 (intervalo de confianza del 95%: 0,70–0,87); el punto de corte óptimo fue de 0,8 (sensibilidad del 22,7% y especificidad del 98,6%). En el análisis multivariante, el ITB fue el mejor predictor independiente de CI (p<0,0001). Conclusiones: El ITB es un método sencillo, barato y eficiente, que complementa los métodos diagnósticos actuales en el reconocimiento del DTA de origen coronario (AU)

Background and objective: Acute chest pain (ACP) is a non-specific symptom that may be the expression of coronary artery disease (CAD). Atherosclerosis is usually present in more than one vascular territory. Ankle-brachial index (ABI) is a useful tool for the diagnosis of peripheral arterial disease (PAD). Our aim was to evaluate the value of ABI in patients with ACP when CAD is suspected. Patients and methods: We performed a cross-sectional study of 94 patients, mean age: 57.4 (12.2), admitted consecutively due to ACP with suspicion of CAD. ABI and presence of CAD were determined. Results: CAD was present in 22 patients (23.4%) and absent in 72 (76.6%). Asymptomatic PAD (ABI≤0.9) was present in 6 patients (27.2%) of CAD group and in 7 patients (9.7%) of the non-CAD group. Significant difference was found in ABI based on the presence or not of CAD [0.95 (0.23) vs 1.17 (0.15), p<0.001]. The diagnostic value of ABI for CAD detection was evaluated: area under the ROC curve was 0.8 (IC 95%: 0.70–0.87) and optimal cut-off point was 0.8 (sensitivity=22.7% and specificity=98.6%). In the multivariate analysis, ABI was the best independent predictor of CAD (p<0.001).Conclusion: ABI is a simple, cheap and efficient method, which complements other conventional diagnostic methods in the recognition of patients with ACP due to CAD (AU)