PRECISE-DAPT, ARC-HBR, or Simplified Clinical Evaluation for the Prediction of Major Bleeding After Percutaneous Coronary Intervention in older Patients.

Older patients have been remarkably underrepresented in bleeding risk cohorts. Thus, the PRECISE-DAPT (Derivation and validation of the predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy) and Academic Research Consortium for High Bleeding Risk (ARC-HBR) scores are not validated in older adults. Therefore, we sought to evaluate the PRECISE-DAPT and ARC-HBR scores in an exclusively older population and assess the prognostic value of a truly simplified clinical evaluation (SCE), consisting of only 3 binary clinical variables (hemoglobin <11 g/100 ml, previous bleeding, and anticipated use of anticoagulants). This is a retrospective analysis of the prospective single-center older-HCD registry. Consecutive patients aged ≥75 years who underwent percutaneous coronary intervention from 2012 to 2019 were included. The primary end point was postdischarge bleeding at 12 months of follow-up, defined according to the Bleeding Academic Research Consortium 3 or 5 criteria. A total of 693 patients with a mean age of 81 (±4.4) years were included in the study and 60 patients (6.8%) met the primary end point. The PRECISE-DAPT and ARC-HBR scores did not significantly predict postdischarge bleeding in the Cox regression models (hazard ratio 1.65 [0.78 to 3.42] and 1.46 [0.72 to 4.24], respectively), whereas the SCE outperformed both scores (hazard ratio 2.47, 1.34 to 4.49). All 3 scores exhibited a moderate discriminatory potential, as determined by a receiver-operating characteristic curve analysis (areas under the curve 0.601, 0.621, and 0.616, respectively), with no significant differences between them. The SCE showed an Integrated Discrimination Improvement of 0.25, p = 0.02 (SCE vs ARC-HBR) and 0.24, p = 0.01 (SCE vs PRECISE-DAPT), with an Net Reclassification Improvement of 6.54%, p = 0.37 and 7.12%, p = 0.43, respectively. In conclusion, the PRECISE-DAPT score and ARC-HBR criteria showed insufficient predictive value in older adults. A truly SCE consisting of 3 easily accessible variables not only provides equal discriminatory potential but also demonstrates superior predictive value, as determined by Cox regression models. This makes it a highly appealing tool for risk stratification, pending its evaluation in larger prospective studies.

Percutaneous Left Atrial Appendage Closure in Patients with Non-Valvular Atrial Fibrillation and End-Stage Renal Disease on Hemodialysis: A Case Series.

Non-valvular atrial fibrillation (NVAF) is the most common cardiac arrhythmia in the general population, and its prevalence increases among patients with chronic kidney disease (CKD) undergoing hemodialysis. This population presents high risk of both hemorrhagic and thrombotic events, with little evidence regarding the use of oral anticoagulation treatment (OAT) and multiple complications arising from it; however, stroke prevention with percutaneous left atrial appendage closure (LAAC) is an alternative to be considered. We retrospectively describe the safety and efficacy of percutaneous LAAC in eight patients with NVAF and CKD on hemodialysis during a 12-month follow-up. The mean age was 78.8 years (range 64-86; SD ± 6.7), and seven patients were male. The mean CHA2DS2-VASC and HAS-BLED scores were high, 4.8 (SD ± 1.5) and 3.8 (SD ± 1.3), respectively. Seventy-five percent of the patients were referred for this intervention due to a history of major bleeding, with gastrointestinal bleeding being the most common type, while the remaining twenty-five percent of the patients were referred because of a high risk of bleeding. The percutaneous LAAC procedure was successfully completed in 100% of the patients, with complete exclusion of the appendage without complications or leaks exceeding 5 mm. There was one death not related to the procedure four days after the intervention. Among the other seven patients, no deaths, cardioembolic events or major bleeding were reported during the follow-up period. In our sample, percutaneous LAAC appears to be a safe and effective alternative to anticoagulation in patients with NVAF and CKD on hemodialysis.

Outcomes Prediction in Complex High-Risk Indicated Percutaneous Coronary Interventions in the Older Patients.

Complex high-risk indicated percutaneous coronary intervention (CHIP-PCI) is a poorly defined concept, which has not been validated in an older population before. This study aimed to evaluate the predictive value of the CHIP-PCI score in a large cohort of elderly patients and to identify potential further risk factors. This is a pooled analysis of 3 registries that included patients aged ≥75 years who underwent percutaneous coronary intervention from 2012 to 2019: the multicenter prospective EPIC05-Sierra 75 study, the multicenter retrospective PACO-PCI (EPIC-15) registry, and the single-center, prospective Elderly-HCD registry. A total of 2,725 patients with a mean age of 81 ± 4 years were included in the study; 269 patients (10%) met the primary end point of 1-year major adverse cardiac and cerebrovascular events (MACCEs), and 51 patients (2%) had in-hospital MACCEs. Of the 12 investigated original CHIP-PCI score variables, 5 were independent predictors: previous myocardial infarction, left ventricular ejection fraction <30%, chronic kidney disease, left main coronary artery percutaneous coronary intervention, and nonradial access. Furthermore, diabetes mellitus, anemia, and severe calcification showed to be significant predictors of MACCEs. The additional variables improved the discriminatory value of the CHIP-PCI score for 1-year MACCEs (modified CHIP-PCI score: area under the curve [AUC] 0.647 vs original CHIP-PCI score: AUC 0.598, p = 0.02) and in-hospital MACCEs (AUC 0.729 vs 0.657, p = 0.003, respectively). In conclusion, the CHIP-PCI score retains its prognostic value in older patients for in-hospital MACCEs; however, it is of limited value at 1-year follow-up. The modified CHIP-PCI score, including the 5 patient-related and 3 procedure-related factors, significantly improved its discriminatory potential.

Impact of operators experience on peri-procedural outcomes with Watchman FLX: Insights from the FLX-SPA registry.

BACKGROUND: The Watchman FLX is a device upgrade of the Watchman 2.5 that incorporates several design enhancements intended to simplify left atrial appendage occlusion (LAAO) and improve procedural outcomes. This study compares peri-procedural results of LAAO with Watchman FLX (Boston Scientific, Marlborough, Massachusetts) in centers with varying degrees of experience with the Watchman 2.5 and Watchman FLX. METHODS: Prospective, multicenter, "real-world" registry including consecutive patients undergoing LAAO with the Watchman FLX at 26 Spanish sites (FLX-SPA registry). Implanting centers were classified according to the center's prior experience with the Watchman 2.5. A further division of centers according to whether or not they had performed ≤ 10 or > 10Watchman FLX implants was prespecified at the beginning of the study. Procedural outcomes of institutions stratified according to their experience with the Watchman 2.5 and FLX devices were compared. RESULTS: 359 patients [mean age 75.5 (SD8.1), CHA2DS2-VASc 4.4 (SD1.4), HAS-BLED 3.8(SD0.9)] were included. Global success rate was 98.6%, successful LAAO with the first selected device size was achieved in 95.5% patients and the device was implanted at first attempt in 78.6% cases. There were only 9(2.5%) major peri-procedural complications. No differences in efficacy or safety results according to the centers previous experience with Watchman 2.5 and procedural volume with Watchman FLX existed. CONCLUSIONS: The Watchman FLX attains high procedural success rates with complete LAA sealing in unselected, real-world patients, along with a low incidence of peri-procedural complications, regardless of operators experience with its previous device iteration or the number of Watchman FLX devices implanted.

Uncommon presentation of coronary sinus endocarditis.

A 79-year-old man, who underwent femoropopliteal bypass surgery 1 month prior to admission, presented with fever and fatigue. ECG showed complete atrioventricular block. Transthoracic echocardiography was performed, revealing a round homogeneous right atrial mass and severe mitral regurgitation. Transoesophageal echocardiography revealed involvement the coronary sinus (CS). Computed tomography imaging demonstrated abscess of the atrioventricular sulcus and infiltration of the CS.

Recurrent embolisms despite adequate anticoagulant therapy in a patient with prosthetic heart valves and atrial fibrillation: a case report.

BACKGROUND: Antithrombotic management in patients with atrial fibrillation (AF) that have undergone heart valve surgery may be challenging, especially in the context of thromboembolic events during follow-up. The combination of pharmacological therapies with modern transcatheter interventions allows these more complex cases to be overcome. CASE SUMMARY: We present the case of a 66-year-old female with a history of AF and mechanical aortic and mitral valve replacement, which was admitted to the hospital complaining of dizziness and unsteady gait. A computerized tomography scan of the brain confirmed the diagnosis of embolic stroke. Two years later, the patient complained of sudden onset of chest pain, accompanied by electrocardiographic abnormalities and elevated high-sensitivity troponin T. Emergency cardiac catheterization revealed embolic myocardial infarction with distal occlusion of the obtuse marginal artery. Again, 2 years later, the patient suffered a new cerebral embolic event. Given the adequate anticoagulation therapy throughout almost the entire clinical course, percutaneous left atrial appendage closure was proposed as an adjunct to vitamin K antagonist treatment. Notably, intraprocedural transoesophageal echocardiography revealed the presence of a previously undetected left atrial appendage thrombus, thus an embolic protection device was used during the procedure, which was successfully carried out without complications. DISCUSSION: This case report demonstrates the complexity of the antithrombotic management in patients with AF and prosthetic heart valves, and highlights the importance of an individualized approach, integrating new therapeutic strategies to achieve success, in patients that present thromboembolic events despite adequate anticoagulation therapy.

Incidence and Predictors of Progression in Asymptomatic Patients With Stable Heart Failure.

Data from previous heart failure (HF) trials suggest that patients with mild symptoms (NYHA II) actually have a poor clinical outcome. However, these studies did not assess clinical stability and rarely included patients in NYHA I. We sought to determine the incidence of short-term clinical progression in supposedly stable HF patients in NYHA I. In addition, we aimed to investigate the predictive value of widely available electrocardiographic and echocardiographic parameters for short-term disease progression. This is a retrospective study including 153 consecutive patients with HF with reduced and mid-range ejection fraction (HFrEF: LVEF<40%; HFmrEF: LVEF 40-49%) in NYHA I with no history of decompensation within the previous 6 months. All patients underwent comprehensive baseline echocardiographic and electrocardiographic assessment. The primary endpoint was the composite of cardiovascular death, hospitalization and need for intensification of HF treatment within a 12 month follow-up period. The cumulative incidence of HF progression was 17.8%, with a median time to event of 193 days. Death and hospitalization due to HF accounted for three-quarters of the events. QRS duration ≥120ms and mitral regurgitation grade >1 showed to be significant predictors of HF progression (HR: 8.92, p<0.001; and HR: 4.10, p<0.001, respectively). Patients without these risk factors had a low incidence of clinical events (3.8%). In conclusion, almost one in five supposedly stable HF patients in NYHA I experience clinical progression in short-term follow-up. Simple electrocardiographic and echocardiographic predictors may be useful for risk stratification and could help to improve individual HF patient management and outcomes.

Ventricular tachycardia secondary to thyrotoxic periodic paralysis: A case report.

Thyrotoxic periodic paralysis (TPP) is a rare but potentially life-threatening entity, which is characterized by sudden onset of muscle weakness and can in exceptional cases be associated with more severe symptoms, such as severe hypokalemia. We present the rare case of a young patient presenting with monomorphic ventricular tachycardia secondary to hypokalemia due to TPP. This case report highlights the importance of recognition of TPP as a rare cause of VT. A high index of suspicion is needed since signs of hyperthyroidism may be subtle. However, early diagnosis is crucial in order to avoid cardiovascular complications and improve outcomes.

Atrial cholangiocarcinoma diagnosed by cardiac magnetic resonance imaging.

In this rare case of intrahepatic cholangiocarcinoma (ICC) tumor thrombus with right atrial (RA) invasion, we describe its diagnostic workup based on cardiac magnetic resonance imaging (cMRI). An 85-year-old man underwent transthoracic echocardiography due to dyspnea, revealing a RA mass. Comprehensive cMRI evaluation, including cine bright blood, T1- and T2-weighed, fat-suppressed, and contrast-enhanced imaging, was performed and diagnosis of ICC tumor thrombus with RA invasion was made. This first description of cMRI-guided diagnosis of RA invasion by ICC tumor thrombus points out the usefulness of cMRI for the diagnostic approach of RA masses suggestive of tumor thrombus.

Improvement in quality of life with sacubitril/ /valsartan in cardiac resynchronization non-responders: The RESINA (RESynchronization plus an Inhibitor of Neprilysin/Angiotensin) registry.

BACKGROUND: Clinical management of cardiac resynchronization therapy (CRT) non-responders is difficult, and their prognosis is poor. The aim of the present study was to evaluate whether treatment with sacubitril/valsartan can improve quality of life (QoL) parameters in these patients. METHODS: Thirty five non-responders to CRT were included (75 ± 7 years, 28% females, mean left ventricular ejection fraction 28 ± 8%, 54% non-ischemic cardiomyopathy) with maximally optimized drug therapy and New York Heart Association class II-III. They were all on angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers and were switched to sacubitril/valsartan. One week before and 6 months after initiation of the therapy they completed both the Minnesota Living with Heart Failure (MLWHF) and the 12-item Kansas City Cardiomyopathy Questionnaires (KCCQ-12). The primary outcome was the effect of sacubitril/valsartan on the physical, clinical, social and emotional QoL parameters and number of hospitalizations. RESULTS: The mean total scores of both questionnaires improved from baseline to the follow-up visit at 6-months (KCCQ-12 40 ± 10 to 47 ± 10; p < 0.001; MLWHF 40 ± 15 to 29 ± 15; p < 0.001). The best results were seen in the KCCQ-12 total symptom domains (77% improvement), the MLWHF physical domain (81% improvement), and the MLWHF emotional domain (71% improvement). Two patients died during follow-up. The mean number of hospitalizations reduced significantly (1 ± 0.6 vs. 0.5 ± 0.8; p = 0.003) CONCLUSIONS: In CRT non-responders, sacubitril/valsartan significantly improved overall QoL, physical limitations and emotional domains and reduced the number of hospitalizations.

Clinical risk factors for the prediction of acute kidney injury post cardiac resynchronization therapy in an elderly population.

BACKGROUND: Data on the occurrence of acute kidney injury (AKI) in patients undergoing cardiac resynchronization therapy (CRT) implantation is limited and no previous studies investigated its impact in an elderly population. CRT implantation requires a relatively low quantity of contrast medium. Previous studies, however, focused primarily on contrast medium as etiological factor for AKI, reporting a high incidence (8-14%). The high incidence of AKI in absence of use of substantial amounts of contrast volume, suggests the existence of other factors that contribute to AKI. OBJECTIVES: To determine the predictive value of patient and procedure-related risk factors for the occurrence of AKI post CRT, as well as the AKIs impact on length of in-hospital stay (LOS) and 1-year mortality. METHODS: Retrospective observational study, including consecutive patients that underwent CRT implantation in a single center. RESULTS: 60 patients with a mean age of 77 ± 8.4 years were included in the study and Twelve (20%) developed AKI. Prior renal insufficiency (p = 0.03; OR = 15.4), larger procedure time (p = 0.02; OR = 1.03), intra-operative hypotension (p < 0.01; OR = 1.72) and bleeding (p = 0.01 (OR = 7.86), showed to predict AKI significantly. AKI associated a significantly longer LOS (12 vs 3 days, p < 0.01). No significant differences regarding 1-year mortality were observed (p = 0.19; HR = 2.7 for patients with AKI). CONCLUSIONS: AKI is a frequent complication of CRT implantation with an important impact on in-hospital stay, especially in the elderly. In addition to contrast administration, clinical factors could play a significant role in the occurrence of AKI.

Estrategia invasiva frente a conservadora en pacientes frágiles con IAMSEST. Diseño del ensayo clínico MOSCA-FRAIL / Invasive versus conservative strategy in frail patients with NSTEMI: the MOSCA-FRAIL clinical trial study design

Introducción y objetivos: Aunque las guías de práctica clínica recomiendan una estrategia invasiva para el infarto agudo de miocardio sin elevación del segmento ST (IAMSEST), en la práctica clínica esta estrategia se infrautiliza en ancianos frágiles. Además estos enfermos habitualmente quedan excluidos de los ensayos clínicos, por lo que la evidencia es escasa. Nuestra hipótesis es que una estrategia invasiva para el anciano con fragilidad y IAMSEST mejorará el pronóstico. Métodos: Se trata de un estudio prospectivo, multicéntrico y aleatorizado que compara una estrategia invasiva frente a una conservadora en ancianos frágiles con IAMSEST. Los criterios de inclusión son: IAMSEST, edad ≥ 70 años y fragilidad definida por al menos 4 criterios de la escala Clinical Frailty Scale. Se aleatorizará a los participantes a una estrategia invasiva (coronariografía y revascularización si se considera anatómicamente indicada) o conservadora (tratamiento médico y coronariografía solo en caso de inestabilidad clínica persistente). El objetivo principal será el número de días vivo fuera del hospital durante el primer año. El objetivo coprincipal será el tiempo hasta la presentación de muerte cardiovascular, reinfarto agudo de miocardio o revascularización tras el alta. El tamaño de la muestra estimado es de 178 pacientes (89 por grupo), asumiendo un incremento del 20% en la proporción de días vivo fuera del hospital con la estrategia invasiva. Resultados: Los resultados del estudio aportarán información novedosa para el tratamiento del anciano frágil con IAMSEST. Conclusiones: Nuestra hipótesis es que una estrategia invasiva mejorará el pronóstico de los pacientes ancianos frágiles con IAMSEST. Si esta hipótesis se confirmara, la situación de fragilidad no debería disuadir al cardiólogo de indicar un tratamiento invasivo. Ensayo registrado en ClinicalTrials.gov (Identificador: NCT03208153)

Introduction and objectives: Although clinical guidelines recommend invasive management in non-ST-segment elevation myocardial infarction (NSTEMI), this strategy is underused in frail elderly patients in the real world. Furthermore, these patients are underrepresented in clinical trials and therefore the evidence is scarce. Our hypothesis is that an invasive strategy will improve prognosis in elderly frail patients with NSTEMI. Methods: This will be a prospective, multicenter, randomized trial, in which the conservative and invasive strategies will be compared in patients meeting all of the following inclusion criteria: NSTEMI diagnosis, age ≥ 70 years, and frailty defined by a category ≥ 4 in the Clinical Frailty Scale. Participants will be randomized to an invasive (coronary angiogram and revascularization if anatomically amenable) or conservative (medical treatment and coronary angiogram only if persistent clinical instability) strategy. The primary endpoint will be the number of days alive out of hospital during the first year. The coprimary endpoint will be the time until the first cardiac event (cardiac death, reinfarction or postdischarge revascularization). We estimate a sample size of 178 patients (89 per arm), considering an increase of 20% in the proportion of days alive out of hospital with the invasive management. Results: The results of this study will add important knowledge to inform the management of frail elderly patients hospitalized with NSTEMI. Conclusions: We hypothesize that the invasive strategy will improve outcomes in frail elderly patients with NSTEMI. If this is confirmed, frailty status should not dissuade physicians from implementing an invasive management strategy. Clinical trial registration: URL: http://www.clinicaltrials.gov .Identifier: NCT03208153

Invasive Versus Conservative Strategy in Frail Patients With NSTEMI: The MOSCA-FRAIL Clinical Trial Study Design.

INTRODUCTION AND OBJECTIVES: Although clinical guidelines recommend invasive management in non-ST-segment elevation myocardial infarction (NSTEMI), this strategy is underused in frail elderly patients in the real world. Furthermore, these patients are underrepresented in clinical trials and therefore the evidence is scarce. Our hypothesis is that an invasive strategy will improve prognosis in elderly frail patients with NSTEMI. METHODS: This will be a prospective, multicenter, randomized trial, in which the conservative and invasive strategies will be compared in patients meeting all of the following inclusion criteria: NSTEMI diagnosis, age ≥ 70 years, and frailty defined by a category ≥ 4 in the Clinical Frailty Scale. Participants will be randomized to an invasive (coronary angiogram and revascularization if anatomically amenable) or conservative (medical treatment and coronary angiogram only if persistent clinical instability) strategy. The primary endpoint will be the number of days alive out of hospital during the first year. The coprimary endpoint will be the time until the first cardiac event (cardiac death, reinfarction or postdischarge revascularization). We estimate a sample size of 178 patients (89 per arm), considering an increase of 20% in the proportion of days alive out of hospital with the invasive management. RESULTS: The results of this study will add important knowledge to inform the management of frail elderly patients hospitalized with NSTEMI. CONCLUSIONS: We hypothesize that the invasive strategy will improve outcomes in frail elderly patients with NSTEMI. If this is confirmed, frailty status should not dissuade physicians from implementing an invasive management strategy. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov.Identifier: NCT03208153.

Area strain from 3D speckle-tracking echocardiography as an independent predictor of early symptoms or ventricular dysfunction in asymptomatic severe mitral regurgitation with preserved ejection fraction.

The indication for surgery in asymptomatic severe mitral regurgitation (SMR) with preserved left ventricular ejection fraction (LVEF) is controversial. We sought to study 3D myocardial mechanics in this population and test 3D-speckle tracking (3DST) parameters as possible predictors of events. 45 asymptomatic patients with SMR and LVEF >60 % and 20 control individuals without cardiac disease underwent 3DST echocardiography. MR group additionally underwent further clinical monitoring. Dyspnea, LVEF under 60 %, or admissions for heart failure were considered as events. When compared with control group, MR group showed lower percentage of global 3D strain, (35.4 ± 9.1 vs. 43.9 ± 10.6; p = 0.003), lower radial strain, lower area change rate and higher end-diastolic volume. In a follow-up time of 23.2 ± 14.5 months we found 15 events (33.3 %). When comparing the remaining patients with this new-onset HF group we found significant differences in longitudinal strain (-17.9 ± 3.3 vs. -15.8 ± 2.1; p = 0.036), area strain (AS) (-48.6 ± 4.6 vs. -43.7 ± 6.2; p = 0.006), circumferential strain (-35.8 ± 4.7 vs. -31.8 ± 6.1; p = 0.034), 3D LVEF (67.1 ± 4.6 vs. 63.0 ± 7.4; p = 0.034) and E/E' index (13.5 ± 3.9 vs. 19.3 ± 9.5; p = 0.006). In multivariate Cox regression AS alone was the only independent predictor. A cutoff value of AS greater than -41.6 % reached a hazard ratio of 4.41 (p = 0.004) for prediction of events. In asymptomatic patients with SMR and preserved ejection fraction, 3DST derived AS is a promising tool for predicting the development of heart failure. This finding may be useful for guiding the selection of patients for early mitral valve repair/replacement surgery even if they are asymptomatic.

Trombosis arterial múltiple y resistencia a la antiagregación convencional / Multiple arterial thrombosis and resistance to conventional antiaggregation

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