Invasive Treatment Strategy in Adults With Frailty and Non-ST-Segment Elevation Myocardial Infarction: A Secondary Analysis of a Randomized Clinical Trial.

Importance: The MOSCA-FRAIL randomized clinical trial compared invasive and conservative treatment strategies in patients with frailty with non-ST-segment elevation myocardial infarction (NSTEMI). It showed no differences in the number of days alive and out of the hospital at 1 year. Objective: To assess the outcomes of the MOSCA-FRAIL trial during extended follow-up. Design, Setting, and Participants: The MOSCA-FRAIL randomized clinical trial was conducted at 13 hospitals in Spain between July 7, 2017, and January 9, 2021, and included 167 adults (aged ≥70 years) with frailty (Clinical Frailty Scale score ≥4) and NSTEMI. In this preplanned secondary analysis, follow-up was extended to January 31, 2023. Data analysis was performed from April 5 to 29, 2023, using the intention-to-treat principle. Interventions: Patients were randomized to a routine invasive (coronary angiography and revascularization if feasible [n = 84]) or a conservative (medical treatment with coronary angiography only if recurrent ischemia [n = 83]) strategy. Main outcomes and measures: The primary end point was the difference in restricted mean survival time (RMST). Secondary end points included readmissions for any cause, considering recurrent readmissions. Results: Among the 167 patients included in the analysis, the mean (SD) age was 86 (5) years; 79 (47.3%) were men and 88 (52.7%) were women. A total of 93 deaths and 367 readmissions accrued. The RMST for all-cause death over the entire follow-up was 3.13 (95% CI, 2.72-3.60) years in the invasive and 3.06 (95% CI, 2.84-3.32) years in the conservative treatment groups. The RMST analysis showed inconclusive differences in survival time (invasive minus conservative difference, 28 [95% CI, -188 to 230] days). Patients under invasive treatment tended to have shorter survival in the first year (-28 [95% CI, -63 to 7] days), which improved after the first year (192 [95% CI, 90-230] days). Kaplan-Meier mortality curves intersected, displaying higher mortality to 1 year in the invasive group that shifted to a late benefit (landmark analysis hazard ratio, 0.58 [95% CI, 0.33-0.99]; P = .045). Early harm was more evident in the subgroup with a Clinical Frailty Scale score greater than 4. No differences were found for the secondary end points. Conclusions and Relevance: In this extended follow-up of a randomized clinical trial of patients with frailty and NSTEMI, an invasive treatment strategy did not improve outcomes at a median follow-up of 1113 (IQR, 443-1441) days. However, a differential distribution of deaths was observed, with early harm followed by later benefit. The phenomenon of depletion of susceptible patients may be responsible for this behavior. Trial registration: ClinicalTrials.gov Identifier: NCT03208153.

Effect of Routine Invasive vs Conservative Strategy in Older Adults With Frailty and Non-ST-Segment Elevation Acute Myocardial Infarction: A Randomized Clinical Trial.

Importance: To our knowledge, no randomized clinical trial has compared the invasive and conservative strategies in frail, older patients with non-ST-segment elevation acute myocardial infarction (NSTEMI). Objective: To compare outcomes of invasive and conservative strategies in frail, older patients with NSTEMI at 1 year. Design, Setting, and Participants: This multicenter randomized clinical trial was conducted at 13 Spanish hospitals between July 7, 2017, and January 9, 2021, and included 167 older adult (≥70 years) patients with frailty (Clinical Frailty Scale score ≥4) and NSTEMI. Data analysis was performed from April 2022 to June 2022. Interventions: Patients were randomized to routine invasive (coronary angiography and revascularization if feasible; n = 84) or conservative (medical treatment with coronary angiography for recurrent ischemia; n = 83) strategy. Main Outcomes and Measures: The primary end point was the number of days alive and out of the hospital (DAOH) from discharge to 1 year. The coprimary end point was the composite of cardiac death, reinfarction, or postdischarge revascularization. Results: The study was prematurely stopped due to the COVID-19 pandemic when 95% of the calculated sample size had been enrolled. Among the 167 patients included, the mean (SD) age was 86 (5) years, and mean (SD) Clinical Frailty Scale score was 5 (1). While not statistically different, DAOH were about 1 month (28 days; 95% CI, -7 to 62) greater for patients managed conservatively (312 days; 95% CI, 289 to 335) vs patients managed invasively (284 days; 95% CI, 255 to 311; P = .12). A sensitivity analysis stratified by sex did not show differences. In addition, we found no differences in all-cause mortality (hazard ratio, 1.45; 95% CI, 0.74-2.85; P = .28). There was a 28-day shorter survival in the invasive vs conservatively managed group (95% CI, -63 to 7 days; restricted mean survival time analysis). Noncardiac reasons accounted for 56% of the readmissions. There were no differences in the number of readmissions or days spent in the hospital after discharge between groups. Neither were there differences in the coprimary end point of ischemic cardiac events (subdistribution hazard ratio, 0.92; 95% CI, 0.54-1.57; P = .78). Conclusions and Relevance: In this randomized clinical trial of NSTEMI in frail older patients, there was no benefit to a routine invasive strategy in DAOH during the first year. Based on these findings, a policy of medical management and watchful observation is recommended for older patients with frailty and NSTEMI. Trial Registration: ClinicalTrials.gov Identifier: NCT03208153.

Infective endocarditis in patients with solid organ transplantation. A nationwide descriptive study.

BACKGROUND: Solid organ transplantation (SOT) implies immunosuppression and frequent health care contact. Our aim was to compare the characteristics of patients with infective endocarditis (IE) and SOT against those without SOT. METHODS: We used data from the Spanish Collaboration on Endocarditis during the period 2008-2018. RESULTS: We identified 4794 cases of IE, 85 (1.8%) in SOT (56 kidney, 18 liver, 8 heart, 3 lung). Thirteen patients with other transplantation types (bone marrow, hematopoietic precursors, and cornea) were excluded from the analysis. Compared with patients without SOT, patients with SOT had lower median age (61 vs. 69 years, p<0.001), more comorbidities (mean age-adjusted Charlson index 5.7±2.9 vs. 4.9±2.9, p=0.004), a lower prevalence of native valvular heart disease (29.4 vs. 45.4%, p=0.003), more in-hospital and healthcare-related IE (70.5% vs. 36.3%, p<0.001) and staphylococcal etiology (57.7% vs. 39.7%, p=0.001). Patients with SOT had more frequent kidney function worsening (47.1% vs. 34.6%, p=0.02), septic shock (25.9% vs. 12.1 %, p<0.001), sepsis (27.1% vs. 17.2%, p=0.02), and less surgery indication (54.1% vs 66.3%, p=0.02) and surgery (32.9% vs. 46.3%, p=0.01) than patients without SOT. There were no significant differences in mortality: inhospital (30.6% SOT vs. 25.6% without SOT, p=0.31), 1-year (38.8% SOT vs. 31.9% without SOT, p=0.18). CONCLUSIONS: Most IE in SOT recipients are nosocomial and over 70% are health care-related. Half have previously normal heart valves and almost 60% are due to Staphylococcus spp. infections. Mortality seems to be similar to non-SOT counterparts.

Diagnosis, prevention, and management of delirium in the intensive cardiac care unit.

Delirium is a frequent complication in patients admitted to intensive cardiac care units (ICCU) with potentially severe consequences including increased risks of mortality, cognitive impairment and dependence at discharge, and longer times on mechanical ventilation and hospital stay. Delirium has been widely documented and studied in general intensive care units and in patients after cardiac surgery, but it has barely been studied in acute nonsurgical cardiac patients. Moreover, delirium (especially in its hypoactive form) is commonly misdiagnosed. We propose a protocol for delirium prevention and management in ICCUs. A daily comprehensive assessment to improve detection should be done using validated scales (ie, confusion assessment method). Preventive measures are particularly relevance and constitute the basis of treatment as well, acting on reversible risk factors, including environmental interventions, such as quiet time, sleep promotion, family support, communication, and adequate treatment of pain and dyspnea. Pharmacological prophylaxis is not indicated with the exception of patients at risk of withdrawal syndrome but should only be used in patients with confirmed delirium. Dexmedetomidine is the drug of choice in patients with severe agitation, and those weaning from invasive mechanical ventilation. As the complexity of ICCUs increases, clinical scenarios posing challenges for the management of delirium become more frequent. Efforts should be done to improve the identification of patients at risk during admission in order to establish preventive interventions to avoid this complication. Patient-centered protocols will increase the awareness of the healthcare professionals for better prevention and earlier diagnosis and will positively impact on prognosis.

Temporal Trends in Mechanical Complications of Acute Myocardial Infarction in the Elderly.

BACKGROUND: Reperfusion therapy led to an important decline in mortality after ST-segment elevation myocardial infarction (STEMI). Because the rate of cardiogenic shock has not changed dramatically, the authors speculated that a reduction in the incidence or fatality rate of mechanical complications (MCs), the second cause of death in these patients, could explain this decrease. OBJECTIVES: This study sought to assess time trends in the incidence, management, and fatality rates of MC, and its influence on short-term mortality in old patients with STEMI. METHODS: Trends in the incidence and outcomes of MC between 1988 and 2008 were analyzed by Mantel-Haenszel linear association test in 1,393 consecutive patients ≥75 years of age with first STEMI. RESULTS: Overall in-hospital mortality decreased from 34.3% to 13.4% (relative risk reduction, 61%; p < 0.001). Although the absolute mortality due to MC decreased from 9.6% to 3.3% (p < 0.001), the proportion of deaths due to MC among all deaths did not change (28.1% to 24.5%; p = 0.53). The incidence of MC decreased from 11.1% to 4.3% (relative risk reduction 61%) with no change in their hospital fatality rate over time (from 87.1% to 82.4%; p = 0.66). The proportion of patients undergoing surgical repair decreased from 45.2% to 17.6% (p = 0.04), with no differences in post-operative survival (from 28.6% to 33.3%; p = 0.74). CONCLUSIONS: Although the incidence of MC has decreased substantially since the initiation of reperfusion therapy in elderly STEMI patients, this reduction was proportional to other causes of death and was not accompanied by an improvement in fatality rates, with or without surgery. MCs are less frequent but remain catastrophic complications of STEMI in these patients.

Pérdida de estimulación biventricular continua en pacientes con terapia de resincronización cardiaca: incidencia, causas y resultados / Loss of continuous biventricular pacing in cardiac resynchronization therapy patients: incidence, causes, and outcomes

Introducción y objetivos. En los últimos años se ha asistido a un gran aumento en el número de implantes de dispositivos cardiacos con terapia de resincronización cardiaca. Los beneficios obtenidos con dicha terapia están directamente relacionados con el mantenimiento de la estimulación biventricular continua. Este trabajo analiza la incidencia de pérdida de estimulación biventricular, sus causas, la actitud adoptada y los resultados. Métodos. Se analizaron los datos clínicos y de seguimiento de una serie de pacientes consecutivos de un centro a los que se implantó un dispositivo con terapia de resincronización cardiaca. Resultados. Se estudió a un total de 136 pacientes. Durante un seguimiento medio de 33,4 meses, 45 pacientes (33%) sufrieron pérdida de estimulación biventricular continua. Las causas más frecuentes fueron las taquiarritmias auriculares (21,3%), seguidas de la dislocación de cables (18%) y el fallo de captura del cable de ventrículo izquierdo (13,1%). La pérdida de estimulación biventricular continua fue transitoria y corregible en la mayoría (88,5%) de los casos y ocurrió más precozmente en los casos de dislocación de cables, sobresensado y estimulación extracardiaca. No hubo diferencias significativas de mortalidad entre los grupos de pacientes con y sin pérdida de estimulación biventricular continua (p=0,88). Conclusiones. Pese a los avances técnicos en la terapia de resincronización cardiaca, la pérdida de la estimulación biventricular continua es una situación clínica frecuente pero corregible en la mayoría de los casos. Un seguimiento estrecho de los pacientes y una actitud proactiva garantizan lograr la estimulación biventricular continua en la mayoría de los pacientes (AU)

Introduction and objectives. In recent years, implantation of cardiac resynchronization therapy devices has significantly increased. The benefits of this therapy are directly related to the maintenance of continuous biventricular pacing. This study analyzed the incidence, causes, and outcomes of loss of continuous biventricular pacing, and the approach adopted. Methods. We analyzed the clinical and follow-up data of a series of consecutive patients from a single center who underwent implantation of a cardiac resynchronization therapy device. Results. The study included 136 patients. During a mean follow-up of 33.4 months, loss of continuous biventricular pacing occurred in 45 patients (33%). The most common causes included atrial tachyarrhythmias (21.3%), lead macrodislodgement (18%), and loss of left ventricular capture (13.1%). In most patients (88.5%), loss of continuous biventricular pacing was transient and correctable, and occurred earlier in the follow-up when the cause was lead macrodislodgement, oversensing, or extracardiac stimulation. There were no significant differences in mortality between patients with and without loss of continuous biventricular pacing (P=.88). Conclusions. Despite technical advances in cardiac resynchronization therapy, loss of continuous biventricular pacing is common; however, this loss can usually be corrected. In most patients, continuous biventricular pacing can be ensured by close monitoring and follow-up and a proactive approach (AU)

Right atrial indexed volume in healthy adult population: reference values for two-dimensional and three-dimensional echocardiographic measurements.

BACKGROUND: Current guidelines do not recommend routine assessment of right atrial volume due to the lack of standardized data. Three-dimensional wall-motion tracking (3D-WMT) is a new technology that allows us to calculate volumes without any geometric assumptions. The aim of this study was to define the indexed reference values for two-dimensional echocardiography (2D-echo) and 3D-WMT in adult healthy population and to assess the intermethod, intra- and interobserver agreement. METHODS: Prospective study. Nonselected healthy subjects were enrolled. Every patient underwent a 2D-echo and a 3D-WMT examination. 2D-echo right atrial volume was obtained by using the area-length method (A-L) from four- and two-chamber view. 3D-echo volumes were assessed by 3D-WMT. Values were indexed by the patient's body surface area. RESULTS: Sixty consecutive healthy subjects were enrolled. Mean age was 57 ± 12-years old and 27 patients (45%) were male. Average indexed right atrial volume obtained by 2D-echo and 3D-echo was 16.76 ± 8.15 mL/m(2) and 19.05 ± 6.87 mL/m(2) , respectively. Univariate linear regression analysis between 2D-echo and 3D-echo right atrial volumes shows a weak correlation between right atrial volume obtained with 2D-echo compared with 3D-WMT (r = 0.29, CI 95% 0.029-0.66, P = 0.033). The agreement analysis shows a similar result (intraclass correlation coefficient [ICC] = 0.28). The intra- and interobserver agreement analysis showed a better agreement when using 3D-WMT. CONCLUSIONS: This is the first study that reports the reference indexed right atrial volume values by means of 2D-echo and 3D-echo in healthy population. 3D-WMT is a feasible and reproducible method to determine right atrial volume.

Loss of continuous biventricular pacing in cardiac resynchronization therapy patients: incidence, causes, and outcomes.

INTRODUCTION AND OBJECTIVES: In recent years, implantation of cardiac resynchronization therapy devices has significantly increased. The benefits of this therapy are directly related to the maintenance of continuous biventricular pacing. This study analyzed the incidence, causes, and outcomes of loss of continuous biventricular pacing, and the approach adopted. METHODS: We analyzed the clinical and follow-up data of a series of consecutive patients from a single center who underwent implantation of a cardiac resynchronization therapy device. RESULTS: The study included 136 patients. During a mean follow-up of 33.4 months, loss of continuous biventricular pacing occurred in 45 patients (33%). The most common causes included atrial tachyarrhythmias (21.3%), lead macrodislodgement (18%), and loss of left ventricular capture (13.1%). In most patients (88.5%), loss of continuous biventricular pacing was transient and correctable, and occurred earlier in the follow-up when the cause was lead macrodislodgement, oversensing, or extracardiac stimulation. There were no significant differences in mortality between patients with and without loss of continuous biventricular pacing (P=.88). CONCLUSIONS: Despite technical advances in cardiac resynchronization therapy, loss of continuous biventricular pacing is common; however, this loss can usually be corrected. In most patients, continuous biventricular pacing can be ensured by close monitoring and follow-up and a proactive approach.

Presentación fatal de un mixoma cardiaco / Fatal presentation of a cardiac myxoma

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Endocarditis trombótica no bacteriana e insuficiencia valvular aórtica grave. Resolución tras quimioterapia / Nonbacterial thrombotic endocarditis and severe aortic valve regurgitation. Resolution after chemotherapy

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Electrodo de desfibrilación Sprint Fidelis: experiencia de nueve centros en España / Sprint Fidelis Defibrillation Lead: a nine-center experience in Spain

Introducción y objetivos. Los electrodos de desfibrilación Sprint Fidelis presentan riesgo de disfunción precoz. La mayor parte de las series en la literatura provienen de un solo centro. Describimos la experiencia clínica en nueve centros españoles. Métodos. Se analizaron los datos clínicos, del implante y el seguimiento de todos los pacientes con un electrodo Sprint Fidelis, describiendo los casos problema, calculando la supervivencia del electrodo a medio plazo e identificando posibles predictores de disfunción. Resultados. Se incluyó un total de 378 electrodos en 376 pacientes (el 85,7% varones), con una media de edad de 64,9±13,6 años. El 59,8% se implantó en pacientes con cardiopatía isquémica. La fracción de eyección ventricular izquierda era 33,4%±14,5%. En el 74,8% de los casos se implantó por punción subclavia izquierda. Tras un seguimiento medio de 30,9±14 meses, 16 pacientes presentaron disfunción del electrodo; la supervivencia a 36 meses fue del 96,1%. En 11 electrodos ocurrió una disfunción aislada del sistema de sensado/estimulación; en 3, del sistema de alta energía, y en 2, de ambos. Una mejor función ventricular se asoció con una mayor probabilidad de fractura del electrodo (el 42,4%±16% frente al 33%±14,3%; p=0,011); tres centros presentaron una tasa de fracturas superior al 10% y los seis restantes, inferior al 5%. Conclusiones. En esta serie multicéntrica de 378 electrodos, la supervivencia estimada a 3 años resultó mayor que en series previas, con un perfil de presentación clínica similar de las disfunciones. La fracción de eyección ventricular izquierda y el centro implantador fueron variables asociadas a la presencia de disfunción (AU)

Introduction and objectives. Sprint Fidelis defibrillation leads are prone to early failure. Most of the reported series come from a single institution. This paper describes the clinical experience in nine Spanish hospitals. Methods. Clinical, implant, and follow-up data of all patients with a Sprint Fidelis lead were analyzed. All cases of lead failure were identified, medium-term lead survival was calculated, and possible predictors for lead failure were determined. Results. In total, 378 leads in 376 patients were studied. The mean age (male 85.7%) was 64.9±13.6years. The majority of patients (59.8%) had ischemic heart disease. Mean left ventricular ejection fraction was 33.4%±14.5%. Left subclavian vein puncture was used in 74.8%. During a mean follow-up of 30.9±14 months, 16 lead failures have occurred, with a lead survival of 96.1% at 36 months after implantation. Eleven of 16 lead failures were caused by failure of pace/sense conductors, 3 by defects in the high-voltage conductor, and 2 by defects in both types of conductors. A less depressed left ventricular ejection fraction was associated with an increased probability of lead failure (42.4%±16% vs. 33%±14.3%; P=.011). Three hospitals presented a rate of lead failure higher than 10%; the rate was less than 5% in the remaining 6 hospitals. Conclusions. In this multicenter series of 378 leads, the 3-year estimated survival was higher than that reported in prior series. Clinical presentation of lead failures was similar to that reported previously. Left ventricular ejection fraction and hospital of implantation were variables associated to lead failure (AU)

[Sprint fidelis defibrillation lead: a nine-center experience in Spain]. / Electrodo de desfibrilación Sprint Fidelis: experiencia de nueve centros en España.

INTRODUCTION AND OBJECTIVES: Sprint Fidelis defibrillation leads are prone to early failure. Most of the reported series come from a single institution. This paper describes the clinical experience in nine Spanish hospitals. METHODS: Clinical, implant, and follow-up data of all patients with a Sprint Fidelis lead were analyzed. All cases of lead failure were identified, medium-term lead survival was calculated, and possible predictors for lead failure were determined. RESULTS: In total, 378 leads in 376 patients were studied. The mean age (male 85.7%) was 64.9 ± 13.6 years. The majority of patients (59.8%) had ischemic heart disease. Mean left ventricular ejection fraction was 33.4% ± 14.5%. Left subclavian vein puncture was used in 74.8%. During a mean follow-up of 30.9 ± 14 months, 16 lead failures have occurred, with a lead survival of 96.1% at 36 months after implantation. Eleven of 16 lead failures were caused by failure of pace/sense conductors, 3 by defects in the high-voltage conductor, and 2 by defects in both types of conductors. A less depressed left ventricular ejection fraction was associated with an increased probability of lead failure (42.4% ± 16% vs. 33% ± 14.3%; P =.011). Three hospitals presented a rate of lead failure higher than 10%; the rate was less than 5% in the remaining 6 hospitals. CONCLUSIONS: In this multicenter series of 378 leads, the 3-year estimated survival was higher than that reported in prior series. Clinical presentation of lead failures was similar to that reported previously. Left ventricular ejection fraction and hospital of implantation were variables associated to lead failure.