Transaxillary implantation of the Impella CP mechanical circulatory support device as a bridge to heart transplant: first experience in Spain

Carta científic

In-hospital postoperative infection after heart transplantation: risk factors and development of a novel predictive score

[Abstract] Introduction: Infection is one of the most significant complications following heart transplantation (HT). The aim of this study was to identify specific risk factors for early postoperative infections in HT recipients, and to develop a multivariable predictive model to identify HT recipients at high risk. Methods: A single-center, observational, and retrospective study was conducted. The dependent variable was in-hospital postoperative infection. We examined demographic and epidemiological data from donors and recipients, surgical features, and adverse postoperative events as independent variables. Backwards, stepwise multivariable logistic regression with a P-value < 0.05 was used to identify clinical factors independently associated with the risk of in-hospital postoperative infections following HT. Results: Six hundred seventy-seven patients were included in this study. During the in-hospital postoperative period, 348 episodes of infection were diagnosed in 239 (35.9%) patients. Seven variables were identified as independent clinical predictors of early postoperative infection after HT: history of diabetes mellitus, previous sternotomy, preoperative mechanical ventilation, primary graft failure, major surgical bleeding, use of mycophenolate mofetil, and use of itraconazole. Based on the results of multivariable models, we constructed a 7-variable (8-point) score to predict the risk of in-hospital postoperative infection in HT recipients, which showed a reasonable ability to predict the risk of in-hospital postoperative infection in this population. Prospective external validation of this new score is warranted to confirm its clinical applicability. Conclusions: In-hospital postoperative infection is a common complication after HT, affecting 35% of patients who underwent this procedure at our institution. Diabetes mellitus, previous sternotomy, preoperative mechanical ventilation, primary graft failure, major surgical bleeding, use of mycophenolate mofetil, and itraconazole were all independent clinical predictors of early postoperative infection after HT

Estado serológico frente a Toxoplasma gondii en receptores de trasplante cardiaco: ¿un factor pronóstico independiente?

[Resumen] Introducción y objetivos. Analizar la influencia pronóstica del estado serológico frente a Toxoplasma gondii en receptores de trasplante cardiaco (TC). Métodos. Se realizó un estudio retrospectivo unicéntrico con 657 receptores de TC entre 1991 y 2015. Mediante dos modelos multivariantes de Cox se comparó la supervivencia y la incidencia de episodios clínicos adversos de los receptores seropositivos (n = 481) y los receptores seronegativos (n = 176) frente a T. gondii. El modelo 1 incluyó edad y sexo, y el modelo 2 incluyó otros factores de confusión potenciales. Resultados. Con una mediana de seguimiento de 2.903 días (rango intercuartílico: 898-4.757), fallecieron 250 pacientes seropositivos (52%) y 72 receptores seronegativos (41%) frente a T. gondii. Los pacientes seropositivos presentaron mayor mortalidad no ajustada tras el TC (hazard ratio [HR] = 1,31; intervalo de confianza del 95% [IC95%], 1,00-1,70). Tras el ajuste multivariante, este efecto perdió su significación estadística (modelo 1: HR = 1,09; IC95%, 0,83-1,43; modelo 2: HR = 1,12; IC95%, 0,85-1,47). La seropositividad frente a T. gondii del receptor se asoció de modo independiente con mayor riesgo de rechazo agudo (modelo 1: HR = 1,36; IC95%, 1,06-1,74; modelo 2: HR = 1,29; IC95%, 1,01-1,66). Los modelos multivariantes no pusieron de manifiesto una influencia significativa del estado serológico frente a T. gondii del receptor sobre la incidencia de infección, neoplasias, enfermedad vascular del injerto o el desenlace combinado muerte cardiaca o retrasplante. Tampoco se observó una influencia pronóstica significativa de la concordancia donante-receptor respecto al estado serológico frente a T. gondii. Conclusiones. El presente estudio no ha puesto de manifiesto un efecto pronóstico independiente del estado serológico frente a T. gondii en los receptores de TC

In-Hospital Post-Operative Infection after Heart Transplantation: Epidemiology, Clinical Management, and Outcome

Observational study[Abstract] Background: Infection is a major cause of morbidity and mortality after heart transplantation (HT). Little information about its importance in the immediate post-operative period is available. The aim of this study was to analyze the characteristics, incidence, and outcomes of in-hospital post-operative infections after HT. Methods: We conducted an observational, single-center study based on 677 adults who underwent HT from 1991 to 2015 and who survived the surgical intervention. In-hospital post-operative infections were identified retrospectively according to the medical finding in the clinical records. Results: Over a mean hospital stay of 24.5 days, 239 patients (35.3%) developed 348 episodes of infection (2 episodes per 100 patient-days). The most common sources of infection were those related to invasive procedures (respiratory infections, 115 [33%]; urinary tract infections, 47 [13.5%]; bacteremia, 42 [12.1%]; surgical site infections, 25 [7.2%]), in addition to abdominal focus (33, 9.5%). Enterobacteriaceae (76, 21.8%) and gram-positive cocci (58, 16.7%) were the predominant germs, although opportunistic infections were not infrequent (69, 19.8%). Ninety-five septic episodes were detected with a mean Sequential Organ Failure Assessment Score of 9.5 ± 5.3 points, with hemodynamic failure being the most severe organ dysfunction and renal dysfunction the most frequent one. Management included broad-spectrum antibiotics in 48.8% of episodes and surgical management in 13.8%. The overall antimicrobial success rate was 96.3%. Higher in-hospital mortality was observed among infected patients (15.1% vs. 10.3%), but this difference was not statistically significant (p = 0.067). The one-year survival and events were not different between patients suffering from a post-operative infection and those who did not. Conclusions: In-hospital infections were frequent in the post-operative period after HT and were associated with a poor short-term outcome. Patients who survived sepsis had a similar one-year morbidity and mortality compared with patients who did not develop an infection

Valor pronóstico del índice de riesgo nutricional en receptores de trasplante cardiaco

[Abstract] Introduction and objectives. To study the prognostic impact of preoperative nutritional status, as assessed through the nutritional risk index (NRI), on postoperative outcomes after heart transplantation (HT). Methods. We conducted a retrospective, single-center study of 574 patients who underwent HT from 1991 to 2014. Preoperative NRI was calculated as 1.519 × serum albumin (g/L) + 41.7 × (body weight [kg] / ideal body weight [kg]). The association between preoperative NRI and postoperative outcomes was analyzed by means of multivariable logistic regression and multivariable Cox regression. Results. Mean NRI before HT was 100.9 ± 9.9. According to this parameter, the prevalence of severe nutritional risk (NRI < 83.5), moderate nutritional risk (83.5 ≤ NRI < 97.5), and mild nutritional risk (97.5 ≤ NRI < 100) was 5%, 22%, and 10%, respectively. One year post-transplant mortality rates in these 4 categories were 18.2%, 25.3%, 7.9% and 10.2% (P < .001), respectively. The NRI was independently associated with a lower risk of postoperative infection (adjusted OR, 0.97; 95%CI, 0.95-1.00; P = .027) and prolonged postoperative ventilator support (adjusted OR, 0.96; 95%CI, 0.94-0.98; P = .001). Patients at moderate or severe nutritional risk had significantly higher 1-year post-HT mortality (adjusted HR, 1.55; 95%CI, 1.22-1.97; P < .001). Conclusions. Malnourished patients have a higher risk of postoperative complications and mortality after HT. Preoperative NRI determination may help to identify HT candidates who might benefit from nutritional intervention.[Resumen] Introducción y objetivos. Analizar el impacto del estado nutricional preoperatorio, evaluado mediante el índice de riesgo nutricional (IRN), en el pronóstico tras el trasplante cardiaco (TxC). Métodos. Se realizó un estudio retrospectivo de 574 pacientes que recibieron un TxC entre 1991 y 2014 en un centro. El IRN preoperatorio se calculó como 1,519 × albúmina (g/l) + 41,7 × (peso real [kg] / peso ideal [kg]). La asociación entre IRN preoperatorio y eventos clínicos posoperatorios se analizó mediante modelos multivariables de regresión logística y regresión de Cox. Resultados. El IRN preoperatorio medio de la población del estudio era de 100,9 ± 9,9. Según este parámetro, las prevalencias de riesgo nutricional grave (IRN < 83,5), moderado (83,5 ≤ IRN < 97,5) y leve (97,5 ≤ IRN < 100) antes del TxC eran el 5, el 22 y el 10% respectivamente. Las tasas de mortalidad a 1 año tras el TxC en estas 4 categorías fueron del 18,2, el 25,3, el 7,9 y el 10,2% (p < 0,001) respectivamente. El IRN preoperatorio resultó predictor independiente de menor riesgo de infección posoperatoria (odds ratio ajustada [ORa] = 0,97; intervalo de confianza del 95% [IC95%], 0,95-1,00; p = 0,027) y ventilación mecánica prolongada posoperatoria (ORa = 0,96; IC95%, 0,94-0,98; p = 0,001). Los pacientes con riesgo nutricional moderado a grave mostraron mayor mortalidad a 1 año tras el TxC (hazard ratio ajustada = 1,55; IC95%, 1,22-1,97; p < 0,001). Conclusiones. Los pacientes desnutridos tienen mayor riesgo de complicaciones posoperatorias y muerte tras el TxC. La determinación del IRN podría facilitar la identificación de candidatos a TxC que se beneficien de intervenciones nutricionales en espera del órgano

Usefulness of the INTERMACS scale for predicting outcomes after urgent heart transplantation

[Abstract] Introduction and objectives. Our aim was to assess the prognostic value of the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) scale in patients undergoing urgent heart transplantation (HT). Methods. Retrospective analysis of 111 patients treated with urgent HT at our institution from April, 1991 to October, 2009. Patients were retrospectively assigned to three levels of the INTERMACS scale according to their clinical status before HT. Results. Patients at the INTERMACS 1 level (n = 31) more frequently had ischemic heart disease (p = 0.03) and post-cardiothomy shock (p = 0.02) than patients at the INTERMACS 2 (n = 55) and INTERMACS 3-4 (n = 25) levels. Patients at the INTERMACS 1 level showed higher preoperative catecolamin doses (p = 0.001), a higher frequency of use of mechanical ventilation (p < 0.001), intraaortic balloon (p = 0.002) and ventricular assist devices (p = 0.002), and a higher frequency of preoperative infection (p = 0.015). The INTERMACS 1 group also presented higher central venous pressure (p = 0.02), AST (p = 0.002), ALT (p = 0.006) and serum creatinine (p < 0.001), and lower hemoglobin (p = 0.008) and creatinine clearance (p = 0.001). After HT, patients at the INTERMACS 1 level had a higher incidence of primary graft failure (p = 0.03) and postoperative need for renal replacement therapy (p = 0.004), and their long-term survival was lower than patients at the INTERMACS 2 (log rank 5.1, p = 0.023; HR 3.1, IC 95% 1.1-8.8) and INTERMACS 3-4 level (log rank 6.1, p = 0.013; HR 6.8, IC 95% 1.2-39.1). Conclusions. Our results suggest that the INTERMACS scale may be a useful tool to stratify postoperative prognosis after urgent HT.[Resumen] Introducción y objetivos. Analizar el valor pronóstico de la escala INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) en pacientes tratados con trasplante cardiaco urgente. Métodos. Análisis retrospectivo de 111 pacientes tratados con trasplante cardiaco urgente en nuestro centro entre abril de 1991 y octubre de 2009. Se asignó retrospectivamente a los pacientes a tres niveles de la escala INTERMACS en función de su situación clínica previa al trasplante cardiaco. Resultados. Los pacientes del grupo INTERMACS 1 (n = 31) presentaban mayor frecuencia de cardiopatía isquémica (p = 0,03) y shock tras cardiotomía (p = 0,02) que los pacientes del grupo INTERMACS 2 (n = 55) y los pacientes del grupo INTERMACS 3-4 (n = 25), así como mayores dosis de catecolaminas (p = 0,001), mayor empleo de ventilación mecánica (p < 0,001), balón de contrapulsación (p = 0,002) y dispositivos de asistencia ventricular (p = 0,002) y mayores tasas de infección preoperatoria (p = 0,015). El grupo INTERMACS 1 también mostraba mayores cifras de presión venosa central (p = 0,02), GOT (p = 0,002), GPT (p = 0,006) y creatinina (p < 0,001) y menores cifras de hemoglobina (p = 0,008) y aclaramiento de creatinina (p = 0,001). Tras el trasplante cardiaco, los pacientes del grupo INTERMACS 1 presentaron mayores incidencias de fracaso primario del injerto (p = 0,03) y necesidad de terapia de sustitución renal (p = 0,004), y su supervivencia a largo plazo fue menor que la de los pacientes de los grupos INTERMACS 2 (log rank = 5,1; p = 0,023; razón de riesgos [HR] = 3,1; intervalo de confianza [IC] del 95%, 1,4-6,8) e INTERMACS 3-4 (log rank = 6,1; p = 0,013; HR = 4; IC del 95%, 1,3-12,3). Conclusiones. Nuestros resultados indican que la escala INTERMACS resulta útil para estratificar el pronóstico postoperatorio tras el trasplante cardiaco urgente

Galectina-3 circulante tras el trasplante cardiaco: dinámica a largo plazo y valor pronóstico

[Abstract] Introduction and objectives: Circulating galectin-3 (Gal-3) is elevated and significantly correlates with all-cause and cardiovascular mortality in patients with heart failure. However, the relationship between serum Gal-3 and heart transplant (HT) outcomes is unclear. The aim of this study was to describe the longitudinal trend and prognostic value of Gal-3 levels after HT. Methods: Banked serum samples were available from 122 HT recipients, collected before transplant and at 1, 3, 6, and 12 months posttransplant. Gal-3 levels in these serum samples were measured by enzyme immune assay. Multivariable Cox regression was performed to determine the prognostic value of 12-month posttransplant Gal-3 serum levels. The primary endpoint was the composite variable all-cause death or graft failure over long-term posttransplant follow-up. Results: Circulating Gal-3 concentration steadily decreased during the first year after HT (median values: pretransplant, 19.1 ng/mL; 1-year posttransplant, 14.6 ng/mL; P<.001). Circulating Gal-3 levels 1-year posttransplant were associated with an increased risk of all-cause death or graft failure (adjusted HR per 1 ng/mL, 1.04; 95%CI, 1.01-1.08; P=.008). The predictive accuracy of this biomarker was moderate: area under the ROC curve, 0.72 (95%CI, 0.60-0.82; P<.001). Conclusions: Circulating Gal-3 steadily decreased during the first year after HT. However, 1-year posttransplant Gal-3 serum levels that remained elevated were associated with increased long-term risk of death and graft failure.[Resumen] Introducción y objetivos. Los valores plasmáticos de galectina-3 (Gal-3) están elevados y se correlacionan con la mortalidad total y cardiovascular en pacientes con insuficiencia cardiaca, pero su correlación con el pronóstico tras el trasplante cardiaco (TxC) es desconocida. El objetivo fue describir la tendencia evolutiva y el valor pronóstico de este biomarcador tras el TxC. Métodos. Mediante enzimoinmunoensayo, se midieron las concentraciones plasmáticas de Gal-3 en muestras de suero de 122 receptores de TxC, antes y 1, 3, 6 y 12 meses después de este. Mediante regresión de Cox se analizó el valor pronóstico del valor plasmático de Gal-3 a los 12 meses del TxC. El objetivo primario del estudio fue la variable combinada muerte o disfunción del injerto. Resultados. Las concentraciones de Gal-3 disminuyeron progresivamente durante el primer año tras el TxC (medianas: pretrasplante, 19,1 ng/ml; 1 año postrasplante, 14,6 ng/ml; p < 0,001). Los valores de Gal-3 1 año tras el TxC se asociaron con mayor riesgo de muerte o disfunción del injerto (HR por 1 ng/ml: 1.04; IC95%: 1,01-1,08; p = 0,008). La capacidad predictiva del biomarcardor fue moderada: área bajo la curva ROC, 0,72 (IC95%: 0,60-0,82; p < 0,001). Conclusiones. Las concentraciones plasmáticas de Gal-3 disminuyeron progresivamente durante el primer año tras el TxC. Un valor plasmático elevado de Gal-3 1 año tras el TxC se correlacionó con un pronóstico adverso.Instituto de Salud Carlos III; PI12/0267

Complicaciones infecciosas relacionadas con la asistencia circulatoria mecánica de corta duración en candidatos a trasplante cardiaco urgente

[Abstract] Introduction and objectives. Short-term mechanical circulatory support is frequently used as a bridge to heart transplant in Spain. The epidemiology and prognostic impact of infectious complications in these patients are unknown. Methods. Systematic description of the epidemiology of infectious complications and analysis of their prognostic impact in a multicenter, retrospective registry of patients treated with short-term mechanical devices as a bridge to urgent heart transplant from 2010 to 2015 in 16 Spanish hospitals. Results. We studied 249 patients, of which 87 (34.9%) had a total of 102 infections. The most frequent site was the respiratory tract (n = 47; 46.1%). Microbiological confirmation was obtained in 78 (76.5%) episodes, with a total of 100 causative agents, showing a predominance of gram-negative bacteria (n = 58, 58%). Compared with patients without infection, those with infectious complications showed higher mortality during the support period (25.3% vs 12.3%, P = .009) and a lower probability of receiving a transplant (73.6% vs 85.2%, P = .025). In-hospital posttransplant mortality was similar in the 2 groups (with infection: 28.3%; without infection: 23.4%; P = .471). Conclusions. Patients supported with temporary devices as a bridge to heart transplant are exposed to a high risk of infectious complications, which are associated with higher mortality during the organ waiting period.[Resumen] Introducción y objetivos. El uso de dispositivos de asistencia circulatoria mecánica de corta duración como puente a trasplante es frecuente en España. Se desconocen la epidemiología y la repercusión de las complicaciones infecciosas en estos pacientes. Métodos. Descripción sistemática de la epidemiología y análisis de la repercusión pronóstica de las complicaciones infecciosas en un registro multicéntrico retrospectivo de pacientes tratados con dispositivos de asistencia circulatoria mecánica de corta duración como puente a trasplante cardiaco urgente entre 2010 y 2015 en 16 hospitales españoles. Resultados. Se estudió a 249 pacientes; 87 (34,9%) de ellos tuvieron un total de 102 infecciones. La vía respiratoria fue la localización más frecuente (n = 47; 46,1%). En 78 casos (76,5%) se obtuvo confirmación microbiológica; se aislaron en total 100 gérmenes causales, con predominio de bacterias gramnegativas (n = 58, 58%). Los pacientes con complicaciones infecciosas presentaron mayor mortalidad durante el periodo de asistencia circulatoria mecánica (el 25,3 frente al 12,3%; p = 0,009) y menor probabilidad de recibir un trasplante (el 73,6 frente al 85,2%; p = 0,025) que los pacientes sin infección. La mortalidad posoperatoria tras el trasplante fue similar en ambos grupos (con infección, el 28,3%; sin infección, el 23,4%; p = 0,471). Conclusiones. Los pacientes tratados con dispositivos de asistencia circulatoria mecánica de corta duración como puente al trasplante cardiaco están expuestos a un alto riesgo de complicaciones infecciosas, las cuales se asocian con una mayor mortalidad en espera del órgano

Axillary implantation of Impella CP allows early rehabilitation of patients in cardiogenic shock bridged to heart transplantation

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